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Bureau of Consumer Financial Protection.
Notice of policy.
The Bureau of Consumer Financial Protection (Bureau) is issuing its Policy to Encourage Trial Disclosure Programs (Policy), which is intended to carry out the Bureau's authority under of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act).
The Policy is effective on October 29, 2013.
For additional information about the Policy, contact Will Wade-Gery, Division of Research, Markets and Regulations, Consumer Financial Protection Bureau, at (202) 435–7700.
In subsection 1032(e) of the Dodd-Frank Act, 12 U.S.C. 5532(e), Congress gave the Bureau authority to provide certain legal protections to companies to conduct trial disclosure programs. This authority can be used to help further the Bureau's statutory objective, stated in subsection 1021(b)(5) of the Act, to “facilitate access and innovation” in the “markets for consumer financial products and services.”
In line with this authority, the Bureau is publishing the Policy that is laid out in full in the final section of this Notice. Under its terms, if the Bureau approves a specific trial, then, for the duration of an agreed testing period, the Bureau will deem a testing company's disclosure, to the extent that it is used in accordance with the terms and conditions approved by the Bureau, to be in compliance with, or hold it exempt from, applicable federal disclosure requirements. The Bureau believes that there may be significant opportunities to enhance consumer protection by facilitating innovation in financial products and services and enabling companies to research informative, cost-effective disclosures. The Bureau also recognizes that in-market testing, involving companies and consumers in real world situations, may offer particularly valuable information with which to improve disclosure rules and model forms.
On December 17, 2012, the Bureau published a notice inviting the general public and other Federal agencies to comment on any aspect of its proposed Policy to Encourage Trial Disclosure Programs (the Proposed Policy).
All commenters supported the stated goals of the Proposed Policy. Most comments asked for clarification or further detailing around specific parts of the Proposed Policy. Some urged changes to the Proposed Policy either to create more incentives for the regulated community to participate in trial disclosure programs or to provide for additional consumer protections in approved tests. One comment opposed implementation of the Proposed Policy, at least in its current form; this commenter also disputed the Bureau's legal authority for certain aspects of the Proposed Policy.
This section provides a summary of the comments received by subject matter. It also summarizes the Bureau's assessment of the comments by subject matter and, where applicable, describes the resulting changes that the Bureau is making in the final Policy. With some specific exceptions, the Bureau has not made changes to the substance of the Policy. In response to certain comments, however, it has revised the Policy to provide additional clarity and elaboration around a number of specific points.
As noted in the Proposed Policy, Section 1032(e) of the Dodd-Frank Act gives the Bureau authority to permit trial programs that are designed to “improve upon” existing disclosures. One consumer group contended that the Proposed Policy exceeds the Bureau's legal authority in two respects: (1) By not requiring trial disclosure programs to meet the criteria for model forms prescribed by the Bureau under Section 5532(b) of the Act, 12 U.S.C. 5532(b); and (2) by potentially permitting trial disclosure programs that are designed to test cost savings alone. The Bureau believes both contentions lack legal merit.
Section 5532(b)(1) authorizes the Bureau to issue model forms that “may be used at the option of a covered person.” Section 5532(b)(2) sets forth three “minimum” features such model forms must possess. These provisions do not limit the trial disclosures that the Bureau may approve under Section 5532(e). In that provision, Congress gave the Bureau authority to permit testing of disclosures that violate disclosure requirements imposed directly on covered persons by the Bureau. There is no textual or other reason to think that Congress intended the Bureau's authority under Section 5532(e) to be circumscribed by Section 5532(b).
Indeed, adding the Section 5532(b)(2) criteria to the Policy arguably would frustrate Congress' purposes in enacting Section 5532(e). Thus, a proposal to change a delivery mechanism, as opposed to the content of the disclosure, would not track against the criteria for a model form. Yet there is nothing in Section 1032(e) to suggest that Congress intended to exclude changed delivery mechanisms from the list of potential improvements. As a matter of policy, however, to the extent a proposal includes revised disclosures, the Bureau believes those should meet the stated 1032(b)(2) criteria of plain language, clear format and design, and
The Bureau also sees no legal or policy reason to eliminate cost-effectiveness as a sufficient criterion for an “improved” disclosure. In the Bureau's view, a trial disclosure that is intended to maintain the same level of consumer understanding but in a more cost effective manner counts as an improved disclosure. Under the Policy, however, the Bureau will not approve any trial disclosure that it believes will weaken consumer understanding of valuable information that is the focus of a regulatory obligation. That outcome is not one that the Policy is intended to enable, and the Bureau has revised the Policy to make that clear.
Most comments concerned the approval process for trial disclosure programs. Comments focused on the areas identified below.
Several trade associations and financial services companies questioned whether, in light of the costs involved in designing and implementing trial disclosure programs, companies will have sufficient incentive to use the Policy. For the most part, however, these commenters did not urge more streamlined application or participation procedures. Instead, they requested a clear indication from the Bureau that several covered persons—potentially facilitated by a trade organization—may properly spread the costs of participation among themselves, thereby improving the incentive to participate. Some trade associations noted that absent such collaboration, industry participants would lack the resources to conduct a trial program.
The Bureau would welcome collaboration and cost-sharing, and it has clarified the final Policy to this effect. To help ensure adequate protection for consumers, however, the Bureau must know the identity of each specific in-market tester before approving that entity's participation. As a result, the Bureau will not give final approval to any proposed trial disclosure unless the entities involved are specifically identified. At the same time, however, the Bureau sees no reason why a single trial disclosure program may not properly be proposed and implemented by more than one covered person. In fact, as both industry and consumer commenters noted, multi-party tests may offer more robust and reliable results. By the same token, the Policy should not be read to prevent a trade association—or indeed any other entity, including non-profit groups or third-party vendors—from helping to facilitate cost-spreading.
In addition, the Policy does not rule out the possibility of the Bureau conditionally approving a particular disclosure for testing without at that point requiring the specific identity of all participants. In this kind of staggered approval arrangement, there would be a follow-on process for specific testers to secure approval to use the disclosure. But even if the Bureau were to stage approval in this manner, the Policy would still not permit a particular tester to claim the benefit of a waiver unless the Bureau ultimately approves it
Citing the costs of developing a proposal and implementing a trial disclosure program, several commenters urged the Bureau to permit covered persons to contact the Bureau to discuss a proposal before they submit complete applications. This initial contact could help companies avoid the costs of developing proposals that are unlikely to meet with the Bureau's approval, whether because of the merits of the proposal or because the Bureau is close to approving a duplicative proposal. The Policy is not intended to limit this kind of initial contact. The present Policy is one component part of the Bureau's Project Catalyst initiative, which invites companies to bring innovation-related concerns to the Bureau's attention at
Several commenters, including industry and consumer group commenters, suggested that the Policy accommodate iterative testing of disclosures. The Bureau acknowledges that in some cases, iterative testing, using relatively small test populations, may help refine and improve disclosure concepts. Instead of a single, larger test, of a preset disclosure, this kind of approach involves a sequence of smaller tests that enable ongoing improvements to a test disclosure concept. Both forms of testing may serve well in different contexts, and the Bureau intends for the Policy to support both approaches.
In cases where iterative testing is appropriate, therefore, the Bureau will follow a staggered approach to waiver approval. At an initial stage, an iterative proposal should follow all the normal terms of the Policy, with the exception that it may not include all forms of the disclosure to be tested, to the extent that these are unknown at the point of initial submission. Any such proposal should explain why iterative testing is the more effective means of proceeding with respect to the particular disclosure. If the Bureau approves the program, an initial waiver will then cover the first test disclosure, and the Bureau will commit in the Terms and Conditions document governing that waiver to consider later iterations of the test disclosure for follow-on waivers on a defined fast-track basis. The Policy thereby enables iterative testing, where it is appropriate, while also ensuring that each tested disclosure is specifically authorized.
Several consumer groups asked that the Policy require that all proposed disclosures be subject to full notice and comment. In contrast, a financial service provider cautioned that such a procedure would dissuade companies from proposing trial disclosure programs because it would add considerable time and expense to the process. In the Bureau's assessment, requiring notice and comment for each proposed disclosure would conflict with Congress's instruction to issue standards and procedures “designed to encourage covered persons to conduct trial disclosure programs.” (12 U.S.C. 5532(e)(2).) The Bureau believes that it is highly unlikely that covered persons would be willing to subject proposals to full notice and comment, not least because of the extended time period involved. In addition, a test disclosure does not represent a proposed Bureau rule. Test results could help the Bureau to put forward proposed rule changes, but full notice and comment would then apply at that point.
Consumer groups also proposed that tests be approved only when there is no statutory liability associated with the disclosure process. In addition, they proposed that no in-market tests proceed until after “lab-based” qualitative testing of each proposed disclosure.
The Bureau does not agree that tests should be limited to disclosures for which non-compliance carries no statutory liability. Section 1032(e) authorizes the Bureau to apply a time-limited safe harbor with respect to disclosure requirements under “a rule or an enumerated consumer law.”
The Bureau agrees with commenters that qualitative testing will often be a useful means of showing that a disclosure is worth testing. That is not a compelling reason, however, to make qualitative testing an absolute requirement for test approval. The approval process calls for reasonable grounds to expect the revised disclosures to represent an improvement. In many cases, those grounds will consist—at least in part—of qualitative test results. But that need not always be the case. Other grounds could certainly supply a sufficient basis for expecting improved outcomes. Similar disclosures may have been used and shown to be effective for related consumer financial products, or prior research may offer reasonable grounds to believe the revised disclosure will be an improvement.
Some commenters asked the Bureau to identity priority areas for potential tests. The Bureau does not rule out taking this step at some point in the future. In considering ways to improve disclosure policy, the Bureau may in the future identify one or more areas as particularly appropriate for testing.
Several trade associations and industry participants asked the Bureau to clarify the scope of the safe harbor that will be provided to approved participants. In particular, they asked whether the waivers would shield participants from (i) private litigation by consumers and (ii) enforcement or other proceedings by other regulators.
The Bureau recognizes that Section 1032(e) will not provide the incentive to test new disclosures that Congress intended unless the scope of any approved waivers is clear. Entities that the Bureau approves for a waiver—so long as their conduct accords with the terms of approval—should not face private liability exposure for violating those provisions of a federal disclosure statute or rule that the Bureau identifies as being within the scope of the waiver. Because such a waiver deems the trial disclosure to be in compliance with or exempt it from the provisions identified by the Bureau, there is no basis under those provisions for a private suit based on the company's use of the disclosure. The same rationale applies to other federal and state regulators even if they have enforcement or supervisory authority as to the “enumerated consumer laws” for which the Bureau has rulemaking authority. When a Bureau-issued waiver is in effect, there can be no predicate for an enforcement or supervisory action by such a regulator that is both based on statutory or regulatory provisions that are within the scope of the waiver and against a company with an approved program in compliance with the terms of the wavier.
It is true that certain other federal regulators may, in certain circumstances, issue rules that overlap with the Bureau's rules. (
Finally, several commenters asked the Bureau to state that disclosures approved under the Policy are not deceptive. The Bureau does not intend to approve test disclosures that it considers deceptive. As a result, the Bureau anticipates being able to make this kind of statement when it publishes notice of a waiver. In either case, however, the Bureau's determination would be provisional. Unless and until otherwise indicated, the Bureau's statement or waiver would apply only to disclosures that an approved party made under the terms of that particular approved trial disclosure program.
The Proposed Policy specified that if the Bureau decides to revoke or partially revoke a waiver for failure to follow the waiver's terms, it: (i) Will do so in writing, specifying the reason or reasons for its action; and (ii) may offer an opportunity to correct any such failure before revoking a waiver. Several commenters found these procedural protections insufficient and requested that they be enhanced in various ways.
The Bureau acknowledges that entities may reasonably request some opportunity to dispute grounds for a potential revocation. Before determining to issue a revocation, therefore, the Bureau will notify the company of its grounds for its potential revocation, and permit the company an opportunity to respond, consistent with the terms of this Policy. The Policy has been clarified to this effect.
Commenters raised two public disclosure concerns.
Citing protocols for conducting research on human subjects, consumer groups urged that consumers be given the chance to opt out of test participation. They also requested that test disclosures be clearly identified as such. One industry submission suggested that the Bureau inform consumers after the fact of their participation in a test.
The Bureau does not agree that standard practice argues for requiring consumer consent in this context. In-market testing of consumer behavior and reactions to new products or new ways of delivering services is a constant of modern life. Companies routinely carry out such tests using their customer base, without consumer consent or awareness. The fact that companies must share test results with the Bureau does not compel a different outcome here. As the statute makes clear, 1032(e) tests are still conducted
Furthermore, there is very good reason not to identify test disclosures at the time of delivery. As one commenter observed, disclosures only work to the extent consumers read them. A critical test of any disclosure's effectiveness, therefore, is whether consumers decide to read it in any given case. As a result, if consumers are told that a disclosure is for a test, it will no longer be possible to test for the most basic and controlling component of disclosure effectiveness. Moreover, requiring such disclosure would be in tension with Congress's recognition in section 1032 that public disclosure of programs may appropriately be limited in order to
The Bureau has considered requiring companies to alert consumers that they are in a test population—regardless of whether the consumers are in a control group or in the group to receive a test disclosure.
Several consumer groups urged that all test results be made public. After careful consideration, the Bureau has decided not to revise the Proposed Policy to this effect. Congress has directed that public disclosure be limited as necessary to encourage covered persons to conduct effective tests. (
Commenters also requested clarification on a number of discrete issues.
The Bureau confirms that disclosure improvements may properly consist of revised forms of delivery, not simply changes to the content of disclosures. This was already covered at footnote 7 of the Proposed Policy. It is now reflected in the eligibility criteria listed in Section A of the final Policy.
Submissions for approval can be made via electronic means. Submitters can use the Project Catalyst email address. The Policy has been revised accordingly.
Several consumer groups requested that the Bureau monitor tests for potential harm to consumers. The Proposed Policy already called for proposals to include plans to mitigate any harm identified. To further address the concern raised, however, the Bureau has amended the eligibility criteria to include both an identification of any risks of consumer harm that may be associated with the proposed program and a description of how the program mitigates any such risks.
The text of the final Policy is as follows.
Consumers need timely and understandable information to make the financial decisions that they believe are best for themselves and their families. Much federal consumer protection law, therefore, rests on the assumption that accurate and effective disclosures will help Americans understand the costs, benefits, and risks of different consumer financial products and services. In Section 1032 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), Congress gave the Consumer Financial Protection Bureau (Bureau) authority to develop rules to ensure that consumers receive such disclosures, as well as model forms to help companies comply with those rules.
In subsection 1032(e) of the Dodd-Frank Act, Congress also gave the Bureau authority to approve “trial disclosure programs.”
Accordingly, the Bureau is issuing its Policy on trial disclosure programs.
The policy has four sections:
• Section A describes which proposed programs will be considered eligible for a temporary waiver;
• Section B lists factors the Bureau will consider in deciding which eligible programs to approve for such a waiver;
• Section C describes the Bureau's procedures for issuing waivers; and
• Section D describes how we will disclose information about these programs.
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The information that should be submitted to demonstrate eligibility, as described further in Section A below, has been deemed to be a collection of information for these purposes. The OMB control number for this collection is 3170–0039. It expires on 09/30/2016. The time required to complete this information collection is estimated to average between 2 and 10 hours per response, including the time for reviewing any instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The obligation to respond to this collection of information is required to obtain a benefit to the extent that the information is to establish eligibility for a temporary waiver, as described in this policy. Comments regarding this collection of information, including the estimated response time, suggestions for improving the usefulness of the information, or suggestions for reducing the burden to respond to this collection should be submitted to Bureau at the Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, or by email to
To be considered eligible for a waiver, a proposal should:
1. Identify the testing company or companies;
2. Describe the new disclosures or delivery methods that are to be tested;
If a proposal is for iterative testing, it should include copies of all forms of the disclosure that are known at the time of initial submission. It should explain why iterative testing is the more effective means of proceeding with respect to the particular disclosure concept. In addition, it should include a proposal for a streamlined approval process for different iterations of the disclosure. Again, no disclosure can be subject to a waiver under Section 1032(e) unless the specific tester has been approved to test that specific disclosure.
3. Describe how these changes are expected to improve upon existing disclosures,
4. Provide a reasonable basis for expecting these improvements, and metrics for testing whether such improvements are realized;
5. Identify the duration of the test and the size, location, and nature of the consumer population involved in the test, and explain why that duration and scope are reasonably necessary for sound testing;
6. Identify any risks of consumer harm that may be associated with the proposed program, describe how the program mitigates such risks, and explain the testing procedures that will be used to assess for potential consumer harm during the course of the test;
7. Identify with particularity which provisions of current rules or enumerated consumer laws are to be temporarily waived in connection with the trial disclosure program;
8. Identify any third-party vendors to be used in connection with the proposed program and describe their proposed role;
9. Contain a commitment to and schedule for sharing test result data
10. Acknowledge that the Bureau may revoke any approved waiver if the program violates the terms and conditions under which the Bureau approves the program; and
11. Explain how the testing company will address disclosure requirements for the test population at the conclusion of the test period.
All proposals should be submitted via email to
To decide whether to approve a proposed program for a waiver,
1. The extent to which the program may help the Bureau develop disclosure rules or policies that better enable consumers to understand the costs, benefits, and risks associated with consumer financial products or services;
2. The extent to which the program may help the Bureau develop more cost-effective disclosure rules or policies;
3. The extent to which the program anticipates, controls for, and mitigates risks to consumers;
4. The strength and record of the company's compliance management system relative to the size, nature, and complexity of the company's consumer business;
5. How effectively and efficiently the program will test for potential improvements to consumer understanding and/or the cost-effectiveness of disclosures, and how narrowly the program is tailored to the testing objectives;
6. The extent to which existing data or other evidence indicate that the proposed changes will realize the intended improvements; and
7. The extent to which the company intends to permit public disclosure of test results.
In reviewing and approving applications, the Bureau will also take into consideration the scope and nature of programs currently underway as well as the Bureau's available resources.
When the Bureau approves a waiver, it will provide the company or companies that receive the waiver with the specific terms and conditions of its approval.
Waiver terms and conditions will be in writing in an integrated document entitled “1032(e) Trial Disclosure Waiver: Terms and Conditions.” This document will be signed by the Director of the Bureau or by his or her designee, and by an officer of each company approved for a waiver in connection with the program.
In addition, the document will:
1. Identify the company or companies that are receiving a waiver;
2. Specify the new disclosure(s) or delivery methods to be used by that company or companies under the terms of the waiver;
3. Specify the rules and statutory provisions that the Bureau will waive during the test period for the testing company or companies;
4. Specify the temporary duration of the waiver;
5. Describe and delineate the test population(s); and
6. Specify any other conditions on the effectiveness of the waiver, such as the terms of testing, data sharing, certification of compliance with the terms of the waiver, and/or public disclosure.
The Bureau will publish notice on its Web site of any trial disclosure program that it approves for a waiver. The notice will: (i) Identify the company or companies conducting the trial disclosure program; (ii) summarize the changed disclosures to be used, their intended purpose, and the duration of their intended use; (iii) summarize the scope of the waiver and the Bureau's reasons for granting it; and (iv) state that the waiver only applies to the testing company or companies in accordance with the approved terms of use.
Public disclosure of any other information regarding trial programs is governed by the Bureau's Rule on Disclosure of Records and Information.
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are superseding airworthiness directive (AD) 2012–24–09 for Lycoming Engines TIO–540–AK1A, and Continental Motors, Inc. (CMI) TSIO–360–MB, TSIO–360–SB, and TSIO–360–RB reciprocating engines, with certain Hartzell Engine Technologies (HET) turbochargers, model TA0411, installed. AD 2012–24–09 required removing certain HET turbochargers from service before further flight. This AD also requires removing certain HET turbochargers from service before further flight. This AD was prompted by a report that an additional engine, the CMI LTSIO–360–RB, has the affected HET turbochargers installed. We are issuing this AD to prevent turbocharger turbine wheel failure, reduction or complete loss of engine power, loss of engine oil, oil fire, and damage to the airplane.
This AD is effective November 13, 2013.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 20, 2012 (77 FR 72203, December 5, 2012).
We must receive any comments on this AD by December 13, 2013.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Hartzell Engine Technologies, LLC, 2900 Selma Highway, Montgomery, AL 36108, phone: 334–386–5400; fax: 334–386–5450; Internet:
You may examine the AD docket on the Internet at
Christopher Richards, Aerospace Engineer, Chicago Aircraft Certification Office, FAA, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847–294–7156; fax: 847–294–7834; email:
On November 29, 2012, we issued AD 2012–24–09, Amendment 39–17279 (77 FR 72203, December 5, 2012), for Lycoming Engines TSIO–540–AK1A, and CMI TSIO–360–MB, TSIO–360–SB, and TSIO–360–RB reciprocating engines, with certain HET turbochargers, model TA0411, part numbers 466642–0001; 466642–0002; 466642–0006; 466642–9001; 466642–9002; or 466642–9006, or with certain HET model TA0411 turbochargers overhauled or repaired since August 29, 2012. On January 7, 2013, we issued a correction to AD 2012–24–09 (78 FR 2615, January 14, 2013), which corrected the affected Lycoming Engines engine model from “TSIO–540–AK1A” to “TIO–540–AK1A.” AD 2012–24–09 required removing the affected turbochargers from service before further flight. AD 2012–24–09 resulted from a report of a turbocharger turbine wheel that failed a static strength test at the manufacturing facility. We issued AD 2012–24–09 to prevent turbocharger turbine wheel failure, reduction or complete loss of engine power, loss of engine oil, oil fire, and damage to the airplane.
Since we issued AD 2012–24–09 (77 FR 72203, December 5, 2012; corrected January 14, 2013 (78 FR 2615)), we received a report that an additional engine, the CMI LTSIO–360–RB, has the affected HET turbochargers installed.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires removing the affected turbochargers from service before further flight.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the AD requires removal of the affected turbochargers before further flight. Therefore, we find that notice and opportunity for prior public comment are impracticable and that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 56 engines of U.S. registry with affected turbochargers installed. We also estimate that it will take about 4 hours to remove a turbocharger from service. The average labor rate is $85 per hour. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $19,040.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 13, 2013.
This AD supersedes AD 2012–24–09, Amendment 39–17279 (77 FR 72203, December 5, 2012; corrected January 14, 2013 (78 FR 2615)).
This AD applies to certain Lycoming Engines TIO–540–AK1A, and Continental Motors, Inc. (CMI) LTSIO–360–RB, TSIO–360–MB, TSIO–360–SB, and TSIO–360–RB reciprocating engines with a Hartzell Engine Technologies (HET) turbocharger installed that has a model number, part number, and serial number identified in Tables 1 and 2 of HET Alert Service Bulletin (ASB) No. 048, dated November 16, 2012.
This AD was prompted by a report that an additional engine, the CMI LTSIO–360–RB, has the affected HET turbochargers installed. We are issuing this AD to prevent turbocharger turbine wheel failure, reduction or complete loss of engine power, loss of engine oil, oil fire, and damage to the airplane.
(1) Comply with this AD within the compliance times specified, unless already done.
(2) After the effective date of this AD and before further flight, remove from service any turbocharger identified in Tables 1 and 2 of HET ASB No. 048, dated November 16, 2012.
After the effective date of this AD, do not return to service, and do not operate without a special flight permit, any engine with an HET turbocharger installed that is identified in Tables 1 and 2 of HET ASB No. 048, dated November 16, 2012.
Special flight permits are limited to when:
(1) Ferry flights do not exceed three hours duration;
(2) The turbocharger boost is set to “Off” in the cockpit (if equipped); and
(3) The wastegate for the turbocharger is safety wired in the locked open position.
(1) The Manager, Chicago Aircraft Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request.
(2) AMOCs approved for AD 2012–24–09 (77 FR 72203, December 5, 2012; corrected January 14, 2013 (78 FR 2615)) remain in effect for this AD.
For more information about this AD, contact Christopher Richards, Aerospace Engineer, Chicago Aircraft Certification Office, FAA, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847–294–7156; fax: 847–294–7834; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(3) The following service information was approved for IBR on December 20, 2012 (77 FR 72203, December 5, 2012; corrected January 14, 2013 (78 FR 2615)).
(i) Hartzell Engine Technologies Alert Service Bulletin No. 048, dated November 16, 2012.
(ii) Reserved.
(4) For service information identified in this AD, contact Hartzell Engine Technologies, LLC, 2900 Selma Highway, Montgomery, AL 36108, phone: 334–386–5400; fax: 334–386–5450; Internet:
(5) You may view this service information at the FAA, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125.
(6) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202 741 6030, or go to:
Internal Revenue Service (IRS), Treasury.
Temporary regulations; correcting amendments.
This document contains amendments to temporary regulations relating to guidance for taxpayers electing to establish a mixed straddle using straddle-by-straddle identification. These amendments include a change to the applicability date of the temporary regulations pursuant to which the temporary regulations apply to transactions established after the date of publication of the Treasury decision adopting these rules as final regulations in the
Pamela Lew or Robert B. Williams at (202) 622–3950 (not a toll-free number).
The temporary regulations that are the subject of these amendments are under section 1092 of the Internal Revenue Code (Code). The temporary regulations (TD 9627) were published in the
The Treasury Department and the IRS received comments raising concerns about the immediate applicability date of the temporary regulations. In response to those comments, this document amends the temporary
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
Section 1.1092(b)–6T also issued under 26 U.S.C. 1092(b)(1).
Section 1.1092(b)–6T also issued under 26 U.S.C. 1092(b)(2).* * *
The amendments read as follows:
(b)(6)
The amendments read as follows:
* * *
(b) * * * The following examples assume that this section applies to identified mixed straddles established after August 1, Year 2.
On August 13, Year 2, A enters into a section 1256 contract. As of the close of the day on August 15, Year 2, there is $500 of unrealized loss on the section 1256 contract. On August 16, Year 2, A enters into an offsetting non-section 1256 position and makes a valid election to treat the straddle as a section 1092(b)(2) identified mixed straddle. A continues to hold both positions of the section 1092(b)(2) identified mixed straddle on January 1, Year 3. Under these circumstances, A will recognize the $500 loss on the section 1256 contract that existed prior to establishing the section 1092(b)(2) identified mixed straddle on the last business day of Year 2 because the section 1256 contract would be treated as sold on December 31, Year 2, (the last business day of the taxable year) under section 1256(a). The loss recognized in Year 2 will be treated as 60% long-term capital loss and 40% short-term capital loss. All gains and losses occurring after the section 1092(b)(2) identified mixed straddle is established are accounted for under the applicable provisions in § 1.1092(b)–3T.
On September 3, Year 1, A enters into a non-section 1256 position. As of the close of the day on August 22, Year 2, there is $400 of unrealized short-term capital gain on the non-section 1256 position. On August 23, Year 2, A enters into an offsetting section 1256 contract and makes a valid election to treat the straddle as a section 1092(b)(2) identified mixed straddle. On September 10, Year 2, A closes out the section 1256 contract at a $500 loss and disposes of the non-section 1256 position, realizing an $875 gain. Under these circumstances, A has $400 of short-term capital gain attributable to the non-section 1256 position prior to the day the section 1092(b)(2) identified mixed straddle was established. The $400 unrealized gain earned on the non-section 1256 position will be recognized on September 10, Year 2, when the non-section 1256 position is disposed of. The gain will be short-term capital gain. See § 1.1092(b)–2T for rules concerning holding period. On September 10, Year 2, the gain of $875 on the non-section 1256 position will be reduced to $475 to take into account the $400 of unrealized gain when the section 1092(b)(2) identified mixed straddle was established. The $475 gain on the non-section 1256 position will be offset by the $500 loss on the section 1256 contract. The net loss of $25 from the straddle will be treated as 60% long-term capital loss and 40% short-term capital loss because it is attributable to the section 1256 contract.
(c)
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule; approval of amendment.
We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Mississippi regulatory program (Mississippi Program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Mississippi proposed revisions to its regulations regarding: definitions; identification of interests; lands eligible for remining; permit eligibility determination; review of permit applications; eligibility for provisionally issued permits; criteria for permit approval or denial; initial review and finding requirements for improvidently issued permits; notice requirements for improvidently issued permits; suspension or rescission requirements for improvidently issued permits; unanticipated events or conditions at remining sites; verification of ownership or control application information; who may challenge ownership or control listings and findings; how to challenge an ownership or control listing or finding; burden of proof for ownership or control challenges; written agency decision on challenges to ownership or control listings or findings; post-permit issuance requirements for regulatory authorities and other actions based on
Sherry Wilson, Director, Birmingham Field Office. Telephone: (205) 290–7282 Email:
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “. . . a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act . . .; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Mississippi program effective September 4, 1980. You can find background information on the Mississippi program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Mississippi program in the September 4, 1980,
By email dated July 26, 2012 (Administrative Record No. MS–0423), the Mississippi Department of Environmental Quality (Mississippi or the Department) sent us an amendment to its program under SMCRA (30 U.S.C. 1201
We announced receipt of the proposed amendment in the September 19, 2012,
By email dated March 4, 2013 (Administrative Record No. MS–0423–03), Mississippi requested that we suspend processing of their proposed amendment while they made some administrative corrections to their submission. Mississippi submitted their administratively revised proposed rule by email dated June 28, 2013 (Administrative Record No. MS–0423–04). We did not reopen the comment period for the additional changes because they were entirely administrative in nature and did not substantively affect the Mississippi Program.
We are approving the amendment as described below. The following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are also approving the administrative changes made by Mississippi throughout their proposed rule, which primarily consisted of changing the word “chapter” to “rule” and “subpart” to “chapter.” Statutory references were added at the end of each chapter and rule. Any revisions that we do not specifically discuss below concerning non-substantive wording or editorial changes can be found in the full text of the program amendment available at
Mississippi proposed to add new definitions for “Previously Mined Area” and “Violation”; and revised the definitions for “Applicant Violator System or AVS”; “Knowing or Knowingly”; “Slope”; and “Willfully.” Mississippi's new definitions and revised definitions are substantively the same as counterpart Federal regulations at 30 CFR 701.5. Mississippi also corrected a reference to a regulatory citation within its definition of “Ownership or Control Link,” which has no Federal counterpart. Revision of this previously approved definition does not make Mississippi's program less effective than the Federal regulation. Therefore, we approve Mississippi's new and revised definitions.
Mississippi proposed to add additional language clarifying the requirements for information to be included in a permit application concerning the identification of interests for the applicant and operator and for the entry of the applicant's information into the Applicant Violator System (AVS). We find that Mississippi's new language is substantively the same as counterpart Federal regulations at 30 CFR 778.8, 778.9, and 778.11. Therefore, we approve Mississippi's revisions.
Mississippi proposed to add new § 2902 regarding lands eligible for remining. The regulation requires that any person who submits a permit application to conduct a surface coal mining operation on lands eligible for remining must comply with all the requirements of the regulations; including the permitting requirements of § 3130, which concerns unanticipated events or conditions at remining sites. We find that Mississippi's new regulation is substantively the same as the counterpart Federal regulation at 30 CFR 785.25. Therefore, we approve Mississippi's new regulation.
Mississippi proposed to add new § 3102 which explains the roles and responsibilities of the Department and the Permit Board on whether the applicant is eligible to receive a permit. We find that Mississippi's new regulation is substantively the same as the counterpart Federal regulation at 30 CFR 773.12. Therefore, we are approving Mississippi's new regulation.
Mississippi proposed renumbering § 3113 Review of Permit Applications, to § 3112 Review of Permit Applications. This change allows Mississippi's regulations to remain in compliance with other portions of its regulations. We find that these revisions make Mississippi's regulations no less effective than the Federal regulations. Therefore, we approve Mississippi's revision.
Mississippi proposed to add new § 3113 regarding the applicant's eligibility for a provisionally issued permit. This applies to any applicant that applies for a permit or who owns or controls a surface coal mining and reclamation operation with outstanding permit violations. We find that Mississippi's new regulation is substantively the same as the counterpart Federal regulation at 30 CFR 773.14. Therefore, we approve Mississippi's new regulation.
Mississippi proposed to revise its citations in § 3115(m) to require compliance with new § 3102(d) regarding update of compliance information prior to permit issuance. Mississippi added new paragraphs (n) and (o) to clarify the requirements regarding permit approval criteria for proposed remining operations. We find that Mississippi's revised citations and new paragraphs (n) and (o) are substantively the same as counterpart Federal regulations at 30 CFR 773.15(k)(1) and (m)(i), (ii), and (iii). Therefore, we approve Mississippi's revisions.
Mississippi proposed to delete old language in § 3127 regarding general procedures for improvidently issued permits. Mississippi replaced its old language with new language regarding what the Permit Board must do when it has reason to believe that a permit has been improvidently issued. The revision describes the written permit findings the Permit Board must make regarding improvidently issued permits and how a permittee can challenge those findings. We find that Mississippi's newly added language is substantively the same as the counterpart Federal regulation at 30 CFR 773.21. Therefore, we approve Mississippi's revisions.
Mississippi proposed to add new § 3128 regarding the responsibilities of the Department in serving the notice of suspension or rescission of improvidently issued permits. We find that Mississippi's new regulation is substantively the same as the counterpart Federal regulation at 30 CFR 773.22. Therefore, we approve Mississippi's new regulation.
Mississippi proposed to delete old language in § 3129 regarding revocation or suspension procedures for improvidently issued permits. Mississippi replaced this old language with new language regarding the Permit Board's responsibilities for: (1) Suspension or rescission of improvidently issued permits; (2) evaluation of permittee evidence; (3) administrative review of the findings; and (4) terms of the notice of cessation of operations. We find that Mississippi's revisions are substantively the same as counterpart Federal regulations at 30 CFR 773.21 and 773.23. Therefore, we approve Mississippi's revisions.
Mississippi proposed to add new § 3130 regarding an applicant's eligibility for a permit if he has on record an unabated violation resulting from unanticipated events or conditions at an existing or past permit on lands eligible for remining. We find that Mississippi's new regulation is substantively the same as the counterpart Federal regulation at 30 CFR 773.13. Therefore, we approve Mississippi's new regulation.
Mississippi proposed revisions to § 3131 regarding what Mississippi must do when it receives an application and it appears that neither the applicant nor the operator has any mining experience. Specifically, it requires the Department to investigate to determine whether there may be additional owners or controllers. If additional owners or controllers are identified, Mississippi requires such persons to disclose their identity and make certifications, and requires their identification information be entered into AVS. We find that these revisions allow Mississippi to fully meet the Federal requirements of 30 CFR 773.10 and 773.11 regarding review of permit history and review of compliance history, thereby making Mississippi's regulation no less effective than the Federal regulations. Therefore, we approve Mississippi's revisions.
Mississippi proposed to delete old language in § 3133 regarding the review of ownership or control and violation information and add new language regarding who may challenge an ownership or control listing or finding. We find that the new language is substantively the same as the counterpart Federal regulation at 30 CFR 773.25. Therefore, we approve Mississippi's revisions.
Mississippi proposed to delete old language in § 3135 regarding procedures for challenging ownership or control listings or findings, and replaced it with new language regarding how to challenge an ownership or control listing or finding. It explains that to challenge an ownership or control listing or finding, the person making the challenge must submit a written explanation of the basis for the challenge, along with evidence or explanatory material that a person wishes to provide. We find that this new language is substantively the same as the counterpart Federal regulation at 30 CFR 773.26. Therefore, we approve Mississippi's revisions.
Mississippi proposed to delete old language in § 3136 regarding written agency decisions on challenges to ownership or control listings or findings and replaced it with new language regarding the burden of proof for ownership or control challenges. This applies to anyone who challenges a listing of ownership or control, or a finding of ownership or control made under § 3138(g). It requires anyone who challenges an ownership or control listing or finding to prove by a preponderance of evidence that they either do not or did not own or control the relevant portion of a surface coal mining operation. We find that Mississippi's new language is substantively the same as the counterpart Federal regulation at 30 CFR 773.27. Therefore, we approve Mississippi's revisions.
Mississippi proposed to delete old language in § 3137 regarding standards for challenging ownership or control links and the status of violations, and replaced it with new language regarding written agency decisions on challenges to ownership or control listings or
Mississippi proposed to add new § 3138 regarding the Department's responsibilities after permit issuance related to ownership, control, and violation information. It also allows the permittee to request a preliminary hearing related to such actions. We find that Mississippi's new section is substantively the same as the counterpart Federal regulation at 30 CFR 774.11. Therefore, we approve Mississippi's new regulation.
Mississippi proposed to add new § 3139 regarding the responsibilities of permittees for providing information following a cessation order after a permit has been issued. We find that Mississippi's new section is substantively the same as the counterpart Federal regulation at 30 CFR 774.12. Therefore, we are approving Mississippi's new regulation.
Mississippi proposed to add new § 5396 regarding backfilling and grading requirements on previously mined areas with preexisting highwalls. The regulation states that the requirements of § 5391(a)(1) and (2) requiring elimination of highwalls will not apply to remining operations where the volume of all reasonably available spoil is insufficient to completely backfill the highwall. Instead, the highwall is to be backfilled to the maximum extent practical in accordance with a set of criteria articulated in the regulation. We find that Mississippi's new section is substantively the same as the counterpart Federal regulation at 30 CFR 816.106. Therefore, we approve Mississippi's new regulation.
Mississippi proposed to add a new chapter to its regulations regarding alternative enforcement that provides for criminal penalties and civil actions to compel compliance with provisions of the Act by adding § 7301 Scope, § 7303 General Provisions, § 7305 Criminal Penalties, and § 7307 Civil Actions for Relief. We find that Mississippi's new Chapter 73 Alternative Enforcement is substantively the same as counterpart Federal regulations at 30 CFR Part 847. Therefore, we approve Mississippi's new Chapter 73.
We asked for public comments on the amendments, but did not receive any.
On August 1, 2012, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendments from various Federal agencies with an actual or potential interest in the Mississippi program (Administrative Record No. MS–0423–01). We did not receive any comments.
Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from the EPA for those provisions of the program amendments that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On August 1, 2012, we requested comments on Mississippi's amendments (Administrative Record No. MS–0423–01), but neither the SHPO nor ACHP responded to our request.
Based on the above findings, we approve the amendments Mississippi sent us on July 26, 2012, as revised June 28, 2013.
To implement this decision, we are amending the Federal regulations at 30 CFR Part 924 that codify decisions concerning the Mississippi program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.
This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.
This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.
The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of sections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10) decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.
This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the
In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on federally recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. This determination is based on the fact that the Mississippi program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Mississippi program has no effect on federally recognized Indian tribes.
On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.
This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).
This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507
The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.
This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 924 is amended as set forth below:
30 U.S.C. 1201
Environmental Protection Agency (EPA).
Final rule.
EPA is approving a State implementation plan (SIP) revision submitted by California to address Clean Air Act (CAA) contingency measure requirements for the 1997 annual and 24-hour national ambient air quality standard (NAAQS) for fine particulate matter (PM
This rule is effective on November 29, 2013.
You may inspect the supporting information for this action, identified by docket number EPA–R09–OAR–2013–0384, by one of the following methods:
1. Federal eRulemaking portal,
2. Visit our regional office at, U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105–3901.
Doris Lo, EPA Region IX, (415) 972–3959,
Throughout this document, “we,” “us” and “our” refer to EPA.
On June 24, 2013 (78 FR 37741), EPA proposed to approve the “South Coast Air Quality Management District Proposed Contingency Measures for the 2007 PM
EPA provided a 30-day public comment period on our proposed action. The comment period ended on July 24, 2013. We received one public comment and respond to that comment below.
We are finalizing our proposal to conclude that the Contingency Measures SIP submitted by CARB on November 14, 2011, as supplemented on April 24, 2013, satisfies the attainment contingency measure requirement in CAA section 172(c)(9) for the 1997 PM
We are also finalizing our proposal to conclude that the RFP contingency measure requirement in CAA section 172(c)(9) for the 2012 milestone year is moot as applied to the South Coast because the area achieved its SIP-approved emission reduction benchmarks for the 2012 RFP year.
Today's final approval corrects deficiencies that were the basis for EPA's partial disapproval of the South Coast PM
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 30, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Intergovernmental relations, Incorporation by reference, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(432) The following plan was submitted on November 14, 2011, by the Governor's Designee.
(i) [Reserved].
(ii) Additional materials.
(A) South Coast Air Quality Management District.
(
(
(
(B) State of California Air Resources Board.
(
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Because EPA received adverse comment, we are withdrawing the direct final rule for the Amendment to Standards and Practices for All Appropriate Inquiries published on August 15, 2013.
Effective October 29, 2013, EPA withdraws the direct final rule published at 78 FR 49690, on August 15 2013.
Rachel Lentz, Office of Brownfields and Land Revitalization (5105–T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0002; telephone number: 202–566–2745; fax number: 202–566–
Because EPA received adverse comment, we are withdrawing the direct final rule for the Amendment to Standards and Practices for All Appropriate Inquiries published on August 15, 2013 (78 FR 49690). We stated in that direct final rule that if we received adverse comment by September 16, 2013, the direct final rule would not take effect and we would publish a timely withdrawal in the
Administrative practice and procedure, Hazardous substances.
Accordingly, EPA withdraws the amendments to 40 CFR 312.11(c), published in the
Federal Communications Commission.
Final rule.
In this document, the Federal Communications Commission (Commission) amends the text-to-911 “bounce-back” requirement as it applies to Commercial Mobile Radio Service (CMRS) providers when consumers are roaming. In the May 2013
Effective October 29, 2013.
Nicole McGinnis, Federal Communications Commission, Public Safety and Homeland Security Bureau, 445 12th Street SW., Room 7–A814, Washington, DC 20554. Telephone: (202) 418–2877, email:
This is a summary of the Commission's
1.
2.
3.
4. Two other commenting parties, Blooston Rural Carriers (Blooston) and NCTA, support not requiring host providers to provide a bounce-back message to a roaming consumer at this time, based on current technical considerations. Blooston agrees with CTIA that origination of a bounce-back message by a roaming provider is technically infeasible. Blooston further argues that the Commission should not require home providers to originate a bounce-back message in this scenario because the home provider cannot determine the location of the consumer on the host provider's network, and therefore cannot determine whether the PSAP serving the consumer's location supports text-to-911. Thus, Blooston argues that the bounce-back rule should not apply to consumers while roaming until a technological solution can be worked out by industry standard-setting bodies that would enable the home provider to determine the consumer's location on the host provider's network. NCTA similarly argues that implementation of the roaming portion of the bounce-back rule should be delayed until a technical solution is developed by standards-setting bodies and implemented.
5. APCO filed an opposition to the Petition, arguing that CTIA has failed to demonstrate that complying with the Commission's rule is not technically feasible. APCO objects that CTIA's proposal would result in all roaming customers receiving a bounce-back message even in situations where the roaming consumer is located in an area where the local PSAP accepts text-to-911. APCO contends that if a roaming consumer is in an area where the PSAP supports text-to-911, the home and host providers should be required to deliver the consumer's text to the PSAP rather than sending a bounce-back message. APCO argues that delivery of a text-to-911 from a roaming customer to the PSAP serving the customer's area is technically feasible under existing standards. In reply, CTIA disputes APCO's contention that a technical solution exists to support routing of 911 texts from roaming customers to PSAPs. CTIA also argues that the issues APCO raises regarding the feasibility of text-to-9-1-1 while roaming “are directed at the second part of the NPRM, which is still pending before the Commission.”
6. In an
7. In the
8. Accordingly, the Commission amends § 20.18(n)(7) to reflect that the host provider must not impede the consumer's text message to 911 to the consumer's home provider and/or any bounce-back message generated by the home provider back to the consumer. The host provider is not under any obligation to originate a bounce-back message to the consumer or otherwise ensure that the home provider generates a bounce-back message in response to the consumer's text to 911.
9. As revised, § 20.18(n)(7) specifies that a host provider shall not impede the text message to 911 of a consumer roaming on its network and/or impede any bounce-back message originated by the home provider to that roaming consumer. It is the home provider's responsibility to generate the bounce-back message. This apportionment of responsibility between the roaming and home providers assures that consumers receive potentially lifesaving bounce-back messages, while taking into account the technical realities of current network architecture. The revised language also accounts for whether the home provider is supporting text-to-911 in the area where the consumer initiates a text message to 911.
10. The Commission denies CTIA's petition to the extent it seeks elimination of § 20.18(n)(7) of the bounce-back rule. In light of its amendment of the rule, the Commission finds that compliance with the rule is technically feasible and does not raise the concerns referenced in CTIA's petition. The Commission finds that there was adequate notice to adopt the rule and that, as amended, the rule is consistent with the record in the underlying proceeding. The Commission does not agree with Blooston that it should eliminate the roaming portion of the bounce-back rule in its entirety or otherwise defer implementation of the rule. The bounce-back requirement addresses an important public safety interest in providing consumers immediate notification of non-delivery of their text to the PSAP. To eliminate bounce-back messaging in roaming situations would risk leaving roaming consumers without information as to whether their text reached the appropriate PSAP, potentially endangering them by preventing or delaying their attempt to
11. With respect to APCO's argument that host providers should be able to route consumer texts to 911 to the appropriate PSAP, the Commission notes that the questions APCO raises about the technical feasibility of requiring host providers to route texts to 911 are part of the broader and still-pending portion of the Commission's rulemaking proceeding. Therefore, the Commission does not address these issues in this order, but reserves them for consideration in the next phase of the proceeding. Today's order is limited in scope to the limited issue of how responsibility is apportioned for delivering bounce-back messages to consumers when those consumers are roaming.
12. Finally, in order to effectuate the modifications described herein, the Commission waives § 20.18(n)(7) on its own motion, pending the effective date of the amended rule. In light of the potential technical difficulties associated with complying with § 20.18(n)(7) as originally drafted, the Commission concludes there is good cause to waive application of this portion of the bounce-back rule until the effective date of the amendments adopted in this order. The remainder of § 20.18(n), which was published in the
13. The Commission concludes that good cause exists to make the effective date of the modifications adopted in this
14. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA). Therefore the Order on Reconsideration does not contain any new or modified information collection burdens for small businesses with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002.
15. The Regulatory Flexibility Act (RFA) requires that agencies prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not have a significant economic impact on a substantial number of small entities.” The RFA defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).
16. The Commission hereby certifies that this
17. The Commission will send a copy of this
18. Accessible formats of this
19. Accordingly,
20.
21.
22.
23.
24.
Communications common carriers, Communications equipment, Radio.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 20 as follows:
47 U.S.C. 151, 154, 160, 201, 251–254, 301, 303, 303(b), 303(r), 307, 309, 316, 319, 324, 332, 333, 615a, 615a–1, 615b, and 615c unless otherwise noted. Section 20.12 is also issued under 47 U.S.C. 1302.
(n) * * *
(7) Notwithstanding any other provisions in this section, when a consumer is roaming on a covered text provider's host network pursuant to § 20.12, the covered text provider operating the consumer's home network shall have the obligation to originate an automatic bounce-back message to such consumer when the consumer is located in an area where text-to-911 service is unavailable, or the home provider does not support text-to-911 service in that area at the time. The host provider shall not impede the consumer's 911 text message to the home provider and/or any automatic bounce-back message originated by the home provider to the consumer roaming on the host network.
Agricultural Marketing Service, USDA.
Proposed rule and referendum order.
This proposed rule would amend the Watermelon Research and Promotion Plan (Plan) importer membership requirements to serve on the National Watermelon Promotion Board (Board). The Board recommended eliminating the requirement that an importer import more than 50 percent of the total volume handled and imported in order to qualify as an importer member. This change would allow for additional parties to qualify as an importer member. This proposed rule also announces that the U.S. Department of Agriculture (USDA or Department) will conduct a referendum among eligible producers, handlers, and importers of watermelons to determine whether they favor the amendment to the Plan.
The voting period for the referendum will be from January 13, 2014 through January 27, 2014. To be eligible to vote, persons must have produced, handled, or imported watermelons during the representative period from January 1, through December 31, 2012, and must currently be a producer, handler, or importer of watermelons. Additionally, producers must be engaged in the growing of 10 acres or more of watermelons and importers must import 150,000 or more pounds of watermelons annually. Importers who import less than 150,000 pounds of watermelons annually and did not apply for and receive reimbursements of assessments during the representative period are eligible to vote in the referendum. The referendum will be conducted by mail ballot. Ballots must be received by the referendum agents no later than the close of business 4:30 p.m., Eastern daylight-standard time, January 27, 2014, to be counted.
Copies of the proposed amendment may be obtained from: Referendum Agent, Promotion and Economics Division, Fruit and Vegetable Program, AMS, USDA, 1400 Independence Avenue SW., Stop 0244, Room 1406–S, Washington, DC 20250–0244; telephone: (888) 720–9917 (toll free); fax: (202) 205–2800; or it can be viewed at
Jeanette Palmer, Marketing Specialist, Promotion and Economics Division, Fruit and Vegetable Program, AMS, U.S. Department of Agriculture, Stop 0244, 1400 Independence Avenue SW., Room 1406–S, Washington, DC 20250–0244; telephone: (888) 720–9917 (toll free); Direct line: 202–720–9915; facsimile: (202) 205–2800; or electronic mail:
This rule is issued under the Watermelon Research and Promotion Plan [7 CFR part 1210]. The Plan is authorized under the Watermelon Research and Promotion Act (Act) [7 U.S.C. 4901–4916].
A proposed rule was published in the
Pursuant to section 1655 of the Act, a referendum will be conducted among watermelon producers, handlers, and importers to determine whether they favor amending the Plan to eliminate the requirement that an importer import more than 50 percent of the total volume handled and imported in order to qualify as an importer member.
The representative period for establishing voter eligibility for the referendum shall be the period from January 1 through December 31, 2012. Section 1653(b) of the Act requires that the amendment be approved by a majority of watermelon producers, handlers, and importers voting in the referendum. Only producers of 10 acres or more of watermelons, watermelon handlers, and importers of 150,000 or more pounds of watermelons annually, and importers who import less than 150,000 pounds of watermelons annually and who did not apply for and receive reimbursements of assessments during the representative period will be eligible to vote in the referendum. The referendum shall be conducted by mail ballot from January 13, 2014 through January 27, 2014. Ballots must be received by the referendum agents no later than the close of business 4:30 p.m., Eastern daylight-standard time, January 27, 2014, to be counted.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has waived the review process.
This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review revealed that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.
In addition, this rule has been reviewed under Executive Order 12988, Civil Justice Reform. The rule is not intended to have retroactive effect.
The Act allows producers, producer-packers, handlers, and importers to file a written petition with the Secretary of Agriculture (Secretary) if they believe that the Plan, any provision of the Plan, or any obligation imposed in connection with the Plan, is not established in accordance with the law. In any petition, the person may request a modification of the Plan or an
In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C. 601–612], AMS has examined the economic impact of this rule on the small producers, handlers, and importers that would be affected by this rule. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened.
The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (handlers and importers) as those having annual receipts of no more than $7 million. Under these definitions, the majority of the producers, handlers, and importers that would be affected by this rule would be considered small entities. Producers of less than 10 acres of watermelons are exempt from this program. Importers of less than 150,000 pounds of watermelons per year are also exempt.
USDA's National Agricultural Statistics Service (NASS) data for the 2012 crop year indicates that about 306 hundredweight (cwt.) of watermelons were produced per acre within the United States. The 2012 grower price published by NASS was $13.30 per hundredweight. Thus, the value of watermelon production per acre in 2012 averaged about $4,070 (306 cwt. x $13.30). At that average price, a producer would have to farm over 184 acres to receive an annual income from watermelons of $750,000 ($750,000 divided by $4,070 per acre equals 184). Accordingly, as previously noted, a majority of the watermelon producers would be classified as small businesses.
Based on the Board's data, using an average of the free on board (f.o.b.) price of $.181 per pound and the number of pounds handled in 2012, none of the watermelon handlers had receipts over the $7 million threshold. Therefore, the watermelon handlers would all be considered small businesses. A handler would have to ship over 38 million pounds of watermelons to be considered large (38,674,033 times $.181 f.o.b. equals $7 million).
According to the Board, there are approximately 950 producers, 230 handlers, and 137 importers who are required to pay assessments under the program.
Based on the watermelon import assessments received for the year 2012, the United States imported watermelons worth over $237 million. The largest volume of watermelon imports came from Mexico which accounted for 86 percent of the total volume in 2012. Other suppliers of imported watermelons are Guatemala at 9 percent and Honduras at 2 percent. The remaining 3 percent of imported watermelons came from Costa Rica, Nicaragua, Canada, Dominican Republic, and Panama.
Based on the U.S. Customs and Border Protection (Customs) and Board data, it is estimated that there are about 201 importers of watermelon. Not all of these importers are required to pay assessments under the program. Using 2012 Customs data, all of the importers import less than $7.0 million worth of watermelon annually. Therefore, all of the watermelon importers would be considered small entities.
The Board's audit records show import assessments for the calendar years 2010, 2011, and 2012 at $746,043, $855,890, and $824,897 respectively. Based on this data, the three-year average of import assessments for watermelon totals $808,943 ($2,426,830 divided by 3). This represents approximately 30 percent of the total assessments paid to the Board. Currently, the Board membership distribution consists of 14 producers, 14 handlers, 8 importers, and 1 public member. A final rule that increased the number of importers on the Board was published in the July 18, 2011,
The Watermelon Research and Promotion Improvement Act of 1993 amended the Watermelon Research and Promotion Act by adding importer members to the Board, among other things. At that time the industry recommended that, in order to qualify as an importer member on the Board, an individual that both handles and imports watermelons may vote for importer members and serve as an importer member if that person imports 50 percent or more of the combined total volume of watermelons handled and imported by that person. A final rule was published in the
At the time of this amendment there was a more clear division of roles among producers, handlers, and importers. In other words, those individuals that imported watermelons did not cross over into handling or producing watermelons as much as they do now. Since then, the industry has become more consolidated and of the 137 importers required to pay assessments, 42 also handle watermelons and would be eligible to serve as either handler or importer member.
At its February 26, 2011, meeting, the Board voted unanimously, to modify the importer eligibility requirements to serve on the Board. The Board is having difficulty finding eligible importers to serve on the Board because of the requirement in the Plan that a person who both imports and handles watermelons will be counted as an importer only if that person imports 50 percent or more of the combined total volume of watermelons handled and imported by that person. The Board voted to eliminate the 50 percent or more requirement of the combined total volume of watermelons handled and imported by a person to allow more individuals to become eligible to serve on the Board as an importer. Individuals that both handle and import would be allowed to decide which part of the industry they would prefer to represent regardless of the volume handled or imported. The industry believes that this change would increase the importer representation on the Board by allowing more individuals to be eligible to serve. This action may also increase diversity on the Board.
The Board considered a second alternative to change the 50 percent or more of the combined total volume of watermelons handled and imported by the person to 25 percent or more of the combined total volume of watermelons handled and imported by the person. However, the Board did not choose this option because they wanted to allow more importers to be eligible for nomination on the Board and found this purpose better served if they eliminated the percentage requirement altogether. By eliminating the percentage requirement for the importer member, this will allow for smaller importer businesses to become eligible to serve as an importer member on the Board.
Section 1655 of the Act provides for referenda to be conducted to ascertain approval of changes to the Plan prior to going into effect. In order to implement the amendment to the Plan, the Secretary must determine that the
In accordance with the Office of Management and Budget (OMB) regulation [5 CFR part 1320] which implements the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the information collection and recordkeeping requirements that are imposed by the Plan have been approved previously and assigned OMB number 0581–0093, except that the background form, has been approved under OMB number 0505–0001.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other programs.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
We have performed this Regulatory Flexibility Analysis regarding the impact of this amendment to the Plan on small entities, and we did not receive any comments on the analysis. Additionally, the estimated numbers in the RFA represents the total universe of watermelon producers, handlers, and importers and not those who may be eligible to vote in the referendum.
Under the Plan, the Board administers a nationally coordinated program of research, development, advertising, and promotion designed to strengthen the watermelon's position in the market place and to establish, maintain, and expand markets for watermelons. This program is financed by assessments on producers growing 10 acres or more of watermelons, handlers of watermelons, and importers of 150,000 pounds of watermelons or more per year. The Plan specifies that handlers are responsible for collecting and submitting both the producer and handler assessments to the Board, reporting their handling of watermelons, and maintaining records necessary to verify their reports. Importers are responsible for payment of assessments to the Board on watermelons imported into the United States through the U.S. Customs and Border Protection. This action would not have any impact on the assessment rates paid by producers, handlers, and importers.
Membership on the Board consists of two producers and two handlers for each of the seven districts established by the Plan, at least one importer, and one public member. The Board currently consists of 37 members: 14 producers, 14 handlers, 8 importers, and 1 public member. A final rule to increase the number of importers on the Board was published in the July 18, 2011,
The Watermelon Research and Promotion Improvement Act of 1993 amended the Watermelon Research and Promotion Act by adding importer members to the Board, among other things. At that time the industry recommended that, in order to qualify as an importer member on the Board, an individual that both handles and imports watermelons may vote for importer members and serve as an importer member if that person imports 50 percent or more of the combined total volume of watermelons handled and imported by that person. A final rule was published in the
At its February 26, 2011, meeting, the Board voted unanimously to modify the importer eligibility requirements to serve on the Board. The Board is having difficulty finding eligible importers to serve on the Board because of the requirement in the Plan that a person who both imports and handles watermelon will be counted as an importer if that person imports 50 percent or more of the combined total volume of watermelons handled and imported by that person. The Board voted to eliminate the 50 percent or more requirement of the combined total volume of watermelons handled and imported by a person to allow more individuals to become eligible to serve on the Board as an importer. Individuals that both handle and import would be allowed to decide which part of the industry they would prefer to represent regardless of the volume handled or imported. The industry believes that this change would increase the importer representation on the Board by allowing more individuals to be eligible to serve. This action may also increase diversity on the Board.
Accordingly, the proposed rule would amend sections 1210.321(d) and 1210.404(g) which reference importer eligibility requirements to be nominated to the Board. These sections would be revised to specify that a person who both imports and handles watermelons may participate in the nomination process and serve on the Board as either an importer or handler, but not both.
Also, sections 1210.363(b) and 1210.602(a) as published in the proposed rule have been modified to remove unnecessary language. These sections pertain to referenda; the language removed does not affect the way the referendum will be conducted or how the results will be determined. Thus, the changes to sections 1210.363(b) and 1210.602(a) will not be voted on in the referendum.
For the changes to sections 1210.321(d) and 1210.404(g) of the Plan to become effective, the proposed amendment must be approved by a majority of eligible producers, handlers, and importers of watermelons voting in a referendum. Only producers of 10 acres or more of watermelons; watermelon handlers, and importers of 150,000 or more pounds of watermelons annually, and importers who import less than 150,000 pounds of watermelons annually and did not apply for and receive reimbursements of assessments during the representative period will be eligible to vote in the referendum. Accordingly, a referendum will be conducted among eligible producers, handlers, and importers of watermelons. The referendum will be conducted by mail ballot from January 13, 2014 through January 27, 2014. Ballots must be received by the referendum agents no later than the close of business 4:30 p.m., Eastern daylight-standard time, January 27, 2014, to be counted.
A thirty-day comment period was provided to allow interested persons to respond to this proposal which was published in the
Of the 16 comments received, 14 comments supported the proposed amendment. One comment was opposed to the watermelon program in general and was not within the scope of this rulemaking action. One comment discussed how the amendments were presented and made recommendations on writing the regulation so it is easier for the public to understand.
In general, commenters supporting the amendment stated the change would allow more importers to be eligible to serve on the Board. One commenter stated this would allow the Board to fill vacant seats on the Board with qualified individuals who are interested in serving the watermelon industry.
One commenter who supported the importer requirement change recommended adding a clause that the eligible importer should not import less than 10 percent of their total combined volume imported and handled. As previously mentioned, the Board considered reducing the 50 percent requirement to a lower level such as 25 percent, so that persons who import and handle watermelons could serve on the Board as an importer if 25 percent of their combined volume was imported. However, the Board wants to allow more individuals to serve on the Board and thus recommended eliminating the percentage requirement altogether. No changes have been made to the proposed rule based on this comment.
Another commenter who supported the proposed change suggested adding a clause to prevent a board member who imports less than 10 percent of watermelons to use their position to steer or direct the research and promotion activities to suit their personal needs. There are 37 Board members, and each member may vote on all budgets, marketing, research, and promotional activities as described in sections 1210.325 and 1210.328 of the Plan. Further, any action of the Board requires the concurring votes of a majority of those present and voting. No changes have been made to the proposed rule based on this comment.
As mentioned above, one commenter recommended writing the regulation so that it is easier for the public to understand. The Department reviewed the recommendations and adopted some of them as discussed in the following paragraphs.
The commenter suggested that section 1210.321(d) of the Plan regarding nominations and selections be revised to be more informative and easier to understand. The Department agrees and has simplified the last portion of this section as published in the proposed rule to specify that all importers may participate in the nomination process. A person who both imports and handles watermelons may participate in the nomination process and serve on the Board as either an importer or handler, but not both.
The commenter also suggested that section 1210.363(b) of the Plan which discusses suspension and termination be clarified. The Department agrees and has simplified the section to remove unnecessary language. The language removed does not affect the way the referendum will be conducted or how the results will be determined. Thus, the change to section 1210.363(b) will not be voted on in the referendum.
The commenter also recommended revising the language of section 1210.404(g) of the Plan which discussed the importer member nomination and selection. The Department agrees the language should be clarified and has revised the language to specify that a person who both imports and handles watermelons may participate in the nomination process and serve on the Board as either an importer or handler, but not both.
The commenter also recommended revising section 1210.602(a) of the Plan regarding voting in a referendum. The Department agrees and has simplified the section to remove language that is not necessary. The language removed does not affect the way the referendum will be conducted or how the results will be determined. Thus, the change to section 1210.602(b) will not be voted on in the referendum.
The commenter suggested changing the headings in sections 1210.321, 1210.363, 1210.404 and 1210.602 to a question format to be more useful and easier for the public to understand. Regulations for research and promotion programs are used primarily by a sector of the public who are industry members familiar with the program or persons who administer the program's day-to-day operations. Each program begins with an index that lists the sections of each program for ease of reference. Industry members and program administrators have found the format useful. Changing the format in the manner suggested would cause confusion. Thus, no changes to the proposed rule have been made based on this comment.
The commenter also made suggestions to sections that were not included in the first proposed rule published in February 2013. The commenter recommended replacing the term “Secretary” with the name of the office or official who takes action on the program. Section 1210.301 of the Plan defines Secretary to mean not only the Secretary of Agriculture, but also any person to whom the Secretary has delegated authority. Names of offices and titles change periodically within the Department and it would be inefficient and costly to engage in rulemaking to revise the terms in the Plan each time. Thus, no changes have been made to the proposed rule based on this comment.
The commenter also recommended using the term “marketer” and defining it within the regulation to avoid repeating the terms “producer,” “handler,” and “importer.” The commenter believes using the term marketer would be easier for the reader to understand. Producers, handlers, and importers perform different roles in the industry which are defined in sections 1210.306, 1210.307, and 1210.314 respectively in the Plan. Producers grow watermelons. Handlers perform functions like grading, packing, or processing and placing watermelons in channels of commerce. Importers import watermelons into the United States. In the field of agriculture, marketers are typically persons who sell product into channels of trade. Producers, handlers and importers do not all market watermelons, and categorizing all three as marketers would likely create confusion in the industry. The terms are also consistent with the Watermelon Research and Promotion Act. Thus, no changes have been made to the proposed rule based on this comment.
For the proposed amendments to the Plan and to become effective, they must be approved by a majority of the eligible producers, handlers, and importers voting in the referendum. The proposed changes to the regulations will be made effective, if the proposed amendments to the Plan are approved in referendum.
While the proposal set forth below has not received the approval of USDA, it is determined that the proposed amendment is consistent with and would effectuate the purposes of the Act.
It is hereby directed that a referendum be conducted among eligible watermelon producers, handlers, and importers to determine whether they favor amending the Watermelon Research and Promotion Plan to eliminate the requirement that an importer import more than 50 percent of the total volume handled and imported in order to qualify as an importer
The referendum shall be conducted from January 13, 2014 through January 27, 2014. The referendum agents will mail the ballots to be cast in the referendum and voting instructions to all known eligible watermelon producers, handlers, and importers prior to the first day of the voting period. Only producers of 10 acres or more of watermelon; watermelon handlers, and importers of 150,000 or more pounds of watermelons annually, and importers who import less than 150,000 pounds of watermelons annually and did not apply for and receive reimbursements of assessments annually during the representative period will be eligible to vote in the referendum. Any eligible watermelon producers, handlers, and importers who do not receive a ballot should contact the referendum agent no later than one week before the end of the voting period. Ballots must be received by the referendum agents no later than the close of business 4:30 p.m., Eastern daylight-standard time, January 27, 2014, to be counted.
Jeanette Palmer, Sonia Jimenez and Marlene Betts, PED, FVP, AMS, USDA, Stop 0244, Room 1406–S, 1400 Independence Avenue SW., Washington, DC 20250–0244, are designated as the referendum agents of the Department to conduct this referendum. The referendum procedures specified in sections 1210.600 through 1210.607 of the Plan, which were issued pursuant to the Act, shall be used to conduct the referendum.
Administrative practice and procedure, Advertising, Consumer information, Marketing agreements, Reporting and recordkeeping requirements, Watermelon promotion.
For the reasons set forth in the preamble, part 1210, chapter XI of title 7 is proposed to be amended as follows:
7 U.S.C. 4901–4916 and 7 U.S.C. 7401.
(d) Nominations for importer positions that become vacant may be made by mail ballot, nomination conventions, or by other means prescribed by the Secretary. The Board shall provide notice of such vacancies and the nomination process to all importers through press releases and any other available means as well as direct mailing to known importers. All importers may participate in the nomination process. A person who both imports and handles watermelons may participate in the nomination process and serve on the Board as either an importer or handler, but not both.
(b) The Secretary may conduct a referendum at any time and shall hold a referendum on request of the Board or at least 10 percent of the combined total of the watermelon producers, handlers, and importers to determine if watermelon producers, handlers, and importers favor termination or suspension of this Plan. The Secretary shall suspend or terminate this Plan at the end of the marketing year whenever the Secretary determines that the suspension or termination is favored by a majority of the watermelon producers, handlers, and importers voting in such referendum who, during a representative period determined by the Secretary, have been engaged in the production, handling, or importing of watermelons and who produced, handled, or imported more than 50 percent of the combined total of the volume of watermelons produced, handled, or imported by those producers, handlers, and importers voting in the referendum. Any such referendum shall be conducted by mail ballot.
(g) A person who both imports and handles watermelons may participate in the nomination process and serve on the Board as either an importer or handler, but not both.
(a) Each person who is an eligible producer, handler, or importer as defined in this subpart, at the time of the referendum and who also was a producer, handler, or importer during the representative period, shall be entitled to one vote in the referendum:
Nuclear Regulatory Commission.
Rescheduling of public meeting.
The U.S. Nuclear Regulatory Commission (NRC) has rescheduled to November 12 the Waste Confidence public meeting it initially planned to hold in Oak Brook, Illinois, on October 24, 2013. The NRC postponed this meeting as a result of lapsed appropriations. The rescheduled meeting will allow the NRC to receive public comments on proposed amendments to the NRC's regulations pertaining to the environmental impacts of the continued storage of spent nuclear fuel beyond a reactor's licensed life for operation and prior to ultimate disposal (the proposed Waste Confidence rule) and the draft generic environmental impact statement (DGEIS), NUREG–2157, “Waste Confidence Generic Environmental Impact Statement,” that forms a regulatory basis for the proposed amendments. The meeting is open to the public, and anyone may attend. The NRC will publish notices for other postponed and rescheduled Waste Confidence public meetings as soon as practicable.
The NRC plans to hold its rescheduled Waste Confidence public meeting in Oak Brook, Illinois, on November 12, 2013. This document contains specific meeting information in the
Please refer to Docket ID NRC–2012–0246 when contacting the NRC about the availability of information for the proposed Waste Confidence rule and DGEIS. You may access publicly available information related to these documents by any of the following methods:
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Sarah Lopas, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–287–0675; email:
The NRC published the proposed Waste Confidence Rule in the
Prior to the lapse in appropriations in October 2013, the NRC staff held two Waste Confidence public meetings (one in Rockville, Maryland, on October 1, and one in Denver, Colorado, on October 3). The NRC postponed five meetings (in San Luis Obispo and Carlsbad, California; Perrysburg, Ohio; Minnetonka, Minnesota; and Oak Brook, Illinois) as a result of lapsed appropriations. The NRC has rescheduled the meetings in Carlsbad and San Luis Obispo, California, on November 18 and November 20, respectively. The NRC will publish notices for rescheduled meetings in Perrysburg, Ohio, and Minnetonka, Minnesota, as soon as practicable. Five additional Waste Confidence public meetings remain scheduled as publicized in 78 FR 54789: Chelmsford, Massachusetts, on October 28; Tarrytown, New York, on October 30; Charlotte, North Carolina, on November 4; Orlando, Florida, on November 6; and Rockville, Maryland, on November 14.
The November 12 public meeting will take place in the Oak Brook Ballroom of the Chicago Marriott Oak Brook, 1401 West 22nd Street, Oak Brook, Illinois. The meeting will start at 7:00 p.m. Central Standard Time and will continue until 10:00 p.m. Central Standard Time. Additionally, the NRC staff will host informal discussions during an open house one hour prior to the start of the meeting. The open house will start at 6:00 p.m. Central Standard Time.
The NRC staff will receive comments from the public during the comment-period portion of the meeting. The public meeting will be transcribed and will include: (1) a presentation on the contents of the DGEIS and proposed Waste Confidence rule; and (2) the opportunity for government agencies, organizations, and individuals to provide comments on the DGEIS and proposed rule. No oral comments on the DGEIS or proposed Waste Confidence rule will be accepted during the pre-meeting, open-house session. To be considered, oral comments must be presented during the transcribed portion of the public meeting. The NRC staff will also accept written comments at any time during the public meeting.
Persons interested in presenting oral comments at the November 12 public meeting are encouraged to pre-register. Persons may pre-register to present oral comments by calling 301–287–9392 or by emailing
If special equipment or accommodations are needed to attend or present information at the public meeting, then the need should be brought to the NRC's attention no later than 10 days prior to the meeting to provide the NRC staff adequate notice to determine whether the request can be accommodated. The meeting agenda and participation details will be available on the NRC's Public Meeting Schedule Web site at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Rescheduling of public meetings.
The U.S. Nuclear Regulatory Commission (NRC) has rescheduled the Waste Confidence public meetings it initially planned to hold in San Luis Obispo and Carlsbad, California, on October 7 and October 9, respectively. The NRC postponed these meetings as a result of lapsed appropriations. The Waste Confidence public meeting in Carlsbad will now be held on November 18, 2013. The Waste Confidence public meeting in San Luis Obispo will now be held on November 20, 2013. The rescheduled meetings will allow the NRC to receive public comments on proposed amendments to the NRC's regulations pertaining to the environmental impacts of the continued storage of spent nuclear fuel beyond a reactor's licensed life for operation and prior to ultimate disposal (the proposed Waste Confidence rule) and the draft generic environmental impact statement (DGEIS), NUREG–2157, “Waste Confidence Generic Environmental Impact Statement,” that forms a regulatory basis for the proposed rule. The meetings are open to the public, and anyone may attend. The NRC will publish notices for other postponed and rescheduled Waste Confidence public meetings as soon as practicable.
The NRC plans to hold a rescheduled Waste Confidence public meeting in Carlsbad, California, on November 18, 2013. The NRC plans to hold a rescheduled Waste Confidence public meeting in San Luis Obispo, California, on November 20, 2013. This document contains specific meeting information in the
Please refer to Docket ID NRC–2012–0246 when contacting the
• Federal Rulemaking Web Site: Go to
• NRC's Waste Confidence Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may access publicly available documents online in the NRC Library at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Sarah Lopas, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–287–0675; email:
The NRC published the proposed Waste Confidence Rule in the
Prior to the lapse in appropriations in October 2013, the NRC staff held two Waste Confidence public meetings (one in Rockville, Maryland, on October 1, and one in Denver, Colorado, on October 3). The NRC postponed five meetings (in San Luis Obispo and Carlsbad, California; Perrysburg, Ohio; Minnetonka, Minnesota; and Oak Brook, Illinois) as a result of lapsed appropriations. The NRC has rescheduled the meeting in Oak Brook, Illinois, on November 12. The NRC will publish notices for rescheduled meetings in Perrysburg, Ohio, and Minnetonka, Minnesota, as soon as practicable. Five additional Waste Confidence public meetings remain scheduled as publicized in 78 FR 54789: Chelmsford, Massachusetts, on October 28; Tarrytown, New York, on October 30; Charlotte, North Carolina, on November 4; Orlando, Florida, on November 6; and Rockville, Maryland, on November 14.
The November 18 public meeting will take place at the Sheraton Carlsbad Resort and Spa, 5480 Grand Pacific Drive, Carlsbad, California. The November 20 public meeting will take place at the Courtyard by Marriott San Luis Obispo, 1605 Calle Joaquin Road, San Luis Obispo, California. Each meeting will start at 7:00 p.m. Pacific Standard Time and will continue until 10:00 p.m. Pacific Standard Time. Additionally, the NRC staff will host informal discussions during an open house one hour prior to the start of each meeting. The open houses will start at 6:00 p.m. Pacific Standard Time.
The NRC staff will accept comments from the public during the comment-period portion of the meetings. The public meetings will be transcribed and will include: (1) A presentation on the contents of the DGEIS and proposed Waste Confidence rule; and (2) the opportunity for government agencies, organizations, and individuals to provide comments on the DGEIS and proposed rule. No oral comments on the DGEIS or proposed Waste Confidence rule will be accepted during the pre-meeting, open-house sessions. To be considered, oral comments must be presented during the transcribed portions of the public meetings. The NRC staff will also accept written comments at any time during the public meetings.
Persons interested in presenting oral comments at the November 18 or 20 public meetings are encouraged to pre-register. Persons may pre-register to present oral comments at either meeting by calling 301–287–9392 or by emailing
If special equipment or accommodations are needed to attend or to present information at either public meeting, then the need should be brought to the NRC's attention no later than 10 days prior to the meeting to provide the NRC staff adequate notice to determine whether the request can be accommodated. The meeting agenda and participation details for each meeting will be available on the NRC's Public Meeting Schedule Web site at
For the Nuclear Regulatory Commission.
National Nuclear Security Administration (NNSA), Department of Energy (DOE).
Notice of a second public meeting and extension of comment period.
On September 7, 2011, DOE issued a notice of proposed rulemaking (NOPR) to propose the first comprehensive updating of regulations concerning Assistance to Foreign Atomic Energy Activities since 1986. The NOPR reflected a need to make the regulations consistent with current global civil nuclear trade practices and nonproliferation norms, and to update the activities and technologies subject to the Secretary of Energy's specific authorization and DOE reporting requirements. It also identified destinations with respect to which most assistance would be generally authorized. Remaining destinations would require a specific authorization by the Secretary of Energy. After careful consideration of all comments received, DOE published a supplemental notice of proposed rulemaking (SNOPR) on August 2, 2013, to respond to those comments, propose new or revised rule changes, and afford interested parties an opportunity to comment.
A public meeting on the SNOPR was held at DOE's headquarters on August 5, 2013. A second public meeting will be held on November 15, 2013 at the Washington Grand Hyatt, 1000 H St. NW., Washington, DC 20001.
In conjunction with the timing of this second public meeting, the Department is extending the comment period to November 29, 2013. The extension will facilitate conducting the second public meeting and afford additional time for the public to review and comment on the proposed regulation. The Department looks forward to hearing feedback from the public on the proposed regulations.
DOE will continue to accept written comments on the SNOPR published August 2, 2013 (78 FR 46829) submitted electronically or postmarked on or before November 29, 2013. The second public meeting will be held on November 15, 2013, from 9 a.m. to 12 p.m. at the Washington Grand Hyatt, 1000 H St. NW., Washington, DC 20001. Due to space limitations, DOE asks that interested persons send their requests to attend this meeting, by no later than 4:30 p.m. on November 13, 2013.
Interested persons should send their requests to attend the second public meeting via email to
1.
2.
3.
Due to potential delays in DOE's receipt and processing of mail sent through the U.S. Postal Service, DOE encourages responders to submit comments electronically to ensure timely receipt.
All submissions must include the RIN for this rulemaking, RIN 1994–AA02. For additional information and instructions on submitting comments, see the “Public Comment Procedures” heading of the
Richard Goorevich, Senior Policy Advisor, Office of Nonproliferation and International Security, NA–24, National Nuclear Security Administration, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, telephone 202–586–0589; Janet Barsy, Office of the General Counsel, GC–53, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, telephone 202–586–3429; or Katie Strangis, National Nuclear Security Administration, 1000 Independence Avenue SW., Washington, DC 20585, telephone 202–586–8623.
On September 7, 2011, DOE issued a notice of proposed rulemaking (NOPR) to propose the first comprehensive updating of regulations concerning Assistance to Foreign Atomic Energy Activities since 1986. (76 FR 55278) The NOPR reflected a need to make the regulations consistent with current global civil nuclear trade practices and nonproliferation norms, and to update the activities and technologies subject to the Secretary of Energy's specific authorization and DOE reporting requirements. It also identified destinations with respect to which most assistance would be generally authorized and destinations that would require a specific authorization by the Secretary of Energy. After careful consideration of all comments received, DOE published a SNOPR on August 2, 2013, to respond to those comments, propose new or revised rule changes, and afford interested parties a second opportunity to comment. (78 FR 46829)
A public meeting on the SNOPR was held at the DOE Forrestal Building located in Washington, DC, on August 5, 2013. A second public meeting on the SNOPR will be held on November 15, 2013, from 9 a.m. to 12 p.m. at the Washington Grand Hyatt, 1000 H St, NW Washington, DC, 20001. Interested persons should send their requests to attend the second public meeting via email to
Persons interested in giving an oral presentation at the second public meeting should provide a daytime phone number where the person can be reached in the email requesting attendance. Each oral presentation may be limited and may in no instance be longer than 20 minutes. Persons making an oral presentation are requested to provide 3 copies of their prepared statement to the public meeting and submit it at the registration desk. DOE reserves the right to select the persons who will speak. DOE also reserves the right to schedule speakers' presentations and to establish the procedures for conducting the meeting. A DOE official will be designated to preside at the meeting.
The meeting will not be a judicial or evidentiary-type hearing. Any further procedural rules for the conduct of the meeting will be announced by the presiding official. After the public meeting, interested persons may submit comments until the end of the comment period. A transcript of the meeting will be made, and the entire record of this rulemaking will be retained by DOE and posted at regulations.gov.
Due to the lapse in the fiscal year 2014 appropriation and associated impacts on government operations, the Department will extend the comment period to November 29, 2013. The extension will facilitate conducting the second public meeting and afford additional time for the public to review and comment on the SNOPR.
As provided in the SNOPR, if you submit information that you believe to be exempt by law from public disclosure, you should submit one complete copy, as well as one copy from which the information claimed to be exempt by law from public disclosure has been deleted. DOE is responsible for the final determination with regard to disclosure or nondisclosure of the information and for treating it accordingly under the DOE Freedom of Information regulations at 10 CFR 1004.11.
Federal Aviation Administration (FAA), DOT.
Notice of proposed special conditions.
This action proposes special conditions for Airbus Model A350–900 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with a braking system that affects the airplane's pivoting behavior. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to
Send your comments on or before December 13, 2013.
Send comments identified by docket number FAA–2013–0890 using any of the following methods:
• Federal eRegulations Portal: Go to
• Mail: Send comments to Docket Operations, M–30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12–140, West Building Ground Floor, Washington, DC 20590–0001.
• Hand Delivery or Courier: Take comments to Docket Operations in Room W12–140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays.
• Fax: Fax comments to Docket Operations at 202–493–2251.
Privacy: The FAA will post all comments it receives, without change, to
Docket: Background documents or comments received may be read at
Todd Martin, FAA, Airframe/Cabin Safety, ANM–115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057–3356; telephone (425) 227–1178; facsimile (425) 227–1320.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the proposed special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.
We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.
On August 25, 2008, Airbus applied for a type certificate for their new Model A350–900 series airplane. Later, Airbus requested and the FAA approved an extension to the application for FAA type certification to June 28, 2009. The Model A350–900 series airplane has a conventional layout with twin wing-mounted Rolls-Royce Trent engines. It features a twin aisle 9-abreast economy class layout, and accommodates side-by-side placement of LD–3 containers in the cargo compartment. The basic Model A350–900 series configuration will accommodate 315 passengers in a standard two-class arrangement. The design cruise speed is Mach 0.85 with a Maximum Take-Off Weight of 602,000 lbs. Airbus proposes the Model A350–900 series airplane to be certified for extended operations (ETOPS) beyond 180 minutes at entry into service for up to a 420-minute maximum diversion time.
The Airbus Model A350–900 series airplane is equipped with a braking system that affects the airplane's pivoting behavior. During pivoting the braking system inhibits braking on some wheels. Title 14 Code of Federal Regulations (14 CFR) 25.503 and European Aviation Safety Agency (EASA) Certification Specification (CS) section 25.503, each specify limit loads due to pivoting, however, system effects are not taken into account.
Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Airbus must show that the Model A350–900 series meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25–1 through 25–128.
If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model A350–900 series because of a novel or unusual design feature, special conditions are prescribed under § 21.16.
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the proposed special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and proposed special conditions, the Model A350–900 series must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36 and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92–574, the “Noise Control Act of 1972.”
The FAA issues special conditions, as defined in 14 CFR 11.19, under § 11.38, and they become part of the type-certification basis under § 21.17(a)(2).
The Airbus Model A350–900 series airplane will incorporate the following novel or unusual design features: a braking system that affects the airplane's pivoting behavior.
Within the Aviation Rulemaking Advisory Committee, the Loads and Dynamics Harmonization Working Group developed criteria for determining pivoting loads. The group recommended, for airplanes with more than two main landing gear units, a rational pivoting maneuver that takes into account the effects of the braking system and tire characteristics, in lieu of the current requirement. Although the Airbus Model A350–900 series airplane has two main landing gear units, EASA and the FAA propose to apply the same criteria on this airplane.
As discussed above, these proposed special conditions apply to Airbus Model A350–900 series airplanes. Should Airbus apply later for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the proposed special conditions would apply to that model as well.
This action affects only certain novel or unusual design features on the Airbus Model A350–900 series airplanes. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Airbus Model A350–900 series airplanes in lieu of § 25.503:
1. The main landing gear and supporting structure must be designed for the loads induced by pivoting during ground maneuvers.
(a) The following rational pivoting maneuvers must be considered:
(i) Towing at the nose gear at the critical towing angle with no brakes applied, including cases with torque links disconnected; and separately,
(ii) Application of symmetrical or unsymmetrical forward thrust to aid pivoting, with or without braking by pilot action on the pedals.
(b) The airplane is assumed to be in static equilibrium, with the loads being applied at the ground contact points.
(c) The limit vertical load factor must be 1.0, and:
(i) For wheels with brakes applied, the coefficient of friction must be 0.8,
(ii) For wheels with brakes not applied, the ground tire reactions must be based on reliable tire data.
Federal Aviation Administration (FAA), DOT.
Availability of an initial regulatory flexibility analysis.
This document announces the availability of and request for comments on the initial regulatory flexibility analysis for the previously published Airworthiness Directive (AD) 2013–09–05 that applies to certain Twin Commander Aircraft LLC Models 690, 690A, and 690B airplanes. AD 2013–09–05 requires inspection for cracking of the outer fuselage attachments, the lower wing main spar, the vertical channels, the upper picture window channels, aft cabin pressure web, external wing to fuselage fillets, and fasteners; repair or replacement of damaged parts as necessary; and modification of the structure with reinforced parts.
Comments must be received on or before December 13, 2013.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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Kathleen Arrigotti, Aerospace Engineer, FAA, Seattle Aircraft Certification Office (ACO), Airframe Branch, ANM–120S, 1601 Lind Avenue SW., Renton, WA 98057; telephone: (425) 917–6426; fax: (425) 917–6590; email:
We issued AD 2013–09–05; Amendment 39–17446, which was published in the
The Regulatory Flexibility Act of 1980 (Pub. L. 96–354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration. The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. In accordance with Section 608 of the Regulatory Flexibility Act, an agency head may waive or delay completion of some or all of the requirements of Section 603 by providing a written finding that the final rule is being promulgated in response to an emergency that makes compliance or timely compliance with the provisions of Section 603 impracticable. The agency issued AD 2013–09–05 in response to an immediate safety of flight condition that made compliance with the provisions of Section 603 impracticable. After issuing AD 2013–09–05, the agency reviewed the AD actions and determined that the final rule did have a significant economic impact on a substantial number of small entities. The following presents the initial regulatory flexibility analysis prepared by the agency as described in the RFA.
We issued AD 2013–09–05 for certain Twin Commander Aircraft LLC Models 690, 690A, and 690B airplanes. The AD requires inspection for cracking of the outer fuselage attachments, the lower wing main spar, the vertical channels, the upper picture window channels, aft cabin pressure web, external wing to fuselage fillets, and fasteners; repair or replacement of damaged parts as necessary; and modification of the structure with reinforced parts. The AD was prompted by cracks found in the upper picture window frame channels, left- and right-hand wing main spar frame support channels, and aft pressure bulkhead web. This condition, if not corrected, could result in structural failure of the airplane. We issued the AD to correct the unsafe condition on these products.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more
We issued the AD under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in the AD.
Compliance with AD 2013–09–05 must occur within the times specified, unless already done.
Inspect the airplane structural components, at the compliance times specified in paragraphs (g)(1)(i) through (g)(1)(iv) of the AD following Part I of Twin Commander Aircraft LLC Service Bulletin 241, September 26, 2012:
• For airplanes with 10,000 or more hours time-in-service (TIS), inspect within the next 30 days after May 29, 2013 (the effective date of the AD).
• For airplanes with 7,500 through 9,999 hours TIS, inspect within the next 60 days after May 29, 2013 (the effective date of the AD).
• For airplanes with 5,000 through 7,499 hours TIS, inspect within the next 6 months after May 29, 2013 (the effective date of the AD).
• For airplanes with less than 5,000 hours TIS, inspect when the airplane accumulates a total of 5,000 hours TIS or within the next 12 months after May 29, 2013 (the effective date of the AD), whichever occurs later.
If any damage, cracks, and/or cracks that exceed the allowable limits specified in the service bulletin are found during the inspection required in paragraph (g)(1) of the AD, before further flight, repair or replace parts as necessary following Twin Commander Aircraft LLC Service Bulletin 241, dated, September 26, 2012. If Twin Commander Aircraft LLC Service Bulletin 241, dated, September 26, 2012, does not give procedures for repair of the damaged area, before further flight, you must contact Twin Commander Aircraft LLC to obtain repair instructions approved by the Seattle ACO specifically for compliance with this AD and incorporate those instructions. You can find contact information for Twin Commander Aircraft LLC in paragraph (l)(2) of the AD.
• Before further flight after completing the actions in paragraphs (g) and (h) of the AD, modify and reassemble the airplane using the modification and reassembly procedures in Part II of Twin Commander Aircraft LLC Service Bulletin 241, dated, September 26, 2012.
• Although Twin Commander Aircraft LLC Service Bulletin 241, dated September 26, 2012, states that at least one person on the modification team must have completed the Twin Commander Aircraft LLC approved training, the FAA does not require that a mechanic complete this specialized training to do the modification work required in the AD. Regulations 14 CFR 65.81(a) and 14 CFR 65.81(b) provide criteria about qualifications of those performing maintenance; in this case, the requirements of the AD.
There are no rules that duplicate, overlap, or conflict with AD 2013–09–05.
Under the RFA, the FAA must determine whether a final rule significantly affects a substantial number of small entities. This determination is typically based on small entity size and revenue thresholds that vary depending on the affected industry. To determine the number of small entities affected by the airworthiness directive, we searched the FAA Aircraft Registry database. The database provides ownership information for 175 of the airplanes affected by AD 2013–09–05, and average airplane values for these airplanes are available in the
The FAA aircraft registry categorizes owners of affected airplanes as individuals, co-owners, corporations, and governments. A review of the corporations shows that an overwhelming majority are privately held. In most cases, the information about these corporations cannot be determined because financial and employment data for privately held entities is sparse. Nevertheless, the FAA believes the number of small business entities affected by the AD is substantial.
The serial numbers for the 175 affected airplanes that we have information on was used to look up average retail values in the
The economic impact on small entities due to the AD is significant. This determination is based on the percentage of the cost of compliance per airplane ($58,090) to the average retail value per airplane ($451,000), which is estimated to be 12.9 percent.
Based on the discussion above, complying with the AD is determined to be significant economic impact on a substantial number of small entities.
The FAA considered possible alternative actions and determined the actions taken were necessary to address the unsafe condition. The FAA did not extend the compliance time because we needed to act immediately to address the immediate safety problem. The inspection and modification both involve a complex disassembly that comprises most of the labor cost associated with the AD. Performing the modification while the airplane is already disassembled for inspection saves owners the labor cost of disassembling twice. If discrepancies are not found in the inspection, no repair expense, beyond the mandated modification expense, will occur.
The Trade Agreements Act of 1979 (Pub. L. 96–39), as amended by the Uruguay Round Agreements Act (Pub. L. 103–465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $143.1 million in lieu of $100 million. The AD does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.
We invite you to send any written relevant data, views, or arguments about this IRFA. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Pratt & Whitney (PW) PW2037, PW2037D, PW2037M, PW2040, PW2040D, PW2043, PW2146, PW2240, PW2337, PW2643, and F117–PW–100 turbofan engines. This proposed AD was prompted by a rupture of the diffuser-to-high-pressure turbine (HPT) case flange. This proposed AD would require a one-time eddy current inspection (ECI) of affected engines with certain diffuser and HPT cases installed. This AD also proposes to require a fluorescent-penetrant inspection (FPI) of the diffuser case rear flange and HPT case front flange. We are proposing this AD to prevent failure of the diffuser-to-HPT case flange, which could lead to uncontained engine failure and damage to the airplane.
We must receive comments on this proposed AD by December 30, 2013.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For service information identified in this proposed AD, contact Pratt & Whitney, 400 Main St., East Hartford, CT 06108; phone: 860–565–8770; fax: 860–565–4503. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125.
You may examine the AD docket on the Internet at
Robert Morlath, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7154; fax: 781–238–7199; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We received a report of an engine event in October 2011 that resulted in a rupture of the engine diffuser-to-HPT case flange. The rupture caused the engine cowl doors to break open, which resulted in damage to the underside of the airplane's wing. Subsequent investigation revealed that the root cause of this rupture was a crack that originated in HPT case M-flange boltholes (the forward flange of the HPT case that mates with the rear outer flange of the diffuser case). This condition, if not corrected, could result in failure of the diffuser-to-HPT case flange, which may cause an uncontained engine failure and damage to the airplane.
We reviewed PW Service Bulletin (SB) No. PW2000 72–763, Revision 1, dated August 30, 2013, and PW PW2000 Series Engine Manual part number 1A6231. The SB describes procedures for inspecting the flanges of the HPT case and the diffuser case.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require an on-wing ECI of the diffuser case and HPT case flanges. This proposed AD would also require an FPI of all engine diffuser cases and all HPT cases.
PW SB No. PW2000 72–763, Revision 1, dated August 30, 2013, requires that operators complete an on-wing ECI by August 31, 2013. We are proposing that the ECI be performed within 100 flight cycles or 30 days after the effective date of this AD, whichever is earlier.
We estimate that this proposed AD will affect 638 engines installed on airplanes of U.S. registry. Of the 638 engines, we estimate that about 58 engines will be subject to ECI and all engines will be subject to the FPI. We also estimate that it would take about 5 hours to perform the ECI and 3 hours to perform the FPI required by this proposed AD. Materials cost for the FPI will be about $20 per engine. The average labor rate is $85 per hour. Based on these figures, we estimate the total cost of this proposed AD to U.S. operators to be $200,100.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This proposed regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 30, 2013.
None.
This AD applies to all Pratt & Whitney (PW) PW2037, PW2037D, PW2037M, PW2040, PW2040D, PW2043, PW2146, PW2240, PW2337, PW2643, and F117–PW–100 turbofan engines.
This AD was prompted by a rupture of the diffuser-to-high-pressure turbine (HPT) case flange. We are issuing this AD to prevent failure of the diffuser-to-HPT case flange, which could lead to uncontained engine failure and damage to the airplane.
Unless already done, comply with this AD within the compliance times specified.
(1) For diffuser and HPT cases identified by serial number (S/N) in Table 1 to paragraph (e) of this AD:
(i) Within 100 flight cycles or 30 days after the effective date of this AD, whichever is earlier, eddy current inspect the diffuser case and the HPT case M-flange.
(ii) For engines installed on the aircraft, use paragraphs 3.G. through 3.L. in the “For Engines Installed on the Aircraft” section of the Accomplishment Instructions of PW Service Bulletin (SB) No. PW2000 72–763, Revision 1, dated August 30, 2013, to perform the inspection.
(iii) For engines removed from the aircraft, use paragraphs 3.B. through 3.G. in the “For Engines Removed From the Aircraft” section of the Accomplishment Instructions of PW Service Bulletin (SB) No. PW2000 72–763, Revision 1, dated August 30, 2013, to perform the inspection.
(2) For all diffuser and HPT cases:
(i) At the next piece part exposure and every piece part exposure thereafter, perform a high sensitivity fluorescent-penetrant inspection (FPI) of the entire diffuser case rear flange (M-flange) and bolt holes.
(ii) At the next piece part exposure and every piece part exposure thereafter, perform a high sensitivity FPI of the entire HPT case forward flange (M-flange) and bolt holes.
After the effective date of this AD, do not install any engine with a diffuser or HPT case with serial number listed in Table 1 to paragraph (e) of this AD, onto any aircraft, that was not inspected per paragraph (e) of this AD.
If you performed an eddy current inspection of the diffuser case and HPT case M-flange using paragraphs 3.G. through 3.L. in the “For Engines Installed on the Aircraft” section or paragraphs 3.B. through 3.G. in the “For Engines Removed from the Aircraft” section of the Accomplishment Instructions of PW SB PW2000 72–763, dated March 22, 2013, you met the requirements of paragraph (e)(1) of this AD.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request.
(1) For more information about this AD, contact Robert Morlath, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7154; fax: 781–238–7199; email:
(2) Pratt & Whitney Engine Manual, part number 1A6231, Chapter 72–41–00, Inspection/Check-02, (Task 72–41–00–230–002) and Chapter 72–52–00, Inspection/Check-02 (Task 72–52–00–230–000), which are not incorporated by reference in this AD, can be obtained from Pratt & Whitney, using the contact information in paragraph (i)(3) of this AD.
(3) For service information identified in this AD, contact Pratt & Whitney, United Technologies Corporation, 400 Main St., East Hartford, CT 06108; phone: 860–565–8770; fax: 860–565–4503.
(4) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Pratt & Whitney Canada Corp. (P&WC) PT6A–114 and PT6A–114A turboprop engines. This proposed AD was prompted by several incidents of compressor turbine (CT) blade failure, including two fatalities, resulting in power loss and in-flight shutdown (IFSD) of the engine. This proposed AD would require initial and repetitive borescope inspections (BSIs) of CT blades, and the removal from service of blades that fail inspection. We are proposing this AD to prevent failure of CT blades, which could lead to damage to the engine or to the airplane.
We must receive comments on this proposed AD by December 30, 2013.
You may send comments by any of the following methods:
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For service information identified in this proposed AD, contact Pratt & Whitney Canada Corp., 1000 Marie-Victorin, Longueuil, Quebec, Canada, J4G 1A1; phone: 800–268–8000; fax: 450–647–2888; Internet:
You may examine the AD docket on the Internet at
James Lawrence, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7176; fax: 781–238–7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation, which is the aviation authority for Canada, has issued Canada AD CF–2013–21, dated August 1, 2013, (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
There have been a number of reported incidents where compressor turbine (CT) blade failures have caused power loss on PT6A–114 & PT6A–114A engines, resulting in in-flight shutdown (IFSD). Investigation by engine manufacturer Pratt & Whitney Canada (P&WC) has determined that when operated at high power and high temperature settings, the subject CT blades are prone to crack/fracture as result of creep and/or sulfidation.
This product has been approved by the aviation authority of Canada and is approved for operation in the United States. Pursuant to our bilateral agreement with Canada, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information provided by Transport Canada Civil Aviation and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This proposed AD would require initial and repetitive BSI of CT blades and the removal from service of blades that fail the inspection.
We estimate that this proposed AD affects 300 engines installed on aircraft of U.S. registry. We also estimate that it would take about 4 hours per engine to comply with this proposed AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $102,000.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This proposed regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 30, 2013.
None.
This AD applies to all Pratt & Whitney Canada Corp. (P&WC) PT6A–114 and PT6A–114A turboprop engines.
This AD was prompted by several incidents of compressor turbine (CT) blade failure, including two fatalities, resulting in power loss and in-flight shutdown (IFSD) of the engine. We are issuing this AD to prevent failure of CT blades, which could lead to damage to the engine or to the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 150 operating hours after the effective date of this AD, perform a borescope inspection (BSI) of CT blades for engines with 500 or more hours time since new (TSN) that have not been previously inspected, or more than 500 flight hours time since last inspection (TSLI).
(2) Thereafter, repeat the inspection in paragraph (e)(1) of this AD within every additional 500 flight hours TSLI.
(3) During the next hot section inspection (HSI) after the effective date of this AD, replace the complete set of CT blades with blades eligible for installation.
(4) If CT blades listed in paragraphs (g)(1) or (g)(2) of this AD, are installed to comply with paragraph (e)(3) of this AD, you must still comply with the 500-hour TSLI repetitive inspection requirement of paragraph (e)(2) of this AD.
Replacing all CT blades with new CT blades, P/N 3072791–01, and Disk Balance Assembly, P/N 3072801–01; or with new CT blades, P/N 3072791–02, and Disk Balance Assembly, P/N 3072801–02; is terminating action for this AD.
CT blades eligible for installation are:
(1) New CT blades, other than those listed in paragraphs (g)(3) and (g)(4) of this AD;
(2) CT blades, other than those listed in paragraphs (g)(3) and (g)(4) of this AD, that have met the inspection requirements of paragraphs (e)(1) and (e)(2) of this AD;
(3) CT blade, P/N 3072791–01, and Disk Balance Assembly, P/N 3072801–01; and
(4) CT blade, P/N 3072791–02, and Disk Balance Assembly, P/N 3072801–02.
If you performed P&WC Service Bulletin (SB) No. PT6A–72–1669, Revision 9, dated June 28, 2013, or earlier versions, you have met the initial inspection requirements of this AD. However, you must still comply with the 500-hour TSLI repetitive inspection requirement of paragraph (e)(2) of this AD.
The Manager, Engine Certification Office, FAA, may approve AMOCs to this AD. Use the procedures found in 14 CFR 39.19 to make your request.
(1) For more information about this AD, contact James Lawrence, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781–238–7176; fax: 781–238–7199; email:
(2) Refer to Transport Canada Civil Aviation AD CF–2013–21, dated August 1, 2013, for more information. You may examine the AD on the Internet at
(3) For guidance on the initial and repetitive BSIs mandated by this AD, refer to P&WC SB No. PT6A–72–1669 and P&WC SB No. PT6A–72–1727, which are not incorporated by reference in this AD. The SBs can be obtained from Pratt & Whitney Canada Corp. using the contact information in paragraph (j)(4) of this AD.
(4) For service information identified in this AD, contact Pratt & Whitney Canada Corp., 1000 Marie-Victorin, Longueuil, Quebec, Canada, J4G 1A1; phone: 800–268–8000; fax: 450–647–2888; Internet:
(5) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781–238–7125.
Federal Trade Commission (FTC or Commission).
Notice of extension of Commission determination and public comment deadlines.
The FTC is extending the deadlines for Commission determination of applications for approval of proposed parental consent methods by AssertID, Inc. (“AssertID”), Imperium LLC (“Imperium”), and iVeriFly, Inc. (“iVeriFly”) pursuant to the Children's Online Privacy Protection Rule. In addition, the FTC is extending the deadline for filing public comments concerning Imperium's application for approval of a parental consent method and the proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (“kidSAFE”), owned and operated by Samet Privacy, LLC, under the safe harbor provision of the Children's Online Privacy Protection Rule.
Written comments must be received by November 4, 2013.
Interested parties may file comments online or on paper, by following the instructions in the Request for Comment part of the
Kandi Parsons, Attorney, (202) 326–2369, Peder Magee, Attorney, (202) 326–3538, or Kristin Cohen, (202) 326–2276, Division of Privacy and Identity Protection, Federal Trade Commission, Washington, DC 20580.
On October 20, 1999, the Commission issued its final Rule
The Children's Online Privacy Protection Rule provides that the Commission shall issue a written determination within 120 days of the filing of an application for approval of a verifiable parental consent method.
In addition, during the time when the government was shut down, interested parties were unable to submit comments on Imperium's application for approval of a parental consent method or on kidSAFE's proposed self-regulatory guidelines. The Commission has decided to extend the comment period for both matters until November 4, 2013.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before November 4, 2013. For comments concerning Imperium, write “Imperium Application for Parental Consent Method, Project No. P–135419” on your comment. For comments concerning kidSAFE, write “kidSAFE Application for Safe Harbor, Project No. P–135418” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment doesn't include any sensitive personal information, such as Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment doesn't include any sensitive health information, including medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file your comment concerning Imperium at
If you file your comment concerning Imperium on paper, write “Imperium Application for Parental Consent Method, Project No. P–135419” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H–113 (Annex E), 600 Pennsylvania Avenue NW., Washington, DC 20580. If you file your comment concerning kidSAFE on paper, write “kidSAFE Application for Safe Harbor, Project No. P–135418” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H–113 (Annex E), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
By direction of the Commission.
Food and Drug Administration, HHS.
Notification of public meeting.
The Food and Drug Administration (FDA or we) is announcing three public meetings to discuss the proposed rule to establish requirements for current good manufacturing practice and hazard analysis and risk-based preventive controls for animal food. This proposed rule is one of several proposed rules that will establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to inform the public of the provisions of the proposed rule and the rulemaking process (including how to submit comments, data, and other information to the rulemaking docket) as well as solicit oral stakeholder and public comments on the proposed rule and to respond to questions about the proposed rule.
See section II, “How to Participate in the Public Meetings,” in the
See section II, “How to Participate in the Public Meetings,” in the
FSMA (Pub. L. 111–353) was signed into law by President Obama on January 4, 2011, to better protect public health by helping to ensure the safety and security of the food supply. FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. Among other things, FSMA requires FDA to issue regulations requiring preventive controls for human food and animal food, set standards for produce safety, and require importers to have a program to verify that the food products they bring into the United States are produced in a manner consistent with applicable FDA food safety requirements.
FSMA was the first major legislative reform of FDA's food safety authorities in more than 70 years, even though FDA has increased the focus of its food safety efforts on prevention over the past several years. The proposed rule for preventive controls for food for animals can be found elsewhere in this issue of the
The proposed rule would establish regulations regarding the manufacturing, processing, packing, or holding of animal food in two ways. First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would include new preventive control provisions intended to implement section 103 of FSMA for animal food. In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with FDA under the FD&C Act. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take appropriate corrective actions, and maintain records documenting these actions.
For information on the proposed rule for preventive controls for food for animals and related fact sheets, see FDA's FSMA Web page located at
FDA is holding the public meetings on the proposed rule for preventive controls for food for animals to inform the public about the proposed rule and the rulemaking process, including how to submit comments, data, and other information to the rulemaking docket; to respond to questions about the proposed rule; and to provide an opportunity for interested persons to make oral presentations. Due to limited space and time, FDA encourages all persons who wish to attend the meetings to register in advance. There is no fee to register for the public meetings, and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. Onsite registration will be accepted, as space permits, after all preregistered attendees are seated.
Those requesting an opportunity to make an oral presentation during the time allotted for public comment at the meeting are asked to submit a request and to provide the specific topic or issue to be addressed. Due to the anticipated high level of interest in presenting public comment and limited time available, FDA is allocating 3 minutes to each speaker to make an oral presentation. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. If time permits, individuals or organizations that did not register in advance may be granted the opportunity to make an oral presentation. FDA would like to maximize the number of individuals who make a presentation at the meeting and will do our best to accommodate all persons who wish to make a presentation or express their opinions at the meeting.
FDA encourages persons and groups who have similar interests to consolidate their information for presentation by a single representative. After reviewing the presentation requests, FDA will notify each participant before the meeting of the approximate time their presentation is scheduled to begin, and remind them of the presentation format (i.e., 3-minute oral presentation without visual media).
While oral presentations from specific individuals and organizations will be necessarily limited due to time constraints during the public meeting, stakeholders may submit electronic or written comments discussing any issues of concern to the administration record (the docket) for the rulemaking. All relevant data and documentation should be submitted with the comments to Docket No. FDA–2011–N–0922. Submit electronic comments to
Table 1 of this document provides information on participation in the public meetings:
Information and data submitted voluntarily to FDA during the public meeting will become part of the administrative record for the rulemaking and will be accessible to the public at
Food and Drug Administration, HHS.
Notification; request for comments.
The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled “Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” (the draft RA). The purpose of the draft RA is to provide a science-based risk analysis of those activity/animal food combinations that would be considered low risk. FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA.
Submit either electronic or written comments on the draft RA by February 26, 2014.
Submit electronic comments on the draft RA to
Mary J. Bartholomew, Center for Veterinary Medicine (HFV–200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–8172.
On January 4, 2011, FSMA (Pub. L. 111–353) was signed into law. Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to create a new section 418 with the same name. Section 418 of the FD&C Act (21 U.S.C. 350g) contains requirements applicable to food facilities that are required to register under section 415 of the FD&C Act (21 U.S.C. 350d) and mandates Agency rulemaking. Section 418(a) of the FD&C Act is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food (including animal food) manufactured, processed, packed, or held by the facility; identify and implement preventive controls; monitor the performance of those controls; and maintain records of the monitoring. Section 418(a) of the FD&C Act specifies that the purpose of the preventive controls is to prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 (21 U.S.C. 342). Section 418(b) of the FD&C Act requires that the hazard analysis identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility. Sections 418(c) to (i) of the FD&C Act contain additional requirements applicable to facilities, including requirements for preventive controls (section 418(c)), monitoring (section 418(d)), corrective actions (section 418(e)), verification (section 418(f)), recordkeeping (section 418(g)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Elsewhere in this issue of the
Section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of the activities that are included as part of the definition of the term “facility” under section 415 of the FD&C Act (Registration of Food Facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 (21 U.S.C. 350j) (Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report) of the FD&C Act for certain facilities as FDA deems appropriate. Section 415 of the FD&C Act directs FDA to require by regulation that any facility engaged in manufacturing, processing, packing, or holding food for human or animal consumption in the United States be registered with FDA. The registration requirement in section 415 of the FD&C Act does not apply to farms. Our regulations that implement section 415 and require food facilities to register with FDA are established in 21 CFR part 1, subpart H (Registration of Food Facilities).
Section 103(c)(1)(C) of FSMA directs the Secretary of Health and Human Services (the Secretary) to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover: (1) Specific types of on-farm packing or holding of animal food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific animal foods and (2) specific on-farm manufacturing and processing activities as such activities relate to specific animal foods that are not consumed on that farm or on another farm under common ownership.
Section 103(c)(1)(D)(i) of FSMA requires that the Secretary consider the results of the science-based risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C Act (including requirements for hazard analysis and preventive controls) and the mandatory inspection frequency in section 421 of the FD&C Act, or modify the requirements in sections 418 or 421 of the FD&C Act, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific animal foods the Secretary determines to be low risk. Section 103(c)(1)(D)(ii) of FSMA provides, in relevant part, that the exemptions or modifications described in section 103(c)(1)(D)(i) shall apply only to small businesses and very small businesses, as defined in the regulation issued under section 418(n) of the FD&C Act.
As explained in the draft RA, we conducted the qualitative risk assessment to identify activity/animal food combinations that would be considered low risk (Ref. 1). We focused on activity/animal food combinations that we identified as being conducted on farms, but we did not consider activity/animal food combinations that would be solely within the farm definition (such as growing grains) and, thus, are not relevant to the requirements of section 103 of FSMA. We considered the risk of activity/animal food combinations rather than separately considering the risk of
In the draft RA, we describe the approach applied to define a low-risk activity and low-risk activity/animal food combinations to determine activities on animal food that are out of scope of the draft RA, and to evaluate hazards associated with activity/animal food combinations within the scope of the draft RA (Ref. 1). We followed the risk assessment framework of the Codex Alimentarius Commission (Ref. 2), which involves hazard identification, hazard characterization, exposure assessment, and risk characterization.
The draft RA addresses nine specific questions:
Question 1: What are the animal foods that would be manufactured, processed, packed, or held by a farm mixed-type facility?
Question 2: What are the activities that might be conducted by farm mixed-type facilities on those animal foods?
Question 3: What are the hazards reasonably likely to occur in those animal foods?
Question 4: For the purpose of determining whether an activity/animal food combination is low risk, which hazards should be considered to have a reasonable probability of causing serious adverse health consequences or death to humans or animals?
Question 5: For the purpose of determining whether an activity/animal food combination is low risk, what animal foods have inherent controls that significantly minimize or prevent a biological hazard that is reasonably likely to occur in these animal foods and that is reasonably likely to cause serious adverse health consequences or death to humans or animals?
Question 6: What interventions significantly minimize or prevent a hazard that is reasonably likely to occur in these animal foods and that is reasonably likely to cause serious adverse health consequences or death to humans or animals?
Question 7: Which of these activities are reasonably likely to introduce, or increase the potential for occurrence of, hazards that are reasonably likely to cause serious adverse health consequences or death to humans or animals and what are these hazards?
Question 8: Which of these activities are interventions to significantly minimize or prevent hazards that are reasonably likely to cause serious adverse health consequences or death to humans or animals from consumption of these animal foods?
Question 9: Which activity/animal food combinations are low risk, i.e., what on-farm activity/animal food combinations are not reasonably likely to introduce hazards that are reasonably likely to cause serious adverse health consequences or death to humans or animals or serve as preventive controls (interventions) to significantly minimize or prevent a hazard that is reasonably likely to cause serious adverse health consequences or death to humans or animals?
As discussed in the draft RA, a specific activity may have a different classification within the classes of manufacturing, processing, packing, and holding (with consequences for what regulations apply to the activity) based on whether the animal food being operated upon is a raw agricultural commodity (RAC) or a processed animal food and whether a RAC was grown or raised on the farm performing the activity or a farm under the same ownership (Ref. 1). In the draft RA, we first characterize the risk of activity/animal food combinations without the overlay of the applicable statutory and regulatory framework. Doing so focuses the risk characterization on the risk of the activity/animal food combinations themselves. We then add that regulatory overlay and characterize the risk of activity/animal food combinations in three regulatory groups shaped by the applicable regulatory factors and the resulting activity classifications:
• Regulatory Group Type 1: Low-risk packing and holding activities that might be conducted on a farm on animal food not grown, raised, or consumed on that farm or another farm under the same ownership;
• Regulatory Group Type 2: Low-risk manufacturing and processing activities that might be conducted on a farm on the farm's own RACs for distribution into commerce; and
• Regulatory Group Type 3: Low-risk manufacturing and processing activities that might be conducted on a farm on animal food other than the farm's own RACs for distribution into commerce.
We are seeking comments that can be used to improve:
• The approach used;
• The assumptions made;
• The data used; and
• The transparency of the draft RA.
Specifically we request comment on:
• The definitions of “low-risk activity” and “low-risk activity/animal food combination”;
• The animal food types and activity/animal food combinations that we are considering outside the scope of the draft RA and those we are considering within the scope of the draft RA;
• The approach to characterizing the risk of an activity/animal food combination;
• The questions addressed by the draft RA; and
• The answers to those questions.
We submitted a draft RA to a group of scientific experts external to FDA for peer review and revised the draft RA, as appropriate, considering the experts' comments. A report concerning the external peer review is available for public review, and can be accessed from our Web site (Ref. 3). We will consider public comments regarding the draft RA in preparing a final version of the RA.
Interested persons may submit either electronic comments regarding the draft RA to
The draft RA is available electronically at
The following references have been placed on display in the Division of Dockets Management (see
1. FDA, “Draft Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the
2. Codex Alimentarius Commission, “Codex Alimentarius Commission Procedural Manual, Twentieth Edition,” 2011.
3. FDA, “Peer Review Report. External Peer Review of the FDA/CVM Draft Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm,” 2013. Available at
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking by cross-reference to temporary regulations and notice of public hearing; correction.
This document contains amendments to proposed regulations relating to guidance for taxpayers electing to establish a mixed straddle using straddle-by-straddle identification. These amendments include a change to the applicability date of the proposed regulations pursuant to which the proposed regulations would apply to transactions established after the date of publication of the Treasury decision adopting these rules as final regulations in the
Comments must be received by October 31, 2013. Request to speak and outlines of topics to be discussed at the public hearing scheduled for December 4, 2013, at 10 a.m. must be received by October 31, 2013.
Send submissions to: CC:PA:LPD:PR (REG–112815–12), room 5205, Internal Revenue Service, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG–112815–12), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically via the Federal eRulemaking Portal at
Pamela Lew or Robert B. Williams at (202) 622–3950 (not a toll-free number).
The proposed regulations that are the subject of these amendments are under section 1092 of the Internal Revenue Code (Code). The text of temporary regulations (TD 9627), published in the
The Treasury Department and the IRS received comments raising concerns about the immediate applicability date of the temporary regulations. In response to those comments, the Treasury Department and the IRS are amending the temporary regulations to limit the application of the identified mixed straddle transaction rules in § 1.1092(b)-6T to section 1092(b)(2) identified mixed straddles established after the date of publication of the Treasury decision adopting the rules as final regulations in the
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
26 U.S.C. 7805 * * *.
Section 1.1092(b)–6 also issued under 26 U.S.C. 1092(b)(1).
Section 1.1092(b)–6 also issued under 26 U.S.C. 1092(b)(2).* * *
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to partially approve and partially disapprove State Implementation Plan (SIP) revisions submitted by the State of Nevada on October 12, 2011, July 23, 2012, and August 30, 2012, pursuant to the requirements of the Clean Air Act (CAA or the Act) for the implementation, maintenance, and enforcement of the 2008 Lead (Pb) national ambient air quality standards (NAAQS). We refer to such SIP revisions as “infrastructure” SIPs because they are intended to address basic structural SIP requirements for new or revised NAAQS including, but not limited to, legal authority, regulatory structure, resources, permit programs, monitoring, and modeling necessary to assure attainment and maintenance of the standards. We are taking comments on
Written comments must be received on or before November 29, 2013.
Submit your comments, identified by Docket ID Number EPA–R09–OAR–2013–0663, by one of the following methods:
1.
2.
3.
4.
Rory Mays, Air Planning Office (AIR–2), U.S. Environmental Protection Agency, Region IX, (415) 972–3227,
Throughout this document, the terms “we,” “us,” and “our” refer to EPA.
Section 110(a)(1) of the CAA requires each state to submit to EPA, within three years after the promulgation of a primary or secondary NAAQS or any revision thereof, a SIP that provides for the “implementation, maintenance, and enforcement” of such NAAQS. Many of the section 110(a)(2) SIP elements relate to the general information and authorities that constitute the “infrastructure” of a state's air quality management program and SIP submittals that address these requirements are referred to as “infrastructure SIPs.” These infrastructure SIP elements are as follows:
• Section 110(a)(2)(A): Emission limits and other control measures.
• Section 110(a)(2)(B): Ambient air quality monitoring/data system.
• Section 110(a)(2)(C): Program for enforcement of control measures and regulation of new and modified stationary sources.
• Section 110(a)(2)(D)(i): Interstate pollution transport.
• Section 110(a)(2)(D)(ii): Interstate and international pollution abatement.
• Section 110(a)(2)(E): Adequate resources and authority, conflict of interest, and oversight of local and regional government agencies.
• Section 110(a)(2)(F): Stationary source monitoring and reporting.
• Section 110(a)(2)(G): Emergency episodes.
• Section 110(a)(2)(H): SIP revisions.
• Section 110(a)(2)(J): Consultation with government officials, public notification, and prevention of significant deterioration (PSD) and visibility protection.
• Section 110(a)(2)(K): Air quality modeling and submission of modeling data.
• Section 110(a)(2)(L): Permitting fees.
• Section 110(a)(2)(M): Consultation/participation by affected local entities.
Two elements identified in section 110(a)(2) are not governed by the three-year submission deadline of section 110(a)(1) and are therefore not addressed in this action. These elements relate to part D of title I of the CAA, and submissions to satisfy them are not due within three years after promulgation of a new or revised NAAQS, but rather are due at the same time nonattainment area plan requirements are due under section 172. The two elements are: (i) section 110(a)(2)(C) to the extent it refers to permit programs required under part D [nonattainment new source review (NSR)], and (ii) section 110(a)(2)(I), pertaining to the nonattainment planning requirements of part D. As a result, this action does not address infrastructure elements related to the nonattainment NSR portion of section 110(a)(2)(C) or related to 110(a)(2)(I).
In addition, this rulemaking does not address three substantive issues that are not integral to acting on a state's infrastructure SIP submission: (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction (SSM) at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP approved emissions limits with limited public process or without requiring further approval by EPA, that may be contrary to the CAA (“director's discretion”); and, (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule.”
Instead, EPA has indicated that it has other authority to address any such existing SIP defects in other rulemakings, as appropriate. A detailed rationale for why these issues are not part of the scope of infrastructure SIP rulemakings can be found in EPA's August 3, 2012 proposed rule entitled “Partial Approval and Disapproval of Air Quality Implementation Plans; Nevada; Infrastructure Requirements for Ozone and Fine Particulate Matter” in section I.C. (“Scope of the Infrastructure SIP Evaluation”).
On October 15, 2008, EPA issued a revised NAAQS for Pb.
The Nevada Division of Environmental Protection (NDEP) submitted “Nevada's Clean Air Act § 110(a)(1) and (2) State Implementation Plan for the 2008 Pb NAAQS” on October 12, 2011,
These submittals included cover letters from the NDEP Administrator to the Region IX Regional Administrator and tables for each air quality management jurisdiction in Nevada (i.e., NDEP, Clark County, and Washoe County Health District) that list and discuss how state and local provisions address the elements of CAA section 110(a)(2). Each submittal also includes attachments that, among other things, compile the State and local rules and statutes that are currently approved into the Nevada SIP or that apply locally and are supportive of Nevada meeting the infrastructure SIP requirements, and provide evidence of public notice and an opportunity for public comment or hearing prior to adoption and submittal of the SIP revisions. We find that these submittals meet the procedural requirements for public participation under CAA section 110(a)(2) and 40 CFR 51.102.
We are proposing to act on all three submittals since they collectively address the infrastructure SIP requirements for the 2008 Pb NAAQS. We refer to them collectively herein as “Nevada's Pb Infrastructure Submittal.”
EPA has evaluated Nevada's Pb Infrastructure Submittal and the existing provisions of the Nevada SIP for compliance with the CAA section 110(a) requirements for the 2008 Pb NAAQS. Our Pb Infrastructure SIP Technical Support Document (“Pb TSD”) contains more detailed evaluations and is available in the public docket for this rulemaking, which may be accessed online at
Based upon our evaluation as presented in the TSDs, EPA proposes to approve Nevada's Pb Infrastructure Submittal with respect to the following infrastructure SIP requirements:
• Section 110(a)(2)(A): Emission limits and other control measures.
• Section 110(a)(2)(B): Ambient air quality monitoring/data system.
• Section 110(a)(2)(C) (in part): Program for enforcement of control measures and regulation of new and modified stationary sources.
• Section 110(a)(2)(D)(i) (in part): Interstate pollution transport.
• Section 110(a)(2)(D)(ii) (in part): Interstate pollution abatement and international air pollution.
• Section 110(a)(2)(E): Adequate resources and authority, conflict of interest, and oversight of local and regional government agencies.
• Section 110(a)(2)(F) (in part): Stationary source monitoring and reporting.
• Section 110(a)(2)(G): Emergency episodes.
• Section 110(a)(2)(H): SIP revisions.
• Section 110(a)(2)(J) (in part): Consultation with government officials, public notification, and prevention of significant deterioration (PSD) and visibility protection.
• Section 110(a)(2)(K): Air quality modeling and submission of modeling data.
• Section 110(a)(2)(L): Permitting fees.
• Section 110(a)(2)(M): Consultation/participation by affected local entities.
EPA proposes to disapprove Nevada's Pb Infrastructure Submittal with respect to the following infrastructure SIP requirements (details of the partial disapprovals are presented after this list):
• Section 110(a)(2)(C) (in part): Program for enforcement of control measures and regulation of new and modified stationary sources.
• Section 110(a)(2)(D)(i) (in part): Interstate pollution transport.
• Section 110(a)(2)(D)(ii) (in part): Interstate pollution abatement and international air pollution.
• Section 110(a)(2)(F) (in part): Stationary source monitoring and reporting.
• Section 110(a)(2)(J) (in part): Consultation with government officials, public notification, and prevention of significant deterioration (PSD) and visibility protection.
As explained more fully in our Pb TSD, we are proposing to disapprove the NDEP and Washoe County portions of Nevada's Pb Infrastructure Submittal with respect to the PSD-related requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), 110(a)(2)(D)(ii), and 110(a)(2)(J) because the Nevada SIP does not fully satisfy the statutory and regulatory requirements for PSD permit programs under part C, title I of the Act. Both NDEP and Washoe County AQMD currently implement the Federal PSD program in 40 CFR 52.21 for all regulated new source review (NSR) pollutants, pursuant to delegation agreements with EPA. See 40 CFR 52.1485.
We are proposing to disapprove the Clark County portion of Nevada's Pb Infrastructure Submittal with respect to the PSD-related requirements of CAA sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J) because Clark County's SIP-approved PSD permit program does not contain provisions that satisfy the statutory and regulatory requirements concerning condensable particulate matter (PM) and PM
Our proposed disapprovals of the NDEP and Clark County portions of the Nevada Pb Infrastructure Submittal with respect to section 110(a)(2)(C) also stem from unique circumstances regarding NDEP and Clark County's permit programs for the regulation of new and modified minor sources and minor modifications of major sources, herein referred to as “minor NSR.” Within this infrastructure SIP proposal, we are not proposing to approve or disapprove existing minor NSR regulations. However, in 2012, EPA finalized rulemakings on Nevada's submittals addressing minor NSR for sources under NDEP and Clark County DAQ jurisdiction, which included limited disapprovals.
As described in our Pb TSD, the resulting FIP obligations for these minor NSR program deficiencies have already been triggered by EPA's 2012 actions on the NSR rules submitted for sources under NDEP
For the requirement of section 110(a)(2)(D)(i)(II) (regarding interference with other states' required measures to prevent significant deterioration of air quality), we propose to disapprove Nevada's Pb Infrastructure SIP for the reasons discussed above and in our Pb TSD in connection with the PSD-related requirements of CAA section 110(a)(2)(C).
With respect to the requirement in CAA section 110(a)(2)(D)(ii) concerning compliance with section 126 requirements regarding interstate pollution abatement, EPA proposes to disapprove the NDEP and Washoe County portions of Nevada's Pb Infrastructure Submittal, for the reasons discussed above and in our Pb TSD in connection with the PSD-related requirements of CAA section 110(a)(2)(C).
For Section 110(a)(2)(F), we propose to disapprove the Clark County portion of Nevada's Pb Infrastructure Submittal with respect to subsection 110(a)(2)(F)(iii) because Clark County has repealed its regulation, Section 24, which formerly addressed the correlation requirement of this subsection, without submitting a SIP revision to replace it.
As discussed in our Pb TSD, the resulting FIP obligation for this stationary source correlation requirement for the Clark County portion of the Nevada SIP has already been triggered by EPA's 2012 action on Nevada's infrastructure SIP submittals for the 1997 ozone, 1997 PM
For the PSD related requirements of Section 110(a)(2)(J) we propose to disapprove Nevada's Pb Infrastructure Submittal for the reasons discussed above and in our Pb TSD in connection with the PSD-related requirements of section 110(a)(2)(C).
EPA takes very seriously a proposal to disapprove a state plan, as we believe that it is preferable, and preferred in the provisions of the Clean Air Act, that these requirements be implemented through state plans. A state plan need not contain exactly the same provisions that EPA might require, but EPA must be able to find that the state plan is consistent with the requirements of the Act. Further, EPA's oversight role requires that it assure consistent implementation of Clean Air Act requirements by states across the country, even while acknowledging that individual decisions from source to source or state to state may not have identical outcomes. EPA believes these proposed disapprovals are the only path that is consistent with the Act at this time.
Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of part D, title I of the CAA (CAA sections 171–193) or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP Call) starts a sanctions clock. Nevada's Pb Infrastructure Submittal was not submitted to meet either of these
In addition, CAA section 110(c)(1) provides that EPA must promulgate a FIP within two years after finding that a State has failed to make a required submission or disapproving a State implementation plan submission in whole or in part, unless EPA approves a SIP revision correcting the deficiencies within that two-year period. As discussed in section III.B of this proposed rule and in our Pb TSD, we are proposing several partial disapprovals. With one exception, however, these disapprovals would not result in new FIP obligations, either because EPA has already promulgated a FIP to address the identified deficiency or because a FIP clock has been triggered by EPA's disapproval of a prior SIP submission based on the same identified deficiency. The provisions for which our proposed disapproval, if finalized, would not result in a new FIP obligation include:
• PSD-related requirements in sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), 110(a)(2)(D)(ii), and 110(a)(2)(J): For NDEP and Washoe County, EPA has already promulgated the federal PSD program (see 40 CFR 52.1485);
• PSD-related requirements in sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J): For Clark County, EPA's October 18, 2012 final action on Clark County's PSD regulations triggered a November 19, 2014 deadline for EPA to promulgate a FIP addressing this requirement (77 FR 64039);
• Minor NSR requirement in section 110(a)(2)(C): EPA's September 27, 2012 final action on NDEP's minor NSR regulations (77 FR 59321) and October 18, 2012 final action on Clark County's minor NSR regulations (77 FR 64039) triggered deadlines of October 29, 2014 and November 19, 2014, respectively, for EPA to promulgate FIPs addressing the identified deficiencies;
• Section 110(a)(2)(F)(iii): For Clark County, EPA's October 23, 2012 final action on Nevada's Infrastructure SIP submittals for the 1997 ozone, 1997 PM
The one disapproval that would trigger a new FIP clock concerns the requirement under sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) and 110(a)(2)(J) regarding PSD increments for PM
We anticipate that NDEP will submit SIP revisions that adequately address the deficiencies identified in EPA's 2012 actions on NDEP's minor NSR program, Clark County's permit program (i.e., both PSD and minor NSR), Nevada's infrastructure SIPs for the 1997 ozone, 1997 PM
This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq, because this proposed partial approval and partial disapproval of SIP revisions under CAA section 110 will not in-and-of itself create any new information collection burdens but simply proposes to approve certain State requirements, and to disapprove certain other State requirements, for inclusion into the SIP. Burden is defined at 5 CFR 1320.3(b).
The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's proposed rule, we certify that this proposed action will not have a significant impact on a substantial number of small entities. This proposed rule does not impose any requirements or create impacts on small entities. This proposed partial SIP approval and partial SIP disapproval under CAA section 110 will not in-and-of itself create any new requirements but simply proposes to approve certain State requirements, and to disapprove certain other State requirements, for inclusion into the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome compliance or reporting requirements or timetables or exemptions from all or part of the rule. Therefore, this action will not have a significant economic impact on a substantial number of small entities.
We continue to be interested in the potential impacts of this proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531–1538 for State, local, or tribal governments or the private sector. EPA has determined that the proposed partial approval and partial disapproval action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This action proposes to approve certain pre-existing requirements, and to disapprove certain other pre-existing requirements, under State or local law,
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely proposes to approve certain State requirements, and to disapprove certain other State requirements, for inclusion into the SIP and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, Executive Order 13132 does not apply to this action.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP on which EPA is proposing action would not apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this proposed action.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5–501 of the Executive Order has the potential to influence the regulation. This proposed action is not subject to Executive Order 13045 because it is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This proposed partial approval and partial disapproval under CAA section 110 will not in-and-of itself create any new regulations but simply proposes to approve certain State requirements, and to disapprove certain other State requirements, for inclusion into the SIP.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104–113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
The EPA believes that this proposed action is not subject to requirements of Section 12(d) of NTTAA because application of those requirements would be inconsistent with the Clean Air Act.
Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA lacks the discretionary authority to address environmental justice in this proposed rulemaking.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Particulate matter, Pb, Reporting and recordkeeping requirements.
42 U.S.C. 7401 et seq.
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
The U.S. Environmental Protection Agency is extending the comment period for the NPDES Electronic Reporting Rule, published on July 30, 2013. EPA is soliciting public comment on a new regulation that would require electronic reporting for current paper-based NPDES reports. This action will save time and resources for permittees, states, tribes, territories, and EPA while improving compliance and providing better protection of the Nation's waters. The proposed Clean Water Act regulation would require permittees and regulators to use existing, available information technology to electronically report information and data related to the NPDES permit program in lieu of filing written reports. In response to requests from stakeholders, this action extends the comment period for 45 days.
Comments on the preliminary plan published on July 30, 2013 (78 FR 46006), will be accepted through December 12, 2013. Comments provided electronically will be considered timely if they are submitted by 11:59 p.m. Eastern Time on December 12, 2013.
Submit your comments, identified by Docket ID No. EPA–HQ–OECA–2009–0274 by one of the following methods:
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For additional information, please contact John Dombrowski, Director, Enforcement Targeting and Data Division, Office of Compliance (mail code 2222A), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC, 20460; telephone number: (202) 566–0742; email address:
On July 30, 2013 (78 FR 46006), EPA published the proposed NPDES Electronic Reporting Rule. This proposed rule describes EPA's approach to substitute electronic reporting for paper-based reports, which will over the long term save time and resources for permittees, states, tribes, territories, and EPA while improving compliance and better protecting the Nation's waters. The proposed rule would require permittees and regulators to use existing, available information technology to electronically report information and data related to the NPDES permit program in lieu of filing written reports.
The original comment deadline was October 28, 2013. Numerous stakeholders have requested an extension to the comment period in order to adequately understand and comment on the preliminary plan. This action extends the comment period for 45 days.
Office of the Secretary, Interior.
Proposed rule.
This rule proposes procedures for the disposition of unclaimed human remains, funerary objects, sacred objects, or objects of cultural patrimony discovered on Federal lands after November 16, 1990. It would implement section 3 (b) of the Native American Graves Protection and Repatriation Act of 1990.
Comments must be received by December 30, 2013.
You may submit comments, identified by the Regulation Identifier Number (RIN) 1024–AE00, by any of the following methods:
• Federal rulemaking portal:
• Mail or hand delivery to: Dr. Sherry Hutt, Manager, National NAGPRA Program, National Park Service, 1201 Eye Street NW., (2253), Washington, DC 20005.
Dr. Sherry Hutt, Manager, National NAGPRA Program, National Park Service, 1201 Eye Street NW., 8th floor, Washington, DC 20005; telephone (202) 354–1479; facsimile (202) 371–5197.
The Native American Graves Protection and Repatriation Act of 1990 (NAGPRA, or the Act) requires the Secretary of the Interior to:
(1) Promulgate regulations for disposition of human remains, funerary objects, sacred objects, or objects of cultural patrimony (“cultural items” under NAGPRA) not claimed under section 3(a) of the Act.
(2) Develop these regulations in consultation with the Review Committee established under the Act, Native American groups, representatives of museums and the scientific community pursuant to Section 3(b) of the Act.
To the extent that Federal agencies have possession of and responsibility to care for human remains, funerary objects, sacred objects, or objects of cultural patrimony, the authority in 36 CFR Part 79 under section 101(a)(7)(A) of the National Historic Preservation Act (16 U.S.C. 470a) applies. When we published the NAGPRA regulations on December 4, 1995 (60 FR 62134), we reserved section 10.7, where we are now proposing to locate this new rule.
Consultation regarding 43 CFR 10.7 began in 2005. On three separate occasions, we (the National Native American Graves Protection and Repatriation Program) consulted with representatives of Indian tribes, Native Hawaiian organizations, museums, and scientific organizations. We also consulted with the Review Committee during its scheduled meetings in Albuquerque, NM (November 2005); Washington, DC (April 2007); Phoenix, AZ (October 2007); and again in Washington, DC (November 2010). Before the first three meetings with tribal representatives, museums, and scientific organizations, we published a Notice of Consultation in the
We published the proposed questions for the consultation at Albuquerque, NM on November 15–17, 2005 as part of the Notice of Consultation on October 7, 2005 (70 FR 58741). They were as follows:
(1) How should the regulations deal with the distinction between cultural items for which ownership or control has been ascertained under 43 CFR 10.6(a) but the identified lineal descendant, Indian tribe, or Native Hawaiian organization has not claimed the cultural items and cultural items for which ownership or control cannot be ascertained under 43 CFR 10.6(a)?
(2) How long may a cultural item removed from Federal land after November 16, 1990 remain in Federal agency possession before it is considered unclaimed?
(3) What are the appropriate dispositions for unclaimed cultural items?
(4) How should the regulations deal with the management, preservation, and use of unclaimed cultural items?
Over 100 people attended the consultation meetings. Oral and written comments and recommendations were provided from representatives of 18 Indian tribes and 7 museums and scientific organizations. The oral comments were transcribed and all comments retained.
Results of the comments and recommendations according to the four published questions were as follows:
(1) How should the regulations deal with the distinction between cultural items for which ownership or control has been ascertained under 43 CFR 10.6(a) but the identified lineal descendant, Indian tribe, or Native Hawaiian organization has not claimed the cultural items and cultural items for which ownership or control cannot be ascertained under 43 CFR 10.6(a)? This question elicited the greatest diversity of opinion.
• Some commenters acknowledged the distinction as posed. Cultural items in the first category would be subject to special conditions, such as restrictions on research, exhibition, conservation without the written permission of the appropriate lineal descendant or tribal official.
• Some commenters rejected the distinction, recommending that all cultural items must be treated with respect while in Federal control.
• Some commenters proposed alternative distinctions among cultural items for which ownership or control is “inherent” under 25 U.S.C. 3002(a)(1) and (a)(2)(B); cultural items that are claimable under 25 U.S.C. 3002(a)(2)(B) or (a)(2)(C); and cultural items that are not claimable under 25 U.S.C. 2002(a)(2)(B) or (a)(2)(C). Only cultural items in the second category would be subject to regulations regarding the disposition of unclaimed cultural items.
• Some commenters proposed another alternative distinction between human remains and funerary objects and sacred objects and objects of cultural patrimony.
As a general matter, participants emphasized that human remains and funerary objects would be subject to a common understanding of respect for the dead and the right to a proper burial.
(2) How long may a cultural item removed from Federal land after November 16, 1990, remain in Federal agency possession before it is considered unclaimed?
Most commenters recommended that Federal agencies should maintain cultural items removed from Federal land until a claim is made, although some proposed that unclaimed human remains and funerary objects should be reburied in a timely manner.
(3) What are the appropriate dispositions for unclaimed cultural items?
Most commenters recommended that unclaimed cultural items should be held indefinitely until claimed by a lineal descendant, Indian tribe, or Native Hawaiian organization, although some proposed that unclaimed human remains and funerary objects should be reburied in a timely manner.
(4) How should the regulations deal with the management, preservation, and use of unclaimed cultural items?
Commenters generally agreed that unclaimed cultural items should be managed, preserved, and used in accordance with provisions of the regulations at 36 CFR Part 79 governing federally owned and administered archeological collections.
We published the proposed questions for comment at the consultation meeting scheduled for Washington, DC, as part of the Notice of Consultation on April 11, 2007 (69 FR 18192). They were as follows:
(1) How should the regulations address distinctions between human remains, funerary objects, sacred objects, or objects of cultural patrimony that remain in Federal care and for which ownership or control is with a lineal descendant or an Indian tribe or Native Hawaiian organization on whose lands the cultural items were discovered; an Indian tribe or Native Hawaiian organization has stated a claim based on cultural affiliation, aboriginal land, or cultural relationship; a non-federally recognized Indian group has stated a claim based on relationship of shared group identity; and no claim has been made?
(2) Do current regulations regarding the curation of federally owned and administered archaeological collections at 36 CFR 79 adequately address
Oral and written comments and recommendations were provided from representatives of 16 Indian tribes and 5 museums and scientific organizations. The comments were as follows:
• Tribal representatives spoke to the general importance of treating all human remains and cultural objects with respect. Information about unclaimed remains or objects should be widely accessible by Native peoples and not limited to distribution only to recognized tribes.
• For many tribal people, “unclaimed” is a concept in law but without cultural meaning. Others may be willing to undertake repatriation on behalf of those tribes. Reinterment is paramount. If there are cases of unclaimed remains and items, the first critical question that should be answered is “why?”
• The ability to respond with claims may be limited by scarce tribal resources. This does not diminish the importance of cultural beliefs about remains and objects. Often, the difficulty of assessing the significance of scientific knowledge relative to traditional knowledge derives from misunderstandings when either is not well understood.
• Tribal representatives stated there should be no time limits for consultation on disposition. This is especially important when healing is a critical aspect of repatriation. There should be early consultation among tribes and Federal agencies regarding appropriate treatments, repatriation procedures, and the potential for formal agreements. This should include archival care for records about Native Americans and considerations to ensure confidentiality and security for those records.
• Museum and scientific organization representatives spoke to the general importance of treating all human remains and cultural objects with dignity and respect. There was support for all of the procedures and types of information needed to establish the priorities of claimants. The paramount role of federally recognized tribes was supported.
• The regulations should include a definition of “unclaimed.” This is particularly important because sound curation methods should ensure that care is sensitive and effective until a substantiated claim and decision about disposition can be made. The Federal curation regulations at 36 CFR Part 79 are sufficient. They also are sufficiently flexible to allow consideration of a variety of sensitive treatments in consultation with tribes and Native Hawaiian organizations.
• Information about collections should be shared. One of the most important aspects of this is that claimants have the opportunity to have a broader understanding about curatorial procedures, the potential for cooperative relationships, and the availability of the widest range of disposition alternatives.
We published the proposed questions for comment at the consultation meeting scheduled for Phoenix, AZ, as part of the Notice of Consultation on August 13, 2007 (72 FR 45213); they were the same questions as those in the prior notice.
The consultation meetings were attended by representatives of more than 13 Indian tribes and 5 museums and scientific organizations. Oral and written comments and recommendations were provided from representatives of 12 Indian tribes and 11 museum and scientific organizations.
Participants made general comments and recommendations as follows:
• For remains with lineal descendents on or off of tribal land it was stressed by tribal representatives that the care of these remains should be addressed in full consultation with the tribes. Further analysis should be addressed only with tribal consent. Tribes should have access to all burial records regardless of where they originate. One tribe recommended that when control is determined to be vested with a tribe, that tribe must determine proper and respectful disposition of remains, funerary objects, sacred objects or objects of cultural patrimony.
• For remains where there has been a claim based on cultural affiliation or aboriginal land consultation with the tribes must take place and analysis must take place only with tribal consent. Tribes should have access to all burial records regardless where they originate. Tribal representatives stressed that when cultural affiliation has been established, tribal representatives may designate a lead tribe to address consultation. It was stressed that it can be hard to understand ownership from a tribal perspective. While the concept of ownership can be hard for traditional tribal people to comprehend, museums and universities embrace the concept of ownership, making mutual understanding more difficult. Tribal representatives emphasized another major perspective about the difficulty of conducting research to determine cultural affiliation without economic and human resources.
• From the perspective of the tribal representatives, the treatment of unclaimed human remains must be done with the utmost respect. One scientific organization stated that there should be no statute of limitations on NAGPRA claims. Curation should continue in accordance with applicable law until a lineal descendent or group authorized by NAGPRA directs otherwise. All parties should be encouraged to communicate with applicable institutions regarding their rights and interests, especially to reduce the risk of other claimants with lesser rights obtaining repatriation due to lack of knowledge about the existence of higher priority claimants' rights.
• Tribal leaders noted that if the culturally affiliated tribe does not wish to repatriate the remains, funerary objects, objects of cultural patrimony, or sacred objects, they must be consulted on proper and respectful housing for the remains or objects.
• If a non-federally recognized Indian group states a claim based on a cultural connection, a determination about the extent of that connection with that group should be made. The remains must be housed in accordance to specifications determined through consultation with the culturally connected group, regardless of the Federal status of the tribe, until a decision regarding permanent disposition can be reached. Tribal representatives concurred that remains or objects should be repatriated to the lineal descendent or an Indian tribe or Native Hawaiian organization most closely connected for appropriate care and handling regardless of the Federal status of the tribe or group. If the culturally connected group does not wish to accept repatriation, they still should be consulted about proper and respectful housing.
• Tribes recognized that claims might not be made because potential claimant tribes do not have information or do not have resources necessary to receive remains or other collections. These facts do not diminish the cultural or spiritual beliefs associated with remains or objects, especially with regard to basic conditions of respect and dignity that should be accorded to human remains. There was discussion about the government-to-government relationship that must be maintained between Federal agencies and Indian tribes. Tribes noted that tribal sovereignty also was an issue that should be considered by institutions, universities, and states. They considered that the importance of traditional knowledge should be part of
○ Separation of human remains from associated funerary objects.
○ Public displays of human remains and funerary objects.
○ Unnecessary disturbance, handling or transport of human remains.
○ Archeological processing of human remains and funerary objects.
○ Physical modifications of human remains and associated funerary objects.
○ Housing together sacred objects and objects of cultural patrimony.
• Tribes were concerned about the extent to which the regulations for curation of federally owned and administered archeological collections at 36 CFR Part 79 adequately address the management, preservation, and use of human remains, funerary objects, sacred objects, or objects of cultural patrimony. One tribe recommended amendment of the curation regulations to reflect the fact that human remains cannot be “owned.” Others noted that the care aspects listed above should be incorporated into the curation regulations. Tribes discussed amendments on the section on “uses of collections” to include limitations on scientific or educational purposes, limitations on loans and access by tribes for religious or cultural purposes.
• Tribal representatives noted that, regardless of the provisions in the Federal statutes, working closely with the states to address state burial laws was important.
The meeting agendas were made public 30 days or more before each meeting, and notice of the date and place of each meeting was published in the
• There should be ways to provide technical assistance through the National NAGPRA Program for making determinations involving aboriginal lands, for accessing reference materials, and for using databases.
• Potential claimants should be fully informed, and should be consulted when no claims are made and alternative dispositions are considered. Until determinations are made, collections should remain with Federal agencies.
• Sensitivity toward traditional cultural practices, respect, and dignity regarding treatment of human remains and associated funerary objects was important.
• Reinterment was acknowledged as an important option.
• New categories for unclaimed remains should be avoided, especially given the potential for new information that may be developed which would help in any determinations about disposition.
• There is a need for a database of unclaimed remains and objects.
• Human remains and funerary objects should remain separate from other cultural objects and should be subject to special care and handling in consultation with priority claimants.
• Study or documentation of the unclaimed human remains and cultural items should proceed only with consent of the priority claimants or after consultation with the culturally affiliated or culturally related tribes. Baseline documentation, however, such as number of individuals, age, sex, should be recorded.
• No time limit should be imposed for responding to potential claimants, and human remains and cultural items should remain in Federal care until such time as a claimant comes forward and disposition is determined.
• To facilitate claims, Federal agencies should hold consultations with lineal descendants, tribes or Native Hawaiian organizations on whose tribal lands such objects or remains were discovered, and other tribal entities that may have a cultural affiliation or relationship with the human remains or cultural objects.
• Federal agencies considering treatments should be guided by the regulations at 36 CFR Part 79.
• There is a need for a definition of “unclaimed.” It is important to shield unclaimed cultural items from educational uses.
• It is important to allow access for traditional cultural practices.
A definition of “unclaimed cultural items” (that is, human remains, funerary objects, sacred objects, or objects of cultural patrimony) clarifies that this is a category subject to the provisions of the NAGPRA and of regulations to determine priority of ownership and control. Those procedures are the subject of 43 CFR 10.3 through 10.6. Once priority of ownership has been determined, some priority claimants may choose not to exercise their right. Alternatively, no potential claimants may have been identified. These two conditions constitute the category of unclaimed cultural items. The procedures defined in the new § 10.7 provide guidance on how to proceed.
A general statement in paragraph 10.7(a) about the purposes of the new section clarifies the applicable statutory authority, how the new section is to be applied, and what procedures in the regulations must be completed. The results of work done previously, particularly with regard to consultation and appropriate determination of disposition, have continued applicability, and the new section imposes no new requirements for consultation and documentation.
The rule is limited to Federal lands, as NAGPRA's provision on new discoveries on tribal lands puts the tribal land owner in control of cultural items above all claimants except lineal descendants.
The provisions in paragraph 10.7(b) provide guidance about disposition. They:
• Clarify which regulatory procedures must be completed before any potential implementation of § 10.7;
• Provide options for disposition, according to the new definition of “unclaimed cultural items” in paragraph 10.2(h), including considerations for reinterment;
• Require public notification before disposition;
• Establish Federal curation regulations at 36 CFR Part 79 as standards for care and management;
• Encourage consideration of care with specific sensitivity to tribal and Native Hawaiian traditions;
• Provide flexibility to house human remains and associated funerary objects separately;
• Require appropriate information about remains and objects to be made publicly accessible via a nationwide database to be maintained by the National NAGPRA Program;
• Require Federal agencies to submit their lists of unclaimed cultural items, with descriptive information, within two years of the excavation; and
• Acknowledge that, while human remains and funerary objects are intrinsically protected under NAGPRA, no items are intrinsically sacred objects or objects of cultural patrimony, but instead they rely on tribal or group context to qualify as protected items under NAGPRA.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is significant because it could interfere with an action taken or planned by another agency.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the SBREFA. This rule:
a. Does not have an annual effect on the economy of $100 million or more.
b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments, or the private sector. A statement containing the information required by the UMRA (2 U.S.C. 1531
This rule does not affect a taking of private property or otherwise have taking implications under Executive Order 12603. A takings implication assessment is not required. This rule concerns the discretionary disposition of only those Native American cultural items for which identified potential claimants, upon notice, have not exercised their right to claim or no potential claimants can reasonably be identified.
Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. A Federalism summary impact statement is not required.
This rule complies with the requirements of Executive Order 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
In accordance with the President's memorandum of April 29, 1994, “Government to Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 218), and Department of Interior Manual 512 DM 2, “Departmental Responsibilities for Indian Trust Resources,” this rule has a potential effect on federally recognized Indian tribes. The proposed rule was developed in consultation with the NAGPRA Review Committee, which includes members nominated by Indian tribes. Formal consultation with the NAGPRA Review Committee was held on November 16–17, 2005, in Albuquerque, NM; on April 19–20, 2007, in Washington, DC; on October 15–16, 2007, in Phoenix, AZ; on May 15–16, 2008, in De Pere, WI; on October 30–31, 2009, in Sarasota, FL; and on November 18–19, 2010, in Washington, DC.
Formal consultation with Indian tribes began on November 15, 2005, in Albuquerque, NM, and continued on April 18, 2007, in Washington, DC, and October 14, 2007, in Phoenix, AZ. Testimony or comments were received from representatives of 18 Indian tribes and three Indian organizations. We will fully consider tribal and Review Committee views in the final rule.
This rule does not contain any new collection of information that requires approval by the Office of Management and Budget under the PRA of 1995 (44 U.S.C. 3501
This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the NEPA is not required because the rule is covered by a categorical exclusion under 516 DM 2, Appendix 1.10, Policies, directives, regulations, and guidelines that are of an administrative, financial, legal, technical, or procedural nature and whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case. We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under the NEPA.
This rule is not a significant energy action under the definition in Executive Order 13211. A statement of Energy Effects is not required.
We are required by Executive Orders 12866 (section 1(b)(12)), 12988 (section
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in the
This proposed rule was prepared by staff of the National NAGPRA Program and counsel of the Division of Parks and Wildlife and the Division of Indian Affairs in the Office of the Solicitor.
It is the policy of the Department of the Interior, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, interested persons may submit written comments regarding this proposed rule identified by the RIN 1024–AE00 to
1. The applicability of Federal curation regulations at 36 CFR Part 79 or other standards, guidelines, and protocols being used by state, local, or tribal governments that address the preservation or management of Native American cultural items.
2. The appropriateness of using a priority structure in determining the disposition of unclaimed human remains, funerary objects, sacred objects, or objects of cultural patrimony.
3. The alternative of reinterment.
4. Using newspaper notice for potential claimants of unclaimed items, and any other approaches of notifying the public that are equally or more effective. Is there a role in other technological means to provide effective notice to tribes? Is it necessary for notices under this section be published in the
This proposed rule may also be viewed at
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment- including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Administrative practice and procedure, Hawaiian Natives, Historic preservation, Indians-claims, Indians-lands, Museums, Reporting and record keeping requirements.
In consideration of the foregoing, the NPS proposes to amend 43 CFR Part 10 as follows:
16 U.S.C. 470dd, 25 U.S.C. 9 and 3001
(h
(1) That have been excavated or removed from Federal lands after November 16, 1990; and
(2) Whose disposition of ownership or control under 25 U.S.C. 3002(a) and § 10.6 of this part has not occurred because either:
(i) No identified potential claimant, upon notice, has exercised its right to claim ownership or control of the cultural items; or
(ii) No potential claimant can reasonably be identified.
(a) A Federal agency that has unclaimed cultural items (human remains, funerary objects, sacred objects, or objects of cultural patrimony) must:
(1) Submit a list of the items to the Manager, National NAGPRA Program that describes the place of discovery and the nature of the unclaimed cultural items. This list must be received by [DATE 2 YEARS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
(2) Care for and manage unclaimed cultural items consistent with the regulations at 36 CFR Part 79.
(3) To the maximum extent feasible, consider and respect the traditions of any potential claimants concerning the unclaimed cultural items, including, but not limited to, traditions regarding housing, maintenance, and preservation.
(b) Subject to paragraph (d) of this section, a Federal agency that has unclaimed cultural items may transfer them to another Indian tribe or Native Hawaiian organization.
(c) Subject to paragraph (d) of this section, a Federal agency that has unclaimed human remains and funerary objects may reinter them or offer them for disposition according to applicable State or other law.
(d) Before a Federal agency makes a transfer or reinterment under paragraphs (b) or (c) of this section, it must:
(1) Submit the list required under paragraph (a)(1) of this section to the Manager, National NAGPRA Program.
(2) Publish a notice of the proposed transfer or reinterment in a newspaper of general circulation in the area in which the unclaimed cultural items were excavated or removed and in a newspaper of general circulation in the area in which each potential claimant now resides. The notice must explain the nature and affiliation, if any, of the unclaimed cultural items, and solicit claims under the priority of ownership or control in section 3(a) of the Act and
(3) Send to the Manager, National NAGPRA Program a copy of the notice published under paragraph (d)(2) of this section and information on when and in what newspaper(s) the notice was published.
(e) This section implements section 3(b) of the Native American Graves Protection and Repatriation Act at 25 U.S.C. 3002(b).
Federal Communications Commission.
Petition for reconsideration.
In this document, a Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding by Donald J. Evans on behalf of NTCH, Inc.
Oppositions to the Petition must be filed on or before November 13, 2013. Replies to an opposition must be filed on or before November 25, 2013.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Matthew Pearl, Wireless Telecommunications Bureau, phone: (202) 418–2607 or TTY (202) 418–7233.
This is a summary of Commission's document, Report No. 2992, released September 24, 2013. The full text of Report No. 2992 is available for viewing and copying in Room CY–B402, 445 12th Street SW., Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI) (1–800–378–3160). The Commission will not send a copy of this
National Aeronautics and Space Administration.
Proposed rule.
NASA is proposing to amend the NASA FAR Supplement (NFS) to incorporate a proposal adequacy checklist for proposals in response to solicitations that require the submission of certified cost or pricing data.
Interested parties should submit comments to NASA at the address below on or before December 30, 2013 to be considered in formulation of the final rule.
Interested parties may submit comments, identified by RIN number 2700–AE13 via the Federal eRulemaking Portal:
William Roets, NASA, Office of Procurement, email:
This proposed rule supports the NASA Assistant Administrator for Procurement's “Reducing Transaction Costs in NASA Procurements” initiative by incorporating the requirement for a proposal adequacy checklist into the NFS at 1815.408–70(c), and associated solicitation provision at NFS 1852.215–85, to ensure offerors take responsibility for submitting thorough, accurate, and complete proposals. The provision will be included in solicitations that require the submission of certified cost or pricing data.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866. This proposed rule is not a major rule under 5 U.S.C. 804.
NASA does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. However, an Initial Regulatory Flexibility Analysis has been performed and is summarized as follows:
This proposed rule amends the NFS to add a checklist for NASA contractors to complete under solicitations that require the submission of certified cost or pricing data. This rule supports the NASA Assistant Administrator for Procurement's “Reducing Transaction Costs in NASA Procurements” initiative by increasing uniformity across NASA and minimizing local variations in this area which will decrease proposal preparation costs.
The objective of this proposed rule is to ensure that offerors submit thorough, accurate, and complete proposals. By completing the checklist, offerors will be able to self-validate the adequacy of their proposals which will improve the quality of their initial proposal submissions. This will reduce the need for contractors to rework their initial proposal submissions which will save the Government time and resources in performing the evaluation of the proposal.
The rule will apply to actions where certified cost or pricing data is required. Based on data collected in FPDS–NG for FY2010–2012, there are on average 1162
This proposed rule imposes no new reporting requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules. No alternatives were identified that would meet the objectives of the rule. Excluding the small number of small business concerns that may be subject to the rule would not be in the best interest of the small business concerns or the Government because the proposal adequacy checklist was created directly from requirements already in the Federal Acquisition Regulation. While the checklist does not add burden, it provides a useful tool for ensuring proposal adequacy.
NASA invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities. NASA will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 and RIN number 2700–AE13 in correspondence.
This proposed rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. Chapter 35). However, these changes to the NFS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 9000–0013, entitled “Cost or Pricing Data Exemption Information.”
Government procurement.
Accordingly, 48 CFR parts 1815 and 1852 are proposed to be amended as follows:
42 U.S.C. 2473(c)(1).
(c) When the solicitation requires the submission of certified cost or pricing data, the contracting officer shall include 1815.215–85, Proposal Adequacy Checklist, in the solicitation to facilitate submission of a thorough, accurate, and complete proposal.
42 U.S.C. 2473(c)(1).
As prescribed in 1815.408–70(c), use the following provision:
The offeror shall complete and submit as part of their proposal the following checklist, providing location of requested information, or an explanation of why the requested information is not provided. In preparation of the offeror's checklist, offerors may elect to have their prospective subcontractors use the same or similar checklist as appropriate.
(End of provision)
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service, propose to designate critical habitat for
We will accept comments received or postmarked on or before December 30, 2013. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Stephen P. Henry, Acting Field Supervisor, Ventura Fish and Wildlife Office, U.S. Fish and Wildlife Service, 2493 Portola Road, Suite B, Ventura, CA, 93003; telephone 805–644–1766; facsimile 805–644–3958. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800–877–8339.
We intend that any final action resulting from this proposed rule will be based on the best scientific data available and be as accurate and as effective as possible. Therefore, we request comments or information from the public, other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Act (16 U.S.C. 1531
(2) Specific information on:
(a) The amount and distribution of
(b) What may constitute “physical or biological features essential to the conservation of the species,” within the geographical range currently occupied by the species;
(c) Where these features are currently found;
(d) Whether any of these features may require special management considerations or protection;
(e) What areas that are currently occupied by the species contain features essential to the conservation of the species that should be included in the designation and why; and
(f) What areas not occupied at the time of listing are essential for the conservation of the species and why.
(3) Land use designations and current or planned activities in the areas occupied by the species or proposed to be designated as critical habitat, and possible impacts of these activities on this species and proposed critical habitat.
(4) Comments or information that may assist us in identifying or clarifying the primary constituent elements (PCEs).
(5) Information on the projected and reasonably likely impacts of climate change on Vandenberg monkeyflower and proposed critical habitat.
(6) Any probable economic, national security, or other relevant impacts of designating any area that may be included in the final designation. We are particularly interested in any impacts on small entities, and the benefits of including or excluding areas from the proposed designation that are subject to these impacts.
(7) Any foreseeable impacts on energy supplies, distribution, and use resulting from the proposed designation and, in particular, any impacts on electricity production, and the benefits of including or excluding any particular areas that exhibit these impacts.
(8) Whether any specific areas we are proposing for critical habitat designation should be considered for exclusion under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any specific area outweigh the benefits of including that area under section 4(b)(2) of the Act. We specifically seek comments on whether the existing management plans for Burton Mesa Ecological Reserve and La Purisima Mission State Historic Park (SHP), respectively, provide a conservation benefit to Vandenberg monkeyflower and its habitat. We also seek comments on whether there is a reasonable expectation that the conservation management strategies and actions in these management plans will be implemented into the future.
(9) Whether our approach to designating critical habitat could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments.
(10) The likelihood of adverse social reactions to the designation of critical habitat and how the consequences of such reactions, if likely to occur, would relate to the conservation and regulatory benefits of the proposed critical habitat designation.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in the
We will post your entire comment—including your personal identifying information—on
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
All previous Federal actions are described in the proposal to list Vandenberg monkeyflower as an endangered species under the Act published elsewhere in today's
In this proposed rule, we intend to discuss only those topics directly relevant to the designation of critical habitat. Additional information pertaining to Vandenberg monkeyflower description, taxonomy, life history, geographic setting, climate, and habitat can be found in the proposed listing rule published elsewhere in today's
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features:
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance,
Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and the landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.
Under the first prong of the Act's definition of critical habitat, areas within the geographic area occupied by the species at the time it is listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific and commercial data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat). In identifying those physical and biological features within an area, we focus on the principal biological or physical constituent elements (primary constituent elements (PCEs) such as roost sites, nesting grounds, seasonal wetlands, water quality, tide, soil type) that are essential to the conservation of the species. We consider PCEs to be those specific elements of the physical or biological features that provide for a species' life history processes and, under the appropriate conditions, are essential to the conservation of the species.
Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographic area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. We designate critical habitat in areas outside the geographic area occupied by a species only when a designation limited to its range would be inadequate to ensure the conservation of the species.
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the
When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. Additional information sources may include the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, other unpublished materials, or experts' opinions or personal knowledge.
Habitat is dynamic, and species may move from one area to another over time. Therefore, we recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act, (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species, and (3) the prohibitions of section 9 of the Act if actions occurring in these areas may affect the species. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will contribute to recovery of this species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of these planning efforts calls for a different outcome.
Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12), require that, to the maximum extent prudent and determinable, the Secretary designate critical habitat at the time the species is determined to be an endangered or threatened species. Our regulations (50 CFR 424.12(a)(1)) state that the designation of critical habitat is not prudent when one or both of the following situations exist: (1) The species is threatened by taking or other activity and the identification of critical habitat can be expected to increase the degree of threat to the species; or (2) the designation of critical habitat would not be beneficial to the species.
As discussed in the Factor B discussion of our proposed listing rule (published elsewhere in today's
In the absence of finding that the designation of critical habitat would increase threats to a species, if there are any benefits to a critical habitat designation, then a prudent finding is
Having determined that designation is prudent, under section 4(a)(3) of the Act we must find whether critical habitat for the Vandenberg monkeyflower is determinable. Our regulations at 50 CFR 424.12(a)(2) state that critical habitat is not determinable when one or both of the following situations exist:
(i) Information sufficient to perform required analyses of the impacts of the designation is lacking, or
(ii) The biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat.
When critical habitat is not determinable, the Act allows the Service an additional year to publish a critical habitat designation (16 U.S.C. 1533(b)(6)(C)(ii)).
We reviewed the available information pertaining to the biological needs of the species, habitat characteristics where this species is located, and potential impacts of designation. This and other information represent the best scientific data available and led us to conclude that the designation of critical habitat is determinable for Vandenberg monkeyflower.
Climate change will be a particular challenge for biodiversity because the interaction of additional stressors associated with climate change and current stressors may push species beyond their ability to survive (Lovejoy 2005, pp. 325–326). The synergistic implications of climate change and habitat fragmentation are the most threatening facet of climate change for biodiversity (Hannah and Lovejoy 2005, p. 4). Current climate change predictions for terrestrial areas in the Northern Hemisphere indicate warmer air temperatures, more intense precipitation events, and increased summer continental drying (Field
Documentation of climate-related changes that have already occurred in California (Bell
In accordance with section 3(5)(A)(i) and 4(b)(1)(A) of the Act and regulations at 50 CFR 424.12, in determining which areas within the geographic area occupied by the species at the time of listing to designate as critical habitat, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. These include, but are not limited to:
(1) Space for individual and population growth and for normal behavior;
(2) Food, water, air, light, minerals, or other nutritional or physiological requirements;
(3) Cover or shelter;
(4) Sites for breeding, reproduction, or rearing (or development) of offspring; and
(5) Habitats that are protected from disturbance or are representative of the historical, geographic, and ecological distributions of a species.
We derive the specific physical or biological features required for Vandenberg monkeyflower from studies of this species' habitat, ecology, and life history as described below. Additional information can be found in the proposed listing rule published elsewhere in today's
Vandenberg monkeyflower only occurs in sandy openings (canopy gaps) within dominant vegetation consisting of Burton Mesa chaparral (see the “Background” section in the proposed listing rule published elsewhere in today's
Canopy gaps are important for seed germination and seedling establishment, and for maintaining the seed banks of many chaparral species (Davis
Numerous studies have recognized canopy gaps in mature chaparral as important microhabitats where some subshrubs and herbs [such as Vandenberg monkeyflower] persist between fires (Horton and Kraebel 1955, pp. 258–261; Vogl and Schorr 1972, pp. 1182–1187; Keeley
When fire occurs, it clears out aboveground living vegetation and dead wood, deposits nutrient-rich ash, and makes space and sunlight available for seedling establishment. High numbers of herbaceous annuals and perennials appear shortly after fire has cleared away the tall, dense shrubs (Gevirtz
The gaps in the canopy where this species occurs consist of loose, sandy soils. The Burton Mesa dune sheet is the largest exposure of mid-Pleistocene sands in the Santa Maria Basin (Hunt 1993, p. 14). These dunes are old enough to have developed a soil profile, classified as Tangair and Narlon soils (Soil Conservation Service 1972). Subsurface soils are typically hardened by iron oxides; however, surface exposures are commonly composed of loose sand (Hunt 1993, p. 15). The oldest dune deposits lie beneath dunes that were wind-deposited approximately 10,000 to 25,000 to as much as 125,000 years ago (Orme and Tchakerian 1986, pp. 155–156; Johnson 1983, in Hunt 1993, p. 15). Contributing to the formation of these vast dune systems was a rapid fall in sea level approximately 18,000 years ago, perhaps as much as 300 ft (91 m) below the present shoreline, which exposed vast quantities of sediment that were later transported miles inland by onshore winds (Hunt 1993, p. 16).
The more recent dune deposits (i.e., 10,000 to 125,000 years ago) comprise the bulk of the dunes found on Burton Mesa. These newer dunes on Burton Mesa are composed of poorly consolidated to unconsolidated red to yellow sands with a clay-enriched B-horizon profile; the substratum is generally a dense, cemented sand layer (Hunt 1993, p. 16). This cemented layer may contribute to the water-holding capacity of the soil, which in turn affects the types of plants and vegetation communities observed. Additionally, both the older and newer dune deposits have substrates with significantly higher proportions of fine sands relative to even more recent sand deposits, thus forming a dense soil (Hunt 1993, p. 16). Topsoil in Burton Mesa is uniformly medium sand, but the depth of soil to bedrock varies throughout the mesa, and several soil types are present (Davis
This species appears more closely tied to loose, sandy soil than to a specific soil type. Therefore, because Vandenberg monkeyflower occurs on all soil types listed above, but appears to be more closely associated with loose, sandy soils regardless of the soil type, we identify loose, sandy soils on Burton Mesa as a physical or biological feature for Vandenberg monkeyflower.
The structure of the chaparral habitat on Burton Mesa is a mosaic of maritime chaparral vegetation (which includes maritime chaparral and maritime chaparral mixed with coastal scrub, oak woodland, and small patches of native grasslands (Wilken and Wardlaw 2010, p. 2)) and sandy openings (canopy gaps) that varies from place to place (see
Contiguous chaparral habitat on Burton Mesa is important for population growth of Vandenberg monkeyflower because it also provides habitat for insect pollinators. Pollinators move pollen from one flower to another predominantly within the same plant population, but they can move pollen to another plant population if it is close enough and the pollinator is capable of carrying the pollen across that distance. Annual
Under the Act and its implementing regulations, we are required to identify the physical or biological features essential to the conservation of Vandenberg monkeyflower in areas occupied at the time of listing, focusing on the features' PCEs. We consider PCEs to be the elements of physical or biological features that provide for a species' life history processes and, under the appropriate conditions, are essential to the conservation of the species.
Based on our current knowledge of the physical or biological features and habitat characteristics required to sustain the species' life-history processes, we determine that the PCEs specific to Vandenberg monkeyflower are:
(1) Native maritime chaparral communities of Burton Mesa comprising maritime chaparral and maritime chaparral mixed with coastal scrub, oak woodland, and small patches of native grasslands. The mosaic structure of the native plant communities (arranged in a mosaic of dominant vegetation and sandy openings (canopy gaps)), may change spatially as a result of succession, and physical processes such as windblown sand and wildfire.
(2) Loose sandy soils on Burton Mesa. As mapped by the Natural Resources Conservation Service (NRCS), these could include the following soil series: Arnold Sand, Marina Sand, Narlon Sand, Tangair Sand, Botella Loam, Terrace Escarpments, and Gullied Land.
With this proposed designation of critical habitat, we intend to identify the physical or biological features essential to the conservation of the species, through the identification of the features' PCEs sufficient to support the life-history processes of the species. All units and subunits proposed to be designated as critical habitat are currently occupied by Vandenberg monkeyflower and contain the PCEs.
When designating critical habitat, we assess whether the specific areas within the geographic area occupied by the species at the time of listing contain physical and biological features that are essential to the conservation of the species and that may require special management considerations or protection. All areas proposed as critical habitat will require some level of management to address the current and future threats to the physical and biological features essential to the conservation of Vandenberg monkeyflower. In all areas, special management is needed to ensure that the habitat is able to provide for the growth and reproduction of the species.
The habitat where Vandenberg monkeyflower occurs faces threats from urban development, maintenance of existing utility pipelines, anthropogenic fire, unauthorized recreational activities, and most substantially the expansion of invasive, nonnative plants (see
As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. We review available information pertaining to the habitat requirements of the species. In accordance with the Act and its implementing regulation at 50 CFR 424.12(e), we consider whether designating additional areas—outside those occupied at the time of listing—are necessary to ensure the conservation of the species. We are proposing to designate critical habitat in areas within the geographic area occupied by Vandenberg monkeyflower at the time of listing and that contain sufficient elements of the physical or biological features essential to the conservation of the species. We are not currently proposing to designate any areas outside the geographic area occupied by the species at the time of listing because the area within Burton Mesa that encompasses the extant occurrences would be sufficient for the conservation of the species.
We used data from research published in peer-reviewed articles; reports and survey forms prepared for Federal, State, and local agencies and private corporations; site visits; regional Geographic Information Systems (GIS) layers, including soil and land use coverage; and data submitted to the California Natural Diversity Database (CNDDB). We also reviewed available information that pertains to the ecology, life history, and habitat requirements of this species. This material included information and data in peer-reviewed articles, reports of monitoring and habitat characterizations, reports submitted during section 7 consultations, and information received from local experts regarding Burton Mesa or Vandenberg monkeyflower.
Determining specific areas that Vandenberg monkeyflower occupies is challenging because areas may be occupied by the species even if no plants appear above ground (i.e., resident seed banks may be present with little or no visible aboveground expression of the species) (see “Background—Life History” section of the listing rule published elsewhere in today's
We used a multistep process to delineate critical habitat boundaries.
(1) Using Burton Mesa as a palette, we placed a minimum convex polygon around all nine extant occurrences and
(2) We used GIS to overlay soil data (NRCS) across Burton Mesa, not excluding any soil types at this time because Vandenberg monkeyflower appears to be tied more closely to loose sandy soil than to a specific soil type. Therefore, to define suitable sandy soil where Vandenberg monkeyflower may occur, we included all soil types where the species is currently extant. These soil types include Arnold Sand, Marina Sand, Narlon Sand, Tangair Sand, Botella Loam, Terrace Escarpments, and Gullied Land. Additionally, we did not remove areas that comprise a small percentage of a different soil type if it was within a larger polygon of a suitable soil type because these areas were below the mapping resolution of the NRCS soil data we utilized.
(3) We expanded the distance from each extant occurrence and one potentially extirpated occurrence up to 1 mi (1.6 km) beyond the known outer edge of each occurrence of Vandenberg monkeyflower for the following reasons:
(a) We sought to maintain connectivity between occurrences of Vandenberg monkeyflower because seeds are primarily dispersed by gravity, along with wind, water, and small mammals. Habitat connectivity, especially canopy gaps where the species occurs, provides the necessary space needed for reproduction, dispersal, and individual and population growth (see “Physical and Biological Features” section above).
(b) A 1-mi (1.6-km) distance from each extant occurrence provides space for pollinator habitat. Vandenberg monkeyflower has a mixed mating system, and is dependent on pollinators to achieve seed production (see “Life History” section of the proposed listing rule published elsewhere in today's
(c) Providing a critical habitat boundary that is 1 mi (1.6 km) from the nine extant occurrences and one potentially extirpated occurrence of Vandenberg monkeyflower captures most of the remaining native vegetation on Burton Mesa, from east of the developed area on Vandenberg AFB through La Purisima Mission SHP (see “Distribution of Vandenberg Monkeyflower” section of proposed listing rule). In some instances, we expanded critical habitat farther than 1 mi (1.6 km) if the PCEs were contiguously present up-canyon. Expanding the boundary to 1 mi (1.6 km) created larger and contiguous blocks of suitable habitat, which have the highest likelihood of persisting through the environmental extremes that characterize California's climate, and of retaining the genetic variability to withstand future stressors (such as invasive, nonnative species or climate change). Additionally, contiguous blocks of habitat maintain connectivity, which is important because habitat fragmentation can result in loss of genetic variation (Young
(d) We considered a critical habitat boundary at a distance of 0.5 mi (0.8 km) from the nine extant locations and one potentially extirpated location. This shorter distance, however, did not maintain connectivity of occurrences, did not encompass the remaining native vegetation of Burton Mesa, and did not represent a sufficient distance to encompass long-distance seed dispersal or the distance that pollinators may travel. Except as described above in (c), we did not consider any distance larger than 1 mi (1.6 km) because the 1-mile distance captures the remaining native vegetation and the distribution of Vandenberg monkeyflower, and any distance greater than 1 mi (1.6 km) also captured habitat that is not suitable for this species. Therefore, the areas within our critical habitat boundaries include the range of plant communities and soil types in which Vandenberg monkeyflower is found, maintain connectivity of occurrences, and provide for the sandy openings mixed within the dominant vegetation. The delineated critical habitat contains the elements of physical and biological features that are essential to the conservation of the species.
We did not include agricultural areas because, while the underlying dune sheet may be present depending on the land use practices, the topsoil would most likely not consist of loose sandy soil and the associated vegetation community would not exist. A few smaller agriculture and grazing plots exist within the Burton Mesa Ecological Reserve, but agricultural lands mostly occur to the south and east of the Reserve and La Purisima Mission SHP.
When determining proposed critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other
We are proposing to designate critical habitat on lands that we have determined are within the geographical area occupied by the species at the time of listing (occupied at the time of listing) and contain the physical or biological features essential to the conservation of the species and which may require special management considerations or protection.
One unit (including four subunits) is proposed for designation based on sufficient elements of physical or biological features being present to support Vandenberg monkeyflower life-history processes. All of the subunits contain all of the identified elements of physical or biological features and support multiple life-history processes.
The critical habitat designation is defined by the map or maps, as modified by any accompanying regulatory text, presented at the end of this document in the rule portion. We include more detailed information on the boundaries of the critical habitat designation in the unit descriptions section of this document. We will make the coordinates or plot points or both on which each map is based available to the public on
We are proposing one unit consisting of four subunits as critical habitat for Vandenberg monkeyflower. The critical habitat areas we describe below constitute our best assessment of areas that meet the definition of critical habitat for Vandenberg monkeyflower. The unit we propose as critical habitat is Burton Mesa, which contains four subunits: (1) Vandenberg, (2) Santa Lucia, (3) Encina, and (4) La Purisima (see Table 1 below). The critical habitat areas described below are within the geographical area occupied by the species at the time of listing, contain the physical and biological features essential to the conservation of the species, and may require special management considerations or protections. We are not proposing to designate any critical habitat in areas outside the geographical area occupied by the species at the time of listing. Table 1 includes the approximate area included within each proposed critical habitat subunit.
We present brief descriptions of the Burton Mesa Unit and the four subunits, and reasons why they meet the definition of critical habitat for Vandenberg monkeyflower below.
The Burton Mesa Unit contains most of the remaining native maritime chaparral vegetation on Burton Mesa, roughly from the eastern boundary of Vandenberg AFB; to the eastern boundary of La Purisima Mission SHP; to the Purisima Hills in the north; and to the agricultural fields south of the Burton Mesa Ecological Reserve and north of the Santa Ynez River. The vegetation is structured in a mosaic that contains canopy gaps mixed with dominant woody and herbaceous vegetation (PCE 1), and the unit contains the loose, sandy soils on which Vandenberg monkeyflower occurs (PCE 2). Therefore, the Burton Mesa Unit provides all of the basic requirements for Vandenberg monkeyflower individual and population growth and
Subunit 1 is within the geographical area occupied by Vandenberg monkeyflower at the time of listing and consists of 277 ac (112 ha). Subunit 1 is located adjacent to and between two extant occurrences (Oak Canyon and Pine Canyon, which are located on Vandenberg AFB) and is known to support suitable habitat for Vandenberg monkeyflower. Although Vandenberg monkeyflower plants have not yet been documented within this subunit, the area harbors the PCEs, and is contiguous with and between Vandenberg AFB lands that are known to be occupied; thus, this area within the proposed subunit (and the adjacent, contiguous land on Vandenberg AFB) is considered to be within the geographical area occupied by the species at the time of listing. The adjacent land on Vandenberg AFB is essential to the conservation of the species; however, we are not proposing to designate Vandenberg AFB as critical habitat within this subunit because we have exempted Vandenberg AFB from critical habitat designation under section 4(a)(3)(B) of the Act (see Exemptions section below). Therefore, subunit 1 is composed entirely of Federal land (100 percent) exclusively owned and managed by the Department of Justice (DOJ) and which contains the U.S. Bureau of Prisons Federal Penitentiary Complex at Lompoc (Lompoc Penitentiary). The subunit consists of the westernmost portion of DOJ lands, from the Vandenberg AFB boundary line to roughly the bottom slope of Santa Lucia Canyon. Subunit 1 contains the appropriate vegetation structure of contiguous chaparral habitat with canopy gaps (PCE 1) and loose, sandy soils (PCE 2) that support Vandenberg monkeyflower. Subunit 1 provides connectivity of habitat between occurrences, habitat for pollinators, and space for establishment of new plants from seeds that are dispersed from adjacent extant occurrences of Vandenberg monkeyflower.
The features essential to the conservation of the species may require special management considerations or protection due to threats from invasion of nonnative plants. Ground disturbance within this subunit could remove suitable habitat and create additional openings for nonnative plants to invade and degrade the quality of the habitat.
Subunit 2 is within the geographical area occupied by Vandenberg monkeyflower at the time of listing, is currently occupied by the species, and consists of 1,484 ac (601 ha). This subunit includes State lands (96 percent) within Burton Mesa Ecological Reserve, relatively small portions of local agency lands (for example, school districts, water districts, community services districts) (less than 1 percent) and private lands (3 percent). Subunit 2 contains the appropriate vegetation structure of contiguous chaparral habitat with canopy gaps (PCE 1) and loose, sandy soils (PCE 2) that support Vandenberg monkeyflower. The eastern boundary of Vandenberg AFB delineates the western boundary of this subunit. Subunit 2 includes most of the Vandenberg and Santa Lucia Management Units of the Reserve. Subunit 2 extends from Purisima Hills at the northern extent through the width of Burton Mesa to the agricultural lands south of the Reserve, and to the eastern boundary of the Vandenberg and Santa Lucia Management Units where these units abut Vandenberg Village.
Subunit 2 supports one extant occurrence (Volans Avenue) and one potentially extirpated occurrence (Lower Santa Lucia Canyon) of Vandenberg monkeyflower. Between 2006 and 2011, the Volans Avenue occurrence has consisted of no more than 25 individuals; the potentially extirpated occurrence was last observed in 1985 (see the “Distribution of Vandenberg Monkeyflower—Historical Locations” section of the proposed listing rule published elsewhere in today's
The features essential to the conservation of the species may require special management considerations or protection due to threats from invasion of nonnative plants, and activities such as utility maintenance, and ORV and casual recreational uses. These activities could remove suitable habitat and Vandenberg monkeyflower individuals, and create additional openings for nonnative plants to invade and degrade the quality of the habitat. We are considering to exclude from the Santa Lucia Subunit approximately 1,422 ac (576 ha) of lands within the Burton Mesa Ecological Reserve pursuant to section 4(b)(2) of the Act (see Exclusions section below).
Subunit 3 is within the geographical area occupied by Vandenberg monkeyflower at the time of listing and consists of 2,000 ac (809 ha). This subunit contains State-owned lands (73 percent), including most of the Encina Management Unit of the Burton Mesa Ecological Reserve, local agency lands (1.2 percent), and privately owned lands such as areas adjacent to the Clubhouse Estates residential development (26 percent) (see Table 1 above). Subunit 3 contains the appropriate vegetation structure of contiguous chaparral habitat with canopy gaps (PCE 1) and loose, sandy soils (PCE 2) that support Vandenberg monkeyflower. Subunit 3 extends from approximately the Purisima Hills to the north, through the Reserve and to the agricultural lands just south of the Reserve boundary, and is between Vandenberg Village and State Route 1 to the east and the residential communities of Mesa Oaks and Mission Hills to the west. Subunit 3 supports two extant occurrences of Vandenberg monkeyflower (Clubhouse Estates and Davis Creek). Between 2006 and 2011, hundreds of individuals have been observed on more than one occasion at each of these occurrences (see “Current Status of Vandenberg Monkeyflower” section of the proposed listing rule published elsewhere in today's
The features essential to the conservation of the species may require special management considerations or protection due to threats from invasion of nonnative plants, development, utility maintenance, and OHV and casual recreational uses. These activities could remove suitable habitat and Vandenberg monkeyflower individuals, result in trampling of individual plants, and create additional openings for nonnatives to invade and degrade the quality of the habitat. We are considering to exclude from the Encina Subunit approximately 1,460 ac (591 ha) of lands within the Burton Mesa Ecological Reserve (see Exclusions section below) pursuant to section 4(b)(2) of the Act.
Subunit 4 is within the geographical area occupied by Vandenberg monkeyflower at the time of listing and consists of 2,024 ac (819 ha). Subunit 4 contains mostly State-owned lands (89 percent) consisting of most of La Purisima Mission SHP and a small portion of the La Purisima Management Unit of the Burton Mesa Ecological Reserve that is north of La Purisima Mission SHP. This subunit also contains private land to the east of La Purisima Mission SHP (11 percent), and a small portion of local agency lands (less than 1 percent) (see Table 1 above). Subunit 4 contains the appropriate vegetation structure of contiguous chaparral habitat with canopy gaps (PCE 1) and loose, sandy soils (PCE 2) that support Vandenberg monkeyflower. This subunit extends approximately from the Purisima Hills in the north to the southern boundary of La Purisima Mission SHP, and between the residential communities of Mesa Oaks and Mission Hills to the west and to just east of, and outside, the State Park's eastern boundary. Subunit 4 supports two extant occurrences of Vandenberg monkeyflower in La Purisima Mission SHP (La Purisima East and La Purisima West). Between 2006 and 2011, more than 2,000 individuals of Vandenberg monkeyflower have been observed among the sites on both the east and west side of Purisima Canyon (see “Current Status of Vandenberg Monkeyflower” section of the proposed listing rule published elsewhere in today's
The features essential to the conservation of the species may require special management considerations or protection due to threats from invasion of nonnative plants that could reduce the amount and quality of suitable habitat. We are considering to exclude from the La Purisima Subunit approximately 1,792 ac (725 ha) of State lands—250 ac (101 ha) of Reserve lands managed by California Department of Fish and Wildlife (CDFW) and 1,542 ac (624 ha) of La Purisima Mission SHP lands managed by California State Parks (see Exclusions section below) pursuant to section 4(b)(2) of the Act.
Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they fund, authorize, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.
Decisions by the 5th and 9th Circuit Courts of Appeals have invalidated our regulatory definition of “destruction or adverse modification” (50 CFR 402.02) (see
If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. Examples of actions that are subject to the section 7 consultation process are actions on State, tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251
As a result of section 7 consultation, we document compliance with the requirements of section 7(a)(2) through our issuance of:
(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or
(2) A biological opinion for Federal actions that may affect, or are likely to adversely affect, listed species or critical habitat.
When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:
(1) Can be implemented in a manner consistent with the intended purpose of the action,
(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,
(3) Are economically and technologically feasible, and
(4) Would, in the Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.
Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.
Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where we have listed a new species or subsequently designated critical habitat that may be affected and the Federal agency has retained discretionary involvement or control over the action (or the agency's discretionary involvement or control is authorized by law). Consequently, Federal agencies sometimes may need to request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions with discretionary involvement or control may affect subsequently listed species or designated critical habitat.
The key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical
Section 4(b)(8) of the Act requires us to briefly evaluate and describe, in any proposed or final regulation that designates critical habitat, activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation.
Activities that may affect critical habitat, when carried out, funded, or authorized by a Federal agency, should result in consultation for Vandenberg monkeyflower. These activities include, but are not limited to:
(1) Actions that would lead to the destruction or alteration of Vandenberg monkeyflower habitat. Such activities could include, but are not limited to, development, road and utility repairs and maintenance, anthropogenic fires, and some casual recreational uses. These activities could lead to loss of habitat; removal of the seed bank; introduction and proliferation of invasive, nonnative plants; reduction of pollinators; and habitat fragmentation.
(2) Actions that create ground disturbance and would lead to significant invasive, nonnative plant competition. Such activities could include, but are not limited to, any activity that results in ground disturbance and creates additional open areas for invasive, nonnative plants to invade Vandenberg monkeyflower habitat. Invasive, nonnative plants quickly establish in disturbed areas and outcompete native vegetation, including Vandenberg monkeyflower in the sandy openings (see
The Sikes Act Improvement Act of 1997 (Sikes Act) (16 U.S.C. 670a) required each military installation that includes land and water suitable for the conservation and management of natural resources to complete an integrated natural resource management plan (INRMP) by November 17, 2001. An INRMP integrates implementation of the military mission of the installation with stewardship of the natural resources found on the base. Each INRMP includes:
(1) An assessment of the ecological needs on the installation, including the need to provide for the conservation of listed species;
(2) A statement of goals and priorities;
(3) A detailed description of management actions to be implemented to provide for these ecological needs; and
(4) A monitoring and adaptive management plan.
Among other things, each INRMP must, to the extent appropriate and applicable, provide for fish and wildlife management; fish and wildlife habitat enhancement or modification; wetland protection, enhancement, and restoration where necessary to support fish and wildlife; and enforcement of applicable natural resource laws.
The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108–136) amended the Act to limit areas eligible for designation as critical habitat. Specifically, section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) now provides: “The Secretary shall not designate as critical habitat any lands or other geographic areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.”
We consult with the military on the development and implementation of INRMPs for installations with listed species. We analyzed INRMPs developed by military installations located within the range of the proposed critical habitat designation for Vandenberg monkeyflower to determine if they are exempt under section 4(a)(3) of the Act. Vandenberg AFB is the only Department of Defense land with a completed, Service-approved INRMP within the proposed critical habitat designation.
Vandenberg AFB has a Service-approved INRMP. The U.S. Air Force (on Vandenberg AFB) committed to working closely with us and CDFW to continually refine the existing INRMP as part of the Sikes Act's INRMP review process. Based on our review of the INRMP for this military installation, and in accordance with section 4(a)(3)(B)(i) of the Act, we have determined that certain lands within this installation meet the definition of critical habitat, and that conservation efforts identified in this INRMP, as modified by the 2012 Addendum, will provide a benefit to Vandenberg monkeyflower (see the following sections that detail this determination for the installation). Therefore, lands within this installation are exempt from critical habitat designation under section 4(a)(3)(B) of the Act. In summary, we are not including as proposed critical habitat approximately 4,159 ac (1,683 ha) on Vandenberg AFB that meet the definition of critical habitat but are exempt from designation under section 4(a)(3)(B) of the Act.
Vandenberg AFB is headquarters for the 30th Space Wing, the Air Force's Space Command unit that operates Vandenberg AFB and the Western Test Range and Pacific Missile Range. Vandenberg AFB operates as an aerospace center supporting west coast launch activities for the Air Force, Department of Defense, National Aeronautics and Space Administration, and commercial contractors. The three primary operational missions of Vandenberg AFB are to launch, place, and track satellites in near-polar orbit; to test and evaluate the Intercontinental ballistic missile systems; and to support aircraft operations in the western range. Vandenberg AFB lies on the south-central California coast, approximately 275 mi (442 km) south of San Francisco, 140 mi (225 km) northwest of Los Angeles, and 55 mi (88 km) northwest of Santa Barbara. The 99,100-ac (40,104-ha) base extends along approximately 42 mi (67 km) of Santa Barbara County coast, and varies in width from 5 to 15 mi (8 to 24 km).
The Vandenberg AFB INRMP was prepared to provide strategic direction to ecosystem and natural resources management on the Base. The long-term goal of the INRMP is to integrate all management activities in a manner that sustains, promotes, and restores the health and integrity of ecosystems using an adaptive management approach. The INRMP was designed to: (1) Summarize existing management plans and natural resources literature pertaining to Vandenberg AFB, (2) identify and analyze management goals in existing plans, (3) integrate the management goals and objectives of individual plans, (4) support Base compliance with applicable regulatory requirements, (5) support the integration of natural resource stewardship with the Air Force mission, and (6) provide direction for monitoring strategies.
Vandenberg AFB completed an INRMP in May 2011 (Air Force 2011c). The INRMP includes chapters that identify invasive, nonnative plants on the Base as well as step-down goals for the management of threatened and endangered species on the Base. However, since Vandenberg monkeyflower was not a listed species at that time, specific goals for this plant were not included. In 2012, the Air Force approved an addendum to the May 2011 INRMP that addresses specific goals for Vandenberg monkeyfower (Air Force 2012). Management considerations that provide a conservation benefit to Vandenberg monkeyflower in the addendum are:
(1) Avoiding Vandenberg monkeyflower and its habitat to the maximum extent practicable by relocating and redesigning proposed projects, and using biological monitors during project activities.
(2) Conducting nonnative species control efforts that target veldt grass across Vandenberg AFB. The Air Force has programmed more than $500,000 to treat veldt grass, with funding that started in 2009 and would continue through 2019.
(3) Training Base personnel in the identification of sensitive species and their habitats, including Vandenberg monkeyflower, prior to implementing nonnative species control actions.
(4) Implementing a fire response program, such as a Burned Area Emergency Response project, which includes post-fire monitoring, habitat restoration, erosion control, and nonnative species management.
(5) Developing a controlled burning program that would include portions of Vandenberg monkeyflower habitat.
(6) Conducting habitat and threat assessments to help decide the best approach for restoration actions.
(7) Periodic surveys of Vandenberg monkeyflower populations on the Base.
Vandenberg AFB supports four extant occurrences of Vandenberg monkeyflower located in Oak, Pine, Lakes, and Santa Lucia Canyons. Between 2006 and 2011, these four locations contained multiple occurrences; in 2010 specifically, more than 5,000 individuals were observed amongst all occurrences (see “Occurrences Located on Vandenberg AFB” section of the proposed listing rule published elsewhere in today's
Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if she determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless she determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making that determination, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor.
In considering whether to exclude a particular area from the designation, we identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, and evaluate whether the benefits of exclusion outweigh the benefits of inclusion. If the analysis indicates that the benefits of exclusion outweigh the benefits of inclusion, the Secretary may exercise her discretion to exclude the area only if such exclusion would not result in the extinction of the species.
When identifying the benefits of inclusion for an area, we consider the additional regulatory benefits that area would receive from the protection from adverse modification or destruction as a result of actions with a Federal nexus; the educational benefits of mapping essential habitat for recovery of the listed species; and any benefits that may result from a designation due to State or Federal laws that may apply to critical habitat.
When identifying the benefits of exclusion, we consider, among other things, whether exclusion of a specific area is likely to result in conservation; the continuation, strengthening, or encouragement of partnerships; or implementation of a management plan that provides equal to or more conservation than a critical habitat designation would provide.
In the case of Vandenberg monkeyflower, the benefits of critical habitat include public awareness of the presence of Vandenberg monkeyflower, the importance of habitat protection, and in cases where a Federal nexus exists, the potential increased habitat protection for Vandenberg monkeyflower due to the protection from adverse modification or destruction of critical habitat.
When we evaluate the existence of a conservation plan (or similar management plan) when considering the benefits of exclusion, we consider a variety of factors, including but not limited to, whether the plan is finalized, how it provides for the conservation of the essential physical or biological features, whether there is a reasonable expectation that the conservation management strategies and actions contained in a management plan will be implemented into the future, whether the conservation strategies in the plan are likely to be effective, and whether the plan contains a monitoring program or adaptive management to ensure that the conservation measures are effective and can be adapted in the future in response to new information.
After identifying the benefits of inclusion and the benefits of exclusion, we carefully weigh the two sides to evaluate whether the benefits of exclusion outweigh those of inclusion. If our analysis indicates that the benefits of exclusion outweigh the benefits of inclusion, we then determine whether exclusion would result in extinction. If exclusion of an area from critical habitat will result in extinction, we will not exclude it from the designation.
Based on the information provided by entities seeking exclusion, as well as any additional public comments received, we will evaluate whether certain lands in the proposed critical habitat Subunits 2, 3, and 4 are appropriate for exclusion from the final designation pursuant to section 4(b)(2) of the Act. If the analysis indicates that the benefits of excluding lands from the final designation outweigh the benefits of designating those lands as critical habitat, then the Secretary may exercise her discretion to exclude the lands from the final designation.
After considering the following areas under section 4(b)(2) of the Act, we are considering excluding them from the critical habitat designation for Vandenberg monkeyflower. These areas include lands proposed for critical habitat within the Burton Mesa Ecological Reserve (including a portion of lands in Subunit 2—Santa Lucia, a portion of lands in Subunit 3—Encina, and a portion of lands in Subunit 4—La Purisima) and lands proposed for critical habitat within La Purisima Mission SHP (a portion of lands in Subunit 4—La Purisima). Table 2 below provides approximate areas (ac, ha) of these lands that meet the definition of critical habitat and are under our consideration for possible exclusion under section 4(b)(2) of the Act.
However, we specifically solicit comments on the inclusion or exclusion of these areas. In the paragraphs below, we provide a detailed analysis of our consideration to exclude these lands under section 4(b)(2) of the Act.
Under section 4(b)(2) of the Act, we consider the economic impacts of specifying any particular area as critical habitat. In order to consider economic impacts, we are preparing an analysis of the economic impacts of the proposed critical habitat designation and related factors. The critical habitat subunits, as proposed, include Federal lands under the jurisdiction of the Department of Justice for the Lompoc Penitentiary, State lands with recreational uses, and private lands.
During the development of a final designation, we will consider economic impacts based on information in our economic analysis, public comments, and other new information, and areas may be excluded from the final critical habitat designation under section 4(b)(2) of the Act and our implementing regulations at 50 CFR 424.19.
Under section 4(b)(2) of the Act, we consider whether there are lands owned or managed by the Department of Defense or Department of Homeland Security where a national security impact might exist. As discussed above under the Exemptions section, we are exempting Department of Defense lands at Vandenberg AFB because we have determined that the INRMP and addendum provide a conservation benefit to Vandenberg monkeyflower. We have also determined that the remaining lands within the proposed designation of critical habitat for the species are not owned or managed by the Department of Defense or Department of Homeland Security, and, therefore, we anticipate no impact on national security.
Under section 4(b)(2) of the Act, we consider any other relevant impacts in addition to economic impacts and impacts on national security. We consider a number of factors, including whether the landowners have developed any HCPs or other management plans for the area, or whether there are conservation partnerships that would be encouraged by designation of, or exclusion from, critical habitat. In addition, we look at any tribal issues, and consider the government-to-government relationship of the United States with tribal entities. We also consider any social impacts that might occur because of the designation.
We consider a current land management or conservation plan (HCPs as well as other types) to provide adequate management or protection if it meets the following criteria:
(1) The plan is complete and provides a conservation benefit for the species and its habitat;
(2) there is a reasonable expectation that the conservation management strategies and actions will be implemented into the future, based on past practices, written guidance, or regulations; and
(3) the plan provides conservation strategies and measures consistent with currently accepted principles of conservation biology.
Portions of the proposed critical habitat subunits may warrant exclusion from designation as critical habitat under section 4(b)(2) of the Act based on partnerships with the State for management of the Burton Mesa Ecological Reserve and La Purisima Mission SHP, and the management and protection afforded by the general management plans the State has developed for the Reserve and the La Purisima Mission SHP, as discussed below.
(1) Minimizing damage to sensitive natural resources from ground disturbance.
(2) Minimizing the presence and impact of invasive, nonnative species.
(3) Maintaining a network of trails for public use while protecting resources and preventing unauthorized uses.
(4) Maintaining habitat continuity around the Reserve to limit the fragmentation of native vegetation on Burton Mesa.
(5) Restoring native areas that have been altered by humans to natural habitats.
(6) Monitoring the effectiveness and validity of the management actions.
(7) Encouraging public education about the ecosystem of the Reserve.
(8) Developing a fire (fuel) management plan to provide for public safety of nearby residential areas and to protect the numerous special status plants and animals on the Reserve (Gevirtz
These management objectives would benefit Vandenberg monkeyflower by reducing the loss of suitable habitat; minimizing the presence and expansion of invasive, nonnative plants; minimizing the pathways for nonnative plants to invade suitable habitat; reducing potential trampling of individual plants during casual recreational use; and maintaining an adequate fire regime for the benefit of the native Burton Mesa chaparral vegetation. Although aspects of this general management plan address to some degree the above criteria for exclusion of lands from critical habitat designation (for instance, it provides a conservation benefit and strategies and measures consistent with currently accepted principles of conservation biology), we have concerns whether funding and staffing will be available to adequately implement this plan to protect Vandenberg monkeyflower in the future. We are considering the exclusion of State lands covered by the Reserve's plan that provide for the conservation of Vandenberg monkeyflower. We are requesting comments on the benefit to Vandenberg monkeyflower from this plan and our consideration to exclude these lands from the final designation under section 4(b)(2) of the Act (see the Information Requested section).
Although the primary goal of the La Purisima Mission SHP plan is historical preservation, there are resource management directives specific to La Purisima Mission SHP that would include the habitat where Vandenberg monkeyflower occurs, which include:
(1) Preserving Burton Mesa chaparral.
(2) Protecting and managing rare and endangered plants in perpetuity.
(3) Maintaining a network of trails for public use while protecting resources and preventing unauthorized uses.
(4) Controlling nonnative plants that have become established in La Purisima Mission SHP.
(5) Developing a wildfire management plan (Cox 2013, pers. comm.).
These management objectives would benefit Vandenberg monkeyflower by reducing the loss of suitable habitat; minimizing the presence and expansion of invasive, nonnative plants; minimizing the pathways for nonnative plants to invade suitable habitat; reducing potential trampling of individual plants during casual recreational use; and implementing wildfire management guidelines to minimize the potential impact to natural resources while suppressing fires. Although there are aspects of this general management plan that address to some degree the above criteria for exclusion of lands from critical habitat designation (for instance, it provides a conservation benefit and strategies and measures consistent with currently accepted principles of conservation biology), we have concerns whether funding and staffing will be available to adequately implement this plan to protect Vandenberg monkeyflower in the future. We are considering the exclusion of State lands covered by this general management plan that provide for the conservation of Vandenberg monkeyflower. We are requesting comments on the benefit to Vandenberg monkeyflower from La Purisima Mission SHP's general management plan (see the Information Requested section).
In preparing this proposal, we have determined that there are currently no HCPs or other management plans for Vandenberg monkeyflower, and the proposed designation does not include any tribal lands. We anticipate no impact on tribal lands, partnerships, or HCPs from this proposed critical habitat designation.
In accordance with our joint policy on peer review published in the
We will consider all comments and information received during this comment period on this proposed rule during our preparation of a final determination. Accordingly, the final decision may differ from this proposal.
Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. Requests must be received within 45 days after the date of publication of this proposed rule in the
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include such businesses as manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and forestry and logging operations with fewer than 500 employees and annual business less than $7 million. To determine whether small entities may be affected, we will consider the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.
Importantly, the incremental impacts of a rule must be
Under the RFA, as amended, and following recent court decisions, Federal agencies are only required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself, and not the potential impacts to indirectly affected entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried by the Agency is not likely to adversely modify critical habitat. Therefore, only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Under these circumstances, it is our position that only Federal action agencies will be directly regulated by this designation. Therefore, because Federal agencies are not small entities, the Service may certify that the proposed critical habitat rule will not have a significant economic impact on a substantial number of small entities.
We acknowledge, however, that in some cases, third-party proponents of the action subject to permitting or funding may participate in a section 7 consultation, and thus may be indirectly affected. We believe it is good policy to assess these impacts if we have sufficient data before us to complete the necessary analysis, whether or not this analysis is strictly required by the RFA. While this regulation does not directly regulate these entities, in our draft economic analysis we will conduct a brief evaluation of the potential number of third parties participating in consultations on an annual basis in order to ensure a more complete examination of the incremental effects of this proposed rule in the context of the RFA.
In conclusion, we believe that, based on our interpretation of directly regulated entities under the RFA and relevant case law, this designation of critical habitat will only directly regulate Federal agencies which are not by definition small business entities. Therefore, we certify that, if promulgated, this designation of critical habitat would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required. However, though not necessarily required by the RFA, in our draft economic analysis for this proposal we will consider and evaluate the potential effects to third parties that may be involved with consultations with Federal action agencies related to this action.
Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. Oil extraction is still occurring on the oil field to the north of the Burton Mesa Ecological Reserve that is operated by Plains Exploration and Production Company (PXP). Multiple remnant pipelines associated with oil production remain in several locations just outside of the Reserve's boundaries (Gevirtz
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(1) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)–(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.
(2) We do not believe that this rule will significantly or uniquely affect small governments because approximately 85 percent of the lands being proposed for Vandenberg monkeyflower critical habitat are on lands managed by State agencies, primarily CDFW and California State Parks. A small percentage of land (38 ac (15 ha), or 0.7 percent) proposed as critical habitat falls within the land use jurisdiction of local agencies (such as special-use districts, water districts, and community service districts). The local-agency lands proposed as critical habitat are a small percentage of the total land area proposed. Small governments would be affected only to the extent that any programs having Federal funds, permits, or other authorized activities must ensure that their actions would not adversely affect critical habitat. Moreover, these agencies would be required to meet other regulatory mechanisms (such as CEQA) in addition to compliance with the Act. Therefore, a Small Government Agency Plan is not required. However, we will further evaluate this issue as we conduct our economic analysis, and review and revise this assessment if appropriate.
In accordance with Executive Order 12630 (“Government Actions and Interference with Constitutionally Protected Private Property Rights”), this rule is not anticipated to have significant takings implications. As discussed above, the designation of critical habitat affects only Federal actions. Critical habitat designation does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. We have not yet completed the economic analysis for this proposed rule. Once the economic analysis is available, we will review and revise this preliminary assessment as warranted, and prepare a Takings Implication Assessment.
In accordance with Executive Order 13132 (Federalism), this proposed rule does not have significant Federalism effects. A Federalism summary impact statement is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of, this proposed listing and critical habitat designation with appropriate State resource agencies in California. The designation may have some benefit to these governments because the areas that contain the physical or biological features essential to the conservation of the species are more clearly defined, and the elements of the features necessary to the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist local governments in long-range planning (rather than having them wait for case-by-case section 7 consultations to occur).
Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.
In accordance with Executive Order 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. We have proposed designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, the proposed rule identifies the elements of physical or biological features essential to the conservation of Vandenberg monkeyflower. The areas of proposed critical habitat are presented on maps, and the rule provides several options for the interested public to obtain more detailed location information, if desired.
This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses pursuant to the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes.
We determined that there are no tribal lands that are within the geographical area occupied by Vandenberg monkeyflower at the time of listing that contain the features essential to the conservation of the species, and no tribal lands outside the geographical area occupied by Vandenberg monkeyflower at the time of listing that are essential for the conservation of the species. Therefore, we are not proposing to designate critical habitat for Vandenberg monkeyflower on tribal lands.
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in the
A complete list of references cited in this rulemaking is available on the Internet at
The primary authors of this package are the staff members of the Ventura Fish and Wildlife Office.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361–1407; 1531–1544; 4201–4245; unless otherwise noted.
(a)
Family Phrymaceae:
(1) Critical habitat units are depicted for Santa Barbara County, California, on the maps below.
(2) Within these areas, the primary constituent elements of the physical or biological features essential to the conservation of Vandenberg monkeyflower consist of two components:
(i) Native maritime chaparral communities of Burton Mesa comprised of maritime chaparral and maritime chaparral mixed with coastal scrub, oak woodland, and small patches of native grasslands. The mosaic structure of the native plant communities (arranged in a mosaic of dominant vegetation and sandy openings (canopy gaps)), may change spatially as a result of succession, and physical processes such as windblown sand and wildfire.
(ii) Loose sandy soils on Burton Mesa. As mapped by the Natural Resources Conservation Service (NRCS), these could include the following soil series: Arnold Sand, Marina Sand, Narlon Sand, Tangair Sand, Botella Loam, Terrace Escarpments, and Gullied Land.
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the effective date of any final rule designating critical habitat for Vandenberg monkeyflower.
(4)
(5)
(6) Unit 1, Subunit 1 (Vandenberg) and Subunit 2 (Santa Lucia): Santa Barbara County, California. Map of Unit 1, Subunits 1 and 2 follows.
(7) Unit 1, Subunit 3 (Encina) and Subunit 4 (La Purisima): Santa Barbara County, California. Map of Unit 1, Subunits 3 and 4, follows:
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments regarding (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104–13. Comments regarding (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Food and Nutrition Service, USDA.
Notice; Extension of Comment Period.
Sections 3(k), (p) and (r), Section 7, and Section 9 of the Food and Nutrition Act of 2008 (“the Act”), and Title 7 Parts 271, 274, and 278 of the Code of Federal Regulations (“the regulations”) provide factors for determining the eligibility of retail food stores to participate in the Supplemental Nutrition Assistance Program (“SNAP”). This notice requests information from any and all interested parties on opportunities to enhance retailer definitions and requirements in a manner that improves access to healthy food choices for SNAP participants as well as program integrity, and ensures that only those retailers that effectuate the purpose of SNAP are authorized to accept benefits. The Food and Nutrition Service (“FNS”) considers access to a variety of healthy foods at SNAP retailers to be fundamental to the effectiveness of this critical nutrition assistance program. FNS is requesting information to understand what policy changes and, as needed, statutory changes, should be considered for retailer authorizations. FNS will use this information in determining how to make positive progress in the available healthy choices for program participants at authorized SNAP retail stores. The comment period is being extended to provide additional time for interested parties to review this request for information.
The comment period for the notice that was published on August 20, 2013 (78 FR 51136) has been extended from October 21, 2013 to November 6, 2013. To be assured of consideration, comments must be postmarked on or before November 6, 2013.
Comments may be submitted through the Federal eRulemaking Portal at
All comments submitted in response to this notice will be included in the record and will be made available to the public at
Shanta Swezy, Chief, Retailer Management and Issuance Branch, Food and Nutrition Service, (703) 305–2238.
At the end of fiscal year (FY) 2012, over 246,000 retailers were authorized to redeem SNAP benefits. This is an increase of almost 100,000 authorized stores since 2005. According to the most recent data available (2012), 82 percent of all benefits redeemed were redeemed at supermarkets, large grocers and superstores. Approximately 18 percent of benefits were redeemed at smaller stores, including convenience stores, small grocers and farmers' markets. Less than one percent were redeemed by authorized treatment programs, group homes, homeless meal providers, communal dining facilities and shelters as provided for in statute. A 2009 FNS study on benefit use indicates that 96.3 percent of all SNAP beneficiaries shopped at supermarkets or superstores at least once each month.
According to Sections 3(k), (p) and (r), and Section 9 of the Act, and Title 7, Parts 271 and 278 of the regulations, to be eligible to participate in SNAP, stores must sell food for home preparation and consumption and meet one of the criteria below:
(A) Offer for sale, on a continuous basis (any given day of operation), at least three varieties of qualifying foods in each of the following four staple food groups, with perishable foods in at least two of the categories:
• Meat, poultry or fish
• Bread or cereal
• Vegetables or fruits
• Dairy products
(B) More than one-half (50 percent) of the total dollar amount of all things (food, nonfood, gas and services) sold in the store must be from the sale of eligible staple foods.
The last major changes to the store eligibility requirements took place in the early 1990's as a result of congressional action. Today, a store that consistently stocks as few as 12 total food items from the required staple foods categories could technically be licensed to participate in SNAP. Store authorization data collected from retailers by USDA indicates that over 90,000 currently authorized SNAP retailers have substantial (over 50 percent) sales that stem from ineligible items.
In addition to providing minimal access to healthy food, retailers that do not provide sufficient healthful offerings often tend to be those stores that present the greatest integrity challenges for USDA. The sale or exchange of SNAP benefits for cash is referred to as “trafficking”, an illegal activity punishable by law. According to the latest FNS trafficking study covering the period 2009–2011, 99.5 percent of all trafficking stores involve retailers
FNS is concerned that there are a large and growing number of authorized retailers that do not provide healthful food offerings to SNAP recipients and that engage in fraud. These retailers represent a management challenge for the program that must be balanced against the need to ensure effective access to healthful, nutritious food for SNAP households. FNS has an interest in assuring that all authorized retailers will play by the rules and further the purpose of SNAP.
FNS' objectives are to improve the availability of more healthful foods without compromising access to nutritious food for SNAP participants, or unnecessarily burdening the retailers that redeem SNAP benefits, and to improve the integrity of the program. The Agency is seeking public input regarding the following questions, with particular attention to impacts of each on program integrity, healthy food choices, access to food and retailer operations:
1. Is ensuring that SNAP retailers provide SNAP clients access to healthy food choices a reasonable priority for establishing SNAP store eligibility criteria?
2. Are there store types that clearly meet all of the Program goals and, consequently, should always be eligible for SNAP participation?
3. Conversely, are there store types that do not effectively improve access to food choices (e.g. stores that sell low amounts of food when compared to the amounts of distilled liquor, tobacco and/or lottery tickets sold) and, therefore, should always be ineligible for SNAP participation?
4. Would a different definition of the “staple foods
5. How should prepared foods with multiple ingredients, such as chicken pot pie or other frozen dinners, or single serving meat jerky packages, be treated with regards to “staple foods” categories?
6. Do twelve items (the minimum amount necessary to meet SNAP authorization criterion A, by virtue of needing three varieties in the four different staple food categories) provide adequate variety for a retailer to further the Program's purpose? If not, what would be a more appropriate requirement?
7. Currently, retailers who are authorized under criterion A are required to stock perishable items (e.g., fresh, frozen or refrigerated fruits and vegetables; dairy; meats, poultry and fish; bread or cereal) in two categories. Should perishable items be required in more than two categories?
8. Are 50 percent of sales in staple foods, as currently required for criterion B, sufficient to ensure that a SNAP authorized store furthers the program's purpose, given the current definition of “staple foods”? Would this percentage be sufficient if the definition of “staple foods” is changed to exclude items high in added sugar, sodium or solid fats?
9. Should stores whose primary business (as evidenced by marketing, inventory or sales) is not the sale of food, be eligible to participate in SNAP?
10. Restaurants are generally prohibited from being SNAP retailers, and hot foods cannot be purchased with SNAP benefits. However, there are authorized retailers who primarily sell food for immediate consumption, often on premises, but also sell their products cold and heat them for SNAP recipients immediately after purchase for a nominal fee. These stores qualify today based on the array of raw ingredients, such as unbaked pizza or raw fish. Should such stores be eligible for participation in SNAP?
11. Should all retailers who meet SNAP eligibility criteria be authorized, even when sufficient store access for recipients is not a concern?
12. If store access were a concern in an area where no store meets basic eligibility criteria for SNAP authorization, how should FNS select the stores to authorize that best serve the needs of the client population? Should FNS employ an evaluation and scoring system? If so, what criteria should make up such a system?
13. How should integrity and management priorities be balanced against healthy food choice criteria in the SNAP authorization process? What elements could be used to assess integrity risks, and how should they be applied?
14. Are there any other ways in which the criteria for retailer eligibility should be changed? If so, how?
(k)
(r)(1) Except as provided in paragraph (2),
(A) Meat, poultry, or fish.
(B) Bread or cereals.
(C) Vegetables or fruits.
(D) Dairy products.
(2) “
Food Safety and Inspection Service, USDA.
Notice of availability and opportunity for comments.
The Food Safety and Inspection Service (FSIS) is announcing the availability of a compliance guide to assist livestock slaughter establishments in complying with the regulatory requirements for humane handling and slaughter of livestock. FSIS encourages operators of livestock slaughter establishments to follow this guidance.
The Agency must receive comments by December 30, 2013.
A downloadable version of the compliance guide is available to view and print at
FSIS invites interested persons to submit comments on this notice. Comments may be submitted by either of the following methods:
Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205–0495, or by Fax: (202) 720–2025.
The Humane Methods of Slaughter Act (HMSA) of 1978 (7 U.S.C. 1901 et seq.) requires the use of humane methods for handling and slaughtering livestock. The HMSA states that “the use of humane methods in the slaughter of livestock prevents needless suffering; results in safer and better working conditions for persons engaged in the slaughtering industry; brings about improvement of products and economies in slaughtering operations; and produces other benefits for producers, processors, and consumers which tend to expedite an orderly flow of livestock and livestock products in interstate and foreign commerce.”
The HMSA is referenced in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 603) and is implemented by FSIS humane handling and slaughter regulations found at 9 CFR part 313. Establishments are required to meet the humane handling and slaughter requirements in the regulations the entire time they hold livestock in connection with slaughter.
On September 9, 2004, FSIS announced that livestock slaughter establishments should implement and maintain a systematic approach to humane handling and slaughter to best ensure compliance with the HMSA, FMIA, and the implementing regulations (69 FR 54625). A systematic approach is a comprehensive way of evaluating how livestock enter and move through an establishment. The 2004 notice outlined four steps establishments should take to develop and maintain a systematic approach. The guidance summarizes these four steps and states that under a systematic approach, establishments should:
(1) Assess the ability of their livestock handling and slaughter practices to minimize distress and injury to livestock;
(2) Design facilities and implement handling practices that minimize distress and injury to livestock;
(3) Periodically evaluate facilities and handling methods to ensure that they continue to minimize distress and injury to livestock; and
(4) When necessary, modify facilities and handling methods to ensure that they continue to minimize distress and injury to livestock.
The guidance also explains that if an establishment takes this systematic approach and incorporates three additional features, FSIS would consider it a “robust” systematic approach. These three features are:
(1) The establishment develops written procedures that it will implement to stay in compliance with the regulations or to come back into compliance should it fail to implement the program as written or fail to prevent noncompliance;
(2) The establishment maintains written records that demonstrate that the program is being implemented as written, and that the program is effectively preventing identified potential noncompliances; and
(3) These written procedures and records are made available for FSIS review upon request.
The Agency has developed a compliance guide to assist establishments in developing, implementing, and maintaining a systematic approach to humane handling and slaughter of livestock to comply with the regulatory requirements. Although the guide sets out recommendations rather than requirements, FSIS encourages livestock slaughter establishments to follow this guidance. This guide represents FSIS's thinking, and FSIS will update it as necessary to reflect comments received any additional information that becomes available.
The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.)
Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at (202) 720–2600 (voice and TTY).
To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250–9410 or call (202) 720–5964 (voice and TTY). USDA is an equal opportunity provider and employer.
FSIS will announce this notice online through the FSIS Web page located at
FSIS will also make copies of this
Forest Service, USDA.
Notice of withdrawal.
The Crescent Ranger District is withdrawing their intent to prepare an Environmental Impact Statement (EIS) for the Marsh project. The original Notice of Intent (NOI) was published in the
Tim Foley, Team Leader, Crescent Ranger District, P.O. Box 208, Crescent, Oregon, 97733, phone (541) 433–3200.
Forest Service, USDA.
Notice of meeting.
The Black Hills National Forest Advisory Board (Board) will meet in Rapid City, South Dakota. The Board is established consistent with the Federal Advisory Committee Act of 1972 (5 U.S.C. App. II) (FACA), and the Forest and Rangeland Renewable Resources Planning Act of 1974 (16 U.S.C. 1600 et seq.) (RPA), the National Forest Management Act of 1976 (16 U.S.C. 1612) (NFMA), and the Federal Public Lands Recreation Enhancement Act (Pub. L. 108–447) (REA).
The purpose of the Board is to provide advice and recommendations on a broad range of forest issues such as forest plan revisions or amendments and forest health, including fire and mountain pine beetle epidemics, travel management, forest monitoring and evaluation, recreation fees, and site-specific projects having forest-wide implications.
The meeting is open to the public. The purpose of the meeting is to: (1) To provide an orientation to the Board regarding Forest Funding, including appropriations and trends; (2) provide an update to the Board regarding Cave Management and White Nose Syndrome in Bats; and (3) discuss Motorized Travel Permit Fees.
The meeting will be held November 20, 2013, at 1:00 p.m.
The meeting will be held at the Forest Service Mystic Ranger District Office, 8221 South Highway 16, Rapid City SD. Written comments may be submitted as described under
Scott Jacobson, Committee Management Officer, Black Hills National Forest Supervisor's Office, 605–673–9216,
The following business will be conducted: (1) Orientation to Forest Funding including appropriations and trends; (2) an update on Cave Management and White Nose Syndrome in Bats; and (3) a discussion regarding Motorized Trail Permit Fees. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before the meeting. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by November 8, 2013, to be scheduled on the agenda. Written comments and time requests for oral comments must be sent to Scott Jacobson, Supervisor's Office, Black Hills National Forest, 1019 North Fifth Street, Custer, SD 57730, or by email to
(1) Review the independent auditors' report of Commission's financial statements for fiscal year 2012–2013; (2) Review the Low-Level Radioactive Waste (LLRW) generation information for 2012; (3) Consider a proposed budget for fiscal year 2014–2015; (4) Review recent regional and national developments regarding LLRW management and disposal; and (5) Elect the Commission's Officers.
Enforcement and Compliance, formerly Import Administration, International Trade Administration, Department of Commerce.
On July 1, 2013, the Department of Commerce (the “Department”) initiated the first five-year (“sunset”) review of the antidumping duty order on laminated woven sacks from the People's Republic of China (“PRC”) pursuant to section 751(c) of the Tariff Act of 1930, as amended (the “Act”).
Irene Gorelik, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482–6905.
On July 30, 2013, the Department received an adequate substantive response from domestic interested party Laminated Woven Sacks Committee (“Petitioner”) within the deadline specified in 19 CFR 351.218(d)(3)(i).
All issues raised in this sunset review are addressed in the “Issues and Decision Memorandum for the Expedited First Sunset Review of the Antidumping Duty Order on Laminated woven sacks from the People's Republic of China” from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, dated concurrently with, and hereby adopted by, this notice (“Decision Memorandum”). The issues discussed in the Decision Memorandum include the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the order was to be revoked. Parties may find a complete discussion of all issues raised in the review and the corresponding recommendations in this public memorandum which is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Services System (“IA ACCESS”). Access to IA ACCESS is available to registered users at
The merchandise covered by the order
We determine that revocation of the order would be likely to lead to continuation or recurrence of dumping at the following weighted-average percentage margins:
This notice also serves as the only reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return of destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This sunset review and notice are in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act.
Enforcement and Compliance, formerly Import Administration, International Trade Administration, Department of Commerce.
On July 15, 2013, the Department of Commerce (the “Department”) published the
Steven Hampton, AD/CVD Operations, Office 5, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington DC 20230; telephone (202) 482–0116.
On July 15, 2013, the Department published the
The products covered by the order are certain hot-rolled carbon steel flat products of a rectangular shape, of a width of 0.5 inch or greater, neither clad, plated, nor coated with metal and whether or not painted, varnished, or coated with plastics or other non-metallic substances, in coils (whether or not in successively superimposed layers), regardless of thickness, and in straight lengths of a thickness of less than 4.75 mm and of a width measuring at least 10 times the thickness. Universal mill plate (
All products that meet the physical and chemical description provided above are within the scope of the order unless otherwise excluded. The following products, for example, are outside or specifically excluded from the scope of the order:
• Alloy hot-rolled steel products in which at least one of the chemical elements exceeds those listed above (including,
• Society of Automotive Engineers (“SAE”)/American Iron & Steel Institute (“AISI”) grades of series 2300 and higher.
• Ball bearing steels, as defined in the HTSUS.
• Tool steels, as defined in the HTSUS.
• Silico-manganese (as defined in the HTSUS) or silicon electrical steel with a silicon level exceeding 2.25 percent.
• ASTM specifications A710 and A736.
• USS abrasion-resistant steels (USS AR 400, USS AR 500).
• All products (proprietary or otherwise) based on an alloy ASTM specification (sample specifications: ASTM A506, A507).
• Non-rectangular shapes, not in coils, which are the result of having been processed by cutting or stamping and which have assumed the character of articles or products classified outside chapter 72 of the HTSUS.
The merchandise subject to the order is classified in the HTSUS at subheadings: 7208.10.15.00, 7208.10.30.00, 7208.10.60.00, 7208.25.30.00, 7208.25.60.00, 7208.26.00.30, 7208.26.00.60, 7208.27.00.30, 7208.27.00.60, 7208.36.00.30, 7208.36.00.60, 7208.37.00.30, 7208.37.00.60, 7208.38.00.15, 7208.38.00.30, 7208.38.00.90, 7208.39.00.15, 7208.39.00.30, 7208.39.00.90, 7208.40.60.30, 7208.40.60.60, 7208.53.00.00, 7208.54.00.00, 7208.90.00.00, 7211.14.00.90, 7211.19.15.00, 7211.19.20.00, 7211.19.30.00, 7211.19.45.00, 7211.19.60.00, 7211.19.75.30, 7211.19.75.60, and 7211.19.75.90. Certain hot-rolled carbon steel flat products covered by the order, including: vacuum degassed fully stabilized; high strength low alloy; and the substrate for motor lamination steel may also enter under the following tariff numbers: 7225.11.00.00, 7225.19.00.00, 7225.30.30.50, 7225.30.70.00, 7225.40.70.00, 7225.99.00.90, 7226.11.10.00, 7226.11.90.30, 7226.11.90.60, 7226.19.10.00, 7226.19.90.00, 7226.91.50.00, 7226.91.70.00, 7226.91.80.00, and 7226.99.00.00. Subject merchandise may also enter under 7210.70.30.00, 7210.90.90.00, 7211.14.00.30, 7212.40.10.00, 7212.40.50.00, and 7212.50.00.00. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.
In the
Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of review. The Department announced a refinement to its assessment practice in NME cases.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (2) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 90.83 percent; and (3) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to the administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results and this notice in accordance with sections 751(a)(1) and 777(i) of the Act.
Enforcement and Compliance, formerly Import Administration, International Trade Administration, Department of Commerce.
On July 10, 2013, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain large diameter carbon and alloy seamless standard, line, and pressure pipe (over 4
Nancy Decker or Joshua Morris, AD/CVD Operations, Office 1, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482–0196, and (202) 482–1779, respectively.
On July 10, 2013, the Department published the preliminary results of the administrative review of the antidumping duty order on certain large diameter carbon and alloy seamless standard, line, and pressure pipe (over 4
The Department has conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).
The products covered by the order are large diameter seamless carbon and alloy (other than stainless) steel standard, line, and pressure pipes produced, or equivalent, to the American Society for Testing and Materials (ASTM) A–53, ASTM A–106, ASTM A–333, ASTM A–334, ASTM A–589, ASTM A–795, and the American Petroleum Institute (API) 5L specifications and meeting the physical parameters described below, regardless of application. The scope of the order also includes all other products used in standard, line, or pressure pipe applications and meeting the physical parameters described below, regardless of specification, with the exception of the exclusions discussed below. Specifically included within the scope of the order are seamless pipes greater than 4.5 inches (114.3 mm) up to and including 16 inches (406.4 mm) in outside diameter, regardless of wall-thickness, manufacturing process (hot finished or cold-drawn), end finish (plain end, beveled end, upset end, threaded, or threaded and coupled), or surface finish.
The seamless pipes subject to the order are currently classifiable under the subheadings 7304.10.10.30, 7304.10.10.45, 7304.10.10.60, 7304.10.50.50, 7304.19.10.30, 7304.19.10.45, 7304.19.10.60, 7304.19.50.50, 7304.31.60.10, 7304.31.60.50, 7304.39.00.04, 7304.39.00.06, 7304.39.00.08, 7304.39.00.36, 7304.39.00.40, 7304.39.00.44, 7304.39.00.48, 7304.39.00.52, 7304.39.00.56, 7304.39.00.62, 7304.39.00.68, 7304.39.00.72, 7304.51.50.15, 7304.51.50.45, 7304.51.50.60, 7304.59.20.30, 7304.59.20.55, 7304.59.20.60, 7304.59.20.70, 7304.59.60.00, 7304.59.80.30, 7304.59.80.35, 7304.59.80.40, 7304.59.80.45, 7304.59.80.50, 7304.59.80.55, 7304.59.80.60, 7304.59.80.65, and 7304.59.80.70 of the Harmonized Tariff Schedule of the United States (HTSUS).
Specifications, Characteristics, and Uses: Large diameter seamless pipe is used primarily for line applications such as oil, gas, or water pipeline, or utility distribution systems. Seamless pressure pipes are intended for the conveyance of water, steam, petrochemicals, chemicals, oil products,
Seamless standard pipes are most commonly produced to the ASTM A–53 specification and generally are not intended for high temperature service. They are intended for the low temperature and pressure conveyance of water, steam, natural gas, air and other liquids and gasses in plumbing and heating systems, air conditioning units, automatic sprinkler systems, and other related uses. Standard pipes (depending on type and code) may carry liquids at elevated temperatures but must not exceed relevant ASME code requirements. If exceptionally low temperature uses or conditions are anticipated, standard pipe may be manufactured to ASTM A–333 or ASTM A–334 specifications.
Seamless line pipes are intended for the conveyance of oil and natural gas or other fluids in pipe lines. Seamless line pipes are produced to the API 5L specification. Seamless water well pipe (ASTM A–589) and seamless galvanized pipe for fire protection uses (ASTM A–795) are used for the conveyance of water.
Seamless pipes are commonly produced and certified to meet ASTM A–106, ASTM A–53, API 5L–B, and API 5L–X42 specifications. To avoid maintaining separate production runs and separate inventories, manufacturers typically triple or quadruple certify the pipes by meeting the metallurgical requirements and performing the required tests pursuant to the respective specifications. Since distributors sell the vast majority of this product, they can thereby maintain a single inventory to service all customers.
The primary application of ASTM A–106 pressure pipes and triple or quadruple certified pipes in large diameters is for use as oil and gas distribution lines for commercial applications. A more minor application for large diameter seamless pipes is for use in pressure piping systems by refineries, petrochemical plants, and chemical plants, as well as in power generation plants and in some oil field uses (on shore and off shore) such as for separator lines, gathering lines and metering runs. These applications constitute the majority of the market for the subject seamless pipes. However, ASTM A–106 pipes may be used in some boiler applications.
The scope of the order includes all seamless pipe meeting the physical parameters described above and produced to one of the specifications listed above, regardless of application, with the exception of the exclusions discussed below, whether or not also certified to a non-covered specification. Standard, line, and pressure applications and the above-listed specifications are defining characteristics of the scope of the order. Therefore, seamless pipes meeting the physical description above, but not produced to the ASTM A–53, ASTM A–106, ASTM A–333, ASTM A–334, ASTM A–589, ASTM A–795, and API 5L specifications shall be covered if used in a standard, line, or pressure application, with the exception of the specific exclusions discussed below.
For example, there are certain other ASTM specifications of pipe which, because of overlapping characteristics, could potentially be used in ASTM A–106 applications. These specifications generally include ASTM A–161, ASTM A–192, ASTM A–210, ASTM A–252, ASTM A–501, ASTM A–523, ASTM A–524, and ASTM A–618. When such pipes are used in a standard, line, or pressure pipe application, such products are covered by the scope of the order.
Specifically excluded from the scope of the order are:
A. Boiler tubing and mechanical tubing, if such products are not produced to ASTM A–53, ASTM A–106, ASTM A–333, ASTM A–334, ASTM A–589, ASTM A–795, and API 5L specifications and are not used in standard, line, or pressure pipe applications.
B. Finished and unfinished oil country tubular goods (OCTG), if covered by the scope of another antidumping duty order from the same country. If not covered by such an OCTG order, finished and unfinished OCTG are included in the scope when used in standard, line or pressure applications.
C. Products produced to the A–335 specification unless they are used in an application that would normally utilize ASTM A–53, ASTM A–106, ASTM A–333, ASTM A–334, ASTM A–589, ASTM A–795, and API 5L specifications.
D. Line and riser pipe for deepwater application,
With regard to the excluded products listed above, the Department will not instruct U.S. Customs and Border Protection (CBP) to require end-use certification until such time as petitioner or other interested parties provide to the Department a reasonable basis to believe or suspect that the products are being utilized in a covered application. If such information is provided, we will require end-use certification only for the product(s) (or specification(s)) for which evidence is provided that such products are being used in a covered application as described above. For example, if, based on evidence provided by petitioner, the Department finds a reasonable basis to believe or suspect that seamless pipe produced to the A–335 specification is being used in an A–106 application, we will require end-use certifications for imports of that specification. Normally we will require only the importer of record to certify to the end use of the imported merchandise. If it later proves necessary for adequate implementation, we may also require producers who export such products to the United States to provide such certification on invoices accompanying shipments to the United States.
Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the merchandise subject to the scope is dispositive.
We have made no changes to our findings announced in the
Also consistent with the
Because we found that CNRL did not sell subject merchandise to an unaffiliated customer in the United States, or to unaffiliated customers for exportation to the United States, but exported all the subject merchandise back to CNRL in Canada we will instruct CBP to liquidate its entries covered by this review without regard to antidumping duties.
The Department clarified its “automatic assessment” regulation on May 6, 2003. This clarification will apply to POR entries by JFE, Nippon, NKK, and SMI because these companies certified that they made no POR shipments of subject merchandise for which they had knowledge of U.S. destination and we are making a final determination of no shipments. We will instruct CBP to liquidate these entries at the all-others rate established in the less-than-fair-value investigation (68.88 percent) if there is no rate for the intermediary involved in the transaction. For a full discussion of this clarification,
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results and this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, Formerly Import Administration, International Trade Administration, Department of Commerce.
As a result of the determinations by the Department of Commerce (the Department) and the U.S. International Trade Commission (USITC) that revocation of the antidumping duty order on welded large diameter line pipe (LDLP) from Japan would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, the Department is publishing a notice of continuation of this antidumping duty order.
John Drury or Angelica Mendoza, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–0195 and (202) 482–3019, respectively.
On December 6, 2001, the Department published the antidumping duty order on LDLP from Japan.
As a result of this sunset review, the Department determined that revocation of the antidumping duty order on LDLP from Japan would likely lead to continuation or recurrence of dumping and, therefore, notified the USITC of the magnitude of the margins likely to prevail should the order be revoked.
On October 2, 2013, the USITC determined, pursuant to section 751(c) of the Act, that revocation of the antidumping duty order on LDLP from Japan would be likely to lead to a continuation or recurrence of material injury to an industry in the United Sates within a reasonably foreseeable time.
The product covered by this order is certain welded carbon and alloy line pipe, of circular cross section and with an outside diameter greater than 16 inches, but less than 64 inches, in diameter, whether or not stenciled. This product is normally produced according to American Petroleum Institute (API) specifications, including Grades A25, A, B, and X grades ranging from X42 to X80, but can also be produced to other specifications. The product currently is classified under U.S. Harmonized Tariff Schedule (HTSUS) item numbers 7305.11.10.30, 7305.11.10.60, 7305.11.50.00, 7305.12.10.30, 7305.12.10.60, 7305.12.50.00, 7305.19.10.30. 7305.19.10.60, and 7305.19.50.00. Although the HTSUS item numbers are provided for
Having an outside diameter greater than or equal to 18 inches and less than or equal to 22 inches, with a wall thickness measuring 0.750 inch or greater, regardless of grade.
Having an outside diameter greater than or equal to 24 inches and less than 30 inches, with wall thickness measuring greater than 0.875 inches in grades A, B, and X42, with wall thickness measuring greater than 0.750 inches in grades X52 through X56, and with wall thickness measuring greater than 0.688 inches in grades X60 or greater.
Having an outside diameter greater than or equal to 30 inches and less than 36 inches, with wall thickness measuring greater than 1.250 inches in grades A, B, and X42, with wall thickness measuring greater than 1.000 inches in grades X52 through X56, and with wall thickness measuring greater than 0.875 inches in grades X60 or greater.
Having an outside diameter greater than or equal to 36 inches and less than 42 inches, with wall thickness measuring greater than 1.375 inches in grades A, B, and X42, with wall thickness measuring greater than 1.250 inches in grades X52 through X56, and with wall thickness measuring greater than 1.125 inches in grades X60 or greater.
Having an outside diameter greater than or equal to 42 inches and less than 64 inches, with a wall thickness measuring greater than 1.500 inches in grades A, B, and X42, with wall thickness measuring greater than 1.375 inches in grades X52 through X56, and with wall thickness measuring greater than 1.250 inches in grades X60 or greater.
Having an outside diameter equal to 48 inches, with a wall thickness measuring 1.0 inch or greater, in grades X–80 or greater.
In API grades X80 or above, having an outside diameter of 48 inches to and including 52 inches, and with a wall thickness of 0.90 inch or more.
In API grades X100 or above, having an outside diameter of 48 inches to and including 52 inches, and with a wall thickness of 0.54 inch or more.
An API grade X–80 having an outside diameter of 21 inches and wall thickness of 0.625 inch or more.
As a result of the determinations by the Department and the USITC that revocation of the antidumping duty order on LDLP from Japan would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on LDLP from Japan.
U.S. Customs and Border Protection will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of this order will be the date of publication in the
This five-year (sunset) review and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act.
National Institute of Standards and Technology (NIST), Department of Commerce.
Notice; request for comments.
The National Institute of Standards and Technology (NIST) seeks comments on the preliminary version of the Cybersecurity Framework (“preliminary Framework”). The preliminary Framework was developed by NIST using information collected through the Request for Information (RFI) that was published in the
Comments must be received by 5:00 p.m. Eastern Time December 13, 2013.
Both written and electronic comments should be submitted using the comment template form available electronically from the NIST Web site at:
The preliminary Cybersecurity Framework is available electronically from the NIST Web site at:
Diane Honeycutt, telephone: 301–975–8443, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899–8930 or via email:
The national and economic security of the United States depends on the reliable functioning of critical infrastructure,
Under the Executive Order,
The Cybersecurity Framework will provide a prioritized, flexible, repeatable, performance-based, and cost-effective approach, including information security measures and controls to help owners and operators of critical infrastructure and other interested entities to identify, assess, and manage cybersecurity-related risk while protecting business confidentiality, individual privacy and civil liberties. To enable technical innovation and account for organizational differences, the Cybersecurity Framework will not prescribe particular technological solutions or specifications. It will include guidance for measuring the performance of an entity in implementing the Cybersecurity Framework and will include methodologies to identify and mitigate impacts of the Framework and associated information security measures and controls on business confidentiality and to protect individual privacy and civil liberties.
As a non-regulatory Federal agency, NIST developed the preliminary Framework in a manner that is consistent with its mission to promote U.S. innovation and industrial competitiveness through the development of standards and guidelines in consultation with stakeholders in both government and industry. The preliminary Framework seeks to provide owners and operators of critical infrastructure the ability to implement security practices in the most effective manner while allowing organizations to express requirements to multiple authorities and regulators. Issues relating to harmonization of existing relevant standards and integration with existing frameworks were also considered. While the focus is on the Nation's critical infrastructure, the preliminary Framework was developed in a manner to promote wide adoption of practices to increase cybersecurity across all sectors and industry types.
The preliminary Framework was developed through an open public review and comment process that included information collected through Request for Information (RFI), 78 FR 13024 (February 26, 2013), and a series of public workshops. Comments received in response to the RFI are available at
NIST held four open public workshops to provide the public with additional opportunities to provide input. The first workshop was conducted on April 3, 2013, at the Department of Commerce in Washington, DC The second workshop was conducted on May 29–31, 2013, at Carnegie Mellon University in Pittsburgh, Pennsylvania. The third workshop was conducted on July 10–12, 2013, at the University of California, San Diego. The fourth workshop was conducted on September 11–13, 2013, at the University of Texas at Dallas. Agenda, discussion materials, and presentation slides for each of these workshops are available at
Throughout the process, NIST issued public updates on the development of the Cybersecurity Framework. NIST issued the first update on June 18, 2013, and it is available at
The preliminary Framework incorporates existing consensus-based standards to the fullest extent possible, consistent with requirements of the National Technology Transfer and Advancement Act of 1995,
Request for Comments:
NIST seeks public comments on the preliminary Cybersecurity Framework. The draft report is available electronically from the NIST Web site at:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of a determination of overfishing or an overfished condition.
This action serves as a notice that NMFS, on behalf of the Secretary of Commerce (Secretary), has determined that Georges Bank (GB) cod and Gulf of Maine (GOM) cod are subject to overfishing and continue to be in an overfished condition.
NMFS, on behalf of the Secretary, notifies the appropriate fishery management council (Council) whenever it determines that overfishing is occurring, a stock is in an overfished condition, a stock is approaching an overfished condition, or when a rebuilding plan has not resulted in adequate progress toward ending overfishing and rebuilding affected fish stocks.
Mark Nelson, (301) 427–8565.
Pursuant to sections 304(e)(2) and (e)(7) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1854(e)(2) and (e)(7), and implementing regulations at 50 CFR 600.310(e)(2), NMFS, on behalf of the Secretary, must notify Councils whenever it determines that a stock or stock complex is: overfished; approaching an overfished condition; or an existing rebuilding plan has not ended overfishing or resulted in adequate rebuilding progress. NMFS also notifies Councils when it determines a stock or stock complex is subject to overfishing. Section 304(e)(2) further requires NMFS to publish these notices in the
The 2013 Stock Assessment Workshop (SAW) 55, showed that overfishing was occurring on both Georges Bank cod and Gulf of Maine cod, and that both stocks remain in an overfished condition. The New England Fishery Management Council has been notified of the results of SAW 55 and has taken action to end overfishing and rebuild these two stocks through Framework 48.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific and Statistical Committee (SSC) on November 15, 2013 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Friday, November 15, 2013 at 8:30 a.m.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465–0492.
The NEFMC's Scientific and Statistical Committee (SSC) will meet to specify overfishing levels (OFLs) and develop Acceptable Biological Catch (ABC) recommendations for Atlantic sea scallops for fishing years 2014 and 2015 (default) and for the Northeast Skate Complex for fishing years 2014 through 2016. The Committee will consider information provided to it by the Council's Scallop Plan Development Team (PDT) and by the Skate PDT. The Committee will also review the 2012 update assessment for Gulf of Maine (GOM) haddock and the work of the Groundfish PDT in order to reconsider ABC and OFL for GOM haddock for fishing years 2013–15.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465–0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scallop Committee on November 14, 2013 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Thursday, November 14, 2013 at 9 a.m.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465–0492.
The Committee will continue development of potential alternatives for FY2014 and FY2015 (default) specifications being considered in Framework 25. Specifications include days-at-sea allocations, access area allocations, individual fishing quota (IFQ) allocations for the general category fishery, a hard total allowable catch (TAC) for the Northern Gulf of Maine (NGOM) area and target TAC for vessels with a general category incidental catch permit. The Committee will also finalize other measures being considered: (1) Measures for unused 2012 and 2013 Closed Area I access area trips; and (2) accountability measures for Southern New England/Mid Atlantic (SNE/MA) windowpane flounder. The Committee will make final recommendations for the Council to consider for 2014 Council work priorities. Finally, there will be a presentation from the Northeast Regional Ocean Council (NROC) about regional ocean planning efforts, specifically fishing characterization maps that have been developed. Other issues may be discussed.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465–0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of open meeting.
This notice sets forth the schedule of a forthcoming meeting of the DoC NOAA National Climate Assessment and Development Advisory Committee (NCADAC).
Dr. Cynthia Decker, Designated Federal Officer, National Climate Assessment and Development Advisory Committee, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301–734–1156, Fax: 301–713–1459, Email:
The National Climate Assessment and Development Advisory Committee was established in December 2010. The committee's mission is to synthesize and summarize the science and information pertaining to current and future impacts of climate change upon the United States; and to provide advice and recommendations toward the development of an ongoing, sustainable national assessment of global change impacts and adaptation and mitigation strategies for the Nation. Within the scope of its mission, the committee's specific objective is to produce a National Climate Assessment.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permits.
Notice is hereby given that six individuals and institutions have been issued Letters of Confirmation for activities conducted under the General Authorization for Scientific Research on marine mammals. See
The Letters of Confirmation and related documents are available for review upon written request or by appointment in the following office:
Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)427–8401; fax (301)713–0376.
Office of Protected Resources, Permits and Conservation Division, (301)427–8401.
The requested Letters of Confirmation have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Defense Acquisition University, DoD.
Notice.
In compliance with Section 3506(c)(2)(A) of the
Consideration will be given to all comments received by December 30, 2013.
You may submit comments, identified by docket number and title, by any of the following methods:
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To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Center Director, Student Information System, Performance and Resource Management, Defense Acquisition University, 9820 Belvoir Road, Ft. Belvoir, VA 22060, or call the Center Director for the Student Information System, Performance and Resource Management, at 703–805–4288.
Respondents are university applicants and instructors who willingly provide personal information to take courses administered by the Defense Acquisition University. Failure to provide required information results in the individual being denied access to DAU and its course offerings. The data is used by DoD and college officials to: Provide for the administration of and a record of academic performance of current, former, and nominated students; verify grades; select instructors; make decisions to admit students to programs and classes, and to release students from programs; serve as a basis for studies to determine improved criteria for selecting students into classes; forecast demand for future course offerings, and to develop statistics relating to duty assignments and qualifications based on DoD mandated training needs.
Department of Defense.
Notice.
The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Department of Defense Military Family Readiness Council will take place. The purpose of this meeting is to refine the Council recommendations that will be included in the 2013 Military Family Readiness Council reports to the congressional defense committees and the Secretary of Defense.
Friday, November 22, 2013, from 1:00 p.m. to 3:30 p.m.
Pentagon Conference Center B6 (escorts will be provided from the Pentagon Metro entrance).
Ms. Melody McDonald or Ms. Betsy Graham, Office of the Deputy Assistant Secretary of Defense (Military Community & Family Policy), 4800 Mark Center Drive, Alexandria, VA 22350–2300, Room 3G15. Telephones (571) 372–0880; (571) 372–0881 and/or email: OSD Pentagon OUSD P–R Mailbox Family Readiness Council,
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102–3.150.
Pursuant to 5 U.S.C. 552b and 41 CFR 102–3.140 through 102–3.165, this meeting is open to the public, subject to the availability of space. Persons desiring to attend may contact Ms. Melody McDonald at 571–372–0880 or email OSD Pentagon OUSD P–R Mailbox Family Readiness Council,
Pursuant to 41 CFR 102–3.105(j) and 102–3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the Council. Persons desiring to submit a written statement to the Council must notify the point of contact listed in
Exact order may vary.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Consideration will be given to all comments received by November 29, 2013.
Fred Licari, 571–372–0493.
Written comments and recommendations on the proposed information collection should be sent to Ms. Jasmeet Seehra at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.
You may also submit comments, identified by docket number and title, by the following method:
• Federal eRulemaking Portal:
Written requests for copies of the information collection proposal should be sent to Ms. Toppings at WHS/ESD Information Management Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350–3100.
Federal Energy Regulatory Commission.
Request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting the information collections, FERC–511 (Transfer of Hydropower License
Comments on the collections of information are due November 29, 2013.
Comments filed with OMB, identified by the OMB Control Nos. 1902–0069 (FERC–511) and 1902–0079 (FERC–515) should be sent via email to the Office of Information and Regulatory Affairs at
A copy of the comments should also be sent to the Federal Energy Regulatory Commission, identified by the Docket Nos. IC13–19–000 and IC13–20–000, by either of the following methods:
• eFiling at Commission's Web site:
• Mail/Hand Delivery/Courier: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.
Ellen Brown may be reached by email at
This notice is combined for administrative purposes only. The FERC–511 and FERC–515 will remain separate information collections with separate OMB Control Numbers.
The total estimated annual cost burden to respondents is $64,496 [(920 hours/2080 hours per year) * $145,818/year
The total estimated annual cost burden to respondents is $56,084 [(800 hours/2080 hours per year) * $145,818/year
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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All documents may be filed electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on October 17, 2013, pursuant to section 206 of the Federal Power Act (FPA) and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Frankfort Electric and Water Plant Board and the Cities of Barbourville, Bardstown, Bardwell, Benham, Berea, Corbin, Falmouth, Madisonville, Nicholasville, Paris, and Providence, Kentucky (Complainants or Kentucky Municipals) filed a formal complaint against the Kentucky Utilities Company, (Respondents), seeking an investigation and refund effective date under FPA section 206 and ask that the proceeding be consolidated with Docket no. ER13–2428–000.
The Kentucky Municipals certify that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Comment Date: 5:00 p.m. Eastern Time on November 6, 2013.
Take notice that the following Draft License Application (DLA) and draft Preliminary Draft Environmental Assessment (PDEA) have been filed with the Commission and are available for public inspection.
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All comments on the draft PDEA and DLA should be sent to the addresses noted above in Item (h), and filed with the Commission.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
All comments must bear the heading Preliminary Comments, Preliminary Recommendations, Preliminary Terms and Conditions, or Preliminary Prescriptions.
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Juneau Hydropower, Inc. has mailed a copy of the draft PDEA and DLA to interested entities and parties. Copies of these documents are available for review at the Juneau Public Library, 292 Marine Way, Juneau, Alaska 99801, or at the Juneau Hydropower, Inc. Web site,
m. With this notice, we are initiating consultation with the Alaska State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the regulations of the Advisory Council on Historic Preservation, 36 CFR 800.4.
Take notice that on October 3, 2013, the Deputy Secretary of the Department of Energy, pursuant to the authority vested by sections 301(b), 302(a), 402(e), 641, 642, 643, and 644, of the Department of Energy Organization Act (Pub. L. 95–91), and by Delegation Order Nos. 00–037.00 (December 6, 2001) and 00–001.00E (June 6, 2013), confirmed, approved, and placed in effect on an interim basis in Rate Order SWPA–66, Southwestern Power Administration Integrated System Rates for the period October 1, 2013 through September 30, 2017.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on October 3, 2013, the Deputy Secretary of the Department of Energy, pursuant to the authority vested by sections 301(b), 302(a), 402(e), 641, 642, 643, and 644, of the Department of Energy Organization Act (Pub. L. 95–91), and by Delegation Order Nos. 00–037.00 (December 6, 2001) and 00–001.00E (June 6, 2013), confirmed, approved, and placed in effect on an interim basis in Rate Order SWPA–67, Southwestern Power Administration annual rate for the sale of power and energy from the Rayburn Project to the Sam Rayburn Dam Electric Cooperative, Inc.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
On October 21, 2013, the Commission held a drawing to determine priority between competing preliminary permit applications with identical filing times. In the event that the Commission concludes that neither of the applicants' plans is better adapted than the other to develop, conserve, and utilize in the public interest the water resources of the region at issue, the priority established by this drawing will serve as the tiebreaker. Based on the drawing, the order of priority is as follows:
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e) (1) (v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped chronologically, in ascending order. These filings are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff may attend the meetings of the Southwest Power Pool, Inc. (SPP) Regional Entity Trustee (RE), Regional State Committee (RSC) and Board of Directors, as noted below. Their attendance is part of the Commission's ongoing outreach efforts.
All meetings will be held at the SPP Corporate Offices, 201 Worthen Drive, Little Rock, AR 722111. The phone number is (501) 312–9000.
October 28, 2013 (8:00 a.m.–12:00 p.m.)
October 28, 2013 (1:00 p.m.–5:00 p.m.)
October 29, 2013 (8:00 a.m.–3:00 p.m.)
The discussions may address matters at issue in the following proceedings:
These meetings are open to the public.
For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249–5937 or
Environmental Protection Agency (EPA).
Notice of annual adjustment factors for excess emissions penalty.
The Acid Rain Program under title IV of the Clean Air Act provides for automatic excess emissions penalties in dollars per ton of excess emissions for sources that do not meet their annual Acid Rain emissions limitations. This notice states the dollars per ton excess emissions penalty amounts, which must be adjusted for each compliance year commensurate with changes in the Consumer Price Index (CPI), for compliance years 2013 and 2014.
Robert L. Miller, Clean Air Markets Division (6204J), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460, at (202) 343–9077 or
The Acid Rain Program under title IV of the Clean Air Act limits annual sulfur dioxide and nitrogen oxide emissions of fossil fuel-fired utility units. Under the Acid Rain Program, affected sources must hold enough allowances to cover their sulfur dioxide emissions, and certain coal-fired sources must meet an emission limit for nitrogen oxides. Under 40 CFR 77.6, sources that do not meet these requirements must pay a penalty without demand to the Administrator based on the number of excess tons emitted times $2,000 as adjusted by an annual adjustment factor, which must be published in the
The annual adjustment factor for adjusting the penalty for excess emissions of sulfur dioxide and nitrogen oxides under 40 CFR 77.6(b) for compliance year 2013 is 1.8489. This value is derived using the CPI for 1990 and 2012 (defined respectively at 40 CFR 72.2 as the CPI for August of the year before the specified year for all urban consumers) and results in an automatic penalty of $3,698 per excess ton of sulfur dioxide or nitrogen oxides emitted for 2013.
The annual adjustment factor for adjusting the penalty for such excess emissions under 40 CFR 77.6(b) for compliance year 2014 is 1.8770. This value is derived using the CPI for 1990 and 2013 and results in an automatic penalty of $3,754 per excess ton of sulfur dioxide or nitrogen oxides emitted for 2014.
Federal Communications Commission.
Notice and request for comments.
The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology;
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before December 30, 2013. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to the Federal Communications Commission via email to
For additional information about the information collection, contact Cathy Williams at (202) 418–2918.
The information is used by the Commission staff in carrying out its duties under the Communications Act. The information collections are necessary for the Commission to maintain effective oversight of U.S. carriers that are affiliated with, or involved in certain co-marketing or similar arrangements with, foreign carriers that have market power. Additionally, the information collections are necessary to analyze market trends to determine whether amendment of the Commission's existing rules or proposals of new rules are necessary to promote effective competition and prevent anti-competitive behavior between American and foreign carriers.
Federal Communications Commission.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501–3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before December 30, 2013. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418–2918.
The purpose of this information collection is to continually streamline
Federal Election Commission.
Thursday, October 31, 2013 at 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694–1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer, Telephone: (202) 694–1220.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 12, 2013.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414:
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B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001:
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Board of Governors of the Federal Reserve System, October 23, 2013.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 22, 2013.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001:
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Board of Governors of the Federal Reserve System, October 23, 2013.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning contractor use of interagency fleet management system vehicles. A notice was published in the
Submit comments on or before November 29, 2013.
Submit comments identified by Information Collection 9000–0032, Contractor Use of Interagency Fleet Management System Vehicles, by any of the following methods:
• Regulations.gov:
Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000–0032, Contractor Use of Interagency Fleet Management System Vehicles”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000–0032, Contractor Use of Interagency Fleet Management System Vehicles” on your attached document.
• Fax: 202–501–4067.
• Mail: General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., 2nd Floor, Washington, DC 20405–0001. ATTN: Hada Flowers/IC 9000–0032, Contractor Use of Interagency Fleet Management System Vehicles.
Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA (202) 501–1448 or email at
If it is in the best interest of the Government, the contracting officer may authorize cost-reimbursement contractors to obtain, for official purposes only, interagency fleet management system (IFMS) vehicles and related services. Federal Acquisition Regulation (FAR) 51.205 and the clause at FAR 52.251–2, Interagency Fleet Management System (IFMS) Vehicles and Related Services are to be used in solicitations and contracts when a cost reimbursement contract is contemplated and the contracting officer may authorize the contractor to use interagency fleet management system (IFMS) vehicles and related services.
Before a contracting officer may authorize cost-reimbursement contractors to obtain IFMS vehicles and related services, the contracting officer must have, among other requirements:
• A written statement that the contractor will assume, without the right of reimbursement from the Government, the cost or expense of any use of the IFMS vehicles and services not related to the performance of the contract;
• Evidence that the contractor has obtained motor vehicle liability insurance covering bodily injury and property damage, with limits of liability as required or approved by the agency, protecting the contractor and the Government against third-party claims arising from the ownership, maintenance, or use of an IFMS vehicle; and
• Considered any recommendations of the contractor. The information is used by the Government to determine whether it is in the Government's best interest to authorize a cost-reimbursement contractor, for official purposes only, to use IFMS vehicles and related services.
Authorized contractors shall submit requests for IFMS vehicles and related services in writing to the appropriate GSA point of contact in accordance with the FAR. Contractors' requests for vehicles or related services must include:
• Two copies of the agency authorization;
• The number of vehicles and related services required and period of use;
• A list of employees who are authorized to request the vehicles or related services;
• A listing of equipment authorized to be serviced; and
• Billing instructions and address.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
There is no centralized database in the Federal Government that captures information on agencies' use of the IFMS for this information collection; however, agencies annually report motor vehicle fleet data using the GSA Federal Automotive Statistical Tool (FAST), a web-based reporting tool cosponsored by GSA and the Department of Energy.
For this information collection requirement data from Fiscal Year (FY) 2012 was retrieved from the Federal Procurement Data System (FPDS) to determine the number of agencies that awarded cost reimbursable contracts that may utilize IFMS to provide vehicles to contractors for official purposes only. FPDS identified approximately 120 contracting agencies
World War One Centennial Commission.
Meeting notice.
Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2). This notice provides the schedule and agenda for the November 15, 2013, meeting of the World War One Centennial Commission (the Commission). The meeting is open to the public and the site is accessible to individuals with disabilities.
Daniel S. Dayton, Designated Federal Officer, c/o The Foundation for the Commemoration of the World Wars, 701 Pennsylvania Avenue NW., #123, Washington, DC 20004–2608 202–380–0725 (note: this is not a toll-free number).
Contact Daniel S. Dayton at 202–380–0725 to register to comment during the meeting's 30 minute public comment period. Registered speakers/organizations will be allowed 5 minutes and will need to provide written copies of their presentations. Requests to comment at the meeting must be received by 5:00 p.m. Eastern Standard Time (EST), November 12, 2013. Written comments may be provided to Mr. Dayton at
The World War One Centennial Commission was established by Public Law 112–272, as a commission to ensure a suitable observance of the centennial of World War I, to provide for the designation of memorials to the service of members of the United States Armed Forces in World War I, and for other purposes. Under this authority, the Committee will plan, develop, and execute programs, projects, and activities to commemorate the centennial of World War I, encourage private organizations and State and local governments to organize and participate in activities commemorating the centennial of World War I, facility and coordinate activities throughout the United States relating to the centennial of World War I, serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of World War I, and develop recommendations for Congress and the President for commemorating the centennial of World War I.
• Introductions and plans for today's meeting—DFO
• Committee Reports
• Old Business
• New Business
• 30 minute public comment period for individuals pre-registered per instructions above. Each individual will be able to speak for no more than 5 minutes.
• Closing comments
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 30, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Feed Materials Production Center (FMPC) in Fernald, Ohio, who were not employed by National Lead of Ohio, NLO, or the Department of Energy or its predecessor agencies, who worked at FMPC from January 1, 1951, through December 31, 1983, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work
This designation will become effective on October 30, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 1–877–222–7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a decision to designate a class of employees from the Feed Materials Production Center (FMPC) in Fernald, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 30, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Feed Materials Production Center (FMPC) in Fernald, Ohio, from January 1, 1954, through December 31, 1967, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation will become effective on October 30, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 1–877–222–7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a decision to designate a class of employees from the Pantex Plant in Amarillo, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 30, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Pantex Plant in Amarillo, Texas, from January 1, 1984, through December 31, 1991, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation will become effective on October 30, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 1–877–222–7570. Information requests can also be submitted by email to
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a determination concerning a petition to add a class of employees from Baker Brothers, in Toledo, Ohio, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). On September 30, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
All Atomic Weapons Employees and Department of Energy employees, contractors and subcontractors who worked at the Baker Brothers site in Toledo, Ohio, during the applicable covered residual radiation and remediation period from January 1, 1945, through December 31, 1996.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 1–877–222–7570. Information requests can also be submitted by email to
42 U.S.C. 7384q.
National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a determination concerning a petition to add a class of employees from the Pantex Plant in Amarillo, Texas, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). On September 30, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Pantex Plant in Amarillo, Texas, from January 1, 1951, through December 31, 1957.
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 1–877–222–7570. Information requests can also be submitted by email to
42 U.S.C. 7384q.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639–7570 or send an email to
Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System (OMB #0920–0612, exp. 1/31/2014)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
The WISEWOMAN program (Well-Integrated Screening and Evaluation for Women Across the Nation), administered by the Centers for Disease Control and Prevention (CDC), was established to examine ways to improve the delivery of services for women who have limited access to health care and elevated risk factors for cardio vascular disease (CVD). The program focuses on reducing CVD risk factors and provides screening services for selected risk factors such as elevated blood cholesterol, hypertension, and abnormal blood glucose levels. The program also provides women with referrals to lifestyle programs and medical care. The WISEWOMAN program currently provides services to approximately 45,000 women who are jointly enrolled in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), also administered by CDC. CDC collects information from WISEWOMAN awardees through the “WISEWOMAN Reporting System” (OMB No. 0920–0612, exp. 1/31/2014).
New WISEWOMAN cooperative agreements were awarded in 2013 and CDC seeks to continue information collection for three years, with revisions. The new funding period will reflect an increased emphasis on efficient oversight of program awardees and documenting program outcomes. As a result, the WISEWOMAN information collection will be revised to support updated program goals. Revisions to be implemented include a reduction in the frequency of progress report submission—from twice per year to once per year—and changes to the content of the Minimum Data Element (MDE) submissions. This will result in an overall net decrease in respondent burden. The first reports based on the revised reporting requirements will be submitted to CDC in April 2014.
The hardcopy progress report provides a narrative summary of each awardee's objectives and the activities undertaken to meet program goals, including public education and outreach. The estimated burden per response is 16 hours.
The MDE include information that describes risk factors for the women served in each program and the number and type of lifestyle program sessions they attend. MDE information has previously been submitted to CDC in two electronic transmissions. The burden for Screening and Assessment MDE was estimated at 16 hours per response and the burden for Lifestyle Program MDE was estimated at 8 hours per response.
Upon OMB approval of the proposed Revision, the MDE will be submitted as a single electronic file with a combined estimated burden per response of 24 hours. The total number of MDE variables will increase from 66 to 85. The number of variables relating to Lifestyle Programs will decrease and the number of variables relating to Screening and Assessment will increase.
CDC will continue to use the information collected from WISEWOMAN awardees to support continuous program monitoring and improvement activities, evaluation, and assessment of program outcomes. The overall program evaluation is designed to demonstrate how WISEWOMAN can obtain more complete health data on vulnerable populations, promote public education about disease incidence, cardiovascular disease risk-factors, health promotion, to improve the availability of screening and diagnostic services for under-served women, ensure the quality of services provided to under-served women, and develop strategies for improved interventions. Participation in this information collection is required as a condition of cooperative agreement funding. There are no costs to respondents other than their time.
The total annualized burden hours are 1,344.
This notice is published less than the required 15 days prior to the start of the announced meeting, in accordance with Section 102–3.150(b) of the GSA Final Rule (2001) that allows for exceptions to the meeting notification time requirement. Section 102–3.150(b) states the following: “In exceptional circumstances, the agency or an independent Presidential advisory committee may give less than 15 calendar days' notice, provided that the reasons for doing so are included in the advisory committee meeting notice published in the
In this case, the agency is giving less than 15 days' notice due to the recent furlough status of United States Federal Government, including the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, from October 1–16, 2013.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee:
In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2015.
The agenda is subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
This notice is published less than the required 15 days prior to the start of the announced meeting, in accordance with Section 102–3.150(b) of the GSA Final Rule (2001) that allows for exceptions to the meeting notification time requirement. Section 102–3.150(b) states the following: “In exceptional circumstances, the agency or an independent Presidential advisory committee may give less than 15 calendar days' notice, provided that the reasons for doing so are included in the advisory committee meeting notice published in the
In this case, the agency is giving less than 15 days' notice due to the recent furlough status of United States Federal Government, including the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, from October 1–16, 2013.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
This notice is published less than the required 15 days prior to the start of the announced meeting, in accordance with Section 102–3.150(b) of the GSA Final Rule (2001) that allows for exceptions to the meeting notification time requirement. Section 102–3.150(b) states the following: “In exceptional circumstances, the agency or an independent Presidential advisory committee may give less than 15 calendar days' notice, provided that the reasons for doing so are included in the advisory committee meeting notice published in the
In this case, the agency is giving less than 15 days' notice due to the recent furlough status of United States Federal Government, including the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, from October 1–16, 2013.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
This notice is published less than the required 15 days prior to the start of the announced meeting, in accordance with Section 102–3.150(b) of the GSA Final Rule (2001) that allows for exceptions to the meeting notification time requirement. Section 102–3.150(b) states the following: “In exceptional circumstances, the agency or an independent Presidential advisory committee may give less than 15 calendar days' notice, provided that the reasons for doing so are included in the advisory committee meeting notice published in the
In this case, the agency is giving less than 15 days' notice due to the recent furlough status of United States Federal Government, including the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, from October 1–16, 2013.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces, the following meeting of the aforementioned committee:
Agenda items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Tobacco Products Scientific Advisory Committee, Office of Science, Center for Tobacco Products.
FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Nominations received on or before December 30, 2013, will be given first consideration for membership on the Tobacco Products Scientific Advisory Committee. Nominations received after December 30, 2013, will be considered for nomination to the committee as later vacancies occur.
All nominations for membership should be sent electronically to
Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site by using the following link:
FDA is requesting nominations for voting members on the Tobacco Products Scientific Advisory Committee. Elsewhere in this issue of the
The Tobacco Products Scientific Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of 12 members including the Chair. Members and the Chair are selected by the Commissioner or designee from among individuals knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The Committee shall include nine technically qualified voting members, selected by the Commissioner or designee. The nine voting members shall be physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology,
In addition to the voting members, the committee shall include three nonvoting members who are identified with industry interests. These members shall include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry.
Any interested person may nominate one or more qualified individuals for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available. Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Notice is hereby given of a change in the meeting of the Transplantation, Tolerance, and Tumor Immunology Study Section, October 3, 2013, 8:30 a.m. to October 4, 2013, 12:00 p.m., Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC 20037 which was published in the
The meeting will be held at the Washington Plaza Hotel, 10 Thomas Circle NW., Washington, DC 20005. The meeting will start on November 21, 2013 at 8:00 a.m. and will end on November 22, 2013 at 1:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, October 11, 2013, 10:00 a.m. to 5:00 p.m., National Institutes of Health, Two Democracy Plaza, Suite 959, 6707 Democracy Boulevard, Bethesda, MD 20892, which was published in the
The meeting notice is amended to change the date from October 22, 2013, to November 19–20, 2013 at 8:00 a.m. to 6:00 p.m. The location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, October 22, 2013, 11:00 a.m. to 5:00 p.m., National Institutes of Health, Two Democracy Plaza, Suite 951, 6707 Democracy Boulevard, Bethesda, MD 20892, which was published in the
The meeting notice is amended to change the date from October 22, 2013, to December 11, 2013. The time and location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Tumor Cell Biology Study Section, October 16, 2013, 08:00 a.m. to October 17, 2013, 05:00 p.m., Hotel Kabuki, 1625 Post Street, San Francisco, CA 94115 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on November 16, 2013 at 8:00 a.m. and end on November 17, 2013 at 7:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 11, 2013, 08:00 a.m. to October 11, 2013, 05:00 p.m., Doubletree Hotel Washington, 1515 Rhode Island Ave. NW., Washington, DC 20005 which was published in the
The meeting will be held at National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on November 15, 2013 at 9:00 a.m. and end on November 15, 2013 at 4:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Prokaryotic Cell and Molecular Biology Study Section, October 25, 2013, 08:00 a.m. to October 25, 2013, 06:00 p.m., Avenue Hotel Chicago, 160 E. Huron Street, Chicago, IL 60611 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 on December 17, 2013, starting at 10:00 a.m. and ending at 07:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the Board of Scientific Counselors for Clinical Sciences and Epidemiology National Cancer Institute and the Board of Scientific Counselors for Basic Sciences National Cancer Institute.
The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual other conducted by the National Cancer Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government Shutdown of October 2013.
Notice is hereby given of a change in the meeting of the Child Psychopathology and Developmental Disabilities Study Section, October 17, 2013, 8:00 a.m. to October 18, 2013, 5:00 p.m., The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on November 18, 2013 at 8:00 a.m. and will end on November 20, 2013 at 10:00 a.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Molecular Genetics B Study Section, October 02, 2013, 07:00 p.m. to October 03, 2013, 06:00 p.m., Handlery Union Square Hotel, 351 Geary Street, San Francisco, CA 94102 which was published in the
The meeting will start on November 16, 2013 at 7:00 a.m. and end on November 16, 2013 at 5:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Surgery, Anesthesiology and Trauma Study Section, October 02, 2013, 08:00 a.m. to October 03, 2013, 05:00 p.m., The Allerton Hotel, 701 North Michigan Avenue, Chicago, IL, 60611 which was published in the
The meeting will start on December 9, 2013 at 8:00 a.m. and end on December 10, 2013 at 5:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Biomedical Imaging Technology B Study Section, October 07, 2013, 08:00 a.m. to October 08, 2013, 05:00 p.m., Hilton Alexandria Mark Center, 5000 Seminary Road, Alexandria, VA, 22311 which was published in the
The meeting will start on November 24, 2013 at 06:00 p.m. and end on November 25, 2013 at 06:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 25, 2013, 01:00 p.m. to October 25, 2013, 05:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will start on November 20, 2013 at 08:00 a.m. and end on November 21, 2013 at 05:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 29, 2013, 10:00 a.m. to October 29, 2013, 03:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
The meeting will be held on November 12, 2013, from 01:00 p.m. to 04:30 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, October 07, 2013, 1:00 p.m. to October 07, 2013, 4:00 p.m., National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 which was published in the
The meeting will be held on November 4, 2013 from 1:00 p.m. until 4:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
Notice is hereby given of a change in the meeting of the Clinical Oncology Study Section, October 07, 2013, 08:00 a.m. to October 07, 2013, 07:00 p.m., Holiday Inn Riverwalk, 217 N Saint Mary's Street, San Antonio, TX, 78205 which was published in the
The meeting will be held at the Crowne Plaza Tysons Corner Hotel. 1960 Chain Bridge Road, McLean, VA 22102, on November 18, 2013, starting at 08:00 a.m. and ending at 06:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Vascular Cell and Molecular Biology Study Section, October 17, 2013, 08:00 a.m. to October 18, 2013, 12:00 p.m., Doubletree Hotel Washington, 1515 Rhode Island Ave. NW., Washington, DC 20005 which was published in the
The meeting will be held on December 3, 2013, at 7:30 a.m. and will end at 7:30 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Musculoskeletal Tissue Engineering Study Section, October 17, 2013, 08:00 a.m. to October 18, 2013, 05:30 p.m., Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the
The meeting will be held at the DoubleTree by Hilton, Bethesda, 8120 Wisconsin Avenue, Bethesda, MD 20814, on November 18, 2013, starting at 08:00 a.m. and ending at 07:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Cancer Immunopathology and Immunotherapy Study Section, October 03, 2013, 08:00 a.m. to October 03, 2013, 06:00 p.m., Washington Marriott at Metro Center, 775 12th Street NW., District of Columbia, DC 20005 which was published in the
The meeting will be held at the Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814, on November 5, 2013, starting at 08:00 a.m. and ending at 06:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Myocardial Ischemia and Metabolism Study Section, October 02, 2013, 08:00 a.m. to October 03, 2013, 05:00 p.m., Hotel Kabuki, 1625 Post Street, San Francisco, CA 94115 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on December 17, 2013 at 10:00 a.m. and end on December 19, 2013 at 06:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 24, 2013, 2:00 p.m. to 5:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on October 29, 2013 at 2:00 p.m. to 5:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Molecular and Integrative Signal Transduction Study Section, October 10, 2013, 08:00 a.m. to October 11, 2013, 05:30 p.m., Sheraton Gunter Hotel, 205 East Houston Street, San Antonio, TX, 78205 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on November 6, 2013 at 10:00 a.m. and end on November 7, 2013 at 05:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Synthetic and Biological Chemistry A Study Section, October 21, 2013, 08:00 a.m. to October 22, 2013, 12:00 p.m., Hotel Palomar, 2121 P Street NW., Washington, DC, 20037 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on December 18, 2013 at 09:00 a.m. and end on December 20, 2013 at 05:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 24, 2013, 01:00 p.m. to October 24, 2013, 04:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on November 12, 2013 from 03:30 p.m. to 06:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Development—2 Study Section, October 10, 2013, 08:00 a.m. to October 10, 2013, 06:00 p.m., Doubletree Hotel Washington, 1515 Rhode Island Ave NW., Washington, DC 20005 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on December 12, 2013 at 9:00 a.m. and end on December 12, 2013 at 7:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Biobehavioral Regulation, Learning and Ethology Study Section, October 21, 2013, 08:30 a.m. to October 22, 2013, 05:00 p.m., Lorien Hotel & Spa, 1600 King Street, Alexandria, VA, 22314 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on December 2, 2013 at 08:30 a.m. and end on December 6, 2013 at 05:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Cellular and Molecular Immunology—B Study Section, October 17, 2013, 08:30 a.m. to October 18, 2013, 05:00 p.m., Avenue Hotel Chicago, 160 E. Huron Street, Chicago, IL 60611 which was published in the
The meeting will be held at the Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. The meeting will start on December 5, 2013 at 08:30 a.m. and end on December 6, 2013 at 05:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 1, 2013, 12:00 a.m. to October 1, 2013, 5:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
The meeting will be held on November 26, 2013, from 12:00 p.m. to 3:30 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, IMM–K81, October 24, 2013, 4:30 p.m. to October 24, 2013, 6:00 p.m., Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW., Washington, DC, 20037 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on November 13, 2013 at 8:00 a.m. and will end on November 14, 2013 at 8:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 24, 2013, 08:00 a.m. to October 25, 2013, 05:00 p.m., Embassy Suites DC Convention Center, 900 10 Street NW., Washington, DC, 20001, which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on November 21, 2013 at 08:00 a.m. and end on November 22, 2013 at 06:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Environmental Health Sciences Special Emphasis Panel, October 10, 2013, 12:30 p.m. to October 10, 2013, 5:00 p.m., NIEHS/National Institutes of Health, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 which was published in the
This meeting, originally scheduled for October 10, 2013, will be held on November 14, 2013 from 1 p.m. to 4 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Oral, Dental and Craniofacial Sciences Study Section, October 16, 2013, 08:00 a.m. to October 17, 2013, 05:00 p.m., Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD, 20814 which was published in the
The meeting will start on November 19, 2013 at 9:00 a.m. and will end on November 20, 2013 at 5:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
This meeting notice is being published less than 15 days in advance of the meeting due to the Government shutdown of October 2013.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 11, 2013, 01:30 p.m. to October 11, 2013, 04:30 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on December 2, 2013 from 03:00 p.m. to 06:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, ZRG1 F07–K (20), October 24, 2013, 08:00 a.m. to October 24, 2013, 04:30 p.m., Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue NW, Washington, DC, 20037 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on November 13, 2013 at 8:00 a.m. and will end on November 14, 2013 at 8:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Eye Institute Special Emphasis Panel, October 21, 2013, 08:00 a.m. to October 23, 2013, 12:00 p.m., National Institutes of Health, 5635 Fishers Lane, Bethesda, MD, 20892 which was published in the
Due to the Government Shutdown of October 2013, the meeting has been
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 22, 2013, 11:00 a.m. to October 22, 2013, 01:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
The meeting will be held on November 19, 2013. The time and location remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Nuclear and Cytoplasmic Structure/Function and Dynamics Study Section, October 15, 2013, 8:00 a.m. to October 16, 2013, 6:00 p.m., Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC, 20015 which was published in the
The meeting will be held at The Palomar Hotel, 2121 P. Street, Washington, DC 20037. The meeting will start on November 11, 2013 at 8:00 a.m. and will end on November 11, 2013 at 7:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 21, 2013, 08:00 a.m. to October 21, 2013, 05:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on November 22, 2013. The meeting time and location will remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Social Sciences and Population Studies A Study Section, October 3, 2013, 8:30 a.m. to October 4, 2013, 12:00 p.m., Renaissance, Washington, DC Hotel, 999 Ninth Street NW., Washington, DC 20001 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892. The meeting will start on December 17, 2013 at 9:00 a.m. and end on December 17, 2013 at 7:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 18, 2013, 1:00 p.m. to 2:00 p.m., The William F. Bolger Center, 9600 Newbridge Drive, Potomac, MD 20854 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. The meeting will start on October 31, 2013 at 11:00 a.m. and will end at 12:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Cancer Biomarkers Study Section, October 18, 2013, 08:00 a.m. to October 18, 2013, 06:00 p.m., Houston JW Marriott, 5150 Westheimer Road, Houston, TX 77056 which was published in the
The meeting will start on December 16, 2013 at 8:00 a.m. and end on December 16, 2013 at 6:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Advisory Eye Council, October 17, 2013, 8:30 a.m. to October 17, 2013, 5:00 p.m., NIH, Neuroscience Building, 6001 Executive Boulevard, Conference Room D, Rockville, MD 20852 which was published in the
Due to the Government Shutdown of October 2013, the meeting has been rescheduled to October 28, 2013, 2:00 p.m. to 3:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, October 3, 2013, 8:30 a.m. to 5:00 p.m., National Institutes of Health, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda, MD 20892, which was published in the
The meeting notice is amended to change the date from October 3, 2013, to November 4–6, 2013. The time and location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 22, 2013, 11:30 a.m. to October 22, 2013, 02:30 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held on November 12, 2013. The meeting time and location remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, October 15, 2013, 01:00 p.m. to October 15, 2013, 02:30 p.m., National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD, 20892 which was published in the
The meeting will be held on November 4, 2014 from 2:00 p.m. until 4:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Chemo/Dietary Prevention Study Section, October 10, 2013, 08:00 a.m. to October 10, 2013, 07:00 p.m., Holiday Inn San Francisco Fisherman's Wharf, 1300 Columbus Avenue, San Francisco, CA 94133 which was published in the
The meeting will be held at Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The meeting will start on December 9, 2013 at 8:00 a.m. and end on December 9, 2013 at 7:00 p.m. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 4, 2013, 12:00 p.m. to October 4, 2013, 5:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on September 10, 2013, 78 FR 55269.
The meeting will be held on November 26, 2013, from 1:00 p.m. to 5:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Tumor Microenvironment Study Section, October 21, 2013, 08:00 a.m. to October 22, 2013, 05:00 p.m., Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015 which was published in the
The meeting will be held at the National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, on November 5, 2013, starting at 08:00 a.m. and ending at 07:00 p.m. The meeting is closed to the public.
Part N, National Institutes of Health (NIH), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (40 FR 22859, May 27, 1975, as amended most recently at 77 FR 1941, January 12, 2012, and redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as set forth below to reflect a functional statement amendment for the
Section N–T, Organization and Functions, under the heading
(1) Provides leadership and formulates research goals and long-term plans to accomplish the Institute's mission of child health; maternal health; problems of human development, with special reference to intellectual and developmental disabilities; family structure and the dynamics of human population; the reproductive process; and medical rehabilitation; (2) conducts, fosters, and supports biomedical and behavioral research through research grants, research contracts, and research performed in its own laboratories; (3) supports training in fundamental sciences and clinical disciplines through individual and institutional research training awards; (4) promotes the application of research findings to clinical practice; (5) cooperates in government-wide efforts to improve health and provides consultation to Federal agencies and non-Federal groups in the development of programs to improve health; (6) coordinates and integrates research efforts with service-oriented health agencies; and (7) disseminates information related to research findings to practitioners and the general public for improving health.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276–1243.
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Executive Order 12862 directs agencies that “provide significant services directly to the public” to “survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services.” SAMHSA provides significant services directly to the public, including treatment providers and State substance abuse and mental health agencies, through a range of mechanisms, including publications, training, meetings, technical assistance and Web sites. Many of these services are focused on information
The primary use for information gathered is to identify strengths and weaknesses in current service provisions by SAMHSA and to make improvements that are practical and feasible. Several of the customer satisfaction surveys expected to be implemented under this approval will provide data for measurement of program effectiveness under the Government Performance and Results Act (GPRA). Information from these customer surveys will be used to plan and redirect resources and efforts to improve or maintain a high quality of service to health care providers and members of the public. Focus groups may be used to develop the survey questionnaire in some instances.
The estimated annual hour burden is as follows:
Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 2–1057, One Choke Cherry Road, Rockville, MD 20857 or email her a copy at
Federal Emergency Management Agency, DHS.
Final Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of November 20, 2013 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646–4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Adminstrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of New Mexico (FEMA–4148–DR), dated September 30, 2013, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–2833.
Notice is hereby given that, in a letter dated September 30, 2013, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of New Mexico resulting from severe storms and flooding during the period of July 23–28, 2013, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the State of New Mexico.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to Section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Nancy M. Casper, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of New Mexico have been designated as adversely affected by this major disaster:
Bernalillo, Colfax, Luna, Sandoval, and Socorro Counties and the Cochiti, Kewa (Santa Domingo), San Felipe, and Sandia Pueblos for Public Assistance.
All counties and Indian Tribes within the State of New Mexico are eligible to apply for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Pennsylvania (FEMA–4149–DR), dated October 1, 2013, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–2833.
Notice is hereby given that, in a letter dated October 1, 2013, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:
I have determined that the damage in certain areas of the Commonwealth of Pennsylvania resulting from severe storms, tornadoes, and flooding during the period of June 26 to July 11, 2013, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the Commonwealth of Pennsylvania.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to Section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Donald L. Keldsen, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Pennsylvania have
Centre, Clearfield, Clinton, Crawford, Fayette, Huntingdon, Jefferson, Lawrence, Venango, and Wayne Counties for Public Assistance.
All counties within the Commonwealth of Pennsylvania are eligible to apply for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
FEMA gives notice of the maximum amount for assistance under the Individuals and Households Program for emergencies and major disasters declared on or after October 1, 2013.
Michael Grimm, Recovery Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 212–1000.
Section 408 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act), 42 U.S.C. 5174, prescribes that FEMA must annually adjust the maximum amount for assistance provided under the Individuals and Households Program (IHP). FEMA gives notice that the maximum amount of IHP financial assistance provided to an individual or household under section 408 of the Stafford Act with respect to any single emergency or major disaster is $32,400. The increase in award amount as stated above is for any single emergency or major disaster declared on or after October 1, 2013. In addition, in accordance with 44 CFR 61.17(c), this adjustment includes the maximum amount of available coverage under any Group Flood Insurance Policy (GFIP) issued for those disasters.
FEMA bases the adjustment on an increase in the Consumer Price Index for All Urban Consumers of 1.5 percent for the 12-month period, which ended in August 2013. The Bureau of Labor Statistics of the U.S. Department of Labor released the information on September 17, 2013.
Catalog of Federal Domestic Assistance No. 97.048, Federal Disaster Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs.
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
60-Day Notice and request for comments; Extension of an existing collection of information.
As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Vessel Entrance or Clearance Statement (CBP Form 1300). This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13).
Written comments should be received on or before December 30, 2013, to be assured of consideration.
Direct all written comments to U.S. Customs and Border Protection, Attn: Tracey Denning, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229–1177.
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229–1177, at 202–325–0265.
CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs burden to respondents or record keepers from the collection of information (a total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection:
Office of the Assistant Secretary for Housing-Federal Housing Commissioner HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described in this notice. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on this proposed collection of information. The purpose of this notice is to allow for 60 days of public comment on HUD's proposed renewal of its currently approved collection.
Comments Due Date: December 30, 2013.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410–5000; telephone 202–402–3400 (this is not a toll-free number) or email at
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents to be submitted to OMB may be found at:
The hourly rate is an estimate based on an average annual salary of 62,000 for developers and mortgagees.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in this notice on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information.
(3) Ways to enhance the quality, utility, and clarity of the information to be collected or any content of the Closing Documents.
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(5) With respect to the Construction Contract (HUD–92442M) and the HUD Amendment to AIA Document B108 (HUD–92408–M) (“Owner-Architect Agreement”), are there states with attorney fee shifting statutes that favor contractors and/or architects, such that contractors and/or architects are awarded attorney's fees when they prevail against owners in litigation, but owners who prevail are not similarly awarded attorney's fees unless there is an explicit provision for such awards in the construction contract or owner-architect agreement? If so, does this create an imbalance between the parties that HUD should address in these form documents? Further, irrespective of whether such state fee shifting statutes exist, should the Construction Contract (HUD–92442M) and the HUD Amendment to AIA Document B108 (HUD–92408–M) be revised to include a provision allowing attorney fees to the prevailing party in litigation?
(6)
(7)
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Policy, Management and Budget, Interior.
Meeting.
This notice announces the rescheduling of the U.S. Extractive Industries Transparency Initiative (USEITI) public outreach sessions that were cancelled due to the Federal Government lapse in appropriations. This notice also serves to extend the public's opportunity to comment on the draft USEITI Candidacy Application.
The online webinar that had been scheduled for October 2, 2013 will now take place November 4, 2013, from 1:00–3:00 p.m. Eastern Time. View the presentation via WebEx at
The public outreach session scheduled for October, 10, 2013 is rescheduled for November 14, 2013, and will occur in-person from 4:00 p.m. to 7:00 p.m. Eastern Time at the Office of Surface Mining Reclamation and Enforcement, 3 Parkway Center, 2nd Floor, Pittsburgh, Pennsylvania 15220. Members of the public may attend in person.
The deadline to submit public comments on the draft USEITI Candidacy Application is extended to November 18, 2013. Comments may be provided in writing or in person at the public outreach sessions and public webinar, or online at
Rosita Compton Christian, USEITI Secretariat; 1849 C Street NW., MS–4211, Washington, DC 20240. You may also contact the USEITI Secretariat via email at
The U.S. Department of the Interior established the USEITI Advisory Committee (Committee) on July 26, 2012, to serve as the initial USEITI multi-stakeholder group. More information about the Committee, including its charter, can be found at
If you require special assistance (such as an interpreter for the hearing impaired), please notify Interior staff in advance of the meetings at 202–208–0272 or via email at
Anyone wishing to provide comments during the public comment period must submit written statements by November 18, 2013to
For more information on USEITI, visit
30-day Notice.
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements in the regulations under Subpart P,
You must submit comments by November 29, 2013.
Submit comments by either fax (202) 395–5806 or email (OIRA_Submission@omb.eop.gov) directly to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for the Department of the Interior (1014–0006). Please provide a copy of your comments to BSEE by any of the means below.
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Nicole Mason, Regulations and Standards Branch, (703) 787–1605, to request additional information about this ICR. To see a copy of the entire ICR submitted to OMB, go to
In addition to the general rulemaking authority of the OCSLA at 43 U.S.C. 1334, section 301(a) of the Federal Oil and Gas Royalty Management Act (FOGRMA), 30 U.S.C. 1751(a), grants authority to the Secretary to prescribe such rules and regulations as are reasonably necessary to carry out FOGRMA's provisions. While the majority of FOGRMA is directed to royalty collection and enforcement, some provisions apply to offshore operations. For example, section 108 of FOGRMA, 30 U.S.C. 1718, grants the Secretary broad authority to inspect lease sites for the purpose of determining whether there is compliance with the mineral leasing laws. Section 109(c)(2) and (d)(1), 30 U.S.C. 1719(c)(2) and (d)(1), impose substantial civil penalties for failure to permit lawful inspections and for knowing or willful preparation or submission of false, inaccurate, or misleading reports, records, or other information. Because the Secretary has delegated some of the authority under FOGRMA to BSEE, 30 U.S.C. 1751 is included as additional authority for these requirements.
Regulations implementing these responsibilities are under 30 CFR part 250. Responses are mandatory and/or required to obtain or retain a benefit. No questions of a sensitive nature are asked. The BSEE will protect proprietary information according to the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR 2); 30 CFR 250.197,
The BSEE uses the information collected to ascertain the condition of drilling sites for the purpose of preventing hazards inherent in sulphur drilling and production operations and to evaluate the adequacy of equipment and/or procedures to be used during the conduct of drilling, well-completion, well-workover, and production operations. The BSEE uses the information to:
• Ascertain that a discovered sulphur deposit can be classified as capable of production in paying quantities.
• Ensure accurate and complete measurement of production to determine the amount of sulphur royalty payments due the United States; and that the sale locations are secure, production has been measured accurately, and appropriate follow-up actions are initiated.
• Ensure the adequacy and safety of firefighting systems; the drilling unit is fit for the intended purpose; and the adequacy of casing for anticipated conditions.
• Review drilling, well-completion, well-workover diagrams and procedures, as well as production operation procedures to ensure the safety of the proposed sulphur drilling, well-completion, well-workover and proposed production operations.
• Monitor environmental data during sulphur operations in offshore areas where such data are not already available to provide a valuable source of information to evaluate the performance of drilling rigs under various weather and ocean conditions. This information is necessary to make reasonable determinations regarding safety of operations and environmental protection.
To comply with the public consultation process, on July 16, 2013, we published a
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following application to conduct certain activities with endangered or threatened species. With some exceptions, the Endangered Species Act of 1973, as amended (Act), prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act requires that we invite public comment before issuing these permits.
To ensure consideration, please send your written comments by November 29, 2013.
You may submit comments or requests for copies or more information by any of the following methods. Alternatively, you may use one of the following methods to request hard copies or a CD–ROM of the documents. Please specify the permit you are interested in by number (e.g., Permit No. TE–XXXXXX).
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Kathy Konishi, Permit Coordinator, Ecological Services, (303) 236–4212 (phone);
The Act (16 U.S.C. 1531
A permit granted by us under section 10(a)(1)(A) of the Act authorizes the permittee to conduct activities with U.S. endangered or threatened species for scientific purposes, enhancement of propagation or survival, or interstate commerce (the latter only in the event that it facilitates scientific purposes or enhancement of propagation or survival). Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
We invite local, State, and Federal agencies and the public to comment on the following application. Documents and other information the applicant has submitted with this application is available for review, subject to the requirements of the Privacy Act (5 U.S.C. 552a) and Freedom of Information Act (5 U.S.C. 552).
The applicant requests a permit to conduct presence/absence surveys in the States of Nebraska and Kansas through trap (take) and release of the American burying beetle (
In compliance with the National Environmental Policy Act (42 U.S.C. 4321
All comments and materials we receive in response to this request will be available for public inspection, by appointment, during normal business hours at the address listed in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Bureau of Land Management, U.S. Department of the Interior.
Notice of Public Meeting.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Boise District Resource Advisory Council (RAC), will hold a meeting as indicated below.
The meeting will be held November 19, 2013, at the Boise District Office, located at 3948 S. Development Avenue, Boise, Idaho, beginning at 9:00 a.m. and adjourning at 2:00 p.m. Members of the public are invited to attend. A public comment period will be held.
Marsha Buchanan, Supervisory Administrative Specialist and RAC Coordinator, BLM Boise District, 3948 Development Ave., Boise, ID 83705, Telephone (208) 384–3364.
The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in southwestern Idaho. A report on 2013 wildland fire activity within Boise District and the region will be provided as well as an update on the Paradigm Project. Council members will discuss priority projects for the coming year based on BLM-Idaho priorities. The RAC members will be briefed on ongoing fuels projects. Agenda items and location may change due to changing circumstances. The public may present written or oral comments to members of the Council. At each full RAC meeting, time is provided in the agenda for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance should contact the BLM Coordinator as provided above. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
Bureau of Land Management, Interior.
Notice of filing of plats of surveys.
The Bureau of Land Management (BLM) has officially filed the plats of survey of the lands described below in the BLM Idaho State Office, Boise, Idaho, effective 9:00 a.m., on the dates specified.
Bureau of Land Management, 1387 South Vinnell Way, Boise, Idaho, 83709–1657.
These surveys were executed at the request of the Bureau of Land Management to meet their administrative needs. The lands surveyed are:
The plat representing the dependent resurvey of portions of the north and east boundaries and the subdivisional lines, and the subdivision of sections 1 and 12, T. 11 S., R. 37 E., of the Boise Meridian, Idaho, Group Number 1363, was accepted July 9, 2013.
The plat representing the dependent resurvey of portions of the north boundary and subdivisional lines, and the subdivision of sections 6, 7, 8, and 9, T. 11 S., R. 38 E., of the Boise Meridian, Idaho, Group Number 1361, was accepted July 9, 2013.
The plat representing the dependent resurvey of portions of the east boundary and subdivisional lines, and the subdivision of sections 13, 17, 20, 21, 24, 27, 28, and 29, T. 8 N., R. 39 E., of the Boise Meridian, Idaho, Group Number 1351, was accepted July 9, 2013.
The plat representing the dependent resurvey of portions of the north boundary and subdivisional lines, and the subdivision of section 5, and a metes-and-bounds survey in section 5, T. 7 N., R. 23 E., of the Boise Meridian, Idaho, Group Number 1381, was accepted August 26, 2013.
The plat representing the dependent resurvey of portions of the Boise Base Line (south boundary), west boundary, and subdivisional lines, and the subdivision of section 31, T. 1 N., R. 12 E., of the Boise Meridian, Idaho, Group Number 1360, was accepted August 30, 2013.
The plat representing the dependent resurvey of portions of the west boundary, subdivisional lines, and the original 1911 meanders of the Salmon River in section 7, and the subdivision of section 7, the survey of the 2012 meanders of the Salmon River in section 7, and the survey of certain 2012 partition lines in section 7, T. 12 N., R. 19 E., Boise Meridian, Idaho, Group Number 1382, was accepted September 4, 2013.
The plat representing the dependent resurvey of portions of the south boundary and subdivisional lines, and the subdivision of sections 27, 29, and 32, T. 15 N., R. 27 E., Boise Meridian, Idaho, Group Number 1391, was accepted September 5, 2013.
This survey was executed at the request of the Bureau of Indian Affairs to meet their administrative needs. The lands surveyed are:
The plat representing the dependent resurvey of portions of the Boise Meridian (east boundary), south boundary, subdivisional lines, and subdivision of sections 15, 30, and 31, and the further subdivision of sections 15, 30, and 31, T. 35 N., R. 1 W., Boise Meridian, Idaho, Group Number 1352, was accepted September 30, 2013.
This survey was executed at the request of the U.S.D.A. Forest Service to meet their administrative needs. The lands surveyed are:
The supplemental plat was prepared to show amended lottings in sections 2, 3, 10, and 11, T. 28 N., R. 3 E., Boise Meridian, Idaho, Group Number 1402, was accepted August 27, 2013.
Bureau of Land Management, Interior.
Notice of filing of plats of survey.
The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on November 29, 2013.
Protests of the survey must be filed before November 29, 2013 to be considered.
Protests of the survey should be sent to the Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101–4669.
Blaise Lodermeier, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101–4669, telephone (406) 896–5128 or (406) 896–5009,
This survey was executed at the request of the BLM Butte Field Office, and was necessary to determine federal interest lands.
The lands we surveyed are:
The plat, in one sheet, representing the dependent resurvey of a portion of the Boulder Guide Meridian and the survey of a certain lot within Section 36, Township 10 North, Range 4 West, Principal Meridian, Montana, was accepted October 17, 2013.
We will place a copy of the plat, in one sheet, and related field notes we described in the open files. They will be available to the public as a matter of information. If the BLM receives a protest against this survey, as shown on this plat, in one sheet, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file this plat, in one sheet, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.
43 U.S.C. Chap. 3.
Bureau of Land Management, Interior.
Notice of filing of plats of survey.
The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on November 29, 2013.
Protests of the survey must be filed before November 29, 2013 to be considered.
Protests of the survey should be sent to the Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101–4669.
Blaise Lodermeier, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101–4669, telephone (406) 896–5128 or (406) 896–5009,
This survey was executed at the request of the BLM Malta Field Office, and was necessary to determine federal interest lands.
The lands we surveyed are:
T. 25 N., R. 25 E.
The plat, in two sheets, representing the dependent resurvey of a portion of the subdivisional lines and Block 7 of the Zortman Townsite, Township 25 North, Range 25 East, Principal Meridian, Montana, was accepted October 17, 2013.
We will place a copy of the plat, in two sheets, in the open files. They will be available to the public as a matter of information. If the BLM receives a protest against this survey, as shown on this plat, in two sheets, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file this plat, in two sheets, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.
43 U.S.C. Chap. 3.
Bureau of Land Management, Interior.
Notice.
The Assistant Secretary of the Interior for Policy, Management and Budget proposes to extend the duration of Public Land Order (PLO) No. 7060 for an additional 20-year term. PLO No. 7060 withdrew 464.93 acres of public land from settlement, sale, location, or entry under the general land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, to protect the Sacramento Pass Recreation Area (SPRA) in White Pine County, Nevada. This notice gives the public an opportunity to comment on the proposed extension and to request a public meeting.
For a period of 90 days from the date of publication of this notice, all persons who wish to submit comments, suggestions, objections, or request a public meeting in connection with the proposed withdrawal extension may do so in writing until January 27, 2014.
Comments and meeting requests should be sent to the District Manager, Bureau of Land Management (BLM), Ely District Office, HC33 Box 33500, 702 North Industrial Way, Ely, Nevada 89301.
Elena Montenegro-Long, BLM, Schell Field Office at 775–289–1800, or email
The BLM has filed an application to extend the withdrawal established by PLO No. 7060 (59 FR 28790 (1994)), for an additional 20-year term. PLO No. 7060 will expire on June 2, 2014, unless extended. PLO No. 7060 is incorporated herein by reference. The land withdrawn by PLO No. 7060 is located about 50 miles east of Ely, Nevada, along State Highway 50. The purpose of the withdrawal extension is to continue to protect a developed campground consisting of picnic facilities, camping areas, vaulted toilets, walking trails, and trailhead access for dispersed recreation opportunities such as hiking, horseback riding, and low-impact camping.
The use of a right-of-way, interagency agreement, or cooperative agreement would not provide adequate protection for the capital improvement investment that the BLM has made in the SPRA.
No additional water rights would be needed to fulfill the purpose of the requested withdrawal extension.
There are no suitable alternative sites since the land described contains the developed campground and improvements of interest for protection.
All persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal extension may present their views in writing to the BLM Ely District Office at the address in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Notice is hereby given that an opportunity for a public meeting is afforded in connection with the proposed withdrawal extension. All interested persons who desire a public meeting for the purpose of being heard on the proposed withdrawal extension must submit a written request to the District Manager, BLM Ely District Office at the address in the
The application will be processed in accordance with the regulations set forth in 43 CFR 2310.4.
National Park Service, Interior.
Meeting notice.
As required by the Federal Advisory Committee Act (5 U.S.C. Appendix 1–16), the National Park Service (NPS) is hereby giving notice that the Gates of the Arctic National Park Subsistence Resource Commission (SRC) will hold a meeting to develop and continue work on NPS subsistence program recommendations and other related subsistence management issues. The NPS SRC program is authorized under Title VIII, Section 808 of the Alaska National Interest Lands Conservation Act, Public Law 96–487.
The Gates of the Arctic National Park SRC will meet from 9:00 a.m. to 5:00 p.m. or until business is completed on Tuesday, November 5, 2013 to Wednesday, November 6, 2013.
The SRC will meet at the Gates of the Arctic National Park and Preserve office located at 4175 Geist in Fairbanks, Alaska. For more detailed information regarding this meeting, contact Designated Federal Official Greg Dudgeon, Superintendent, at (907) 457–5752; or Clarence Summers, Subsistence Manager, at (907) 644–3603. If you are interested in applying for SRC membership, contact the Superintendent or visit the park Web site at:
The proposed meeting agenda for each meeting includes the following:
SRC meeting locations and dates may change based on inclement weather or exceptional circumstances. If the meeting date and location are changed, the Superintendent will issue a press release and use local newspapers and radio stations to announce the meeting.
This meeting is open to the public and will have time allocated for public testimony. The public is welcome to present written or oral comments to the SRC. The meeting will be recorded and meeting minutes will be available upon request from the Park Superintendent for public inspection approximately six weeks after the meeting. Before including your address, telephone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request renewed approval for the collection of information for the State Processes for Designating Areas Unsuitable for Surface Coal Mining Operations. This collection request has been forwarded to the Office of Management and Budget (OMB) for review and approval. The information collection request describes the nature of the information collection and the expected burden and cost.
OMB has up to 60 days to approve or disapprove the information collections but may respond after 30 days. Therefore, public comments should be submitted to OMB by November 29, 2013, in order to be assured of consideration.
Comments may be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget, Department of the Interior Desk Officer, via email at
To receive a copy of the information collection request contact John Trelease at (202) 208–2783, or electronically at
The OMB regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104–13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. OSM has submitted a request to OMB to renew its approval of the collection of information contained in: 30 CFR Part 764—State Processes for Designating Areas Unsuitable for Surface Coal Mining Operations. OSM is requesting a 3-year term of approval for each information collection activity.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this collection is 1029–0030, and is displayed in 30 CFR 764.10.
As required under 5 CFR 1320.8(d), a
Send comments on the need for the collection of information for the performance of the functions of the agency; the accuracy of the agency's burden estimates; ways to enhance the quality, utility and clarity of the information collection; and ways to minimize the information collection burdens on respondents, such as use of automated means of collections of the information, to the addresses listed under
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
United States International Trade Commission.
Notice.
Cynthia Trainor (202–205–3354), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202–205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202–205–2000. General information concerning the Commission may also be obtained by accessing its internet server (
On June 20, 2013, the Commission established a
The Commission's new schedule for the review is as follows: Requests to appear at the hearing must be filed with the Secretary to the Commission not later than November 13, 2013; the prehearing conference will be held at the U.S. International Trade Commission Building at 9:30 a.m. on November 15, 2013; the prehearing staff report will be placed in the nonpublic record on November 7, 2013; the deadline for filing prehearing briefs is November 14, 2013; the hearing will be held at the U.S. International Trade Commission Building at 9:30 a.m. on November 21, 2013; the deadline for filing posthearing briefs is November 27, 2013; the Commission will make its final release of information on December 5, 2013; and final party comments are due on December 9, 2013.
For further information concerning this investigation see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
This investigation is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has issued a limited exclusion order against infringing products of respondents T-Tech Tattoo Device Inc. of Ontario, Canada (“T-Tech”), Yiwu Beyond Tattoo Equipments Co., Ltd. of Yiwu City, China (“Yiwu”), and Guangzhou Pengcheng Cosmetology Firm of Guangzhou, China (“Guangzhou Pengcheng”). The investigation is terminated.
Megan M. Valentine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 708–2301. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on March 6, 2012, based on a complaint filed by MT.Derm GmbH of Berlin, Germany and Nouveau Cosmetique USA Inc. of Orlando, Florida (collectively “Complainants”) alleging violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337), as amended (“section 337”), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain ink application devices and components thereof and methods of using the same by reason of infringement of certain claims of U.S. Patent Nos. 6,345,553 (“the '553 patent”) and 6,505,530 (“the '530 patent”). 77 FR 13351, Mar. 6, 2012. The Commission's Notice of Investigation (“NOI”) named T-Tech, Yiwu, and Guangzhou Pengcheng as respondents. The complaint was served on all named respondents on March 1, 2012. The Office of Unfair Import Investigations was named as a party to the investigation.
On April 16, 2012, Complainants filed a motion seeking a determination that respondents T-Tech, Yiwu, and Guangzhou be found in default based on their failure to respond to the Complaint and Notice of Investigation. On May 1, 2012, the ALJ issued Order No. 5, ordering the respondents to show cause by close of business on May 16, 2012, why they should not be found in default. No response was filed, and on May 31, 2012, the ALJ issued an initial determination (“ID”) (Order No. 7), granting the motion for default pursuant to section 210.16(a)(1) of the Commission's Rules of Practice and Procedure (19 CFR 210.16(a)(1)). On June 6, 2012, T-Tech submitted correspondence to the Commission stating that it had not received any prior communication from the Commission and arguing that the ID finding it in default should be reviewed. On June 13, 2012, the IA filed a petition for review of Order No. 7 as to the finding of default against T-Tech. On June 29, 2012, the Commission determined not to review the portion of Order No. 7 finding Yiwu and Guanzhou Pengcheng in default pursuant to section 210.16 of the Commission's Rules of Practice and Procedure (19 CFR 210.16), but reversed the finding of default against T-Tech. Notice (June 29, 2012).
On March 20, 2013, Complainants filed a motion for summary determination of violation of section 337 against T-Tech. On April 17, 2013, Complainants also filed a motion for an ID finding T-Tech in default pursuant to Commission Rule 210.17(e). On April 19, 2013, the ALJ issued Order No. 32, ordering T-Tech to show cause as to why it should not be found in default for failing to comply with deadlines set forth in the procedural schedule. On April 25, 2013, T-Tech filed a response to Order No. 32. On April 29, 2013, the IA filed a response in support of Complainants' motion requesting that T-Tech be found in default. On July 17, 2013, the ALJ issued an ID (Order No. 35), granting-in-part Complainants' motion for summary determination of violation against T-Tech or, in the alternative, granting Complainants' motion for an ID finding T-Tech in default pursuant to section 210.17 of the Commission's Rules of Practice and Procedure (19 CFR 210.17). On August 16, 2013, the Commission determined not to review the portion of the ID finding T-Tech in default. 78 FR 52212–13, Aug. 22, 2013. The Commission found the portion of Order No. 35 granting summary determination of violation moot.
Complainants and the Commission investigative attorney (“IA”) submitted
The Commission finds that the statutory requirements of section 337(g) (19 U.S.C. 1337(g)) is met with respect to respondents Yiwu and Guangzhou Pengcheng. Accordingly, pursuant to section 337(g)(1) (19 U.S.C. 1337(g)(1)) and Commission rule 210.16(c) (19 CFR 210.16(c)), the Commission presumes the facts alleged in the complaint to be true and finds that Yiwu and Guangzhou Pengcheng are in violation of section 337. The Commission further finds that T-Tech is in violation of section 337 pursuant to section 210.17 of the Commission's Rules of Practice and Procedure (19 CFR 210.17), which states that a failure to participate in an investigation may provide a basis for a finding of violation of section 337 under section 337(d)(1) (19 U.S.C. 1337(d)(1)).
The Commission has determined that the appropriate form of relief in this investigation is a limited exclusion order prohibiting the unlicensed entry of certain ink application devices and components thereof that are manufactured abroad by or on behalf of, or imported by or on behalf of, respondents Yiwu and T-Tech by reason of infringement of one or more of claims 1–3, 7, 8, 19, and 20 of the `530 patent. The Commission has also determined to issue a limited exclusion order prohibiting the unlicensed entry of certain ink application devices and components thereof that are manufactured abroad by or on behalf of, or imported by or on behalf of, respondent Guangzhou Pengcheng by reason of infringement of one or more of 1–3, 7–12 and 16–20 of the `530 patent and claims 1–4, 10, 12–14, 21–23, and 26–28 of the `553 patent. The Commission has further determined that the public interest factors enumerated in section 337(g)(1) (19 U.S.C. 1337(g)(1)) and section 337(d)(1) (19 U.S.C. 1337(d)(1)) do not preclude issuance of the limited exclusion order. Finally, the Commission has determined that the bond for importation during the period of Presidential review shall be in the amount of 100 percent of the entered value of the imported subject articles of all defaulting respondents. The Commission's order was delivered to the President and the United States Trade Representative on the day of its issuance.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
United States International Trade Commission.
November 1, 2013 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205–2000.
Open to the public.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
United States International Trade Commission.
Appointment of Individuals to Serve as Members of Performance Review Board.
The Chairman of the U.S. International Trade Commission has appointed the following individuals to serve on the Commission's Performance Review Board (PRB):
Patricia Connelly, Director of Human Resources, U.S. International Trade Commission (202) 205–2651.
This notice is published in the
Hearing impaired individuals are advised that information on this matter can be obtained by contacting our TDD terminal on (202) 205–1810.
By order of the Chairman.
Federal Bureau of Investigation (FBI), DOJ.
Meeting notice.
The purpose of this notice is to announce the meeting of the Federal Bureau of Investigation's Criminal Justice Information Services (CJIS) Advisory Policy Board (APB). The CJIS APB is a federal advisory committee established pursuant to the Federal Advisory Committee Act (FACA). This meeting announcement is being published as required by Section 10 of the FACA.
The FBI CJIS APB is responsible for reviewing policy issues and appropriate technical and operational issues related to the programs administered by the FBI's CJIS Division, and thereafter, making appropriate recommendations to the FBI Director. The programs administered by the CJIS Division are the Integrated Automated Fingerprint Identification System/Next Generation Identification, Interstate Identification Index, Law Enforcement Online, National Crime Information Center, National Instant Criminal Background Check System, National Incident-Based Reporting System, National Data Exchange, and Uniform Crime Reporting.
This meeting is open to the public. All attendees will be required to sign-in at the meeting registration desk. Registrations will be accepted on a space available basis. Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the Designated Federal Officer (DFO). Any member of the public may file a written statement with the Board. Written comments shall be focused on the APB's current issues under discussion and may not be repetitive of previously submitted written statements. Written comments should be provided to Mr. R. Scott Trent, DFO, at least seven (7) days in advance of the meeting so that the comments may be made available to the APB for their consideration prior to the meeting.
Anyone requiring special accommodations should notify Mr. Trent at least seven (7) days in advance of the meeting.
The APB will meet in open session from 8:30 a.m. until 5 p.m., on December 4–5, 2013.
The meeting will take place at Sheraton Atlanta Hotel, 165 Courtland Street NE., Atlanta, Georgia 30303, telephone (404) 659–6500.
Inquiries may be addressed to Ms. Jillana L. Plybon; Management and Program Assistant; CJIS Training and Advisory Process Unit, Resources Management Section; FBI CJIS Division, Module C2, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306–0149; telephone (304) 625–5424, facsimile (304) 625–5090.
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Claim for Reimbursement of Benefit Payments and Claims Expense under the War Hazards Compensation Act,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
Submit comments on or before November 29, 2013.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
The OWCP is responsible for administering the War Hazards Compensation Act (WHCA) (42 U.S.C. 1701
Insurance carriers and the self-insured file a Claim for Reimbursement of Benefit Payments and Claims Expense under the War Hazards Compensation Act, Form CA–278, to request reimbursement. Regulations implementing the WHCA permit the OWCP to collect the information needed to consider an insurance carrier's or self-insured's reimbursement request.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Notice.
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Coal Mine Rescue Teams: Arrangements for Emergency Medical Assistance and Transportation for Injured Persons—Agreements, Reporting Requirements, and Posting Requirements,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
Submit comments on or before November 29, 2013.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR covers the following requirements for a coal mine: reporting to the MSHA how the mine will comply with mine rescue team requirements; reporting to the MSHA alternative mine rescue capability for a small and remote mine; providing an annual certification to the MSHA that each mine rescue team designated to provide mine rescue coverage meets applicable requirements; maintaining a record of mine rescue equipment testing, medical physical examinations of mine rescue team members, and mine rescue team training; posting a copy of the mine rescue notification plan and providing a written copy to a designated mine worker representative; and posting at appropriate places of an underground or surface mine the names, titles, addresses, and telephone numbers of all persons or services currently available under medical assistance and transportation arrangements. Coal mine operators, supervisors, and employees, as well as State and Federal mine inspectors use the records to provide assurance that each mine operator and mine rescue team is prepared for a mine emergency. Records also show that mine rescue team equipment has been examined and tested and is in good working order. Training records show that mine rescue team members and the responsible persons at the mine are competent to respond to a mine emergency involving a fire, an explosion, or a gas or water inundation.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2013. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. It should also be noted that existing information collection requirements submitted to the OMB receive a month-to-month extension
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Notice.
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Submit comments on or before November 29, 2013.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
Regulations 30 CFR 75.315 make it mandatory for a mine operator electing to use belt air to ventilate a working section or area where mechanized equipment is being installed or removed to maintain records used by coal mine supervisors, miners, and Federal and State mine inspectors to show required examinations and tests were conducted. These records give insight into hazardous conditions that have been or may be encountered. Inspection records help in making decisions that ultimately affect the safety and health of miners working in belt air mines. Federal Mine Safety and Health Act of 1977 section 103(h) (30 U.S.C. 813(h)) authorizes the MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2013. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. It should also be noted that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Energy Employees Occupational Illness Compensation Program Act Forms,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
Submit comments on or before November 29, 2013.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
The OWCP is the primary agency responsible for administering the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA) (42 U.S.C. 7384
Regulations 20 CFR 30.100, –.101, –.102, –.103, –.111, –.112, –.113, –.114, –.206, –.207, –.212, –.213, –.214, –.215, –.221, –.222, –.226, –.231, –.232, –.415, –.416, –.417, –.505, –.620, –.806, –.905, and –.907 implementing the EEOICPA contain information collection requirements covered by this ICR. The OWCP also uses this ICR to obtain PRA authorization to implement the information collection requirement found at 42 U.S.C. 7385s–11.
The OWCP uses forms covered by this ICR to determine a claimant's eligibility for EEOICPA compensation and responses are required to obtain or retain benefits. The information collections in this ICR collect demographic, factual, and medical information needed to determine entitlement to EEOICPA benefits. Before the OWCP can pay benefits, the case file must contain medical and employment evidence showing the claimant's eligibility. The various collections covered by this ICR and the purpose of each are listed below:
Form EE–1—A living current or former employee completes the form to file a claim under parts B and/or E. The form requests information about the illness or illnesses being claimed and information about tort suits, settlements, or awards in litigation; State workers' compensation benefits; and fraud convictions that affect entitlement. This form is also available in Spanish. (20 CFR 30.100, –.103, –.505, and –.620.)
Form EE–2—The survivor of a deceased employee uses the form to file a claim under parts B and/or E. The form requests information regarding both the survivor and the deceased employee. The form also requests information about illnesses, tort suits, settlements, or awards in litigation; State workers' compensation benefits; and fraud convictions that affect entitlement. This form is also available in Spanish. (20 CFR 30.101, –.103, –.505, and –.620.)
Form EE–3—The form gathers information about the employee's work history. This form is also available in Spanish. (20 CFR 30.103, –.111, –.113, –.114, –.206, –.212, –.214, –.221, and –.231.)
Form EE–4—The employee or survivor uses the form to support the claimed employment history by affidavit. This form is also available in Spanish. (20 CFR 30.103, –.111, –.113, –.114, –.206, –.212, –.214, –.221, and –.231.)
Form EE–5A—A claimant must provide supplemental employment evidence to substantiate periods of
Form EE–5B—A current or former DOE contractor provides information to substantiate periods of unverified employment. There is no standard form or format for the submission of the information. For purposes of identification only, this requirement has been designated Form EE–5B. (20 CFR 30.106.)
Form EE–7—The OWCP uses this form to inform an employee, survivor, or physician of the medical evidence needed to establish a diagnosis of an occupational illness under part B or a covered illness under part E. This form is also available in Spanish. (20 CFR 30.103, –.207, –.215, –.222, –.232(a) and (b), –.415, –.416, and –.417.)
Form EE–7A—A claimant is required to provide information about when an injury, illness, or disability is sustained because of an occupational illness under part B or a covered illness under part E. There is no standard form or format for the submission of this medical information. For purposes of identification only, this requirement has been designated Form EE–7A. (20 CFR 30.207, –.215, –.222, –.226, and –.232(c).)
Form EE–8—The OWCP sends this letter with enclosure EN–8 to a claimant to obtain information about an employee's smoking history when lung cancer due to radiation is claimed. Department of Health and Human Services (HHS) guidelines require the OWCP to ask for information regarding the employee's smoking history before the OWCP can determine the probability of causation for radiogenic lung cancer. (20 CFR 30.213.)
Form EE–9—The OWCP sends this letter with enclosure EN–9 to a claimant to obtain information concerning the race or ethnicity of the employee when radiogenic skin cancer is claimed. HHS guidelines require the OWCP to ask for this particular information regarding the employee's race/ethnicity before the OWCP can determine the probability of causation for radiogenic skin cancer. (20 CFR 30.213.)
Form EE–10—A covered part E employee who has received an award for wage-loss and/or impairment due to a covered illness uses this form to provide information needed to support a claim for an additional award for a subsequent calendar year of wage-loss and/or any additional impairment. (20 CFR 30.102, –.103, and –.505.)
Form EE–11A—The OWCP sends this letter about impairment benefits under part E with enclosure EN–11A to a claimant to obtain medical evidence needed to support an initial award for permanent impairment due to an accepted covered illness. (20 CFR 30.905 and –.907.)
Form EE–11B—The OWCP sends this letter with enclosure EE–11B to a part E claimant to obtain the factual and medical evidence necessary to support an initial award for wage-loss benefits due to an accepted covered illness. (20 CFR 30.806.)
Form EE–12—The OWCP sends this letter with enclosure EN–12 to a covered part B or E employee receiving medical benefits to collect updated information about settlements or awards in litigation and State workers' compensation benefits that affect continuing entitlement. (20 CFR 30.100 and –.505.)
Form EE–13—The OWCP sends this letter with enclosure EN–13 to a State workers' compensation authority to identify covered part E employees receiving medical benefits who have also been awarded State workers' compensation for their covered illnesses. (42 USC 7385s–11.)
Form EE–16—The OWCP sends this letter with enclosure EN–16 to a claimant to verify/obtain updated information about tort suits, settlements, or awards in litigation; State workers' compensation benefits; and fraud convictions that affect entitlement immediately prior to issuance of a recommended decision on the claim. (20 CFR 30.505 and –.620.)
Form EE–20—The OWCP sends this letter with enclosure EN–20 to a claimant to obtain financial information necessary to pay approved claims under part B or E. (20 CFR 30.505 and –.620.)
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
The DOL obtains OMB approval for this information collection under Control Number 1240–0002. This ICR has been classified as a revision, because—in accordance with Department of the Treasury guidance—Form EE–20 has been changed to delete the option to request payment by paper check. The current approval is scheduled to expire on October 31, 2013; however, it should be noted that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. New information collection requirements would only take effect upon OMB approval. For additional substantive information about this ICR, see the related notice published in the
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
9:30 a.m., Tuesday, November 5, 2013
NTSB Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314–6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314–6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates including weather-related cancellations are also available at
Candi Bing, (202) 314–6403 or by email at
Peter Knudson, (202) 314–6100 or by email at
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from September 19, 2013, to October 2, 2013. The last biweekly notice was published on October 1, 2013 (78 FR 60321). Due to the Federal Government shutdown, there was no biweekly publication on October 15, 2013.
You may submit comment by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on accessing information and submitting comments, see “Accessing Information and Submitting Comments” in the
Please refer to Docket ID NRC–2013–0233 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods:
•
•
•
Please include Docket ID NRC–2013–0233 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in section 50.92 of Title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR Part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1–F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with the NRC guidance available on the NRC's public Web site at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC`s Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the following three factors in 10 CFR 2.309(c)(1)(i)-(iii).
For further details with respect to this license amendment application, see the application for amendment which is available for public inspection at the NRC's PDR, located at One White Flint North, Room O1–F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
DPC has in effect an NRC-approved E-Plan. There are no longer credible events that would result in doses to the public beyond
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
DPC has in effect an NRC-approved E-Plan. There are no longer credible events that would result in doses to the public beyond the owner controlled area boundary that would exceed the EPA PAGs. LACBWR was shutdown 25 years ago. Emergency Planning Zones beyond the owner controlled area and the associated protective actions are no longer required. No headquarters personnel, personnel involved in off-site dose projections, or personnel with special qualifications are required to augment the LACBWR Emergency Response Organization. The advanced state of decommissioning is reflected in the updated and revised ODCM [Offsite Dose Calculation Manual] which shows that there are no longer any events at the former plant that could exceed the EPA PAGs for dose to a member of the public.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Margin of safety is related to the ability of the fission product barriers (fuel cladding, reactor coolant system, and primary containment) to perform their design functions during and following postulated accidents. DPC has in effect an NRC-approved E-Plan. There are no longer credible events that would result in doses to the public beyond the owner controlled area boundary that would exceed the EPA PAGs. LACBWR was shutdown 25 years ago. Emergency Planning Zones beyond the owner controlled area and the associated protective actions are no longer required. No headquarters personnel, personnel involved in offsite dose projections, or personnel with special qualifications are required to augment the LACBWR Emergency Response Organization. The advanced state of decommissioning is reflected in the updated and revised ODCM which shows that there are no longer any events at the former plant that could exceed the EPA PAGs for dose to a member of the public.
Therefore, the proposed change does not involve a significant reduction in margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The proposed change is described in Technical Specification Task Force (TSTF) Standard TS Change Traveler TSTF–477 adds an action statement for two inoperable control room subsystems.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). The proposed changes add an action statement for two inoperable control room subsystems. The equipment qualification temperature of the control room equipment is not affected. Future changes to the Bases or licensee-controlled document will be evaluated pursuant to the requirements of 10 CFR 50.59, “Changes, test and experiments,” to ensure that such changes do not result in more than a minimal increase in the probability or consequences of an accident previously evaluated.
The proposed changes do not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, and configuration of the facility or the manner in which the plant is operated and maintained. The proposed changes do not adversely affect the ability of structures, systems and components (SSCs) to perform their intended safety function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed changes do not affect the source term, containment isolation, or radiological consequences of any accident previously evaluated. Further, the proposed changes do not increase the types and the amounts of radioactive effluent that may be released, nor significantly increase individual or cumulative occupation/public radiation exposures.
Therefore, the changes do not involve a significant increase in the probability or consequences of any accident previously evaluated.
The proposed changes add an action statement for two inoperable control room subsystems. The changes do not involve a physical altering of the plant (i.e., no new or different type of equipment will be installed) or a change in methods governing normal plant operation. The requirements in the TS continue to require maintaining the control room temperature within the design limits.
Therefore, the changes do not create the possibility of a new or different kind of accident from any previously evaluated.
The proposed changes add an action statement for two inoperable control room subsystems. Instituting the proposed changes will continue to maintain the control room temperature within design limits. Changes to the Bases or license controlled document are performed in accordance with 10 CFR 50.59. This approach provides an effective level of regulatory control and ensures that the control room temperature will be maintained within design limits.
The proposed changes maintain sufficient controls to preserve the current margins of safety.
Based upon the reasoning above, the NRC staff concludes that the amendment request involves no significant hazards consideration.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
EGC [Exelon Generation Company, LLC] has evaluated whether or not a significant hazards consideration is involved with the proposed amendments by focusing on the three standards set forth in 10 CFR 50.92, “Issuance of amendment,” as discussed below:
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change revises the definition of SDM. SDM is not an initiator of any accident previously evaluated. Accordingly, the proposed change to the definition of SDM has no effect on the probability of any accident previously evaluated. SDM is an assumption in the analysis of some previously evaluated accidents and inadequate SDM could lead to an increase in consequences of those accidents. However, the proposed change revises the SDM definition to ensure that the correct SDM is determined for all fuel types at all times during the fuel cycle. As a result, the proposed change does not adversely affect the consequences of any accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change revises the definition of SDM. The change does not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed) or a change in the methods governing normal plant operations. The change does not alter assumptions made in the safety analysis regarding SDM.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change revises the definition of SDM. The proposed change does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The proposed change ensures that the SDM assumed in determining safety limits, limiting safety system settings or limiting conditions for operation is correct for all BWR fuel types at all times during the fuel cycle.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
Based on the above, EGC concludes that the proposed change presents no significant hazards consideration under the standards set forth in 10 CFR 50.92(c), and, accordingly, a finding of “no significant hazards consideration” is justified.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the requested amendments involve no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change would allow the use of Optimized ZIRLO
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
Use of Optimized ZIRLO
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in the margin of safety?
Response: No.
The proposed change will not involve a significant reduction in the margin of safety because it has been demonstrated that the material properties of the Optimized ZIRLO
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
Because, this proposed change requires a departure from Tier 1 information in the Westinghouse Advanced Passive 1000 DCD, the licensee also requested an exemption from the requirements of the Generic DCD Tier 1 in accordance with 10 CFR 52.63(b)(1).
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes do not result in any physical changes to the plant, and therefore do not change any safety-related design requirement, qualification requirement or function. The proposed changes do not involve any accident initiating event or component failure, thus, the probabilities of the accidents previously evaluated are not affected. The proposed changes do not affect the radioactive material releases used in the accident analyses, thus, the radiological releases in the accident analyses are not affected.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes do not result in any physical changes to the plant, and therefore do not adversely affect any structure, system or component. No safety-related equipment qualification or design function is affected. The proposed changes do not introduce a new failure mode or create a new fault or sequence of events that could result in a radioactive material release.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed changes do not result in any physical changes to the plant, and therefore do not change valve performance, including containment isolation. No safety acceptance criterion would be exceeded or challenged. No safety-related function would be affected. Valve qualification would not be affected. The proposed changes do not affect compliance with existing design codes and regulatory criteria and do not affect any safety analysis.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
• Initiate main steam line isolation
• Closing the pressurizer power-operated relief valves block valves
• Securing all reactor coolant pumps
• Closing feedwater isolation valves
• Securing the startup feedwater pump
• Isolating reactor coolant system (RCS) letdown
• Securing the centrifugal charging pumps
In addition, STPNOC proposes to credit the automatic trip of the main turbine upon the initiation of a manual reactor trip for meeting the alternate shutdown capability. A thermal-hydraulic analysis demonstrates that these operations will ensure that the RCS process variables remain within those values predicted for a loss of normal alternating current (a-c) power, as required by Section III.L.1 of 10 CFR part 50, appendix R.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change credits operations in the control room prior to evacuation in the event of a fire in order to meet safe shutdown performance criteria. The design function of structures, systems and components (SSC) are not impacted by the proposed change. The proposed change will not initiate an event. The proposed change does not alter or prevent the ability of SSCs from performing their intended function to mitigate the consequences of an initiating event. The proposed change does not increase the probability of occurrence of a fire or any other accident previously evaluated.
The proposed operations are feasible and reliable and demonstrate that the unit can be safely [shut down] in the event of a fire with no significant increase in consequences.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of
Response: No.
The proposed change credits operations in the control room prior to evacuation in the event of a fire in order to meet safe shutdown performance criteria. The proposed change does not install or remove any plant equipment. The proposed change does not alter the design, physical configuration, or mode of operation of any plant structure, system or component. Therefore, the proposed change does not introduce any new failure mechanisms or malfunctions that can initiate an accident.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change credits operations in the control room prior to evacuation in the event of a fire in order to meet safe shutdown performance criteria. The proposed change has no effect on the availability, operability, or performance of safety-related systems and components. The proposed change does not alter the design, configuration, operation, or function of any plant structure, system or component. The ability of any structure, system or component to perform its designated safety function is unaffected by the proposed change.
Thermal-hydraulic analyses demonstrate that the proposed operations to be performed in the control room will ensure that the reactor coolant system process variables remain within those values predicted for a loss of normal a-c power, as required by section III.L of 10 CFR part 50, appendix R. After control of the plant is achieved by the alternative shutdown system, the plant can be safely transitioned to cold shutdown conditions. A single fire-induced spurious actuation will not negate the proposed operations.
Considerable fire protection defense-in-depth features exist such that it is unlikely that a fire in the control room would result in evacuation. In the remote likelihood that control room evacuation is required and none of the proposed operator actions other than the manual reactor trip and automatic turbine trip are performed prior to arrival at the alternative shutdown stations, analyses confirm that adequate core cooling is maintained so that fuel cladding integrity is not challenged. The capability to achieve and maintain safe shutdown is maintained.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the request for amendments involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequence of an accident previously evaluated?
Response: No.
The proposed changes described in this TS amendment request, do not alter the safety functions of the WBN Offsite Power system. Design calculations document that CSSTs A and B have adequate capacity to supply all connected loads including one train of shutdown boards in all allowable alignments and meet the separation requirements for offsite power sources. The consequences of an accident are not changed when using CSST A or B to power the shutdown boards because these CSSTs are rated to carry all required loads for any design basis accidents. The failure of a CSST is not considered to be an initiator of a plant accident and therefore the probability or consequences of accidents or events previously evaluated, as described in the UFSAR, is not changed.
Therefore, this proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
As stated above, malfunctions of the CSSTs are not considered to be an initiator for plant accidents and the modifications to the offsite power system do not create a new or different kind of accident. The purpose of the offsite power system is to provide a source of power to the safety related equipment required to mitigate a design basis accident. CSSTs A and B have been physically upgraded and proven by design calculation to meet all required GDC [General Design Criterion] 17 requirements for separation and voltage stability. Using CSSTs A and B as alternate sources of shutdown power does not negatively affect the offsite power systems ability to meet its design function.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
CSSTs A and B have adequate design margin to meet all possible loading scenarios as long as both CSSTs A and B are operational prior to one being used as a source of offsite power. This requirement is added to the control room drawings, plant design criteria and the UFSAR in order to ensure acceptable margin is always available prior to CSSTs A or B being used as a source of offsite power.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The previously evaluated accident that could be affected is a complete loss of offsite power (LOOP). Analyses have been performed to confirm that power distribution system voltages and currents with both of the new Unit 2 alternate normal to emergency bus ties in service are adequate during a unit trip scenario. The conditions under which the Unit 2 manual transfer capability is verified are the same as Unit 1. The verification test may only be performed under conditions that will not challenge steady state operation or challenge the safety of the unit. Therefore, the Unit 2 verification test (manual transfer between Unit 2 normal offsite circuit and alternate required offsite circuit) will not significantly increase the probability of a LOOP.
Should a LOOP occur, the consequences are unaffected by availability of offsite power (normal offsite circuit and alternate required offsite circuit). Therefore, the Unit 2 verification test (normal offsite circuit and alternate required offsite circuit) will not affect the consequences of an accident previously evaluated.
2. Does the change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The purpose of the surveillance test is to verify the capability to manually transfer AC power sources from the normal offsite circuit to the alternate required offsite circuit.
The only effect of the change is to permit the new Unit 2 required offsite circuits to be tested in the same manner and frequency as the corresponding Unit 1 circuits. Since the Unit 2 circuits are similar to the Unit 1 circuits, and the Unit 1 test is a required TS Surveillance to demonstrate operability of the alternate offsite circuits, permitting the Unit 2 circuits to undergo the same surveillance test will not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change enables SR testing of the new Unit 2 alternate offsite AC circuits to verify the capability to manually transfer AC power sources from the normal offsite circuit to the alternate required offsite circuit as is performed in Unit 1.
The margin of safety is related to the confidence in the ability of the fission product barriers to perform their design functions during and following an accident situation and the ability of the ECCS to provide adequate core cooling. These barriers include the fuel cladding, the reactor coolant system, and the containment system. The proposed change does not directly affect these barriers, nor does it involve any adverse impact on the Class 1E circuits or SSCs supplied by Class 1E power. In fact, it enhances the ability to power the required ECCS equipment during accident conditions.
Therefore, the proposed change will not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment involves changes to the Surry Containment Leakage Rate Testing Program. The proposed amendment does not involve a physical change to the plant or a change in the manner in which the plant is operated or controlled. The primary containment function is to provide an essentially leak-tight barrier against the uncontrolled release of radioactivity to the environment for postulated accidents. As such, the containment itself and the testing requirements to periodically demonstrate the integrity of the containment do not involve any accident precursors or initiators. Therefore, the probability of occurrence of an accident previously evaluated is not significantly increased by the proposed amendment.
The proposed amendment adopts the NRC-accepted guidelines of NEI 94–01, Revision 3–A, for development of the Surry Power Station Units 1 and 2 performance-based containment testing program. Implementation of these guidelines continues to provide adequate assurance that during design basis accidents, the primary containment and its components will limit leakage rates to less than the values assumed in the plant safety analyses. The potential consequences of extending the ILRT interval to 15 years have been evaluated by analyzing the resulting changes in risk. The increase in risk in terms of person-rem per year within 50 miles resulting from design basis accidents was estimated to be acceptably small and determined to be within the guidelines published in, RG 1.174. Additionally, the proposed change maintains defense-in-depth by preserving a reasonable balance among prevention of core damage, prevention of containment failure, and consequence mitigation. Dominion has determined that the increase in Conditional Containment Failure Probability due to the proposed change would be very small. Therefore, it is concluded that the proposed amendment does not significantly increase the consequences of an accident previously evaluated.
Based on the above discussion, it is concluded that the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed amendment adopts the NRC-accepted guidelines of NEI 94–01, Revision 3–A, for the development of the Surry performance-based leakage testing program and establishes a 15-year interval for the performance of the containment ILRT. The containment and the testing requirements to periodically demonstrate the integrity of the containment exist to ensure the plant's ability to mitigate the consequences of an accident and do not involve any accident precursors or initiators. The proposed change does not involve a physical change to the plant (i.e., no new or different type of equipment will be installed) and does not
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed amendment adopts the NRC-accepted guidelines of NEI 94–01, Revision 3–A, for the development of the Surry performance-based leakage testing program and establishes a 15-year interval for the performance of the containment ILRT. This amendment does not alter the manner in which safety limits, limiting safety system setpoints, or limiting conditions for operation are determined. The specific requirements and conditions of the Containment Leakage Rate Testing Program, as defined in the TS, ensure that the degree of primary containment structural integrity and leak-tightness that is considered in the plant's safety analysis is maintained. The overall containment leakage rate limit specified by the TS is maintained, and the Type A, Type B, and Type C containment leakage tests will be performed at the frequencies established in accordance with the NRC-accepted guidelines of NEI 94–01, Revision 3–A. Containment inspections performed in accordance with other plant programs serve to provide a high degree of assurance that the containment will not degrade in a manner that is not detectable by an ILRT. A risk assessment using the current Surry PRA model concluded that extending the ILRT test interval from ten years to 15 years results in a very small change to the Surry risk profile.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
Based on the above, Dominion concludes that the proposed amendment presents no significant hazards consideration under the standards set forth in 10 CFR 50.92(c), and, accordingly, a finding of “no significant hazards consideration” is justified.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items are available for public inspection at the NRC's Public Document Room (PDR), located at One White Flint North, Room O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. Publicly available documents created or received at the NRC are accessible electronically through the Agencywide Documents Access and Management System (ADAMS) in the NRC Library at
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 23, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 25, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 25, 2013.
No.
The Commission's related evaluation of the amendment, finding of emergency circumstances, state consultation, and final NSHC determination are contained in a safety evaluation dated October 9, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 18, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 24, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 7, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 9, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 26, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 2, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 18, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 25, 2013.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 20, 2013.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 19, 2013.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License amendment request; opportunity to request a hearing and to petition for leave to intervene.
The U. S. Nuclear Regulatory Commission (NRC) has received, by letter dated September 23, 2013, a request to amend Homestake Mining Company of California's (HMC's or Licensee's) license to change the background monitoring location used to measure radon-222 concentrations in air.
A request for a hearing or petition for leave to intervene must be filed by December 30, 2013.
Please refer to Docket ID NRC–2013–0138 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this action by the following methods:
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John Buckley, Office of Federal and State Materials and Environmental Management Programs, telephone: 301–415–6607; email:
The NRC has received, by letter dated September 23, 2013, a request to amend Homestake Mining Company of California's (HMC's or Licensee's) license to change the background monitoring location used to measure radon-222 concentrations in air. Specifically, HMC is requesting to amend Table 1—Environmental Monitoring Program Excluding Groundwater Monitoring, referenced in License Condition 10 (LC10) to reflect the replacement of HMC–16 with HMC–1Off as the background location for radon-22 monitoring. Upon NRC's review and approval, Table 1—Environmental Monitoring Program Excluding Groundwater Monitoring, will be revised by replacing radon monitoring location HMC–16 with new location HMC–1Off. HMC's evaluation of background monitoring locations titled, “Basis for Selection of a Representative Background Monitoring Location for the Homestake Uranium Mill Site, SUA–1471” dated September 2013, can be found in ADAMS under Accession No. ML13281A790.
HMC–16 was identified in Table 1 as the background radon-222 monitoring location in HMC's license amendment request dated September 2, 1993 (ADAMS Accession No. ML13274A418). Amendment No. 16, incorporating Table 1, was approved on September 23, 1993. Additional documents related to the license amendment application can be found in ADAMS under Docket No. 04008903.
An NRC administrative completeness review found the application acceptable for a technical review (ADAMS Accession No. ML13274A290). Prior to approving the amendment request, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations. The NRC's findings will be documented in a safety evaluation report.
Within 60 days after the date of publication of this
Any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written petition for leave to intervene. As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The petition must provide the name, address, and telephone number of the petitioner and specifically explain the reasons why intervention should be permitted with particular reference to the following factors: (1) The nature of the petitioner's right under the Act to be made a party to the proceeding; (2) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (3) the possible effect of any order that may be entered in the proceeding on the petitioner's interest.
A petition for leave to intervene must also include a specification of the contentions that the petitioner seeks to have litigated in the hearing. For each contention, the petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC's regulations, policies, and procedures. The Atomic Safety and Licensing Board will set the time and place for any prehearing conferences and evidentiary hearings, and the appropriate notices will be provided.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the following three factors in 10 CFR 2.309(c)(1)(i)–(iii).
A State, local governmental body, Federally-recognized Indian tribe, or agency thereof may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by December 30, 2013. The petition must be filed in accordance with the filing instructions in section III of this document, and should meet the requirements for petitions for leave to intervene set forth in this section. A State, local governmental body, Federally-recognized Indian tribe, or agency thereof may also have the opportunity to participate in a hearing as a nonparty under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by December 30, 2013.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with the NRC's guidance available on the NRC's public Web site at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For the Nuclear Regulatory Commission.
Weeks of October 28, November 4, 11, 18, 25, December 2, 2013.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of November 4, 2013.
There are no meetings scheduled for the week of November 11, 2013.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of November 25, 2013.
There are no meetings scheduled for the week of December 2, 2013.
The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—301–415–1292. Contact person for more information: Rochelle Bavol, 301–415–1651.
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g. braille, large print), please notify Kimberly Meyer, NRC Disability Program Manager, at 301–287–0727, or by email at
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301–415–1969), or send an email to
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form ID (OMB Control No. 3235–0328; SEC File No. 270–291) is used by
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94–409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, October 31, 2013 at 1:00 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Stein, as duty officer, voted to consider the items listed for the Closed Meeting in a closed session.
The subject matter of the Closed Meeting will be:
institution and settlement of injunctive actions;
institution and settlement of administrative proceedings;
adjudicatory matters;
amicus consideration; and
other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551–5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes to amend certain procedural rules to implement the change in the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday. The text of the proposed rule change is available at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On August 21, 2013, the Exchange filed to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange has adopted rules to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange is making the proposed rule changes to further harmonize its rules in connection with a recently approved rule filing made by OCC which made substantially similar changes.
In order to provide a smooth transition to the Friday expiration, OCC has begun to move the expiration exercise procedures to Friday for all standard expiration contracts even though the contracts would continue to expire on Saturday.
Certain option contracts have already been listed with Saturday expiration dates as distant as January 2016 (which is the furthest out expiration as of the date of this filing). For these contracts, transitioning to a Friday expiration for newly listed option contracts expiring after February 1, 2015 would create a situation under which certain options with open interest would expire on a Saturday while other options with open interest would expire on a Friday in the same expiration month.
Clearing members have expressed a clear preference to not have a mix of options with open interest that expire on different days in a single month.
Since the rule changes implementing the change in expiration date apply only to new series of standard expiration contracts opened for trading consistent with the OCC rules and having expiration dates later than February 1, 2015, the Exchange is proposing to amend certain rules relating to the procedures of the Exchange. The proposed changes take into account that, during a transition period, there will be options with open interest having both Friday and Saturday expiration dates.
More specifically, the Exchange is proposing to amend Chapter 1, General Provisions, Section 1(a)(16) to provide that European-style options can be exercised only on the expiration date if such day is a business day or, in the case of option contracts expiring on a day that is not a business day, the last business day prior to expiration.
In addition, the Exchange seeks to amend Chapter III, Business Conduct, Section 12(a)(ii) with respect to certain timing for restrictions on the exercise of option contracts. Specifically, the Exchange proposes to specify that the 10 business day period referenced in Section 12(a)(ii) includes the expiration date for an option contract that expires on a business day. With respect to index options, restrictions on exercise may be in effect until the opening of business on the business day of their expiration or, in the case of an option contract expiring on a day that is not a business day, on the last business day before the expiration date. In addition, the Exchange proposes to amend Section 12(a)(iii)(2) to specify that exercises of expiring American-style, cash-settled index options would not be prohibited on an expiration date that is a business day (i.e., for Friday expirations), or, in the case of an option contract expiring on a non-business day (as is currently the case for Saturday expirations), on the last business day prior to expiration.
The Exchange also proposes to amend Chapter IV, Securities Traded on NOM, Section 6(c) to differentiate between Friday and Saturday expirations. Specifically, the Exchange would specify that, in the event of unusual market conditions, additional series of individual stock options may be added in the discretion of the Exchange until the close of trading on the business day prior to expiration in the case of an option contract expiring on a business day (i.e., Thursday for a Friday expiration), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, until the close of trading on the second business day prior to expiration (i.e., until the close of trading on Thursday for Saturday expirations).
Additionally, the Exchange proposes to amend Chapter V, Regulation of Trading on NOM, Section 6(f)(ii) to add greater specificity regarding the timing surrounding notifications to the Exchange of a Catastrophic Error. Specifically, the Exchange proposes to specify that, for transactions in an expiring options series that take place on an expiration day that is a business day (i.e., for Friday expirations), a party must notify MarketWatch by 5:00 p.m. ET that same day. For transactions in an expiring options series that take place on the business day immediately prior to a non-business expiration day (i.e., for Saturday expirations), a party must notify MarketWatch by 5:00 p.m. ET on such business day (i.e., on Friday).
The Exchange's proposal includes several proposed changes to Chapter VIII, Exercises and Deliveries, Section 1 in order to differentiate between Friday and Saturday expirations. First, the Exchange proposes to specify in Section 1(b) that special procedures apply to the exercise of equity options on the business day of their expiration (i.e., for
Additionally, the Exchange proposes to amend Chapter XIV, Index Rules, Section 2(g)–(q) to reorder the defined terms into alphabetical order. In newly renumbered Section 2(h) the definition of “European-style index option” is modified to provide that the term European-style index option means an option on an industry or market index that can be exercised only on the expiration date if such day is a business day or, in the case of option contracts expiring on a day that is not a business day, the last business day prior to expiration.
The Exchange also seeks to amend Sections 10 and 11 of Chapter XIV, Index Rules to differentiate between Friday and Saturday expirations. Section 10(a) would be amended to specify that transactions with respect to the MSCI EAFE Index may be effected on NOM until 11:00 a.m. ET on the business day of expiration, or, in the case of an option contract expiring on a day that is not a business day, the business day immediately prior to the last business day before the expiration date.
The proposed rule change to Section 11(a)(5) would provide that the last day of trading for A.M.-settled index options shall be the business day (i.e., on Thursday) immediately prior to the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, the business day immediately prior to the last business day before the expiration date (i.e., Thursday for Saturday expirations). In addition, the current index value at the expiration of an A.M.-settled index option would be determined on the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, on the last business day before its expiration (i.e., Friday). The Exchange also proposes to amend Section 11(a)(5)(i) to refer to Section 10(g) in order to correct a cross-reference. With respect to P.M.-settled index options, the proposal would specify that the last day of trading for P.M.-settled index options would be the business day of expiration, or, in the case of an option contract expiring on a day that is not a business day, on the last business day before its expiration date. Additionally, it is proposed that Section 11(c)(2) would be amended to specify that new series of index option contracts may be added up to, but not on or after, the fourth business day prior to expiration for an option contract expiring on a business day (i.e., up to, but not on or after, the opening of trading on Monday morning for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the fifth business day prior to expiration. The Exchange also proposes to amend Section 11(d) to more generally specify that the reported level of the underlying index that is calculated by the reporting authority for the purposes of determining the current index value at expiration of an A.M.-settled index option may differ from the level of the index that is separately calculated and reported reflecting trading activity subsequent to the opening of trading in any of the underlying securities.
As stated above, the Exchange believes the proposed change will keep the Exchange consistent with the processing at OCC and will enable the Exchange to give effect to the industry-wide initiative. In addition, the Exchange understands that other exchanges have filed similar rules to differentiate between Friday and Saturday expiration dates for standard options on listed classes.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that implementing the change to Friday expiration processing and eventually transitioning to Friday expiration for all monthly expiration contracts would foster cooperation and coordination with persons engaged in facilitating transactions in securities. In particular, the Exchange believes that keeping its rules consistent with those of the industry will protect all participants in the market by eliminating confusion and would facilitate the long-term goal of OCC and its clearing members to move the expiration process for all monthly
In addition, the proposed changes will foster cooperation and coordination with persons engaged in regulating clearing, settling, processing information with respect to, and facilitating transactions in securities by aligning a pivotal part of the options processing to be consistent industry wide. If the industry were to differ, investors would suffer from confusion and be more vulnerable to inadvertent violations of different exchange rules. The proposed changes do not permit unfair discrimination between any members because they are applied to all members equally. In the alternative, the Exchange believes that the proposed changes help all members by keeping the Exchange consistent with OCC practices and those of other exchanges.
NASDAQ does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Specifically, the Exchange does not believe the proposed rule change will impose a burden on intramarket competition because it will be applied to all members equally. In addition, the Exchange does not believe the proposed rule change will impose any burden to intermarket competition because it will be applied industry-wide, apply to all market participants and is designed to allow OCC to streamline the expiration process for all monthly expiration contracts and increase operational efficiencies for OCC and its clearing members.
The proposed rule change is structured to enhance competition because the shift from an expiration date of the Saturday following the third Friday to the third Friday is anticipated to be adopted industry-wide and will apply to multiple listed classes. The proposed changes in turn will allow NOM to continue to compete with other exchanges making similar rule changes. For the reasons above, the Exchange does not believe that the proposed rule change would impose a burden on competition.
Written comments were neither solicited nor received. The Exchange notes, however, that a favorable comment was submitted to the OCC filing.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the
The Exchange proposes to amend certain procedural rules to implement the change in the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On August 21, 2013, the Exchange filed to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange has adopted rules to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange is making the proposed rule changes to further harmonize its rules in connection with a recently approved rule filing made by OCC which made substantially similar changes.
In order to provide a smooth transition to the Friday expiration, OCC has begun to move the expiration exercise procedures to Friday for all standard expiration contracts even though the contracts would continue to expire on Saturday.
Certain option contracts have already been listed with Saturday expiration dates as distant as January 2016 (which is the furthest out expiration as of the date of this filing). For these contracts, transitioning to a Friday expiration for newly listed option contracts expiring after February 1, 2015 would create a situation under which certain options with open interest would expire on a Saturday while other options with open interest would expire on a Friday in the same expiration month.
Clearing members have expressed a clear preference to not have a mix of options with open interest that expire on different days in a single month.
Since the rule changes implementing the change in expiration date apply only to new series of standard expiration contracts opened for trading consistent with the OCC rules and having expiration dates later than February 1, 2015, the Exchange is proposing to amend certain rules relating to the procedures of the Exchange. The proposed changes take into account that, during a transition period, there will be options with open interest
More specifically, the Exchange seeks to amend Rule 1006 with respect to certain timing for restrictions on the exercise of American style option. Specifically, the Exchange proposes to specify that the 10 business day period referenced in Rule 1006 includes the expiration date for an option contract that expires on a business day. In addition, the proposal would amend Rule 1006A to provide that restrictions may be in effect for index options until the open of business on the business day of expiration, or, in the case of an option contract expiring on a day that is not a business day, the business day prior to the expiration date.
The Exchange also proposes to amend Rule 1012, Series of Options Open for Trading, to differentiate between Friday and Saturday expirations. Specifically, the Exchange proposes to amend Rule 1012(a)(i)(B) to specify that additional series of individual stock options may be added in unusual market conditions until the close of trading on the business day prior to expiration in the case of an option contract expiring on a business day (i.e., Thursday for a Friday expiration), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, until the close of trading on the second business day prior to expiration (i.e., until the close of trading on Thursday for Saturday expirations). The Exchange also seeks to modify Rule 1012(b) to specify that, on a business day of expiration, or, in the case of an option contract expiring on a non-business day, on the business day prior to the expiration date of a series of options, a closing rotation shall commence at 4:00 p.m. in the case of options on stocks or 4:15 p.m. in the case of options on designated Exchange-Traded Fund Shares.
The Exchange's proposal includes several proposed changes to Rules 1042 and 1042A in order to differentiate between the exercise procedures for Friday and Saturday expirations. First, the Exchange proposes to specify in Rule 1042(b) that special procedures apply to the exercise of equity options on the business day of their expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, on the last business day before their expiration. Second, the Exchange proposes to specify in Rule 1042(c) that, regarding exercise cut-off times, option holders have until 5:30 p.m. EST on the business day of their expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, on the business day immediately prior to the expiration date. Third, the Exchange proposes to specify in Rule 1042(h) that the advance notice described therein is applicable if provided by the Exchange on or before 5:30 p.m. EST on the business day (i.e., on Thursday) immediately prior to the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the business day immediately prior to the last business day before the expiration date (i.e., Thursday for Saturday expirations). Fourth, the Exchange proposes to amend Rule 1042, Commentary .03 to specify that the reference therein to “unusual circumstances” includes, but is not limited to, a significant news announcement concerning the underlying security of an option contract that is scheduled to be released just after the close on the business day the option contract expires (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the business day immediately prior to expiration. In addition, the Exchange proposes to amend Rule 1042A(b) to make clear when certain procedures do not apply with respect to the exercise of any stock index option series on the business day of expiration, or in the case of an option expiring on a day that is not a business day, the business day prior to the expiration date.
The Exchange also seeks to modify Rule 1047(c) to specify that an Options Exchange Official has the authority to conduct a closing rotation on a business day of expiration, or, in the case of an option contract expiring on a non-business day, on the trading day prior to expiration where the underlying stock or Exchange-Traded Fund Share did not open or was halted, whenever such action is deemed necessary in the interests of maintaining a fair and orderly market and to protect investors. Rule 1047, Commentary .01(c) also would be modified to clarify certain procedures relating to closing rotations that may commence on a business day of expiration, or, in the case of an option contract expiring on a non-business day, on the last trading day prior to expiration with respect to expiring stock option contracts, expiring stock option contracts or options on Exchange-Traded Fund Shares.
Additionally, the Exchange proposes to amend Rule 1092 to add greater specificity regarding the timing surrounding notifications to the Exchange of a Catastrophic Error. Specifically, the Exchange proposes to specify that, for such transactions in an expiring options series that take place on an expiration day that is a business day (i.e., for Friday expirations), a party must notify the Exchange by 5:00 p.m. ET that same day. For such transactions in an options series that take place on the business day immediately prior to an expiration day that is not a business day (i.e., for Saturday expirations), an Exchange member must notify the Exchange's Regulatory staff by 5:00 p.m. ET on such business day (i.e., on Friday).
Additionally, it is proposed that Rule 1101A(b)(i) would be amended to specify that due to unusual market conditions new series of index option contracts may be added up to, but not on or after, the fourth business day prior to expiration for an option contract expiring on a business day (i.e., up to, but not on or after, the opening of trading on Monday morning for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the fifth business day prior to expiration. Similarly, Rule 1002C is proposed to be modified to specify that due to unusual market conditions new series of PHLX FOREX Options may be added consistent with the timing described above for new series of index option contracts. The Exchange also proposes to modify Rule 1101A(c) and Rule 1101A, Commentary .01 to specify the applicable hours for trading for index options series and options on the Full Value MSCI EAFE Index on an expiration date that is a business day or the business day prior to expiration when the expiration date is a non-business day.
The Exchange also seeks to clarify rules governing the closing settlement value of certain option contracts. Rule 1057, as proposed to be amended, would provide that the closing settlement value for U.S. dollar-settled foreign currency options on the currencies listed therein, shall be the Exchange Spot Price at 12:00:00 Eastern Time (noon) on the expiration date, if that expiration date is a business day, or on the business day prior to expiration, when the expiration date is a non-business day, unless the Exchange determines to apply an alternative closing settlement value as a result of
As stated above, the Exchange believes the proposed change will keep the Exchange consistent with the processing at OCC and will enable the Exchange to give effect to the industry-wide initiative. In addition, the Exchange understands that other exchanges have filed similar rules to differentiate between Friday and Saturday expiration dates for standard options on listed classes.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that implementing the change to Friday expiration processing and eventually transitioning to Friday expiration for all monthly expiration contracts would foster cooperation and coordination with persons engaged in facilitating transactions in securities. In particular, the Exchange believes that keeping its rules consistent with those of the industry will protect all participants in the market by eliminating confusion and would facilitate the long-term goal of OCC and its clearing members to move the expiration process for all monthly expiration contracts from Saturday to Friday night. The proposed changes thus allow for a more orderly market by allowing all options markets, including the clearing agencies, to have the same expiration date for standard options and to have clarity around the procedures that apply during the transition period when both Friday and Saturday expirations will exist for standard options.
In addition, the proposed changes will foster cooperation and coordination with persons engaged in regulating clearing, settling, processing information with respect to, and facilitating transactions in securities by aligning a pivotal part of the options processing to be consistent industry wide. If the industry were to differ, investors would suffer from confusion and be more vulnerable to inadvertent violations of different exchange rules. The proposed changes do not permit unfair discrimination between any members because they are applied to all members equally. In the alternative, the Exchange believes that the proposed changes help all members by keeping the Exchange consistent with OCC practices and those of other exchanges.
Phlx does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Specifically, the Exchange does not believe the proposed rule change will impose a burden on intramarket competition because it will be applied to all members equally. In addition, the Exchange does not believe the proposed rule change will impose any burden to intermarket competition because it will be applied industry-wide, apply to all market participants and is designed to allow OCC to streamline the expiration process for all monthly expiration contracts and increase operational efficiencies for OCC and its clearing members.
The proposed rule change is structured to enhance competition because the shift from an expiration date of the Saturday following the third Friday to the third Friday is anticipated to be adopted industry-wide and will apply to multiple listed classes. The proposed changes in turn will allow Phlx to continue to compete with other exchanges making similar rule changes. For the reasons above, the Exchange does not believe that the proposed rule change would impose a burden on competition.
Written comments were neither solicited nor received. The Exchange notes, however, that a favorable comment was submitted to the OCC filing.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes to amend certain procedural rules to implement the change in the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday. The text of the proposed rule change is available at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On August 21, 2013, the Exchange filed to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange has adopted rules to change the expiration date for most option contracts to the third Friday of the expiration month instead of the Saturday following the third Friday.
The Exchange is making the proposed rule changes to further harmonize its rules in connection with a recently approved rule filing made by OCC which made substantially similar changes.
In order to provide a smooth transition to the Friday expiration, OCC has begun to move the expiration exercise procedures to Friday for all standard expiration contracts even though the contracts would continue to expire on Saturday.
Certain option contracts have already been listed with Saturday expiration dates as distant as January 2016 (which is the furthest out expiration as of the date of this filing). For these contracts, transitioning to a Friday expiration for newly listed option contracts expiring after February 1, 2015 would create a situation under which certain options with open interest would expire on a Saturday while other options with open interest would expire on a Friday in the same expiration month.
Clearing members have expressed a clear preference to not have a mix of options with open interest that expire on different days in a single month.
Since the rule changes implementing the change in expiration date apply only to new series of standard expiration contracts opened for trading consistent with the OCC rules and having expiration dates later than February 1, 2015, the Exchange is proposing to amend certain rules relating to the procedures of the Exchange. The proposed changes take into account that, during a transition period, there will be options with open interest having both Friday and Saturday expiration dates.
More specifically, the Exchange is proposing to amend Chapter 1, General Provisions, Section 1(a)(25) to provide that European-style options can be exercised only on the expiration date if such day is a business day or, in the case of option contracts expiring on a day that is not a business day, the last business day prior to expiration.
In addition, the Exchange seeks to amend Chapter III, Business Conduct, Section 12(a)(ii) with respect to certain timing for restrictions on the exercise of option contracts. Specifically, the Exchange proposes to specify that the 10 business day period referenced in Section 12(a)(ii) includes the expiration date for an option contract that expires on a business day. With respect to index options, restrictions on exercise may be in effect until the opening of business on the business day of their expiration or, in the case of an option contract expiring on a day that is not a business day, on the last business day before the expiration date. In addition, Section 12(a)(iii)(2) would be amended to specify that exercises of expiring American-style, cash-settled index options would not be prohibited on an expiration date that is a business day (i.e., for Friday expirations), or, in the case of an option contract expiring on a non-business day (as is currently the case for Saturday expirations), on the last business day prior to expiration.
The Exchange also proposes to amend Chapter IV, Securities Traded on BX Options, Section 6(c) to differentiate between Friday and Saturday expirations. Specifically, the Exchange would specify that additional series of individual stock options may be added in unusual market conditions until the close of trading on the business day prior to expiration in the case of an option contract expiring on a business day (i.e., Thursday for a Friday expiration), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, until the close of trading on the second business day prior to expiration (i.e., until the close of trading on Thursday for Saturday expirations).
Additionally, the Exchange's proposal would change Chapter V, Regulation of Trading on BX Options, Section 6(f)(ii) to add greater specificity regarding the timing surrounding notifications to the Exchange of a Catastrophic Error. Specifically, the Exchange proposes to specify that, for such transactions in an expiring options series that take place on an expiration day that is a business day (i.e., for Friday expirations), a party must notify MarketWatch by 5:00 p.m. ET that same day. For such transactions in an options series that take place on the business day immediately prior to an expiration day that is not a business day (i.e., for Saturday expirations), a party must notify MarketWatch by 5:00 p.m. ET on such business day (i.e., on Friday).
The Exchange's proposal includes several proposed changes to Chapter VIII, Exercises and Deliveries, Section 1 in order to differentiate between Friday and Saturday expirations. First, the Exchange proposes to specify in Section 1(b) that special procedures apply to the exercise of equity options on the business day of their expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, on the last business day before their expiration. Second, the Exchange proposes to specify in Section 1(c) that, regarding exercise cut-off times, option holders have until 5:30 p.m. ET on the business day of their expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, on the business day immediately prior to the expiration date. Third, the Exchange proposes to specify in Section 1(h) that the advance notice described therein is applicable if provided by the Exchange on or before 5:30 p.m. ET on the business day (i.e., on Thursday) immediately prior to the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the business day immediately prior to the last business day before the expiration date (i.e., Thursday for Saturday expirations). Fourth, the Exchange proposes to amend Section 1(i) at ii. to specify that the reference therein to “unusual circumstances” includes, but is not limited to, a significant news announcement concerning the underlying security of an option
Additionally, the Exchange seeks to amend Chapter XIV, Index Rules, Section 2(g)–(p) to reorder the defined terms into alphabetical order. In newly renumbered Section 2(h), the definition of “European-style index option” is modified to provide that the term European-style index option means an option on an industry or market index that can be exercised only on the expiration date if such day is a business day or, in the case of option contracts expiring on a day that is not a business day, the last business day prior to expiration.
The Exchange also seeks to amend Section 11 of Chapter XIV, Index Rules to differentiate between Friday and Saturday expirations. The proposed rule change to Section 11(a)(5) would provide that the last day of trading for A.M.-settled index options would be the business day (i.e., on Thursday) immediately prior to the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, the business day immediately prior to the last business day before the expiration date (i.e., Thursday for Saturday expirations). In addition, the current index value at the expiration of an A.M.-settled index option would be determined on the business day of expiration (i.e., for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, on the last business day before its expiration (i.e., Friday). The Exchange also proposes to amend Section 11(a)(5)(i) to refer to Section 10(g) in order to correct a cross-reference. Additionally, it is proposed that Section 11(c)(2) would be amended to specify that new series of index option contracts may be added up to, but not on or after, the fourth business day prior to expiration for an option contract expiring on a business day (i.e., up to, but not on or after, the opening of trading on Monday morning for Friday expirations), or, in the case of an option contract expiring on a day that is not a business day, and as is currently the case for Saturday expirations, the fifth business day prior to expiration. The Exchange also proposes to amend Section 11(d) to more generally specify that the reported level of the underlying index that is calculated by the reporting authority for the purposes of determining the current index value at expiration of an A.M.-settled index option may differ from the level of the index that is separately calculated and reported reflecting trading activity subsequent to the opening of trading in any of the underlying securities.
As stated above, the Exchange believes the proposed changes will keep the Exchange consistent with the processing at OCC and will enable the Exchange to give effect to the industry-wide initiative. In addition, the Exchange understands that other exchanges have filed similar rules to differentiate between Friday and Saturday expiration dates for standard options on listed classes.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that implementing the change to Friday expiration processing and eventually transitioning to Friday expiration for all monthly expiration contracts would foster cooperation and coordination with persons engaged in facilitating transactions in securities. In particular, the Exchange believes that keeping its rules consistent with those of the industry will protect all participants in the market by eliminating confusion and would facilitate the long-term goal of OCC and its clearing members to move the expiration process for all monthly expiration contracts from Saturday to Friday night. The proposed changes thus allow for a more orderly market by allowing all options markets, including the clearing agencies, to have the same expiration date for standard options and to have clarity around the procedures that apply during the transition period when both Friday and Saturday expirations will exist for standard options.
In addition, the proposed changes will foster cooperation and coordination with persons engaged in regulating clearing, settling, processing information with respect to, and facilitating transactions in securities by aligning a pivotal part of the options processing to be consistent industry wide. If the industry were to differ, investors would suffer from confusion and be more vulnerable to inadvertent violations of different exchange rules. The proposed changes do not permit unfair discrimination between any members because they are applied to all members equally. In the alternative, the Exchange believes that the proposed changes help all members by keeping the Exchange consistent with OCC practices and those of other exchanges.
BX does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Specifically, the Exchange does not believe the proposed rule change will impose a burden on intramarket competition because it will be applied to all members equally. In addition, the Exchange does not believe the proposed rule change will impose any burden to intermarket competition because it will be applied industry-wide, apply to all market participants and is designed to allow OCC to streamline the expiration process for all monthly expiration contracts and increase operational efficiencies for OCC and its clearing members.
The proposed rule change is structured to enhance competition
Written comments were neither solicited nor received. The Exchange notes, however, that a favorable comment was submitted to the OCC filing.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “SEA”)
FINRA is filing revisions to the content outline and selection specifications for the Investment Company and Variable Contracts Products Representative (Series 6) examination program.
The revised content outline is attached.
The text of the proposed rule change is available on FINRA's Web site at
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Section 15A(g)(3) of the Act
Pursuant to NASD Rule 1032(b)
In consultation with a committee of industry representatives, FINRA recently undertook a review of the Series 6 examination program. As a result of this review, FINRA is proposing to make revisions to the content outline to reflect changes to the laws, rules and regulations covered by the examination and to incorporate the functions and associated tasks currently performed by an Investment Company and Variable Contracts Products Representative. FINRA also is proposing to make changes to the format of the content outline.
The current content outline is divided into six sections. The following are the six sections and the number of questions associated with each of the sections, denoted Section 1 through Section 6:
1. Securities Markets, Investment Securities and Economic Factors, 8 questions;
2. Securities and Tax Regulation, 23 questions;
3. Marketing, Prospecting and Sales Presentation, 18 questions;
4. Evaluation of Customers, 13 questions;
5. Product Information; Investment Company Securities and Variable Contracts, 26 questions; and
6. Opening and Servicing Customer Accounts, 12 questions.
Each section also includes the applicable laws, rules and regulations associated with that section. The current outline also includes a preface (addressing, among other things, the purpose, administration and scoring of the examination), sample questions and reference materials.
FINRA is proposing to divide the content outline into four major job functions that are performed by an Investment Company and Variable Contracts Products Representative. The following are the four major job functions, denoted Function 1 through Function 4, with the associated number of questions:
Function 1: Regulatory fundamentals and business development, 22 questions;
Function 2: Evaluates customers' financial information, identifies investment objectives, provides information on investment products, and makes suitable recommendations, 47 questions;
Function 3: Opens, maintains, transfers and closes accounts and retains appropriate account records, 21 questions; and
Function 4: Obtains, verifies, and confirms customer purchase and sale instructions, 10 questions.
Each function also includes specific tasks describing activities associated with performing that function. There are four tasks (1.1–1.4) associated with Function 1; four tasks (2.1–2.4) associated with Function 2; three tasks (3.1–3.3) associated with Function 3; and two tasks (4.1–4.2) associated with Function 4.
As noted above, FINRA also is proposing to revise the content outline to reflect changes to the laws, rules and regulations covered by the examination. Among other revisions, FINRA is proposing to revise the content outline to reflect the adoption of rules in the consolidated FINRA rulebook (
FINRA is proposing similar changes to the Series 6 selection specifications and question bank.
Finally, FINRA is proposing to make changes to the format of the content outline, including the preface, sample questions and reference materials. Among other changes, FINRA is proposing to: (1) Add a table of contents;
The number of questions on the Series 6 examination will remain at 100 multiple-choice questions,
The current Series 6 content outline is available on FINRA's Web site, at www.finra.org/brokerqualifications/exams. The revised Series 6 content outline will replace the current content outline on FINRA's Web site.
FINRA is filing the proposed rule change for immediate effectiveness. FINRA proposes to implement the revised Series 6 examination program on December 16, 2013. FINRA will announce the proposed rule change and the implementation date in a Regulatory Notice.
FINRA believes that the proposed revisions to the Series 6 examination program are consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The updated examination aligns with the functions and associated tasks currently performed by an Investment Company and Variable Contracts Products Representative and tests knowledge of the most current laws, rules, regulations and skills relevant to those functions and associated tasks. As such, the proposed revisions would make the examination more efficient and effective.
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
PHLX proposes to establish for PHLX orders (“PHLX Orders”) Managed Data Solution fees for non-display usage (“Non-Display Usage”), and to establish that Managed Data Solutions containing Top of PHLX Options (also known as “TOPO”) are for non-display usage.
While the changes proposed herein are effective upon filing, the Exchange has designated that the amendments be operative on November 1, 2013.
The text of the proposed rule change is available at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
PHLX is proposing to create a new data distribution model (a Managed Data Solution for Non-Display Usage) to further the distribution of the PHLX Orders datafeed. PHLX is also proposing to establish that Managed Data Solutions containing Top of PHLX Options are for non-display usage. The proposed Managed Data Solution for non-display usage is similar to data distribution models currently in use and aligns PHLX with other markets in the NASDAQ OMX Group.
The Managed Data Solution proposal offers a delivery method to firms seeking simplified market data administration. The Managed Data Solution for Non-Display Usage may be offered by Distributors externally distributing data to clients and/or client organizations that are using the PHLX Orders information internally for Non-Display Usage. This new pricing and administrative option is in response to industry demand, as well as due to changes in the technology used to distribute market data. As such, rather than substantive changes the proposal reflects current data distribution practices in the industry. Distributors offering Managed Data Solutions for Non-Display Usage continue to be fee liable for the applicable distributor fees for the receipt and distribution of PHLX Orders data.
This Managed Data Solution for Non-Display Usage is a delivery option that will assess a new, innovative fee schedule to Distributors of PHLX Orders that provide data feed solutions such as an Application Programming Interface (API) or similar automated delivery solutions to Recipients for Non-Display Usage with only limited entitlement controls (
Currently, the Exchange does not distinguish between Managed Data Solution Recipients and a recipient of an uncontrolled data product. Some Distributors believe that the Managed Data Solution for Non-Display Usage is a viable alternative to an uncontrolled data product. Some Distributors have even delayed deploying new PHLX Orders offerings, pending the initiation of Managed Data Solutions for Non-Display Usage. Thus, offering a Managed Data Solution fee schedule would not only result in PHLX offering lower fees for existing Managed Data Recipients utilizing a Managed Data Solution, but will allow new Distributors to deliver Managed Data Solutions to new clients, thereby increasing transparency of the market.
PHLX proposes to establish two fees for Distributors that adopt the Managed Data Solution for Non-Display Usage to Distributors, a monthly Managed Data Solution Administration fee of $2,000 and a monthly Subscriber fee of $500.
PHLX believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Commission concluded that Regulation NMS—by lessening the regulation of the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition:
[E]fficiency is promoted when broker-dealers who do not need the data beyond the prices, sizes, market center identifications of the NBBO and consolidated last sale information are not required to receive (and pay for) such data. The Commission also believes that efficiency is promoted when broker-dealers may choose to receive (and pay for) additional market data based on their own internal analysis of the need for such data.
The decision of the United States Court of Appeals for the District of Columbia Circuit in
The court in
PHLX does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. PHLX's ability to price its PHLX Orders Managed Data Solution fees is constrained by (1) competition between exchanges and other trading platforms that compete with each other in a variety of dimensions; (2) the existence of inexpensive real-time consolidated data and market-specific data and free delayed consolidated data; and (3) the inherent contestability of the market for this data.
The market for proprietary data products is currently competitive and inherently contestable because there is fierce competition for the inputs necessary to the creation of proprietary data and strict pricing discipline for the proprietary products themselves. Numerous exchanges compete with each other for listings, trades, and market data itself, providing virtually limitless opportunities for entrepreneurs who wish to produce and distribute their own market data. This proprietary data is produced by each individual exchange, as well as other entities, in a vigorously competitive market.
Transaction execution and proprietary data products are complementary in that market data is both an input and a byproduct of the execution service. In fact, market data and trade execution are a paradigmatic example of joint products with joint costs. The decision whether and on which platform to post an order will depend on the attributes of the platform where the order can be posted, including the execution fees, data quality and price and distribution of its data products. Without trade executions, exchange data products cannot exist. Moreover, data products are valuable to many end users only insofar as they provide information that end users expect will assist them or their customers in making trading decisions.
The costs of producing market data include not only the costs of the data distribution infrastructure, but also the costs of designing, maintaining, and operating the exchange's transaction execution platform and the cost of regulating the exchange to ensure its fair operation and maintain investor confidence. The total return that a trading platform earns reflects the revenues it receives from both products and the joint costs it incurs. Moreover, the operation of the exchange is characterized by high fixed costs and low marginal costs. This cost structure is common in content and content distribution industries such as software, where developing new software typically requires a large initial investment (and continuing large investments to upgrade the software), but once the software is developed, the incremental cost of providing that software to an additional user is typically small, or even zero (
An exchange's BD customers view the costs of transaction executions and of data as a unified cost of doing business with the exchange. A BD will direct orders to a particular exchange only if the expected revenues from executing trades on the exchange exceed net transaction execution costs and the cost of data that the BD chooses to buy to support its trading decisions (or those of its customers). The choice of data products is, in turn, a product of the value of the products in making profitable trading decisions. If the cost of the product exceeds its expected value, the BD will choose not to buy it. Moreover, as a BD chooses to direct fewer orders to a particular exchange, the value of the product to that BD decreases, for two reasons. First, the product will contain less information, because executions of the BD's trading activity will not be reflected in it. Second, and perhaps more important, the product will be less valuable to that BD because it does not provide information about the venue to which it is directing its orders. Data from the competing venue to which the BD is directing orders will become correspondingly more valuable.
Similarly, in the case of products such as this that are distributed through market data vendors, the vendors provide price discipline for proprietary data products because they control the primary means of access to end users. Vendors impose price restraints based upon their business models. For example, vendors such as Bloomberg and Reuters that assess a surcharge on data they sell may refuse to offer proprietary products that end users will not purchase in sufficient numbers. Internet portals, such as Google, impose a discipline by providing only data that will enable them to attract “eyeballs” that contribute to their advertising revenue. Retail BDs, such as Schwab and Fidelity, offer their customers proprietary data only if it promotes trading and generates sufficient commission revenue. Although the business models may differ, these vendors' pricing discipline is the same: They can simply refuse to purchase any proprietary data product that fails to provide sufficient value. PHLX and other producers of proprietary data products must understand and respond to these varying business models and pricing disciplines in order to market proprietary data products successfully. Moreover, PHLX believes that products such as this can enhance order flow to PHLX, thereby encouraging wider participation in the market by investors with access to the Internet or television. Conversely, the value of such products to distributors and investors decreases if order flow falls, because the products contain less content.
Analyzing the cost of market data distribution in isolation from the cost of all of the inputs supporting the creation of market data will inevitably underestimate the cost of the data. Thus, because it is impossible to create data without a fast, technologically robust, and well-regulated execution system, system costs and regulatory costs affect the price of market data. It would be equally misleading, however, to attribute all of the exchange's costs to the market data portion of an exchange's joint product. Rather, all of the exchange's costs are incurred for the unified purposes of attracting order flow, executing and/or routing orders, and generating and selling data about market activity. The total return that an exchange earns reflects the revenues it receives from the joint products and the total costs of the joint products.
Competition among trading platforms can be expected to constrain the aggregate return each platform earns from the sale of its joint products, but different platforms may choose from a range of possible, and equally reasonable, pricing strategies as the means of recovering total costs. For example, some platforms may choose to pay rebates to attract orders, charge relatively low prices for market information (or provide information free of charge) and charge relatively high prices for accessing posted liquidity. Other platforms may choose a strategy of paying lower liquidity rebates to attract orders, setting relatively low prices for accessing posted liquidity and setting relatively high prices for market information. Still others may provide most data free of charge and rely exclusively on transaction fees to recover their costs. Finally, some platforms may incentivize use by providing opportunities for equity ownership, which may allow them to charge lower direct fees for executions and data.
In this environment, there is no economic basis for regulating maximum prices for one of the joint products in an industry in which suppliers face competitive constraints with regard to the joint offering. Such regulation is unnecessary because an “excessive” price for one of the joint products will ultimately have to be reflected in lower prices for other products sold by the firm, or otherwise the firm will experience a loss in the volume of its sales that will be adverse to its overall profitability. In other words, an increase
The level of competition and contestability in the market is evident in the numerous alternative venues that compete for order flow, including thirteen SRO markets, as well as internalizing BDs and various forms of alternative trading systems (“ATSs”), including dark pools and electronic communication networks (ECNs”). Each SRO market competes to produce transaction reports via trade executions, and two FINRA-regulated TRFs compete to attract internalized transaction reports. It is common for BDs to further and exploit this competition by sending their order flow and transaction reports to multiple markets, rather than providing them all to a single market. Competitive markets for order flow, executions, and transaction reports provide pricing discipline for the inputs of proprietary data products.
The large number of SROs, TRFs, BDs, and ATSs that currently produce proprietary data or are currently capable of producing it provides further pricing discipline for proprietary data products. Each SRO, TRF, ATS, and BD is currently permitted to produce proprietary data products, and many currently do or have announced plans to do so, including NASDAQ, NYSE, NYSE MKT, NYSE Arca, BATS, and Direct Edge.
Any ATS or BD can combine with any other ATS, BD, or multiple ATSs or BDs to produce joint proprietary data products. Additionally, order routers and market data vendors can facilitate single or multiple BD' production of proprietary data products. The potential sources of proprietary products are virtually limitless.
Market data vendors provide another form of price discipline for proprietary data products because they control the primary means of access to end Subscribers. Vendors impose price restraints based upon their business models. For example, vendors such as Bloomberg and Thomson Reuters that assess a surcharge on data they sell may refuse to offer proprietary products that end Subscribers will not purchase in sufficient numbers. Internet portals, such as Google, impose a discipline by providing only data that will enable them to attract “eyeballs” that contribute to their advertising revenue. Retail broker-dealers, such as Schwab and Fidelity, offer their customers proprietary data only if it promotes trading and generates sufficient commission revenue. Although the business models may differ, these vendors' pricing discipline is the same: they can simply refuse to purchase any proprietary data product that fails to provide sufficient value. PHLX and other producers of proprietary data products must understand and respond to these varying business models and pricing disciplines in order to market proprietary data products successfully.
In addition to the competition and price discipline described above, the market for proprietary data products is also highly contestable because market entry is rapid, inexpensive, and profitable. The history of electronic trading is replete with examples of entrants that swiftly grew into some of the largest electronic trading platforms and proprietary data producers: Archipelago, Bloomberg Tradebook, Island, RediBook, Attain, TracECN, BATS Trading and Direct Edge. A proliferation of dark pools and other ATSs operate profitably with fragmentary shares of consolidated market volume.
Regulation NMS, by deregulating the market for proprietary data, has increased the contestability of that market. While BDs have previously published their proprietary data individually, Regulation NMS encourages market data vendors and BDs to produce proprietary products cooperatively in a manner never before possible. Multiple market data vendors already have the capability to aggregate data and disseminate it on a profitable scale, including Bloomberg, and Thomson Reuters.
Competition among platforms has driven PHLX continually to improve its platform data offerings and to cater to customers' data needs. For example, PHLX has developed and maintained multiple delivery mechanisms (IP, multi-cast, and compression) that enable customers to receive data in the form and manner they prefer and at the lowest cost to them. PHLX has created new products like Depth Data, TOPO and TOPO Plus Orders, because offering data in multiple formatting allows PHLX to better fit customer needs. PHLX offers data via multiple extranet providers, thereby helping to reduce network and total cost for its data products. PHLX has developed an online administrative system to provide customers transparency into their datafeed requests and streamline data usage reporting.
Despite these enhancements and a dramatic increase in message traffic, PHLX's fees for market data have remained flat. In fact, as a percent of total Subscriber costs, PHLX data fees have fallen relative to other data usage costs—including bandwidth, programming, and infrastructure—that have risen. The same holds true for execution services; despite numerous enhancements to PHLX's trading platform, absolute and relative trading costs have declined. Platform competition has intensified as new entrants have emerged, constraining prices for both executions and for data.
The vigor of competition for proprietary information is significant and the Exchange believes that this proposal itself clearly evidences such competition. PHLX is offering a new pricing model in order to keep pace with changes in the industry and evolving customer needs. It is entirely optional and is geared towards attracting new customers, as well as retaining existing customers.
The Exchange has witnessed competitors creating new products and innovative pricing in this space over the course of the past year. PHLX continues to see firms challenge its pricing on the basis of the Exchange's explicit fees being higher than the zero-priced fees from other competitors such as BATS. In all cases, firms make decisions on how much and what types of data to consume on the basis of the total cost of interacting with PHLX or other exchanges. Of course, the explicit data fees are but one factor in a total platform analysis. Some competitors have lower transactions fees and higher data fees, and others are vice versa. The market for this proprietary
Written comments were neither solicited nor received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
All submissions should refer to File Number SR–Phlx–2013–105. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Colorado (FEMA–4145–DR), dated 09/24/2013.
Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of COLORADO, dated 09/24/2013, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 4.
This is an amendment of the Presidential declaration of a major disaster for the State of Colorado (FEMA–4145–DR), dated 09/14/2013.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Colorado, dated 09/14/2013 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration (SBA).
Notice of open Federal Advisory Committee meetings.
The SBA is issuing this notice to announce the location, date, time and agenda for the 1st quarter meetings of
The meetings for the 1st quarter will be held on the following dates: Tuesday, October 29, 2013 at 1:00 p.m. EST; Tuesday, November 19, 2013 at 1:00 p.m. EST; Tuesday, December 17, 2013 at 1:00 p.m. EST.
These meetings will be held via conference call.
Pursuant to section 10(a) of the Federal Advisory Committee Act (5 U.S.C. Appendix 2), SBA announces the meetings of the National SBDC Advisory Board. This Board provides advice and counsel to the SBA Administrator and Associate Administrator for Small Business Development Centers.
The purpose of these meetings is to discuss following issues pertaining to the SBDC Advisory Board:
The meeting is open to the public however advance notice of attendance is requested. Anyone wishing to be a listening participant must contact Monika Cuff by fax or email. Her contact information is Monika Cuff, Program Specialist, 409 Third Street SW., Washington, DC 20416, Phone, 202–205–7310, Fax 202–481–5624, email,
Additionally, if you need accommodations because of a disability or require additional information, please contact Monika Cuff at the information above.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to December 30, 2013.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Susan B. Summers, who may be reached on 703–875–5411 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Form DS–3057 is designed to collect medical information to provide medical providers with current and adequate information to base decisions on whether a federal employee and family members will have sufficient medical resources at a diplomatic mission abroad to maintain the health and fitness of the individual and family members.
The information collected will be collected through the use of an electronic forms engine or by hand written submission using a pre-printed form.
State Justice Institute.
Grant Guideline for FY 2014.
This Guideline sets forth the administrative, programmatic, and financial requirements attendant to Fiscal Year 2014 State Justice Institute grants, cooperative agreements, and contracts.
October 29, 2013.
Jonathan Mattiello, Executive Director, State Justice Institute, 11951 Freedom Drive, Suite 1020, Reston, VA 20190, 571–313–8843,
Pursuant to the State Justice Institute Act of 1984 (42 U.S.C. 10701, et seq.), SJI is authorized to award grants, cooperative agreements, and contracts to state and local courts, nonprofit organizations, and others for the purpose of improving
The following Grant Guideline is adopted by the State Justice Institute for FY 2014.
SJI was established by State Justice Institute Authorization Act of 1984 (42 U.S.C. 10701 et seq.) to improve the administration of justice in the state courts of the United States. Incorporated in the State of Virginia as a private, nonprofit corporation, SJI is charged, by statute, with the responsibility to:
• Direct a national program of financial assistance designed to assure that each citizen of the United States is provided ready access to a fair and effective system of justice;
• Foster coordination and cooperation with the federal judiciary;
• Promote recognition of the importance of the separation of powers doctrine to an independent judiciary; and
• Encourage education for judges and support personnel of state court systems through national and state organizations.
To accomplish these broad objectives, SJI is authorized to provide funding to state courts, national organizations which support and are supported by state courts, national judicial education organizations, and other organizations that can assist in improving the quality of justice in the state courts. SJI is supervised by a Board of Directors appointed by the President, with the advice and consent of the Senate. The Board is statutorily composed of six judges; a state court administrator; and four members of the public, no more than two of the same political party.
Through the award of grants, contracts, and cooperative agreements, SJI is authorized to perform the following activities:
A. Support technical assistance, demonstrations, special projects, research and training to improve the administration of justice in the state courts;
B. Provide for the preparation, publication, and dissemination of information regarding state judicial systems;
C. Participate in joint projects with federal agencies and other private grantors;
D. Evaluate or provide for the evaluation of programs and projects to determine their impact upon the quality of criminal, civil, and juvenile justice and the extent to which they have contributed to improving the quality of justice in the state courts;
E. Encourage and assist in furthering judicial education; and,
F. Encourage, assist, and serve in a consulting capacity to state and local justice system agencies in the development, maintenance, and coordination of criminal, civil, and juvenile justice programs and services.
SJI is authorized by Congress to award grants, cooperative agreements, and contracts to the following entities and types of organizations:
A.
B.
C.
1. The principal purpose or activity of the applicant is to provide education and training to state and local judges and court personnel; and
2. The applicant demonstrates a record of substantial experience in the field of judicial education and training.
D.
1. Provided that the objectives of the project can be served better, the Institute is also authorized to make awards to:
a. Nonprofit organizations with expertise in judicial administration;
b. Institutions of higher education;
c. Individuals, partnerships, firms, corporations (for-profit organizations must waive their fees); and
d. Private agencies with expertise in judicial administration.
2. SJI may also make awards to state or local agencies and institutions other than courts for services that cannot be adequately provided through nongovernmental arrangements (42 U.S.C. 10705(b)(3)).
E.
SJI is prohibited from awarding grants to federal, tribal, and international courts.
SJI is offering six types of grants in FY 2014: Project Grants, Technical Assistance (TA) Grants, Curriculum Adaptation and Training (CAT) Grants, Partner Grants, Strategic Initiatives Grants (SIG) Program, and the Education Support Program (ESP).
The SJI Board of Directors has established Priority Investment Areas for grant funding. SJI will allocate significant financial resources through grant-making for these Priority Investment Areas (in no ranking order):
• Language Access and the State Courts—e.g., interpretation service plans, remote interpretation (outside the courtroom), interpreter certification, courtroom services (plain language forms, Web sites, etc.).
• Self-Represented Litigation—e.g., court-operated self-help centers, online services, training.
• Reengineering in Response to Budget Reductions—e.g., the process of court reengineering, regionalization or centralization of services, structural changes, the electronic record.
• Remote Technology—e.g., innovative use of technology to improve the business operations of courts and provide enhanced services outside the courtroom.
• Human Trafficking and the State Courts—e.g., technical assistance/training, trafficking victim identification and assistance.
• Immigration Issues and the State Courts—e.g., impact of federal and state immigration law and policies, juvenile and family issues, technical assistance/training.
• Guardianship, Conservatorship, and Elder Issues—e.g., court visitor programs, electronic reporting, reports, technical assistance/training.
Project Grants are intended to support innovative education and training, research and evaluation, demonstration, and technical assistance projects that can improve the administration of justice in state courts locally or nationwide. Project Grants may ordinarily not exceed $300,000. Examples of expenses not covered by Project Grants include the salaries, benefits, or travel of full- or part-time court employees. Grant periods for Project Grants ordinarily may not exceed 36 months.
Applicants for Project Grants will be required to contribute a cash match of not less than 50 percent of the total cost of the proposed project. In other words, grant awards by SJI must be matched at least dollar for dollar by grant applicants. Applicants may contribute the required cash match directly or in cooperation with third parties. Prospective applicants should carefully review Section VI.8. (matching requirements) and Section VI.16.a. (non-supplantation) of the Guideline prior to beginning the application process. Funding from other federal departments or agencies may not be used for cash match. If questions arise, applicants are strongly encouraged to consult SJI.
A temporary reduced cash match process is available for state courts submitting Project Grant applications. The use of this cash match reduction authority is intended to help the state courts in this climate of severe budget reductions. The process requires the state court to formally request a reduced cash match, and that the request be certified by the chief justice of that state. The state court must explain in detail how it is facing budgetary cutbacks that will result in significant reductions in other services, and why it will be unable to undertake the project without a cash match reduction. This must be described in detail in the application and verified by the chief justice of that state. Only state courts may apply for a cash match reduction.
Applicants should examine their projected project costs closely, and if they are unable to cover half the costs of the project, they may apply for a reduction in cash match. Applicants are strongly encouraged to provide as much cash match as possible in their application, as some cash match contribution is still required.
Applicants are also encouraged to provide the percentage of budget reductions in their court(s), and the measures that have been taken by the jurisdiction/state to handle the budget shortfalls. This may include staff reductions, as well as reductions in services and programs. Some cash contribution is still required for Project Grants, and should be reflected in the budget proposal for the project. For example, if the total cost of the proposed project is $100,000, the normal cash match would be $50,000. However, if the applicant is unable to provide $50,000 for the activities, but is able to contribute $25,000, the budget should show the request to SJI totaling $75,000, with the cash match of $25,000.
As set forth in Section I., SJI is authorized to fund projects addressing a broad range of program areas. Funding will not be made available for the ordinary, routine operations of court systems.
TA Grants are intended to provide state or local courts, or regional court associations, with sufficient support to obtain expert assistance to diagnose a problem, develop a response to that problem, and implement any needed changes. TA Grants may not exceed $50,000. Examples of expenses not covered by TA Grants include the salaries, benefits, or travel of full- or part-time court employees. Grant periods for TA Grants ordinarily may not exceed 24 months. In calculating project duration, applicants are cautioned to fully consider the time required to issue a request for proposals, negotiate a contract with the selected provider, and execute the project.
Applicants for TA Grants will be required to contribute a
CAT Grants are intended to: (1) Enable courts and regional or national court associations to modify and adapt model curricula, course modules, or conference programs to meet states' or local jurisdictions' educational needs; train instructors to present portions or all of the curricula; and pilot-test them to determine their appropriateness, quality, and effectiveness, or (2) conduct judicial branch education and training programs, led by either expert or in-house personnel, designed to prepare judges and court personnel for innovations, reforms, and/or new technologies recently adopted by grantee courts. CAT Grants may not exceed $30,000. Examples of expenses not covered by CAT Grants include the salaries, benefits, or travel of full- or part-time court employees. Grant periods for CAT Grants ordinarily may not exceed 12 months.
Applicants for CAT Grants will be required to contribute a match of not less than 50 percent of the grant amount requested, of which 20 percent must be cash. In other words, an applicant seeking a $30,000 CAT grant must provide a $15,000 match, of which up to $12,000 can be in-kind and not less than $3,000 must be cash. Funding from other federal departments and agencies may not be used for cash match. CAT Grant application procedures can be found in section IV.C.
Partner Grants are intended to allow SJI and federal, state, or local agencies or foundations, trusts, or other private entities to combine financial resources in pursuit of common interests. SJI and its financial partners may set any level for Partner Grants, subject to the entire amount of the grant being available at the time of the award. Grant periods for Partner Grants ordinarily may not exceed 36 months.
Partner Grants are subject to the same cash match requirement as Project Grants. In other words, grant awards by SJI must be matched at least dollar-for-dollar. Partner Grants are initiated and coordinated by the funding organizations. More information on Partner Grants can be found in section IV.D.
The Strategic Initiatives Grants (SIG) program provides SJI with the flexibility to address national court issues as they occur, and develop solutions to those problems. This is an innovative approach where SJI uses its expertise and the expertise and knowledge of its grantees to address key issues facing state courts across the United States.
The funding is used for grants or contractual services, and any remaining balance not used for the SIG program will become available for SJI's other grant programs. The program is handled at the discretion of the SJI Board of Directors and staff outside the normal grant application process (i.e., SJI will initiate the project).
The Education Support Program (ESP) is intended to enhance the skills, knowledge, and abilities of state court judges and court managers by enabling them to attend out-of-state, or to enroll in online, educational and training programs sponsored by national and state providers that they could not otherwise attend or take online because of limited state, local, and personal budgets. An ESP award only covers the cost of tuition up to a maximum of $1,000 per award. ESP application procedures can be found in section IV.E.
An application for a Project Grant must include an application form; budget forms (with appropriate documentation); a project abstract and program narrative; a disclosure of lobbying form, when applicable; and certain certifications and assurances (see below). See
The application form requests basic information regarding the proposed project, the applicant, and the total amount of funding requested from SJI. It also requires the signature of an individual authorized to certify on behalf of the applicant that the information contained in the application is true and complete; that submission of the application has been authorized by the applicant; and that if funding for the proposed project is approved, the applicant will comply with the requirements and conditions of the award, including the assurances set forth in Form D.
An application from a state or local court must include a copy of Form B signed by the state's chief justice or state court administrator. The signature denotes that the proposed project has been approved by the state's highest court or the agency or council it has designated. It denotes further that, if applicable, a cash match reduction has been requested, and that if SJI approves funding for the project, the court or the specified designee will receive, administer, and be accountable for the awarded funds.
Applicants must submit a Form C. In addition, applicants must provide a detailed budget narrative providing an explanation of the basis for the estimates in each budget category (see subsection A.4. below).
If funds from other sources are required to conduct the project, either as match or to support other aspects of the project, the source, current status of the request, and anticipated decision date must be provided.
This form lists the statutory, regulatory, and policy requirements with which recipients of Institute funds must comply.
Applicants other than units of state or local government are required to disclose whether they, or another entity that is part of the same organization as the applicant, have advocated a position before Congress on any issue, and to identify the specific subjects of their lobbying efforts (see section VI.A.7.).
The abstract should highlight the purposes, goals, methods, and anticipated benefits of the proposed project. It should not exceed 1 single-spaced page.
The program narrative for an application may not exceed 25 double-spaced pages. The pages should be numbered. This page limit does not include the forms, the abstract, the budget narrative, and any appendices containing resumes and letters of cooperation or endorsement. Additional background material should be attached only if it is essential to impart a clear understanding of the proposed project. Numerous and lengthy appendices are strongly discouraged.
The program narrative should address the following topics:
The applicant should include a clear, concise statement of what the proposed project is intended to accomplish. In stating the objectives of the project, applicants should focus on the overall programmatic objective (e.g., to enhance understanding and skills regarding a specific subject, or to determine how a certain procedure affects the court and litigants) rather than on operational objectives.
The applicant must describe how the proposed project addresses one or more Priority Investment Areas. If the project does not address one or more Priority Investment Areas, the applicant must provide an explanation why not.
If the project is to be conducted in any specific location(s), the applicant should discuss the particular needs of the project site(s) to be addressed by the project and why those needs are not being met through the use of existing programs, procedures, services, or other resources.
If the project is not site-specific, the applicant should discuss the problems that the proposed project would address, and why existing programs, procedures, services, or other resources cannot adequately resolve those problems. In addition, the applicant should describe how, if applicable, the project will be sustained in the future through existing resources.
The discussion should include specific references to the relevant literature and to the experience in the field. SJI continues to make all grant reports and most grant products available online through the National Center for State Courts (NCSC) Library and Digital Archive. Applicants are required to conduct a search of the NCSC Library and Digital Archive on the topic areas they are addressing. This search should include SJI-funded grants, and previous projects not supported by SJI. Searches for SJI grant reports and other state court resources begin with the NCSC Library section. Applicants must discuss the results of their research; how they plan to incorporate the previous work into their proposed project; and if the project will differentiate from prior work.
(1) Tasks and Methods. The applicant should delineate the tasks to be performed in achieving the project objectives and the methods to be used for accomplishing each task. For example:
(a)
(b)
(c)
(d)
(2) Evaluation. Projects should include an evaluation plan to determine whether the project met its objectives. The evaluation should be designed to provide an objective and independent assessment of the effectiveness or usefulness of the training or services provided; the impact of the procedures, technology, or services tested; or the validity and applicability of the research conducted. The evaluation plan should be appropriate to the type of project proposed.
The applicant should present a detailed management plan, including the starting and completion date for each task; the time commitments to the project of key staff and their responsibilities regarding each project task; and the procedures that would ensure that all tasks are performed on time, within budget, and at the highest level of quality. In preparing the project time line, Gantt Chart, or schedule, applicants should make certain that all project activities, including publication or reproduction of project products and their initial dissemination, would occur within the proposed project period. The management plan must also provide for the submission of Quarterly Progress and Financial Reports within 30 days after the close of each calendar quarter (i.e., no later than January 30, April 30, July 30, and October 30), per section VI.A.13.
Applicants should be aware that SJI is unlikely to approve a limited extension of the grant period without strong justification. Therefore, the management plan should be as realistic as possible and fully reflect the time commitments of the proposed project staff and consultants.
The program narrative in the application should contain a description of the product(s) to be developed (e.g., training curricula and materials, Web sites or other electronic multimedia, articles, guidelines, manuals, reports, handbooks, benchbooks, or books), including when they would be submitted to SJI. The budget should include the cost of producing and disseminating the product to the state chief justice, state court administrator, and other appropriate judges or court personnel. If final products involve electronic formats, the applicant should indicate how the product would be made available to other courts. Discussion of this dissemination process should occur between the grantee and SJI prior to the final selection of the dissemination process to be used.
(1) Dissemination Plan. The application must explain how and to whom the products would be disseminated; describe how they would benefit the state courts, including how they could be used by judges and court personnel; identify development, production, and dissemination costs covered by the project budget; and present the basis on which products and services developed or provided under the grant would be offered to the court community and the public at large (i.e., whether products would be distributed at no cost to recipients, or if costs are involved, the reason for charging recipients and the estimated price of the product) (see section VI.A.11.b.). Ordinarily, applicants should schedule all product preparation and distribution activities within the project period.
Applicants proposing to develop web-based products should provide for sending a notice and description of the document to the appropriate audiences to alert them to the availability of the Web site or electronic product (i.e., a written report with a reference to the Web site).
Three (3) copies of all project products should be submitted to SJI, along with an electronic version in HTML or PDF format. Discussions of final product dissemination should be conducted with SJI prior to the end of the grant period.
(2) Types of Products. The type of product to be prepared depends on the nature of the project. For example, in most instances, the products of a research, evaluation, or demonstration project should include an article summarizing the project findings that is publishable in a journal serving the courts community nationally, an executive summary that would be disseminated to the project's primary audience, or both. Applicants proposing to conduct empirical research or evaluation projects with national import should describe how they would make their data available for secondary analysis after the grant period (see section VI.A.14.a.).
The curricula and other products developed through education and training projects should be designed for use by others and again by the original participants in the course of their duties.
(3) SJI Review. Applicants must submit a final draft of all written grant products to SJI for review and approval at least 30 days before the products are submitted for publication or reproduction. For products in Web site or multimedia format, applicants must provide for SJI review of the product at the treatment, script, rough-cut, and final stages of development, or their equivalents. No grant funds may be obligated for publication or reproduction of a final grant product without the written approval of SJI (see section VI.A.11.f.).
(4) Acknowledgment, Disclaimer, and Logo. Applicants must also include in all project products a prominent acknowledgment that support was received from SJI and a disclaimer paragraph based on the example provided in section VI.A.11.a.2. in the Grant Guideline. The “SJI” logo must appear on the front cover of a written product, or in the opening frames of a Web site or other multimedia product, unless SJI approves another placement. The SJI logo can be downloaded from SJI's Web site:
An applicant that is not a state or local court and has not received a grant from SJI within the past three years should indicate whether it is either a national non-profit organization controlled by, operating in conjunction with, and serving the judicial branches of state governments, or a national non-profit organization for the education and training of state court judges and support personnel (see section II). If the applicant is a non-judicial unit of federal, state, or local government, it must explain whether the proposed services could be adequately provided by non-governmental entities.
The applicant should include a summary of the training and experience of the key staff members and consultants that qualify them for conducting and managing the proposed project. Resumes of identified staff
Applicants that have not received a grant from SJI within the past three years should include a statement describing their capacity to administer grant funds, including the financial systems used to monitor project expenditures (and income, if any), and a summary of their past experience in administering grants, as well as any resources or capabilities that they have that would particularly assist in the successful completion of the project.
Unless requested otherwise, an applicant that has received a grant from SJI within the past three years should describe only the changes in its organizational capacity, tax status, or financial capability that may affect its capacity to administer a grant.
If the applicant is a non-profit organization (other than a university), it must also provide documentation of its 501(c) tax-exempt status as determined by the Internal Revenue Service and a copy of a current certified audit report. For purposes of this requirement, “current” means no earlier than two years prior to the present calendar year.
If a current audit report is not available, SJI will require the organization to complete a financial capability questionnaire, which must be signed by a certified public accountant. Other applicants may be required to provide a current audit report, a financial capability questionnaire, or both, if specifically requested to do so by the Institute.
Non-governmental applicants must submit SJI's Disclosure of Lobbying Activities Form E, which documents whether they, or another entity that is a part of the same organization as the applicant, have advocated a position before Congress on any issue, and identifies the specific subjects of their lobbying efforts.
If the cooperation of courts, organizations, agencies, or individuals other than the applicant is required to conduct the project, the applicant should attach written assurances of cooperation and availability to the application, or send them under separate cover. Letters of general support for a project are also encouraged.
In addition to Project Grant applications, the following section also applies to Technical Assistance and Curriculum Adaptation and Training grant applications.
The budget narrative should provide the basis for the computation of all project-related costs. When the proposed project would be partially supported by grants from other funding sources, applicants should make clear what costs would be covered by those other grants. Additional background information or schedules may be attached if they are essential to obtaining a clear understanding of the proposed budget. Numerous and lengthy appendices are strongly discouraged.
The budget narrative should cover the costs of all components of the project and clearly identify costs attributable to the project evaluation.
The applicant should set forth the percentages of time to be devoted by the individuals who would staff the proposed project, the annual salary of each of those persons, and the number of work days per year used for calculating the percentages of time or daily rates of those individuals. The applicant should explain any deviations from current rates or established written organizational policies. No grant funds or cash match may be used to pay the salary and related costs for a current or new employee of a court or other unit of government because such funds would constitute a supplantation of state or local funds in violation of 42 U.S.C. 10706(d)(1); this includes new employees hired specifically for the project. The salary and any related costs for a current or new employee of a court or other unit of government may only be accepted as in-kind match.
For non-governmental entities, the applicant should provide a description of the fringe benefits provided to employees. If percentages are used, the authority for such use should be presented, as well as a description of the elements included in the determination of the percentage rate.
The applicant should describe the tasks each consultant would perform, the estimated total amount to be paid to each consultant, the basis for compensation rates (e.g., the number of days multiplied by the daily consultant rates), and the method for selection. Rates for consultant services must be set in accordance with section VII.I.2.c. Prior written SJI approval is required for any consultant rate in excess of $800 per day; SJI funds may not be used to pay a consultant more than $1,100 per day. Honorarium payments must be justified in the same manner as consultant payments.
Transportation costs and per diem rates must comply with the policies of the applicant organization. If the applicant does not have an established travel policy, then travel rates must be consistent with those established by the federal government. The budget narrative should include an explanation of the rate used, including the components of the per diem rate and the basis for the estimated transportation expenses. The purpose of the travel should also be included in the narrative.
Grant funds may be used to purchase only the equipment necessary to demonstrate a new technological application in a court or that is otherwise essential to accomplishing the objectives of the project. In other words, grant funds cannot be used strictly for the purpose of purchasing equipment. Equipment purchases to support basic court operations ordinarily will not be approved. The applicant should describe the equipment to be purchased or leased and explain why the acquisition of that equipment is essential to accomplish the project's goals and objectives. The narrative should clearly identify which equipment is to be leased and which is to be purchased. The method of procurement should also be described. Purchases of automated data processing equipment must comply with section VII.I.2.b.
The applicant should provide a general description of the supplies necessary to accomplish the goals and objectives of the grant. In addition, the applicant should provide the basis for the amount requested for this expenditure category.
Construction expenses are prohibited except for the limited purposes set forth in section VI.A.16.b. Any allowable construction or renovation expense should be described in detail in the budget narrative.
Anticipated postage costs for project-related mailings, including distribution of the final product(s), should be described in the budget narrative. The cost of special mailings, such as for a survey or for announcing a workshop, should be distinguished from routine operational mailing costs. The bases for all postage estimates should be included in the budget narrative.
Anticipated costs for printing or photocopying project documents, reports, and publications should be included in the budget narrative, along with the bases used to calculate these estimates.
Indirect costs are only applicable to organizations that are not state courts or government agencies. Recoverable indirect costs are limited to no more than 75 percent of a grantee's direct personnel costs, i.e. salaries plus fringe benefits (see section VII.I.4.).
Applicants should describe the indirect cost rates applicable to the grant in detail. If costs often included within an indirect cost rate are charged directly (e.g., a percentage of the time of senior managers to supervise project activities), the applicant should specify that these costs are not included within its approved indirect cost rate. These rates must be established in accordance with section VII.I.4. If the applicant has an indirect cost rate or allocation plan approved by any federal granting agency, a copy of the approved rate agreement must be attached to the application.
a. Every applicant must submit an original and three copies of the application package consisting of Form A; Form B, if the application is from a state or local court, or a Disclosure of Lobbying Form (Form E), if the applicant is not a unit of state or local government; Form C; the Application Abstract; the Program Narrative; the Budget Narrative; and any necessary appendices.
Letters of application may be submitted at any time. However, applicants are encouraged to review the grant deadlines available on the SJI Web site. Receipt of each application will be acknowledged by letter or email.
b. Applicants submitting more than one application may include material that would be identical in each application in a cover letter. This material will be incorporated by reference into each application and counted against the 25-page limit for the program narrative. A copy of the cover letter should be attached to each copy of the application.
Applicants for TA Grants may submit an original and three copies of a detailed letter describing the proposed project, as well as a Form A—State Justice Institute Application; Form B—Certificate of State Approval from the State Supreme Court, or its designated agency; and Form C—Project Budget in Tabular Format (see
Although there is no prescribed form for the letter, or a minimum or maximum page limit, letters of application should include the following information:
a. Need for Funding. The applicant must explain the critical need facing the applicant, and the proposed technical assistance that will enable the applicant meet this critical need. The applicant must also explain why state or local resources are not sufficient to fully support the costs of the project. In addition, the applicant should describe how, if applicable, the project will be sustained in the future through existing resources.
The discussion should include specific references to the relevant literature and to the experience in the field. SJI continues to make all grant reports and most grant products available online through the National Center for State Courts (NCSC) Library and Digital Archive. Applicants are required to conduct a search of the NCSC Library and Digital Archive on the topic areas they are addressing. This search should include SJI-funded grants, and previous projects not supported by SJI. Searches for SJI grant reports and other state court resources begin with the NCSC Library section. Applicants must discuss the results of their research; how they plan to incorporate the previous work into their proposed project; and if the project will differentiate from prior work.
b. Project Description. The applicant must describe how the proposed project addressed one or more Priority Investment Areas. If the project does not address one or more Priority Investment Areas, the applicant must provide an explanation why not.
The applicant must describe the tasks the consultant will perform, and how would they be accomplished. In addition, the applicant must identify which organization or individual will be hired to provide the assistance, and how the consultant was selected. If a consultant has not yet been identified, what procedures and criteria would be used to select the consultant (applicants are expected to follow their jurisdictions' normal procedures for procuring consultant services)? What specific tasks would the consultant(s) and court staff undertake? What is the schedule for completion of each required task and the entire project? How would the applicant oversee the project and provide guidance to the consultant, and who at the court or regional court association would be responsible for coordinating all project tasks and submitting quarterly progress and financial status reports?
If the consultant has been identified, the applicant should provide a letter from that individual or organization documenting interest in and availability for the project, as well as the consultant's ability to complete the assignment within the proposed time frame and for the proposed cost. The consultant must agree to submit a detailed written report to the court and SJI upon completion of the technical assistance.
c. Likelihood of Implementation. What steps have been or would be taken to facilitate implementation of the consultant's recommendations upon completion of the technical assistance? For example, if the support or cooperation of specific court officials or committees, other agencies, funding bodies, organizations, or a court other than the applicant would be needed to adopt the changes recommended by the consultant and approved by the court, how would they be involved in the review of the recommendations and development of the implementation plan?
Applicants must follow the same guidelines provided under Section IV.A.4. A completed Form C—Project Budget, Tabular Format and budget narrative must be included with the letter requesting technical assistance.
The budget narrative should provide the basis for all project-related costs, including the basis for determining the estimated consultant costs, if compensation of the consultant is
Recipients of TA Grants do not have to submit an audit report but must maintain appropriate documentation to support expenditures (see section VI.A.3.).
Letters of application should be submitted according to the grant deadlines provided on the SJI Web site.
If the support or cooperation of agencies, funding bodies, organizations, or courts other than the applicant would be needed in order for the consultant to perform the required tasks, written assurances of such support or cooperation should accompany the application letter. Letters of general support for the project are also encouraged. Support letters may be submitted under separate cover; however, they should be received by the same date as the application.
In lieu of formal applications, applicants should submit an original and three photocopies of a detailed letter as well as a Form A—State Justice Institute Application; Form B—Certificate of State Approval; and Form C—Project Budget, Tabular Format (see
Although there is no prescribed format for the letter, or a minimum or maximum page limit, letters of application should include the following information.
a. For adaptation of a curriculum:
(1) Project Description. The applicant must describe how the proposed project addresses one or more Priority Investment Areas. If the project does not address one or more Priority Investment Areas, the applicant must provide an explanation why not. Due to the high costs of travel to attend training events, the innovative use of distance learning is highly encouraged.
The applicant must provide the title of the curriculum that will be adapted, and identify the entity that originally developed the curriculum. The applicant must also address the following questions: Why is this education program needed at the present time? What are the project's goals? What are the learning objectives of the adapted curriculum? What program components would be implemented, and what types of modifications, if any, are anticipated in length, format, learning objectives, teaching methods, or content? Who would be responsible for adapting the model curriculum? Who would the participants be, how many would there be, how would they be recruited, and from where would they come (e.g., from a single local jurisdiction, from across the state, from a multi-state region, from across the nation)?
(2) Need for Funding. The discussion should include specific references to the relevant literature and to the experience in the field. SJI continues to make all grant reports and most grant products available online through the National Center for State Courts (NCSC) Library and Digital Archive. Applicants are required to conduct a search of the NCSC Library and Digital Archive on the topic areas they are addressing. This search should include SJI-funded grants, and previous projects not supported by SJI. Searches for SJI grant reports and other state court resources begin with the NCSC Library section. Applicants must discuss the results of their research; how they plan to incorporate the previous work into their proposed project; and if the project will differentiate from prior work.
The applicant should explain why state or local resources are unable to fully support the modification and presentation of the model curriculum. The applicant should also describe the potential for replicating or integrating the adapted curriculum in the future using state or local funds, once it has been successfully adapted and tested. In addition, the applicant should describe how, if applicable, the project will be sustained in the future through existing resources.
(3) Likelihood of Implementation. The applicant should provide the proposed timeline, including the project start and end dates, the date(s) the judicial branch education program will be presented, and the process that will be used to modify and present the program. The applicant should also identify who will serve as faculty, and how they were selected, in addition to the measures taken to facilitate subsequent presentations of the program. Ordinarily, an independent evaluation of a curriculum adaptation project is not required; however, the results of any evaluation should be included in the final report.
(4) Expressions of Interest by Judges and/or Court Personnel. Does the proposed program have the support of the court system or association leadership, and of judges, court managers, and judicial branch education personnel who are expected to attend? Applicants may demonstrate this by attaching letters of support.
b. For training assistance:
(1) Need for Funding. The applicant must describe how the proposed project addresses one or more Priority Investment Areas. If the project does not address one or more Priority Investment Areas, the applicant must provide an explanation why not.
The discussion should include specific references to the relevant literature and to the experience in the field. SJI continues to make all grant reports and most grant products available online through the National Center for State Courts (NCSC) Library and Digital Archive. Applicants are required to conduct a search of the NCSC Library and Digital Archive on the topic areas they are addressing. This search should include SJI-funded grants, and previous projects not supported by SJI. Searches for SJI grant reports and other state court resources begin with the NCSC Library section. Applicants must discuss the results of their research; how they plan to incorporate the previous work into their proposed project; and if the project will differentiate from prior work.
The applicant should describe the court reform or initiative prompting the need for training. The applicant should also discuss how the proposed training will help the applicant implement planned changes at the court, and why state or local resources are not sufficient to fully support the costs of the required training. In addition, the applicant should describe how, if applicable, the project will be sustained in the future through existing resources.
(2) Project Description. The applicant must identify the tasks the trainer(s) will be expected to perform, which organization or individual will be hired, and, if in-house personnel are not the trainers, how the trainer will be selected. If a trainer has not yet been identified, the applicant must describe the procedures and criteria that will be used to select the trainer. In addition, the applicant should address the following questions: What specific tasks would the trainer and court staff or regional court association members undertake? What presentation methods will be used? What is the schedule for completion of each required task and the entire project? How will the applicant oversee the project and
If the trainer has been identified, the applicant should provide a letter from that individual or organization documenting interest in and availability for the project, as well as the trainer's ability to complete the assignment within the proposed time frame and for the proposed cost.
(3) Likelihood of Implementation. The applicant should explain what steps have been or will be taken to coordinate the implementation of the training. For example, if the support or cooperation of specific court or regional court association officials or committees, other agencies, funding bodies, organizations, or a court other than the applicant will be needed to adopt the reform and initiate the training proposed, how will the applicant secure their involvement in the development and implementation of the training?
Applicants must also follow the same guidelines provided under Section IV.A.4. Applicants should attach a copy of budget Form C and a budget narrative (see subsection A.4. above) that describes the basis for the computation of all project-related costs and the source of the match offered.
For curriculum adaptation requests, applicants should allow at least 90 days between the Board meeting and the date of the proposed program to allow sufficient time for needed planning. Letters of support for the project are also encouraged. Applicants are encouraged to call SJI to discuss concerns about timing of submissions.
SJI and its funding partners may meld, pick and choose, or waive their application procedures, grant cycles, or grant requirements to expedite the award of jointly-funded grants targeted at emerging or high priority problems confronting state and local courts. SJI may solicit brief proposals from potential grantees to fellow financial partners as a first step. Should SJI be chosen as the lead grant manager, Project Grant application procedures will apply to the proposed Partner Grant.
Applicants may not receive more than one ESP award in a two-year fiscal year period unless the course specifically assumes multi-year participation, such as a certification program or a graduate degree program in judicial studies in which the applicant is currently enrolled (neither exception should be taken as a commitment on the part of the SJI Board of Directors to approve serial ESP awards). If the course assumes multi-year participation, awards will be limited to one per fiscal year. Attendance at annual or mid-year meetings or conferences of a state or national organization does not qualify as an out-of-state educational program for the ESP, even though it may include workshops or other training sessions.
The ESP only covers the cost of tuition up to a maximum of $1,000 per award, per course. Awards will be made for the exact amount requested for tuition. Funds to pay tuition in excess of $1,000, and other cost of attending the program such as travel, lodging, meals, materials, transportation to and from airports (including rental cars) must be obtained from other sources or borne by the ESP award recipient. Applicants are encouraged to check other sources of financial assistance and to combine aid from various sources whenever possible. An ESP award is not transferable to another individual. It may be used only for the course specified in the application unless the applicant's request to attend a different course that meets the eligibility requirements is approved in writing by SJI.
a. Recipients. Because of the limited amount of funding available, only full-time judges of state or local trial and appellate courts; full-time professional, state, or local court personnel with management and supervisory responsibilities; and supervisory and management probation personnel in judicial branch probation offices are eligible for the program. Senior judges, part-time judges, quasi-judicial hearing officers including referees and commissioners, administrative law judges, staff attorneys, law clerks, line staff, law enforcement officers, and other executive branch personnel are not eligible.
b. Courses. An ESP award is only for: (1) A course presented in a state other than the one in which the applicant resides or works, or (2) an online course. The course must be designed to enhance the skills of new or experienced judges and court managers; or be offered by a recognized graduate program for judges or court managers.
Applicants are encouraged not to wait for the decision on an ESP application to register for an educational program they wish to attend. SJI does not submit the names of ESP award recipients to educational organizations, nor provide the funds to the educational organization. ESP funds are provided as reimbursements directly to the recipient.
a. Education Support Program Application—Form ESP–1 (see
b. Education Support Program Concurrence—Form ESP–2 Judges and court managers applying for the program must submit the original written concurrence of the chief justice of the state's supreme court (or the chief justice's designee) on Form ESP–2. The signature of the presiding judge of the applicant's court may not be substituted for that of the state's chief justice or the chief justice's designee. The chief justice or state court administrator must notify SJI of the designees within the state for ESP purposes.
Applications may be submitted at any time but will be reviewed on a quarterly basis. This means ESP awards will be on a “first-come, first-considered” basis. The dates for applications to be received by SJI for consideration in FY 2014 are November 1, February 1, May 1, and August 1. These are
SJI staff will answer inquiries concerning application procedures.
a. Project Grant applications will be rated on the basis of the criteria set forth below. SJI will accord the greatest weight to the following criteria:
(1) The soundness of the methodology;
(2) The demonstration of need for the project;
(3) The appropriateness of the proposed evaluation design;
(4) If applicable, the key findings and recommendations of the most recent evaluation and the proposed responses to those findings and recommendations;
(5) The applicant's management plan and organizational capabilities;
(6) The qualifications of the project's staff;
(7) The products and benefits resulting from the project, including the extent to which the project will have long-term benefits for state courts across the nation;
(8) The degree to which the findings, procedures, training, technology, or other results of the project can be transferred to other jurisdictions;
(9) The reasonableness of the proposed budget; and,
(10) The demonstration of cooperation and support of other agencies that may be affected by the project.
b. In determining which projects to support, SJI will also consider whether the applicant is a state court, a national court support or education organization, a non-court unit of government, or other type of entity eligible to receive grants under SJI's enabling legislation (see section II.); the availability of financial assistance from other sources for the project; the amount of the applicant's match; the extent to which the proposed project would also benefit the federal courts or help state courts enforce federal constitutional and legislative requirements; and the level of appropriations available to SJI in the current year and the amount expected to be available in succeeding fiscal years.
TA Grant applications will be rated on the basis of the following criteria:
a. Whether the assistance would address a critical need of the applicant;
b. The soundness of the technical assistance approach to the problem;
c. The qualifications of the consultant(s) to be hired or the specific criteria that will be used to select the consultant(s);
d. The commitment of the court or association to act on the consultant's recommendations; and,
e. The reasonableness of the proposed budget.
SJI also will consider factors such as the level and nature of the match that would be provided, diversity of subject matter, geographic diversity, the level of appropriations available to SJI in the current year, and the amount expected to be available in succeeding fiscal years.
CAT Grant applications will be rated on the basis of the following criteria:
a. For curriculum adaptation projects:
(1) The goals and objectives of the proposed project;
(2) The need for outside funding to support the program;
(3) The appropriateness of the approach in achieving the project's educational objectives;
(4) The likelihood of effective implementation and integration of the modified curriculum into ongoing educational programming; and,
(5) Expressions of interest by the judges and/or court personnel who would be directly involved in or affected by the project.
b. For training assistance:
(1) Whether the training would address a critical need of the court or association;
(2) The soundness of the training approach to the problem;
(3) The qualifications of the trainer(s) to be hired or the specific criteria that will be used to select the trainer(s);
(4) The commitment of the court or association to the training program; and
(5) The reasonableness of the proposed budget. SJI will also consider factors such as the reasonableness of the amount requested; compliance with match requirements; diversity of subject matter, geographic diversity; the level of appropriations available to SJI in the current year; and the amount expected to be available in succeeding fiscal years.
The selection criteria for Partner Grants will be driven by the collective priorities of SJI and other organizations and their collective assessments regarding the needs and capabilities of court and court-related organizations. Having settled on priorities, SJI and its financial partners will likely contact the courts or court-related organizations most acceptable as pilots, laboratories, consultants, or the like.
ESP awards are only for programs that either: (1) Enhance the skills of judges and court managers; or (2) are part of a graduate degree program for judges or court personnel. Awards are provided on the basis of:
a. The date on which the application and concurrence (and support letter, if required) were sent (“first-come, first-considered”);
b. The unavailability of state or local funds, or funding from another source to cover the costs of attending the program, or participating online;
c. The absence of educational programs in the applicant's state addressing the topic(s) covered by the educational program for which the award is being sought;
d. Geographic balance among the recipients;
e. The balance of ESP awards among educational providers and programs;
f. The balance of ESP awards among the types of courts and court personnel (trial judge, appellate judge, trial court administrator) represented; and
g. The level of appropriations available to SJI in the current year and the amount expected to be available in succeeding fiscal years.
The postmark or courier receipt will be used to determine the date on which the application form and other required items were sent.
SJI's Board of Directors will review the applications competitively. The Board will review all applications and decide which projects to fund. The decision to fund a project is solely that of the Board of Directors. The Chairman of the Board will sign approved awards on behalf of SJI.
The Board will review the applications competitively. The Board will review all applications and decide which projects to fund. The decision to fund a project is solely that of the Board of Directors. The Chairman of the Board will sign approved awards on behalf of SJI.
A committee of the Board of Directors will review ESP applications quarterly. The committee will review the applications competitively. The Chairman of the Board will sign approved awards on behalf of SJI.
SJI's internal process for the review and approval of Partner Grants will depend on negotiations with fellow financiers. SJI may use its procedures, a partner's procedures, a mix of both, or entirely unique procedures. All Partner Grants will be approved by the Board of Directors.
Unless a specific request is made, unsuccessful applications will not be returned. Applicants are advised that SJI records are subject to the provisions of the Federal Freedom of Information Act, 5 U.S.C. 552.
SJI will send written notice to applicants concerning all Board decisions to approve, defer, or deny their respective applications. For all applications (except ESP applications), if requested, SJI will convey the key issues and questions that arose during the review process. A decision by the Board to deny an application may not be appealed, but it does not prohibit resubmission of a proposal based on that application in a subsequent funding cycle.
With the exception of those approved for ESP awards, applicants have 30 days from the date of the letter notifying them that the Board has approved their application to respond to any revisions requested by the Board. If the requested revisions (or a reasonable schedule for submitting such revisions) have not been submitted to SJI within 30 days after notification, the approval may be rescinded and the application presented to the Board for reconsideration. In the event an issue will only be resolved after award, such as the selection of a consultant, the final award document will include a Special Condition that will require additional grantee reporting and SJI review and approval. Special Conditions, in the form of incentives or sanctions, may also be used in other situations.
The State Justice Institute Act contains limitations and conditions on grants, contracts, and cooperative agreements awarded by SJI. The Board of Directors has approved additional policies governing the use of SJI grant funds. These statutory and policy requirements are set forth below.
No funds made available by SJI may be used to support or conduct training programs for the purpose of advocating particular non-judicial public policies or encouraging non-judicial political activities (42 U.S.C. 10706(b)).
If the qualifications of an employee or consultant assigned to a key project staff position are not described in the application or if there is a change of a person assigned to such a position, the recipient must submit a description of the qualifications of the newly assigned person to SJI. Prior written approval of the qualifications of the new person assigned to a key staff position must be received from the Institute before the salary or consulting fee of that person and associated costs may be paid or reimbursed from grant funds (see section VIII.A.7.).
Recipients of project grants must provide for an annual fiscal audit which includes an opinion on whether the financial statements of the grantee present fairly its financial position and its financial operations are in accordance with generally accepted accounting principles (see section VII.K. for the requirements of such audits). ESP award recipients, Curriculum Adaptation and Training Grants, and Technical Assistance Grants are not required to submit an audit, but they must maintain appropriate documentation to support all expenditures (see section VIII.K.).
Budget revisions among direct cost categories that: (a) Transfer grant funds to an unbudgeted cost category, or (b) individually or cumulatively exceed five percent of the approved original budget or the most recently approved revised budget require prior SJI approval (see section VIII.A.1.).
Personnel and other officials connected with SJI-funded programs must adhere to the following requirements:
a. No official or employee of a recipient court or organization shall participate personally through decision, approval, disapproval, recommendation, the rendering of advice, investigation, or otherwise in any proceeding, application, request for a ruling or other determination, contract, grant, cooperative agreement, claim, controversy, or other particular matter in which SJI funds are used, where, to his or her knowledge, he or she or his or her immediate family, partners, organization other than a public agency in which he or she is serving as officer, director, trustee, partner, or employee or any person or organization with whom he or she is negotiating or has any arrangement concerning prospective employment, has a financial interest.
b. In the use of SJI project funds, an official or employee of a recipient court or organization shall avoid any action which might result in or create the appearance of:
(1) Using an official position for private gain; or
(2) Affecting adversely the confidence of the public in the integrity of the Institute program.
c. Requests for proposals or invitations for bids issued by a recipient of Institute funds or a subgrantee or subcontractor will provide notice to prospective bidders that the contractors who develop or draft specifications, requirements, statements of work, and/or requests for proposals for a proposed procurement will be excluded from bidding on or submitting a proposal to compete for the award of such procurement.
If any patentable items, patent rights, processes, or inventions are produced in the course of SJI-sponsored work, such fact shall be promptly and fully reported to the Institute. Unless there is a prior agreement between the grantee and SJI on disposition of such items, SJI shall determine whether protection of the invention or discovery shall be sought. SJI will also determine how the rights in the invention or discovery, including rights under any patent issued thereon, shall be allocated and administered in order to protect the public interest consistent with “Government Patent Policy” (President's Memorandum for Heads of Executive Departments and Agencies, February 18, 1983, and statement of Government Patent Policy).
a. Funds awarded to recipients by SJI shall not be used, indirectly or directly, to influence Executive Orders or similar promulgations by federal, state or local agencies, or to influence the passage or defeat of any legislation by federal, state or local legislative bodies (42 U.S.C. 10706(a)).
b. It is the policy of the Board of Directors to award funds only to support applications submitted by organizations that would carry out the objectives of their applications in an unbiased
All grantees other than ESP award recipients are required to provide a match. A match is the portion of project costs not borne by the Institute. Match includes both cash and in-kind contributions. Cash match is the direct outlay of funds by the grantee or a third party to support the project. In-kind match consists of contributions of time and/or services of current staff members, new employees, space, supplies, etc., made to the project by the grantee or others (e.g., advisory board members) working directly on the project or that portion of the grantee's federally-approved indirect cost rate that exceeds the Guideline's limit of permitted charges (75 percent of salaries and benefits).
Under normal circumstances, allowable match may be incurred only during the project period. When appropriate, and with the prior written permission of SJI, match may be incurred from the date of the Board of Directors' approval of an award. The amount and nature of required match depends on the type of grant (see section III.).
The grantee is responsible for ensuring that the total amount of match proposed is actually contributed. If a proposed contribution is not fully met, SJI may reduce the award amount accordingly, in order to maintain the ratio originally provided for in the award agreement (see section VII.E.1.). Match should be expended at the same rate as SJI funding.
The Board of Directors looks favorably upon any unrequired match contributed by applicants when making grant decisions. The match requirement may be waived in exceptionally rare circumstances upon the request of the chief justice of the highest court in the state or the highest ranking official in the requesting organization and approval by the Board of Directors (42 U.S.C. 10705(d)). The Board of Directors encourages all applicants to provide the maximum amount of cash and in-kind match possible, even if a waiver is approved. The amount and nature of match are criteria in the grant selection process (see section V.B.1.b.).
Other federal department and agency funding may not be used for cash match.
No person may, on the basis of race, sex, national origin, disability, color, or creed be excluded from participation in, denied the benefits of, or otherwise subjected to discrimination under any program or activity supported by SJI funds. Recipients of SJI funds must immediately take any measures necessary to effectuate this provision.
No recipient may contribute or make available SJI funds, program personnel, or equipment to any political party or association, or the campaign of any candidate for public or party office. Recipients are also prohibited from using funds in advocating or opposing any ballot measure, initiative, or referendum. Officers and employees of recipients shall not intentionally identify SJI or recipients with any partisan or nonpartisan political activity associated with a political party or association, or the campaign of any candidate for public or party office (42 U.S.C. 10706(a)).
(1) Recipients of SJI funds must acknowledge prominently on all products developed with grant funds that support was received from the SJI. The “SJI” logo must appear on the front cover of a written product, or in the opening frames of a multimedia product, unless another placement is approved in writing by SJI. This includes final products printed or otherwise reproduced during the grant period, as well as re-printings or reproductions of those materials following the end of the grant period. A camera-ready logo sheet is available on SJI's Web site:
(2) Recipients also must display the following disclaimer on all grant products: “This [document, film, videotape, etc.] was developed under [grant/cooperative agreement] number SJI-[insert number] from the State Justice Institute. The points of view expressed are those of the [author(s), filmmaker(s), etc.] and do not necessarily represent the official position or policies of the State Justice Institute.”
(3) In addition to other required grant products and reports, recipients must provide a one page executive summary of the project. The summary should include a background on the project, the tasks undertaken, and the outcome. In addition, the summary should provide the performance metrics that were used during the project, and how performance will be measured in the future.
(1) SJI's mission is to support improvements in the quality of justice and foster innovative, efficient solutions to common issues faced by all courts. SJI has recognized and established procedures for supporting research and development of grant products (e.g. a report, curriculum, video, software, database, or Web site) through competitive grant awards based on merit review of proposed projects. To ensure that all grants benefit the entire court community, projects SJI considers worthy of support (in whole or in part), are required to be disseminated widely and available for public consumption. This includes open-source software and interfaces. Costs for development, production, and dissemination are allowable as direct costs to SJI.
(2) Applicants should disclose their intent to sell grant-related products in the application. Grantees must obtain SJI's prior written approval of their plans to recover project costs through the sale of grant products. Written requests to recover costs ordinarily should be received during the grant period and should specify the nature and extent of the costs to be recouped, the reason that such costs were not budgeted (if the rationale was not disclosed in the approved application), the number of copies to be sold, the intended audience for the products to be sold, and the proposed sale price. If the product is to be sold for more than $25, the written request also should include a detailed itemization of costs that will be recovered and a certification that the costs were not supported by either SJI grant funds or grantee matching contributions.
(3) In the event that the sale of grant products results in revenues that exceed the costs to develop, produce, and disseminate the product, the revenue must continue to be used for the authorized purposes of SJI-funded project or other purposes consistent with the State Justice Institute Act that have been approved by SJI (see section VII.G.).
Except as otherwise provided in the terms and conditions of a SJI award, a recipient is free to copyright any books, publications, or other copyrightable materials developed in the course of a SJI-supported project, but SJI shall reserve a royalty-free, nonexclusive and irrevocable right to reproduce, publish,
All products and, for TA and CAT grants, consultant and/or trainer reports (see section VI.B.1 & 2) are to be completed and distributed (see below) not later than the end of the award period, not the 90-day close out period. The latter is only intended for grantee final reporting and to liquidate obligations (see section VII.L.).
In addition to the distribution specified in the grant application, grantees shall send:
(1) Three (3) copies of each final product developed with grant funds to SJI, unless the product was developed under either a Technical Assistance or a Curriculum Adaptation and Training Grant, in which case submission of 2 copies is required; and
(2) An electronic version of the product in HTML or PDF format to SJI.
No grant funds may be obligated for publication or reproduction of a final product developed with grant funds without the written approval of SJI. Grantees shall submit a final draft of each written product to SJI for review and approval. The draft must be submitted at least 30 days before the product is scheduled to be sent for publication or reproduction to permit SJI review and incorporation of any appropriate changes required by SJI. Grantees must provide for timely reviews by the SJI of Web site or other multimedia products at the treatment, script, rough cut, and final stages of development or their equivalents.
All products prepared as the result of SJI-supported projects must be originally-developed material unless otherwise specified in the award documents. Material not originally developed that is included in such products must be properly identified, whether the material is in a verbatim or extensive paraphrase format.
No funds made available by SJI may be used directly or indirectly to support legal assistance to parties in litigation, including cases involving capital punishment.
a. Recipients of SJI funds other than ESP awards must submit Quarterly Progress and Financial Status Reports within 30 days of the close of each calendar quarter (that is, no later than January 30, April 30, July 30, and October 30). The Quarterly Progress Reports shall include a narrative description of project activities during the calendar quarter, the relationship between those activities and the task schedule and objectives set forth in the approved application or an approved adjustment thereto, any significant problem areas that have developed and how they will be resolved, and the activities scheduled during the next reporting period. Failure to comply with the requirements of this provision could result in the termination of a grantee's award.
b. The quarterly Financial Status Report must be submitted in accordance with section VII.H.2. of this Guideline. A final project Progress Report and Financial Status Report shall be submitted within 90 days after the end of the grant period in accordance with section VII.L.1. of this Guideline.
Upon request, grantees must make available for secondary analysis backup files containing research and evaluation data collected under an SJI grant and the accompanying code manual. Grantees may recover the actual cost of duplicating and mailing or otherwise transmitting the data set and manual from the person or organization requesting the data. Grantees may provide the requested data set in the format in which it was created and analyzed.
Except as provided by federal law other than the State Justice Institute Act, no recipient of financial assistance from SJI may use or reveal any research or statistical information furnished under the Act by any person and identifiable to any specific private person for any purpose other than the purpose for which the information was obtained. Such information and copies thereof shall be immune from legal process, and shall not, without the consent of the person furnishing such information, be admitted as evidence or used for any purpose in any action, suit, or other judicial, legislative, or administrative proceedings.
Human subjects are defined as individuals who are participants in an experimental procedure or who are asked to provide information about themselves, their attitudes, feelings, opinions, and/or experiences through an interview, questionnaire, or other data collection technique. All research involving human subjects shall be conducted with the informed consent of those subjects and in a manner that will ensure their privacy and freedom from risk or harm and the protection of persons who are not subjects of the research but would be affected by it, unless such procedures and safeguards would make the research impractical. In such instances, SJI must approve procedures designed by the grantee to provide human subjects with relevant information about the research after their involvement and to minimize or eliminate risk or harm to those subjects due to their participation.
Each application for funding from a state or local court must be approved, consistent with state law, by the state supreme court, or its designated agency or council. The supreme court or its designee shall receive, administer, and be accountable for all funds awarded on the basis of such an application (42 U.S.C. 10705(b)(4)). See section VII.C.2.
To ensure that SJI funds are used to supplement and improve the operation of state courts, rather than to support basic court services, SJI funds shall not be used for the following purposes:
a. To supplant state or local funds supporting a program or activity (such as paying the salary of court employees who would be performing their normal duties as part of the project, or paying rent for space which is part of the court's normal operations);
b. To construct court facilities or structures, except to remodel existing facilities or to demonstrate new architectural or technological techniques, or to provide temporary facilities for new personnel or for personnel involved in a demonstration or experimental program; or
c. Solely to purchase equipment.
After providing a recipient reasonable notice and opportunity to submit written documentation demonstrating why fund termination or suspension should not occur, SJI may terminate or suspend funding of a project that fails to comply substantially with the Act,
At the conclusion of the project, title to all expendable and nonexpendable personal property purchased with SJI funds shall vest in the recipient court, organization, or individual that purchased the property if certification is made to and approved by SJI that the property will continue to be used for the authorized purposes of the SJI-funded project or other purposes consistent with the State Justice Institute Act. If such certification is not made or SJI disapproves such certification, title to all such property with an aggregate or individual value of $1,000 or more shall vest in SJI, which will direct the disposition of the property.
Recipients of TA and CAT Grants must comply with the requirements listed in section VI.A. (except the requirements pertaining to audits in subsection A.3. above and product dissemination and approval in subsection A.11.e. and f. above) and the reporting requirements below:
Recipients of TA Grants must submit to SJI one copy of a final report that explains how it intends to act on the consultant's recommendations, as well as two copies of the consultant's written report.
Recipients of CAT Grants must submit one copy of the agenda or schedule, outline of presentations and/or relevant instructor's notes, copies of overhead transparencies, power point presentations, or other visual aids, exercises, case studies and other background materials, hypotheticals, quizzes, and other materials involving the participants, manuals, handbooks, conference packets, evaluation forms, and suggestions for replicating the program, including possible faculty or the preferred qualifications or experience of those selected as faculty, developed under the grant at the conclusion of the grant period, along with a final report that includes any evaluation results and explains how the grantee intends to present the educational program in the future, as well as two copies of the consultant's or trainer's report.
1. ESP award recipients are responsible for disseminating the information received from the course to their court colleagues locally and, if possible, throughout the state.
Recipients also must submit to SJI a certificate of attendance from the program and a copy of the notice of any funding received from other sources. A state or local jurisdiction may impose additional requirements on ESP award recipients.
2. To receive the funds authorized by an ESP award, recipients must submit an ESP Payment Request (Form ESP–3) together with a paid tuition statement from the program sponsor.
ESP Payment Requests must be submitted within 90 days after the end of the course, which the recipient attended.
3. ESP recipients are encouraged to check with their tax advisors to determine whether an award constitutes taxable income under federal and state law.
The compliance requirements for Partner Grant recipients will depend upon the agreements struck between the grant financiers and between lead financiers and grantees. Should SJI be the lead, the compliance requirements for Project Grants will apply, unless specific arrangements are determined by the Partners.
The purpose of this section is to establish accounting system requirements and offer guidance on procedures to assist all grantees, sub-grantees, contractors, and other organizations in:
1. Complying with the statutory requirements for the award, disbursement, and accounting of funds;
2. Complying with regulatory requirements of SJI for the financial management and disposition of funds;
3. Generating financial data to be used in planning, managing, and controlling projects; and
4. Facilitating an effective audit of funded programs and projects.
Except where inconsistent with specific provisions of this Grant Guideline, the following circulars are applicable to SJI grants and cooperative agreements under the same terms and conditions that apply to federal grantees. The circulars supplement the requirements of this section for accounting systems and financial record-keeping and provide additional guidance on how these requirements may be satisfied (circulars may be obtained on the OMB Web site at
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All grantees receiving awards from SJI are responsible for the management and fiscal control of all funds. Responsibilities include accounting for receipts and expenditures, maintaining adequate financial records, and refunding expenditures disallowed by audits.
a. Each application for funding from a state or local court must be approved, consistent with state law, by the state supreme court, or its designated agency or council.
b. The state supreme court or its designee shall receive all SJI funds awarded to such courts; be responsible for assuring proper administration of SJI funds; and be responsible for all aspects of the project, including proper accounting and financial record-keeping by the subgrantee. These responsibilities include:
(1) Reviewing Financial Operations. The state supreme court or its designee should be familiar with, and periodically monitor, its sub-grantee's financial operations, records system, and procedures. Particular attention should be directed to the maintenance of current financial data.
(2) Recording Financial Activities. The sub-grantee's grant award or
(3) Budgeting and Budget Review. The state supreme court or its designee should ensure that each sub-grantee prepares an adequate budget as the basis for its award commitment. The state supreme court should maintain the details of each project budget on file.
(4) Accounting for Match. The state supreme court or its designee will ensure that sub-grantees comply with the match requirements specified in this Grant Guideline (see section VI.A.8.).
(5) Audit Requirement. The state supreme court or its designee is required to ensure that sub-grantees meet the necessary audit requirements set forth by SJI (see sections K. below and VI.A.3.).
(6) Reporting Irregularities. The state supreme court, its designees, and its sub-grantees are responsible for promptly reporting to SJI the nature and circumstances surrounding any financial irregularities discovered.
The grantee is responsible for establishing and maintaining an adequate system of accounting and internal controls and for ensuring that an adequate system exists for each of its sub-grantees and contractors. An acceptable and adequate accounting system:
1. Properly accounts for receipt of funds under each grant awarded and the expenditure of funds for each grant by category of expenditure (including matching contributions and project income);
2. Assures that expended funds are applied to the appropriate budget category included within the approved grant;
3. Presents and classifies historical costs of the grant as required for budgetary and evaluation purposes;
4. Provides cost and property controls to assure optimal use of grant funds;
5. Is integrated with a system of internal controls adequate to safeguard the funds and assets covered, check the accuracy and reliability of the accounting data, promote operational efficiency, and assure conformance with any general or special conditions of the grant;
6. Meets the prescribed requirements for periodic financial reporting of operations; and
7. Provides financial data for planning, control, measurement, and evaluation of direct and indirect costs.
Accounting for all funds awarded by SJI must be structured and executed on a “Total Project Cost” basis. That is, total project costs, including SJI funds, state and local matching shares, and any other fund sources included in the approved project budget serve as the foundation for fiscal administration and accounting. Grant applications and financial reports require budget and cost estimates on the basis of total costs.
Matching contributions should be applied at the same time as the obligation of SJI funds. Ordinarily, the full matching share must be obligated during the award period; however, with the written permission of SJI, contributions made following approval of the grant by the Board of Directors, but before the beginning of the grant, may be counted as match. If a proposed cash or in-kind match is not fully met, SJI may reduce the award amount accordingly to maintain the ratio of grant funds to matching funds stated in the award agreement.
All grantees must maintain records that clearly show the source, amount, and timing of all matching contributions. In addition, if a project has included, within its approved budget, contributions which exceed the required matching portion, the grantee must maintain records of those contributions in the same manner as it does SJI funds and required matching shares. For all grants made to state and local courts, the state supreme court has primary responsibility for grantee/sub-grantee compliance with the requirements of this section (see subsection C.2. above).
All financial records, including supporting documents, statistical records, and all other information pertinent to grants, sub-grants, cooperative agreements, or contracts under grants, must be retained by each organization participating in a project for at least three years for purposes of examination and audit. State supreme courts may impose record retention and maintenance requirements in addition to those prescribed in this section.
The retention requirement extends to books of original entry, source documents supporting accounting transactions, the general ledger, subsidiary ledgers, personnel and payroll records, canceled checks, and related documents and records. Source documents include copies of all grant and sub-grant awards, applications, and required grantee/sub-grantee financial and narrative reports. Personnel and payroll records shall include the time and attendance reports for all individuals reimbursed under a grant, sub-grant or contract, whether they are employed full-time or part-time. Time and effort reports are required for consultants.
The three-year retention period starts from the date of the submission of the final expenditure report.
Grantees and sub-grantees are expected to see that records of different fiscal years are separately identified and maintained so that requested information can be readily located. Grantees and sub-grantees are also obligated to protect records adequately against fire or other damage. When records are stored away from the grantee's/sub-grantee's principal office, a written index of the location of stored records should be on hand, and ready access should be assured.
Grantees and sub-grantees must give any authorized representative of SJI access to and the right to examine all records, books, papers, and documents related to an SJI grant.
Records of the receipt and disposition of project-related income must be maintained by the grantee in the same manner as required for the project funds that gave rise to the income and must be reported to SJI (see subsection H.2. below). The policies governing the disposition of the various types of project-related income are listed below.
A state and any agency or instrumentality of a state, including institutions of higher education and hospitals, shall not be held accountable for interest earned on advances of project funds. When funds are awarded to sub-grantees through a state, the sub-
The grantee/sub-grantee may retain all royalties received from copyrights or other works developed under projects or from patents and inventions, unless the terms and conditions of the grant provide otherwise.
Registration and tuition fees may be considered as cash match with prior written approval from SJI. Estimates of registration and tuition fees, and any expenses to be offset by the fees, should be included in the application budget forms and narrative.
If the sale of products occurs during the project period, the income may be treated as cash match with the prior written approval of SJI. The costs and income generated by the sales must be reported on the Quarterly Financial Status Reports (Form F) and documented in an auditable manner. Whenever possible, the intent to sell a product should be disclosed in the application or reported to SJI in writing once a decision to sell products has been made. The grantee must request approval to recover its product development, reproduction, and dissemination costs as specified in section VI.A.11.b.
Other project income shall be treated in accordance with disposition instructions set forth in the grant's terms and conditions.
The procedures and regulations set forth below are applicable to all SJI grant funds and grantees.
Grantees will receive funds on a U.S. Treasury “check-issued” or electronic funds transfer (EFT) basis. Upon receipt, review, and approval of a Request for Reimbursement (Form R) by SJI, payment will be issued directly to the grantee or its designated fiscal agent. The Form R, along with the instructions for its preparation, and the SF 3881 Automated Clearing House (ACH/Miscellaneous Payment Enrollment Form for EFT) are available on the Institute's Web site:
b. Principle of Minimum Cash on Hand. Grantees should request funds based upon immediate disbursement requirements. Grantees should time their requests to ensure that cash on hand is the minimum needed for disbursements to be made immediately or within a few days.
a. General Requirements. To obtain financial information concerning the use of funds, the Institute requires that grantees/sub-grantees submit timely reports for review.
b. Due Dates and Contents. A Financial Status Report is required from all grantees, other than ESP award recipients, for each active quarter on a calendar-quarter basis. This report is due within 30 days after the close of the calendar quarter. It is designed to provide financial information relating to SJI funds, state and local matching shares, project income, and any other sources of funds for the project, as well as information on obligations and outlays. A copy of the Financial Status Report (Form F), along with instructions, are provided at www.sji.gov/forms. If a grantee requests substantial payments for a project prior to the completion of a given quarter, SJI may request a brief summary of the amount requested, by object class, to support the Request for Reimbursement.
Failure of the grantee to submit required financial and progress reports may result in suspension or termination of grant payments.
Except as may be otherwise provided in the conditions of a particular grant, cost allowability is determined in accordance with the principles set forth in
No costs may be recovered to liquidate obligations incurred after the approved grant period. Circulars may be obtained on the OMB Web site at
a. Pre-agreement Costs. The written prior approval of SJI is required for costs considered necessary but which occur prior to the start date of the project period.
b. Equipment. Grant funds may be used to purchase or lease only that equipment essential to accomplishing the goals and objectives of the project. The written prior approval of SJI is required when the amount of automated data processing (ADP) equipment to be purchased or leased exceeds $10,000 or software to be purchased exceeds $3,000.
c. Consultants. The written prior approval of SJI is required when the rate of compensation to be paid a consultant exceeds $800 a day. SJI funds may not be used to pay a consultant more than $1,100 per day.
d. Budget Revisions. Budget revisions among direct cost categories that (i) transfer grant funds to an unbudgeted cost category or (ii) individually or cumulatively exceed five percent (5%) of the approved original budget or the most recently approved revised budget require prior SJI approval (see section VIII.A.1.).
Transportation and per diem rates must comply with the policies of the grantee. If the grantee does not have an established written travel policy, then travel rates must be consistent with those established by the federal government. SJI funds may not be used to cover the transportation or per diem costs of a member of a national organization to attend an annual or other regular meeting, or conference of that organization.
Indirect costs are only applicable to organizations that are not state courts or government agencies. These are costs of an organization that are not readily assignable to a particular project but are necessary to the operation of the organization and the performance of the project. The cost of operating and maintaining facilities, depreciation, and administrative salaries are examples of the types of costs that are usually treated as indirect costs. Although SJI's policy requires all costs to be budgeted directly, it will accept indirect costs if a grantee has an indirect cost rate approved by a federal agency. However, recoverable indirect costs are limited to no more than 75 percent of a grantee's direct personnel costs (salaries plus fringe benefits).
(1) A copy of an indirect cost rate agreement or allocation plan approved for a grantee during the preceding two
(2) Where flat rates are accepted in lieu of actual indirect costs, grantees may not also charge expenses normally included in overhead pools, e.g., accounting services, legal services, building occupancy and maintenance, etc., as direct costs.
For state and local governments, SJI has adopted the standards set forth in Attachment O of
The property management standards as prescribed in Attachment N of
Each recipient of a Project Grant must provide for an annual fiscal audit. This requirement also applies to a state or local court receiving a sub-grant from the state supreme court. The audit may be of the entire grantee or sub-grantee organization or of the specific project funded by the Institute. Audits conducted in accordance with the Single Audit Act of 1984 and
Timely action on recommendations by responsible management officials is an integral part of the effectiveness of an audit. Each grantee must have policies and procedures for acting on audit recommendations by designating officials responsible for: (1) Follow-up, (2) maintaining a record of the actions taken on recommendations and time schedules, (3) responding to and acting on audit recommendations, and (4) submitting periodic reports to SJI on recommendations and actions taken.
Ordinarily, SJI will not make a subsequent grant award to an applicant that has an unresolved audit report involving SJI awards. Failure of the grantee to resolve audit questions may also result in the suspension or termination of payments for active SJI grants to that organization.
Within 90 days after the end date of the grant or any approved extension thereof (see subsection L.2. below), the following documents must be submitted to SJI by grantees (other than ESP award recipients):
a. Financial Status Report. The final report of expenditures must have no unliquidated obligations and must indicate the exact balance of unobligated funds. Any unobligated/unexpended funds will be deobligated from the award by SJI. Final payment requests for obligations incurred during the award period must be submitted to the Institute prior to the end of the 90-day close-out period. Grantees who have drawn down funds in excess of their obligations/expenditures, must return any unused funds as soon as it is determined that the funds are not required. In no instance should any unused funds remain with the grantee beyond the submission date of the final Financial Status Report.
b. Final Progress Report. This report should describe the project activities during the final calendar quarter of the project and the close-out period, including to whom project products have been disseminated; provide a summary of activities during the entire project; specify whether all the objectives set forth in the approved application or an approved adjustment have been met and, if any of the objectives have not been met, explain why not; and discuss what, if anything, could have been done differently that might have enhanced the impact of the project or improved its operation. These reporting requirements apply at the conclusion of every grant other than an ESP award.
Upon the written request of the grantee, SJI may extend the close-out period to assure completion of the grantee's close-out requirements. Requests for an extension must be submitted at least 14 days before the end of the close-out period and must explain why the extension is necessary and what steps will be taken to assure that all the grantee's responsibilities will be met by the end of the extension period
All requests for programmatic or budgetary adjustments requiring Institute approval must be submitted by the project director in a timely manner (ordinarily 30 days prior to the implementation of the adjustment being requested). All requests for changes from the approved application will be carefully reviewed for both consistency with this Grant Guideline and the enhancement of grant goals and objectives. Failure to submit adjustments in a timely manner may result in the termination of a grantee's award.
The following grant adjustments require the prior written approval of SJI:
1. Budget revisions among direct cost categories that (a) transfer grant funds to an unbudgeted cost category or (b) individually or cumulatively exceed five percent (5%) of the approved original budget or the most recently approved revised budget (see section VII.I.2.d.).
2. A change in the scope of work to be performed or the objectives of the project (see subsection D. below).
3. A change in the project site.
4. A change in the project period, such as an extension of the grant period and/or extension of the final financial or progress report deadline (see subsection E. below).
5. Satisfaction of special conditions, if required.
6. A change in or temporary absence of the project director (see subsections F. and G. below).
7. The assignment of an employee or consultant to a key staff position whose qualifications were not described in the
8. A change in or temporary absence of the person responsible for managing and reporting on the grant's finances.
9. A change in the name of the grantee organization.
10. A transfer or contracting out of grant-supported activities (see subsection H. below).
11. A transfer of the grant to another recipient.
12. Pre-agreement costs (see section VII.I.2.a.).
13. The purchase of automated data processing equipment and software (see section VII.I.2.b.).
14. Consultant rates (see section VII.I.2.c.).
15. A change in the nature or number of the products to be prepared or the manner in which a product would be distributed.
All grantees must promptly notify SJI, in writing, of events or proposed changes that may require adjustments to the approved project design. In requesting an adjustment, the grantee must set forth the reasons and basis for the proposed adjustment and any other information the program manager determines would help SJI's review.
If the request is approved, the grantee will be sent a Grant Adjustment signed by the SJI Executive Director. If the request is denied, the grantee will be sent a written explanation of the reasons for the denial.
Major changes in scope, duration, training methodology, or other significant areas must be approved in advance by SJI. A grantee may make minor changes in methodology, approach, or other aspects of the grant to expedite achievement of the grant's objectives with subsequent notification to SJI.
A request to change or extend the grant period must be made at least 30 days in advance of the end date of the grant. A revised task plan should accompany a request for an extension of the grant period, along with a revised budget if shifts among budget categories will be needed. A request to change or extend the deadline for the final financial report or final progress report must be made at least 14 days in advance of the report deadline (see section VII.L.2.).
Whenever an absence of the project director is expected to exceed a continuous period of one month, the plans for the conduct of the project director's duties during such absence must be approved in advance by the Institute. This information must be provided in a letter signed by an authorized representative of the grantee/sub-grantee at least 30 days before the departure of the project director, or as soon as it is known that the project director will be absent. The grant may be terminated if arrangements are not approved in advance by SJI.
If the project director relinquishes or expects to relinquish active direction of the project, SJI must be notified immediately. In such cases, if the grantee/sub-grantee wishes to terminate the project, SJI will forward procedural instructions upon notification of such intent. If the grantee wishes to continue the project under the direction of another individual, a statement of the candidate's qualifications should be sent to SJI for review and approval. The grant may be terminated if the qualifications of the proposed individual are not approved in advance by SJI.
No principal activity of a grant-supported project may be transferred or contracted out to another organization without specific prior approval by SJI. All such arrangements must be formalized in a contract or other written agreement between the parties involved. Copies of the proposed contract or agreement must be submitted for prior approval of SJI at the earliest possible time. The contract or agreement must state, at a minimum, the activities to be performed, the time schedule, the policies and procedures to be followed, the dollar limitation of the agreement, and the cost principles to be followed in determining what costs, both direct and indirect, will be allowed. The contract or other written agreement must not affect the grantee's overall responsibility for the direction of the project and accountability to SJI.
Federal Aviation Administration (FAA), DOT.
Request for public comment.
The Federal Aviation Administration is requesting public comment on request by the Louisville Regional Airport Authority to temporarily change a portion of airport property from aeronautical to non-aeronautical use at the Bowman Field Airport, Louisville, Kentucky. The request consists approximately of 0.41 acres of temporary use. This action is taken under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Comments must be received on or before November 29, 2013.
Documents are available for review at the Louisville Regional Airport Authority, 700 Administration Drive, Louisville, KY 40209; and the FAA Memphis Airports District Office, 2600 Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118–2482. Written comments on the Sponsor's request must be delivered or mailed to: Mr. Phillip J. Braden, Manager, Memphis Airports District Office, 2600
In addition, a copy of any comments submitted to the FAA must be mailed or delivered to Mr. Charles T. Miller, Executive Director, Louisville Regional Airport Authority, P.O. Box 9129, Louisville, KY 40209.
Mr. Tommy L. Dupree, Team Lead/Civil Engineer, Federal Aviation Administration, Memphis Airports District Office, 2600, Thousand Oaks Boulevard, Suite 2250, Memphis, TN 38118–2482. The application may be reviewed in person at this same location, by appointment.
The FAA proposes to rule and invites public comment on the request to lease property for non-aeronautical purposes at Bowman Field Airport, Louisville, KY 42103. Under the provisions of AIR 21 (49 U.S.C. 47107(h)(2)).
On September 30, 2013, the FAA determined that the request to lease property for non-aeronautical purposes at Bowman Field Airport meets the procedural requirements of the Federal Aviation Administration. The FAA may approve the request, in whole or in part, no later than November 29, 2013.
The following is a brief overview of the request:
The Louisville Regional Airport Authority is proposing the lease of approximately 0.41 acres, a partial of Parcel 48, bounded by Roger E. Schupp Street to the north, Dutchman's Lane to the south, Tucker Boulevard to the east, and Gast Boulevard to the west. The non-aeronautical lease is for a period of 5 (five) years, with an option of 5 (five) years that can be exercised by the airport authority. The non-aeronautical lease is for the purpose of leasing said property to an adjacent land owner, The Jewish Family & Career Services of Louisville, Inc., to be used as a parking lot.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
Federal Highway Administration (FHWA), Department of Transportation (DOT) and other Federal agencies.
Notice of Limitations on Claims for Judicial Review of Actions by FHWA and other Federal agencies.
This notice announces final environmental actions taken by the FHWA, the National Park Service (NPS), the United States Fish and Wildlife Service (USF&WS), and other Federal agencies that are final within the meaning of 23 U.S.C. § 139(
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(
Michelle Eraut, Acting Environmental Program Manager, FHWA, 610 East 5th Street, Vancouver, WA, Telephone: (360) 619–7967. For the NPS: Roy M. Zipp, Environmental Protection Specialist, North Cascades National Park, 810 State Route 20, Sedro-Wolley, WA 98284, Telephone: 360–854–7313. For the USF&WS, Greg Kurz, Central Washington Field Office, 215 Melody Lane, Suite 119, Wenatchee, WA 98801, Telephone: (509) 665–3508. The FHWA Stehekin Valley Road Improvement Project Record of Decision, NPS Stehekin River Corridor Implementation Plan Environmental Impact Statement (EIS) and Record of Decision (ROD), is available upon written request from the Federal Highway Administration at the address shown above. Comments or questions concerning this proposed action should be directed to the FHWA at the address provided above.
Notice is hereby given that the FHWA, has taken final agency action subject to 23 U.S.C. § 139(
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Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of Limitations on Claims for Judicial Review of Actions by FHWA, United States Army Corps of Engineers (USACE), United States Forest Service (USFS), United States Fish & Wildlife Service (USF&WS), and other Federal agencies.
This notice announces final environmental actions taken by the FHWA, USACE, USFS, USF&WS, NMFS and other Federal agencies that are final within the meaning of 23 U.S.C. 139(
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(
For FHWA, Michelle Eraut, Program Development Team Leader, Federal Highway Administration, 530 Center Street NE., Suite 420, Salem, Oregon 97301, Telephone: (503) 587–4716. The US 26: MP 49.20–MP 57.45 categorical exclusion is available upon written request from the Federal Highway Administration at the address shown above. Comments or questions concerning this proposed action and the US 26: MP 49.20–MP 57.45 should be directed to the FHWA at the address provided above. For USACE, Dominic Yballe, Regulatory Project Manager, (503) 808–4392, 333 SW. 1st Avenue, Portland, Oregon 97208–2946. For USFS, Bill Westbrook, Zigzag District Ranger, (503) 622–2001, 70220 E. Highway 26, Zigzag, Oregon 97049. For USF&WS, Kevin Maurice, (503) 231–6179, Wildlife Biologist, 2600 SE. 98th Avenue, Suite 100, Portland, Oregon 97266.
Notice is hereby given that the FHWA has taken final agency action subject to 23 U.S.C. 139(
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Notice of Limitation on Claims for Judicial Review of Actions by FHWA and Other Federal Agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. § 139(l)(1). The actions relate to a proposed highway project, I–77 High Occupancy/Toll (HOT) lanes, from I–277 (Brookshire Freeway—Exit 11) to NC 150 (Exit 36), Mecklenburg and Iredell Counties, North Carolina. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filled on or before March 28, 2014. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mr. Clarence W. Coleman, P. E., Preconstruction and Environment Director, Federal Highway Administration, 310 New Bern Avenue, Suite 410, Raleigh, North Carolina, 27601–1418; Telephone: (919) 747–7014; email:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency action subject to 23 U.S.C. 139(
(1) I–3311C—Construct two HOT lanes along I–77 from just north of the I–77/I–85 interchange (connecting to I–5405 HOT lane project) to and along I–277.
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(2) I–5405—I–77 from I–277 (Brookshire Freeway) to Exit 28; convert existing HOV lanes to HOT lanes and extend northward to Exit 28. Add additional HOT lane in each direction beginning at I–85 to Exit 28 for a total of 2 HOT lanes in each direction.
(3) I–4750AA—Construct one HOT lane in each direction along I–77 from Exit 28 (connecting to I–5405 HOT lane project) to Brawley School Road (Exit 35), with construction ending approximately 5,500 feet north of the NC 150 bridge (Exit 36). Northbound and southbound HOT designations begin and end at Brawley School Road (Exit 35).
(4) Designation of HOT lanes as HOT 3+.
The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Finding of No Significant Impact (FONSI) for the project, approved on October 16, 2013, and in other documents in the FHWA administrative record. The FONSI and other documents in the FHWA administrative record file are available by contacting the FHWA or NCDOT at the addresses provided above.
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1.
2.
3.
4.
5.
6.
7.
8.
9.
23 U.S.C. 139(l)(1)
Federal Highway Administration (FHWA), DOT.
Notice of Limitation on Claims for Judicial Review of Actions by FHWA and other Federal Agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 USC § 139(l)(1). The actions relate to a proposed highway project, Circle Interchange, I–90/I–94 and I–290/Congress Parkway in Cook County, Illinois. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C .139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before March 28, 2014. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Ms. Catherine A. Batey, Division Administrator, Federal Highway Administration, 3250 Executive Park Drive, Springfield, Illinois 62703, Phone: (217) 492–4640, Email address:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following highway project in the State of Illinois: reconstruct and widen the Circle Interchange, I–90/I–94 and I–290/Congress Parkway, a total project length of approximately 2.7 miles including two new flyover ramps and nine cross street bridges. The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Environmental Assessment (EA) for the project approved on June 11, 2013 the Finding of No Significant Impact (FONSI) issued on September 17, 2013; and in other documents in the FHWA administrative record. The EA, FONSI, and other documents in the FHWA administrative record file are available by contacting the FHWA or the Illinois Department of Transportation at the addresses provided above. The EA and FONSI and all other supporting documentation can be viewed and downloaded from the project Web site at
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321–4351] Federal-Aid Highway Act [23 U.S.C. 109 and 23 U.S.C. 128].
2. Air: Clean Air Act [42 U.S.C. 7401–7671(q)].
3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303 and 23 U.S.C. 138].
4. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)–2000(d)(1)].
5. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f)
6. Wildlife: Endangered Species Act [16 U.S.C. 1531–1544 and Section 1536]; Migratory Bird Treaty Act [16 U.S.C. 703–712].
7. Wetlands and Water Resources: Clean Water Act (Section 401 and 404) [33 U.S.C. 1251–1377]; Wild and Scenic Rivers Act [16 U.S.C. 1271–1287].
8. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations.
23 U.S.C. 139(l)(1).
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before November 29, 2013.
Comments should refer to docket number MARAD–2013–0114. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23–453, Washington, DC 20590. Telephone 202–366–0903, Email
As described by the applicant the intended service of the vessel WEATHERVANE is:
The complete application is given in DOT docket MARAD–2013–0114 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Surface Transportation Board, DOT.
Notice tentatively authorizing finance transaction.
All Aboard America! Holdings, Inc. (AHI), Celerity AHI Holdings SPV, LLC (Celerity Holdings), and Celerity Partners IV, LLC (Celerity Partners) (collectively, Applicants) have filed an application under 49 U.S.C. 14303 for their acquisition of control of Sureride Charter, Inc. d/b/a Sundiego Charter Company (Sundiego). The Board is tentatively approving and authorizing the transaction, and, if no opposing comments are timely filed, this notice will be the final Board action. Persons wishing to oppose the application must follow the rules at 49 CFR 1182.5 and 1182.8.
Comments must be filed by December 13, 2013. Applicants may file a reply by December 30, 2013. If no comments are filed by December 13, 2013, this notice shall be effective on December 14, 2013.
Send an original and 10 copies of any comments referring to Docket No. MCF 21055 to: Surface Transportation Board, 395 E Street SW., Washington, DC 20423–0001. In addition, send copies of comments to Applicant's representative: Mark J. Andrews, Strasburger & Price, LLP, Suite 640, 1700 K Street NW., Washington, DC 20006.
Jonathon Binet, (202) 245–0368. Federal Information Relay Service (FIRS) for the hearing impaired: 1–800–877–8339.
AHI is a noncarrier corporation established under the laws of Delaware. A plurality of AHI's stock is held by a group of investors participating in Celerity Holdings, a noncarrier limited liability company organized under the laws of Delaware. Celerity Partners, the managing member of Celerity Holdings, is also a noncarrier limited liability company organized under the laws of Delaware. Applicants currently control two carriers, Hotard Coaches, Inc. (Coaches) and Industrial Bus Lines, Inc. d/b/a All Aboard America! (Industrial).
Sundiego is a California corporation and is controlled through stock ownership by Richard and Beverly Ann Illes (Mr. and Mrs. Illes), noncarrier individuals residing in California. Sundiego holds authority from the FMCSA as a motor carrier of passengers (MC–324772) and holds an intrastate registration from the California Public Utilities Commission (CPUC) as a Class B charter-party carrier of passengers. Applicants state that Sundiego operates 58 full-sized motor coaches and 9 smaller vehicles (including minibuses, vans, and a limousine). According to Applicants, Sundiego conducts charter, sightseeing, and various types of shuttle operations for a variety of customers out of its headquarters in National City, Cal., a suburb of San Diego. Applicants state that these operations are conducted to, from, and within California and adjoining states, as well as to Mexico. Applicants indicate that 65 percent of Sundiego's revenues are derived from contracted transit and dedicated shuttle operations, with the remainder from charter operations. Of those charter operations, airport transfers account for 10 percent and cruise ship transfers account for 4 percent of Sundiego's revenues.
Under the proposed transaction, Applicants seek permission for AHI (and for Celerity Holdings and Celerity Partners indirectly) to acquire 100 percent control of Sundiego through a stock purchase agreement (SPA) between AHI and Mr. and Mrs. Illes. According to Applicants, top management at Sundiego would remain involved in the business after the acquisition, and Mr. and Mrs. Illes would become minority shareholders in AHI. Applicants state that closing of the proposed transaction is scheduled on or about December 10, 2013, if Board approval is obtained by then.
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least: (1) The effect of the proposed transaction on the adequacy of transportation to the public; (2) the total fixed charges that result; and (3) the interest of affected carrier employees. Applicants have submitted information, as required by 49 CFR 1182.2, including the information to demonstrate that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b), and a statement that Applicants' motor passenger carriers and Sundiego's aggregate gross operating revenues for the preceding 12 months exceeded $2 million,
With respect to the effect of the transaction on the adequacy of transportation to the public, Applicants state that the proposed acquisition would have no significant impact because Applicants do not intend to change substantially the physical operations historically conducted by Sundiego. Rather, Applicants anticipate enhancing operations by implementing vehicle sharing arrangements, by providing coordinated driver training and safety management services, and by centralizing various management support functions. With respect to fixed charges, Applicants state that their control of Sundiego would generate economies of scale that would reduce a variety of unit costs and that, with its increased market position, Applicants would be able to access financing on more favorable terms. In addition to better interest rates, Applicants expect that the combined carriers would be able to enhance modestly their volume purchasing power, thus reducing insurance premiums and achieve deeper volume discounts for equipment and fuel. Applicants state that the transaction would have a positive impact on employee interests, as the economies and efficiencies resulting from the proposed acquisition would directly benefit Sundiego's employees by maintaining job security and retaining or expanding the volume of available work.
Applicants further state that the acquisition would have no adverse impact on competition, because the geographic markets in which Sundiego and Coaches/Industrial compete are adjacent, but do not significantly overlap. Industrial's primary service areas in Arizona, New Mexico, and Texas are west of Sundiego's California-based market. Applicants note that round trips generated by each carrier might extend into overlapping states, but the beginning and end points seldom, if ever, overlap between Sundiego and Coaches/Industrial. Applicants also state that Sundiego faces other competition in both charter and shuttle services in San Diego and Los Angeles. Further, Applicants note that services provided under contract and on a “spot basis” also face competition from local and nationwide operators. Applicants state that competition includes five locally-based carriers, three carriers in the Los Angeles area, and four large nationwide providers of service.
On the basis of the application, the Board finds that the proposed acquisition is consistent with the public interest and should be tentatively approved and authorized. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will be adopted to reconsider the application.
Board decisions and notices are available on our Web site at
This decision will not significantly affect either the quality of the human environment or the conservation of energy resources.
1. The proposed transaction is approved and authorized, subject to the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective December 14, 2013, unless opposing comments are filed by December 13, 2013.
4. A copy of this notice will be served on: (1) The U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW., Washington, DC 20530; and (3) the U.S. Department of Transportation, Office of the General Counsel, 1200 New Jersey Avenue SE., Washington, DC 20590.
By the Board, Chairman Elliott, Vice Chairman Begeman, and Commissioner Mulvey.
Youngstown & Southeastern Railway Company (Y&SR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to continue to operate a line of railroad that extends 35.7 miles between milepost 0.0 in Youngstown, Ohio, and milepost 35.7 in Darlington, Pa. (the Line). The Line is currently owned by Columbiana County Port Authority (CCPA) and has been operated by Y&SR under a lease from CCPA. In addition, Y&SR will operate as an agent of, and in the name of, Mule Sidetracks, L.L.C. (MSLLC), three miles of contiguous track segments, running east of milepost 0.0 and connecting to the Line, that are being permanently assigned by CCPA to MSLLC and will facilitate interchange with Norfolk Southern Railway Company (NSR) and CSX Transportation, Inc. (CSXT).
This transaction is related to a verified notice of exemption filed in
The transaction may be consummated on or after November 12, 2013, the effective date of the exemption.
Y&SR certifies that its projected annual revenues as a result of this transaction will not exceed $5 million annually and will not result in Y&SR becoming a Class I or Class II carrier.
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35774, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423–0001. In addition, a copy of each pleading must be served on John D. Heffner, Strasburger & Price, LLP, 1700 K Street NW., Suite 640, Washington, DC 20006.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Community Development Financial Institutions Fund, Department of the Treasury.
Request for public comment.
This notice invites comments from the public on certain programmatic and administrative aspects of the Community Development Financial Institutions Fund's (CDFI Fund) Bank Enterprise Award (BEA) Program, pursuant to the BEA Program regulations set forth at 12 CFR part 1806 (the Interim Rule). All materials submitted will be available for public inspection and copying.
All comments and submissions must be received by December 30, 2013.
Comments should be sent by mail to: CDFI Fund, BEA Program Office, U.S. Department of the Treasury, 1500 Pennsylvania Ave., NW., Washington, DC 20220; by email to
Information regarding the CDFI Fund and its programs may be downloaded from the CDFI Fund's Web site at
Through the BEA Program, the CDFI Fund encourages Insured Depository Institutions to increase their activities in the form of loans, investments, services, and technical assistance provided within Distressed Communities, as well as investments in Community Development Financial Institutions (CDFIs) through grants, stock purchases, loans, deposits, and other forms of financial and technical assistance. The increase in these activities is measured from a Baseline Period to an Assessment Period. Each capitalized term used in this Request for Public Comments is more fully defined either in the Interim Rule or the Notice of Funds Availability for the FY 2013 BEA Program award round (
A.
As stated in Section VII “Application Review Information” of the NOFA, the CDFI Fund may choose not to approve a BEA Program award at the time of application if the Applicant and/or its affiliates' most recent overall CRA assessment rating is below “Satisfactory.” This determination is made during the review of the application.
The CDFI Fund is considering making this an “Eligibility” requirement (Section III of the NOFA). If implemented, Section III of the NOFA would inform prospective Applicants that a CRA rating of below “Satisfactory” during the Baseline Period or the Assessment Period of the applicable BEA Program award round will result in ineligibility.
1. Should the CDFI Fund consider an Applicant ineligible if the Applicant's CRA rating is below “Satisfactory” and the CRA examination date was within the applicable Baseline or Assessment Period? If so, please indicate why. If not, please provide a specific reason why not.
2. Should the CDFI Fund consider an Applicant ineligible if the Applicant's most recent CRA rating is below “Satisfactory” but the CRA examination date was prior to the applicable Baseline or Assessment Period? If so, please indicate why. If not, please provide a specific reason why not.
3. Should the CDFI Fund perform additional due diligence to obtain an update on the status or progress made by the Applicant to improve its CRA rating prior to making an eligibility determination? If so, in which of the two scenarios above should additional due diligence be performed? Should that information be self-reported by the
B.
As stated in Section VII “Application Review Information” of the NOFA, the CDFI Fund may choose not to approve a BEA Program Award at the time of application if the Applicant received a going concern opinion on its most recent audit. This determination is made during the review of the application.
The CDFI Fund is considering making this an “Eligibility” requirement (Section III of the NOFA). If implemented, Section III of the NOFA would inform prospective Applicants that a going concern audit opinion during the Baseline Period or the Assessment Period of the applicable BEA Program award round will result in ineligibility.
1. Should the CDFI Fund consider an Applicant ineligible to apply for a BEA Program award if the Applicant received a going concern on its most recent audit report? If not, please provide a specific reason why not.
2. Is there additional financial health information that the CDFI Fund should consider in making eligibility determinations? If so, please describe.
A.
1. Should the current definition of Integrally Involved be revised or replaced? If so, how should the CDFI Fund define Integrally Involved?
2. What other factors should the CDFI Fund consider when determining an updated definition of Integrally Involved?
B.
1. Should the CDFI Fund revise, replace, or add to the existing types of CDFI-Related, Distressed Community Financing or Service Activities to include financial products or services relevant to the current economic environment? If so, please indicate the specific type of activity that should be considered, the reasons why it should be considered, and to the extent possible, the benefits of the activity to residents of Distressed Communities. If the suggestion is that a particular activity type be revised or replaced, please explain why.
C.
If a BEA applicant funds a certified CDFI that administers or supports a Pay for Success activity, the activity could qualify as a CDFI-related activity under the current Interim Rule. The CDFI Fund is considering revising the Distressed Community Financing Activities category to include the funding component of Pay for Success activities by FDIC-insured financial institutions as a qualified activity. An example of a Pay for Success activity which could qualify in the Distressed Community Financing Activities category, is a loan or investment made by an FDIC-insured financial institution to an organization that funds a Pay for Success activity located in a BEA Distressed Community. The Applicant would still need to be a FDIC-insured financial institution, and the borrower would still need to be located in a BEA Distressed Community in order for the transaction to qualify. Disbursement of a Pay for Success award would be contingent upon verification that the agreed upon social outcomes for which the award determination was based have been achieved.
1. Should the CDFI Fund add Pay for Success activities as an eligible Distressed Community Financing Activity? If so, please indicate why. If not, please indicate why not.
2. If Pay for Success activities are added, should the CDFI Fund cap the amount of BEA Program awards related to these activities? If so, explain why and be specific regarding the amount in award dollars and/or percentage.
3. Would the addition of Pay for Success activities as an eligible Distressed Community Financing Activity incentivize financial institutions to increase the funding of Pay for Success activities?
4. Do financial institutions currently fund Pay for Success activities? If so, what are the attributes of the financial institutions? For example, are they predominately certified-CDFIs, community banks, minority depository institutions, small banks, large banks, etc.?
D.
1. Should the CDFI Fund prohibit loans or investments to certain types of businesses that otherwise meet other BEA Program eligibility requirements from qualifying for the BEA Program? For example, should the CDFI Fund consider a loan to a liquor store, gambling facility, etc. that otherwise meets other BEA Program eligibility requirements, an ineligible activity? If so, to which types of businesses should loans or investments be considered ineligible? If not, please provide a specific reason why not. Also, please discuss the positive or negative impact that loans or investments to these types of businesses may have on a Distressed Community.
E.
1. How impactful are BEA Program awards to the recipient financial institutions?
2. Should the CDFI Fund consider making fewer, significantly larger awards? For example, with an appropriation of $18 million, the CDFI Fund could make 18 awards of $1 million each.
3. What other factors should the CDFI Fund consider regarding the size of BEA Program awards?
A.
In addition to the information currently captured, the CDFI Fund is considering adding two columns to Worksheet 2: BEA Report of Transactions: (1) Description of Business Financed; and (2) NAICS Code of the Business Financed. These two columns would only apply to loans or investments provided to businesses.
1. Would the addition of these columns significantly increase the burden on Applicants or result in any potential issues that the CDFI Fund may not have considered?
2. Should the supporting documentation requirements apply to every transaction, to only certain specific transaction types, or to transactions of a certain amount?
B.
1. Should the CDFI Fund require Applicants to provide supporting documentation for loans or investments of less than $250,000? If so, what type of supporting documentation should be required?
2. Would lowering the threshold amount for requiring supporting documentation requirements significantly increase the burden on Applicants or result in any potential issues that the CDFI Fund may not have considered?
3. Should the supporting documentation requirements apply to every transaction, to only certain specific transaction types, or to transactions of a certain amount?
A.
12 U.S.C. 1834a, 4703, 4703 note, 4713, 4717; 31 U.S.C. 321; 12 CFR part 1806.
Department of the Treasury, Office of the Comptroller of the Currency.
Notice of Federal Advisory Committee Meeting.
The Office of the Comptroller of the Currency (OCC) announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).
A public meeting of the MSAAC will be held on Monday, November 18,
The November 18, 2013, meeting of the MSAAC will be held at the Crowne Plaza Chicago Metro, 733 West Madison, Chicago, IL 60661. Members of the public may submit written statements to
Donna Deale, Deputy Comptroller for Thrift Supervision, (202) 649–5420, Office of the Comptroller of the Currency, Washington, DC 20219.
By this notice, the OCC is announcing that the OCC MSAAC will convene a meeting on Monday, November 18, 2013, at the Crowne Plaza Chicago Metro, 733 West Madison, Chicago, IL 60661. The meeting is open to the public and will begin at 1:00 p.m. CST. The agenda includes a discussion of current topics of interest to the industry. The purpose of the meeting is for the MSAAC to advise the OCC on the regulatory changes or other steps the OCC may be able to take to ensure the continued health and viability of mutual savings associations and other issues of concern to the existing mutual savings associations.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the Interim Final Rules, Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan under the Patient Protection and Affordable Care Act.
Written comments should be received on or before December 30, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Kerry Dennis at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number.
Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule establishes, for the first time, conditions of participation (CoPs) that community mental health centers (CMHCs) must meet in order to participate in the Medicare program. These CoPs focus on the care provided to the client, establish requirements for staff and provider operations, and encourage clients to participate in their care plan and treatment. The new CoPs enable CMS to survey CMHCs for compliance with health and safety requirements.
These regulations are effective on October 29, 2014.
Mary Rossi-Coajou, (410) 786–6051.
In 2012, 100 certified Community Mental Health Centers (CMHCs) billed Medicare for partial hospitalization services. Currently, there are no Conditions of Participation (CoPs) in place for Medicare-certified CMHCs. As such, an insufficient regulatory basis exists to ensure quality and safety for CMHC care. Sections 1102 and 1871 of the Social Security Act (the Act) give CMS the general authority to establish CoPs for Medicare providers. Therefore, we are establishing for the first time a set of requirements that Medicare-certified CMHCs must meet in order to participate in the Medicare program. These CoPs will help to ensure the quality and safety of CMHC care for all clients served by the CMHC, regardless of payment source.
These requirements focus on a short term, person-centered, outcome-oriented process that promotes quality client care. Requirements for CMHC services encompass—(1) personnel qualifications; (2) client rights; (3) admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client; (4) treatment team, active treatment plan, and coordination of services; (5) quality assessment and performance improvement; and (6) organization, governance, administration of services, and partial hospitalization services. Bridging these CMHC requirements are quality assessment and performance improvement program requirements that build on a provider's own quality management system to improve client care performance. We expect CMHCs to furnish health care that meets the essential health and quality standards that are established by this rule; therefore, a CMHC will be expected to use its own quality management system to monitor and improve its own performance and compliance.
Section 1832(a)(2)(J) of the Act established coverage of partial hospitalization services for Medicare beneficiaries in CMHCs. Section 1861(ff)(2) of the Act defines partial hospitalization services as a broad range of mental health services “that are reasonable and necessary for the diagnosis or active treatment of the individual's condition, reasonably expected to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization, and furnished pursuant to such guidelines relating to frequency and duration of services as the Secretary shall by regulation establish. . . .”
Section 4162 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990) (Pub. L. 101–508) amended sections 1832(a)(2) and 1861(ff)(3) of the Act to allow CMHCs to provide partial hospitalization services. Under the Medicare program, apart from limited telehealth services, CMHCs are recognized as Medicare providers only for partial hospitalization services (see 42 CFR 410.110).
A CMHC, in accordance with section 1861(ff)(3)(B) of the Act, is an entity that meets applicable licensing or certification requirements for CMHCs in the State in which it is located, and provides the set of services specified in section 1913(c)(1) of the Public Health Service Act (PHS Act). However, CMS has learned that most States either do not have a certification or licensure program for these types of facilities, or have regulatory requirements that apply only to CMHCs that receive Medicaid or other direct state funding.
A CMHC may receive Medicare payment for partial hospitalization services only if it meets the core requirements at § 410.2 and provides partial hospitalization program (PHP) services that are in accordance with regulations at § 424.24(e).
When the partial hospitalization program benefit in CMHCs was first enacted, CMHCs were certified based on self-attestation. Currently, CMHCs are Medicare-certified and Medicare-enrolled based on a CMS Regional Office determination that the provider meets the definition of a CMHC at section 1861(ff)(3)(B) of the Act and provides the core services described in section 1913(c)(1) of the PHS Act. CMS has received complaints regarding some CMHCs, such as their ceasing to provide services once the CMHC has been certified, physically mistreating clients, and providing fragmented care. As there are no CoPs in place for CMHCs, many participating CMHCs have never had an onsite survey visit by CMS after their initial certification. Furthermore, there are currently only limited circumstances in which CMS can terminate a CMHC from Medicare participation based on the result of a complaint investigation. Without such health and safety standards in place, CMS's oversight of CMHCs is severely limited.
Medicare is responsible for establishing requirements to promote the health and safety of care provided to its beneficiaries. We believe that basic health and safety standards should be established for CMHCs in order to protect clients and their families. Establishing CMHC CoPs will enable CMS to survey providers, through State survey and certification agencies, to ensure that the care being furnished meets the standards.
On August 20, 2012, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) published a report entitled Questionable Billing by Community Mental Health Centers, OEI–04–11–00100
We developed the CMHC requirements based on the following principles:
• A focus on the continuous, integrated, mental health care process that a client experiences across all CMHC services.
• Activities that center around client assessment, the active treatment plan, and service delivery.
• Use of a person-centered, interdisciplinary approach that recognizes the contributions of various skilled professionals and other support personnel and their interaction with each other to meet the client's needs.
• Promotion and protection of client rights.
Based on these principles, we proposed and are finalizing the following six CoPs: (1) Personnel qualifications; (2) client rights; (3) admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client; (4) treatment team, active treatment plan, and coordination of services; (5) quality assessment and performance improvement; and (6) organization, governance, administration of services, and partial hospitalization services.
The “Personnel qualifications” CoP establishes staff qualifications for the CMHC.
The “Client rights” CoP emphasizes a CMHC's responsibility to respect and promote the rights of each CMHC client.
The “Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client” CoP reflects the critical nature of a comprehensive assessment in determining appropriate treatments and accomplishing desired health outcomes.
The “Treatment team, active treatment plan, and coordination of services” CoP incorporates a person-centered interdisciplinary team approach, in consultation with the client's primary health care provider (if any).
The “Quality assessment and performance improvement” CoP challenges each CMHC to build and monitor its own quality management system to monitor and improve client care performance.
The “Organization, governance, administration of services, and partial hospitalization services” CoP charges each CMHC with the responsibility for creating and implementing a governance structure that focuses on and enhances its coordination of services to better serve its clients.
Two of the CoPs, “Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client” and “Treatment team, active treatment plan, and coordination of services,” establish a cycle of individualized client care. The client's care needs will be comprehensively assessed, enabling the interdisciplinary team, with the client, to establish an active treatment plan. The active treatment plan will be implemented, and the results of the care will be evaluated by updating the comprehensive assessment and active treatment plan.
These CoPs present an opportunity for CMHCs, States, and CMS to join in a partnership for improvement. CMHC programming will reflect a person-centered approach that will affect how State survey and certification agencies and CMS manage the survey process. This approach provides opportunities for improvement in client care.
We published a proposed rule in the
We specified that the new subpart J would include the basis and scope of the subpart, definitions, and the six CoPs and requirements.
We provided a 60-day public comment period in which we received a total of 203 timely comments from accrediting bodies, consumer advocacy organizations, CMHCs, individuals, national health care provider organizations, State agencies, and State health care provider organizations. Overall, the majority of commenters were supportive of the proposed changes. Summaries of the major issues and our responses are set forth below.
At § 485.900, we proposed to cite the statutory authority for CMHCs to provide services that are payable under Medicare Part B. In addition, we proposed to describe the scope of provisions in proposed subpart J.
At § 485.902, we proposed to define the following terms to be used in the CoPs for CMHCs under the proposed subpart J: “active treatment plan,” “community mental health center (CMHC),” “comprehensive assessment,” “employee of a CMHC,” “initial evaluation,” “representative,” “restraint,” “seclusion,” and “volunteer”.
We proposed to add a new CoP at § 485.904 to establish staff qualifications for CMHCs. The proposed CoP was divided into two standards.
At § 485.904(a), “Standard: General qualification requirements,” we proposed to require that all professionals who furnish services directly, under an individual contract, or under arrangements with a CMHC, be legally authorized (licensed, certified or registered) in accordance with applicable Federal, State and local laws, and be required to act only within the scope of their State licenses, certifications, or registrations. We also proposed that all personnel qualifications would have to be kept current at all times.
At § 485.904(b), “Standard: Personnel qualifications for certain disciplines,” we proposed to require staff qualifications to be consistent with, or similar to, those set forth in CoPs for other provider types in the Medicare regulations. Specifically, we proposed personnel requirements for the following disciplines: Administrator of a CMHC, Clinical Psychologist, Clinical Social Worker, Mental Health Counselor, Occupational Therapist, Physician, Psychiatric Registered Nurse, and Psychiatrist.
Commenters also stated that CMS is required to accept the scope of state licensure of various mental health care professionals in the context of Medicare's partial hospitalization program benefit. Congress explicitly stated in the Social Security Act that individual and group therapy services provided within a partial hospitalization program at a CMHC can be conducted by physicians, psychologists or “other mental health professionals to the extent authorized under State law”, as noted in Section 1861(ff)(2)(A) of the Act.
Other commenters stated that psychiatric registered nursing is specialized nursing care and an integral component in the provision of services at CMHCs. As a result, those commenters recommended that CMS remove the word “registered” and broaden the definition of “psychiatric nurse” so that it includes all licensed nurses who possess the requisite education and experience as outlined in the CoP. Furthermore, the commenters requested that the personnel requirement for psychiatric registered nurses remain in accordance with § 410.43(a)(4)(iii), “trained psychiatric nurses,” and eliminate the word “Registered.” Commenters also requested that psychiatric nurses be permitted to facilitate education groups and to perform mental health assessments in the CMHC setting, as allowed by state law.
Some commenters believe that the clinical social worker definition should be expanded to reflect the services that they perform. The definition recommended by the commenters was “Clinical social work services include the assessment, diagnosis, treatment, and prevention of mental illness, emotional, and other behavioral disturbances.”
• Have a Bachelor's degree in social work (BSW) from an institution accredited by the Council on Social Work Education; or a Bachelor's degree in psychology or sociology, and be supervised by an MSW who meets the qualifications set out at § 410.73 of this chapter.
If a CMHC chooses to employ a social worker with a Bachelor's degree in social work, psychology or sociology, the services of the social worker must be provided under the supervision of a clinical social worker with an MSW or a doctoral degree in social work from a school of social work accredited by the Council on Social Work Education. Such BSW must also meet the qualifications set out at § 410.73 of this chapter. We believe that requiring MSW supervision of BSW services will help ensure that client needs are met. The MSW supervisor role is that of an active advisor, consulting with the BSW on assessing the needs of clients, developing and updating the social work portion of the active treatment plan, and delivering care to clients. The supervision may occur over the telephone, through electronic communication, or any combination thereof.
Some commenters raised concern that the standard contains no verification that the psychologists are trained in health service provisions and that only requiring a generic license to authorize the individual to engage in a variety of psychological services does not distinguish between individuals who are trained and experienced in health service provision and those who are trained in research, teaching, or industrial/organizational fields.
We also agree that protecting the clients served by the CMHC is of great importance. The personnel requirements for psychologists at § 485.904(b)(2) reference the clinical psychologist qualification requirements at § 410.71(d). We understand the importance of requiring the schools to be accredited. However, we do not have any data indicating that clinical psychologists graduating from non-accredited programs reduces the level of quality care provided to clients served. Without formal evidence, modifying the psychologist personnel requirement in the CoPs would create a discrepancy between the conditions of participation and the payment policy requirements at § 410.71(d).
Other commenters requested that CMS add requirements for mental health technicians and drivers. The commenters also expressed concern regarding the level of supervision of these employees. Furthermore, the commenters stated that many CMHCs employ drivers who also work as “Mental Health Techs”. It is unclear if these medically unlicensed individuals have direct contact with clients and if so, what level of supervision should be expected.
We proposed to add a new CoP at § 485.910. The proposed CoP was divided into six standards.
At § 485.910(a), “Standard: Notice of rights and responsibilities,” we proposed to set forth certain rights to which CMHC clients would be entitled, and to require that CMHCs inform each client verbally of these rights in a language and manner that the client or client's representative (if appropriate) or surrogate understands.
We also proposed to require that the client be provided a written copy of client rights information. This information would have to be accessible to persons who have limited English proficiency (LEP).
At § 485.910(a)(1), we proposed that the notice of rights and responsibilities, including information concerning how to file a grievance, would be given to the client, the client's representative or surrogate, as appropriate, during the initial evaluation, as described at proposed § 485.914(b).
At § 485.910(b), “Standard: Exercise of rights and respect for property and person,” we proposed that a client be able to exercise his or her rights, have his or her property and person respected, voice grievances, and not be subjected to discrimination or reprisal for exercising his or her rights.
Furthermore, at § 485.910(b)(2), we proposed procedures if the client has been adjudged incompetent under State law. At (b)(3), the proposed rule addressed the appointment of a legal representative. We also proposed at § 485.910, “Standard: Rights of the client,” that the client would have the right to—(1) participate in the active treatment planning process; (2) refuse care or treatment; (3) have his or her records kept confidential; (4) be free from mistreatment, neglect, abuse, and misappropriation of his or her personal property; (5) receive information about limitations on CMHC services; and (6) not be compelled to perform services for the CMHC.
At § 485.910(d), “Standard: Addressing violations of client rights,” we proposed that CMHC personnel be required to report all complaints of alleged violations of clients' rights to the CMHC administrator. We also proposed that the CMHC immediately investigate all alleged violations, take intermediate actions to prevent further potential client rights violations during the investigation period, and take appropriate corrective action, where necessary. Furthermore, we proposed that the CMHC report the violations to appropriate authorities having jurisdiction within 5 working days of the CMHC becoming aware of the verified violations of client rights.
We proposed the client rights CoP to act as a safeguard of client health and
At § 485.910(e), “Standard: Restraint and seclusion,” we addressed the use of restraints and seclusion in a CMHC. We proposed that all clients have the right to be free from physical or mental abuse, and corporal punishment. Since accidental injuries and deaths have been documented in medical facilities due to the use of restraint and seclusion, we want to strongly discourage the use of restraints or seclusion in a CMHC environment where the clients are receiving services on an outpatient basis. However, we are aware that under extremely rare instances their application may be warranted for brief periods of time, and only while awaiting transport of the client to a hospital for evaluation and treatment when exhibiting behavior that threatens immediate harm to the client or others. In response to accidental injuries and deaths, we published hospital restraint and seclusion requirements on December 8, 2006 (71 FR 71378) that included a new standard at § 482.13. The hospital restraint and seclusion CoP is the basis for the proposed CMHC restraint and seclusion CoP, with modifications to the regulatory requirements to accommodate this outpatient setting.
The proposed restraint and seclusion standard was divided into five elements. These elements focused on the proper use of seclusion and restraints and the need for CMHC personnel to receive training and education on the proper use of seclusion and restraint application and techniques, as well as the use of alternative methods for handling situations that arise. The standard proposed specific requirements for physician orders for seclusion or restraint, along with a corresponding order for the client's immediate transfer to a hospital when restraint or seclusion is ordered. The standard also included a requirement that there must be specific documentation in the client's clinical record regarding the use of restraints.
At § 485.910(f), “Standard: Restraint or seclusion: Staff training requirements,” we address the training of the CMHC staff. The training consists of specific intervals, content and trainer requirements. § 485.910(g), “Standard: Death reporting requirements” states that a CMHC would have to report to its CMS regional office no later than close of business the next business day, any death that occurs while a client is restrained or in seclusion while awaiting transfer to the hospital.
Additionally, commenters also stated that there should also be additional emphasis on the provision of sign language interpretation for individuals who are deaf, and alternative written formats such as Braille and large print for individuals who are visually impaired.
Section 504 of the Rehabilitation Act of 1973 prohibits discrimination on the basis of disability in programs or activities that receive Federal financial assistance. Therefore, as recipients of Federal financial assistance (that is, loans, grants, or Medicare or Medicaid reimbursements), CMHCs must comply with the nondiscrimination requirements. Furthermore, there are also several sections of the Americans with Disabilities Act (ADA) that require facilities, such as CMHC providers, to provide appropriate accommodations for their clients. Since section 504 and the ADA provisions are applicable to CMHCs, we are not addressing the specifics of these requirements in the CoPs.
We also understand the commenters' concern with the CMHC internal investigation procedures. We believe requiring CMHCs to investigate potential violations of client rights by CMHC staff (including contracted or arranged services) may represent a conflict of interest, or insufficient to protect clients and their families.
For this reason, we are amending the requirement at § 485.910(d)(4) to require that all violations be reported to State survey and certification agencies, and verified by the appropriate investigator, violations also be reported to State and local entities having jurisdiction. While we understand the commenters' concern with the CMHC internal investigation procedures, we believe requiring CMHCs to investigate potential violations of client rights by CMHC staff (including contracted or arranged services) will protect clients and their families. Reporting violations, when verified in accordance with CMHC policies and procedures and any applicable State and local laws and regulations related to client health and safety, is an integral part of improving the quality of CMHC care provided to Medicare beneficiaries. Ultimately the CMHC must follow Federal and State laws related to client health and safety, as well as follow its own internal policies and procedures. We expect significant violations, such as illegal actions by CMHC staff, to be reported to State and local authorities. We believe that the framework in this regulation, coupled with a CMHC's own policies and procedures and State and local requirements related to client health and safety, will allow CMHCs to adapt the requirements to the particular needs and concerns of their client populations now and in the future.
If State requirements for reporting violations are stricter than our Federal requirements, the stricter State requirements would take precedence. Stricter State requirements may be those that require violations to be reported regardless of whether they are verified, or requirements that verified violations be reported in less than five days. However, if State requirements are less stringent than Federal requirements, then the Federal requirements will take precedence.
We emphasize that in states where the use of seclusion and restraint techniques are permitted, they may only be used to protect the client or others from immediate harm, and their use would trigger immediate transportation to a hospital. In the rare occurrence that a restraint and seclusion order is
Should a seclusion or restraint-related death occur, our intent is to ensure that the CMHC immediately notify CMS and begin to fully investigate the death. Waiting to determine if the death was directly caused by the use of restraint or seclusion could potentially have negative impact on other clients being served by the CMHC. We acknowledge that seclusion and restraint are rarely, if ever, used and that the likelihood of death ever having to be reported is extremely low. However, it is imperative that the CMHC report any instance where a death of a client is associated with the use of seclusion or restraint. Should a seclusion or restraint-related death occur, we would initiate an onsite complaint survey of the CMHC in accordance with the existing complaint investigation process.
We proposed to add a new CoP at § 485.914 to establish requirements for admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client. The proposed CoP at § 485.914 identified general areas that would be included in a client assessment and the timeframes for completing the assessments to help the CMHC ensure it was identifying the needs in all areas in a timely fashion. The proposed CoP was divided into five standards.
At § 485.914(a), “Standard: Admission,” we proposed to require the CMHC to determine whether a client is appropriate for the services the CMHC provides. At § 485.914(b), “Standard: Initial evaluation,” we proposed to require the CMHC psychiatric registered nurse or clinical psychologist to complete the initial evaluation. We stated that the care needs identified in the initial evaluation would include, but would not be limited to, those necessary for treatment and management of the psychiatric illness. We also specified that the initial assessment would be completed within 24 hours of the client admission to the CMHC.
At § 485.914(c), “Standard: Comprehensive assessment,” we proposed that a physician-led interdisciplinary team, in consultation with the client's primary health care provider (if any), complete the comprehensive assessment. We stated that the comprehensive assessment would build from the initial evaluation and identify the client's physical, psychological, psychosocial, emotional and therapeutic needs. The interdisciplinary team would be composed of a doctor of medicine, osteopathy or psychiatry; a psychiatric registered nurse, a clinical psychologist, a clinical social worker, an occupational therapist, and other licensed mental health counselors, as necessary. Each member of the team would provide input within the scope of that individual's practice. As proposed, the comprehensive assessment would include information about the client's psychiatric illness and history, complications and risk factors, drug profile review, and the need for referrals and further evaluations by appropriate health care professionals. The comprehensive assessment would be completed within 3 working days after the admission to the CMHC.
At § 485.914(d), “Standard: Update of the comprehensive assessment,” we proposed that the CMHC would update the comprehensive assessment via the physician-led interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), no less frequently than every 30 days, and when changes in the client's status, response to treatment, or goals occurred. The update would have to include information on the client's progress toward desired outcomes, a reassessment of the client's response to care and therapies, and the client's goals. We believe that these frequent reviews are necessary since clients with ongoing mental illness may be subject to frequent and/or rapid changes in status, needs, acuity, and circumstances, and the client's treatment goals may change, thereby affecting the type and frequency of services that should be furnished. The physician-led interdisciplinary treatment team would use assessment information to guide necessary reviews and/or changes to the client's active treatment plan.
At § 485.914(e), “Standard: Discharge or transfer of the client,” we proposed that the CMHC complete a discharge summary and forward it to the receiving facility/provider, if any, within 48 hours of discharge or transfer from the CMHC. If the client is being discharged due to non-compliance with the treatment plan, the CMHC would forward the discharge summary and, if requested, other pertinent clinical record information to the client's primary health care provider (if any). The discharge summary would be required to include—(1) a summary of the services provided while a client of the CMHC, including the client's symptoms, treatment and recovery goals and preferences, treatments, and therapies; (2) the client's current active treatment plan at the time of discharge; (3) the client's most recent physician orders; and (4) any other documentation that would assist in post-discharge continuity of care. Furthermore, under this standard we proposed that the CMHC would have to adhere to all Federal and State-related requirements pertaining to medical privacy and the release of client information. We believe this standard would help ensure that the information flow between the CMHC and the receiving entity was smooth, and that the appropriate care continued without being compromised (where applicable).
We also understand that there may be unlicensed staff (completing their education or licensure requirements) conducting initial evaluations under the supervision of a licensed professional. We believe that the initial evaluation is paramount in meeting the immediate needs of the client and beginning the active treatment plan. Therefore, we have amended the language at § 485.914(b)(1) to allow a licensed mental health professional acting within his or her State scope of practice to conduct the initial evaluation. We will allow staff working towards completing their education or licensure requirements to complete the initial evaluation under the direct supervision of a licensed mental health professional (as required by all State law and regulations related to the supervision of unlicensed professionals and students) employed by the CMHC.
We would like to stress the importance of client privacy and confidentiality and remind CMHCs that HIPAA applies to release of protected health information by CMHCs; it is generally prohibited to release client information to non-health care entities without the express consent of the client. If CMHCs do release such information to state or local agencies, they must generally obtain consent from the client before such release.
We proposed to add a new CoP at § 485.916 to establish requirements for an active treatment plan and coordination of services.
At § 485.916(a), “Standard: Delivery of services,” we proposed that the CMHC designate a physician-led interdisciplinary team for each client. We proposed that the interdisciplinary team include a psychiatric registered nurse, clinical psychologist, or a Master's level prepared or Doctoral level prepared social worker, who would be a coordinator responsible, with the client, for directing, coordinating and managing the care and services provided to the client. The team would be composed of individuals who would work together to meet the physical, medical, psychosocial, emotional, and therapeutic needs of CMHC clients.
The CMHC would designate a psychiatric registered nurse, clinical psychologist or clinical social worker who was a member of the interdisciplinary treatment team to coordinate care, ensure the continuous assessment of each client's needs, and ensure the implementation and revision of the active treatment plan. Depending on the number and/or type of clients served by the CMHC, the CMHC may have more than one interdisciplinary team. If so, the CMHC is required to designate one treatment team responsible for establishing policies and procedures governing the day-to-day operations of the CMHC, and the care and services provided to clients.
At § 485.916(b), “Standard: Active treatment plan,” we proposed to require that all CMHC services furnished to clients follow a written active treatment plan established by the CMHC physician-led interdisciplinary treatment team and the client (and representative, if any), in accordance with the client's psychiatric needs and goals within 3 working days after the client's admission to the CMHC. The CMHC would have to ensure that each client and, if relevant, primary
At § 485.916(c), “Standard: Content of the active treatment plan,” we proposed to require that each client's active treatment plan reflects client goals and interventions for problems identified in the comprehensive and updated assessments. This proposed requirement would ensure that care and services were appropriate to the level of each client's specific needs. The active treatment plan would include all of the services necessary for the care and management of the psychiatric illness. We would also require a detailed statement of the type, duration and frequency of services, including social work, counseling, psychiatric nursing and therapy services. Services furnished by other staff trained to work with psychiatric clients necessary to meet the specific client's needs should also be documented. The interdisciplinary treatment team should document the client's and representative's (if any) understanding, involvement, and agreement with the active treatment plan, in accordance with the CMHC's own policies. This would include information about the client's need for services and supports, and treatment goals and preferences.
At § 485.916(d), “Standard: Review of the active treatment plan,” we proposed that a revised active treatment plan be updated with current information from the client's comprehensive assessment and information concerning the client's progress toward achieving outcomes and goals specified in the active treatment plan. The active treatment plan would have to be reviewed at intervals specified in the plan, but no less frequently than every 30 calendar days.
At § 485.916(e) “Standard: Coordination of services,” we proposed to require that the CMHC maintain a system of communication and integration to enable the interdisciplinary treatment team to ensure the overall provision of care and the efficient implementation of day-to-day policies and procedures. This proposed standard would also make it easier for the CMHC to ensure that the care and services are provided in accordance with the active treatment plan, and that all care and services provided are based on the comprehensive and updated assessments of the client's needs. An effective communication system also enables the CMHC to ensure the ongoing sharing of information among all disciplines providing care and services, whether the care and services are being provided by employees or by individuals under contract with the CMHC.
In the instance of partial hospitalization, clients need acute services and must be under the care of a physician. According to the statutory requirements, which are implemented in CMS regulations at 42 CFR 424.24(e), PHP services must be prescribed by a physician and under the supervision of a physician pursuant to an individualized, written plan of treatment established and periodically reviewed by a physician (in consultation with appropriate staff participating in such program). Furthermore, upon admission, a physician must certify that in absence of PHP services, the person would otherwise require inpatient psychiatric treatment. If continued PHP treatment is necessary, a physician must recertify as of the 18th day of treatment and no less than every 30 days after that documenting the need for this level of service. Therefore, a physician is inextricably involved in a PHP client's treatment team.
At § 485.916(a)(2), we proposed a psychiatric registered nurse, a clinical psychologist, or a clinical social worker, who is a member of the interdisciplinary team to coordinate care and treatment decisions with each client, to ensure that each client's needs were assessed and to ensure the active treatment plan was implemented as indicated. We understand that there may be other licensed mental health professionals serving on the interdisciplinary team that could be appropriate to coordinate the client's care. Therefore, we have amended the language at § 485.916(a)(2) to allow the CMHC to determine (based on the findings of the client's comprehensive assessment) which appropriate licensed mental health professional(s) on the client's interdisciplinary team should coordinate care and treatment decisions with each client. This coordinator role would work to ensure that each client's needs are assessed and to ensure that the active treatment plan is implemented as indicated.
In the instances of partial hospitalization, due to the acuity level of the clients served, we expect the partial hospitalization program to meet the requirement at § 424.24.
We proposed to add a new CoP at § 485.917 to specify the requirements for a quality assessment and performance improvement program (QAPI). The proposed QAPI CoP was divided into five standards.
At § 485.917(a), “Standard: Program scope,” we proposed that a CMHC QAPI would include, but not be limited to, an ongoing program that is able to show measureable improvement in indicators linked to improving client care outcomes and behavioral health support services. We expect that a CMHC would use standards of care and the findings made available in current literature to select indicators to monitor its program. The CMHC would have to measure, analyze, and track quality indicators, including areas such as adverse client events and other aspects of performance that assess processes of care, CMHC services and operations. The term “adverse client events,” as used in the field, refers to occurrences that are harmful or contrary to the targeted client outcomes, including sentinel events such as an unexpected occurrence involving death or serious injury. The use of restraint or seclusion is contrary to targeted client outcomes; therefore, we would consider the use of restraint or seclusion to be an adverse client event that would be tracked and analyzed as part of the QAPI program.
At § 485.917(b), “Standard: Program data,” we proposed to require the CMHC to incorporate quality indicator data, including client care data and other relevant data, into its QAPI program. A fundamental barrier in identifying quality care is lack of measurement tools. Measurement tools can identify opportunities for improving medical care and examining the impact of interventions.
We did not propose to require CMHCs to use any particular process, tools or quality measures. However, a CMHC that uses available quality measures could expect an enhanced degree of insight into the quality of its services and client satisfaction.
The CMHC could also develop its own data elements and measurement process as part of its program. A CMHC would be free to develop a program that meets its needs. We recognize the diversity of provider needs and concerns with respect to QAPI programs. As such, a provider's QAPI program would not be judged against a specific model. We expect the CMHC to develop and implement a continuous QAPI program that stimulates the CMHC to constantly monitor and improve its own performance, and to be responsive to the needs and satisfaction levels of the clients it serves.
At § 485.917(b), we proposed to require that data collected by the CMHC, regardless of the source of the data elements, would be collected in accordance with the detail and frequency specifications established by the CMHC's governing body. Once collected, the CMHC would use the data to monitor the effectiveness and safety of services, and target areas for improvement. The main goal of the proposed standard would be to identify and correct ineffective and/or unsafe care. We expect CMHCs to assess their potential client load and identify circumstances that could lead to significant client care issues, and concentrate their energies in these areas.
At § 485.917(c), “Standard: Program activities,” we proposed to require the CMHC to set priorities for its performance improvement activities that focus on high risk, high volume or problem-prone areas; consider the prevalence and severity of identified problems; and give priority to improvement activities that affect client safety, and quality of client outcomes. We expect that a CMHC would take immediate action to correct any identified problems that would directly or potentially threaten the care and safety of clients. Prioritizing areas of improvement is essential for the CMHC to gain a strategic view of its operating environment and to ensure consistent quality of care over time.
We also proposed to require the CMHC to track adverse client events, analyze their causes, and implement preventive actions that include feedback and learning throughout the CMHC. In implementing its QAPI program, a CMHC is expected to treat staff and clients/representatives as full partners in quality improvement. Staff members and clients/representatives are in a unique position to provide the CMHC with structured feedback on, and suggestions for, improving the CMHC's performance. We expect the CMHC to demonstrate how the staff and clients have contributed to its quality improvement program.
At § 485.917(d), “Standard: Performance improvement projects,” we proposed to require that the number and scope of improvement projects conducted annually would reflect the scope, complexity and past performance of the CMHC's services and operations. The CMHC would document what improvement projects were being conducted, the reasons for conducting them and the measurable progress achieved by them.
At § 485.917(e), “Standard: Executive responsibilities,” we proposed to require that the CMHC's governing body would be responsible and accountable for ensuring that the ongoing quality improvement program is defined, implemented, maintained, and evaluated annually. The governing body would ensure that the program addressed priorities for improved quality of care and client safety. The governing body would also have to specify the frequency and level of detail of the data collection and ensure that all quality improvement actions were evaluated for effectiveness. The governing body's most important role would be to ensure that staff was furnishing, and clients were receiving, safe, effective, quality care. Therefore, it would be incumbent on the governing body to lend its full support to agency quality improvement and performance improvement efforts.
CMHCs utilizing resources from a quality improvement organization will still be expected to provide separate documentation evidencing their QAPI program.
We proposed to add a new CoP at § 485.918, to set out the CMHC's administrative and governance structure and to clarify performance expectations for the governing body. As explained in the proposed rule, the overall goal of this CoP is to ensure that the management structure is organized and accountable. The proposed CoP was divided into seven standards.
In the proposed organization and administration of services CoP, we proposed to list the services that the statute (section 1861(ff)(3) of the Act) requires CMHCs to furnish. We also proposed a standard that would require a CMHC to provide in-service training to all employees and staff, including those under contract or under arrangements, who have client contact. This requirement would assist in ensuring that all staff serving CMHC clients was up to date on current standards of practice. The CMHC would be required to have written policies and procedures describing its methods for assessing staff skills and competency, and to maintain a written description of in-service training offered during the previous 12 months.
At § 485.918(a), “Standard: Governing body and administrator,” we proposed to emphasize the responsibility of the CMHC governing body (or designated persons so functioning) for managing all CMHC facilities and services, including fiscal operations, quality improvement, and the appointment of the administrator. The administrator would be responsible for the day-to-day operation of the CMHC and would report to the governing body. The administrator would have to be a CMHC employee, and meet the education and experience requirements established by the CMHC's governing body. The specifics of the administration of the CMHC would be left to the discretion of the governing body, thereby affording the CMHC's management with organizational flexibility. The proposed governing body standard reflects our goal of promoting the effective management and administration of the CMHC as an organizational entity without dictating prescriptive requirements for how a CMHC must meet that goal.
At § 485.918(b), “Provision of services,” we proposed to specify a comprehensive list of services that a CMHC would be required to provide. At § 485.918(b)(1)(v), we proposed to require the CMHC to provide at least 40 percent of its services to individuals who are not eligible for benefits under title XVIII of the Act (Medicare). This proposed requirement would track the changes to § 410.2 set out in the November 24, 2010 Outpatient Prospective Payment System (OPPS)
Enactment of section 1301(a) of HCERA revised the definition of a CMHC set forth at section 1861(ff)(3)(B) of the Act by adding a provision to the existing requirements for CMHCs, effective on the first day of the first calendar quarter that began at least 12 months after the date of enactment (that is, April 1, 2011). As of that date, a Medicare-participating CMHC must provide at least 40 percent of its services to individuals who are not eligible for benefits under Medicare.
We proposed to measure whether a CMHC is providing at least 40 percent of its services to individuals who are not eligible for Medicare benefits by the amount of reimbursement for all services furnished. Additionally, we proposed to measure the 40 percent of its services on an annual basis. We solicited public comments on whether we should determine if a CMHC meets the 40 percent requirement annually or at some other interval. We also solicited comments on both the definition of terms used in any approach to measuring the 40 percent threshold and the data sources for that measurement. Specifically, since the measure proposed to determine the 40 percent threshold was total reimbursement from all payers, for all services provided, we were interested in comments on how we should define reimbursement.
We also requested feedback on whether the proposed calculation should include uncompensated care or any other aspect of reimbursement, and on whether CMS should require the CMHCs to attest to whether they meet the 40 percent requirement, or whether we should subject them to verification auditing.
Furthermore, we stated our interest in receiving comments on any other approaches that could constitute a measure of the 40 percent threshold. We stressed that we were concerned that the implementation of this provision not negatively impact access to care.
Medicare-certified CMHCs are already required to provide most of the services set out in the proposed provision of services standard through the existing CMS payment rules (42 CFR 410.2, § 410.110, and § 424.24(e)). It is essential for CMHCs to have sufficient numbers of appropriately educated and trained staff to meet these service expectations. For example, CMHCs that provide partial hospitalization services could provide the services of “other staff trained to work with psychiatric clients” (42 CFR 410.43(a)(3)(iii)). Non-specified staff might be responsible for supervising clients and ensuring a safe environment. CMHCs would be expected to have a sufficient number of appropriately-trained staff to meet these responsibilities at all times.
At § 485.918(c), “Standard: Professional management responsibility,” we proposed to require that where services are furnished by other than CMHC staff, a CMHC would have to have a written agreement with another agency, individual, or organization that furnishes the services. Under this agreement, the CMHC would retain administrative and financial management and oversight of staff and services for all arranged services. The CMHC would have to have a written agreement that specified that all services would have to be authorized by the CMHC, be furnished in a safe and effective manner, and be delivered in accordance with established professional standards, the policies of the CMHC and the client's active treatment plan. As part of retaining financial management responsibility, the CMHC would retain all payment responsibility for services furnished under arrangement on its behalf.
At § 485.918(d), “Standard: Staff training,” which would apply to all employees, staff under contract, and volunteers, we proposed to require a CMHC to take steps to develop appropriate in-service programs, including initial orientation for each new employee or volunteer furnishing services. The new employee orientation would address specific job duties. The CMHC could also provide staff training under arrangement.
We would not require a specific staff in-service training program; rather, we would expect each CMHC to determine the scope of its own program, including the manner in which it chose to deliver the training, assess competence levels, determine training content, determine the duration and frequency of training for all employees, and track the training on a yearly basis.
At § 485.918(e)(1), “Standard: Environmental conditions,” and (e)(2), “Building,” we proposed to require the CMHC to provide services in an environment that is safe, functional, sanitary, comfortable, and in compliance with all Federal, State, and local health and safety standards, as well as State health care occupancy regulations. We indicated that these proposed requirements would help to ensure that CMHC services are provided in a physical location that is both safe and conducive to meeting the needs of CMHC clients.
At § 485.918(e)(3), ”Infection control,” we proposed to address the seriousness and potential hazards of infectious and communicable diseases. We would require a CMHC to develop policies, procedures, and monitoring, as well as take specific actions to address the prevention and control of infections and disease.
We believe that a CMHC should follow nationally accepted infection control standards of practice and ensure that all staff know and use current best preventive practices. Periodic training is one way to assure staff understanding, and we would expect the CMHC to establish a method to ensure that all staff receives appropriate training. Where infection and/or communicable diseases are identified, we would expect actions be taken to protect all the clients and staff.
At § 485.918(e)(4), “Therapy sessions,” we proposed that the CMHCs ensure that all individual and group therapy sessions be conducted in a manner that maintains client privacy and dignity. We believe that a safe, private environment would enhance the effectiveness of the therapy sessions.
At § 485.918(f), “Standard: Partial hospitalization services,” we proposed that all partial hospitalization services would be required to meet all applicable requirements of 42 CFR parts 410 and 424.
At § 485.918(g), “Standard: Compliance with Federal, State, and local laws and regulations related to the health and safety of clients,” we proposed that the CMHC and its staff be required to operate and furnish services in compliance with all applicable Federal, State, and local laws and regulations related to the health and safety of clients. If State or local law provided for licensing of CMHCs, the CMHC would have to be licensed. In addition, the CMHC staff would have to follow the CMHC's policies and procedures.
• Numerator: The numerator would include an unduplicated census of individuals who rely solely on health care coverage provided through private sector insurance or public health programs other than Medicare, indigent individuals and any other uninsured or inadequately insured individuals who receive behavioral health services from the CMHC.
• Denominator: The denominator would include an unduplicated census for all clients who receive services from the CMHC.
• Validation: For each reporting period, the CMHC could attest to the accuracy of the numbers reported to CMS for the patient-centric numerator and denominator identified above. Medicare providers are required to prepare attestations in other contexts involving eligibility to receive Medicare reimbursement, including, but not limited to, the attestations used in the calculation of bad debt.
• Annual Reporting Period: Adopt an annual reporting period based on a facility's cost reporting year.
• Failure to Meet Performance Level: Providers that fail to meet the 40 percent threshold by more than five percent during a particular year should be placed on probation for 12 months and required to develop and implement a corrective action plan to bring the facility into compliance with the 40 percent requirement. If a facility fails to meet the threshold for a second consecutive year, that CMHC should be rendered ineligible for Medicare reimbursement during the subsequent year.
We will not be using the proposed language on reimbursement or cost report information to calculate the 40 percent. Rather, we will require all CMHCs to verify their compliance with the 40 percent requirement by sending documentation to the appropriate Part A/Part B Medicare Administrative Contractor (A/B MAC) from an independent entity such as an accounting technician, which will certify that it has reviewed the client care data for the CMHC. The documentation must be sent upon initial application for Medicare provider status, and upon revalidation, including off cycle revalidation, thereafter to the relevant A/B MAC (see revalidation requirements at § 424.515). The documentation must state whether the CMHC met or did not meet the 40 percent requirement for the prior 3 months (in the case of the initial application) or for each of the intervening 12 month periods between initial enrollment and revalidation. If the CMHC did not meet the 40 percent threshold, the A/B MAC will notify the CMHC that they have 30 days to correct the issue or their Medicare enrollment and billing privileges will be denied for non-compliance (see § 424.530(a)(1)) or revoked for non-compliance (see § 424.535(a)(1)).
If an A/B MAC denies or revokes a CMHC's Medicare billing privileges, the CMHC is afforded provider enrollment appeal rights, and may reapply or seek reinstatement into the Medicare program subject to the provisions found in § 424.535.
We appreciate the commenters' suggestions related to failure to meet the 40 percent threshold. However, we disagree with the proposed probationary period and the suggestion of a 5 percent margin. The law does not allow for a probationary period or margins. This final rule becomes effective one year after publication of this rule in the
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We published a proposed rule in the
We have made several assumptions and estimates in order to assess the time that it will take for a CMHC to comply with the provisions and the associated costs of compliance. CMHC client data from outside sources are limited; therefore, our estimates are based on available Medicare data. We have detailed these assumptions and estimates in Table 1 below. We have also detailed many of the standards within each CoP, and have noted whether or not there is an impact for each in the section below. However, the requirements contained in many of the CoPs are already standard medical or business practices and, as a result, do not pose an additional burden on CMHCs.
Section 485.910(a) requires that the CMHC develop a notice of rights statement to be provided to each client. We estimate that it will require 8 hours on a one-time basis to develop this notice, and the CMHC administrator would be responsible for this task, at a cost of $528 per CMHC and $52,800 for all CMHCs nationwide. In addition, this standard requires that the CMHC obtain the client's and client representative's (if appropriate) signature confirming that he or she has received a copy of the notice of rights and responsibilities. The CMHC will have to retain the signed documentation showing that it complied with the requirements, and that the client and the client's representative demonstrated an understanding of these rights. We estimate that the time it will take for the CMHC to document the information will be 2.5 minutes per client or approximately 9.47 hours per CMHC. At an average of 2.5 minutes (.0417 hours) per client to complete both tasks, we estimate that all CMHCs will use 947 hours to comply with this requirement (.0417 hours per client × 22,700 clients). The estimated cost associated with these requirements is $44,509, based on a psychiatric nurse performing this function (947 hours × $47 per hour).
We note that we do not impose any new language translation or interpretation requirements. Under Title VI of the Civil Rights Act of 1964, recipients of federal financial assistance, such as CMHCs, have long been prohibited from discriminating on the basis of race, color, or national origin. Language interpretation is required under some circumstances under that statute and the HHS regulations at 45 CFR part 80 (see previous discussion of Office for Civil Rights guidance issued in 2003). Because we impose no new requirements not already fully encompassed in that regulation and guidance, we have estimated no paperwork burden.
Section 485.910(d)(2) requires a CMHC to document a client's or client representative's complaint of an alleged violation and the steps taken by the CMHC to resolve it. The burden associated with this requirement is the time it will take to document the necessary aspects of the issues. In late 2007, the American Association of Behavioral Health and The Joint Commission informed us that we could anticipate 52 complaints per year per CMHC and that it will take the administrator 5 minutes per complaint at the rate of $66/hr to document the complaint and resolution activities, for an annual total of 4.33 hours per CMHC or 433 hours for all CMHCs. The estimated cost associated with this requirement is $28,578.
Section 485.910(d)(4) requires the CMHC to report within 5 working days of becoming aware of the violation, all confirmed violations to the state and local bodies having jurisdiction. We anticipate that it will take the administrator 5 minutes per complaint to report, for an annual total of 4.33 hours per CMHC or 433 hours for all CMHCs. The estimated cost associated with this requirement is $28,578.
Section 485.910(e)(2) requires written orders for a physical restraint or seclusion, and § 485.910(e)(4)(v) requires physical restraint or seclusion be supported by a documentation in the client's clinical record of the client's response or outcome. The burden associated with this requirement is the time and effort necessary to document the use of physical restraint or seclusion in the client's clinical record. We estimate that it will take 45 minutes per event for a nurse to document this information. Similarly, we estimate that there will be 1 occurrence of the use of physical restraint or seclusion per CMHC annually. The estimated annual burden associated with this requirement for all CMHCs is 75 hours. The estimated cost associated with this burden for all CMHCs is $3,525.
Section 485.910(f) specifies restraint or seclusion staff training requirements. Specifically, § 485.910(f)(1) requires that all client care staff working in the CMHC be trained and able to demonstrate competency in the application of restraints and implementation of seclusion, monitoring, assessment, and providing care for a client in restraint or seclusion, and on the use of alternative methods to restraint and seclusion. Section 485.910(f)(4) requires that a CMHC document in the personnel records that each employee successfully completed the restraint and seclusion training and demonstrated competency in the skill. We estimate that it will take 35 minutes per CMHC to comply with these requirements. The estimated total annual burden associated with these requirements is 58 hours. The estimated cost associated with this requirement is $2,726.
Section 485.910(g) requires the CMHC to report any death that occurred while a CMHC client was in restraint or seclusion in the CMHC while awaiting transfer to a hospital. We have a parallel requirement in all other CMS rules dealing with programs and providers where restraint or seclusion may be used (for example, in our hospital conditions of participation). Based on informal discussions with the CMHC industry and The Joint Commission, we believe restraints and seclusion are rarely, if ever, used in CMHCs, and that there are very few deaths (if any) that occur due to restraint or seclusion in a CMHC. Several commenters stated that the majority of CMHCs have a restraint or seclusion free policy. Therefore, restraint or seclusion is not permitted in these agencies. Hence, we believe the number of deaths associated with this requirement is estimated at zero. Under 5 CFR 1320.3(c)(4), this requirement is not subject to the PRA as it would affect
Section 485.914(b) through (e) requires each CMHC to conduct and document in writing an initial evaluation and a comprehensive client-specific assessment; maintain documentation of the assessment and any updates; and coordinate the discharge or transfer of the client. The burden associated with these requirements is the time required to record the initial evaluation and comprehensive assessment, including changes and updates. We believe that documenting a client's initial evaluation and comprehensive assessment is a usual and customary business practice under 5 CFR 1320.3(b)(2) and, as such, the burden associated with it is exempt from the PRA.
Section 485.914(e) requires that, if the client were transferred to another facility, the CMHC is required to forward a copy of the client's CMHC discharge summary and clinical record, if requested, to that facility. If a client is discharged from the CMHC because of noncompliance with the treatment plan or refusal of services from the CMHC, the CMHC is required to provide a copy of the client's discharge summary and clinical record, if requested, to the client's primary health care provider. The burden associated with this requirement is the time it takes to forward the discharge summary and clinical record, if requested. This requirement is considered to be a usual and customary business practice under 5 CFR 1320.3(b)(2) and, as such, the burden associated with it is exempt from the PRA.
Section 485.916(b) requires all CMHC care and services furnished to clients and their families to follow a written active treatment plan established by the interdisciplinary treatment team. The CMHC is required to ensure that each client and representative receives education provided by the CMHC, as appropriate, for the care and services identified in the active treatment plan.
The provisions at § 485.916(c) specify the minimum elements that the active treatment plan must include. In addition, in § 485.916(d), the interdisciplinary team is required to review, revise, and document the active treatment plan as frequently as the client's condition requires, but no less frequently than every 30 calendar days. A revised active treatment plan must include information from the client's updated comprehensive assessment, and must document the client's progress toward the outcomes specified in the active treatment plan. The burden associated with these requirements is the time it takes to document the active treatment plan (.1667 hours per client or approximately 3,784 hours nationally) estimated to be a total of $1,778 per CMHC or $177,848 nationally. Additionally, we estimate any revisions to the active treatment plan (approximately 5 minutes) will cost $525 per CMHC or $88,877 nationally (1891 hours × $47/hour).
Section 485.916(e) requires a CMHC to develop and maintain a system of communication and integration to ensure compliance with the requirements contained in § 485.916(e)(1) through (e)(5). The burden associated with this requirement will be the time and effort required to develop and maintain the system of communication in accordance with the CMHC's policies and procedures. We believe that the requirement is usual and customary business practice under 5 CFR 1320.3(b)(2) and, as such, the burden associated with it is exempt from the PRA.
Section 485.917 requires a CMHC to develop, implement, and maintain an effective ongoing CMHC-wide data driven quality assessment and performance improvement (QAPI) program. The CMHC is required to maintain and demonstrate evidence of its quality assessment and performance improvement program and be able to demonstrate its operation to CMS. The CMHC is required to take actions aimed at performance improvement and, after implementing those actions, must measure its success and track its performance to ensure that improvements were sustained. The CMHC is required to document what quality improvement projects were conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
The burden associated with these requirements is the time it takes to document the development of the quality assessment and performance improvement and associated activities. We estimate that it will take each CMHC administrator an average of 4 hours per year at the rate of $66/hr to comply with these requirements for a total of 400 hours annually. The estimated cost associated with this requirement is $26,400.
Section 485.918(b) lists care and services a Medicare CMHC must be primarily engaged in regardless of payer type. Specifically, § 485.918(b)(1)(v) requires the CMHC to provide at least 40 percent of its items and services to individuals who are not eligible for benefits under title XVIII of the Act as measured by the total number of CMHC clients treated by the CMHC and not paid for by Medicare, divided by the total number of clients treated by the CMHC. The burden associated with this requirement is the time it takes for an independent entity contracted by the CMHC to calculate compliance with the 40 percent requirement and create a letter for the CMHC to submit to CMS. We estimate it will take the independent entity an average of 5 hours per new CMHC applicant and 5 hours for each CMHC that is due for its every 5 year revalidation to calculate compliance with the 40 percent requirement and create a letter to CMS. We estimate there will be 10 new CMHC applicants per year for a total of 50 hours annually and an estimated cost of $1,200. We estimate there will be 20 CMHCs up for revalidation each year for a total of 100 hours for all CMHCs, with an estimated cost of $2,400. Therefore, the annual reporting for new CMHC applicants and CMHC revalidation is estimated at 150 hours with a total cost of $3,600.
Section 485.918(c) lists the CMHC's professional management responsibilities. A CMHC could enter into a written agreement with another agency, individual, or organization to furnish any services under arrangement. The CMHC is required to retain administrative and financial management, and oversight of staff and services for all arranged services, to ensure the provision of quality care. The burden associated with this requirement is the time and effort necessary to develop, draft, execute, and maintain the written agreements. We believe these written agreements are part of the usual and customary business practices of CMHCs under 5 CFR 1320.3(b)(2) and, as such, the burden associated with them is exempt from the PRA.
Section 485.918(d) describes the standard for training. In particular, § 485.918(d)(2) requires a CMHC to
Section 485.918(e)(3) requires the CMHC to maintain policies, procedures, and monitoring of an infection control program for the prevention, control and investigation of infection and communicable diseases. The burden associated with this requirement is the time it takes to develop and maintain policies and procedures and document the monitoring of the infection control program. We believe this documentation is part of the usual and customary medical and business practices of CMHCs and, as such, is exempt from the PRA under 5 CFR 1320.3(b)(2).
Table 2 below summarizes the estimated reporting and recordkeeping burden for this final rule.
If you comment on these information collection and recordkeeping requirements, please submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS–3202–F]; Fax: (202) 395–6974; or Email:
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The overall economic impact for all new CoPs in this final rule is estimated to be $3 million in the first year of implementation and $2.2 million annually thereafter. Therefore, this is not an economically significant or major final rule.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Individuals and States are not included in the definition of a small entity. For purposes of the RFA, most CMHCs are considered to be small entities, either by virtue of their nonprofit or government status or by having revenues of less than $10 million in any one year (for details, see the Small Business Administration's Web site at
We estimate that implementation of this rule will cost CMHCs approximately $3 million, or approximately $30,000 per average CMHC, in the first year of implementation and $2.2 million, or approximately $22,000 per average CMHC, after the first year of implementation and annually thereafter. Therefore, the Secretary has determined that this final rule will not have a significant impact on a substantial number of small entities, because the cost impact of this rule is less than 1 percent of total CMHC Medicare revenue (approximately $218 million per year, as shown by CY 2010 claims data).
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2013, that threshold is approximately $141 million. This final rule will not have an impact on the expenditures of State, local, or tribal governments in the aggregate, or on the private sector of $141 million.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule has no Federalism implications.
We are establishing a new subpart J under the regulations at 42 CFR part 485 to incorporate the CoPs for CMHCs (which will be effective 12 months after the publication of this final rule). The new subpart J includes the basis and scope of the subpart, definitions, and six conditions.
Section III of this rule, Collection of Information Requirements, provides a detailed analysis of the burden hours and associated costs for all burdens related to the collection of information by CMHCs that are required by this rule. That section, in tandem with this regulatory impact analysis section, presents a full account of the burdens that are imposed by this rule. As shown above in table 2 the total cost of all information collection requirements in the first year is estimated to be $457,441. In addition, table 3 below presents the total first year cost of $2,596,809 for all other requirements. Therefore, the total cost for implementing all CoP requirements, including information collection and other costs that CMHCs must meet in order to participate in the Medicare program, is estimated to be $3 million in the first year of implementation and 2.2 million annually thereafter.
We have detailed, below, many of the standards within each CoP, and have noted whether or not there is an impact for each. However, the requirements contained in many of the provisions are already standard medical or business practices. These requirements will, therefore, not pose additional burden to CMHCs because they are already standards of practice.
Section 485.910(a), “Standard: Notice of rights and responsibilities,” requires that during the initial evaluation, the CMHC must provide the client and the client's representative or surrogate (if appropriate) with verbal and written notice of the client's rights and responsibilities in a language and manner that the individual understands. Communicating with clients, and their representatives or surrogates, in a manner that meets their communication needs is a standard practice in the health care industry. Because we are implementing a requirement that is fully compatible with existing civil rights requirements and guidance, we believe that the requirement to communicate with clients in a manner that meets their communication needs will impose no additional costs.
In addition, this standard requires a CMHC to provide each CMHC client and representative verbal and written notification of the CMHC client's rights. We estimate the burden for the time associated with providing the verbal notice will be 2.5 minutes (0.0417 hours) per client or approximately 9.47 hours per CMHC. We note that the burden associated with providing the written notice is discussed in the Collection of Information section of this rule. We estimate that all CMHCs will use 947 hours to comply with this requirement (0.0417 hours per client × 22,700 clients). The estimated cost associated with these requirements is $44,509, based on a psychiatric registered nurse performing this function (947 hours × $47 per hour).
With respect to the CoP for client rights, the standard addressing violations of client rights requires a CMHC to investigate alleged client rights violations, and take corrective actions when necessary and appropriate. We estimate that the CMHC administrator will spend, on average, 25 minutes investigating each alleged client rights violation. For purposes of our analysis, we assume that an average CMHC will investigate 1 alleged violation per week, for a total of 22 hours annually, at a cost of $1,452
In addition, we are implementing three standards under the CoP for client rights pertaining to restraint and seclusion, staff training requirements for restraints and seclusion, and death reporting requirements. These standards include requirements that guide the appropriate use of seclusion and restraint interventions in CMHCs, when necessary, to ensure the physical safety of the client and others while awaiting the client's transport to a hospital. They are adapted from the clients' rights CoP for hospitals published as a final rule in the
We anticipate that CMHCs will be minimally impacted by these standards. Several public commenters stated that restraints and seclusion are never used in CMHCs and therefore are not needed in CMHCs. However, we are still estimating the burden to facilities for restraint and seclusion use. We do not have access to several key pieces of information to estimate the burden. For example, we do not have data on the volume of staff in CMHCs, or the varying levels and qualifications of CMHC staff that may use restraint and seclusion. Factors such as size of facility, services rendered, staffing, and client populations vary as well. We are hesitant to make impact estimates in this rule that may not account for these and other unforeseen variations. Below we discuss the anticipated effects on providers of the standards related to restraints and seclusion.
The restraint and seclusion standards set forth the client's rights in the event that he or she is restrained or secluded, and sets limits on when and by whom restraint or seclusion can be implemented. We recognize that there will be some impact associated with performing client assessment and monitoring to ensure that seclusion or restraint is only used in a safe and effective manner, when necessary, to protect the client and others from immediate harm, pending transport to the hospital. However, client assessment and monitoring are standard components of client care, and this requirement does not pose a burden to a CMHC.
The standards on staff training for restraint or seclusion that we are codifying at § 485.910(f) set out the staff training requirements for all appropriate client care involving the use of seclusion and restraint in the CMHC. Training is important for the provision of safe and effective restraint or seclusion use. We require that before staff apply restraints, implement seclusion, perform associated monitoring and assessment of the restrained or secluded client, or provide care for a restrained or secluded client, the staff be trained and able to demonstrate competency in the performance of these actions. The staff training requirements will address the following broad areas: Training intervals, training content, trainer requirements, and training documentation.
To reduce regulatory burden and create a reasonable requirement while assuring client safety, we are mandating that only those staff who would be involved in the application of restraint or seclusion or performing associated monitoring and assessment of, or providing care for, restrained or secluded clients would be required to have this training.
In this final rule, we are finalizing broad topics to be covered in training, and are not requiring that staff be trained by an outside organization. We believe that in-house training could be more economical than sending staff off site for instruction. However, CMHCs will have the option of sending either selected or all staff to outside training if they believe this is warranted.
Therefore, we have based our burden estimate on a CMHC nurse being trained by an outside organization (for example, the Crisis Prevention Institute) to provide such training. We believe that most CMHCs then will have this nurse function as a program developer and as a trainer of the appropriate CMHC staff. In addition, we believe in most instances this professional will be a psychiatric registered nurse.
Train-the-trainer programs are the way many CMHCs provide staff instruction. For example, the 4-day instructor certification program given by the Crisis Prevention Institute (CPI, Inc.) costs $1,999 for tuition plus travel, lodging, and participant salary. More detailed information regarding the train-the-trainer programs can be found on CPI, Inc.'s Web site at
We estimate, on average, that the cost to train one nurse will include the following expenses: (1) Round trip travel at approximately $400 to cover the need for either local or distant travel; (2) lodging for 3 nights (at $120 per night) for approximately $360; and (3) meals and incidental expenses for 4 days (at $50 per day) for approximately $200, depending upon the location within the particular State. Therefore, we anticipate the cost to train one nurse is approximately $2,959 plus the nurse's total salary of $1,504 for 4 days (at $376 per day). The total estimated training cost for all CMHCs is approximately $446,300.
We believe that CMHCs will add seclusion and restraint training onto their in-service training programs. The train-the-trainer program described above provides CMHCs with the necessary personnel and materials to implement a staff-wide seclusion and restraint training program. We estimate that developing this staff-wide training program requires 40 hours of the trainer's time on a one-time basis for all affected CMHCs, at a cost of $1,880 per CMHC.
We are requiring that each individual who could potentially be involved in restraint and seclusion of a client have training in the proper techniques. According to the National Association of Psychiatric Health Systems (NAPHS), initial training in de-escalation techniques, restraint and seclusion policies and procedures, and restraint and seclusion techniques range from 7 to 16 hours of staff and instructor time.
Due to a lack of data on the average number of employees in a CMHC, for purposes of this analysis only, we assume that an average CMHC will need to train seven employees in seclusion and restraint techniques. Based on one psychiatric registered nurse trainer conducting an 8-hour training course for seven CMHC staff members, we estimate that this requirement will cost $2,728 as calculated below.
• 8 trainer hours at $47/hr = $376
• 56 trainee hours at $42/hr = $2352
• $376 trainer cost + $2,352 trainee costs = $2,728
We are also requiring that each individual receive documented, updated training. Again, according to National Association of Psychiatric Health Systems (NAPHS), annual updates involve about four hours of staff and instructor time per employee who has direct client contact. We assume an average size CMHC has seven employees with direct client contact who must be trained in de-escalation techniques. Therefore, we estimate that it will cost $1,364 annually to update each person's training as shown below.
• 4 trainer hours at $47/hr = $188
• 28 trainee hours at $42/hr = $1,176
• $188 trainer costs + $1,176 trainee costs = $1,364
We require that each CMHC revise its training program annually as needed. We estimate this task, which must be completed by the trainer, to take approximately 4 hours annually per CMHC and have calculated below the
• 4 hours × $47/hr = $188 per CMHC
• $188 per CMHC × 100 CMHCs = $18,800 nationwide
Table 4 below shows the initial year (one-time) and annual estimated CMHC burden, respectively, associated with the standards for the client rights CoP.
With respect to the CoP for admission, initial evaluation, comprehensive assessment and discharge or transfer of the client, we believe that several of the standards associated with the CoP are unlikely to impose a burden on CMHCs. Specifically, the requirements for admitting a client, initially evaluating a client, and completing a comprehensive assessment of each client's needs are standard medical practice; therefore, they do not impose a burden upon a CMHC.
Moreover, the requirement to update the comprehensive assessment does not impose a burden upon CMHCs. Currently, all CMHCs are required by CMS payment rules (§ 424.24(e)(3)) to recertify a Medicare client's eligibility for partial hospitalization services. Therefore, the 13,600 Medicare beneficiaries who received partial hospitalization services have already received an updated assessment in order for the CMHC to recertify their eligibility. In addition, updating client assessments is part of standard medical practice to ensure that care is furnished to meet current client needs and treatment goals. Therefore, we believe that this requirement does not impose a burden upon a CMHC. Further, as part of the CMHC care model, it is assumed that clients will eventually be discharged or transferred from the CMHC's care. As such, CMHCs routinely plan for and implement client discharges and transfers. Therefore, we believe that the standard for the discharge or transfer of the client is part of a CMHC's standard practice and does not pose additional burden to CMHCs.
Under the CoP for treatment team, active treatment plan, and coordination of services, we assessed the potential impact of the following standards on CMHCs: Delivery of services, active treatment plan, content of the active treatment plan, review of the active treatment plan, and coordination of services. First, the standard for delivery of services sets forth the required members of each CMHC's client's active treatment team and requires these members to work together to meet the needs of each CMHC client. We believe it is standard practice within the CMHC industry to include these identified members in an active treatment team and, therefore, this requirement does not pose a burden.
Furthermore, this standard requires the CMHC to determine the appropriate licensed mental health processional, who is a member of the client's interdisciplinary treatment team, to be designated for each client as a care coordinator. The designated individual will be responsible for coordinating an individual client's care, including ensuring that the client's needs are fully assessed and reassessed in a timely manner, and that the client's active treatment plan is fully implemented. CMHCs may choose to assign a single individual to perform this function for all clients of the CMHC, or it may divide this duty between several individuals, assigning specific clients to specific individuals. While we believe that CMHCs already actively work to coordinate client assessment, care planning, and care implementation, we also believe that designating specific individuals to perform this function may be new to CMHCs. We estimate that, on average, designated CMHC staff will spend 20 to 30 minutes per client per week (76 to 114 hours annually) overall to fulfill this requirement. The annual cost per CMHC associated with this requirement is $3,572 to $5,358 for a psychiatric registered nurse, $2,356 to $3,534 for a mental health counselor, or $2,660 to $3,990 for a clinical social worker. The aggregate annual cost for all CMHCs is $357,200 to $535,800 if a psychiatric registered nurse is used; $235,600 to $353,400 if a mental health counselor is used, or $266,000 to $399,000, if a clinical social worker is used. This estimated burden is shown in Table 5 below.
Finally, paragraph (a)(4) of this standard requires a CMHC that has more than one interdisciplinary treatment team to designate a single team that is responsible for establishing policies and procedures governing the day-to-day provision of CMHC care and services. We believe that using multiple disciplines to establish client care policies and procedures is standard practice and does not pose a burden.
The active treatment plan standard and its content sets forth the requirements for each client's active treatment plan. The written active treatment plan will be established by the client and interdisciplinary treatment team. It will address the client's needs as they were identified in the initial evaluation and subsequent comprehensive assessment. We estimate that establishing the first comprehensive active treatment plan requires 35 minutes of the interdisciplinary treatment team's time. We estimate that compliance with the requirements at § 485.916(c) requires a licensed professional member of the
The standard for review of the active treatment plan requires the interdisciplinary treatment team to review and revise the active treatment plan as necessary, but no less frequently than every 30 calendar days. We estimate that updating the content of the active treatment plan requires 10 minutes of the interdisciplinary treatment team's time. Therefore, we estimate that compliance with the requirements at § 485.916(d) requires a licensed professional member of the interdisciplinary team (for this burden estimate we used the nurse) a total of 10 minutes per client, for a total of 38 hours per CMHC. Based on the nurse's hourly rate, the total cost will be $1,786 per CMHC.
In addition, the coordination of services standard requires a CMHC to have and maintain a system of communication, in accordance with its own policies and procedures, to ensure the integration of its services and systems. We believe that active communication within health care providers, including CMHCs, is standard practice; therefore, this requirement does not impose a burden.
Table 5 below shows the annual estimated CMHC burden associated with the standards for the treatment team, active treatment plan, and coordination of services CoP.
The proposed rule provided guidance to the CMHC on how to establish a quality assessment and performance improvement program. It is estimated that a CMHC will spend approximately 20 hours a year to implement a quality assessment and performance improvement program. Many providers are already using comprehensive quality assessment and performance improvement programs for accreditation or independent improvement purposes. For those providers who choose to develop their own quality assessment and performance improvement program, we estimate that it will take 9 hours to create a program. We also estimate that CMHCs will spend 4 hours a year collecting and analyzing data. In addition, we estimate that a CMHC will spend 3 hours a year training their staff and 4 hours a year implementing performance improvement activities. Both the program development and implementation will most likely be managed by that CMHC's administration. Based on an administrator's hourly rate, the total cost of the quality assessment and performance improvement condition of participation is $1,320 per CMHC.
Table 6 below shows the annual estimated CMHC burden associated with the standards for the quality assessment and performance improvement CoP.
Under the CoP for organization, governance, administration of services, and partial hospitalization services, we assessed the potential impact of the following standards on CMHCs: Governing body and administration, provision of services, professional management responsibility, staff training, and physical environment. The governing body and administration standard requires a CMHC to have a designated governing body that assumes
The provision of services standard sets forth a comprehensive list of services that CMHCs are currently required by statute and regulation to furnish, requires the CMHC and all individuals furnishing services on its behalf to meet applicable State licensing and certification requirements, and requires the CMHC to provide at least 40 percent of its items and services to individuals who are not eligible for benefits under title XVIII of the Act.
In addition, the professional management responsibility standard requires that, if a CMHC chooses to provide certain services under agreement, it must ensure that the agreement is written. This standard will also require the CMHC to retain full professional management responsibility for the services provided under arrangement on its behalf. Full professional management responsibility will include paying for the arranged services and ensuring that the services are furnished in a safe and effective manner. Having a written agreement and retaining professional management of all care and services provided is standard practice in the health care industry. Therefore, this requirement does not impose a burden.
Further, the staff training standard requires a CMHC to educate all staff who have contact with clients and families about CMHC care and services. It also requires a CMHC to provide an initial orientation for each staff member that addresses his or her specific job duties. Educating staff about the nature of CMHC care and their particular job duties are standard practices that would not impose a burden upon CMHCs.
This standard also requires a CMHC to assess the skills and competency of all individuals furnishing client and family care in accordance with its own written policies and procedures.
Finally, this standard requires a CMHC to provide and document its in-service training program. This standard does not prescribe the content or format of the CMHC's assessment and in-service training programs. Rather, it allows CMHCs to establish their own policies and procedures to meet their individual needs and goals. For example, this can be done by in-servicing on a need recognized through the QAPI program. We believe these requirements reflect standard practice in the industry and present no additional burden.
The physical environment standard requires CMHCs to furnish services in a safe, comfortable, and private environment that meets all Federal, State, and local health and safety requirements and occupancy rules. We believe that this requirement does not impose a burden on CMHCs as it is considered standard practice to provide services in a physical location that is both safe and conducive to meeting the needs of CMHC clients.
This standard also requires a CMHC to have an infection control program. While basic precautions such as thorough hand washing and proper disposal of medical waste are standard practice, developing a comprehensive infection control program may impose a burden on CMHCs. We estimate that an administrator will spend 8 hours on a one-time basis developing infection control policies and procedures and 2 hours per month conducting follow up efforts. The estimated cost associated with this provision is $528 to develop the infection control program and $1,584 annually to follow-up on infection control issues in the CMHC. We believe that staff education regarding infection control will be incorporated into the CMHC's in-service training program, described above and therefore doesn't impose additional burden.
Table 7 below shows the initial year (one-time) and annual estimated CMHC burden, respectively, associated with the standards for the organization, governance, administration of services, and partial hospitalization services CoP.
We believe that the burden associated with this rule is reasonable and necessary to ensure the health and safety of all CMHC clients.
We do not expect the CoPs for CMHCs included in this rule to affect any other providers.
The budget impacts to the Medicare and Medicaid programs resulting from implementation of the CoPs for CMHCs included in this rule are negligible. Even though there is likely to be an increase in CMS activities, such as on-site surveys, as a result of this final rule, CMS will likely be compelled by budgetary constraints to accommodate these activities into its existing budget. We note, however, that the rule-induced activities have an opportunity cost equal to the value of activities that would have been done in the rule's absence.
CMHC providers have been operating without federally-issued health and safety requirements since the 1990 inception of Medicare coverage of partial hospitalization services in CMHCs. In place of Federal standards, we have relied upon State certification and licensure requirements to ensure the health and safety of CMHC clients.
We also considered proposing a more comprehensive set of CoPs for CMHCs. Such a comprehensive set of CoPs would go beyond the requirements in this rule to address other areas of CMHC services and operations, such as a clinical records requirement that would outline the specific contents of a clinical record. While we believe that these areas are important and may warrant additional consideration in future rulemaking, we do not believe that it is appropriate to begin with an expansive set of CoPs at this time. Furthermore, a comprehensive set of CoPs may be difficult for CMHCs to manage, considering that many CMHCs are not currently required to meet any health and safety standards. As a result, we chose to focus on a core set of requirements and allow for the option of additional CoPs in the future.
Additionally, we considered proposing fewer CoPs. However, all of the CoPs included in this regulation are intended to act as a cohesive system. For example eliminating the assessment requirement would most likely cause issues with the formation of the interdisciplinary team and the client's active treatment plan. We believe that the CoPs build on each other, and that eliminating one or more would introduce vulnerabilities in patient safety.
We estimate that this final rule will cost CMHCs approximately $3 million in the first year of implementation and approximately $2.2 million annually thereafter. We believe that the burden associated with this rule is reasonable and necessary to ensure the health and safety of all CMHC clients.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Grant programs—health, Health facilities, Medicaid, Privacy, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395 (hh)).
(a)
(1) Section 1832(a)(2)(J) of the Act specifies that payments may be made under Medicare Part B for partial hospitalization services furnished by a community mental health center (CMHC) as described in section 1861(ff)(3)(B) of the Act.
(2) Section 1861(ff) of the Act describes the items and services that are covered under Medicare Part B as “partial hospitalization services” and the conditions under which the items and services must be provided. In addition, section 1861(ff) of the Act specifies that the entities authorized to provide partial hospitalization services under Medicare Part B include CMHCs and defines that term.
(3) Section 1866(e)(2) of the Act specifies that a provider of services for purposes of provider agreement requirements includes a CMHC as defined in section 1861(ff)(3)(B) of the Act, but only with respect to providing partial hospitalization services.
(b)
As used in this subpart, unless the context indicates otherwise—
(1) Who works for the CMHC and for whom the CMHC is required to issue a W–2 form on his or her behalf; or
(2) For whom an agency or organization issues a W–2 form, and who is assigned to such CMHC if the CMHC is a subdivision of an agency or organization.
(1) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces
(2) A drug or medication when it is used as a restriction to manage the client's behavior or restrict the client's freedom of movement, and which is not a standard treatment or dosage for the client's condition.
(a)
(b)
(1)
(2)
(3)
(4)
(i) Has a baccalaureate degree in social work from an institution accredited by the Council on Social Work Education, or a baccalaureate degree in psychology or sociology, and is supervised by a clinical social worker, as described in paragraph (b)(3) of this section; and
(ii) Has 1 year of social work experience in a psychiatric healthcare setting.
(5)
(6)
(7)
(8)
(9)
(i) Is a nurse practitioner who meets the qualifications at § 410.75 of this chapter; or
(ii) Is a clinical nurse specialist who meets the qualifications at § 410.76 of this chapter.
(10)
(11)
The client has the right to be informed of his or her rights. The CMHC must protect and promote the exercise of these client rights.
(a)
(2) During the initial evaluation, the CMHC must inform and distribute written information to the client concerning its policies on filing a grievance.
(3) The CMHC must obtain the client's and/or the client representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities.
(b)
(i) Exercise his or her rights as a client of the CMHC.
(ii) Have his or her property and person treated with respect.
(iii) Voice grievances and understand the CMHC grievance process; including but not limited to grievances regarding mistreatment and treatment or care that is (or fails to be) furnished.
(iv) Not be subjected to discrimination or reprisal for exercising his or her rights.
(2) If a client has been adjudged incompetent under State law by a court of proper jurisdiction, the rights of the client are exercised by the person appointed in accordance with State law to act on the client's behalf.
(3) If a State court has not adjudged a client incompetent, any legal representative designated by the client in accordance with State law may exercise the client's rights to the extent allowed under State law.
(c)
(1) Be involved in developing his or her active treatment plan.
(2) Refuse care or treatment.
(3) Have a confidential clinical record. Access to or release of client information and the clinical record client information is permitted only in accordance with 45 CFR parts 160 and 164.
(4) Be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of client property.
(5) Receive information about specific limitations on services that he or she will be furnished.
(6) Not be compelled to perform services for the CMHC, and to be compensated by the CMHC for any work performed for the CMHC at prevailing wages and commensurate with the client's abilities.
(d)
(1) Ensure that all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of client property by anyone, including those furnishing services on behalf of the CMHC, are reported immediately to the CMHC's administrator by CMHC employees, volunteers and contracted staff.
(2) Immediately investigate all alleged violations involving anyone furnishing services on behalf of the CMHC and immediately take action to prevent further potential violations while the alleged violation is being verified. Investigations and documentation of all alleged violations must be conducted in accordance with procedures established by the CMHC.
(3) Take appropriate corrective action in accordance with State law if the alleged violation is investigated by the CMHC's administration or verified by an outside entity having jurisdiction, such as the State survey and certification agency or the local law enforcement agency; and
(4) Ensure that, within 5 working days of becoming aware of the violation, all violations are reported to the State survey and certification agency, and verified violations are reported to State and local entities having jurisdiction.
(e)
(2) The use of restraint or seclusion must be in accordance with the written order of a physician or other licensed independent practitioner who is authorized to order restraint or seclusion in accordance with State law and must not exceed one 1-hour duration per order.
(3) The CMHC must obtain a corresponding order for the client's immediate transfer to a hospital when restraint or seclusion is ordered.
(4) Orders for the use of restraint or seclusion must never be written as a standing order or on an as-needed basis.
(5) When a client becomes an immediate threat to the physical safety of himself or herself, staff or other individuals, the CMHC must adhere to the following requirements:
(i) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the client or other individuals from harm.
(ii) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the client or other individuals from harm.
(iii) The use of restraint or seclusion must be implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by State law.
(iv) The condition of the client who is restrained or secluded must be continuously monitored by a physician or by trained staff who have completed the training criteria specified in paragraph (f) of this section.
(v) When restraint or seclusion is used, there must be documentation in the client's clinical record of the following:
(A) A description of the client's behavior and the intervention used.
(B) Alternatives or other less restrictive interventions attempted (as applicable).
(C) The client's condition or symptom(s) that warranted the use of the restraint or seclusion.
(D) The client's response to the intervention(s) used, including the rationale for continued use of the intervention.
(E) The name of the hospital to which the client was transferred.
(f)
(1)
(i) Before performing any of the actions specified in this paragraph (f).
(ii) As part of orientation.
(iii) Subsequently on a periodic basis, consistent with the CMHC's policy.
(2)
(i) Techniques to identify staff and client behaviors, events, and environmental factors that may trigger circumstances that could require the use of restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) In facilities where restraint and seclusion are permitted, choosing the least restrictive intervention based on an individualized assessment of the client's medical and behavioral status or condition.
(iv) The safe application and use of all types of restraint or seclusion that are permitted in the CMHC, including training in how to recognize and respond to signs of physical and psychological distress.
(v) In facilities where restraint and seclusion are permitted, clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.
(vi) In facilities where restraint and seclusion are permitted, monitoring the physical and psychological well-being of the client who is restrained or secluded, including, but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by the CMHC's policy.
(3)
(4)
(g)
(1) The CMHC must report to CMS each death that occurs while a client is in restraint or seclusion awaiting transfer to a hospital.
(2) Each death referenced in paragraph (g)(1) of this section must be
(3) Staff must document in the client's clinical record the date and time the death was reported to CMS.
The CMHC must ensure that all clients admitted into its program are appropriate for the services the CMHC furnishes in its facility.
(a)
(2) For clients assessed and admitted to receive partial hospitalization services, the CMHC must also meet separate requirements as specified in § 485.918(f).
(b)
(2) The initial evaluation, at a minimum, must include the following:
(i) The admitting diagnosis as well as other diagnoses.
(ii) The source of referral.
(iii) The reason for admission as stated by the client or other individuals who are significantly involved.
(iv) Identification of the client's immediate clinical care needs related to the psychiatric diagnosis.
(v) A list of current prescriptions and over-the-counter medications, as well as other substances that the client may be taking.
(vi) For partial hospitalization services only, include an explanation as to why the client would be at risk for hospitalization if the partial hospitalization services were not provided.
(3) Based on the findings of the initial evaluation, the CMHC must determine the appropriate members of each client's interdisciplinary treatment team.
(c)
(2) The comprehensive assessment must be completed in a timely manner, consistent with the client's immediate needs, but no later than 4 working days after admission to the CMHC.
(3) The comprehensive assessment must identify the physical, psychological, psychosocial, emotional, therapeutic, and other needs related to the client's psychiatric illness. The CMHC's interdisciplinary treatment team must ensure that the active treatment plan is consistent with the findings of the comprehensive assessment.
(4) The comprehensive assessment, at a minimum, must include the following:
(i) The reasons for the admission.
(ii) A psychiatric evaluation, completed by a psychiatrist, non-physician practitioner or psychologist practicing within the scope of State licensure that includes the medical history and severity of symptoms. Information may be gathered from the client's primary health care provider (if any), contingent upon the client's consent.
(iii) Information concerning previous and current mental status, including but not limited to, previous therapeutic interventions and hospitalizations.
(iv) Information regarding the onset of symptoms of the illness and circumstances leading to the admission.
(v) A description of attitudes and behaviors, including cultural and environmental factors that may affect the client's treatment plan.
(vi) An assessment of intellectual functioning, memory functioning, and orientation.
(vii) Complications and risk factors that may affect the care planning.
(viii) Functional status, including the client's ability to understand and participate in his or her own care, and the client's strengths and goals.
(ix) Factors affecting client safety or the safety of others, including behavioral and physical factors, as well as suicide risk factors.
(x) A drug profile that includes a review of all of the client's prescription and over-the-counter medications; herbal remedies; and other alternative treatments or substances that could affect drug therapy.
(xi) The need for referrals and further evaluation by appropriate health care professionals, including the client's primary health care provider (if any), when warranted.
(xii) Factors to be considered in discharge planning.
(xiii) Identification of the client's current social and health care support systems.
(xiv) For pediatric clients, the CMHC must assess the social service needs of the client, and make referrals to social services and child welfare agencies as appropriate.
(d)
(2) The assessment must be updated no less frequently than every 30 days.
(3) The update must include information on the client's progress toward desired outcomes, a reassessment of the client's response to care and therapies, and the client's goals.
(e)
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(2) If a client refuses the services of a CMHC, or is discharged from a CMHC due to noncompliance with the treatment plan, the CMHC must forward to the primary health care provider (if any) a copy of—
(i) The CMHC discharge summary.
(ii) The client's clinical record, if requested.
(3) The CMHC discharge summary must include—
(i) A summary of the services provided, including the client's symptoms, treatment and recovery goals and preferences, treatments, and therapies.
(ii) The client's current active treatment plan at time of discharge.
(iii) The client's most recent physician orders.
(iv) Any other documentation that will assist in post-discharge continuity of care.
(4) The CMHC must adhere to all Federal and State-related requirements pertaining to the medical privacy and the release of client information.
The CMHC must designate an interdisciplinary treatment team that is responsible, with the client, for directing, coordinating, and managing the care and services furnished for each client. The interdisciplinary treatment team is composed of individuals who work together to meet the physical, medical, psychosocial, emotional, and therapeutic needs of CMHC clients.
(a)
(2) Based on the findings of the comprehensive assessment, the CMHC must determine the appropriate licensed mental health professional, who is a member of the client's interdisciplinary treatment team, to coordinate care and treatment decisions with each client, to ensure that each client's needs are assessed, and to ensure that the active treatment plan is implemented as indicated.
(3) The interdisciplinary treatment team may include:
(i) A doctor of medicine, osteopathy or psychiatry (who is an employee of or under contract with the CMHC).
(ii) A psychiatric registered nurse.
(iii) A clinical social worker.
(iv) A clinical psychologist.
(v) An occupational therapist.
(vi) Other licensed mental health professionals, as necessary.
(vii) Other CMHC staff or volunteers, as necessary.
(4) If the CMHC has more than one interdisciplinary team, it must designate the treatment team responsible for establishing policies and procedures governing the coordination of services and the day-to-day provision of CMHC care and services.
(b)
(c)
(1) Client diagnoses.
(2) Treatment goals.
(3) Interventions.
(4) A detailed statement of the type, duration, and frequency of services, including social work, psychiatric nursing, counseling, and therapy services, necessary to meet the client's specific needs.
(5) Drugs, treatments, and individual and/or group therapies.
(6) Family psychotherapy with the primary focus on treatment of the client's conditions.
(7) The interdisciplinary treatment team's documentation of the client's or representative's and primary caregiver's (if any) understanding, involvement, and agreement with the plan of care, in accordance with the CMHC's policies.
(d)
(e)
(1) Ensure that the interdisciplinary treatment team maintains responsibility for directing, coordinating, and supervising the care and services provided.
(2) Ensure that care and services are provided in accordance with the active treatment plan.
(3) Ensure that the care and services provided are based on all assessments of the client.
(4) Provide for and ensure the ongoing sharing of information among all disciplines providing care and services, whether the care and services are provided by employees or those under contract with the CMHC.
(5) Provide for ongoing sharing of information with other health care and non-medical providers, including the primary health care provider, furnishing services to a client for conditions unrelated to the psychiatric condition for which the client has been admitted, and non-medical supports addressing environmental factors such as housing and employment.
The CMHC must develop, implement, and maintain an effective, ongoing, CMHC-wide data-driven quality assessment and performance improvement program (QAPI). The CMHC's governing body must ensure that the program reflects the complexity of its organization and services, involves all CMHC services (including those services furnished under contract or arrangement), focuses on indicators related to improved behavioral health or other healthcare outcomes, and takes actions to demonstrate improvement in CMHC performance. The CMHC must maintain documentary evidence of its quality assessment and performance improvement program and be able to demonstrate its operation to CMS.
(a)
(2) The CMHC must measure, analyze, and track quality indicators; adverse client events, including the use of restraint and seclusion; and other aspects of performance that enable the CMHC to assess processes of care, CMHC services, and operations.
(b)
(2) The CMHC must use the data collected to do the following:
(i) Monitor the effectiveness and safety of services and quality of care.
(ii) Identify opportunities and priorities for improvement.
(3) The frequency and detail of the data collection must be approved by the CMHC's governing body.
(c)
(i) Focus on high risk, high volume, or problem-prone areas.
(ii) Consider incidence, prevalence, and severity of problems.
(iii) Give priority to improvements that affect behavioral outcomes, client safety, and person-centered quality of care.
(2) Performance improvement activities must track adverse client events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the CMHC.
(3) The CMHC must take actions aimed at performance improvement and, after implementing those actions, the CMHC must measure its success and track performance to ensure that improvements are sustained.
(d)
(1) The number and scope of distinct performance improvement projects conducted annually, based on the needs of the CMHC's population and internal organizational needs, must reflect the scope, complexity, and past performance of the CMHC's services and operations.
(2) The CMHC must document what performance improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(e)
(1) That an ongoing QAPI program for quality improvement and client safety is defined, implemented, maintained, and evaluated annually.
(2) That the CMHC-wide quality assessment and performance improvement efforts address priorities for improved quality of care and client safety, and that all improvement actions are evaluated for effectiveness.
(3) That one or more individual(s) who are responsible for operating the QAPI program are designated.
The CMHC must organize, manage, and administer its resources to provide CMHC services, including specialized services for children, elderly individuals, individuals with serious mental illness, and residents of its mental health service area who have been discharged from an inpatient mental health facility.
(a)
(2) The CMHC's governing body must appoint an administrator who reports to the governing body and is responsible for the day-to-day operation of the CMHC. The administrator must be a CMHC employee and meet the education and experience requirements established by the CMHC's governing body.
(b)
(i) Provides outpatient services, including specialized outpatient services for children, elderly individuals, individuals with serious mental illness, and residents of its mental health service area who have been discharged from inpatient mental health facilities.
(ii) Provides 24-hour-a-day emergency care services.
(iii) Provides day treatment, partial hospitalization services other than in an individual's home or in an inpatient or residential setting, or psychosocial rehabilitation services.
(iv) Provides screening for clients being considered for admission to State mental health facilities to determine the appropriateness of such services, unless otherwise directed by State law.
(v) Provides at least 40 percent of its items and services to individuals who are not eligible for benefits under title XVIII of the Act, as measured by the total number of CMHC clients treated by the CMHC for whom services are not paid for by Medicare, divided by the total number of clients treated by the CMHC for each 12-month period of enrollment.
(A) A CMHC is required to submit to CMS a certification statement provided by an independent entity that certifies that the CMHC's client population meets the 40 percent requirement specified at this paragraph (b)(1)(v).
(B) The certification statement described in paragraph (b)(1)(v)(A) of this section is required upon initial application to enroll in Medicare, and as a part of revalidation, including any off cycle revalidation, thereafter carried out pursuant to § 424.530 of this chapter. Medicare enrollment will be denied or revoked in instances where the CMHC fails to provide the certification statement as required. Medicare enrollment will also be denied or revoked if the 40 percent requirement as specified in this paragraph (b)(1)(v) is not met.
(vi) Provides individual and group psychotherapy utilizing a psychiatrist, psychologist, or other licensed mental health counselor, to the extent authorized under State law.
(vii) Provides physician services.
(viii) Provides psychiatric nursing services.
(ix) Provides clinical social work services.
(x) Provides family counseling services, with the primary purpose of treating the individual's condition.
(xi) Provides occupational therapy services.
(xii) Provides services of other staff trained to work with psychiatric clients.
(xiii) Provides drugs and biologicals furnished for therapeutic purposes that cannot be self-administered.
(xiv) Provides client training and education as related to the individual's care and active treatment.
(xv) Provides individualized therapeutic activity services that are not primarily recreational or diversionary.
(xvi) Provides diagnostic services.
(2) The CMHC and individuals furnishing services on its behalf must meet applicable State licensing and certification requirements.
(c)
(1) Authorized by the CMHC.
(2) Furnished in a safe and effective manner.
(3) Delivered in accordance with established professional standards, the policies of the CMHC, and the client's active treatment plan.
(d)
(2) A CMHC must provide an initial orientation for each individual furnishing services that addresses the specific duties of his or her job.
(3) A CMHC must assess the skills and competence of all individuals furnishing care and, as necessary, provide in-service training and education programs where indicated. The CMHC must have written policies and procedures describing its method(s)
(e)
(2)
(3)
(4)
(f)
(1) Provide services as defined in § 410.2 of this chapter.
(2) Provide the services and meet the requirements specified in § 410.43 of this chapter.
(3) Meet the requirements for coverage as described in § 410.110 of this chapter.
(4) Meet the content of certification and plan of treatment requirements as described in § 424.24(e) of this chapter.
(g)
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for 15 species on the island of Hawaii. In addition, we are recognizing a taxonomic change for one Hawaiian plant currently listed as an endangered species and revising the List of Endangered and Threatened Plants accordingly. The effect of this regulation is to conserve these species under the Act.
This rule is effective on November 29, 2013.
This final rule is available on the Internet at
Loyal Mehrhoff, Field Supervisor, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Boulevard, Room 3–122, Honolulu, HI 96850; by telephone at 808–792–9400; or by facsimile at 808–792–9581. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800–877–8339.
The final critical habitat designation for
Federal actions for these species prior to October 17, 2012, are outlined in our proposed rule (77 FR 63928), which was published on that date. Publication of the proposed rule opened a 60-day comment period, which closed on December 17, 2012. In addition, we published a public notice of the proposed rule on October 20, 2012, in the local Honolulu Star Advertiser, West Hawaii Today, and the Hawaii Tribune Herald newspapers. On April 30, 2013, we published in the
The table below (Table 1) provides the scientific name, common name, and listing status for the species that are the subjects of this final rule.
We listed
On the island of Hawaii, as on most of the Hawaiian Islands, native species that occur in the same habitat types (ecosystems) depend on many of the same biological features and the successful functioning of that ecosystem to survive. We have therefore organized the species addressed in this final rule by common ecosystem. Although the listing determination for each species is analyzed separately, we have organized the individual analysis for each species within the context of the broader ecosystem in which it occurs to avoid redundancy. In addition, native species that share ecosystems often face a suite of common factors that may be a threat to them, and ameliorating or eliminating these threats for each individual species often requires the exact same management actions in the exact same areas. Effective management of these threats often requires implementation of conservation actions at the ecosystem scale to enhance or restore critical ecological processes and provide for long-term viability of those species in their native environment. Thus, by taking this approach, we hope not only to organize this final rule efficiently, but also to more effectively focus conservation management efforts on the common threats that occur across these ecosystems. Those efforts would facilitate restoration of ecosystem functionality for the recovery of each species, and provide conservation benefits for associated native species, thereby potentially precluding the need to list other species under the Act that occur in these shared ecosystems. In addition, this approach is in accord with the primary stated purpose of the Act (see section 2(b)): “to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved.”
We are listing the plants
For each species, we identified and evaluated those factors that adversely impact the species and that may be common to all of the species at the ecosystem level. For example, the degradation of habitat by nonnative ungulates is considered a threat to all 15 species, and is likely a threat to many, if not most or all, of the native species within a given ecosystem. We consider such a threat factor to be an “ecosystem-level threat,” as each individual species within that ecosystem faces a threat that is essentially identical in terms of the nature of the impact, its severity, its timing, and its scope. Beyond ecosystem-level threats, we further identified and evaluated threat factors that may be unique to certain species and that do not apply to all species under consideration within the same ecosystem. For example, the threat of predation by nonnative wasps is unique to the picture-wing fly
Please refer to the proposed rule (77 FR 63928; October 17, 2012) for a description of the island of Hawaii and associated map, and for a description of the 10 ecosystems on Hawaii Island that support the 15 species. We have made minor revisions to our description of the anchialine pool ecosystem described in the proposed rule (77 FR 63928; October 17, 2012); therefore, we have included the revised version in its entirety in this final rule (see
There are 12 different ecosystems (anchialine pool, coastal, lowland dry, lowland mesic, lowland wet, montane dry, montane mesic, montane wet, subalpine, alpine, dry cliff, and wet cliff) recognized on the island of Hawaii. The 15 species addressed in this final rule occur in 10 of these 12 ecosystems (none of the 15 species are reported in subalpine and alpine ecosystems). The 10 Hawaii Island ecosystems that support the 15 species are described in the proposed rule (77 FR 63928; October 17, 2012), with the exception of a revised description of the anchialine pool ecosystem below; see Table 2 (above) for a list of the species that occur in each ecosystem type.
Anchialine pools are land-locked bodies of water that have indirect underground connections to the sea, contain varying levels of salinity, and show tidal fluctuations in water level. Anchialine pool habitats can be distinguished from similar systems (i.e., tidal pools) in that they are land-locked with no surface connections to water sources either saline or fresh, but have subterranean hydrologic connections to both fresh and ocean water where water flows through cracks and crevices, and remain tidally influenced (Holthuis 1973, p. 3; Stock 1986, p. 91). Anchialine habitats are ecologically distinct and unique, and while widely distributed throughout the world, they only occur in the United States in the Hawaiian Islands (Brock 2004, pp. i, 2, and 12). In Hawaii, the anchialine pool ecosystem has been reported from Oahu, Molokai, Maui, Kahoolawe, and Hawaii Island. In the Hawaiian Islands, there are estimated to be 600 to 700 anchialine pools, with the majority occurring on the island of Hawaii (Brock 2004, p. i). Over 80 percent of the State's anchialine pools are found on the island of Hawaii, with a total of approximately 520 to 560 pools distributed over 130 sites along all but the island's northernmost and steeper northeastern shorelines. Characteristic animal species include crustaceans (e.g., shrimps, prawns, amphipods, isopods, etc.), several fish species, mollusks, and other invertebrates adapted to the pools' surface and subterranean habitats (Brock 2004, p. i; The Nature Conservancy (TNC) 2009, pp. 1–3). Generally, vegetation within the anchialine pools consists of various types of algal forms (blue-green, green, red, and golden-brown). The majority of Hawaii's anchialine pools occur in bare or
Below is a brief description of each of the 15 species, presented in alphabetical order by genus. Plants are presented first, followed by animals.
In order to avoid confusion regarding the number of locations of each species (a location does not necessarily represent a viable population, as in some cases there may only be one or a very few representatives of the species present), we use the word “occurrence” instead of “population.” Each occurrence is composed only of wild (i.e., not propagated and outplanted) individuals.
The feeding habits of
Although over 400 of the estimated 520 to 560 anchialine pool habitats have been surveyed on the island of Hawaii,
Four surveys have been conducted at Lua o Palahemo (Maciolek and Brock 1974, pp. 1–73; Kensley and Williams 1986, pp. 417–426; Bozanic 2004, p. 1–3; Wada 2012, pers. comm.; Wada
On October 17, 2012, we published a proposed rule to list 15 Hawaii Island species (13 plants, 1 picture-wing fly, and 1 anchialine pool shrimp) as endangered throughout their ranges, and to designate critical habitat for 3 plant species (77 FR 63928). The comment period for the proposal opened on October 17, 2012, for 60 days, ending on December 17, 2012. We requested that all interested parties submit comments or information concerning the proposed rule. We contacted all appropriate State and Federal agencies, county governments, elected officials, scientific organizations, and other interested parties and invited them to comment. In addition, we published a public notice of the proposed rule on October 20, 2012, in the local Honolulu Star Advertiser, West Hawaii Today, and the Hawaii Tribune Herald newspapers, at the beginning of the comment period. We received four requests for public hearings. On April 30, 2013, we published a document (78 FR 25243) reopening the comment period on the October 17, 2012, proposed rule (77 FR 63928), announcing the availability of our draft economic analysis (DEA) on the proposed critical habitat, and requesting comments on both the proposed rule and the DEA. In addition, in that same document (78 FR 25243; April 30, 2013), we announced a public information meeting and hearing, which was held in Kailua-Kona, Hawaii, on May 15, 2013.
During the comment periods, we received 33 comment letters, including the 11 peer review comment letters, on the proposed listing of 15 species, proposed taxonomic change for 1 endangered plant species, and proposed designation of critical habitat. In this final rule, we address only the comments regarding the proposed listing of 15 species and proposed taxonomic change for 1 plant species. Comments addressing the proposed critical habitat designation will be fully addressed in a separate rulemaking action, and published in the
Two commenters were State of Hawaii agencies ((1) Hawaii Department of Business, Economic Development, and Tourism's Hawaii Housing Finance and Development Corporation, and (2) Hawaii Department of Hawaiian Home Lands); one was a county agency (County of Hawaii Planning Department); two were Federal agencies; and 28 were nongovernmental organizations or individuals. During the May 15, 2013, public hearing, no individuals or organizations made comments on the proposed listing.
All substantive information related to the listing of the 15 species or the taxonomic change for 1 species provided during the comment periods has either been incorporated directly into this final determination or is addressed below. Comments received were grouped into general issues specifically relating to the proposed listing status of the 13 plants, or the picture-wing fly or anchialine pool shrimp, or the proposed taxonomic change for 1 plant species, and are addressed in the following summary and incorporated into the final rule as appropriate.
In accordance with our peer review policy published in the
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Under the Act, we determine whether a species is an endangered species or a threatened species because of any of five factors (see Summary of Factors Affecting the 15 Species, below), and we are required to make listing determinations solely on the basis of the best scientific and commercial data available, pursuant to section 4(b)(1)(A) of the Act. Based on the best available information we determined that
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Nonnative fish have been intentionally introduced to Lua o Palahemo in the past (see “Dumping of Trash and Introduction of Nonnative Fish” under
The intentional introduction of native marine fish is possible at the Manuka pools that support
On Maui, both aholehole and papio have been found in the larger anchialine pools closest to the ocean at Ahihi Kinau NAR, where high surf and storm waves appear to wash those and other native marine fish into the pools (Wada 2013, in litt.). However, these pools are
Native marine fish species have a purely marine (pelagic) larval stage, so a population of native fishes in an anchialine pool is likely to be individuals that are introduced to pools post larvae-stage (Sakihara 2013, in litt.). According to Brock (2004, p. 9), native marine fish are typically found in pools in close proximity to the ocean and it is believed that the biological status of these pools changes with successful colonization or mortality of marine fishes in these pools. The presence of native fish in Hawaiian anchialine pools usually signals the lack of hypogeal shrimp (Brock 2004, p. 9). Brock (2004, p. 29) also states that native marine fish are not able to complete their life cycles in anchialine pools, so the impacts to hypogeal shrimp are temporary (i.e., only as long as the fish occupy the pool) and that hypogeal shrimp may successfully hide in crevices from predatory fish and thus possibly recolonize a pool after the fish die off. Therefore, although
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The definition of an anchialine pool includes being tidally influenced due to a subterranean connection to the ocean, so we agree that the lava tube is connected to a marine habitat and fauna, although to what extent and what depth is not known at this time. The size (i.e., a smaller cracks versus a wide diameter lava tube) of the connection to the marine environment will determine to some extent the species present in a given anchialine pool; the better the connection to the sea, the more likely a pool will have marine organisms (Brock 2004, p. 9). For example, the unusual ecotypic variant of the moray eel (
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Under the Act, we determine whether a species is an endangered species or a threatened species because of any of five factors (see Summary of Factors Affecting the 15 Species, below), and we are required to make listing determinations solely on the basis of the best available scientific and commercial data
All of the comments we received from Federal agencies have been incorporated, as appropriate, in the Description of the 15 Species, above, and Summary of Changes from Proposed Rule, below.
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In preparing this final rule, we reviewed and fully considered comments from the peer reviewers and public on the proposed listing for 15 species. This final rule incorporates the following substantive changes to our proposed listing, based on the comments we received:
(1) We added inundation by high surf as a threat to the newly listed plant
(2) We added the nonnative understory plant species
(3) We added the nonnative vine
(4) We added the nonnative canopy plant species
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(6) Hawaii State biologists discovered a population of
(7) We revised the statement that incorrectly indicated that the outplanted individuals of
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued
If we determine that the level of threat posed to a species by one or more of the five listing factors is such that the species meets the definition of either endangered or threatened under section 3 of the Act, that species may then be listed as endangered or threatened. The Act defines an endangered species as “in danger of extinction throughout all or a significant portion of its range,” and a threatened species as “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The threats to each of the individual 15 species are summarized in Table 3, and discussed in detail below.
The following constitutes a list of ecosystem-scale threats that affect the species in this final rule in one or more of the 10 described ecosystems on Hawaii Island:
(1) Foraging and trampling of native plants by feral pigs (
(2) Ungulate destruction of seeds and seedlings of native plant species via foraging and trampling (Cuddihy and Stone 1990, pp. 63, 65) facilitates the conversion of disturbed areas from native to nonnative vegetative communities.
(3) Disturbance of soils by feral pigs from rooting can create fertile seedbeds for alien plants (Cuddihy and Stone 1990, p. 65), some of them spread by ingestion and excretion by pigs.
(4) Increased nutrient availability as a result of pigs rooting in nitrogen-poor soils, which facilitates establishment of alien weeds. Introduced vertebrates are known to enhance the germination of alien plants through seed scarification in digestive tracts or through rooting and fertilization with feces of potential seedbeds (Stone 1985, p, 253). In addition, alien weeds are more adapted to nutrient-rich soils than native plants (Cuddihy and Stone 1990, p. 65), and rooting activity creates open areas in forests allowing alien species to completely replace native stands.
(5) Rodent damage to plant propagules, seedlings, or native trees, which changes forest composition and structure (Cuddihy and Stone 1990, p. 67).
(6) Feeding or defoliation of native plants from alien insects, which reduces geographic ranges of some species because of damage (Cuddihy and Stone 1990, p. 71).
(7) Alien insect predation on native insects, which affects pollination of native plant species (Cuddihy and Stone 1990, p. 71).
(8) Significant changes in nutrient cycling processes because of large numbers of alien invertebrates, such as earthworms, ants, slugs, isopods, millipedes, and snails, resulting in changes to the composition and structure of plant communities (Cuddihy and Stone 1990, p. 73).
Each of the above threats is discussed in more detail below, and summarized in Table 3.
The Hawaiian Islands are located over 2,000 mi (3,200 km) from the nearest continent. This isolation has allowed the few plants and animals that arrived in the Hawaiian Islands to evolve into many highly varied and endemic species (species that occur nowhere else in the world). The only native terrestrial mammals in the Hawaiian Islands are two bat taxa, the extant Hawaiian hoary bat (
Native Hawaiian plants are therefore highly vulnerable to the impacts of introduced mammals and alien plants. In addition, species restricted and adapted to highly specialized locations (e.g.,
The consequences of past land use practices, such as agricultural or urban development, have resulted in little or no native vegetation below 2,000 ft (600 m) throughout the Hawaiian Islands (TNC 2007–
Development and urbanization of the lowland dry ecosystem on Hawaii Island is a threat to one species in this rule,
Introduced mammals have greatly impacted the native vegetation, as well as the native fauna, of the Hawaiian Islands. The presence of introduced alien mammals is considered one of the primary factors underlying the alteration and degradation of native plant communities and habitats on the island of Hawaii. The destruction or degradation of habitat due to nonnative ungulates (hoofed mammals), including pigs, goats, cattle, sheep, and mouflon, is currently a threat to the 10 ecosystems (lowland dry, lowland mesic, lowland wet, montane dry, montane mesic, montane wet, coastal, anchialine pool, dry cliff, and wet cliff) on Hawaii Island and their associated species. Habitat degradation or destruction by ungulates is also a threat to all 13 plant species and the picture-wing fly in this final rule (Table 3). Habitat degradation or destruction by ungulates is a threat to the anchialine pool shrimp at Lua o Palahemo, but is not reported to pose a threat to the four pools that support this species at Manuka.
The destruction or degradation of habitat due to pigs is currently a threat to nine of the Hawaii Island ecosystems (coastal, lowland dry, lowland mesic, lowland wet, montane dry, montane mesic, montane wet, dry cliff, and wet cliff) and their associated species. In Hawaii, pigs have been described as the most pervasive and disruptive nonnative influence on the unique native forests of the Hawaiian Islands, and are widely recognized as one of the greatest current threats to forest ecosystems (Aplet
These feral animals are extremely destructive and have both direct and indirect impacts on native plant communities. While rooting in the earth in search of invertebrates and plant material, pigs directly impact native plants by disturbing and destroying vegetative cover, and by trampling plants and seedlings. It has been estimated that at a conservative rooting rate of 2 sq yards (yd) (1.7 sq m) per minute, with only 4 hours of foraging a day, a single pig could disturb over 1,600 sq yd (1,340 sq m) (or approximately 0.3 ac, or 0.12 ha) of groundcover per week (Anderson
Pigs reduce or eliminate plant regeneration by damaging or eating seeds and seedlings (further discussion of predation by nonnative ungulates is provided under
Pigs have been cited as one of the greatest threats to the public and private lands within the Olaa Kilauea Partnership (an area of land that includes approximately 32,000 ac (12,950 ha) in the upper sections of the Olaa and Waiakea forests above Volcano village) that comprise the lowland mesic, lowland wet, montane mesic, and montane wet ecosystems that support individuals of three of the plant species in this final rule (
Many of the most important host plants of Hawaiian picture-wing flies (
The destruction or degradation of habitat due to goats is currently a threat to all 10 of the described ecosystems on Hawaii Island (anchialine pool, coastal, lowland dry, lowland mesic, lowland wet, montane dry, montane mesic, montane wet, dry cliff, and wet cliff) and their associated species. Goats occupy a wide variety of habitats on Hawaii Island, where they consume native vegetation, trample roots and seedlings, accelerate erosion, and promote the invasion of alien plants
Goats are be highly destructive to native vegetation, and contribute to erosion by eating young trees and young shoots of plants before they can become established, creating trails that damage native vegetative cover, promoting erosion by destabilizing substrate and creating gullies that convey water, and dislodging stones from ledges that can cause rockfalls and landslides and damage vegetation below (Cuddihy and Stone 1990, pp. 63–64). A recent study by Chynoweth
The destruction or degradation of habitat due to cattle is currently a threat to five of the described ecosystems (anchialine pool, lowland mesic, lowland wet, montane mesic, and montane wet) on Hawaii Island and their associated species. Feral cattle eat native vegetation, trample roots and seedlings, cause erosion, create disturbed areas into which alien plants invade, and spread seeds of alien plants in their feces and on their bodies. The forest in areas grazed by cattle degrades to grassland pasture, and plant cover is reduced for many years following removal of cattle from an area. In addition, several alien grasses and legumes purposely introduced for cattle forage have become noxious weeds (Tomich 1986, pp. 140–150; Cuddihy and Stone 1990, p. 29).
The wet forests of Kohala Mountain are reported to have a feral cattle population of at least 100 individuals that are causing forest degradation by trampling and browsing, which leads to subsequent increased nitrogen availability through deposition of feces (Stone 1985, p. 253), all of which contribute to the influx of nonnative plant and animal species (KMWP 2007, pp. 54–55; Laws 2010, in litt.). Feral cattle are reported from remote regions on Hawaii Island, including the back of both Pololu and Waipio Valleys (KMWP 2007, p. 55). Feral cattle are a threat to the lowland wet and montane wet ecosystems on Kohala Mountain where individuals of
The destruction or degradation of habitat due to feral sheep is currently a
In 1962, game hunters intentionally crossbred feral sheep with mouflon sheep and released them on Mauna Kea (Tomich 1986, pp. 156–163). In
Five of the described ecosystems (lowland mesic, lowland wet, montane dry, montane mesic, and montane wet) on Hawaii Island, and their associated species are currently threatened by the destruction or degradation of habitat due to mouflon sheep. The mouflon sheep (mouflon), native to Asia Minor, was introduced to the islands of Lanai and Hawaii in the 1950s, as a managed game species, and has become widely established on these islands (Tomich 1986, pp. 163–168; Cuddihy and Stone 1990, p. 66; Hess 2008, p. 1). In 1968, mouflon were introduced to Kahuku Ranch (now a unit of HVNP) on Mauna Loa for trophy hunting. By 2008, mouflon ranged over the southern part of Mauna Loa in the Kahuku area on adjacent public and private lands (Hess 2008, p. 1). According to Ikagawa (2011, in litt.), mouflon are found on the slopes of both Mauna Loa and Mauna Kea. Ikagawa (2011, in litt.) also notes that mouflon and mouflon-sheep hybrids are found from sea level to over 3,280 ft (1,000 m) elevation. Mouflon have high reproduction rates; for example, the original population of 11 individuals on the island of Hawaii has increased to more than 2,500 in 36 years, even though mouflon are hunted as a game animal (Hess 2008, p. 3). Mouflon only gather in herds when breeding, thus limiting control techniques and hunting efficiency (Hess 2008, p. 3; Ikagawa 2011, in litt.). Mouflon are both grazers and browsers, and have decimated vast areas of native forest and shrubland through browsing and bark stripping (Stone 1985, p. 271; Cuddihy and Stone 1990, pp. 63, 66; Hess 2008, p. 3). Mouflon also create trails and pathways through thick vegetation, leading to increased runoff and erosion through soil compaction. In some areas, the interaction of browsing and soil compaction has led to a change from native rainforest to grassy scrublands (Hess 2008, p. 3). Field biologists have observed habitat degradation in five of the described ecosystems (lowland mesic, lowland wet, montane dry, montane mesic, and montane wet) that support four plants (
Between 2010 and 2011, an unauthorized introduction of axis deer (
In summary, the 15 species dependent upon the 10 ecosystems identified in this final rule (anchialine pool, coastal, lowland dry, lowland mesic, lowland
Native vegetation on all of the main Hawaiian Islands has undergone extreme alteration because of past and present land management practices, including ranching, the deliberate introduction of nonnative plants and animals, and agricultural development (Cuddihy and Stone 1990, pp. 27, 58). The original native flora of Hawaii (species that were present before humans arrived) consisted of about 1,000 taxa, 89 percent of which were endemic (species that occur only in the Hawaiian Islands). Over 800 plant taxa have been introduced from elsewhere, and nearly 100 of these have become pests (e.g., injurious plants) in Hawaii (Smith 1985, p. 180; Cuddihy and Stone 1990, p. 73; Gagne and Cuddihy 1999, p. 45). Of these 100 nonnative pest plant species, over 35 species have altered the habitat of 14 of the 15 species in this final rule (only the anchialine pool shrimp is not directly impacted by nonnative plants (see Table 3)).
The most-often cited effects of nonnative plants on native plant species are competition and displacement. Competition may be for water, light, or nutrients, or it may involve allelopathy (chemical inhibition of other plants). Alien plants displace native species of plants by preventing their reproduction, usually by shading and taking up available sites for seedling establishment. Alien plant invasions alter entire ecosystems by forming monotypic stands, changing fire characteristics of native communities, altering soil-water regimes, changing nutrient cycling, or encouraging other nonnative organisms (Smith 1989, pp. 61–69; Vitousek
Nonnative plants pose serious and ongoing threats to 14 of the 15 species (not the anchialine pool shrimp) in this final rule throughout their ranges by destroying and modifying habitat. They can adversely impact microhabitat by modifying the availability of light and nutrient cycling processes, and by altering soil-water regimes. They can also alter fire regimes affecting native plant habitat, leading to incursions of fire-tolerant nonnative plant species into native habitat. Alteration of fire regimes clearly represents an ecosystem-level change caused by the invasion of nonnative grasses (D'Antonio and Vitousek 1992, p. 73). The grass lifeform supports standing dead material that burns readily, and grass tissues have large surface-to-volume ratios and can dry out quickly (D'Antonio and Vitousek 1992, p. 73). The flammability of biological materials is determined primarily by their surface-to-volume ratio and moisture content, and secondarily by mineral content and tissue chemistry (D'Antonio and Vitousek 1992, p. 73). The finest size classes of material (mainly grasses) ignite and spread fires under a broader range of conditions than do woody fuels or even surface litter (D'Antonio and Vitousek 1992, p. 73). The grass life form allows rapid recovery following fire; there is little above-ground structural tissue, so almost all new tissue fixes carbon and contributes to growth (D'Antonio and Vitousek 1992, p. 73). Grass canopies also support a microclimate in which surface temperatures are hotter, vapor pressure deficits are larger, and the drying of tissues more rapid than in forests or woodlands (D'Antonio and Vitousek 1992, p. 73). Thus, conditions that favor fire are much more frequent in grasslands (D'Antonio and Vitousek 1992, p. 73).
Nonnative plants outcompete native plants by growing faster, and some may release chemicals that inhibit the growth of other plants. Nonnative plants may also displace native species by preventing their reproduction, usually by shading and taking up available sites for seedling establishment (Vitousek
In summary, nonnative plants adversely impact native habitat in Hawaii, including 9 of the described Hawaii Island ecosystems that support 14 of the 15 species (not the anchialine pool shrimp), and directly adversely impact the 13 plant species, by: (1) Modifying the availability of light through alterations of the canopy structure; (2) altering soil-water regimes; (3) modifying nutrient cycling; (4) altering the fire regime affecting native plant communities (e.g., successive fires that burn farther and farther into native habitat, destroying native plants and removing habitat for native species by altering microclimatic conditions to favor alien species); and (5) ultimately converting native-dominated plant communities to nonnative plant communities (Smith 1985, pp. 180–181; Cuddihy and Stone, 1990, p. 74; D'Antonio and Vitousek 1992, p. 73; Vitousek
A summary of the specific impacts of nonnative plant species is included below. Please refer to the proposed rule (77 FR 63928; October 17, 2012) for a list of nonnative plants organized by their ecosystems, a detailed discussion of their specific negative effects on the 14 affected Hawaii Island species, and the literature cited for each nonnative plant species. In particular, we note that we provide discussions of nonnative plants in coastal, lowland wet, dry cliff, and wet cliff ecosystems in this rule (below), but the discussions for nonnative plants in the lowland dry, lowland mesic, montane dry, montane mesic, and montane wet ecosystems can be found in the October 17, 2012, proposed rule (77 FR 63928). Based on comments we received on the proposed rule, we have also added information below regarding the nonnative plants wedelia, strawberry guava, and skunk weed that pose threats to three plants,
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Nonnative plant species that pose a threat to
Nonnative plant species that are a threat to
Nonnative plant species that are a threat to the 7 of the 13 plant species (
Nonnative plant species that pose a threat to the three plant species (
Fire is an increasing, human-exacerbated threat to native species and native ecosystems in Hawaii. The historical fire regime in Hawaii was characterized by infrequent, low severity fires, as few natural ignition sources existed (Cuddihy and Stone 1990, p. 91; Smith and Tunison 1992, pp. 395–397). It is believed that prior to human colonization, fuel was sparse and inflammable in wet plant communities and seasonally flammable in mesic and dry plant communities. The primary ignition sources were volcanism and lightning (Baker
Because several Hawaiian plants show some tolerance of fire, Vogl proposed that naturally occurring fires may have been important in the development of the original Hawaiian flora (Vogl 1969 in Cuddihy and Stone 1990, p. 91; Smith and Tunison 1992, p. 394). However, Mueller-Dombois (1981 in Cuddihy and Stone 1990, p. 91) points out that most natural vegetation types in Hawaii would not carry fire before the introduction of alien grasses, and Smith and Tunison (1992, p. 396) state that native plant fuels typically have low flammability. Because of the greater frequency, intensity, and duration of fires that have resulted from the introduction of nonnative plants (especially grasses), fires are now destructive to native Hawaiian ecosystems (Brown and Smith 2000, p. 172), and a single grass-fueled fire can kill most native trees and shrubs in the burned area (D'Antonio and Vitousek 1992, p. 74).
Fire represents a threat to four of the species found in the lowland dry, lowland mesic, lowland wet, montane dry, and montane mesic ecosystems addressed in this final rule: the plants
For decades, fires have impacted rare or endangered species and their habitat (HDOFAW 2002, pp. 1, 4–6; Dayton 2007, in litt.; Joint Fire Science Program (JFSP) 2009, pp. 1–12; Weise
Fire is a threat to the Kona (leeward) side of Hawaii Island. In the past 50 years, there have been three wildfires that burned 20,000 ac (8,094 ha) or more: (1) 20,000 ac (8,094 ha) burned at Puuwaawaa Ranch in 1985; (2) 20,000 acres (8,094 ha) burned at the U.S. Army's PTA in 1994; and (3) 25,000 ac (10,117 ha) burned in Waikoloa in 2005 (Thompson 2005, in litt.). The only known occurrence (25 to 40 individuals) of the plant
Fire is also a threat to the picture-wing fly
Throughout the Hawaiian Islands, increased fuel loads and human-ignited fires caused the average acreage burned to increase five-fold from the early 1900s (1904 to 1939) to the mid-1900s (1940 to 1976) (La Rosa
Fire is a threat to three plant species (
Hurricanes adversely impact native Hawaiian terrestrial habitat and exacerbate the impacts resulting from other threats such as habitat degradation by ungulates and competition with nonnative plants. They do this by destroying native vegetation, opening the canopy and thus modifying the availability of light, and creating disturbed areas conducive to invasion by nonnative pest species (see “Specific Nonnative Plant Species Impacts,” on page 63952 of our October 17, 2012, proposed rule (77 FR 63928)) (Asner and Goldstein 1997, p. 148; Harrington
Hurricanes affecting Hawaii were only rarely reported from ships in the area from the 1800s until 1949. Between 1950 and 1997, 22 hurricanes passed near or over the Hawaiian Islands, 5 of which caused serious damage (Businger 1998, pp. 1–2). In November 1982, Hurricane Iwa struck the Hawaiian Islands, with wind gusts exceeding 100 mph (161 kph), causing extensive damage, especially on the islands of Niihau, Kauai, and Oahu (Businger 1998, pp. 2, 6). Many forest trees were
In addition to habitat destruction and nonnative plant introduction resulting from hurricanes, high winds and intense rains from hurricanes can directly kill individual picture-wing flies to the point of decimating an entire population (Carson 1986, p. 7; Foote and Carson 1995, pp. 369–370). High winds can also dislodge fly larvae from their host plants, destroy host plants, and expose the fly larvae to predation by nonnative yellowjacket wasps (see “Nonnative Western Yellow-Jacket Wasps,” under
Since 1950, 13 hurricanes have passed near but not over Hawaii Island. Eleven of these hurricanes brought heavy rain, strong wind, or high surf to the island, which caused erosion, flash floods, and other damage (Fletcher III
Although there is historical evidence of only one hurricane (1861) that approached from the east and impacted the islands of Maui and Hawaii (Businger 1998, p. 3), damage from future hurricanes could further decrease the remaining native plant-dominated habitat areas that support the 13 plant species and the picture-wing fly (
Rockfalls, treefalls, landslides, heavy rain, inundation by high surf, and erosion damage and destroy individual plants, destabilize substrates, and alter hydrological patterns that result in changes to native plant and animal communities. In the open sea near Hawaii, rainfall averages 25 to 30 in (635 to 762 mm) per year, yet the islands may receive up to 15 times this amount in some places, caused by orographic features (physical geography of mountains) (Wagner
Rockfalls, treefalls, landslides, heavy rain, inundation by high surf, and subsequent erosion are a threat to four of the plant species (
Two plant species,
Pohakuloa Training Area (the location of the only known individuals of the plant
Severe episodes of drought cannot only directly kill individuals of a species or entire populations, but drought frequently leads to an increase in the number and intensity of forest and brush fires (see “Habitat Destruction and Modification by Fire,” above), causing a reduction of native plant cover and habitat, an increase in nonnative plant and animal species, and a reduction in availability of host plants for the picture-wing fly (Giambelluca
Our analyses under the Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (Le Treut
Climate change will be a particular challenge for the conservation of biodiversity because the introduction and interaction of additional stressors may push species beyond their ability to survive (Lovejoy 2005, pp. 325–326). The synergistic implications of climate change and habitat fragmentation are the most threatening facet of climate change for biodiversity (Hannah
The magnitude and intensity of the impacts of global climate change and increasing temperatures on native Hawaiian ecosystems are unknown. Currently, there are no climate change studies that specifically address impacts to the Hawaii Island ecosystems discussed here or the 15 species at issue in this rule. Based on the best available information, climate change impacts could lead to the loss of native species that comprise the communities in which the 15 species occur (Pounds
The average ambient air temperature (at sea level) is projected to increase by about 4.1 degrees Fahrenheit (°F) (2.3 degrees Centigrade (°C)) with a range of 2.7 °F to 6.7 °F (1.5 °C to 3.7 °C) by 2100 worldwide (Trenberth
Overall, the daily temperature range in Hawaii is decreasing, resulting in a warmer environment, especially at higher elevations and at night. In the main Hawaiian Islands, predicted changes associated with increases in temperature include a shift in vegetation zones upslope, shift in animal species' ranges, changes in mean precipitation with unpredictable effects on local environments, increased occurrence of drought cycles, and increases in the intensity and number of hurricanes (Loope and Giambelluca 1998, pp. 514–515; U.S. Global Change Research Program (US–GCRP) 2009, pp. 1–188). In addition, weather regime changes (e.g., droughts, floods) will likely result from increased annual average temperatures related to more frequent El Niño episodes in Hawaii (Giambelluca
Globally, the warming atmosphere is creating a plethora of anticipated and unanticipated environmental changes such as melting ice caps, decline in annual snow mass, sea-level rise, ocean acidification, increase in storm frequency and intensity (e.g., hurricanes, cyclones, and tornadoes), and altered precipitation patterns that contribute to regional increases in floods, heat waves, drought, and wildfires that also displace species and alter or destroy natural ecosystems (Pounds
As global surface temperature rises, the evaporation of water vapor increases, resulting in higher concentrations of water vapor in the atmosphere, further resulting in altered global precipitation patterns (U.S. National Science and Technology Council (US–NSTC) 2008, pp. 69–94; US–GCRP 2009, pp. 1–188). While annual global precipitation has increased over the last 100 years, the combined effect of increases in evaporation and evapotranspiration is causing land surface drying in some regions leading to a greater incidence and severity of drought (US–NSTC 2008, pp. 69–94; US–GCRP 2009, pp. 1–188). Over the past 100 years, the Hawaiian Islands have experienced an annual decline in precipitation of just over 9 percent (US–NSTC 2008, p. 70). Other data on precipitation in Hawaii, which include sea-level precipitation and the added orographic effects, show a steady and significant decline of about 15 percent over the last 15 to 20 years (Chu and Chen 2005, pp. 4,881–4,900; Diaz
In the oceans around Hawaii, the average annual rainfall at sea level is about 25 in (63.5 cm). The orographic features of the islands increase this annual average to about 70 in (177.8 cm) but can exceed 240 in (609.6 cm) in the wettest mountain areas. Rainfall is distributed unevenly across each high island, and rainfall gradients are extreme (approximately 25 in (63.5 cm) per mile), creating both very dry and very wet areas. Global climate modeling predicts that, by 2100, net precipitation at sea level near the Hawaiian Islands will decrease in winter by about 4 to 6 percent, with no significant change during summer (IPCC AR4 2007, pp. 1–73). Downscaling of global climate models indicates that wet-season (winter) precipitation will decrease by 5 percent to 10 percent, while dry-season (summer) precipitation will increase by about 5 percent (Timm and Diaz 2009, pp. 4,261–4,280). These data are also supported by a steady decline in stream flow beginning in the early 1940s (Oki 2004, p. 1). Altered seasonal moisture regimes can have negative impacts on plant growth cycles and overall negative impacts on natural ecosystems (US–GCRP 2009, pp. 1–188). Long periods of decline in annual precipitation result in a reduction in moisture availability; an increase in drought frequency and intensity; and a self-perpetuating cycle of nonnative plants, fire, and erosion (US–GCRP 2009, pp. 1–188; Warren 2011, pp. 221–226) (see “Habitat Destruction and Modification by Fire,” above). These impacts may negatively affect the 15 species in this final rule and the 10 ecosystems that support them.
A tropical cyclone is the generic term for a medium-scale to large-scale, low-pressure storm system over tropical or subtropical waters with organized convection (i.e., thunderstorm activity) and definite cyclonic surface wind circulation (counterclockwise direction in the Northern Hemisphere) (Holland
For more information on this topic, see “Habitat Destruction and Modification by Hurricanes,” above.
On a global scale, sea level is rising as a result of thermal expansion of warming ocean water; the melting of ice sheets, glaciers, and ice caps; and the addition of water from terrestrial systems (Climate Institute 2011, in litt.). Sea level rose at an average rate of 0.1 in (1.8 mm) per year between 1961 and 2003 (IPCC 2007, pp. 30–73), and the predicted increase by the end of this century, without accounting for ice sheet flow, ranges from 0.6 ft to 2.0 ft (0.18 m to 0.6 m) (IPCC AR4 2007, p. 30). When ice sheet and glacial melt are incorporated into models the average estimated increase in sea level by the year 2100 is approximately 3 to 4 ft (0.9 to 1.2 m), with some estimates as high as 6.6 ft (2.0 m) to 7.8 ft (2.4 m) (Rahmstorf 2007, pp. 368–370; Pfeffer
In summary, increased interannual variability of ambient temperature, precipitation, hurricanes, and sea-level rise and inundation would provide additional stresses on the 10 ecosystems and the 15 associated species in this final rule because they are highly vulnerable to disturbance and related invasion of nonnative species. The probability of a species going extinct as a result of such factors increases when its range is restricted, habitat decreases, and population numbers decline (IPCC 2007, pp. 8–11). In addition, these 15 species are at a greater risk of extinction due to the loss of redundancy and resiliency created by their limited ranges, restricted habitat requirements, small population sizes, or low numbers of individuals. Therefore, we expect these 15 species to be particularly vulnerable to projected environmental impacts that may result from changes in climate and subsequent impacts to their habitats (e.g., Loope and Giambelluca 1998, pp. 504–505; Pounds
Anchialine pool habitats can gradually disappear when organic and mineral deposits from aquatic production and wind-blown materials accumulate through a process known as senescence (Maciolek and Brock 1974, p. 3; Brock 2004, pp. 11, 35–36). Conditions promoting rapid senescence are known to include an increased amount of sediment deposition, good exposure to light, shallowness, and a weak connection with the water table, resulting in sediment and detritus accumulating within the pool instead of being flushed away with tidal exchanges and groundwater flow (Maciolek and Brock 1974, p. 3; Brock 2004, pp. 11, 35–36).
Based upon what we know about healthy anchialine pool systems (Brock 2004, pp. 11, 35–36), one or more factors, combined with increased sedimentation, are degrading the health of the Lua o Palahemo pool system, one of the two known locations of
Second, increased sedimentation in Lua o Palahemo is overloading the capacity of the pool and lava tube below to adequately flush water to maintain the water quality needed to support the micro-organisms that are fed upon by several of the pool's shrimp species (e.g.,
Third, increased sedimentation and the inability of the pool system to adequately flush its waters are either diminishing or preventing migration and recolonization of the pool by the hypogeal shrimp species from the surrounding porous watertable bedrock. In other words, this lack of porosity is affecting the movement of shrimp to and from food resources, and the accumulating sediment and detritus reduce productivity within the pool. This reduction in productivity reduces the carrying capacity of the habitat to support hypogeal shrimp like
During a dive survey in 1985, visibility within the lava tube portion of Lua o Palahemo was as great as 20 m (66 ft) (Kinsley and Williams 1986, pp. 417–437). During this dive survey, Kensley and Williams (1986, p. 418) estimated that other species of hypogeal shrimp co-occurring with
During the 2010 survey, it was discovered that a possible partial collapse of the interior rock walls of Lua o Palahemo pool had occurred, and this collapse caused the difficulty experienced by the survey team to survey (via snorkeling) to any depth below the pool's surface (Wada 2010, in litt.). This collapse also contributed to the reduced flushing in the pool portion of Lua o Palahemo, leading to an accumulation of sediment and detritus in the pool. This accumulation of sediment is reducing both food productivity (i.e., reduce the abundance and availability of other species of hypogeal shrimp co-occurring with
There are no approved habitat conservation plans (HCPs), candidate conservation agreements (CCAs), or safe harbor agreements (SHAs) that specifically address these 15 species and threats from habitat destruction or modification. We acknowledge that in the State of Hawaii there are several voluntary conservation efforts that may be helping to ameliorate the threats to the 15 species listed as endangered in this final rule due to habitat destruction and modification by nonnative species, fire, natural disasters, and climate change, and the interaction of these threats. However, these efforts are overwhelmed by the number of threats, the extent of these threats across the landscape, and the lack of sufficient resources (e.g., funding) to control or eradicate them from all areas where these 15 species occur now or occurred historically. Some of the voluntary conservation efforts include the 11 island-based watershed partnerships, including the 3 partnerships on Hawaii Island (Three Mountian Alliance (TMA), Kohala Watershed Partnership (KWP), and the Mauna Kea Watershed Alliance (MKWA)). These partnerships are voluntary alliances of public and private landowners “committed to the common value of protecting forested watersheds for water recharge, conservation, and other ecosystem services through collaborative management” (
Current watershed partnership projects on Hawaii Island that will benefit one or more of the 15 species listed as endangered in this final rule include both the building of new fenced exclosures and the maintenance of existing exclosures to exclude feral ungulates. The TMA is preparing to build a fenced exclosure of approximately 12,000 ac (4,856 ha) in the Kau FR bordering the Kahuku Unit of HVNP (Big Island Video News, May 23, 2012) in an area where several occurrences of
The State of Hawaii's Plant Extinction Prevention (PEP) Program supports conservation of plant species by securing seeds or cuttings (with permission from the State, Federal, or private landowners) from the rarest and most critically endangered native species for propagation and outplanting (
Voluntary conservation actions undertaken by TNC on one (Kona Hema Preserve) of their three preserves on Hawaii Island provide a conservation benefit to individuals of the plants
Voluntary conservation actions undertaken by several private landowners (Kamehameha Schools; Kaloko Properties Corporation, Stanford Carr Development (SCD)—Takeshi Sekiguchi Associates (TSA) Kaloko Makai, LLC, and Takeshi Sekiguchi Associates (TSA) Corporation; Lanihau Properties; Palamanui Global Holdings, LLC; and DHHL) are described in our October 17, 2012, proposed rule (77 FR 63928). These conservation actions provide a conservation benefit and ameliorate some of the threats from nonnative species and wildfire to the plant
The threats to the habitats of each of the 15 species in this final rule are occurring throughout the entire range of each of the species, except where noted above. These threats include land conversion by agriculture and urbanization, nonnative ungulates and plants, fire, natural disasters, environmental changes resulting from climate change, sedimentation, and the interaction of these threats. While the conservation measures described above are a step in the right direction toward addressing the threats to the 15 species, due to the pervasive and expansive nature of the threats resulting in habitat degradation, these measures are insufficient across the landscape and in effort to eliminate these threats to any of the 15 species in this final rule.
Development and urbanization of lowland dry habitat on Hawaii Island represents a serious and ongoing threat to
The effects from ungulates are ongoing because ungulates currently occur in all of the 10 ecosystems that support the 15 species in this final rule. The threat posed by introduced ungulates to the species and their habitats in this final rule that occur in these 10 ecosystems (see Table 3) is serious, because they cause: (1) Trampling and grazing that directly impact the plant communities, which include all 13 of the plant species listed as endangered in this rule, and impact the host plants used by the picture-wing fly for shelter, foraging, and reproduction; (2) increased soil disturbance, leading to mechanical damage to individuals of the 13 plant species listed as endangered in this final rule, and also plants used by the picture-wing fly for shelter, foraging, and reproduction; (3) creation of open, disturbed areas conducive to weedy plant invasion and establishment of alien plants from dispersed fruits and seeds, which results over time in the conversion of a community dominated by native vegetation to one dominated by nonnative vegetation (leading to all of the negative impacts associated with nonnative plants, listed below); and (4) increased erosion, followed by sedimentation, affecting the anchialine pool habitat of
Nonnative plants represent a serious and ongoing threat to 14 of the 15 species listed as endangered in this final rule (all 13 plant species and the picture-wing fly (see Table 3)) through habitat destruction and modification, because they: (1) Adversely impact microhabitat by modifying the availability of light; (2) alter soil-water regimes; (3) modify nutrient cycling processes; (4) alter fire characteristics of native plant habitat, leading to incursions of fire-tolerant nonnative plant species into native habitat; (5) outcompete, and possibly directly inhibit the growth of, native plant species; and (6) create opportunities for subsequent establishment of nonnative vertebrates and invertebrates. Each of these threats can convert native-dominated plant communities to nonnative plant communities (Cuddihy and Stone 1990, p. 74; Vitousek 1992, pp. 33–35). This conversion has negative impacts on all 13 plant species listed as endangered here, as well as the native plant species upon which the picture-wing fly depends for essential life-history needs.
The threat from fire to 4 of the 15 species in this final rule that depend on lowland dry, lowland mesic, lowland wet, montane dry, and montane mesic ecosystems (the plants
Natural disasters, such as hurricanes, are a threat to native Hawaiian terrestrial habitat, including 9 of the 10 ecosystems (all except the anchialine pool ecosystem) addressed here, and the 13 plant species listed as endangered in this final rule, because they result in direct impacts to ecosystems and individual plants by opening the forest canopy, modifying available light, and creating disturbed areas that are conducive to invasion by nonnative pest plants (Asner and Goldstein 1997, p. 148; Harrington
Rockfalls, treefalls, landsides, heavy rain, inundation by high surf, and erosion are a threat to four of the species in this final rule (the plants
Changes in environmental conditions that may result from global climate change include increasing temperatures, decreasing precipitation, increasing storm intensities, and sea-level rise and coastal inundation. The consequent impacts on the 15 species listed as endangered in this final rule are related to changes in microclimatic conditions in their habitats. These changes have the potential to cause the loss of native species, including the 15 species being listed as endangered in this final rule, due to direct physiological stress, the loss or alteration of habitat, or changes in disturbance regimes (e.g., droughts, fire, storms, and hurricanes).
Sedimentation of the Lua o Palahemo pool system is a threat to the anchialine pool shrimp (
The plant species
The genus
While we are aware of two collections of the anchialine pool shrimp
We are unaware of voluntary conservation efforts to reduce overcollection of Hawaiian
We have no evidence to suggest that overutilization for commercial, recreational, scientific, or educational purposes poses a threat to 12 of the 13 plant species, the picture-wing fly, or the anchialine pool shrimp in this final rule. The plant species
We are not aware of any threats to the 13 plant species, anchialine pool shrimp, or picture-wing fly listed as endangered in this final rule that are attributable to disease.
Hawaii's plants and animals evolved in nearly complete isolation from continental influences. Successful colonization of these remote volcanic islands was infrequent, and many organisms never succeeded in establishing populations. As an example, Hawaii lacks any native ants or conifers, has very few families of birds, and has only a single native land mammal—a bat (Loope 1998, p. 748). In the absence of any grazing or browsing mammals, plants that became established did not need mechanical or chemical defenses against mammalian herbivory such as thorns, prickles, and production of toxins. As the evolutionary pressure to either produce or maintain such defenses was lacking, Hawaiian plants either lost or never developed these adaptations (Carlquist 1980, p. 173). Likewise, native Hawaiian birds and insects experienced no evolutionary pressure to develop anti-predator mechanisms against mammals or invertebrates that were not historically present on the island. The native flora and fauna of the islands are thus particularly vulnerable to the impacts of introduced nonnative species, as discussed below.
In addition to the habitat impacts discussed above (see “Habitat Destruction and Modification by Introduced Ungulates” under
We have direct evidence of ungulate damage to the 13 plant species listed as endangered species in this final rule, as well as to the two host plants of the picture-wing fly listed as an endangered species in this final rule. Magnacca
In addition, there are direct observations of pig herbivory, on either the fresh seedlings, fruits, seeds, or leaves, on each of the 13 plant species in this final rule, including
Feral goats thrive on a variety of food plants, and are instrumental in the decline of native vegetation in many areas (Cuddihy and Stone 1990, p. 64). Feral goats trample roots and seedlings, cause erosion, and promote the invasion of alien plants. They are able to forage in extremely rugged terrain and have a high reproductive capacity (Clarke and Cuddihy 1980, p. C–20; van Riper and van Riper 1982, pp. 34–35; Tomich 1986, pp. 153–156; Cuddihy and Stone 1990, p. 64). Goats were observed to browse on native plant species in the following genera:
Goats seek out seedlings and juveniles of
Four of the plant species listed as endangered in this final rule (
In HVNP, Cuddihy reported that there were twice as many native plant species as nonnatives found in areas that had been fenced to exclude feral cattle, whereas on the adjacent, nonfenced cattle ranch, there were twice as many nonnative plant species as natives (Cuddihy 1984, pp. 16, 34). Skolmen and Fujii (1980, pp. 301–310) found that
Feral sheep browse and trample native vegetation, and have decimated large areas of native forest and shrubland (Tomich 1986, pp. 156–163; Cuddihy and Stone 1990, p. 65–66). Large areas of Hawaii Island have been devastated by sheep. For example, sheep browsing reduced seedling establishment of
Mouflon sheep graze native vegetation, trample undergrowth, spread weeds, and cause erosion. On the island of Hawaii, mouflon sheep browsing led to the decline in the largest population of the endangered
Recent research by Ikagawa (2011, in litt.) suggests that the plant species
The recent introduction of axis deer to Hawaii Island raises a significant concern due to the reported damage axis deer cause on the island of Maui (see
Axis deer on Maui follow a cycle of grazing and browsing in open lowland grasslands during the rainy season (November–March) and then migrate to the lava flows of montane mesic forests during the dry summer months to graze and browse native plants (Medeiros 2010, pers. comm.). Axis deer are known to favor the native plants
There are three species of introduced rats in the Hawaiian Islands: Polynesian rat (
Rats impact native plants by eating fleshy fruits, seeds, flowers, stems, leaves, roots, and other plant parts (Atkinson and Atkinson 2000, p. 23), and can seriously affect regeneration. Research on rats in forests in New Zealand has also demonstrated that, over time, differential regeneration as a consequence of rat predation may alter the species composition of forested areas (Cuddihy and Stone 1990, pp. 68–69). Rats have caused declines or even the total elimination of island plant species (Campbell and Atkinson 1999, cited in Atkinson and Atkinson 2000, p. 24). In the Hawaiian Islands, rats may consume as much as 90 percent of the seeds produced by some trees, or in some cases prevent the regeneration of forest species completely (Cuddihy and Stone 1990, pp. 68–69). All three species of rat (black, Norway, and Polynesian) have been reported to be a serious threat to many endangered or threatened Hawaiian plants (Stone 1985, p. 264; Cuddihy and Stone 1990, pp. 67–69). Plants with fleshy fruits are particularly susceptible to rat predation, including some of the species listed as endangered in this rule. For example, the fruits of plants in the bellflower family (e.g.,
In Hawaii, the introduction of nonnative fish, including bait-fish, into anchialine pools has been a major contributor to the decline of native shrimp (TNC 1987 cited in Chan 1995, p. 1; Chan 1995, pp. 1, 8, 17–18; Brock and Kam 1997, p. 50; Brock 2004, p. 13–17; Kinzie 2012, in litt.). Predation by, and competition with, introduced nonnative fish is considered the greatest threat to native shrimp within anchialine pool ecosystems (Bailey-Brock and Brock 1993, p. 354; Brock 2004, pp. 13–17). These impacts are discussed further under
Predation by nonnative slugs adversely impacts 5 of the 13 plant species (
Little is known about predation of certain rare plants by slugs; however, information in the U.S. Army's 2005 “Status Report for the Makua Implementation Plan” indicates that slugs can be a threat to all species of
Joe and Daehler (2008, p. 252) found that native Hawaiian plants are more vulnerable to slug damage than nonnative plants. In particular, they found that the individuals of the endangered plants
The western yellow-jacket wasp (
The number of native parasitic Hymenoptera (parasitic wasps) in Hawaii is limited, and only species in the family Eucoilidae are known to use Hawaiian picture-wing flies as hosts (Montgomery 1975, pp. 74–75; Kaneshiro and Kaneshiro 1995, pp. 44–45). However, several species of small parasitic wasps (Family Braconidae), including
Ants are not a natural component of Hawaii's arthropod fauna, and native species evolved in the absence of predation pressure from ants. Ants can be particularly destructive predators because of their high densities, recruitment behavior, aggressiveness, and broad range of diet (Reimer 1993, pp. 13–17). Ants can prey directly upon native arthropods, exclude them through interference or exploitation competition for food resources, or displace them by monopolizing nesting or shelter sites (Krushelnychy
At least 47 species of ants are known to be established in the Hawaiian Islands (Krushelnycky 2008, pp. 1–11), and at least 4 particularly aggressive species (the big-headed ant (
The big-headed ant originated in central Africa (Krushelnycky
The long-legged ant appeared in Hawaii in 1952, and now occurs on Hawaii, Kauai, Maui, and Oahu (Reimer
Like
The Argentine ant (
The rarity or disappearance of native picture-wing fly species, including the species listed as endangered in this final rule, from historical observation sites over the past 100 years is due to a variety of factors. While there is no documentation that conclusively ties the decrease in picture-wing fly observations to the establishment of nonnative ants in lowland mesic, montane mesic, and montane wet ecosystems on Hawaii Island, the presence of nonnative ants in these habitats and the decline of picture-wing fly observations in some areas in these habitats suggest that nonnative ants may have played a role in the decline of some populations of the picture-wing fly listed as endangered in this rule. As nonnative predatory ants are found in three of the described ecosystems (lowland mesic, montane mesic, and montane wet) on Hawaii Island in which the picture-wing fly occurs, the data from the above studies, in addition to direct observations from field biologists, suggest that nonnative predatory ants contribute to the reduction in range and abundance of the picture-wing fly (Science Panel 2005, pp. 1–23).
Predation by the two-spotted leaf-hopper (
The Hawaiian Islands now support several species of nonnative beetles (family Scolytidae, genus
There are no approved HCPs, CCAs, or SHAs that specifically address these 15 species and threats from predation. We acknowledge that in the State of Hawaii there are several voluntary conservation efforts (e.g., construction of fences) that may be helping to ameliorate the threats to the 15 species listed as endangered in this final rule due to predation by nonnative animal species, specifically predation by feral ungulates on the 13 plants species. However, these efforts are overwhelmed by the number of threats, the extent of these threats across the landscape, and the lack of sufficient resources (e.g., funding) to control or eradicate them from all areas where these 15 species occur now or occurred historically. See “Conservation Efforts to Reduce Habitat Destruction, Modification, or Curtailment of Range” under
We are unaware of any information that indicates that disease is a threat to any of the 15 species in this final rule.
Although conservation measures are in place in some areas where each of the 15 species in this final rule occurs, information does not indicate that they are ameliorating the threat of predation described above. Therefore, we consider predation by nonnative animal species (pigs, goats, cattle, sheep, mouflon sheep, rats, slugs, wasps, ants, the two-spotted leaf hopper, and beetles) to pose an ongoing threat to all 13 plant species and the picture-wing fly in this final rule throughout their ranges for the following reasons:
(1) Observations and reports have documented that pigs, goats, cattle, sheep, and mouflon sheep browse and trample all 13 plant species and the host plants of the picture-wing fly in this rule (see Table 3), in addition to other studies demonstrating the negative impacts of ungulate browsing and trampling on native plant species of the islands (Spatz and Mueller-Dombois 1973, p. 874; Diong 1982, p. 160; Cuddihy and Stone 1990, p. 67).
(2) Nonnative rats and slugs cause mechanical damage to plants and destruction of plant parts (branches, fruits, and seeds), and are considered a threat to 11 of the 13 plant species in this rule (see Table 3). All of the plants and the picture-wing fly in this final rule are impacted by either introduced ungulates, as noted in item (1) above, or nonnative rats and slugs, or both.
(3) Predation of adults and larvae of Hawaiian picture-wing flies by the western yellow-jacket wasp has been observed, and it has been suggested that wasp predation has played a significant role in the dramatic declines of some populations of picture-wing flies (Carson 1986, pp. 3–9; Foote and Carson 1995, p. 371; Kaneshiro and Kaneshiro 1995, pp. 40–45; Science Panel 2005, pp. 1–23). Because western yellow-jacket wasps are found in the three
(4) Parasitic wasps purposefully introduced to Hawaii to control nonnative pest fruit flies will indiscriminately sting any fly larvae when attempting to lay their eggs. Predation by one or more of these nonnative parasitic wasps is a threat to
(5) Picture-wing flies are vulnerable to predation by ants, and the range of
(6) The plant
These threats are serious and ongoing, act in concert with other threats to the species, and are expected to continue or increase in magnitude and intensity into the future without effective management actions to control or eradicate them. In addition, negative impacts to native Hawaiian plants on Hawaii Island from grazing and browsing by axis deer are likely should this nonnative ungulate increase in numbers and range on the island.
Nonnative ungulates pose a major ongoing threat to all 13 plant species, and to the picture-wing fly, through destruction and degradation of terrestrial habitat, and through direct predation of the 13 plant species (see Table 3). In addition, nonnative ungulates (feral goats and cattle) pose an ongoing threat to the anchialine pool shrimp through destruction and degradation of its anchialine pool habitat at Lua o Palahemo (feral ungulates are not reported to pose a threat to the anchialine pool habitat at Manuka). Feral goats and cattle trample and forage on both native and nonnative plants around and near the pool opening at Lua o Palahemo, and increase erosion around the pool and sediment entering the pool. The State of Hawaii provides game mammal (feral pigs, goats, cattle, sheep, and mouflon sheep) hunting opportunities on 42 State-designated public hunting areas on the island of Hawaii (H.A.R. 13–123; Mello 2011, pers. comm.). The State's management objectives for game animals range from maximizing public hunting opportunities (e.g., “sustained yield”) in some areas to removal by State staff, or their designees, in other areas (H.A.R. 13–123). Ten of the 13 plant species (
The capacity of Federal and State agencies and their nongovernmental partners in Hawaii to mitigate the effects of introduced pests, such as ungulates and weeds, is limited due to the large number of taxa currently causing damage (Coordinating Group on Alien Pest Species (CGAPS) 2009). Many invasive weeds established on Hawaii Island have currently limited but expanding ranges and are of concern. Resources available to reduce the spread of these species and counter their negative ecological effects are limited. Control of established pests is largely focused on a few invasive species that cause significant economic or environmental damage to public and private lands. Comprehensive control of an array of invasive pests and management to reduce disturbance regimes that favor certain invasive species remain limited in scope. If current levels of funding and regulatory support for invasive species control are maintained on Hawaii Island, the Service expects existing programs to continue to exclude or, on a very limited basis, control invasive species only in high-priority areas. Threats from established pests (e.g., nonnative ungulates, weeds, and invertebrates) are ongoing and expected to continue into the future.
Currently, four agencies are responsible for inspection of goods arriving in Hawaii (CGAPS 2009). The Hawaii Department of Agriculture (HDOA) inspects domestic cargo and vessels, and focuses on pests of concern to Hawaii, especially insects or plant diseases not yet known to be present in the State (HDOA 2009). The U.S. Department of Homeland Security's Customs and Border Protection (CBP) is responsible for inspecting commercial, private, and military vessels and aircraft, and related cargo and passengers arriving from foreign locations. CBP focuses on a wide range of quarantine issues involving non-propagative plant materials (processed and unprocessed); wooden packing materials, timber, and products; internationally regulated commercial species under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES); seeds and plants listed as noxious; soil; and pests of concern to the greater United States, such as pests of mainland U.S. forests and agriculture. The U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Plant Protection and Quarantine (USDA–APHIS–PPQ) inspects propagative plant material,
The State of Hawaii's unique biosecurity needs are not recognized by Federal import regulations. Under the USDA–APHIS–PPQ's commodity risk assessments for plant pests, regulations are based on species considered threats to the mainland United States and do not address many species that could be pests in Hawaii (Hawaii Legislative Reference Bureau (HLRB) 2002, pp. 1–109; USDA–APHIS–PPQ 2010, pp. 1–88; CGAPS 2009, pp. 1–14). Interstate commerce provides the pathway for invasive species and commodities infested with non-Federal quarantine pests to enter Hawaii. Pests of quarantine concern for Hawaii may be intercepted at Hawaiian ports by Federal agents, but are not always acted on by them because these pests are not regulated under Federal mandates. Hence, Federal protection against pest species of concern to Hawaii has historically been inadequate. It is possible for the USDA to grant Hawaii protective exemptions under the “Special Local Needs Rule,” when clear and comprehensive arguments for both agricultural and conservation issues are provided; however, this exemption procedure operates on a case-by-case basis. Therefore, that avenue may only provide minimal protection against the large diversity of foreign pests that threaten Hawaii.
Adequate staffing, facilities, and equipment for Federal and State pest inspectors and identifiers in Hawaii devoted to invasive species interdiction are critical biosecurity gaps (HLRB 2002, pp. 1–14; USDA–APHIS–PPQ 2010, pp. 1–88; CGAPS 2009, pp. 1–14). State laws have recently been passed that allow the HDOA to collect fees for quarantine inspection of freight entering Hawaii (e.g., Act 36 (2011) H.R.S. 150A–5.3). Legislation passed and enacted on July 8, 2011 (H.B. 1568), requires commercial harbors and airports in Hawaii to provide biosecurity and inspection facilities to facilitate the movement of cargo through the ports. This enactment is a significant step toward optimizing the biosecurity capacity in the State of Hawaii; however, only time will determine the true effectiveness of this legislation. From a Federal perspective, there is a need to ensure that all civilian and military port and airport operations and construction are in compliance with the Federal Endangered Species Act of 1973, as amended. The introduction of new pests to the State of Hawaii is a significant risk to federally listed species because the existing regulations are inadequate for the reasons discussed in the sections below.
The State of Hawaii's laws prohibit the importation of all animals unless they are specifically placed on a list of allowable species (HLRB 2002, pp. 1–109; CGAPS 2010, pp. 1–14). The importation and interstate transport of invasive vertebrates is federally regulated by the Service under the Lacey Act as “injurious wildlife” (Fowler
Recently (2010–2011), unauthorized introduction of axis deer (
Predation by nonnative invertebrate pests (slugs, wasps, ants, leafhoppers, and beetles) negatively impacts 6 of the 13 the plant species and the picture-wing fly (see Table 3 and
Nonnative plants destroy and modify habitat throughout the ranges of 14 of the 15 species listed as endangered in this final rule (see Table 3, above). As such, they represent a serious and ongoing threat to each of these species. In addition, nonnative plants have been shown to outcompete native plants and convert native-dominated plant communities to nonnative plant communities (see “Habitat Destruction and Modification by Nonnative Plants,” under
The State of Hawaii allows the importation of most plant taxa, with limited exceptions, if shipped from domestic ports (HLRB 2002; USDA–APHIS–PPQ 2010; CGAPS 2010). Hawaii's plant import rules (H.A.R. 4–70) regulate the importation of 13 plant taxa of economic interest; regulated crops include pineapple, sugarcane, palms, and pines. Certain horticultural crops (e.g., orchids) may require import permits and have pre-entry requirements that include treatment or quarantine or both, prior to or following entry into the State. The State noxious weed list (H.A.R. 4–68) and USDA–APHIS–PPQ's Restricted Plants List restrict the import of a limited number of noxious weeds. If not specifically prohibited, current Federal regulations allow plants to be imported from international ports with some restrictions. The Federal Noxious Weed List (see 7 CFR 360.200) includes few of the many globally known invasive plants, and plants in general do not require a weed risk assessment prior to importation from international ports. USDA–APHIS–PPQ is in the process of finalizing rules to include a weed risk assessment for newly imported plants. Although the State has general guidelines for the importation of plants, and regulations are in place regarding the plant crops mentioned above, the intentional or inadvertent introduction of nonnative plants outside the regulatory process and movement of species between islands and from one watershed to the next continues, which represents a threat to native flora for the reasons described above. In addition, government funding is inadequate to provide for sufficient inspection services and monitoring. One study concluded that the plant importation laws virtually ensure new invasive plants will be introduced via the nursery and ornamental trade, and that outreach efforts cannot keep up with the multitude of new invasive plants being distributed. The author states the only thing that wide-scale public outreach can do in this regard is to let the public know new invasive plants are still being sold, and they should ask for noninvasive or native plants instead (Martin 2007, in litt.).
In 1995, the Coordinating Group on Alien and Plant Species (CGAPS), a partnership comprised primarily of managers from every major Federal, State, County, and private agency and organization involved in invasive species work in Hawaii, facilitated the formation of the Hawaii Invasive Species Council (HISC), which was created by gubernatorial executive order in 2002, to coordinate local initiatives for the prevention and control of invasive species by providing policy-level direction and planning for the State departments responsible for invasive species issues. In 2003, the Governor signed into law Act 85, which conveys statutory authority to the HISC to continue to coordinate approaches among the various State and Federal agencies, and international and local initiatives for the prevention and control of invasive species (HDLNR 2003, p. 3–15; HISC 2009; H.R.S. 194–2(a)). Some of the recent priorities for the HISC include interagency efforts to control nonnative species such as the plants
The Lua o Palahemo anchialine pool is located in a remote, largely undeveloped area, but is well known and frequently visited by residents and visitors for recreational opportunities, as indicated by the numerous off-road vehicle tracks around the pool (USFWS 2012 in litt.; Richardson 2012, in litt., pp. 1–2). As of the 2010 survey, a sign posted near Lua o Palahemo indicates that individuals who disturb the site are subject to fines under Haw. Rev. Stat. 6E (Hawaii's State Historic Preservation Act (SHPA)). This statute makes it unlawful for any person to take, appropriate, excavate, injure, destroy, or alter any historic property or aviation artifact located upon lands owned or controlled by the State or any of its political subdivisions, except as permitted by the State. Violators are subject to fines of not less than $500 nor more than $10,000 for each separate offense. However, regardless of the above warning, sometime between the 2010 survey and the June 2012 visit by Service biologists, the sign had been removed by unknown persons (Richardson 2012, in litt., pp. 1–2).
Three of the four anchialine pools in Manuka that support
On the basis of the above information, existing State and Federal regulatory mechanisms are not adequately preventing the introduction of nonnative species to Hawaii via interstate and international mechanisms, or intrastate movement of nonnative species between islands, and watersheds in Hawaii, and thus do not adequately protect each of the 13 plant species and the picture-wing fly in this final rule from the threat of new introductions of nonnative species, or from the continued expansion of nonnative species populations on and between islands and watersheds. Nonnative species prey upon species, modify or destroy habitat, or directly compete with one or more of these 14 species for food, space, and other necessary resources. The impacts from these introduced threats are ongoing and are expected to continue into the future.
In addition, the existing regulatory mechanisms do not provide adequate protection for the anchialine pool shrimp,
The State's current management of nonnative game mammals is inadequate to prevent the degradation and destruction of habitat of the 13 plant species, the anchialine pool shrimp, and the picture-wing fly (
Existing State and Federal regulatory mechanisms are not effectively preventing the introduction and spread of nonnative species from outside the State of Hawaii and between islands and watersheds within the State of Hawaii. Habitat-altering, nonnative plant species (
Existing State and Federal regulatory mechanisms do not provide adequate protection for the anchialine pool shrimp
As all 13 plant species and the picture-wing fly experience threats from habitat degradation and loss by nonnative plants (
Other factors that pose threats to some or all of the 15 species include dumping of trash and the introduction of nonnative fish, small numbers of populations and small population sizes, hybridization, lack of or declining regeneration, loss of host plants, and other activities. Each threat is discussed in detail below, along with identification of which species are affected by these threats.
The depressional features of anchialine pools make them susceptible to dumping. Refuse found in degraded pools and pools that have been filled in with rubble has been dated to about 100 years old, and the practice continues today (Brock 2004, p. 15). Lua o Palahemo, one of the two known locations of
In general, the accidental or intentional introduction and spread of nonnative fish (bait and aquarium fish) is considered the greatest threat to anchialine pools in Hawaii (Brock 2004, p. 16). Maciolek (1983, p. 612) found that the abundance of shrimp in a given population is indirectly related to predation by fish. The release of mosquito fish (
Lua o Palahemo is highly accessible to off-road vehicle traffic and located near an area frequented by residents and visitors for fishing and other outdoor recreational activities. The pool is vulnerable to the intentional dumping of trash and introduction of nonnative fish (bait and aquarium fish) because the area is easily accessible to vehicles and human traffic, and yet due to its remote location, is far from regulatory oversight by the DHHL or the Hawaii State Deparment of Aquatic Resources (DAR). According to Brock (2012, pers. comm.), sometime in the 1980s, nonnative fish were introduced into Lua o Palahemo. It is our understanding that the fish were subsequently removed with a fish poison, and to our knowledge the pool currently remains free of nonnative fish. The most commonly used piscicide (fish pesticide) in the United States for management of fish in freshwater systems is a naturally occurring chemical, marketed as Rotenone. Rotenone use in marine systems (including anchialine pools) is illegal according to the Environmental Protection Agency (EPA 2007, pp. 22–23, 29, 32; Finlayson et al. 2010, p. 2).
Three of the four pools that support
As the anchialine pool shrimp
Off-road vehicles frequent the area surrounding the Lua o Palahemo anchialine pool that supports one of the two known occurrences of
Species that are endemic to single islands are inherently more vulnerable to extinction than are widespread species, because of the increased risk of genetic bottlenecks; random demographic fluctuations; climate change effects; and localized catastrophes, such as hurricanes, drought, rockfalls, landslides, and disease outbreaks (Pimm
A limited number of individuals (fewer than 50 individuals) is a threat to the following six plant species listed as endangered in this final rule:
• The only known occurrences of
•
•
• Habitat destruction or direct predation by ungulates, nonnative plants, drought, and fire are threats to the 25 to 40 individuals of
Like most native island biota, the endemic anchialine pool shrimp and Hawaiian picture-wing fly are particularly sensitive to disturbances due to low number of individuals, low population numbers, and small geographic ranges. We consider the picture-wing fly vulnerable to extinction due to threats associated with low number of individuals and low number of populations because
Natural hybridization is a frequent phenomenon in plants and can lead to the formation of new species (Orians 2000, p. 1,949), or sometimes to the decline of species through genetic assimilation or “introgression” (Ellstrand 1992, pp. 77, 81; Levine
Lack of, or low levels of, regeneration (reproduction and recruitment) in the wild has been observed, and is a threat to,
Competition with nonnative tipulid flies (large crane flies, family Tipulidae) for larvae host plants adversely impacts the picture-wing fly listed in this final rule. The Hawaiian Islands now support several species of nonnative tipulid flies, and the larvae of some species within this group feed within the decomposing bark of some of the host plants utilized by picture-wing flies, including
There are no approved HCPs, CCAs, SHAs, MOUs, or other voluntary actions that specifically address these 15 species and the threats from other natural or manmade factors. We are unaware of any voluntary conservation actions to address the threat of dumping of trash and introduction of nonnative fish into anchialine pools that support the anchialine pool shrimp,
The conservation measures described above are insufficient to eliminate the threat from other natural or manmade factors to each of the 15 species listed as endangered in this final rule. We consider the threats from dumping of trash and introduction of nonnative fish into the pools that support the anchialine pool shrimp in this final rule to be serious threats that can occur at any time, although their occurrence is not predictable. The use of anchialine pools for dumping of trash and introduction of nonnative fish are widespread practices in Hawaii and can occur at any time at the Lua o Palahemo and Manuka pools. Nonnative fish prey on or outcompete native, herbivorous anchialine pool shrimp that serve as the prey base for predatory species of shrimp, including the anchialine pool shrimp listed as endangered in this rule. In addition, recreational use of off-road vehicles that frequent Lua o Palahemo are a threat to the shrimp, due to the resulting erosion and sedimentation that builds up in the pool (for impacts associated with sedimentation, see
We consider the threat from limited number of populations and few (less than 50) individuals to be a serious and ongoing threat to 6 plant species in this final rule (
The threat to the picture-wing fly from limited numbers of individuals and populations is ongoing and is expected to continue into the future because: (1) This species may experience reduced reproductive vigor due to inbreeding depression; (2) it may experience reduced levels of genetic variability leading to diminished capacity to adapt and respond to environmental changes, thereby lessening the probability of long-term persistence; (3) a single catastrophic event (e.g., hurricane, drought) may result in extirpation of remaining populations and extinction of this species; and (4) species with few known locations, such as
The threat from hybridization is unpredictable but an ongoing and ever-present threat to
Competition for host plants with nonnative tipulid flies is a threat to
The primary factors that pose serious and ongoing threats to one or more of the 15 species throughout their ranges in this final rule include: Habitat degradation and destruction by agriculture and urbanization, nonnative ungulates and plants, fire, natural disasters, sedimentation, and potentially climate change, and the interaction of these threats (Factor A); overutilization due to collection of seeds and seedlings of the plant
We have carefully assessed the best scientific and commercial information available regarding threats to each of the 15 species. We find that each of the 13 plant species and the picture-wing fly face threats that are ongoing and expected to continue into the future throughout their ranges from the present destruction and modification of their habitats from nonnative feral ungulates and nonnative plants (Factor A). Destruction and modification of habitat by development and urbanization is a threat to one plant species (
We find that the anchialine pool shrimp faces threats that are ongoing and expected to continue into the future from the present destruction and modification of its anchialine pool habitat at Lua o Palahemo, one of only two known locations for this species, due to sedimentation resulting from degradation of the immediate area surrounding this anchialine pool from nonnative feral ungulates (cattle and goats). Sedimentation reduces both food productivity and the ability of Lua o Palahemo to support the anchialine pool shrimp (Factor A).
Overcollection for commercial and recreational purposes poses a threat to
Predation and herbivory on all 13 plant species by feral pigs, goats, cattle, sheep, mouflon, rats, slugs, two-spotted leaf hoppers, or beetles poses a serious and ongoing threat, as does predation of the picture-wing fly by nonnative wasps and ants (Factor C).
Existing regulatory mechanisms are inadequate to reduce current and ongoing threats posed by nonnative plants and animals to all 15 species, and human dumping of nonnative fish and trash into the anchialine pools that support the anchialine pool shrimp
There are serious and ongoing threats to six plant species (
The anchialine pool shrimp faces threats from the intentional dumping of trash and introduction of nonnative fish into its pool habitat in the two known locations. In addition, the pools that support
These threats are exacerbated by these species' inherent vulnerability to extinction from stochastic events at any time because of their endemism, small numbers of individuals and populations, and restricted habitats.
The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that each of these 15 endemic species is presently in danger of extinction throughout its entire range, based on the severity and scope of the ongoing and projected threats described above. These threats are exacerbated by small population sizes, the loss of redundancy and resiliency of these species, and the continued inadequacy of existing protective regulations. Based on our analysis, we have no reason to believe that population trends for any of the species that are the subjects of this final rule will improve, nor will the negative impacts of current threats acting on the species be effectively ameliorated in the future. Therefore, on the basis of the best available scientific and commercial information, we are listing the following 15 species as endangered species in accordance with section 3(6) of the Act: The plants
Under the Act and our implementing regulations, a species may warrant
Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain activities. Recognition through listing results in public awareness and conservation by Federal, State, and local agencies: Private organizations; and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection measures required of Federal agencies and the prohibitions against certain activities involving listed animals and plants are discussed, in part, below.
The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.
Recovery planning includes the development of a recovery outline shortly after a species is listed, preparation of a draft and final recovery plan, and revisions to the plan as significant new information becomes available. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. The recovery plan identifies site-specific management actions that will achieve recovery of the species, measurable criteria that help to determine when a species may be downlisted or delisted, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (comprised of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outlines, draft recovery plans, and the final recovery plans will be available from our Web site (
Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private and State lands.
Funding for recovery actions may be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, under section 6 of the Act, the State of Hawaii will be eligible for Federal funds to implement management actions that promote the protection and recovery of the 15 species. Information on our grant programs that are available to aid species recovery can be found at:
Please let us know if you are interested in participating in recovery efforts for these species. Additionally, we invite you to submit any new information on these species whenever it becomes available and any information you may have for recovery planning purposes (see
Section 7(a) of the Act, as amended, requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(1) of the Act mandates that all Federal agencies shall utilize their authorities in furtherance of the purposes of the Act by carrying out programs for the conservation of endangered and threatened species listed pursuant to section 4 of the Act. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of a listed species or result in destruction or adverse modification of critical habitat. If a Federal action may affect the continued existence of a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.
For the 15 plants and animals listed as endangered species in this final rule, Federal agency actions that may require consultation as described in the preceding paragraph include, but are not limited to, actions within the jurisdiction of the Natural Resources Conservation Service, the U.S. Army Corps of Engineers, the U.S. Fish and Wildlife Service, and branches of the Department of Defense (DOD). Examples of these types of actions include activities funded or authorized under the Farm Bill Program, Environmental Quality Incentives Program, Ground and Surface Water Conservation Program, Clean Water Act (33 U.S.C. 1251 et seq.), Partners for Fish and Wildlife Program, and DOD construction activities related to training or other military missions.
The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered wildlife and plants. The prohibitions, codified at 50 CFR 17.21 for wildlife and 17.61 for plants, apply. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed wildlife species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. In addition, for plants listed as endangered, the Act prohibits the malicious damage or destruction on areas under Federal jurisdiction and the removal, cutting, digging up, or damaging or destroying of such plants in knowing violation of any State law or regulation, including State criminal trespass law. Certain exceptions to the
We may issue permits to carry out otherwise prohibited activities involving endangered or threatened wildlife or plant species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 and 17.62 for endangered wildlife and plants, respectively. With regard to endangered wildlife, a permit must be issued for the following purposes: For scientific purposes, to enhance the propagation and survival of the species, and for incidental take in connection with otherwise lawful activities. For endangered plants, a permit must be issued for scientific purposes or for the enhancement of propagation or survival. Requests for copies of the regulations regarding listed species and inquiries about prohibitions and permits may be addressed to U.S. Fish and Wildlife Service, Pacific Region, Ecological Services, Eastside Federal Complex, 911 NE. 11th Avenue, Portland, OR 97232–4181 (telephone 503–231–6131; facsimile 503–231–6243).
It is our policy, as published in the
(1) Unauthorized collecting, handling, possessing, selling, delivering, carrying, or transporting of the species, including import or export across State lines and international boundaries, except for properly documented antique specimens of these taxa at least 100 years old, as defined by section 10(h)(1) of the Act;
(2) Activities that take or harm the picture-wing fly or anchialine pool shrimp by causing significant habitat modification or degradation such that it causes actual injury by significantly impairing its essential behavior patterns. This may include introduction of nonnative species that compete with or prey upon the picture-wing fly or anchialine pool shrimp, or the unauthorized release of biological control agents that attack any life stage of these two species; and
(3) Damaging or destroying any of the 13 listed plants in violation of the Hawaii State law prohibiting take of listed species.
Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Pacific Islands Fish and Wildlife Office (see
Federal listing of the 15 species included in this rule automatically invokes State listing under Hawaii's Endangered Species law (H.R.S. 195D 1–32) and supplements the protection available under other State laws. These protections prohibit take of these species and encourage conservation by State government agencies. Further, the State may enter into agreements with Federal agencies to administer and manage any area required for the conservation, management, enhancement, or protection of endangered species (H.R.S. 195D–5). Funds for these activities could be made available under section 6 of the Act (Cooperation with the States). Thus, the Federal protection afforded to these species by listing them as endangered species is reinforced and supplemented by protection under State law.
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
A complete list of references cited in this rule is available on the Internet at
The primary authors of this final rule are the staff members of the Pacific Islands Fish and Wildlife Office.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361–1407; 1531–1544; 4201–4245, unless otherwise noted.
(h) * * *
(h) * * *
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), hereby list four Colombian species, the blue-billed curassow (
This rule becomes effective November 29, 2013.
This final rule is available on the Internet at
Janine Van Norman, Chief, Branch of Foreign Species, Endangered Species Program, U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Room 420, Arlington, VA 22203; telephone 703–358–2171; facsimile 703–358–1735. If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 800–877–8339.
Under the Endangered Species Act (Act), a species may warrant protection through listing if it is an endangered or threatened species throughout all or a significant portion of its range. Under the Act, if a species is determined to be endangered or threatened we are required to publish in the
Under the Endangered Species Act, we are required to determine whether a species is endangered or threatened because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the blue-billed curassow, Cauca guan, and gorgeted wood-quail are facing threats due to all of these five factors, and the brown-banded antpitta and Esmeraldas woodstar are facing threats due to four of these five factors (factors A, C, D, and E).
In this final rule, we utilize public comments and peer review to inform our final determination, as required under the Act. When we published the proposed rule on July 7, 2009, we opened a 60-day comment period on the proposed listing for these five species. On November 10, 2009, we reopened the comment period for an additional 60 days (74 FR 57987). During the comment periods, we sought comments from independent specialists (peer reviewers) on the specific assumptions and conclusions in our listing proposal to ensure that the designation of these species as endangered is based on scientifically sound data, assumptions, and analyses. In addition, we sought comments from interested parties and the general public. We considered all comments and information received during the comment periods. In this final rule, we present and respond to peer reviewer and public comments. This rule finalizes the protection proposed for these five foreign bird species as endangered, following careful consideration of all comments we received during the public comment periods.
We have not analyzed the costs or benefits of this rulemaking action because the Act precludes consideration of such impacts on listing and delisting determinations. Instead, listing and delisting decisions are based solely on the best scientific and commercial information available regarding the status of the subject species.
On November 24, 1980, the Service received a petition (1980 petition) from Dr. Warren B. King, Chairman of the International Council for Bird Preservation (ICBP), to add 60 foreign bird species to the List of Endangered and Threatened Wildlife (50 CFR 17.11(h)), including two species from Colombia (the Cauca guan and the gorgeted wood-quail). In response to the 1980 petition, we published a positive 90-day finding on May 12, 1981 (46 FR 26464), to initiate a status review for 58 foreign species, noting that two of the species identified in the petition were already listed under the Act. On January 20, 1984 (49 FR 2485), we published a 12-month finding within an annual review on pending petitions and description of progress on all species petition findings addressed therein. In that notice, we found that all 58 foreign bird species from the 1980 petition were warranted but precluded by higher-priority listing actions. On May 10, 1985, we published the first annual notice (50 FR 19761), in which we continued to find that listing all 58 foreign bird species from the 1980 petition was warranted but precluded. In our next annual notice, published on January 9, 1986 (51 FR 996), we found that listing 54 species from the 1980 petition, including the two Colombian species mentioned above, continued to be warranted but precluded, whereas new information caused us to find that listing four other species in the 1980 petition was no longer warranted. We published additional annual notices on the remaining 54 species included in the 1980 petition on July 7, 1988 (53 FR 25511); December 29, 1988 (53 FR 52746); and November 21, 1991 (56 FR 58664), in which we indicated that the Cauca guan and the gorgeted wood-quail, along with the remaining species in the 1980 petition, continued to be warranted but precluded.
On May 6, 1991, we received a petition (1991 petition) from Alison
Per the Service's listing priority guidelines (September 21, 1983; 48 FR 43098), we identified the listing priority numbers (LPNs) (ranging from 1 to 12) for all outstanding foreign species in our 2007 ANOR (72 FR 20184), published on April 23, 2007. In that notice, the five species included in this final rule were designated with an LPN of 2, and it was determined that their listing continued to be warranted but precluded because of other listing activity. A listing priority of 2 indicates that the subject species face imminent threats of high magnitude. With the exception of LPN 1, which addresses monotypic genera that face imminent threats of high magnitude, category 2 represents the Service's highest priority.
On July 29, 2008 (73 FR 44062), we published in the
On July 7, 2009, the Service published in the
On November 10, 2009, the Service published in the
We base this finding on a review of the best scientific and commercial information available, including all information received during the public comment period. In the July 7, 2009, proposed rule, we requested that all interested parties submit information that might contribute to development of a final rule. On November 10, 2009, we reopened the public comment period where we again requested that all interested parties submit information that might contribute to development of a final rule. We also contacted appropriate scientific experts and organizations and invited them to comment on the proposed listings. We received comments from five individuals; four of which were from peer reviewers.
We reviewed all comments we received from the public and peer reviewers for substantive issues and new information regarding the proposed listing of these species, and we address those comments below. All the commenters and peer reviewers supported the proposed listing. Two comments included additional information for consideration; the remaining three comments simply supported the proposed listing without providing scientific or commercial data.
In accordance with our policy published on July 1, 1994 (59 FR 34270), we solicited expert opinions from individuals with scientific expertise that included familiarity with the species, the geographic region in which the species occurs, and conservation biology principles. We received responses from four of the peer reviewers from whom we requested comments. They generally agreed that the description of the biology and habitat for the species was accurate and based on all relevant literature. Some new information was provided for one of the species, as described below. Some of the new information has been incorporated into this final rule. In some cases, it has been indicated in the citations by “personal communication” (pers. comm.), which indicates an email, facsimile, or telephone conversation; while in other cases, the research citation is provided.
Based on the comments we received during the comment period, we revised the blue-billed curassow life-history description to state that a breeding season also occurs in June through August. We also included information about the diminished impact of outreach efforts on transitory populations in our discussion of blue-billed curassow conservation education. In addition to these revisions, we made several minor editorial changes and corrections to text in this final rule.
Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act. The five factors are: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence.
Under the Act, we may determine a species to be endangered or threatened. An endangered species is defined as a species that is in danger of extinction throughout all or a significant portion of its range. A threatened species is defined as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. Therefore, we evaluated the best available scientific and commercial information on each species under the five listing factors to determine whether they met the definition of endangered or threatened.
On a species-by-species basis, a summary of the biology and distribution of each species, followed by information regarding the status of, and threats to, the species in relation to the five factors provided in section 4(a)(1) of the Act are discussed below. The Colombian species are considered first, in alphabetical order, as follows: Blue-billed curassow, brown-banded antpitta, Cauca guan, and gorgeted wood-quail. These are followed by the Ecuadorian species, the Esmeraldas woodstar.
The blue-billed curassow, endemic to Colombia, is a large (82–92 centimeters (cm) (32–36 inches (in)), tree-dwelling member of the Cracid family (Cracidae) (Salaman
The blue-billed currassow was first taxonomically described by Fraser in 1852 and placed in the family Cracidae, within the order Galliformes.
Blue-billed curassows prefer undisturbed, heterogeneous primary forests in the humid lowlands of the Sierra Nevada de Santa Marta Mountains at elevations up to 1,200 meters (m) (3,937 feet (ft)) (Salaman
The blue-billed curassow is terrestrial and feeds mostly on fruit and leaves, and sometimes on worms and carrion. It plays an important role in dispersing seeds and regenerating tropical forests (BLI 2007d, p. 1; Brooks 2006, p. 17; Brooks and Strahl 2000, pp. 5–8; Cuervo and Salaman 1999, p. 8).
Cracids are slow to reproduce, with a replacement rate of at least 6 years (Silva and Strahl 1991, p. 50). Curassows reach sexual maturity in their second year (Throp 1964, p. 130). Blue-billed curassows form monogamous pairs that share responsibilities for young (Todd
During the mating season, the male blue-billed curassows make “booming” calls that can be heard 500 m (1,640 ft) away (Ochoa-Quintero
The blue-billed curassow historically occurred in northern Colombia, from the base of the Sierra Nevada de Santa Marta (in the northern Departments of Magdalena La Guijaira, and Cesar), west to the Sinú valley (Department of Córdoba), through the Río Magdalena (through the Departments (from south to north) of Huila, Tolima, Caldas, Antioquia, Santander, Bolivar, Magdalena, and La Guajira) (BLI 2007a, p. 1; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361). The species' historic range encompassed an area of approximately 106,700 square kilometers (km
The current range of the blue-billed curassow is estimated to be a 2,090-km
In 1993, sightings were reported in the northern Departments of Córdoba (at La Terretera, near Alto Sinú) and Bolívar (in the Serranía de San Jacinto (San Jacinto Mountains)) (Williams,
There is little information on population numbers for the various reported locations of the species, and political instability within the country makes it difficult to know the exact population size of this species (Houston Zoo 2008). In 2002, Cuervo (2002, p. 141) considered the Serranía de las Quinchas and Serranía de San Lucas populations to be the stronghold of the species. However, surveys in 2003 led researchers to believe that Serranía de las Quinchas serves as the species' stronghold (BLI 2007d, pp. 2, 5–6). In 2003, the population at Serranía de las Quinchas (Boyacá Department) location was estimated to be between 250 and 1,000 birds. The only other information on the subpopulation level is a report from Strewe and Navarro (2003, p. 32), based on field studies conducted between 2000 and 2001, that hunting had nearly extirpated the blue-billed curassow from a site in San Salvador (La Guijara) (Factor B).
Using the International Union for Conservation of Nature and Natural Resources (IUCN) categories, the blue-billed curassow population was estimated according to IUCN criteria to be more than 1,000 but fewer than 2,500 in 1994 (BLI 2007d, p. 2). In 2001, Brooks and Gonzalez-Garcia (2001, p. 184) estimated the total population to be much fewer than 2,000 individuals. In 2002, it was estimated that the species had lost 88 percent of its habitat and half of its population within the last three generations, or 30 years (Cuervo 2002, p. 141). Local reports indicate an overall declining trend characterized by recent rapid declines of all subpopulations (BLI 2007d, p. 1; Cuervo 2002, p. 138; Strahl
The blue-billed curassow is identified as a critically endangered species under Colombian law (EcoLex 2002, p. 12). The species is considered one of the most threatened cracids by the IUCN Cracid Specialist Group. The species is categorized by the IUCN as `Critically Endangered,' with habitat loss as a primary threat (BLI 2004b, p. 1; Cuervo 2002, p. 141; del Hoyo 1994 p. 340; Strahl
The blue-billed curassow prefers undisturbed, heterogeneous forests and is rarely found in secondary or even slightly disturbed forests (Cuervo and Salaman 1999, p. 7). The blue-billed curassow occurs today in several disjunct locations along a much-restricted part of its historic distribution (Brooks and Gonzalez-Garcia 2001, p. 183; Collar
Primary forest habitats throughout Colombia have undergone extensive deforestation. Viña
In a similar study specific to the western Andean Amazon area of Colombia (in the Departments of Arauca, Casemere, Meta, Vichada, Amazonas, Caquetá, Guainia, Guaviare, Putumayo, and Vaupés), deforestation between 1980 and 1990 totaled 52,320 km
The decline in blue-billed curassow population numbers (see Population estimates, above) is inextricably linked to habitat loss. The blue-billed curassow became increasingly rare during the 20th Century, as much of the lower-elevation forests in their historic range of the Río Magdalena and Río Cauca Valleys were deforested, forcing the blue-billed curassow to move to higher elevations (Cuervo and Salaman 1999, p. 8). By the 1980s, the species had disappeared from a large portion of its previous range (Collar
Deforestation and fragmentation caused by human encroachment are ongoing throughout the blue-billed curassow's range, including: Antioquía (on the slopes of the Serranía de San Lucas and Bajo Cauca-Nechí Regional Reserve area); Santander and Boyacá Departments (on the slopes of the Serranía de las Quinchas); and in the southeastern Department of Cauca (in northeastern and lower Cauca Valley), where timber extraction and mining continue (Urueña
The cultivation of illegal crops (including coca) poses additional threats to the environment beyond encouraging the destruction of montane forests (Balslev 1993, p. 3). Van Schoik and Schulberg (1993, p. 21) noted that coca crop production destroys the soil quality by causing the soil to become more acidic, which depletes the soil nutrients and ultimately impedes the regrowth of secondary forests in abandoned fields. Although Colombia continues to be the leading coca bush producer (United Nations Office of Drugs and Crime (UNODC)
In 2006, eradication efforts were undertaken on over 2,130 km
A study conducted on the effects of habitat fragmentation on Andean birds within western Colombia determined two primary conditions that increased a species' vulnerability to habitat fragmentation and susceptibility to local extirpation and extinction: (1) Species that were located at the upper or lower limit of their altitudinal or geographical distribution (as is the case for the blue-billed curassow, which formerly occupied the now-cleared lower elevation forests and is relegated to isolated forest fragments within its current range), and (2) species that were large fruit-eating birds with limited distributions and narrow habitat preferences (also traits of the blue-billed curassow) (Kattan and Álvarez-Lopez 1996, pp. 5–6). The study also determined that 31 percent of the historical bird populations in western Colombia had become extinct or locally extirpated by 1990, largely as a result of habitat fragmentation from deforestation and human encroachment (Kattan and Álvarez-Lopez 1996, p. 5; Kattan
The most direct physical consequence of habitat fragmentation is loss of habitat heterogeneity (the variety, relative abundance, and spatial configuration of differing habitat types); habitat heterogeneity is a characteristic preferred by the blue-billed curassow (see Habitat and Life History, above) (Kattan and Álvarez-Lopez 1996, p. 6). Local reports indicate an overall declining trend, characterized by recent rapid declines of all populations of blue-billed curassows (BLI 2007d, p. 1; Cuervo 2002, p. 138; Strahl
In addition to the direct detrimental effect of habitat loss, blue-billed curassows and other cracids are susceptible to indirect effects of habitat disturbance and fragmentation (Brooks and Strahl 2000, p. 10; Silva and Strahl 1991, p. 38). A study conducted in northwestern Colombia suggests that habitat destruction and fragmentation may increase a species' vulnerability to predation (Arango-Vélez and Kattan 1997, pp. 140–142) (Factor C). Habitat fragmentation, in combination with growing numbers of human settlements, has made the species' habitat more accessible and more vulnerable to hunting (Factor B) and predation (Factor C). Habitat loss also compounds the species' decline in population numbers (estimated to be between 1,000 and 2,500 individuals) (BLI 2004b, p. 1) (see Factor E, Small population size).
Several areas within the blue-billed curassow's current range are designated as national parks or other types of preserves, including Tayrona and Sierra Nevada de Santa Marta National Parks (both in Antioquía Department) (Cuervo 2002, p. 140) and the Colorados Sanctuary (Bolívar Department), which protects part of the Serranía de San Jacinto (BLI 2007d, pp. 2–3; Urueña
(1) Serranía de San Lucas (Antioquía) is not a protected area, but is one of the largest remaining tracts of forest that is the least disturbed (WWF 2001b, p. 1). Even so, only a few isolated forest patches survive above 1,000 m (3,280 ft) in the northern lowlands (Antioquia Department) (Donegan and Salaman 1999, p. 4). Ongoing pressures on this habitat include human encroachment for natural resources, colonization, ranching, logging, and crop production, as well as pollution of the Magdelena and Cauca Rivers (WWF 2001b, p. 3). In 1996, there was a gold rush that led to deforestation for logging, settlements, conversion to agriculture, and coca production (BLI 2007d, p. 3). Using
(2) The Paramillo National Park (Antioquía and Córdoba Departments), created in 1977, encompasses an area 4,600 km
(3) The Bajo Cauca-Nechí Regional Reserve (Antioquía and Córdoba Departments), created in 1999, is located within a large tract (450 km
(4) El Paujíl Bird Reserve (Santander and Boyacá Departments) is a private reserve established in Serranía de las Quinchas (WorldTwitch Colombia 2004, p. 3). In the early 1990s, the Serranía de las Quinchas (Boyacá Department, central Colombia) was considered one of the last remaining well-preserved cloud forests and the largest tract of lowland wet forest in the region, with up to 500 km
The blue-billed curassow prefers undisturbed habitat, and the remaining small populations are limited to four or five small, disjunct, and isolated areas in seven different Departments. Within the past 30 years, or three generations, the species is estimated to have lost 88 percent of its habitat and half of its population. Deforestation and conversion of primary forests for human settlements and agriculture has led to habitat fragmentation throughout the species' range and to isolation of remaining populations. Habitat loss and fragmentation were factors in the species' historical decline (over the past 50 years) and caused localized extirpations, and continue to be factors negatively affecting the blue-billed curassow in the wild. Human encroachment into the species' preferred primary forest habitat has resulted in habitat alteration and disturbance activities that have caused declines in the blue-billed curassow population. Cultivation of illegal drug crops, such as cocaine, leads to further deforestation and alters soil compositions, hindering regeneration of abandoned fields. In addition, drug eradication programs involving the aerial spraying of nonspecific herbicides lead to further environmental degradation and destruction of primary forest habitat.
Three of the four most important refugia continue to undergo habitat destruction, and regulatory mechanisms are inadequate to mitigate the primary threats to this species (Factor D). A private refuge, the El Paujíl Bird Reserve, was formed to protect the blue-billed curassow and its habitat, which includes a large amount of suitable habitat, but may be lacking in its ability to adequately protect the species (Factors B and D). Habitat fragmentation contributes to the species' vulnerability to hunting (Factor B) and predation (Factor C) by increasing human and predator access to the habitat. The species' historic range, which encompassed approximately 106,700 km
Blue-billed curassows are hunted by indigenous people and local residents for subsistence, sport, trade, and entertainment (Brooks and Gonzalez-Garcia 2001, p. 183; Brooks and Strahl 2000, p. 10; Cuervo and Salaman 1999, p. 9; Throp 1964, p. 127; Urueña
Hunting affects the blue-billed curassow in all life stages. In 1999, hunters in Antioquío (where the blue-billed curassow is known on the slopes of the Serranía de San Lucas and Bajo Cauca-Nechí Regional Reserve area) reported killing as many as 20 blue-billed curassows within the prior 20 years (Donegan and Salaman 1999, p. 21). In 2004, it was reported that hunting had abated somewhat, because productive hunting grounds had become too remote from villages and because the communities have access to domestic meat (Melo and Ochoa 2004, as cited in Urueña
Most hunting occurs during the mating season, when males are more easily located by their booming mating calls (Cuervo and Salaman 1999, p. 9; del Hoyo 1994, p. 336), which can be heard from up to 500 m (1,640 ft) away (Ochoa-Quintero
Habitat fragmentation and concomitant human encroachment (Factor A) have made the species' habitat more accessible, resulting in the species becoming more vulnerable to hunting. A study conducted in French Guiana provided a quantitative estimate of the effect of hunting on a related cracid species, the black curassow (
In 1988, Colombia listed the blue-billed curassow in Appendix III of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (UNEP–WCMC 2008c). An Appendix III listing requires that the listing range country (in this case, Colombia) must issue an export permit for all exports of the species when the Management Authority of Colombia is satisfied that specimens have been legally obtained and live specimens will be transported such that risk of injury, damage, and cruelty are minimized. Imports require the prior presentation of a certificate of origin and, where the import is from Colombia, an export permit. In the case of rexports, a reexport certificate issued by the country of re-export is required (UNEP–WCMC 2008a). According to the World Conservation Monitoring Centre (WCMC), a total of 12 live birds have been traded internationally since 1990 (UNEP–WCMC 2008e). This trade consisted of imports of two individuals into the United States and five birds into Mexico in the early 1990s, and exports of five captive-bred specimens from the United States to Colombia and Belgium. Therefore, commercial international trade in wild specimens over the past 20 years has not been extensive.
The blue-billed curassow has been collected from the wild for use in zoos and in captive-breeding programs, both domestically and abroad. A small number of birds have been collected by the Cali Zoo and Santa Fe de Medellin Zoo in Colombia (Cuervo 2002, p. 142), and small collections are held in the United States, including the Houston Zoo and San Diego Zoo, as well as in Japan and Mexico (Brooks and Strahl 2000, p. 15; Cuervo 2002, p. 142). The Cali and Houston Zoo collections are being used for captive breeding, which we consider vital to conserving and recovering this species (Factor E). International trade for zoos and captive-breeding purposes does not contribute to the endangerment of the species. We believe that this limited amount of international trade, controlled via CITES, is not a threat to the species.
The blue-billed curassow is hunted and collected from the wild at all life stages throughout its current range. Blue-billed curassow eggs and chicks are collected for food and sale in local markets, or are often captured and held in captivity as pets or as a future food source. Hunting results in the direct removal of eggs, juveniles, and adults from the population. Blue-billed curassows are slow to reproduce, produce a low clutch size, and exhibit a poor replacement rate (see Habitat and Life History). Hunting can destroy pair bonds and remove potentially reproductive adults from the breeding pool. The species is particularly vulnerable to hunting and collection pressures due to the ease in locating this large bird during its breeding season. The majority of hunting occurs during the mating season, when males are heard calling for females, leading to disproportionate hunting of males. Hunting disturbances during the breeding season disrupt breeding activities, further compounding the threats associated with hunting mortalities. There are continued reports of hunting pressures on the species; these pressures have been and continue to be compounded by ongoing human encroachment into previously undisturbed forests (Factor A). Hunting and collection negatively affects the global population of the blue-billed curassow, due to its small population size and fragmented distribution. Hunting, combined with habitat fragmentation (Factor A), increases the possibility of local extirpation since the blue-billed curassow is unlikely to
We are unaware of information regarding disease or the potential for significant disease outbreaks in the blue-billed curassow. As a result, we do not consider disease to be a threat to the species.
According to Delacour and Amadon (1973), predators of cracids include snakes (suborder Serpentes), foxes (family Canidae), wild cats (
Other studies concerning the effects of habitat fragmentation on avian predation show similar results (Keyser 2002, p. 186; Renjifo 1999, p. 1,133; Keyser
Snakes, foxes, feral cats, feral dogs, and raptors are all predators of cracids. Predation results in the direct removal of eggs, juveniles, and adults from the population. Blue-billed curassows are slow to reproduce, produce a low clutch size, and exhibit a poor replacement rate (see Habitat and Life History). Predation can destroy pair bonds and remove potentially reproductive adults from the breeding pool. Studies on similar species in similar Andean habitats indicate that vulnerability to predation by generalist predators increases with increased habitat fragmentation and smaller patch sizes. Predation exacerbates the genetic complications associated with the species' small population size (Factor E). Because of the species' small population size and inability to recolonize isolated habitat fragments (Factor E), predation renders the species vulnerable to local extirpation. Therefore, we find that predation, compounded by ongoing habitat destruction (Factor A) and hunting (Factor B), is a threat to the blue-billed curassow.
Regulatory mechanisms may provide species-specific or habitat-specific protections. An evaluation of the adequacy of regulatory mechanisms within Colombia to mitigate or remove the threats to the blue-billed curassow is provided below, beginning with species-specific and followed by habitat-specific protection mechanisms.
The Colombian Government has enacted and ratified numerous domestic and international laws, decrees, and resolutions for managing and conserving wildlife and flora (Matallana-T 2005, p. 121). Colombian Law No. 99 of 1993 (Creating the Ministry of the Environment and Renewable Natural Resources and organizing the National Environmental System (SINA)) sets out the principles governing environmental policy in Colombia, and provides that the country's biodiversity be protected and used primarily in a sustainable manner (EcoLex 1993, p. 2). Resolution No. 584 of 2002 (Species that are endangered wildlife in the national territory) provides a list of Colombian wildlife and flora that are considered threatened. Threatened is defined as those species whose natural populations are at risk of extinction, as their habitat, range, or ecosystems that support them have been affected by either natural causes or human actions. Threatened species are further categorized as critically endangered, endangered, or vulnerable. A critically endangered species (CR) is one that faces a very high probability of extinction in the wild in the immediate future, based on a drastic reduction of its natural populations and a severe deterioration of its range; an endangered species (EN) is one that has a high probability of extinction in the wild in the near future, based on a declining trend of its natural populations and a deterioration of its range; and a vulnerable species (VU) is one that is not in imminent danger of extinction in the near future, but it could be if natural population trends continue downward and deterioration of its range continues (EcoLex 2002, p. 10).
The blue-billed curassow is considered a critically endangered species under Colombian law pursuant to paragraph 23 of Article 5 of Law No. 99, as outlined in Resolution No. 584 (EcoLex 2002, p. 12). This status confers certain protections upon the species. Resolution No. 849 of 1973 (laws governing commercial hunting of saínos, boas, anacondas, and birds throughout the country) and Resolution No. 787 of 1977 (laws governing sport hunting of mammals, birds, and reptiles of wildlife), regulate and prohibit commercial and sport hunting of all wild bird species, respectively, except those specifically identified by the Ministry of the Environment or otherwise permitted (EcoLex 1973, p. 1; EcoLex 1977, p. 3). The Ministry of the Environment does not permit the blue-billed curassow to be hunted commercially or for sport because of its status as a critically endangered species. Neither Resolution prohibits subsistence hunting. As discussed under Factor B, commercial and sport hunting are not threats to this species, but subsistence hunting continues to threaten the species throughout its range, including within protected areas. Thus, these Resolutions are ineffective at reducing the existing threat of subsistence hunting to the blue-billed curassow.
Additional efforts to protect the species from subsistence hunting are inadequate. Within El Paujíl Reserve, for instance, there are penalties for shooting or trapping the species (BLI 2007d, p. 3). However, as recently as 2006, it was reported that both chicks and eggs continued to be collected in the Serranía de las Quinchas region, where the Reserve is located, for domestic use and for sale at local markets (Cuervo 2002, p. 139; Urueña
The blue-billed curassow is listed in Appendix III of CITES (see Factor B). CITES is an international treaty among 177 nations, including Colombia (which became a Party in 1981) and the United States (which became a Party in 1975) (UNEP–WCMC 2008a, p. 1). In the United States, CITES is implemented through the U.S. Endangered Species Act (Act). The Act designates the Secretary of the Interior as the Scientific and Management Authorities to implement the treaty, with all functions carried out by the Service. Under this treaty, countries work together to ensure that international trade in animal and plant species is not detrimental to the survival of wild populations by regulating the import, export, reexport, and introduction from the sea of CITES-listed animal and plant species (USFWS 2008, p. 1). As discussed under Factor B, we do not consider commercial international trade to be a threat impacting the blue-billed curassow.
Colombia has numerous laws and regulations pertaining to forests and forestry management, including: The Forestry Law of 1959 (Law 2—[On] forest economy [of the] nation and conservation [of] renewable natural resources) (EcoLex 1959); the Forestry Code of 1974 (Decree 2,811—National code of renewable natural resources and protection of the environment) (Faolex 1974), and the forest plan of 1996 (Decree 1,791—Forest Improvement Plan) (Faolex 1996). A new forest law was developed and approved in 2006 (Law No. 1,021, General [Forestry] Law). The new law seeks to: (1) Further promote forest plantations and create financial mechanisms for investments, (2) provide for rigorous control and expanded sustainable use of natural forests, (3) and regulate and further develop forest concessions in the country (International Tropical Timber Organization (ITTO) 2006, p. 218). However, the ITTO considers the Colombian forestry sector to be lacking in law enforcement and on-the-ground control of forest resources, with no specific standards for large-scale forestry production, no forestry concession policies, and a lack of transparency in the application of the various laws regulating wildlife and their habitats (ITTO 2006, p. 222).
Resource management in Colombia is highly decentralized. Resources are managed within local municipalities by one of 33 Autonomous Regional Corporations known as CARs (Corporaciones Autónomas Regionales) (Matallana-T 2005, p. 121). CARs are corporate bodies of a public nature, endowed with administrative and financial autonomy to manage the environment and renewable natural resources (Law 99 of 1993). The blue-billed curassow is currently known to occur within seven different Departments, each of which is managed by a separate local entity. These corporations grant concessions, permits, and authorizations for forest harvesting (ITTO 2006, p. 219). Forty percent of Colombia's public resources are managed by local municipalities, making Colombia one of the most decentralized countries in terms of forestry management in Latin America (Matallana-T 2005, p. 121).
Monitoring of resource use and forest development authorized by these corporations is conducted mostly by local nongovernmental organizations. Governmental institutions responsible for oversight appear to be underresourced and unable to maintain an effective presence in the field (ITTO 2006, p. 222). Consequently, there is no vehicle for overall coordination of species management for multijurisdictional species such as the blue-billed curassow. The private Proaves-Colombia Foundation plans to generate a national strategy for the conservation of the blue-billed curassow through the project, “Saving the Blue-billed Curassow” (Quevedo
Currently there are approximately 49 nationally recognized protected areas in Colombia (Matallano-T 2005, p. 121). The five most common categories of habitat protection are: (1) National Natural Park (an area whose ecosystems have not been substantially altered by human exploitation or occupation, and where plant and animal species, or complex geomorphological landscapes have historical, cultural, scientific, educational, aesthetic, or recreational value); (2) Wildlife Sanctuary for Fauna and Flora (an area dedicated to preserve species or communities of wildlife, and to conserve genetic resources of wildlife); (3) National Natural Reserve (an area that preserves flora and fauna and is established for the study of its natural wealth); (4) Panoramic Park (a parcel of land of panoramic, cultural, or natural value preserved for education and relaxation); and (5) Unique National Area (a rare or unique ecosystem) (Matallano-T 2005, p. 121). Several areas considered to be important refuges for the blue-billed curassow are protected areas and are managed by autonomous corporations, including: (1) The Paramillo National Natural Park (Antioquía and Córdoba Departments) and (2) The Bajo Cauca–Nechí Regional Natural Reserve (Antioquía and Córdoba Departments) (BLI 2007d, p. 3; Cuervo 2002, p. 139), both of which are managed by Corantioquia (Corantioquia 2008, p. 1).
(1) The Paramillo National Natural Park (Antioquía and Córdoba Departments) is a large Park, but no protective measures have been implemented to curb human impacts on the habitat and species by the indigenous and farming residents within the park (BLI 2007a, pp. 1–2; BLI 2007d, p. 3) (Factor A). Cocaine cultivation is occurring within the Park boundaries (UNODC and GOC 2005, p. 45). Dam construction on the Sinú River, part of the species' historic range (BLI 2007a, p. 1; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361), has caused ongoing flooding in the area since its completion in 1998 (NGO Working Group on Export Development Canada 2003, p. 31; Cuervo 2002, p. 139). Thus, the designation of this area as a Park has not mitigated human-induced habitat destruction (Factor A).
(2) The Bajo Cauca-Nechí Regional Natural Reserve (Antioquía and Córdoba Departments) encompasses suitable habitat for the blue-billed curassow, but the species has not been confirmed within the Reserve (BLI 2007d, p. 3). Nonetheless, it is notable that this Reserve, which is designated to preserve and research flora and fauna, allows logging (Fundación Viztaz 2007, p. 2). Thus, should the species be located therein, this Reserve's designation as a preserve would not mitigate the threat from habitat destruction (Factor A).
The privately owned El Paujíl Bird Preserve, which was established specifically to protect the blue-billed curassow and its habitat (BLI 2007d, p. 2) (Factor A), has measures in place to penalize shooting or trapping the
Aside from the Paramillo National Park, which includes habitat in the upper elevational limit of the blue-billed curassow's preferred range (Cuervo 2002, p. 140), no effective protective measures have been undertaken (BLI 2007d, p. 2; Brooks and Gonzalez-Garcia 2001, p. 183) in that the regulatory mechanisms in these protected areas do not mitigate habitat destruction, which is a primary risk factor for this species (Factor A). Thus, these protected areas do not provide sufficient protections to mitigate the effects from habitat loss (Factor A) or reduce threats from hunting and collection (Factor B).
Colombia has numerous laws and regulatory mechanisms intended to protect and manage wildlife and their habitats. The blue-billed curassow is considered critically endangered under Colombian law and lives within several managed forests or protected areas. However, on-the-ground enforcement of existing wildlife protection and forestry laws and oversight of the local jurisdictions implementing and regulating activities are ineffective at mitigating the primary threats to the blue-billed curassow. As discussed in Factor A, habitat destruction, degradation, and fragmentation continue throughout the existing range of the blue-billed curassow. As discussed in Factor B, uncontrolled hunting and commercial use of the blue-billed curassow are ongoing and continue to negatively affect the continued existence of the species. Moreover, the lack of a species conservation strategy and the decentralized management of natural resources in Colombia provide no overall coordination in the conservation efforts for species including the blue-billed curassow, which ranges in multiple jurisdictions. Despite ongoing work toward developing a national conservation strategy for the species, it is not known whether it will be formally adopted by the Government of Colombia, and at this time we are unable to determine whether the strategy will be effective in reducing the threats to this species on a local or rangewide basis. Therefore, we find that the existing regulatory mechanisms currently in place for the blue-billed curassow do not reduce or remove the factors threatening the species, thus we find that Factor D is a threat to the blue-billed curassow.
Three additional factors affect the blue-billed curassow: Limited ability to disperse to unoccupied habitat; small population size, and unsuccessful captive-breeding programs.
The blue-billed curassow exhibits several characteristics that make it unlikely to disperse into isolated habitat fragments in order to repopulate patches of suitable habitat. The blue-billed curassow requires a large home range of primary tropical forest (Cuervo 2002, pp. 138–140). The habitat patches within the blue-billed curassow's current range are described by researchers as fragmented, disjunct, and isolated (Donegan and Huertas 2005, p. 29; Salaman
Deforestation and habitat loss throughout the blue-billed curassow's historic range has resulted in fragmented, disjunct, and isolated populations in the remaining four or five patches of tropical humid and premontane forests and caused regional extirpations of the blue-billed curassow (Brooks and Gonzalez-Garcia 2001, p. 183; Cuervo and Salaman 1999, p. 7; Collar
The blue-billed curassow's restricted and fragmented range, combined with its small population size (Cuervo 2002, p. 138; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361), makes the species particularly vulnerable to the threat of adverse genetic effects and susceptible to extinction through natural or manmade events that destroy individuals and their habitat (BLI 2007d, pp. 1–2; Cuervo 2002, p. 140; Brooks and Gonzalez-Garcia 2001, pp. 185–190). Meta-population analysis involves the study of the dynamics of an entire population by studying movements within local populations (Hanski 1998, p. 41). “A meta-population composed of extinction-prone local populations in a small patch network is necessarily more threatened than are meta-populations in large and well connected networks” (Hanski 1998, p. 42). Considering that not all blue-billed curassow individuals in a population are breeding at any one time, the actual number of individuals contributing to population growth will be a smaller number than the total number of individuals.
Small population sizes render species vulnerable to any of several risks, including loss of genetic variation, inbreeding depression, and accumulation of deleterious genes. Inbreeding can have individual or population-level consequences either by increasing the phenotypic expression (the outward appearance or observable structure, function, or behavior of a living organism) of recessive, deleterious alleles or by reducing the overall fitness of individuals in the population (Charlesworth and Charlesworth 1987, p. 238; Shaffer 1981, p. 131). Small, isolated populations of wildlife species are also susceptible to demographic problems (Shaffer 1981, p. 131), which may include reduced reproductive success of individuals and chance disequilibrium of sex ratios. Chance disequilibrium of sex ratios would be further exacerbated by preferential hunting of male birds (Factor B). This species' risk of extinction is further compounded by ongoing collection of eggs and chicks, and by hunting-related disturbances that may disrupt breeding pairs (Factor B). Once a population is reduced below a certain number of individuals, it tends to rapidly decline towards extinction (Franklin 1980, pp. 147–148; Gilpin and Soulé 1986, p. 25; Holsinger 2000, pp. 64–65; Soulé 1987, p. 181).
A captive-breeding program is being developed within the species' range (see Current Range and Distribution, above) by Fundación Ecolombia, based at the Wildlife Rehabilitation Centre in Los Farallones (Antioquía Department, Colombia). The captive-held population includes three males and two females. The program has met with little success because attempts to breed the species in captivity have been unsuccessful to date (two sterile eggs laid in 2003 and none since). The species is historically known to be a poor breeder in captivity (Throp 1964, p. 127). The program is exploring artificial insemination for future breeding (Wildlife Protection Foundation (WPF) 2007, p. 2). The Houston Zoo, however, which has maintained cracids since the 1960s, has bred the species for 30 years and has successfully raised at least 10 blue-billed curassows in captivity (Houston Zoo 2008, p. 2; Todd
The blue-billed curassow's small population size increases its vulnerability to genetic risks associated with small population sizes that negatively impact the species' long-term viability and increase the possibility of localized extirpations of the remaining fragmented populations. Further, the species is unlikely to repopulate areas of suitable habitat from which a subpopulation has been extirpated because it avoids crossing the disturbed areas that separate the remaining suitable habitat for this species. Range-country attempts at captive breeding have been unsuccessful, and the stock in U.S. captive-breeding programs is limited; therefore, the captive-breeding program is not contributing to reintroduction of the species in the wild and so is not currently mitigating the problem of small population size. Therefore, we believe that, in combination with the risks to the species from habitat destruction (Factor A), hunting (Factor B), and predation (Factor C), the blue-billed curassow is vulnerable to localized extirpation or extinction from which the species would be unable to recover, due to its small population size and apparent inability to repopulate fragmented, isolated habitats such as those currently present within this species' range.
The five primary factors that threaten the survival of the blue-billed curassow are: (1) Habitat destruction, fragmentation, and degradation (Factor A); (2) overexploitation due to hunting and collecting of eggs and chicks (Factor B); (3) predation (Factor C); (4) inadequacy of regulatory mechanisms to reduce the threats to the species (Factor D); and (5) small population size and isolation of remaining populations (Factor E).
The direct loss of habitat through widespread deforestation and conversion of primary forests to human settlement and agricultural uses has led to the fragmentation of habitat throughout the range of the blue-billed curassow and isolation of the remaining populations (Factor A). The species' historic range, which encompassed approximately 106,700 km
The blue-billed curassow is hunted or collected, whole or in parts, in all life stages (eggs, juveniles, adults, feathers, and other body parts) throughout its current range by both indigenous people and by local settlers for both sustenance and sport; for domestic use in rituals; and for sale to tourists (Factor B). Several life-history traits of the species contribute to its vulnerability to hunting and collection: Its large size, ease of location during breeding season, trusting nature, low productivity (1–2 eggs), and a replacement rate of 6 years (taking an individual of the species an average of 6 years to replace itself). Adults are hunted mainly during the breeding season, when males are most vulnerable and more easily located by their loud mating calls that are audible at long distances. The direct take of males disrupts sex ratios in this species, which forms monogamous pairs, and this take also disrupts mating activities. Hunting pressure has caused severe depletion or near extirpation in portions of its historical range, despite the continued availability of suitable habitat (primary forest). The effects of hunting are exacerbated by ongoing habitat fragmentation (Factor A), which increases accessibility into the species' habitat, rendering it more vulnerable to hunting. Concomitantly, increased conversion of primary forest habitat has encouraged further human settlement within the blue-billed curassow's habitat. Hunting poses an imminent threat of extinction and is a factor that currently endangers the species.
Blue-billed curassows are vulnerable to predation by generalist predators, including snakes, foxes, feral cats, feral dogs, and raptors (Factor C). Habitat fragmentation (Factor A) contributes to this vulnerability, because research indicates that predation increases with increased habitat fragmentation and smaller patch sizes. Predation leads to the direct removal of eggs, juveniles, and adults from the population, exacerbating risks associated with the species' small population size (see below). Predation can destroy pair bonds and remove potentially reproductive adults from the breeding pool. The blue-billed curassow is slow to reproduce and produces a low clutch size, and predation exacerbates this species' already poor replacement rate (see Habitat and Life History).
The threats from habitat destruction, hunting, and predation are compounded by the species' small population size (Factor E). The blue-billed curassow's population has been reduced by 50 percent within the last 30 years. The species' low population estimate of fewer than 2,000 individuals, combined with its restricted, fragmented, and isolated habitat, makes the species particularly vulnerable to numerous human factors (e.g., agricultural development, armed conflict, fire, dams and reservoir development, increased human settlement, illicit drug production and control, mining activities, oil development and distribution, and road development).
Finally, despite numerous laws and regulatory mechanisms (Factor D) to administer and manage wildlife and their habitats, on-the-ground enforcement of these laws and oversight of the local jurisdictions implementing and regulating activities within the species' habitat are inadequate to mitigate the effects of habitat loss (Factor A) and hunting (Factor B). Habitat destruction and hunting continues within the species' range and, aside from El Paujíl Bird Preserve, no other areas provide effective protective measures for protecting the blue-billed curassow from ongoing hunting or its habitat from ongoing destruction.
We have carefully assessed the best available scientific and commercial information regarding the past, present, and potential future threats faced by the blue-billed curassow. We conclude that the ongoing threats to the blue-billed curassow, habitat destruction (Factor A), hunting (Factor B), and predation (Factor C), exacerbated by the species' small population size and limited dispersal ability (Factor E), and compounded by inadequate regulatory mechanisms to mitigate these threats (Factor D), to be equally present and of the same magnitude throughout the species' entire current range. We further conclude, based on the best available scientific and commercial information, that the magnitude of these threats are of an extent that places the species in danger of extinction at this time. Therefore, on the basis of our analysis of the best available scientific and commercial information, we conclude that the blue-billed curassow is endangered throughout its range, and thus should be designated an endangered species under the Act.
The brown-banded antpitta is a member of the ground-antbird Family (Formicariidae), is approximately 18 cm (7 in) long from bill to tail, and endemic to the west slope of the central Andes of Colombia (Krabbe and Schulenberg 2003, p. 682; Fjeldså and Krabbe 1990, p. 414; Hilty and Brown 1986, p. 422). The species is locally known as “Tororoi” (Beltrán and Kattan 2002). This bird is a uniform dark brown, with a dingy white throat and underbelly.
The brown-banded antpitta was first taxonomically described by Chapman in 1911 and placed in the Ground-Antbird Family (Formicariidae). The type specimen (the actual specimen that was first described by Chapman) was obtained from Laguneta (Quindío Department) (Beltrán and Kattan 2002, p. 327). Laguneta is, therefore, referred to as the “type locality.”
The brown-banded antpitta currently inhabits the humid understory and forest floor habitats of mid-montane and cloud forests between 2,400 and 2,600 m (7,874 and 8,530 ft) with high density of herbaceous plants and shrubs (Krabbe and Schulenberg 2003, p. 719; Kattan and Beltrán 1999, p. 272). The species has been observed in older (30-year-old) secondary-growth forest habitats and alder (
Researchers consider antpitta life histories to be among the least known of Neotropical bird species (Dobbs
Nothing is known about the brown-banded antpitta's reproductive ecology, except that its peak reproductive period is between March and May (Beltrán and Kattan 2002, pp. 326–327) and that both parents feed the young (del Hoyo 2003, p. 719). Drawing from studies on similar species, including the Colombian species, scaled antpitta (
The brown-banded antpitta was historically known from a single location, near Laguneta in the central Andes (centrally located in the Department of Quindío), which ranges in altitude from 1,859 m (6,100 ft) in the surrounding valleys to 3,140 m (10,300 ft) at its highest point (Chapman 1917, pp. 35–36, 396). In 1917, the valley leading to Laguneta was described as gently rising until about 2,530 m (8,300 ft), when the terrain rose steeply up to 2,896 ft (9,500 ft). The vegetation was described as open, with scattered palms and little other vegetation until about 2,835 m (9,300 ft), where the forest began (Chapman 1917, p. 36). At 3,140 m (10,300 ft), the forest was described as dense with little undergrowth, except in occasional clearings dominated by dense shrubs so thick as to be impenetrable without a knife (Chapman 1917, p. 35). Eleven specimens were collected between 1911 and 1942; the species was last observed and collections were made at the type locality at Laguneta in 1942 (Beltrán and Kattan 2002, p. 325; Collar
Chapman (1917, p. 36) described the practice of slash-and-burn agriculture around Laguneta in 1917, noting that much of the hillside between 2,530 and 2,835 m (8,300–9,300 ft) was bare and close-cropped, having been burned and cleared. By 1994, the forested area providing habitat for the brown-banded antpitta in and around the type locality near Laguneta had been mostly destroyed (Collar
The current range of the brown-banded antpitta is described as humid understory and forest floors of mid-montane and cloud forests, preferring altitudes between 2,400 and 2,600 m (7,874 and 8,530 ft), in areas with a high density of herbs and shrubs (Krabbe and Schulenberg 2003, p. 719; Kattan and Beltrán 1999, p. 272). The current range is estimated to be 300 km
There have been few quantitative surveys of the brown-banded antpitta. Available population information is provided for the four areas considered to be important refugia for the species (as discussed in Factor A). The population located within the Ucumarí Regional Park has been surveyed twice. In the first survey, conducted from 1994 to 1997, 11 brown-banded antpittas were captured and banded. In a subsequent survey of a 0.17–1 km
Qualitative surveys conducted from 1998 to 2000 in the Río Toche Valley determined that the brown-banded antpitta is uncommon and local (Beltrán and Kattan 2002, p. 326). One individual was observed in 1999 (Cuervo
A census of the population in the Río Blanco river basin was undertaken in June 2000, within an approximately 5 km (3 mi) transect. Researchers inferred the presence of at least 30 individuals, based on vocalizations they elicited in response to recordings of the species' alarm call (Beltrán and Kattan 2002, p. 326). There is no information on the estimated population size of brown-banded antpitta within the Río Blanco area. Thus, this population may contain 30 individuals, but the upper limit of the population estimate is unknown.
The species is not currently known to inhabit the Reserve del Cañon del Quindío. Although the species was observed there in 1911 and 1942 (Beltrán and Kattan 2002, p. 325; Collar
The IUCN estimates that the largest subpopulation contains 424 individuals (BLI 2007f, p. 4), but it is unclear as to which subpopulation this estimate refers. The global population of brown-banded antpitta is estimated by the IUCN to be larger than 250 individuals, but not more than 999 birds (BLI 2007f, p. 1), equating to approximately 338 to 756 individuals (BLI 2007f, p. 4). It is estimated that the species has lost up to 9 percent of its population in the last 10 years, or 3 generations, and that this rate of decline will continue over the next 10 years (BLI 2007f, p. 4). Additional information on the population size of this species is provided in the discussion of Factor E, below.
The brown-banded antpitta is identified as an endangered species under Colombian law pursuant to paragraph 23 of Article 5 of the Law 99 of 1993, as outlined in Resolution No. 584 of 2002 (EcoLex 2002, p. 12). The IUCN has classified the species as `Endangered' since 1994 because it is known from very few locations and occupies a very small range (BLI 2004c, p. 1).
The brown-banded antpitta inhabits the humid understory and forest floor habitats of mid-montane and cloud forests between 1,800 and 2,600 m (5,905 and 8,530 ft) that have a high density of herbs and shrubs (Krabbe and Schulenberg 2003, p. 719; Kattan and Beltrán 1999, p. 272). The current range is estimated to be 300 km
Colombia has experienced extensive deforestation in the last half of the 20th Century as a result of habitat conversion for human settlements, road building, agriculture, and timber extraction. A 23-year study, from 1973 to 1996, demonstrated that these activities reduced the amount of primary forest cover in Colombia by approximately 3,605 hectares (ha) (8,908 acres (ac)) annually, representing a nearly one-third total loss of primary forest habitat (Viña
A study conducted on the effects of habitat fragmentation on Andean birds within western Colombia determined that 31 percent of the historical bird populations in western Colombia had become extinct or locally extirpated by 1990, largely as a result of habitat fragmentation from deforestation and human encroachment (Kattan and Álvarez-Lopez 1996, p. 5; Kattan
In addition to the direct detrimental effect of habitat loss, there are several indirect effects of habitat disturbance and fragmentation (Brooks and Strahl 2000, p. 10; Silva and Strahl 1991, p. 38). Roads create barriers to animal movement, expose animals to traffic hazards, and increase human access to habitat, facilitating further exploitation and habitat destruction (Hunter 1996, pp. 158–159). Researchers have observed that road building and other infrastructure improvements in previously remote forested areas have increased accessibility and facilitated further habitat destruction, exploitation, and human settlement (Etter
Illegal drug crops are cultivated within the brown-banded antpitta's range. In 2003, nearly 80 percent of the heroin entering the United States came from opium (
The most important refugia for the brown-banded antpitta include: (1) Ucumarí Regional Park, (2) the Río Toche Valley, (3) the Río Blanco catchment, and (4) Reserva Departamental del Cañon del Quindío. These refugia are discussed below.
(1) Ucumarí Regional Park (Risaralda Department) covers an area of approximately 44 km
(2) In Río Toche Valley (Tolima Department), on the southeastern slope of Volcán Tolima, the brown-banded antpitta is considered uncommon and local (Beltrán and Kattan 2002, p. 326; BLI 2004c, p. 2; Kattan and Beltrán 2002, p. 238). This habitat is described as fragmented, and it is estimated that the natural cover has been reduced by 15 percent at elevations between 1,900 and 3,200 m (6,234 and 10,499 ft). The majority of suitable habitat is above 2,200 m (7,218 ft) in elevation, and Kattan and Beltrán (2002, p. 238) consider it to be of sufficient size to support a population of brown-banded antpitta, making this an important area of suitable habitat for the species (p. 327).
(3) Río Blanco catchment (Caldas Department) comprises a strip less than 200 km (124 mi) long on the Central Cordilla, between 2,300 and 3,100 m (7,546 and 10,171 ft) (BLI 2004c, p. 2; Beltrán and Kattan 2002, pp. 325, 238). The area is considered to be of sufficient size to support the species (Kattan and Beltrán 2002, p. 238). However, the species has been observed at this location only once, in the year 2000 (Beltrán and Kattan 2002, p. 328).
(4) Reserva Departamental del Cañon del Quindío (Quindío Department): The Department of Conservation and Management of Alto Quindío owns and manages this 56 km
Nearly all the other forested habitat below 3,300 m (10,827 ft) in the Central Andes where the brown-banded antpitta occurred historically has been deforested and cleared for agricultural land use (BLI 2004c, p. 2). The remaining forests providing suitable habitat for the brown-banded antpitta have become fragmented and isolated, and are surrounded by or being converted to pasture and agricultural crops (e.g., coffee plantations, potatoes, and beans) (BLI 2004c, p. 2). Approximately 85 percent of forested habitat at altitudes between 1,900 m (6,234 ft) and 3,200 m (10,499 ft) has been converted to other land uses (BLI 2004c, p. 2; Cuervo 2002, p. 327; Stattersfield
Deforestation has greatly affected the current population size and distributional range of the brown-banded antpitta (Kattan and Beltrán 1997, p. 367; Collar
The brown-banded antpitta prefers the humid understory and forest floor habitats of midmontane and cloud forests between 2,400 and 2,600 m (7,874 and 8,530 ft) and has been observed in older (30-year-old) secondary-growth forest habitats and alder plantations. Habitat destruction, alteration, conversion, and fragmentation continue to be factors affecting the brown-banded antpitta. The direct loss of habitat through widespread deforestation and conversion of primary forests for human settlement and agricultural uses has led to the habitat fragmentation throughout the brown-banded antpitta's range. Cultivation of illegal drug crops, such as cocaine, leads to further deforestation and alters soil compositions, hindering regeneration of abandoned fields. In addition, drug eradication programs involving the aerial spraying of nonspecific herbicides lead to further environmental degradation and destruction of primary forest habitat. The current populations are small, very localized, and limited to a narrow elevational band that contains fragmented, disjunct, and isolated habitat. The species does not appear capable of recolonizing areas of suitable habitat that are isolated from extant locations (see Factor E, Likelihood to Disperse).
Historically, the species was known only in one location, near Laguneta, which had been reduced to 10 percent of its original vegetative cover by 1994. Currently, the species' range is estimated to be 300 km
We are not aware of any information currently available that addresses the occurrence of overutilization that may be causing a decline of the brown-banded antpitta. Therefore, we do not consider overutilization for commercial, recreational, scientific, or educational purposes to be a threat to the brown-banded antpitta.
We are unaware of information regarding disease or the potential for significant disease outbreaks in the brown-banded antpitta. As a result, we do not consider disease to be impacting the status of the species in the wild.
Both terrestrial and avian predators prey upon antpittas, including the mountain coati (
Mountain coatis, tayras, squirrel cuckoos, and crimson-rumped toucanets are known antpitta predators. Predation results in the direct removal of eggs, juveniles, and adults from the population. The brown-banded antpitta produces a low clutch size (see Habitat and Life History), and predation can remove potentially reproductive adults from the breeding pool. Moreover, habitat fragmentation has occurred and is ongoing throughout the brown-banded antpitta's range (Factor A). Studies on similar species in similar Andean habitats indicate that vulnerability to predation increases with increased habitat fragmentation and smaller patch sizes. The brown-banded antpitta does not have sophisticated antipredator response mechanisms, making this species particularly vulnerable to an increased risk of predation. Predation exacerbates the genetic complications associated with the species' small population size (Factor E). Because of the species' small population size and inability to recolonize isolated habitat fragments (Factor E), predation renders the species vulnerable to local extirpation. Therefore, we find that predation, exacerbated by ongoing habitat destruction (Factor A), is a threat to the brown-banded antpitta.
Regulatory mechanisms may provide species-specific or habitat-specific protections. An evaluation of the adequacy of regulatory mechanisms within Colombia to mitigate or remove the threats to the brown-banded antpitta is provided below, beginning with species-specific and followed by habitat-specific protection mechanisms.
Colombia has enacted numerous laws to protect species and their habitats (Matallana-T 2005, p. 121). The brown-banded antpitta is listed as an endangered species under Colombian Law 99 of 1993 (EcoLex 1993, p. 2) and Resolution No. 584 of 2002 (EcoLex 2002, pp. 10, 12). A full description of these laws and the categorization of threatened species in Colombia were provided above, as part of the Factor D analysis for the blue-billed curassow. This threat status confers protections upon the species, including protection from commercial take under Resolution No. 849 of 1973 and Resolution No. 787 of 1977 (EcoLex 1977, p. 3; EcoLex 1973, p. 1). Hunting is not a threat to this species. Therefore, this law is not effective at reducing the primary threat to the species—habitat destruction.
Colombia has enacted numerous forestry laws and forestry management practices (Law No. 2 (EcoLex 1959); Decree No. 2,811 (Faolex 1974); Decree No. 1,791 (Faolex 1996); Law No. 1,021 (EcoLex 2006)). Weaknesses in the implementation of these laws and the decentralized nature of Colombian resource management are described in detail above for the blue-billed curassow (Factor D) (ITTO 2006, pp. 218–219, 222; Matallana-T 2005, pp. 121–122). The brown-banded antpitta ranges in multiple Departments (currently known in Risaralda, Caldas, and Tolima), all of which are administered by different autonomous corporations. Habitat destruction, the primary threat to the brown-banded antpitta, is ongoing throughout the species' range (Factor A). The lack of a national conservation strategy for the brown-banded antpitta, combined with decentralized natural resource management in Colombia, may hamper conservation of the brown-banded antpitta. The existing laws and the decentralized nature of forestry management are ineffective at protecting the brown-banded antpitta and its habitat even within protected areas (Brooks and Gonzalez-Garcia 2001, p. 183).
Colombia has several categories of national habitat protection (Matallana-T 2005, pp. 121–122), which were described above, as part of the Factor D analysis for the blue-billed curassow (Matallana-T 2005, pp. 121–122). Of the four areas identified as refugia for the brown-banded antpitta, two are considered protected areas under Colombian law: (1) The Ucumarí Regional Park and (2) Reserva del Cañon del Quindío.
(1) The Ucumarí Regional Park (Risaralda Department) is managed by the Corporación Autónoma Regional de Risaralda (CARDER) (BLI 2008a, p. 3), with the primary goals of conservation and ecotourism. The Park is managed for multiple uses, including agriculture and cattle grazing (BLI 2008a, p. 1), and includes recreation and commercial areas for activities such as camping and freshwater fishing (CARDER 1995, pp. 3–4). According to the management plan for the Park that was instituted in 1995, recreational and commercial activities are permitted only when they do not significantly alter the environment (CARDER 1995, pp. 3–4). However, according to BirdLife International (2008a, p. 3), there has been little in the way of conservation planning, and the habitat within the protected area continues to undergo pressures from agricultural expansion, firewood collection, and selective cutting. Consequently, the threat from habitat destruction (Factor A) is not reduced or ameliorated.
(2) Reserva del Cañon del Quindío (Quindío Department) is managed by the Corporación Autónoma Regional del Quindío (2008, p. 1). According to the management plan for the Department of Quindío (
Colombia has numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats. The brown-banded antpitta is listed as endangered under Colombian law and lives within forested or protected areas that are regulated by law. However, on-the-ground enforcement of existing wildlife protection and forestry laws and oversight of the local jurisdictions implementing and regulating activities are ineffective at mitigating the primary threat to the brown-banded antpitta. As discussed for Factor A, habitat destruction, degradation, and fragmentation continue throughout the existing range of the brown-banded antpitta. Under Colombian law, there are two protected areas containing suitable habitat for the brown-banded antpitta. The species is known to occur in only one of these areas, wherein resources are managed for commercial and recreational uses. Conservation planning within both areas is lacking, so that the existence of these protected areas does not mitigate the threat of habitat loss. Therefore, we find that the existing regulatory mechanisms currently in place are inadequate to mitigate the primary threats to the brown-banded antpitta.
Two additional factors affect the brown-banded antpitta: Its likelihood to disperse and small population size.
The brown-banded antpitta exhibits several characteristics indicative of its vulnerability to local extirpation and inability to recolonize previously inhabited locations, despite the presence of suitable habitat. This ground-dwelling species (Beltrán and Kattan 2002, p. 327) has a high territorial fidelity and, although dispersal capabilities are not well-known (Cuervo 2002, p. 327), except those in the banding study by Kattan and Beltrán (2002, p. 234), the farthest known distance traveled by any one individual bird was 0.041 km
There have been few quantitative studies of brown-banded antpitta populations. A total of 48 individuals have been directly observed at 2 locations (Ucumarí Regional Park and Río Toche) (Cuervo
The IUCN has estimated the brown-banded antpitta's total population size to be more than 250 and fewer than 999 adult individuals in a 300-km
In a review by Jetz
This conclusion is supported by Beltrán and Kattan (2002, p. 328), who noted that, out of a potential habitat of 855 km
Based on genetic considerations, in the absence of quantitative studies specific to this species, a generally accepted approximation of minimum viable population size is described by the 50/500 rule (Shaffer 1981, p. 133; Soulé 1980, pp. 160–162). According to this rule, the minimum viable population size is defined as the minimum number of individuals that is sufficient to respond over time to unexpected environmental conditions within the species' habitat (Shaffer 1981, pp. 132–133; Soulé 1980, pp. 160–162). This rule states that an effective population size (N
Given that the global population size is a qualitative assessment that may be an overestimate, that the actual number of breeding pairs is unknown but smaller than this number, and that the species exists in subpopulations that are unlikely to disperse into other locations, it is beneficial to analyze the fitness of the subpopulations that have been quantitatively assessed. The best-studied subpopulation is located within the Ucumarí Regional Park. A total of 47 individuals have been directly observed, and researchers estimate that the area may support as many as 106 individuals (Kattan and Beltrán 2002, pp. 232–233; Kattan and Beltrán 1999, p. 276; Kattan and Beltrán 1997, pp. 367–369). Forty-seven is just below the minimum effective population size required to avoid risks from inbreeding (N
Small population sizes render species vulnerable to genetic risks that can have individual or population-level consequences on the genetic level and can increase the species' susceptibility to demographic problems, as explained in more detail above for the blue-billed curassow (Factor E, Small Population Size) (Charlesworth and Charlesworth 1987, p. 238; Shaffer 1981, p. 131). Once a population is reduced below a certain number of individuals, it tends to rapidly decline toward extinction (Holsinger 2000, pp. 64–65; Soulé 1987, p. 181; Gilpin and Soulé 1986, p. 25; Franklin 1980, pp. 147–148).
The brown-banded antpitta's restricted range, combined with its small population size (Cuervo 2002, p. 138; Cuervo and Salaman 1999, p. 7; del
The brown-banded antpitta's small population size increases its vulnerability to genetic risks associated with small population sizes that negatively impact the species' long-term viability and increase the possibility of localized extirpations of the remaining fragmented populations. Further, the species is unlikely to repopulate areas of suitable habitat from which it has been locally extirpated because it exhibits high territorial fidelity and has never repopulated suitable existing habitat within the Department of Quindío, where the species' type locality (Laguneta) is located and the species has not been observed since 1942. Consequently, we believe that, in combination with the risks to the species from habitat destruction (Factor A) and predation (Factor C), the brown-banded antpitta is vulnerable to localized extirpation or extinction from which the species would be unable to recover, due to its small population size and apparent inability to repopulate fragmented, isolated habitats such as that currently present within this species' range.
The four primary factors that threaten the survival of the brown-banded antpitta are: (1) Habitat destruction, fragmentation, and degradation (Factor A); (2) predation (Factor C); (3) inadequacy of regulatory mechanisms to reduce the threats to the species (Factor D); and (4) small population size and isolation of remaining populations (Factor E).
The direct loss of habitat through widespread deforestation and conversion of primary forests to human settlement and agricultural uses has led to the fragmentation of habitat throughout the range of the brown-banded antpitta and isolation of the remaining populations. The species has been locally extirpated in its type locality and has experienced a 55 percent reduction of suitable habitat, and its range is estimated to be 300 km
Brown-banded antpittas are vulnerable to predation by mountain coatis, tayras, squirrel cuckoos, and crimson-rumped toucanets (Factor C). Habitat fragmentation (Factor A) contributes to this vulnerability, because research indicates that predation increases with increased habitat fragmentation and smaller patch sizes. Predation leads to the direct removal of eggs, juveniles, and adults from the population, exacerbating risks associated with the species' small population size and the risk of local extirpation (Factor E). Brown-banded antpittas, as with other antpittas, produce a low clutch size (see Habitat and Life History), and predation can destroy pair bonds and remove potentially reproductive adults from the breeding pool.
The threats from habitat destruction (Factor A) and predation (Factor C) are compounded by the species' small population size (Factor E). The brown-banded antpitta has undergone a population decline that is closely associated with a reduction in range caused by habitat destruction (Factor A). The brown-banded antpitta's small population size of between 338 and 756 individuals is likely to be an overestimate based on the fact that population sizes for narrow-ranging species are typically overestimated when based on extent of occurrence. The species' subpopulations, one of which is estimated to include only 46 to 106 individuals, are isolated from each other. The species' confirmed absence from suitable habitat within its historic range, combined with the species' high territorial fidelity, suggests that the species is incapable of repopulating suitable habitat without human intervention. We are unaware of any reintroduction or recovery programs for this species. The species' small population size increases its vulnerability to natural and human factors (e.g., genetic isolation, agricultural development, increased human settlement, and road development) that could lead to local extirpation, which the species has already experienced in its type locality due to habitat destruction. Within the last three generations, or 10 years, the brown-banded antpitta has undergone up to a 9 percent reduction in population size and, at the current level of habitat destruction, this rate of decline is projected to continue over the next 10 years. Below a certain number, species' populations are unable to recover and, given the small number and isolated nature of existing brown-banded antpitta populations, such reductions in numbers could lead to extinction of the brown-banded antpitta.
Although Colombia has adopted numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats, on-the-ground enforcement of these laws and oversight of the local jurisdictions implementing and regulating activities are inadequate to address the primary threat to this species, which is habitat loss (Factor A). Several populations of brown-banded antpitta are within sanctuaries or preserves; however, habitat destruction and hunting continues within these areas, and regulations are not uniformly enforced, monitoring is limited, and management plans are not developed or implemented, resulting in ineffective protective measures for conservation of the species.
We have carefully assessed the best available scientific and commercial information regarding the past, present, and potential future threats faced by the brown-banded antpitta. We consider the ongoing threats to the brown-banded antpitta, habitat destruction (Factor A) and predation (Factor C), exacerbated by the species' small population size and limited dispersal ability (Factor E), and compounded by inadequate regulatory mechanisms to mitigate these threats (Factor D), to be equally present and of the same magnitude throughout the species' entire current range. Based on this information, we find that the brown-banded antpitta is in danger of extinction throughout all of its range.
The Cauca guan, a member of the Cracid family, is endemic to the central and western slopes of the Andes of Colombia (Delacour and Amadon 2004, pp. 133–135; Brooks and Strahl 2000, p. 13; Hilty and Brown 1986, p. 125). It is a large bird, measuring approximately 76 cm (30 in) in length (Hilty and Brown 1986, p. 125). The species is locally known as “Pava Caucana” (Rios
The Cauca guan was first taxonomically described by Bangs in
The Cauca guan has been observed in mature tropical humid forests and in fragmented secondary forests, forest edges, and plantations of the exotic Chinese ash (
Cauca guans feed mostly on fruit and leaves (including those of the nonnative Chinese ash trees) and occasionally on invertebrates and flowers (Muñoz
The Cauca guan's historical distribution included the east slopes of the West Andes and the Cauca, Patía, and Dagua Valleys, in the Departments of Cauca, Quindío, Risaralda, and Valle de Cauca. The historic range is estimated to have been approximately 24,900 km
From the beginning of the 20th Century through the 1950s, the species was considered common (BLI 2007h, p. 1; Renjifo 2002, p. 126). Between the 1970s and 1980s, there was extensive deforestation in the Cauca Valley, and the species went unobserved during this time, leading researchers to suspect that the Cauca guan was either extinct or on the verge of extinction (Brooks and Strahl 2000, p. 14; del Hoyo 1994, pp. 337, 349; Hilty and Brown 1986, p. 125; Hilty 1985, p. 1,004). The species was rediscovered in 1987 (Renjifo 2002, p. 124).
Today, the Cauca guan inhabits the eastern and western slopes of the West and Central Andes Mountain ranges, in the Departments of Cauca, Quindío, Risaralda, and Valle de Cauca (BLI 2007h, p. 1; Kattan
The habitat consists primarily of forest fragments, and although continuous cover remains at elevations above 2,000 m (6,562 ft) (Kattan
Cauca guan populations are characterized as small, ranging from only tens of individuals or, in rare instances, hundreds (Renjifo 2002, p. 12). BirdLife International reported that the largest subpopulation contained an estimated 50 to 249 individuals; however, they do not specify to which population this refers, and these figures are not found in any of the other literature regarding population surveys of the Cauca guan. Ucumarí Regional Park has been considered the stronghold of the species (BLI 2007h, p. 1). Sixteen individuals were counted in 1990, and the species was characterized as “common” in plantations in 1994–1995 (Wege and Long 1995, p. 141). Since then, there have been scant sightings of Cauca guan there (Renjifo 2002, p. 125; Wege and Long 1995, p. 141), including the observation of one individual in the Park in 2004 (Scanlon 2004, pp. 1–3). There have been no population surveys within the Park to determine the species' current population size therein.
Munchique National Natural Park (Cauca) is considered to be the most important locality for this species in the southern portion of its range because of the extensive remaining forest habitat, although habitat destruction is ongoing there (see Factor A). The species was last recorded in Munchique in 1987, but has not been confirmed there since (Kattan
Kattan
In 2006, Kattan (
The Cauca guan is listed as endangered under Colombian law (EcoLex 2002, p. 12). The IUCN categorizes the species as `Endangered' due to its small, contracted range composed of widely fragmented patches of habitat (BLI 2004e, p. 1).
Historically, Cauca guans were considered common (BLI 2007h, p. 1; Renjifo 2002, p. 126). They inhabited the eastern slopes of the west Andes and the dry forests of the Cauca, Dagua, and Patía Valleys, in the Departments of Cauca, Quindío, and Valle del Cauca (Renjifo 2002, p. 124) (see Historical Distribution, above), in a range extending over approximately 24,900 km
Colombia has experienced extensive deforestation in the last half of the 20th Century as a result of habitat conversion for human settlements, road building, agriculture, and timber extraction. A 23-year study, from 1973 to 1996, demonstrated that these activities reduced the amount of primary forest cover in Colombia by approximately 3,605 ha (8,908 ac) annually, representing a nearly one-third total loss of primary forest habitat (Viña
Human-induced deforestation and environmental degradation have caused the Cauca guan to shift its range and elevational distribution to the few remaining forest remnants. The Cauca guan was once considered to occur only on the eastern slopes of the West Andes and Cauca, Patía, and Dagua Valleys (Renjifo 2002, p. 128). Today, the species occurs on the western slopes of the central and western Andes of Colombia (BLI 2007h, p. 1; Kattan
Habitat destruction and alteration, in addition to shifting the species to the fringes of its former range, have caused the Cauca guan to shift in its altitudinal distribution (Cuervo and Salaman 1999, p. 8). Nearly all the forested habitat below 3,300 m (10,827 ft) in the Central Andes, where the Cauca guan occurs today, has been deforested and cleared for agricultural land use, such as pasture, coffee plantations, potatoes, and beans (BLI 2004c, p. 2). Approximately 85 percent of forested habitat at altitudes between 1,900 m (6,234 ft) and 3,200 m (10,499 ft) has been converted to other land uses (BLI 2004c, p. 2; Cuervo 2002, p. 327; Stattersfield
Since 1987, the Cauca guan has been observed only in the remaining and much-restricted forest remnants of the following Departments: Cauca (in the years 1987, 1989, and 1992), Quindío (1995–1997), Risaralda (1989, 1995–1997, 2000, 2001), and Valle de Cauca (1988, 1999, 2000) (Delacour and Amadon 2004, p. 135; Kattan
Although continuous cover remains in some locations above 2,000 m (6,562 ft) (Kattan
Cocaine and opium have been cultivated throughout the Cauca guan's range. The cultivation of illegal crops (including coca and opium) in Colombia destroys montane forests (Balslev 1993, p. 3). Coca production destroys the soil quality by causing the soil to become more acidic, which depletes the soil nutrients and ultimately impedes the regrowth of secondary forests in abandoned fields (Van Schoik and Schulberg 1993, p. 21). As of 2004, the estimated total amount of land under cultivation for cocaine equaled 80,000 ha (197,683 ac); 4,000 ha (9,884 ac) of land are under opium cultivation (UNODC
Colombia continues to be the leading coca bush producer (UNODC
This stabilization of the amount of land under cultivation for illegal drug crops is also attributed to heightened eradication efforts. Between 2002 and 2004, aerial spraying occurred over more than 1,300 km
Drug eradication efforts in Colombia have further degraded and destroyed primary forest habitat by using nonspecific aerial herbicides to destroy illegal crops (BLI 2007d, p. 3; Álvarez 2005, p. 2,042; Cárdenas and Rodríguez Becerra 2004, p. 355; Oldham and Massey 2002, pp. 9–12). Herbicide spraying has introduced harmful chemicals into Cauca guan habitat and has led to further destruction of the habitat by forcing illicit growers to move to new, previously untouched forested areas (Álvarez 2007, pp. 133–143; BLI 2007d, p. 3; Álvarez 2005, p. 2,042; Cárdenas and Rodríguez Becerra 2004, p. 355; Oldham and Massey 2002, pp. 9–12; Álvarez 2002, pp. 1,088–1,093). Between 1998 and 2002, cultivation of illicit crops increased 21 percent each year, with a concomitant increase in deforestation of formerly pristine areas of approximately 60 percent (Álvarez 2002, pp. 1,088–1,093).
The Cauca guan requires large territories for foraging (Kattan 2004, p. 11), but today is relegated mostly to small forest fragments (Kattan
An analysis of the effects of habitat fragmentation on Andean birds within western Colombia established that 31 percent of the historical bird populations in western Colombia had become extinct or locally extirpated by 1990, largely as a result of habitat fragmentation from deforestation caused by human encroachment (Kattan and Álvarez-Lopez 1996, p. 5; Kattan
The Cauca guan, as with other cracids, is susceptible to indirect effects of habitat disturbance and fragmentation (Brooks and Strahl 2000, p. 10; Silva and Strahl 1991, p. 38). A study conducted in northwestern Colombia demonstrated that habitat destruction and fragmentation may increase a species' vulnerability to predation (Arango-Vélez and Kattan 1997, pp. 140–142) (Factor C). In addition, habitat fragmentation, combined with continuing human encroachment, increases the species' vulnerability to hunting (Factor B). Habitat fragmentation may affect population densities by shifting the availability of resources, such as food (Kattan
The Cauca guan has recently been confirmed in the following locations: (1) Otún-Quimbaya Flora and Fauna Sanctuary; (2) Reserva La Sirena; (3) Reserva Forestal de Yotoco; (4) Chorro
(1) Otún-Quimbaya Flora and Fauna Sanctuary (Department of Risaralda), a 4.9-km
This Sanctuary is adjacent to the Ucumarí Regional Park (Kattan
(2) Reserva La Sirena (Valle de Cauca) is located above 2,000 m (6,562 ft) and consists of fragmented riparian forest in various stages of succession (Kattan
(3) Reserva Forestal de Yotoco (Valle de Cauca) is an isolated 5.6-km
(4) Chorro de Plata (Valle de Cauca) is a 2-km
(5) Munchique National Natural Park (Cauca) is considered an important locality in the southern portion of the species' range, because the species was historically seen there several times and because suitable habitat still exists there (Kattan
There are several areas of suitable habitat in which the Cauca guan has not been observed, but that could serve as important potential habitat for the species (see Factor E, Likelihood to Disperse), including: (1) Bosques del Oriente del Risaralda, (2) Cañon del Rio Barbas y Bremen, (3) Finca la Betulia Reserva la Patasola,and (4) Reserva Natural Cajibío. These areas are described below.
(1) Bosques del Oriente del Risaralda (Risaralda): This 23-km
(2) Cañon del Rio Barbas y Bremen (Risaralda): This 51-km
(3) Finca la Betulia Reserva la Patasola (Quindío): This 17-km
(4) Reserva Natural Cajibío (Cauca): This 0.52-km
These refugia are limited in size, isolated from each other, and undergoing varying levels of human encroachment and deforestation (Kattan
The habitat preferred by the Cauca guan—humid forests or secondary forests, forest edges, and plantations in proximity to humid forests—has been largely destroyed by cultivation, grazing, human settlements, road building, and other human activities. The species' range has been reduced from 24,900 km
Cracids are considered particularly vulnerable to hunting pressures and are among those species most rapidly depleted by hunting (Redford 1992, p. 419). Several factors contribute to the sensitivity of Cauca guans to hunting, including: their large size, ease of locating them during their breeding season, their trusting nature, their low productivity (1–2 eggs) relative to other Galliformes, their long generation time, their dependence upon specific habitat, and their poor dispersal qualities (Brooks 1999, p. 43; del Hoyo 1994, p. 336; Silva and Strahl 1991, p. 38). This species, as with other guans, tends to aggregate within its habitat, generally based on resource availability. For instance, Cauca guans tend to congregate around fruit trees at certain times of year (Kattan
Cauca guans, and other cracids (e.g., chachalacas (
Subsistence hunting may play a role in the decline or possible local extirpation of the species from at least two locations. In the late 1990s, subsistence hunting was widespread in the Ucumarí Regional Park and Munchique National Natural Park (Strahl
Habitat fragmentation and concomitant human encroachment (Factor A) have made the species' habitat more accessible and the species more vulnerable to hunting. A study conducted in French Guiana provided a quantitative estimate of the effect of hunting on a related cracid species, the black curassow (
Cracids serve as a major food source in Colombia, and the Cauca guan, as the largest cracid living within its area of distribution, is sought after by locals. Hunting results in the direct removal of eggs, juveniles, and adults from the population. Cauca guans are slow to reproduce, produce a low clutch size,
We are unaware of any information regarding disease or the potential for significant disease outbreaks in the Cauca guan populations. As a result, we do not consider disease to be a threat to the species.
Predators of cracids include snakes, foxes, feral cats, feral dogs, and raptors (Delacour and Amadon 1973). Cauca guans are also slow to reproduce, with a long fledging period (up to 1 year) and a replacement rate of at least 6 years (Rios
Snakes, foxes, feral cats, feral dogs, and raptors are all predators of cracids. Predation results in the direct removal of eggs, juveniles, and adults from the population. Cauca guans are slow to reproduce, produce a low clutch size, require a long fledging period, and exhibit a poor replacement rate (see Habitat and Life History, above). Predation can destroy pair bonds and remove potentially reproductive adults from the breeding pool. Cauca guan habitat is fragmented and small (Factor A), and studies on similar species in similar Andean habitats indicate that vulnerability to predation by generalist predators increases with increased habitat fragmentation and smaller patch sizes. Predation exacerbates the genetic complications associated with the species' small population size (Factor E). Because of the species' small population size and inability to recolonize isolated habitat fragments (Factor E), predation renders the species vulnerable to local extirpation. Therefore, we find that predation, exacerbated by ongoing habitat destruction (Factor A) and hunting (Factor B), is a threat to the Cauca guan.
Regulatory mechanisms may provide species-specific or habitat-specific protections. An evaluation of the adequacy of regulatory mechanisms within Colombia to mitigate or remove the threats to the Cauca guan is provided below, beginning with species-specific and followed by habitat-specific protection mechanisms.
Colombia has enacted numerous laws to protect species and their habitats (Matallana-T 2005, p. 121). The Cauca guan is listed as an endangered species under Colombian Law 99 of 1993 (EcoLex 1993, p. 2) and Resolution No. 584 of 2002 (EcoLex 2002, pp. 10, 12). A full description of these laws and the categorization of threatened species in Colombia were provided above, as part of the Factor D analysis for the blue-billed curassow. This threat status confers protections upon the species, including protection from commercial take under Resolution No. 849 of 1973 and Resolution No. 787 of 1977 (EcoLex 1973, p. 1; EcoLex 1977, p. 3). Neither Resolution prohibits subsistence hunting. As discussed under Factor B, commercial and sport hunting are not threats to this species, but subsistence hunting continues to threaten the species throughout its range, including within protected areas.
Hunting may play a role in the decline or possible local extirpation of the species from two protected areas, Munchique National Natural Park and Ucumarí Regional Park, where subsistence hunting was widespread in the 1990s (Strahl
Colombia has enacted numerous forestry laws and forestry management practices (Law No. 2 (EcoLex 1959); Decree No. 2,811 (Faolex 1974); Decree No. 1,791 (Faolex 1996); Law No. 1,021 (EcoLex 2006)). Weaknesses in the implementation of these laws and the decentralized nature of Colombian resource management are described in detail above for the blue-billed curassow (Factor D) (ITTO 2006, pp. 218–219, 222; Matallana-T 2005, pp. 121–122). Experts consider these decentralized management mechanisms ineffective at protecting the Cauca guan from habitat destruction (Factor A) or hunting (Factor B) (Muñoz
Colombia has several categories of national habitat protection (Matallana-T 2005, pp. 121–122), which were described above, as part of the Factor D analysis for the blue-billed curassow (Matallana-T 2005, pp. 121–122). The Cauca guan occurs within national parks (including the Ucumarí Regional Park, last confirmed Cauca guan sighting in 2004 (Scanlon 2004, pp. 1–3), and Munchique National Natural Park, confirmed in 1987 (Salaman
The Cauca guan ranges in multiple Departments (currently known in Cauca, Quindío, Risaralda, Valle de Cauca), each of which administers their own natural resources under different autonomous corporations (ITTO 2006, p. 219; Law 99 of 1993). We are unaware of any coordinated species management plan. Therefore, in view of the decentralized resource management structure, the absence of a conservation strategy for the species, the threats to the Cauca guan from habitat destruction (Factor A) and hunting (Factor B) are not mitigated.
Colombia has numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats. The Cauca guan is listed as endangered under Colombian law and occurs within several protected areas. However, on-the-ground enforcement of existing wildlife protection and forestry laws and oversight of the local jurisdictions implementing and regulating activities are ineffective at mitigating the primary threats to the Cauca guan. As discussed for Factor A, habitat destruction, degradation, and fragmentation continue throughout the existing range of the Cauca guan. As discussed for Factor B, uncontrolled subsistence hunting of the Cauca guan is ongoing and continues to negatively affect the continued existence of the species. Moreover, the lack of a species conservation strategy and the decentralized management of natural resources in Colombia provide no overall coordination in the conservation of species such as Cauca guans, which range in multiple jurisdictions. Therefore, we find that the existing regulatory mechanisms currently in place are inadequate to mitigate the primary threats to the Cauca guan.
Two additional factors affect the Cauca guan: Its minimal likelihood for dispersal and the species' small population size.
The Cauca guan exhibits characteristics indicative of an inability to disperse into isolated habitat fragments and recolonize patches of suitable habitat that have undergone a localized extirpation. The Cauca guan prefers habitat of mature humid forests (Collar
Existing habitat for the Cauca guan is fragmented, with large distances between the remaining primary forest fragments (Cuervo and Salaman 1999, p. 7; Hanski 1998, pp. 45–46) and an ever-growing human presence in and around the species' existing habitat (BLI 2004c, p. 2; Cuervo 2002, p. 327; Renjifo 2002, pp. 124–128; Cuervo and Salaman 1999, p. 8; Stattersfield
Habitat destruction (Factor A) and hunting (Factor B) have affected the current population size and distributional range of the Cauca guan (Collar
Small population sizes render species vulnerable to genetic risks that can have individual or population-level consequences on the genetic level and can increase the species' susceptibility to demographic problems, as explained in more detail above for the blue-billed curassow (Factor E, Small Population Size) (Charlesworth and Charlesworth 1987, p. 238; Shaffer 1981, p. 131). Once a population is reduced below a certain number of individuals, it tends to rapidly decline towards extinction (Holsinger 2000, pp. 64–65; Soulé 1987, p. 181; Gilpin and Soulé 1986, p. 25; Franklin 1980, pp. 147–148).
In the absence of quantitative studies specific to this species, a general approximation of minimum viable population size is the 50/500 rule, as described above as part of the Factor E analysis for the brown-banded antpitta (Shaffer 1981, pp. 132–133; Soulé 1980, pp. 160–162). The total population size of the Cauca guan is estimated to be between 196 and 342 individuals. While 196 individuals is above the minimum population size required to avoid short-term genetic consequences, 342 falls below the threshold minimum number of 500 individuals required for long-term fitness of a population.
Moreover, because the Cauca guan exists in isolated forest fragments and is unlikely or incapable of dispersing to disjunct patches, each disjunct locality likely acts as a subpopulation. Therefore, the resiliency of each of these subpopulations will be lower than that of the global population. The largest reported subpopulation, in Otún-Quimbaya Flora and Fauna Sanctuary,
The Cauca guan's small population size, combined with its restricted range and inability to repopulate suitable habitat following local extirpations (Renjifo 2002, p. 138; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361), makes the species particularly vulnerable to the threat of adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events that destroy individuals and their habitat (BLI 2007, pp. 1–2; Renjifo 2002, p. 140; Holsinger 2000, pp. 64–65; Young and Clarke 2000, pp. 361–366).
The Cauca guan is now confirmed only in several isolated locations. The Cauca guan is unlikely or incapable of dispersing into suitable habitat that is isolated from extant populations, and the species' overall small population size makes it vulnerable to genetic and demographic risks that negatively impact the species' short- and long-term viability. The Cauca guan's small population size, restricted range, and inability to repopulate suitable habitat following local extirpations expose the species to threats associated with adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events that destroy individuals and their habitat. Therefore, we believe that, in combination with the risks to the species from habitat destruction (Factor A), hunting (Factor B), and predation (Factor C), the Cauca guan is vulnerable to localized extirpation or extinction from which the species would be unable to recover, due to its small population size and apparent inability to repopulate fragmented, isolated habitats such as those currently present within this species' range.
The five primary factors that threaten the survival of the Cauca guan are: (1) Habitat destruction, fragmentation, and degradation (Factor A); (2) overexploitation due to hunting; (3) predation (Factor C); (4) inadequacy of regulatory mechanisms to reduce the threats to the species (Factor D); and (5) small population size and isolation of remaining populations (Factor E). The Cauca guan, a large, primarily terrestrial bird, prefers humid forests or secondary forests, forest edges, and plantations that are in close proximity (within 1 km (0.62 mi)) to humid forests.
Habitat destruction, alteration, conversion, and fragmentation were factors in the Cauca guan's historical decline. The species has experienced a 95 percent range reduction since the 1950s, such that the estimated suitable habitat available to the species is approximately 560 km
Although the Cauca guan, which is listed in Colombia as endangered, occurs on lands designated by the Colombian Government as “protected areas,” and it is illegal to commercially hunt the species, the existing laws and their enforcement are inadequate (Factor D) to mitigate the effects of ongoing habitat destruction (Factor A) and subsistence hunting (Factor B). Moreover, natural resource management within Colombia is highly decentralized, each district managing their resources autonomously. Thus, there is no overall coordination for the conservation and recovery of the Cauca guan, which ranges in several autonomous districts.
Widespread deforestation and conversion of primary forests has led to the fragmentation of habitat throughout the Cauca guan's range. The remaining suitable habitat is limited to a few disjunct and isolated forest fragments, only a few hundred hectares (100 hectares = 1 km
Habitat fragmentation also increases the species' susceptibility to hunting (Factor B). The Cauca guan is hunted throughout its current range. As the largest cracid living within its area of distribution, the Cauca guan is sought after by locals as a major food source. Despite being illegal (Factor D), subsistence hunting of Cauca guans continues throughout its range, including within protected areas. Hunting may be responsible for the species' local extirpation from the Ucumarí Regional Park, considered the stronghold for the species in the 1990s, and the Munchique National Natural Park.
Habitat fragmentation exposes the species to greater risk of extinction caused by adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events (Factor E). At the beginning of the 20th Century through the 1950s, the species was considered common. Habitat fragmentation has led to the isolation of remaining subpopulations, which are estimated to range from tens of individuals or a few hundred individuals at most, thus affecting the
Thus, the Cauca guan is at risk from both near-term genetic complications (such as inbreeding and demographic shifts) and the lack of long-term fitness (such as the ability to adapt to changing conditions). Because the species exists in isolated subpopulations, the risk from near-term genetic consequences, such as inbreeding and demographic shifts, is further magnified. These potential genetic problems are exacerbated by ongoing human-induced threats, such as habitat destruction (Factor A) and hunting (Factor B), factors which are not being mitigated by existing regulations (Factor D), and are further magnified by the species' inability to repopulate isolated, fragmented patches of suitable habitat, where Cauca guan populations have undergone decline or local extirpation (Factor E).
We have carefully assessed the best available scientific and commercial information regarding the past, present, and potential future threats faced by the Cauca guan. We consider the ongoing threats to the Cauca guan, habitat destruction (Factor A), hunting (Factor B), and predation (Factor C), exacerbated by the species' small population size and limited dispersal ability (Factor E), and compounded by inadequate regulatory mechanisms to mitigate these threats (Factor D), to be equally present and of the same magnitude throughout the species' entire current range. Based on this information, we find that the Cauca guan is in danger of extinction throughout all of its range.
The gorgeted wood-quail, endemic to Colombia and a member of the New World Quail Family (Odontophoridae), is approximately 25 cm (10 in) long (del Hoyo 1994, p. 431; Fjeldså and Krabbe 1990, p. 141; Hilty and Brown 1986, p. 133). The species is locally known as “perdiz Santandereana” or “perdiz de monte” (Sarria and Álvarez 2002, p. 158), and may be referred to by the more general term “forest partridge” in English (BLI 2007g, p. 1). Mainly dark brown with black spots on upper parts, the male has a speckled black and white face, and a white collar on his throat surrounded on the upper and lower side by a band of black. Underparts are rufous-chestnut colored with white spotting. The female appears similar to the male; however, the female has a black collar surrounded by white bands on her throat (BLI 2007g, p. 1).
The gorgeted wood-quail was first taxonomically described in 1844 by Gould, who placed the species in the Odontophoridae family, also known as the New World Quails (BLI 2007g, p. 1). The type specimen (the actual specimen that was first described by Gould) was obtained in the Colombian Department of Cundinamarca (Hilty and Brown 1986, p. 133), although details on the location were not provided with the description (Warren 1966, p. 318). Therefore, we will refer to the Department of Cundinamarca as the “type locality.”
The gorgeted wood-quail prefers montane temperate and humid subtropical forests dominated by roble,
The gorgeted wood-quail is primarily terrestrial (Fuller
The gorgeted wood-quail historically occurred on the western slope of the East Andes, in the Departments of Santander and Cundinamarca in Colombia (del Hoyo 1994, p. 431; Fjeldså and Krabbe 1990, p. 141; Hilty and Brown 1986, p. 133). Since the 17th Century, extensive logging and land conversion in Cundimarca to agricultural uses nearly denuded all the forests of this area below 2,500 m (8,202 ft) (BLI 2007g, p. 3; Hilty and Brown 1986, p. 133). Habitat destruction is considered the primary factor that led to the historical decline and extirpation of this species from Cundinamarca (Fuller
For many years, the species was known only from two specimens collected in 1915 from its type locality in Cundinamarca (Hilty and Brown 1986, p. 133). Although the species was
The gorgeted wood-quail is endemic to the west slope of the East Andes, in the Magdalena Valley (Donegan and Huertas 2005, p. 29), and is known only in the central Colombian Department of Santander (del Hoyo 1994, p. 431; Fjeldså and Krabbe 1990, p. 141; Hilty and Brown 1986, p. 133). The current range of this species is between 10 km
Since 1970, the species has only been reported in the central Colombian Department of Santander, with fewer than 10 sightings. Visual observations of this species have been scant; most reports have been inferred from auditory detections (Sarria and Álvarez 2002, pp. 158–159). In 1970, the species was observed in Cuchilla del Ramo forest (Wege and Long 1995, p. 143), but has not been confirmed there since that time (BLI 2007g, p. 2) (see also Factor A). The species has been observed and most recently confirmed in three locations: (1) Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary, (2) Cachalú Biological Reserve, and (3) Serranía de los Yarguíes. These confirmed sightings are briefly described below.
(1) Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary (Santander Department): The gorgeted wood-quail was confirmed at this location in 1979 (BLI 2007g, p. 2) and again in 1988 (Sarria and Álvarez 2002, p. 160; Wege and Long 1995, p. 144). In 2004, the species was reported in the oak forests within the Province of Guanentá (BLI 2007g, p. 2), but it is unclear whether these observations occurred within the Sanctuary.
(2) Cachalú Biological Reserve (Santander Department): The gorgeted wood-quail was confirmed in this Reserve in 1999, 2000, and 2001 (BLI 2007g, p. 2; Sarria and Álvarez 2002, pp. 158–159; Fuller
(3) Serranía de los Yarguíes (Santander Department): The species has also been confirmed at this location in 2003 and 2004 (BLI 2007g, p. 2; Turner 2006, p. 22; Donegan and Huertas 2005, p. 29; Donegan
Generally speaking, these localities are in two disjunct locations within the Department of Santander. Serranía de los Yarguíes is in northern Santander and the other two localities are adjacent to each other in southern Santander (Rainforest Alliance 2008, p. 2; Donegan and Huertas 2005, p. 30). These habitats are described more fully under Factor A (Refugia).
To the best of our knowledge, there have been no quantitative studies to determine the species' population size. The population estimates for the gorgeted wood-quail are based on qualitative surveys and extrapolations using suitable habitat estimates (BLI 2007g, p. 2; Turner 2006, p. 22; Donegan and Huertas 2005, p. 29; Donegan
All other population estimates have been inferred from auditory calls or suitable habitat extrapolations. It is not unusual to infer population estimates for elusive, ground-dwelling species, such as the gorgeted wood-quail, for which direct observation is difficult. However, extrapolating population estimates based on suitable habitat can lead to overestimations of population sizes, especially for narrow-ranging species, such as the gorgeted wood-quail. The potential for overestimation was discussed above, in the analysis of the brown-banded antpitta (Factor E, Small Population Size). For instance, researchers recently estimated that the Serranía de los Yarguíes population may hold a significantly greater number of birds than ever known. Given the inferred density of the species (based on auditory observation) and the extent of forest cover in the Serranía de los Yarguíes, researchers predicted that an excess of 250 individuals was present at the site (Donegan and Huertas 2005, p. 30; Donegan
Turner (2006, p. 22) extrapolated the population size, based on satellite images of the area, which indicated that 30,000 ha (74,131 ac) of forest at elevations between 1,500 and 2,200 m (4,921 and 7,218 ft) on the western slope and 2,700 and 2,900 m (8,858 and 9,514 ft) on the eastern slope were available to the species. This yielded a predicted population size of between 1,800 and 3,300 individuals. However, we believe that this population estimate, based on the availability of suitable habitat, may be an overestimate for this species for two reasons: (1) The population may not be randomly distributed throughout the suitable habitat, as assumed by these researchers, and (2) the extrapolation does not take into account human-induced threats, such as hunting (Sarria and Álavarez 2002, pp. 160–161) (Factor B). Therefore, until Turner's (2006, p. 22) predictions have been ground-truthed, we are unable to consider the predicted population estimate of between 1,800 and 3,300 individuals to be a reliable reflection of the current population size. Consequently, we consider the population estimate of between 189 to 486 individuals (BLI 2007g, p. 1) to be the best available estimate of the gorgeted wood-quail.
The gorgeted wood-quail is identified as a critically endangered species under Colombian law (EcoLex 2002, p. 12). The species is classified as `Critically Endangered' on the IUCN Red List, due to its small and highly fragmented range, with recent population records from only two areas (BLI 2004d; BLI 2007g, pp. 1, 5).
In the early part of the 20th Century, the gorgeted wood-quail was known only in the oak forests in the Department of Cundinamarca. However, extensive deforestation and habitat conversion for agricultural use nearly denuded all the oak forests in Cundinamarca below 2,500 m (8,202 ft) (BLI 2007g, p. 3; Hilty and Brown 1986, p. 133). Deforestation left little remaining suitable habitat for the gorgeted wood-quail, which prefers primary forests and tolerates secondary-growth forests near primary forests (BLI 2007g, p. 3; Sarria and Álvarez 2002, p. 159) at altitudes from 1,500 to 2,500 m (4,921 to 8,202 ft) (Fuller
Deforestation, in combination with hunting (Factor B), may have led to the local extirpation of the gorgeted wood-quail from another location. After no confirmed reports of the species in nearly 20 years (Sarria and Álvarez 2002, pp. 158–159), the species was rediscovered in Cuchilla del Ramo forest (in the Department of Santander) in 1970 (Sarria and Álvarez 2002, pp. 158–159; Wege and Long 1995, p. 143) and last confirmed there in 1988 (Collar
Today, the gorgeted wood-quail is endemic to the western slopes of the East Andes in the Department of Santander, Colombia (Collar
Colombian forests have undergone extensive alteration during the 20th Century to establish human settlements, build roads, extract timber, and pursue agriculture. Between 1973 and 1996, these activities reduced the amount of primary forest cover in Colombia by approximately 3,605 ha (8,908 ac) annually, representing a nearly one-third total loss of primary forest habitat (Viña
Human-induced deforestation and environmental degradation have caused the gorgeted wood-quail to shift its range from the Department of Cundinamarca to the Department of Santander. The species was first observed in Santander within Cuchilla del Ramo forest in 1970 (Wege and Long 1995, p. 143), but has not been confirmed there since then (BLI 2007g, p. 2). The presence of the species has been documented only about 10 times, and most of these are based on auditory detections. The species has been most recently confirmed in the following three locations: (1) Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary (BLI 2007g, p. 2; Sarria and Álvarez 2002, p. 160; Wege and Long 1995, p. 144), (2) Cachalú Biological Reserve (BLI 2007g, p. 2; Sarria and Álvarez 2002, pp. 158–159; Fuller
Cocaine and opium has been cultivated throughout the gorgeted wood-quail's range. The cultivation of illegal crops (including coca and opium) in Colombia destroys montane forests (Balslev 1993, p. 3). Coca crops also destroy the soil quality by causing the soil to become more acidic, which depletes the soil nutrients and ultimately impedes the regrowth of secondary forests in abandoned fields (Van Schoik and Schulberg 1993, p. 21). As of 2004, an estimated 80,000 ha (197,683 ac) were under cocaine cultivation and 4,000 ha (9,884 ac) were under opium cultivation (UNODC
Colombia continues to be the leading coca bush producer (UNODC
Drug eradication efforts in Colombia have further degraded and destroyed primary forest habitat by using nonspecific aerial herbicides to destroy illegal crops (BLI 2007d, p. 3; Álvarez 2005, p. 2042; Cárdenas and Rodríguez Becerra 2004, p. 355; Oldham and Massey 2002, pp. 9–12). Herbicide spraying has introduced harmful chemicals into gorgeted wood-quail habitat and has led to further destruction of the habitat by forcing illicit growers to move to new, previously untouched forested areas (Álvarez 2007, pp. 133–143; BLI 2007d, p. 3; Álvarez 2005, p. 2,042; Cárdenas and Rodríguez Becerra 2004, p. 355; Oldham and Massey 2002, pp. 9–12 Álvarez 2002, pp. 1088–1093). Between 1998 and 2002, cultivation of illicit crops increased by 21 percent each year, with a concomitant increase in deforestation of formerly pristine areas of approximately 60 percent (Álvarez 2002, pp. 1,088–1,093).
An analysis of the effects of habitat fragmentation on Andean birds within western Colombia determined that 31
The gorgeted wood-quail has been observed, and most recently confirmed, in the following three locations: (1) Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary, (2) Cachalú Biological Reserve, and (3) the Serranía de los Yarguíes.
(1) Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary (Santander Department): This 10,420-ha (25,748-ac) humid subtropical and temperate oak forest on the western slope of the East Andes was declared a protected natural area in 1993 (Rainforest Alliance, 2008 p. 2; The Nature Conservancy (TNC) 2008, p. 1; Andrade and Repizzo 1994, p. 43). This area has long been considered the largest remaining sizeable oak forest tract remaining in the northern area of the East Andes, even as recently as the year 2005 (Donegan and Huertas 2005, p. 11; Sarria and Álvarez 2002, p. 160; Stattersfield
Beginning in the 1960s, habitat conversion accelerated in the East Andes (Stattersfield
(2) Cachalú Biological Reserve: This 1,300-ha (3,212-ac) Reserve (TNC 2008, p. 1) was established in 1997 adjacent to Guanentá Alto Rio Fonce Flora and Fauna Sanctuary (Rainforest Alliance 2008, p. 2). It encompasses primarily mature oak forests and secondary areas (regenerating pastureland) at altitudes between 1,850 and 2,750 m (6,070 and 9,022 ft). Most of the secondary areas within the Reserve have been regenerating for 20 years. About 4 percent of land formerly used for pastureland and slash-and-burn agriculture has been left to regenerate within the last 8 years (BLI 2007g, p. 10). The species was first observed at this location in 1999 and again in 2000 and 2001 (BLI 2007g, p. 2; Sarria and Álvarez 2002, pp. 158–159; Fuller
While human population pressures in northern Santander have not been as great as in other parts of the Andes, 70 percent of the subsistence population living locally has had a major influence on the upper montane forest system. Slash-and-burn agriculture (clearing small plots of land for agriculture and settlement) and subsistence extractive activities (such as harvesting wood, plant fibers, and animals) have turned the upper montane forests into extraction forests (Rainforest Alliance 2008, p. 2). Ongoing slashing and burning on the outskirts of the Reserve could further degrade the integrity of the habitat within the Reserve (BLI 2007g, p. 11).
(3) Serranía de los Yarguíes (Yarguíes Mountains): This 175,000-ha (432,425-ac) forest is located in southern Santander and ranges in altitude between 200 and 3,200 m (656 and 10,499 ft) (BLI 2007g, p. 12; Donegan and Huertas 2005, p. 30). This area was previously unsurveyed for birds, due to political instability and occupation by revolutionary armed forces (Donegan and Huertas 2005, pp. 11, 29–30; Donegan
Habitat destruction, alteration, conversion, and fragmentation were factors in the species' historical decline and continue to be factors affecting the gorgeted wood-quail. The direct loss of habitat through widespread deforestation and conversion of primary forests for agricultural uses has led to a 95 percent range reduction for the species, leading to extirpation of the species in its type locality (in Cundinamarca) and an apparent shift in the species' range (to Santander). The species is known only in three locations, where habitat conversion and poaching of the gorgeted wood-quail are ongoing. Deforestation, habitat conversion, and drug eradication efforts have reduced the amount of suitable habitat at elevations preferred by the species, such that its current range is between 10 and 27 km
Galliformes such as the gorgeted wood-quail are chiefly terrestrial birds that are easily hunted or trapped, and they have been closely associated with humans throughout history as a source for food, ornamental collection, commercial trade, and recreational hunting (Fuller
Hunting, in combination with deforestation, may have led to the local extirpation of this species from Cuchilla del Ramo (Department of Santander), where the species was first observed in 1970 (Sarria and Álvarez 2002, pp. 158–159; Wege and Long 1995, p. 143) and last confirmed in 1988 (Collar
In addition, Arango-Vélez and Kattan (1997, pp. 140–142) conducted a study on the effect of habitat fragmentation on birds in Colombia and found that habitat fragmentation facilitates hunting because smaller habitat patches allow hunters to more easily penetrate the entire plot (Arango-Vélez and Kattan 1997, pp. 140–142).
The gorgeted wood-quail is hunted (poached) throughout its current range for local consumption or local food trade. Hunting results in the direct removal of individuals from the population and can remove potentially reproductive adults from the breeding pool. This primarily terrestrial species is particularly vulnerable to hunting pressures due to its small population size (Factor E) and fragmented distribution (Factor A). Researchers believe that the gorgeted wood-quail is only capable of escaping hunting pressures when adjacent suitable habitat exists. There are continued reports of hunting pressures on the species; these pressures have been and continue to be exacerbated by ongoing human encroachment into previously undisturbed forests (Factor A). Hunting, combined with habitat fragmentation (Factor A), increases the possibility of local extirpation since the gorgeted wood-quail is unlikely to reoccupy an area that has been depleted through hunting (Factor E, Likelihood to Disperse). Hunting may have led to the local extirpation of the species in a portion of its range. Hunting pressures are ongoing and affect the entire population of gorgeted wood-quail. Therefore, we find that hunting is a threat to the gorgeted wood-quail throughout its range.
We are not aware of any information regarding disease or the potential for significant disease outbreaks in gorgeted wood-quail populations. As a result, we do not consider disease to be a threat to the species.
Potential quail predators include feral dogs, tayras, dwarf squirrels (
Feral dogs, tayras, dwarf squirrels, tree squirrels, common opossums, kinkajous, Central American agoutis, and South American coatis are potential gorgeted wood-quail predators. Predation results in the direct removal of individuals from the population and can remove potentially reproductive adults from the breeding pool. This primarily terrestrial species is particularly vulnerable to predation pressures due to its small population size (Factor E) and fragmented distribution (Factor A). Habitat fragmentation has occurred and is ongoing throughout the species' range. Studies on similar species in similar Andean habitats indicate that vulnerability to predation increases with increased habitat fragmentation and smaller patch sizes. Predation exacerbates the genetic complications associated with the species' small population size (Factor E). Because of the species' small population size and inability to recolonize isolated habitat fragments (Factor E), predation renders the species vulnerable to local extirpation. Therefore, we find that predation, exacerbated by ongoing habitat destruction (Factor A) and hunting (Factor B), is a threat to the gorgeted wood-quail.
Regulatory mechanisms may provide species-specific or habitat-specific protections. An evaluation of the adequacy of regulatory mechanisms within Colombia to mitigate or remove the threats to the gorgeted wood-quail is provided below, beginning with species-specific and followed by habitat-specific protection mechanisms.
Colombia has enacted numerous laws to protect species and their habitats (Matallana-T 2005, p. 121). The gorgeted wood-quail is listed as a critically endangered species under Colombian Law 99 of 1993 (EcoLex 1993, p. 2) and Resolution No. 584 of 2002 (EcoLex 2002, pp. 10, 12). A full description of these laws and the categorization of threatened species in Colombia were provided above, as part of the Factor D analysis for the blue-billed curassow. Under Resolution No. 849 of 1973 and Resolution No. 787 of 1977, the Ministry of the Environment does not permit the gorgeted wood-quail to be hunted commercially or for sport because of its status as a critically endangered species (EcoLex 1973, p. 1; EcoLex 1977, p. 3). Neither Resolution prohibits subsistence hunting, which is a threat to the species throughout its range (Factor B). Gorgeted wood-quail is hunted within the Serranía de los Yarguíes, which has no protected status (BLI 2007g, p. 13), despite being considered the stronghold for the species (Turner 2006, p. 22; Donegan and Huertas 2005, p. 29). Thus, these Resolutions are ineffective at reducing the existing threat of subsistence hunting to the gorgeted wood-quail (Factor B).
Colombia has enacted numerous forestry laws and forestry management practices (Law No. 2 (EcoLex 1959); Decree No. 2,811 (Faolex 1974); Decree No. 1,791 (Faolex 1996); Law No. 1,021 (EcoLex 2006)). Weaknesses in the implementation of these laws and the decentralized nature of Colombian resource management are described in detail above for the blue-billed curassow (Factor D) (ITTO 2006, pp. 218–219, 222; Matallana-T 2005, pp. 121–122). These regulatory mechanisms are ineffective at protecting the gorgeted wood-quail (BLI 2007g, p. 13; ITTO 2006, p. 222). Habitat destruction continues to be a problem within the unprotected forests of Serranía de los Yarguíes (BLI 2007g, p. 13), considered the stronghold of the species (Turner 2006, p. 22; Donegan and Huertas 2005, p. 29), and on the outskirts of the Reserva Biológica Cachalú, where the species has also been observed (BLI 2007g, p. 10). Therefore, we determine that forestry regulations are not effective in mitigating the threats to the gorgeted wood-quail from habitat destruction (Factor A).
Colombia has several categories of national habitat protection (Matallana-T 2005, pp. 121–122), which were more fully described above, as part of the Factor D analysis for the blue-billed curassow (Matallana-T 2005, pp. 121–122). The gorgeted wood-quail occurs within two protected areas: the Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary (Sarria and Álvarez 2002, p. 160; Fuller
Colombia has adopted numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats. The gorgeted wood-quail is considered critically endangered under Colombian law and lives within two protected areas. However, on-the-ground enforcement of existing wildlife protection and forestry laws and oversight of the local jurisdictions implementing and regulating activities are ineffective at mitigating the primary threats to the gorgeted wood-quail. As discussed for Factor A, habitat destruction, degradation, and fragmentation continue throughout the existing range of the gorgeted wood-quail. As discussed for Factor B, uncontrolled hunting of the gorgeted wood-quail is ongoing and negatively affects the continued existence of the species. Therefore, we find that the existing regulatory mechanisms currently in place are inadequate to mitigate the primary threats of habitat destruction (Factor A) and hunting (Factor B) to the gorgeted wood-quail.
Two additional factors affect the gorgeted wood-quail: its minimal likelihood for dispersal and the species' small population size.
The gorgeted wood-quail is currently known in three localities in two disjunct locations within the Department of Santander: Serranía de los Yarguíes, in northern Santander, and Cachalú Biological Reserve and Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary, in southern Santander (Rainforest Alliance 2008, p. 2; TNC 2008, p. 1; Donegan and Huertas 2005, p. 30). Although there is little information on the species' dispersal capabilities, the isolated, fragmented nature of the remaining suitable habitat is considered by researchers to be a hindrance to its ability to disperse because: (1) The gorgeted wood-quail is primarily a terrestrial species that is found at mid-to-upper-elevation forests (1,750–2,050 m (5,741–6,726 ft)) on the western slopes of the East Andes (BLI 2007g, p. 2; Sarria and Turner 2006, p. 22; Donegan and Huertas 2005, p. 29; Donegan
Deforestation (Factor A) and overutilization (Factor B) have greatly affected the current population size and distributional range of the gorgeted wood-quail (Collar
The gorgeted wood-quail's restricted range, combined with its small population size (Sarria and Álvarez 2002, p. 138; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361), makes the species particularly vulnerable to the threat of adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events that destroy individuals and their habitat (Young and Clarke 2000, pp. 361–366; Holsinger 2000, pp. 64–65; Primack 1998, pp. 279–308). Small population sizes render species vulnerable to genetic risks that can have individual or population-level consequences on the genetic level and can increase the species' susceptibility to demographic problems, as explained in more detail above for the blue-billed curassow (Factor E, Small Population Size) (Charlesworth and Charlesworth 1987, p. 238; Shaffer 1981, p. 131). Once a population is reduced below a certain number of individuals, it tends to rapidly decline towards extinction (Holsinger 2000, pp. 64–65; Soulé 1987, p. 181; Gilpin and Soulé 1986, p. 25; Franklin 1980, pp. 147–148).
In the absence of quantitative studies specific to this species, a general approximation of minimum viable population size is the 50/500 rule, as described above as part of the Factor E analysis for the brown-banded antpitta (Shaffer 1981, pp. 132–133; Soulé 1980, pp. 160–162). The total population size of the gorgeted wood-quail is estimated to be between 186 and 486 individuals. While 186 individuals is above the minimum population size required to avoid short-term genetic consequences, 486 falls just below the threshold minimum number of 500 individuals required for long-term fitness of a population and does not take into account that not all members of the population will be contributing to population growth at any one time.
Because the gorgeted wood-quail exists in two isolated, disjunct habitat fragments, between which they are unlikely to disperse, an examination of the fitness of each subpopulation is more appropriate. For the purposes of this analysis, although we have reservations about the precision of these estimates (see Population Estimates discussion above), we will use the following two population estimates: 250 individuals in Northern Santander and 30–66 individuals in southern Santander. Upon examination of these estimates, both populations are clearly below the threshold required for long-term fitness in a population. The lower limit of the population estimate for the southern Santander population is below the threshold required to avoid short-term risks such as inbreeding and demographic shifts, whereas the upper limit is barely above the 50-individual threshold. Therefore, we currently consider these subpopulations (and the species as a whole) to be at risk due to the lack of short- and long-term viability.
The gorgeted wood-quail is unlikely or incapable of dispersing into suitable habitat that is isolated from extant populations, and the species' overall small population size makes it vulnerable to genetic and demographic risks that negatively impact the species' short- and long-term viability. Habitat destruction through deforestation (Factor A) and overutilization through hunting (Factor B) have greatly affected the species' current population size. Believed to be extinct or on the verge of extinction within the past 30 years, the species is now confirmed in three areas of two disjunct locations. The gorgeted wood-quail's small population size, combined with its restricted range and inability to repopulate disjunct suitable habitat following local extirpations, makes the species particularly vulnerable to the threat of adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events that destroy individuals and their habitat.
The five primary factors that threaten the survival of the gorgeted wood-quail are: (1) Habitat destruction, fragmentation, and degradation (Factor A); (2) overexploitation due to hunting (Factor B); (3) predation (Factor C); (4) inadequacy of regulatory mechanisms to reduce the threats to the species (Factor D); and (5) small population size and isolation of remaining populations (Factor E). The gorgeted wood-quail, a small terrestrial bird, prefers primary montane forests or adjacent secondary forests at altitudes between 1,750 and 2,050 m (5,741 and 6,726 ft). The species' historic range has been reduced by 92 percent, extirpating the species from its type locality in the Department of Cundinamarca and causing the species to shift to the extremes of its range and elevational distribution (Factor A). The estimated suitable habitat available to the species is approximately 10–27 km
Within the past decade, the gorgeted wood-quail has been confirmed in only three locations: Serranía de los Yarguíes, in northern Santander, and adjacent localities in the Guanentá-Alto Rio Fonce Flora and Fauna Sanctuary and Cachalú Biological Reserve, in southern Santander. Much of the primary forest, mid-elevation habitat preferred by the species has been destroyed by human activities, such as slash-and-burn agriculture, grazing, and extractive industries (Factor A). Illegal crop production, which continues throughout the species' range, has altered soil compositions, hindering regeneration of abandoned fields. In addition, drug eradication programs involving the aerial spraying of nonspecific herbicides have further degraded the environment and destroyed primary forest habitat.
In combination, these threats exacerbate the negative consequences to the species. For example, habitat fragmentation (Factor A) increases the species' vulnerability to hunting (Factor B). Poaching, in combination with habitat destruction, may have led to the local extirpation of the gorgeted wood-quail from Cuchilla del Ramo. This population was only discovered in 1970 and, amidst ongoing habitat destruction and hunting pressures, has not been observed there since 1988. Thus, deforestation and hunting within the past 30 years may have led to the extirpation of the gorgeted wood-quail from this location.
Habitat fragmentation also exposes the species to greater risk of extinction caused by adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., hunting or deforestation) events (Factor E). The species' population has decreased by up to 9 percent in the past 10 years and has likely been extirpated from at least one location (Cundinamarca) due to habitat loss and from another locality (Cuchilla del Ramo) due to a combination of habitat loss and hunting. The global population of the gorgeted wood-quail is estimated to be between 187 and 486 individuals. Given that the gorgeted wood-quail is likely to interact as subpopulations and is unlikely to disperse between patches of fragmented habitat, the effective population size is actually much smaller than its estimated global population would imply. This small population size puts the gorgeted wood-quail at risk from both near-term genetic complications (such as
The gorgeted wood-quail is listed as critically endangered, making it illegal to hunt the species, and two of the three known localities are within protected areas. However, habitat destruction and poaching are ongoing throughout the species' range (Factor D). Thus, the regulations in place are ineffective in protecting the gorgeted wood-quail and its habitat.
We have carefully assessed the best available scientific and commercial information regarding the past, present, and potential future threats faced by the gorgeted wood-quail. We consider the ongoing threats to the gorgeted wood-quail, habitat destruction (Factor A), hunting (Factor B), and predation (Factor C), exacerbated by the species' small population size and limited dispersal ability (Factor E), and compounded by inadequate regulatory mechanisms to mitigate these threats (Factor D), to be equally present and of the same magnitude throughout the species' entire current range. Based on this information, we find that the gorgeted wood-quail is in danger of extinction throughout its range.
Esmeraldas woodstar, a member of the hummingbird family (Trochilidae) and endemic to Ecuador, is approximately 6.5 cm (2.5 in.) in length (del Hoyo
Esmeraldas woodstar was first taxonomically described by Simon in 1889 (BLI 2007e, p. 1). The type specimen (the actual specimen that was first described) of the Esmeraldas woodstar was obtained from the moist forest habitat near Esmeraldas City, in the Department of Esmeraldas (Collar
Simon placed the species in the Trochilidae family, under the name
Esmeraldas woodstar is a range-restricted, forest-dwelling species with highly localized populations (BLI 2007f, pp. 1–3; Schuchmann 1999, p. 532; Collar
Esmeraldas woodstar has been seen most often along forest borders, with females especially seen perching on dead twigs (Ridgely and Greenfield 2001b, p. 295). The species forages mainly in the canopy and has been recorded “hawking” insects from the air, as well as foraging nectar from flowers of the strawberry tree (
The type locality for the Esmeraldas woodstar (the location of its first discovery) was in Esmeraldas, near Esmeraldas City, and the last specimen was observed there and in the Department of Manabi in 1912 (Collar
Today, Esmeraldas woodstar ranges in northwestern Ecuador, in the Departments of Esmeraldas, Manabi, and Guayas, along the slopes of the coastal cordillera up to 500 m (1,640 ft) (Ridgely and Greenfield 2001b, p. 295; Schuchmann 1999, p. 468; del Hoyo
The species was rediscovered on ridges above the lower Río Ayampe (in northwest Guayas/Manabi) in March 1990, near the Machalilla National Park (BLI 2007c, p. 2; Becker
Since then, the species has been observed at the following locations: Esmeraldas: Suá, in January 1993, and Muisne, in 1994 (month unknown); Manabi: Isla de La Plata (part of the Machalilla National Park), December–January 1998 (BLI 2007c, p. 2; Ridgely and Greenfield 2001a, p. 389; Williams and Tobias 1991, p. 39). The species was not observed on Isla de La Plata during a bird survey conducted in June 2000 (Cisneros-Heredia 2005, p. 24), reconfirming their absence from this habitat during nonbreeding months.
Esmeraldas woodstar is considered a rare, range-restricted species with highly localized populations in three general areas (BLI 2007c, pp. 1–3; Schuchmann 1999, p. 532). There have been no population surveys of this species. BirdLife International estimated that the population currently includes between 186 and 373 individuals, based on estimates using similar species of hummingbirds (BLI 2007c, p. 6).
The Esmeraldas woodstar is identified as an endangered species under Ecuadorian law (EcoLex 2003b, p. 36). This species is classified as `Endangered' on the IUCN Red List, due to severe fragmentation within the woodstar's restricted range (IUCN 2006).
The Esmeraldas woodstar is restricted to the semihumid forests and woodlands from sealevel to 500 m (1,600 ft) along the Coastal Cordillera of western Ecuador (Ridgely and Greenfield 2001b, p. 295; del Hoyo
The semihumid, semievergreen forest environment preferred by the Esmeraldas woodstar is one of the most threatened forest habitats in the Neotropics (Schuchmann 1999, p. 532; Collar
Forested habitat within western Ecuador, including that within the Esmeraldas woodstar's range, has diminished rapidly due to logging, clearing for agriculture, and road development (Dodson and Gentry 1991, pp. 283–293). The primary moist forest habitat at the species' type locality (Esmeraldas City) has been replaced with pastures and scattered trees (Collar
Ongoing deforestation has transformed forested habitat within the region to a patchwork of cropland, with fewer than 5 percent of the forested areas remaining only on steep slopes that cannot be cultivated (Best and Kessler 1995, p. 35; Stattersfield
The species is currently known in three localities: (1) Isla de la Plata, (2) Machalilla National Park, and (3) Loma Alta Communal Ecological Reserve.
(1) Isla de la Plata: This 1,420-ha (3,508-ac) island is approximately 27 km (17 mi) from the coast of the Department of Manabí and is actually part of the Machalilla National Park (see below). The species was last observed on the island in 1998 (BLI 2007c, p. 2; Becker
(2) Machalilla National Park: This 34,393-ha (84,985-ac) Park was established in 1979 (BLI 2007c, pp. 11, 13) and is designated as a Ramsar Wetland of International Importance (BLI 2007c, p. 13) (see Factor D). In addition to the male sighting on Isla de La Plata, a female was also observed within the Park in 1998 (Becker
This park is populated, and residents subsist on farming and cattle-raising (BLI 2007c, pp. 11, 13; Lasso 1997, p. 3). Portions of land within the Park have been converted to pastures or cropland (Lasso 1997, p. 3). Some previously deforested areas have been left to regenerate (BLI 2007c, p. 13). However,
(3) Loma Alta Communal Ecological Reserve: This 6,000-ha (14,826-ac) area was declared a Reserve in 1996 (BLI 2007c, p. 17). The Reserve was created to protect the watershed and to help preserve the land of four groups of indigenous inhabitants. The Reserve encompasses a variety of habitats from dry to cloud forests (BLI 2007c, p. 15). About 500 ha (1,235 ac) of the Reserve is dedicated to cultivation of the Panama hat plant (
Esmeraldas woodstars are rare, range-restricted species with highly localized populations in three disjunct locations within an area of approximately 1,155 km
Stattersfield
In 1987, the Esmeraldas woodstar was listed in CITES Appendix II (UNEP–WCMC 2008b, p. 1), which includes species that are not necessarily threatened with extinction, but which require regulation of international trade to ensure that trade of the species is compatible with the species' survival. International trade in specimens of Appendix-II species is authorized through permits or certificates under certain circumstances, including verification that trade will not be detrimental to the survival of the species in the wild and that the specimens were legally acquired (UNEP–WCMC 2008a, p. 1). According to the World Conservation Monitoring Centre (WCMC), there has been one international transaction permitted by CITES since listing. In 1993, 100 “bodies” were imported to Mexico through the United States. According to the trade data, the specimens were being traded for commercial purposes and were seized by inspectors (UNEP–WCMC 2008d, p. 1). No further CITES-recorded trade in this species has occurred since that time. Although we are no longer able to determine the exact details surrounding this seizure, we consider the seizure and lack of ensuing trade to be supportive that CITES has been effective in controlling commercial trade in this species. Therefore, we do not consider international trade for commercial purposes to be a threat to the species.
Tourism occurs year-round at Isla de la Plata and has been known to occasionally disturb the native birds (BLI 2007c, pp. 2, 9–10). There is no information regarding whether Esmeraldas woodstar is among the native species that is adversely affected by ecotourism or other human disturbance.
We are unaware of any other information currently available that addresses the occurrence of overutilization for commercial, recreational, scientific, or educational purposes that may be affecting the Esmeraldas woodstar population. Consequently, we do not consider this factor to be a threat to the species.
We are unaware of information regarding disease or the potential for significant disease outbreaks in the Esmeraldas woodstar. As a result, we do not consider disease to be a threat to the species.
Hummingbird eggs and chicks are most vulnerable to predation. Known hummingbird predators that are found in cloud forest habitat in Ecuador include domestic cats (
On Isla de La Plata, nonnative predators, including cats and spiny rats (
According to BirdLife International, an eradication program is underway to remove feral animals from the island (BLI 2007c, p. 10). One project to control the introduced cat population on Isla De La Plata, being supported by the World Conservation Foundation, would trap the feral cats, neuter them, and return them to the wild, with the eventual goal of preventing further reproduction of the feral population. This project will also help to better quantify the extent of the invasion on the island (Rosero 2006, p. 5). However, predation on the island continues to be a threat to native bird species, including the Esmeraladas woodstar, both on the Island and in Machalilla National Park (BLI 2007c, p. 10; Rosero 2006, p. 5; Emmons and Albuja 1992, pp. 120–121).
The Esmeraldas woodstar's historic range has been reduced by 99 percent (Dodson and Gentry 1991, p. 293), and remaining suitable habitat is highly fragmented (BLI 2004a, p. 2; Stattersfield
Domestic and feral cats, rats, hawks, owls, snakes, praying mantis, spiders, bees, wasps, frogs, and largemouth bass are all predators of hummingbirds that are found in Esmeraldas woodstar habitat. Predation results in the direct removal of eggs, juveniles, and adults from the population. Esmeraldas woodstars produce a low clutch size and are particularly vulnerable to egg predation by cats on Isla de la Plata (see Habitat and Life History). Esmeraldas woodstar habitat is much reduced and highly fragmented (Factor A), and studies on similar species in similar Andean habitats indicate that vulnerability to predation by generalist predators increases with increased habitat fragmentation and smaller patch sizes. Predation can remove potentially reproductive adults from the breeding pool and exacerbates the genetic complications associated with the species' small population size (Factor E), increasing the species' vulnerability to local extirpation. Therefore, we find that predation, exacerbated by ongoing habitat destruction (Factor A), is a threat to the Esmeraldas woodstar.
Regulatory mechanisms may provide species-specific or habitat-specific protections. An evaluation of the adequacy of regulatory mechanisms within Ecuador to mitigate or remove the threats to the Esmeraldas woodstar is provided below, beginning with species-specific and followed by habitat-specific protection mechanisms.
The Esmeraldas woodstar is protected under Ecuadorian law by Decree No. 3,516 of 2003 (Unified Text of the Secondary Legislation of the Ministry of Environment (EcoLex 2003b, pp. 1–2 and 36). Decree No. 3,516 summarizes the laws governing environmental policy in Ecuador and provides that the country's biodiversity be protected and used primarily in a sustainable manner. Appendix 1 of Decree No. 3,516 lists the Ecuadorian fauna and flora that are categorized as critically endangered (En peligro critico), endangered (En peligro), or vulnerable (Vulnerable) (EcoLex 2003b, p.17). Under this law, Esmeraldas woodstar is categorized as endangered, under the synonym
Esmeraldas woodstar is listed in Appendix II of CITES, to which Ecuador became a Party in 1975 (UNEP–WCMC 2008a, p. 1; USFWS 2008, p. 1). CITES was described in more detail above, as part of the Factor E analysis for the blue-billed curassow. As discussed under Factor B for the Esmeraldas woodstar, we consider that this international treaty has minimized the potential threat to the species from international trade and do not consider international trade to be a threat impacting the Esmeraldas woodstar. However, this treaty does not mitigate threats to the species from habitat destruction (Factor A), predation (Factor C), or its small population size (Factor E). Therefore, protection under this Treaty does not reduce any existing threats to the species.
Ecuador has numerous laws and regulations pertaining to forests and forestry management, including: the Forestry Act (comprising Law No. 74 of 1981—Forest Act and conservation of natural areas and wildlife (Faolex 1981, pp. 1–54) and Law No. 17 of 2004—Consolidation of the Forest Act and conservation of natural areas and wildlife (Faolex 2004, pp. 1–29)); a Forestry Action Plan (1991–1995); the Ecuadorian Strategy for Forest Sustainable Development of 2000 (Estrategia para el Desarrollo Forestal Sostenible); and Decree 346, which recognizes that natural forests are highly vulnerable (ITTO 2006, p. 225). However, the International Tropical Timber Organization considers ecosystem management and conservation in Ecuador, including effective implementation of mechanisms that would protect the Esmeraldas woodstar and its habitat, to be lacking
Extractive harvest practices may pose a threat to the Esmeraldas woodstar (BLI 2007c, p. 13) (Factor A). In 2004, Law No. 17 (Faolex 2004, pp. 1–29) amended the Forest Act of 1981 (Law No. 74) (Faolex 1981, pp. 1–54) to include five criteria for sustainable forest management: (i) Sustainable timber production; (ii) the maintenance of forest cover; (iii) the conservation of biodiversity; (iv) coresponsibility in management; and (v) the reduction of negative social and environmental impacts (ITTO 2006, p. 225; Aguilar and Vlosky 2005, pp. 9–10). In 2001, the Ecuadorian Government worked with the private sector to develop a system of monitoring and control of forest harvest practices. However, in 2003, the Supreme Court of Ecuador declared that the control system was unconstitutional, and new control systems are now being developed (ITTO 2006, p. 225). Approximately 70 percent of the forest products harvested are harvested illegally, are used as fuel wood, or are discarded as waste (ITTO 2006, p. 226; Aguilar and Vlosky 2005, p. 4). Because the extractive harvesting industry is not monitored, the extent of the impact is unknown (BLI 2007c, p. 13). However, we find this law is currently inadequate in monitoring the impacts of extractive harvesting on the Esmeraldas woodstar or to protect the species from potential impacts of extractive harvesting (Factor A).
The governmental institutions responsible for natural resource oversight in Ecuador appear to be under-resourced, and there is a lack of law enforcement on the ground. Despite the creation of a national forest plan, there appears to be a lack of capacity to implement this plan due to insufficient political support, unclear or unrealistic forestry standards, inconsistencies in application of regulations, discrepancies between actual harvesting practices and forestry regulations, the lack of management plans for protected areas, and high bureaucratic costs. These inadequacies have facilitated logging (Dodson and Gentry 1991, pp. 283–293); cattle-raising and persistent grazing from goats and cattle (BLI 2007c, pp. 11, 13, 17; BLI 2004a, p. 2; Lasso 1997, p. 3; Curry 1993, p. 24); clearing for agriculture, subsistence farming, and small local industries (BLI 2007c, pp. 11, 13, 17; Lasso 1997, p. 3; Dodson and Gentry 1991, pp. 283–293); selective harvest of trees for fuelwood and nontimber products (BLI 2007c, p. 13; Aguilar and Vlosky 2005); road development (BLI 2007c, p. 13; Dodson and Gentry 1991, pp. 283–293); and pollution from industrial activities occur within or near protected areas (Lasso 1997, p. 3). In addition, most of Ecuador's forests are privately owned or owned by communities (ITTO 2006, p. 224; Lasso 1997, pp. 2–3), and the management and administration of Ecuador's forest resources and forest harvest practices is insufficient and unable to protect against unauthorized forest harvesting, degradation, and conversion (ITTO 2006, p. 229). Habitat conversion and alteration are ongoing throughout the range of the Esmeraldas woodstar, including within protected areas (BLI 2007c, pp. 10, 13, 17; Butler 2006b, pp. 1–3; FAO 2003b, p. 1). Thus, Ecuadorian forestry regulations have not mitigated the threat of habitat destruction (Factor A).
The Ecuadorian Government recognizes 31 different legal categories of protected lands (e.g., national parks, biological reserves, geo-botanical reserves, bird reserves, wildlife reserves, etc.). Currently, the amount of protected land (both forested and nonforested) in Ecuador totals approximately 4.67 million ha (11.5 million ac) (ITTO 2006, p. 228). However, only 38 percent of these lands have appropriate conservation measures in place to be considered protected areas according to international standards (i.e., areas that are managed for scientific study or wilderness protection, for ecosystem protection and recreation, for conservation of specific natural features, or for conservation through management intervention) (IUCN 1994, pp. 17–20). Moreover, only 11 percent have management plans, and fewer than 1 percent (13,000 ha (32,125 ac)) have implemented those management plans (ITTO 2006, p. 228).
The Esmeraldas woodstar has been recorded in or near two protected areas: (1) Machalilla National Park (Collar
Esmeraldas woodstar occurs within the Machalilla National Park, which was included in the Ramsar List of Wetlands of International Importance in 1990 (BLI 2007c, p. 13). The Ramsar Convention, signed in Ramsar, Iran, in 1971, is an intergovernmental treaty that provides the framework for national action and international cooperation for the conservation and wise use of wetlands and their resources. There are presently 158 Contracting Parties to the Convention (including Ecuador, where the Esmeraldas woodstar occurs), with 1,828 wetland sites, totaling 169 million ha (418 million ac), designated for inclusion in the Ramsar List of Wetlands of International Importance (Ramsar Convention Secretariat 2008, p. 1). Experts consider Ramsar to provide only nominal protection of wetlands, noting that such a designation may increase international awareness of the site's ecological value (Jellison
Ecuador has adopted numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats. The Esmeraldas woodstar is protected under CITES, which we consider has been effective in mitigating the potential threat to this species from commercial trade (Factor B). Esmeraldas woodstar is listed as endangered and ranges within at least two protected areas (Machalilla National Park and Loma Alta Communal Ecological Reserve). However, on-the-ground enforcement of these laws and oversight of the local jurisdictions implementing and regulating activities is insufficient for these measures to be effective in conserving the Esmeraldas woodstar or its habitat. As discussed for Factor A, habitat destruction, degradation, and fragmentation continue throughout the species' range, including lands within protected areas. Therefore, we find that the existing regulatory mechanisms, as implemented, are inadequate to mitigate the primary threats to the Esmeraldas woodstar from habitat destruction (Factor A), predation (Factor C), or its small population size (Factor E).
Two additional factors affect the Esmeraldas woodstar: Its minimal likelihood for dispersal and the species' small population size.
The Esmeraldas woodstar is confined to locations within the Departments of Esmeraldas, Manabi, and Guayas, in lowland moist forest patches that are disjunct and fragmented (BLI 2007f, pp. 1–3; del Hoyo
The Esmeraldas woodstar inhabits a very small and severely fragmented range, which is decreasing rapidly in size due to habitat destruction and various other human factors (Ridgely and Greenfield 2001a, pp. 389–390; Collar
Small population sizes render species vulnerable to genetic risks that can have individual or population-level consequences on the genetic level and can increase the species' susceptibility to demographic problems, as explained in more detail above for the blue-billed curassow (Factor E, Small Population Size) (Charlesworth and Charlesworth 1987, p. 238; Shaffer 1981, p. 131). Once a population is reduced below a certain number of individuals, it tends to rapidly decline towards extinction (Holsinger 2000, pp. 64–65; Soulé 1987, p. 181; Gilpin and Soulé 1986, p. 25; Franklin 1980, pp. 147–148).
In the absence of quantitative studies specific to this species, a general approximation of minimum viable population size is the 50/500 rule, as described above, as part of the Factor E analysis for the brown-banded antpitta (Shaffer 1981, pp. 132–133; Soulé 1980, pp. 160–162). The total population size of the Esmeraldas woodstar is estimated to be between 186 and 373 individuals. The lower estimate of 186 individuals meets the theoretical threshold for the minimum effective population size required to avoid risks from inbreeding (N
The Esmeraldas woodstar's restricted range combined with its small population size (Cuervo 2002, p. 138; Cuervo and Salaman 1999, p. 7; del Hoyo 1994, p. 361) makes the species particularly vulnerable to the threat of adverse natural (e.g., genetic, demographic, or environmental) and manmade (e.g., deforestation, habitat alteration, wildfire) events that destroy individuals and their habitat (Young and Clarke 2000, pp. 361–366; Holsinger 2000, pp. 64–65; Primack 1998, pp. 279–308). Therefore, we currently consider the single Esmeraldas woodstar population to be at risk due to the lack of long-term viability.
The Esmeraldas woodstar is currently limited to a few small populations within a limited habitat range, with a small estimated population size that leaves the species vulnerable to genetic and demographic risks that negatively impact its long-term viability. The species' population size is estimated to have declined considerably within the past 10 years (50–79 percent), and this rate of decline is expected to continue. Based on this information, we have determined that the species is particularly vulnerable to the threat of adverse natural (e.g., genetic, demographic, or predation) and manmade (e.g., slash-and-burn agriculture or infrastructural development) events that destroy individuals and their habitat, and that these genetic and demographic risks are exacerbated by ongoing habitat destruction (Factor A) and predation (Factor C).
The four primary factors that threaten the survival of the Esmeraldas woodstar are: (1) Habitat destruction, fragmentation, and degradation (Factor A); (2) predation (Factor C); (3) inadequate regulatory mechanisms (Factor D); and (4) limited size and isolation of remaining populations (Factor E). The Esmeraldas woodstar is a tiny hummingbird endemic to Ecuador. Esmeraldas woodstars are a rare, range-restricted species with highly localized populations in three disjunct locations—in the Ecuadorean Departments of Esmeraldas, Guayas, and Manabí. The species occurs in lowland semi-humid or semievergreen forests and woodlands, from sealevel to 500 m (1,600 ft) along the Coastal Cordillera of western Ecuador. Preferring primary evergreen forests, the species is also known to occupy low-altitude secondary-growth areas during the breeding season (December–March). The current extent of the species' range is approximately 1,155 km
The primary threat to this species is habitat loss (Factor A), caused by widespread deforestation and conversion of primary forests for numerous human activities. The species' range has been reduced by 99 percent. The semihumid and semievergreen forests preferred by this species have undergone extensive deforestation. Habitat-altering activities that have occurred include: logging; cattle-raising and persistent grazing from goats and cattle; forest clearing for agriculture, subsistence farming, and small local industries; selective harvest of trees for fuelwood and nontimber products; road development; and pollution from industrial activities (Factors A). These activities are ongoing and occurring throughout the species' range—including within protected areas where the species occurs (Machalilla National Park, Isla de La Plata, and Loma Alta Communal Ecological Reserve). Because regulatory mechanisms are ineffective at reducing these activities (Factor D), habitat destruction and alteration are expected to continue.
The species' population is estimated to have declined 50 to 79 percent within the last 10 years, a decline which is attributed to habitat loss. The Esmeraldas woodstar has a small estimated population size (between 186 and 373 individuals), which renders the
Esmeraldas woodstars are vulnerable to predation by a variety of predators, including domestic and feral cats, rats, hawks, owls, snakes, praying mantis, spiders, bees, wasps, frogs, and largemouth bass (Factor C). Habitat fragmentation (Factor A) contributes to this vulnerability, because research indicates that predation increases with increased habitat fragmentation and smaller patch sizes. Predation leads to the direct removal of eggs, juveniles, and adults from the population, exacerbating risks associated with the species' small population size. Esmeraldas woodstars are particularly vulnerable to predation by wild cats during the breeding season on Isla de La Plata, where cats have been known to prey particularly upon bird eggs. Esmeraldas woodstars produce a low clutch size (see Habitat and Life History), and predation can remove potentially reproductive adults from the breeding pool.
The Esmeraldas woodstar is classified as an endangered species under Ecuadorian law, and part of the species' range is included within two protected areas. Despite numerous laws and regulatory mechanisms to administer and manage wildlife and their habitats, existing laws are inadequate (Factor D) to protect the species and its habitat from ongoing habitat loss (Factor A) and predation by nonnative animals (Factor C), even within the protected areas.
We have carefully assessed the best available scientific and commercial information regarding the past, present, and potential future threats faced by the Esmeraldas woodstar. We consider the ongoing threats to the Esmeraldas woodstar, habitat loss (Factor A) and predation (Factor C), exacerbated by the species' small population size and limited dispersal ability (Factor E), and compounded by inadequate regulatory mechanisms (Factor D), to be equally present and of the same magnitude throughout the species' entire current range. Based on this information, we find that the Esmeraldas woodstar is endangered throughout its range.
Conservation measures provided to species listed as endangered or threatened under the Act include recognition, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and encourages and results in conservation actions by national governments, private agencies and groups, and individuals.
Section 7(a) of the Act, as amended, and as implemented by regulations at 50 CFR part 402, requires Federal agencies to evaluate their actions within the United States or on the high seas with respect to any species that is proposed or listed as endangered or threatened, and with respect to its critical habitat, if any is being designated. However, given that the blue-billed curassow, the brown-banded antpitta, the Cauca guan, the gorgeted wood-quail, and the Esmeraldas woodstar are not native to the United States, no critical habitat is being proposed for designation with this rule.
Section 8(a) of the Act authorizes limited financial assistance for the development and management of programs that the Secretary of the Interior determines to be necessary or useful for the conservation of endangered and threatened species in foreign countries. Sections 8(b) and 8(c) of the Act authorize the Secretary to encourage conservation programs for foreign endangered species and to provide assistance for such programs in the form of personnel and the training of personnel.
The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife. Consequently, these prohibitions would be applicable to the blue-billed curassow, the brown-banded antpitta, the Cauca guan, the gorgeted wood-quail, and the Esmeraldas woodstar. These prohibitions, under 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to “take” (take includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or to attempt any of these) within the United States or upon the high seas, import or export, deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of a commercial activity or to sell or offer for sale in interstate or foreign commerce, any endangered wildlife species. It also is illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken in violation of the Act. Certain exceptions apply to agents of the Service and State conservation agencies.
We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 for endangered species, and at 17.32 for threatened species. With regard to endangered wildlife, a permit may be issued for the following purposes: for scientific purposes, to enhance the propagation or survival of the species; and for incidental take in connection with otherwise lawful activities.
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), need not be prepared in connection with regulations adopted under section 4(a) of the Act. We published a notice outlining our reasons for this determination in the
A list of the references cited in this final rule is available at
The primary authors of this proposed rule are Arnold Roessler of the Endangered Species Program (Sacramento, California) and Dr. Patricia De Angelis of the Division of Scientific Authority, U.S. Fish and Wildlife Service.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we hereby amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361–1407; 1531–1544; 4201–4245; unless otherwise noted.
(h) * * *
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.
Submit either electronic or written comments on the proposed rule by February 26, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 29, 2013 (see the “Paperwork Reduction Act of 1995” section of this document).
You may submit comments, identified by Docket No. FDA–2011–N–0922 and/or Regulatory Information Number (RIN) 0910–AG10 by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document).
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
Submit written submissions in the following ways:
• Mail/Hand delivery/Courier (for paper or CD–ROM submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Kim Young, Center for Veterinary Medicine (HFV–230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9207, email:
The proposed rule would establish regulations regarding the manufacturing, processing, packing, or holding of animal food in two ways. First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food. In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with FDA under FDA's current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions.
To put these changes in context, and to provide legal, regulatory, scientific, and technical information relevant to the new provisions, the Agency provides several sections of background. This background discusses the current approaches to animal food safety; summarizes the Food and Drug Administration Amendments Act of 2007 (FDAAA) as it applies to pet food; provides an overview of the provisions of FSMA applicable to this proposed rule; and describes a variety of hazards that have been associated with animal foods and animal food safety problems (including outbreaks of foodborne illness) that have resulted from these hazards. An Appendix also describes the role of testing as a verification measure in a food safety system and the role of supplier approval and verification programs in a food safety system.
The proposed rule would establish certain CGMP provisions to ensure the safety and suitability of animal food. The implementation of these practices and procedures would protect against the contamination of animal food. The proposed CGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene.
The proposed rule also would implement the requirements of section 103 of FSMA for animal food facilities that must register under section 415 of the FD&C Act (21 U.S.C. 350d) to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:
• A written food safety plan;
• Hazard analysis;
• Preventive controls for hazards that are reasonably likely to occur;
• Monitoring;
• Corrective actions;
• Verification; and
• Associated records.
The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. The Agency does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities.
The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls. Facilities that manufacture, process, pack, or hold animal food and that are required to register with FDA under section 415 of the FD&C Act would be required to comply with the proposed regulation unless they are covered by an exemption. The table immediately below summarizes these proposed exemptions in general terms. Importantly, the table in this Executive Summary does not include all the details that a facility must consider to determine whether an exemption applies. The Agency provides those details in the proposed rule (proposed § 507.5) and explains them in section VIII.C.
The proposed rule also would establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption. The proposed rule would establish requirements that would apply to all records that would be required by the various proposed provisions. The proposed recordkeeping provisions would implement specific requirements of FSMA regarding records associated with the new provisions for hazard analysis and risk-based preventive controls and would allow facilities to show, and FDA to determine, compliance with the regulatory requirements.
The proposed rule would require that a qualified individual prepare the food safety plan, validate preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the required reanalysis of a food safety plan. The proposed rule also would establish minimum requirements for the “qualified individual,” who would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Only a trained individual or individual qualified by job experience is capable of effectively executing these activities.
FDA is requesting comment on when and how other elements of a preventive controls system are an appropriate means of implementing the statutory directives, including: A product testing program, an environmental monitoring program, and a supplier approval and verification program, as appropriate.
The summary of the costs and potential benefits of the proposed rule are presented in the table that follows.
On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353). This law enables FDA to better protect public health by helping to ensure the safety and security of the human and animal food supply. FSMA enables the Agency to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides the Agency with new enforcement authorities to help achieve higher rates of compliance with risk-based, prevention-oriented safety standards and to better respond to and contain problems when they do occur. In addition, the law gives the Agency important new tools to better ensure the safety of imported human and animal foods and directs the Agency to build an integrated national food safety system in
This new law continues efforts by the human and animal food industries and government to protect and improve the safety of the nation's food supply. At the Federal level, these efforts go back to the Pure Food and Drug Act of 1906, the United States' first national food safety law. FSMA carries forward the basic principle embodied in the 1906 law that food establishments have the primary responsibility and capacity to make food safe and that government's role is to set standards for food safety and provide oversight to help ensure standards are met.
Since passage of the 1906 Act, and the most recent revision of its basic food safety provisions in the Federal Food, Drug, and Cosmetic Act of 1938, the combined efforts of the food industry and government have produced a set of standards and practices that make the U.S. food supply among the safest in the world. These efforts include the development and adoption by FDA of CGMP standards for human food that have long provided the regulatory foundation for human food safety. They also include, in more recent years, the adoption for some elements of the animal and human food supply of more targeted, risk-based approaches, such as embodied in the Hazard Analysis and Critical Control Points (HACCP) approach to food safety.
HACCP was pioneered by the human food industry and reflects the understanding that food safety is best assured if each producer and processor understands the hazards that are reasonably likely to occur in their particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate the hazard. FDA has by regulation required seafood and juice processors to implement the HACCP approach to preventive controls. The U.S. Department of Agriculture (USDA) has also mandated HACCP for meat and poultry processors, and many human food companies have implemented such modern preventive control systems for other commodities.
While these efforts have contributed to progress on food safety, significant human and animal food safety challenges persist in today's complex, dynamic, and global food system. Today's food supply is highly diverse and increasingly complex, with many new foods in the marketplace that pose new food safety challenges. New pathogens are emerging, and the Agency is seeing commonly known pathogens appear in foods where they have not been traditionally seen. The population of individuals at greater risk for foodborne illness, such as those who are immune-compromised, is increasing. When illness outbreaks occur, they can have devastating impacts on public health and impose substantial economic disruption and cost on the human and animal food industry. The food safety challenge is only compounded by globalization and the increasing amount of imported human and animal food.
Congress responded to today's food safety challenges by enacting FSMA. FSMA builds on past experience and the strong foundation provided by the current food safety system, but it also marks an historic turning point for food safety. FSMA directs FDA to build a food safety system for the future that makes modern, science- and risk-based preventive controls the norm across all sectors of the food system; meets the food safety challenges of the global food system; and establishes stronger partnerships for food safety across all levels of government and with the private sector to ensure optimal use of public and private resources. FDA has embarked on a comprehensive effort to build the food safety system mandated by Congress, as described on its FSMA implementation Web page at
A top priority for FDA are those FSMA-required regulations that provide the framework for industry's implementation of preventive controls and FDA's ability to oversee their implementation for both domestic and imported food. These include, among others, regulations establishing preventive control standards for human food and animal food facilities, produce safety standards, standards that define the accountability of importers to verify the safety of food produced overseas, and a new program for accrediting private bodies to provide credible certifications that regulated entities are meeting U.S. safety standards. A proposed rule on foreign supplier verification is closely interconnected to this rule on preventive controls for animal food (and the preventive controls proposed rule for human food), and published in the
In this document, the Agency proposes standards to implement the requirement in section 103 of FSMA for the adoption of preventive controls in animal food facilities. This preamble provides information on FDA's previous efforts in working to establish CGMPs and process controls for animal food, because these past efforts are the critical starting point and foundation for FSMA implementation. The preamble explains and provides additional background on the rationale for the Agency's proposed regulations implementing FSMA's preventive controls requirement and new CGMPs for the animal food industry. The Agency is seeking comments on all aspects of this proposal.
The document for the proposed rule for preventive controls for human food, published in the
Ensuring the safety of animal food is complex in light of several factors. Animal food is made for a wide variety of species, including animals from which human foods are derived, pet animals, and laboratory animals. Many animals consume one food as their sole source of nutrition. Therefore, the food that they consume must be nutritionally adequate or the food presents a safety hazard to the animals. Nutrient deficiencies or excesses can raise safety concerns. Because different species have different nutritional needs, certain quantities of a nutrient that are needed by one species of animal could pose a health risk to another species of animal. Therefore, safety issues for animal food can be raised not only by biological, chemical, physical, or radiological contaminates of the food that can cause animal or human health concerns, but also by nutrient deficiencies (or excesses) for the animals.
Animal foods are also handled in a wide variety of settings. Some foods are handled on farms or in feed mills. Other foods, like pet foods, are handled in homes and often in the kitchen. If the pet food is contaminated with a pathogen of human health concern, this could result in secondary contamination of human food-contact surfaces or human food. Humans could become ill from the pathogen through handling the pet food or through these secondary contaminations.
The discussion that follows explains current regulatory tools and other approaches the Agency has explored to address the safety of animal food for animals, the safety of food from food-producing animals consumed by humans, and the safety of humans handling animal food.
This proposed rule would implement needed controls for animal food. This
The Agency's efforts to upgrade animal food safety in this country are continually evolving. Historically, FDA's animal food program focused on specific safety issues, such as unsafe tissue residues resulting from feeding of medicated animal food, Bovine Spongiform Encephalopathy (BSE), and
• Pre-approval of additives for use in animal food;
• Establishing limits for hazards in animal food;
• Providing education and training;
• Conducting research;
• Performing inspections;
• Taking enforcement for ensuring compliance with Agency regulations; and
• Establishing partnerships with State regulators with responsibility for animal food safety.
The AFSS concept also includes oversight of animal food production, including manufacture, labeling, storage, distribution and use of all animal food at all stages of production and use. A key element of the AFSS concept is a systems approach that includes best management practices during the “manufacturing, labeling, storage, and distribution” of all animal food, coupled with steps to identify hazards and to minimize or eliminate, as appropriate, the occurrence of those hazards.
The AFSS Working Group held public meetings on the AFSS concept in September 2003 and April 2005. The meetings were designed primarily to give stakeholders an opportunity to present information to FDA about the direction and scope of the AFSS. Three additional meetings, held in September 2006, May 2007, and May 2008, informed stakeholders of the risk assessment initiatives being undertaken by the AFSS Working Group. Information on these meetings can be found at the Agency's Web site (Ref. 1).
The AFSS Working Group used a number of sources in developing its current design of components comprising the AFSS, including comments from the public solicited through public meetings and interactions with State regulatory officials, industry representatives, veterinarians and consumers. In addition, the working group reviewed some of the approaches used by the Agency and by industry to ensure human food safety, such as HACCP systems, Standard Operating Procedures (SOPs), Sanitation Standard Operating Procedures (SSOPs), and CGMPs, to determine their applicability and usefulness to animal food control and regulatory oversight in a risk-based preventive system. The working group also reviewed the Codex Code of Practice on Good Animal Feeding as a comparison to help identify gaps in the Agency's current regulatory approach to animal food safety (Ref. 2). The Codex Code was accepted by the European Union along with other foreign entities and the U.S. delegation, which was comprised of U.S. Federal and State Government officials and industry advisors to the Codex's Task Force on Good Animal Feeding Practices.
The AFSS Working Group identified seven operating components to comprise the AFSS. These components cover processes to ensure that:
• Ingredients used in animal food are safe;
• The methods used to make, store, and distribute animal food result in safe products;
• The Agency acquires timely information about unsafe animal food and, when appropriate, makes such information publicly available;
• The levels of regulatory oversight are commensurate with risk to human and animal health;
• Training, education, and outreach activities keep the Agency's partners and stakeholders well informed and ensure that the Agency and State animal food regulatory personnel are adequately trained; and
• An active and aggressive research program is employed to generate data to aid in addressing animal food safety issues.
With the assistance of regulated animal food industry, the public, and State regulatory personnel, the working group identified gaps in the regulation of labeling, processing, and distribution of animal food products. The working group describes these gaps and ways to address them in the fourth AFSS Framework Document dated January 2010, which can be found on FDA's Web site (Ref. 3).
One critical gap is the lack of Federal regulations to fully address all aspects of producing safe animal food associated with the receiving, manufacturing, processing, packing, holding and distribution of animal food (including pet food, animal feed, and raw materials and ingredients) that does not contain animal drugs (i.e., non-medicated animal food). To fill this gap, the working group began developing a process control standards proposed rule, which aimed to prevent, eliminate, or reduce to acceptable levels the potential risks posed to human and animal health through a systems approach in which adequate control steps would be established throughout the animal food manufacturing process. After the passage of FSMA, the Agency incorporated the work begun on the proposed rule for process control standards into this proposed rule for preventive controls for animal food.
In addition, the AFSS Working Group is developing and systematically applying a method that ranks risks associated with all identified hazards. The use of risk concepts is not new for the Agency, as FDA routinely tries to estimate public health impact in deciding where to focus regulatory effort in general. The Agency relies heavily on evaluation of risk posed by hazards that occur in animal food when making decisions about food safety. Information on the AFSS can be found at the Agency's Web site (Ref. 4).
Section 402 of the FD&C Act (21 U.S.C. 342) deems food, including animal food, adulterated in several circumstances, including:
a. If it bears or contains any poisonous or deleterious substance which may render it injurious to health (section 402(a)(1));
b. If it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a) of the FD&C Act (21 U.S.C. 346a) (section 402(a)(2)(B));
c. If it bears or contains an unapproved food additive or an unapproved new animal drug (section 402(a)(2)(C));
d. If it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food (section 402(a)(3)); and
e. If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health (section 402(a)(4)).
While the Agency has issued regulations related to the safety of specific types of animal food and the use of certain food substances in animal food, as will be described further in this preamble, section 402 of the FD&C Act applies to all animal food in interstate commerce.
Animal foods that are thermally processed low-acid foods packaged in hermetically sealed containers are subject to the regulations in 21 CFR 500.23, which in turn states the provisions of part 113 (21 CFR part 113) applies to animal food. Part 113 establishes the criteria by which FDA determines whether the facilities, methods, practices, and controls used by the commercial processor in the manufacture, processing, or packing of low-acid foods in hermetically sealed containers are operated or administered in a manner adequate to protect the public health.
The regulation in § 589.2000 (21 CFR 589.2000), prohibiting the use of certain animal proteins in ruminant feed, was published on June 5, 1997 (62 FR 30936). It was designed to prevent the establishment and amplification of BSE, through animal food, by prohibiting the use of certain proteins derived from mammalian tissue in the feeding of ruminant animals. This BSE regulation affects renderers, protein blenders, commercial animal food manufacturers, distributors (including retailers), transporters of animal food and ingredients, on-farm animal food mixers, and ruminant feeders.
On December 7, 2000, the USDA/Animal and Plant Health Inspection Service (USDA/APHIS) enacted regulations prohibiting the importation into the United States of all meat and bone meal (MBM), meat meal, bone meal, blood meal, tankage, offal, tallow, or any product containing such, which originated directly from countries identified as having BSE, or from countries having inadequate systems in place to prevent BSE (9 CFR 94.18 and 95.4). The prohibitions include all rendered products of animal origin including poultry meal and fishmeal that are processed in these countries, regardless of species of origin, unless the material is from a non-ruminant species and meets certain conditions assuring no contamination with ruminant material. These prohibitions were deemed necessary by APHIS because of the possibility of cross contamination with the BSE agent. Subsequently, on January 20, 2001, FDA issued Import Alert #99–25, “Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin” (Ref. 5).
On April 25, 2008, FDA published a final rule in the
FDA assesses compliance of the BSE regulations through the Agency's BSE/Ruminant Feed Ban Inspection Program (7371.009) (Ref. 6). This program is designed to assess an animal food facility's operational practices and procedures in preventing the spread of BSE through inspectional observations and sampling.
Section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) provides that a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the FD&C Act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
In May 1965, the Agency issued Current Good Manufacturing Practice for Medicated Feeds, which implemented section 501(a)(2)(B) of the FD&C Act for medicated animal food (30 FR 6475). The purpose of this medicated feed regulation, part 225 (21 CFR part 225), was to establish specific criteria for CGMPs that would ensure the safety, identity, strength, and the quality and purity characteristics of medicated feed. Medicated feed that is not manufactured, processed, packed, or held in conformity with part 225 is adulterated under section 501(a)(2)(B) of the FD&C Act.
The medicated feed CGMPs ensure a pure, safe drug product through requiring specific preventive measures during manufacturing, processing, packing, and holding. In general, the CGMPs in part 225 do not apply to the manufacturing, processing, packing, and holding of non-medicated animal food, even if manufactured in the same facility. However, non-medicated feed would be deemed adulterated under section 402(a)(2)(C)(ii) of the FD&C Act if contaminated with a new animal drug.
FDA regulations that establish animal food labeling standards in part 501 (21 CFR part 501) include requirements for a statement of identity, net quantity statement, manufacturer's name and address, and proper listing of ingredients. In addition, the FDAAA required FDA to issue regulations to update the standards for pet food labeling. These implementing regulations are currently being developed by FDA. Further discussion of FDAAA is presented in section II.B.
GRAS is an acronym for the phrase Generally Recognized as Safe. Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a substance is not a food additive if it is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. A listing of substances that are considered by the Agency to be generally recognized as safe for specific intended uses in animal food is found in 21 CFR parts 582 and 584.
Under section 201(s) of the FD&C Act and 21 CFR 570.30, a substance may be deemed to be GRAS if it is generally
A GRAS substance is not subject to premarket review and approval by FDA. A firm may market a GRAS substance intended for use in animal food based on its own determination that the intended use is GRAS. If the intended use of the substance is not GRAS, the substance and firm marketing it for this use may be subject to enforcement action by FDA.
Although not required to do so, firms that have determined that the intended use of a substance in animal food is GRAS may petition FDA to affirm that a substance is GRAS under certain conditions of use under 21 CFR 570.35(c). Alternatively, they may participate in FDA's GRAS notification pilot program. On June 4, 2010, FDA announced that it would begin a voluntary pilot program for GRAS notifications for substances added to animal food (75 FR 31800). This program is based on an April 17, 1997 proposed rule on GRAS notification (62 FR 18938).
Under section 201(s) of the FD&C Act, a food additive means “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or in the case of a substance used in food prior to January 1, 1958, through scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. . .”. Other substances that are excluded from the definition of a food additive include pesticide chemical residues, pesticide chemicals, color additives, prior sanctioned substances, and new animal drugs.
Many substances added to an animal food are food additives, varying by composition and intended use. A food additive generally provides one or more of the following attributes: nutrition, aroma/flavor, stabilization, emulsification, and preservation. A listing of food additives permitted in animal food, including drinking water for animals, is found in 21 CFR part 573.
To market a food additive, a sponsor must first petition FDA by submitting information that includes all relevant data bearing on the effect the additive is intended to have in or on food and full reports of investigations made with respect to the safety of the food additive. If FDA approves the petition, FDA publishes a regulation prescribing the conditions of use under which the additive may be safely used. The regulations that apply to food additives used in animal foods and that describe the food additive petition process are published in 21 CFR part 571.
A color additive, as defined in 201(t)(1) of the FD&C Act, includes a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source that is capable of imparting color when added or applied to food. The listing of approved human and animal food color additives is found in 21 CFR parts 73 and 74.
A color additive must be shown to be safe and be listed in the Code of Federal Regulations before it may be used to color foods. An interested person may petition FDA for the listing of a color additive, which includes the submission of data demonstrating the color additive is safe and suitable for the proposed use, as described in 21 CFR part 71. The FDA will, upon written request, advise on the adequacy of studies planned to yield these data (21 CFR 70.42(c)).
The Agency's Feed Contaminants Program (FCP) is an animal food sampling and inspection program that addresses most animal food contaminants, including pesticides, industrial chemicals, dioxins, heavy metals, mycotoxins, and pathogens. It does not address drug residues and agents that cause BSE and other transmissible spongiform encephalopathies (TSEs), as those contaminants are tested for under other programs. Under the FCP, FDA conducts random surveillance sample collections and inspections as well as followup investigations when an animal food sample is found to contain violative levels of contaminants.
The contaminants addressed by the FCP can be hazardous to livestock health and production, pet health, and to human health through residues in animal-derived human food. Many of the more frequently identified contaminants in animal food are toxic, carcinogenic, mutagenic, teratogenic, or otherwise deleterious to animals, humans, or both.
Animal food facilities are inspected by FDA and State Agencies. Many of the inspections are performed for FDA by states that have entered into a contract to conduct inspections in accordance with the Agency's procedures. Under State partnership and cooperative agreements, States agree to conduct inspections under their own authorities and to share the results with FDA. Inspections of animal food facilities play an important role in ensuring the safety of the nation's animal food supply.
FDA has issued numerous guidance documents (hereinafter, “guidance” or “guidances”) to assist the animal food industry in implementing food safety regulatory requirements under FDA's jurisdiction. The Agency issues guidances, in accordance with its regulations in § 10.115 (21 CFR 10.115) for “good guidance practices,” to describe its interpretation of or policy on a regulatory issue. Guidances do not establish legally enforceable rights or responsibilities and do not legally bind the public or FDA (§ 10.115(d)(1)). Accordingly, regulated industry is not required to employ the approaches contained in a guidance and instead may choose to use an alternative approach, provided that the alternative approach complies with the relevant statutes and regulations (§ 10.115(d)(2)). Although guidances do not legally bind FDA, they represent the Agency's current thinking on a particular interpretation of or policy regarding a given regulatory issue (§ 10.115(d)(3)). Under § 10.115(c)(1) and (g), FDA publishes a guidance in draft form for public comment before issuing the guidance in final form, except where prior public participation is not feasible or appropriate, if the guidance: (1) Sets forth initial interpretations of statutory or regulatory requirements, (2) sets forth changes in interpretation or policy that are of more than a minor nature; (3) includes complex scientific issues, or (4) covers highly controversial issues.
FDA generally issues guidance to industry for the purpose of communicating the Agency's policy decisions and interpretations of its regulatory requirements so that regulated industry better understands
FDA issues guidance to its staff in the form of a compliance policy guide (CPG). The primary purpose of a CPG is to explain FDA's policy on regulatory issues related to the statutes and regulations that FDA is responsible for implementing. CPGs advise FDA field inspection and compliance personnel as to FDA's standards and procedures to be applied when determining industry compliance with our regulatory requirements. FDA issues CPGs in accordance with its regulation for good guidance practices in § 10.115 and makes the CPGs available to the public, thereby providing regulated industry with additional insight into how the Agency interprets the statutes and regulations it is responsible for implementing for purposes of assessing compliance with the Agency's regulatory requirements. In general, FDA's animal food safety CPGs are relatively focused in scope. For example, the Agency has issued a CPG regarding
On September 27, 2007, the FDAAA (21 U.S.C. 2102) was signed into law (Pub. L. 110–85). Section 1002(a) of Title X (Food Safety) of the FDAAA requires the Secretary of Health and Human Services (HHS), in consultation with relevant stakeholder groups, including the Association of American Feed Control Officials (AAFCO), veterinary medical associations, animal health organizations, and pet food manufacturers, to issue new regulations establishing, among other things, processing standards for pet foods. A public meeting that included representatives for the previously mentioned stakeholders was held May 13, 2008, after publication of a notice in the
Neither the FDAAA, nor its legislative history, described what Congress meant by “processing standards” for pet food. In many instances the same ingredients and manufacturing processes are used to produce animal food for both non-food-producing animals, including pets, and food-producing animals. FDA determined that it would not be feasible to implement or enforce processing standards that only applied to one segment of the industry (i.e., pet food.)
The proposed rule for process control standards that the Agency was developing (see the discussion in section II.A.1) included all animal food. After FDAAA was signed into law, a discussion of FDAAA and the requirements for processing standards for pet food was added to the preamble of the proposed rule for process controls standards to clarify that the proposed rule would satisfy these requirements for pet food. After FSMA was enacted, the Agency decided to issue one rule that would satisfy the mandate of section 1002(a) of FDAAA and section 103 of FSMA.
FSMA was signed into law by the President on January 4, 2011 (Pub. L. 111–353). Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418 (21 U.S.C. 350g) with the same name. Many of the provisions in section 103 of FSMA that are relevant to this rulemaking are codified in section 418 of the FD&C Act.
In addition to those areas specified in section 418(a) of the FD&C Act, sections 418(b) through (i) contain more specific requirements applicable to facilities. These include corrective actions (section 418(e)), verification (section 418(f)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit “[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].” Section X discusses proposed requirements (proposed subpart C) that would implement these provisions of section 418 of the FD&C Act.
Section 103 of FSMA contains two separate rulemaking provisions. Section 103(a) of FSMA requires rulemaking related to the hazard analysis and risk-based preventive controls required by section 418 of the FD&C Act. In addition, section 103(c) of FSMA requires rulemaking in two areas: (1) Clarification of certain aspects of the definition of the term “farm” under section 415 of the FD&C Act (Registration of Food Facilities) and (2) possible exemption from or modification of requirements of section 418 and section 421 of the FD&C Act (21 U.S.C. 350j) (Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report) for certain facilities as the Secretary deems appropriate and as further specified in section 103(c)(1)(D) of FSMA.
Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms “small business” and “very small business,” taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. These terms are significant because section 103 of FSMA contains several provisions specific to such entities.
• Small and very small businesses are subject to modifications or exemptions from requirements under section 418 or 421 of the FD&C Act for facilities engaged only in specific types of on-farm activities and involving foods that the Secretary determines to be low risk (section 103(c)(1)(D) of FSMA).
• Small and very small businesses are not subject to section 418 of the FD&C Act until 6 months (small businesses) or 18 months (very small businesses) after the effective date of FDA's final rule (section 103(i) of FSMA).
• A very small business is deemed a “qualified facility” and would, therefore, qualify for the exemptions as discussed in section VIII.C.1. (section 418(l)(1)(B) of the FD&C Act).
Consistent with section 418(l)(5) of the FD&C Act, FDA has consulted with the USDA during its study of the food processing sector. The study is available in the docket established for this proposed rule (Ref. 16). The Agency requests comment on that study. Section VIII.B discusses the proposed definitions for small business and very small business for animal food facilities. FDA will consider comments regarding the study, as well as comments regarding the proposed definitions for small and very small business, in any final rule based on this proposed rule.
The requirement in section 415 of the FD&C Act that a facility must register does not apply to farms. FDA's implementing regulations for section 415 (21 CFR part 1, subpart H; later in this document stated as the section 415 registration regulations) define “farm,” in relevant part, as “a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both” (§ 1.227(b)(3)) (21 CFR 1.227(b)(3)).
The term “farm” includes a facility that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(i)). Under that same definition, the term “farm” also includes a facility that manufactures/processes food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership (§ 1.227(b)(3)(ii)).
Section 103(c)(1)(A) of FSMA requires that not later than 9 months after the date of enactment, the Secretary publish a notice of proposed rulemaking in the
• “Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and
• Specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.”
As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing, or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk (section 103(c)(1)(D)(i) of FSMA). Any exemption or modification is limited to small and very small businesses (section 103(c)(1)(D)(ii) of FSMA).
Section VII discusses the Agency's approach to the requirement in FSMA section 103(c) for a science-based risk analysis of the types of on-farm manufacturing, processing, packing, or holding operations that can involve animal food that is not consumed on that farm or on another farm under common ownership for purposes of section 415 of the FD&C Act and request comment on that approach. The final approach will consider comments received to this proposed rule.
Section VIII.C discusses proposed exemptions for small and very small businesses that are solely engaged in certain types of “low risk” activities involving the on-farm manufacturing, processing, packing, and holding of certain “low risk” animal foods from the requirements of section 418 of the FD&C Act (proposed § 507.5(e) and (f)). The Agency also discusses its tentative conclusion that it should not exempt or modify the frequency requirements under section 421 based solely upon whether a facility only engages in such low-risk activity/food combinations and is a small or very small business.
Section 418(m) of the FD&C Act also authorizes the Secretary to exempt or modify the requirements for compliance with section 418 for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment. Section VIII.E describes the proposal for how the requirements of proposed part 507 would apply to such facilities that store animal food (proposed § 507.10). Section X.I discusses the proposed modified requirements for such facilities, directed at the storage of packaged animal foods that are not exposed to the environment and that require time/temperature control to limit the growth of, or toxin formation by, microorganisms of animal and human health significance (proposed § 507.48).
FDA proposes to implement section 103 of FSMA in several regulations, rather than a single regulation that covers all food and hazards subject to preventive controls. This proposal is applicable to certain hazards that may be associated with a food facility that manufactures, processes, packs or holds animal food. Section 103 of FSMA applies to “food,” which is not limited to human food. Section 201(f) of the FD&C Act defines “food” to include “articles used for food or drink for man or other animals.” FDA tentatively concludes that the differences between human and animal food are best addressed through separate rulemakings. Section 418(m) of the FD&C Act authorizes the Secretary, by regulation, to modify the requirements for compliance under the section with respect to facilities that are engaged solely in the production of food for animals other than man. The Agency has tentatively concluded that the requirements of section 418 of the FD&C Act are needed to ensure the safety of animal food and in turn the health of animals, the health of humans who are exposed to animal food, and the safety of animal derived products for human consumption. Therefore, the Agency is proposing requirements to implement section 418 of the FD&C Act for animal food with only few modifications (e.g., no allergen controls.) The Agency requests comment on whether the requirements in section 418 of the FD&C Act should be modified further for facilities that are solely engaged in the production of food for animals other than man, based on scientific and public health principles.
HACCP is a preventive strategy for food safety that involves a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of hazards from a particular food or food production process or practice and the control of those hazards. FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA. For a full discussion of HACCP and preventive controls systems comparisons, please see section II.C of the document for the proposed rule for the preventive controls for human food (78 FR 3646).
Historically, the Agency has focused on specific animal food safety issues as problems arise, typically after the distribution of the contaminated animal food. Examples include safety issues related to BSE, chronic wasting disease, mycotoxins (especially aflatoxin in animal food intended for lactating dairy cattle), dioxins, melamine, and microbial contamination in pet foods.
The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid (chemicals called triazines) in 2007 is a prime example. The actions taken by two protein suppliers in China to intentionally adulterate wheat gluten and rice protein concentrate for economic reasons affected a large number of pet food facilities in the United States and created a nationwide problem by causing illness and death in many dogs and cats. The addition of melamine to wheat gluten and rice protein concentrate resulted in a high nitrogen reading during Kjeldahl testing, a test method used to estimate protein levels in foods. By adding the melamine, a non-protein source of nitrogen, the suppliers created a falsely high estimate of protein in their products. While melamine by itself is relatively non-toxic to mammals, the melamine used to adulterate the wheat gluten and rice protein concentrate in this incident had been combined with cyanuric acid, creating a mixture that became toxic. The presence of cyanuric acid with melamine resulted in a precipitation of crystals (melamine cyanurate) when mixed in a solution (Ref. 17). When the animals ingested the adulterated food, the mix of these two chemicals was absorbed into the blood stream and ultimately created an accumulation of crystals in the tubules of the animals' kidneys, leading to kidney disease and death in many animals.
By the time the cause of the illness and deaths was identified, melamine and cyanuric acid contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Checks to ensure the safety of the imported ingredients had not been conducted by the importer or by the pet food manufacturers that incorporated the ingredients into pet food.
During the investigation, FDA determined that leftovers from the production of pet food (commonly called fines) and salvaged, finished pet food products were routinely used in the production of feed for some food-producing animals (e.g., swine and poultry). It was ultimately discovered that some of these fines and salvaged pet food were adulterated with melamine (and other triazine analogs). Urine from swine (that were being raised for human food consumption) that had eaten this contaminated food was tested and found to contain melamine. This discovery resulted in the holding of animals before their marketing for human food in order to provide time for the U.S. government to conduct a risk assessment to ensure the safety of the meat for human consumption. It was ultimately determined there was no risk to human health from eating meat from these animals due to the small amounts of contaminants in the animal feed eaten.
The contaminated wheat gluten was also used in the manufacture of fish food used in fish hatcheries for food-producing fish. As a result, there was a recall of the affected fish food. These situations with food-producing animals emphasized the link between adulterated animal food (and ingredients) and the potential for adverse effects on human health.
The melamine incident underscored the difficulty in tracing an adulterated ingredient that has been used in a large number of food products. The list of recalled animal foods was constantly updated for multiple weeks after the initial identification of the adulterated ingredients as the distribution of those ingredients was traced. Pet food companies who thought their pet foods were safe because their formulations did not included the use of wheat gluten or rice protein concentrate were surprised to find some of their products were indeed adulterated with the melamine and cyanuric acid. An FDA investigation revealed that a contracted pet food manufacturer was substituting rice protein concentrate for other sources of protein called for in these formulations without contacting the parent company.
Additional incidents of animal food contamination not discovered until after the food was distributed include the detection of dioxin in feed. Dioxin has been linked to adverse health effects in humans, such as cancer, immune suppression, and reproductive or developmental effects. Dioxin is a concern in food-producing animals because human dioxin exposure in the United States comes primarily from the consumption of animal products. In 1997, the USDA's Food Safety and Inspection Service, through their dioxin sampling survey, identified dioxins in poultry tissue. Through a multi-agency investigation, the FDA traced this contamination to high levels of dioxins present in an anti-caking agent (ball clay) used in animal food. That same year, FDA issued a statement to users of ball clay products in animal feed requesting those companies to cease the use of ball clay products in animal feeds and feed ingredients (Ref. 18). In 2002, a foreign government identified high dioxin levels in a mineral product intended for animal food imported from the United States (Ref. 19). The source of the dioxin was related to the high temperature used in the mineral manufacturing process. In 2003, another dioxin incident in minerals was identified as a result of an FDA food sampling assignment. In this case, the mineral premix manufacturer purchased a trace mineral that was a by-product of a metal smelting process (Ref. 20). Internationally, in 1999, animal feed contaminated with dioxin and polychlorinated biphenyls in Belgium resulted in animal and human exposure in Europe. The Belgium government estimated the economic impact of the dioxin crisis cost $493 million, of which $106 million was lost in the swine industry alone. The total cost is much greater when factoring in the impact that occurred to the animal and human food industries in European countries that imported contaminated animal food (livestock feed) or human food from Belgium (Ref. 21). In 2009, a dioxin incident occurred in Ireland involving swine feed that resulted in a global recall of Irish pork. This incident resulted in the Irish government providing € 200 million ($266 million) compensation packages for the Irish pork industry due to their economic losses (Ref. 22). These incidents raised public awareness of the problem of dioxin contamination in animal food.
Another animal food contaminant that can cause illness and injury to animals and humans is aflatoxin. Aflatoxins are naturally occurring mycotoxins that are produced by many species of the fungus
Microbial contamination of animal food is also a high concern for the Agency, not only for animals consuming the contaminated food, but also for humans that handle that contaminated animal food. In 2007, FDA identified S. Schwarzengrund, a rare serotype of
In 2010, the CDC notified FDA of an outbreak of salmonellosis (
In June of 2008, following an inspection, FDA initiated a mass seizure of animal food at a pet food distribution center after finding the animal food products were vulnerable to contamination, such as microbial contamination, as a result of infestation of the facility by rodents, birds and other pests. Rodent pellets, rodent urine stains, and bird droppings were found throughout the facility, including on bags and pouches of pet food. Rodents had chewed holes in some of the bags of dry dog and cat food and bird seed. The facility was not taking measures to control pest infestation.
Another mass seizure of animal food was executed in August of 2009 at a feed mill because of similar violations. In both cases, the seized products violated section 402(a)(4) of the FD&C Act because the animal food was being held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
In April 2012, epidemiologic and laboratory investigations conducted by officials in local, state, and federal public health, agriculture, and regulatory agencies linked a
These examples demonstrate that the safe production and distribution of animal food and ingredients, along with safe meat, milk, and eggs derived from animals that consume this food is an important public health concern, both domestically and globally. The Agency needs to assure the consumer, both here and abroad, that it has a regulatory system designed to ensure production of safe animal food in the United States. Requiring facilities to manufacture, process, pack, or hold animal food under these proposed CGMPs and proposed preventive controls program would help provide that assurance. In addition, the U.S. Government, the animal food industry, animal producers, pet owners and consumers need to have assurance that animal food imported into the United States is safe.
FDA monitors adverse food events through various means, such as FDA's Reportable Food Registry, FDA's Pet Food Early Warning Surveillance System, consumer complaints, tracking industry recalls and FDA and State inspection findings. From fiscal year (October through September) 2006 through 2012, there were 2,277 animal food product recalls. In 2007 alone, 1,054 animal food products were recalled due to contamination with melamine. Reasons for other animal food recalls include contamination with aflatoxins, dioxins,
For calendar years 2008 through 2012, over 2,500 consumer complaints were called into FDA's district offices regarding animal food for pets and livestock. The complaints ranged from animals refusing to eat their food to animal illness and deaths associated with consumption of an animal food. During the melamine contamination incident in 2007, FDA received over 13,000 consumer complaints about pet food, and over 18,000 calls. Many of these consumer complaints were associated with recalled pet food products contaminated with melamine and cyanuric acid (a contamination that was linked by laboratory testing to illness and deaths in animals as discussed in section II.E.1).
In September of 2009, the Agency established the Reportable Food Registry (RFR), where manufacturers, processors, packers, and holders of human or animal food are required to report to the Agency if there is reasonable probability that an article of
In May, 2010, the Agency implemented the Safety Reporting Portal, where consumers can submit complaints regarding adverse events in animals associated with the consumption of pet food products. From May 2010 through September 2012 the Agency received over 2,900 consumer complaints for pet food through the Safety Reporting Portal and all were reviewed and evaluated by FDA.
The safety of food is principally ensured by the effective implementation of scientifically valid preventive control measures throughout the food chain (Refs. 29 and 30). Prevention of hazards in animal food is much more effective than trying to differentiate safe from unsafe food using testing. Although testing is rarely considered a control measure, it plays a very important role in ensuring the safety of food. An important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard (Refs. 31 and 32). Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan. As discussed in the Appendix to this document (see sections I.C, I.E, and I.F of the Appendix), microbial testing may include:
• Testing raw materials and ingredients to verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients;
• Testing the environment to verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate animal food; and
• Testing finished product to verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the animal food.
Each type of testing provides information applicable to managing hazards in animal foods, depending on the animal food and process. The Agency discusses the role of testing as a verification measure in a food safety system in section I of the Appendix to this document.
An animal food can become contaminated through the use of contaminated raw materials or ingredients as evident by the large recall of pet food because of contamination of wheat gluten with melamine (see discussion in section II.E.1). The development of a supplier approval and verification program is part of a preventive approach. Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. Using a preventive approach, a facility receiving raw materials or ingredients from a supplier can help ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.
A supplier approval and verification program is a means of ensuring that raw materials and ingredients are procured from those suppliers that can meet facility specifications and have appropriate programs in place, including those related to the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program is essential to provide initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients. The Agency discusses supplier approval and verification programs in more detail in section II of the Appendix to this document.
On April 20, 2011, FDA held a public meeting entitled “FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities” (notice of the meeting published in the
This proposed rule would apply to animal facilities required to register with FDA under section 415 of the FD&C Act, unless subject to an exemption. This would include manufacturing, processing, packing, and holding of finished products that are intended to be fed to animals, including livestock, pets, and other captive animals, as well as the manufacturing, processing, packing, and holding of ingredients that may be used in animal foods. Some industry sectors, such as renderers and grain and oilseed processors, have long been considered animal food manufacturers and would be subject to the proposed rule. In addition, industry sectors that are newer, such as biofuel manufacturing (suppliers of distillers grain for animal food), or other entities that may not have been thought of as animal food manufacturers in the past, such as mineral refining and manufacturing, would be subject to the proposed rule to the extent that they are engaged in manufacturing, processing, packing, or holding of animal food.
This proposed rule would not apply to farms. For example, farms manufacturing, processing, packing, and
In complying with the Hazard Analysis and Risk-Based Preventive Controls section of the proposed rule (subpart C), facilities that manufacture, process, pack, or hold animal food for a single species of animal would focus on hazards most likely to be associated with the ingredients they use, as well as hazards most likely to occur during manufacturing, processing, packing, or holding at the facility, relevant to that species of animal. Facilities that manufacture, process, pack, or hold an ingredient would focus on reducing hazards associated with the ingredient and those species of animal that may consume animal food containing that ingredient. Facilities that manufacture, process, pack, or hold animal food for a range of species or variety of uses would need to consider a more diverse number and type of hazards. In addition to focusing on hazards associated with their incoming ingredients or the types of equipment they use, a feed mill that manufactures food for multiple species would need to be aware of nutritional sensitivities of the animals for which it makes food. For example, a manufacturer that makes food for swine, which can tolerate a relatively large amount of copper in their diet, and food for sheep, which are very sensitive to copper, would need to adopt controls that would ensure that the sheep food it does not contains levels of copper that are unsafe for sheep.
Pet foods usually contain ingredients from the same sources used to make food for livestock and pet foods are sometimes manufactured in the same facilities as food for livestock. For these reasons the Agency has not proposed different rules for these different types of facilities. However, the hazards associated with pet food may be significantly different from the risks associated with food for livestock, and the facility manufacturing, processing, packing, or holding would need to identify and address these hazards. Pet foods usually come into the home, so in addition to being safe for pets to eat, they also would need to be safe for the pet owner to handle. For example, pet foods and treats have been known to carry
The proposed rule would establish part 507 and contains regulations regarding the manufacturing, processing, packing, or holding of animal food. The proposed rule would establish new provisions for CGMPs for animal food and ingredients, and it would establish new provisions for risk-based preventive controls.
Under the proposed rule, part 507 would be divided into the following subparts:
• Subpart A—General Provisions;
• Subpart B—Current Good Manufacturing Practice;
• Subpart C—Hazard Analysis and Risk-Based Preventive Controls;
• Subpart D—Withdrawal of an Exemption Applicable to a Qualified Facility;
• Subpart E is Reserved; and
• Subpart F—Requirements Applying to Records That Must Be Established and Maintained.
The proposed rule would establish general provisions under subpart A of part 507. These provisions include the applicability and status, definitions, specified exemptions for certain facilities from the requirements of proposed subpart C (hazard analysis and risk-based preventive controls), and specified exemptions for certain establishments from the requirements from subpart B (current good manufacturing practice). The proposed exemptions from subpart C would be consistent with the requirements established by FSMA or the discretion provided by FSMA. The subjects of the specified exemptions relate to:
• Animal food establishments that do not have to register under section 415 of the FD&C Act;
• Activities subject to existing Agency regulations governing microbiological hazards for low acid canned animal foods;
• Activities subject to the Standards for Produce Safety in section 419 of the FD&C Act;
• A “qualified” facility;
• Certain low-risk packing or holding activity/animal food combinations conducted on a farm by a small or very small business;
• Certain low-risk manufacturing/processing activity/animal food combinations conducted on a farm by a small or very small business;
• Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing;
• Facilities that are solely engaged in the holding or transportation of RACs; and
• Facilities solely engaged in the storage of packaged animal food that is not exposed to the environment, although the storage of such food that requires time/temperature control to prevent the growth of, or toxin formation by, pathogenic microorganisms would be subject to modified requirements that would be established in proposed subpart C.
Proposed subpart A would also implement certain provisions in sections 418(l) and (m) of the FD&C Act for modified requirements with respect to implementing the modified requirements specified in section 418(l) of the FD&C Act for facilities that satisfy the statutory criteria for a “qualified facility.” The Agency proposes to establish requirements that include:
• Submission to FDA of documentation that the facility is a qualified facility; and
• Submission to FDA of documentation demonstrating that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or
• Submission to FDA of documentation that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries.
Proposed subpart B would establish general baseline good manufacturing practices for facilities manufacturing, processing, packing, and holding animal food. These provisions would include specific requirements for:
• Personnel in animal food facilities such as following good hygiene practices, and protection of food from contamination from personal effects;
• The plant and grounds including proper cleaning, maintenance, and elimination of pests;
• Sanitary operations including maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests;
• Sanitary facilities and controls such as the plant's water supply, plumbing, and toilet and hand-washing facilities;
• Equipment and utensils including the cleaning and maintenance of such items and protecting animal food from contamination;
• Processes and controls including following adequate sanitation principles, proper labeling of ingredients and finished animal food, ensuring the safety of raw materials, and prevention of contamination of animal food during processing; and
• Warehousing and distribution to protect animal food against contamination and deterioration.
The Agency proposes to require that the owner, operator, or agent in charge of a facility have and implement a written food safety plan that includes as applicable:
• A hazard analysis;
• Preventive controls;
• Monitoring procedures;
• Corrective Action procedures;
• Verification procedures; and
• A recall plan.
The Agency proposes to require that the written hazard analysis identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards. The hazard analysis would include an evaluation of the identified hazards to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.
The Agency proposes to require that the owner, operator, or agent in charge of a facility identify and implement preventive controls (including at critical control points, if any) to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented and that the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act. The preventive controls would include, as appropriate:
• Parameters associated with the control of the hazard and the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur;
• Process controls;
• Sanitation controls;
• A recall plan; and
• Any other necessary controls.
The Agency proposes to require that the written recall plan be developed for animal food with hazards that are reasonably likely to occur.
The Agency proposes to require the monitoring of the preventive controls to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.
The Agency proposes to require that facilities establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.
The Agency proposes to require that facilities conduct certain verification activities, including:
• Validation of a subset of the preventive controls;
• Verification that monitoring is being conducted;
• Verification that appropriate decisions about corrective actions are being made; and
• Verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur.
The Agency also proposes to require reanalysis of the food safety plan at least once every 3 years and more often when circumstances warrant.
Acting on the discretion provided to FDA by section 418(m) of the FD&C Act, the Agency proposes to require that the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment conduct certain activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance, including:
• Establishing and implementing temperature controls;
• Monitoring the temperature controls;
• Taking appropriate corrective actions when there is a problem with temperature controls;
• Verifying that temperature controls are consistently implemented; and
• Establishing and maintaining the following records:
• Records documenting the monitoring of temperature controls;
• Records of corrective actions; and
• Records documenting verification activities.
The Agency requests comments on these proposed requirements.
The Agency proposes to establish qualification requirements for a “qualified individual,” who would be required to do or oversee the preparation of the food safety plan, validation of preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the reanalysis of a food safety plan. A “qualified individual” would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
The Agency proposes to establish a list of records that would be required under proposed subpart C, including the written food safety plan and records documenting monitoring of preventive controls, corrective actions, verification,
Proposed subpart D would implement the provisions of section 418(l)(3) of the FD&C Act and establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption.
Proposed subpart F would establish requirements that would apply to all records that would be required by the various proposed provisions of proposed part 507, including:
• General requirements related to the content and form of records;
• Additional requirements specific to the food safety plan;
• Requirements for record retention;
• Requirements for official review of records by FDA; and
• Public disclosure.
Section 103(i)(1) of FSMA, General Rule, provides that “[t]he amendments made by this section shall take effect 18 months after the date of enactment” (i.e., by July 4, 2012). Section 103(i)(2) of FSMA, Flexibility for Small Businesses, provides that “[n]otwithstanding paragraph (1),” the amendments made by this section “shall apply” to a small business and very small business beginning on the dates that are 6 months and 18 months, respectively, “after the effective date” of FDA's final regulation.
FDA is implementing the amendments made by section 103 to the FD&C Act through this rulemaking for animal food (except as they relate to intentional contamination). FDA tentatively concludes that it is appropriate to provide a sufficient time period following publication of the final regulation for facilities to come into compliance. The final regulation will contain provisions that affect which facilities are subject to section 418 and which provisions apply to particular facilities. Without these provisions of the regulation in effect, facilities would be uncertain as to the applicability of certain requirements to them. Further, FDA tentatively concludes that compliance with section 418 will be facilitated greatly by the detail and explanation that will be provided by the final regulation.
Most animal food facilities have not been subject to CGMPs and no animal food facility has been subject to preventive controls as put forth in this proposed rule. However, individual animal food facilities, either individually or through feed industry associations have implemented SOPs that are likely to be sufficient to satisfy some of the proposed requirements. The Agency tentatively concludes that the concepts in the proposed CGMPs will not be new to the animal food industry. Still, the Agency expects that the majority of facilities will need to make substantial changes if the proposed regulations are adopted. FDA recognizes that it can take time to implement a food safety system for animal food that would require among other things, CGMPs, performance of a hazard analysis, development of preventive controls, and monitoring of preventive controls.
FDA is proposing that the final rule would be effective 60 days after publication in the
Section 103(c)(1)(A) of FSMA requires the Secretary to “publish a notice of proposed rulemaking in the
A discussion of the Agency's clarification of the treatment of activities that are included as part of the definition of the term “facility” in section 415 as well as proposed changes to definitions in the section 415 registration regulations can be found in section VIII of the document for the proposed rule for preventive controls for human food (78 FR 3646).
Section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover “(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.” Section VII.B describes a draft Qualitative Risk Assessment (the section 103(c)(1)(C) draft RA) (Ref. 33) the Agency performed to satisfy this requirement.
Section 103(c)(1)(D)(i) of FSMA requires that, as part of the section 103(c) rulemaking, “the Secretary shall consider the results of the science-based risk analysis . . . and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by [section 103 of FSMA]) including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201 [of FSMA]), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.” Section 103(c)(1)(D)(ii) of FSMA provides that the exemptions or modifications described in section 103(c)(1)(D)(i) “shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by [FSMA], if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act.” Section VII.C discusses the results of the section 103(c)(1)(C) draft RA. In section VII.D, the Agency sets forth its tentative conclusions regarding combinations of on-farm manufacturing, processing, packing, and holding activities and animal foods determined to be low risk, considering the results of the section 103(c)(1)(C) draft RA. In section VII.E, the Agency discusses a proposed approach to using the results of the section 103(c)(1)(C) draft RA for the purposes of section 421 of the FD&C Act. Section VIII.C. discusses the Agency's proposal to exempt low-risk combinations of activities and animal foods from the requirements of section 418 of the FD&C Act when performed by farm mixed-type facilities that are small or very small businesses as would be defined in proposed § 507.3.
For a complete discussion of FSMA section 103(c) and on-farm activities, please refer to section VIII.B through VIII.D of the document for the proposed rule for preventive controls for human food (78 FR 3646).
As discussed in section VII.A, section 103(c)(1)(C) of FSMA directs the Secretary to conduct a science-based risk analysis as part of the section 103(c) rulemaking. The science-based risk analysis is to cover “(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.”
As used in section 103(c)(1) of FSMA, the term “risk analysis” is ambiguous. One interpretation is that the common meaning of the term is intended—a simple evaluation of whether activity/animal food combinations are likely to result in the consumer (animals in relation to food for animals) becoming ill. Another interpretation is that the “risk analysis” should be consistent with the formal definition and related terms used by Codex with respect to food safety (Ref. 34):
• Risk is a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
• Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication.
• Risk assessment is a scientifically-based process consisting of hazard identification, hazard characterization, exposure assessment, and risk characterization.
• Risk management is the process, distinct from risk assessment, of weighing policy alternatives, in consultation with interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.
• Risk communication is the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.
Because section 103(c)(1)(C) of FSMA calls for a science-based risk analysis, the Agency is applying the Codex definitions to the extent possible. It is not clear whether the requirement of section 103(c)(1)(C) of FSMA to conduct a science-based risk analysis was intended to encompass all three components of risk analysis. Section 103(c)(1)(D) of FSMA requires the Secretary to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in section 418 of the FD&C Act, including hazard analysis and preventive controls, and the mandatory inspection frequency of section 421, or to modify those requirements for facilities engaged in on-farm manufacturing, processing, packing, or holding activities determined to be low risk involving animal foods determined to be low risk. Thus, section 103(c)(1)(D) of FSMA is focused on ensuring that the Agency's risk management decisions with respect to exempting or modifying requirements applicable to low-risk on-farm activity/animal food combinations under sections 418 and 421 are science-based, as determined by an analysis of the risk of specific types of on-farm activity/animal food combinations required by section 103(c)(1)(C). The Agency therefore tentatively concludes that the analysis required by section 103(c)(1)(C) should be limited to an assessment of the risk of specific types of on-farm activity/animal food combinations for the purposes of making the risk management decisions required by section 103(c)(1)(D). The risk communication component of the risk analysis is accomplished through the discussion of that assessment in this document, the opportunities for public comment (on the risk assessment and on this proposed rule), and the Agency's evaluation of, and response to, comments in a final rule.
Consistent with this approach, the Agency conducted a qualitative risk assessment (Ref. 33) (“section 103(C)(1)(C) draft RA”) related to activity/animal food combinations for the purpose of determining which activity/animal food combinations would be considered low risk. The Agency focused on activity/animal food combinations that were identified as being conducted on farms (and, thus, might be conducted by farm mixed-type facilities), but the Agency did not consider activity/animal food combinations that would be solely within the farm definition (such as the growing and harvesting of crops) and, thus, are not relevant to the requirements of section 103 of FSMA. The Agency focused on considering the risk of activity/animal food
Elsewhere in this issue of the
In this section, the Agency reports the results of the section 103(C)(1)(C) draft RA, arranged in three lists. References to “farms” in these lists should be understood to include farm mixed-type facilities. The lists are shaped by the proposed definitions for harvesting, manufacturing/processing, packing, or holding in the section 415 registration regulations (discussed in section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646), the organizing principles (discussed in section VIII.D of the document for the proposed rule for preventive controls for human food) that form the basis for those proposed definitions, and the examples of activity classifications. As discussed in section VIII.E of the document for the proposed rule for preventive controls for human food, the same activity may be classified differently (among the categories of harvesting, manufacturing/processing, packing, or holding) depending on whether the animal food being operated upon is a RAC and whether the RAC was grown or raised on the farm or farm mixed-type facility performing the activity or a farm under the same ownership and whether the animal food is consumed on the farm that produced it or another farm under the same ownership. The Agency requests comment on the lists in sections VII.C.1, VII.C.2, and VII.C.3.
For purposes of this document, grains are the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are grown and processed for use as meal, flour, baked goods, and cereals (including cereal grains, pseudo cereals, pulses, and other plants used in the same fashion) to be used in animal food. Examples of animal food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, and buckwheat. Oilseeds are the small, hard fruits or seeds of arable crops that are grown and processed mainly for the oil that is extracted from them. Examples of animal food oilseeds include soybean, cottonseed, and rapeseed. Grains and oilseeds are field-dried before harvest. Post-harvest drying or dehydrating that further reduces the moisture content of harvested grains and oilseeds for the purpose of storage or transportation is considered an activity separate from field drying done before harvest. In the lists that follow, the terms grain and oilseed are used in a general sense while the terms dried grain and dried oilseed are used to designate specifically those harvested grains and oilseeds that have been further dried or dehydrated for the purpose of storage or transportation.
The section 103(c)(1)(C) draft RA identified the following low-risk packing and holding activity/animal food combinations when conducted on a farm on animal food not grown, raised, or consumed on that farm or another farm under the same ownership:
• Conveying, weighing, sorting, culling, or grading (incidental to storing):
• Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
• Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, sunflower);
• Grain or oilseed byproducts;
• Forage (e.g., hay or ensiled material); or
• Other plants or plant byproducts (e.g., almond, peanut or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
• Storing:
• Dried grain;
• Dried oilseed;
• Byproducts of dried grain or dried oilseed;
• Forage; or
• Other plants or plant byproducts.
• Packing:
• Grain;
• Oilseed;
• Grain or oilseed byproducts;
• Forage; or
• Other plants or plant byproducts.
• Mixing (incidental to packing or storing):
• Grain, whole; or
• Forage.
The Agency notes that the same activities performed on a farm's own RACs, or animal food consumed on the farm or another farm under the same ownership, would be within the farm definition and therefore were outside the scope of the section 103(c)(1)(C) draft RA.
The section 103(c)(1)(C) draft RA identified the following low-risk manufacturing/processing activity/animal food combinations when conducted on a farm on the farm's own RACs distribution into commerce:
• Cracking, crimping, or flaking:
• Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
• Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower) ; or
• Grain or oilseed byproducts.
• Crushing, grinding, milling, pulverizing, or dry rolling:
• Grain;
• Oilseed;
• Grain or oilseed byproducts;
• Forage (e.g., hay or ensiled material); or
• Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
• Making silage
• Chopping, or shredding hay.
• Extracting (mechanical) or wet rolling:
• Grain; or
• Oilseed.
The section 103(c)(1)(C) draft RA identified the following low-risk manufacturing/processing activity/animal food combinations when conducted on animal food other than the farm's own RACs for distribution into commerce:
• Cracking, crimping, flaking, or shelling:
• Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
• Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower) ; or
• Grain or oilseed byproducts.
• Crushing, grinding, milling, pulverizing, or dry rolling:
• Grain;
• Oilseed;
• Grain or oilseed byproducts;
• Forage (e.g., hay or ensiled material); or
• Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
• Making silage.
• Chopping or shredding hay.
• Extracting (mechanical) or wet rolling:
• Grain; or
• Oilseed.
• Labeling:
• Grain, whole;
• Oilseed, whole;
• Sifting, separating, or sizing:
• Grain;
• Oilseed;
• Grain or oilseed byproducts; or
• Other plants or plant byproducts.
Based on the results of the section 103(c)(1)(C) draft RA regarding on-farm low-risk activity/animal food combinations, the Agency is proposing in § 507.5(e) and (f) to exempt farm mixed-type facilities that are small or very small businesses (as defined in proposed § 507.3) from requirements under section 418 of the FD&C Act if the only activities subject to section 418 that the business conducts are low-risk activity/animal food combinations (see the discussion of these proposed exemptions in section VIII.C). The proposed exemptions would not exempt eligible facilities from the requirement to register under section 415 of the FD&C Act.
The Agency tentatively concludes that it should consider the low-risk on-farm activity/animal food combinations identified in the section 103(c)(1)(C) draft RA as a factor in identifying high-risk facilities that are small and very small businesses and allocating inspection resources under section 421 of the FD&C Act, Targeting of Inspectional Resources for Domestic Facilities. However, at this time, the Agency tentatively concludes that it should not exempt or modify the frequency requirements under section 421 based solely upon whether a facility only engages in such low-risk activity/animal food combinations and is a small or very small business. Current data limitations impact the Agency's ability to accurately identify such facilities, and it must be able to identify such facilities in order to implement an exempted or modified inspection frequency schedule. The Agency requests comment on whether it should establish data submission requirements that would allow the Agency to identify these types of facilities in order to exempt such facilities from the inspection frequencies, or modify the inspection frequencies that apply to such facilities, under section 421 of the FD&C Act. Examples of data elements that the Agency might need in order to identify these facilities include: Identification of a facility as a farm mixed-type facility, annual monetary value of sales, number of employees, animal food category/activity type. The Agency also requests comment on these possible data elements and any other criteria that may be appropriate for the purposes of allocating inspection resources to these facilities.
FDA is proposing in § 507.1(a) that the criteria and definitions in part 507 apply in determining whether an animal food is adulterated: (1) Within the meaning of section 402(a)(3) of the FD&C Act in that the animal food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the FD&C Act in that the animal food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Proposed § 507.1(a) also would establish that the criteria and definitions in part 507 apply in determining whether an animal food is in violation of section 361 of the Public Health Service Act (the PHS Act) (42 U.S.C. 264). The Agency notes that section 418(a) of the FD&C Act provides that facilities subject to that section must “identify and implement preventive controls to . . . provide assurances that . . . food is not adulterated under section 402 [of the FD&C Act]” and that similar references to preventing adulteration under section 402 of the FD&C Act also appear in section 418(c) and (e). The Agency tentatively concludes that the link between the proposed provisions and the potential for adulteration provides a basis for applying the criteria and definitions in proposed part 507 in determining whether, under particular circumstances, an animal food is adulterated under section 402(a)(3) or (a)(4) or in violation of section 361 of the PHS Act.
Section 103(e) of FSMA amends section 301 of the FD&C Act by adding a new section—(uu)—to the list of acts and the causing thereof that are prohibited. Under section 301(uu), the following act, and the causing thereof, is prohibited:”[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].” To clearly communicate that failure to comply with regulations established under section 418 is a prohibited act, proposed § 507.1(b) would establish that the operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the FD&C Act or the regulations implementing section 418 [of the FD&C Act] in subparts C, D, or F of proposed part 507, and § 507.7 of proposed part 507, is a prohibited act under section 301(uu) of the FD&C Act.
Proposed § 507.1(c) would establish that animal food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations. FDA has established CGMP requirements for thermally processed low-acid foods packaged in hermetically sealed containers (proposed rule, 41 FR 30444, July 23, 1976; final rule, 44 FR 16209, March 16, 1979; currently established in part 113; and 61 FR 37681, July 19, 1996; currently established in § 500.23). Therefore, animal foods that are subject to 21 CFR 500.23 and part 113 are subject to the requirements of § 500.23 and part 113 even though they are foods covered by the current good manufacturing practice requirements of proposed part 507.
Proposed § 507.1(d) would apply to facilities that manufacture, process, pack, or hold animal food and human food. The Agency wanted to address the instances where a facility may handle both animal and human food in some form, to make it clear which proposed rule would apply for that facility manufacturing, processing, packing, or holding these foods. In addition, in some facilities, “waste” from human
FDA requests comment on the applicability of the requirements of this proposed rule to FSIS official establishments that manufacture, process, pack, or hold food for animals. And, if applicable, to what extent should the requirements apply to these establishments?
In developing the following proposed definitions, FDA aimed to be consistent with proposed part 117 of the proposed rule for preventive controls for human food (see the document for the proposed rule for preventive controls for human food (78 FR 3646)). The Agency also considered how these currently existing and proposed definitions should be clarified for use in the animal food context.
The Agency is proposing in § 507.3 that the terms defined in section 201 of the FD&C Act would be applicable to such terms when used in this part, unless otherwise specified. Additional terms are listed, defined, and discussed in alphabetical order in this section. These definitions are based on the Agency's experience in regulating human food, animal food, common usage in the animal food industry, and definitions in section 418 of the FD&C Act.
Proposed § 507.3 defines “adequate” as that which is needed to accomplish the intended purpose in keeping with good public health practice.
FDA is proposing to define the term “affiliate” as it is defined in section 418(l)(4)(A) of the FD&C Act to mean any facility that controls, is controlled by, or is under common control with another facility. This term relates to the determination of whether a facility meets the definition of a qualified facility.
Proposed § 507.3 defines “animal food” as food for animals other than man, and includes pet food, feed, and raw materials and ingredients. When used in this part, the phrase “animal food” does not refer to food derived from animals that is intended for human consumption.
Proposed § 507.3 defines “batter” to mean a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.
Proposed § 507.3 defines “blanching” to mean, except for tree nuts and peanuts, a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.
Proposed § 507.3 defines “calendar day” to mean every day shown on the calendar.
Proposed § 507.3 defines “critical control point (CCP)” as a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
The Agency is proposing to define the term “environmental pathogen” to mean a microorganism that is of animal or human health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment.
FDA is proposing to define the term “facility” as it is defined in section 418(o)(2) of the FD&C Act to mean a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act, in accordance with part 1, subpart H. FDA tentatively concludes that the definition of facility should include a reference to the regulation that implements section 415 of the FD&C Act and proposed to update the definition in § 1.227 in section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646). The regulation implementing section 415 of the FD&C Act provides important details to help firms determine whether they are required to register.
The Agency is proposing to cross-reference the definition of “farm” rather than to define it in proposed part 507 because the definition of “farm,” under both current § 1.227(b)(3) and proposed § 1.227 (found in section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646)) includes the word “facility” with a meaning that is broader than the meaning of “facility” in section 418(o)(2) of the FD&C Act. Under part I, subpart H, the term “facility” is not limited to entities that are required to register under section 415 of the FD&C Act. The Agency is proposing to cross-reference the definition of “farm” to reduce the potential confusion that could result if the Agency used the term “facility” to have two different meanings within proposed part 507.
Proposed § 507.3 defines “food” to mean food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients.
Proposed § 507.3 defines “food-contact surfaces” as those surfaces that contact food and those surfaces from
The Agency is proposing to define the term “harvesting” as follows: Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised, or another farm under the same ownership. Harvesting does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership are examples of harvesting. The Agency is proposing the same definition of “harvesting” here as in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646)).
The Agency is proposing to define “hazard” to mean any biological, chemical, physical, or radiological agent that is reasonably likely to cause illness or injury in animals or humans in the absence of its control. The phrase “in animals or humans” is included in this definition because a biological, chemical, physical, or radiological agent in animal food could cause injury and illness to not only animals, but to humans that handle the animal food, or eat products (such as milk, meat, or eggs) derived from animals that ingested the food. The Agency is proposing to include radiological agents to implement section 418(b)(1)(A) of the FD&C Act, which includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with a facility. For further discussion on the definition of “hazard” and its consistency with HACCP, see section X.B of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency is proposing to define the phrase “hazard reasonably likely to occur” to mean a hazard for which a prudent person who manufactures, processes, packs, or holds food would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, or held in the absence of those controls. For further discussion on the definition of “hazard reasonably likely to occur” and its consistency with HACCP, see section X.B of the document for the proposed rule for preventive controls for human food (78 FR 3646). This concept is used in FDA's HACCP regulations for juice (21 CFR 120.7(a)(2)) and seafood (§ 123.6(a) (21 CFR 123.6(a))), and in the meat and poultry HACCP regulation (9 CFR 417.2(a)(1)).
The Agency is proposing to define the term “holding” to mean storage of food. Holding facilities would include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks. For farms and farm mixed-type facilities, holding would also include activities traditionally performed by farms for the safe or effective storage of raw agricultural commodities grown or raised on the same farm or another farm under the same ownership, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. The Agency is proposing the same definition of “holding” here as in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human (78 FR 3646)).
The Agency is proposing to define the term “lot” to mean the food produced during a period of time indicated by a specific code.
The Agency is proposing to define the term “manufacturing/processing” to mean making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. The proposed definition would also state that examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. For farms and farm mixed-type facilities, manufacturing/processing would not include activities that are part of harvesting, packing, or holding. The Agency is proposing the same definition of “manufacturing/processing” here as in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646)).
Proposed § 507.3 defines “microorganisms” to mean yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species having animal or human health significance. The term “undesirable microorganisms” includes those microorganisms that are of animal and human health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated. FDA considers not only yeasts, molds, bacteria and viruses, but also protozoa and microscopic parasites, to be microorganisms of importance in the safe and sanitary production of animal food.
The Agency is proposing to define the term “mixed-type facility” to mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. An example of such a facility would be a “farm mixed-type facility,” which is an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. The Agency is proposing to use the same definition as would be established in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human (78 FR 3646)).
The Agency is proposing to define the term “monitor” to mean to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification. For further discussion on the definition of “monitor” and its consistency with HACCP, see section X.B of the document for the proposed rule for preventive controls for human (78 FR 3646)).
The Agency is proposing to define the term “packaging”, when used as a verb, to mean placing food into a container that directly contacts the food and that the consumer receives. This definition would match the definition of “packaging” in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human (78 FR 3646)). For purposes of animal food, the use of the term “consumer” refers to the person purchasing the animal food to feed to an
The Agency is proposing to define the term “packing” as it is defined in proposed § 1.227 (see section VIII.E of the document for the proposed rule for preventive controls for human food (78 FR 3646) to mean placing food into a container other than packaging the food. For farms and farm mixed-type facilities, packing also includes activities traditionally performed by farms to prepare raw agricultural commodities grown or raised on the same farm or another farm under the same ownership for storage and transport, but does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act.
Proposed § 507.3 defines “pest” to mean any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae. For example, mice would be objectionable animals in the animal food manufacturing, processing, packing or holding environment because they can cause contamination of food and food contact surfaces with pathogens of animal or human health significance.
Proposed § 507.3 defines “plant” to mean the building or establishment or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of food.
The Agency is proposing to define “preventive controls” to mean those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. The proposed definition would incorporate the definition in section 418(o)(3) of the FD&C Act.
Proposed § 507.3 defines “qualified end-user” to mean, with respect to an animal food, the consumer of the food (where the term does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227 of this chapter) that:
a. Is located:
○ In the same State as the qualified facility that sold the food to such restaurant establishment; or
○ Not more than 275 miles from such facility; and
b. Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
The proposed definition matches the definition in section 418(l)(4)(B) of the FD&C Act. As discussed previously in this section of the document, for purposes of this proposed rule, the term “consumer” refers to the purchaser of the animal food to feed to an animal(s), and the animal(s) consuming the food. With respect to animal food, restaurants include pet shelters, kennels and veterinary facilities in which animal food is provided to animals, as provided in § 1.227 of this chapter.
Proposed § 507.3 defines “qualified facility” to mean (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility as to which both of the following apply:
• During the 3-year period preceding the applicable calendar year, the average annual monetary value of the animal food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the animal food sold by such facility to all other purchasers; and
• The average annual monetary value of the animal food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
This definition is based on the criteria in section 418(l)(1) of the FD&C Act. The Agency is specifying “animal food” in this definition as it intends to only include the sale of food for animals and not the sale of human food in determining whether a facility meets the requirements in those cases where a facility sells both. The Agency requests comment on whether food for animals and humans should be aggregated in determining whether a facility that sells both meets the statutory criteria of a qualified facility.
Proposed § 507.3 defines “qualified individual” to mean a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. The Agency is proposing to define the term “qualified individual” to have a concise term to use in proposed provisions that would require that an activity be performed by such an individual. The Agency is proposing to establish requirements for a qualified individual in proposed section § 507.50 (see section X.J).
Proposed § 507.3 defines “quality control operation” to mean a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
Proposed § 507.3 defines “reasonably foreseeable hazard” “to mean a potential biological, chemical, physical, or radiological hazard that may be associated with the facility or the food. This term is used in FSMA and the concept is grounded in the hazard evaluation process in HACCP systems.
Proposed § 507.3 defines “rework” to mean clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as animal food.
Proposed § 507.3 defines “safe moisture level” as a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for food is related to its water activity (a
Proposed § 507.3 defines “sanitize” to mean to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of animal and human health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for animals or humans. For example, an appropriate sanitizing process for a facility that manufactures, processes, packs or holds animal food can be one that does not cause illness to the person implementing it and does not make the food unsafe for the intended animal species, person handling the food or humans consuming human food derived from animals that consume the animal food. It is well established that sanitizers can be inactivated by organic material and, thus, are not effective unless used on clean surfaces (Ref. 35). The Agency recognizes that in certain situations effective cleaning and sanitizing of food-contact surfaces for animal food helps protect the health of animals by controlling the transmission of animal diseases. Effective cleaning and sanitizing of food-contact surfaces for animal food can also protect human
Proposed § 507.3 defines “should,” explaining that “should” is used to state recommended or advisory procedures or identify recommended equipment. “Should” denotes non-binding guidance. Consistent with the Agency's good guidance practices regulation (21 CFR 10.115), proposed provisions containing the word “should” are draft guidance at this stage. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
The Agency is proposing to define “significantly minimize” to mean to reduce to an acceptable level, including to eliminate. “Significantly minimize” and “preventive control” are terms used in FSMA and are consistent with the definition of “control measure” in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) HACCP guidelines, the Codex HACCP Annex, and FDA's HACCP regulation for juice. The NACMCF HACCP guidelines define “control measure” as any action or activity that can be used to prevent, eliminate or reduce a significant hazard (Ref. 29). The Codex HACCP Annex defines “control measure” as any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level (Ref. 36). For further discussion on the definition of “significantly minimize” and its consistency with the term “control measure” as used in HACCP, see section X.B.4 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency is proposing to define the term “small business” to mean a business employing fewer than 500 persons. See section VIII.B.2 for additional discussion of small business.
The proposed limit of 500 employees would include all employees of the business rather than be limited to the employees at a particular facility. FDA conducted a study as required by section 418(l)(5) of the FD&C Act that was used to help determine this definition. That study is available in the docket established for this proposed rule (Ref. 16). The Agency requests comment on that study, particularly in regards to business size for animal food facilities. The Agency will consider comments regarding the study, as well as comments regarding its proposed definition for small business, in any final rule based on this proposed rule.
The Agency is proposing to define the term “subsidiary,” as it is defined in section 418(l)(4)(D) of the FD&C Act, to mean any company that is owned or controlled directly or indirectly by another company.
The Agency is proposing to define the term “validation” to mean that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards.
The Agency is proposing to define the term “verification” to mean those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan. For further discussion on the use of the terms “validation” and “verification” in HACCP, see section X.B.4 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency is proposing to define the term “very small business” to mean, for purposes of this proposed part 507, a business that has less than $500,000 in total annual sales of animal foods, adjusted for inflation (Option 1 of co-proposal). As one co-proposal, the Agency is proposing to define the term “very small business” to mean a business that has less than $1,000,000 in total annual sales of animal foods, adjusted for inflation (Option 2). As another co-proposal, the Agency is proposing to define the term “very small business” to mean a business that has less than $2,500,000 in total annual sales of animal foods, adjusted for inflation (Option 3). See section VIII.B.2 for additional discussion of the definition of very small business.
The Agency is proposing to define the term “water activity (a
FDA conducted a Food Processing Sector Study as required by section 418(l)(5) of the FD&C Act (Ref. 16). The purpose of that study was to make determinations in five areas as required by section 418(l)(5)(A) of the FD&C Act and to use the results of the study in defining the terms “small business” and “very small business.” These areas include, in part: (1) Distribution of food production by type and size of operation, (2) the proportion of food produced by each type and size of operation, (3) the number and types of food facilities co-located on farms, (4) the incidence of foodborne illness originating from each size and type of operation, and (5) the effect on foodborne illness risk associated with certain activities regarding food. The Food Processing Sector Study provides information on the number of establishments and average sales per establishment by industry and size of operation. FDA's proposed definitions are informed by that study. The food processing sector study is available in the docket established for this proposed rule (Ref. 16). The Agency requests comment on that study. The Agency will consider comments regarding the study, as well as comments regarding its proposed definitions “small business” and “very small business,” in any final rule based on this proposed rule.
Section 418(l)(5)(B) of the FD&C Act required consideration of harvestable acres, income, the number of employees, and the volume of product in defining the terms “small business” and “very small business.” The Food Processing Sector Study (Ref. 16) concluded that there was no consistent pattern across food categories, including the pet food and animal feed categories, in terms of which sizes of establishments contribute most to foodborne illness risk. “Harvestable acres,” “income,” “the number of employees,” and “the volume of food harvested” are all ways to measure the size of an operation. Income does not appear to be the most relevant measure, since facility income may be derived from multiple sources, many of which are not food-related. “Harvestable acres” and “volume of food harvested” are similar measures that appear primarily relevant to the growing and harvesting of crops, which are activities not subject to this regulation. Harvestable acres and volume of food harvested do not provide a meaningful measure with respect to the risk from pet food or animal feed produced by a farm mixed-type facility (a pet food or animal feed facility co-located on a farm subject to this regulation); the Agency's qualitative risk assessment of manufacturing, processing, packing, and holding activities conducted in a facility co-located on a farm showed that risk was related to activity/animal food combinations; these animal foods could be harvested from large or small farms (see section VII.B for a discussion of that qualitative risk assessment). A high risk activity/animal food combination (i.e., a not low-risk activity/food combination) could be conducted on a farm with
Under proposed § 507.5(e) a farm mixed-type facility that meets the definition of a small business and only conducts specific packing or holding activity/animal food combinations would be eligible for an exemption from subpart C. Similarly, under proposed § 507.5(f) a farm mixed-type facility that meets the definition of a small business and only conducts specific manufacturing/processing activity/animal food combinations would be eligible for an exemption from subpart C. Based on the Food Processing Sector Study, the Agency estimates that approximately 4,439 facilities would be part of a small business under the proposed definition and thus satisfy the size requirement of the exemption in proposed § 507.5(e) and proposed § 507.5(f). Of those facilities, the Agency estimates that approximately 188 would be co-located on farms. A subset of those facilities would qualify for the exemption from subpart C based on their manufacturing/processing and packing and holding activities.
Based on the Food Processing Sector Study the Agency estimates that businesses employing fewer than 500 employees produce approximately 18 percent (based on sales) of all manufactured food produced in the United States and 86.9 percent of all manufactured pet food and animal feed. As discussed in section VI, the compliance date for a small business would be 2 years after the date of publication of the final rule. Under this proposed definition, 4,439 facilities would be subject to this compliance date.
The definition of very small business is relevant to 3 provisions of the proposed rule. It would affect which facilities qualify for the exemption in § 507.5(e) for on-farm packing or holding, and the exemption in § 507.5(f) for on-farm manufacturing/processing, of animal food by a very small business if the only activities subject to section 418 of the FD&C Act are the specific low-risk activity/animal food combinations listed in those sections. It would also affect which facilities are automatically “qualified” facilities subject to the modified requirements in § 507.7 and what the compliance date is for such facilities.
The definition of very small business affects which facilities qualify for the exemption in § 507.5(e) for on-farm packing or holding, and the exemption in § 507.5(f) for on-farm manufacturing/processing, of animal food by a very small business if the only activities subject to section 418 of the FD&C Act are the specific low-risk activity/animal food combinations listed in those sections,
The definition of very small business affects which facilities are automatically “qualified” facilities subject to the modified requirements in proposed § 507.7, and the applicable compliance dates for such facilities. There are two ways a facility may be “qualified” and thus subject to the modified requirements in proposed § 507.7. The first, limited annual monetary value of sales, is based on fixed criteria set out in FSMA section 418(l)(1)(C). The second, as provided by section 418(l)(1)(B), is to be a very small business as defined by FDA. Therefore, the Agency discusses the effect of the proposed definitions for very small business in relation to the existing requirements for qualified facilities in section 418(l)(1)(C).
One possible definition of the term “very small business,” for the purposes of proposed part 507, would be a business that has less than $500,000 in total annual sales of animal food, adjusted for inflation (Option 1 of the co-proposal). From the Food Processing Sector Study it is apparent that the number of co-located facilities is concentrated at the smaller end of the size spectrum. Using data from Dun & Bradstreet, FDA estimates that 3 co-located facilities would meet the size requirement for the exemptions in proposed § 507.5(e) and (f). A subset of those facilities might then qualify for
The proposed definition of $500,000 uses a dollar amount for sales that is, essentially, the same as the maximum dollar amount of sales by a qualified facility to end-users other than those that would satisfy the definition of “qualified end-users,” except unlike with section 418(l)(1)(C) of the FD&C Act, there would be no requirement that more than half of sales must be to qualified end-users. The $500,000 definition of very small business would add approximately 3 domestic facilities to the number of qualified facilities. FDA estimates that no additional domestic animal food facilities beyond these 3 domestic facilities would be qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 3 domestic qualified facilities. These 3 domestic qualified facilities would have a 3 year compliance date. As a group, businesses with less than $500,000 in total annual sales of animal food produce less than 0.003 percent of all animal food produced in the United States when measured by dollar value.
One possible definition of the term “very small business,” for the purposes of proposed part 507, would be a business that has less than $1,000,000 in total annual sales of animal food, adjusted for inflation (Option 2 of the co-proposal). Using data from Dun & Bradstreet (in the Food Processing Sector Study), FDA estimates that the same 3 facilities that met the $500,000 exemption would meet this exemption level but no additional facilities would meet the size requirement for the exemptions in proposed § 507.5(e) and proposed § 507.5(f). A subset of those facilities might then qualify for the exemption from subpart C based on their manufacturing/processing, packing, or holding activities.
Defining very small business to mean a business that has less than $1,000,000 in total annual sales of animal food would add approximately 619 domestic facilities to the number of qualified facilities. FDA estimates that no additional domestic pet food or animal feed facilities beyond these 619 domestic facilities would be qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 619 domestic qualified facilities. These 619 domestic qualified facilities would have a 3-year compliance date. As a group, businesses with less than $1,000,000 in total annual sales of animal food produce less than 1.71 percent of all pet food and animal feed produced in the United States when measured by dollar value.
One possible definition of the term “very small business,” for the purposes of proposed part 507, would be a business that has less than $2,500,000 in total annual sales of animal food, adjusted for inflation (Option 3 of the co-proposal). Using data from Dun & Bradstreet, FDA estimates that the same 3 facilities that met the $500,000 and $1,000,000 exemption would met this exemption level but no additional facilities would meet the size requirement for the exemption in proposed § 507.5(e) and proposed § 507.5(f). A subset of those facilities might then qualify for the exemption from subpart C based on their manufacturing/processing, packing, or holding activities.
As compared to Option 2, defining very small business to mean a business that has less than $2,500,000 in total annual sales of animal food would add another approximately 2,880 domestic facilities to the number of qualified facilities. FDA estimates that no additional domestic pet food or animal feed facilities beyond these 3,499 (the 619 facilities that qualify at the $1,000,000 exemption level plus the 2,880 facilities that qualify at the $2,500,000 exemption level) domestic facilities would be qualified facilities under section 418(l)(1)(C) of the FD&C Act, leading to a total of 3,499 domestic qualified facilities. These 3,499 domestic qualified facilities would have 3 year compliance date. As a group, businesses with less than $2,500,000 in total annual sales of animal food produce less than 20.8 percent of all pet food and animal feed produced in the United States when measured by dollar value.
FDA is proposing different annual gross sales levels for the three definition options of very small business for animal food facilities than proposed for human food facilities. In the proposed rule for preventive controls for human food (78 FR 3646), FDA proposed three options for annual gross sales levels for very small business. Option 1 would be $250,000, Option 2 would be $500,000, and Option 3 would be $1 million. For the proposed rule for preventive controls for animal food, FDA is proposing three different options for annual gross sales levels for very small business. Option 1 would be $500,000, Option 2 would be $1 million, and Option 3 would be $2.5 million. In general, the animal food industry sector is more heavily weighted toward the medium and larger facilities, when based on gross annual sales, than is the human food industry sector. For example, facilities producing livestock or poultry feed often buy and sell product measured in tons, resulting in high annual gross sales. Though the annual gross sales levels would be higher for each option in the proposed animal food rule, the percent of facilities and percent of sales exempted would be comparable to the annual gross sales levels for the three options for the proposed rule for human food.
Proposed § 507.5(a) would exempt establishments not required to register under section 415 of the FD&C Act. According to section 415(c)(1) of the FD&C Act, establishments that are not required to register include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in 21 CFR 123.3(k)). The Agency has interpreted these terms in § 1.227. For example, in the animal food context, a “restaurant” includes pet shelters, kennels, and veterinary facilities in which food is provided to animals. A “retail food establishment” is an establishment that sells food directly to consumers as their primary business function, where the term “consumer” does not include a business. A grocery store, including the pet food aisle, would be an example. In
In section VIII.B of the document for the proposed rule for preventive controls for human food (78 FR 3646), FDA proposed to further clarify the scope of the definition of “farm” for the purposes of section 415 of the FD&C Act to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term “farm” would include: (1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership and (2) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. Because this definition of “farm” reflects the Agency's interpretation of the term in section 415 of the FD&C Act, establishments that meet this definition would not be required to register under section 415 of the FD&C Act and would therefore be excluded from the scope of this rulemaking under proposed § 507.5(a). For example, a farm that manufactures/processes food, e.g., by using mobile equipment to mix grain and forage with a commercially produced protein/mineral supplement into a total-mixed ration to feed to dairy cattle on its farm, or another farm under the same ownership, would be exempt from this proposed rule. As another example, a crop farm that grows, harvests, and stores agronomic crops such as alfalfa hay, corn, and other feed grains for distribution into commerce as animal food would be exempt from the proposed rule.
Similarly, the exemption in § 507.5(a) would exempt activities of farm mixed-type facilities that fall within the farm definition previously mentioned. As discussed in section VIII.B of this document and section VIII.E.1 of the document for the proposed rule for preventive controls for human food (78 FR 3646), a “mixed-type facility” would be an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. An example of such a facility would be a “farm mixed-type facility,” an establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. FDA tentatively concludes that the portion of a farm mixed-type facility that is within the farm definition—and therefore the portion that is exempt from registration under section 415 of the FD&C Act—should be treated the same way for the purposes of proposed § 507.5(a) as the same activities on farms that only conduct activities within the farm definition.
Section 418 of the FD&C Act sets forth requirements for the owner, operator, or agent is in charge of a “facility,” defined in 418(o)(2) as a domestic facility or foreign facility that is required to register under section 415. Therefore section 418 of the FD&C Act only applies to establishments that are required to register under section 415.
The Agency tentatively concludes that these facilities should not be subject to the CGMPs in proposed part 507 for several reasons. Establishments that are not required to register under section 415 of the FD&C Act are not commonly known to be sources of animal food adulteration, they do not commonly stockpile large inventories of animal food, and the rapid turnover of inventory further reduces the risk that these establishments will adulterate animal food products they use. In addition, most of the animals that are housed and cared for by this sector are not food-producing animals, narrowing the scope of the human health risk.
Most of these establishments are already regulated by other agencies, often multiple agencies, who already address animal food safety to some degree. For example, many establishments that are not required to register under section 415 of the FD&C Act fall under the purview of the Animal Welfare Act (AWA), implemented by USDA. The AWA and its implementing regulations provide for safe food and housing for animals in indoor, outdoor and sheltered housing establishments, and those under the control of dealers and exhibitors, among others. Implementing regulations enforced by USDA specify that the food provided to animals in these establishments must be uncontaminated and wholesome (e.g., 9 CFR 3.9). In addition, veterinary clinics, among others of these types of establishments, are regulated by State governments.
FDA also has other established regulations that incorporate feeding practices and animal food storage. For example, § 589.2000, Animal Proteins Prohibited in Animal Feed, addresses, among other things, the feeding of ruminant animals. The Agency does inspect ruminant feeders, including farms and other establishments that may feed ruminant animals to ensure compliance with this regulation. Although the focus of the Agency's inspection work under this regulation is farms raising ruminant animals such as cattle, sheep, goats, elk, and bison intended to produce meat and milk for human consumption, the Agency also visits a small number of other establishments to make sure those industry sectors are aware of, and following, these regulations as they care for their ruminant animals.
Certain establishments that are not required to register under section 415 of the FD&C Act conduct nonclinical laboratory studies in animals to support applications for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. These establishments must comply with Good Laboratory Practice regulations already in place in part 58 (21 CFR part 58), which include certain food safety measures. For example, § 58.45 states “there shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means.” In addition, § 58.90(g) states “feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol . . .”
Finally, while establishments that are not required to register under section 415 of the FD&C Act would not need to comply with the proposed rule, they would still be subject to the adulteration provisions of section 402 of the FD&C Act.
Section 418(j)(1)(C) of the FD&C Act provides that section 418 of the FD&C Act shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with,
The Agency tentatively concludes that it should interpret section 418(j)(1)(C) to exempt those activities of a facility that are subject to § 500.23 and part 113, and only those activities. Such an interpretation would fulfill the apparent goal of the exemption without being too narrow or too broad. The Agency also tentatively concludes that it should include the exemption provided in section 418(j)(1)(C) of the FD&C Act in the proposed rule to establish by regulation the reach of the exemption as the Agency has interpreted it. Proposed § 507.5(b) would provide that subpart C would not apply with respect to activities that are subject to § 500.23 and part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) at a facility if the owner, operator, or agent in charge of the facility is required to comply with, and is in compliance with, § 500.23 and part 113 with respect to such activities. Consistent with section 418(j)(2) of the FD&C Act, proposed § 507.5(b) would establish that the exemption would be applicable only with respect to the microbiological hazards that are regulated under § 500.23 and part 113. A facility that is required to comply with, and is in compliance with, § 500.23 and part 113 would be subject to the requirements in proposed subpart C for hazards such as chemical hazards (e.g., pesticide residues), physical hazards (e.g., metal fragments that could be introduced from equipment) and radiological hazards (e.g., high concentrations of radium-226, radium-228 or uranium in well water used in product). A facility that is required to comply with, and is in compliance with, § 500.23 and part 113 also would be subject to the requirements in proposed subpart C for biological hazards not regulated under § 500.23 and part 113. For example, the heat-stable toxin produced by the
The Agency requests comment on the criteria that should be used to determine whether a facility is in compliance with § 500.23 and part 113.
Section 418(k) of the FD&C Act provides that section 418 of the FD&C Act “shall not apply to activities of a facility that are subject to section 419 [of the FD&C Act].” Section 419, “Standards for Produce Safety,” requires FDA to establish by regulation “science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which [FDA] has determined that such standards minimize the risk of serious adverse health consequences or death.” Section 419(h) of the FD&C Act provides that section 419 of the FD&C Act “shall not apply to activities of a facility that are subject to section 418 [of the FD&C Act.]” FDA issued a proposed rule to implement section 419 on January 16, 2013 (78 FR 3504.) That proposed rule would apply section 419 to “farms” (as would be defined in proposed §§ 1.227 and 1.328 of the proposed rule for preventive controls for human food (78 FR 3646) that are not required to register under section 415 of the FD&C Act and to farms that conduct an activity (or activities) that triggers the section 415 registration requirement (“farm mixed-type facilities”), but only with respect to their activities that are within the farm definition and therefore do not trigger the registration requirement. The Agency tentatively concludes that it should include a provision implementing section 418(k) of the FD&C Act in the proposed rule for clarity and consistency, though section 419 of the FD&C Act applies only to human food. Proposed § 507.5(c) would provide that subpart C would not apply to activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety).
Section 418(l) of the FD&C Act establishes modified requirements for “qualified facilities.” The Agency describes what a qualified facility is in section VIII.D, where the Agency proposes the requirements for such a facility (proposed § 507.7). The Agency also defines the term “qualified facility” in proposed § 507.3 (see the discussion of definitions in section VIII.B). Section 418(l)(2)(A) of the FD&C Act provides that a qualified facility “shall not be subject to the requirements under [sections 418(a) through (i) and (n) of the FD&C Act];” as a practical matter with respect to the provisions of this proposed rule, section 418(l)(2)(A) of the FD&C Act provides that a qualified facility would be exempt from the requirements of proposed subpart C. Importantly, section 418(l)(3) of the FD&C Act provides that the Secretary of HHS may withdraw the exemption provided in section 418(l)(2)(A) under certain circumstances. The Agency discusses the withdrawal provisions of section 418(l)(3), and its proposed provisions to implement section 418(l)(3) (proposed subpart D), in section XI.
The Agency tentatively concludes that it should include the exemption provided in section 418(l)(2)(A) of the FD&C Act in the proposed rule to establish by regulation the reach of the provision. Proposed § 507.5(d) would provide that subpart C would not apply
In the proposed rule for preventive controls for human food (78 FR 3646), FDA proposed adding a new definition of the term “Mixed-type facility” to § 1.227. The proposed definition would also state that an example of such a facility is a “farm mixed-type facility,” which is an establishment that grows and harvests crops or raises animals, and may conduct other activities within the farm definition, but also conducts activities that require the establishment to be registered. Mixed-type facility would mean an establishment that engages in both activities that are exempt from registration under section 415 of the FD&C Act and activities that require the establishment to be registered. Because the specific classes of activities mentioned in FSMA section 103(c) are, by definition, on-farm activities that do not fall within the farm definition, Congress has explicitly directed FDA to engage in rulemaking addressing establishments that conduct activities that are outside the farm definition on farms. Accordingly, FDA proposed to define the term “farm mixed-type facility” to refer to these establishments (78 FR 3646).
As discussed in section VII.A.2, section 103(c)(1)(C) of FSMA requires that the Secretary conduct a science-based risk analysis of “(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific animal foods; and (ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.” As discussed in section VII.B, consistent with the requirements of section 103(c)(1)(C) of FSMA the Agency has conducted a qualitative risk assessment related to activity/animal food combinations for the purpose of determining which activity/animal food combinations would be considered low risk.
Section 103(c)(1)(D)(i) of FSMA requires that, in issuing the regulations under section 103(c)(1)(A), “the Secretary shall consider the results of the science-based risk analysis conducted under [section 103(c)(1)(C) of FSMA], and shall exempt certain facilities from the requirements in section 418 of the [FD&C Act] . . ., including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of [the FD&C Act] . . . or modify the requirements in [sections 418 or 421 of the FD&C Act], as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.” Section 103(c)(1)(D)(ii) of FSMA provides that “[t]he exemptions or modifications under section 103(c)(1)(D)(i) of FSMA shall not include an exemption from the requirement to register under section 415 of the [FD&C Act] . . . if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the [FD&C Act].”
1. Conveying, weighing, sorting, culling, or grading (incidental to storing):
• Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
• Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, sunflower);
• Grain or oilseed byproducts;
• Forage (e.g., hay or ensiled material); or
• Other plants or plant byproducts (e.g., almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
2. Storing:
• Dried grain;
• Dried oilseed;
• Byproducts of dried grain or dried oilseed;
• Forage; or
• Other plants or plant byproducts.
3. Packing:
• Grain;
• Oilseed;
• Grain or oilseed byproducts;
• Forage; or
• Other plants or plant byproducts.
4. Mixing (incidental to packing or storing):
• Grain, whole; or
• Forage.
The low-risk on farm packing and holding activity/animal food combinations on food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed-type facility under the same ownership reflect the findings of the analysis required by section 103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
For purposes of proposed § 507.5(e) and (f), “other plant byproducts” includes such things as barley hulls, cottonseed hulls, corn cobs, oat hulls, rice hulls, and straw. Grain and oilseed byproducts can be considered part of “grain and oilseed” as a general matter, but FDA has addressed those foods separately for the purpose of the risk evaluation and the proposed § 507.5(e) and (f) exemptions in order to accurately reflect differences in activity/animal food combinations likely to be performed on farm mixed-type facilities on grain and oilseed byproducts as compared to other grains and oilseeds, as well as differences in risk across those activity/animal food combinations.
1. When conducted on a farm/farm mixed-typed facility's own (those grown or raised on that farm/farm mixed-type facility or another farm/farm mixed-type facility under the same ownership) raw agricultural commodities for distribution into commerce:
• Cracking, crimping, flaking:
○ Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
○ Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or
○ Grain or oilseed byproducts.
• Crushing, grinding, milling, pulverizing, or dry rolling:
○ Grain;
○ Oilseed;
○ Grain or oilseed byproducts;
○ Forage (e.g., hay or ensiled material); or
○ Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
• Making silage.
• Chopping, or shredding hay.
• Extracting (mechanical) or wet rolling:
○ Grain; or
○ Oilseed.
2. When conducted on animal food other than the farm mixed-typed facility's own raw agriculture commodities for distribution into commerce:
• Cracking, crimping, flaking, or shelling:
○ Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
○ Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or
○ Grain or oilseed byproducts.
• Crushing, grinding, milling, pulverizing, or dry rolling:
○ Grain;
○ Oilseed;
○ Grain or oilseed byproducts;
○ Forage (e.g., hay or ensiled material); or
○ Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
• Making silage.
• Chopping or shredding hay.
• Extracting (mechanical) or wet rolling:
○ Grain; or
○ Oilseed.
• Labeling:
○ Grain whole; or
○ Oilseed whole.
• Sifting, separating, or sizing:
○ Grain;
○ Oilseed;
○ Grain or oilseed byproducts; or
○ Other plants or plant byproducts.
The low-risk on-farm manufacturing/processing activity/animal food combinations reflect the findings of the analysis required by section 103(c)(1)(C) of FSMA, discussed in sections VII.B and VII.C.
In § 507.5(g), the Agency is proposing that subpart C would not apply to facilities solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing. And in § 507.5(h), the Agency is proposing that subpart B would not apply to the holding or transportation of one or more “raw agricultural commodities,” as defined in section 201(r) of the FD&C Act.
The current 21 CFR 110.19(a) for human food, provides that establishments engaged solely in the harvesting, storage, or distribution of one or more RACs, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public, are exempt from the requirements of part 110 (21 CFR part 110). In section VIII.D of the document for the proposed rule for preventive controls for human food (78 FR 3646), the Agency discusses the meaning of the term raw agricultural commodity. The Agency tentatively concludes that the exemption for RACs from proposed part 507 subpart B for animal food is consistent with the treatment of RACs for human food.
Section 418(m) of the FD&C Act provides in relevant part that FDA may by regulation “exempt or modify the requirements for compliance under [section 418 of the FD&C Act] with respect to facilities that are solely engaged in . . . the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing”.
This provision would exempt, for example, facilities that only store whole grains (such as corn, wheat, barley, oats, and soybeans) for animal food from subpart C. This would include facilities such as grain elevators provided that such facilities do not conduct other activities subject to section 418 of the FD&C Act. Outbreaks of illness associated with feeding RACs to animals have not been traced back to storage facilities solely engaged in the storage of RACs. In addition, facilities that are solely engaged in the storage of RACs are exempt from the current part 110 CGMP regulations for human food, and FDA proposes to also exempt these facilities from the proposed CGMPs for animal food. Such facilities would remain subject to the requirements of the FD&C Act. For example, if animal food is stored under insanitary conditions whereby the animal food may become contaminated with filth or rendered injurious to health, the animal food would be adulterated under section 402(a)(4) of the FD&C Act.
While outbreaks of illness associated with feeding RACs to animals have not been traced back to storage facilities solely engaged in the storage of RACs, FDA is aware of changes in feeding practices which might increase the risk associated with feeding RACs obtained
While the Agency tentatively concludes that animal food facilities such as grain elevators that are solely engaged in the storage of grains that are raw agricultural commodities should be exempt from proposed subpart B and proposed subpart C, the Agency does have some concerns. One of those concerns is the potential for mycotoxins, such as aflatoxins, fumonisins, and DON, to be present in RACs obtained by farms and fed to animals. This concern is largely mitigated for RACs intended for human food because RACs for human food routinely undergo further processing and are rarely consumed in the “raw” state.
Mycotoxins are toxic by-products of mold that can develop in certain agricultural commodities pre-harvest or post-harvest while in storage. Mycotoxins can reduce animal productivity, cause sudden death if fed in large quantities, and can become a component of milk and eggs intended for human consumption.
Mycotoxin contamination varies greatly from year to year and by geographic region of the country, depending on weather conditions that stress crops and predispose to mold growth. In regions of the country where conditions tend to favor mold growth, grain elevators and other buyers routinely monitor for this hazard and turn away producers whose crops exceed FDA's action levels for the various mycotoxins. For example, grain elevators will reject corn that tests higher than 20 parts per billion for aflatoxin, the action level established by FDA for use in feed for animal species other than beef cattle, swine, poultry, or when the intended species is not known. Grain elevators in other regions of the country are familiar with the weather phenomena that predispose to mycotoxin production and monitor incoming shipments of grain accordingly. The grain industry is also familiar with proper drying and storing procedures to prevent mold growth and mycotoxin production. Therefore, due to controls already in place by the grain industry, and due to regulatory oversight by USDA under the United States Grain Standards Act, FDA has tentatively concluded to exempt facilities solely holding grains from preventive controls.
However, the Agency is seeking comment on whether animal food facilities, such as grain elevators, that are solely engaged in the storage of grains that are raw agricultural commodities should be exempt from subpart B and subpart C of proposed part 507; how many of these types of facilities and operations are in the United States; and what is the best approach to ensure that the raw agricultural commodities distributed by these facilities to animal feeding operations are free of hazards that would be likely to cause illness or injury to animals or humans.
In the proposed rule for preventive controls for human food (78 FR 3646), the Agency is proposing that proposed subpart C, “Hazard Analysis and Risk-Based Preventive Controls,” would not apply to certain alcoholic beverages and a very narrow set of prepackaged other food at alcoholic beverage facilities, based on the Agency's interpretation of section 116 of FSMA. Under proposed § 117.5(i), subpart C of the human food rule would not apply with respect to food that is not an alcoholic beverage at certain alcoholic beverage facilities, provided that such food (1) is in prepackaged form that prevents any direct human contact with such food, and (2) constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury (see section X.C.7 of the document for the proposed rule for preventive controls for human food (78 FR 3646)). Section 116 of FSMA applies to animal food. However, the Agency is not aware of any animal food at alcoholic beverage facilities that would be exempt from section 418 of the FD&C Act under the proposed interpretation, and therefore is not aware of any animal food at alcoholic beverage facilities that would be exempt from proposed subpart C, “Hazard Analysis and Risk-Based Preventive Controls,” for animal food. For example, FDA understands that many breweries and distilleries sell spent grains, such as brewers dried grains and distillers dried grains, as animal food. Because those spent grains are not alcoholic beverages themselves, and they are not in a prepackaged form that prevents any direct human contact with the food, the Agency tentatively concludes that subpart C of this proposed rule would apply to them.
Section 418(l) of the FD&C Act establishes modified requirements for “qualified facilities.” As discussed in section II.C, section 418(l)(1) of the FD&C Act establishes the conditions for a facility to be a “qualified facility” based on either business size (section 418(l)(1)(B) of the FD&C Act) or a combination of the average monetary value of the food sold and the value of food sold to qualified end users as compared to all other purchasers (section 418(l)(1)(C) of the FD&C Act), and proposed § 507.3 would establish a definition for “qualified facility” based on section 418(l)(1).
Sections 418(l)(2)(A) and (B) of the FD&C Act provide that a qualified facility is exempt from the requirements of sections 418(a) through (i) and (n) of the FD&C Act (i.e., the requirements for hazard analysis and risk-based preventive controls), but must instead submit two types of documentation to the Secretary of HHS. The first type of required documentation relates to food safety practices at the facility, and section 418(l)(2)(B)(i) of the FD&C Act provides two options for satisfying this documentation requirement. Under section 418(l)(2)(B)(i)(I) of the FD&C Act, the qualified facility may choose to submit documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective. Alternatively, under section 418(l)(2)(B)(i)(II) of the FD&C Act, the qualified facility may choose to submit documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law.
The second type of required documentation relates to whether the facility satisfies the definition of a qualified facility. Under section 418(l)(2)(B)(ii) of the FD&C Act, the facility must submit documentation, as specified by the Secretary in a guidance document, that the facility is a qualified facility under section 418(l)(1)(B) of the FD&C Act or section 418(l)(1)(C) of the FD&C Act.
Section 418(l)(7)(A) of the FD&C Act requires that a qualified facility that is exempt from the requirements under sections 418 (a) through (i) and subsection (n), and that does not prepare documentation under section 418(l)(2)(B)(i)(I)of the FD&C Act, provide notification to consumers by one of two procedures, depending on whether a food packaging label is required on the food. With respect to an animal food for which an animal food packaging label is required by the Secretary of HHS under any other provision of the FD&C Act, section 418(l)(7)(A)(i) of the FD&C Act requires that a qualified facility include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed. With respect to an animal food for which an animal food packaging label is not required by the Secretary of HHS under any other provisions of the FD&C Act, section 418(l)(7)(A)(ii) of the FD&C Act requires that a qualified facility prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.
Proposed § 507.7(a)(1) would require that a qualified facility submit to FDA documentation that the facility is a qualified facility. Consistent with the conditions in section 418(l)(1) of the FD&C Act for a facility to be a qualified facility, and the Agency's proposed definition (proposed § 507.3) of “qualified facility,” the documentation would be directed to either the status of the facility as a very small business (as would be defined in proposed § 507.3) or the applicability of conditions for average annual monetary value and the value of food sold to qualified end users as compared to other purchasers (as would be included in the definition of qualified facility in proposed § 507.3). As discussed further in section VIII.D.5, FDA tentatively concludes that a statement from the owner, operator, or agent in charge of a qualified facility certifying that the facility is a very small business, otherwise meets the definition of a qualified facility under proposed § 507.3, or both, would be acceptable for the purposes of satisfying the requirements that would be established in proposed § 507.7(a)(1). The Agency would not, for example, require that a facility submit financial information to FDA demonstrating its total sales or to the proportion of sales to qualified end users.
Proposed § 507.7(a)(1) also would establish that, for the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011. The conditions related to average annual monetary value established in section 418(l)(1)(C) of the FD&C Act, and the definition of very small business in proposed § 507.3, allow adjustment for inflation. To establish a level playing field for all facilities that may satisfy definition of a qualified facility, the Agency is proposing to establish the baseline year for the calculation in proposed § 507.7(a)(1). The Agency is proposing to establish 2011 as the baseline year for inflation because 2011 is the year that FSMA was enacted into law. The Agency tentatively concludes that because Congress provided a specific dollar amount in section 418(l)(1)(C)(ii)(II) of the FD&C Act, i.e., $500,000, and it provided that the dollar amount should be adjusted for inflation, it is reasonable to establish the baseline year as the year that the law was enacted.
Proposed § 507.7(a)(2) would provide two options for satisfying the documentation requirement in section 418(l)(2)(B)(i) of the FD&C Act related to food safety practices at the facility. Proposed § 507.7(a)(2)(i) would allow qualified facilities to submit documentation to demonstrate that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective to satisfy this requirement.
Proposed § 507.7(a)(2)(i) would implement the provisions of section 418(l)(2)(B)(i)(I) of the FD&C Act, except that proposed § 507.7(a)(2)(i) would specify monitoring the performance of the preventive controls to ensure that such controls are effective (emphasis added). As discussed in section II.C, under the overall framework of the proposed requirements that would be established in subpart C, monitoring is directed to performance of preventive controls. Thus, proposed § 507.7(a)(2)(i) is consistent with the statute and the overall framework of this proposed rule.
Proposed § 507.7(a)(2)(ii) would provide another option for satisfying the documentation requirement in section 418(l)(2)(B)(i) of the FD&C Act related to food safety practices at the facility by allowing qualified facilities to submit documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries. Proposed § 507.7(a)(2)(ii) would implement the provisions of section 418(l)(2)(B)(i)(II) of the FD&C Act.
FDA tentatively concludes that a statement from the owner, operator, or agent in charge of a qualified facility certifying that the facility: (1) Has identified the potential hazards associated with the animal food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective or (2) that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, would be acceptable for the purposes of satisfying the requirements that would be established in proposed § 507.7(a)(2). The Agency would not, for example, require that a facility submit documentation to FDA demonstrating the content of their hazard identification, preventive controls, or monitoring of the implementation of preventive controls; or copies of their non-Federal licenses, inspection reports, certificates, permits, credentials, or certifications.
Proposed § 507.7(b) would require that qualified facilities submit the
Proposed § 507.7(b)(2) would provide an option to submit documentation by mail. A qualified facility would have the option to submit documents in a paper format or in an electronic format on a CD–ROM, by mail to the U.S. Food and Drug Administration, ATTN: Qualified Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 20993. “Mail” would include the U.S. mail and businesses that can deliver documents to the address provided. The Agency would recommend that an owner, operator or agent in charge of a qualified facility submit by mail only if the qualified facility does not have reasonable access to the Internet. It is not efficient for FDA to receive such documents by mail.
The Agency is not proposing to provide for submission by fax. The Agency expects that there may be technical difficulties or loss or mix-up of some submitted information if the Agency were to allow for submission by fax.
Proposed § 507.7(c)(1) would require that the documentation that would be required by section § 507.7(a) be submitted to FDA initially within 90 days of the applicable compliance date of the rule. As discussed in section VI, the compliance date for a small business would be 2 years after the date of publication of the final rule and the compliance date for a very small business would be 3 years after the date of publication of the final rule.
Proposed § 507.7(c)(2) would require that the documentation that would be required by proposed § 507.7(a) also must be resubmitted to FDA at least every 2 years, or whenever there is a material change to the information that would be described in proposed § 507.7(a). For the purposes of proposed § 507.7, a material change would be one that changes whether or not a facility is a “qualified facility.” The status of a facility as a qualified facility has the potential to change materially on an annual basis. For example, if a facility reports that it is a very small business (i.e., under one option identified in proposed § 507.3, has less than $500,000 in total annual sales of animal food, adjusted for inflation), its total annual sales of animal food likely would change on an annual basis, and could change so as to exceed $ 500,000. Likewise, if a facility reports that it otherwise satisfies the definition of a qualified facility, its total annual sales of animal food and value of animal food sold to qualified end users as compared to other purchasers likely would change on an annual basis, and could change so as to no longer satisfy the definition of a qualified facility.
Consistent with section 418(l)(2)(B)(ii) of the FD&C Act, the Agency intends to issue guidance regarding documentation that would be submitted under proposed § 507.7(a)(1) to demonstrate that a facility is a qualified facility. As discussed in sections VIII.D.2.a and VIII.D.2.b, the Agency tentatively concludes that certified statements from the owner, operator, or agent in charge of a qualified facility would be acceptable for the purposes of satisfying the requirements that would be established in proposed § 507.7(a)(1) and (a)(2).
To inform the guidance required under section 418(l)(2)(B)(ii) of the FD&C Act and any other guidance that may be useful in addressing questions regarding submission of documentation under this subpart, in this document the Agency requests comment on an option it is considering regarding the submission of documentation. Specifically, the Agency requests comment on the efficiency and practicality of submitting the required documentation using the existing mechanism for registration of food facilities, with added features to enable a facility to identify whether or not the facility is a qualified facility. A facility that does not identify itself as a qualified facility would not be prompted to provide additional information under proposed § 507.7(a).
A facility that identifies itself as a qualified facility would be prompted to provide the following information by checking items that apply. Such items could include:
• Whether the facility satisfies the conditions for a qualified facility:
○ As a very small business as that term would be defined in proposed § 507.3;
○ As a facility that otherwise satisfies the definition of qualified facility in proposed § 507.3 based on average monetary value of sales and value of animal food sold to qualified end users as compared to other purchasers; or
○ Both of the conditions.
• Whether the facility:
○ Has identified the potential hazards associated with the animal food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective;
○ Is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries; or
○ Both of the conditions.
In essence, such a system would provide for self-certification that the facility has appropriate information demonstrating that the facility is a qualified facility and either has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the implementation of the preventive controls to ensure that such controls are effective; or is in compliance with State, local, county, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries. Such a system may include a statement reminding submitters that anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties under 18 U.S.C. 1001. Using such a system, a qualified facility could update the documentation required by proposed § 507.7(a) during the biennial registration required by section 415(a)(3) of the FD&C Act.
Proposed § 507.7(d) would require that a qualified facility that does submit the type of documentation directed to food safety practices described in § 507.7(a)(2)(i) provide notification to consumers as to the name and complete business address of the facility where the animal food was manufactured or processed (including the street address or P.O. box, city, State, and zip code for domestic facilities, and comparable full address information for foreign facilities) consistent with section 418(l)(7) of the FD&C Act. If an animal
Proposed § 507.7(d) would enable consumers to contact the facility where an animal food was manufactured or processed (e.g., if the consumer identifies or suspects a food safety problem with a product) irrespective of whether the animal food product bears a label. The use of the term “business address” in section 418(l)(7) of the FD&C Act contrasts with Congress' use of a different term, “place of business,” in section 403(e) of the FD&C Act (21 U.S.C. 343(e)). Section 403(e) provides that foods in package form are misbranded unless the product label bears the name and place of business of the manufacturer, packer, or distributor of the food. The Agency's regulations interpret “place of business” as requiring only the firm's city, state, and zip code to appear on the product label, as long as the firm's street address is listed in a current telephone directory or other city directory (21 CFR 501.5(d)). The Agency tentatively concludes that the use of the term “business address” in section 418(l)(7) demonstrates Congress' intent to require the facility's full address, including the street address or P.O. box, to appear on labels or other required notifications when the facility has opted to not submit documentation directed to food safety practices under section 418(l)(2)(B)(i)(I) of the FD&C Act. If Congress had considered the less complete address already required under section 403(e)(1) of the FD&C Act and the “place of business” labeling regulation (§ 501.5(d)) to be adequate for notification to consumers for animal foods required to bear labels, there would have been no need to impose a new, more specific requirement in section 418(l)(7) for the facility's “business address” to appear on the food label. When proposed § 507.7(d) would apply to an animal food for which a food packaging label is required under any other provision of the FD&C Act, the complete business address would substitute for the “place of business” required under section 403(e)(1) of the FD&C Act and § 501.5(d) and would not impose any requirement for a label that would be in addition to any label required under any other provision of the FD&C Act. The Agency asks for comment on this interpretation.
Proposed § 507.7(e) would require that a qualified facility maintain records relied upon to support the documentation that would be required by § 507.7(a). Proposed § 507.7(a) would not require that a qualified facility establish any new records, but merely retain those that the facility relied upon to support the documentation that would be required by proposed § 507.7(a). Proposed § 507.7(e) would establish that the records that a qualified facility must maintain are subject to the requirements of subpart F of part 507. As discussed in section XII, proposed subpart F would provide the general requirements that apply to all records required to be established and maintained by proposed part 507, including provisions for retention of records and for making records available for official review. Together, proposed § 507.7(a) and (b) would make the underlying records qualified facilities would rely on to support their self-certifications available to FDA upon request. The Agency tentatively concludes that it is appropriate to require that the records relied upon to support a self-certified statement be retained and made available to FDA upon request.
Section 418(m) of the FD&C Act provides, in relevant part, that “[t]he Secretary may, by regulation, exempt or modify the requirements for compliance under [section 418 of the FD&C Act] with respect to facilities that are solely engaged in . . . the storage of packaged foods that are not exposed to the environment.”
In a letter dated July 22, 2011, an industry coalition of the American Bakers Association, the American Frozen Food Institute, the Grocery Manufacturers Association, the International Bottled Water Association, the International Dairy Foods Association, the International Warehouse Logistics Association, the Peanut and Tree Nut Processors Association, and the Snack Food Association (the section 418(m) petitioners) submitted a citizen petition (Docket No. FDA–2011–P–0561). The petition requests that FDA issue regulations under section 418(m) of the FD&C Act “to exempt from compliance or modify the requirements for compliance under section 418 [of the FD&C Act] for facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment, by allowing such facilities to satisfy the requirements of that section through compliance with the [CGMPs] mandated for such facilities by [current] § 110.93.” For full discussion of this petition, please see the discussion in section X.D of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency tentatively agrees in part, and disagrees in part, with the section 418(m) petitioners. As discussed more fully in the paragraphs that follow, FDA agrees that it is appropriate for facilities solely engaged in the storage of unexposed packaged animal food to be exempt from the requirements that would be established in proposed subpart C, provided that the animal food does not require time/temperature control for safety. For unexposed packaged animal food that requires time/temperature control for safety, FDA disagrees that such an exemption is warranted, but tentatively concludes that unexposed packaged animal food that requires time/temperature control for safety could be subject to modified requirements rather than to the full requirements that would be established in proposed subpart C.
The Agency disagrees that warehouse operators do not have access to information relevant to conducting a hazard analysis and establishing risk-based preventive controls. The principal hazard that would be identified in any hazard analysis for unexposed packaged animal food is the potential for the growth of, or toxin formation by, microorganisms of animal or human health significance when an unexposed refrigerated packaged animal food requires time/temperature control for safety. Information about this hazard and appropriate preventive controls for this hazard is widely available (Refs. 39, 40, and 41). For example, the 2009 Edition of FDA's Food Code defines “Potentially Hazardous Food (Time/Temperature Control for Safety Food)” as a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin
FDA also disagrees that proposed § 507.28 alone would be adequate for addressing environmental problems such as a flood in the facility and pest control problems, even though the animal food in question is not exposed to the environment and pest control problems with the container would likely be visible to the warehouse operator. However, FDA tentatively concludes that proposed § 507.28, along with other applicable provisions of proposed part 507, subpart B, such as pest control in proposed § 507.19, do adequately address most safety-related issues that may arise in facilities solely engaged in the storage of unexposed packaged animal food. FDA disagrees that proposed § 507.28, or other provisions in proposed part 507, subpart B, justifies the exemption from all preventive control requirements sought by the petitioners in the specific case of unexposed refrigerated packaged animal food that requires time/temperature control for safety (later in this document stated as unexposed refrigerated packaged TCS animal food). As discussed more fully in section X.I, such animal food requires the implementation of an appropriate preventive control (temperature), monitoring that control, taking corrective actions when there is a problem with that control, verifying that the control is consistently implemented, and establishing and maintaining records documenting the monitoring, corrective actions, and verification. FDA tentatively concludes that it is appropriate to distinguish between packaged animal food that requires such time/temperature control and packaged animal food that does not.
FDA also disagrees that an exemption provided under section 418(m) of the FD&C Act should be established in a manner that has the potential to be interpreted more broadly than section 418(m) provides. The section 418(m) petitioners request that FDA establish a provision that “A facility that is engaged solely in the storage, holding, warehousing, or distribution of packaged foods that are not exposed to the environment shall be exempt from the requirements of section 418 [of the FD&C Act]”, whereas section 418(m) provides discretion for an exemption “with respect to facilities that are solely engaged in . . . the storage of packaged foods that are not exposed to the environment.” Under proposed § 507.3, “holding” would mean storage of animal food, and holding facilities would include, relevant to unexposed packaged animal food, warehouses and cold storage facilities. To the extent that a facility that is engaged solely in “warehousing” or “distribution” of unexposed packaged animal food is merely “storing” or “holding” the animal food, an exemption established using the language provided by section 418(m) would apply to that facility. However, to the extent that a facility that is engaged solely in “warehousing” or “distribution” of unexposed packaged animal food is not merely “storing” or “holding” the animal food, an exemption established using the language provided by section 418(m) would not apply to that facility.
In response to the petition, FDA is proposing to establish an exemption from subpart C for facilities solely engaged in the storage of unexposed packaged animal food (proposed § 507.10). FDA also is proposing to establish modified requirements at such facilities to require that the owner, operator, or agent in charge of such a facility comply with modified requirements for any unexposed refrigerated packaged TCS animal food (proposed § 507.48). See the discussion of proposed § 507.10 in the next section and the discussion of proposed § 507.48 in section X.I.
Proposed § 507.10(a) would provide that subpart C does not apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment. Proposed § 507.10(b) would establish that unexposed packaged animal food at such facilities is subject to modified requirements that would be established in proposed § 507.48. As discussed more fully in section X.I, the modified requirements would mandate that such a facility establish and implement appropriate temperature controls, monitor the temperature controls, take corrective actions, verify that the temperature controls are consistently implemented, and establish and maintain records documenting the monitoring, corrective actions, and verification activities for unexposed refrigerated packaged TCS animal food. These modified requirements would be a subset of the proposed requirements that would be established in subpart C.
There are limited routes of contamination for unexposed packaged animal food in a facility that solely stores unexposed packaged animal food (e.g., packaged animal food in containers in a warehouse). Contamination can occur, for example, if rodents gnaw through packages or if human waste from an improperly maintained toilet facility spills and seeps into paper-based packaging. However, with one exception, the CGMP requirements in proposed subpart B (e.g., proposed §§ 507.17, 507.19, 507.20, and 507.28) would apply to the storage of unexposed packaged animal food and be adequate to prevent such contamination so that it would not be necessary for the owner, operator, or agent in charge of a facility to address these routes of contamination by applying the hazard analysis and risk-based preventive controls that would be established in proposed subpart C. The exception would be for the rare circumstances in which RACs are packaged in a manner in which the RACs are not exposed to the environment. An establishment solely engaged in storing RACs would be exempt from CGMPs in proposed subpart B. Such an establishment would continue to be subject to section 402(a)(4) of the FD&C Act. An establishment that is solely engaged in the storage of packaged RACs that are not exposed to the environment may find the provisions of proposed subpart B helpful in ensuring compliance with section 402(a)(4) of the FD&C Act.
Many of the requirements that would be established in proposed subpart C would be directed to manufacturing, processing, and packing animal food and would not apply to the storage of unexposed packaged animal food that does not require time/temperature control for safety. This is the case for:
• Process controls (proposed § 507.36(d)(1));
• Sanitation controls (proposed § 507.36(d)(2));
• Monitoring of process controls and sanitation controls (proposed § 507.39);
• Corrective actions (proposed § 507.42);
• Verification (including initial validation) of process controls (proposed § 507.45); and
• A recall plan (proposed § 507.38) (recalls generally are initiated by the manufacturer, processor, or packer of the animal food).
FDA tentatively concludes that the outcome of a hazard analysis for storage of unexposed packaged animal food that does not require time/temperature control for safety is that there are no hazards reasonably likely to occur. FDA also tentatively concludes that there would be little animal and human health benefit to requiring the owner, operator, or agent in charge of each facility solely engaged in the storage of such animal food to conduct its own hazard analysis and document that outcome in its own animal food safety plan. Likewise, FDA tentatively concludes that there would be no need for the facility to establish and implement preventive controls, with corresponding monitoring, corrective actions, or verification (including validation), because there would be no hazards reasonably likely to occur to trigger such activities. FDA also tentatively concludes that there would be no need for a qualified individual to conduct activities such as preparing the animal food safety plan (proposed § 507.30(c)); validating the preventive controls (proposed § 507.45(a)); reviewing records for implementation and effectiveness of preventive controls and appropriateness of corrective actions (proposed § 507.45(c)); or performing reanalysis of the animal food safety plan (proposed § 507.45(e)(4)), because the facility would not need to conduct these activities. Thus, with the exception of the unexposed refrigerated packaged TCS animal food, FDA tentatively concludes that the animal food safety system that would be established in proposed subpart C is not needed to significantly minimize or prevent the occurrence of hazards that could affect unexposed packaged animal food at a facility solely engaged in the storage of such animal food.
The purpose of proposed § 507.10(b) is to make clear that although a facility solely engaged in the storage of unexposed packaged animal food is exempt from subpart C, such a facility is subject to modified requirements that would be established in proposed § 507.48. These requirements would apply to the storage of unexposed refrigerated packaged TCS animal food. The Agency explains the basis for those proposed requirements in section X.I.
The preventive controls system will result in controls that are specific to each facility based on the hazards it identifies and the controls it determines are necessary to control such hazards. Although FDA has had general baseline controls that apply to most establishment manufacturing, processing, packing, and holding human food in its current good manufacturing regulations under part 110, FDA has not had such baseline controls for facilities manufacturing, processing, packing, and holding animal food. The animal food industry, as well as governmental entities and international bodies, have recognized the need for basic safety and sanitation measures that apply across the board to facilities handling animal food. The AAFCO passed its “Model Good Manufacturing Practice Regulations for Feed and Feed Ingredients” in August 2009 and published them in 2010 in the AAFCO
The Codex Animal Production and Health Manual of Good Practices for the Feed Industry is a collaborative effort between the Food and Agriculture Organization (FAO) of the United Nations, and the International Feed Industry Federation, with significant contributions from members of a number of national feed industry trade associations, members of individual companies within the feed industry, and animal feed experts from universities. The good manufacturing practices (GMPs) described in Section 3 (Ref. 43) of the manual are practices and procedures intended to ensure the safety and suitability of animal food throughout the feed chain, and provide for such practices and procedures to be implemented in the following areas: Buildings and facilities; location of feed establishment; design and layout; internal structure and fittings; water supply; cleaning facilities; air quality, temperature and ventilation; lighting; equipment; personal hygiene; cleaning; maintenance; pest control; waste; drains; storage; transport; and training.
The Prerequisite Programmes for Food Safety in the Manufacture of Food and Feed for Animals (Publicly Available Specification (PAS) 222) (Ref. 44) were prepared by the British Standard Institution and the PAS 222 Steering Group, with sponsorship by Safe Supply of Affordable Food Everywhere. The British Standard Institution is an independent, private, non-governmental, non-industry organization that develops standards for a variety of industries. It is the standards setting body of the United Kingdom (Ref. 44). The steering group was made up of members from Agriculture Industries Confederation, Cargill, FAO, Foundation for Food Safety Certification, Land O'Lakes, Nestle, and Nutreco. PAS 222 specifies requirements addressing the following areas: Site and associated utilities; processes, including workspaces and employee facilities; supplies of air, water, and other utilities; supporting services, including waste disposal; suitability of equipment and accessibility for cleaning, maintenance, and preventive maintenance; management of ingredients; management of medications; measures for the prevention of contamination; sanitation; pest control; personnel hygiene; rework; product withdrawal procedures; warehousing and transportation; formulation of products; specifications for services; training and supervision of personnel; product information; and food defense, biovigilance, and bioterrorism.
The GMPs described previously are the product of efforts by government, industry, and international animal health organizations. They are very
In addition to the risk to animals, the proposed animal food CGMPs address risks to human health from individuals handling animal foods or individuals consuming products from food-producing animals. The human food CGMPs in part 110 are designed to address risks to humans, and the Agency has experience and expertise in the human food CGMPs. Therefore, after considering the animal food CGMP documents from the previously mentioned organizations, and the Agency's CGMP regulations for human food, the Agency tentatively concludes that the human food CGMPs provide an appropriate starting point for the animal food CGMPs. The Agency requests comments on this tentative conclusion. The CGMPs proposed here in subpart B for animal food address the same areas as the current human food CGMPs in part 110 and the proposed revisions that would be incorporated into proposed part 117 (under the proposed rule for preventive controls for human food published (78 FR 3646)) and cover the following areas: Personnel; plant and grounds; sanitary operations; sanitary facilities and controls; equipment and utensils; processes and controls; and warehousing and distribution.
The proposed animal food CGMPs are not identical to the current and proposed human food CGMPs. The proposed animal food CGMPs do not address “cross-contact”, which for human foods is related to the inadvertent incorporation of allergens into foods. The Agency is not aware of evidence indicating that foodborne allergens pose a significant health risk to animals, or to humans through handling animal food. In addition, the proposed animal food CGMPs do not include a provision related to raw materials and ingredients, including rework susceptible to contamination with pests, undesirable microorganism, or extraneous materials complying with FDA regulations for natural or unavoidable defects if a manufacturer wishes to use such materials in manufacturing such food. Unlike for human food, there is no agency regulation for natural or unavoidable defects for animal foods at this time. The proposed animal food CGMPs do not include the limitation in the current human food CGMPs (part 110) that food manufacturing areas and equipment used for manufacturing human food must not be used to manufacture nonhuman food grade animal food or inedible products, unless there is no reasonable possibility for contamination of the human food. The Agency does not consider such a limitation necessary for ensuring the safety of animal food, if the animal food is subject to the proposed CGMPs.
While FDA has tentatively concluded that CGMPs similar to those for human food would be appropriate for animal food, the Agency understands that animal food is produced in a wide diversity of facility types, from small portable animal food mixing units that travel from farm to farm, to large facilities that manufacture food for multiple species of livestock and pets. The Agency is also aware that once the animal food is produced, it may be fed to animals in environments and on surfaces that are not clean. However, basic sanitation measures for animal food are important. For example, the 2010
To emphasize the need for required CGMPs in the animal food industry, the following are actual observations from the FDA 483, List of Observations for a feed mill associated with the
“8. On xx/xx/10, the following observations were noted at the ****** Feed Mill located at *****, IA:
Specifically,
• Birds were observed roosting and flying, chicks heard chirping in the storage and milling facility. In addition, nesting material was observed in the feed mill closed mixing system, ingredient storage and truck filling areas.
• Raw ingredient bins and feed sensors accessible from the roof of the facility had rusted holes and feed grain level sensors ajar in the outdoor environment. These include:
• Ingredient storage bin 12 containing slat, had a rusted gap about a
• Ingredient storage bin 21 containing ground corn had a hole approximately 3 inches by
• At the base of the feed grain level sensor leading into ingredient storage bin 21, containing ground corn, there was an open hole.
• Feed grain level sensor leading into ingredient storage bin 7, containing meat and bone meal, was off to the side with approximately a 2 inch gap. Avian like feces was observed on top to this feed sensor.
• Finished feed tanks 4 and 18 did not have covers on top of the finished feed tank chutes.
• Outdoor whole kernel corn grain bins 4 and 6 observed to have the top side doors/lids open to the environment and pigeons were observed entering and leaving these opening. Birds were also observed sitting/flying around and over openings.”
In addition to the previous observations, environmental samples collected from a top floor outlet location and two second floor covers all tested positive for
Whether animal food was the source of this
As discussed in section II.E, the CDC reported that in a 2006–2007 multi-state outbreak, 79 human cases of salmonellosis were subsequently linked to
The previous examples demonstrate that failure of an animal food facility to control the overall plant production environment, whether the plant manufactures, processes, packs, or holds food for pets or for food-producing animals, can and does result in human disease. In addition, regulations addressing the production of human food obtained from animals do not address the safety or production of animal food being fed to those food-producing animals. The Agency concludes that the previously described situations point to the need for this proposed rule for animal food, including the need for CGMPs.
The Agency realizes that there is a spectrum of animal food producers and production facilities and that the hazards and risks can vary greatly. Therefore the Agency is requesting comment on its thinking that CGMPs similar to those for human food are appropriate for animal food. The Agency is also requesting comment on whether CGMP requirements that would be more appropriate for some types of animal food may not be appropriate for other types, and, if so, how the Agency can or should distinguish between those types during the various stages of animal food processing.
The need for enforceable baseline standards for producing safe animal food was a major consideration in FDA's decision to propose CGMPs as part of its preventive controls regulations. Animal food facilities that are not subject to section 418 of the FD&C Act would be required to meet these baseline practices proposed in these CGMPs to prevent contamination of animal food. Facilities that are already adhering to trade association best practices, international standards described above, AAFCO model GMPs, or State animal feed regulations, may have their own strong quality control programs in place and may already be satisfying the CGMP requirements proposed here. Those firms that do not have such practices in place would have to implement them under this proposed rule, or be subject to enforcement action by FDA.
FDA is proposing in § 507.14 to require that personnel in animal food facilities conform to hygienic practices and receive appropriate training to protect against contamination of animal food. Section 507.14(a) would require that employees with an illness or open lesion that could reasonably be a source of contamination of animal food report the condition to their supervisor and refrain from performing activities that could result in contamination of animal food.
This proposed requirement is similar to PAS 222 at 13.5, which requires persons known or suspected to be infected with, or carrying, a disease or illness transmissible through animal feed intended for feeding within the home to be prevented from handling such food and food contract surfaces. Codex animal food CGMPs include a similar provision for all food employees who may be carriers for any disease or illness likely to be transmitted through animal food (Refs. 2 and 44).
Proposed § 507.14(a) would also require that while on duty employees maintain adequate personal cleanliness as appropriate for the activities they are performing. For example, employees would be required to wash their hands before starting work and at any other time when the hands become soiled or contaminated. The Agency is not proposing to require that employees wash their hands after each absence from the work station, as in the human food CGMPs, because in the animal food industry employee responsibilities are not typically limited to work stations. Employees would also need to secure jewelry and other objects such as personal belongings, tools, and writing implements to prevent them from falling into animal food, and store clothing and personal belongings in areas where they will not contaminate animal food. The Agency has received RFR reports of foreign objects such as pieces of a metal tape measure, plastic pieces from a hard hat, stainless steel shavings, and fragments of a soda can that were mixed into the animal food. In most of these reports, animal deaths occurred due to the consumption of the foreign objects in the food (Ref. 48).
For animal food, the Agency is not proposing some of the requirements in the human food CGMPs as proposed part 117. FDA tentatively concludes that certain requirements are necessary for ensuring the safety of animal food across the board, while other precautions may be important for some animal food facilities and not others, depending on the type of animal food handled at the facility, the species for which the animal food is intended, and whether human consumers could come into direct contact with the animal food, among other considerations. For example, the Agency is not proposing specific requirements for: Employees to wear certain types of outer garments; maintenance of gloves; wearing, hair nets, beard covers, etc.; confining certain activities to areas other than where animal food may be exposed or where equipment or utensils are washed; or specifying the foreign substances for which necessary precautions must be taken to protect against contamination of animal food, animal food-contact surfaces, or animal food packaging materials. The animal food proposed rule includes a general provision that would require the establishment to take any other necessary precautions to protect against contamination of animal food, animal food-contacts, or animal food packing materials. This broad provision would allow the individual facility to determine if it needed to use outer garments, hairnets, etc. for the particular animal food being manufactured, processed, packed, or held at that facility. FDA tentatively concludes that this approach is appropriate when considering the diversity of the animal food industry.
Both the PAS 222 and the Codex animal food CGMPs address these areas,
Proposed § 507.14(b) would recommend that personnel responsible for identifying plant sanitation failures or animal food contamination should have a background of education or experience to provide a level of competency necessary for production of clean and safe animal food. It would also recommend that animal food handlers and supervisors receive appropriate training in proper food handling techniques, food-protection principals, and be informed about the risks of poor personal hygiene and insanitary practices. The PAS 222, the AAFCO Model animal food CGMPs, and the Codex animal food CGMPs all provide for training of personnel in their areas of responsibility. As discussed in section IX.C, FDA is requesting comment on whether to change the recommendations to requirements for education or training in proper food handling techniques and food-protection principles.
FDA is proposing in § 507.14(c) that responsibility for ensuring compliance with all requirements in subpart B be clearly assigned to competent supervisory personnel.
Plant, as defined in proposed § 507.3, means the building or establishment or parts thereof used in connection with the manufacturing, processing, packing, or holding of animal food. FDA is proposing in § 507.17(a) that the area around a plant be maintained so that it does not serve as a source of contamination of animal food.
Methods for adequately maintaining the grounds around a plant include properly storing equipment, removing litter and waste, and cutting weeds and grass within the immediate vicinity of plant buildings and structures. Litter, waste, tall grass, weed, and old equipment around plants can harbor pests which will try to enter the facility and could contaminate animal food and ingredients. Roads, yards, parking lots, and other areas in the vicinity of the plant would be required to be maintained and adequately drained so as not to contribute to contamination of animal food by seepage, foot-borne filth, or providing a breeding place for pests. Water seepage into animal food ingredients and finished products can promote growth of mold which could produce mycotoxins in the animal food. The PAS 222 (p. 4) contains a provision similar to proposed section 507.17(a). It provides the [s]ites to be maintained in good order. Vegetation shall be tended, removed or otherwise managed to address animal food safety hazards. Roads, yards and parking areas shall be drained to prevent standing water and shall be maintained (Ref. 44).
Proposed § 507.17(b) would require that the plant's size, construction and design allow for cleaning, maintenance, and exclusion of pests. Specifically, this proposed section would require that the size of the plant provide sufficient space to place equipment, store materials, and allow precautions to be taken to prevent contamination of animal food inside the plant and in outdoor bulk vessels. It would also require that construction of the plant be such that floors, walls, and ceilings can be kept clean and in good repair; that condensate from fixtures, ducts, and pipes not contaminate animal food; that there be enough space between equipment and walls to permit employees to perform their duties and protect against contaminating animal food; that lighting be adequate, and lighting fixtures, skylights, and other glass suspended over exposed food be of such construction that in case of breakage, glass does not contaminate animal food; that sufficient ventilation be provided to minimize odors and vapors without contaminating animal food; and that where necessary, adequate screening be provided to protect against pests. Proposed § 507.17(b) would also require that the design and construction of buildings and structures allow for separation of operations, for example by location or time, to reduce the potential for contamination of animal food, animal food-contact surfaces, and animal food-packaging material with microorganisms, chemicals, filth, or other extraneous material.
The Codex animal food CGMPs contain similar provisions that state that locations, design and construction of premises should deter pests and restrict access to pests to a minimum. Building and facilities should be designed to allow easy access for cleaning, including access to the inside of relevant equipment. There should be enough space to satisfactorily conduct all process operations and products inspections. Lighting sources should be sufficient to ensure that hygienic conditions are maintained throughout the product and storage areas. There should be protected lighting fixtures. There should be adequate means of ventilation to minimize airborne contamination of animal food from aerosols and condensation droplets (Ref. 2).
Proposed § 507.19(a) would require that buildings, fixtures, and other physical structures be maintained in sufficient sanitary condition and repair to prevent animal food from becoming adulterated. Equipment and utensils would need to be cleaned and sanitized to protect against contamination of animal food, animal food contact surfaces, and animal food packaging materials. Reports of animal food contamination continue to be reported to the Agency due to improper flushing (cleaning) of equipment. In one incident, a vitamin D supplement for a poultry food was carried over to a dog food. The excessive vitamin D levels in the pet food caused toxicity in the animals consuming the food (Ref. 48). In addition, during facility inspections, FDA has identified forklifts, carts and other material handling equipment as sources of cross contamination between raw ingredients and finished products.
The PAS 222 provides for cleaning programs to be established and documented to maintain hygienic conditions. The Codex animal food CGMPs provide that cleaning should remove residues and dirt that may be a source of contamination. Sufficient standard of cleanliness should be employed to ensure that exposure to pests and pathogens is minimized at all stages of processing, storage, and handling of animal food (Ref. 43).
FDA is proposing in § 507.19(b) that cleaning compounds and sanitizing agents must be free from undesirable microorganisms, and that they must be safe and adequate for the conditions of use. Compliance with this requirement could be verified by any effective means, including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination.
In § 507.19(c), the Agency proposes that only certain types of toxic materials, such as cleaning compounds, laboratory testing reagents, and lubrications for equipment, be used or stored in the plant. In addition these compounds must be identified, held, and stored in a manner that protects against contaminating animal food.
Both the PAS 222 and the Codex animal food CGMPs provide for cleaning and sanitizing agents to be stored separately to minimize the risk of contaminating animal food.
Proposed § 507.19(d) would require that effective measures be taken to
FDA is proposing in § 507.19(e)(1) and (e)(2) that animal food contact surfaces be cleaned as frequently as necessary to protect against contamination of animal food. Cleaning requirements would vary depending, for example, on whether equipment and utensils are used for manufacturing or holding low-moisture animal food, used for wet processing operations, or used in continuous production operations.
Proposed § 507.19(e)(3) would recommend that single-service articles (such as paper cups or paper towels) be stored in appropriate containers. Section 507.19(e)(3) is also proposing that these single-service articles be handled, dispensed, used, and disposed of in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials. As discussed in section IX.C, FDA is requesting comment on whether to change the recommendations to requirements for the storage of the single-service articles in appropriate containers.
Proposed § 507.19(f) recommends that non-animal food-contact surfaces of equipment used in the operation of the plant be cleaned in a manner and as frequently as necessary to protect against contamination of animal food, animal food-contact surfaces, and animal food-packaging materials. As discussed in section IX.C, FDA also is requesting comment on whether to change proposed § 507.19(f) to require rather than recommend that non-animal food-contact surfaces of equipment used in the operation of a food plant be cleaned in a manner and as frequently as necessary to protect against contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.
Proposed § 507.19(g) would recommend that cleaned and sanitized portable equipment with animal food-contact surfaces be stored in a place and in a way that would protect any animal-food contact surfaces from contamination. As discussed in section IX.C, FDA also is requesting comment on whether to change proposed § 507.19(g) to require rather than recommend that cleaned and sanitized portable equipment with animal food-contact surfaces and utensils be stored in a location and manner that protects animal food-contact surfaces from contamination.
In § 507.20(a), the Agency is proposing that the plant's water supply be sufficient for the operations intended and derived from an adequate source. Any water that contacts animal food, animal food-contact surfaces, or animal food-packaging materials would need to be safe and of adequate sanitary quality. For example, steam added to animal food during the pelleting process would be required to be from a water source that is not contaminated with chemicals, such as petroleum, or pesticides. Running water at a suitable temperature and pressure would need to be provided in all areas where required for the processing of animal food, for the cleaning of equipment, utensils, and animal food-packaging materials, or for employee sanitary facilities.
Proposed § 507.20(b) would require that plumbing in the plant be of adequate size and design and adequately installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the plant; (2) properly convey sewage and liquid disposable waste from the plant; (3) avoid constituting a source of contamination to animal food, water supplies, equipment, or utensils or creating an unsanitary condition; (4) provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and (5) ensure that there is not backflow from, or cross-connection between piping systems that discharge waste water or sewage, and piping systems that carry water for animal food or animal food manufacturing.
Proposed § 507.20(c) would require that sewage be disposed of through an adequate sewerage system or through other adequate means.
FDA is proposing in § 507.20(d) that each plant provide its employees with adequate, readily accessible toilet facilities, and that the toilet facilities be kept clean and not serve as a potential source of contamination of animal food, animal food contact surfaces, or animal food-packaging materials. Proposed § 507.20(e) would require that each plant provide hand-washing facilities that are adequate, convenient, and furnish running water at a suitable temperature to ensure that an employee's hands are not a source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials. Proposed § 507.20(f) would require that rubbish be conveyed, stored, and disposed of in such a way that minimizes the development of odors and the potential to attract, harbor, or create a breeding place for pests.
Sanitary facilities and controls are similarly addressed in PAS 222 in sections 5.2 (water supply), 6.2 (containers for waste), 6.3 (waste management and removal), 6.4 (drains and drainage), and 13.2 (personnel hygiene facilities) (Ref. 44). Water supply, cleaning facilities, waste, and drains are also covered in the Codex animal food CGMPs (Ref. 43). Many of the requirements in the proposed CGMPs follow closely to the PAS and CODEX provisions.
The Agency is proposing specific requirements for equipment and utensils used in animal food facilities. Proposed § 507.22(a)(1), (a)(2), and (a)(4) through (a)(6) would require that plant equipment and utensils be designed and constructed to allow for the cleaning and maintenance necessary to ensure that animal food would not be contaminated with non-food-grade lubricants, fuel, metal fragments, contaminated water such as condensate, or other contaminants. These requirements would reduce the likelihood of hazards in the animal food that could come from equipment components, such as coolant from an electrical motor leaking onto food contact surfaces. Animal food contact surfaces of equipment and utensils used in the plant would need to be made of nontoxic materials and resist corrosion from contact with animal food or cleaning and sanitizing agents. Proposed § 507.22(a)(3) would recommend that equipment be installed and maintained in such a way to facilitate the cleaning of that equipment and the adjacent spaces. As discussed in section IX.C, FDA also is requesting comment on whether to change proposed § 507.22(a)(3) to require rather than recommend that equipment be installed and maintained in such a way to facilitate the cleaning of that equipment and adjacent spaces.
Proposed § 507.22(b) would require that seams on food-contact surfaces be maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the
In § 507.22(e), the Agency proposes that freezer and cold storage compartments must be fitted with an indicating thermometer or temperature recording device if the freezer or compartment will be used to store animal food cable of supporting growth of microorganisms.
Proposed § 507.22(f) would require the instruments and controls used for measuring, regulating, or recording various attributes such as temperature, pH, and water activity (a
Proposed § 507.22(g) would require that if compressed air or other gases are mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment, the gas would need to be treated in a way that would not lead to contamination of animal food.
The proposed requirements in § 507.22 are similar to recommendations in the equipment sections of the AAFCO and Codex CGMPs that address the design, construction, and maintenance of equipment to prevent contamination of animal food (Refs. 42 and 43).
Proposed § 507.25(a) addresses operations in the manufacturing, processing, packing and holding of animal food. It would require plant management to ensure that all such operations are conducted in accordance with adequate sanitation principles. In addition, it would require plant management to ensure that appropriate quality control operations are employed so that animal food-packaging materials are safe and suitable, that overall sanitation of the plant is under the supervision of one or more competent individuals assigned responsibility for this function, and that all reasonable precautions are taken so that production procedures do not contribute to contamination from any source. In multiple animal food recalls, the cause of the problem was determined to be
Proposed § 507.25(a) also addresses labeling controls. It would require that containers holding animal food, raw materials, or ingredients be labeled to accurately identify the contents. The Agency considers the correct identification of animal food, raw materials, and ingredients to be an important step in preventing or minimizing inappropriate handling or utilization of the animal food products during their manufacture, processing, packing, or holding. Labeling for finished animal food products would be required to contain the specific information and instructions needed so the food can be safely used for the intended animal species. Properly labeled finished product could prevent, for example, animal food containing micronutrients such as copper or selenium from being fed to animals for which these ingredients could be injurious to health.
FDA's human food CGMPs, on which the Agency is modeling these animal food CGMPs, do not include labeling controls. However, the Agency tentatively concludes that such controls are necessary for animal food, because unlike human food, a finished animal food is often the animal's sole source of nutrition. Animals of different species can be adversely affected by too low or too high levels of certain nutrients in the food. Because of this, it is important that the labeling correctly reflects the contents of the product and provides the necessary information on how to use the product safely for the type of animals being fed.
The AAFCO Model animal food CGMPs include labeling controls. It provides that a label or other unique identifier shall be affixed to, or accompany, feed and/or feed ingredients to maintain identity and facilitate safe and effective use. Labels shall be stored, handled and used in a manner that minimizes errors. Obsolete labels shall be discarded promptly (Ref. 42). The PAS 222 provides that information on content and intended use of animal food products shall be communicated to customers, for example, on a product label. It also requires that procedures be in place detailing the correct labeling of products in accordance with applicable regulations (Ref. 44).
FDA is proposing in § 507.25(b) that raw materials and ingredients be inspected and segregated or otherwise handled as necessary to ensure that they are clean and suitable for processing into animal food and stored under conditions that will protect against contamination and deterioration and that water used for washing, rising, or conveying animal food must be safe and of adequate sanitary quality. If water is reused, it must not increase the level of contamination of animal food. This section would also require that raw materials and ingredients including rework, be held in bulk, or in containers designed and constructed to protect against contamination, and be held at a temperature, relative humidity, and manner that would prevent the animal food from becoming adulterated. Material scheduled for rework would need to be identified as such. In addition, proposed paragraph (b) would require that raw materials and ingredients must either not contain levels of microorganisms that are reasonably likely to cause illness or injury to animals, or be processed or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated. Raw materials and ingredients susceptible to contamination with aflatoxin or other natural toxins would need to be in compliance with current FDA regulations for any poisonous or deleterious substances before these materials or ingredients are incorporated into finished animal food. Raw materials received frozen, such as raw meat for raw pet food, would need to be kept frozen until use. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and ingredients from becoming adulterated. Raw materials received and stored in bulk form would need to be held in a manner that protects against contamination.
Proposed § 507.25(b)(1)(iv) would recommend that containers and carriers of raw materials be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of animal food. Visual inspection alone could identify certain physical hazards in incoming raw materials and ingredients and prevent certain contaminated ingredients from being added to animal food. As discussed in section IX.C, FDA also is
Proposed § 507.25(c) would require that equipment, utensils, and finished animal food containers used in manufacturing operations be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. All animal food manufacturing, processing, packing, and holding would need to be conducted under conditions that minimize the potential for the growth of microorganisms and contamination of animal food. Animal food that can support the rapid growth of undesirable microorganisms would be required to be held at temperatures that will prevent the animal food from becoming adulterated during manufacturing, processing, packing and holding. Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling water activity that are taken to destroy or prevent the growth of undesirable microorganisms would need to be adequate under the conditions of manufacturing, handling, and distribution to prevent animal food from being adulterated. Effective measures would also need to be taken to protect against the inclusion of metal or other extraneous material in animal food. Animal food, raw materials, and ingredients that are adulterated would need to be disposed of in a manner that protects against the contamination of other animal food or, if the adulterated animal food is capable of being reconditioned, be reconditioned using an effective method that has been proven to be safe.
Proposed § 507.25(c)(10) would recommend that animal food be protected from contaminants that my drip, drain, or be drawn into the food. Section 507.25(c)(11) is proposing to recommend that when heat blanching is required in the preparation of animal food, be effected by heating the animal food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the animal food or passing it to subsequent manufacturing without delay. Proposed paragraph (c)(11) of this section also would recommend that thermophilic growth and contamination in blanchers be minimized by the use of adequate operating temperatures and by periodic cleaning. As discussed in section IX.C, FDA also is requesting comment on whether to change proposed § 507.25(c)(10) and (c)(11) from recommendation to requirements.
Proposed § 507.28(a) would require storage and transportation of animal food to be conducted under conditions that will protect against biological, chemical, physical, and radiological contamination of animal food, as well as against deterioration of the animal food and the container. Establishing a process to control warehouse and distribution practices ensures that the inventory is depleted before the products have deteriorated or decomposed to the point where a hazard develops that would require a preventive control measure. Conveyances used to distribute animal food, including trucks or rail cars, would need to be in a condition that would not contaminate animal food. The Agency is concerned about animal food being adulterated due to improper clean out of conveyances. In one reported incident, recycled broken glass was not completely cleaned out of a tractor trailer used to ship a cattle feed resulting in the glass being dispersed throughout the animal food when it was delivered to the farm (Ref. 48). Additional incidents of incomplete truck clean out include urea contamination of cattle feed that resulted in illness and death to the animals that ingested it (Ref. 48). Animal food that is loaded into a conveyance concurrently with materials that could contaminate the food would need to be properly protected, or loaded onto a separate conveyance. Deterioration of the animal food leading to spoilage or loss of nutrient value would need to be prevented, for example by using properly enclosed conveyances with functioning refrigeration units for animal food requiring temperature control, and by using a stock rotation system during storage.
The Codex animal food CGMPs provide that all means of transport should be appropriately cleaned to control and minimize the risk of contamination. Such vehicles should be subject to regular cleaning and sanitizing programs to ensure clean transport conditions and no accumulation of residual material (Ref. 2). The AAFCO Model animal food CGMPs provide that vehicles used to transport animal food be inspected for cleanliness and structural integrity prior to loading and that feed ingredients or other materials or substances that may pose a risk of adulterating feed or ingredients must not be loaded onto the same vehicle unless measures are taken to minimize such risk (Ref. 42).
In this section, the Agency requests comment on whether non-binding (should) provisions in proposed subpart B of proposed part 507, should be changed to required (must) provision in the final rule.
The Agency believes that all of the proposed CGMP provisions, including the “should” provisions, are science-based and an important part of a modern food safety system. Because these non-binding provisions have been in place for decades for human food in current part 110, they are widely used and commonly accepted in many sectors of the human food industry. Similarly, the animal food industry is familiar with the principles behind these non-binding provisions. In addition, under section 418(o)(3) of the FD&C Act, the procedures, practices, and processes described in the definition of preventive controls may include sanitation procedures for food contact surfaces of utensils and equipment; supervisor, manager, and employee hygiene training; and CGMPs under part 110 (or any successor regulations).
The costs related to a fully mandatory sanitary operations, process, and controls program would be for the additional time that workers spend in compliance with those parts of proposed §§ 507.19 and 507.20 that are changed from “should” to “must.” That alternative, when implemented as part of a preventive approach, would impose incremental annual costs to qualified facilities. Those incremental costs have not been estimated due to a lack of data on current compliance with this alternative at those facilities and the incremental work efforts that would be required with these changes. Most non-qualified facilities would have met the requirements by following the requirements for sanitation controls in subpart C. Those that do not have hazards that are reasonably likely to occur or those with sanitation controls that do not fully address the requirements of the sanitary operations, however, would need to review their operations and implement additional procedures.
Table 1 identifies each of the potential differences in the CGMPs in proposed part 507 subpart B that would establish requirements (musts) instead of recommendations (shoulds) and either explains the reason for establishing the requirement or, for such differences with longer explanations, refers to the section where the potential requirement is explained.
Proposed § 507.14(b), provides guidance that personnel responsible for identifying sanitation failures or animal food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe animal food. Proposed § 507.14(b) further recommends that animal food handlers and supervisors receive appropriate training in proper animal food handling techniques and animal food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.
As discussed in section II.A.1 of the document for the proposed rule for preventive controls for human food (78 FR 3646), a CGMP Working Group Report identified specific areas that presented an opportunity to modernize the CGMP regulation for human food. One recommendation was to “require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products. This training must be delivered in a manner that can be easily understood by the worker. Food processors must maintain a record of this training for each worker” (Ref. 49). The Agency's analysis of human food recalls also indicates that ineffective employee training was a root cause of 32 percent of CGMP-related recalls in the 1999–2003 analysis (Ref. 50); deficiencies in training were identified as a contributing factor in 24 percent of CGMP-related primary recalls in the 2008–2009 analysis (Ref. 51). While the Agency does not currently have animal food CGMP regulations to enable it to analyze animal food recalls based on CGMP violations, it believes that these trends of recalls in the human food facilities due to ineffective employee training would be found in the animal food industry as well. In addition, as discussed with respect to the proposed definition of preventive controls (see section VIII.B), section 418(o)(3) of the FD&C Act recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training (section 418(o)(3)(B)) and CGMPs under part 110 (section 418(o)(3)(F)) as some of the procedures, practices, and processes that may be included as preventive controls.
The vast majority of costs related to a mandatory education and training program would be for the time that workers would be training rather than in production. Lacking data on the education and training programs offered by animal food production facilities, FDA used responses to a 2010 survey of human food production facilities to gauge training needs. The Agency estimates that this alternative, when implemented as part of a preventive approach, could impose an annual cost of $1,136 for those facilities with 10 production employees to $18,300 for those with 200 production employees and that do not already comply with this alternative. This would result in an estimated total annual cost of $11.0 million for domestic and foreign animal food facilities (Ref. 52).
The Agency requests comment on how best to revise proposed § 507.14(b) in light of section 418(o)(3) of the FD&C Act and the recommendations of the human food CGMP Working Group with respect to training. Should the Agency replace the proposed recommendations for personnel education and experience with requirements? Doing so would be consistent with the emphasis in section 418(o)(3) of the FD&C Act on the importance of both training and CGMPs in preventing hazards from occurring in animal foods in its definition of preventive controls and with the recommendation in the human food CGMP Working Group Report. If so, what is the appropriate level of specificity? For example, should the Agency simply replace the “shoulds” in the proposed § 507.14(b) with “musts”? This would provide flexibility for each establishment to determine the type and frequency of education and training appropriate for its personnel.
FDA also requests comment on whether more detail would be appropriate, by, for example:
• Specifying that each person engaged in animal food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) receive training as appropriate to the person's duties;
• Specifying the frequency of training (e.g., upon hiring and periodically thereafter);
• Specifying that training include the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene, as applied at the facility; and
• Specifying that records document required training of personnel and, if so, specifying minimum requirements for the documentation (e.g., the date of the training, the type of training, and the person(s) trained).
The Agency also requests comment on whether to establish some or all of the potential requirements for education and training in subpart B, subpart C, or both. If the Agency establishes a requirement for education and training in subpart B, that requirement would apply to all persons who manufacture, process, pack, or hold animal food, with the exceptions of persons who would be exempt from subpart B (e.g., under proposed § 507.5(a) and (h), a requirement in subpart B would not apply to farms, or the holding or transportation of one or more raw agricultural commodities as defined in section 201(r) of the FD&C Act). On the other hand, if the Agency establishes a requirement for education and training in subpart C, that requirement would not apply to persons who would be exempt from the requirements of proposed subpart C (e.g., qualified facilities).
Section 418(h) of the FD&C Act requires that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act] to address those hazards. Section 418(h) of the FD&C Act also requires such written plan, together with the documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.
Proposed § 507.30(a) would specify that the owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan. The Agency uses the term “written food safety plan” in proposed § 507.30(a) to mean the “written plan” referred to in section 418(h) of the FD&C Act. To make clear that the written plan is related to animal
In drafting the proposed requirements for subpart C described in the paragraphs that follow, the Agency uses wording and formatting that is in some cases slightly different from analogous provisions in the proposed rule for preventive controls for human food published (78 FR 3646). Two types of differences are meant to be substantive: Those relating to ready-to-eat food and those relating to food allergens. Both of those concepts are not applicable in the animal food context. In addition, proposed subpart C of proposed part 507 addresses nutrient imbalances, which are relevant to animal food but not, for the most part, to human food. Otherwise, provisions in proposed subpart C of proposed 507 are meant to have the same meaning as the analogous provisions in proposed subpart C of proposed rule for human food.
Proposed § 507.30(a) would require that the plan be written as is expressly required by section 418(h). A written food safety plan is essential for the facility to implement the plan consistently, train its employees, and periodically reanalyze and update the plan. It is also essential to a facility's food safety team, to auditors, and to inspectors. Proposed § 507.30(a) would implement section 418(h) of the FD&C Act. Proposed § 507.30(a) would provide flexibility for the owner, operator, or agent in charge of the facility to either prepare the written food safety plan or have that plan prepared, in whole or in part, on its behalf. In addition, proposed § 507.30 would provide flexibility for facilities in the development of their food safety plans by allowing facilities to group animal food types or production method types if the hazards, control measures, parameters, and required procedures such as monitoring are essentially identical.
Proposed § 507.30(a) would require that the owner, operator, or agent in charge of a facility implement the written food safety plan. Although section 418(h) of the FD&C Act is silent with respect to implementation of the required written plan, other provisions of section 418 address implementation. For example, section 418(c) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility both establish and implement preventive controls (emphasis added). In addition, other provisions of section 418 (e.g., section 418(d) regarding monitoring, section 418(e) regarding corrective actions, and section 418(f) regarding verification) all establish requirements related to the preventive controls required under section 418(c). As discussed later in this section of the document, the written food safety plan would include the hazard analysis required under section 418(b) of the FD&C Act, the preventive controls required under section 418(c) of the FD&C Act, the monitoring procedures required under section 418(d) of the FD&C Act, the corrective action procedures required under section 418(e) of the FD&C Act, the verification procedures required under section 418(f) of the FD&C Act, and the recall plan as authorized by section 418(o)(3)(E) of the FD&C Act. Specific provisions for implementing these sections of the statute would be established throughout proposed subpart C.
Proposed § 507.30(b) would specify the food safety plan must be prepared by (or its preparation overseen by) a qualified individual. (See the discussion in section X.J regarding the qualifications of a qualified individual as would be established in proposed § 507.50(b)). Section 418 of the FD&C Act requires that firms identify and implement preventive controls and that facilities monitor and verify the effectiveness of the preventive controls. A qualified individual must develop the food safety plan in order to ensure the preventive controls are effective. The plan must be designed to identify and to significantly minimize or prevent hazards in order to prevent illness or injury to animals or humans. Designing a plan requires an individual who is knowledgeable in the concepts of preventive controls, the hazards associated with a product and process, the appropriate preventive controls, with associated monitoring and corrective actions for those hazards, and appropriate verification activities for the applicable preventive controls. Such knowledge requires scientific and technical expertise developed through training, experience, or both.
Section 418 of the FD&C Act does not address the qualifications of the individual who would prepare the food safety plan. However, proposed § 507.30(b) is consistent with the Federal regulations for seafood, juice, and meat and poultry (parts 123 and 120 (21 CFR parts 123 and 120) and 9 CFR part 417 respectively). One way to comply with proposed § 507.30(b) could be for a team of individuals (for example, a “HACCP team” or a “food safety team”) to develop the food safety plan under the oversight of a qualified individual. Each member of a HACCP or food safety team generally brings specific expertise important in developing the plan. For example, a microbiologist could provide knowledge of microbial hazards, an engineer could establish the critical parameters for delivery of heat treatments, and a maintenance supervisor could identify sources of metal contamination. Proposed § 507.30 would not require that all such members of a food safety team satisfy the requirements in proposed § 507.30(b) for a qualified individual. However, under proposed § 507.30(b), a qualified individual must be responsible for ensuring that all components the food safety plan have been developed, including reviewing all information contained in the food safety plan, thereby verifying the hazard analysis and food safety plan developed by the food safety team.
Proposed § 507.30(c)(1) through (c)(6) would require that the contents of a written food safety plan include:
• The hazard analysis as required by § 507.33;
• The preventive controls as required by § 507.36;
• The recall plan as required by § 507.38;
• The procedures, and the frequency with which these procedures will be performed, for monitoring the implementation of the preventive controls as required by § 507.39;
• The corrective action procedures as required by § 507.42; and
• The verification procedures and the frequency with which they will be performed as required by § 507.45.
Section 418(h) requires that the written plan document and describe the procedures used by the facility to comply with the requirements of section 418, “
FDA interprets the requirement in section 418(h) of the FD&C Act that the written plan document and describe the procedures used by the facility to comply with the requirements of section
FDA interprets the requirement in section 418(h) that the written plan describe the procedures used by the facility to comply with the requirements of section 418, including analyzing the hazards and identifying the preventive controls adopted to address those hazards, to mean that the contents of the food safety plan must include the hazard analysis conducted by the facility and the preventive controls that a facility must establish for hazards that its hazard analysis identifies as reasonably likely to occur, rather than procedures for analyzing the hazards and procedures for identifying the preventive controls. The general requirement in section 418(a) of the act is directed, in relevant part, to evaluating the hazards that could affect animal food manufactured, processed, packed, or held by a facility, and identifying and implementing preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such animal food is not adulterated under section 402 of the FD&C Act. Review of the evaluation of hazards in the hazard analysis is sufficient to determine the adequacy of the hazard analysis. Written procedures for conducting the hazard analysis are not necessary. Similarly, the preventive controls identified by the facility can be reviewed fully for adequacy without having a separate procedures document.
The overall framework of section 418 of the FD&C Act is directed to a facility rather than, for example, a corporate entity that may have multiple facilities. For example, under section 418(b) of the FD&C Act the owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards
Federal HACCP regulations for seafood juice, meat and poultry allow the HACCP plan to group food types or production method types if hazards, critical control points, critical limits, and required procedures such as monitoring, are essentially identical (§ 123.6(b)(2), § 120.8(a)(2), and 9 CFR 417.2(b)(2) respectively.) However, these do provide that any required features of the plan that are unique to a specific product or production method be clearly delineated in the plan and observed in practice. This type of grouping would be allowed under proposed § 507.30, and thus would provide flexibility for facilities in the development of their food safety plans.
Section 418(b)(1) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including: (1) Biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and (2) hazards that occur naturally, or may be unintentionally introduced. Section 418(b)(3) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall develop a written analysis of the hazards.
As discussed in section II.C.2.f, proposed part 507 is not intended to address “hazards that may be intentionally introduced, including by acts of terrorism.” Therefore, the Agency would not be implementing section 418(b)(2) of the FD&C Act in this proposed rule.
Section 418(c)(1) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented. Section 418(c)(3) of the FD&C Act specifies that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act, or misbranded under section 403(w) of the FD&C Act.
Section 403(w) of the FD&C Act addresses the labeling of major food allergens, as defined in 201(qq) of the FD&C Act. The misbranding provisions in section 403 of the FD&C Act, when read together with other provisions of the Food Allergen Labeling and Consumer Protection Act, appear to be intended for human food. Therefore, this proposed rule does not address section 403(w) misbranding.
Sections 418(c)(1) and (c)(3) of the FD&C Act, which will be discussed more fully in section X.C.2, are relevant to the discussion of proposed § 507.33(a) regarding the purpose of the hazard analysis required by section 418(b) of the FD&C Act.
In developing the proposed requirement for a hazard analysis, the Agency considered the language of section 418(b)(1) of the FD&C Act describing the hazards that a facility would be required to identify and evaluate, i.e., “known or reasonably foreseeable hazards that may be associated with the facility.” The Agency considers the “known or reasonably foreseeable hazards” in section 418(b) of the FD&C Act to be analogous to the “potential hazards” discussed in the NACMCF HACCP guidelines, and the hazards that are required to be identified to determine if they are “hazards that may be reasonably expected to occur at each step” in the Codex HACCP Annex, or “reasonably likely to occur” in Federal HACCP regulations for seafood, juice, and meat and poultry (Refs. 29 and 36).
Proposed § 507.33(a) would establish the requirement to identify and evaluate hazards by conducting a hazard analysis. The specific requirements for the hazard identification are in proposed § 507.33(b) (see section X.B.3) and specific requirements for the hazard evaluation in proposed § 507.33(c) and (d) (see sections X.B.4 and X.B.5.)
Proposed § 507.33(a) would require that the identification and evaluation of hazards be done “for each type of animal food manufactured, processed, packed, or held at the facility.” In developing the proposed requirement
The process of identifying and evaluating the hazards that may occur for specific types of animal food handled in a facility provides an efficient means for keeping track of multiple hazards that may occur in a facility that handles several types of animal food. Such a process also provides an efficient means for ensuring that preventive controls are applied to specific animal food products when required. Thus, a facility may need to conduct multiple hazard analyses. For example, a facility that uses an animal protein blend (by-products derived from meat and animal production industries) as an ingredient in the manufacture of food intended for swine, poultry, dogs and cats, would be required by proposed § 507.33 to identify the
To give another example, a facility that uses corn as a raw material in the manufacture of animal food intended for lactating dairy cows, beef cattle, swine, and poultry, would determine if aflatoxin is a reasonably foreseeable hazard that is reasonably likely to occur in the corn. An evaluation of the hazard would include the adverse health consequences to humans consuming milk and milk products from the dairy cows (See FDA Compliance Policy Guide (CPG) 683.100, Action Levels for Aflatoxins in Animal Feeds) (Ref. 15). This evaluation is likely to differ from the evaluation of aflatoxin in corn used to manufacture food for beef cattle, swine, and poultry, where higher levels of aflatoxin, to a point, would not be likely to cause illness or injury to the animals that consume the food or to humans consuming food products derived from those animals (Ref. 15). As a result, in evaluating the same hazard, the hazard analysis for the food for dairy cattle would lead to a different conclusion than the hazard analysis for the food for beef cattle, swine, and poultry.
Proposed § 507.33(a) would identify the purpose of the hazard analysis, i.e., to determine whether there are hazards that are reasonably likely to occur in animal food. Although section 418(b)(1) of the FD&C Act does not explicitly identify the purpose of the hazard analysis, the Agency interprets the combined requirements of sections 418(b), (c)(1) and (c)(3) of the FD&C Act to reflect a purpose, i.e., to enable the facility to identify and, where necessary, implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the animal food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act. If, for example, a facility concludes during the hazard analysis that one or more (or even all) reasonably foreseeable hazards are not reasonably likely to occur in the facility, the facility could conclude that there is no need to implement preventive controls for those hazards. The purpose of the hazard analysis identified in proposed § 507.33 is consistent with the purpose identified in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry.
b.
The written hazard analysis would include the justification for whatever conclusion the owner, operator, or agent in charge of a facility reaches, including a conclusion that no hazards are reasonably likely to occur. Thus, proposed § 507.33(a) would not limit the requirement for a written hazard analysis to those circumstances where the owner, operator, or agent in charge of a facility identifies one or more hazards that are reasonably likely to occur. Under proposed § 507.33(a), a written hazard analysis would be required even if the conclusion of the analysis is that there are no hazards reasonably likely to occur.
Proposed § 507.33(b) would require that the hazard analysis consider hazards that may occur naturally or may be unintentionally introduced, including:
• Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of animal or human health significance (proposed § 507.33(b)(1));
• Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances (proposed § 507.33(b)(2));
• Physical hazards (proposed § 507.33(b)(3)) ; and
• Radiological hazards (proposed § 507.33(b)(4)).
Proposed § 507.33(b) would implement section 418(b)(1) of the FD&C Act and would establish four groups of hazards (i.e., biological, chemical, physical, and radiological).
Proposed § 507.33(b)(1) would include microbiological hazards within the category of biological hazards. Examples of microbiological hazards include:
• Parasites (which are required to be considered by section 418(b)(1)(A) of the FD&C Act). A parasite is an organism that lives on or in an organism of another species (often called the host organism) and receives its nutritional requirements from that other species.
• Environmental pathogens (e.g.,
• Other microorganisms of animal or human health significance, including molds (e.g.,
Proposed § 507.33(b)(2) would include substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances (all of which except nutrient imbalances, are explicitly required to be considered by section 418(b)(1)(A) of the FD&C Act) within the category of chemical hazards. Pesticide residues may be present in animal food at levels in excess of a tolerance level established by the U.S. Environmental Protection Agency (EPA). Natural toxins such as aflatoxin and gossypol are well recognized as hazards in animal food products such as corn and cottonseed, respectively (Refs. 53 and 54. Residues of natural toxins such as aflatoxin may be present in human food (such as milk) derived from dairy cattle consuming animal food contaminated with the toxin in excess of a tolerance or safe level established and enforced by FDA (Ref. 15). Decomposition of animal food consists of microbial breakdown of the normal food product tissues and the subsequent enzyme-induced chemical changes. These changes are manifested by abnormal odors, taste, texture, color, etc., and can lead to reduced food intake or rejection of the food by the intended animal species, resulting in illness or death. For example, the metabolic activity of
Nutrient imbalance hazards can result from excessive levels of a nutrient in animal food leading to toxicity (e.g., copper poisoning in sheep consuming food with excessive levels of copper), or a nutrient deficiency in the food that can compromise the health of animals (e.g., chickens fed riboflavin deficient diets experience curled toe disease) (Refs. 56, 57, 58, and 59). Nutrient imbalances are particularly problematic for animal food, because often one animal food type is the sole source of an animal's diet. A nutrient imbalance hazard in animal food would pose a greater risk to the health of animals fed a sole source diet than animals receiving multiple types of animal food (like humans eat).
Nutrient imbalance hazards can also result from diets containing essential nutrients in inappropriate proportions of essential nutrients. For example, an animal's calcium needs cannot be considered independently of phosphorus. Calcium, an essential mineral, may be adequate in forage (especially legumes) for grazing cattle. Phosphorus, however, can be deficient in the forages, and since calcium and phosphorus work hand in hand for the animal's muscle and metabolic functions, respectively, supplemental phosphorus at an appropriate level would be needed for cattle on forage-based diets. Calcium and phosphorus are also the major mineral constituents of bone. The calcium to phosphorus ratio in the animal food for cattle would need to be maintained in the desired range to prevent negative health effects associated with nutrient imbalance (e.g. rickets in young animals, osteomalacia in adult animals, reduced resistance to disease, overall reduced productivity including reduced food intake, reduced conception rates, or reduced milk production in cattle) (Refs. 60 and 61).
Proposed § 507.33(b)(3) would require that the hazard analysis consider physical hazards, which are required to be considered by section 418(b)(1)(A) of the FD&C Act. Examples of physical hazards include pieces of wood, stones, glass, or metal fragments that could inadvertently be introduced into animal food. Physical hazards may be associated with raw materials, especially raw agricultural products. The facility and equipment can also be a source of physical hazards (e.g., pieces of glass from glass container breakage and metal pieces such as nuts and bolts from equipment used during manufacturing/processing).
Proposed § 507.33(b)(4) would require that the hazard analysis consider radiological hazards. Examples of radiological hazards include radionuclides such as radium-226, radium-228, uranium, strontium-90 and iodine-131. Section 418(b)(1)(A) of the FD&C Act requires that radiological hazards be considered, and animal food may be subject to contamination with radiological hazards, e.g., if water used to manufacture the animal food contains a radionuclide.
Proposed § 507.33(c) would require that the hazard analysis contain an evaluation of the hazards identified in § 507.33(b) of this section to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur. Proposed § 507.33(c) would implement sections 418(b)(1) and (c)(3) of the FD&C Act. Contamination of animal food with biological hazards often leads to immediate or near-term onset of illness or injury (e.g., gastrointestinal illness in humans after handling pet treats contaminated with
Contamination of animal food with chemical hazards may also lead to immediate or near-term obvious onset of illness, e.g., mycotoxins in large doses can be the primary agent causing acute health or production problems such as diarrhea, metritis, mastitis, or reduced conception rates in a dairy herd (Ref. 64). In other instances, the focus of the evaluation for chemical hazards would be directed to their long term effects, such as liver diseases in animals or humans exposed to aflatoxin over long periods (Refs. 65 and 66). Proposed § 507.33(c) would require that such chemical hazards be considered to determine whether they are reasonably likely to occur even if the chemical hazard occurs infrequently.
Physical hazards such as hard and sharp foreign objects that may be present in animal food can pose a health risk to the animals that consume the food. Hard or sharp foreign objects in animal food may cause traumatic injury, including laceration and perforation of tissues of the throat, stomach and intestine (Ref. 67). Although physical hazards may occur infrequently, under proposed § 507.33(c) the potential for severe consequences would require consideration of these physical hazards to determine whether they are reasonably likely to occur. Factors relevant to an evaluation of the severity of illness or injury caused by a physical hazard include the potential size of the object, the nature of the food, and whether the intended animal species or production class is susceptible to the physical hazard (Ref. 68).
Contamination of animal food with radiological hazards generally is evaluated for long-term effects such as the potential for cancer (Ref. 69). A significant radiation dose could be received as a result of consumption of animal food contaminated as a result of an accident at a nuclear power plant or other types of accidents (Ref. 69) (see also 63 FR 43402, August 13, 1998). Foods may contain unsafe levels of radionuclides (Ref. 70). Thus, although radiological hazards occur infrequently, under proposed § 507.33(c) the potential for severe consequences would require consideration of radiological hazards to determine whether they are reasonably likely to occur for a particular food or facility, especially when circumstances arise that could lead to contamination of food with radiological hazards.
The purpose of section 418(b)(1) and (c)(3) of the FD&C Act seems clear, i.e., that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards for the purpose of identifying and implementing preventive controls to provide assurances that identified hazards will be significantly minimized or prevented and that animal food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act. The process of evaluating animal food hazards to determine which potential hazards require preventive controls must take into account the consequences of exposure (i.e., severity of illness or injury) as well as the probability of occurrence (i.e., frequency) to provide assurances that the animal food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 of the FD&C Act. Proposed § 507.33(c) would implement this statutory direction.
Proposed § 507.33(d) would require that, in conducting the hazard evaluation, the qualified individual must consider the effect of the following on the safety of the finished animal food, including:
• The formulation of the animal food;
• The condition, function, and design of the facility and equipment;
• Raw materials and ingredients;
• Transportation practices;
• Manufacturing/processing procedures;
• Packaging activities and labeling activities;
• Storage and distribution;
• Intended or reasonably foreseeable use;
• Sanitation, including employee hygiene; and
• Any other relevant factors.
The Agency tentatively concludes that these are factors that a prudent person who manufactures, processes, packs, or holds animal food would consider when evaluating identified hazards to determine whether they are reasonably likely to occur. As the Agency indicated when proposing FDA's HACCP regulation for juice, a prudent processor should consider factors such as these in doing a hazard analysis (63 FR 20450 at 20468, April 24, 1998).
Proposed § 507.33(d)(1) would require that the hazard evaluation consider the formulation of the animal food. The addition of certain ingredients such as acids and preservatives may be critical to the safety of the food, since they may inhibit growth of, or even kill, microorganisms of animal and health significance. This could impact the evaluation of the potential for growth of pathogens in the animal food during manufacturing, processing, packing or holding. A multi-component food may have individual ingredients that on their own do not support growth of undesirable microorganisms, e.g., because of their oil content or salt content that affects a
Proposed § 507.33(d)(2) would require that the hazard evaluation consider the condition, function, and design of the facility and equipment. The condition, function, or design of a facility or its equipment could potentially result in the introduction of hazards into animal food. For example, older equipment (e.g., older belt, bucket elevator, or auger conveying equipment) may be more difficult to clean (e.g., with close fitting components or hollow parts) and, thus, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen proliferation in niche environments. Proposed § 507.33(d)(2) would require that facilities with such equipment consider the impact of the equipment on the potential for a pathogen to be a hazard that is reasonably likely to occur; in those situations, a preventive control such as enhanced sanitation controls may be appropriate, particularly if the equipment is used in production of animal food products that would not undergo further processing to eliminate pathogens prior to consumption. Equipment designed such that there is metal-to-metal contact may generate metal fragments. Proposed § 507.33(d)(2) would require that facilities with such equipment consider the impact of the equipment on the potential for generation of such metal fragments to be a hazard that is reasonably likely to occur; if so, a preventive control such as metal detectors may be appropriate.
Proposed § 507.33(d)(3) would require that the hazard evaluation consider the effect of raw materials and ingredients on the safety of the finished animal food. While there is an overlap between raw materials and ingredients, not all raw materials are ingredients. Before being used in the manufacturing process, raw materials are often altered to be used in different processes. For example, molasses, a thick, dark syrup, is a byproduct of sugar refining that is used as an ingredient in animal food for cattle. Briefly, to make molasses from sugar cane, washed cane stalks are shredded into short pieces and cane
Production and harvesting practices may impact whether raw materials and ingredients contain hazards. For example, machine-harvested forage or hay is more likely to be contaminated with physical hazards than hand-harvested forage or hay, because the machinery often picks up foreign material from the field. For this reason, machine-harvested forage or hay may lead to increased incidence of hardware disease in cattle (e.g., traumatic reticuloperitonitis developing as a result of perforation of the reticulum), which often occurs when animals consume food contaminated with physical hazards. Cattle commonly ingest heavy, sharp foreign objects because they take large mouthfuls of food and do not completely chew food before swallowing. The disease is common when greenchop, silage, and hay are made from fields that contain old rusting fences or baling wire, because these foods are often machine-harvested. The grain ration may also be a source of physical hazards due to accidental addition of metal such as nails, nuts, or bolts during the production process (Ref. 67).
Proposed § 507.33(d)(4) would require that the hazard evaluation consider the effects of transportation practices on the safety of the finished animal food. Animal food can become unsafe as a result of poor transportation practices. For example, failure to adequately control temperature during transportation could make animal food unsafe if the product requires time and temperature controls to ensure safety. Distributing animal food in bulk without adequate protective packaging can make the food susceptible to contamination during transportation, e.g., from pathogens or chemicals present in an inadequately cleaned vehicle or from other inadequately protected foods that are being co-transported and are potential sources of contamination (Ref. 72).
The Sanitary Food Transportation Act of 2005 (SFTA) gives FDA authority to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. The Agency published an Advance Notice of Proposed Rulemaking on April 30, 2010 (75 FR 22713), to request data and information on the food transportation industry and its practices and expects to issue a separate proposed rule to implement the SFTA. FDA does not expect a future rulemaking implementing the SFTA to eliminate the need for the owner, operator, or agent in charge of a facility to consider transportation practices when determining whether a hazard is reasonably likely to occur.
Proposed § 507.33(d)(5) would require that the hazard evaluation consider the effects of manufacturing/processing procedures on the safety of finished animal food. For example, hazards may arise from manufacturing/processing operations such as cooling or holding of certain animal food products due to the potential for germination of pathogenic spore forming bacteria such as
Proposed § 507.33(d)(6) would require that the hazard evaluation consider the effects of packaging activities and labeling activities on the safety of finished animal food. For example, the hazards that are reasonably likely to occur would be different depending on whether the animal food product is distributed in bulk form or packaged in bags. Labels on food for livestock would direct the person feeding animals to use the correct food product for the intended animal species. For example, it is well known that feeding food products to sheep that were intended for other ruminant animal species such as cattle can lead to copper toxicity (poisoning); proper labeling would help to guard against sheep being fed animal food products that are unsafe for sheep.
Proposed § 507.33(d)(7) would require that the hazard evaluation consider the effects of storage and distribution on the safety of finished animal food. For example, biological hazards are more likely to be a hazard that is reasonably likely to occur during storage and distribution in animal food products that require refrigerated storage to maintain safety than in shelf-stable foods. Shelf-stable foods are designed such that biological hazards are controlled.
Proposed § 507.33(d)(8) would require that the hazard evaluation consider the intended or reasonably foreseeable use on the safety of finished animal food. For example, gossypol, a natural toxin commonly occurs in cottonseed food products, can cause severe illness in immature ruminants and young pigs, but the older animals can tolerate low levels of the chemical hazard in their diets. Therefore gossypol would be identified as a hazard of concern if it is reasonably likely to occur at low levels in food for immature ruminants and young pigs but less of a concern in food for older ruminants and for mature pigs.
Proposed § 507.33(d)(9) would require that the hazard evaluation consider the effects of sanitation, including employee hygiene, on the safety of finished animal food. Sanitation measures and practices can impact the likelihood of a hazard being introduced into animal food. For example, the frequency with which a production line in a pet food facility is shut down for a complete cleaning can impact the potential for food residues to transfer pathogens from equipment to foods (e.g., pathogens present on raw meat products that could carry over into the next production cycle on a line). Practices directed at worker health and
Proposed § 507.33(d)(10) would require that the hazard evaluation consider the effect of any other relevant factors that might potentially affect the safety of the finished animal food. For example, an unexpected natural disaster could flood some or all of a facility, creating insanitary conditions and potentially contaminating the facility with harmful microorganisms or chemical residues. Following a natural disaster, environmental contaminants that could be brought into the facility could be hazards reasonably likely to occur in a facility that manufactures, processes, packs, or holds animal food.
Further discussion of the hazard analysis, including comparison to HACCP, can be found in section XII.B of the document for the proposed rule for preventive controls for human food (78 FR 3646).
Section 418(c)(1) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented. Section 418(c)(1)(3) of the FD&C Act, in relevant part, specifies that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act
Section 418(o)(3) of the FD&C Act defines preventive controls and proposed § 507.3 would include the statutory definition in proposed part 507. Under section 418(o)(3), the procedures, practices, and processes described in the definition of preventive controls may include the following:
• Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment (section 418(o)(3)(A) of the FD&C Act);
• Supervisor, manager, and employee hygiene training (section 418(o)(3)(B) of the FD&C Act);
• An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment (section 418(o)(3)(C) of the FD&C Act);
• A recall plan (section 418(o)(3)(E) of the FD&C Act);
• CGMPs under part 110 or any successor regulations (section 418(o)(3)(F) of the FD&C Act); and
• Supplier verification activities that relate to the safety of food (section 418(o)(3)(G) of the FD&C Act).
Proposed § 507.36(a) would require that the owner, operator, or agent in charge of a facility identify and implement preventive controls, including at critical control points (CCPs), if any, to provide assurances that hazards identified in the hazard analysis as reasonably likely to occur will be significantly minimized or prevented and the animal food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act.
As discussed in section X.B, proposed § 507.33(a) would require that the owner, operator, or agent in charge of a facility conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are “reasonably likely to occur.” Under proposed § 507.36(a), a facility that determines through its hazard analysis that there are hazards that are reasonably likely to occur would then be required to identify and implement preventive controls for those hazards. Preventive controls would be required when applicable hazards are identified as reasonably likely to occur. The types of preventive controls implemented would depend on the facility and the animal food it produces. Most hazards would be addressed through process controls and sanitation controls. For any type of preventive control, a facility would have the flexibility to identify and implement preventive controls from among all procedures, practices, and processes available to it that would provide the assurances that would be required by proposed § 507.36(a).
Proposed § 507.36(a) would implement section 418(c) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for juice, seafood, and meat and poultry, although there are some differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. It differs in part in that preventive controls may be required at points other than at CCPs and critical limits would not be required for all preventive controls. Under proposed § 507.36(a), a processor could address hazards that are reasonably likely to occur through preventive controls that would be applied at CCPs, but doing so would not be the only option available to the facility in all circumstances. In some cases adequate assurances could be achieved via preventive controls implemented through other procedures and practices of a facility, such as its control parameters for the occurrence of nutrient imbalance hazards, which may not have specific CCPs.
Whatever types of preventive controls a facility chooses to apply in its operations, the requirement in proposed § 507.36(a) would be risk-based. Establishing risk-based preventive controls involves consideration of the available scientific data and information related to animal food safety risks. Typically, the hazard evaluation will enable the facility to determine appropriate risk-based preventive controls for the hazard based on the severity of the hazard and the likelihood of its occurrence.
For example, as discussed in section II.F.4 of this document,
Proposed § 507.36(b) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur be written. Proposed § 507.36(b) would implement section 418(h) of the FD&C Act which, as discussed in section X.A.1, requires that the owner, operator, or agent in charge of a facility prepare a written food safety plan that, among other things, identifies the preventive controls
Proposed § 507.36(c)(1) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, as appropriate to the facility and the animal food, parameters associated with the control of the hazard, such as parameters associated with heat processing, irradiating, and refrigerating animal foods. The parameters are those factors that must be controlled to ensure the hazard will be significantly minimized or prevented. The specific parameters required, and how they would be controlled, would depend on the facility and the animal food. For example, for a heat process, parameters such as temperature and time must be controlled. The heating temperature may be controlled through controls on oven temperature (as when heating product in an oven). The heating time may be controlled by the belt speed for the conveyor on a continuous oven. A facility would have flexibility to establish controls on heating temperature and time through these or other mechanisms.
Some preventive controls may not have specific parameters associated with them. For example, preventive controls for metal may include an equipment preventive maintenance program and a metal detector on the packaging line. These programs may not have specific factors that must be controlled to prevent metal contamination. Sanitation procedures may include scrubbing certain pieces of equipment by hand; this may not require the identification of specific parameters.
Proposed § 507.36(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, as appropriate to the facility and the animal food, the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur. Some of the preventive controls a facility may implement may be based upon scientific studies or other information that demonstrate the effectiveness of the control measure at specific values of a biological, chemical, physical, or radiological parameter e.g., the application of heat to animal food at a specific time/temperature combination to adequately reduce pathogens. Proposed § 507.36(c) would also require that a facility that establishes such a preventive control specify values of the essential parameters to be applied in implementing the control. Specifying these values would enable the facility to implement them consistently and would facilitate validation of the preventive controls as would be required by proposed § 507.45(a). Proposed § 507.36(c)(1) and (c)(2) would implement section 418(c) of the FD&C Act and are consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal regulations for seafood, juice, and meat and poultry, although there are some differences related to the differences between HACCP systems and the preventive control system established by section 418 of the FD&C Act. FSMA does not use the term “critical limit.” Critical limits may not be appropriate for preventive controls that are not applied at CCPs. Thus, proposed § 507.36(c)(1) and (c)(2) use a broader term, i.e., parameter, to encompass preventive controls that may or may not apply at CCPs.
Proposed § 507.36(d)(1) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include process controls that include those procedures, practices, and processes performed on an animal food during manufacturing/processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur. Process controls do not include those procedures, practices, and processes that are not applied to the animal food itself, e.g., controls of personnel or the environment that may be used to significantly minimize or prevent hazards that are reasonably likely to occur but are not applied to the food itself. Specifying that process controls are employed during manufacturing/processing to significantly minimize or prevent hazards that are reasonably likely to occur would distinguish those controls applied in manufacturing/processing that significantly minimize or prevent hazards (e.g., screening, drying, cooking, and, irradiating) from other types of controls that may be applied in manufacturing/processing to provide the desired product (e.g., controls for product size and shape).
As discussed in section X.C.4 of this document, proposed § 507.36(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, when applicable, the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled. (For process controls in particular, the term “parameter” used in proposed § 507.36(c)(1), and the value associated with the parameter in proposed § 507.36(c)(2), are associated with the term “critical limit” used in HACCP systems.)
For example, a facility that holds shelled corn in bulk storage units for an extended time period until it is sold or mixed into an animal food may identify the potential for growth of aflatoxin-producing molds on the corn as a hazard reasonably likely to occur. As a process control to prevent such molds from growing on the corn during storage, the facility may elect to dry the corn to a specific moisture content (e.g., no more than 15 percent) prior to placing the corn in storage. The process control would be “drying” and the associated parameter would be moisture level, with its maximum value, or limit, being 15 percent.
Proposed § 507.36(d)(2)(i)(A) and (B) would establish two requirements for sanitation controls where necessary to significantly minimize or prevent hazards that are reasonably likely to occur. Proposed § 507.36(d)(2)(i)(A) would require that the owner, operator or agent in charge of the facility implement, where relevant to hazards that are reasonably likely to occur, sanitation controls that would include procedures for the cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment. Examples of such sanitation controls include cleaning and sanitizing procedures (including appropriate frequencies for these procedures, concentrations of cleaning and sanitizing compounds, method of application, and contact time). Such controls can prevent contamination of animal food with microorganisms of animal or human health significance, including environmental pathogens that result from inadequate cleaning of animal food-contact surfaces.
Proposed § 507.36(d)(2)(i)(B) would require that the owner, operator or agent
Proposed § 507.36(d)(2)(ii) would require that the owner, operator, or agent in charge of a facility take action to correct, in a timely manner, conditions and practices that are not consistent with the procedures that would be established in proposed § 507.36(d)(2)(i)(A) or (B) or that result in insanitary conditions that could lead to cross-contamination with a hazard.
Proposed § 507.36(d)(2)(iii) would provide that the owner, operator, or agent in charge of a facility is not required to follow the corrective actions that would be established in proposed § 507.42(a) and (b) when the owner, operator, or agent in charge of a facility takes action, in accordance with proposed § 507.36(d)(2)(ii), to correct conditions and practices that are not consistent with the procedures in proposed § 507.36(d)(2)(i) (A) or (B). As discussed in section X.F, proposed § 507.42(a) would require that the owner, operator or agent in charge of a facility establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented, and outlines specific components that must be included. Proposed § 507.42(b) would require specific actions in the event of an unanticipated problem when a preventive control is not properly implemented and a specific corrective action procedure has not been established or a preventive control is found to be ineffective. For sanitation controls, proposed § 507.36(d)(2)(ii) would require that the owner, operator or agent in charge of a facility take action to correct, in a timely manner, conditions and practices that are not consistent with the established sanitation control practices.
There are many different ways in which conditions and practices for sanitation can deviate from the established procedures. In many instances the actions taken will be the same, regardless of the deviation. The corrective actions will generally involve re-establishing sanitary conditions (e.g., re-cleaning a piece of equipment) and/or retraining personnel to carry out the procedures correctly. In many instances the procedural deviations are not reasonably likely to impact product (e.g., insanitary animal food-contact surfaces are usually detected by a pre-production inspection of the equipment by plant personnel; deviations in cleaning solution strength rarely result in the production of unsafe product if other cleaning and sanitizing procedures were properly carried out). Thus, there is rarely a need to evaluate the impact of the sanitation failure on animal food and to prevent animal food from entering commerce, as would be required by proposed § 507.42(a)(2) and (a)(3). Because the corrective actions that will need to be taken for most sanitation controls are so general, the Agency sees little benefit in requiring a facility to develop written corrective action procedures for the many sanitation deviations that could occur. The Agency does expect the facility to take action to correct conditions and practices as appropriate to the situation as would be required by proposed § 507.36(d)(2)(ii). The requirement in proposed § 507.36(d)(2)(ii) to take action to correct, in a timely manner, sanitation conditions and practices that are not in accordance with procedures is consistent with proposed § 507.42(a)(1), which would require that appropriate action be taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur.
Proposed § 507.36(d)(2)(iv) would require that all corrective actions taken in accordance with proposed § 507.36(d)(2)(ii) be documented in records that would be subject to verification in accordance with proposed § 507.45(b)(2) and records review in accordance with proposed § 507.45(c)(1)(i) and (c)(2). The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken.
Proposed § 507.36(d)(3) would require that preventive controls include, as appropriate, a recall plan as would be required by proposed § 507.38. Proposed § 507.36(d)(3) would incorporate the statutory definition of “preventive controls” from section 418(o)(3)(E) of the FD&C Act, which establishes that preventive controls may include a recall plan. The Agency includes the details of the recall plan in proposed § 507.38 and discusses it in section X.D of this document.
Proposed § 507.36(d)(4) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include any other controls necessary to satisfy the requirements of proposed § 507.36(a), i.e., to significantly minimize or prevent hazards identified in the hazard analysis and to provide assurance that the animal food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act.
FDA notes that some of the controls listed in section 418(o) of the FD&C Act are not explicitly identified in proposed § 507.36. As discussed in section X.B, the Agency is not interpreting misbranding under section 403(w), major allergens, to apply to animal food. Therefore, the proposed preventive controls for animal food do not include allergen controls. In section X.K, the Agency requests comment on an environmental monitoring program (which section 418(o)(3)(C) of the FD&C Act indicates is one of the procedures, practices, and processes that preventive controls may include, and which section 418(f)(4) of the FD&C Act identifies as a verification activity.) In section X.L, the Agency also requests comment on a supplier approval and verification program as one of the procedures, practices, and processes
Proposed § 507.36(e)(1)(i) through (iii) would specify that, except as provided by proposed § 507.36(e)(2), the preventive controls required under this section would be subject to monitoring as would be required by proposed § 507.39; corrective actions as would be required by proposed § 507.42; and verification as would be required by proposed § 507.45. Proposed § 507.36(e)(1)(i) through (iii) would restate the requirements of proposed §§ 507.39, 507.42, and 507.45 to clearly communicate the applicability of proposed §§ 507.39, 507.42, and 507.45 to the preventive controls that would be required under proposed § 507.36 and would establish no new requirements.
Proposed § 507.36(e)(2) would provide that the recall plan that would be established in proposed § 507.38 would not be subject to the requirements of proposed § 507.36(e)(1). A recall plan would address animal food that had left the facility, whereas the proposed requirements for monitoring, corrective actions, and verification would all be directed at animal food while it remains at the facility. Thus, as proposed, the requirements for monitoring, corrective actions, and verification have limited applicability to a recall plan. However, a “mock recall” (i.e., a simulated recall situation) is a verification activity that could identify problems with a recall plan, enable a facility to correct the problems, and provide reasonable assurance that the recall plan would be effective in removing products from commerce. FDA requests comments on whether to include a requirement for a mock recall as verification activity in the final rule.
Section 418(c) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that:
• Hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented (section 418(c)(1) of the FD&C Act); and
• The food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act (section 418(c)(3) of the FD&C Act).
Under section 418(o)(3)(D), the procedures, practices, and processes described in the definition of preventive controls may include, in relevant part, a recall plan.
Proposed § 507.38(a) would require that the owner, operator, or agent in charge of a facility establish a written recall plan for animal food with a hazard that is reasonably likely to occur. Although a recall is different from other preventive controls in that it is carried out after a product is distributed, it shares the purpose of significantly minimizing or preventing hazards, which is accomplished by limiting feeding of the affected animal food. Time is critical during a recall. A written recall plan is essential to minimizing the time needed to accomplish a recall; additional time during which the animal food is on the market can result in additional animal (or human) exposure. Following an existing plan that addresses all necessary elements of a recall helps minimize delay created by uncertainty as to the appropriate actions to take and helps ensure critical actions are not overlooked.
Proposed § 507.38(a) would implement sections 418(c)(1) and (3) of the FD&C Act and 418(o)(3)(E) of the FD&C Act. Recommendations for addressing a recall, applicable to both human food and animal food, can be found in FDA's general guidance on policy, procedures, and industry responsibilities regarding recalls in part 7 (21 CFR part 7), subpart C (§§ 7.40 through 7.59). The guidance advises firms to prepare and maintain a current written contingency plan for use in initiating and effecting a recall (§ 7.59). Section 507.38(a) would require that the owner, operator, or agent in charge of a facility develop a written recall plan and assign responsibility for performing all actions in the plan.
Proposed § 507.38(b) would require that the written recall plan include procedures to perform the following actions:
• Directly notify the direct consignees of the product being recalled and how to return or dispose of the affected product (proposed § 507.38(b)(1));
• Notify the public about any hazard presented by the animal food when appropriate to protect animal or human health (proposed § 507.38(b)(2));
• Conduct effectiveness checks to verify that the recall is carried out (proposed § 507.38(b)(3)); and
• Appropriately dispose of recalled product, e.g., through destroying the product, reprocessing, or diverting to a use that does not present a safety concern (proposed § 507.38(b)(4)).
Procedures that describe the action to be taken would enable a facility to act promptly by following its plan when the facility determines that a recall is warranted rather than developing a plan of action after the need for a recall is identified. Procedures that assign responsibility for taking those steps would save the time needed to make such determinations during a recall and enable the owner, operator, or agent in charge of a facility to clearly communicate such responsibilities to applicable managers or staff so that such managers or staff can take action as soon as the decision to conduct a recall is made.
Directly notifying direct consignees about the recall (proposed § 507.38(b)(1)) is the most effective mechanism to ensure direct consignees know that the product is being recalled and is consistent with FDA's general guidance on recall communications in § 7.49(a). Further, instructing direct consignees how to return or dispose of an affected product minimizes the chance the affected product will be disposed of improperly and allows direct consignees to act quickly. Further, it is consistent with FDA's guidance on the content of recall communications in § 7.49(c)(4). FDA has provided guidance to industry on a model recall letter (Ref. 73). This guidance may be useful in developing procedures for directly notifying direct consignees about the recall and on how
Notification procedures could identify a variety of communication means, including email, telephone, fax, text messaging, and urgent mail delivery. Notification procedures that would establish only a general notification to the public (e.g., through a press release or through information posted on a facility's Web site), without procedures for concurrent contact directly with direct consignees about how to access the general notification, would not satisfy proposed § 507.38(b)(1); a general notification to the public would rely on the chance that the direct consignees would see the information and may not be effective.
Notifying the public about any hazard presented by the animal food when appropriate to protect human or animal health is a common practice (e.g., see FDA's Web site that provides information gathered from press releases and other public notices about recalls of animal food, Animal & Veterinary Recalls & Withdrawals) (Ref. 74). Notifying the public in such circumstances is consistent with the Agency's guidance on a recall strategy that the purpose of a public warning is to alert the public that a product being recalled presents a hazard to human or animal health (§ 7.42(b)). Notifying the public, in addition to direct consignees, may not be necessary to protect the public if, for example, the animal food being recalled was all distributed to animal feeding operations (who were notified as a direct consignee) and not distributed for retail sale. Procedures in the recall plan for notifying the public could include model press releases and procedures for disseminating information to the public though press releases or other means, such as by information posted on the facility's Web site or provided to end users of the animal food using social media. FDA has provided guidance to industry with a model press release for the presence of
An effectiveness check is a procedure designed to verify that all notified consignees have received notification about the recall and have taken appropriate action; procedures to conduct effectiveness checks would be consistent with FDA's guidance on a recall strategy in § 7.42(c)(3). Procedures to conduct an effectiveness check could expand on the procedures used to directly contact consignees about the recall, e.g., to include forms for consignees to provide information about the amount of recalled product on hand, to include information on follow up contacts via phone or email, or to include personal visits to consignees by sales representatives. FDA has provided guidance to industry on conducting effectiveness checks (Ref. 73). This guidance includes a model effectiveness check letter, a model effectiveness check response form that could be sent to a consignee, and a model questionnaire to be used during effectiveness checks conducted by telephone or by personal visit.
A facility that receives recalled product from its customers must appropriately dispose of the product, e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or by destroying the product. These types of disposition actions are similar to the disposition actions that a facility would consider as a corrective action as a result of a problem that is discovered before the product leaves the facility (see, e.g., the discussion of corrective actions in the final rule to establish FDA's HACCP regulation for seafood; 60 FR 65095 at 65127). Procedures for disposition of a product can help the facility ensure that disposition of recalled product will be appropriate and will not present a risk to animals. Implementation of such procedures is part of determining whether a recall can be considered terminated. Thus, having procedures in place can result in more efficient completion of a recall. Under § 7.55, appropriate disposition of recalled product is a consideration in determining whether a recall is terminated.
FDA requests comment on whether the procedures to be included in the recall plan (i.e., to directly notify consignees, to notify the public, to conduct effectiveness checks, and to appropriately dispose of recalled product) are appropriate for all types of facilities or if they should be modified for certain facilities.
FDA requests comment on whether the Agency should require a recall plan to include procedures and assignments of responsibility for notifying FDA of recalls subject to the plan. Notifying FDA could enhance the effectiveness of a recall by allowing FDA to take appropriate steps to minimize the risk of illness or injury related to recalled products. As discussed in section II.E of this document, notifying FDA of a reportable food (including animal food) is required by section 417 of the FD&C Act. Reportable food reports include information about whether a reportable food is being recalled. Thus, in some cases, reporting a recall to FDA could be accomplished by submitting a reportable food report required under section 417. In other cases, facilities could notify the local FDA district office of the recall.
Section 418(a) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the performance of the preventive controls. Section 418(d) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved. The outcomes relevant to this proposal are those that provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and that food manufactured, processed, packed or held by a facility will not be adulterated under section 402 of the FD&C Act.
Section 418(g) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility maintain records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act.
Section 418(h) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act.
Proposed § 504.3 would define “monitor” to mean “to conduct a planned sequence of observations or measurements to assess whether a process, point, or procedure is under control and to produce an accurate record for use in verification.” Monitoring is essential to managing food safety because it facilitates tracking of the operation (i.e., the “process, point, or procedure” that is being controlled). This provides ongoing information about whether the process, point, or procedure is under control (i.e., operating according to plan), and can provide information about shifts away from control. If monitoring indicates that there is a trend towards loss of control, a facility can take action to bring the process back into control before a deviation from a maximum or minimum value (critical limit) occurs. For example, if the minimum oven
Proposed § 507.3 would define “verification” to mean those “activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan.” One aspect of verification, as proposed, is the initial validation of a food safety plan to determine that the plan is scientifically and technically sound, that all hazards have been identified, and that if the food safety plan is properly implemented these hazards will be effectively controlled. Another aspect of verification is evaluating whether the facility's food safety system is functioning according to the food safety plan. Both of these aspects are directed at the effectiveness of a preventive control; they establish that the preventive control is scientifically valid for controlling the hazard and verify that the preventive control is accomplishing its intended purpose. Examples of verification activities include review of monitoring records and review of records for deviations and corrective actions. The Agency discusses verification activities in more detail during its discussion of proposed § 507.45 (Verification) in section X.G.
Monitoring and verification are closely related; both address the performance of preventive controls, and verification relies in part on monitoring records to establish that preventive controls developed to significantly minimize or prevent hazards are being implemented according to plan. Three provisions of section 418(f) of the FD&C Act (Verification) are particularly relevant when considering the role of monitoring. First, section 418(f)(1) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that “the preventive controls implemented . . . are adequate to control the hazards identified . . . ” Second, section 418(f)(2) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that “the owner, operator, or agent is conducting monitoring . . .” Third, section 418(f)(4) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that “the preventive controls implemented . . . are effectively and significantly minimizing or preventing the occurrence of identified hazards . . .”
Section 418(a) requires monitoring the “performance” of preventive controls whereas section 418(d) requires monitoring their “effectiveness.” The Agency tentatively concludes that the language of section 418 regarding monitoring is ambiguous and that it would be appropriate to require monitoring of the performance of preventive controls. “Performance” means “the execution or accomplishment of an action, operation, or process undertaken or ordered” (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 2157) and is consistent with use of “monitoring” in traditional HACCP. Monitoring the performance of preventive controls would be undertaken to determine whether a facility is implementing its preventive controls and would generate records that would be used to verify implementation of the controls. For example, monitoring performance could include visual observation and measurements of temperature, time, pH, and moisture level. In contrast, “effectiveness” refers to the quality of “having an effect or result” (Shorter Oxford English Dictionary, Fifth Ed. (2002), p. 794) and is not consistent with use of the term “monitoring in traditional HACCP. The term “verification,” not “monitoring” is used to refer to effectiveness in traditional HACCP systems. Monitoring the effectiveness of preventive controls would evaluate whether the preventive controls were working.
Requiring monitoring of the effectiveness of the preventive controls would be redundant with required verification activities. Section 418(f) requires verification that the preventive controls are “effectively and significantly minimizing the occurrence of the identified hazards . . .” The activities necessary for such verification are the same as would be required for monitoring the effectiveness of the preventive controls. Requiring monitoring of effectiveness rather than performance of the preventive controls would create a significant gap in the preventive controls system. In contrast, monitoring the performance of preventive controls would provide evidence that the preventive controls established to control the identified hazards are implemented appropriately and thereby are effectively and significantly minimizing or preventing hazards.
Section 418(n)(5) of the FD&C Act directs the Secretary, in issuing these regulations, to review hazard analysis and preventive control programs in existence to ensure that this regulation is consistent to the extent practicable with applicable domestic and internationally-recognized standards in existence. Requiring monitoring of the performance of preventive controls is consistent with applicable domestic and internationally recognized standards.
Therefore, the Agency tentatively concludes that this interpretation is reasonable and proposes to adopt it in the proposed requirements implementing section 418(d) of the FD&C Act. The Agency requests comment on this interpretation.
Proposed § 507.39(a) would require that the monitoring procedures be written. Under section 418(d) of the FD&C Act, the owner, operator, or agent in charge of a facility must monitor the effectiveness of the preventive controls implemented under section 418(c) of the FD&C Act. Under section 418(h) of the FD&C Act, the procedures used by the
Proposed § 507.39(a) would facilitate tracking the implementation of the preventive controls to provide assurance that they are consistently performed; if monitoring indicates that there is a trend towards loss of control, a facility can take action to bring the process back into control before a preventive control is not properly implemented and potentially unsafe product is produced. Further, if monitoring is conducted with sufficient frequency to ensure preventive controls are consistently performed, it will detect if a preventive control is not properly implemented (e.g., if the temperature of an oven falls below the temperature needed to ensure safety), indicating loss of control and signaling the need for an appropriate corrective action. Finally, the proposed monitoring requirement would result in written documentation for use in verification.
To assist the animal food industry in developing their food safety plan, the Agency, in proposed § 507.39(a)(1) through (a)(6), lists the monitoring procedures that it tentatively considers to be the minimum information needed to provide assurances that the outcomes described in proposed § 507.36, “Preventive controls for hazards that are reasonably likely to occur,” are achieved. The owner, operator, or agent in charge of the facility, in their written monitoring procedures would need to include the preventive controls that will be monitored. The procedures would also need to include who will perform the monitoring, how the monitoring will be performed, what parameter will be measured if applicable, the frequency of monitoring, and any additional information needed to endure proper monitoring of the preventive controls.
Continuous monitoring is possible with many types of physical and chemical parameters. For example, the temperature and time for many thermal processes can be recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the affected product can be retained and evaluated to determine the appropriate disposition. Examples of other parameters that can be monitored continuously include pressure, flow rate, and pH.
Continuous monitoring may not be possible, or even necessary, in all cases. For example, it may not be practical to continuously monitor the size of particles in a food to ensure they do not exceed the maximum dimensions that are required to ensure a process such as cooking, cooling, or acidification can be properly implemented. If monitoring is not continuous, it may be difficult to ensure that the preventive controls are consistently implemented and a problem has not occurred. Thus, according to NACMCF, the frequency of non-continuous monitoring must be sufficient to ensure that a CCP (or, in the case of this proposed rule, a preventive control) is under control (Ref. 31). The Codex HACCP Annex also notes that, if monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control (Ref. 36). The frequency of non-continuous monitoring would depend on factors such as the proximity of operating conditions to the conditions needed to ensure safety and the variability of the process. For example, if the temperature needed to ensure safety of baked pet treats is 300 °F, non-continuous monitoring would need to be more frequent when an oven for baking pet treats is operated at 350 °F than when the oven is operated at 400 °F. As another example, if temperatures vary by 30 °F during processing, monitoring would need to be more frequent than if the variation is only 10–15 degrees.
The monitoring records would be used to verify that the preventive controls are adequate, as would be required by proposed § 507.45(a), and to verify that the preventive controls are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur, as would be required by proposed § 507.45(d).
Together, proposed §§ 507.39(a), (b), and (c) and 507.45(a), (b), and (d) would establish a system that would provide assurance that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented and that food manufactured, processed, packed or held by such facility will not be adulterated under section 402 of the FD&C Act.
Section 418(h) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act. Section 418(e) specifies that the owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective:
• Appropriate action is taken to reduce the likelihood of recurrence of the implementation failure (section 418(e)(1) of the FD&C Act);
• All affected food is evaluated for safety (section 418(e)(2) of the FD&C Act); and
• All affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (section 418(e)(3) of the FD&C Act).
Section 418(f)(4) of the FD&C Act requires, in relevant part, that the owner, operator, or agent in charge of a facility verify that the preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards.
Proposed § 507.42(a) would require that the owner, operator, or agent in
The benefits from identifying corrective action procedures in advance of the need to actually take corrective action largely derive from having the procedures in written form. Written corrective action procedures would be essential to the facility's animal food safety team, to auditors, and to inspectors. The facility's animal food safety team will be responsible for ensuring that appropriate corrective actions are taken if preventive controls are not properly implemented. Having access to appropriate, written corrective action procedures determined in advance of the need for such action can ensure that correct and complete actions are taken in a timely fashion without the need for the team to meet and decide on the appropriate action. Having written corrective action procedures available for auditors and for inspectors is essential for them to assess the adequacy of the animal food safety plan; the procedures a facility will use to address implementation failures are essential to the production of safe food, and without them a complete assessment cannot be made. Written corrective action procedures also would be useful for training purposes, so that employees who would need to implement the corrective action procedures will be prepared for what they would need to do.
Proposed § 507.42(a) would implement section 418(e) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must establish corrective action procedures) and section 418(h) of the FD&C Act (i.e., that the owner, operator, or agent in charge of a facility must prepare a written plan).
Proposed § 507.42(a) would require that corrective action procedures describe the steps to be taken to ensure that:
• Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur (proposed § 507.42(a)(1));
• All affected animal food is evaluated for safety (proposed § 507.42(a)(2)); and
• All affected animal food is prevented from entering into commerce, if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (proposed § 507.42(a)(3)).
The hazard analysis and risk-based preventive controls in this proposed rule are designed to identify hazards that are reasonably likely to occur, and to significantly minimize or prevent the occurrence of such hazards and provide assurances that such animal food is not adulterated under section 402 of the FD&C Act. However, a preventive controls system accounts for the possibility of implementation and effectiveness problems and includes procedures for addressing those problems and any affected food.
Proposed § 507.42(a) would implement section 418(e)(1) through (e)(3) of the FD&C Act. Section 418(e)(1) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry. Section 418(e)(1) and proposed § 507.42(a)(1) explicitly require that action be taken to reduce the likelihood of recurrence of the implementation failure. Although not prescribed by proposed § 507.42(a)(1), reducing the likelihood of recurrence of an implementation failure is best accomplished by identifying the root cause of failure and then taking action to address that root cause. If the root cause is not identified and corrected, it is more likely that the failure will recur. For example, if the temperature of a heat process cannot be maintained, a corrective action to raise the temperature using the controller may correct the problem short-term. However, if the root cause is a lack of boiler capacity to run multiple heating units at the same time, corrective action should address replacing the boiler to increase capacity.
Proposed § 507.42(a)(2) and (a)(3), would require that corrective action procedures include an evaluation of all food affected by a problem and procedures for ensuring that affected food is prevented from entering into commerce if the owner, operator or agent in charge of the facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act. Such an evaluation is implicit in the Agency's HACCP regulations for seafood and juice (§§ 123.7(b) and 120.10(a)) in that these sections do not explicitly require that food affected by the problem be evaluated, but do require that steps be taken to ensure that product that is injurious to health or otherwise adulterated does not enter commerce. Although the Agency's HACCP regulations for seafood and juice do not specify the steps that must be described in a corrective action plan, the regulations require that specific steps be taken when a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation (§§ 123.7(c) and 120.10(b), respectively). Under the seafood and juice HACCP regulations, required steps include segregating and holding affected product, performing or obtaining a review to determine the acceptability of the affected product for distribution and taking corrective action, when necessary, to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation.
Proposed § 507.42(b)(1) through (b)(3) would require that if a preventive control is not properly implemented and a specific corrective action has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility take corrective action to identify and correct the problem, evaluate all affected food for safety, and, as necessary, prevent affected food from entering commerce as would be done following the corrective action procedure under proposed § 507.42(a)(3). However, a facility might not anticipate all of the problems that may occur, and a facility may
Proposed § 507.42(b)(4) would require that the owner, operator, or agent in charge of a facility reanalyze the food safety plan in accordance with proposed § 507.45(e) to determine whether modification of the food safety plan is required if a preventive control is not properly implemented and a specific corrective action has not been established, or if a preventive control is found to be ineffective. (The Agency uses the term “reanalyze” when it refers to a reassessment of the validity of a preventive control or the food safety plan to control a hazard.) Under proposed § 507.45(a), the verification required by section 418(f) of the FD&C Act would include validation of the food safety plan, referring to whether it is effectively controlling the hazards or “working correctly.” See section X.G of this document for a discussion of proposed requirements for verification (including validation and reanalysis) under section 418(f) of the FD&C Act. Proposed § 507.42(b)(4) would apply to unanticipated food safety problems, and the unanticipated nature of the problems is relevant to the reanalysis of the food safety plan. If the owner, operator, or agent in charge of a facility has assessed its procedures, practices, and processed and has not identified a specific failure as a foreseeable occurrence, the owner, operator, or agent in charge must assess whether the problem is simply an implementation failure that could be expected to occur in the normal course of manufacturing, processing, packing or holding the food, or the result of a system-wide problem that is not being properly addressed by the plan (e.g., ineffective preventive controls.) If the problem is simply an implementation failure, and such a failure is now a foreseeable circumstance, reanalysis of the food safety plan would be necessary to determine whether a corrective action procedure should be established for that foreseeable failure. Likewise, if the problem is the result of a system-wide problem that is not being properly addressed by the plan (or is otherwise a result of ineffective preventive controls), reanalysis of the food safety plan would be necessary to identify effective preventive controls. Either way, reanalyzing the food safety plan and modifying it as necessary would be necessary to reduce the risk of recurrence of the problem. Proposed § 507.42(b)(4) is consistent with the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry.
Proposed § 507.42(c) would require that all corrective actions taken in accordance with this section be documented in records that are subject to verification in accordance with § 507.45(b)(2) and records review in accordance with § 507.45(c)(1)(i) and (c)(2). The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken.
Section 418(f) of the FD&C Act requires that the owner, operator, or agent in charge of a facility verify that:
• The preventive controls implemented under section 418(c) of the FD&C Act are adequate to control the hazards identified under section 418(b) of the FD&C Act (section 418(f)(1) of the FD&C Act);
• The owner, operator, or agent is conducting monitoring in accordance with section 418(d) of the FD&C Act (section 418(f)(2) of the FD&C Act);
• The owner, operator, or agent is making appropriate decisions about corrective actions taken under section 418(e) of the FD&C Act (section 418(f)(3) of the FD&C Act);
• The preventive controls implemented under section 418(c) of the FD&C Act are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means (section 418(f)(4) of the FD&C Act); and
• There is documented, periodic reanalysis of the plan under section 418(i) of the FD&C Act to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats (section 418(f)(5) of the FD&C Act).
In addition, section 418(g) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.
Further, section 418(i) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall conduct a reanalysis under section 418(b) of the FD&C Act (the requirement to identify and evaluate known or reasonably foreseeable hazards) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. The owner, operator, or agent shall revise the written plan required under section 418(h) of the FD&C Act if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under section 418(i) of the FD&C Act to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.
Proposed § 507.45(a)(1)(i) would require that validation occur prior to implementation of the food safety plan or, when necessary, during the first six weeks of production. The validation of preventive controls includes collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies), as discussed in the next section of this document. The collected data or information, or the studies, would establish a scientific and technical basis for the preventive controls used, in particular those that involve critical control points. This scientific and technical basis largely must be established prior to producing a product to ensure that the animal food produced using those preventive controls will be safe. However, as a practical matter, the scientific and technical basis for some aspects of a preventive control may require production conditions and, thus, would be established by the collection of data or information during, rather than before, producing a product. For example, ensuring that limits for control parameters can be met during production would be done under production conditions. FDA tentatively concludes that preventive controls that require the collection of data or information, or studies, during production conditions are part of validation, and, thus proposed § 507.45(a)(1)(i) would require that the validation of preventive controls be performed, when necessary, during the first 6 weeks of production. The Agency selected six weeks as a time interval that would be adequate to allow facilities to methodically collect data and information during production, yet would be close to implementation of a preventive control.
FDA requests comment on whether the proposed timeframe for validation should be shorter or longer. Comments should provide the basis for an alternative timeframe.
Proposed § 507.45(a)(1)(ii) would require that the validation of the preventive controls be performed whenever a reanalysis of the food safety plan reveals the need to do so. The circumstances under which a reanalysis would be required are addressed in proposed § 507.45(e)(1). Proposed § 507.45(e)(2) would require that the owner, operator, or agent in charge of a facility complete such reanalysis and implement any additional preventive controls needed to address the hazard identified, if any, before the change in activities at the facility is operative, or, when necessary, during the first 6 weeks of production. All preventive controls established to address a hazard identified as reasonably likely to occur must have a scientific and technical basis; establishing that scientific and technical basis is a validation activity regardless of whether the preventive control is established in the facility's initial food safety plan or as a result of reanalysis of the food safety plan.
The scientific and technical information that would be evaluated to determine whether preventive controls effectively control the hazards that are reasonably likely to occur may include scientific publications, government documents, predictive mathematical models and other risk-based models, and technical information from equipment manufacturers, trade associations, and other sources. If the qualified individual conducting the validation relies on sources such as scientific publications, the qualified individual would need to ensure during validation that the conditions used by the facility are consistent with those described in the publication that is being used to support the adequacy of the preventive control measure to control the hazard. For example, if a study demonstrates adequate inactivation of
Predictive mathematical models that describe the growth, survival, or inactivation of microorganisms in foods may provide scientific and technical information useful in determining whether a process would be adequate to reduce microorganisms of public health concern (Refs. 79 and 80). Other risk-based models may examine the impact of a control measure on a hazard and may be useful if appropriately validated for a specific animal food. If the model is for a different food, it may still provide useful validation information that could be supplemented by additional data. For example, there are many mathematical models for thermal resistance of
A process validation study would establish the relationship between parameters such as process times and temperatures and other factors and the rate at which pathogens are reduced, and a prevalence study would determine the levels at which pathogens may occur in the raw material, ingredient, or animal food product to establish the cumulative amount of pathogen reduction that would be required to adequately reduce the risk of illness from that pathogen. Such studies are typically published or otherwise broadly disseminated within the scientific community and, when properly designed and carried out, are generally regarded by experts as scientifically definitive with respect to the matters addressed by the study. However, if scientific and technical information is not available or is insufficient to support the adequacy of a preventive control measure to control the hazard, the owner, operator or agent in charge of a facility would need to conduct controlled scientific studies to establish that a preventive control measure is adequate to control the hazard.
Information is available in the literature that can assist in the design of studies to support the adequacy of preventive control measures. For example, NACMCF has published information on “Parameters for Determining Inoculated Pack/Challenge Study Protocols” (Ref. 80). Studies to validate preventive control measures must be conducted by persons with experience and expertise relevant to the product, process and hazard to be controlled. Under proposed § 507.45(a)(1), any studies needed to provide the scientific and technical information to establish the validity of the plan would either be conducted by a qualified individual (as would be defined in proposed § 507.3) or would be overseen by a qualified individual. In other words, the qualified individual need not have the experience and expertise to conduct validation studies, but must have sufficient expertise in risk-based preventive controls to understand the studies and how they support the validity of the preventive controls with respect to the hazard of concern.
• The sanitation controls that would be established in proposed § 507.36(d)(2); and
• The recall plan that would be established in proposed § 507.38.
According to NACMCF, verification involves activities to determine the validity of the HACCP plan and that the system is operating according to the plan (Ref. 29). Thus, validation is a verification activity. The purpose of validation is to provide the scientific and technical basis for ensuring that the preventive controls implemented are adequate to control the hazards identified as reasonably likely to occur. FDA tentatively concludes that validation, i.e., the evaluation of scientific and technical information, is either not an essential activity, is not practical or is not relevant, for the controls identified in proposed § 507.45(a)(3).
As discussed in section X.C.6, proposed § 507.36(d)(2)(i)(A) would require that, where relevant to hazards that are reasonably likely to occur, sanitation controls include procedures for the cleanliness of animal food-contact surfaces, including food-contact surfaces of utensils and equipment. Traditionally, sanitarians employed by the facility, or experts employed by companies that supply cleaning and sanitizing compounds, will establish critical parameters and associated limits for cleaning and sanitation, including the choice and strength of the cleaning and sanitizing chemicals, contact time, and temperature requirements, based on studies conducted by the manufacturers of the products. Antimicrobial solutions applied to animal food processing equipment and utensils to sanitize such objects after they have been washed are included in the definition of “pesticide chemical” and therefore, are subject to regulation by EPA under section 408 of the FD&C Act. Chapter 4 (Additional Considerations for Antimicrobial Products) of EPA's “Pesticide Registration Manual” (Refs. 81 and 82) outlines EPA's requirements and recommendations for registration of antimicrobial substances, including testing against a validated protocol to be granted EPA-registered claims for pathogen reduction. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the adequacy of the sanitation controls that would be required by proposed § 507.36(d)(2)(i)(A). Monitoring activities to ensure the procedures are followed will provide assurance that the controls are functioning as intended to prevent hazards from insanitary animal food-contact surfaces. The Agency requests comment on this approach.
As discussed in section X.C.6, proposed § 507.36(d)(2)(i)(B) would require that, where relevant to hazards that are reasonably likely to occur, sanitation controls include procedures for the prevention of cross-contamination from insanitary objects and from employees to animal food, animal food packaging material, and other animal food-contact surfaces and from raw product to processed product. As already discussed with respect to proposed § 507.36(d)(2)(i)(A), sanitation controls to prevent cross-contamination can be established by companies that supply cleaning and sanitizing compounds without the need for validation.
As discussed in section X.D.7, a recall plan can significantly minimize or prevent hazards by limiting consumption of affected animal food during a recall. Following an existing plan that addresses all necessary elements of a recall helps minimize delay created by uncertainty as to the appropriate actions to take and helps ensure critical actions are not overlooked. The proposed requirement to validate a preventive control by collecting and evaluating scientific and technical information or by conducting studies simply does not apply to such a plan. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the recall plan that would be required by proposed § 507.38.
Proposed § 507.45(b)(1) would require that the owner, operator, or agent in charge of a facility verify that monitoring is being conducted, as would be required by proposed § 507.39. One example of verification
Proposed § 507.45(b)(1) would not specify the verification activities that must be conducted for monitoring. The Agency requests comment on whether proposed § 507.45(b)(1) should do so, and if so, what verification activities should be required.
Proposed § 507.45(b)(2) would require that the owner, operator, or agent in charge of a facility verify that appropriate decisions about corrective actions are being made, as would be required by proposed § 507.42 and by proposed § 507.36(d)(2)(ii). An example of verification that appropriate decisions about corrective actions are being made is observation of the corrective actions being taken, e.g., by a supervisor. Proposed § 507.45(b)(2) would implement section 418(f)(3) of the FD&C Act.
Proposed § 507.45(b)(2) would not specify the verification activities that must be conducted for corrective actions. The Agency requests comment on whether proposed § 507.45(b)(2) should do so, and if so, what verification activities should be required.
Proposed § 507.45(b)(3) would require that the owner, operator, or agent in charge of a facility verify the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur, including the requirements in proposed § 507.45(b)(3) and § 507.45(c), as appropriate to the facility and the animal food. Proposed § 507.45(b)(3) and (c) would implement section 418(f)(4) of the FD&C Act, which requires in relevant part verification by “appropriate means” that the preventive controls “are effectively and significantly minimizing or preventing the occurrence of identified hazards.”
Instrument calibration is performed on a regular or periodic basis based upon the type of instrument being used and its sensitivity to factors such as the operating environment and the wear and tear of ongoing use. The type of instruments used in a particular facility and the manner of their use will largely determine the need for, and the frequency of, calibration, and the frequency of calibration is often prescribed by the instrument manufacturer. Therefore, proposed § 507.45(b)(4) would not specify a frequency for calibration.
Proposed § 507.45(c) would establish that the purpose of the review of records would be to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decision were made about corrective actions. The Agency tentatively concludes that review of the records required by proposed § 507.45(c)(1)(i) and (ii) would accomplish these purposes. Reviewing monitoring records can reveal whether they contain information on all the parameters that were to be monitored to determine whether a process is delivered in accordance with the food safety plan. For example, if the size of the animal food to be baked and the temperature and the time of baking are critical to the safety of the animal food, review of the monitoring records would demonstrate whether all three parameters were monitored and whether the values were within specified parameter values. Reviewing monitoring records can reveal whether a process followed the procedures specified in the facility's food safety plan (e.g., if the monitoring records show the temperature of every other batch of a baked animal food when the plan specified the measurement of every batch). Review of monitoring records also can reveal whether any information is missing, e.g., a designated lot number, so that the missing information can be quickly identified and added to the record if necessary. The Agency seeks comment on this proposal.
If the review of the records reveals that the records do not contain all information specified by the food safety plan, or that the procedure in the food safety plan was not followed, the facility will not be able to conclude that its
Review of records can also reveal whether appropriate decisions were made about corrective actions. The review should determine whether all the corrective action procedures required by proposed § 507.42(a) have been followed, e.g., that actions are taken to prevent recurrence of the problem, that affected animal food has been evaluated for safety, and that affected animal food is prevented from entering commerce unless it can be determined that the animal food is not adulterated under section 402 of the FD&C Act. For example, a food safety plan may require that each package of product pass through a properly functioning metal detector and that the operator determine every two hours whether metal test pieces of a specified type and size are rejected when passed through the metal detector. If one of the test pieces was not rejected but production continued until a supervisor doing a verification check noted the problem, then corrective actions should have been taken and a corrective action record produced. A review of the corrective action records should reveal that all packages of product that passed through the metal detector since the last test showing the metal detector was functioning appropriately were held and passed through a functioning metal detector before being released into commerce. The records should also show that the metal detector was adjusted to reject the metal test pieces before it was used again to check product during production.
Proposed § 507.45(c) would require that the review of records be performed by (or under the oversight of) a qualified individual (see the discussion in section X.I regarding the activities that must be performed (or overseen) by a qualified individual as would be established in proposed § 507.50). The review of records is critical to assessing the facility's application of the preventive controls system and, thus, is fundamental to ensuring its successful operation.
Proposed § 507.45(c)(1)(i) would require review of the monitoring and corrective action records within a week after the records are made. Although proposed § 507.45(c)(1)(i) would establish a more frequent review of these records than recommended in the NACMCF guidelines (which recommend monthly verification of monitoring records and corrective action records), it is consistent with the Agency's HACCP regulations for seafood (§ 123.8(a)(3)(i) and (ii)) and juice (§ 120.11(a)(1)(iv)(A) and (B)), which require that the review of monitoring records and corrective action records occur within one week of the day that the records are made. Even for shelf-stable foods (e.g., low-acid canned foods and acidified foods) the Agency's experience has demonstrated that review of these kinds of records is a critical verification tool (60 FR 65096 at 65133, December 18, 1995). As discussed in the seafood HACCP final rule (60 FR 65096 at 65132), review of records needs to occur with sufficient frequency so as to ensure that any problems in the design and implementation of the HACCP plan are uncovered promptly and to facilitate prompt modifications. The concept is roughly that of a “feedback loop,” with information coming out of the record review process in such a timely manner that it can have impact on the production of subsequent lots of the product. If a problem with product is discovered during a review of records, all product since the last review could be affected. Although verification prior to shipment provides a valuable added assurance, FDA explained in the preamble to the seafood HACCP final rule (60 FR 65096 at 65132) that with highly perishable products this is not always possible and that a weekly review of monitoring and corrective action records would provide for timely feedback of information and limit the amount of product impacted by any problems identified during the review of the records.
Proposed § 507.45(c)(1)(ii) would require review of the records related to calibration, within a reasonable time after the records are made. The review of calibration records will depend in part on the frequency with which calibrations occur, which will be established in the food safety plan. If calibrations occur daily, it would be reasonable to review these records weekly. Where several instruments are calibrated each month, a monthly review of all the calibrations would be reasonable. Consequently, FDA tentatively concludes that setting a specific frequency for review of these records is not warranted.
As noted previously, proposed § 507.45(c) would require a review of records in part to determine whether the preventive controls are effective. A review should determine whether monitoring and corrective actions have been done in accordance with the food safety plan and whether the instruments used in monitoring and verification were properly calibrated. If food safety activities appropriate to the facility have been conducted in accordance with the plan and this is reflected in the records, the facility thus verifies the preventive controls are effective, i.e., that its preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards as required by Section 418(f) of the FD&C Act.
Proposed § 507.45(d) would require that the owner, operator, or agent in charge of a facility establish and implement written procedures for the frequency of calibrating process monitoring instruments and verification instruments. The Agency is proposing to require written procedures for the frequency of calibration because the frequency of calibration will vary depending on the instrument and the process or verification activity that it pertains to.
The Agency is not proposing to require that written procedures be developed for all verification procedures. In some instances the records of verification activities provide the information needed to understand how the verification activity has been carried out and to assess whether the verification activity is adequately demonstrating that the preventive controls are effective in significantly minimizing or preventing the hazards reasonably likely to occur. For example, the Agency is not proposing to require
Section 418(f) of the FD&C Act establishes certain requirements for verification, and section 418(h) of the FD&C Act requires that the procedures used by the facility to comply with the requirements of section 418 be included in the written plan. Requiring verification procedures to be written implements the requirements in section 418 of the FD&C Act and is consistent with the requirements in HACCP regulations for seafood, juice, and meat/poultry. For further discussion, see section XII.B.6 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
• At least once every 3 years (proposed § 507.45(e)(1)(i));
• Whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard (proposed § 507.45(e)(1)(ii));
• Whenever the owner, operator or agent in charge becomes aware of new information about potential hazards associated with the animal food (proposed § 507.45(e)(1)(iii));
• Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established (proposed § 507.45(e)(1)(iv));
• Whenever a preventive control is found to be ineffective (proposed § 507.45(e)(1)(v)); and
• Whenever FDA requires a reanalysis in response to newly identified hazards and developments in scientific understanding (proposed § 507.45(e)(1)(vi).
For example, if a facility that conducts baking operations for pet treats makes design changes to its oven to increase product throughput, the facility would be required to reanalyze its food safety plan because a design change to equipment that is used to control a hazard that is reasonably likely to occur would be a significant change in the activities conducted at the facility.
The owner, operator or agent in charge of a facility may become aware of a problem due to the finding of a hazard in an animal food as the result of testing by a regulatory agency (Federal, State, tribal, or foreign government) that would require an analysis of the food safety plan to ensure the hazard is significantly minimized or prevented by appropriate preventive controls. In addition, new hazards can emerge, e.g., as identified through the investigation of outbreaks. For example in 2006–2007 there was an outbreak of salmonellosis due to contamination of peanut butter with
As noted in section X.F of this preamble, proposed § 507.42(b)(4) would require that the owner, operator, or agent in charge of a facility reanalyze the food safety plan in accordance with proposed § 507.45(e) to determine whether modification of the food safety plan is required if a preventive control is not properly implemented or is found to be ineffective, and a specific corrective action has not been established. If the owner, operator, or agent in charge of a facility has not identified a specific failure as a foreseeable occurrence, the deviation may be the result of a system-wide problem that is not being properly addressed by the food safety plan (e.g., ineffective preventive controls). Thus, an unforeseen failure for which a corrective action was not identified may indicate an ineffective preventive control, and a reanalysis of the food safety plan is warranted. Similarly, when information arises indicating that the preventive control has not been effective in significantly minimizing or preventing a hazard from occurring, a reanalysis must be conducted to determine if the food safety plan should be modified to ensure that the preventive controls implemented are adequate to significantly minimize or prevent a hazard identified as reasonably likely to occur.
Proposed § 507.45(e) would implement section 418(f)(5) and (i) of the FD&C Act and is consistent with the NACMCF HACCP guidelines, the Codex HACCP guidelines, the Codex validation guidelines, and Federal HACCP regulations for seafood, juice, and meat and poultry. A discussion on “reanalysis” (or “reassessment of the hazard analysis” as it is called) in HACCP systems can be found in section XII.G.7 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The requirement in proposed § 507.45(e)(1) that the periodic reanalysis of the food safety plan occur at least once every 3 years is explicitly required by section 418(i) of the FD&C Act. The Agency tentatively concludes that, as a practical matter, the proposed requirement for reanalysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard makes it likely that reanalysis would occur more frequently than every 3 years because such changes are likely to occur more frequently than every 3 years.
Proposed § 507.45(f) would require that all verification activities taken in accordance with this section be documented in records and would implement section 418(g) of the FD&C Act.
Briefly, as relevant to proposed § 507.48, specific provisions of section 418 of the FD&C Act require, in relevant part, that the owner, operator, or agent in charge of a facility:
• Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and develop a written analysis of the hazards (section 418(b) of the FD&C Act);
• Identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act (section 418(c) of the FD&C Act);
• Monitor the effectiveness of the preventive controls implemented under section 418 (c) of the FD&C Act to provide assurances that the outcomes described in section 418(c) shall be achieved (section 418(d) of the FD&C Act);
• Establish procedures to ensure that, if the preventive controls implemented under section 418(c) of the FD&C Act are not properly implemented or are found to be ineffective, appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; all affected food is evaluated for safety; and all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 of the FD&C Act (section 418(e) of the FD&C Act);
• Verify that the preventive controls are adequate to control the hazards the owner, operator, or agent is conducting monitoring and is making appropriate decisions about corrective actions and the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards and there is documented, periodic reanalysis of the plan under section 418(i) of the FD&C Act to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats (section 418(f) of the FD&C Act);
• Maintain, for not less than 2 years, records documenting the monitoring of the preventive controls instances of nonconformance material to food safety
• Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards section 418(h) of the FD&C Act);
• Conduct a reanalysis under section 418(b) of the FD&C Act whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier (section 418(i) of the FD&C Act).
In addition to these requirements directed to the owner, operator, or agent in charge of a facility, section 418(m) of the FD&C Act provides, in relevant part, that the Secretary may, by regulation, exempt or modify the requirements for compliance under section 418 of the FD&C Act with respect to facilities that are solely engaged in the storage of packaged foods that are not exposed to the environment.
As discussed in section VIII.E of this document, proposed § 507.10 would both provide that proposed part 507 subpart C does not apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment (proposed § 507.10(a)) and establish that such a facility is subject to modified requirements in proposed § 507.48 (proposed § 507.10(b)). In the remainder of the discussion of these modified requirements, the Agency refers to “packaged food that is not exposed to the environment” as “unexposed packaged animal food,” and to “unexposed refrigerated packaged animal food that requires time/temperature control for safety” as “unexposed refrigerated packaged TCS animal food.” As noted in section VIII.E, the Agency considers “not exposed to the environment” and “unexposed” to mean that the animal food is in a form that prevents any direct human contact with the food. The modified requirements in proposed § 507.48 would apply to unexposed refrigerated packaged TCS animal food. In essence, proposed § 507.48 distinguishes between unexposed packaged animal food and unexposed refrigerated packaged TCS animal food. This distinction is based on hazards that are reasonably likely to occur during the storage of unexposed refrigerated packaged TCS animal food, but are not reasonably likely to occur during the storage of unexposed packaged animal food that does not require time/temperature control for safety.
When an unexposed packaged animal food is a refrigerated TCS animal food, the principal hazard for the unexposed refrigerated packaged TCS animal food is the potential for the growth of, or toxin production by, microorganisms of animal or human health significance. Information about this hazard for TCS foods in general (i.e., not limited to unexposed packaged animal food) is widely available (Refs. 39, 40, and 86). In brief, the need for time/temperature control is primarily determined by: (1) The potential for contamination with microorganisms of animal or human health significance and (2) the potential for subsequent growth and/or toxin production. Refrigeration has long been used to retard deterioration of the flavor, color, and texture of foods including animal food. More importantly, refrigeration helps maintain the microbiological safety of potentially hazardous foods (62 FR 8248; February 24, 1997).
Failure to maintain animal food at appropriate temperatures may result in the growth of microorganisms that may have contaminated the food before, or at the time of, harvest or during processing, handling, or storage. The rate of growth of these microorganisms is reduced as the storage temperature is lowered. Proper refrigeration, therefore, prevents or slows the growth of animal and human pathogens and spoilage microorganisms and reduces the likelihood of foodborne illness (62 FR 8248). A review of the factors that influence microbial growth and an analysis of microbial hazards related to time/temperature control of foods for safety can be found in a report (issued by the Institute of Food Technologists (IFT) under contract to FDA) on the Evaluation and Definition of Potentially Hazardous Foods (Ref. 86). The IFT report describes properties of common food commodities and the microbiological hazards that may occur from consuming particular food commodities, emphasizing microbial concerns that would be associated with temperature abuse of the products. The IFT report discusses foods for which time/temperature control may be necessary for safety (Ref. 86). Most types of animal food that are stored refrigerated have not been processed to eliminate pathogenic sporeformers, including
Examples of refrigerated foods that are capable of supporting the growth of pathogenic sporeformers such as
Such information is sufficiently well-known and accepted that the Agency tentatively concludes that the outcome of each individual hazard analysis for an unexposed refrigerated packaged TCS animal food, conducted by the owner, operator, or agent in charge of each individual facility solely engaged in the storage of unexposed packaged animal food, would be the same. That outcome would be that the potential for the growth of, or toxin production by, microorganisms of animal or human health significance is a hazard reasonably likely to occur in any unexposed refrigerated packaged TCS animal food. Likewise, information about appropriate preventive controls for this hazard is widely available (Refs. 41 and 78). Such information is sufficiently well-known and accepted that the Agency tentatively concludes that the appropriate preventive control
In light of the general recognition of the hazard that is reasonably likely to occur in a refrigerated packaged TCS animal food and the appropriate preventive control for that hazard, the Agency tentatively concludes that it is appropriate to specify the hazard and appropriate preventive control in the regulation. Under this approach, it would not be necessary for each individual facility solely engaged in the storage of unexposed packaged animal food to conduct its own hazard analysis and reach its own conclusion about the hazard and the appropriateness of temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance. Instead, what would remain for the facility to do to comply with section 418 of the FD&C Act for the activity of storing an unexposed refrigerated packaged TCS animal food would be a subset of the requirements for hazard analysis and risk-based preventive controls that would be established in proposed subpart C to implement section 418 of the FD&C Act. None of these requirements would require a qualified individual. This subset of requirements would be to:
• Implement temperature controls (section 418(c) of the FD&C Act);
• Monitor temperature (section 418(d) of the FD&C Act);
• Take appropriate corrective actions when there is a problem with temperature control (section 418(e) of the FD&C Act);
• Conduct applicable verification activities (review of records) (section 418(f) of the FD&C Act); and
• Establish and maintain certain records (section 418(g) of the FD&C Act).
The Agency seeks comment on the proposed list of modified requirements.
The Agency also tentatively concludes that it would not be necessary for each individual facility solely engaged in the storage of unexposed packaged animal food to conduct the reanalysis specified in section 418(i) of the FD&C Act with respect to storing an unexposed refrigerated packaged TCS animal food. As discussed in section X.G of this document, reanalysis would apply in determining whether to apply any additional preventive controls and in determining whether to update the written plan. Under this approach, FDA would have identified the preventive control, and it would be FDA's responsibility, through rulemaking, to require any additional preventive control. Likewise, under FDA's approach, the facility would not be required to develop a food safety plan and, therefore, would not need to update the plan. If, for example, the facility changes its procedures for temperature control, the specific activities that the facility would be required to conduct (monitoring temperature; taking appropriate corrective actions if there is a problem with temperature control; conducting applicable verification activities; and establishing and maintaining appropriate records) would be adequate to address the change in procedure for temperature control.
Proposed § 507.48(a) would require that the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment conduct certain activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance. Briefly, those activities would encompass:
• Establishing and implementing temperature controls (proposed § 507.48(a)(1));
• Monitoring the temperature controls (proposed § 507.48(a)(2));
• If there is a problem with the temperature controls for such refrigerated packaged animal food, taking appropriate corrective actions (proposed § 507.48(a)(3));
• Verifying that temperature controls are consistently implemented (proposed § 507.48(a)(4)); and
• Establishing and maintaining certain records (proposed § 507.48(a)(5)).
More specifically, proposed § 507.48(a)(1) would require that the owner, operator, or agent in charge of a facility subject to proposed § 507.48 establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance in an unexposed refrigerated packaged TCS animal food. There are two fundamental questions that the owner, operator, or agent in charge of a facility subject to proposed § 507.48 would need to know the answers to in order to comply with proposed § 507.48 for any given unexposed refrigerated packaged animal food:
• Is the animal food a TCS food?
• If the animal food is a TCS food, what is the appropriate temperature for storage of the food?
The two primary ways in which the owner, operator, or agent in charge of a facility subject to proposed § 507.48 can obtain the answers to these questions are through: (1) Information provided by the manufacturer, processor, or packer of the animal food, either in documents exchanged between the parties in the course of business or by label statements placed on the animal food by the manufacturer, processor, or packer of the food and (2) applicable scientific and technical support literature.
As discussed in section VIII.E, a citizen petition submitted to FDA (Docket No. FDA–2011–P–0561) asserted that facilities work closely with the food manufacturers to understand the conditions and controls that need to be utilized to ensure the quality of the foods they store and distribute and, in many cases, those conditions and controls are formalized in written contracts. If the conditions for storage are not formalized in written contracts or by other means (e.g., through documents of the trade that travel with a food product when it moves within the supply chain), information relevant to safe storage of the food may be provided by the manufacturer, processor, or packer of the food on the food label. For example, in 1997 FDA published guidelines for labeling food that needs refrigeration by consumers due to the potential for the food to be rendered unsafe due to the growth of infectious or toxigenic microorganisms if “temperature abused” (62 FR 8248). FDA recommended that foods requiring refrigeration by the consumer for safety be labeled “IMPORTANT Must be Kept Refrigerated to Maintain Safety” (62 FR 8248 at 8251) and that foods that are intended to be refrigerated but that do not pose a safety hazard if temperature abused be labeled more simply, e.g.; “Keep refrigerated.” Such labeling can provide facilities with the information to identify TCS animal food. The Agency tentatively concludes that similar food safety principles applied in human food storage would be relevant to animal food. Further, the Agency tentatively concludes that it would be rare for a facility solely engaged in the storage of unexposed packaged animal food to not have information regarding whether a refrigerated packaged food requires time/temperature control for
In a situation where the owner, operator or agent in charge of a facility does not have information from the manufacturer, processor, or packer of the food about whether an unexposed refrigerated packaged animal food requires time/temperature control for safety and, if so, what specific temperature controls are necessary for safe storage of the food, the owner, operator, or agent in charge of the facility could either consult the scientific and technical literature to determine whether a particular food is a TCS animal food or assume that any unexposed refrigerated packaged food is a TCS animal food. Information about food that is TCS animal food, and about the appropriate temperatures to address the potential for microorganisms of animal or human health significance to grow or produce toxin, in food are well-established in the scientific literature. Documents prepared by or on behalf of FDA regarding appropriate time/temperature controls for safety (Refs. 86 and 87) provide numerous references to the primary scientific literature and serve as the basis for time/temperature controls for a variety of foods including animal food. The two temperatures commonly cited in these documents as maximum temperatures for safe storage of refrigerated food are 41 °F (5 °C) and 45 °F (7 °C). The cited maximum temperature depends on the type of food; in some cases, a maximum storage temperature is established through rulemaking in a regulation. For example:
• FDA regulations for the prevention of
• The PMO provides for pasteurized Grade “A” milk and milk products to be held at 45 °F (7 °C) (Ref. 77).
• The FDA Food Code, which has been widely adopted in state laws, recommends holding most potentially hazardous (TCS) food at 41 °F (7 °C) or lower (Ref. 88).
Storage of refrigerated food at or below one of these two temperatures (i.e., 41 °F (5 °C) or 45 °F (7 °C)) consistent with storage temperatures required by regulation or recommended in widely adopted documents such as the PMO and the FDA Food Code would satisfy proposed § 507.48(a).
The Agency considers frozen animal food to be a subset of refrigerated animal food. The temperature and time required for a frozen animal food to become unsafe would result in significant quality issues for such food. Although there have been occasional problems with frozen animal food being subject to temperatures that allow some thawing in storage and distribution, the Agency is not aware of situations in which frozen animal food has been associated with the food becoming unsafe. Thus, the Agency tentatively concludes that it would be rare for an unexposed frozen packaged animal food to be a TCS animal food.
Proposed § 507.48(a)(2) would require that the owner, operator, or agent in charge of a facility solely engaged in the storage of unexposed packaged animal food monitor the temperature controls established for unexposed refrigerated packaged TCS animal food with sufficient frequency to provide assurance that they are consistently performed. Monitoring can be done by use of a continuous temperature-recording device (e.g., a recording thermometer) that indicates and records the temperature accurately within the refrigeration compartment with a visual check of the recorded data at least once per day. Monitoring as would be required by proposed § 507.48(a)(2) would provide the owner, operator, or agent in charge of the facility with factual information with which to judge whether the temperature control is operating as intended. Proposed § 507.48(a)(2) is modified relative to the analogous monitoring requirement that would be established in proposed § 507.39(a) in subpart C in that proposed § 507.48(a)(2) would not require written procedures for monitoring. The records of monitoring (which would be required by proposed § 507.48(a)(5)(i)) would demonstrate the frequency of monitoring. The Agency requests comment on whether there would be a benefit to requiring a facility to develop written procedures for monitoring temperature.
Proposed § 507.48(a)(3) would require that, if there is a problem with the temperature controls for unexposed refrigerated packaged TCS animal food, the owner, operator, or agent in charge of a facility solely engaged in the storage of unexposed packaged animal food take appropriate corrective actions to correct a problem with the control of temperature for any refrigerated packaged animal food and reduce the likelihood that the problem will recur (proposed § 507.48(a)(3)(i)); evaluate all affected animal food for safety (proposed § 507.48(a)(3)(ii)); and prevent the animal food from entering commerce, if the owner, operator, or agent in charge of a facility cannot ensure the affected animal food is not adulterated under section 402 of the FD&C Act (proposed § 507.48(a)(3)(iii)). Such corrective actions would be necessary if, for example, there was a failure to maintain adequate temperature control. Proposed § 507.48(a)(3) is modified relative to the analogous proposed requirement for corrective actions that would be established in proposed § 507.42(a) in subpart C in that proposed § 507.48(a)(3) would not require written procedures for corrective actions. In essence, there is a single action to correct the problem (i.e., to restore temperature control), followed by the need to evaluate the animal food for safety and to prevent animal food from entering commerce when appropriate. The corrective actions taken, including information to document that product was not exposed to temperatures and times that would compromise the safety of the product, would be documented in records subject to agency review. It may be necessary for the owner, operator, or agent in charge of the facility to consult with the applicable manufacturer, processor, or packer of the animal food to determine the appropriate disposition of the food.
Proposed § 507.48(a)(4)(i) would require that the owner, operator, or agent in charge of a facility solely engaged in the storage of unexposed packaged animal food verify that temperature controls are consistently implemented by calibrating temperature monitoring and recording devices. As discussed in section X.G.5.b of this document, calibration provides assurance that an instrument is measuring accurately. If these instruments are not properly calibrated, the values they provide may not provide the necessary assurance temperatures are adequate to significantly minimize or prevent the growth of, or toxin production by, microorganisms of animal or human health significance in an unexposed refrigerated packaged TCS animal food. Proposed § 507.48(a)(4)(i) is analogous to proposed § 507.45(b)(3)(ii) in subpart C, which would establish a verification requirement for calibration of process monitoring instruments and verification instruments.
Proposed § 507.48(a)(4)(ii) would require that the owner, operator, or agent in charge of a facility solely engaged in storage of unexposed packaged animal food verify that temperature controls are consistently
Proposed § 507.48(a)(4)(iii) would require that the owner, operator, or agent in charge of a facility solely engaged in storage of unexposed packaged animal food verify that temperature controls are consistently implemented by reviewing the records of monitoring and actions taken to correct a problem with the control of temperature within a week after the records are made. As discussed in section X.G.5.e, the purpose of the review of records would be to ensure that the records are complete, that the temperatures recorded were adequate to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public animal or human significance in an unexposed refrigerated packaged TCS animal food, and that appropriate actions were taken to correct any problem with the control of temperature for any unexposed refrigerated packaged TCS animal food. A weekly review of monitoring and corrective action records would provide for timely feedback of information and limit the amount of product impacted by any problems identified during the review of the records. Proposed § 507.48(a)(4)(iii) is analogous to proposed § 507.45(c)(1)(i) in subpart C, which would establish a verification requirement for review of records of monitoring and corrective action records within a week after the records are made.
Proposed § 507.48(a)(4) is modified relative to the analogous proposed verification requirements in proposed § 507.45 in that proposed § 507.48(a)(4) would not require validation or reanalysis. There is a single control to verify, which limits the need for many of the verification procedures that might otherwise apply. As noted above, the temperatures to control growth of microbial pathogens are well documented and do not require validation that they are effective in controlling the potential for microorganisms of animal or human health significance to grow, or produce toxin, in animal food The reasons for not requiring reanalysis were discussed previously in this section. Proposed § 507.48(a)(4) is also modified relative to the analogous proposed verification requirements in proposed § 507.45 in that proposed § 507.48(a)(4) would not require that a qualified individual perform or oversee the review of records of calibration or records of monitoring and actions taken to correct a problem with the control of temperature. The nature of these records does not require the qualifications that would be required under proposed § 507.50(b).
Proposed § 507.48(a)(5) would require that the owner, operator, or agent in charge of a facility solely engaged in storage of unexposed packaged animal food establish and maintain records documenting the monitoring of temperature controls for any unexposed refrigerated packaged TCS animal food (proposed § 507.48(a)(5)(i)); records of corrective actions taken when there is a problem with the control of temperature for any unexposed refrigerated packaged TCS animal food (proposed § 507.48(a)(5)(ii)); and records documenting verification activities (proposed § 507.48(a)(5)(iii)). The records that document monitoring would be used to verify that the temperature controls are effectively and significantly minimizing or preventing the growth of, or toxin production by, microorganisms of animal or human health significance. The records that document corrective actions would be used to verify that appropriate decisions about corrective actions are being made and appropriate corrective actions are being taken. The records that document verification activities would be used to document that this key element of a food safety plan has been implemented. These records would be necessary to demonstrate compliance with the requirements and as such would be useful to inspectors and auditors. Proposed § 507.48 (a)(5) is analogous to provisions in proposed §§ 507.36(d)(2)(iv), 507.39(c), and 507.45(e) in subpart C, which would require documentation of monitoring, corrective actions, and verification activities, respectively.
Proposed § 507.48(b) would establish that the records that a facility must establish and maintain under proposed § 507.48(a)(5) are subject to the requirements of proposed subpart F. Proposed subpart F would establish requirements that would apply to all records that would be required under part 507. FDA describes the requirements of proposed subpart F in section XII. Proposed § 507.48(b) is analogous to proposed § 507.55(b) in subpart C.
Proposed § 507.50(a) would require that one or more qualified individuals prepare the food safety plan (proposed § 507.30), validate the preventive controls (proposed § 507.45(a)), review records for implementation and effectiveness of preventive controls (proposed § 507.45(c)), and perform reanalysis of the food safety plan (proposed § 507.45(e)). The Agency has discussed the basis for requiring that a trained individual perform or oversee these functions in its discussion of each applicable proposed provision. The Agency is listing the functions that must be performed by a trained individual in § 507.50(a) for simplicity and are not imposing any additional requirement through this list. A single individual with appropriate qualifications could perform all of the listed functions, but there would be no requirement for the same individual to perform all the listed functions.
Proposed § 507.50(b) would establish the qualification requirements applicable to a qualified individual. To be qualified, an individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, or be otherwise qualified through job experience to develop and apply a food safety system. Training or job experience is essential to the effective development and implementation of a hazard analysis and risk-based preventive controls. Only a trained individual or individual qualified by job experience is capable of effectively executing certain activities, such as identifying hazards that are reasonably likely to occur; identifying preventive controls that will address those hazards; evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the hazards that are reasonably likely to occur; determining the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur; determining whether monitoring procedures and corrective action procedures are appropriate; and determining whether specific corrective actions have been appropriate and effective. In addition, the products produced by the animal food industry are diverse, and the hazards that are
FDA will be working with an animal food alliance to develop a standardized curriculum for any final rule establishing requirements for hazard analysis and risk-based preventive controls. Having a standardized curriculum on which facilities, as well as private organizations and academia that conduct training, can base their materials and training would provide a framework to ensure minimum training requirements are met.
Proposed § 507.50(b) also would provide that the qualified individual may be, but is not required to be, an employee of the facility. FDA expects that some facilities may rely on assistance from qualified individuals that are not employees of the facility, such as individuals associated with universities, trade associations, and consulting companies. Proposed § 507.50(b) is consistent with HACCP regulations for seafood and juice, which have virtually identical requirements (§§ 123.10 and 120.13(b), respectively). The option in proposed § 507.50(b) would provide flexibility to facilities subject to the rule. Such flexibility may be particularly important for those facilities that have limited technical expertise.
Proposed § 507.50(c) would require that all applicable training be documented in records, including the date of the training, the type of training, and the person(s) trained. Such records would be a simple mechanism to demonstrate that a person has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as would be required under proposed § 507.50(b) should the qualified individual not be otherwise qualified through job experience to develop and apply an animal food safety system.
Section 418(g) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.
Section 418(h) of the FD&C Act, in relevant part, specifies that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act to address those hazards. Section 418(h) of the FD&C Act also specifies that the written plan, together with the documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.
Proposed § 507.55(a)(1) through (a)(5) would require that the owner, operator, or agent in charge of a facility establish and maintain the following records:
• The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan;
• Records that document the monitoring of preventive controls;
• Records that document corrective actions;
• Records that document verification, including, as applicable, those related to validation; monitoring; corrective actions; calibration of process monitoring and verification instruments; records review; and reanalysis; and
• Records that document applicable training for the qualified individual.
Proposed § 507.55(a) would not establish any new requirements, but merely make it obvious at a glance what records are required under proposed part 507, subpart C.
Proposed § 507.55(b) would provide that the records that the owner, operator, or agent in charge of a facility must establish and maintain are subject to the requirements of proposed part 507, subpart F. As discussed in section XII, proposed subpart F would provide the general requirements that apply to all records required to be established and maintained by proposed part 507, including provisions for retention of records and for making records available for official review.
As discussed in section II.C.2, section 418(n) requires FDA to establish science-based minimum standards for, among other things, implementing preventive controls. In addition, section 418(f) requires certain verification of those preventive controls. In this section of the preamble, the Agency discusses several preventive controls (i.e., supplier controls) and verification measures (i.e., environmental and product testing programs) that FDA is not including as provisions in proposed part 507, subpart C.
As the Agency discussed in section X.C.1, section 418(c) requires the owner, operator, or agent in charge of a facility to identify and implement preventive controls. Section 418(o)(3) defines “preventive controls” to mean “those risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent [identified hazards] and that are consistent with current scientific understanding of safe food manufacturing, processing, packing, or holding . . . .” Section 418(o)(3) indicates that those procedures, practices, and processes may include environmental monitoring, supplier verification activities, and certain sanitation controls. In addition, environmental and product testing programs are set out in section 418(f)(4): Section 418(f)(4) requires that the owner, operator, or agent in charge of a facility “verify that . . . the preventive controls . . . are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.”
The Agency believes that the preventive controls and verification measures discussed in this section are an important part of a modern animal food safety system. The Agency believes that the preventive controls discussed in this section (i.e., a supplier approval and verification program), when implemented appropriately in particular facilities, are “risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food
As discussed (see section I of this document), animal food safety is best assured if each facility understands the hazards that are reasonably likely to occur in its particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate those hazards. From a regulatory perspective, specifying the circumstances and manner in which these controls and practices are to be applied must take into account the wide array of factors, including the diversity among animal food products, the wide variety of manufacturing and processing methods used to produce the animal food, the variety of sources for raw materials and ingredients, variations in the nature and types of hazards associated with manufacturing, processing, packing, and holding animal food, and the possibility that different mitigation methods may achieve the same end. Further, regulatory requirements should make clear when one of these preventive controls or verification measures is necessary yet also be sufficiently flexible to account for a vast number of animal food and facility combinations and circumstances.
Although the Agency is not including provisions for environmental and product testing programs or a supplier approval and verification program in this proposed rule, the Agency recognizes that these preventive controls and verification measures, when implemented appropriately in particular facilities, can play important roles in effective animal food safety programs. The role and need for these measures varies depending on the type of products and activities of the facility. To facilitate comment and share the Agency's current thinking, the Agency discusses the topics of environmental and product testing programs and a supplier approval and verification program immediately below. See the Appendix to this document for additional background information relevant to these topics.
As discussed in section X.G.1, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that “the preventive controls implemented under [section 418(c) of the FD&C Act] are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means” The statute does not indicate the specific circumstances where product testing would be required or the specific manner in which such testing should be performed. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the owner, operator, or agent in charge of a facility could consider a number of factors to establish a product testing program.
Although finished product testing is rarely considered a preventive control, it plays a very important role as a verification measure in ensuring the safety of animal food, when implemented appropriately in particular facilities. Similarly, testing of raw materials or ingredients by a facility that is receiving the product often plays an important role in verification of hazard control that is performed by its supplier. Thus, an important purpose of testing is to verify that preventive controls, including those related to suppliers and those related to environmental monitoring, are controlling the hazard (Refs. 31 and 32). Testing is used in conjunction with other verification measures in the animal food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan.
Finished product testing is more important and useful when there is a reasonable probability that exposure to an identified hazard will result in serious adverse health consequences or death to humans or animals. FDA believes that there are certain situations in which finished product testing is particularly useful as a verification measure, including the following circumstances:
• The outcome of the hazard analysis conducted under proposed § 507.33 is that a biological hazard is reasonably likely to occur in an ingredient and the preventive controls established and implemented under proposed § 507.36 do not include a process control that will significantly minimize the hazard. An example is a dry blending operation that mixes a variety of ingredients such as seeds, nuts that may be contaminated with
• The outcome of the hazard analysis conducted under proposed § 507.33 is that a biological hazard is reasonably likely to occur in an ingredient that is added during manufacturing after the stage that applies a process control to significantly minimize biological hazards. An example is pet food (such as dry pet food and pet treats) in which untreated flavorings that may contain
• The outcome of the hazard analysis conducted under proposed § 507.33 is that a biological hazard is reasonably likely to occur as a result of handling of a product or exposure of a product to the environment after a process control that significantly minimizes a hazard such that a hazard could be introduced or re-introduced into the product. An example is the manufacture of pet treats, such as pig ears, that after heat treating become contaminated with
In addition, the frequency of testing and the number of samples tested must be determined and needs to take into account a variety of hazard/commodity/facility considerations. FDA believes that factors to consider include whether ingredients that may contain a hazard have been tested, the extent of any environmental monitoring program, and whether other programs established by the facility provide added assurance that the potential for hazards has been minimized. The frequency of testing and the number of samples tested should have a scientific basis. Sampling plans and their performance have been described in the literature (Refs. 89, 90, and 91) and are included in several Codex documents (Refs. 92 and 93). The Agency discusses likely considerations that could impact finished product verification testing in more detail in section I.F of the Appendix.
Although the Agency is not including a testing provision in this proposed rule, the Agency estimates that a requirement for a finished product testing program, when implemented appropriately in particular facilities, could impose an incremental annual cost of $15,000–$28,000 per facility based on size
FDA requests comment on when and how product testing programs are an appropriate means of implementing the statutory directives set out above. Although the Agency has not included these provisions in the proposed rule, the Agency requests comment on their inclusion in a final rule. Should a product testing program be limited to finished product testing or include raw material testing? What is the appropriate level of specificity for a product testing program? For example, should the Agency simply require that the owner, operator, or agent in charge conduct, as appropriate to the facility and the animal food, finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards that are reasonably likely to occur? This would provide flexibility to account for the wide diversity of animal food and animal food manufacturing, processing, packing, and holding systems subject to this rule and be consistent with the discussions within this proposed rule.
FDA also requests comment on whether more detail would be appropriate, by, for example:
• Specifying particular hazards, situations or product types for which finished product testing would be required;
• Specifying the frequency of testing and, if so, whether this frequency should depend on the type of product;
• Identifying appropriate sampling plans for finished product testing;
• Requiring periodic testing for trend analysis and statistical process control; and
• Requiring written procedures for conducting finished product testing and, if so, also require that procedures for finished product testing be scientifically valid and include the procedures for sampling and the sampling frequency.
FDA also requests comment on the impact of product testing requirements on small businesses and on whether any product testing verification requirements should differ based on the size of the operation.
As discussed in section X.G.1 of this document, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that “the preventive controls implemented under [section 418(c) of the FD&C Act] are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.” In addition, section 418(o)(3) indicates that preventive controls may include environmental monitoring to verify the effectiveness of pathogen controls is an example of preventive controls. The statute does not indicate the specific circumstances where environmental testing would be required or the specific manner in which such testing should be performed. Nevertheless, FDA believes that this testing can form an important component of a modern animal food safety system. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, is particularly useful as a verification measure for preventive controls (i.e., sanitation controls) when contamination of animal food with an environmental pathogen is a hazard reasonably likely to occur.
As discussed in section X.B.3, proposed § 507.33(b) would require a hazard identification that must consider hazards that may occur naturally or may be unintentionally introduced. The data from recalls and the RFR support a conclusion that
As discussed in section I.E.2 of the Appendix to this document, the Agency is also aware that listeriosis occurs in a number of animal species, especially ruminant animals, and is asking for comment on whether
Although the Agency is not including an environmental testing provision in this proposed rule, the Agency estimates that an environmental monitoring program for
The facilities that could adopt environmental monitoring programs are facilities producing animal food products, such as dry pet food, exposed to the environment prior to packaging, whereby they may become contaminated and for which such testing would be particularly useful as a verification measure for sanitation controls.
FDA requests comment on when and how environmental testing is an appropriate means of implementing the statutory directives set out above. Although the Agency has not included these provisions in the proposed rule, the Agency requests comment on their inclusion in a final rule. If they are included, what is the appropriate level of specificity? For example, should the Agency simply require the performance of environmental monitoring, for an
• Specifying the environmental pathogen or the indicator organism for which the samples must be tested;
• Specifying the corrective actions that should be taken if environmental testing identifies the presence of an environmental pathogen, such as;
• Conducting microbial sampling and testing of surrounding surfaces and areas to determine the extent of the contamination and the potential source of the contamination;
• Cleaning and sanitizing the contaminated surfaces and surrounding areas to eliminate the test organism;
• Conducting additional microbial sampling and testing to determine whether the contamination has been eliminated; and
• Conducting finished product testing.
• Specifying the locations within the facility at which samples must be collected;
• Specifying the frequency of collection of environmental samples (e.g., weekly or monthly depending on risk). For example, should the frequency of collection:
• Be greatest for animal foods that are likely to be handled by certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems after a minimal treatment that may not adequately reduce the environmental pathogen?
• Be greater for an environmental pathogen that is frequently introduced into a facility (e.g.,
• Be greater for products that undergo significant handling and exposure to the environment than for products that undergo limited or no handling or have little exposure to the environment?
• Increase as a result of finding the environmental pathogen or an indicator of the environmental pathogen or as a result of situations that pose an increased risk of contamination, e.g., construction? (Refs. 94 and 95).
• Requiring written procedures for conducting environmental testing and, if so, also requiring that procedures for environmental testing be scientifically valid and include the procedures for sampling and the sampling frequency;
• Requiring data analysis to detect trends.
The Agency further requests comment on whether there is benefit in conducting routine environmental monitoring for other organisms in addition to, or instead of, the environmental pathogen of concern.
Section 418(c) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that:
• Hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented; and
• The animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act.
Section 418(o)(3)(G) of the FD&C Act indicates that the procedures, practices, and processes described in the definition of preventive controls may include supplier verification activities that relate to the safety of food. While FSMA refers only to supplier verification activities, supplier approval, together with supplier verification, is widely accepted in the domestic and international food safety community. The development of a supplier approval and verification program can be part of a preventive approach. The NACMCF HACCP guidelines describe supplier controls as one of the common prerequisite programs for the safe production of food products and recommend that each facility assure that its suppliers have in place effective CGMP and food safety programs (Ref. 29). Likewise, Codex addresses the safety of ingredients in the General Principles of Food Hygiene and recommends that, where appropriate, specifications for raw materials be identified and applied and laboratory tests be conducted to establish fitness for use (Ref. 34).
Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. Using a preventive approach, a facility receiving raw materials or ingredients from a supplier can help ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.
A supplier approval and verification program can help ensure that raw materials and ingredients are procured from those suppliers that can meet company specifications and have appropriate programs in place to address the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program can help provide initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients.
The statute does not indicate the specific circumstances where supplier verification would be required or the specific manner in which supplier verification should be performed, and FDA is not including provisions for such verification in this proposed rule. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the owner, operator, or agent in charge of a facility could consider a number of factors to determine the specific circumstances and manner where it would be appropriate to perform supplier verification. FDA believes that factors to consider include:
• The nature of the adverse consequences associated with the hazard, such as whether consumption or handling of animal food containing the hazard may result in serious adverse health consequences or death to humans or animals; and
• The establishment that would be controlling the hazard associated with the raw material or ingredient (e.g., the facility that receives the raw material or ingredient, the supplier of that raw material or ingredient, or even a supplier to the supplier of the raw material or ingredient).
The vast majority of costs related to a supplier approval and verification program are due to verification activities such as audits and testing of raw materials and ingredients, which would likely be selected based on the hazard associated with the raw material or ingredient and where the hazard is controlled. Although the Agency is not including a provision for such a program in this proposed rule, the Agency estimates that a requirement for a supplier approval and verification program, if implemented as part of a
FDA requests comment on when and how supplier approval and verification is an appropriate means of implementing the statutory directives set out previously. Although the Agency has not included these provisions in the proposed rule, the Agency requests comment on their inclusion in a final rule. If they are included, what is the appropriate level of specificity? Should the requirement be very general, for example, requiring a supplier approval and verification program as appropriate to the facility and the animal food, when appropriate based on risk? FDA also requests comment on who a supplier approval and verification program should apply to, e.g., should it apply to all facilities that manufacture, process, pack, or hold animal food, or be limited (such as to facilities that manufacture or process animal food)?
FDA also requests comment on whether more detail would be appropriate, by, for example:
• Requiring that the supplier approval and verification program include a written list of approved suppliers;
• Requiring that, in determining appropriate verification activities, the owner, operator, or agent in charge of a facility consider relevant regulatory information regarding the supplier, including whether the raw material or ingredient is the subject of an FDA warning letter or import alert relating to the safety of the animal food.
• Specifying circumstances when a supplier approval and verification program would not be required, e.g., when the preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the hazards the receiving facility has identified as reasonably likely to occur; or when the receiving facility obtains from its customer written assurance that the customer has established and is following procedures that will significantly minimize or prevent the hazard.
• Specifying that the type of verification activity be linked to the seriousness of the hazard, e.g., whether to:
• Require an onsite audit when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals;
• Provide more flexibility with respect to hazards for which there is not a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, e.g., periodic onsite audits, periodic or lot-by-lot sampling and testing of the raw material or ingredient, and periodic review of the supplier's animal food safety records;
• Specifying requirements for audits, e.g., the qualifications (including training, experience, and conflict of interest) for persons who conduct audits; content of an audit (such as compliance with applicable animal food safety regulations and, when applicable, compliance with a facility's food safety plan);
• Specifying the frequency of verification activities (e.g., initially, annually, or periodically);
• Specifying whether, for some hazards, it will be necessary to conduct more than one verification activity to provide adequate assurances that the hazard is significantly minimized or prevented;
• Providing for alternative requirements if a supplier is a qualified facility, e.g., documenting that the supplier is a qualified facility and obtaining written assurance that the supplier is producing the raw material or ingredient in compliance with sections 402 of the FD&C Act;
• Specifying those records that would be appropriate for a supplier approval and verification program;
• Providing for substitution of a regulatory inspection (e.g., by FDA or a comparable State regulatory agency or foreign animal food safety authority), for an onsite audit; and
• Specifying that a receiving facility take appropriate action (e.g., discontinuing use of a supplier) if the facility determines that the supplier is not controlling hazards that the receiving facility has identified as reasonably likely to occur.
FDA is aware that many firms that could be affected by supplier verification may be importing their ingredients. The Agency believes that these firms are interested in how a supplier verification component of preventive controls will interface with the regulations FDA is required to implement foreign supplier verification under new section 805 of the FD&C Act (21 U.S.C. 384a). Section 805 requires FDA to issue regulations to require importers to implement foreign supplier verification programs (FSVPs) that are adequate to provide assurances that the importer's foreign suppliers produce food, including animal food, in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of animal and human health protection as those required under section 418 (concerning hazard analysis and preventive controls) of the FD&C Act, and in compliance with section 402 (concerning adulteration) of the FD&C Act.
On July 29, 2013, FDA published in the
Likewise, FDA is aware that there is great interest from its trading partners on, among other things, the potential overlap between the supplier verification requirements in preventive controls and in FSVP. FDA believes that the approach to harmonization between supplier verification and FSVP described above would adequately address this and comports with its obligations under the World Trade Organization trade agreements, including adherence to the principles of the Sanitary and Phytosanitary (SPS) Agreement.
FDA is committed to meeting the requirements of the SPS Agreement and to complying with its obligations under that Agreement as the Agency implements FSMA. In enacting FSMA, Congress explicitly recognized the importance of compliance with international agreements by providing in section 404 of FSMA that “[n]othing in [FSMA] shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.” While the statutory provisions in FSMA governing supplier verification by domestic facilities and foreign supplier verification by importers differ in some respects, they are based on common risk-based principles. Implementation of these risk-based principles will assure a general consistency of approach with respect to foreign and domestic facilities
This section discusses two measures (review of consumer, customer, and other complaints, and submission of a food safety profile) that FDA is not proposing as specific provisions in proposed part 507, subpart C. Although these measures are not explicitly included in section 418, the Agency believes that the preventive controls and verification measures discussed in this section are an important part of a modern food safety system.
The role of consumer complaints in evaluating the effectiveness of a food safety plan is reflected in the HACCP regulations for seafood and juice. The HACCP regulation for seafood (§ 123.8(a)(2)(i)) requires that verification activities include a review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points. The HACCP regulation for juice (§ 120.11(a)(1)(i)) requires that verification activities include a review of any consumer complaints that have been received by the processor to determine whether the complaints relate to the performance of the HACCP plan or reveal the existence of unidentified critical control points. FDA notes that the role of consumer complaints is not discussed in the NACMCF guidelines or the Codex guidelines, and their review is not required by the FSIS HACCP regulation for meat and poultry. However, as discussed in the seafood HACCP proposed rule (59 FR 4142 at 4157, January 28, 1994), no system is foolproof, and consumer complaints may be the first alert for a processor that deviations are occurring and are not being prevented or uncovered by the processor's HACCP controls.
Further, although most consumer complaints will be related to quality issues, recent experience has demonstrated the value that consumer and customer complaints can provide in bringing attention to possible problems within a facility's preventive controls activities. FDA has received a number of animal food submissions to the RFR (Ref. 48) that have suggested that environmental pathogens hazards were not adequately addressed in a supplier's food safety plan. Some of these were identified through customer verification testing and others through complaints from consumers to a facility. A facility may also receive alerts as a result of state surveillance and testing programs.
Although this proposed rule does not include a provision regarding a review of complaints, the Agency estimates that a requirement that facility personnel review consumer, customer, or other complaints could impose an additional annual cost of $2,800 per facility. This would result in an estimated total annual cost of $1,767,000 for domestic facilities.
The Agency requests comment on whether and how a facility's review of complaints, including complaints from consumers, customers, or other parties, should be required as a component of its activities to verify that its preventive controls are effectively minimizing the occurrence of hazards.
Proposed § 507.30 would require that the owner, operator, or agent in charge of a facility prepare, or have prepared, a written food safety plan. The food safety plan would include the hazard analysis, preventive controls, and other records. Currently, information of this type is not reviewed by FDA investigators until they are physically present at a facility and have begun an inspection. In light of the large number of facilities that would be covered by this proposal, FDA recognizes several potential benefits to having a facility's food safety plan in advance of an inspection, if the Agency were to require facilities to do so. Having such plans could aid in the efficient oversight of preventive controls by allowing FDA to better target inspectional activities to facilities that produce animal foods that have an increased potential for contamination (particularly with biological hazards) and to improve on-site inspections by focusing attention on hazards and preventive controls for which the facility appears to have deficiencies. Facilities would benefit from the Agency's advance preparation through interaction with better-informed investigators and potentially reduced inspection time. The Agency could also more quickly identify facilities that had not established preventive controls for specific hazards of concern to the Agency and advise them to fill such gaps to prevent a problem before it occurs. Also, FDA could use the plans in evaluating the need for guidance on specific hazards or controls and prioritizing guidance to areas where it is needed most.
FDA believes that there are significant obstacles to realizing these benefits from submission of food safety plans, however. The agency would expect to receive a very large number of plans. Further, these plans would be expected to vary significantly in content and format. Assimilating the underlying information in a way that would be useful to the Agency would be an immense challenge. Moreover, not all of the information in such plans may be essential to realizing the potential benefits described above. Therefore, to most efficiently realize the potential benefits of having certain information prior to an inspection, the Agency requests comment on whether to require submission to FDA of a subset of the information that would be in a food safety plan. This information, which could be referred to as a “facility profile,” could be submitted through an electronic form using a menu selection approach. The use of an electronic form would enhance the Agency's ability to store the information in a searchable form. Ideally, a searchable electronic system could allow FDA to assess information when a problem occurs with certain types of foods or controls, so that the Agency could target inspections to facilities that manufacture, process, or pack, animal food types that are at increased risk for a food safety problem; to facilities that appear to have insufficient controls to prevent a problem; or to facilities using a control the Agency concludes is ineffective at controlling hazards. The data elements for a facility profile could include some or all of the following:
• Contact information;
• Facility type;
• Products;
• Hazards identified for each product;
• Preventive controls established for each of the identified hazards;
• Third-party audit information (have you had one and which audit firm(s));
• Preventive control employee training conducted;
• Facility size (square footage);
• Full time operation or seasonal;
• Operations schedule.
This information could be submitted at the same time as facility registration and updated biennially simultaneously with the required biennial update of the food facility registration. FDA requests comment on the utility and necessity of such an approach and on the specific types of information that would be useful in developing a facility profile. The Agency also requests comment on any additional benefits that might be obtained from using such an approach and any potential concerns with this approach.
The Agency has previously announced an opportunity for public comment on the proposed collection of additional food facility profile information on a voluntary basis from firms that complete the FDA food facility registration process (77 FR 27779, May 11, 2012). In that notice, the Agency noted that FSMA added section 421 of the FD&C Act (21 U.S.C. 350j), which directed FDA to allocate resources to inspect facilities according to the known safety risks of the facilities. The Agency also noted that food facility profile information voluntarily provided to FDA would help FDA to determine whether a firm is high-risk or non-high-risk and that the Agency will use the profile information to assist in determining the frequency at which it will inspect the firm. In contrast to the voluntary submission of food facility profile information described in that notice, in this document, the Agency is also requesting comment on whether the submission of such information should be required.
Section 418(l)(3)(A) of the FD&C Act specifies that, in the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under section 418(l) of the FD&C Act, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under section 418(l) of the FD&C Act. Section 418 does not expressly prescribe the procedures for withdrawing an exemption provided to a qualified facility under section 418(l). The Agency tentatively concludes that it is appropriate to be transparent about the process it would use to withdraw an exemption and that the Agency should include the process in the proposed rule.
Proposed § 507.60(a) would provide that FDA may withdraw the exemption that would be applicable to a qualified facility under proposed § 507.5(c) in the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility. Proposed § 507.60(a) would implement the statutory language of section 418(l)(3)(A) of the FD&C Act. An outbreak of foodborne illness is the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food (or exposure to a common food in the case of microbiological illness in humans from handling animal food.) Animal food can become contaminated at many different steps: On the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; and at the location of the animal. When foodborne illness is associated with food, a traceback investigation may enable FDA to directly link the illness to the facility or facilities that manufactured, processed, packed, and/or held the animal food. See section XIV.B.1 of the document for the proposed rule for preventive controls for human food (78 FR 3646) for a discussion of an FDA traceback investigation.
Proposed § 507.60(b) would provide that FDA may withdraw the exemption applicable to a qualified facility under proposed § 507.5(c) if FDA determines that it is necessary to protect animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility. As an example, FDA may receive reports to the RFR under section 417 of the FD&C Act about contamination of an animal food, and the reports may lead the Agency to investigate a qualified facility that manufactured, processed, packed or held the animal food. If the investigation finds conduct or conditions associated with the facility that are material to the safety of the animal food (for example, conduct or conditions that likely led to the contamination of the animal food), FDA would consider withdrawing the exemption applicable to the facility under proposed § 507.5(c) if doing so would be necessary to protect animal or human health and prevent or mitigate a foodborne illness outbreak. Likewise, if during a routine inspection of a qualified facility, FDA discovers conditions and practices that are likely to lead to contamination of animal food with microorganisms of animal or human health significance, such as
Proposed § 507.62(a) would provide that, if FDA determines that an exemption applicable to a qualified facility under § 507.5(c) should be withdrawn, any officer or qualified employee of FDA may issue an order to withdraw the exemption. The Agency intends to create and maintain a written record of a determination that the withdrawal of an exemption is warranted and to include the basis for the determination in the written record.
Proposed § 507.62(b) would require that an FDA District Director in whose district the qualified facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), or an FDA official senior to such Director, must approve an order to withdraw the exemption as part of the withdrawal determination procedure before the order is issued. A Regional Food and Drug Director is an example of an FDA official senior to a District Director. The Deputy Director and Director of the Office of Surveillance and Compliance at the Center for Veterinary Medicine are examples of an FDA official senior to the Director of the Division of Compliance. Requiring prior approval of a withdrawal order by a District Director or an FDA official senior to a District Director is consistent with the approval requirement for a detention order in part 1, subpart K
Proposed § 507.62(c) would require that FDA issue an order to withdraw the exemption to the owner, operator, or agent in charge of the qualified facility. The requirements of section 418 of the FD&C Act are directed to the owner, operator, or agent in charge of a facility. The Agency tentatively concludes that the statutory language of section 418 enables FDA to issue an exemption withdrawal order to any of these persons.
Proposed § 507.62(d) would require that FDA issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.
Proposed § 507.65(a) through (i) would require that an order to withdraw an exemption applicable to a qualified facility under § 507.5(c) include the following information:
FDA tentatively concludes that the requirements that it proposes in § 507.65 would provide the owner, operator, or agent in charge of a qualified facility subject to a withdrawal with adequate notice of the basis for the Agency's determination to withdraw the exemption and of their opportunity to appeal the Agency's determination and to request an informal hearing. The proposed notification procedures are similar to and consistent with the notification requirements in other regulations involving administrative action, such as administrative detention of food under § 1.393 orders for diversion or destruction of shell eggs under the PHS Act under § 118.12(a)(i), and with procedures for an informal hearing in part 16.
Proposed § 507.67(a) would require that the owner, operator, or agent in charge of a qualified facility that receives an order to withdraw an exemption applicable to that facility under § 507.5(c) either comply with applicable requirements of this part within 60 calendar days of the date of the order; or appeal the order within 10 calendar days of the date of the order in accordance with the requirements of § 507.69. The Agency tentatively concludes that either of the two circumstances that could result in the determination that an exemption should be withdrawn (as described in proposed § 507.60) warrant prompt compliance with the rule in the interest of animal or human health. The Agency tentatively concludes that 10 calendar days for the submission of an appeal from the date of the receipt of a withdrawal order is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that comes to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
Proposed § 507.67(b) would establish that submission of an appeal, including submission of a request for an informal hearing, will not delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner of Food and Drugs, as a matter of discretion, determines that delay or a stay is in the public interest. For example, the submission of an appeal of a withdrawal order with a request for an informal hearing under proposed § 507.67(b) would not prevent FDA from simultaneously detaining animal food from the facility under section 304(h) of the FD&C Act, seizing animal food from the facility under section 304(a) of the FD&C Act, or seeking or enforcing an injunction under section 302 of the FD&C Act.
Proposed § 507.67(c) would require that, if the owner, operator, or agent in charge of the qualified facility appeals the order, and FDA confirms the order, the owner, operator, or agent in charge of the facility must comply with applicable requirements of this part within 60 calendar days of the date of the order. Proposed § 507.67(c) would make clear that the 60 calendar day timeframe for compliance applies regardless of whether the owner, operator, or agent in charge of a facility requests, and FDA grants, a hearing. As already discussed, FDA tentatively concludes that the circumstances that lead to a determination that an exemption should be withdrawn warrant prompt compliance in the interest of animal or human health.
Proposed § 507.69(a) would require that, to appeal an order to withdraw an exemption applicable to a qualified facility under § 507.5(c), the owner, operator, or agent in charge of the facility must: (1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the same information for the Director of the Division of Compliance in the Center for Veterinary Medicine), at the mailing address, email address, or facsimile number identified in the order within 10 calendar days of the date of the order and (2) respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which the owner, operator or agent in charge of the facility relies.
Allowing the owner, operator, or agent in charge of the facility to submit an appeal in person, by mail, email, or fax would provide for flexibility as well as speed. For example, submitting in person would give the owner, operator, or agent in charge direct knowledge that
Proposed § 507.69(b) would provide that, in a written appeal of the order withdrawing an exemption provided under § 507.5(c), the owner, operator, or agent in charge of the facility may include a written request for an informal hearing as provided in § 507.71. Requesting an informal hearing does not mean that a hearing will be held, because FDA may deny the request (see discussion of proposed § 507.71(b) in the next section of this document). However, if the owner, operator, or agent in charge of the facility does not request an informal hearing at the time the written appeal is submitted, the owner, operator, or agent in charge of the facility will not be entitled to an informal hearing. Instead, FDA will make a final decision based on the written appeal and its supporting materials.
Proposed § 507.71(a)(1) would provide that, if the owner, operator, or agent in charge of the facility appeals the order, the owner, operator, or agent in charge of the facility may request an informal hearing. Proposed § 507.71(a)(1) would restate an option that would be included in proposed § 507.69(b) to highlight the opportunity to request an informal hearing. Proposed § 507.71(a)(2) would require that, if the owner, operator, or agent in charge of the facility appeals the order, the owner, operator, or agent in charge of the facility must submit any request for an informal hearing together with its written appeal submitted in accordance with § 507.69 within 10 calendar days of the date of the order. The Agency tentatively concludes that requiring submission of a request for an informal hearing in writing at the time that the owner, operator, or agent in charge of the facility would be required to submit a written appeal is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that would come to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if FDA denies the appeal.
Proposed § 507.71(b) would establish that a request for an informal hearing may be denied, in whole or in part, if the presiding officer determines that no genuine and substantial issue of material fact has been raised by the material submitted. Proposed § 507.71(b) would also provide that if the presiding officer determines that a hearing is not justified, written notice of the determination will be given to the owner, operator, or agent in charge of the facility explaining the reason for the denial. Under proposed § 507.69(a), a written appeal would be required to respond with particularity to the facts and issues contained in the withdrawal order, including any supporting documentation upon which the owner, operator or agent in charge of the facility relies. If the materials submitted do not directly address the facts and issues contained in the withdrawal order in a manner that suggests that there is a dispute regarding the material facts contained in the order, the presiding officer may determine that an informal hearing is not warranted. The presiding officer may include written notice of the determination that a hearing is not justified as part of the final decision on the appeal.
Proposed § 507.73(a) would establish that, if the owner, operator or agent in charge of the facility requests an informal hearing, and FDA grants the request, the hearing will be held within 10 calendar days after the date the appeal is filed or, if applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in charge of the facility and FDA. The Agency tentatively concludes that, if it grants a request for an informal hearing, holding the hearing within 10 calendar days, or within an alternative timeframe as agreed upon in writing, is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that would come to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
Proposed § 507.73(b) would establish that the presiding officer may require that a hearing conducted under this subpart E be completed within 1 calendar day, if appropriate. The Agency tentatively concludes that, if it grants a request for an informal hearing, limiting the time for the hearing itself to be completed within 1 calendar day is appropriate for purposes of the efficient adjudication of the appeal of a withdrawal order and would provide reasonable due process that would come to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
Proposed § 507.73(c)(1) through (c)(7) would establish that, if the owner, operator or agent in charge of the facility requests an informal hearing, and FDA grants the request, FDA must conduct the hearing in accordance with part 16, except that:
• The order withdrawing an exemption under §§ 507.62 and 507.65, rather than the notice under § 16.22(a), provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter.
• A request for a hearing under this subpart D must be addressed to the FDA District Director (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine) as provided in the order withdrawing an exemption.
• Section 507.75, rather than § 16.42(a), describes the FDA employees who preside at hearings under this subpart.
• Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 2 calendar days of issuance of the report. The presiding officer will then issue the final decision.
• Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding
• No party shall have the right, under § 16.119 of this chapter to petition the Commissioner of Food and Drugs for reconsideration or a stay of the presiding officer's final decision.
• If FDA grants a request for an informal hearing on an appeal of an order withdrawing an exemption, the hearing must be conducted as a regulatory hearing under part 16, except that § 16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 507.73(c)(5) constitutes the exclusive record for the presiding officer's final decision. For purposes of judicial review under § 10.45 (21 CFR 10.45), the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
Under § 16.1(b), the procedures in part 16 apply when a regulation provides a person with an opportunity for a hearing on a regulatory action under part 16. Section 418 of the FD&C Act does not expressly provide for a hearing if circumstances lead FDA to determine that an exemption provided to a qualified facility under proposed § 507.5(c) should be withdrawn. However, the Agency tentatively concludes as a matter of agency discretion that providing an opportunity for a hearing by regulation in this subpart of the proposed rule would provide appropriate process to the owner, operator, or agent in charge of a qualified facility subject to withdrawal of the facility's exemption. The Agency also tentatively concludes that the modified part 16 procedures contained in this proposed rule would provide the owner, operator, or agent in charge of a qualified facility subject to a withdrawal order sufficient fairness and due process while enabling FDA to expeditiously adjudicate an appeal of a withdrawal order for which an informal hearing has been granted.
Section 16.119 provides that, after any final administrative action that is the subject of a hearing under part 16, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under § 10.33 or may petition for a stay of the decision or action under § 10.35. Proposed § 507.73(c)(6) would specify that these procedures for reconsideration and stay would not apply to the process of withdrawing an exemption provided under proposed § 507.5(c). The circumstances that may lead FDA to withdraw an exemption include an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility, or the Agency's determination that it is necessary to protect animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility. Such circumstances require prompt action. Under § 16.120, a qualified facility that disagrees with FDA's decision to withdraw an exemption provided under § 507.5(c) has an opportunity for judicial review in accordance with § 10.45.
Proposed § 507.75 would require that the presiding officer for an appeal, and for an informal hearing, must be an FDA Regional Food and Drug Director or another FDA official senior to an FDA District Director. Under § 16.42(b), an officer presiding over an informal hearing is to be free from bias or prejudice and may not have participated in the investigation or action that is the subject of the hearing or be subordinate to a person, other than the Commissioner, who has participated in such investigation or action. An order for the withdrawal of an exemption applicable to a qualified facility must be approved by a District Director or an official senior to a District Director. It is therefore necessary that appeals of a decision to issue a withdrawal order should be handled by persons in positions senior to the District Directors. The Regional Food and Drug Director is such a person and could be from the same region where the facility is located, provided that the Regional Food and Drug Director did not participate in the determination that an exemption should be withdrawn and is otherwise free from bias or prejudice. Alternatively, the Regional Food and Drug Director could be from a different region than the region where the facility is located, for example in the event the Regional Food and Drug Director for the region in which the facility is located is the FDA official who approved the withdrawal order.
Proposed § 507.77(a) would require that, if the owner, operator, or agent in charge of a facility appeals the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the tenth calendar day after the appeal is filed. Under proposed § 507.60, FDA would issue a withdrawal order either in the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility or if FDA determines that an exemption withdrawal is necessary to protect animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the animal food located at the facility. The Agency tentatively concludes that it will need 10 calendar days to review the written appeal and the materials submitted with the written appeal, and that a final decision confirming or revoking a withdrawal order should be issued as quickly as possible in the interest of the public health and to provide reasonable due process that would come to closure sufficiently in advance of the effective date of the order to provide an opportunity for the facility to come into compliance if the Agency denies the appeal.
Proposed § 507.77(b)(1) would require that, if the owner, operator, or agent in charge of a facility appeals the order and requests an informal hearing and, if FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 507.73(c)(4), and must issue a final decision within the 10 calendar day period after the hearing is held. The Agency tentatively concludes that it is appropriate to grant the owner, operator, or agent in charge of a qualified facility subject to a withdrawal order the opportunity to review and submit comments to the presiding officer's report because the report is part of the record of a final agency action (see discussion of proposed § 507.83 in this section of the document) that is not subject to further reconsideration by FDA. The presiding officer would have discretion to determine whether to revise the report of the hearing in light of any comments that might be submitted by any of the hearing participants.
Proposed § 507.77(b)(2) would require that, if the owner, operator, or agent in charge of a facility appeals the order and requests an informal hearing and if FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or
Proposed § 507.80(a) through (c) would establish that an order to withdraw an exemption applicable to a qualified facility under § 507.5(c) is revoked if:
• The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10 calendar days after the hearing, or issues a decision revoking the order within that time; or
• The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time; or
• The owner, operator, or agent in charge of the facility appeals the order without requesting an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time.
The Agency tentatively concludes that an order to withdraw an exemption may be revoked in one of two manners. First, the Agency is proposing that the FDA officer responsible for adjudicating the appeal and presiding over a hearing, if one is granted, may expressly issue a written decision revoking the order within the specified 10 calendar day timeframes. Second, the Agency is proposing that the failure of the FDA officer responsible for adjudicating an appeal to issue a final decision expressly confirming the order within the specified timeframes will also serve to revoke the order. The Agency tentatively concludes that fairness would warrant the revocation of a withdrawal order if FDA is unable to meet the proposed deadlines for expressly confirming an order.
Proposed § 507.84 would establish that confirmation of a withdrawal order by the presiding officer is considered a final agency action for purposes of section 702 of title 5 of the United States Code (5 U.S.C. 702). A confirmation of an order withdrawing an exemption therefore would be reviewable by the courts under section 702 of title 5 and in accordance with § 10.45.
The Agency proposes to amend § 16.1(b)(2) to include part 507, subpart D, relating to the withdrawal of an exemption applicable to a qualified facility, to the list of regulatory provisions under which regulatory hearings are available.
FDA is proposing to create a new subpart F to establish requirements applying to records that must be established and maintained according to the requirements of this proposed rule. As discussed in section X.J, section 418 of the FD&C Act prescribes several requirements relevant to recordkeeping. The statutory provisions that are most relevant to proposed subpart F are:
• Section 418(a) of the FD&C Act, which requires, in relevant part, that the owner, operator, or agent in charge of a facility maintain records of monitoring the performance of preventive controls as a matter of routine practice;
• Section 418(b)(3) of the FD&C Act, which requires, in relevant part, that the owner, operator, or agent in charge of a facility develop a written analysis of the hazards;
• Section 418(g) of the FD&C Act, which requires, in relevant part, that the owner, operator, or agent in charge of a facility maintain certain records for not less than 2 years. The records identified in section 418(g) include records documenting the monitoring of the preventive controls implemented under section 418(c) of the FD&C Act, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under section 418(f)(4) of the FD&C Act, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions;
• Section 418(h) of the FD&C Act, which requires, in relevant part, that the owner, operator, or agent in charge of a facility prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section and that such written plan, together with documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request;
• Section 418(n)(1)(A) of the FD&C Act, which provides, in relevant part, that FDA shall issue regulations to establish science-based minimum standards for documenting hazards and documenting the implementation of the preventive controls under this section;
• Section 402(a)(4) of the FD&C Act, which provides that food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
• Section 701(a) of the FD&C Act 21 U.S.C. 371(a), which provides FDA with authority to issue regulations for the efficient enforcement of the FD&C Act;
• Section 361(a) of the Public Health Service Act (42 U.S.C. 264(a)), which provides FDA with authority to make and enforce such regulations as in FDA's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession; and
• Section 418(l)(2)(B) of the FD&C Act, which requires a qualified facility to submit documentation to the Secretary related to its qualified status and also submit either documentation of the facility's implementation and monitoring of preventive controls or documentation of its compliance with other appropriate non-Federal food safety laws.
Proposed § 507.100(a) would establish that, except as provided by proposed § 507.100(d) and (e), all records required by proposed part 507 would be subject to all requirements of proposed subpart F. FDA tentatively concludes that the requirements in proposed subpart F describing how records must be established and maintained, including the general requirements, record retention requirements, and requirements for official review and public disclosure, are applicable to all records that would be required under all subparts, because records that would be required under each of the subparts aid
Proposed § 507.100(b) would establish that all records required by proposed part 507 are subject to the disclosure requirements under part 20 (21 CFR part 20). FDA's regulations in part 20, the Freedom of Information Act (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 1905), and the FD&C Act, govern FDA's disclosures of information, including treatment of commercial confidential information and trade secret information. The Agency's general policies, procedures, and practices relating to the protection of confidential information received from third parties would apply to information received under this rule.
Proposed § 507.100(c) would require that all records required by part 507 be made promptly available to a duly authorized representative of the Secretary upon oral or written request. Proposed § 507.100(c) implements subsection 418(h) of the FD&C Act and is necessary in order for FDA to determine compliance with the requirements of part 507.
Proposed § 507.100(c) does not explicitly require a facility to send records to the Agency rather than making the records available for review at a facility's place of business. FDA requests comments on whether proposed § 507.100(c) should be modified to explicitly address this circumstance, and if so, whether FDA should require that the records be submitted electronically. Obtaining a facility's food safety plan without going to a facility could be useful to FDA in a number of different circumstances, such as to determine whether a recently identified hazard is being addressed by affected facilities.
Proposed § 507.100(d) would establish that the requirements of proposed § 507.100 apply only to the written food safety plan and is discussed in more detail in section XII.D.
Proposed § 507.100(e) would provide that the requirements of § 507.102(a)(2), (a)(4), and (a)(5) and (b) do not apply to the records required by proposed § 507.7(e) pertaining to qualified facilities. As discussed in section VIII.D, proposed § 507.7(e) would require that a qualified facility maintain records relied upon to support the self-certification that would be required by proposed § 507.7(a). Such documentation would be directed to the financial basis (and, when applicable, percentage of sales to qualified end users) as well as to food safety practices at the qualified facility, and could range from invoices to a food safety plan to an operating license issued by a state or local authority. Such records would not be expected to satisfy the provisions of proposed § 507.102(a)(2), (a)(4), and (a)(5) and (b) (which are discussed in the next section). To make clear that a qualified facility need not comply with provisions that do not apply to its records, the Agency is proposing to specify that those provisions do not apply to such records.
Proposed § 507.102 contains general requirements that would apply to records that would be required under proposed part 507, including the format for required records, the recording of actual values and observations obtained during monitoring, when records must be created, and information that must be included in each record.
Proposed § 507.102(a)(1) would require that the records be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records. True copies of records should be of sufficient quality to detect whether the original record was changed or corrected in a manner that obscured the original entry (e.g., through the use of white-out). Proposed § 507.102(a)(1) would provide flexibility for mechanisms for keeping records while maintaining the integrity of the recordkeeping system. The proposed requirement allowing true copies provides options that may be compatible with the way records are currently being kept in plants and facilities.
Proposed § 507.102(a)(1) also would require that electronic records be kept in accordance with part 11 (21 CFR part 11). Part 11 provides criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. The proposed requirement clarifies and acknowledges that records required by part 507 may be retained electronically, provided that they comply with part 11.
FDA tentatively concludes that it is appropriate to apply the requirements of part 11 to the records that would be required to be kept under proposed part 507. However, the Agency requests comment on whether there are any circumstances that would warrant not applying part 11 to records that would be kept under proposed part 507. For example, would a requirement that electronic records be kept according to part 11 mean that current electronic records and recordkeeping systems would have to be recreated and redesigned, which the Agency determined to be the case in the regulation “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (69 FR 71562, December 9, 2004 (the BT records regulation)). For the purposes of the records requirements in the BT records regulation, the Agency concluded that it was not necessary for new recordkeeping systems to be established as long as current practices would satisfy the requirements of the Act and, therefore, the Agency exempted the records from the requirements of part 11 (§ 1.329(b)). The Agency also exempted records related to certain cattle materials prohibited from use in human food and cosmetics from part 11 (21 CFR 189.5(c)(7) and 700.27(c)(7), respectively). The Agency also seeks comment on whether it should allow additional time for electronic records to be kept in accordance with part 11. Comments should provide the basis for any view that the requirements of part 11 are not warranted.
Proposed § 507.102(a)(2)would require that records contain the actual values and observations obtained during monitoring. It is neither possible to derive the full benefits of a preventive controls system, nor to verify the operation of the system, without recording actual values and observations to produce an accurate record. Notations that monitoring measurements, such as heat treatment temperatures, are “satisfactory” or “unsatisfactory,” without recording the actual times and temperatures, are vague and subject to varying interpretations and, thus, will not ensure that controls are working properly. In addition, it is not possible to discern a trend toward loss of control without actual measurement values.
Proposed § 507.102(a)(3), (a)(4), and (a)(5) would require that records be accurate, indelible, and legible (proposed § 507.102(a)(3)); be created concurrently with performance of the activity documented (proposed
Proposed § 507.102(b)would require that the records include: (1) The name and location of the plant or facility; (2) the date and time of the activity documented; (3) the signature or initials of the person performing the activity; and (4) where appropriate, the identity of the product and the production code, if any. The name and location of the plant or facility and the date and time would allow the owner, operator, or agent in charge of a plant or facility (and, during inspection, an FDA investigator) to assess whether the record is current, to identify when and where any deviation occurred, and to track corrective actions. The signature of the individual who made the observation would ensure responsibility and accountability. In addition, if there is a question about the record, a signature would ensure that the source of the record will be known. Linking a record to a specific product (and, when applicable, the production code) would enable the owner, operator, or agent in charge of a facility to isolate product that has not been processed properly when there has been a problem, thereby limiting the impact of the problem (such as the need to reprocess product or to recall product) to only those lots with the problem.
Proposed § 507.106 would require that the owner, operator, or agent in charge of a facility sign and date the food safety plan upon initial completion and upon any modification. Such a signature would provide direct evidence of the owner, operator, or agent's acceptance of the plan and commitment to implementation of the plan. Additionally, the signature, along with the date of signing, would serve to minimize potential confusion over the authenticity of any differing versions or editions of the document that might exist.
Proposed § 507.108 contains requirements on the length of time records that would be required under proposed part 507 must be retained and allowances for offsite storage of records under certain circumstances.
Proposed § 507.108(a) would require that all records that would be required by proposed part 507 be retained at the plant or facility for at least 2 years after the date they were prepared. Proposed § 507.108(b) would require that records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and evaluations, must be retained at the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food safety plan (§ 507.30) or records that document validation of the written food safety plan (§ 507.45(a)). Proposed § 507.108(a) and (b) implement subsection 418(g) of the FD&C Act, which requires certain records to be maintained for not less than 2 years.
While FDA established shorter records retention requirements for records related to perishable foods in the BT records, seafood HACCP, and juice HACCP regulations, in this case Congress determined and specified in section 418(g) of the FD&C Act that the minimum retention period for the majority of the records required under the implementing regulations for all foods, regardless of perishability, be 2 years. Therefore, FDA tentatively concludes that the same requirement should apply to all records required under this section, regardless of the perishability of the food to which the record relates. This would simplify plants' or facilities' duties in compliance because there would only be one 2-year retention period to apply to any record required under proposed part 507. This 2-year retention period would run either from the date the record was prepared, for day-to-day operational records; or from the date at which use of the record is discontinued, for records relating to the general adequacy or equipment or processes (e.g., the written food safety plan and records that document validation of the written food safety plan). The Agency requests comments on the record keeping requirements for animal food, including whether the Agency should use its authority in section 418(m) of the FD&C Act to modify these requirements with respect to facilities that are solely engaged in the production of food for animals other than man.
Proposed § 507.108(c) would provide that, except for the food safety plan, use of offsite storage for records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan would be required to remain onsite. FDA realizes that the proposed requirements for recordkeeping could require some plants or facilities to store a significant quantity of records, and that there may not be adequate storage space in the plant or facility for all of these records. Providing for offsite storage of most records after 6 months would enable a facility to comply with the proposed requirements for record retention while reducing the amount of space needed for onsite storage of the records without interfering with the purpose of record retention, because the records will be readily available.
Proposed § 507.108(c) would also provide that electronic records are considered to be onsite if they are accessible from an onsite location. Computerized systems within corporations can be networked, allowing for the sending and receiving of information in a secure fashion to all of the different food processing facilities of that corporation worldwide. This type of system can be used to provide access at multiple locations to records from multiple plants or facilities.
Proposed § 507.108(d) would provide that if the plant or facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but must be returned to the plant or facility within 24 hours for official review upon request. Allowing for transfer of records will give practical storage relief to seasonal operations or those closed for other reasons for prolonged periods.
Please see this discussion in section XVI of the document for the proposed rule for preventive controls for human food (78 FR 3646).
FDA is proposing conforming changes to several applicable sections of the CFR that would add a reference to part 507. The affected sections in title 21 CFR are:
• § 225.1 Current good manufacturing practice;
• § 500.23 Thermally processed low-acid foods packaged in hermetically sealed containers; and
• § 579.12 Incorporation of regulations in part 179.
FDA is proposing the CGMP regulations under the FD&C Act and the Public Health Service Act. FDA is proposing all other requirements under the FDA Food Safety Modernization Act, the FD&C Act, the Public Health Service Act, and the FDAAA of 2007.
FDA is proposing CGMP requirements in proposed subparts A, B, and F. FDA's legal authority to require CGMPs derives from sections 402(a)(3), 402(a)(4) and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). Section 402(a)(3) of the FD&C Act provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under section 701(a) of the FD&C Act, FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. The proposed rule also includes new requirements necessary to prevent food from being adulterated (either because it consists in whole or in part of a filthy, putrid, or decomposed substance, because it is otherwise unfit for food, or because it has been held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health). A regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for the efficient enforcement of the FD&C Act. See, e.g., regulations to require HACCP systems for fish and fishery products (part 123) and juice (part 120), regulations to require a safe handling statement on cartons of shell eggs that have not been treated to destroy
In addition to the FD&C Act, FDA's legal authority for the proposed CGMP requirements derives from the PHS Act to the extent such measures are related to communicable disease. Authority under the PHS Act for the proposed regulations is derived from the provisions of sections 311, 361, and 368 (42 U.S.C. 243, 264, and 271) that relate to communicable disease. The PHS Act authorizes the Secretary to make and enforce such regulations as “are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State” (section 361(a) of the PHS Act). (See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary.) Many provisions in the proposed rule are necessary to prevent animal food from being contaminated with microorganisms of human health significance, such as
Section 103 of FSMA, Hazard Analysis and Risk-Based Preventive Controls, amends the FD&C Act to create a new section 418, which mandates rulemaking. Section 418(n)(1)(A) of the FD&C Act requires that the Secretary issue regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls. Section 418(n)(1)(B) of the FD&C Act requires that the regulations define the terms “small business” and “very small business,” taking into consideration the study of the food processing sector required by section 418(l)(5) of the FD&C Act. Section 103(e) of FSMA creates a new section 301(uu) in the FD&C Act (21 U.S.C. 331(uu)) to prohibit the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act.
In addition to rulemaking requirements, section 418 contains requirements applicable to the owner, operator, or agent in charge of a facility required to register under section 415. Section 418(a) is a general provision that requires the owner, operator, or agent in charge of a facility to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. Section 418(a) specifies that the purpose of the preventive controls is, in relevant part, to prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 of the FD&C Act. In addition to the general requirements in section 418(a) of the FD&C Act, sections 418(b)–(i) contain more specific requirements applicable to facilities. These include hazard analysis (§ 418(b)), preventive controls (§ 418(c)), monitoring (§ 418(d)), corrective actions (§ 418(e)), verification (§ 418(f)), recordkeeping (§ 418(g)), a written plan and documentation (§ 418(h)), and reanalysis of hazards (§ 418(i)). Proposed requirements (proposed subparts C and F) that would implement these provisions of section 418 of the FD&C Act are discussed in sections X and XII.
The Agency is proposing certain requirements in order to efficiently enforce these requirements of section 418. For example, section 418(g) and (h) of the FD&C Act prescribe certain recordkeeping, maintenance, and access requirements for certain kinds of records. As discussed in section XII, the Agency is proposing to establish one set of requirements that would apply to all records that would be required under the proposed rule. This approach will facilitate compliance with the rule on the part of facilities, and will allow for
Section 418(j) through (m) of the FD&C Act and section 103(c)(1)(D) and (g) of FSMA provide authority for certain exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to low-acid canned food (section 418(j)); activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety) (section 418(k)); qualified facilities (section 418(l)); facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment (section 418(m)); and facilities engaged only in certain low-risk on-farm activities on certain foods conducted by small or very small businesses (section 103(c)(1)(D) of FSMA). Proposed provisions that would implement these provisions of section 418 of the FD&C Act and section 103 of FSMA are discussed in sections VII, VIII, and X.
FDA tentatively concludes that the provisions in proposed subpart C and related requirements in proposed subparts A, D, and F should be applicable to activities that are intrastate in character. Facilities are required to register under section 415 of the FD&C Act regardless of whether the food from the facility enters interstate commerce (§ 1.225(b)). The plain language of section 418 of the FD&C Act applies to facilities that are required to register under section 415 (section 418(o)(2) of the FD&C Act) and does not exclude a facility because food from such a facility is not in interstate commerce. Section 301(uu) of the FD&C Act provides that “the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418”, or the causing thereof, is a prohibited act.
FDA also is proposing the provisions in subpart C and related requirements in subparts A, D, and F, under sections 402(a)(3), (a)(4), and 701(a) of the FD&C Act to the extent such requirements are necessary to prevent food from being held under insanitary conditions whereby it may become contaminated with filth or rendered injurious to health, or being unfit for food. FDA is also proposing those provisions under sections 311, 361, and 368 of the PHS Act relating to communicable disease to the extent those provisions are necessary to prevent the interstate spread of communicable disease.
The animal food safety system that the Agency is proposing would require a facility to conduct a hazard analysis to determine those hazards that are reasonably likely to occur and establish and implement preventive controls for those hazards. To ensure that controls are properly implemented and effectively controlling the hazards, the proposed animal food safety system would establish requirements for monitoring, corrective actions, and verification, including validation that the preventive controls are adequate to control the identified hazards. The proposed animal food safety system also would require a recall plan. Certain activities would be required to be conducted (or overseen) by a qualified individual and certain activities would be required to be documented. A written food safety plan would include the hazard analysis, the preventive controls that would be established and implemented to address those hazards determined to be reasonably likely to occur, procedures for monitoring, corrective actions, and verification; and a recall plan. The written plan and other documentation would be required to be made promptly available to a duly authorized representative of the Secretary upon oral or written request. FDA tentatively concludes that, taken as a whole, the animal food safety system described here is necessary to help prevent food safety problems associated with biological, chemical, physical, and radiological hazards in animal foods. Therefore, the proposed system is necessary to prevent animal food from being adulterated because it is unfit for food or because it has been held under insanitary conditions whereby it may become contaminated with filth or may be rendered injurious to health and to prevent the spread of communicable disease.
Finally, FDA is proposing the provisions in subparts B and C and related requirements in subparts A, D, and F, under section 1002(a) of Title X of the FDAAA of 2007 (21 U.S.C. 2102), which requires the Secretary to establish processing standards for pet food. The proposed animal food safety system would require tailored standards for facilities processing animal food (including animal feed, pet food, and their raw materials and ingredients).
FDA has examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA has developed a PRIA that presents the benefits and costs of this proposed rule (Ref. 52). FDA believes that the proposed rule will be a significant regulatory action as defined by Executive Order 12866. FDA requests comments on the PRIA.
The summary analysis of benefits and costs included in this document is drawn from the detailed PRIA (Ref. 52) which is available at
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because many small businesses will need to implement a number of new preventive controls, FDA acknowledges that the final rules resulting from this proposed rule will have a significant economic impact on a substantial number of small entities.
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, the Office of Management and Budget (OMB) has determined that this proposed rule is a major rule for the purpose of congressional review.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2012) Implicit Price Deflator for the Gross Domestic Product. FDA expects that the proposed rule will result in a 1-year expenditure that would exceed this amount.
The analyses that FDA has performed in order to examine the impacts of this proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4) are available to the public in the docket for this proposed rule (Ref. 52).
This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in the proposed rule have been submitted to OMB for review under section 3507(d) of the Paperwork Reduction Act of 1995. FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the
The analyses that FDA has performed in order to examine the impacts of this proposed rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) is available to the public in the docket (Docket No. FDA–2011–N–0922) for this proposed rule (Ref. 96).
FDA has determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
Interested persons may submit either electronic comments regarding this document to
The following references have been placed on display in the Division of Dockets Management (see
1. FDA, “Animal Feed Safety System (AFSS) Meetings” (
2. Food and Agriculture Organization of the United Nations (FAO) and International Feed Industry Federation (IFIF), “Good practices for the feed industry—Implementing the Codex Alimentarius Code of Practice on Good Animal Feeding” 2010.
3. FDA, “Fourth Draft: Framework of the FDA Animal Feed Safety System” January 2010.
4. FDA, “Animal Feed Safety System (AFSS) Information” (
5. DA, “Import Alert 99–25: Detention Without Physical Examination of Animal Feed, Animal Feed Ingredients and Other Products for Animal Use Consisting or Containing Ingredients of Animal Origin and Not the Subject of a Valid USDA Import Permit” (
6. FDA, “Compliance Program 7371.009, BSE/Ruminant Feed Ban Inspections” October 2003.
7. FDA, “GFI #67, Small Entities Compliance Guide for Renderers” February 1998.
8. FDA, “GFI #68, Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors” February 1998.
9. FDA, “GFI #69, Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations” February 1998.
10. FDA, “GFI #76, Questions and Answers BSE Feed Regulation” July 1998.
11. FDA, “GFI #158, Use of Material from Deer and Elk in Animal Feed” September 2003.
12. FDA, “GFI, Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-products for Animal Feed” June 2010.
13. FDA, “GFI # 122, Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores” November 2004.
14. FDA, “Compliance Policy Guide Sec. 690.800
15. FDA, “Compliance Policy Guide Sec. 683.100 Action Levels for Aflatoxins in Animal Feeds” (
Administrative practice and procedure.
Animal drugs, Animal feeds, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Animal drugs, Animal feeds, Cancer, Labeling, Packaging and containers, Polychlorinated biphenyls (PCB's).
Animal foods, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Animal feeds, Animal foods, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be amended as follows:
15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.
(b) * * *
(2) * * *
§§ 507.60 through 507.83 (part 507, subpart D) relating to withdrawal of exemption applicable to a qualified facility.
21 U.S.C. 351, 352, 360b, 371, 374.
(d) In addition, non-medicated feed is subject to part 507 of this chapter.
21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e.
Except as provided in § 507.5(b), the provisions of parts 507 and 113 of this chapter apply to the manufacturing, processing, or packing of low-acid foods in hermetically sealed containers, and intended for use as food for animals.
21 U.S.C. 321, 331, 342, 350c, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
(a) The criteria and definitions in this part will apply in determining whether an animal food is adulterated:
(1) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and
(2) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether an animal food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264).
(b) The operation of a facility that manufactures, processes, packs, or holds animal food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with and is not in compliance with section 418 of the Federal Food, Drug, and Cosmetic Act or subparts C, D, and F of this part and § 507.7 is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act.
(c) Animal food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.
(d) Animal food for sale in the United States must be manufactured, processed, packed, and held in accordance with the requirements in this part, subject to the exemptions in § 507.5. If a facility is required to comply with subpart B of this part and is also required to comply with subpart B of part 117 of this chapter because the facility manufactures, processes, packs, or holds human food, then the facility may choose to comply with the requirements in subpart B of part 117, instead of subpart B of part 507, as to the manufacturing, processing, packing, and holding of animal food at that facility. If a facility is required to comply with subpart C of part 507 and is also required to comply with subpart C of part 117 of this chapter, then the facility may choose to comply with the requirements in subpart C of part 117 as to the manufacturing, processing, packing, and holding of animal food at the facility, instead of subpart C of part 507, so long as the food safety plan also addresses all hazards that are reasonably likely to occur in the animal food, including nutrient imbalances. In both instances, when applying the requirements of part 117 of this chapter to animal food, the term “food” in part 117 includes animal food.
The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:
(1) Is located:
(i) In the same State as the qualified facility that sold the food to such restaurant or retail food establishment; or
(ii) Not more than 275 miles from such facility; and
(2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
(1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the animal food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the animal food sold by such facility to all other purchasers; and
(2) The average annual monetary value of all animal food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
(a) This part does not apply to establishments (including “farms” as defined in § 1.227(b) of this chapter) that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act.
(b) Activities in animal food facilities that are regulated under, and are in compliance with, § 500.23 and part 113 of this chapter (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers) are exempt from subpart C of part 507 only with respect to those microbiological hazards regulated under part 113. The facilities must comply with subparts C and F of this part regarding all other potential hazards and must comply with subparts A and B of this part.
(c) Subpart C of this part does not apply to activities of a facility that are subject to section 419 of the Federal Food, Drug, and Cosmetic Act (Standards for Produce Safety).
(d) Except as provided in subpart D of this part, qualified facilities are exempt from subpart C of this part if they comply with the requirements in § 507.7.
(e) Subpart C of this part does not apply to on-farm packing or holding of animal food by a small or very small business if the only packing and holding activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts are the following low-risk packing or holding activity/animal food combinations on animal food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed-type facility under the same ownership:
(1) Conveying, weighing, sorting, culling, or grading (incidental to storing):
(i) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
(ii) Oilseed (e.g., cottonseed, linseed, rapeseed, soybean, sunflower);
(iii) Grain or oilseed byproducts;
(iv) Forage (e.g., hay or ensiled material); or
(v) Other plants or plant byproducts (e.g., almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
(2) Storing:
(i) Dried grain;
(ii) Dried oilseed;
(iii) Byproducts of dried grain or dried oilseed;
(iv) Forage; or
(v) Other plants or plant byproducts.
(3) Packing:
(i) Grain;
(ii) Oilseed;
(iii) Grain or oilseed byproducts;
(iv) Forage; or
(v) Other plants or plant byproducts.
(4) Mixing (incidental to packing or storing):
(i) Grain, whole; or
(ii) Forage.
(f) Subpart C does not apply to on-farm low-risk manufacturing/processing activities conducted by a small or very small business if the only manufacturing/processing activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts consists of the following:
(1) When conducted on a farm mixed-typed facility's own raw agriculture commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act, (those grown or raised on that farm mixed-type facility or another farm/farm mixed-typed facility under the same ownership) for distribution into commerce:
(i) Cracking, crimping, or flaking:
(A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
(B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or
(C) Grain or oilseed byproducts.
(ii) Crushing, grinding, milling, pulverizing, or dry rolling:
(A) Grain;
(B) Oilseed;
(C) Grain or oilseed byproducts;
(D) Forage (e.g., hay or ensiled material); or
(E) Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
(iii) Making silage.
(iv) Chopping or shredding hay.
(v) Extracting (mechanical) or wet rolling:
(A) Grain; or
(B) Oilseed.
(2) When conducted on animal food other than the farm mixed-typed facility's own raw agriculture commodities for distribution into commerce:
(i) Cracking, crimping, flaking, or shelling:
(A) Grain (e.g., barley, corn, rice, oat, sorghum, triticale, wheat);
(B) Oilseed (e.g., cotton seed, linseed, rapeseed, soybean, sunflower); or
(C) Grain or oilseed byproducts.
(ii) Crushing, grinding, milling, pulverizing, or dry rolling:
(A) Grain;
(B) Oilseed;
(C) Grain or oilseed byproducts;
(D) Forage (e.g., hay or ensiled material); or
(E) Other plants or plant byproducts (e.g., such as almond, peanut, or soybean hulls, citrus, other fruit including culled fruit, potatoes, or other vegetables including culled vegetables).
(iii) Making silage.
(iv) Chopping or shredding hay.
(v) Extracting (mechanical) or wet rolling:
(A) Grain; or
(B) Oilseed.
(vi) Labeling:
(A) Grain whole; or
(B) Oilseed whole.
(vii) Sifting, separating, or sizing:
(A) Grain;
(B) Oilseed;
(C) Grain or oilseed byproducts; or
(D) Other plants or plant byproducts.
(g) Subpart C of this part does not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.
(h) Subpart B of this part does not apply to the holding or transportation of one or more raw agricultural commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
(a) A qualified facility is exempt from subpart C of this part provided that for the calendar year in which it is to be considered a qualified facility, the facility has submitted to FDA documentation that:
(1) Demonstrates the facility is a qualified facility as defined in § 507.3. For the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011; and
(2)(i) Demonstrates the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the animal food being manufactured, processed, packed, or held at the facility, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or
(ii) Demonstrates the facility is in compliance with state, local, county, or other applicable non-Federal food safety law. This documentation may include inspection reports, certification by an appropriate agency (such as a State department of agriculture), or other documentation deemed appropriate by FDA.
(b) The documentation required by paragraph (a) of this section must be submitted to FDA by any one of the following means:
(1) To submit electronically, go to
(2) To submit documents in a paper format or in an electronic format on a CD–ROM, mail these to the U.S. Food and Drug Administration, ATTN: Qualified Facility Coordinator, 10903 New Hampshire Ave., Silver Spring, MD 20993. We recommend that an owner, operator, or agent in charge of a facility submit by mail only if the facility does not have reasonable access to the Internet.
(c) The documentation required by paragraph (a) of this section must be:
(1) Submitted to FDA initially within 90 days of the applicable compliance date of this part; and
(2) Resubmitted at least every 2 years, or whenever there is a material change to the information described in paragraph (a) of this section. For the purpose of this section, a material change is one that changes whether or not a facility is a “qualified facility”.
(d) A qualified facility that does not submit documentation under paragraph (a)(2)(i) of this section must provide notification to consumers as to the name and complete business address (the street address, city, state, and ZIP code for domestic facilities, and comparable full address information for foreign facilities) of the facility where the animal food was manufactured or processed as follows:
(1) Such notification must appear in a prominent and conspicuous location on the label for animal food required to bear a package label under any other provision of the Federal Food, Drug, and Cosmetic Act.
(2) For animal food that is not required to bear a food packaging label, the notification must appear prominently and conspicuously, at the point of purchase, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or in an electronic notice, in the case of Internet sales.
(e) A qualified facility must maintain those records relied upon to support the documentation required by § 507.7(a)(2). These records are subject to the requirements of subpart F of this part.
(a) Subpart C of this part does not apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment and does not require time/temperature control to ensure the safety of the animal food.
(b) A facility solely engaged in the storage of packaged animal food that is not exposed to the environment but requires time/temperature control is subject to the modified requirements in § 507.48.
(a) Plant management must take all reasonable measures and precautions to ensure that:
(1) Any person who, by his own acknowledgement, by medical examination, or by supervisory observation, is shown to have, or appears to have any illness, open skin lesion, or other source of abnormal microbial contamination by which there is a reasonable possibility of animal food, animal food-contact surfaces, or animal food-packaging materials becoming contaminated, is excluded from any operations which may be expected to result in such contamination until the condition is resolved;
(2) Personnel have been instructed to report such health conditions to their supervisors;
(3) All persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of animal food. The methods for maintaining cleanliness include:
(i) Maintaining adequate personal cleanliness;
(ii) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work and at any other time when the hands may have become soiled or contaminated;
(iii) Removing all unsecured jewelry and other objects that might fall into animal food, equipment, or containers;
(iv) Storing clothing or other personal belongings in areas other than where animal food is exposed or where equipment or utensils are washed; and
(v) Taking any other necessary precautions to protect against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials with microorganisms or foreign substances.
(b) Personnel responsible for identifying sanitation failures or animal food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe animal food. Animal food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and unsanitary practices.
(c) Responsibility for ensuring compliance by all personnel with all requirements of this subpart must be clearly assigned to competent supervisory personnel.
(a) The grounds about an animal food plant under the control of the operator must be kept in a condition that will protect against the contamination of animal food. The methods for adequate maintenance of grounds must include:
(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests;
(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where animal food is exposed;
(3) Adequately draining areas that may contribute to contamination of animal food by seepage, foot-borne filth, or providing a breeding place for pests; and
(4) Treating and disposing of waste so that it does not constitute a source of contamination in areas where animal food is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a)(1) through (a)(3) of this section, care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of animal food contamination.
(b) The plant's buildings and structures must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for animal food-production purposes (i.e., manufacturing, processing, packing, and holding). The plant must:
(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe animal food.
(2) Permit the taking of proper precautions to reduce the potential for contamination of animal food, animal food-contact surfaces, or animal food-packaging materials with microorganisms, chemicals, filth, and other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: Location, time, partition, air flow, enclosed systems, or other effective means.
(3) Permit the taking of proper precautions to protect animal food in outdoor bulk vessels by any effective means, including:
(i) Using protective coverings;
(ii) Controlling areas over and around the vessels to eliminate harborages for pests;
(iii) Checking on a regular basis for pests and pest infestation; and
(iv) Skimming fermentation vessels, as necessary.
(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts, and pipes does not contaminate animal food, animal food-contact surfaces, or animal food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating animal food, animal food-contact surfaces, or animal food-packaging materials.
(5) Provide adequate lighting in hand-washing areas, toilet rooms, areas where animal food is examined, processed, or stored, and areas where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, and skylights, or other glass items suspended over exposed animal food in any step of preparation, or otherwise protect against animal food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate animal food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating animal food, animal food-packaging materials, and animal food-contact surfaces.
(7) Provide, where necessary, adequate screening or other protection against pests.
(a) Buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent animal food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.
(b) Cleaning compounds and sanitizing agents must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means, including purchase of these substances under a supplier's guarantee or certification or examination of these substances for contamination.
(c) The following applies to toxic materials:
(1) Only the following toxic materials may be used or stored in a plant where animal food is processed or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and operation; and
(iv) Those necessary for use in the plant's operations.
(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.
(d) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.
(e) All animal food-contact surfaces, including utensils and animal food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against contamination of animal food.
(1) Animal food-contact surfaces used for manufacturing, processing or holding low-moisture animal food must be in a clean, dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and animal food-contact surfaces of the equipment must be cleaned and sanitized as necessary.
(3) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and must be handled, dispensed, used, and disposed of in a manner that protects against contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.
(f) Non-animal food-contact surfaces of equipment used in the operation of an animal food plant should be cleaned in a manner and as frequently as necessary to protect against contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.
(g) Cleaned and sanitized portable equipment with animal food-contact surfaces and utensils should be stored in a location and manner that protects animal food-contact surfaces from contamination.
(a) The water supply must be sufficient for the operations intended and must be derived from an adequate source. Any water that contacts animal food, animal food-contact surfaces, or animal food-packaging materials must be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of animal food, for the cleaning of equipment, utensils, and animal food-packaging materials, or for employee sanitary facilities.
(b) Plumbing must be of adequate size and design and adequately installed and maintained to:
(1) Carry sufficient quantities of water to required locations throughout the plant;
(2) Properly convey sewage and liquid disposable waste from the plant;
(3) Avoid constituting a source of contamination to animal food, water supplies, equipment, or utensils or creating an unsanitary condition;
(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and
(5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for animal food or animal food manufacturing.
(c) Sewage must be disposed of through an adequate sewerage system or through other adequate means.
(d) Each plant must provide its employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.
(e) Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.
(f) Rubbish must be conveyed, stored, and disposed of in a way to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of animal food, animal food-contact surfaces, animal food-packaging materials, water supplies, and ground surfaces.
(a)(1) All plant equipment and utensils must be designed and of such material and workmanship to be adequately cleanable, and must be properly maintained;
(2) The design, construction, and use of equipment and utensils must preclude the adulteration of animal food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants;
(3) All equipment should be installed and maintained in such a way to facilitate the cleaning of the equipment and all adjacent spaces;
(4) Animal food-contact surfaces must be made of materials that resist corrosion when in contact with animal food;
(5) Animal food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of animal food, and, if applicable, the action of cleaning compounds and sanitizing agents; and
(6) Animal food-contact surfaces must be maintained to protect animal food from being contaminated.
(b) Seams on animal food-contact surfaces must be maintained so as to minimize accumulation of food particles, dirt, and organic matter, and thus minimize the opportunity for growth of microorganisms.
(c) Equipment in the animal food manufacturing or handling area that does not come into contact with animal food must be constructed in such a way that it can be kept in a clean condition.
(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be of a design and construction that enables them to be maintained in an appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold animal food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device installed to show the temperature accurately within the compartment.
(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, a
(g) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be treated in such a way that animal food is not contaminated.
(a) Plant management must ensure that:
(1) All operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with adequate sanitation principles;
(2) Containers holding animal food, raw materials, or ingredients are labeled to accurately identify the contents;
(3) The labeling for the finished animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species;
(4) Appropriate quality control operations are employed so that animal food-packaging materials are safe and suitable;
(5) The overall sanitation of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;
(6) All reasonable precautions are taken so that production procedures do not contribute to contamination from any source;
(7) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination; and
(8) All animal food that has become contaminated to the extent that it is adulterated is rejected, or if permissible, treated or processed to eliminate the contamination.
(b) Raw materials and ingredients:
(1) Must be inspected and segregated or otherwise handled as necessary to ensure that they are clean and suitable for processing into animal food and must be stored under conditions that will protect against contamination and minimize deterioration. In addition:
(i) Raw materials must be washed or cleaned as necessary to remove soil or other contamination;
(ii) Water used for washing, rinsing, or conveying animal food must be safe and of adequate sanitary quality;
(iii) Water may be reused for washing, rinsing, or conveying animal food if it does not increase the level of contamination of the animal food; and
(iv) Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of animal food.
(2) Must not contain levels of microorganisms that may render the food injurious to the health of animals or humans, or they must be treated (e.g., heat) during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated;
(3) Susceptible to contamination with aflatoxin or other natural toxins must comply with current FDA regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished animal food;
(4) Including rework, must be held in bulk, or in containers designed and constructed in a way that protects against contamination, and must be held at a temperature and relative humidity and in a manner that prevents the animal food from becoming adulterated. Material scheduled for rework must be identified as such;
(5) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and ingredients from becoming adulterated; and
(6) Whether liquid or dry, received and stored in bulk form must be held in a manner that protects against contamination.
(c) For the purposes of manufacturing operations, the following apply:
(1) Equipment, utensils, and finished animal food containers must be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. When necessary, equipment must be taken apart for thorough cleaning;
(2) All animal food manufacturing, processing, packing, and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of animal food;
(3) Animal food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the animal food from becoming adulterated during manufacturing, processing, packing, and holding;
(4) Measures taken to destroy or prevent the growth of undesirable microorganisms, such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling a
(5) Work-in-process and rework must be handled in a manner that protects against contamination and the growth of undesirable microorganisms;
(6) Effective measures must be taken to protect finished animal food from contamination by raw materials, ingredients, or refuse. When raw materials, ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated animal food. Animal food transported by conveyor must be protected against contamination as necessary;
(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or animal food must be constructed, handled, and maintained during manufacturing, processing, packing, or holding in a manner that protects against contamination of animal food;
(8) Effective measures must be taken to protect against the inclusion of metal or other extraneous material in animal food;
(9) Adulterated animal food, raw materials, and ingredients must be disposed of in a manner that protects against the contamination of other animal food or, if the adulterated animal food, raw materials, or ingredients are capable of being reconditioned, they must be reconditioned using a method that has been proven to be effective;
(10) Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, defatting, and forming must be performed in a way that protects animal food against contamination. Animal food should be protected from contaminants that may drip, drain, or be drawn into the animal food;
(11) Heat blanching, when required in the preparation of animal food, should be effected by heating the animal food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the animal food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning;
(12) Batters, breading, sauces, gravies, dressings, and other similar preparations must be treated or maintained in such a manner that they are protected against contamination;
(13) Filling, assembling, packaging, and other operations must be performed in such a way that the animal food is protected against contamination and growth of undesirable microorganisms;
(14) Animal food, including dry mixes, nuts, intermediate moisture animal food, and dehydrated animal food, that relies on the control of a
(15) Animal food that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at the appropriate pH; and
(16) When ice is used in contact with animal food, it must be made from water that is safe and of adequate sanitary quality, and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
Storage and transportation of animal food must be conducted under conditions that will protect against biological, chemical, physical, and radiological contamination of animal food as well as against deterioration of the animal food and the container.
(a) The owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan.
(b) The written food safety plan must be prepared by (or its preparation overseen by) a qualified individual.
(c) The written food safety plan must include:
(1) The hazard analysis as required by § 507.33;
(2) The preventive controls as required by § 507.36;
(3) The recall plan as required by § 507.38;
(4) The procedures and the frequency with which these procedures will be conducted for monitoring the performance of the preventive controls as required by § 507.39;
(5) The corrective action procedures as required by § 507.42; and
(6) The verification procedures and the frequency with which they will be performed as required by § 507.45.
(a) The owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur and develop a written hazard analysis.
(b) The hazard analysis must consider hazards that may occur naturally or may be unintentionally introduced including:
(1) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of animal or human health significance;
(2) Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances;
(3) Physical hazards; and
(4) Radiological hazards.
(c) The hazard analysis must contain an evaluation of the hazards identified in paragraph (b) of this section to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.
(d) The hazard analysis must consider the effect of the following on the safety of the finished animal food:
(1) The formulation of the animal food;
(2) The condition, function, and design of the facility and equipment;
(3) Raw materials and ingredients;
(4) Transportation practices;
(5) Manufacturing/processing procedures;
(6) Packaging activities and labeling activities;
(7) Storage and distribution;
(8) Intended or reasonably foreseeable use;
(9) Sanitation, including employee hygiene; and
(10) Any other relevant factors.
For hazards identified in the hazard analysis as reasonably likely to occur:
(a) The owner, operator, or agent in charge of a facility must identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis as reasonably likely to occur will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.
(b) Preventive controls must be written.
(c) Preventive controls must include, as appropriate to the facility and animal food:
(1) Parameters associated with the control of the hazard, such as parameters associated with heat processing, irradiating, and refrigerating animal foods; and
(2) The maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur.
(d) Preventive controls must include, as appropriate:
(1) Process controls that include those procedures, practices, and processes performed on an animal food during manufacturing/processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur;
(2) Sanitation controls:
(i) Where necessary to significantly minimize or prevent hazards that are reasonably likely to occur, procedures for the:
(A) Cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment; and
(B) Prevention of cross-contamination from insanitary objects and from personnel to animal food, animal food packaging material, and other animal food-contact surfaces and from raw product to processed product.
(ii) The owner, operator, or agent in charge must take action to correct, in a timely manner, conditions and practices that are not consistent with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this section.
(iii) The owner, operator, or agent in charge of the facility is not required to follow the corrective actions described in § 507.42(a) and (b) when the owner, operator, or agent in charge of a facility takes action, in accordance with paragraph (d)(2)(ii) of this section, to correct conditions and practices that are not consistent with the procedures in paragraph (d)(2)(i)(A) or (d)(2)(i)(B) of this section.
(iv) All corrective actions taken in accordance with paragraph (d)(2)(ii) of this section must be documented in records that are subject to verification in accordance with § 507.45(b)(2) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).
(3) A recall plan as required by § 507.38; and
(4) Any other controls necessary to satisfy the requirements of paragraph (a) of this section.
(e)(1) Except as provided by paragraph (e)(2) of this section, the preventive controls required under this section are subject to:
(i) Monitoring as required by § 507.39;
(ii) Corrective actions as required by § 507.42; and
(iii) Verification as required by § 507.45.
(2) The recall plan established in § 507.38 is not subject to the requirements of paragraph (e)(1) of this section.
(a) The owner, operator, or agent in charge of a facility must develop a written recall plan for animal food with a hazard that is reasonably likely to occur and assign responsibility for performing all actions in the plan.
(b) The written recall plan must include procedures for:
(1) Directly notifying direct consignees about the animal food being recalled, including how to return or dispose of the affected animal food;
(2) Notifying the public about any hazard presented by the animal food when appropriate to protect animal and human health;
(3) Conducting effectiveness checks (as described in part 7 of this chapter) to verify the recall has been carried out; and
(4) The proper disposition (e.g., destroying, reprocessing, or diverting to another use that would not present a safety concern) of the recalled animal food.
(a) The owner, operator, or agent in charge of a facility must establish and implement written procedures for monitoring the preventive controls. These procedures must include:
(1) What preventive controls will be monitored;
(2) Who will perform the monitoring;
(3) How the monitoring will be performed;
(4) What parameter will be measured, if applicable;
(5) Frequency with which the monitoring will be performed; and
(6) Any additional information needed to ensure appropriate monitoring of the preventive controls.
(b) The owner, operator, or agent in charge of a facility must monitor the preventive controls with sufficient frequency to provide assurance that the preventive controls are consistently performed.
(c) Monitoring of preventive controls in accordance with this section must be documented in records that are subject to verification in accordance with § 507.45(b)(1) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).
(a) The owner, operator, or agent in charge of a facility must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented. The corrective active procedures must describe the steps to be taken to ensure:
(1) Appropriate action is taken to identify and correct a problem with implementation of a preventive control to reduce the likelihood that the problem will recur;
(2) All affected animal food is evaluated for safety; and
(3) All affected animal food is prevented from entering into commerce if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated under
(b) If a preventive control is not properly implemented and a specific corrective action procedure has not been established, or a preventive control is found to be ineffective, the owner, operator, or agent in charge of a facility must:
(1) Take corrective action to identify and correct the problem to reduce the likelihood that the problem will recur;
(2) Evaluate all affected animal food for safety;
(3) As necessary, prevent affected animal food from entering commerce as would be done following the corrective action procedure under paragraph (a)(3) of this section; and
(4) Reanalyze the food safety plan in accordance with § 507.45(e) to determine whether modification of the food safety plan is required.
(c) When corrective actions are taken, they must be documented in written records. These records are subject to verification in accordance with § 507.45(b)(2) and records review in accordance with § 507.45(c)(1)(i) and (c)(2).
(a) Except as provided by paragraph (a)(3) of this section, the owner, operator, or agent in charge of a facility must validate that the preventive controls identified and implemented in accordance with § 507.36 to control the hazards identified in the hazard analysis as reasonably likely to occur are adequate to do so. The validation of the preventive controls:
(1) Must be performed (or overseen) by a qualified individual:
(i) Prior to implementation of the food safety plan or, when necessary, during the first 6 weeks of production; and
(ii) Whenever a reanalysis of the food safety plan reveals the need to do so;
(2) Must include collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards that are reasonably likely to occur; and
(3) Need not address:
(i) The sanitation controls in § 507.36(d)(2); and
(ii) The recall plan in § 507.38.
(b) The owner, operator, or agent in charge of a facility must verify that:
(1) Monitoring is conducted as required by § 507.39;
(2) Appropriate decisions about corrective actions are being made as required by § 507.42;
(3) The preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur; and
(4) The activities conducted must include, as appropriate to the facility and the animal food, calibration of process monitoring and verification instruments.
(c) The owner, operator, or agent in charge of a facility must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur by ensuring that a qualified individual is conducting (or overseeing):
(1) A review of the following records in the timeframe specified:
(i) Monitoring and corrective action records within 1 week after the records are made; and
(ii) Records of calibration of instruments within a reasonable time after the records are created.
(2) A review of the records in paragraphs (c)(1)(i) and (c)(1)(ii) of this section to ensure:
(i) The records are complete;
(ii) The activities reflected in the records occurred in accordance with the food safety plan;
(iii) The preventive controls are effective; and
(iv) Appropriate decisions were made about corrective actions.
(d) The owner, operator, or agent in charge of a facility must establish and implement written procedures, as appropriate to the facility and the animal food, for the frequency of calibrating process monitoring and verification instruments.
(e) The owner, operator, or agent in charge of a facility must:
(1) Conduct a reanalysis of the food safety plan:
(i) At least once every 3 years;
(ii) Whenever a significant change is made in the activities conducted at the facility operated by such owner, operator, or agent in charge if the change creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;
(iii) Whenever the owner, operator, or agent in charge becomes aware of new information about potential hazards associated with the animal food;
(iv) Whenever a preventive control is not properly implemented and a specific corrective action procedure has not been established;
(v) Whenever a preventive control is found to be ineffective; and
(vi) Whenever FDA requires a reanalysis in response to newly identified hazards and developments in scientific understanding.
(2) Complete the reanalysis and implement any additional preventive controls needed to address the hazard identified before the change in activities at the facility is operative or, when necessary, during the first 6 weeks of production;
(3) Revise the written food safety plan if a significant change is made, or document the basis for the conclusion that no additional or revised preventive controls are needed; and
(4) Ensure the reanalysis is performed (or overseen) by a qualified individual.
(f) All verification activities taken in accordance with this section must be documented in records.
(a) The owner, operator, or agent in charge of a facility solely engaged in the storage of packaged animal food that is not exposed to the environment must conduct the following activities for any such refrigerated packaged animal food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance:
(1) Establish and implement temperature controls adequate to significantly minimize or prevent the growth of, or toxin formation by, microorganisms of animal or human health significance;
(2) Monitor the temperature controls with sufficient frequency to provide assurance they are consistently performed;
(3) Take appropriate corrective actions if there is a problem with the temperature controls for such refrigerated packaged animal food to:
(i) Correct the problem and reduce the likelihood that the problem will recur;
(ii) Evaluate all affected animal food for safety; and
(iii) Prevent the animal food from entering commerce, if the owner, operator, or agent in charge of the facility cannot ensure the affected animal food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act;
(4) Verify that temperature controls are consistently implemented by:
(i) Calibrating temperature monitoring and recording devices;
(ii) Reviewing records of calibration within a reasonable time after the records are made; and
(iii) Reviewing records of monitoring and corrective actions taken to correct a
(5) Establish and maintain the following records:
(i) Records documenting the monitoring of temperature controls for any such refrigerated packaged animal food;
(ii) Records of corrective actions taken when there is a problem with the control of temperature for any such refrigerated packaged animal food; and
(iii) Records documenting the verification activities.
(b) The records that a facility must establish and maintain under paragraph (a)(5) of this section are subject to the requirements of subpart F of this part.
(a) One or more qualified individuals must do or oversee the following:
(1) Prepare the food safety plan (§ 507.30));
(2) Validate the preventive controls (§ 507.45(a));
(3) Conduct a review of records for implementation and effectiveness of preventive controls and appropriateness of corrective actions (§ 507.45(c));
(4) Perform a reanalysis of the food safety plan (§ 507.45(e)).
(b) To be qualified, an individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum. This individual may be, but is not required to be, an employee of the facility.
(c) All applicable training must be documented in records, including the date of the training, the type of training, and the person(s) trained.
(a) The owner, operator, or agent in charge of a facility must establish and maintain the following records:
(1) The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan;
(2) Records that document the monitoring of preventive controls;
(3) Records that document corrective actions;
(4) Records that document verification, including, as applicable, those related to:
(i) Validation;
(ii) Monitoring;
(iii) Corrective actions;
(iv) Calibration of process monitoring and verification instruments;
(v) Records review; and
(vi) Reanalysis; and
(5) Records that document applicable training for the qualified individual.
(b) The records that the owner, operator, or agent in charge of a facility must establish and maintain are subject to the requirements of subpart F of this part.
FDA may withdraw the exemption applicable to a qualified facility under § 507.5(d):
(a) In the event of an active investigation of a foodborne illness outbreak that is directly linked to the qualified facility; or
(b) If FDA determines that it is necessary to protect the animal or human health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with the qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility.
(a) If FDA determines that an exemption applicable to a qualified facility under § 507.5(d) should be withdrawn, any officer or qualified employee of FDA may issue an order to withdraw the exemption.
(b) An FDA District Director in whose district the qualified facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), or an FDA official senior to such Director, must approve an order to withdraw the exemption.
(c) FDA must issue an order to withdraw the exemption to the owner, operator, or agent in charge of the facility.
(d) FDA must issue an order to withdraw the exemption in writing, signed and dated by the officer or qualified employee of FDA who is issuing the order.
An order to withdraw an exemption applicable to a qualified facility under § 507.5(d) must include the following information:
(a) The date of the order;
(b) The name, address, and location of the qualified facility;
(c) A brief, general statement of the reasons for the order, including information relevant to:
(1) An active investigation of a foodborne illness outbreak that is directly linked to the facility; or
(2) Conduct or conditions associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility.
(d) A statement that the facility must comply with subpart C of this part on the date that is 60 calendar days after the date of the order;
(e) The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart D;
(f) A statement that any informal hearing on an appeal of the order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in § 507.73;
(g) The mailing address, telephone number, email address, and facsimile number of the FDA district office and the name of the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the same information for the Director of the Division of Compliance in the Center for Veterinary Medicine); and
(h) The name and the title of the FDA representative who approved the order.
(a) The owner, operator, or agent in charge of a qualified facility that receives an order under § 507.60 to withdraw an exemption applicable to that facility under § 507.5(d) must either:
(1) Comply with applicable requirements of this part within 60 calendar days of the date of the order; or
(2) Appeal the order within 10 calendar days of the date of the order in accordance with the requirements of § 507.69.
(b) Submission of an appeal, including submission of a request for an informal hearing, will not operate to delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public interest.
(c) If the owner, operator, or agent in charge of the qualified facility appeals the order, and FDA confirms the order, the owner, operator, or agent in charge of the facility must comply with applicable requirements of this part within 60 calendar days of the date of the order.
(a) To appeal an order to withdraw an exemption applicable to a qualified facility under § 507.5(d), the owner, operator, or agent in charge of the facility must:
(1) Submit the appeal in writing to the FDA District Director in whose district the facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), at the mailing address, email address, or facsimile number identified in the order within 10 calendar days of the date of the order;
(2) Respond with particularity to the facts and issues contained in the order, including any supporting documentation upon which the owner, operator, or agent in charge of the facility relies.
(b) In a written appeal of the order withdrawing an exemption provided under § 507.5(d), the owner, operator, or agent in charge of the facility may include a written request for an informal hearing as provided in § 507.71.
(a) If the owner, operator, or agent in charge of the facility appeals the order, the owner, operator, or agent in charge of the facility:
(1) May request an informal hearing; and
(2) Must submit any request for an informal hearing together with its written appeal submitted in accordance with § 507.69 within 10 calendar days of the date of the order.
(b) A request for an informal hearing may be denied, in whole or in part, if the presiding officer determines that no genuine and substantial issue of material fact has been raised by the material submitted. If the presiding officer determines that a hearing is not justified, written notice of the determination will be given to the owner, operator, or agent in charge of the facility explaining the reason for the denial.
If the owner, operator, or agent in charge of the facility requests an informal hearing, and FDA grants the request:
(a) The hearing will be held within 10 calendar days after the date the appeal is filed or, if applicable, within a timeframe agreed upon in writing by the owner, operator, or agent in charge of the facility and FDA.
(b) The presiding officer may require that a hearing conducted under this subpart be completed within 1 calendar day, as appropriate.
(c) FDA must conduct the hearing in accordance with part 16 of this chapter, except that:
(1) The order withdrawing an exemption under §§ 507.62 and 507.65, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter.
(2) A request for a hearing under this subpart must be addressed to the FDA District Director (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine) as provided in the order withdrawing an exemption.
(3) Section 507.75, rather than § 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this subpart.
(4) Section 16.60(e) and (f) of this chapter does not apply to a hearing under this subpart. The presiding officer must prepare a written report of the hearing. All written material presented at the hearing will be attached to the report. The presiding officer must include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and must include a proposed decision, with a statement of reasons. The hearing participant may review and comment on the presiding officer's report within 2 calendar days of issuance of the report. The presiding officer will then issue the final decision.
(5) Section 16.80(a)(4) of this chapter does not apply to a regulatory hearing under this subpart. The presiding officer's report of the hearing and any comments on the report by the hearing participant under § 507.73(c)(4) are part of the administrative record.
(6) No party shall have the right, under § 16.119 of this chapter to petition the Commissioner for reconsideration or a stay of the presiding officer's final decision.
(7) If FDA grants a request for an informal hearing on an appeal of an order withdrawing an exemption, the hearing must be conducted as a regulatory hearing under part 16 of this chapter, except that § 16.95(b) does not apply to a hearing under this subpart. With respect to a regulatory hearing under this subpart, the administrative record of the hearing specified in §§ 16.80(a)(1), (a)(2), (a)(3), and (a)(5), and 507.73(c)(5) constitutes the exclusive record for the presiding officer's final decision. For purposes of judicial review under § 10.45 of this chapter, the record of the administrative proceeding consists of the record of the hearing and the presiding officer's final decision.
The presiding officer for an appeal, and for an informal hearing, must be an FDA Regional Food and Drug Director or another FDA official senior to an FDA District Director.
(a) If the owner, operator, or agent in charge of a facility appeals the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed.
(b) If the owner, operator, or agent in charge of a facility appeals the order and requests an informal hearing:
(1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 507.73(c)(4), and must issue a final decision within 10 calendar days after the hearing is held; or
(2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the date the appeal is filed.
An order to withdraw an exemption applicable to a qualified facility under § 507.5(d) is revoked if:
(a) The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10 calendar days after the hearing, or issues a decision revoking the order within that time; or
(b) The owner, operator, or agent in charge of the facility appeals the order and requests an informal hearing, FDA
(c) The owner, operator, or agent in charge of the facility appeals the order without requesting an informal hearing, and FDA does not confirm the order within the 10 calendar days after the appeal is filed, or issues a decision revoking the order within that time.
Confirmation of a withdrawal order by the presiding officer is considered a final agency action for purposes of 5 U.S.C. 702.
(a) Except as provided by paragraphs (d) and (e) of this section, all records required by this part are subject to all requirements of this subpart F.
(b) Records required by this part are subject to the disclosure requirements under part 20 of this chapter.
(c) All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services upon oral or written request.
(d) The requirements of § 507.106 apply only to the written food safety plan.
(e) The requirements of § 507.102(a)(2), (a)(4), and (a)(5) and (b) do not apply to the records required by § 507.7(e) pertaining to qualified facilities.
(a) Records must:
(1) Be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records, which must be kept in accordance with part 11 of this chapter;
(2) Contain the actual values and observations obtained during monitoring;
(3) Be accurate, indelible, and legible;
(4) Be created concurrently with performance of the activity documented; and
(5) Be as detailed as necessary to provide history of work performed.
(b) All records must include:
(1) The name and location of the plant or facility;
(2) The date and time of the activity documented;
(3) The signature or initials of the person performing the activity; and
(4) Where appropriate, the identity of the product and the production code, if any.
The food safety plan must be signed and dated by the owner, operator, or agent in charge of the facility upon initial completion and upon any modification.
(a) All records required by this part must be retained at the plant or facility for at least 2 years after the date they were prepared.
(b) Records that relate to the general adequacy of the equipment or processes being used by a facility, including the results of scientific studies and evaluations, must be retained at the facility for at least 2 years after their use is discontinued (e.g., because the facility has updated the written food safety plan (§ 507.30) or records that document validation of the written food safety plan (§ 507.45(a)).
(c) Except for the food safety plan, offsite storage of records is permitted after 6 months following the date that the record was made if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.
(d) If the plant or facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location, but must be returned to the plant or facility within 24 hours for official review upon request.
21 U.S.C. 321, 342, 343, 348, 371.
* * * Any facility that treats animal feed and pet food with ionizing radiation must comply with the requirements of part 507 of this chapter and other applicable regulations.
The following appendix will not appear in the Code of Federal Regulations.
Although the proposed rule that is the subject of this document does not include provisions for environmental monitoring or finished product testing, the Agency believes that these regimes can play a critical role in a modern food safety system. In sections XI.K and XI.L, the Agency requests comment on when and how these types of testing are an appropriate means of implementing the statutory directives set out in section 418 of the FD&C Act. In this Appendix, the Agency provides background material on these testing measures.
In some respects, animal food safety is a more complex subject than human food safety in that the feeding of multiple and diverse animal species is involved, many of which are associated with human food in the form of meat, milk and eggs. However, the core principles and approaches used to assess and prevent hazards that are reasonably likely to occur in animal food are similar to those used during the manufacture of food for humans, despite differences in production practices and levels of sanitation involved (Ref. 1).
The safety of food is principally ensured by the effective implementation of scientifically valid preventive control measures throughout the food chain (Ref. 2) (Ref. 3). Prevention of hazards in animal food is much more effective than trying to differentiate safe from unsafe animal food using testing. Although testing is rarely considered a control measure, it plays a very important role in ensuring the safety of animal food. An important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard (Ref. 4) (Ref. 5). Testing is used in conjunction with other verification measures in the food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan. Although testing may be conducted for biological, chemical, physical, or radiological hazards, the most common testing is for microbiological hazards. Thus, much of the testing described below focuses on microbial testing, but many of the issues discussed apply to testing for other hazards as well. The Agency focuses more of its discussion below on verification testing of the environment because of the increasing recognition of the benefits of such testing in identifying conditions that could result in environmental pathogens contaminating animal food; thus such verification testing is important in preventing contamination in animal food, whereas verification testing of raw materials,
As discussed in sections I.C, I.E, and I.F of this Appendix, microbial testing may include:
• Testing raw materials and ingredients to verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients;
• Testing the environment to verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate animal food; and
• Testing finished product to verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the animal food.
Further discussion of verification of preventive controls can be found in section I.A of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
Consistent with the Agency's discussion of the term “scientifically valid” in the proposed rule to establish CGMP requirements for dietary ingredients and dietary supplements for humans (68 FR 12158 at 12198), the Agency uses the term “scientifically valid” with respect to testing to mean using an approach to both sampling and testing that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research. A scientifically valid analytical method is one that is based on scientific data or results published in, for example, scientific journals, references, text books, or proprietary research (68 FR 12158 at 12198). Sampling and testing used for verification in a food safety system must be scientifically valid if they are to provide assurance that preventive controls are effective.
Raw materials and ingredients are often tested as part of a supplier approval and verification program, as one of the verification activities when a preventive control that is adequate to significantly minimize or prevent the hazard is not applied at the receiving facility. The utility and frequency of raw material and ingredient testing for verification of supplier controls depend on many factors, including:
• The hazard and its association with the raw material or ingredient;
• The likelihood that the animal, or person handling the animal food, would become ill if the hazard were present in the raw material or ingredient;
• How that raw material or ingredient will be used by the receiving facility (e.g., the effect of processing on the hazard); and
• The potential for contamination of the facility's environment with the hazard in the raw material or ingredient.
Further discussion of verification testing of raw materials and ingredients can be found in section I.C of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
Animal food can become contaminated with pathogenic microorganisms at many different steps: on the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; and at the location of the animal. Any time animal food is exposed to the environment during a manufacturing, processing, packing, or holding activity, there is the potential for the food to be contaminated with pathogenic microorganisms. As discussed in section VIII.B of the preamble, proposed § 507.3 would define the term “environmental pathogen” to mean a microorganism that is of animal or human health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment. The environmental pathogens most frequently involved in the contamination of animal food leading to foodborne illness are
The Agency discusses
Environmental pathogens may be introduced into a facility through raw materials or ingredients, people, or objects. Once in the facility, environmental pathogens can be a source of contamination of animal food. Further discussion of “Environmental pathogens in the plant environment” can be found in section I.D.4 of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The available data and information associate insanitary conditions in animal and human food facilities with contamination of a number of foods with the environmental pathogen
In 2007, FDA identified S. Schwarzengrund, a rare serotype of
In 2008–2009, an outbreak was linked to
The purpose of monitoring for environmental pathogens in facilities where animal food is manufactured, processed, packed, or held is to verify the implementation and effectiveness of sanitation controls intended to significantly minimize or prevent the potential for an environmental pathogen to contaminate animal food. In so doing, environmental monitoring can find sources of environmental pathogens that remain in the facility after routine cleaning and sanitizing so that the environmental pathogens can be eliminated by appropriate corrective actions (e.g., intensified cleaning and sanitizing, sometimes involving equipment disassembly). For further discussion, see section I.E. of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The term “indicator organism” can have different meanings, depending on the
For additional discussion on indicator organisms, monitoring procedures, and corrective actions, see section I.E.2 through 5 of the Appendix for the proposed rule for preventive controls for human food (78 FR 3646).
Although FDA is not including a provision for finished product testing in this proposed rule, here the Agency sets out some considerations regarding the appropriate use of such testing. The utility of finished product testing for verification depends on many factors that industry currently considers in determining whether finished product testing is an appropriate approach to reducing the risk of: animals consuming contaminated food, humans handling contaminated food, and humans consuming food derived from animals that consumed contaminated food. The first such consideration is the nature of the hazard and whether there is evidence of adverse health consequences from that hazard in the animal food being produced or in a similar animal food. If the hazard were to be present in the animal food, how likely is it that illness will occur and how serious would the consequences be? The more likely and severe the illness, the greater the frequency of conducting verification testing should be. For example,
Another consideration in determining whether finished product testing is appropriate is the intended “consumer” of the animal food and whether indirect exposure of a susceptible population may occur. The greater the sensitivity of the intended “consumer” (as would be the case, for example, for dioxin contamination), the greater the likelihood that finished product testing would be used as a verification activity.
Another consideration in determining whether finished product testing is appropriate is the impact of the animal food on the contaminant. For example, depending on the animal food, pathogens may survive in the food, increase in number, or die off. Finished product testing generally is not conducted if pathogens that may be in an animal food would die off in a relatively short period of time (e.g., before the food reaches the “consumer”).
Additional considerations in determining whether finished product testing is appropriate are the intended use of the animal food; the types of controls the supplier has implemented to minimize the potential for the hazard to be present (e.g., whether the supplier has a kill step for a pathogen); the effect of processing on the hazard; and whether a hazard can be reintroduced into a food that has been treated to significantly minimize the hazard (e.g.,
For an extensive discussion on finished product testing and metrics for microbiological risk management, see sections I.F and I.G of the Appendix for the proposed rule for human food (78 FR 3646).
An animal food can become contaminated through the use of contaminated raw materials or ingredients as evident by the large recall of pet food as a result of contamination of wheat gluten with melamine (see discussion in section II.E.1of the preamble).
The development of a supplier approval and verification program is part of a preventive approach. Because many facilities acting as suppliers procure their raw materials and ingredients from other suppliers, there is often a chain of suppliers before a raw material or other ingredient reaches the manufacturer/processor. To ensure safe animal food and minimize the potential for contaminated animal food to reach the consumer, each supplier in the chain must implement preventive controls appropriate to the animal food and operation for hazards reasonably likely to occur in the raw material or other ingredient. A facility receiving raw materials or ingredients from a supplier must ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.
A supplier approval and verification program is a means of ensuring that raw materials and ingredients are procured from those suppliers that can meet company specifications and have appropriate programs in place, including those related to the safety of the raw materials and ingredients. A supplier approval program can ensure a methodical approach to identifying such suppliers. A supplier verification program provides initial and ongoing assurance that suppliers are complying with practices to achieve adequate control of hazards in raw materials or ingredients.
Supplier approval and verification is widely accepted in the domestic and international food safety community. The NACMCF HACCP guidelines describe Supplier Control as one of the common prerequisite programs for the safe production of food products and recommend that each facility should ensure that its suppliers have in place effective GMP and food safety programs (Ref. 14). Codex specifies that no raw material or ingredient should be accepted by an establishment if it is known to contain parasites, undesirable microorganisms, pesticides, veterinary drugs or toxic, decomposed or extraneous substances which would not be reduced to an acceptable level by normal sorting and/or processing (Ref. 15). Codex also specifies that, where appropriate, specifications for raw materials should be identified and applied and that, where necessary, laboratory tests should be made to establish fitness for use (Ref. 15).
Supplier verification activities include auditing a supplier to ensure the supplier is complying with applicable food safety requirements, such as requirements under proposed part 507. Audit activities may include a range of activities, such as on-site examinations of establishments, review of records, review of quality assurance systems, and examination or laboratory testing of product samples (Ref. 16). Other supplier verification activities include conducting testing or requiring supplier certificates of analysis (COAs), review of food safety plans and records, or combinations of activities such as audits and periodic testing.
An increasing number of establishments that sell food are independently requiring, as a condition of doing business, that their suppliers, both foreign and domestic, become certified as meeting safety (as well as other) standards. In addition, domestic and foreign suppliers (such as producers, co-manufacturers, or re-packers) are increasingly looking to third-party certification programs to assist them in meeting U.S. regulatory requirements (Ref. 16). There are many established third-party certification programs designed for various reasons that are currently being used by industry. Many third party audit schemes used to assess the
To ensure confidence in the delivery of safe food for animals and humans worldwide, the Global Food Safety Initiative (GFSI), a benchmarking organization, was established in 2000 to drive continuous improvement in food safety management systems. Their objectives include reducing risk by delivering equivalence and convergence between effective food safety management systems and managing cost in the global food system by eliminating redundancy and improving operational efficiency (Ref. 17). GFSI has developed a guidance document as a tool that fulfills the GFSI objectives of determining equivalency between food safety management systems (Ref. 17). The document is not a food safety standard, but rather specifies a process by which food safety schemes may gain recognition, the requirements to be put in place for a food safety scheme seeking recognition by GFSI, and the key elements for production of safe food or feed, or for service provision (e.g., contract sanitation services or food transportation) in relation to food safety (Ref. 17). This benchmark document has provisions relevant to supplier approval and verification programs. For example, it specifies that a food safety standard must require that the organization control purchasing processes to ensure that all externally sourced materials and services that have an effect on food safety conform to requirements. It also specifies that a food safety standard must require that the organization establish, implement, and maintain procedures for the evaluation, approval and continued monitoring of suppliers that have an effect on food safety. Thus, all current GFSI-recognized schemes require supplier controls to ensure that the raw materials and ingredients that have an impact on food safety conform to specified requirements. The GFSI guidance document also requires audit scheme owners to have a clearly defined and documented audit frequency program, which must ensure a minimum audit frequency of one audit per year of an organization's facility (Ref. 17).
Because GFSI is a document that outlines elements of a food safety management system for benchmarking a variety of standards, it does not have details about how facilities should comply with the elements. This type of information is found in the food safety schemes that are the basis for certification programs. For example, the Safe Quality Food (SQF) 2000 Code, a HACCP-based supplier assurance code for the food industry, specifies that raw materials and services that impact on finished product safety be supplied by an Approved Supplier. SQF 2000 specifies that the responsibility and methods for selecting, evaluating, approving and monitoring an Approved Supplier be documented and implemented, and that a register of Approved Suppliers and records of inspections and audits of Approved Suppliers be maintained. SQF 2000 requires that the Approved Supplier Program contain, among other items, agreed specifications; methods for granting Approved Supplier status; methods and frequency of monitoring Approved Suppliers; and details of certificates of analysis if required.
According to SQF, the monitoring of Approved Suppliers is to be based on the prior good performance of a supplier and the risk level of the raw materials supplied. The monitoring and assessment of Approved Suppliers can include:
• The inspection of raw materials received;
• The provision of certificates of analysis;
• Third party certification of an Approved Supplier; or
• The completion of 2nd party supplier audits.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service, propose to list Vandenberg monkeyflower as an endangered species under the Endangered Species Act. If we finalize this rule as proposed, it would extend the Endangered Species Act's protections to this plant. The effect of this regulation will be to add Vandenberg monkeyflower to the List of Endangered and Threatened Plants under the Endangered Species Act.
We will accept all comments received or postmarked on or before December 30, 2013. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all information received on
Stephen P. Henry, Acting Field Supervisor, U.S. Fish and Wildlife Service, Ventura Fish and Wildlife Office, 2493 Portola Road, Suite B, Ventura, CA 93003; telephone 805–644–1766; facsimile 805–644–3958. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800–877–8339.
This rule consists of a proposed rule to list Vandenberg monkeyflower (previously identified as a candidate for listing by the name
We have determined Vandenberg monkeyflower faces threats under Factors A, D, and E. The greatest threat to Vandenberg monkeyflower is the presence and expansion of invasive, nonnative plants that are abundant on Burton Mesa, particularly occurring within or adjacent to all known occurrences of Vandenberg monkeyflower. Vandenberg monkeyflower habitat includes sandy openings (canopy gaps) within the dominant vegetation. Ground-disturbing activities (including wildfires) create additional open areas that are invaded by nonnative plants, which precludes establishment of Vandenberg monkeyflower. Furthermore, the availability of habitat for Vandenberg monkeyflower and its small overall population size may be affected by a suite of threats (including stochastic events such as wildfire and a changing climate) acting synergistically on the species. Based on the best available scientific and commercial information, we find that the species has a restricted range, faces ongoing and future threats across its range, and is in danger of extinction throughout all of its range.
We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from the public, other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) The species' biology, range, and population trends, including:
(a) Habitat requirements for establishment, growth, and reproduction;
(b) Genetics and taxonomy;
(c) Historical and current range including distribution patterns;
(d) Historical and current population levels, and current and projected trends; and
(e) Past and ongoing conservation measures for the species, its habitat, or both.
(2) The factors that are the basis for making a listing determination for a species under section 4(a) of the Act (16 U.S.C. 1533(a)), which are:
(a) The present or threatened destruction, modification, or curtailment of its habitat or range;
(b) Overutilization for commercial, recreational, scientific, or educational purposes;
(c) Disease or predation;
(d) The inadequacy of existing regulatory mechanisms; or
(e) Other natural or manmade factors affecting its continued existence.
(3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to Vandenberg monkeyflower and regulations that may be addressing those threats.
(4) Additional information concerning the historical and current status, range, distribution, and population size of Vandenberg monkeyflower, including the locations of any additional occurrences of this species.
(5) Current or planned activities in the areas occupied by Vandenberg monkeyflower and possible impacts of these activities on this species and its habitat.
(6) Information on the projected and reasonably likely impacts of climate change on Vandenberg monkeyflower and its habitat.
(7) Information related to our interpretation and analysis of the best scientific and commercial data and our proposed status determination for the species.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.
Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information may not meet the standard of information required by section 4(b)(1)(A) of the Act, which requires that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection at
We first identified Vandenberg monkeyflower as a candidate species in a notice of review published in the
On May 10, 2011, we filed a multiyear work plan as part of a proposed settlement agreement with Wild Earth Guardians and others in a consolidated case in the U.S. District Court for the District of Columbia. On September 9, 2011, the court accepted our agreement with plaintiffs in
Elsewhere in today's
It is our intent to discuss below only those topics directly relevant to the listing of Vandenberg monkeyflower as endangered in this section of the proposed rule.
Vandenberg monkeyflower is a small, annual herbaceous plant that grows from 0.5 to 10 inches (in) (1.2 to 25.4 centimeters (cm)) tall. The stems are glandular and usually green with purplish tinting. Leaves are obovate (narrowly elliptic) and reach 1.2 in (3 cm) in length. Plants produce a single flower or plants are branched producing multiple flowers. The tubular yellow flowers are bilaterally symmetrical, with the distal ends of the petals forming a unique structure that is likened to a face; hence the common name monkeyflower. Seed capsules are ovoid and reach 0.5 in (1.3 cm) in length. The capsule splits open longitudinally from the tip to release approximately 20 to 100 seeds.
Vandenberg monkeyflower was first described as
In 2012, Barker
The life history of Vandenberg monkeyflower has not been thoroughly studied, but certain characteristics appear similar to other small annual herbs. Vandenberg monkeyflower is shallow-rooted (Thompson 2005, p.131; Consortium of California Herbaria (Consortium 2010)) and has seeds that germinate during winter rains, typically between November and February (Thompson 2005, p. 23), which is similar to other small annual species that grow in sandy openings in chaparral and are adapted to the Mediterranean climate zone of California. For instance,
Vandenberg monkeyflower is sensitive to annual levels of rainfall (Thompson 2005, p. 23), and, therefore, germination of resident seed banks may be low or nonexistent in unfavorable years, with little or no visible aboveground expression of the species. Many annual monkeyflower species, including Vandenberg monkeyflower, need early rainfall along with continued rains in late winter or early spring for a substantial number of seeds to germinate, and do not respond well when only later rainfall is available (Thompson 2005, p. 23; Fraga
Seed banks develop when a plant produces more viable seeds than germinate in any given year. Seed banks contribute to the long-term persistence of a species by sustaining them through periods when conditions are not conducive to adequately germinate, reproduce, and replenish the seed bank (such as when there is not sufficient rainfall for plants to germinate, grow, and produce enough seeds to maintain the population at the same size from year to year) (Rees and Long 1992, entire; Adams
The reproductive biology of Vandenberg monkeyflower has not been specifically studied; however, it is likely similar to closely related
Species of
Seeds of Vandenberg monkeyflower are small and light in weight, dispersing primarily by gravity and also by water and wind over relatively short distances (Thompson 2005, p. 130; Fraga
Vandenberg monkeyflower occurs only at low elevations and close to the coast in a distinct region in western Santa Barbara County known as Burton Mesa (Wilken and Wardlaw 2010, p. 2). Burton Mesa is a physiographic region situated between the Purisima Hills to the north and the Santa Ynez River to the south. The topography of Burton Mesa comprises a low, flat-topped series of hills averaging 400 feet (ft) (133 meters (m)) in elevation (Ferren
Burton Mesa experiences a Mediterranean climate, with mild, moist winters and moderately warm, rainless summers. The region is strongly influenced by the prevailing westerly transoceanic air currents. Late afternoon and early evening are often characterized by onshore breezes or winds during most of the year, but winds are strongest and persistent in late spring and early summer. A marine layer or fog characterizes this coastal region and is heaviest during late spring and early summer mornings. Frost is also a regular occurrence in winter, especially in low-lying areas (Gevirtz
Burton Mesa supports a mosaic of several native vegetation types, including maritime chaparral, maritime chaparral mixed with coastal scrub, oak woodland, and small patches of native grasslands (Wilken and Wardlaw 2010,
Coast live oak is an important dominant in many places on Burton Mesa, attaining 40 to 70 percent crown cover in older undisturbed patches of habitat.
Vandenberg monkeyflower does not grow beneath the canopy of shrubs or oaks, but rather in the sandy openings (canopy gaps) that occur in-between shrubs. Sandy openings have been noted for their high abundance and diversity of annual and perennial herbaceous species, compared to those found in the understory of the shrub canopy (Hickson 1987, Davis
The amount of Vandenberg monkeyflower suitable habitat currently available has changed over time. Prior to 1938, approximately 23,550 ac (9,350 ha) of maritime chaparral was present on Burton Mesa (Hickson 1987, p. 34). For the purposes of this analysis, we determined in 2012 that approximately 10,057 ac (4,070 ha) of maritime chaparral habitat remain on Burton Mesa, which represents a loss of 53 percent of the original upland habitat (Figure 1; Service 2012a, unpublished data). We then estimated the amount of Burton Mesa considered as sandy openings where Vandenberg monkeyflower could potentially occur. Based on inspection of color imagery (National Agriculture Imagery Program (NAIP) 2009) of areas within Burton Mesa where this species occurs, we used the range of image pixel values among 20 point locations to define bare ground while all other pixel values defined vegetated areas. We calculated the total area encompassed by bare ground and vegetation by multiplying the number of bare ground and vegetated pixels by 1 square meter (the ground resolution of a pixel in the NAIP data). Roads, buried pipeline rights-of-way, and building footprints were removed to estimate the percent of Burton Mesa that currently comprise sandy openings.
Results indicate up to approximately 20 percent of the total area of remaining Burton Mesa chaparral comprises sandy openings, which is a high estimate because this may include areas of bare ground that are not sandy openings suitable for Vandenberg monkeyflower, such as walking trails (Service 2012b, unpublished data). The percentage
The structure of Burton Mesa chaparral comprises a mosaic of vegetation patches interspersed with sandy openings that varies from place to place. Within a given substrate, the chaparral composition is a reflection of stand age or shrub canopy cover, disturbance history (whether the area was cleared in the past or nonnative species were planted), history of wildfire, and distance from the coast (Davis
Other low-growing native annual species that often co-occur with Vandenberg monkeyflower in sandy openings include:
The western portion of Burton Mesa is Federal land within Vandenberg AFB (Davis
To the east of Vandenberg AFB, the State of California received 5,078 ac (2,055 ha) from Union Oil Company in 1990 as part of a settlement of two antitrust lawsuits (Gevirtz
Residential communities such as Vandenberg Village, Clubhouse Estates, Mesa Oaks, and Mission Hills fragment (divide into small noncontiguous pieces) the Reserve and other non-Federal lands on Burton Mesa. The southern portion of the mesa and beyond the southern boundary of the Reserve comprises agricultural lands as well as land owned by the Department of Justice (which houses the U.S. Bureau of Prisons Federal Penitentiary Complex at Lompoc (Lompoc Penitentiary)). The jagged northern perimeter of Burton Mesa is adjacent to an active oil field operated by Plains Exploration and Production Company (PXP).
To the east of the Reserve, La Purisima Mission State Historic Park (SHP) contains 980 ac (397 ha) (California State Parks 1991, p. 9) and is separated from the Reserve by the residential communities of Mesa Oaks and Mission Hills. La Purisima Mission SHP also abuts the southern boundary of the La Purisima Management Unit of the Reserve. California State Parks manages La Purisima Mission SHP.
For the purposes of this rule, we define the following terms to refer to individuals of Vandenberg monkeyflower and where they occur. We use the term “occurrence” (consistent with the definition for “element occurrence” used by the California Natural Diversity Data Base (CNDDB)) to be a grouping of plants (individuals) within 0.25 mi (0.4 km) proximity (CNDDB 2010). There may be one or more discrete groupings of plants (individuals) within a single occurrence. We use the term “location” to refer only to a particular site, area, or region, as in “at that location,” with no relation to an assemblage of plants (e.g., polygon, occurrence, population).
We generally describe the area on Burton Mesa where Vandenberg monkeyflower currently occurs as a crescent-shaped area approximately 7 mi (10.7 km) long by 2 mi (3.0 km) wide. All extant individuals of Vandenberg monkeyflower are located within this area (Consortium) 2010), almost exclusively occurring on thin layers of aeolian- (wind-) deposited sands between approximately 100 and 400 ft (30 to 122 m) in elevation (Wilken and Wardlaw 2010, p. 2). We based the description of suitable habitat on viewing U.S. Geological Survey maps and Google Earth
We are aware of historical herbarium collections of Vandenberg monkeyflower from two locations; one of these (Santa Rita Valley) no longer supports habitat for this species (Consortium 2010), and we consider it to be extirpated. The second collection was made from Lower Pine Canyon; although plants have not been relocated at lower Pine Canyon, we consider this collection to be a part of the Pine Canyon occurrence, which is extant. In addition to these two collections, an
The first historical collection of Vandenberg monkeyflower was made in 1931 from the Santa Ynez Valley approximately 5 mi (8 km) west of Buellton along State Highway 246 and east of La Purisima (Consortium 2010; Santa Barbara Botanic Garden (SBBG) 2005). This site was surveyed multiple times in 2006 (Wilken and Wardlaw 2010, Appendix 2); however, no Vandenberg monkeyflower were seen. At some point prior to 1931, seed from Burton Mesa may have blown downwind to this location, but it appears that Vandenberg monkeyflower has been extirpated at this location because no suitable habitat remains due to agricultural conversion (including vineyards and berries (Elvin 2009, pers. obs.) and heavily grazed pastureland (Wilken and Wardlaw 2010, Appendix 2). Therefore, we consider the occurrence of Vandenberg monkeyflower to be extirpated from this location.
The second historical collection of Vandenberg monkeyflower was made in 1960 near lower Pine Canyon (part of the existing Pine Canyon occurrence) on the eastern edge of Vandenberg AFB (Jepson Herbarium 2006; Rancho Santa Ana Botanic Garden 2006). Vandenberg monkeyflower had not been documented since it was collected there in 1960; however, it was observed in 2010 and 2012 up-canyon from this historical location (Lum
The third historical location of Vandenberg monkeyflower was observed, but not collected, in 1985 in the southwestern portion of the Vandenberg Management Unit on the Reserve (Hickson
Because we do not have a wealth of survey data over multiple years to analyze a trend in the long-term persistence of Vandenberg monkeyflower, we consider it most appropriate to use suitable habitat trends as a surrogate for the species' trend. Thus, an increase or decrease in the amount of suitable habitat likely results in a respective increase or decrease in the Vandenberg monkeyflower population.
Surveys for Vandenberg monkeyflower have occurred across this species' range on Burton Mesa during recent years, although the level of effort and precision of the surveys varied between the different biologists who conducted surveys. In 2006, the first year that a concerted effort was made to survey most of the known locations, approximately 2,700 individuals were observed during surveys throughout the known range of the species (Ballard 2006; Wilken and Wardlaw 2010, pp. 2–3, Appendices 1, 2). In 2010, the Air Force observed approximately 5,200 individuals during surveys conducted on 376 ac (152 ha) within Vandenberg AFB (Air Force 2012).
In other years, individuals and agencies (including Air Force, CDFW, and our biologists) have conducted opportunistic surveys of specific sites where this species occurs, but rangewide surveys have not been conducted since 2006. Ballard (
The following sections provide a description of nine specific locations (which contain all extant occurrences identified in Figure 2) where Vandenberg monkeyflower is known to occur, hereby referred to as nine occurrences. All known occurrences are on the following lands: Vandenberg AFB (four occurrences), Burton Mesa Ecological Reserve (three occurrences), and La Purisima Mission SHP (two occurrences) (See Figure 2; Table 1).
There are four locations on Vandenberg AFB that are known to support occurrences of Vandenberg monkeyflower. We refer to these four locations as the Oak, Pine, Lake, and Santa Lucia Canyons occurrences.
(1)
(2)
(3)
(4)
Vandenberg monkeyflower occurs or partially occurs (i.e., part of the occurrence is on the Reserve and part of the occurrence is off the Reserve) at three locations within the Reserve. We refer to these locations as the Volans Avenue, Clubhouse Estates, and Davis Creek occurrences.
(5)
(6)
(7)
The Davis Creek occurrence comprises four locations where Vandenberg monkeyflower has been observed. At “west of Highway 1,” researchers reported 3 individuals in 2006 (Ballard 2006), approximately 100 in 2009 (Rutherford and Ballard
Vandenberg monkeyflower occurs at two separate locations within La Purisima Mission SHP. We refer to these locations of Vandenberg monkeyflower as the La Purisima West and La Purisima East occurrences.
(8)
(9)
In summary, we identified one extirpated location where Vandenberg monkeyflower no longer exists, one location that is considered potentially extirpated, and nine locations where Vandenberg monkeyflower is currently considered extant on Burton Mesa. Most of these extant locations contain multiple scattered individuals, and thus we refer to these areas as nine occurrences, as defined above. We generally characterized the size of Vandenberg monkeyflower occurrences based on multiple observations over a period of years. Two of the nine occurrences (22 percent; Lake Canyon and La Purisima West) each contained over 1,000 individuals in multiple years and are the two largest known occurrences of this species. These largest occurrences include a high of approximately 1,500 individuals at Lake Canyon in 2006 (Elvin
Because we have only one rangewide survey for this species, and because based on our current data and the likelihood that Vandenberg monkeyflower forms a seed bank and expresses variable numbers of aboveground individuals from year to year (see
Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. Each of these factors is discussed below.
Factor A threats to Vandenberg monkeyflower habitat include development (military, State lands, and residential), utility maintenance and miscellaneous activities, invasive, nonnative plants, anthropogenic (influenced by human-caused activity) fire, recreation, and climate change. These impact categories overlap or act in concert with each other to adversely affect Vandenberg monkeyflower habitat.
Development of Vandenberg AFB military facilities within the last century directly removed approximately 6,104 ac (2,470 ha) of Burton Mesa chaparral habitat. Approximately 40 percent of the chaparral that historically occurred on Vandenberg AFB remains, mostly south and east of the primary developed area on Vandenberg AFB (Odion
The Air Force maintains multiple launch facilities at Vandenberg AFB to accomplish their mission (Air Force 2011c, p. 7). There are no launch facilities in suitable habitat for Vandenberg monkeyflower, and the Air Force is not likely to construct new launch facilities within suitable habitat because potential construction would likely occur near the coastline and away from more inland, human-populated areas (Air Force 2009a, p. 16). Additionally, the siting of future facilities is expected to capitalize on existing infrastructure; therefore, disturbance in undeveloped areas would be minimized (Air Force 2009a, p. 32).
Prior to the State Lands Commission acquisition of the Reserve lands in 1990, four land uses were identified in the Reserve area, including agricultural operations, military operations, extractive industries, and urban development (Gevirtz
La Purisima Mission SHP has operated as a State Park since 1937 (California State Parks 1991, p. 107). The current park boundaries encompass a total of 1,900 ac (769 ha). The park unit consists of the historical area, natural area with riding and hiking trails, agriculture, and the maintenance/service and residential area. The total amount of native vegetation is approximately 1,770 ac (716 ha) (Service 2013, unpublished data). There is no current or future threat of habitat destruction from development at La Purisima Mission SHP because the park was established to preserve cultural and natural features of the area.
Three residential communities exist on Burton Mesa east of Vandenberg AFB's boundary including Vandenberg Village, Mission Hills, and Mesa Oaks. These communities harbor associated infrastructure (including major roads such as California State Highway 1, Harris Grade Road, Rucker Road, and Burton Mesa Boulevard), all of which fragment the Burton Mesa chaparral. Vandenberg Village and associated golf course comprise approximately 720 ac (291 ha). Thus, at least 2,000 ac (809 ha) of Burton Mesa chaparral habitat were removed as a result of past development of these three residential communities and their associated infrastructure.
Presented below are three currently approved or proposed projects on private lands that harbor suitable Vandenberg monkeyflower habitat. Data are not available on the specific acreage of sandy openings expected to be lost as a result of these projects, but data are provided on the loss of Burton Mesa chaparral and the number of individuals of Vandenberg monkeyflower observed at, or adjacent to, these project sites.
(1) Clubhouse Estates is a private development located east of Vandenberg Village (LFR, Inc. 2006, p. 1). Santa Barbara County approved the Clubhouse Estates housing development in August 2005 (County of Santa Barbara Planning Commission 2005, p. 4). Approximately 33 ac (13 ha) were proposed to be developed into residential lots; the remaining 120 ac (49 ha) was proposed as open space (LFR, Inc. 2006, p. 1). Most of the Vandenberg monkeyflower individuals known to occur at this location were inside or within 10 ft (3 m) of the approved development footprint that was graded (SAIC 2005b, Figure 4.3–2). Additionally, the ground disturbance increased the extent of invasive, nonnative species at this location, particularly Sahara mustard and veldt grass (Meyer
(2) The Burton Ranch Specific Plan site (Burton Ranch) is located south of the Encina Management Unit of the Reserve. The project was approved in 2006 (City of Lompoc 2012) and totals 149 ac (60 ha). Approximately 83 ac (34 ha) of Vandenberg monkeyflower suitable habitat would be removed (SAIC 2005a, p. 175). Vandenberg monkeyflower has not been observed at this site, although the habitat contains many species commonly associated with Vandenberg monkeyflower (SAIC 2005a, p. 174), and veldt grass is present within the project site. Ground disturbance expected as a result of this approved project would remove native vegetation and may create open areas where veldt grass could invade (see
A 100-ft (30-m) buffer at the northern boundary of the project site and 8 ac (3 ha) of onsite open space were proposed as part of the Burton Ranch project (SAIC 2005a). Preserving chaparral may reduce the potential of nonnative plants to invade the intact Burton Mesa chaparral in the Reserve directly to the north of this project site. Additionally, the project proponent completed a conservation agreement with the Land Trust for Santa Barbara County (Land Trust) to mitigate for the removal of native vegetation (Feeney
(3) Allan Hancock College proposed to develop a public safety complex adjacent to their existing facilities and south of the Davis Creek corridor (Allan Hancock College 2009, p. 28). The project site would remove approximately 59 ac (16 ha) of Burton Mesa chaparral (Allan Hancock College 2009, pp. 134–135). Vandenberg monkeyflower has not been observed within this project site, although a few individuals were observed in 2009 within the chaparral vegetation (Allan Hancock College 2009, p. 113). Therefore, ground disturbance would remove suitable Burton Mesa chaparral and may create open areas for veldt grass to invade. As part of this project, Allan Hancock College proposed to preserve approximately 65 ac (26 ha) of Burton Mesa chaparral near the Davis Creek drainage that is contiguous with the northern portion of the project site (Allan Hancock College 2009, pp. 9, 135). Preserving chaparral in this area may reduce the potential of nonnative plants to invade the intact Burton Mesa chaparral in the Reserve to the north of this project site.
In summary, the majority of development on Vandenberg AFB and the residential communities of Vandenberg Village, Mission Hills, and Mesa Oaks, and the existing infrastructure at La Purisima Mission SHP have existed for decades. Most of Burton Mesa is either State or Federal land on which future development is unlikely; therefore, most of the remaining habitat for Vandenberg monkeyflower would not be directly impacted by future development. However, three recent private developments on the periphery of the State or Federal land either have resulted in or will result in the direct loss of Burton Mesa chaparral. Development within or adjacent to suitable chaparral habitat increases the likelihood of introducing invasive, nonnative species to spread, which is the most significant threat to Vandenberg monkeyflower (see
Utility and pipeline structures occur within the Reserve on Burton Mesa. These existing facilities or structures at times require maintenance to ensure proper operation. As a result, vehicles and foot traffic could occur at or adjacent to these structures and potentially result in trampling of habitat and other soil surface disturbance, which in turn could result in ground disturbance that removes Burton Mesa chaparral and creates open areas in the vegetation that act as pathways for nonnative plants to expand or invade.
Plains Exploration and Production Company (PXP) owns an oil processing plant surrounded by the La Purisima Management Unit of the Reserve (see
The Reserve contains a limited number of existing structures, most of which are remnants of previous land uses. Local land use agencies and public works agencies retain utilities and pipelines, and easements for access; routine maintenance of the utilities is conducted as needed. The Vandenberg Village Community Services District (VVCSD) has several structures (including water tanks, a water processing plant, wells, and water lines and sewer lines) located within the Reserve (Gevirtz
The VVCSD filed a request with the State Lands Commission in May 2010 to acquire 27 ac (11 ha) of land within the Reserve east of their existing water tanks for the construction of a replacement water well (VVCSD 2010). The 27–ac (11–ha) site is within the Burton Mesa Ecological Reserve and is currently leased to the CDFW. Approximately 180 Vandenberg monkeyflower individuals (see the Davis Creek occurrence discussion under the
In summary, there is no indication that ongoing maintenance activities of existing pipelines and utilities have directly impacted Vandenberg monkeyflower habitat. However, utility maintenance actions could result in ground disturbance that removes Burton Mesa chaparral, creating open areas in the vegetation that act as pathways for nonnative plants to invade.
Invasive, nonnative plants occur throughout Burton Mesa and represent the greatest threat to the remaining individuals of, and suitable habitat for, Vandenberg monkeyflower. Invasive, nonnative plants occur across Vandenberg monkeyflower's range, including within and adjacent to occupied habitat at all nine extant locations, as well as at the potentially extirpated location (Lower Santa Lucia Canyon). The presence of invasive, nonnative plants can alter all components of an ecosystem, from directly altering habitat and displacing individuals (the latter of which is described under Factor E), to negatively affecting the abundance and diversity of small mammals and insects that disperse seeds or pollinate the native vegetation.
Disturbance is one of the primary factors that promote invasion of nonnative species (Rejmanek 1996; D'Antonio and Vitousek 1992; Hobbs and Huenneke 1992; Brooks
The expansion of nonnative plants represents a substantial problem as it displaces native vegetation on Burton Mesa. Keil and Holland (1998, p. 27) documented 220 nonnative plant species on Vandenberg AFB, the majority of which are native to the Mediterranean region and a smaller number native to Eurasia, South America, Australia, South Africa, or other regions. A total of 124 nonnative plant species were observed on the Reserve, 17 of which are recognized as high concern because of their severe ecological impacts on native ecosystems (Gevirtz
Several invasive plant species that are present within Vandenberg monkeyflower habitat and of particular concern with regard to altering habitat of Vandenberg monkeyflower on Burton Mesa include veldt grass, pampas grass, bromes, Sahara mustard,
The following paragraphs include a brief discussion of four prolific invasive, nonnative plants (veldt grass, iceplant, Sahara mustard, and pampas grass) that are having the greatest impact to Vandenberg monkeyflower occupied and suitable habitat across its range. We describe general biological impacts these four invasive plants have on native vegetation, including known impacts to Burton Mesa chaparral, and thus, suitable habitat for Vandenberg monkeyflower. We then discuss the specific presence and known impacts of these invasive plants on Burton Mesa chaparral at each of the nine extant Vandenberg monkeyflower locations and one potentially extirpated location. We describe the biological impacts using the best available information, which includes personal observations of many scientists who are local experts concerning Burton Mesa or Vandenberg monkeyflower and its habitat. Available conservation measures to minimize the threat of invasive, nonnative plants are discussed below under
(1)
Veldt grass is spreading rapidly across Vandenberg AFB and the Burton Mesa and represents a significant problem (Gevirtz
Currently, veldt grass occurs in more areas on Vandenberg AFB than where it was initially introduced. On Vandenberg AFB, veldt grass occurs both within and adjacent to occupied Vandenberg monkeyflower habitat and is expanding at Santa Lucia, Lake, and Pine Canyons, and has become the dominant vegetation cover in portions of lower Oak Canyon. Additionally, veldt grass is present and expanding at certain locations on the Reserve, including at the Volans Avenue, Clubhouse Estates, and Davis Creek occurrences. Veldt grass is also present at La Purisima Mission SHP. See section below entitled
(2)
The reproductive potential of iceplant is very high (Schmalzer and Hinkle 1987, p. 18). It propagates by seed and vegetatively; even small stem fragments can regenerate into a new plant (Cal-IPC 2012). Iceplant is a successful invader because seeds are dispersed before or during the time of year when they are most likely to germinate, which allows little time for post-dispersal predation to occur; and the seeds are dispersed by a diversity of mammals (D'Antonio 1990, p. 700). Additionally, Vivrette and Muller (1977, pp. 315–317) showed that the salt leached from iceplant individuals was the limiting factor in the growth and establishment of native grassland species. Salt retained in aerial parts of dried iceplant individuals is transported into the soil through leaching by fog in the summer and rain in the fall (Vivrette and Muller 1977, pp. 311, 316; Kloot 1983, pp. 304–305). On sandy soils, salt deposited in the summer is washed through the soil and replaced by the remaining lower levels of salt leaching out of the plant with the first rains in the fall (Vivrette and Muller 1977, p. 316).
Iceplant is an invasive species of great concern on Vandenberg AFB (Keil and Holland 1998, p. 22). It was originally planted on Base along roads and about buildings to prevent wind erosion (Human 1990, pp. 32, 42). By the mid-1990s, iceplant occupied hundreds of acres on the San Antonio Terrace, having spread into adjacent habitats from plantings along roadsides, the Southern Pacific Railroad tracks, and around missile testing facilities (Earth Tech 1996, p. 264). It is especially prevalent west of the main developed area on Vandenberg AFB because there is extensive iceplant in the adjacent dune habitat and former chaparral habitat, and because of extensive past mechanical disturbance (i.e., land disturbed by mechanical equipment) within the chaparral west of the primary developed area (Odion
Iceplant recruits abundantly within openings in the chaparral canopy such
Iceplant has also been observed in the Reserve (Junak 2011; Meyer 2012, pers. comm.) and at La Purisima Mission SHP (Gevirtz
(3)
Barrows
Sahara mustard was collected at three locations on Vandenberg AFB in the late 1990s and is likely to be more common (Keil
More recently, Sahara mustard has been observed on Department of Justice lands at the Lompoc Penitentiary that is near the southern terminus of Santa Lucia Canyon Road and Oak Canyon, and borders the southwestern corner of the Vandenberg Management Unit of the Reserve (Meyer
(4)
Lambrinos (2000, p. 225) studied the effects of pampas grass invasion at Vandenberg AFB. Plots with pampas grass were compared to adjacent plots of pristine maritime chaparral. The pampas grass-invaded portions of the plots were associated with adjacent, relatively small-scale disturbances, such as dirt roads, water runoff channels, and a paved road. The only disturbance within the plots was narrow trails used by mule deer (
Populations of pampas grass have been well-established on Vandenberg AFB since 1975 (Coulombe and Cooper 1976, pp. 93–94). It was introduced along the railroad tracks (Odion
Pampas grass has also been observed in the Reserve (Junak 2011) and at La Purisima Mission SHP (Gevirtz
In the paragraphs below we discuss the presence of invasive plants that occur within or adjacent to Vandenberg monkeyflower and its habitat at each of the nine extant locations and one potentially extirpated location. The Pine, Lake, and Santa Lucia Canyon locations are grouped based on the information available.
(1)
(2), (3), and (4)
(5)
(6)
(7)
(8) and (9)
Invasive, nonnative plants occur and are expanding throughout the Burton Mesa. More specifically, at least one of the four most problematic invasive plants occurs within or adjacent to suitable habitat at each of the nine extant occurrences of Vandenberg monkeyflower and at one potentially extirpated location. Invasive plants have demonstrated the ability to reduce the diversity of native vegetation and convert the native shrublands into nonnative-dominated vegetation. In some areas, particularly on Vandenberg
With regard to site-specific impacts to Vandenberg monkeyflower habitat, veldt grass has been observed occurring within suitable habitat at each of the nine extant occurrences and at one potentially extirpated location. Recent observations of the habitat at all nine extant occurrences indicate that veldt grass is expanding and becoming dominant in the sandy openings where Vandenberg monkeyflower grows. Because veldt grass will outcompete native vegetation (including overcrowding the sandy openings where Vandenberg monkeyflower grows) and is very difficult to eradicate once it is established, the presence and expansion of veldt grass within known occurrences of Vandenberg monkeyflower is a continuous threat because it reduces the amount and quality of this species' habitat. We also discussed above three other invasive, nonnative species (iceplant, Sahara mustard, and pampas grass) that have substantial impacts to Vandenberg monkeyflower and its habitat. These species, along with numerous other nonnative plant species, are present throughout Burton Mesa and at all extant occurrences of Vandenberg monkeyflower. Similar to veldt grass, the other invasive, nonnative plants reduce the amount and quality of habitat for Vandenberg monkeyflower by outcompeting Burton Mesa chaparral vegetation and decreasing the amount and availability of the sandy openings where Vandenberg monkeyflower grows. Nevertheless, no invasive plant is as prevalent and represents as much of a threat to Vandenberg monkeyflower habitat as veldt grass.
The disturbance to maritime chaparral that anthropogenic fires cause may exceed the tolerance thresholds (ability to tolerate naturally occurring fire regimes and regenerate post-fire) of many shrub species, resulting in an open canopy, the demise of shrublands, and persistence of nonnative plants (Haidinger and Keeley 1993, pp. 143–147). The common pattern after chaparral fires is for native and nonnative annual herbs to dominate for the first year and then gradually decline as the cover of shrub and subshrubs increases (Zedler
At historical fire frequencies, chaparral species are generally resilient to fire because they are well known to regenerate from either resprouting of perennial root crowns or germination of seeds in the soil when heated or exposed to smoke (obligate and sprouter seeders) (Lambert
The long-term fire history for Santa Barbara County indicates that large fires (more than 49,400 ac (20,000 ha) and typically driven by Santa Ana wind conditions) are part of the historical fire regime in this region. The average time between these large fires has remained relatively consistent over the last 500 years, regardless of changes in land use, from the Chumash who purposely set fires along the coast (1425–1770), to Spanish and American settlers (1770–1900) who practiced fire suppression but with little enforcement, to the more recent period (1900–1985) of active fire suppression (Mensing
The historical fire regime on Burton Mesa is unknown (Hickson 1987, p. 25), but it is likely that naturally occurring fires were less frequent as compared to inland areas because the mesa is at low elevation and the few lightning strikes recorded in the region have been in the distant mountains farther inland (Hickson 1988, p. 20). Additionally, because fog, cool temperatures, and cool winds blowing off the ocean are typical, the weather conditions conducive to naturally occurring fires are rare on Burton Mesa (Hickson 1988, p. 22; Gevirtz
The present fire regime on Burton Mesa is likely anthropogenic (Davis
Approximately 34 fires have occurred within or adjacent to Burton Mesa chaparral since 1940 on Vandenberg AFB, east of the main developed area, and from San Antonio Creek south to the Santa Ynez River (Lum
Twenty-eight wildfires occurred on the Reserve and adjacent La Purisima Mission SHP in the period 1950–2003; the most recent wildfire (Harris Grade Fire) occurred in 2000 and was caused by a power line that may have sparked in high winds (Gevirtz
Although the fire interval in maritime chaparral is an important factor in determining species composition, on Burton Mesa, and for Vandenberg monkeyflower habitat specifically, the frequency of fire is secondary to the primary threat, which is the post-fire expansion of invasive, nonnative plants. California's chaparral habitats, like Burton Mesa, are most vulnerable to invasion by nonnative plants in the first few years after fire because fires open large areas of bare, nutrient-rich ground and remove toxins from the soil, chaparral recolonizes much more slowly because of limited seed dispersal, and some seedlings are poor competitors against nonnative annual species (Keeley
Because sites favorable for invasion by nonnative plants tend to be relatively open areas where existing plant cover is minimal (see
In addition to displacing native vegetation, the presence of nonnative plants (in particular nonnative grasses) has increased the supply of readily ignitable fuel and increased the seasonal duration when fuels are susceptible to ignition, both because of their earlier seasonal drying compared to shrubs and their high surface-to-volume ratio (Lambert
The Air Force, CDFW, and California State Parks have developed wildfire prevention and suppression practices not only to minimize the potential for wildfire, but also to minimize the impacts to the biological resources during suppression activities. As part of wildfire management practices, landowners and agencies may create fuel breaks (a permanent area of low volume fuel) to limit the spread of wildfire and to provide access for fire suppression activities (Gevirtz
Fire suppression activities that impact suitable Vandenberg monkeyflower habitat include bulldozed and hand-cut fire lines and the application of fire retardants. During the Highway Incident wildfire, the Air Force cut fire lines that resulted in a loss of Burton Mesa chaparral (Air Force 2009b, p. 28). Additionally, approximately 65,000 gallons (246,052 liters) of fire retardant (which is known to act as a fertilizer enhancing the growth of nonnative grasses (Avery 2001, pp. 17–18)) were spread over this site (Air Force 2009b, p. 28). Therefore, by burning the existing vegetation, fire creates open areas where invasive, nonnative plants can expand. Additionally, fire prevention and suppression activities (e.g., fire breaks and application of fire retardant) can exacerbate the resulting post-fire expansion of nonnative plants by creating open fire lines and if fire retardants add chemicals to the soil that stimulate growth of nonnative vegetation.
The Air Force, CDFW, and California State Parks are studying the feasibility
In summary, because of the human presence and infrastructure on the mesa, the frequency of human-caused wildfires is likely greater than the frequency of the historical fires in the past on Burton Mesa. An increased fire frequency in Burton Mesa chaparral would tend to favor the establishment of nonnative vegetation in open areas at the expense of native vegetation. However, the primary threat to Vandenberg monkeyflower and its habitat from fire is the post-fire expansion of invasive, nonnative plants, regardless of the fire frequency. Because an abundance of nonnative plants already occurs on the mesa and invasive plants rapidly invade open areas, any fire that occurs within or adjacent to Vandenberg monkeyflower habitat is likely to result in an increase of invasive, nonnative vegetation. Likewise, fire suppression activities that include clearing vegetation in fuel breaks or spreading retardant would increase the likelihood of nonnative species invading suitable Vandenberg monkeyflower habitat, as well as enhance the habitat conditions for invasive species expansion. Additionally, because the presence of invasive, nonnative plants creates a positive feedback mechanism, the greater the percent cover of nonnative vegetation, the more likely fires will occur on Burton Mesa. Based on the information presented in this section, the current threat from anthropogenic fire and associated fire suppression activities to Vandenberg monkeyflower habitat described above is expected to continue into the future. Available conservation measures to minimize the threat of anthropogenic wildfire are discussed below (see
Recreational activities that occur throughout Burton Mesa include authorized uses such as hunting, hiking, biking, wildlife observation, and leashed-dog walking. Additionally, off-road vehicle (ORV) use is authorized on Vandenberg AFB (Air Force 2011b, p. 6), but it is not permitted on the Reserve (Gevirtz
On the west end of Burton Mesa on Vandenberg AFB, recreational activities include OHV use and other casual-use activities, such as hunting, picnicking, and horseback riding. There is also an existing 237–ac (96–ha) golf course.
Prior to 1974, Vandenberg AFB was subject to uncontrolled use by ORVs. In April 1974, efforts to establish a program to control ORV use was prompted by dune damage and the complaints of recreational users, along with consideration of soil, water, air, noise, aesthetics, recreational users, wildlife, vegetation, suitability of other public lands, archaeological sites, threatened and endangered species, and the accessibility for users (Air Force 2011b, p. 6). Thus, Vandenberg AFB environmental staff and the Base's motorcycle club designated an ORV area (Air Force 2011b, p. 6). Currently, ORV use occurs within a 600–ac (243–ha) site that is west of the primary developed area on Base and an additional site referred to as Northstar that is located in the northeast portion of the Base (Air Force 2011b, p. 6), both of which are not within Vandenberg monkeyflower habitat. The ORVs use existing trails and roads, and are managed to prevent damage to sensitive areas such as wetlands and highly erodible soils (Air Force 2011b, p. 6). Therefore, ORV use on Vandenberg AFB is not within the vicinity of Vandenberg monkeyflower occurrences on the Base and is not a direct threat to this species and its habitat.
The west end of Burton Mesa on Vandenberg AFB (west of the primary developed area) is heavily disturbed by existing trails and service roads, which may be used by recreationists. Although vehicles using these roads and trails (including wheeled vehicles for recreational activities) likely contribute to the spread of invasive, nonnative plant species on Burton Mesa (see
To the east of the developed area where higher-quality Burton Mesa chaparral still remains and where Vandenberg monkeyflower occurs on Base, recreational activities that may impact the habitat of this species include hunting and picnicking. Hunting occurs over much of the Base and is subject to restrictions at any time based on human safety and security concerns, as well as wildlife management goals (Air Force 2011b, p. 7). Lake Canyon Lakes picnic area is within a few hundred feet of Vandenberg monkeyflower plants that are located in lower Lake Canyon, but the picnic facilities are located on concrete or asphalt and thus not in Vandenberg monkeyflower habitat. Overall, the best available information does not indicate that recreational activities on Base, including hunting and picnicking, are directly impacting Vandenberg monkeyflower or its habitat. However, these activities pose an indirect threat to the habitat quality because they contribute to the spread of nonnative plants within suitable habitat.
There are no formal recreational or public facilities currently within the Reserve, including no designated parking or restroom facilities (Gevirtz
The Volans Avenue occurrence of Vandenberg monkeyflower is located adjacent to Vandenberg Village and a VVCSD pipeline easement that is used by local residents for hiking, jogging, dog walking, and other casual recreational activities. Running events have previously occurred in this area of the Reserve, and the running route was likely in close vicinity to the Volans Avenue occurrence of Vandenberg monkeyflower (Ballard
It is unknown whether disturbance created by casual human use has played a role in the absence of Vandenberg monkeyflower's aboveground expression at this location since 2007. The best available information indicates that recreational activities involving casual human use on the Reserve are having minimal to no direct effect on Vandenberg monkeyflower habitat on Burton Mesa. However, veldt grass, which produces an abundance of seeds and tends to crowd out native species and prevent their reestablishment, is likely reducing the amount of available Vandenberg monkeyflower habitat at this location (see the specific Volans Avenue discussion above under the Review of Invasive, Nonnative Species Present by Occurrence section). Additionally, because Vandenberg monkeyflower habitat is fragmented by recreational trails, the introduction of additional invasive, nonnative plants into this area is likely because spreading of nonnative vegetation is known to occur through visitors' shoes (Gevirtz
Unauthorized ORV use has been reported on the western portions of the Reserve (Santa Lucia Management Unit) from adjacent lands on Vandenberg AFB. It is likely that the trespass is originating from the general public (nonmilitary) because public roadways (such as Santa Lucia Canyon Road) cross Vandenberg AFB lands on this portion of the Base and the Air Force controls the use of ORVs by military staff on the Base. As a result of unauthorized use on the Reserve, CDFW installed a gate in 2009 to control access along Santa Lucia Canyon Road (Meyer
The Santa Barbara County Sheriff and Fire Departments maintain facilities on a county-owned inholding within the Reserve. They have been leasing an adjacent 3–ac (1.2–ha) parcel from the State Lands Commission (SLC) for the last 15 years to maintain their equestrian training facility, and the use of horses has expanded onto the Reserve. The lease has since expired, and the SLC is evaluating whether to renew the lease or modify its terms (Meyer
The Lompoc Valley Flyers Club (Flyers Club) operated a dirt take-off and landing strip for model airplanes, a race track for model cars, and several picnic tables in the Vandenberg Management Unit of the Reserve (just south of California State Highway 1) from 1988 to 2000 (Gevirtz
La Purisima Mission SHP contains roads and trails authorized for use by local residents for hiking, dog walking, and horseback riding, and employs park rangers and staff to maintain the grounds and conduct patrols. Twelve miles (19 km) of riding and hiking trails wind through the park, including 3.7 mi (6 km) of historical trails near the mission and 8.8 mi (14 km) in the surrounding hills (California State Parks 1991, pp. 9, 107). Bicycles are permitted on approximately 5 mi (8 km) of these trails (which are also designated fire roads), and the remainder, with a few exceptions, are open to horses (California State Parks 1991, pp. 9, 107). Vehicle movement and pedestrian and equestrian use do not directly impact Vandenberg monkeyflower habitat at La Purisima Mission SHP because the roads and trails do not overlap where Vandenberg monkeyflower occurs. However, indirect impacts to Vandenberg monkeyflower habitat may occur due to nonnative plant invasions introduced through visitors' shoes, horse hoofs, vehicle tires, and tractor treads (Gevirtz
Off-road vehicle use and other casual recreational activities may contribute to soil disturbance and increase the potential for invasive, nonnative plants to be introduced and further spread across Burton Mesa, including into locations where Vandenberg monkeyflower and its suitable habitat occurs. At this time, the best available information does not indicate that recreational activities pose a substantial direct threat to Vandenberg monkeyflower habitat, although these activities would indirectly affect the habitat by contributing to the spread of invasive, nonnative plants within the habitat and reducing the habitat quality. Available conservation measures to minimize the threat of recreation are discussed below under
Our analyses under the Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). The term “climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2007a, p. 78). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (for example, temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability,
Scientific measurements spanning several decades demonstrate that changes in climate are occurring, and that the rate of change has increased since the 1950s. Examples include warming of the global climate system, and substantial increases in precipitation in some regions of the world and decreases in others (For these and other examples, see IPCC 2007a, p. 30; and Solomon
Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (for example, Meehl
Various changes in climate may have direct or indirect effects on species. These effects may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as interactions of climate with other variables (for example, habitat fragmentation) (IPCC 2007, pp. 8–14, 18–19). Identifying likely effects often involves aspects of climate change vulnerability analysis. Vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (IPCC 2007a, p. 89; see also Glick
As is the case with all stressors that we assess, even if we conclude that a species is currently affected or is likely to be affected in a negative way by one or more climate-related impacts, it does not necessarily follow that the species meets the definition of an “endangered species” or a “threatened species” under the Act. If a species is listed as endangered or threatened, knowledge regarding the vulnerability of the species to, and known or anticipated impacts from, climate-associated changes in environmental conditions can be used to help devise appropriate strategies for its recovery.
Global climate projections are informative and, in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world (for example, IPCC 2007a, pp. 8–12). Therefore, we use “downscaled” climate projections when they are available and have been developed through appropriate scientific procedures, because such projections provide higher resolution information that is more relevant to spatial scales used for analyses of a given species (see Glick
Within central-western California (i.e., counties along the California coast from the San Francisco Bay area south to Santa Barbara County), regional climate models project a mean annual temperature increase of 1.6 to 1.9 degrees Celsius (°C) (2.9–3.4 degrees Fahrenheit (°F)) and a mean diurnal temperature range increase of 0.1 to 0.2 °C (0.2–0.4 °F) by 2070 (Point Reyes Bird Observatory (PRBO) Conservation Science 2011, p. 35). The projected impacts of climate change are warmer winter temperatures, earlier warming in the spring, and increased summer temperatures (PRBO Conservation Science 2011, p. 35). Additionally, regional climate models project a decrease in mean annual rainfall of 2.4 to 7.4 in (6.1 to 18.8 cm) (PRBO Conservation Science 2011, p. 35). The large range of possible precipitation change (−11 percent to −32 percent) is due to different model projections and sensitivity. This sensitivity indicates substantial uncertainty in precipitation projections (PRBO Conservation Science 2011, p. 35). Other scientific sources (Snyder
Of the three major vegetation types within central-western California, decreases in cover are projected for chaparral-coastal scrub habitat (−19 to −43 percent) and blue oak woodland-foothill pine habitat (−44 to −55 percent), and an increase in cover projected for grassland habitat (85 to 140 percent) to 2070 (PRBO Conservation Science 2011, p. 38). Lenihan
To estimate what changes in rainfall and temperature, if any, would occur in the Burton Mesa area over the next 50 years, we used both local weather data and an available projection tool called ClimateWizard (2012). Temperature and precipitation data have been recorded in the City of Lompoc, approximately 4 mi (6.4 km) to the south of Burton Mesa
In a changing climate, conditions could change in a way that would allow both native and nonnative plants to invade the habitat where Vandenberg monkeyflower occurs. A growing body of literature discusses the specific mechanisms by which climate change could affect the abundance, distribution, and long-term viability of plant species, as well as current habitat configuration over time, including (but not limited to): Root
(1) Drier conditions may result in less suitable habitat, or a lower germination success and smaller population sizes.
(2) Higher temperatures may inhibit germination, dry out soil, or affect pollinator services.
(3) The timing of pollinator life cycles may become out-of-sync with timing of flowering.
(4) A shift in the timing and nature of annual precipitation may favor expansion in abundance and distribution of nonnative species.
(5) Drier conditions may result in increased fire frequency, making the ecosystems in which a species currently grows more vulnerable to threats of nonnative plant invasion.
We recognize that climate change is an important issue with potential impacts to species and their habitats, including Vandenberg monkeyflower. Regional climate projections indicate that a warming and drying trend is likely in central-western California, which would likely make habitat less favorable for Vandenberg monkeyflower. However, as stated above, these warming and drying effects may be moderated by the marine influence. Therefore, climate change may not affect Vandenberg monkeyflower or its habitat as quickly or as extensively as may be projected. We will continue to seek additional information concerning how climate change may affect the Burton Mesa area (see Information Received section above).
The Air Force has an approved Integrated Natural Resources Management Plan (INRMP) on Vandenberg AFB, and the CDFW and California State Parks have established natural resources management plans for the Reserve and La Purisima Mission SHP, respectively. Herein, we discuss specific conservation measures as they apply to each threat described above (see
The Air Force developed an INRMP in 2011 (Air Force 2011c) pursuant to the Sikes Act Improvement Act of 1997 (Sikes Act). The Sikes Act requires the Department of Defense to develop and implement INRMPs for military installations in the United States. INRMPs direct the management and use of the lands on a military installation and are prepared in cooperation with the Service and State fish and wildlife agencies to ensure proper consideration of fish, wildlife, and habitat needs. This Vandenberg AFB INRMP was prepared to provide strategic direction to ecosystem and natural resources management on Base. The long-term goal of the INRMP is to integrate all management activities in a manner that sustains, promotes, and restores the health and integrity of ecosystems using an adaptive management approach. The INRMP was designed to: (1) Summarize existing management plans and natural resources literature pertaining to Vandenberg AFB; (2) identify and analyze management goals in existing plans; (3) integrate the management goals and objectives of individual plans; (4) support Base compliance with applicable regulatory requirements; (5) support the integration of natural resource stewardship with the Air Force mission; and (6) provide direction for monitoring strategies. The INRMP includes a chapter that identifies step-down goals for the management of threatened and endangered species on Base; however, since Vandenberg monkeyflower was not a listed species at that time, specific goals for it were not included. In 2012, the Air Force approved an addendum that addresses specific goals for Vandenberg monkeyflower (Air Force 2012). The INRMP and addendum provide for measures that would conserve Vandenberg monkeyflower, as follows:
(1)
(2)
(3)
In the 2012 addendum to their INRMP, the Air Force identifies veldt grass as the most problematic invasive, nonnative plant on Base for Vandenberg monkeyflower. As part of this addendum, the Air Force also identified their 10-year funding program, which included more than $500,000 to treat veldt grass, starting in 2009 and continuing through 2019 (Air Force 2012). While the Air Force does not specify precisely where, when, or how much veldt grass will be treated or removed in specific years, they state that a substantial portion of this effort will focus on areas within the range of Vandenberg monkeyflower (Air Force 2012, p. 1). Through 2012, the Air Force has chemically treated approximately 141 acres (57 ha) of invasive, nonnative plants, mostly treating pampas grass within Burton Mesa chaparral but not near extant Vandenberg monkeyflower occurrences (treatment was to benefit
(4)
(a) Established roads, both paved and unpaved, would be used to the greatest extent possible as fire lines unless an emergency dictates otherwise.
(b) Burned areas would be assessed after a fire for rehabilitation options within 10 days of the area being declared safe for entry.
(c) Vandenberg monkeyflower habitat affected by wildfire and rehabilitation projects will be monitored, which would include recommendations for nonnative species control.
(d) Following any significant wildfire event within the range of Vandenberg monkeyflower on Base, a Burn Area Emergency Response (BAER) project will be initiated. This generally includes implementation of erosion control, native vegetation restoration, firebreak rehabilitation, and invasive species management.
Additionally, the addendum proposes to incorporate portions of Vandenberg monkeyflower habitat in a controlled burn program (Air Force 2012, p. 2).
(5)
Ecological Reserves are established under California State law to provide protection for rare, threatened, or endangered native plants, wildlife, aquatic organisms, and specialized terrestrial or aquatic habitat types. According to the California Code of Regulations (14 CCR Section 630), public entry and use of ecological reserves shall be compatible with the primary purposes of such reserves, and subject to general rules and regulations. The State Lands Commission signed a 49-year lease of the Burton Mesa Ecological Reserve on January 20, 2000. The purpose of the lease is to manage, operate, and maintain these sovereign lands for the sensitive species and habitats they support (Gevirtz
Conservation measures are proposed in the management plan, as outlined below. However, implementation of the management goals is contingent upon available funding and staffing. Currently, no funding is dedicated for the management of the Reserve and it is staffed by 10 percent of one biologist position. Some grant funding has been used for specific management needs.
(1)
(2)
(3)
(4)
(5)
General plans for State Parks are prepared to guide future management and development of State Park System units. The goal of the State Parks natural resource management program is to protect, restore, and maintain the natural resources in the State Park System. A general plan is the primary management document for each unit of the California State Park System, defining a park's primary purpose, and establishing a management direction for its future. The General Plan must satisfy certain requirements of the Public Resources Code and be approved by the California State Park and Recreation Commission before the Department undertakes any development in the park that would constitute a permanent commitment of natural or cultural resources. Further, broad resource management policies concerning State Historic Parks are stated in the Public Resources Code, the California Code of Regulations, and the Department's Resource Management Directives (California State Parks 1991, p. 54). A general management plan for La Purisima Mission SHP was completed in 1991 (California State Parks 1991, entire), and an ecosystem characterization of La Purisima Mission SHP was completed in 2005 (Gevirtz
Conservation measures are proposed in the general management plan, as outlined below. However, implementation of the management goals is contingent upon available funding and staffing. State Parks often rely upon the dedicated work of volunteers. Additionally, while the management plan contains biological resource conservation measures, the primary goal of the plan for La Purisima Mission SHP is to preserve the historical setting and maintain the historical “sense of place”—visitors' sense of stepping back in history (California State Parks 1991, p. 3).
(1)
(2)
(3)
(4)
(5)
Management goals for the Air Force, CDFW, and California State Parks in these plans include, but are not limited to, minimizing the spread and impact of invasive, nonnative species; working with local agencies to recognize the importance of, and resource protections afforded to, sensitive species like Vandenberg monkeyflower and its habitat; and maintaining the natural resources of Burton Mesa, especially Burton Mesa chaparral habitat. The Air Force, CDFW, and California State Parks have attempted to address the greatest threat to Vandenberg monkeyflower by removing or chemically treating invasive, nonnative plants on their lands, respectively. Working collaboratively in some instances, the Service has funded and volunteered manpower to help reduce the spread and impact of invasive, nonnative plants. Overall, because implementation of the management plans is dependent upon available funding and staffing, because of the quantity of invasive, nonnative species that threaten Vandenberg monkeyflower habitat (Burton Mesa chaparral), and because of the difficulty eradicating invasive, nonnative species once they become established on Burton Mesa, the implementation of the management plans as currently constituted would not eliminate the threats described in Factor A.
Most of the historical loss of Burton Mesa chaparral is due to military, residential, and commercial development that occurred in the past and resulted in many developed areas that have existed for decades, although historical loss of chaparral is also due to the presence and expansion of invasive, nonnative plants. Prior to 1938, there were approximately 23,550 ac (9,350 ha) of Burton Mesa chaparral (Hickson 1987, p. 34). In 2012, approximately 10,057 ac (4,070 ha) of Burton Mesa chaparral remained, which represents a loss of 53 percent of the original upland habitat (Service 2012a, unpublished data). Based on the habitat characteristics of Burton Mesa chaparral, it is probable that an equivalent percent loss of sandy openings that occur in-between shrubs may have occurred over this timeframe (see
The majority of remaining Burton Mesa chaparral where Vandenberg monkeyflower occurs is within Federal or State-owned lands and is protected from development. Therefore, large-scale future development of remaining Burton Mesa chaparral is not likely to occur and thus is not a significant threat to Vandenberg monkeyflower. However, smaller scale private property development; access to easements; maintenance of utility, oil, and gas pipelines; fire and fire suppression; and authorized and unauthorized recreational activities may continue to take place throughout Burton Mesa. Some of these activities may occur within Burton Mesa chaparral or adjacent to occurrences of Vandenberg monkeyflower, resulting in the destruction and possible removal of Vandenberg monkeyflower habitat and creating open areas for nonnative plants to invade. Therefore, the direct destruction and alteration of chaparral habitat could continue to occur on a relatively small scale and is thus considered a threat to Vandenberg monkeyflower both currently and in the future.
The presence and proliferation of invasive, nonnative plants is a threat to Vandenberg monkeyflower habitat that has the most significant impact to the species because nonnatives are spreading rapidly across Burton Mesa. The Air Force, CDFW, and California State Parks are implementing conservation measures to address the threat of nonnative plants within Vandenberg monkeyflower habitat. Nevertheless, invasive, nonnative plants are present at all locations where Vandenberg monkeyflower occurs, are known to alter native habitat, including that of Vandenberg monkeyflower, and are reducing the abundance and diversity of native plant species. Many of the nonnative species that occur on Burton Mesa are species deemed to pose significant ecological concerns because they displace native vegetation and occupy sandy openings where Vandenberg monkeyflower grows. Additionally, development that has fragmented the mesa, ground disturbances along easements, and authorized and unauthorized recreational activities increase the pathways for nonnative plants to establish and spread. Moreover, fire increases the potential for the invasion of nonnative plants by creating bare ground that facilitates the spread of nonnative vegetation. Therefore, with the prevailing onshore wind, an abundant upwind source of nonnative plants and seed, and continued ground disturbances, we conclude that the presence and expansion of invasive, nonnative plants is a threat to Vandenberg monkeyflower habitat both currently and in the future.
Climate change may have potential impacts on Vandenberg monkeyflower and its habitat, such as increased temperatures and decreased precipitation that would likely reduce suitable habitat. However, because of the moderating influence of the ocean, the effect of climate change on Burton Mesa flora may be moderated.
No available information indicates any impacts to Vandenberg monkeyflower related to overutilization for commercial, recreational, scientific, or educational purposes or that these activities would increase in the future. Therefore, we do not consider this factor to be a threat to Vandenberg monkeyflower, nor do we expect it to be in the future.
There is no available information indicating any impacts to Vandenberg monkeyflower related to disease or predation, or that disease or predation may become a concern in the future. Therefore, we do not consider disease or predation to be threats to Vandenberg monkeyflower, nor do we expect them to become threats in the future.
Under this factor, we examine whether existing regulatory mechanisms are inadequate to address the threats to Vandenberg monkeyflower discussed under other factors. We give strongest weight to statutes and their implementing regulations, and management direction that stems from those laws and regulations. They are nondiscretionary and enforceable, and are considered a regulatory mechanism under this analysis. Examples include State governmental actions enforced under a State statute or constitution, or Federal action under statute.
Some other programs are more voluntary in nature or dependent on available funding (see
Vandenberg monkeyflower is not federally or State-listed as endangered or threatened. The Service added this species to the Federal list of candidate species on November 10, 2010 (75 FR 69222; see Previous Federal Actions section above); however, candidate species are afforded no protections under the Act. The California Native Plant Society (CNPS) classifies this species as 1B.1, which denotes that a taxon is seriously endangered in California (CNPS 2012).
The California Endangered Species Act (CESA) allows the Fish and Game Commission to designate species, including plants, as threatened or endangered. The CESA makes it illegal to import, export, “take,” possess, purchase, sell, or attempt to do any of those actions to species that are designated as threatened, endangered, or candidates for listing, unless permitted by CDFW. Vandenberg monkeyflower is not listed as threatened or endangered under the CESA (CDFW 2012).
The Native Plant Protection Act (NPPA) was enacted in 1977 and allows the Fish and Game Commission to designate plants as rare or endangered. The NPPA prohibits take of endangered or rare native plants, but includes some exceptions for agricultural and nursery operations, emergencies, and (after properly notifying CDFW) vegetation removal from canals, roads, and other sites, changes in land use, and certain other situations. Vandenberg monkeyflower is not designated as rare or endangered under the NPPA (CDFW 2012).
Ecological Reserves are established under California State law to provide protection for rare, threatened, or endangered native plants, wildlife, aquatic organisms, and specialized terrestrial or aquatic habitat types. Likewise, the goal of the State Parks resource management program is to protect, restore and maintain the natural resources in the State Park System (see
The California Environmental Quality Act (CEQA) requires a full disclosure of the potential impacts that proposed projects on non-Federal lands will have on the environment, including sensitive resources. CEQA does not confer any protection to sensitive species, but merely requires disclosure of potential impacts. Lead CEQA agencies are also required to disclose potential impacts to CNPS list 1B.1 species, including Vandenberg monkeyflower. The lead agency for CEQA analysis is the public agency with primary authority or jurisdiction over the project, and is responsible for conducting a review of the project and consulting with other agencies responsible for resources affected by the project; this agency is typically a county, city, or special district agency. Three proposed projects have undergone CEQA analysis on Burton Mesa in recent years, and the CEQA process adequately disclosed impacts of these projects (see
(1) The County of Santa Barbara, which is the lead agency responsible for CEQA review for projects on non-Federal lands where Vandenberg monkeyflower occurs, approved the Clubhouse Estates residential development in August 2005 (County of Santa Barbara Planning Commission 2005) (see
While the CEQA review disclosed impacts to Vandenberg monkeyflower and its habitat at the Clubhouse Estates project site, the CEQA review does not afford protection to this species or its habitat. Therefore, the County of Santa Barbara included conditions to their approval of the Clubhouse Estates development project. County stipulations to the Clubhouse Estates approval that would benefit Vandenberg monkeyflower and its habitat included: onsite habitat restoration and preservation plan, an open space management plan, onsite habitat restoration, and native plant propagation. Thus, the project proponent (LFR, Inc.) developed a restoration, construction monitoring, and resource protection plan to address the mitigation of native ecological resources impacted by the development project, to provide for restoration of disturbed habitat within the designated open space (Lot 54), and to describe ecological resource protection measures that would be implemented during construction (LFR, Inc. 2006, p. 1, pp. 34–60). The restoration plan was developed (LFR, Inc. 2006) but has not been fully implemented, possibly due to the development project falling into foreclosure in December 2009 (VVCSD 2011). Additionally, LFR, Inc. conducted actions to further preserve Vandenberg monkeyflower by collecting seeds and storing them at the Santa Barbara Botanic Garden, salvaging topsoil from where Vandenberg monkeyflower previously occurred on the project site (which likely contained a seed bank), and depositing the topsoil outside of the project site and within suitable habitat, and transplanting three individual plants (McGowan
The County is also responsible for permitting other activities, such as grading, according to Santa Barbara County Grading Code, Chapter 14. A grading permit would have associated erosion and sediment controls, including best management practices and other conditions of approval that would minimize impacts to sensitive biological resources (County of Santa Barbara Planning and Development 2013; LFR, Inc. 2006, entire). Our records indicate that the Clubhouse Estates project site was cleared prior to the developer's acquisition of a grading permit from the County (Mooney
(2) The City of Lompoc conducted a CEQA review for the Burton Ranch (see
(3) The Allan Hancock College District conducted the CEQA analysis for a proposal to construct a public safety complex at Allan Hancock College (see
Despite implementation of the CEQA process and disclosure of the impacts to this species or its habitat, these projects illustrate that development can constitute a direct threat (removal of Vandenberg monkeyflower individuals) to Vandenberg monkeyflower and/or suitable habitat, and this threat is present and is expected to continue into the future (see
The National Environmental Policy Act (NEPA) requires full disclosure of potential impacts that proposed projects on Federal lands or with Federal involvement will have on the environment, including sensitive resources. The NEPA process would apply to projects proposed on Vandenberg AFB and projects on non-Federal lands that include a Federal nexus, such as funding or permitting by a Federal agency. The NEPA analysis, like CEQA, does not confer any protection to sensitive species, but merely discloses potential impacts. Although Federal agencies may include conservation measures for Vandenberg monkeyflower as a result of the NEPA process, any such measures are typically voluntary in nature and are not required by statute.
For example, although the Vandenberg monkeyflower is not yet a federally threatened or endangered species, it is recognized by Vandenberg AFB as a species deserving of conservation measures as demonstrated by the Air Force's recent submittal of a proposal to include Vandenberg monkeyflower in their INRMP (Air Force 2012). The Air Force could include conservation measures for Vandenberg monkeyflower and its habitat as a result of the NEPA process. The NEPA would not itself regulate activities that might affect Vandenberg monkeyflower, but it would require full evaluation and disclosure of information regarding the effects of contemplated Federal actions on sensitive species and their habitats.
The Sikes Act requires the Department of Defense to develop and implement INRMPs for military installations in the United States. INRMPs direct the management and use of the lands on a military installation and are prepared in cooperation with the Service and State fish and wildlife agencies (i.e., CDFW) to ensure proper consideration of fish, wildlife, and habitat needs (see
The existing regulatory mechanisms at the Federal and State levels require evaluation of potential actions that may impact Vandenberg monkeyflower and its habitat on Burton Mesa. At the Federal level, the NEPA only requires evaluation of impacts to the human environment. The Sikes Act requires military installations to develop INRMPs to ensure proper consideration of fish, wildlife, and habitat needs on their lands. However, no protections are in place at the local, State, and Federal levels that are intended to protect a plant species that is not Federally or State-listed, although Vandenberg AFB has proposed to include this species in their INRMP. Additionally, at least one incident of unauthorized grading occurred without following the required local permit process; loss of Vandenberg monkeyflower individuals and habitat was documented.
Federal and State ownership of much of the occupied Vandenberg monkeyflower habitat and the regulatory purposes that define the use of those Federal and State lands protect the species from direct losses of habitat and provide further protection from many of the forms of disturbance described above. However, the current regulatory regime does not address the majority of impacts associated with loss of Vandenberg monkeyflower habitat (i.e., development of private lands that result in habitat loss, fire and fire suppression efforts, authorized and unauthorized recreation activities, and the invasion and expansion of invasive, nonnative species). As described above under Factor A, the primary threat with the greatest severity and magnitude of impact to Vandenberg monkeyflower is invasive, nonnative species invasion and expansion. The existing regulatory mechanisms currently in place at the local, State, and national levels are inadequate to address this threat to Vandenberg monkeyflower and its habitat.
In Factor A, we discussed how invasive, nonnative plants alter the habitat that supports Vandenberg monkeyflower. In this section, we discuss how invasive, nonnative plants compete with individuals of Vandenberg monkeyflower for light, water, and soil nutrients.
Invasion of nonnative plants and in particular nonnative grasses are a threat to Vandenberg monkeyflower because small annuals such as this species most likely cannot compete with fast-growing nonnative plants for light, water, and soil nutrients (refer to Barrows
(1)
(2)
Many examples exist of invasive, nonnative plants outcompeting native herbs and shrubs for water and soil nutrients, some of which include the following:
(1) Davis and Mooney (1985, p. 528) demonstrated across a grassland-chaparral ecotone in Jasper Ridge Biological Preserve (approximately 7.5 mi (12 km) west of Palo Alto, California) that bare-zone annual herbs, such as
(2) Eliason and Allen (1997, p. 252) conducted a study in the Santa Margarita Ecological Reserve (near Temecula, California) and determined that the growth and survival of transplanted
(3) Melgoza
Because individuals of Vandenberg monkeyflower are small in stature (growing up to 10 in (25.4 cm) tall), invasive, nonnative plants that grow taller in stature and quicker than this species (such as veldt grass and Sahara mustard; see
According to the criteria put forth by the World Conservation Union, as modified for plants, a species that has life history, population, and distribution attributes similar to those of Vandenberg monkeyflower is considered to have a high risk of extinction in the wild in the immediate future (Keith 1998, pp. 1085–1087). Species with few populations and individuals are vulnerable to the threat of naturally occurring events, which can cause extinction through mechanisms operating either at the genetic, population, or landscape level (Shaffer 1981, pp. 131–134; Primack 1998, pp. 279–308). Environmental stochasticity is annual variation in reproduction and death rates in response to weather, disease, competition, predation, or other factors external to the population (Shaffer 1981, p. 131). Natural catastrophes or prolonged drought could also result in the extirpation of a small population (Shaffer 1981, p. 131).
The genetic characteristics of Vandenberg monkeyflower
(1) Four individuals were found in 2006 at Oak Canyon, although no individuals were found during the most recent surveys in 2010 and 2012 (VFWO 2013; Air Force 2012, p. 1; Lum
(2) Twenty-five individuals were found in 2006 at the Santa Lucia Canyon occurrence, and one individual was found during the most recent survey in 2010 (Ballard 2006; Lum
(3) Five individuals were found in 2003 at the Volans Avenue occurrence, one in 2007, and no plants were found in other years surveyed between 2004 and 2009 (Meyer
Vandenberg monkeyflower fits the profile of a species that is considered to have small population numbers for an annual plant and is vulnerable to extinction because it has a restricted geographic range, and less than 10 known occurrences with less than 10,000 mature individuals (Keith 1998, pp. 1085–1087) (see
Species with few populations or those with low numbers may be subject to forces at the population level that affect their ability to complete their life cycles successfully. The number and density of flowering plants in a population can be important determinants of pollinator abundance and behavior (Jennersten 1988, pp. 361–363; Bernhardt
The invasion of nonnative plants has the ability to reduce the abundance of pollinators, which can have deleterious effects on reproduction of native plants. Jennersten (1988, p. 363) found that insect diversity, insect visitation rates to
Annual plants that are subject to wide fluctuations in population numbers from year to year, such as Vandenberg monkeyflower, may have difficulty maintaining a viable population size after a series of poor seed-production years. Additionally, if the host plants (plants being visited by pollinators) are partially self-incompatible, reduction in population size may lead to increased self-pollination and may reduce the level of genetic variability. At the landscape level, random natural events, such as storms, drought, or fire, could destroy a significant percentage of individuals or entire populations. Because Vandenberg monkeyflower comprises a small number of locations and individuals, and is restricted to a small geographic area on Burton Mesa, this species' risk of extinction increases from such naturally occurring events. No empirical information is available to estimate trends for Vandenberg monkeyflower populations; however, the continued decrease in habitat (especially from nonnative plant invasions) is contributing to habitat fragmentation and impacting the species' ability to persist.
Recreational use occurs on Burton Mesa within Vandenberg AFB, the Reserve, and La Purisima Mission SHP. We discussed the effects to Vandenberg monkeyflower habitat resulting from recreational use (see
Competition for light, water, and soil nutrients from invasive, nonnative vegetation, particularly nonnative grasses, is a threat to Vandenberg monkeyflower. Because this species has a restricted range and small population numbers, it is vulnerable to naturally occurring events such as a wildfire, storms, and drought that could negatively affect its growth and productivity. Additionally, because of the restricted range, small number of individuals at each occurrence, and the spread of invasive, nonnative plants adjacent to each occurrence, this species is vulnerable to a reduction of visits by pollinating insects. The best available information indicates that casual recreational use has a minimal impact to individuals. Unauthorized recreational uses (ORVs and mountain biking) have the potential to result in damage to the native vegetation; however, the best information available does not indicate a direct threat to individuals of Vandenberg monkeyflower. Indirect effects of potential ground disturbance could create openings in the vegetation and assist the seed spread and establishment of nonnative vegetation. Therefore, we conclude that competition for resources with invasive, nonnative species and small population size and restricted range are threats to
Many of the threats discussed above act in concert, and the resulting effects to Vandenberg monkeyflower are amplified. For example, some land uses and development or maintenance activities (Factor A) create ground disturbance and subsequent openings in the vegetation where nonnative plants (Factor A) can invade, expand, and outcompete native vegetation (Factor E). Fires on Burton Mesa (Factor A) result in an increase in nonnative vegetation (Factor A). Similarly, an abundance of nonnative vegetation, particularly grasses (Factor A and E), may result in an increase in fire frequency (Factor A). The availability of habitat and small overall population size (Factor E) may be affected in a changing climate and by events such as wildfire (Factor A). Thus, Vandenberg monkeyflower's productivity may be reduced because of these threats, either singularly or in combination. Existing regulatory mechanisms have not proven effective at protecting Vandenberg monkeyflower or its habitat from these threats (Factor D).
The presence of invasive plants is the most significant threat to this species, both alone and in combination with other Factors (e.g., anthropogenic fire, recreation). The combination of factors would likely create a cumulative or synergistic threat to the existence of Vandenberg monkeyflower. Given these circumstances, the combined effects of current threats to the population put the species at risk rangewide, although the magnitude or extent of such threats to the viability of the species is not at this time determinable from available information.
We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to Vandenberg monkeyflower. We have identified threats to Vandenberg monkeyflower attributable to Factors A, D, and E.
In the summary of the threats described in detail above, we found that Vandenberg monkeyflower suitable habitat on Burton Mesa has been displaced by military, residential, and commercial development, although the most significant ongoing threat to Vandenberg monkeyflower is the loss of habitat due to the presence and continual spread of invasive, nonnative plants (Factor A). Approximately 53 percent of Burton Mesa chaparral habitat has been lost, with only 10,057 ac (4,070 ha) of the 23,550 ac (9,350 ha) that existed before 1938 remaining.
Additionally, invasive, nonnative plants, in particular veldt grass, are present and continuing to expand at all nine extant locations. No Vandenberg monkeyflower individuals have been observed at the three smallest extant locations (in the last 3 years at one location and the last 6 years at the other two locations) even though a residual seed bank is likely present. Burton Mesa chaparral is also subject to an anthropogenic fire regime that can increase the presence of invasive plants (Factor A). Casual human recreational use and utility maintenance activities can contribute to habitat disturbance that facilitates pathways for nonnative species to invade Burton Mesa chaparral habitat (Factor A).
Furthermore, invasive, nonnative plants are likely competing with Vandenberg monkeyflower for sunlight, water, and soil resources, and the species' restricted range and small population size makes it vulnerable to changing environmental conditions due to climate change and other random, naturally occurring events (Factor E). Small population size is a highlighted concern in part due to the low number of individuals found to exist at the 3 smallest extant occurrences, in particular 3 of the 9 occurrences that have a range of 0 to 25 individuals documented between 2003 and 2012. The threats described above for Vandenberg monkeyflower occur across its entire range, resulting in a negative impact on the species' distribution, abundance, and probability of long-term persistence. Existing regulatory mechanisms are not adequate to protect the species or its habitat from these identified threats (Factor D).
The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that Vandenberg monkeyflower has a restricted range and is facing ongoing and projected threats across its range. We conclude that it meets the definition of an endangered species throughout its entire range due primarily to: (1) The invasion, spread, and competition of invasive, nonnative species at all nine extant locations; and (2) small population size that makes it vulnerable to stochastic events. These impacts are heightened due to anthropogenic fire conditions that promote further invasion of nonnative species; recreation and other human activities that contribute to the spread of invasive, nonnative species; and continued development on private lands that further reduces and fragments the remaining suitable habitat. The threats to its continued existence are not commencing in the foreseeable future (which would result in a status determination of a threatened species), but are immediate and ongoing. We base this determination on the immediacy, severity, and scope of the threats described above. Therefore, on the basis of the best available scientific and commercial information, we propose listing Vandenberg monkeyflower as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act.
Under the Act and our implementing regulations, a species may warrant listing if it meets the definition of an endangered or threatened species throughout all or a significant portion of its range. The Vandenberg monkeyflower that is proposed for listing in this rule is highly restricted in its range and the threats occur throughout its range. Therefore, we assessed the status of Vandenberg monkeyflower throughout its entire range. The threats to the survival of the species occur throughout the species range and are not restricted to any particular significant portion of that range. Accordingly, our assessment and proposed determination applies to the species throughout its entire range.
Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.
The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the
Recovery planning includes the development of a recovery outline shortly after a species is listed, preparation of a draft and final recovery plan, and revisions to the plan as significant new information becomes available. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. The recovery plan identifies site-specific management actions that will achieve recovery of the species, measurable criteria that indicate when a species may be downlisted or delisted, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (comprising species experts, Federal and State agencies, nongovernmental organizations, or stakeholders) are often established to develop recovery plans. If a final listing rule is completed for Vandenberg monkeyflower, the Service will develop and complete a recovery outline, draft recovery plan, and the final recovery plan that will be available on our Web site (
Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribal, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (for example, restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.
If this species is listed, funding for recovery actions may be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. Additionally, pursuant to section 6 of the Act, the State of California would be eligible for Federal funds to implement management actions that promote the protection and recovery of Vandenberg monkeyflower. Information on our grant programs that are available to aid species recovery can be found at:
Although Vandenberg monkeyflower is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this species. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see
Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.
Federal agencies proposing activities within the species' habitat that may need to conference or consult or both with the Service as described in the preceding paragraph include the Department of Defense, the Bureau of Prisons, the Federal Energy Regulatory Commission, and the Federal Highway Administration. Activities potentially include management and any other landscape-altering activities on Federal lands administered by the Department of Defense or the Bureau of Prisons, issuance of section 404 Clean Water Act permits by the Army Corps of Engineers, construction and management of gas pipeline and power line ROWs licensed by the Federal Energy Regulatory Commission, and funding by the Federal Highway Administration for the construction and maintenance of roads or highways.
The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered plants. All prohibitions of section 9(a)(2) of the Act, implemented by 50 CFR 17.61, apply. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to import or export, transport in interstate or foreign commerce in the course of a commercial activity, sell or offer for sale in interstate or foreign commerce, or remove and reduce the species to possession from areas under Federal jurisdiction. Additionally, for plants listed as endangered, the Act prohibits the malicious damage or destruction on areas under Federal jurisdiction and the removal, cutting, digging up, or damaging or destroying of such plants in knowing violation of any State law or regulation, including State criminal trespass law. Certain exceptions to the prohibitions apply to agents of the Service and State conservation agencies. Vandenberg monkeyflower is not currently designated as rare or endangered under the NPPA or the CESA (CDFW 2012).
CEQA requires a full disclosure of the potential impacts that proposed projects on non-Federal lands will have on the environment, including sensitive resources. However, CEQA does not confer any protection to sensitive species, but merely discloses potential impacts. The lead agency for CEQA analysis is the public agency with primary authority or jurisdiction over the project, and is responsible for conducting a review of the project and consulting with other agencies responsible for resources affected by the project. Under CEQA, lead agencies are required to disclose potential impacts from proposals to CNPS list 1B.1 species; this mechanism may indirectly provide some protection to Vandenberg monkeyflower.
We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife and plant species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.62 for endangered plant species, and at 17.72 for threatened plant species.
It is our policy, as published in the
Removing and reducing to possession Vandenberg monkeyflower from areas under Federal jurisdiction; malicious damage or destruction of Vandenberg monkeyflower from areas under Federal jurisdiction; unauthorized collecting, handling, possessing, selling, delivering, carrying, or transport across State lines and import or export across international boundaries, except for properly documented antique specimens of these taxa at least 100 years old, as defined by section 10(h)(1) of the Act.
Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Ventura Fish and Wildlife Office (see
In accordance with our joint policy on peer review published in the
We will consider all comments and information received during this comment period on this proposed rule during our preparation of a final determination. Accordingly, the final decision may differ from this proposal.
Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. Requests must be received within 45 days after the date of publication of this proposed rule in the
We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We have determined that environmental assessments and environmental impact statements, as defined under the authority of the NEPA (42 U.S.C. 4321
It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the 10th Circuit, we do not need to prepare environmental analyses pursuant to NEPA in connection with designating critical habitat under the Endangered Species Act. We published a notice outlining our reasons for this determination in the
A complete list of references cited in this rulemaking is available on the Internet at
The primary authors of this package are the staff members of the Ventura Fish and Wildlife Office.
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361–1407; 1531–1544; 4201–4245; unless otherwise noted.
(h) * * *