Agricultural Marketing Service
Economic Development Administration
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
Coast Guard
U.S. Customs and Border Protection
Bureau of Safety and Environmental Enforcement
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Reclamation Bureau
Justice Programs Office
Workers Compensation Programs Office
Federal Aviation Administration
Federal Railroad Administration
Maritime Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Agricultural Marketing Service, USDA.
Final rule.
The Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) is revising the United States Standards for Grades of Processed Raisins by removing five references to the term “midget” throughout the standards. These changes will modernize and clarify the standards by removing dual terminology for the same requirement.
Effective July 25, 2016.
Lindsay Mitchell at Standardization Branch, Specialty Crops Inspection Division, Specialty Crops Program, Agricultural Marketing Service, U.S. Department of Agriculture, National Training and Development Center, Riverside Business Park, 100 Riverside Parkway, Suite 101, Fredericksburg, VA 22406, or at phone (540) 361–1120; fax (540) 361–1199; or, email
The changes remove the dual nomenclature terminology “small or midget” for the same requirement from the U.S. Standards for Grades of Processed Raisins. These revisions also affect the grade requirements under the marketing order, 7 CFR parts 989, issued under the Agricultural Marketing Agreement Act of 1937 (7 U.S.C. 601–674) and applicable imports.
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, and distributive impacts and equity. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule.
Pursuant to the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601–612), AMS has considered the economic impact of these revisions on small entities, and prepared the following final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so small businesses will not be unduly or disproportionately burdened. Marketing orders issued under the Act, and the rules issued thereunder, are unique in that they are brought about through group action of small entities acting on their own behalf.
There are approximately 3,000 California raisin producers and 28 handlers subject to regulation under the marketing order. The Small Business Administration defines small agricultural producers as those with annual receipts less than $750,000, and defines small agricultural service firms as those with annual receipts less than $7,500,000 (13 CFR 121.201).
Based on shipment data and other information provided by the Raisin Administrative Committee (RAC), which administers the Federal marketing order for raisins produced from grapes grown in California, most producers and approximately 18 handlers of California raisins may be classified as small entities. The RAC represents the entire California raisin industry; no other state produces raisins commercially. This action should not have any impact on handlers' or growers' benefits or costs.
The action will clarify AMS grade standards by eliminating the use of the term “midget” and consistently using the term “small” for raisins graded in that category. The industry has used the two terms interchangeably for years. The proposed grade standards will be applied uniformly by all handlers.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this rule will not change the information collection and recordkeeping requirements previously approved, and will impose no additional reporting or recordkeeping burden on domestic producers, first handlers, and importers of processed raisins.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule. The rule will impact marketing programs that regulate the handling of processed raisins under 7 CFR part 989. Raisins under a marketing order must meet certain requirements set forth in the grade standards. In addition, raisins are subject to section 8e import requirements under the Agricultural Marketing Act of 1937, as amended (7 U.S.C. 601–674), which requires that imported raisins meet grade, size, and
AMS continually reviews all fruit and vegetable grade standards to ensure their usefulness to the industry, and to modernize language and remove duplicative terminology. On May 13, 2013, AMS received a petition from the Little People of America stating that they “are trying to raise awareness around and eliminate the use of the word midget.” The petition further stated that, “Though the use of the word midget by the USDA when classifying certain food products is benign, Little People of America, and the dwarfism community, hopes that the USDA would consider phasing out the term midget.”
AMS determined that the processed raisin grade standard contained “small or midget” terminology for the same requirement. Before developing these proposed revisions, AMS solicited comments and suggestions about the grade standards from the RAC, which represents the entire California raisin industry. On August 14, 2014, the RAC approved the removal of the term midget from the standards.
On August 21, 2015, AMS published a Proposed Rule in the
Five commenters, one of which represents the dwarfism community, fully support the revisions. Four of them believe the issue is not about political correctness, but, rather, is a matter of common decency and respect. They also believe eliminating the term “midget” from USDA documents will raise awareness that the term is socially unacceptable. In addition, one commenter believes it is redundant to have two names for the same size category. All agree the term “midget” is unneeded and should be removed.
Two of the three opposing commenters believe the USDA should address more important issues and not concern themselves with being “politically correct.” The third stated that even though they understand the concern of Little People of America, they believe addressing the issue is unnecessary, since, in their purchasing experience, they have never encountered raisins identified by size. The USDA and RAC support the Little People of America in the removal of the term “midget” from the raisin standards as a matter of common decency, that there is limited use of the term by industry, and because it is redundant as there is also the term “small” for the size category. No changes have been made to the rule based on the comments.
Based on the information gathered, AMS is removing five references to the term “midget” in the following sections: 52.1845(b) and (c), 52.1850(a)(2) and (a)(3), and Table I. The revisions will modernize and help clarify the language of the standard by removing dual terminology for the same requirement.
Food grades and standards, Food labeling, Frozen foods, Fruit juices, Fruits, Reporting and recordkeeping requirements, Vegetables.
For reasons set forth in the preamble, 7 CFR part 52 is amended as follows:
7 U.S.C. 1621–1627.
(b)
(c)
(a) * * *
(2)
(3)
Agricultural Marketing Service, USDA.
Final rule.
This rule implements a recommendation from the California Desert Grape Administrative Committee (Committee) for an increase of the assessment rate established for the 2016 and subsequent fiscal periods from $0.0250 to $0.0300 per 18-pound lug of grapes handled under the marketing order (order). The Committee locally administers the order, and is comprised of producers and handlers of grapes grown and handled in a designated area of southeastern California. Assessments upon grape handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period began on January 1 and ends December 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Effective June 24, 2016.
Kathie Notoro, Marketing Specialist, or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487–5901, Fax: (559) 487–5906, or Email:
Small businesses may request information on complying with this regulation by contacting Antoinette Carter, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250–0237; Telephone: (202) 720–2491, Fax: (202) 720–8938, or Email:
This rule is issued under Marketing Order No. 925, as amended (7 CFR part 925), regulating the handling of grapes grown in a designated area of southeastern California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601–674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, grape handlers in a designated area of southeastern California are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable grapes beginning on January 1, 2016, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule increases the assessment rate established for the Committee for the 2016 and subsequent fiscal periods from $0.0250 to $0.0300 per 18-pound lug of grapes handled.
The grape marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of grapes grown in a designated area of southeastern California. They are familiar with the Committee's needs and with the costs of goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2015 and subsequent fiscal periods, the Committee recommended, and the USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA based upon recommendation and information submitted by the Committee or other information available to USDA.
The Committee met on November 12, 2015, and unanimously recommended 2016 expenditures of $143,500, a contingency reserve fund of $6,500, and an assessment rate of $0.0300 per 18-pound lug of grapes handled. In comparison, last year's budgeted expenditures were $135,500. The Committee recommended a crop estimate of 5 million, 18-pound lugs, which is lower than the 5.8 million, 18-pound lugs handled last year. The Committee also recommended carrying over a financial reserve of $47,500, which would increase to $54,000, at the end of the fiscal period. The assessment rate of $0.0300 per 18-pound lug of grapes handled recommended by the Committee is $0.0050 higher than the $0.0250 rate currently in effect. The higher assessment rate, applied to shipments of 5 million, 18-pound lugs, is expected to generate $150,000 in revenue and be sufficient to cover anticipated expenses.
The major expenditures recommended by the Committee for the 2016 fiscal period include $28,500 for research, $20,080 for office expenses, $56,500 for management and compliance expenses, $25,000 for consultation services, and $6,500 for a contingency reserve. The $28,500 research project is a continuation of a vine study in progress by the University of California, Riverside.
In comparison, major expenditures for the 2015 fiscal period included $15,500 for research, $17,000 for general office expenses, $62,750 for management and compliance expenses, $25,000 for consultation services, and $9,500 for a contingency reserve. Overall 2016 expenditures include a decrease in management and compliance expenses, and increases in office and research expenses.
The assessment rate recommended by the Committee was derived by evaluating several factors, including estimated shipments for the 2016 season, proposed expenses, and the level of available financial reserves. The Committee determined that the $0.0300 assessment rate should generate $150,000 in revenue to cover the budgeted expenses of $143,500, and a contingency reserve fund of $6,500.
Reserve funds by the end of 2016 are projected to be $54,000. The reserve would be well within the reserve amount authorized under the order. Section 925.41 of the order permits the Committee to maintain approximately one fiscal period's expenses in reserve.
The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA based upon a recommendation and information submitted by the Committee or other available information.
Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate the Committee's recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2016 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601–612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
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. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 12 handlers of southeastern California grapes who are subject to regulation under the marketing order and about 38 grape producers in the production area. Small agricultural service firms are defined by the Small Business Administration as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those whose annual receipts are less than $750,000(13 CFR 121.201).
Seven of the 12 handlers subject to regulation have annual grape sales of less than $7,500,000, according to USDA Market News Service and Committee data. In addition, information from the Committee and USDA's Market News indicates that at least nine of the 38 producers have annual receipts of less than $750,000. Based on the foregoing, it may be concluded that slightly more than half of the grape handlers and a minority of the grape producers could be classified as small entities.
This rule increases the assessment rate established for the Committee and collected from handlers for the 2016 and subsequent fiscal periods from $0.0250 to $0.0300 per 18-pound lug of grapes. The Committee unanimously recommended 2016 expenditures of $143,500, a contingency reserve fund of $6,500, and an assessment rate of $0.0300 per 18-pound lug of grapes handled. The assessment rate of $0.0300 is $0.0050 higher than the 2015 rate. The quantity of assessable grapes for the 2016 season is estimated at 5 million, 18-pound lugs. Thus, the $0.0300 rate should generate $150,000 in income. In addition, reserve funds at the end of the year are projected to be $54,000, which is well within the order's limitation of approximately one fiscal period's expenses.
The major expenditures recommended by the Committee for the 2016 fiscal period include $28,500 for research, $20,080 for general office expenses, $56,500 for management and compliance expenses, $25,000 for consultation services and $6,500 for the contingency reserve.
In comparison, major expenditures for the 2015 fiscal period included $15,500 for research, $17,000 for general office expenses, $62,750 for management and compliance expenses, $25,000 for consultation services, and $9,500 for a contingency reserve. Overall 2016 expenditures include a decrease in management and compliance expenses, and increases in general office expenses, and research expenses.
Prior to arriving at this budget and assessment rate, a subcommittee met to discuss this matter for the purpose of making a recommendation to the Committee. The Committee considered alternative expenditures and assessment rates, to include not increasing the $0.0250 assessment rate. Based on a crop estimate of 5 million, 18-pound lugs, the Committee ultimately determined that increasing the assessment rate to $0.0300 would generate sufficient funds to cover budgeted expenses. Reserve funds at the end of the 2016 fiscal period are projected to be $54,000. This amount is well within the amount authorized under the order.
A review of historical crop and price information, as well as preliminary information pertaining to the upcoming fiscal period, indicates that the shipping point price for the 2015 season averaged about $22.75 per 18-pound lug of California desert grapes handled. If the 2016 price is similar to the 2015 price, estimated assessment revenue as a percentage of total estimated handler revenue will be 0.13 percent for the 2016 season ($0.0300 divided by $22.75 per 18-pound lug).
This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs are offset by the benefits derived from the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the grape production area and all interested persons were invited to attend and participate in Committee deliberations on all issues. Like all Committee meetings, the November 12, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581–0189, Generic Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This rule imposes no additional reporting or recordkeeping requirements on either small or large California grape handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.
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 purposes.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule, as herein set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Grapes, Marketing agreements, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 925 is amended as follows:
7 U.S.C. 601–674.
On and after January 1, 2016, an assessment rate of $0.0300 per 18-pound lug is established for grapes grown in a designated area of southeastern California.
Bureau of Industry and Security, Commerce.
Final rule.
In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to revise the existing Validated End-User (VEU) list for the People's Republic of China by updating the list of eligible items and destinations (facilities) for VEU Advanced Micro Devices, Inc. (AMD). Specifically, BIS amends Supplement No. 7 to part 748 of the EAR to remove an existing “eligible destination” (facility); add a building to an existing address at one of AMD's already approved facilities to which eligible items may be exported, reexported or transferred (in-country); and reflect the recent removal of an existing “eligible item” from the Commerce Control List (CCL).
This rule is effective June 23, 2016.
Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, U.S. Department of Commerce, Phone: 202–482–5991; Email:
Validated End-Users (VEUs) are designated entities located in eligible destinations to which eligible items may be exported, reexported, or transferred (in-country) under a general authorization instead of a license. The names of the VEUs, as well as the dates they were so designated, and their respective eligible destinations (facilities) and items are identified in Supplement No. 7 to part 748 of the EAR. Under the terms described in that supplement, VEUs may obtain eligible items without an export license from BIS, in conformity with section 748.15 of the EAR. Eligible items vary between VEUs and may include commodities, software, and technology, except those controlled for missile technology or crime control reasons on the Commerce Control List (CCL) (part 774 of the EAR).
VEUs are reviewed and approved by the U.S. Government in accordance with the provisions of section 748.15 and Supplement Nos. 8 and 9 to part 748 of the EAR. The End-User Review Committee (ERC), composed of representatives from the Departments of State, Defense, Energy, Commerce, and other agencies as appropriate, is responsible for administering the VEU program. BIS amended the EAR in a final rule published on June 19, 2007 (72 FR 33646), to create Authorization VEU.
In this final rule, BIS amends Supplement No. 7 to part 748 to revise AMD's VEU authorization. Specifically, in this rule BIS removes one of AMD's existing eligible destinations (facilities). Also, in this rule, BIS adds a building to an existing address at one of AMD's facilities already approved under Authorization VEU, to which the company's eligible items may be exported, reexported or transferred (in-country) in the People's Republic of China (PRC) under the authorization. Finally, in this rule, BIS removes Export Control Classification Number (ECCN) 4D002 from the list of AMD's eligible items to reflect the removal of that item from the CCL by 80 FR 29432 (May 21, 2015). The amendments to the eligible destinations (facilities) are in response to a request from AMD, while the amendment to the eligible items list reflects the recent removal of that ECCN from the CCL. All amendments were approved by the ERC. The revisions are as follows:
AMD Technologies (China) Co., Ltd., No. 88, Su Tong Road, Suzhou, China 215021.
With this revision, AMD's “Eligible Items” are as follows: 3D002, 3D003, 3E001 (limited to “technology” for items classified under 3C002 and 3C004 and “technology” for use during the International Technology Roadmap for Semiconductors (ITRS) process for items classified under ECCNs 3B001 and 3B002), 3E002 (limited to “technology” for use during the ITRS process for items classified under ECCNs 3B001 and 3B002), 3E003.e (limited to the “development” and “production” of integrated circuits for commercial applications), 4D001 and 4E001 (limited to the “development” of products under ECCN 4A003.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 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, reducing costs, harmonizing rules, and promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.
2. This rule involves collections previously approved by the Office of Management and Budget (OMB) under Control Number 0694–0088, “Multi-Purpose Application,” which carries a burden hour estimate of 43.8 minutes to prepare and submit form BIS–748; and for recordkeeping, reporting and review requirements in connection with Authorization VEU, which carries an estimated burden of 30 minutes per submission. This rule is expected to result in a decrease in license applications submitted to BIS. Total burden hours associated with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.
4. Pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), BIS finds good cause to waive requirements that this rule be subject to notice and the opportunity for public comment because they are unnecessary. In determining whether to grant VEU designations, a committee of U.S. Government agencies evaluates information about and commitments made by candidate companies, the nature and terms of which are set forth in 15 CFR part 748, Supplement No. 8. The criteria for evaluation by the committee are set forth in 15 CFR 748.15(a)(2). The information, commitments, and criteria for this extensive review were all established through the notice of proposed rulemaking and public comment process (71 FR 38313 (July 6, 2006) (proposed rule), and 72 FR 33646 (June 19, 2007) (final rule)). Given the similarities between the authorizations provided under the VEU program and export licenses (as discussed further below), the publication of this information does not establish new policy. In publishing this final rule, BIS amends the authorization for an existing eligible VEU to remove an eligible destination (facility), revise an existing eligible destination (facility) to add a building, and remove an eligible item no longer listed on the CCL. These changes have been made within the established regulatory framework of the VEU program. Further, this rule does not abridge the rights of the public or eliminate the public's option to export under any of the forms of authorization set forth in the EAR.
Publication of this rule in other than final form is unnecessary because the authorizations granted in the rule are consistent with the authorizations granted to exporters for individual licenses (and amendments or revisions thereof), which do not undergo public review. In addition, as with license applications, VEU authorization applications contain confidential business information, which is necessary for the extensive review conducted by the U.S. Government in assessing such applications. This information is extensively reviewed according to the criteria for VEU authorizations, as set out in 15 CFR 748.15(a)(2). Additionally, just as license applications are reviewed through an interagency review process, the authorizations granted under the VEU program involve interagency deliberation and result from review of public and non-public sources, including licensing data, and the measurement of such information against the VEU authorization criteria. Given the nature of the review, and in light of the parallels between the VEU application review process and the review of license applications, public comment on this authorization and subsequent amendments prior to publication is unnecessary. Moreover, because, as noted above, the criteria and process for authorizing and administering VEUs were developed with public comments, allowing additional public comment on this amendment to individual VEU authorizations, which was determined according to those criteria, is unnecessary.
Section 553(d) of the APA generally provides that rules may not take effect earlier than thirty (30) days after they are published in the
No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required under the APA or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Accordingly, part 748 of the EAR (15 CFR parts 730–774) is amended as follows:
50 U.S.C. 4601
Securities and Exchange Commission.
Final interpretation.
The Securities and Exchange Commission is issuing a final interpretation with respect to the definition of automated quotation under Rule 600(b)(3) of Regulation NMS.
Effective June 23, 2016.
Richard Holley III, Assistant Director, Michael Bradley, Special Counsel, or Michael Ogershok, Attorney-Adviser, Office of Market Supervision, at 202–551–5777, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–7010.
Rule 611 of Regulation NMS provides intermarket protection against trade-throughs for “automated” (as opposed to “manual”) quotations of NMS stocks. Under Regulation NMS, an “automated” quotation is one that, among other things, can be executed “immediately and automatically” against an incoming immediate-or-cancel order. The Regulation NMS Adopting Release issued in 2005 makes clear that this formulation was intended to distinguish and exclude from protection quotations on manual markets that produced delays measured in seconds in responding to an incoming order, because delays of that magnitude would impair fair and efficient access to an
In light of the application of Investors' Exchange LLC (“IEX”)
In general, Rule 611 under Regulation NMS (the “Order Protection Rule,” or “Trade-Through Rule”) protects the best “automated” quotations of exchanges by obligating other trading centers to honor those “protected” quotations by not executing trades at inferior prices, or “trading through” such best automated quotations.
There are several provisions in Regulation NMS that impact whether the Order Protection Rule applies. First, Rule 600(b)(58) defines a “protected quotation” as a “protected bid or a protected offer.”
In order for an exchange to operate as an “automated trading center,” it must, among other things, have “implemented such systems, procedures, and rules as are necessary to render it capable of displaying quotations that meet the requirements for an `automated quotation' set forth in [Rule 600(b)(3) of Regulation NMS].”
i. Permits an incoming order to be marked as immediate-or-cancel;
ii. Immediately and automatically executes an order marked as immediate-or-cancel against the displayed quotation up to its full size;
iii. Immediately and automatically cancels any unexecuted portion of an order marked as immediate-or-cancel without routing the order elsewhere;
iv. Immediately and automatically transmits a response to the sender of an order marked as immediate-or-cancel indicating the action taken with respect to such order; and
v. Immediately and automatically displays information that updates the displayed quotation to reflect any change to its material terms.
Any quotation that does not meet the requirements for an automated quotation is defined in Rule 600(b)(37) as a “manual” quotation.
In adopting Regulation NMS, the Commission recognized that there would be unintentional time delays by automated trading centers in responding to orders, albeit very short ones.
The only precise time standards approved by the Commission in Rule 611 and the Regulation NMS Adopting Release arise in the context of two exceptions to Rule 611 covering circumstances in which trade-through protection would not apply. These exceptions illustrate the time dimensions the Commission had in mind in distinguishing quotations that should receive trade-through protection from those that should not, and notably, both use a one-second standard.
The Commission proposed to interpret “immediate” when determining whether a trading center maintains an “automated quotation” for purposes of Rule 611 “to include response time delays at trading centers that are
The Commission received 24 comments
Several commenters questioned whether
Other commenters expressed concern that intentional access delays, even
In response to a comment that the dictionary definition of the term “immediate[ ]” precludes
The Commission notes that, when it adopted Regulation NMS in 2005, processing times were longer than they are now.
In response to commenters that argued that an intentional
In response to commenters' concern that an intentional delay is not
Systems processing and transit times, whether at the exchange, the market participant sending the order, or its agent, all create latencies in accessing protected quotations.
The Commission acknowledges that interpreting “immediate” to include an intentional
Further, the Commission notes that its interpretation uses a
Several commenters that expressed general concerns with an intentional access delay, even a
The Commission notes that this interpretation does not address whether any particular access delay is unfairly discriminatory, an inappropriate or unnecessary burden on competition, or otherwise inconsistent with the Act. Rather, it clarifies that if an intentional access delay is
Specifically, this interpretation does not obviate the requirement of individualized review of proposed access delays, including
A few commenters asked the Commission to provide more detail on the application of the proposed interpretation.
The interpretation of “immediate” applies to the term as used in Rule 600(b)(3), so that it applies to any intentional delay imposed by an exchange through any means provided by the exchange to access its quotations. Further, as modified here from the proposed interpretation, the interpretation applies only to intentional delays, as unintentional delays are addressed by the existing exception contained in Rule 611(b)(1).
One commenter recommended that the Commission engage in notice and comment rulemaking to effect “a change of this magnitude,” which it argued contradicts the “plain meaning of the term `immediate.' ”
Other commenters focused on what they viewed as a potential opportunity for manipulative activity that could result from an access delay to a market displaying a protected quotation. One commenter opined that an access delay would make it easier to manipulate markets “by taking advantage of stale and inaccessible quotations displayed during the duration of any access delays,” and that such manipulative behavior “could be particularly powerful in relatively illiquid stocks.”
The Commission notes that the scenarios discussed by commenters are not related to the issue addressed by this interpretation—whether an intentional delay that is so short as not
In response to technological and market developments since the adoption of Regulation NMS,
Solely in the context of determining whether a trading center maintains an “automated quotation” for purposes of Rule 611 of Regulation NMS, the Commission does not interpret the term “immediate” used in Rule 600(b)(3) by itself to prohibit a trading center from implementing an intentional access delay that is
The Commission's updated interpretation recognizes that a
The interpretation does not change the existing requirement that, prior to being implemented, an intentional delay of any duration must be fully disclosed and codified in a written rule of the exchange that has become effective pursuant to Section 19 of the Act, where the exchange met its burden of articulating how the purpose, operation, and application of the delay is consistent with the Act and the rules and regulations thereunder applicable to the exchange.
In the Notice of Proposed Interpretation, the Commission stated its preliminary belief “that, in the current market, delays of less than a millisecond in quotation response times may be at a
At this time, the Commission is not adopting the proposed guidance under this interpretation that delays of less than one millisecond are
The Staff will also conduct a study within two years regarding the effects of intentional access delays on market quality, including price discovery and report back to the Commission with the results of any recommendations. Based on the results of that study or earlier as it determines, the Commission will reassess whether further action is appropriate.
Securities.
For the reasons set out in the preamble, the Commission is amending Title 17, chapter II, of the Code of Federal Regulations as follows:
Part 241 is amended by adding Release No. 34–78102 to the list of interpretative releases as follows:
By the Commission.
Federal Energy Regulatory Commission, DOE.
Final rule.
The Federal Energy Regulatory Commission (Commission) is eliminating the exemptions for wind generators from the requirement to provide reactive power by revising the
This Final Rule will become effective September 21, 2016.
Brian Bak (Technical Information), Office of Energy Policy and Innovation, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502–6574,
Gretchen Kershaw (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502–8213,
1. The Federal Energy Regulatory Commission (Commission) is eliminating the exemptions for wind generators from the requirement to provide reactive power by revising the
2. Section 35.28(f)(1) of the Commission's regulations requires every public utility with an open access transmission tariff (OATT) on file to also have on file the
3. The existing
4. As discussed below, however, wind generators have been exempt from the general requirement to provide reactive power absent a study finding that the provision of reactive power is necessary to ensure safety or reliability. The Commission exempted wind generators from the uniform reactive power requirement because, historically, the costs to design and build a wind generator that could provide reactive power were high and could have created an obstacle to the development of wind generation.
5. Given these changes, the Commission finds under section 206 of the Federal Power Act (FPA)
6. Transmission providers require reactive power to control system voltage for efficient and reliable operation of an alternating current transmission system. At times, transmission providers need generators to either supply or consume reactive power. Starting with Order No. 888,
7. Starting with Order No. 2003, the Commission adopted standard procedures and a standard agreement for the interconnection of Large Generating Facilities (the
8. In June 2005, the Commission issued Order No. 661,
9. In May 2005, the Commission issued Order No. 2006,
10. Since the Commission provided these exemptions from the reactive power requirement for wind generators, the equipment needed for a wind generator to provide reactive power has become more commercially available and less costly, such that the cost of installing equipment that is capable of providing reactive power is comparable
11. Based upon this information, on November 19, 2015, the Commission issued a Proposal to Revise Standard Generator Interconnection Agreements (NOPR) that proposed to eliminate the exemptions for wind generators from the requirement to provide reactive power as contained in the
12. In response to the NOPR, 24 entities submitted comments,
13. The Commission finds that, given the changes to the cost of providing reactive power by non-synchronous generators, as well as the growing penetration of such generators, the reactive power requirements in the
14. The requirements adopted by this Final Rule are intended to ensure that all generators, both synchronous and non-synchronous, are treated in a not unduly discriminatory or preferential manner, as required by sections 205 and 206 of the FPA, and to ensure sufficient reactive power is available on the bulk power system as more non-synchronous generators seek to interconnect and more synchronous generators retire.
15. We discuss below the issues raised in the comments.
16. In the NOPR, the Commission proposed to eliminate the exemptions for wind generators from the reactive power requirement, and thereby to require that all newly interconnecting non-synchronous generators provide reactive power as a condition of interconnection.
17. Most commenters agree that the current exemptions for wind generators from the reactive power requirement are unjust, unreasonable, and unduly discriminatory and preferential due to increases in the number and size of non-synchronous generators, and advances in non-synchronous generator technology.
18. Commenters argue that it is more effective to have a standard reactive power requirement for wind generators than requiring transmission providers to show through a System Impact Study the need for reactive power from an interconnecting wind generator on a case-by-case basis because a System Impact Study may not reflect the future needs of the transmission system.
19. Commenters argue that relying on transmission system upgrades after a wind generator interconnects, or relying on more recently interconnected generation resources, to meet reactive power deficiencies may shift the cost of providing reactive power from one interconnection customer to another. Specifically, if a System Impact Study does not show that an earlier interconnecting wind generator needs to provide reactive power, but, as a result of the combination of existing and new wind generators, a System Impact Study for a later interconnecting wind generator does make that showing, the newer interconnecting wind generator would have the entire burden of supplying reactive power instead of sharing equally with the other wind generators creating the need for reactive power.
20. Several independent system operators (ISOs) and regional transmission organizations (RTOs) have been developing new reactive power requirements and procedures to address deficiencies in the current method of requiring transmission providers to show through a System Impact Study that reactive power from an interconnecting wind generator is necessary to ensure safety or reliability.
21. Based on the comments filed in response to the NOPR, and the record in the PJM and ISO–NE proceedings accepting PJM's and ISO–NE's reactive power requirements for non-synchronous generators,
22. Non-synchronous generators other than wind generators currently are not exempt from the reactive power requirement in the
23. Older wind turbine generators consumed reactive power, but, because they did not use inverters like other non-synchronous generators, they lacked the capability to produce and control reactive power without the use of costly equipment.
24. We therefore conclude that improvements in technology, and the corresponding declining costs for newly interconnecting wind generators to provide reactive power, make it unjust, unreasonable, and unduly discriminatory and preferential to exempt such non-synchronous generators from the reactive power requirement when other types of generators are not exempt. Further, requiring all newly interconnecting non-synchronous generators to design their Generating Facilities to maintain the required power factor range ensures they are subject to comparable requirements as other generators.
25. The Commission also is concerned that, as the penetration of non-synchronous generators continues to grow, exempting a class of generators from providing reactive power could create reliability concerns, especially if those generators represent a substantial amount of total generation in a particular region, or if many of the resources that currently provide reactive power are retired from operation. In addition, as noted above, maintaining the exemptions for wind generators places an undue burden on synchronous generators to supply reactive power without a reasonable technological or cost-based distinction between synchronous and non-synchronous generators.
26. The Commission proposed in the NOPR as part of the reactive power requirements for non-synchronous generators to require all newly interconnecting non-synchronous generators to design their Generating Facilities to maintain a composite power delivery at continuous rated power output at the Point of Interconnection at a power factor within the range of 0.95 leading to 0.95 lagging.
27. Several commenters support the Commission's proposal to measure the reactive power requirement at the Point of Interconnection.
28. On the other hand, some commenters disagree with the NOPR proposal and argue that the reactive power requirement should be measured at the generator terminals rather than at the Point of Interconnection for non-synchronous generators. They assert that measuring at the Point of Interconnection would result in significantly higher costs for non-synchronous generators than measuring at the generator terminals. They also argue that, because of the often significant distance between non-synchronous generator terminals and the Point of Interconnection, measuring the reactive power requirement for non-synchronous generators at the generator terminals would result in a reactive power requirement that is comparable to measuring at the Point of Interconnection for synchronous generators.
29. Some commenters argue that, due to the configuration of typical non-synchronous generators, additional investment is required to supplement the inherent dynamic reactive power capability of the generators to meet the reactive power requirement at the Point of Interconnection; therefore, they assert that requiring measurement at the Point of Interconnection would reset the costs for non-synchronous generators to a level higher than that which the Commission considered in approving PJM's independent entity variation.
30. While CAISO allows synchronous generators to provide reactive power at the generator terminals, CAISO does not support providing this option to non-synchronous generators. CAISO argues that measuring the reactive power requirement at the generator terminals is inappropriate for non-synchronous generators because non-synchronous generators often use multiple transformers, collection circuits, and substations to transmit real power across lengthy Interconnection Customer Interconnection Facilities from the generator terminal to the Point of Interconnection, reducing the amount of reactive power that reaches the transmission system. In contrast, CAISO explains that the configuration of synchronous generators typically involves a single transformer and short Interconnection Customer Interconnection Facilities from the generator terminal to the Point of Interconnection, making measuring the reactive power requirement at the generator terminals for synchronous generators appropriate for ensuring that sufficient reactive power is provided to the transmission system.
31. As to the Commission's proposal to require fully dynamic reactive power capability, commenters in support argue that requiring dynamic reactive power capability allows generators to operate across a broader range of operating conditions than allowing static reactive power devices.
32. Conversely, other commenters disagree with the proposal to require fully dynamic reactive power capability. SDG&E contends that such a requirement is not necessary and that allowing non-synchronous generators to use static reactive power devices to meet the reactive power requirement will provide flexibility to generator developers and keep costs at a reasonable level.
33. NextEra argues that if the proposed reactive power requirement is
34. We will require the reactive power requirements in the
35. Non-synchronous generators may meet the dynamic reactive power requirement by utilizing a combination of the inherent dynamic reactive power capability of the inverter, dynamic reactive power devices (
36. Although the Commission in the NOPR considered measuring the reactive power requirements for non-synchronous generators at the Point of Interconnection, we are persuaded by commenters' arguments that requiring fully dynamic reactive power capability at the Point of Interconnection may result in significantly increased costs for non-synchronous generators in meeting the reactive power requirements.
37. In adopting the Point of Interconnection as the point of measurement for large wind plants in Order No. 661, the Commission balanced the case-by-case reactive power requirement with the needs of the transmission system.
38. Similarly, in Order No. 661, the Commission was not convinced that dynamic reactive power capability was needed from every wind generator, and so adopted the case-by-case approach.
39. While measuring the reactive power requirements at the Point of Interconnection would provide the greatest amount of reactive power to the transmission system, the costs associated with providing that level of reactive power do not justify the added benefit to the transmission system.
40. We find establishing dynamic reactive power requirements at the high-side of the generator substation preferable to the suggestion in the comments that, at relative equal cost, reactive power could be provided at the Point of Interconnection as long as the inherent dynamic reactive power produced by the generator can be enhanced with static reactive power capability. By establishing dynamic reactive power requirements at the high-side of the generator substation, non-synchronous generators will be able to provide faster responding and more continuously variable reactive power capability than if they provide static reactive power capability at the Point of Interconnection. In addition, requiring dynamic reactive power capability allows generators to operate across a broader range of operating conditions than allowing static reactive power enhancements.
41. The NOPR proposed to require newly interconnecting non-synchronous generators to design their Generating Facilities to maintain the required power factor range only when the generator's real power output exceeds 10 percent of its nameplate capacity.
42. Several commenters support the 10 percent exemption given current inverter technology.
43. AWEA and LSA and the Joint NYTOs argue that the 10 percent exemption should be increased to 25 percent, consistent with what the Commission approved in PJM.
44. Other commenters oppose the 10 percent exemption, arguing that it is not necessary given the technology available to non-synchronous generators.
45. MISO requests that non-synchronous generators be required to produce reactive power at low and zero-voltage conditions to ensure the robustness of the transmission system.
46. AWEA and LSA request clarification regarding the proposal in the NOPR that non-synchronous generators be required to maintain a “composite power delivery at continuous rated power output at the Point of Interconnection at a power
47. We will not adopt the 10 percent exemption proposed in the NOPR in this Final Rule and will instead require all newly interconnecting non-synchronous generators to design their Generating Facilities to meet the reactive power requirements at all levels of real power output, as is already required of synchronous generators.
48. While some commenters argue that technical limitations exist that prevent non-synchronous generators from providing adequate reactive power at lower levels of real power output, and note that the Commission approved a 25 percent exemption in PJM, several commenters indicate that non-synchronous generators
49. As for AWEA and LSA's and NERC's requested clarifications, we clarify that the amount of reactive power required from non-synchronous generators should be proportionate to the actual output of the generator, such that a 100 MW generator would be required to provide approximately 33 MVAR of reactive power when operating at maximum output (100 MW), and approximately 3.3 MVAR when operating at 10 MW, and so on. This addresses some commenters' concerns that sometimes not all non-synchronous generators at a particular location are operating at a given time (
50. The Commission stated in the NOPR that non-synchronous generators are eligible for the same payments for reactive power as all other generators, consistent with the compensation provisions of the
51. Several commenters support the Commission's proposal to require transmission providers to compensate non-synchronous generators for reactive power on a comparable basis as synchronous generators, provided that non-synchronous generators provide comparable reactive power service.
52. We will not change the Commission's existing policies on compensation for reactive power. Sections 9.6.3 and 11.6 of the currently-effective
53. As a transition mechanism, the Commission proposed in the NOPR to apply the reactive power requirements in this Final Rule to all newly interconnecting non-synchronous generators that, as of the effective date of this Final Rule, either: (1) Have not executed an interconnection agreement; or (2) requested that an interconnection agreement be filed unexecuted that is still pending before the Commission. The Commission also proposed to apply the reactive power requirements to all existing non-synchronous generators making upgrades that require new interconnection requests after the effective date of the Final Rule. The Commission stated that it did not believe it would be reasonable or necessary to require all existing wind generators to provide reactive power because not all such generators are capable of providing reactive power without incurring substantial costs to install new equipment. However, the Commission proposed to require existing wind generators that make upgrades that require new interconnection requests to conform to the new reactive power requirements.
54. CAISO and MISO support the Commission's proposed application of the new reactive power requirements to new and existing non-synchronous generators.
55. In contrast, some commenters argue that the Commission should not apply the new reactive power requirements to generators that have begun or have already received their System Impact Study, depending on the requirements of the Final Rule.
56. NextEra argues that the proposed application of the Final Rule to non-synchronous generators that have not yet executed an interconnection agreement is unreasonable if the Commission requires fully dynamic reactive power capability measured at the Point of Interconnection.
57. Some commenters also oppose the Commission's proposal to apply the reactive power requirements to existing non-synchronous generators making upgrades that require new interconnection requests.
58. SDG&E requests that the Commission clarify that the proposed
59. We will apply the requirements of this Final Rule to all newly interconnecting non-synchronous generators that have not yet executed a Facilities Study Agreement
60. While the Commission proposed in the NOPR to apply the requirements of the Final Rule to all newly interconnecting non-synchronous generators that have not yet executed an interconnection agreement as of the effective date of the Final Rule, or requested that one be filed unexecuted that is still pending, we agree with AWEA and LSA, and NextEra,
61. To avoid these undue burdens, we will apply the requirements of this Final Rule to all newly interconnecting non-synchronous generators that have not yet executed a Facilities Study Agreement as of the effective date of this Final Rule. Pursuant to the
62. In addition, using the execution of a Facilities Study Agreement as the point in the interconnection process for transitioning to the requirements of this Final Rule represents a clearly defined point to avoid confusion in applicability. To further ensure clarity for newly interconnecting non-synchronous generators, we include in the revisions to section 9.6.1 to the
63. We also amend Appendix G to the
64. Some commenters raise concerns with applying the requirements of this Final Rule to existing non-synchronous generators making upgrades that require new interconnection requests.
65. We recognize that there are a variety of triggering points for a new interconnection request in the various transmission provider regions, and the fact that an existing non-synchronous generator making an upgrade may not be installing new equipment. We also acknowledge, as the Commission did in the NOPR, that not all existing wind generators are capable of providing reactive power without incurring substantial costs to install new equipment.
66. We decline AWEA and LSA's request that the reactive power requirement apply only to the incremental capacity that results from an upgrade in the event the System Impact Study shows the need for reactive power.
67. We require transmission providers to propose, as part of their compliance with this Final Rule, tariff revisions implementing the transition mechanism laid out above for existing non-synchronous generators making upgrades to their Generating Facilities that require new interconnection requests.
68. Multiple commenters request that the Commission recognize independent entity variations for ISOs/RTOs and regional differences for transmission providers outside of ISOs/RTOs in evaluating compliance with the Final Rule.
69. We apply here all three of the methods for proposing variations adopted in Order No. 2003: (1) Variations based on Regional Entity reliability requirements; (2) variations that are “consistent with or superior to” the Final Rule; and (3) “independent
70. CAISO argues that the Commission should allow transmission providers to propose additional technical requirements for interconnecting non-synchronous generators related to voltage support, such as requiring automatic voltage control.
71. MATL requests clarification that the Commission will continue to accept tariff arrangements that require customers on merchant transmission lines to self-supply ancillary services. MATL specifically requests that this clarification be included in the final rule compliance obligation, and in similar future proceedings.
72. SCE requests that the Commission expand the scope of the rulemaking proceeding to include low voltage ride-through requirements for synchronous and non-synchronous Generating Facilities smaller than 20 MW.
73. AWEA and LSA request that the Commission limit the reactive power requirements to a specific range of voltage at the Point of Interconnection.
74. Section 35.28(f)(1) of the Commission's regulations requires every public utility with a non-discriminatory OATT on file to also have on file the
9.6.1 Power Factor Design Criteria
The Commission similarly revises section 1.8.1 of the
1.8.1
In addition, the Commission revises paragraph A.ii of Appendix G to the
75. As in Order Nos. 2003
76. In some cases, public utility transmission providers may have provisions in the currently effective LGIAs and SGIAs in their OATTs related to the provision of reactive power by non-synchronous generators that the Commission has deemed to be consistent with or superior to the
77. In addition, some ISOs/RTOs may have provisions in the currently effective LGIAs and SGIAs in their OATTs related to the provision of reactive power by non-synchronous generators that the Commission has accepted as an independent entity variation to the
78. The following collection of information contained in this Final Rule is subject to review by the Office of Management and Budget (OMB) regulations under section 3507(d) of the Paperwork Reduction Act of 1995.
79. The reforms adopted in this Final Rule revise the Commission's
80. While the Commission expects the revisions adopted in this Final Rule will provide significant benefits, the Commission understands that implementation can be a complex and costly endeavor. The Commission solicited comments on the accuracy of provided burden and cost estimates and any suggested methods for minimizing the respondents' burdens. The Commission did not receive any comments concerning its burden or cost estimates. Therefore, the Commission retains the estimates proposed in the NOPR, with minor changes to reflect updated estimates.
• Year 1: $135,000 ($1,080/utility).
• Year 2: $0.
After implementation in Year 1, the revisions adopted in this Final Rule would be complete.
81. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director], email:
82. Comments on the collection of information and the associated burden estimates in this Final Rule should be sent to the Commission in this docket and may also be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission], at the following email address:
83. The Regulatory Flexibility Act of 1980 (RFA)
84. The Small Business Administration (SBA) revised its size standards (effective January 22, 2014) for electric utilities from a standard based on megawatt hours to a standard based on the number of employees, including affiliates. Under SBA's standards, some transmission owners will fall under the following category and associated size threshold: Electric bulk power transmission and control, at 500 employees.
85. The Commission estimates that the total number of public utility transmission providers that would have to modify the LGIAs and SGIAs within their currently effective OATTs is 132. Of these, the Commission estimates that approximately 43 percent are small entities (approximately 57 entities). The Commission estimates the average total cost to each of these entities will be minimal, requiring on average 15 hours or $1,080. According to SBA guidance, the determination of significance of impact “should be seen as relative to the size of the business, the size of the competitor's business, and the impact the regulation has on larger competitors.”
86. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
87. In addition to publishing the full text of this document in the
88. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number of this document, excluding the last three digits, in the docket number field.
89. User assistance is available for eLibrary and the Commission's Web site during normal business hours from the Commission's Online Support at (202) 502–6652 (toll free at 1–866–208–3676) or email at
90. The Final Rule is effective September 21, 2016. However, as noted above, the requirements of this Final Rule will apply only to newly interconnecting non-synchronous generators that have not yet executed a Facilities Study Agreement. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this Final Rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996. This Final Rule is being submitted to the Senate, House, Government Accountability Office, and Small Business Administration.
Electric power rates, Electric utilities, Non-discriminatory open access transmission tariffs.
By the Commission.
The following appendix will not appear in the Code of Federal Regulations.
Internal Revenue Service (IRS), Treasury.
Final and temporary regulations; correction.
This document contains corrections to final and temporary regulations (TD 9761) that were published in the
This correction is effective on June 23, 2016 and applicable on April 8, 2016.
Rose E. Jenkins at (202) 317–6934 (not a toll free number).
The final and temporary regulations (TD 9761) that are the subject of this correction are under sections 304, 367, 956, 7701(l), and 7874 of the Internal Revenue Code.
As published, the final and temporary regulations (TD 9761) contain errors that may prove to be misleading and are in need of clarification.
Accordingly, the final and temporary regulations (TD 9761), that are the subject of FR Doc. 2016–07300, are corrected as follows:
1. On page 20858, in the preamble, the second column, the ninth line from the bottom of the column, the language “section 7874 and § 1.367(a)–3(c) and” is corrected to read “section 7874 and”.
2. On page 20860, in the preamble, the third column, under the paragraph heading “
3. On page 20862, in the preamble, the third column, under the paragraph heading “a. § 1.7874–4T, In General” the fifth and sixth lines, the language “entity acquisition described in section 7874(a)(2)(B)(i) is excluded from the” is corrected to read “entity acquisition is excluded from the”.
4. On page 20869, in the preamble, the first column, the twenty-fifth line from the bottom of the column, the language “60% or 80% on the completion date.” is corrected to read “60 or 80 on the completion date.”.
5. On page 20871, in the preamble, the second column, the third and tenth lines from the top of the first full paragraph, the language “domestic” is removed.
6. On page 20873, in the preamble, the third column, under the paragraph heading “
7. On page 20874, in the preamble, the third column, the twenty-second line from the top of the column, the language “completion date, is treated as an” is corrected to read “completion date is treated as an”.
8. On page 20877, in the preamble, the first column, under the paragraph heading “ii. Exceptions From Recharacterization” the twelfth line of the first full paragraph, the language “recognized. See Section 2.C of this Part” is corrected to read “recognized. See Section 2.c of this Part”.
9. On page 20880, in the preamble, the first column, under the paragraph heading “b. Regulations Implementing the Section 367(b) Asset Dilution Rule” the third line from the bottom of the column, the language “property to a foreign transferee” is corrected to read “property to a transferee foreign”.
Internal Revenue Service (IRS), Treasury.
Final and temporary regulations; correcting amendment.
This document contains corrections to final and temporary regulations (TD 9761) that were published in the
This correction is effective on June 23, 2016 and applicable on April 8, 2016.
Rose E. Jenkins at (202) 317–6934 (not a toll free number).
The final and temporary regulations (TD 9761) that are the subject of this correction are under sections 304, 367, 956, 7701(l), and 7874 of the Internal Revenue Code.
As published, the final and temporary regulations (TD 9761) contain errors that may prove to be misleading and are in need of clarification.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *
(f)
(k)
(a) * * *
(4) * * *
(iii) * * *
(A)
(B) * * * Because LFS was a controlled foreign corporation and a member of the EAG with respect to the inversion transaction on the completion date, and DT was not a United States shareholder with respect to LFS on or before the completion date, LFS is excluded from the definition of expatriated foreign subsidiary pursuant to § 1.7874–12T(a)(9)(ii). * * *
* * *
(B) * * * Because LFSS was not a member of the EAG with respect to the inversion transaction on the completion date, LFSS is not excluded from the definition of expatriated foreign subsidiary pursuant to § 1.7874–12T(a)(9)(ii). * * *
(a) * * * See § 1.367(b)–4T(e) and (f) for rules concerning certain other exchanges after an inversion transaction. * * *
(g) * * *
* * *
(ii) * * *
(B) * * * Although FA (a non-CFC foreign related person) indirectly owns $4x of FT stock both immediately before and after the specified transaction and any related transaction, all of that stock is directly owned by DT (a domestic corporation), and as a result, under paragraph (f)(4) of this section, none of that stock is treated as directly or indirectly owned by FP for purposes of calculating the pre-transaction ownership percentage and the post-transaction ownership percentage with respect to FT. * * *
* * *
(ii) * * * However, after the April 30, 2016 transfer, because FS ceases to be a foreign related person, it ceases to be a specified related person. * * *
(i)
(c) * * *
(4) * * *
(iii)
(m)
(g)
(f) * * *
(3) A
(i)
(g) * * *
* * *
(ii)
(i)
(h) * * *
* * *
(ii) * * * As a result, and because there were no redemptions of FA stock, the excluded amount is $150x (calculated as 100, the total number of prior acquisition shares, multiplied by $1.50x, the fair market value of a single share of FA stock on the completion date with respect to the DT2 acquisition). * * *
* * *
(ii) * * * As a result, the excluded amount is $112.50x, calculated as 75 (100, the total number of prior acquisition shares, less 25, the allocable redeemed shares) multiplied by $1.50x (the fair market value of a single share of FA stock on the completion date with respect to the DT2 acquisition). * * *
* * *
(ii) * * * Accordingly, the excluded amount is $112.50x, calculated as 150 (200, the total number of prior acquisition shares, less 50, the allocable redeemed shares) multiplied by $0.75x (the fair market value of a single class of FA stock on the completion date with respect to the DT2 acquisition). * * *
(j)
(e) * * *
(1)
(f) * * *
* * *
(ii) * * *
(A) The FT acquisition is a foreign acquisition because, pursuant to the FT acquisition, FA (a foreign acquiring corporation) acquires 100 percent of the stock of FT and is thus treated as indirectly acquiring 100 percent of the properties held by FT (an acquired foreign corporation). * * *
(iv) * * * FA's indirect acquisition of FT's properties is a covered foreign acquisition because 35 shares of FA stock (the shares received by Individual B) are held by reason of holding stock in FT; thus, the foreign ownership percentage is 100 percent (35/35). * * *
(h)
(d) * * *
(2) On the completion date, former domestic entity shareholders or former domestic entity partners, as applicable, in the aggregate, own (applying the attribution rules of section 318(a) with the modifications described in section 304(c)(3)(B)) less than five percent (by vote and value) of the stock of (or a partnership interest in) each member of the expanded affiliated group.
(j)
(b) * * * (1)
(2)
(g)
(c)
Bureau of Safety and Environmental Enforcement (BSEE), Interior.
Final rule; correction.
The Bureau of Safety and Environmental Enforcement (BSEE) is correcting a final rule that appeared in the
Effective July 28, 2016.
Betty Cox, Regulations and Standards Branch at (703) 787–1665 or email at
In the FR Doc. 2016–12487 appearing on page 36150 in the
1. On page 36150, in the first column, remove amendatory instruction 20 correcting § 250.904.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Morrison Bridge across the Willamette River, mile 12.8, at Portland, Oregon. The deviation is necessary to accommodate Multnomah County's replacement of the bridge decking. This deviation allows the bridge to only open half of the span, single leaf, to allow for the replacement of bridge decking. The deviation also allows the vertical clearance to be reduced due to the project's containment system.
This deviation is effective from 6 a.m. on April 1, 2017 until 7 p.m. on September 27, 2017.
The docket for this deviation, [USCG–2016–0474] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206–220–7282, email
Multnomah County has requested that the Morrison Bridge across the Willamette River, mile 12.8, be allowed to only open half the span, 92 feet, as opposed to a full opening, 185 feet, to accommodate the replacement of the bridge decking. The County has also requested to reduce the vertical clearance of the non-opening side of the span with scaffolding erected 10 feet below the lower bridge cord for a containment system and to require at least a two hour advance notice for an opening. The Morrison Bridge is a double bascule bridge. When the bascule span is in the closed-to-navigation position, the bridge provides 69 feet of vertical clearance, which will be reduced to 59 feet with the containment system in place. The normal operating schedule for the Morrison Bridge is in accordance with 33 CFR 117.897(c)(3)(iv). The vertical clearance is above Columbia River Datum 0.0.
The deviation period is from 6 a.m. on April 1, 2017 until 7 p.m. on September 27, 2017. The deviation allows the Morrison Bridge operator to only open half the span for maritime traffic with at least a two hour advanced notice. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft.
Vessels able to pass through the Morrison Bridge in the closed position may do so at any time. A tug will be on site to assist vessels through the single leaf span opening upon request. The bridge will be able to open half the span for emergencies with a two hour notice and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the San Francisco Giants Fireworks display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).
The regulations in 33 CFR 165.1191, Table 1, Item number 1 will be enforced from 11 a.m. on June 24, 2016 to 1 a.m. on June 25, 2016.
If you have questions on this notice of enforcement, call or email Lieutenant Junior Grade Christina Ramirez, U.S. Coast Guard Sector San Francisco; telephone (415) 399–3585 or email at
The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 1 on June 24, 2016. From 11 a.m. until 10 p.m. on June 24, 2016 the safety zone will be enforced in the navigable waters around and under the fireworks barge within a radius of 100 feet throughout the loading and transit of fireworks barge at the launch site and until the start of the fireworks display. As indicated below, during the fireworks display, the size of the safety zone will increase to accommodate fall-out and other debris during the display.
From 11 a.m. until 5 p.m. on June 24, 2016 the fireworks barge will be loading pyrotechnics at Pier 50 in San Francisco, CA. From 5 p.m. to 9:30 p.m. on June 24, 2016 the fireworks barge will remain at Pier 50. From 9:30 p.m. to 10 p.m. on June 24, 2016 the loaded fireworks barge will transit from Pier 50 to the launch site near Pier 48 in approximate position 37°46′36″ N., 122°22′56″ W. (NAD83). At the conclusion of the baseball game, approximately 10 p.m. on June 24, 2016, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 700 feet in approximate position 37°46′36″ N., 122°22′56″ W. (NAD83) for the San Francisco Giants Fireworks display in 33 CFR 165.1191, Table 1, Item number 1. Upon the conclusion of the fireworks display, the safety zone shall terminate.
Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in
This notice of enforcement is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice of enforcement, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone within the Coast Guard Sector Long Island Sound (LIS) Captain of the Port (COTP) Zone. This temporary final rule is necessary to provide for the safety of life on navigable waters. Entry into, transit through, mooring, or anchoring within the safety zone is prohibited unless authorized by COTP Sector LIS.
This rule is effective without actual notice from 12:01 a.m. on June 23, 2016 until 12:01 a.m. on July 1, 2016. For the purposes of enforcement, actual notice will be used from January 1, 2016, until June 23, 2016.
Documents mentioned in this preamble are part of docket [USCG–2015–1123]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, contact Lieutenant Junior Grade Martin Betts, Prevention Department, Coast Guard Sector Long Island Sound, telephone (203) 468–4432, email
This rulemaking establishes a safety zone for the waters around Pleasure Beach Bridge, Bridgeport, CT. Corresponding regulatory history is discussed below.
The Coast Guard was made aware on December 9, 2015, of damage sustained to Pleasure Beach Bridge, the result of which created a hazard to navigation. In response, on Tuesday, December 22, 2015, the Coast Guard published a temporary final rule (TFR) entitled, “Safety Zone; Pleasure Beach Bridge, Bridgeport CT” in the
The degraded condition of the Pleasure Beach Bridge structure presents a continued hazard to navigation in the waterway. The Coast Guard is establishing this temporary final rule to mitigate the risk posed by the bridge structure and to allow responsible parties ample time to develop plans to reduce or eliminate the hazard.
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. There is insufficient time to publish an NPRM and solicit comments from the public before establishing a safety zone to address the existing hazard to navigation. The nature of the navigational hazard requires the immediate establishment of a safety zone. Publishing an NPRM and delaying the effective date of this rule to await public comment inhibits the Coast Guard's ability to fulfill its statutory mission to protect ports, waterways and the maritime public.
Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis for this temporary rule is 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5 and Department of Homeland Security Delegation No. 0170. 1 which collectively authorize the Coast Guard to define regulatory safety zones.
On December 9, 2015, the Coast Guard was made aware of damage sustained to Pleasure Beach Bridge, Bridgeport, CT that has created a hazard to navigation. After further analysis of the bridge structure, the Coast Guard concluded that the overall condition of the structure created a continued hazard to navigation. The COTP Sector LIS has determined that the safety zone established by this temporary final rule is necessary to provide for the safety of life on navigable waterways.
The safety zone established by this rule will cover all navigable waters of the entrance channel to Johnsons Creek in the vicinity of Pleasure Beach Bridge, Bridgeport, CT. This safety zone will be bound inside an area that starts at a point on land at position 41–10.2N, 073–10.7W and then east along the shoreline to a point on land at position 41–9.57N, 073–9.54W and then south across the channel to a point on land at position 41–9.52N, 073–9.58W and then west along the shoreline to a point on land at position 41–9.52N, 073–10.5W and then north across the channel back to the point of origin.
This rule prevents vessels from entering, transiting, mooring, or anchoring within the area specifically designated as a safety zone during the
The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the
We developed this rule after considering numerous statutes and E.O.s related to rulemaking.
Below we summarize our analyses based on these statutes and E.O.s and we discuss First Amendment rights of protesters.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) The enforcement of this safety zone will be relatively short in duration; (2) persons or vessels desiring to enter the safety zone may do so with permission from the COTP Sector LIS or a designated representative; (3) this safety zone is designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterway not designated as a safety zone; and (4) the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners to increase public awareness of this safety zone.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601–612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This temporary final rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit, anchor, or moor within a safety zone during the period of enforcement, from January 1, 2016 to July 1, 2016. However, this temporary final rule will not have a significant economic impact on a substantial number of small entities for the same reasons discussed in the Regulatory Planning and Review section.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M 16475.ID, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves the establishment of a safety zone. It is categorically excluded from further review under paragraph 34(g) of Figure 2–1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination, and EA Checklist, WILL BE in the docket for review. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) In accordance with the general regulations in § 165.23, entry into or movement within this zone is prohibited unless authorized by the Captain of the Port, Long Island Sound.
(3) Operators of vessels desiring to enter or operate within the safety zone should contact the COTP Sector Long Island Sound at 203–468–4401 (Sector LIS command center) or the designated representative via VHF channel 16 to obtain permission to do so.
(4) Any vessel given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.
(5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.
This document was received for publication by the Office of Federal Register on June 20, 2016.
Environmental Protection Agency (EPA).
Final rule.
On January 19, 2016, the State of Tennessee, through the Tennessee Department of Environment and Conservation (TDEC), Air Pollution Control Division, submitted a request for the Environmental Protection Agency (EPA) to redesignate the portion of Tennessee that is within the Memphis, Tennessee-Mississippi-Arkansas (Memphis, TN-MS-AR) 2008 8-hour ozone nonattainment area (hereafter referred to as the “Memphis, TN-MS-AR Area” or “Area”) and a related State Implementation Plan (SIP) revision containing a maintenance plan and base year inventory for the Area. EPA is taking the following separate final actions related to the January 19, 2016, redesignation request and SIP revision: Approving the base year emissions inventory for the Area into the SIP; determining that the Memphis, TN-MS-AR Area is attaining the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS); approving the State's plan for maintaining attainment of the 2008 8-hour ozone NAAQS in the Area, including the motor vehicle emissions budgets (MVEBs) for nitrogen oxides (NO
This rule will be effective July 25, 2016.
EPA has established a docket for this action under Docket Identification No. EPA–R04–OAR–2016–0018. All documents in the docket are listed on the
Jane Spann, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303–8960. Ms. Spann can be reached by phone at (404) 562–9029 or via electronic mail at
On May 21, 2012, EPA designated areas as unclassifiable/attainment or nonattainment for the 2008 8-hour ozone NAAQS that was promulgated on March 27, 2008.
Based on the 2008 8-hour ozone nonattainment designation for the Memphis, TN-MS-AR Area, Tennessee was required to develop a nonattainment SIP revision addressing certain Clean Air Act (CAA or Act) requirements. Specifically, pursuant to CAA section 182(a)(3)(B) and section 182(a)(1), the state was required to submit a SIP revision addressing emissions statements and base year emissions inventory requirements, respectively, for its portion of the Area. EPA approved the emissions statements requirements for the Tennessee portion of the Area into the SIP in a final action published on March 5, 2015.
On January 19, 2016, TDEC requested that EPA redesignate Tennessee's portion of the Memphis, TN-MS-AR Area to attainment for the 2008 8-hour ozone NAAQS, and submitted a SIP revision containing a section 182(a)(1) base year emissions inventory and the State's plan for maintaining attainment of the 2008 8-hour ozone standard in the Area, including the MVEBs for NO
Approval of Tennessee's redesignation request changes the legal designation of Shelby County in the Memphis, TN-MS-AR Area, found at 40 CFR 81.325, from nonattainment to attainment for the 2008 8-hour ozone NAAQS. Approval of Tennessee's associated SIP revision also incorporates a section 182(a)(1) base year emissions inventory and a plan into the SIP for maintaining the 2008 8-hour ozone NAAQS in the Tennessee portion of the Area through 2027. The maintenance plan establishes NO
EPA is taking a number of final actions regarding Tennessee's January 19, 2016, request to redesignate the Tennessee portion of the Memphis, TN-MS-AR Area to attainment and associated SIP revision. First, EPA is approving and incorporating Tennessee's section 182(a)(1) base year emissions inventory for the Tennessee portion of the Area into the SIP.
Second, EPA is determining that the Memphis, TN-MS-AR Area is attaining the 2008 8-hour ozone NAAQS.
Third, EPA is approving and incorporating the maintenance plan for the Tennessee portion of the Memphis, TN-MS-AR Area, including the NO
Fourth, EPA is determining that Tennessee has met the criteria under CAA section 107(d)(3)(E) for redesignation of the State's portion of the Memphis, TN-MS-AR Area from nonattainment to attainment for the 2008 8-hour ozone NAAQS. On this basis, EPA is approving Tennessee's redesignation request. As mentioned above, approval of the redesignation request changes the official designation of Shelby County, Tennessee for the 2008 8-hour ozone NAAQS from nonattainment to attainment, as found at 40 CFR part 81.
EPA is also notifying the public that EPA finds the newly-established NO
Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section
• Are not significant regulatory actions subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• are 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
• do 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);
• do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• are 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 CAA; and
• will not have disproportionate human health or environmental effects under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 these actions must be filed in the United States Court of Appeals for the appropriate circuit by August 22, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of these actions 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. These actions may not be challenged later in proceedings to enforce their requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental protection, Air pollution control.
40 CFR parts 52 and 81 is amended as follows:
42 U.S.C. 7401
(e) * * *
42 U.S.C. 7401,
Corporation for National and Community Service.
Interim final rule.
The Corporation for National and Community Service (CNCS) is updating its regulations to reflect required inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
You may send your comments electronically through the Federal government's one-stop rulemaking Web site at
Phyllis Green, Executive Assistant, Office of General Counsel, at 202–606–6709 or email to
The Corporation for National and Community Service (CNCS) is a federal agency that engages more than five million Americans in service through its AmeriCorps, Senior Corps, Social Innovation Fund, and Volunteer Generation Fund programs, and leads the President's national call to service initiative, United We Serve. For more information, visit
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114–74) (the “Act”) to improve the effectiveness of civil monetary penalties and to maintain the deterrent effect of such penalties. The Act requires agencies to make a “catch-up” adjustment to the level of civil monetary penalties through an interim final rulemaking and to adjust the civil monetary penalties for inflation annually.
CNCS identified two civil monetary penalties in its regulations and calculated the catch-up adjustments as specified in the February 24, 2016, OMB Memorandum of the Heads of Executive Departments and Agencies, M–16–06,
The inflation adjustment for each applicable civil monetary penalty is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI–U) for the month of October of the year in which the amount of each civil money penalty was most recently established or modified.
CNCS identified two civil penalties in its regulations: (1) The penalty associated with Restrictions on Lobbying (45 CFR 1230.400) and (2) the penalty associated with the Program Fraud Civil Remedies Act (45 CFR 2554.1).
In 1989, Congress established civil monetary penalties related to Restrictions on Lobbying (Section 319, Pub. L. 101–121; 31 U.S.C. 1352) ranging from $10,000 to $100,000. The multiplier for 1989 is 1.89361. Thus, the new range of possible civil monetary penalties is from $18,936 to $189,361.
The Program Fraud Civil Remedies Act of 1986 (Pub. L. 99–509) established a civil monetary penalty with an upper limit of $5,000. The multiplier for 1986 is 2.15628. Thus, the new upper limit of the civil monetary penalty is $10,781.
This final rule adjusts the civil monetary penalty amounts related to Restrictions on Lobbying (45 CFR 1230.400) and the Program Fraud Civil Remedies Act of 1986 (45 CFR 2554.1). The range of civil monetary penalties related to Restrictions on Lobbying increase from $10,000 to $100,000 to $18,936 to $189,361. The civil monetary penalties for the Program Fraud Civil Remedies Act of 1986 increase from up to $5,000 to up to $10,781.
CNCS finds, under 5 U.S.C. 553(b)(3)(B), that there is good cause to except this rule from the public notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. 553(b). Because CNCS is implementing a final rule pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which requires CNCS to update its regulations based on a prescribed formula, CNCS has no discretion in the nature or amount of the change to the civil monetary penalties. Therefore, notice and comment for these proscribed updates is impracticable and unnecessary. As an interim final rule, no further regulatory action is required for the issuance of this legally binding rule. If you would like to provide technical comments, however, they may be submitted until July 25, 2016.
CNCS has determined that making technical changes to the amount of civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.
This rule is effective August 1, 2016. The adjusted civil penalty amounts apply to civil penalties assessed after August 1, 2016 when the violation occurred after November 2, 2015. If the violation occurred prior to November 2, 2015 or a penalty was assessed prior to August 1, 2016, the pre-adjustment civil penalty amounts in effect prior to August 1, 2106 will apply.
Government contracts, Grant programs, Loan programs, Lobbying, Penalties, Reporting and recordkeeping requirements.
Claims, Fraud, Organization and functions (Government agencies), Penalties.
For the reasons discussed in the preamble, under the authority of 42 U.S.C. 12651c(c), the Corporation for National and Community Service amends chapters XII and XXV, title 45 of the Code of Federal Regulations as follows:
Section 319, Pub. L. 101–121 (31 U.S.C. 1352); Pub. L. 93–113; 42 U.S.C. 4951,
Pub. L. 99–509, Secs. 6101–6104, 100 Stat. 1874 (31 U.S.C. 3801–3812); 42 U.S.C. 12651c–12651d.
Federal Communications Commission.
Final rule.
The Federal Communications Commission (Commission) amends its rules to allow and in certain circumstances to require parties to give the Commission notice of lawsuits by email. First, it requires persons petitioning for judicial review who wish to participate in a “judicial lottery” to notify the Commission of the petition by email. This method will allow timely service, and will eliminate security concerns that arise through in-person service. Further, the new rule encourages, but does not require, notice by email for persons who petition for review but do not seek to participate in a lottery. It likewise encourages, but does not require, notice by email for persons who judicially appeal Commission decisions.
Effective July 25, 2016.
Richard Welch, 202–418–7225.
This is a summary of the Commission's
1. By this order, we revise Section 1.13 of our rules to allow and in certain circumstances require parties to give the Commission notice of lawsuits by email. First, we revise 47 CFR 1.13(a)(1) of our rules to change the procedure by which a party petitioning for review of a Commission decision under 47 U.S.C. 402(a) must notify the Commission in order to take advantage of the random selection procedures described in 28 U.S.C. 2112. That statute provides for a lottery to select a court when parties have petitioned for review of the same FCC decision in more than one court, provided that petitioners serve a copy of the petitions for review on the agency within ten days of issuance of the order under review. 28 U.S.C. 2112(a)(1), (3). Because the procedure is time sensitive
2. Until now, those rules have directed petitioners to make that service in person at the Office of General Counsel in the Commission's Washington, DC headquarters. However, that method of service is not easily reconciled with the security protocols that currently apply to other filings with the Commission. We therefore now revise our rules for these situations to require service by email according to specific procedures, as set out in the new rule. These procedures will allow for timely service on the Commission without raising the issues with respect to Commission security requirements that are currently presented by service in person. We also expect that this method of service will be more convenient for most petitioners and their counsel, especially those located outside of the Washington, DC metropolitan area. For parties who are not represented by counsel and who are unable to use email to effect service, we have retained a method to serve notice in person on the Office of General Counsel. Such parties must telephone prior to service to make arrangements, and are advised to do so at least a day before service, keeping in mind the ten-day statutory deadline by which service must be complete.
3. For the convenience of parties and the Commission, we also revise our rules to authorize—but not require—email notice of lawsuits against the Commission under 47 U.S.C. 402(b). Specifically, we revise section 1.13(b) of our rules, which applies to parties appealing certain licensing-related FCC actions under 47 U.S.C. 402(b), to authorize and encourage service of notices of appeal on the General Counsel by email.
4. Finally, we amend the note to section 1.13 to also encourage service by email of petitions for review under 47 U.S.C. 402(a) by petitioners that are not seeking to participate in a judicial lottery pursuant to 28 U.S.C. 2112. Although there is no requirement under the Federal Rules of Appellate Procedure or section 402 for parties to serve the Commission with such petitions for review, service by email will assist the Commission in timely responding to litigation. Where service by email is impracticable for such petitioners, the Commission requests service by non-electronic means.
5. Because this is a revision to a procedural rule, notice and comment is not required in advance of its adoption.
Administrative practice and procedure, Lawyers, Litigation, and Telecommunications.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:
47 U.S.C. 151, 154(i), 154(j), 155, 157, 160, 201, 225, 227, 303, 309, 332, 1403, 1404, 1451, 1452, and 1455.
(a)
(2) If a party wishes to avail itself of procedures established for selection of a court in the case of multiple petitions for review of the same Commission action, pursuant to 28 U.S.C. 2112(a), but is unable to use email to effect service as described in paragraph (a)(1) of this section, it shall instead, within ten days after the issuance of the order on appeal, serve a copy of its petition for review in person on the General Counsel in the Office of General Counsel, 445 12th Street, SW., Washington, DC 20554. Only parties not represented by counsel may use this method. Such parties must telephone the Litigation Division of the Office of General Counsel beforehand to make arrangements at 202–418–1740. Parties are advised to call at least one day before service must be effected.
(3) Computation of time of the ten-day period for filing copies of petitions for review of a Commission order shall be governed by Rule 26 of the Federal Rules of Appellate Procedure. The date of issuance of a Commission order for purposes of filing copies of petitions for review shall be the date of public notice as defined in § 1.4(b) of the Commission's Rules, 47 CFR 1.4(b).
(b)
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This proposed AD was prompted by heavy corrosion found on the wing rear spar lower girder. This proposed AD would require inspections of the affected areas, modification of the wing trailing edge lower skin panels, and corrective actions if necessary. We are proposing this AD to detect and correct corrosion of the wing rear spar lower girder. This condition could reduce the load-carrying capability of the wing, possibly resulting in structural failure and loss of the airplane.
We must receive comments on this proposed AD by August 8, 2016.
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 NPRM, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88–6280–350; fax +31 (0)88–6280–111; email
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, International Branch, ANM 116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1137; fax 425–227–1149.
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
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015–0113, dated June 22, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F.28 Mark 0070, and 0100 airplanes. The MCAI states:
On an F28 Mark 0070 aeroplane, heavy corrosion was found on the wing rear spar lower girder. At small spots the effective thickness of the vertical flange of the lower girder was almost lost. Subsequently, a number of inspections were accomplished on other aeroplanes to provide additional information on possible corrosion in this area. Because the rear spar lower girder between Wing Stations (WSTA) 9270 and 11794 is hidden from view by the inboard and outboard aileron balancing plates, it is possible that corrosion in this area remains undetected during the zonal inspections in zone 536 and 636 (MRB tasks 062505–00–01 and 062605–00–01).The heavy corrosion was not only found in the area between WSTA 9270 and 11794, but also in the area where the rear spar lower girder is directly visible.
This condition, if not detected and corrected, reduces the load carrying capability of the wing, possibly resulting in structural failure and loss of the aeroplane.
To address this potential unsafe condition, Fokker Services issued Service Bulletin (SB) SBF100–57–049 to provide instructions to detect and remove corrosion and to modify the wing trailing edge lower skin panels into access panels. SBF100–57–050 was issued to provide repair instructions.
For the reasons described above, this [EASA] AD requires inspections of the affected areas and, depending on findings, accomplishment of applicable corrective action(s). This [EASA] AD also requires modification of the wing trailing edge lower skin panels into access panels [This modification is to provide ease of access for later inspection and repairs in the affected areas.], and reporting of the results of the inspections to Fokker Services.
More information on this subject can be found in Fokker Services All Operators Message AOF100.197.
You may examine the MCAI in the AD docket on the Internet at
We reviewed Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, which describes procedures for an inspection for corrosion of certain wing rear spar lower girder areas, modification of the wing trailing edge lower skin panels, and corrective actions if necessary. We also reviewed Fokker Service Bulletin SBF100–57–050, Revision 1, dated May 19, 2015, which describes procedures for repair of the wing spar. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 8 airplanes of U.S. registry.
We also estimate that it would take about 35 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $1,680 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $37,240, or $4,655 per product.
In addition, we estimate that any necessary follow-on actions would take about 372 work-hours and require parts costing $7,600, for a cost of $39,220 per product. We have no way of determining the number of aircraft that might need this action.
We also estimate that it would take about 1 work-hour per product for reporting. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this reporting on U.S. operators to be $680, or $85 per product.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this proposed AD is 2120–0056. The paperwork cost associated with this proposed AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this proposed AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES–200.
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.
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; 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 August 8, 2016.
None.
This AD applies to all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by heavy corrosion found on the wing rear spar lower girder. We are issuing this AD to detect and correct corrosion of the wing rear spar lower girder. This condition could reduce the load-carrying capability of the wing, possibly resulting in structural failure and loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 1,000 flight cycles or 12 months, whichever occurs first after the effective date of this AD, accomplish a one-time detailed visual inspection for corrosion of the wing rear spar lower girder area from WSTA 9270 to 11794, in accordance with Part 1 of the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015.
Within 1,000 flight cycles or 12 months, whichever occurs first after the effective date of this AD, modify the wing trailing edge lower skin panels into access panels, in accordance with Part 1 of the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015.
Within 2,000 flight cycles or 24 months, whichever occurs first after the effective date of this AD, accomplish a one-time detailed visual inspection for corrosion of the wing rear spar lower girder area from WSTA 2635 to 8700 and WSTA 11794 to 12975, in accordance with Part 2 of the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015.
(1) If during any inspection required by paragraph (g) or (i) of this AD, as applicable, corrosion is found, before further flight, remove the corrosion and determine the remaining thickness at the damaged spots, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015. If the remaining thickness at the damaged spots, as determined by this paragraph, is not within the tolerances specified in Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, except as required by paragraph (k)(1) of this AD: Before further flight, accomplish the applicable corrective actions as defined in paragraph (j)(1)(i) or (j)(1)(ii) of this AD, as applicable.
(i) For corrosion damage found outboard of WSTA 8200 only: Repair in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–050, Revision 1, dated May 19, 2015.
(ii) Repair using a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Fokker Services B.V.'s EASA Design Organization Approval (DOA).
(2) If during any inspection required by paragraph (g) or (i) of this AD, only damage to the surface protection is found, or if the remaining thickness at the damaged spots, as determined by paragraph (j)(1) of this AD, is within the tolerances specified in Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, except as required by paragraph (k)(1) of this AD: Before further flight, restore the surface protection in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, except as required by paragraph (k)(2) of this AD.
(1) Where Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, specifies the acceptability of smaller thickness or customized repairs: Before further flight, obtain acceptable tolerances, using a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or EASA; or Fokker Services B.V.'s EASA DOA.
(2) Where Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, specifies contacting Fokker for a customized repair: Before further flight, repair using a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or EASA; or Fokker Services B.V.'s EASA DOA.
Submit a report of the findings both positive and negative of the inspection required by paragraph (g) and (i) of this AD to Fokker Services, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100–57–049, dated March 24, 2015, at the time specified in paragraph (l)(1) or (l)(2) of this AD.
(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.
(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015–0113, dated June 22, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88–6280–350; fax +31 (0)88–6280–111; email
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve elements of two State Implementation Plan (SIP) submissions from the State of Iowa for the Infrastructure SIP Requirements for the 1997 and 2006 Fine Particulate Matter (PM
On September 8, 2011, EPA issued a Finding of Failure to Submit a Complete State Implementation Plan for several states, including Iowa. With respect to Iowa, the Finding of Failure to Submit covered the following 2006 PM
Comments must be received on or before July 25, 2016.
Submit your comments, identified by Docket ID No. EPA–R07–OAR–2014–0213, to
Heather Hamilton, Air Planning and Development Branch, U.S. Environmental Protection Agency, Region 7, 11201 Renner Boulevard, Lenexa, KS 66219;
Throughout this document whenever “we,” “us,” or “our” is used, we refer to EPA. A detailed technical support document (TSD) is included in this rulemaking docket to address the following: A description of CAA section 110(a)(1) and (2) infrastructure SIPs; the applicable elements under sections 110(a)(1) and (2); EPA's approach to the review of infrastructure SIP submissions, and EPA's evaluation of how Iowa addressed the relevant elements of sections 110(a)(1) and (2). This section provides additional information by addressing the following questions:
The EPA is proposing to approve two submissions from the State of Iowa: The infrastructure SIP submissions for the 1997 and 2006 PM
For the 1997 PM
A TSD is included as part of the docket to discuss the details of this proposal.
The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.
The EPA is proposing to approve two submissions from the State of Iowa: The infrastructure SIP submissions for the 1997 and 2006 PM
The EPA's analysis of these submissions is addressed in a TSD as part of the docket to discuss the proposal.
Based upon review of the state's infrastructure SIP submissions and relevant statutory and regulatory authorities and provisions referenced in those submissions or referenced in Iowa's SIP, the EPA believes that Iowa's SIP will meet all applicable required elements of sections 110(a)(1) and (2) with respect to the 1997 and 2006 PM
We are processing this as a proposed action because we are soliciting comments on this proposed action. Final rulemaking will occur after consideration of any comments.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. 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 proposed action:
• Is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
• 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 CAA; 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).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The statutory authority for this action is provided by section 110 of the CAA, as amended (42 U.S.C. 7410).
Environmental protection, Air pollution control, Prevention of significant deterioration, Incorporation by reference, Intergovernmental relations, Particulate Matter, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, EPA proposes to amend 40 CFR part 52 as set forth below:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve elements of the state implementation plan (SIP) submission from Ohio regarding the infrastructure requirements of section 110 of the Clean Air Act (CAA) for the 2012 fine particulate matter (PM
Comments must be received on or before July 25, 2016.
Submit your comments, identified by Docket ID No. EPA–R05–OAR–2015–0824 at
Joseph Ko, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR–18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This
This rulemaking addresses a submission from the Ohio Environmental Protection Agency (OEPA), describing its infrastructure SIP for the 2012 PM
Under sections 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure that their SIPs provide for implementation, maintenance, and enforcement of the NAAQS, including the 2012 PM
EPA highlighted this statutory requirement in an October 2, 2007, guidance document entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM
EPA is acting upon the SIP submission from OEPA that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2012 PM
EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review (NNSR) permit program submissions to address the permit requirements of CAA, title I, part D.
This rulemaking will not cover four substantive areas 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 at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (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”); (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final New Source Review (NSR) Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”); and (iv) transport provisions under section 110(a)(2)(D). Instead, EPA has the authority to, and plans to, address each one of these substantive areas in separate rulemakings. A detailed history and interpretation of infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” (
EPA's guidance for this infrastructure SIP submission is embodied in the 2007 Memo. Specifically, attachment A of the 2007 Memo (Required Section 110 SIP Elements) identifies the statutory elements that states need to submit in order to satisfy the requirements for an infrastructure SIP submission. EPA issued additional guidance documents, the most recent being the 2013 Memo, which further clarifies aspects of infrastructure SIPs that are not NAAQS specific.
As noted in the 2013 Memo, pursuant to section 110(a), states must provide reasonable notice and opportunity for public hearing for all infrastructure SIP submissions. OEPA provided the opportunity for public comment for its 2012 PM
This section requires SIPs to include enforceable emission limits and other control measures, means or techniques, schedules for compliance, and other related matters. EPA has long interpreted emission limits and control measures for attaining the standards as being due when nonattainment planning requirements are due.
Ohio Revised Code (ORC) 3704.03 provides the Director of Ohio EPA with the authority to develop rules and regulations necessary to meet state and Federal ambient air quality standards. Ohio regulates directly emitted particulate matter through the rules in SIP-approved Ohio Administrative Code (OAC) Chapter 3745–17. Ohio also has SIP-approved rules regulating emissions of specific precursors to PM
As previously noted, EPA is not, in this action, proposing to approve or disapprove any existing state provisions or rules related to SSM or director's discretion in the context of section 110(a)(2)(A).
This section requires SIPs to include provisions to provide for establishing and operating ambient air quality monitors, collecting and analyzing ambient air quality data, and making these data available to EPA upon request. EPA determines that Ohio: (i) Monitors air quality at appropriate locations throughout the state using EPA-approved Federal Reference Methods or Federal Equivalent Method monitors; (ii) submits data to EPA's Air Quality System (AQS) in a timely manner; and, (iii) provides EPA Regional Offices with prior notification of any planned changes to monitoring sites or the network plan.
OEPA continues to operate an air monitoring network. EPA approved Ohio's 2015–2016 Annual Air Monitoring Network Plan, including the plan for PM
States are required to include a program providing for enforcement of all SIP measures and the regulation of construction of new or modified stationary sources to meet NSR requirements under PSD and NNSR programs. Part C of the CAA (sections 160–169B) addresses PSD, while part D of the CAA (sections 171–193) addresses NNSR requirements.
The evaluation of each state's submission addressing the infrastructure SIP requirements of section 110(a)(2)(C) covers: (i) Enforcement of SIP measures; (ii) PSD provisions that explicitly identify NO
Ohio EPA maintains an enforcement program to ensure compliance with SIP requirements. ORC 3704.03(R) provides the Director with the authority to enforce rules “consistent with the purpose of the air pollution control laws.” SIP-approved ORC 3704.03 provides the Director with the authority to continue to implement Ohio's minor NSR and major source PSD program. EPA proposes that Ohio has met the SIP enforcement requirements of section 110(a)(2)(C) with respect to the 2012 PM
EPA's “Final Rule to Implement the 8-Hour Ozone National Ambient Air Quality Standard—Phase 2; Final Rule to Implement Certain Aspects of the 1990 Amendments Relating to New Source Review and Prevention of Significant Deterioration as They Apply in Carbon Monoxide, Particulate Matter, and Ozone NAAQS; Final Rule for Reformulated Gasoline” (Phase 2 Rule) was published on November 29, 2005 (
The Phase 2 Rule required that states submit SIP revisions incorporating the requirements of the rule, including the specification of NO
EPA approved revisions to Ohio's PSD SIP reflecting these requirements on October 28, 2014 (79 FR 64119), and therefore, Ohio has met this set of infrastructure SIP requirements of section 110(a)(2)(C) with respect to the 2012 PM
On May 16, 2008 (
The explicit references to SO
The 2008 NSR Rule did not require states to immediately account for gases that could condense to form particulate matter, known as condensables, in PM
EPA approved revisions to Ohio's PSD SIP reflecting these requirements on October 28, 2014 (79 FR 64119), and therefore Ohio has met this set of infrastructure SIP requirements of section 110(a)(2)(C) with respect to the 2012 PM
On October 20, 2010, EPA issued the final rule on the “Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM
The 2010 NSR Rule also established a new “major source baseline date” for PM
On October 28, 2014 (79 FR 64119), EPA finalized approval of the applicable PSD revisions for Ohio, therefore Ohio has met this set of infrastructure SIP requirements of section 110(a)(2)(C) with respect to the 2012 PM
With respect to Elements C and J, EPA interprets the CAA to require each state to make an infrastructure SIP submission for a new or revised NAAQS that demonstrates that the air agency has a complete PSD permitting program meeting the current requirements for all regulated NSR pollutants. The requirements of Element D(i)(II) may also be satisfied by demonstrating the air agency has a complete PSD permitting program correctly addressing all regulated NSR pollutants. Ohio has shown that it currently has a PSD program in place that covers all regulated NSR pollutants, including GHGs.
On June 23, 2014, the United States Supreme Court issued a decision addressing the application of PSD permitting requirements to GHG emissions.
In order to act consistently with its understanding of the Court's decision pending further judicial action to effectuate the decision, EPA is no longer applying EPA regulations that would require that SIPs include permitting requirements that the Supreme Court found impermissible. Specifically, EPA is not applying the requirement that a state's SIP-approved PSD program require that sources obtain PSD permits when GHGs are the only pollutant: (I) That the source emits or has the potential to emit above the major source thresholds, or (ii) for which there is a significant emissions increase from a modification (
EPA will review the Federal PSD rules in light of the Supreme Court opinion. In addition, EPA anticipates that many states will revise their existing SIP-approved PSD programs in light of the Supreme Court's decision. The timing and content of subsequent EPA actions with respect to EPA regulations and state PSD program approvals are expected to be informed by additional legal process before the United States Court of Appeals for the District of Columbia Circuit. At this juncture, EPA is not expecting states to have revised their PSD programs for purposes of infrastructure SIP submissions and is only evaluating such submissions to assure that the state's program correctly addresses GHGs consistent with the Supreme Court's decision.
At present, Ohio's SIP is sufficient to satisfy elements C, D(i)(II), and J with respect to GHGs because the PSD permitting program previously approved by EPA into the SIP continues to require that PSD permits (otherwise required based on emissions of pollutants other than GHGs) contain
For the purposes of the 2012 PM
Certain sub-elements in this section overlap with elements of section 110(a)(2)(D)(i) and section 110(a)(2)(J). These links will be discussed in the appropriate areas below.
Section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment, or interfering with maintenance, of the NAAQS in another state. EPA is not taking action on this infrastructure element in regards to the 2012 PM
Section 110(a)(2)(D)(i)(II) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality or to protect visibility in another state.
EPA notes that Ohio's satisfaction of the applicable PSD requirements for the 2012 PM
EPA has previously approved revisions to Ohio's SIP that meet certain requirements obligated by the Phase 2 Rule and the 2008 NSR Rule. These revisions included provisions that: (1) Explicitly identify NO
With regard to the applicable requirements for visibility protection of section 110(a)(2)(D)(i)(II), states are subject to visibility and regional haze program requirements under part C of the CAA (which includes sections 169A and 169B). The 2013 Memo states that these requirements can be satisfied by an approved SIP addressing reasonably attributable visibility impairment, if required, or an approved SIP addressing regional haze. In this rulemaking, EPA is not proposing to approve or disapprove Ohio's satisfaction of the visibility protection requirements of section 110(a)(2)(D)(i)(II) for the 2010 NO
Section 110(a)(2)(D)(ii) requires each SIP to contain adequate provisions requiring compliance with the applicable requirements of section 126 and section 115 (relating to interstate and international pollution abatement, respectively).
Section 126(a) requires new or modified sources to notify neighboring states of potential impacts from the source. The statute does not specify the method by which the source should provide the notification. States with SIP-approved PSD programs must have a provision requiring such notification by new or modified sources. A lack of such a requirement in state rules would be grounds for disapproval of this element.
Ohio has provisions in its SIP-approved OAC Chapter 3745–31, which is consistent with 40 CFR 51.166(q)(2)(iv), requiring new or modified sources to notify neighboring states of potential negative air quality impacts, and has referenced this program as having adequate provisions to meet the requirements of section 126(a). EPA is proposing that Ohio has met the infrastructure SIP requirements of section 126(a) with respect to the 2012 PM
This section requires each state to provide for adequate personnel, funding, and legal authority under state law to carry out its SIP, and related issues. Section 110(a)(2)(E)(ii) also requires each state to comply with the requirements respecting state boards under section 128.
At the time of its submission, OEPA included its most recent biennial budget with its submittal, which details the funding sources and program priorities addressing the required SIP programs. OEPA has routinely demonstrated that it retains adequate personnel to administer its air quality management program, and Ohio's environmental performance partnership agreement with EPA documents certain funding and personnel levels at OEPA. As discussed in previous sections, ORC 3704.03 provides the legal authority under state law to carry out the SIP. EPA proposes that Ohio has met the infrastructure SIP requirements of these portions of section 110(a)(2)(E) with respect to the 2012 PM
Section 110(a)(2)(E) also requires each SIP to contain provisions that comply with the state board requirements of section 128 of the CAA. That provision contains two explicit requirements: (1) That any board or body which approves permits or enforcement orders under this chapter shall have at least a majority of members who represent the public interest and do not derive any significant portion of their income from persons subject to permits and enforcement orders under this chapter, and (2) that any potential conflicts of interest by members of such board or body or the head of an executive agency
OEPA does not have a board that has the authority to approve enforcement orders or permitting actions as outlined in section 128(a)(1) of the CAA; instead, this authority rests with the Director of OEPA. Therefore, section 128(a)(1) of the CAA is not applicable in Ohio.
Under section 128(a)(2), the head of the executive agency with the power to approve enforcement orders or permits must adequately disclose any potential conflicts of interest. In its June 7, 2013, submission, OEPA notes that EPA has previously approved provisions into Ohio's SIP addressing these requirements (
States must establish a system to monitor emissions from stationary sources and submit periodic emissions reports. Each plan shall also require the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources. The state plan shall also require periodic reports on the nature and amounts of emissions and emissions-related data from such sources, and correlation of such reports by each state agency with any emission limitations or standards established pursuant to this chapter. Lastly, the reports shall be available at reasonable times for public inspection.
OEPA district offices and local air agencies are currently required to witness 50% of all source testing and review 100% of all tests. EPA-approved rules in OAC 3745–15 contain provisions for the submission of emissions reports, and OAC 3745–77 and OAC 3745–31 provide requirements for recordkeeping by sources. EPA recognizes that Ohio has routinely submitted quality assured analyses and data for publication, and therefore proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(F) with respect to the 2012 PM
This section requires that a plan provide for authority that is analogous to what is provided in section 303 of the CAA, and adequate contingency plans to implement such authority. The 2013 Memo states that infrastructure SIP submissions should specify authority, vested in an appropriate official, to restrain any source from causing or contributing to emissions which present an imminent and substantial endangerment to public health or welfare, or the environment.
The regulations at OAC 3745–25 contain provisions which allow the Director of OEPA to determine the conditions that comprise air pollution alerts, warnings, and emergencies. Moreover, the rules contained in OAC 3745–25 provide the requirement to implement emergency action plans in the event of an air quality alert or higher. EPA proposes that Ohio has met the applicable infrastructure SIP requirements for this portion of section 110(a)(2)(G) with respect to the 2012 PM
This section requires states to have the authority to revise their SIPs in response to changes in the NAAQS, availability of improved methods for attaining the NAAQS, or to an EPA finding that the SIP is substantially inadequate.
As previously mentioned, ORC 3704.03 provides the Director of OEPA with the authority to develop rules and regulations necessary to meet ambient air quality standards in all areas in the state as expeditiously as practicable, but not later than any deadlines applicable under the CAA. ORC 3704.03 also provides the Director of OEPA with the authority to develop programs for the prevention, and abatement of air pollution. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(H) with respect to the 2012 PM
The CAA requires that each plan or plan revision for an area designated as a nonattainment area meet the applicable requirements of part D of the CAA. Part D relates to nonattainment areas.
EPA has determined that section 110(a)(2)(I) is not applicable to the infrastructure SIP process. Instead, EPA takes action on part D attainment plans through separate processes.
The evaluation of the submission from Ohio with respect to the requirements of section 110(a)(2)(J) are described below.
States must provide a process for consultation with local governments and Federal Land Managers (FLMs) carrying out NAAQS implementation requirements.
OEPA actively participates in the regional planning efforts that include both the state rule developers as well as representatives from the FLMs and other affected stakeholders. The FLMs are also included in OEPA's interested party lists which provide announcements of draft and proposed rule packages. OAC 3745–31–06 is a SIP-approved rule which requires notification and the availability of public participation related to NSR actions; notification is provided to the general public, executives of the city or county where the source is located, other state or local air pollution control agencies, regional land use planning agencies, and FLMs. OAC 3704.03(K) is a SIP-approved rule that which requires giving reasonable public notice and conducting public hearings on any plans for the prevention, control, and abatement of air pollution that the Director of OEPA is required to submit to EPA. Additionally, Ohio is an active member of the Lake Michigan Air Director's Consortium (LADCO). Therefore, EPA proposes that Ohio has met the infrastructure SIP requirements of this portion of section 110(a)(2)(J) with respect to the 2012 PM
Section 110(a)(2)(J) also requires states to notify the public if NAAQS are exceeded in an area and must enhance public awareness of measures that can be taken to prevent exceedances.
OEPA maintains portions of its Web site specifically for issues related to the 2012 PM
States must meet applicable requirements of section 110(a)(2)(C) related to PSD. Ohio's PSD program in the context of infrastructure SIPs has already been discussed in the paragraphs addressing section 110(a)(2)(C) and 110(a)(2)(D)(i)(II), and EPA notes that the actions for those sections are consistent with the actions for this portion of section 110(a)(2)(J).
Therefore, Ohio has met all of the infrastructure SIP requirements for PSD associated with section 110(a)(2)(J) for the 2012 PM
With regard to the applicable requirements for visibility protection, states are subject to visibility and regional haze program requirements under part C of the CAA (which includes sections 169A and 169B). In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus, we find that there is no new visibility obligation “triggered” under section 110(a)(2)(J) when a new NAAQS becomes effective. In other words, the visibility protection requirements of section 110(a)(2)(J) are not germane to infrastructure SIP for the 2012 PM
SIPs must provide for performing air quality modeling for predicting effects on air quality of emissions from any NAAQS pollutant and submission of such data to EPA upon request.
OEPA reviews the potential impact of major and some minor new sources, consistent with appendix W of 40 CFR parts 51 and 52 “Guidelines on Air Quality Models,” as well as OEPA Engineering Guide 69. These modeling data are available to EPA upon request. The regulatory requirements related to PSD modeling can be found in SIP-approved rule OAC 3745–31–18. Ohio's authority to require modeling conducted by other entities,
This section requires SIPs to mandate each major stationary source to pay permitting fees to cover the cost of reviewing, approving, implementing, and enforcing a permit.
OEPA implements and operates the title V permit program, which EPA approved on August 15, 1995 (60 FR 42045); revisions to the program were approved on November 20, 2003 (68 FR 65401). Additional rules that contain the provisions, requirements, and structures associated with the costs for reviewing, approving, implementing, and enforcing various types of permits can be found in ORC 3745.11. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(L) for the 2012 PM
States must consult with and allow participation from local political subdivisions affected by the SIP. OEPA follows approved procedures for allowing public participation, consistent with OAC 3745–47, which is part of the approved SIP. Consultation with local governments is authorized through ORC 3704.03(B). OEPA provides a public participation process for all stakeholders that includes a minimum of a 30-day comment period and a public hearing for all SIP related actions. EPA proposes that Ohio has met the infrastructure SIP requirements of section 110(a)(2)(M) with respect to the 2012 PM
EPA is proposing to approve most elements of the submission from OEPA certifying that its current SIP is sufficient to meet the required infrastructure elements under sections 110(a)(1) and (2) for the 2012 PM
In the above table, the key is as follows:
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. 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) and 13563 (76 FR 3821, January 21, 2011);
• 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 CAA; 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, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
Environmental Protection Agency (EPA).
Proposed rule; supplemental.
The Environmental Protection Agency (EPA) is issuing a supplement to its July 11, 2013, proposed approval of Indiana's request to redesignate the Indiana portion of the Louisville, Indiana-Kentucky, area to attainment for the 1997 annual national ambient air quality standard (NAAQS or standard) for fine particulate matter (PM
Comments must be received on or before July 25, 2016.
Submit your comments, identified by Docket ID No. EPA–R05–OAR–2011–0698 at
Carolyn Persoon, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR–18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 353–8290,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This
On June 16, 2011, the Indiana Department of Environmental Management (IDEM) submitted a request for EPA to approve the redesignation of the Indiana portion of the Louisville (KY-IN) (Madison Township, Indiana, Jefferson County, Kentucky and Clark and Floyd Counties, Indiana) nonattainment area to attainment of the 1997 PM
On July 11, 2013, EPA proposed to determine that the Indiana portion of the Louisville area had met the requirements for redesignation under section 107(d)(3)(E) of the Clean Air Act (CAA) (78 FR 41735). This proposal was based upon our review of ambient air monitoring data from 2009–2011, and preliminary data from 2012. It contained several related actions.
First, EPA proposed to approve the request from IDEM to change the legal designation of the Indiana portion of the Louisville area from nonattainment to attainment for the 1997 annual PM
In August 2013, EPA issued results of a technical systems audit on the PM
Today, EPA is publishing a supplement to its July 11, 2013, proposed rulemaking. The supplement is based on valid design values for the 2013–2015 period, demonstrating attainment of the standard for the entire Louisville area using the most recent three years of data. Preliminary data for 2016 shows that the entire Louisville area continues to attain the standard. This proposal also discusses the maintenance plan emission projections of 2025 and the impact of the budgets remanded under CSAPR on the Louisville area because the status of these issues has changed from the initial proposal.
In this portion of EPA's supplemental proposal, EPA is soliciting comment on the limited issue of the 2013–2015 design values demonstrating attainment of the standard for the entire Louisville area, the maintenance plan emission projections for 2025, and the impact on the Louisville area of the 2015 D.C. Circuit decision remanding certain CSAPR budgets.
EPA is proposing to determine that the Louisville area is attaining the 1997 annual PM
Data recorded at monitors in 2013, 2014, and 2015 are considered valid and were collected after corrective actions resulting from the technical systems audit. These are the data on which EPA is basing its decision that the Louisville area has attained the 1997 annual PM
Along with the redesignation request, Indiana submitted a revision to its PM
As discussed in detail in the section below, the state's maintenance plan submission expressly documents that the area's emissions inventories will remain below the attainment year inventories through 2025. In addition, for the reasons set forth below, EPA believes that the state's submission, in conjunction with additional supporting information, further demonstrates that the area will continue to maintain the PM
Indiana's plan demonstrates maintenance of the 1997 annual PM
The rate of decline in emissions of PM
A maintenance demonstration need not be based on modeling.
Table 2 shows that, for the period between 2008 and the maintenance projection for 2025, the Louisville area will reduce NO
As Table 1 and 2 demonstrate, monitored PM
In its redesignation request and maintenance plan, the state identified the Clean Air Interstate Rule (CAIR) as a permanent and enforceable measure that contributed to attainment in the Louisville Area. CAIR created regional cap-and-trade programs to reduce SO
In 2008, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) vacated CAIR,
Numerous parties filed petitions for review of CSAPR in the D.C. Circuit, and on August 21, 2012, the court issued its ruling, vacating and remanding CSAPR to EPA and ordering continued implementation of CAIR.
In its redesignation request, Indiana noted that a number of states contributed to PM
To the extent that Louisville relies on CSAPR for maintenance of the standard, EPA has identified the Louisville area as having been significantly impacted by pollution transported from other states in both CAIR and CSAPR, and these rules greatly reduced the tons of SO
EPA is issuing a supplement to its action, published July 11, 2013, which proposed to redesignate the Indiana portion of the Louisville area to attainment for the 1997 annual PM
Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 CAA. Accordingly, these proposed actions do not impose additional requirements beyond those imposed by state law and the CAA. For that reason, these proposed actions:
• Are not “significant regulatory actions” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Are 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
• Do 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);
• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Are 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 CAA; and
• Do 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 proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because a determination of attainment is an action that affects the status of a geographical area and does not impose any new regulatory requirements on tribes, impact any existing sources of air pollution on tribal lands, nor impair the maintenance of ozone national ambient air quality standards in tribal lands.
Environmental protection, Air pollution control, Incorporation by
Environmental protection, Air pollution control, National parks, Wilderness areas.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
We are proposing to approve and implement regulations submitted by the New England and Mid-Atlantic Fishery Management Councils in Framework Adjustment 9 to the Monkfish Fishery Management Plan. This action is necessary to better achieve the goals and objectives of the management plan and achieve optimum yield. The proposed action is intended to enhance the operational and economic efficiency of existing management measures and increase monkfish landings.
Public comments must be received by July 8, 2016.
You may submit comments on this document, identified by NOAA–NMFS–2015–0045, by either of the following methods:
•
•
New England Fishery Management Council staff prepared an environmental assessment (EA) for Monkfish Framework Adjustment 9 that describes the proposed action and other considered alternatives. The EA provides a thorough analysis of the biological, economic, and social impacts of the proposed measures and other considered alternatives, a preliminary Regulatory Impact Review, and economic analysis. Copies of the Framework 9 EA are available on request from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. This document is also available from the following internet addresses:
Allison Murphy, Fishery Policy Analyst, (978) 281–9122.
The monkfish fishery is jointly managed under the Monkfish Fishery Management Plan (FMP) by the New England and the Mid-Atlantic Fishery Management Councils. The fishery extends from Maine to North Carolina from the coast out to the end of the continental shelf. The Councils manage the fishery as two management units, with the Northern Fishery Management Area (NFMA) covering the Gulf of Maine (GOM) and northern part of Georges Bank (GB), and the Southern Fishery Management Area (SFMA) extending from the southern flank of GB through Southern New England (SNE) and into the Mid-Atlantic (MA) Bight to North Carolina.
Monkfish are often caught while fishing for Northeast (NE) multispecies, particularly in the NFMA. This has resulted in two closely related fisheries as a majority of monkfish vessels operating in the NFMA are issued both monkfish and NE multispecies permits. Because this action proposes to modify some requirements for NE multispecies sector vessels, it is also considered Framework Adjustment 54 to the NE Multispecies FMP.
The monkfish fishery is primarily managed by landing limits and a yearly allocation of monkfish days-at-sea (DAS) calculated to enable vessels participating in the fishery to catch, but not exceed, the target total allowable landings (TAL) and the annual catch target (ACT, the TAL plus an estimate of expected discards) in each management area. Both the ACT and the TAL are calculated to maximize yield in the fishery over the long term. Based on a yearly evaluation of the monkfish fishery, the Councils may revise existing management measures through the framework provisions of the FMP, including DAS allocations and landing limits, to better achieve the goals and objectives of the FMP and achieve optimum yield (OY), as required by the Magnuson-Stevens Fishery Conservation and Management Act. Amendment 5 (76 FR 30265; May 25, 2011) defined OY as fully harvesting the ACT.
We completed an operational stock assessment in May 2013 to update the state of the monkfish stocks and provide projections to assist with setting future catch levels. The 2013 assessment update revised existing biological reference points, including a substantial reduction in the overfishing level, and concluded that the two monkfish stocks are neither overfished nor subject to overfishing.
The monkfish fishery has failed to fully harvest the available ACT each year since 2011, particularly in the NFMA where the under-harvest has been more substantial. As a result, the fishery has not been achieving OY in either area in recent years. The Councils developed Framework 9 to enhance the operational efficiency of existing management measures in an effort to better achieve OY.
This action would revise monkfish possession limits specified in 50 CFR 648.94 to help increase monkfish landings and better achieve the ACT caught in the NFMA. Specifically, this
Possession limits differ based on the type of DAS being used by a vessel. Table 1 includes a summary of the current monkfish tail weight possession limits for a vessel fishing under the various DAS available in the NFMA. We are proposing to add another tier to the possession limit system without changing the existing possession limits for a vessel fishing on a NE multispecies DAS or a monkfish DAS. We propose to allow a Category C or D vessel that is fishing under both a NE multispecies and a monkfish DAS in the NFMA to retain an unlimited amount of monkfish (Table 1).
As is currently the case, a Category C or D vessel would still be required to declare a trip at the dock under a NE multispecies A DAS with the option to declare a monkfish-DAS while at sea, and then declare a monkfish DAS while at sea in order or to be exempt from the monkfish possession limits. Alternately, a Category C or D vessel would be required to declare a concurrent NE Multispecies A DAS and a monkfish DAS at the dock prior to starting a trip in order or to be exempt from the monkfish possession limits. Under existing regulations, however, a Category C or D vessel cannot begin a trip under a monkfish-only DAS and add a NE Multispecies A DAS while at sea in order or to be exempt from the monkfish possession limit. A provision to allow this and provide this flexibility is also considered in this proposed rule and discussed in detail below. Without this change, a Category C or D vessel that does not declare a trip under a NE multispecies A DAS and a monkfish DAS (or option to declare a monkfish DAS while at sea) at the dock prior to starting a trip would not be exempt from the monkfish possession limits under this action. In such cases, the existing monkfish possession limits for Category C and D vessels fishing only under a NE multispecies DAS or a monkfish DAS would remain the same, as outlined in Table 1.
This action would revise NE multispecies DAS declaration requirements to help increase operational flexibility and potentially increase monkfish landings in the NFMA. Functionally, this would allow a Monkfish Category C and D vessel enrolled in a NE multispecies sector (referred to as a Category C and D sector vessel in this section) fishing in the NFMA to declare a NE multispecies A DAS while at sea, through the vessel monitoring system (VMS), when certain conditions apply.
We propose to allow a Category C and D sector vessel fishing on either a NE multispecies non-DAS sector trip or a monkfish-only DAS exclusively in the NFMA to declare a NE multispecies A DAS while at sea. Currently, a Category C or D sector vessel that is not declared into the monkfish fishery, but is declared into the NE multispecies fishery on a non-DAS sector trip, is limited to an incidental possession limit for monkfish. In the NFMA, which overlaps with the GOM and GB Regulated Mesh Areas (RMAs), the incidental monkfish possession limit is up to 5 percent of total weight of fish on board.
This measure would also increase flexibility by allowing a vessel to fish in a larger geographic area. Currently, any Category C or D vessel must use its monkfish-only DAS exclusively in a monkfish exempted fishery. An exempted fishery is an area and season demonstrated to have minimal bycatch of NE multispecies when using a specific type of gear. The only monkfish exempted fishery that overlaps with the NFMA is in the Gulf of Maine/Georges Bank Dogfish and Monkfish Gillnet Exemption Area, as described in § 648.80(a)(13). Allowing a vessel to declare a NE multispecies DAS while at sea would allow that vessel to fish outside of these specified areas and retain NE multispecies for the remainder of the trip.
Under this proposed measure, monkfish possession limits would increase from the incidental monkfish possession limit to the monkfish possession limits for Category C and D sector vessels fishing on a NE multispecies A DAS in the NFMA, as summarized in Table 2. We are also proposing to allow a Category C or D sector vessel fishing exclusively in the GOM/GB Dogfish and Monkfish Gillnet Exemption Area to change its VMS declaration from a monkfish-only DAS to a combined monkfish and NE multispecies A DAS while at sea. Under this proposed measure, monkfish possession limits for Category C and D sector vessels would become unlimited, as described in Table 2, should we also approve changes to the possession limits described above.
While we are proposing this measure as recommended by the Councils, we have some concerns. First, our analyses suggest that the necessary implementation costs may not exceed the benefits to the fishery. This measure will require VMS software modifications to allow vessels the ability to declare a NE multispecies A DAS while at sea. We expect this VMS change to cost roughly $100,000, based on other, recent VMS software changes we have implemented. The cost associated with VMS changes is primarily because 4 approved vendors for the Greater Atlantic Region will all be required to update their software onboard vessels using their VMS equipment. This cost is borne solely by the Agency. The EA for Framework 9 identified only a small percent (1.6 percent) of vessels that approached applicable trip limits for non-DAS sector trips and monkfish-only trips. In addition, the Framework 9 EA indicates that few trips would have yielded additional monkfish landings in recent fishing years had the proposed NE multispecies DAS at-sea declaration change been in place. Based on this information, this measure may do little to help the fishery achieve optimum yield. We are interested in public comment on the cost, effectiveness, and utility of this proposed measure. We intend to further evaluate the potential cost/benefit of providing this at-sea declaration flexibility, as well as public comment, when considering the approvability of this measure.
Proposing to allow Category C and D sector vessels fishing on a monkfish-only DAS in the NFMA to declare a NE multispecies A DAS while at sea may not provide as many benefits as first anticipated. As described above, only the GOM/GB Dogfish and Monkfish Gillnet Exemption overlaps with the NFMA. This exempted fishery is open from July 1 through September 14, annually, for a vessel using gillnet gear in the waters of Cape Cod Bay and off southern Maine. Given that the majority of the fleet in the NFMA fishes with trawl gear and cannot take advantage of monkfish-only DAS because they are excluded from this exempted fishery, we are concerned that only a small number of vessels that use gillnet gear would benefit from this flexibility.
Second, allowing a vessel to declare a NE multispecies A DAS after starting a trip on a monkfish-only DAS could potentially circumvent existing NE multispecies pre-trip notification requirements for deploying industry-funded at-sea monitors. We believed, at the time the Council took final action, that limiting the declaration change to sector vessels would mitigate these concerns. Since Council final action, we have continued to discuss the nuances of this potential provision with Regional Office NE multispecies and Northeast Fisheries Science Center, Fishery Sampling Branch staff. We remain concerned that the ability to switch from a monkfish-only DAS to a NE multispecies A DAS would allow vessels to bypass sector monitoring and reporting requirements.
A potential remedy to this loophole is an alternative that would require a vessel to comply with existing pre-trip notification requirements at § 648.11(k) and be subject to sector-funded at-sea monitoring to be able to change declarations at-sea. In addition, we could also require a vessel to submit a sector trip-start hail, described at § 648.10(k)(1)(iii), so that we can identify trips that may use this declaration flexibility.
We recognize that this potential solution may be somewhat less flexible than what was intended by the Councils and was not explicitly contemplated or discussed by the Councils. However, if not imposed, the proposed measures, as recommended, would allow vessels to circumvent sector-related reporting requirements, and inclusion of these measures pursuant to the authority provided to the Secretary of Commerce in section 305(d) of the Magnuson-Stevens Act may therefore be necessary to implement this portion of Framework 9 consistently with the Act. Adding NE multispecies monitoring requirements on these trips could complicate the Northeast Fisheries Observer Program and At-Sea Monitoring Program sea-day schedule assignments, coverage accomplishments, and future coverage needs. Further, fewer fishermen may use the flexibility option if they are at risk of being assigned an at-sea monitor, which industry has to pay for. We are soliciting specific comment from the Councils and the public on both the at-sea declaration flexibility as recommended by the Councils and this potential solution.
If this remedy solution is approved, the pre-trip notification system (PTNS) must be modified to accept monkfish-only trips. Currently, PTNS will only accept trips declared into the NE multispecies (
Finally, we have some enforcement concerns with the proposal to allow Category C and D sector vessels fishing on a monkfish-only DAS in the NFMA to declare a NE multispecies A DAS while at sea. Currently, a Category C or D sector vessel fishing on a monkfish-only DAS in an exempted fishery is required to discard all NE multispecies. Similarly, a Category C or D sector vessel fishing on a NE multispecies A DAS or on a non-DAS sector trip is currently required to retain all legal-sized groundfish. Should this measure be approved, a Category C or D sector vessel would begin a trip discarding all NE multispecies, and then be required to retain all legal-sized NE multispecies, once the vessel declares a NE multispecies DAS. This may introduce confusion about discarding and catch reporting requirements for the industry and complicates the enforceability of this measure. To help provide clarity, pursuant to the authority provided to the Secretary of Commerce in sector 305(d) of the Magnuson-Stevens Act, we could revise the sector discard and operations plan prohibitions at § 648.14(k)(14)(iv) and (viii) and the sector monitoring requirements at § 648.87(b)(1)(v)(A) to make clear that there would be different discard requirements before and after a vessel declares a NE multispecies DAS. We are also soliciting specific comment from the Councils and the public on clarifying the discard requirements.
It should be noted that we may need to delay effectiveness of this measure, should it be approved. Modifications to VMS would likely take months to complete and we are uncertain how long the necessary PTNS changes may take to implement.
We are proposing to revise minimum mesh size requirements at § 648.80(b) and (c) and § 648.91(c)(1)(iii) to increase operational flexibility. The changes would allow vessels to target both monkfish and dogfish while on the same trip. Currently, the following restrictions apply in the SFMA:
• A category C or D vessel fishing on a combined monkfish and NE multispecies A DAS in the SFMA must fish with gillnets no smaller than 10-inches (25.4-cm) diamond mesh;
• Any monkfish-permitted vessel fishing in the SNE Dogfish Gillnet Exemption Area may retain dogfish and incidental limits of other species (excluding monkfish) allowed in the SNE Exemption Area; and
• Any monkfish-permitted vessel fishing in the SNE Monkfish and Skate Gillnet Exemption Area may retain monkfish and skate up to a specified limit and incidental limits of other
The proposed measure would modify a vessel's minimum gillnet mesh size requirements when fishing on a monkfish DAS using roundfish (also called stand-up) gillnets in the SFMA. It would also modify the minimum gillnet mesh size requirements in a smaller portion of the SFMA referred to as the Mid-Atlantic Exemption Area. Finally, this measure changes possession limit requirements in the SNE Dogfish Gillnet Exemption Area and dogfish in the SNE Monkfish and Skate Gillnet Exemption Area so that a vessel may retain both monkfish and dogfish. Please see Figure 1 for a display of these areas.
We are proposing to allow a Category C or D vessel fishing under both a NE multispecies and a monkfish DAS in the SFMA to use 6.5-inch (16.5-cm) roundfish gillnets. We are also proposing to allow any monkfish-permitted vessel fishing on a monkfish-only DAS in the Mid-Atlantic Exemption Area to use 5-inch (12.7-cm) roundfish gillnets in the Mid-Atlantic Exemption Area. Finally, we are proposing to allow a monkfish-permitted vessel fishing on a monkfish-only DAS in either the SNE Dogfish Gillnet Exemption Area or the SNE Monkfish and Skate Gillnet Exemption Area to retain both monkfish and dogfish on the same trip when declared into either area. This measure would also limit a vessel to using 50 roundfish gillnets in the SNE Dogfish and the Mid-Atlantic Exemption Areas. Table 3 summarizes the proposed measures (highlighted in bold) and also includes existing seasonal, gear, and DAS requirements.
A vessel taking advantage of these smaller minimum mesh sizer requirements must still comply with all other requirements of fishing in the SFMA or in the Exemption Areas. Existing monkfish possession limits for vessels issued a limited access monkfish permit and fishing in the SFMA would remain the same.
This proposed rule would correct a number of inadvertent errors, omissions, and ambiguities in existing regulations in order to ensure consistency with, and accurately reflect the intent of, previous actions under the FMP, or to more effectively administer and enforce existing and proposed provisions pursuant to the authority provided to the Secretary of Commerce in section 305(d) of the Magnuson-Stevens Act. The following proposed measures are listed in the order in which they appear in the regulations.
In § 648.10, paragraphs (b)(3), (g)(1), (g)(3), and (g)(3)(ii)(A) would be revised to enhance readability and more clearly state the regulatory requirements.
In § 648.92, paragraph (b)(1)(i) would be revised to enhance readability and more clearly state the regulatory requirements. A reference to the DAS requirements in the SFMA and adjustment for gear conflicts would also be removed, as these references are unnecessary. The reference to DAS requirement in the SFMA in § 648.92(b)(1)(ii) is not needed because that referenced section further explains how the overall DAS allocation may be used. The reference to adjustment for gear conflicts in § 648.96(b)(3) states that the Councils may develop recommendations to address gear conflicts. This reference is unnecessary because those measures would be captured in the regulations and appropriately cross-referenced.
In § 648.94, paragraph (b)(3)(i) would be revised to enhance readability and more clearly state the regulatory requirements. A reference to Category F permits would also be deleted for clarity because it may cause confusion with regard to the possession limits for Category F permits. Possession limit requirements for Category F permits are more clearly outlined in § 648.95.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has made a preliminary determination that this proposed rule is consistent with the Monkfish and NE Multispecies FMPs, Framework 9, provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation, Department of Commerce, certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The Council prepared an analysis of the potential economic impacts of this action, which is included in the draft EA for this action (see
This proposed rule is not expected to place small entities at a competitive disadvantage to large entities. All of the large entities impacted by the proposed action are primarily engaged in shellfish fishing. These large entities may not benefit to the same degree as small entities because the majority of small entities are primarily engaged in finfish fishing. The proposed rule would liberalize trip limits, increase operational flexibility, and relax minimum mesh size requirements, directly benefiting fishermen that are primarily engaged in finfish fishing. In terms of profitability, both small and large entities should benefit from increased operational flexibility from the proposed action, though these benefits are likely to be marginal.
There is no reason to believe small entities will be negatively affected in any way by the proposed measures identified in this rule's preamble. Overall, the net impact on profits from each proposed measure is expected to be slightly positive to neutral because these measures relieve restrictions. Therefore, this action is not expected to have a significant economic impact on a substantial number of small entities.
As a result, an initial regulatory flexibility analysis is not required and none has been prepared.
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:
16 U.S.C. 1801
(b) * * *
(3) A vessel issued a limited access monkfish, Occasional scallop, or Combination permit, whose owner elects to provide the notifications required by this section using VMS, unless otherwise authorized or required by the Regional Administrator under paragraph (d) of this section;
(e) * * *
(5) * * *
(ii) Notification that the vessel is not under the DAS program, the Access Area Program, the LAGC IFQ or NGOM scallop fishery, or any other fishery requiring the operation of VMS, must be received by NMFS prior to the vessel leaving port. A vessel may not change its status after the vessel leaves port or before it returns to port on any fishing trip, unless
(A) The vessel is a scallop vessel and is exempted, as specified in paragraph (f) of this section, or
(B) Unless the vessel is a NE multispecies sector vessel with a Monkfish Category C or D permit declaring a NE multispecies DAS while at sea, as specified in paragraph (g)(3)(ii) of this section.
(g) * * *
(1) The owner or authorized representative of a vessel that is required to or elects to use VMS, as specified in paragraph (b) of this section, must notify the Regional Administrator of the vessel's intended fishing activity by entering the appropriate VMS code prior to leaving port at the start of each fishing trip except:
(i) If notified by letter, pursuant to paragraph (e)(1)(iv) of this section, or
(ii) The vessel is a scallop vessel and is exempted, as specified in paragraph (f) of this section.
(3) A vessel operator cannot change any aspect of a vessel's VMS activity code outside of port, except as follows:
(i) An operator of a NE multispecies vessel is authorized to change the category of NE multispecies DAS used (
(ii) An operator of a vessel issued both a limited access NE multispecies permit and a limited access monkfish Category C or D permit is authorized to change the vessel's DAS declaration under the following circumstances:
(A) From a NE multispecies Category A DAS to a trip also using a monkfish DAS, as provided at § 648.92(b)(1)(iii)(A);
(B) From a NE multispecies sector non-DAS trip to a NE multispecies sector trip using a NE multispecies Category A DAS when fishing in the monkfish Northern Fishery Management Area (NFMA), if that vessel is participating in a sector; or
(C) From a trip under a monkfish-only DAS to a trip under both a monkfish and a NE multispecies Category A DAS when fishing in the monkfish NFMA, if that vessel is participating in a sector.
(m)
(2) * * *
(i) Fish with or use nets with mesh size smaller than the minimum mesh size specified in § 648.91(c) while fishing under a monkfish DAS, except as authorized by § 648.91(c)(1)(iii).
(b) * * *
(2) * * *
(iv)
(6) * * *
(i) * * *
(A) A vessel fishing under the SNE Monkfish and Skate Gillnet Exemption may only fish for, possess on board, or land monkfish as specified in § 648.94(b), spiny dogfish up to the amount specified in § 648.235, and other incidentally caught species up to the amounts specified in paragraph (b)(3) of this section.
(7) * * *
(i) * * *
(A) A vessel fishing under the SNE Dogfish Gillnet Exemption may only fish for, possess on board, or land dogfish and the bycatch species and amounts specified in paragraph (b)(3) of this section, unless fishing under a monkfish DAS. A vessel fishing under this exemption while on a monkfish-only DAS may also fish for, possess on board, and land monkfish up to the amount specified in § 648.94.
(B) All gillnets must have a minimum mesh size of 6-inch (15.2-cm) diamond mesh throughout the net. A vessel fishing under this exemption while on a monkfish-only DAS may not fish with, possess, haul, or deploy more than 50 roundfish gillnets, as defined in § 648.2.
(c) * * *
(2) * * *
(v)
(5)
(ii)
(A)
(B)
(C)
(c) * * *
(1) * * *
(iii)
(A) The owner or operator of a limited access NE multispecies vessel fishing under a NE multispecies category A DAS with gillnet gear in the NFMA
(B) A vessel issued a Category C or D limited access monkfish permit is fishing under both a monkfish and NE multispecies Category A DAS in the SFMA using roundfish gillnets, as defined at § 648.2, with 6.5-inch (16.5-cm) diamond mesh;
(C) A vessel issued a limited access monkfish permit is fishing on a monkfish-only DAS in the Mid-Atlantic Exemption Area using roundfish gillnets with a minimum mesh size of 5 inches (12.7 cm) in accordance with the provisions specified under § 648.80(c)(5); or
(D) A vessel issued a limited access monkfish permit is fishing on a monkfish-only DAS in the Southern New England Dogfish Exemption Area using roundfish gillnets with a minimum mesh size of 6 inches (15.2 cm) in accordance with the provisions specified under § 648.80(b)(7).
(b) * * *
(1) * * *
(i)
(b) * * *
(1)
(i)
(ii)
(iii)
(iv)
(3) * * *
(i)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule.
NMFS proposes to implement annual management measures and harvest specifications to establish the allowable catch levels (
Comments must be received by July 25, 2016.
You may submit comments on this document identified by NOAA–NMFS–2015–0048, by any of the following methods:
•
•
Copies of the report “Pacific Mackerel (
Joshua Lindsay, West Coast Region, NMFS, (562) 980–4034,
During public meetings each year, the estimated biomass for Pacific mackerel is presented to the Pacific Fishery Management Council's (Council) CPS Management Team (Team), the Council's CPS Advisory Subpanel (Subpanel) and the Council's Scientific and Statistical Committee (SSC), and the biomass and the status of the fishery are reviewed and discussed. The biomass estimate is then presented to the Council along with the recommended overfishing limit (OFL) and acceptable biological catch (ABC) calculations from the SSC, along with the calculated ACL, HG, and ACT recommendations, and comments from the Team and Subpanel. Following review by the Council and after reviewing public comment, the Council adopts a biomass estimate and makes its catch level recommendations to NMFS. Under the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
The CPS FMP and its implementing regulations require NMFS to set these annual catch levels for the Pacific mackerel fishery based on the annual specification framework and control rules in the FMP. These control rules include the HG control rule, which in conjunction with the OFL and ABC rules in the FMP, are used to manage harvest levels for Pacific mackerel, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801
1.
2.
3.
4.
At the June 2015 Council meeting, the Council adopted a new full stock assessment for Pacific mackerel completed by NMFS Southwest Fisheries Science Center and along with the Council's SSC, approved the resulting Pacific mackerel biomass estimate of 118,968 mt as the best available science for use in the 2016–2017 fishing year. Based on recommendations from its SSC and other advisory bodies, the Council recommended and NMFS is proposing, an OFL of 24,983 mt, an ABC and ACL of 22,822 mt, an HG of 21,161 mt, and an ACT of 20,161 mt for the fishing year of July 1, 2016, to June 30, 2017.
Under this proposed action, upon attainment of the ACT, the directed fishing would close, reserving the difference between the HG and ACT (1,000 mt) as a set aside for incidental landings in other CPS fisheries and other sources of mortality. For the remainder of the fishing year, incidental landings would also be constrained to a 45 percent incidental catch allowance when Pacific mackerel are landed with other CPS (in other words, no more than 45 percent by weight of the CPS landed per trip may be Pacific mackerel), except that up to 3 mt of Pacific mackerel could be landed incidentally without landing any other CPS. Upon attainment of the HG (21,161 mt), no retention of Pacific mackerel would be allowed in CPS fisheries. In previous years, the incidental set-aside established in the mackerel fishery has been, in part, to ensure that if the directed quota for mackerel was reached that the operation of the Pacific sardine fishery was not overly restricted. There is no directed Pacific sardine fishery for the 2016–2017 season; therefore, the need for a high incidental set-aside is reduced. The purpose of the incidental set-aside and the allowance of an
The NMFS West Coast Regional Administrator would publish a notice in the
Detailed information on the fishery and the stock assessment are found in the report “Pacific Mackerel (
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Fishery Conservation and Management Act, the Assistant Administrator, NMFS, has determined that this proposed rule is consistent with the CPS FMP, other provisions of the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law, subject to further consideration after public comment.
These proposed specifications are exempt from review under Executive Order 12866 because they contain no implementing regulations.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities, for the following reasons:
The U.S. Small Business Administration (SBA) defines small businesses engaged in finfish fishing as those vessels with annual revenues of or below $20.5 million. The small entities that would be affected by the proposed action are the vessels that compose the West Coast CPS finfish fleet and are all considered small businesses under these size standards.
The small entities that would be affected by the proposed action are those vessels that harvest Pacific mackerel as part of the West Coast CPS purse seine fleet. The CPS FMP and its implementing regulations requires NMFS to set an OFL, ABC, ACL, HG, or ACT for the Pacific mackerel fishery based on the harvest control rules in the FMP. These specific harvest control rules are applied to the current stock biomass estimate to derive these catch specifications, which are used to manage the commercial take of Pacific mackerel. A component of these control rules is that as the estimated biomass decreases or increases from one year to the next, so do the applicable quotas. For the 2016–2017 Pacific mackerel fishing season NMFS is proposing an OFL of 24,983 metric tons (mt), an ABC and ACL of 22,822 mt, an HG of 21,161 mt, and an ACT, which is the directed fishing harvest target, of 20,161 mt. These catch specifications are based on a biomass estimate of 118,968 mt.
Pacific mackerel harvest is one component of CPS fisheries off the U.S. West Coast, which primarily includes the fisheries for Pacific sardine, northern anchovy, and market squid. Pacific mackerel are principally caught off southern California within the limited entry portion (south of 39 degrees N. latitude; Point Arena, California) of the fishery. Currently there are 56 vessels permitted in the Federal CPS limited entry fishery off California of which about 25 to 39 vessels have been annually engaged in harvesting Pacific mackerel in recent years (2009–2015). For those vessels that caught Pacific mackerel during that time, the average annual per vessel revenue has been about $1.25 million. The individual vessel revenue for these vessels is well below the SBA's threshold level of $20.5 million; therefore, all of these vessels are considered small businesses under the RFA. Because each affected vessel is a small business, this proposed rule has an equal or similar effect on all of these small entities, and therefore will impact a substantial number of these small entities in the same manner.
NMFS used the ex-vessel revenue information for a profitability analysis, as the cost data for the harvesting operations of CPS finfish vessels was limited or unavailable. For the 2015–2016 fishing year, the maximum fishing level was 25,291 mt and was divided into a directed fishing harvest target (ACT) of 20,469 mt and an incidental set-aside of 5,000 mt. As of April 29, 2016 approximately 3,880 mt of Pacific mackerel was harvested in the 2015–2016 fishing season with an estimated ex-vessel value of approximately $931,200.
The maximum fishing level for the 2016–2017 Pacific mackerel fishing season is 21,161 mt, with an ACT of 20,161 mt and an incidental set-aside of 1,000 mt. This proposed ACT is nearly equivalent to the ACT established for the previous year, thus it is highly unlikely that the ACT proposed in this rule will limit the potential profitability to the fleet from catching Pacific mackerel compared to last season or recent catch levels, as shown below. The annual average U.S. Pacific mackerel harvest in recent years (2010–2015) has been about 5,000 mt. In this period, the landings have not exceeded 11,800 mt. Additionally, annual average landings during the last decade (2005–2015) have not been restricted by the applicable quota. Accordingly, vessel income from fishing is not expected to be altered as a result of this rule as it compares to recent catches in the fishery, including under the previous season's regulations.
Based on the disproportionality and profitability analysis above, the proposed action, if adopted, will not have a significant economic impact on a substantial number of small entities. As a result, an Initial Regulatory Flexibility Analysis is not required, and none has been prepared.
This action does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act.
16 U.S.C. 1801
Architectural and Transportation Barriers Compliance Board.
Notice of meetings.
The Architectural and Transportation Barriers Compliance Board (Access Board) plans to hold its regular committee and Board meetings in Washington, DC, Monday through Wednesday, July 11–13, 2016 at the times and location listed below.
The schedule of events is as follows:
Meetings will be held at the Access Board Conference Room, 1331 F Street NW., Suite 800, Washington, DC 20004.
For further information regarding the meetings, please contact David Capozzi, Executive Director, (202) 272–0010 (voice); (202) 272–0054 (TTY).
At the Board meeting scheduled on the afternoon of Wednesday, July 13, 2016, the Access Board will consider the following agenda items:
Members of the public can provide comments either in-person or over the telephone during the final 15 minutes of the Board meeting on Wednesday, July 13, 2016. Any individual interested in providing comment is asked to pre-register by sending an email to
All meetings are accessible to persons with disabilities. An assistive listening system, Communication Access Realtime Translation (CART), and sign language interpreters will be available at the Board meeting and committee meetings. Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday, July 20, 2016, from 10:00 a.m.–11:00 a.m. EDT. The Committee will discuss findings and recommendations regarding school discipline policies and practices which may facilitate disparities in juvenile justice involvement and youth incarceration rates on the basis of race, color, disability, or sex, in what has become known as the “School to Prison Pipeline,” in preparation to issue a report to the Commission on the topic. This meeting is open to the public via the following toll free call in number 888–471–3843 conference ID 4507232. Any interested member of the public may call this number and listen to the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1–800–977–8339 and providing the Service with the conference call number and conference ID number.
Members of the public are invited to make statements during the designated open comment period. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the
Records and documents discussed during the meeting will be available for public viewing prior to and following the meeting at
The meeting will be held on Wednesday July 20, 2016, from 10:00 a.m.–11:00 a.m. EDT.
Melissa Wojnaroski, DFO, at 312–353–8311 or
U.S. Commission on Civil Rights.
Notice of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the North Carolina Advisory Committee will hold a meeting on Friday, June 29, 2016, at 12 p.m. EST for the purpose of discussing and voting on potential summary memorandum project and to discuss a draft report on environmental justice issues in the state.
The meeting will be held on Wednesday, June 29, 2016 at 12 p.m. EST.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888–455–2296, conference ID: 6491793. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1–800–977–8339 and providing the Service with the conference call number and conference ID number.
Members of the public are invited to make statements to the Committee during the scheduled open comment period. In addition, members of the public may submit written comments; the comments must be received in the regional office by June 25, 2016. Written comments may be mailed to the Southern Regional Office, U.S. Commission on Civil Rights, 61 Forsyth Street, Suite 16T126, Atlanta, GA 30303. They may also be faxed to the Commission at (404) 562–7005, or emailed to Regional Director, Jeffrey Hinton at
Records generated from this meeting may be inspected and reproduced at the Southern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
Toll-free call-in number: 888–455–2296,
Conference ID: 6491793.
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Montana Advisory Committee to the Commission will convene at 10:00 a.m. (MDT) on Wednesday, July 20, 2016, via teleconference. The purpose of the planning meeting is for the Advisory Committee to review progress of planning to conduct a community forum on Border Town Discrimination Against Native Americans in Billings in late August 2016.
Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1–888–503–8175; Conference ID: 5890742. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1–800–977–8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1–888–503–8175, Conference ID: 5890742. Members of the public are invited to submit written comments; the comments must be received in the regional office by
Records and documents discussed during the meeting will be available for public viewing as they become available at
Wednesday, July 20, 2016, at 10:00 a.m. (MDT)
To be held via teleconference:
Conference Call Toll-Free Number: 1–888–503–8175, Conference ID: 5890742.
TDD: Dial Federal Relay Service 1–800–977–8339 and give the operator the above conference call number and conference ID.
Malee V. Craft, Regional Director,
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The Census Bureau conducts the Quarterly Summary of State & Local Government Tax Revenues (Q-Tax Survey) to provide quarterly estimates of state and local government tax revenue at a national level, as well as detailed tax revenue data for individual states. It serves as a timely source of tax data for many data users and policy makers and is the most current information available on a nationwide basis for government tax collections. There are three components to the Q-Tax Survey. The first component is the Quarterly Survey of Property Tax Collections (F–71), which collects property tax data from local governments. The second component is the Quarterly Survey of State Tax Collections (F–72), which collects data comprised of 25 different tax categories for all 50 states. The third component is the Quarterly Survey of Selected Non-Property Taxes (F–73), which collects local tax revenue data for three taxes: sales and gross receipts taxes, individual income taxes, and corporation net income taxes.
The Census Bureau requests a change from paper forms to all-electronic data collection methods for the Q-Tax Survey. The Quarterly Survey of Property Tax Collections (F–71) and Quarterly Survey of Selected Non-Property Taxes (F–73) components will be collected electronically via Centurion, the Census Bureau's primary online reporting system. For the Quarterly Survey of State Tax Collections (F–72) component, respondents will be emailed a spreadsheet to fill out and return electronically.
The Census Bureau conducts the three components of the Q-Tax Survey to collect state and local government tax data for this data series established in 1962. Tax collection data are used to measure economic activity for the Nation as a whole, as well as for comparison among the states. These data are also used in comparing the mix of taxes employed by individual states and in determining the revenue raising capacity of different types of taxes in different states.
Key users of these data include the Bureau of Economic Analysis (BEA), the Federal Reserve Board (FRB), and the Department of Housing and Urban Development (HUD) who rely on these data to provide the most current information on the financial status of state and local governments. These data are included in the quarterly estimates of the National Income and Product Accounts developed by BEA. HUD has used the property tax data as one of nine cost indicators for developing Section 8 rent adjustments. Legislators, policy makers, administrators, analysts, economists, and researchers use these data to monitor trends in public sector revenues. Journalists, teachers, and students use these data as well for their research purposes.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Economic Development Administration, Department of Commerce.
Notice and Opportunity for Public Comment.
Pursuant to Section 251 of the Trade Act 1974, as amended (19 U.S.C. 2341
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the City of San Jose, California, grantee of FTZ 18, requesting to expand Subzone 18G on behalf of Tesla Motors, Inc., located in Palo Alto and Fremont, California. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a–81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on June 15, 2016.
Subzone 18G was approved on September 20, 2012 (77 FR 60672–60673, October 4, 2012) and currently consists of two sites:
In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is August 2, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to August 17, 2016.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230–0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Christopher Kemp at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 9, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty (AD) order on prestressed concrete steel rail tie wire (PC tie wire) from Mexico.
Rebecca Trainor or Aqmar Rahman, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482–4007 and (202) 482–0768, respectively.
For a complete description of the events following the publication of the
The Department conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).
The product covered by this order is prestressed concrete steel rail tie wire. This product is classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 7217.10.8045, but may also be classified under subheadings 7217.10.7000, 7217.10.8025, 7217.10.8030, 7217.10.8090, 7217.10.9000, 7229.90.1000, 7229.90.5016, 7229.90.5031, 7229.90.5051, 7229.90.9000, and 7312.10.3012. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive.
All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as Appendix I.
As a result of this review, the Department determines that a weighted-average dumping margin of 6.33 percent exists for Camesa for the period December 12, 2013, through May 31, 2015.
The Department determines, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
We intend to issue instructions to CBP 41 days after the date of publication of the final results of this review.
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Camesa will be the rate established in these final results; (2) for previously reviewed or investigated companies not participating in this review, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a previous review, or the original less-than-fair-value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 9.99 percent, the all-others rate made effective by the LTFV investigation. These deposit requirements shall remain in effect until further notice.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) 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 double antidumping duties.
This notice serves as the only reminder to parties subject to 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 written notification of return/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.
This administrative review and notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments.
NMFS has received a request from the Alaska Department of Transportation and Public Facilities (ADOT&PF) for authorization to take marine mammals incidental to reconstructing the existing Gustavus Ferry Terminal located in Gustavus, Alaska. The ADOT&PF requests that the incidental harassment authorization (IHA) be valid for one year from September 1, 2017 through August 31, 2018. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an authorization to the ADOT&PF to incidentally take, by harassment, small numbers of marine mammals for its ferry terminal improvements project in Gustavus, AK.
Comments and information must be received no later than July 25, 2016.
Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910, and electronic comments should be sent to
Robert Pauline, Office of Protected Resources, NMFS, (301) 427–8401.
NMFS is preparing an Environmental Assessment (EA) in accordance with National Environmental Policy Act (NEPA) and the regulations published by the Council on Environmental Quality and will consider comments submitted in response to this notice as part of that process. The draft EA will be posted at the foregoing Web site once it is finalized.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
On July 31, 2015, NMFS received an application from the ADOT&PF for the taking of marine mammals incidental to reconstructing the existing ferry terminal at Gustavus, Alaska, referred to as the Gustavus Ferry Terminal. On April 15, 2016, NMFS received a revised application. NMFS determined that the application was adequate and complete on April 20, 2016. ADOT&PF proposes to conduct in-water work that may incidentally harass marine mammals (
Proposed activities included as part of the Gustavus Ferry Improvements project with potential to affect marine mammals include vibratory pile driving and pile removal, as well as impact hammer pile driving.
Species with the expected potential to be present during the project timeframe include harbor seal (
The purpose of the project is to improve the vehicle transfer span and dock such that damage during heavy storms is prevented, and to improve the safety of vehicle and pedestrian transfer operations. ADOT&PF requested an IHA for work that includes removal of the existing steel bridge float and restraint structure and replacing it with two steel/concrete bridge lift towers capable of elevating the relocated steel transfer bridge above the water when not in use. Each tower would be supported by four 30-inch steel piles.
Pile installation and extraction associated with the Gustavus Ferry Terminal project will begin no sooner than September 1, 2017 and will be completed no later than August 31, 2018
Pile driving/removal is estimated to occur for a total of about 114 hours over the course of 16 to 50 days.
The proposed activities will occur at the Gustavus Ferry Terminal located in Gustavus, Alaska on the Icy Passage water body in Southeast Alaska (See Figures 1 and 2 in the Application).
ADOT&PF plans to improve the ferry terminal in Gustavus, Alaska. ADOT&PF will remove the existing steel bridge float and restraint structure and replace it with two steel/concrete bridge lift towers capable of elevating the relocated steel transfer bridge above the water when not in use. Each tower would be supported by four 30-inch steel piles. The project would also expand the dock by approximately 4,100 square feet, requiring 34 new 24-inch steel piles; construct a new steel six-pile (24-inch) bridge abutment; relocate the steel transfer bridge, vehicle apron, and aluminum pedestrian gangway; extract 16 steel piles; relocate the log float to the end of the existing float structure (requiring installation of three 12.75-inch steel piles); install a new harbor access float (assembled from a portion of the existing bridge float) and a steel six-pile (30-inch) float restraint structure; and provide access gangways and landing platforms for lift towers and an access catwalk to the existing breasting dolphins. Contractors on previous ADOT&PF dock projects have typically driven piles using the following equipment:
•
•
•
Similar equipment may be used for the proposed project, though each contractor's equipment may vary.
ADOT&PF anticipates driving one to three piles per day, which accounts for setting the pile in place, positioning the barge while working around existing dock and vessel traffic, splicing sections of pile, and driving the piles. Actual pile driving/removal time for nineteen 12.75-inch-, forty 24-inch-, and fourteen 30-inch-diameter steel piles would be approximately 57 hours of impact driving and 114 hours of vibratory driving over the course of 16 to 50 days in 2017. (See Table 1.)
Marine waters in Icy Passage support many species of marine mammals, including pinnipeds and cetaceans. There are nine marine mammal species documented in the waters of Icy Passage (Dahlheim
Although listed on the NMFS MMPA mapper (NMFS 2014), gray whale sightings in Icy Strait are very rare and there have been only eight sightings since 1997 (Janet Neilson, NPS, personal communication). None of these sightings were in Icy Passage. Therefore, exposure of the gray whale to project impacts is considered unlikely and take is not requested for this species.
The range of Pacific white-sided dolphin is also suggested to overlap with the project action area as portrayed on the NMFS MMPA mapper, but no sightings have been documented in the project vicinity (Janet Neilson, NPS, personal communication, Dahlheim
Although they are documented near the ferry terminal, harbor seal populations in Glacier Bay are declining (Janet Neilson, NPS, personal communication). It is estimated that less than 10 individuals are typically seen near the ferry dock during charter boat operations in the spring and summer (Tod Sebens, CSE, Stephen Vanderhoff, SWE, personal communication). Steller sea lions are common in the ferry terminal area during the charter fishing season (May to September) and are known to haul out on the public dock (Bruce Kruger, Alaska Department of Fish and Game (ADF&G), personal communication). The nearest natural Steller sea lion haulout sites are located on Black Rock on the south side of Pleasant Island and Carolus Point west of Point Gustavus (Mathews
There are confirmed sightings of Dall's porpoise, harbor porpoise, humpback whale, killer whale, and minke whale in Icy Passage (Janet Neilson, NPS, Tod Sebens, CSE, Stephen Vanderhoff, SWE, personal communication). However, sightings are less frequent in Icy Passage than in Icy Strait. Opportunistic sightings of marine mammals by NPS during humpback whale surveys and whale watching tour companies operating out of Gustavus (CSE and WSE operate 100 days of tours in the May to September season), provide the following estimates for each spring/summer season:
• Harbor porpoise are seen in Icy Passage on about 75+ percent of trips.
• Three to four minke whale sightings/season in Icy Strait. One or two in Icy Passage.
• Dall's porpoise have four to 12 sightings/season, mostly in Icy Strait.
• Killer whales have about 12 sightings/season in Icy Strait and one or two sightings a year in Icy Passage.
• Humpback whale sightings in Icy Passage are infrequent but on occasion they are seen between the ferry terminal and Pleasant Island (Stephen Vanderhoff, SWE, personal communication).
By most measures, the populations of marine mammals that utilize Icy Strait are healthy and increasing. Populations of humpback whales using Glacier Bay and surrounding areas are increasing by 5.1 percent per year (Hendrix
In the species accounts provided here, we offer a brief introduction to the species and relevant stock that are likely to be taken as well as available information regarding population trends and threats, and describe any information regarding local occurrence.
Harbor seals occurring in Icy Passage belong to the Glacier Bay/Icy Strait (GB/IS) harbor seal stock. The current statewide abundance estimate for this stock is 7,210 (Muto and Angliss 2015). The GB/IS harbor seals have been rapidly declining despite stable or slightly increasing trends in nearby populations (Womble and Gende 2013). A suite of recent studies suggest that (1) harbor seals in Glacier Bay are not significantly stressed due to nutritional constraints, (2) the clinical health and disease status of seals within Glacier Bay is not different than seals from other stable or increasing populations, and (3) disturbance by vessels does not appear to be a primary factor driving the decline. Long-term monitoring of harbor seals on glacial ice has occurred in Glacier Bay since the 1970s and has shown this area to support one of the largest breeding aggregations in Alaska. After a dramatic retreat of Muir Glacier, in the East Arm of Glacier Bay, between 1973 and 1986 (more than 7 kilometers) and the subsequent grounding and cessation of calving in 1993, floating glacial ice was greatly reduced as a haulout substrate for harbor seals and ultimately resulted in the abandonment of upper Muir Inlet by harbor seals.
Steller sea lions occurring in Icy Passage could belong to either the western or eastern U.S. stock. The current total population estimate for the western stock in Alaska is estimated at 49,497 based on 2014 survey results (Muto and Angliss 2015). To get this estimate, pups were counted during the breeding season, and the number of births is estimated from the pup count. The western stock in Alaska shows a positive population trend estimate of 1.67 percent.
The current total population estimate for the eastern stock of Steller sea lions is estimated at 60,131 based on counts made between 2009 and 2014 (Muto and Angliss 2015). To get this estimate, pups were counted during the breeding season, and the number of births is estimated from the pup count. The best available information indicates the eastern stock of Steller sea lion increased at a rate of 4.18 percent per year (90 percent confidence bounds of 3.71 to 4.62 percent per year) between 1979 and 2010 based on an analysis of pup counts in California, Oregon, British Columbia, and Southeast Alaska.
There are no reliable abundance data for the Alaska stock of Dall's porpoise. Surveys for the Alaska stock of Dall's porpoise are greater than 21 years old (Allen and Angliss 2014). A population estimate from 1987 to 1991 was 83,400. Since the abundance estimate is based on data older than eight years, NMFS does not consider the estimate to be valid and the minimum population number is also considered unknown.
There are three harbor porpoise stocks in Alaska, including the Southeast Alaska stock, Gulf of Alaska stock, and the Bering Sea stock. Only the Southeast Alaska stock occurs in the project vicinity. Harbor porpoise numbers for the Southeast Alaska stock are estimated at 11,146 animals (Allen and Angliss 2014). Abundance estimates for harbor porpoise occupying the inland waters of Southeast Alaska were 1,081 in 2012. However, this number may be biased low due to survey methodology.
The central North Pacific stock of humpback whales occurs in the project area. Estimates of this stock are determined by winter surveys in Hawaiian waters. Point estimates of abundance for Hawaii ranged from 7,469 to 10,252; the estimate from the best model was 10,252 (Muto and Angliss 2015). Using the population estimate of 10,252, the minimum estimate for the central North Pacific humpback whale stock is 9,896 (Muto and Angliss 2015).
Since 1985, the NPS has been monitoring humpback whales in both Glacier Bay National Park and Icy Strait and has published annual reports (
Humpback whales are present in Southeast Alaska in all months of the year, but at substantially lower numbers in the fall and winter. At least 10 individuals were found to over-winter near Sitka, and NMFS researchers have documented one whale that over-wintered near Juneau. It is unknown how common over-wintering behavior is in most areas because there is minimal or no photographic identification effort in the winter in most parts of Southeast Alaska. Late fall and winter whale habitat in Southeast Alaska appears to correlate with areas that have over-wintering herring (lower Lynn Canal, Tenakee Inlet, Whale Bay, Ketchikan, Sitka Sound). In Glacier Bay and Icy Strait, the longest sighting interval recorded by NPS was over a span of 219 days, between April 17 and November 21, 2002, but overwintering in this region is expected to be low (Gabriele
Killer whales occurring in Icy Passage could belong to one of three different stocks: Eastern North Pacific Northern residents stock (Northern residents); Gulf of Alaska, Aleutian Islands, and Bering Sea transient stock (Gulf of Alaska transients); or West Coast transient stock. The Northern resident stock is a transboundary stock, and includes killer whales that frequent British Columbia, Canada, and southeastern Alaska (Allen and Angliss 2014). Photo-identification studies since 1970 have catalogued every individual belonging to the Northern resident stock and in 2010 the population was composed of three clans representing a total of 261 whales.
In recent years, a small number of the Gulf of Alaska transients (identified by genetics and association) have been seen in southeastern Alaska; previously only West Coast transients had been seen in the region (Allen and Angliss 2014). Therefore, the Gulf of Alaska transient stock occupies a range that includes southeastern Alaska. Photo-identification studies have identified 587 individual whales in this stock.
The West Coast transient stock includes animals that occur in California, Oregon, Washington, British Columbia, and southeastern Alaska. Analysis of photographic data identifies 243 individual transient killer whales (Muto and Angliss 2015). The total number of transient killer whales reported above should be considered a minimum count for the West Coast transient stock.
The Alaska stock of minke whales occurs in Icy Strait and Southeast Alaska. At this time, it is not possible to produce a reliable estimate of minimum abundance for this wide ranging stock. No estimates have been made for the number of minke whales in the entire North Pacific. Surveys of the Bering Sea, and from Kenai Fjords in the Gulf of Alaska to the central Aleutian Islands, estimate 1,003 and 1,233 animals, respectively (Allen and Angliss 2014).
This section includes a summary and discussion of the ways that stressors, (
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in hertz (Hz) or cycles per second. Wavelength is the distance between two peaks of a sound wave; lower frequency sounds have longer wavelengths than higher frequency sounds and attenuate (decrease) more rapidly in shallower water. Amplitude is the height of the sound pressure wave or the loudness of a sound and is typically measured using the decibel (dB) scale. A dB is the ratio between a measured pressure (with sound) and a reference pressure (sound at a constant pressure, established by
Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Rms is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Rms accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
When underwater objects vibrate or activity occurs, sound pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in all directions away from the source (similar to ripples on the surface of a pond), except in cases where the source is directional. The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.
Even in the absence of sound from the specified activity, the underwater environment is typically loud due to ambient sound. Ambient sound is defined as environmental background sound levels lacking a single source or point (Richardson
•
•
•
•
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10–20 dB from day to day (Richardson
High levels of vessel traffic are known to elevate background levels of noise in the marine environment. For example, continuous sounds for tugs pulling barges have been reported to range from 145 to 166 dB re 1 μPa rms at 1 meter from the source (Miles
In-water construction activities associated with the project include impact and vibratory pile driving and removal. There are two general categories of sound types: Impulse and non-pulse (defined in the following). Vibratory pile driving is considered to be continuous or non-pulsed while impact pile driving is considered to be an impulse or pulsed sound type. The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
The likely or possible impacts of the proposed pile driving program at the Gustavus Ferry Terminal on marine mammals could involve both non-acoustic and acoustic stressors. Potential non-acoustic stressors could result from the physical presence of the equipment and personnel. Any impacts to marine mammals are expected to primarily be acoustic in nature. Acoustic stressors could include effects of heavy equipment operation and pile installation and pile removal at the Ferry Terminal.
When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data, Southall
•
•
•
•
As mentioned previously in this document, seven marine mammal species (five cetacean and two pinniped) may occur in the project area. Of the seven species likely to occur in the proposed project area, two are classified as low frequency cetaceans (
Potential Effects of Pile Driving Sound—The effects of sounds from pile driving might result in one or more of the following: Temporary or permanent hearing impairment; non-auditory physical or physiological effects; behavioral disturbance; and masking (Richardson
In the absence of mitigation, impacts to marine species would be expected to result from physiological and behavioral responses to both the type and strength of the acoustic signature (Viada
Hearing Impairment and Other Physical Effects—Marine mammals exposed to high intensity sound repeatedly or for prolonged periods can experience hearing threshold shift (TS), which is the loss of hearing sensitivity at certain frequency ranges (Kastak
Temporary Threshold Shift—TTS is the mildest form of hearing impairment that can occur during exposure to a strong sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises, and a sound must be stronger in order to be heard. In terrestrial mammals, TTS can last from minutes or hours to days (in cases of strong TTS). For sound exposures at or somewhat above the TTS threshold, hearing sensitivity in both terrestrial and marine mammals recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals, and none of the published data concern TTS elicited by exposure to multiple pulses of sound. Available data on TTS in marine mammals are summarized in Southall
Given the available data, the received level of a single pulse (with no frequency weighting) might need to be approximately 186 dB re 1 μPa
The above TTS information for odontocetes is derived from studies on the bottlenose dolphin (
Permanent Threshold Shift—When PTS occurs, there is physical damage to the sound receptors in the ear. In severe cases, there can be total or partial deafness, while in other cases the animal has an impaired ability to hear sounds in specific frequency ranges (Kryter, 1985). There is no specific evidence that exposure to pulses of sound can cause PTS in any marine mammal. However, given the possibility that mammals close to a sound source can incur TTS, it is possible that some individuals might incur PTS. Single or occasional occurrences of mild TTS are not indicative of permanent auditory damage, but repeated or (in some cases) single exposures to a level well above that causing TTS onset might elicit PTS.
PTS is considered auditory injury (Southall
Relationships between TTS and PTS thresholds have not been studied in marine mammals but are assumed to be similar to those in humans and other terrestrial mammals, based on anatomical similarities. PTS might occur at a received sound level at least several dB above that inducing mild TTS if the animal were exposed to strong sound pulses with rapid rise time. Based on data from terrestrial mammals, a precautionary assumption is that the PTS threshold for impulse sounds (such as pile driving pulses as received close to the source) is at least 6 dB higher than the TTS threshold on a peak-pressure basis and probably greater than 6 dB (Southall
Measured source levels from impact pile driving can be as high as 214 dB rms. Although no marine mammals have been shown to experience TTS or PTS as a result of being exposed to pile driving activities, captive bottlenose dolphins and beluga whales exhibited changes in behavior when exposed to strong pulsed sounds (Finneran
Non-auditory Physiological Effects—Non-auditory physiological effects or injuries that theoretically might occur in marine mammals exposed to strong underwater sound include stress, neurological effects, bubble formation, resonance effects, and other types of organ or tissue damage (Cox
Disturbance includes a variety of effects, including subtle changes in behavior, more conspicuous changes in activities, and displacement. Behavioral responses to sound are highly variable and context-specific and reactions, if any, depend on species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day, and many other factors (Richardson
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Controlled experiments with captive marine mammals showed pronounced behavioral reactions, including avoidance of loud sound sources (Ridgway
With both types of pile driving, it is likely that the onset of pile driving could result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include (Richardson
The biological significance of many of these behavioral disturbances is difficult to predict. However, the consequences of behavioral modification could be expected to be biologically significant if the change affects growth, survival, or reproduction. Significant behavioral modifications that could potentially lead to effects on growth, survival, or reproduction include:
• Changes in diving/surfacing patterns;
• Habitat abandonment due to loss of desirable acoustic environment; and
• Cessation of feeding or social interaction.
The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southall
Auditory Masking—Natural and artificial sounds can disrupt behavior by masking, or interfering with, a marine mammal's ability to hear other sounds. Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher levels. Chronic exposure to excessive, though not high-intensity, sound could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions. Masking can interfere with detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs only during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.
Masking occurs at specific frequency bands, so understanding the frequencies that the animals utilize is important in determining any potential behavioral impacts. Because sound generated from in-water vibratory pile driving is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds made by porpoises. However, lower frequency man-made sounds are more likely to affect detection of communication calls and other potentially important natural sounds, such as surf and prey sound. It may also affect communication signals when they occur near the sound band and thus reduce the communication space of animals (
Masking has the potential to impact species at the population or community levels as well as at individual levels. Masking affects both senders and receivers of the signals and can potentially in certain circumstances have long-term chronic effects on marine mammal species and populations. Recent research suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, and that most of these increases are from distant shipping (Hildebrand, 2009). All anthropogenic sound sources, such as those from vessel traffic, pile driving, and dredging activities, contribute to the elevated ambient sound levels, thus intensifying masking.
Vibratory pile driving may potentially mask acoustic signals important to marine mammal species. However, the short-term duration and limited affected
Acoustic Effects, Airborne—Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.
Airborne noise will primarily be an issue for pinnipeds that are swimming at the surface or hauled out near the project site within the range of noise levels elevated above the acoustic criteria in Table 4 below. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would previously have been taken as a result of exposure to underwater sound above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Multiple incidents of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in increased behavioral disturbance, in either nature or intensity of disturbance reaction. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.
Besides being susceptible to vessel strikes, cetacean and pinniped responses to vessels may result in behavioral changes, including: Greater variability in the dive, surfacing, and respiration patterns; changes in vocalizations; and changes in swimming speed or direction (NRC, 2003). There will be a temporary and localized increase in vessel traffic during construction.
The primary potential impacts to marine mammal habitat are associated with elevated sound levels produced by vibratory and impact pile driving and removal in the area. However, other potential impacts to the surrounding habitat from physical disturbance are also possible.
Fish react to sounds that are especially strong and/or intermittent low-frequency sounds. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. Hastings and Popper (2005) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. Additional studies have documented effects of pile driving on fish, although several are based on studies in support of large, multiyear bridge construction projects (
The most likely impact to fish from pile driving activities at the project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. In general, impacts to marine mammal prey species are expected to be minor and temporary due to the short timeframe for the project.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses. NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, their habitat. 50 CFR 216.104(a)(11). For the proposed project, ADOT&PF worked with NMFS and proposed the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity. The primary purposes of these mitigation measures are to minimize sound levels from the activities, and to shut down operations and monitor marine mammals within designated zones of influence corresponding to NMFS' current Level A and B harassment thresholds, which are depicted in Table 5 found later in the
In addition to the measures described later in this section, ADOT&PF would employ the following standard mitigation measures:
(a) Conduct briefings between construction supervisors and crews, and marine mammal monitoring team, prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
(b) For in-water heavy machinery work other than pile driving (
(c) To limit the amount of waterborne noise, a vibratory hammer will be used for initial driving, followed by an impact hammer to proof the pile to required load-bearing capacity.
We have carefully evaluated ADOT&PF's proposed mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.
Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1 above).
(3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1 above).
(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1 above).
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of ADOT&PF's proposed measures, including information from monitoring of implementation of mitigation measures very similar to those described here under previous IHAs from other marine construction projects, we have determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. ADOT&PF submitted a marine mammal monitoring plan as part of the IHA application. It can be found in Appendix B of the Application. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.
Any monitoring requirement we prescribe should improve our understanding of one or more of the following:
• Occurrence of marine mammal species in action area (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual responses to acute stressors, or impacts of chronic exposures (behavioral or physiological).
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of an individual; or (2) Population, species, or stock.
• Effects on marine mammal habitat and resultant impacts to marine mammals.
• Mitigation and monitoring effectiveness.
(a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance. Use of spotting scopes and binoculars may be necessary to correctly identify the target.
(b) Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience).
(c) Experience or training in the field identification of marine mammals (cetaceans and pinnipeds).
(d) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations.
(e) Writing skills sufficient to prepare a report of observations that would include such information as the number and type of marine mammals observed; the behavior of marine mammals in the project area during construction; dates and times when observations were conducted; dates and times when in-water construction activities were conducted; dates and times when marine mammals were present at or within the defined disturbance or injury zones; dates and times when in-water construction activities were suspended to avoid injury from construction noise; etc.
(f) Ability to communicate orally, by radio or in person, with project personnel to provide real time information on marine mammals observed in the area as necessary.
In order to effectively monitor the pile driving monitoring zones, the MMO will be positioned at the best practical vantage point. The monitoring position may vary based on pile driving activities and the locations of the piles and driving equipment. These may include the catwalk at the ferry terminal, the contractor barge, or another location deemed to be more advantageous. The monitoring location will be identified with the following characteristics: 1. Unobstructed view of pile being driven; 2. Unobstructed view of all water within a 1.9 km (vibratory driving) and 1.6 km (impact driving) radius of each pile; 3. Clear view of pile-driving operator or construction foreman in the event of radio failure; and 4. Safe distance from pile driving activities in the construction area.
A single MMO will be situated on the Ferry Terminal to monitor the appropriate injury and behavioral disturbance zones during all pile driving activities. Because the action area for vibratory driving disturbance extends for 1.9 kilometers from the Gustavus Ferry Terminal into Icy Strait/Passage, it would be difficult to monitor this area effectively with only terminal-based MMOs. Due to potentially severe and highly unpredictable weather conditions, ADOT&PF has concluded that the use of Pleasant Island-based, mainland-based, or vessel-based MMOs would be infeasible and, in many circumstances, unsafe. However, when possible, ADOT&PF will augment land-based monitoring with information from boats in Icy Strait/Passage. Specifically, the MMO will coordinate with the NPS and whale-watching charters for recent observations of marine mammals within Icy Strait/Passage. This will help inform the MMO of marine mammals in the area. NPS and whale-watching charters could also inform monitoring personnel of any marine mammals seen approaching the disturbance zone. The MMO will conduct telephone checks with NPS and whale-watching charters to monitor the locations of humpback whales and Steller sea lions, which are listed under the Endangered Species Act, within Icy Strait/Passage. Checks will begin three days before pile-driving operations to ascertain the location and movements of these listed species in relation to the disturbance zones. Once construction has begun, checks will be made in the evening after the completion of pile driving activities, in preparation of the next day's monitoring. Use of the organizations identified above to augment monitoring efforts will depend on their observation schedules and locations within the Glacier Bay region. It is expected that these organizations will only be active in May and September during the pile-driving season.
The following additional measures apply to visual monitoring:
• Monitoring will begin 30 minutes prior to pile driving. This will ensure that all marine mammals in the monitoring zone are documented and that no marine mammals are present in the injury zone;
• If a marine mammal comes within or approaches the shutdown zone, such operations shall cease. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals. Their behavior will be monitored and documented. The shutdown zone may only be declared clear, and pile driving started, when the entire shutdown zone is visible (
• When a marine mammal is observed, its location will be determined using a rangefinder to verify distance and a GPS or compass to verify heading;
• If any cetaceans or pinnipeds are observed approaching injury zones, impact pile-driving activities will be immediately halted. The MMO will immediately radio to alert the contractor and raise a red flag, requiring an immediate “all-stop.” Impact pile-driving activities will resume when the animal is no longer proximal to the injury zone or 30 minutes have passed without re-sighting the animal near the zone. The observer will continue to monitor the animal until it has left the larger disturbance zones;
• The MMOs will record any cetacean or pinniped present in the disturbance zone;
• MMOs will record all harbor seals present in the in-air disturbance zone. This applies to animals that are hauled out and those that have surfaced while swimming;
• At the end of the pile-driving day, post-construction monitoring will be conducted for 30 minutes beyond the cessation of pile driving;
• If any cetaceans or pinnipeds are observed approaching the 10-meter exclusion zone, heavy equipment activities will be immediately halted. The observer will immediately radio to alert the contractor and raise a red flag, requiring an immediate “all-stop.” Observers will continue to monitor the animal after it has left the injury zone, if visible;
• If any marine mammal species are encountered during activities that are not listed in Table 1 for authorized taking and are likely to be exposed to SPLs greater than or equal to 160 dB re 1 μPa (rms) for impact driving and 120 dB re 1 μPa (rms), then the Holder of this Authorization must stop pile driving activities and report observations to NMFS' Office of Protected Resources;
• If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal shutdown zone (
• Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted; and
• Pile driving in September or May will end by approximately 5:00 p.m. local time to avoid the late afternoon period when most fishing charters return to the public dock adjacent to the Ferry Terminal. This is also the time of
Observers are required to use approved data forms. Among other pieces of information, ADOT&PF will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the ADOT&PF will attempt to distinguish between the number of individual animals taken and the number of incidents of take. At a minimum, the following information will be collected on the sighting forms:
• Date and time that monitored activity begins or ends;
• Construction activities occurring during each observation period;
• Weather parameters (
• Water conditions (
• Species, numbers, and, if possible, sex and age class of marine mammals;
• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
• Locations of all marine mammal observations; and
• Other human activity in the area.
ADOT&PF will notify NMFS prior to the initiation of the pile driving activities and will provide NMFS with a draft monitoring report within 90 days of the conclusion of the proposed construction work. This report will detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. If no comments are received from NMFS within 30 days of submission of the draft final report, the draft final report will constitute the final report. If comments are received, a final report must be submitted within 30 days after receipt of comments.
Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . .any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”
All anticipated takes would be by Level B harassment resulting from vibratory and impact pile driving and involving temporary changes in behavior. The proposed mitigation and monitoring measures are expected to minimize the possibility of injurious or lethal takes such that take by Level A harassment, serious injury, or mortality is considered discountable. However, it is unlikely that injurious or lethal takes would occur even in the absence of the planned mitigation and monitoring measures.
Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound.
ADOT&PF has requested authorization for the incidental taking of small numbers of marine mammals near the Gustavus Ferry Terminal that may result from impact pile driving, vibratory pile driving and vibratory pile removal. In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider in combination with information about marine mammal density or abundance in the project area. We first provide information on applicable sound thresholds for determining effects to marine mammals before describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take.
We use the generic sound exposure thresholds shown in Table 4 to determine when an activity that produces underwater sound might result in impacts to a marine mammal such that a take by harassment might occur.
The sound field in the project area is the existing ambient noise plus additional construction noise from the proposed project. The primary components of the project expected to affect marine mammals are the sounds generated by impact pile driving, vibratory pile driving, and vibratory pile removal.
In order to calculate the Level A and Level B sound thresholds, ADOT&PF used acoustic monitoring data for this project that had been collected at the Kake Ferry Terminal, located approximately 115 miles south of the project area (MacGillvray
The Gustavus Ferry Terminal improvement project proposes to use
The formula below is used to calculate underwater sound propagation. Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
NMFS typically recommends a default practical spreading loss of 15 dB per tenfold increase in distance. ADOT&PF analyzed the available underwater acoustic data utilizing the practical spreading loss model.
The practical spreading loss model estimates small injury zones for whales (76 m) and pinnipeds (16 m) for pulsed sound generated by piles driven by an impact pile driver within the project area. The disturbance zone for impact pile driving is larger, at approximately 1.6 km from the driven pile for all marine mammals. The disturbance zone for continuous noise generated by a vibratory hammer is similar, predicted to extend for 1.9 km from the pile to an ambient background level of 120 dB. For airborne sound, the Level B disturbance threshold is calculated at 163 m for harbor seals and 51 m for other pinnipeds during impact driving and 36 m for harbor seals during vibratory driving. The selected sound level of 97 dB for vibratory driving is below the 100 dB disturbance threshold for other pinnipeds, so there is no disturbance zone for other pinniped species.
Note that the actual area ensonified by pile driving activities is significantly constrained by local topography relative to the total threshold radius. The actual ensonified area was determined using a straight line-of-sight projection from the anticipated pile driving locations. Distances to the underwater sound isopleths for Level B and Level A are illustrated respectively in Figure 2 and Figure 3 in the Application.
The method used for calculating potential exposures to impact and vibratory pile driving noise for each threshold uses local marine mammal data sets and data from IHA estimates on similar projects with similar actions. All estimates are conservative and include the following assumptions:
• All pilings installed at each site would have an underwater noise disturbance equal to the piling that causes the greatest noise disturbance (
• Exposures were based on estimated work days. Between 16 and 50 work days of pile driving and removal will be required for the proposed project. NMFS will assume that a full 50 days are required to complete pile driving and removal activities.
The calculation for marine mammal exposures, except for Dall's porpoise and killer whales, was estimated using the following:
The methods for the calculation of exposures for Dall's porpoise and killer whales is described under those respective species below.
There are no documented haulout sites for harbor seals in the vicinity of the project. The nearest haulouts, rookeries, and pupping grounds occur in Glacier Bay over 20 miles from the ferry terminal. However, occasionally an individual will haul out on rocks on the north side of Pleasant Island (Stephen Vanderhoff, SWE, personal communication). A recent study of post-breeding harbor seal migrations from Glacier Bay demonstrates that some harbor seals traveled extensively beyond the boundaries of Glacier Bay during the post-breeding season (Womble and Gende 2013). Strong fidelity of individuals for haulout sites during the breeding season was documented in this study as well.
Harbor seals have declined dramatically in Glacier Bay region over the past few decades which may be a reason why there are few observations at the Gustavus Ferry Terminal. Sightings of harbor seals around the ferry terminal used to be more common (Stephen Vanderhoff, SWE, personal communication). NPS has documented one harbor seal observation near the terminal. It is estimated that less than 10 individuals are seen near the ferry dock during charter boat operations from mid- to late-May through September (Tod Sebens, CSE, Stephen Vanderhoff, SWE, Bruce Kruger, ADF&G, personal communication). Harbor seals are also documented in Icy Passage in the winter and early spring (Womble and Gende 2013).
For this analysis, we take a conservative estimate and assume that four harbor seals could be present on any day of pile driving regardless of when the pile driving is conducted (Spring and Fall 2017). Two seals would
•
NMFS proposes authorization for 200 Level B acoustical harassment takes of harbor seals. It is likely that one or more animals will be taken on repeated or subsequent days. Therefore, the number of individual animals taken will likely be less than 200.
There are numerous Steller sea lion haulouts in Icy Strait but none occurring in Icy Passage (Mathews
Steller sea lions are common in the ferry terminal area during the charter fishing season (May to September) and are known to haul out on the public dock (Tod Sebens, CSE, Stephen Vanderhoff, SWE, Janet Neilson, NPS, personal communication Bruce Kruger, ADF&G, personal communication). During the charter fishing season, Steller sea lions begin arriving at the ferry terminal as early as 2:00 p.m. local time, reaching maximum abundance when the charter boats return at approximately 5:00 p.m. local time. The sea lions forage on the carcasses of the sport fish catch and then vacate the area. For the sake of our analysis we propose at least 10 animals will be present every day during charter fishing season. Outside of the charter fishing season, it is assumed that two Steller sea lions may transit in front of the ferry terminal to and from foraging grounds.
For the purpose of our analysis we conservatively estimate that two Steller sea lions will transit within the disturbance zones each day during the months of October and November of 2017 as well as March and April of 2018. We estimate, conservatively, that up to 10 individuals may be present each day in the months of September 2017 and May 2018 during the charter fishing season.
We also assume that 33 total combined days of pile driving/removal will occur in October and November, 2017 as well as in March and April, 2018. Seventeen combined driving days will occur in September, 2017 and May, 2018. Using these estimates we calculate the following number of Steller sea lions may be present in the disturbance zone:
The underwater take estimate for March through November is 236 animals. NMFS proposes authorization for 236 Level B acoustical harassment takes of Steller sea lions. Note that a small number of Steller sea lions (up to five) may have become habituated to human activity and, therefore, it is highly likely that there will be numerous repeated takes of these same animals. (Kruger, ADF&G, personal communication).
Dall's porpoise are documented in Icy Strait but not Icy Passage. Dahlheim
Based on observations of local marine mammal specialists, Dall's porpoise are uncommon in Icy Passage. However, they do occur in Icy Strait and could potentially transit through the disturbance zone. For this analysis, we take the maximum number of 12 sightings per season between May and September, which equates to 2.4 sightings per month. Using this number it is estimated that the following number of Dall's porpoise may be present in the disturbance zone:
Harbor porpoise are common in Icy Strait. Concentrations of harbor porpoise were consistently found in varying habitats surrounding Zarembo Island and Wrangell Island, and throughout the Glacier Bay and Icy Strait regions (Dahlheim
Harbor porpoise could potentially transit through the disturbance zone during pile driving activity. For this analysis we take a conservative estimate and assume that four harbor porpoise (two pods of two per day) could be present on any of the 50 days of pile driving. Using this number it is estimated that the following number of harbor porpoise may be present in the disturbance zone:
Underwater exposure estimate:
NMFS is proposing authorization for 200 Level B acoustical harassment takes of harbor porpoise.
From May to September, humpback whales congregate and forage in nearby Glacier Bay and in Icy Strait. Since 1985, the NPS has been monitoring humpback whales in both Glacier Bay National Park and Icy Strait and publishing annual reports (
In 2013, 237 humpback whales were documented in Icy Strait during the NPS monitoring period; this was a 14 percent increase over the previous high count of 177 whales in 2012 (Neilson
Based on these observations humpback whales appear to be common in Icy Strait and are occasionally seen in Icy Passage. However, NPS believes that whale abundance decreases substantially in September through November and March through April, but has limited data for these periods. For this analysis, we take a conservative estimate and assume that two humpback whales could be present in the disturbance zone on any day of the 50 days of pile driving. Using this number it is estimated that the following number of humpback whales may be present in the disturbance zone:
Underwater exposure estimate:
Based on observations of local marine mammal specialists, the probability of killer whales occurring in Icy Passage is low. However, they do occur in Icy Strait and could potentially transit through the disturbance zone in Icy Passage. Since there is no density information available for killer whales in this area, we assumed a pod size of 27 for resident and six for transient killer whales, based on an average of group sizes observed during surveys in Spring and Fall in Southeast Alaska between 1991 and 2007 (Dalheim
Based on observations of local marine mammal specialists, the probability of minke whales occurring in Icy Passage is low. However, they have been documented in Icy Strait and could potentially transit through the disturbance zone. For this analysis, we take a conservative estimate and assume that one minke whale could be present on any one day during the 50 days of pile driving. Using this number it is estimated that the following number of minke whales may be present in the disturbance zone:
Underwater exposure estimate:
NMFS is therefore proposing authorization for 50 Level B acoustical harassment takes of minke whales.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analyses applies to all the species listed in Table 1. There is little information about the nature of severity of the impacts or the size, status, or structure of any species or stock that would lead to a different analysis for this activity.
Pile driving and pile extraction activities associated with the Gustavus Ferry Terminal improvements project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in Level B harassment (behavioral disturbance) for all species authorized for take, from underwater sound generated from pile driving and removal. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving or drilling is under way.
The takes from Level B harassment will be due to potential behavioral disturbance and potential TTS. Serious injury or death is unlikely for all authorized species and injury is unlikely for these species, as ADOT&PF will enact several required mitigation measures. Soft start techniques will be employed during pile driving operations to allow marine mammals to vacate the area prior to commencement of full power driving. ADOT&PF will establish and monitor shutdown zones for authorized species, which will prevent injury to these species. ADOT&PF will also record all occurrences of marine mammals and any behavior or behavioral reactions observed, any observed incidents of behavioral harassment, and any required shutdowns, and will submit a report upon completion of the project. We have determined that the required mitigation measures are sufficient to reduce the effects of the specified activities to the level of effecting the least practicable adverse impact upon the affected species, as required by the MMPA.
The ADOT&PF's proposed activities are localized and of short duration. The entire project area is limited to the Gustavus Ferry Terminal area and its immediate surroundings. Specifically,
The project also is not expected to have significant adverse effects on affected marine mammals' habitat. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
In summary, this negligible impact analysis is founded on the following factors: (1) The possibility of serious injury or mortality to authorized species may reasonably be considered discountable; (2) the anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior and; (3) the presumed efficacy of the planned mitigation measures in reducing the effects of the specified activity to the level of effecting the least practicable adverse impact upon the affected species. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The specified activity is not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the planned monitoring and mitigation measures, NMFS finds that the total marine mammal take from ADOT&PF's Gustavus Ferry terminal improvement project will have a negligible impact on the affected marine mammal species or stocks.
Table 6 demonstrates the number of animals that could be exposed to received noise levels that could cause Level B behavioral harassment for the proposed work at the Gustavus Ferry Terminal project. The analyses provided above represents between 0.39–27.1 percent of the populations of these stocks that could be affected by harassment, except for Minke whales and Dall's porpoise, since their population numbers are unknown. While the proposed West Coast transient and Northern resident killer whale takes and percentages of stock affected appears high (27.1 percent and 25.3 percent), in reality only 66 transient killer whale individuals are not likely to be harassed. Instead, it is more likely that there will be multiple takes of a smaller number of individuals. Both the West coast transient stock and the Northern Resident stock range from southeastern Alaska, through British Columbia, and into northern Washington. It is unlikely that such a large portion of either stock with ranges of this size would be concentrated in and around Icy Passage.
Furthermore, though there is not a current abundance estimate, the proposed take of 43 Dall's porpoise and
Note that the numbers of animals authorized to be taken for all species, with the exception of resident killer whales, would be considered small relative to the relevant stocks or populations even if each estimated taking occurred to a new individual—an extremely unlikely scenario.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
The proposed Gustavus Ferry Terminal Improvements project will occur near but not overlap the subsistence area used by the villages of Hoonah and Angoon (Wolfe
There are two marine mammal species that are listed as endangered under the ESA with confirmed or possible occurrence in the study area: humpback whale and Steller sea lion (Western DPS). NMFS' Permits and Conservation Division has initiated consultation with NMFS' Protected Resources Division under section 7 of the ESA on the issuance of an IHA to ADOT&PF under section 101(a)(5)(D) of the MMPA for this activity. Consultation will be concluded prior to a determination on the issuance of an IHA.
NMFS is preparing an EA in accordance with the NEPA and will consider comments submitted in response to this notice as part of that process. The draft EA will be posted at
As a result of these preliminary determinations, NMFS proposes to issue an IHA to ADOT&PF for reconstructing the existing Gustavus Ferry Terminal located in Gustavus, Alaska, Alaska, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.
1. This Incidental Harassment Authorization (IHA) is valid from September 1, 2017 through August 31, 2018.
2. This Authorization is valid only for in-water construction work associated with the reconstruction of the existing Gustavus Ferry Terminal located in Gustavus, Alaska.
3. General Conditions.
(a) A copy of this IHA must be in the possession of the Alaska Department of Transportation & Public Facilities (ADOT&PF), its designees, and work crew personnel operating under the authority of this IHA.
(b) The species authorized for taking are harbor seal (
(c) The taking, by Level B harassment only, is limited to the species listed in condition 3(b).
(d) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in condition 3(b) of the Authorization or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.
4. Mitigation Measures.
The holder of this Authorization is required to implement the following mitigation measures:
(a) Time Restriction: For all in-water pile driving activities, ADOT&PF shall operate only during daylight hours when visual monitoring of marine mammals can be conducted;
(b) To limit the amount of waterborne noise, a vibratory hammer will be used for initial driving, followed by an impact hammer to proof the pile to required load-bearing capacity;
(c) Establishment of Level B Harassment Zones of Influence (ZOIs):
(i) Before the commencement of in-water pile driving activities, ADOT&PF shall establish Level B behavioral harassment ZOIs where received underwater sound pressure levels (SPLs) are higher than 160 dB (rms) and 120 dB (rms) re 1 µPa for impulse noise sources (impact pile driving) and non-pulse sources (vibratory hammer), respectively; and
(ii) The ZOIs delineate where Level B harassment would occur. For impact driving, the area within the Level B harassment threshold is between approximately 76 m and 1.6 km. For vibratory driving, the level B harassment area is between 10 m and 1.9 km.
(d) Establishment of shutdown zone—Implement a minimum shutdown zone around the pile of 76 m radius during impact pile driving and 10 m during vibratory driving activities. If a marine mammal comes within or approaches the shutdown zone, such operations shall cease.
(e) Use of Soft-start:
(i) The project will utilize soft start techniques for impact pile driving. Contractors shall be required to provide an initial set of three strikes from the impact hammer at 40 percent reduced energy, followed by a thirty-second
(ii) Whenever there has been downtime of 20 minutes or more without vibratory or impact driving, the contractor will initiate the driving with soft-start procedures described above.
(f) Standard mitigation measures:
(i)(e) ADOT&PF shall conduct briefings between construction supervisors and crews, marine mammal monitoring team, and staff prior to the start of all in-water pile driving, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures; and
(ii) For in-water heavy machinery work other than pile driving (using,
5. Monitoring and Reporting.
The holder of this Authorization is required to report all monitoring conducted under the IHA within 90 calendar days of the completion of the marine mammal monitoring. This report shall detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. If no comments are received from NMFS within 30 days of submission of the draft final report, the draft final report will constitute the final report. If comments are received, a final report must be submitted within 30 days after receipt of comments:
(a) Marine Mammal Observers (MMOs) must have the following qualifications:
(i) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance. Use of spotting scopes and binoculars may be necessary to correctly identify the target;
(ii) Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);
(iii) Experience or training in the field identification of marine mammals (cetaceans and pinnipeds);
(iv) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
(v) Writing skills sufficient to prepare a report of observations that would include such information as the number and type of marine mammals observed; the behavior of marine mammals in the project area during construction; dates and times when observations were conducted; dates and times when in-water construction activities were conducted; dates and times when marine mammals were present at or within the defined disturbance or injury zones; dates and times when in-water construction activities were suspended to avoid injury from construction noise; etc; and
(vi) Ability to communicate orally, by radio or in person, with project personnel to provide real time information on marine mammals observed in the area as necessary.
(b) Visual Marine Mammal Monitoring and Observation:
(i) During impact pile driving, one MMO shall monitor the 1.6-kilometer disturbance zone from the Gustavus Ferry Terminal. The smaller injury zone of 76 meters for whales and 16 meters for pinnipeds will also be monitored by a MMO during impact pile driving. During vibratory driving, one MMO shall monitor the 1.9 km disturbance zone from the Gustavus Ferry Terminal;
(ii) At the beginning of each day, the observer shall determine their vantage positions using a handheld GPS unit. If a MMO changes position throughout the day, each new position will also be determined using a hand-held GPS unit;
(iii) Monitoring shall begin 30 minutes prior to impact pile driving;
(iv) If all marine mammals in the disturbance zone have been documented and no marine mammals are in the injury zone, the coordinator shall instruct the contractor to initiate the soft-start procedure for any impact pile driving;
(v) When a marine mammal is observed, its location shall be determined using a rangefinder to verify distance and a GPS or compass to verify heading;
(vi) If marine mammals listed in 3(b) are observed nearing their respective injury zones, pile-driving activities shall be immediately shut down. Operations shall continue after the animal has been spotted out of the zone or 30 minutes have passed without re-sighting the animal in the zones;
(vii) The MMO shall record all cetaceans and pinnipeds present in the disturbance zones;
(ix) The observer will use their naked eye with the aid of binoculars and a spotting scope to search continuously for marine mammals;
(x) During the in-water operation of heavy machinery (
(xi) At the end of the pile-driving day, post-construction monitoring will be conducted for 30 minutes beyond the cessation of pile driving; and
(xii) If waters exceed a sea-state which restricts the MMO's ability to make observations within the marine mammal shutdown zone (
(c) During pile driving, one MMO shall be positioned at the best practical vantage point. The monitoring position will be on the ferry terminal, but may vary based on pile driving activities and the locations of the piles and driving equipment. The monitoring location will be identified with the following characteristics:
(i) Unobstructed view of pile being driven;
(ii) Unobstructed view of all water within a 1.6 km (impact driving) or 1.9 km (vibratory driving) radius of each pile;
(iii) Clear view of pile-driving operator or construction foreman in the event of radio failure; and
(iv) Safe distance from pile-driving activities in the construction area.
(d) When possible, ADOT&PF shall augment land-based monitoring with information from boats in Icy Strait/Passage by coordinating with the NPS and whale-watching charters. The MMO shall conduct telephone checks with NPS and whale-watching charters to monitor the locations of humpback whales and Steller sea lions within Icy Strait/Passage.
(e) Data Collection:
Observers are required to use approved data forms. Among other pieces of information, ADOT&PF will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, ADOT&PF will attempt to distinguish between the number of individual animals taken and the number of incidents of take. At a minimum, the following information shall be recorded on the sighting forms:
1. Date and time that monitored activity begins or ends;
2. Construction activities occurring during each observation period;
3. Weather parameters (
4. Water conditions (
5. Species, numbers, and, if possible, sex and age class of marine mammals;
6. Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
7. Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
8. Locations of all marine mammal observations; and
9. Other human activity in the area.
(f) Reporting Measures:
(i) In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA, such as an injury (Level A harassment), serious injury or mortality (
1. Time, date, and location (latitude/longitude) of the incident;
2. Name and type of vessel involved;
3. Vessel's speed during and leading up to the incident;
4. Description of the incident;
5. Status of all sound source use in the 24 hours preceding the incident;
6. Water depth;
7. Environmental conditions (
8. Description of all marine mammal observations in the 24 hours preceding the incident;
9. Species identification or description of the animal(s) involved;
10. Fate of the animal(s); and
11. Photographs or video footage of the animal(s) (if equipment is available);
(ii) Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with ADOT&PF to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. ADOT&PF would not be able to resume their activities until notified by NMFS via letter, email, or telephone;
(iii) In the event that ADOT&PF discovers an injured or dead marine mammal, and the lead MMO determines that the cause of the injury or death is unknown and the death is relatively recent (
(iv) In the event that ADOT&PF discovers an injured or dead marine mammal, and the lead MMO determines that the injury or death is not associated with or related to the activities authorized in the IHA (
6. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if NMFS determines the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.
NMFS requests comment on our analysis, the draft authorization, and any other aspect of the Notice of Proposed IHA for ADOT&PF's reconstruction of the existing Gustavus Ferry Terminal located in Gustavus, Alaska. Please include with your comments any supporting data or literature citations to help inform our final decision on ADOT&PF's request for an MMPA authorization.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
In accordance with the Marine Mammal Protection Act (MMPA), we, NMFS, hereby issue a permit for a period of three years to authorize the incidental, but not intentional, taking of individuals from three marine mammal stocks listed under the Endangered Species Act (ESA) by the Bering Sea and Aleutian Islands (BSAI) pollock trawl and BSAI flatfish trawl fisheries: The Western North Pacific (WNP) stock of humpback whales (
This permit is effective for a three-year period beginning June 23, 2016.
Reference materials for this permit, including the negligible impact determination (NID), are available on the Internet at
Jon Kurland, NMFS Alaska Region, 907–586–7638,
Pursuant to section 101(a)(5)(E) of the MMPA, 16 U.S.C. 1361
We are issuing a permit under MMPA section 101(a)(5)(E) to vessels registered in the BSAI pollock trawl and BSAI flatfish trawl fisheries to incidentally take individuals from the WNP and CNP stocks of humpback whales and the Western U.S. stock of Steller sea lions. Humpback whales and the western Distinct Population Segment of Steller sea lions are listed as endangered under the ESA. We have determined that incidental taking from these fisheries will have a negligible impact on these stocks, as documented in our NID (see
We recognize that a proposed change to the ESA listing for humpback whales (80 FR 22303 April 21, 2015), if finalized, might affect the need for an MMPA 101(a)(5)(E) permit for these fisheries to incidentally take humpback whales. However, we are including humpback whales in this permit because the species is currently listed as endangered.
Our proposed permit and draft NID addressed two other marine mammals (the Alaska stocks of bearded and ringed seals) and one other fishery (the BSAI Pacific cod longline fishery) (80 FR 78711, December 17, 2015). On July 25, 2014, the U.S. District Court for the District of Alaska issued a memorandum decision in a lawsuit challenging the listing of bearded seals under the ESA (
A description of the two permitted fisheries can be found in the NID and the
As described above, prior to issuing the permit, we must determine if M/SI incidental to commercial fisheries will have a negligible impact on the affected marine mammal species or stocks. We satisfied this requirement through completion of a NID (see
Although the MMPA does not define “negligible impact,” we have issued regulations providing a qualitative definition of “negligible impact” as defined in 50 CFR 216.103, and through scientific analysis, peer review, and public notice developed a quantitative approach. As it applies here, the definition of “negligible impact” is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to adversely affect the species or stock through effects on annual rates of recruitment or survival.” The development of the approach is outlined in detail in the NID and was described in previous notices for other permits to take threatened or endangered marine mammals incidental to commercial fishing (
In 1999, we proposed criteria to determine whether M/SI incidental to commercial fisheries will have a negligible impact on a listed marine mammal stock for MMPA section 101(a)(5)(E) permits (64 FR 28800, May 27, 1999). In applying the 1999 criteria, Criterion 1 is whether total known, assumed, or extrapolated human-caused M/SI is less than 10 percent of the potential biological removal level (PBR) for the stock. If total known, assumed, or extrapolated human-caused M/SI is less than 10 percent of PBR, the analysis would be concluded, and the impact would be determined to be negligible. If Criterion 1 is not satisfied, we may use one of the other criteria as appropriate. Criterion 2 is satisfied if the total known, assumed, or extrapolated human-caused M/SI is greater than PBR, but fisheries-related M/SI is less than 10 percent of PBR. If Criterion 2 is satisfied, vessels operating in individual fisheries may be permitted if management measures are being taken to address non-fisheries-related mortality and serious injury. Criterion 3 is satisfied if total fisheries-related M/SI is greater than 10 percent of PBR and less than PBR, and the population is stable or increasing. Fisheries may then be permitted subject to individual review and certainty of data. Criterion 4 stipulates that if the population abundance of a stock is declining, the threshold level of 10 percent of PBR will continue to be used. Criterion 5 states
The NID provides a complete analysis of the criteria for determining whether commercial fisheries off Alaska are having a negligible impact on the WNP or CNP stocks of humpback whales or the Western U.S. stock of Steller sea lions. A summary of the analysis and subsequent determination follows. The analysis is based on the 2014 marine mammal stock assessment reports (SARs), which estimate mean or minimum annual mortality for 2008–2012 from observed commercial fisheries and entanglement data from the NMFS Marine Mammal Health and Stranding Network. This is the most recent five-year period for which data were available and had been analyzed when the proposed permit and draft NID were being developed. In cases where available observer data are only available outside that time frame, as is the case for state-managed fisheries, the most recent observer data are used.
Total fisheries-related M/SI per year (0.9, 30 percent of PBR) is greater than 10 percent of the stock's PBR but less than PBR (3.0). We expect only minor fluctuations in fisheries-related M/SI. The stock is considered to be increasing: The most recent abundance estimate represents a 6.7 percent annual rate of increase over the previous (1991–1993) estimate, though this rate is biased high to an unknown degree. Therefore, using Criterion 3 we determine that M/SI incidental to commercial fishing will have a negligible impact on the stock.
CNP humpback whales represent a case not considered by the existing criteria, but data support a negligible impact determination. Total annual human-caused M/SI (15.89, 19.19 percent of PBR) is well below the Criterion 2 M/SI threshold (
Total fisheries related M/SI per year (32.7, 11.2 percent of PBR) is greater than 10 percent of the stock's PBR, but less than PBR (292). We expect only minor fluctuations in fisheries-related M/SI. The level of total human-caused M/SI is estimated to be below PBR and is expected to remain below PBR for the foreseeable future. Survey data collected since 2000 indicate that Steller sea lion decline continues in the central and western Aleutian Islands but regional populations east of Samalga Pass have increased or are stable. Overall, the stock is increasing at an annual rate of 1.67 percent (non-pups) and 1.45 percent (pups). Therefore, using Criterion 3 we determine that M/SI incidental to commercial fishing will have a negligible impact on this stock.
In conclusion, based on the negligible impact criteria outlined in 1999 (64 FR 28800), the 2014 Alaska SARs, and the best scientific information and data available for the time period analyzed in this permit, we have determined that for a period of up to three years, M/SI incidental to the BSAI pollock trawl and BSAI flatfish trawl fisheries will have a negligible impact on the WNP and CNP stocks of humpback whales and the Western U.S. stock of Steller sea lions.
The impacts on the human environment of continuing and modifying the Bering Sea trawl fisheries, including the taking of threatened and endangered species of marine mammals, were analyzed in the 2004 Alaska Groundfish Fisheries Programmatic Supplemental Environmental Impact Statement (PSEIS). The 2015 Alaska Groundfish Fisheries PSEIS Supplemental Information Report reviewed new information since 2004 and concluded that a new PSEIS was not necessary because (1) management changes to the fisheries since 2004 do not constitute a substantial change in the action, and all changes are consistent with the preferred alternative evaluated in the PSEIS, (2) the current status of the resources can be considered within the range of variability analyzed in the 2004 PSEIS, and (3) although new information exists regarding the impacts of the groundfish fisheries on resources, no information indicates that a new analysis would conclude that there is now a significant impact where the 2004 PSEIS concludes that the impact was insignificant.
Because this permit would not modify any fishery operation and the effects of the fishery operations have been evaluated fully in accordance with NEPA, no additional NEPA analysis is required for this permit. Issuing the permit would have no additional impact to the human environment or effects on threatened or endangered species beyond those analyzed in these documents.
Section 4(f) of the ESA requires that we develop recovery plans for ESA-listed species, unless such a plan will not promote the conservation of the species. Recovery Plans for humpback whales and Steller sea lions have been completed (see
MMPA section 118(c) requires that vessels participating in Category I and II fisheries register to obtain an authorization to take marine mammals incidental to fishing activities. Further, section 118(c)(5)(A) provides that registration of vessels in fisheries should, after appropriate consultations, be integrated and coordinated to the maximum extent feasible with existing fisher licenses, registrations, and related programs. MMPA registration for participants in the BSAI trawl fisheries has been integrated with the Federal groundfish limited entry permit process of the Federal Vessel Monitoring System.
BSAI trawl fisheries authorized under this permit are monitored by NMFS-certified observers in the North Pacific Groundfish Observer Program. Observer coverage rates range from 50–100 percent. Accordingly, as required by MMPA section 118, a monitoring program is in place for the BSAI pollock trawl and flatfish trawl fisheries.
MMPA section 118 requires the development and implementation of a TRP in cases where a strategic stock interacts with a Category I or II fishery. The stocks covered under this permit are designated as strategic stocks under the MMPA because they are listed as endangered under the ESA (MMPA section 3(19)(C)). The two fisheries covered by this permit are Category II fisheries. Therefore, the three listed stocks and two fisheries meet the MMPA's triggers for convening a take reduction team (TRT) and developing a TRP.
The obligations to develop and implement a TRP are further subject to the availability of funding. MMPA section 118(f)(3) contains specific priorities for developing TRPs. At this
As described above, all of the requirements to issue a permit to Federally-managed BSAI pollock trawl and BSAI flatfish trawl fisheries have been satisfied. Accordingly, we hereby issue a permit to participants in these two fisheries to incidentally take individuals from the WNP and CNP stocks of humpback whales and the Western U.S. stock of Steller sea lions. As noted under MMPA section 101(a)(5)(E)(ii), no permit is required for vessels in Category III fisheries. For incidental taking of marine mammals to be authorized in Category III fisheries, M/SI must be reported to NMFS. If we determine at a later date that incidental M/SI from commercial fishing is having more than a negligible impact on these stocks, we may use our emergency authority under MMPA section 118 to protect the stocks and may modify the permit issued herein.
MMPA section 101(a)(5)(E) requires NMFS to publish in the
NMFS received three comment letters on the proposed permit and draft NID. The Marine Mammal Commission (Commission) supported issuing the permit while two other commenters, Center for Biological Diversity (Center) and an individual, opposed issuing the permit. Only comments pertaining to the draft NID and proposed permit are responded to in this notice.
Take of ESA-listed marine mammals in state-managed fisheries is subject to the same prohibitions as federally-managed fisheries. But, without the federal nexus, ESA section 7 does not apply to state fisheries. States are responsible for applying for an incidental take permit under ESA
MMPA section 118 provides the framework for addressing marine mammal interactions in commercial fisheries nationwide and includes various metrics and guidance for managing the take reduction program as a whole. First, the program authorizes incidental take of non-ESA-listed marine mammals in commercial fisheries classified as Category I or II (no authorization is required for Category III fisheries). Then, the program directs efforts to reduce M/SI incidental to commercial fisheries and provides for priority-setting when funding is limited. TRPs can and do address marine mammal M/SI in state-managed fisheries. NMFS can authorize incidental take of endangered marine mammals in state fisheries, but is not doing so through this action.
The commenter notes that stocks without minimum abundance estimates are precluded from being considered in the LOF tier analysis, thereby precluding any fisheries that kill or seriously injure those stocks from being classified as Category I or II fisheries. This is incorrect. NMFS may classify fisheries by analogy to other similar fisheries based on various factors (50 CFR 229.2). The commenter references other Category I and II fisheries that take sperm whales, including two pelagic longline fisheries and a drift gillnet fishery. These gear types are not analogous to the GOA sablefish longline fishery, which is a demersal longline fishery, in that the gear used and the fishing practices are substantially different from one another. Both fishing gear and fishing practices are typically related to the risk of entanglement. That said, NMFS will conduct a full evaluation of this stock and this fishery pursuant to the LOF.
Notice and request for comment.
The United States Patent and Trademark Office (USPTO), 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 this continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)).
Written comments must be submitted on or before August 22, 2016.
You may submit comments by any of the following methods:
•
•
•
Requests for additional information should be directed to Kyu Lee, Office of General Law, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450; by telephone at 571–272–6421; or by email at
The purpose of this collection is to cover information requirements related to civil actions and claims involving current and former employees of the United States Patent and Trademark Office (USPTO). The rules for these legal processes may be found under 37 CFR part 104, which outlines procedures for service of process, demands for employee testimony and production of documents in legal proceedings, reports of unauthorized testimony, employee indemnification, and filing claims against the USPTO under the Federal Tort Claims Act (28 U.S.C. 2672) and the corresponding Department of Justice regulations (28 CFR part 14). The public may also petition the USPTO Office of General Counsel under 37 CFR 104.3 to waive or suspend these rules in extraordinary cases.
The procedures under 37 CFR part 104 ensure that service of process intended for current and former employees of the USPTO is handled properly. The USPTO will only accept service of process for an employee acting in an official capacity. This collection is necessary so that respondents or their representatives can serve a summons or complaint on the USPTO, demand employee testimony and documents related to a legal proceeding, or file a claim under the Federal Tort Claims Act. Respondents may also petition the USPTO to waive or suspend these rules for legal processes. This collection is also necessary so that current and former USPTO employees may properly forward service and demands to the Office of General Counsel, report unauthorized testimony, and request indemnification. The USPTO covers current employees as respondents under this information collection even though their responses do not require approval under the Paperwork Reduction Act. In those instances where both current and former employees may respond to the USPTO, the agency estimates that the number of respondents will be small.
There are no forms provided by the USPTO for this collection. For filing claims under the Federal Tort Claims Act, the public may use Standard Form 95 “Claim for Damage, Injury, or Death,” which is provided by the Department of Justice and approved by the Office of Management and Budget (OMB) under OMB Control Number 1105–0008.
By mail or hand delivery to the USPTO.
This collection has filing fees associated with the petition to waive or suspend the legal process rules under 37 CFR 104.3. The USPTO estimates that 5 petitions will be filed per year with a fee of $130, for a total fee cost of $650. There are no other fees associated with this information collection.
Customers may incur postage costs when submitting the information in this collection to the USPTO by mail. The USPTO estimates that the average first-class postage for a mailed submission, other than a Service of Process, will be $0.94 and that up to 56 of these submissions will be mailed to the USPTO per year, for a postage cost of $52.64. The USPTO estimates that the average postage for a Service of Process will be $11.35 and that up to 243 of these submissions will be mailed to the USPTO per year, for a postage cost of $2,758.05. The estimated postage cost for this collection is $2,810.69 per year.
Therefore, the total annual (non-hour) respondent cost burden for this collection, in the form of filing fees ($650.00) and postage costs ($2,810.69), is estimated to be approximately $3,460.69 per year.
Comments are invited on:
(a) Whether the proposed 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 estimate of the burden (including hours and cost) of the proposed collection of information, including the validity of the methodology and assumptions used;
(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,
Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they will also become a matter of public record.
Office of Elementary and Secondary Education, Department of Education.
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2016.
According to the Substance Abuse and Mental Health Services Administration (SAMHSA), trauma results from an event or a series of events, or a set of circumstances that is perceived by an individual as physically or emotionally harmful or life threatening and that has lasting adverse effects on the individual's mental, social, or emotional well-being.
This priority is:
Under this priority, we provide grants to LEAs (or consortia of LEAs) in communities that have experienced Significant civil unrest to expand the capacity of those LEAs to more effectively address the behavioral and mental health needs of affected students in those communities. An increased capacity of enhanced social and emotional supports, combined with other school-based strategies, will offer schools an opportunity to create, strengthen, and maintain safe and supportive learning environments. These projects must:
(a) Expand the capacity of the LEA(s) to more effectively address the behavioral and mental health needs of students, and
(b) Provide increased access for students to school-based counseling services, or referrals to community-based counseling services, for assistance in coping with trauma.
These priorities are:
Under this priority, we provide up to an additional 10 points to an applicant based on the application's description of a credible, high-quality plan to coordinate activities that would be funded under the proposed project with related activities that would be conducted under other programs for which the applicant currently has, or is seeking, funding, including, but not limited to, the Substance Abuse and Mental Health Service Administration's Resiliency in Communities After Stress and Trauma grant program (CFDA 93.243). The coordination plan must include: (1) A description of how the applicant will coordinate with Community-based organizations with experience carrying out similar or related activities to promote student resilience; and (2) evidence of collaboration and coordination through letters of support or a memorandum of understanding from the entities with which the collaboration and coordination will occur. Applicants that receive additional competitive preference points under this priority and who are ultimately awarded a Promoting Student Resilience grant must finalize and implement the high-quality plan described in response to this priority within six months of the grant award.
Under this priority, we provide an additional 5 points to an applicant from a community in which Significant civil unrest resulted in an emergency declaration from the governor. Applicants must provide a copy of the Governor's declaration in the application.
To be eligible for a grant under this competition, an application must include, in addition to the items in the plan listed under Program Requirements, the following:
(a) A description of Significant civil unrest experienced by the LEA(s) and its impact on the learning environment in specific schools;
(b) A Logic model for how the applicant will use grant funds effectively;
(c) A needs assessment of students who, as a result of exposure to Significant civil unrest, would benefit from enhanced or increased behavioral and mental health services. This needs assessment must include input from parents;
(d) A capacity assessment of the LEA's, or LEAs', service delivery system's ability to provide mental and behavioral health services; and
(e) A plan to successfully meet the program requirements for this competition, based on data from the needs assessment and the capacity assessment.
Each grantee must implement a plan described in its approved application to:
(a) Develop, enhance and increase its capacity to provide school-based mental health and behavioral services including, but not limited to:
(1) Providing professional development opportunities for LEA and school mental health staff on how to screen for and respond to civil unrest-related trauma and implement strategies appropriate for school-based mitigation of trauma;
(2) Improving the range, availability, and quality of school-based supports by hiring qualified mental health professionals with experience or training in the behavioral and mental health needs of youth who have experienced trauma related to recent events in their communities; and
(3) Providing training to select school staff, community partners, youth, and parents on the challenges due to exposure to the trauma related to recent events in their communities, and on the importance of screening students and providing interventions to help students cope with traumatic events; and
(b) Providing enhanced or increased behavioral and mental health services and supports while also increasing the grantee's capacity to provide those services and supports.
(1) Is representative of a community or significant segments of a community;
(2) provides educational or related services to individuals in the community; and
(3) has experience carrying out activities promoting student resilience.
(i) There is at least one study that is a—
(A) Correlational study with statistical controls for selection bias;
(B) Quasi-experimental design study that meets the What Works Clearinghouse Evidence Standards with reservations; or
(C) Randomized controlled trial that meets the What Works Clearinghouse Evidence Standards with or without reservations.
(ii) The study referenced in paragraph (i) of this definition found a statistically significant or substantively important (defined as a difference of 0.25 standard deviations or larger) favorable association between at least one critical component and one Relevant outcome presented in the logic model for the proposed process, product, strategy, or practice.
(1) A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.
(2) The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.
(3) The term includes an elementary school or secondary school funded by the Bureau of Indian Affairs but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under the ESEA with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency other than the Bureau of Indian Affairs.
(4) The term includes educational service agencies and consortia of those agencies.
(5) The term includes the State educational agency in a State in which the State educational agency is the sole educational agency for all public schools.
20 U.S.C. 7131, and Title III of Division H of the Consolidated Appropriations Act, 2016 (Pub. L. 114–113).
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applications from this competition.
1.
2.
3.
In order to ensure that grant program activities address the needs of private school children, the applicant must engage in timely and meaningful consultation with appropriate private school officials during the design and development of the proposed program. This consultation must take place before the applicant makes any decision that affects the opportunities of eligible private school children, teachers, and other educational personnel to participate in grant program activities. The eligible entity should engage in a process of timely and meaningful consultation with private school officials and provide them with information related to the projected and final funding amounts for programs and services, including on the process the entity will use in preparing its competitive grant application. Administrative direction and control over grant funds must remain with the grantee.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA number 84.184C.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section.
Our reviewers will not read any pages of your application that exceed the page limit.
3.
Applications for grants under this program must be submitted electronically using the
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet at the following Web site:
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via
7.
Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
a.
Applications for grants under the Promoting Student Resilience Program, CFDA number 84.184C, must be submitted electronically using the Governmentwide
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the Promoting Student Resilience Program at
Please note the following:
• When you enter the
• Applications received by
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through
• You should review and follow the Education Submission Procedures for submitting an application through
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Deirdra Hilliard, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E–249, Washington, DC 20202–6450. FAX: (202) 453–6742.
Your paper application must be submitted in accordance with the mail or hand-delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.184C), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202–4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
We will not consider applications postmarked after the application deadline date.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.184C), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202–4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245–6288.
1.
1.
The Secretary considers the need for the proposed project. In determining the need for the proposed project, the Secretary considers the following factors:
(a) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project. (10 points)
(b) The extent to which specific gaps or weaknesses in services, infrastructure or opportunities have been identified and will be addressed by the proposed project including the nature and magnitude of those gaps or weaknesses. (10 points)
2.
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(a) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (15 points)
(b) The extent to which the proposed project will integrate with or build on similar or related efforts in order to improve Relevant outcome(s) (as defined in 34 CFR 77.1(c)), using existing funding streams from other programs or policies supported by community, State, and Federal resources. (10 points)
(c) The extent to which the proposed project is supported by Evidence of promise (as defined in 34 CFR 77.1(c)). (10 points)
(d) The extent to which the proposed project will establish linkages with other appropriate agencies and organizations providing services to the target population. (5 points)
(e) The extent to which the proposed project encourages parental involvement. (5 points)
3.
The Secretary considers the quality of the personnel who will carry out the proposed project.
(a) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (5 points)
In addition, the Secretary considers the following factor:
(b) The qualifications, including relevant training and experience, of key project personnel. (5 points)
4.
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan of the proposed project, the Secretary considers the following factor:
(a) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (15 points)
5.
The Secretary considers the quality of the project evaluation to be conducted of the proposed project. In determining the quality of the evaluation of the proposed project, the Secretary considers the following factor:
(a) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (10 points)
2.
In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR
(c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.
4.
1. The number of students served by the grant(s) receiving school-based and community mental health services to address student needs resulting from exposure to trauma; and
2. The number of Community-based organizations that are coordinating and sharing resources with each other as a result of the grant(s).
(b) Baseline data. Applicants must provide Baseline data for each of the performance measures listed in (a) and explain why each proposed Baseline is valid; or, if the applicant has determined that there are no established Baseline data for a particular performance measure, explain why there is no established Baseline and explain how and when, during the project period, the applicant will establish a valid Baseline for the performance measure.
Deirdra Hilliard, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E–249, Washington, DC 20202–6450. Telephone: (202) 453–6726 or by email:
If you use a TDD or a TTY, call the Federal Relay Service, toll free, at 1–800–877–8339.
You may also access documents of the Department published in the
Office of Fossil Energy, DOE.
Notice of application.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on February 19, 2016, by Cameron LNG, LLC (Cameron LNG), requesting blanket authorization to export liquefied natural gas (LNG) in an amount up to the equivalent of 254 billion cubic feet (Bcf) of natural gas on a cumulative basis over a two-year period effective as of the commencement of export of commissioning volumes, estimated to be the fourth quarter of 2017, but no later than six months thereafter.
To date, Cameron LNG has been granted 5 long-term, multi-contract authorizations from DOE/FE: (1) Order No. 3059 to export LNG in a volume equivalent to 620 Bcf per year of natural gas from the Cameron Terminal to FTA countries, for a 20-year term; (2) Order No. 3391–A to export LNG in a volume equivalent to 620 Bcf per year of natural gas from the Cameron Terminal to non-FTA countries, for a 20-year term;
Cameron LNG states that, in anticipation of the start of liquefaction operations at the Cameron Terminal, it requests this blanket authorization to engage in short-term exports of LNG produced before the commencement of long-term commercial exports of domestically sourced LNG as approved in DOE/FE Order Nos. 3059, 3391–A, 3620, 3680, and 3797.
Protests, motions to intervene, notices of intervention, and written comments are invited.
Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, July 25, 2016.
The portion of the Application seeking authority to export commissioning volumes to non-FTA countries will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. In reviewing this Application, DOE will consider domestic need for the natural gas, as well as any other issues determined to be appropriate, including whether the arrangement is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG:
•
•
Additionally, DOE will consider the following environmental documents:
•
•
Parties that may oppose this Application should address these issues and documents in their comments and/or protests, as well as other issues deemed relevant to the Application.
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
Interested persons will be provided 30 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, notices of intervention, or motions for additional procedures.
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Interested parties will be provided 30 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.
Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.
Filings may be submitted using one of the following methods: (1) Emailing the filing to
A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based
The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E–042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
U.S. Department of Energy.
Submission for Office of Management and Budget (OMB) review; comment request.
The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection request a three-year extension for Exchange/Sale Report, Excess Personal Property Furnished to Non-Federal Recipients, Agency Report of Motor Vehicle Data, Annual Motor Vehicle Fleet Report, and OMB Control Number 1910–1000. The proposed collection covers information necessary to prepare and submit the annual property reports required by 41 CFR part 102 and the Office of Management and Budget.
Comments regarding this proposed information collection must be received on or before July 25, 2016. 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, please advise the OMB Desk Officer of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202–395–4650.
Written comments may be sent to DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503.
And to: Scott Whiteford, Deputy Director Office of Asset Management, MA–50/L'Enfant Plaza Building, Washington, DC 20585–1615,
Scott Whiteford, at the above address, or by telephone at (202) 287–1563, or by fax (202) 287–1656.
Information for the Excess Personal Property Furnished to Non-Federal Recipients and the Exchange/Sale Report is collected using GSA's Personal Property Reporting Tool and can be found at the following link:
Information for the Federal Fleet Report is collected using the Federal Automotive Statistical Tool and can be found at the following link:
This information collection request contains: (1) OMB No. 1910–1000; (2) Information Collection Request Title: Exchange/Sale Report, Excess Personal Property Furnished to Non-Federal Recipients, Federal Automotive Statistical Tool Report; (3) Type of Review: Renewal; (4) Purpose: The information being collected is data required in order to submit annual personal property reports as required by 41 CFR part 102 and the Office of Management and Budget. Respondents to this information collection request will be the Department of Energy's Management and Operating Contractor and other major site contractors; (5) Annual Estimated Number of Total Respondents: 76 respondents for each of the three reports; (6) Annual Estimated Number of Total Responses: 228 (76 respondents × 3 reports) ; (7) Total annual estimated number of burden hours is 1,672. A breakout of burden hours for each report is listed below:
○ Exchange/Sale 2 hours with 76 respondents,
○ Non-Federal Recipient Report are estimated at 2 hours for 76 estimated,
○ Federal Automotive Statistical Tool at 18 hours for each of the 76 estimated respondents, for a total of 1,368 burden hours.
(8) Annual Estimated Reporting and Recordkeeping Cost Burden is $133,760.
(A) 41 CFR 102–39.85, (B) 41 CFR 102–36.295 and 102–36.300, (C) OMB Circular A–11 section 25.5, (D) 41 CFR 102–34.335.
Take notice that the Commission received the following electric corporate 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 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 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:
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that at 10:23 a.m. on Tuesday, June 21, 2016, the Board of Directors of the Federal Deposit Insurance Corporation met in closed session to consider matters related to the Corporation's supervision, corporate, and resolution activities.
In calling the meeting, the Board determined, on motion of Vice Chairman Thomas M. Hoenig, seconded by Director Thomas J. Curry (Comptroller of the Currency), concurred in by Director Richard Cordray (Director, Consumer Financial Protection Bureau), and Chairman Martin J. Gruenberg, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days' notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the “Government in the Sunshine Act” (5 U.S.C. 552b(c)(2), (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10).
Federal Election Commission.
Tuesday, June 28, 2016 at 10:00 a.m.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
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 July 11, 2016.
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291:
1.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) Account Management function. Participation will be needed from a small group of Filers, Importers of Record, and Consignees, who will use the new ITACS Account Management function and provide feedback to FDA. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email.
To be considered for participation in this ITACS pilot, please send an email with the subject line “ITACS Pilot Participation Request” by July 7, 2016.
Submit pilot participation request emails to FDA's ITACS Support at
Sandra Abbott, Division of Compliance Systems, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852–1740, 301–796–3240,
ITACS currently provides the import trade community with four functions: (1) The ability to check the status of FDA-regulated entries and lines, (2) the ability to submit entry documentation electronically, (3) the ability to electronically submit the location of goods availability for those lines targeted for FDA physical examination, and (4) the ability to check the estimated laboratory analysis completion dates. No user login accounts are necessary to access these functions; all that is necessary is a valid customs entry number that has been successfully transmitted to FDA. FDA has developed, and wishes to test, an ITACS user account management function.
The purpose of this pilot is to test and evaluate a new ITACS account management function.
This pilot will not impact the availability of current functionality of ITACS. Rather, it will provide FDA and a small group of volunteers with the opportunity to test expanded functionality of ITACS, specifically the use of user login accounts. User login accounts enable FDA to distribute Notices of FDA Action to users electronically via email (rather than regular mail) and enable users to download Notices of FDA Action from within ITACS. User login accounts also allow users to view in ITACS the details of specific information requests, which are currently delivered via hard copy Notices of FDA Action. Implementation of user login accounts would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication.
Pilot participants should be prepared to commit to: (1) Attending a kickoff training session, using the new functionality, (2) providing real-time feedback, and (3) participating in any followup meetings FDA deems necessary over the course of the pilot period. Pilot participants should also be willing to receive their Notices of FDA Action electronically in lieu of FDA distribution of paper Notices of FDA action.
FDA currently anticipates the pilot to begin in July 2016 and to last through October 2016. However, these dates are subject to change. A more definitive schedule will be determined after FDA has selected volunteers. FDA will contact selected volunteers via email within 2 weeks of the closure of the solicitation period.
To be considered for participation in this ITACS pilot, please send an email with the subject line “ITACS Pilot Participation Request” to
Please include the following information in your pilot participation request email:
• Your name, position, and contact information including email;
• your firm's name and address; and
• your firm's role in the importation of FDA-regulated entries (Filer, Importer of Record, Consignee, or any combination thereof).
FDA will contact volunteers selected for participation in the pilot program via email within 2 weeks of the closure of the solicitation period.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the
Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email:
In the
FDA regrets that it was unable to publish this notice 15 days prior to the June 28 and 29, 2016, Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. Because the Agency believes there is some urgency to bring these issues to public discussion and qualified members of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled “FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines” supplements the “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide—Data Elements and Message Specification” final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
Submit either electronic or written comments on the Regional Implementation Specifications document at any time.
You may submit comments as follows:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building,
Suranjan De, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993, 240–402–0498, or
On February 21, 2014, FDA issued a
This technical specifications document, which is available on the FDA Guidance Web page at
Persons with access to the Internet may obtain a copy of the FDA Regional Implementation Specifications for ICH E2B(R3) at
Coast Guard, DHS.
Notice and request for comments.
Jefferson Railport Terminal 1 (Texas) LLC, has submitted a Letter of Intent and Preliminary Waterway Suitability Assessment to the Coast Guard Captain of the Port (COTP), Port Arthur, TX regarding the company's plans to construct, own and operate a waterfront facility handling and storing Liquefied Hazardous Gas (LHG) at its Vidor, TX facility located on the Sabine-Neches Waterway. The Coast Guard is notifying the public of this action to solicit public comments on the proposed increase in LHG marine traffic on the Sabine-Neches Waterway.
Comments must be submitted to the online docket via
You may submit comments identified by docket number USCG–2016–0374 using the Federal eRulemaking Portal at
For further information about this notice, call or email Chief Petty Officer Jamie L. Merriman, U.S. Coast Guard; telephone 409–719–5033, email
We encourage you to submit comments or related material in response to this notice. We will consider all submissions and may adjust our final action based on your comments. If you submit a comment, please include the docket number for this notice, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Under 33 CFR 127.007(a), an owner or operator planning to build a new facility
Under 33 CFR 127.009, after receiving an LOI, the COTP issues a Letter of Recommendation (LOR) as to the suitability of the waterway for LNG or LHG marine traffic to the appropriate jurisdictional authorities. The LOR is based on a series of factors outlined in 33 CFR 127.009 that relate to the physical nature of the affected waterway and issues of safety and security associated with LNG or LHG marine traffic on the affected waterway.
The purpose of this notice is to solicit public comments on the proposed increase in LHG marine traffic on the Sabine-Neches Waterway. The Coast Guard believes that input from the public may be useful to the COTP with respect to development of the LOR. Additionally, the Coast Guard intends to task the Area Maritime Security Committee, Port Arthur, TX and the Southeast Texas Waterways Advisory Council with forming a subcommittee comprised of affected port users and stakeholders. The goal of this subcommittee will be to gather information to help the COTP assess the suitability of the associated waterway for increased LHG marine traffic as it relates to navigational safety and security.
On January 24, 2011, the Coast Guard published Navigation and Vessel Inspection Circular (NVIC) 01–2011, “Guidance Related to Waterfront Liquefied Natural Gas (LNG) Facilities”. NVIC 01–2011 provides guidance for owners and operators seeking approval to build and operate LNG facilities. While NVIC 01–2011 is specific to LNG, it provides useful process information and guidance for owners and operators seeking approval to build and operate LHG facilities as well. The Coast Guard will refer to NVIC 01–2011 for process information and guidance in evaluating Jefferson Railport Terminal 1's WSA. A copy of NVIC 01–2011 is available for viewing in the public docket for this notice and also on the Coast Guard's Web site at
This notice is issued under authority of 33 U.S.C. 1223–1225, Department of Homeland Security Delegation Number 0170.1(70), 33 CFR 127.009, and 33 CFR 103.205.
U.S. Customs and Border Protection, Department of Homeland Security.
60-Day Notice and request for comments; revision of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: CBP Form I–94 (Arrival/Departure Record), CBP Form I–94W (Nonimmigrant Visa Waiver Arrival/Departure), and the Electronic System for Travel Authorization (ESTA). This is a proposed extension and revision of an information collection that was previously approved. CBP is proposing that this information collection be extended with a revision to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before August 22, 2016 to be assured of consideration.
Written comments may be mailed to U.S. Customs and Border Protection, Attn: Paperwork Reduction Act Officer, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229–1177.
Requests for additional information should be directed to Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229–1177, or by telephone at 202–325–0123.
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 cost burden to respondents or record keepers from the collection of information (total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for OMB approval. All comments will become a matter of public record. In this document, CBP is soliciting comments concerning the following information collection:
CBP Forms I–94 (Arrival/Departure Record) and I–94W (Nonimmigrant Visa Waiver Arrival/Departure Record) are used to document a traveler's admission into the United States. These forms are filled out by aliens and are used to collect information on citizenship, residency, passport, and contact information. The data elements collected on these forms enable the Department of Homeland Security (DHS) to perform its mission related to the screening of alien visitors for potential risks to national security and the determination of admissibility to the United States. The Electronic System for Travel Authorization (ESTA) applies to aliens seeking to travel to the United States under the Visa Waiver Program (VWP) and requires that VWP travelers provide information electronically to CBP before embarking on travel to the
Pursuant to an interim final rule published on March 27, 2013 in the
ESTA can be accessed at:
On December 18, 2015, the President signed into law the Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015 as part of the Consolidated Appropriations Act of 2016. To meet the requirements of this new Act, DHS strengthened the security of the VWP by enhancing the ESTA application and Form I–94W. In two recent emergency submissions under the Paperwork Reduction Act, additional questions were added to ESTA and to Form I–94W that request information from applicants about countries to which they have traveled on or after March 1, 2011; countries of which they are citizens/nationals; countries for which they hold passports; and Global Entry Numbers.
DHS proposes to add the following question to ESTA and to Form I–94W:
“Please enter information associated with your online presence—Provider/Platform—Social media identifier.” It will be an optional data field to request social media identifiers to be used for vetting purposes, as well as applicant contact information. Collecting social media data will enhance the existing investigative process and provide DHS greater clarity and visibility to possible nefarious activity and connections by providing an additional tool set which analysts and investigators may use to better analyze and investigate the case.
Current Actions: This submission is being made to extend the expiration date with a change to the information collected as a result of adding a question about social media to ESTA and to Form I–94W, as described in the Abstract section of this document. There are no changes to the burden hours or to the information collected on Form I–94, or the I–94 Web site.
Office of the Secretary, HUD.
Notice of final policy statement.
In compliance with Executive Order 13175, “Consultation with Indian Tribal Governments,” HUD adopts this Tribal Government-to-Government Consultation Policy. The purpose of this tribal consultation policy is to enhance communication and coordination between HUD and federally recognized Indian tribes and to outline guiding principles and procedures under which all HUD employees are to operate with regard to federally recognized Indian or Alaska Native tribes. This final policy statement follows publication of an April 8, 2015, request for public comment on HUD's proposed Tribal Consultation Policy and, after consideration of the public comments submitted in response to the April 8, 2015, notice, adopts the proposed policy without change.
Heidi J. Frechette, Deputy Assistant Secretary for Native American Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street SW., Room 4126, Washington, DC 20410, telephone number 202–401–7914 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number via TTY by calling the Federal Relay Service at 800–877–8339 (this is a toll-free number).
Executive Order 13175 (65 FR 67249, published November 9, 2000) recognizes the right of Indian tribes to self-government and supports tribal sovereignty and self-determination. Among other things, it requires that agencies have an accountable process to ensure meaningful and timely input by tribal officials in developing policies that have tribal implications. On November 5, 2009, President Obama reaffirmed the government-to-government relationship between the Federal Government and Indian tribal governments in a White House memorandum that acknowledges that Indian tribes exercise inherent sovereign powers over their members and territory. The November 5, 2009, memorandum also acknowledged that the United States will continue to work with Indian tribes on a government-to-government basis to address issues concerning Indian tribal self-government, tribal trust resources, and Indian tribal treaty and other rights.
Consistent with Executive Order 13175, and the Presidential memorandum of November 5, 2009, HUD undertook a series of consultations
HUD conducted a second round of tribal consultation by sending the revised draft policy to all tribal leaders for their comment. On November 12, 2014, the Department provided all tribal leaders a draft version of HUD's revised tribal government-to-government consultation policy and requested their feedback and opinion on the draft. In response to the Department's November 12, 2014, request for comments, the Department received three comments from Indian tribes and a national organization that represents the housing interests of Native Americans.
More recently, on April 8, 2015, at 70 FR 18858, HUD published a
A. The United States Government has a unique relationship with American Indian governments as set forth in the Constitution of the United States, treaties, statutes, judicial decisions, and Executive orders and Presidential memorandums.
B. On April 29, 1994, a Presidential memorandum was issued reaffirming the Federal Government's commitment to operate within a government-to-government relationship with federally recognized American Indian and Alaska Native tribes, and to advance self-governance for such tribes.
On May 14, 1998, Executive Order 13084,
On November 5, 2009,
C. This consultation policy applies to all HUD programs and policies that have substantial direct effects on Federally recognized Indian tribal governments. In formulating or implementing such policies, HUD will be guided by the fundamental principles set forth in section 2 of Executive Order 13175, to the extent applicable to HUD programs. Section 2 of the Executive order provides as follows:
(a) The United States has a unique legal relationship with Indian tribal governments as set forth in the Constitution of the United States, treaties, statutes, Executive Orders, and court decisions. Since the formation of the Union, the United States has recognized Indian tribes as domestic dependent nations under its protection. The Federal Government has enacted numerous statutes and promulgated numerous regulations that establish and define a trust relationship with Indian tribes.
(b) Our Nation, under the law of the United States, in accordance with treaties, statutes, Executive Orders, and judicial decisions, has recognized the right of Indian tribes to self-government. As domestic dependent nations, Indian tribes exercise inherent sovereign powers over their members and territory. The United States continues to work with Indian tribes on a government-to-government basis to address issues concerning Indian tribal self-government, tribal trust resources, and Indian tribal treaty and other rights.
(c) The United States recognizes the right of Indian tribes to self-government and supports tribal sovereignty and self-determination.
A. “
Consultation is the proactive, affirmative process of: (1) Identifying and seeking input from appropriate Native American governing bodies, community groups, and individuals; and (2) considering their interest as a necessary and integral part of HUD's decisionmaking process.
This definition adds to statutorily mandated notification procedures. The goal of notification is to provide an opportunity for comment; however, with consultation procedures, the burden is on the Federal agency to show that it has made a good faith effort to elicit feedback.
B. “
C. “
D. “
E. “
F. “
A. HUD respects tribal sovereignty and acknowledges the unique relationship between the Federal Government and Indian tribes.
B. HUD recognizes and commits to a government-to-government relationship with federally recognized tribes.
C. HUD recognizes tribes as the appropriate non-Federal parties for making policy decisions and managing programs for their constituents.
D. HUD shall take appropriate steps to remove existing legal and programmatic impediments to working directly and effectively with tribes on programs administered by HUD.
E. HUD shall encourage States and local governments to work with and cooperate with tribes to resolve problems of mutual concern.
F. HUD shall work with other Federal departments and agencies to enlist their interest and support in cooperative efforts to assist tribes to accomplish their goals within the context of all HUD programs.
G. HUD shall be guided by these policy principles in its planning and management activities, including its budget, operating guidance, legislative initiatives, management accountability system, and ongoing policy and
A.
B.
C.
D.
E.
F.
G.
H.
I.
1. A workgroup may be established by HUD and tribes to address specific issues or to draft specific policies that have tribal implications. Tribal representation should be consistent with the established standard of geographically diverse small, medium, and large tribes, whenever possible.
2. Alternate workgroup members may be appointed by written notification signed by the member. Such alternates shall possess the authority of the workgroup member to make decisions on their behalf, if such authority is so delegated to them in writing.
3. The workgroup shall be chaired by at least one tribal workgroup member, selected by the tribal workgroup members, and one HUD representative.
4. The workgroup may conduct its activities through various methods of communication, including in-person meetings, conference calls, and Internet-based meeting platforms. Workgroup members may be accompanied by other individuals for advice, as the members deem necessary.
5. Whenever possible, workgroup products should be circulated to tribal leaders for review and comment.
6. All final recommendations will be given serious consideration by HUD.
On issues relating to tribal self-governance, tribal trust resources, or treaty and other rights, HUD will explore and, where appropriate, use consensual mechanisms for developing regulations, including negotiated rulemaking. HUD may establish a standing committee, consisting of representatives of tribal governments, to consult on the appropriateness of using negotiated rulemaking procedures on particular matters. The procedures governing such a standing committee would be established through the mutual agreement of HUD and tribal governments.
To the extent practicable and permitted by law, HUD shall not promulgate any regulation that is not required by statute, that has tribal implications, and that imposes substantial direct compliance costs on such communities, unless:
A. Funds necessary to pay the direct costs incurred by the Indian tribal government in complying with the regulation are provided by the Federal Government; or
B. HUD, prior to the formal promulgation of the regulation:
1. Consulted with tribal officials early in the process of developing the proposed regulation;
2. In a separately identified portion of the preamble to the regulation as it is to be issued in the
3. Makes available to the Director of OMB any written communications submitted to HUD by such Indian tribal governments.
HUD shall review the processes under which Indian tribal governments apply for waivers of statutory and regulatory requirements, and take appropriate steps to streamline those processes.
A. HUD shall, to the extent practicable and permitted by law, consider any application by an Indian tribal government for a waiver of statutory or regulatory requirements, in connection with any program administered by HUD, with a general view toward increasing opportunities for utilizing flexible policy approaches, at the Indian tribal level, in cases in which the proposed waiver is consistent with the applicable Federal policy objectives and is otherwise appropriate.
B. HUD shall, to the extent practicable and permitted by law, render a decision upon a complete application for a waiver within 90 days of receipt of such application by HUD. HUD shall provide the applicant with timely written notice of the decision and, if the application for a waiver is not granted, the reasons for such denial.
C. This section applies only to statutory or regulatory requirements that are discretionary and subject to waiver by HUD. Applicable civil rights statutes and regulations are not subject to waiver.
The provisions of the Federal Advisory Committee Act (5 U.S.C. App., Pub. L. 92–463, section 2, Oct. 6, 1972, 86 Stat. 770) (FACA) do not apply to consultations undertaken pursuant to this policy. In accordance with section 204(b) of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4, approved March 22, 1995, 109 Stat. 48), FACA is not applicable to consultations between the Federal Government and elected officers of Indian tribal governments (or their designated employees with authority to act on their behalf). As OMB stated in its guidelines implementing section 204(b):
This exemption applies to meetings between Federal officials and employees and . . . tribal governments, acting through their elected officers, officials, employees, and Washington representatives, at which “views, information or advice” are exchanged concerning the implementation of intergovernmental responsibilities or administration, including those that arise explicitly or implicitly under statute, regulation, or Executive order.
The scope of meetings covered by the exemption should be construed broadly to include any meetings called for any purpose relating to intergovernmental responsibilities or administration. Such meetings include, but are not limited to, meetings called for the purpose of seeking consensus; exchanging views, information, advice, and/or recommendations; or facilitating any other interaction relating to intergovernmental responsibilities or administration. (OMB Memorandum 95–20 (September 21, 1995), pp. 6–7, published at 60 FR 50651, 50653 (September 29, 1995)).
This document has been adopted for the purpose of enhancing government-to-government relationships, communications, and mutual cooperation between the United States Department of Housing and Urban Development and tribes and is not intended to, and does not, create any right to administrative or judicial review, or any other right or benefit or trust responsibility, substantive or procedural, enforceable by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other persons. The provisions of FACA are not applicable to this policy. This document is effective on the date it is signed.
Office of the President of Government National Mortgage Association (Ginnie Mae), HUD.
Notice.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
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: Anna Guido., QDAM, Information Reports Management Officer, Department of Housing and Urban Development, 451 7th Street SW., L'Enfant Plaza Building, Room 4186, Washington, DC 20410; email:
Shalei Choi, Ginnie Mae, 451 7th Street SW., Room B–133, Washington, DC 20410; email—
The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).
The Ginnie Mae Multiclass Securities Program consists of Ginnie Mae Real Estate Mortgage Investment Conduit (“REMIC”) securities, Stripped Mortgage-Backed Securities (“SMBS”), and Platinum securities. The Multiclass Securities program provides an important adjunct to Ginnie Mae's secondary mortgage market activities, allowing the private sector to combine and restructure cash flows from Ginnie Mae Single Class MBS into securities that meet unique investor requirements in connection with yield, maturity, and call-option protection. The intent of the Multiclass Securities program is to increase liquidity in the secondary mortgage market and to attract new sources of capital for federally insured or guaranteed loans. Under this program, Ginnie Mae guarantees, with the full faith and credit of the United States, the timely payment of principal and interest on Ginnie Mae REMIC, SMBS and Platinum securities.
This Notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:
(1) 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;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) 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,
Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35 as amended.
Office of the Assistant Secretary for Housing, HUD.
Notice.
The Rental Assistance Demonstration allows Public Housing, Moderate Rehabilitation (Mod Rehab), Rent Supplement (Rent Supp), and Rental Assistance Payment (RAP) properties to convert to long-term project-based Section 8 rental assistance contracts. The documents that subject to this notice are those used to process and complete the conversion process for Public Housing, Mod Rehab, Rent Supp, and RAP properties.
On March 17, 2016, HUD published a 60-day notice announcing proposed changes to the existing Rental Assistance Demonstration (RAD) Documents and solicited public comments on the proposal.
An emergency request has been made to the Office of Management and Budget (OMB) for a short term six-month extension of the existing RAD Documents so that the program can continue to operate while HUD reviews and responds to the comments received during the 60-day comment period, and completes the Paperwork Reduction Act submission process for amending and renewing the RAD Documents for a period of three years.
Office of Management and Budget approval of the existing RAD Documents is set to expire on June 30, 2016.
Stacy Harrison, Recapitalization Program Specialist, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410–8000; telephone: 202–402–4234 (this is not a toll-free number). Hearing- or speech-impaired individuals may access these numbers through TTY by calling the Federal Relay Service at 800–877–8339 (this is a toll-free number).
Office of Assistant Secretary for Public and Indian Housing, HUD.
Notice.
This notice solicits comments and recommendations regarding the establishment of a Tribal Intergovernmental Advisory Committee (TIAC), consisting of tribal representatives, to assist HUD further develop and maintain its Indian housing programs. The TIAC is intended to further communications between HUD and Federally recognized Indian tribes on HUD programs, make recommendations to HUD regarding current program regulations, provide advice in the development of HUD's American Indian and Alaska Native housing priorities, and encourage peer learning and capacity building among tribes and non-tribal entities. Consistent with HUD's Tribal Government-to-Government Consultation Policy, published elsewhere in this
Comments on the proposed structure of the TIAC are due on or before: June 23, 2016.
Interested persons are invited to submit comments on the structure of the Tribal Intergovernmental Advisory Committee. There are two methods for comments to be included in the docket for this rule. Additionally, all submissions must refer to the above docket number and title.
1.
2.
To receive consideration, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
Heidi J. Frechette, Deputy Assistant Secretary for Native American Programs, Office of Public and Indian
Elsewhere in this
To further enhance consultation and collaboration with tribal governments, HUD is proposing to establish the TIAC. Several Federal agencies have established similar tribal advisory committees, including the Environmental Protection Agency, the Department of Health and Human Services, and the Department of the Treasury. These advisory committees convene periodically during the year to exchange information with agency staff, notify tribal leaders of activities or policies that could affect tribes, and provide guidance on consultation. Prior to HUD's establishment of the TIAC, this notice solicits input into the structure of the committee.
A.
(1) To further facilitate intergovernmental communication between HUD and Federally recognized Indian tribal leaders on all HUD programs;
(2) To make recommendations to HUD regarding current program regulations that may require revision, as well as suggest rulemaking methods to develop such changes;
(3) To advise in the development of HUD's American Indian and Alaska Native (AIAN) housing priorities; and
(4) To encourage peer learning and capacity building among tribes and non-tribal entities. The role of the TIAC is to provide recommendations and input to HUD and to provide a vehicle for regular and meaningful consultation and collaboration with tribal officials. HUD will maintain the responsibility to exercise program management, including the drafting of HUD notices and guidance.
B.
C.
D.
The Secretary shall appoint the members of the TIAC. TIAC tribal delegates will serve a term of 2 years. To ensure consistency between tribal terms, delegates will have a staggered term of appointment. In order to establish a staggered term of appointment, half of the tribal members appointed in the inaugural year of the TIAC will serve 2 years and the other half will serve 3 years. Delegates must designate their preference to serve 2 or 3 years; however, HUD will make the final determination on which members will serve for 3 years. Once these members complete these initial terms, future tribal members will serve terms that last 2 years.
E. The establishment of the TIAC is intended to enhance government-to-government relationships, communications, and mutual cooperation between HUD and tribes and is not intended to, and will not, create any right to administrative or judicial review, or any other right or benefit or trust responsibility, substantive or procedural, enforceable by a party against the United States, its agencies or instrumentalities, its officers or employees, or any other persons.
Once a general structure for the TIAC is established, HUD intends to publish a request for nominations for the TIAC in the
Fish and Wildlife Service, Interior.
Notice.
The United States, as a Party to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), will attend the seventeenth regular meeting of the Conference of the Parties to CITES
The public meeting will be held in the South Interior Building Auditorium at 1951 Constitution Avenue NW., Washington, DC. Directions to the building can be obtained by contacting the Division of Management Authority (see
You may submit comments pertaining to items on the provisional agenda for discussion at CoP17 by one of the following methods:
•
•
We will not consider comments sent by email or fax or to an address not listed in
For information pertaining to resolutions, decisions, and other agenda items, contact: Craig Hoover, Chief, Division of Management Authority; telephone 703–358–2095; facsimile 703–358–2298. For information pertaining to species proposals, contact: Rosemarie Gnam, Chief, Division of Scientific Authority; telephone 703–358–1708; fascsimile 703–358–2276.
The Convention on International Trade in Endangered Species of Wild Fauna and Flora, hereinafter referred to as CITES or the Convention, is an international treaty designed to control and regulate international trade in certain animal and plant species that are now or potentially may become threatened with extinction. These species are listed in Appendices to CITES, which are available on the CITES Secretariat's Web site at
Currently 181 countries and the European Union have ratified, accepted, approved, or acceded to CITES; these 182 entities are known as Parties. The Convention calls for regular biennial meetings of the Conference of the Parties, unless the Conference of the Parties decides otherwise. At these meetings, the Parties review the implementation of CITES, make provisions enabling the CITES Secretariat in Switzerland to carry out its functions, consider amendments to the lists of species in Appendices I and II, consider reports presented by the Secretariat and the permanent CITES committees (Standing, Animals, and Plants Committees), and make recommendations for the improved effectiveness of CITES. Any country that is a Party to CITES may propose amendments to Appendices I and II, resolutions, decisions, and other agenda items for consideration by all of the Parties at the meetings.
This is our fifth in a series of
On April 26 and 27, 2016, the United States submitted to the CITES Secretariat, for consideration at CoP17, its species proposals, proposed resolutions, proposed decisions, and other agenda items. These documents are available on our Web site at
The provisional agenda for CoP17 is currently available on the CITES Secretariat's Web site at
We will hold a public meeting to discuss the items on the provisional agenda for CoP17. The public meeting will be held on the date specified in the
Through an additional notice and Web site posting in advance of CoP17, we will inform you about tentative U.S. negotiating positions on species proposals, proposed resolutions, proposed decisions, and agenda items that were submitted by other Parties, the permanent CITES committees, and the CITES Secretariat for consideration at CoP17.
The primary author of this notice is Clifton A. Horton, Division of Management Authority; under the authority of the U.S. Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of receipt of application and proposed incidental harassment authorization; availability of draft environmental assessment; request for comments.
We, the U.S. Fish and Wildlife Service (Service), in response to a request under the Marine Mammal Protection Act of 1972 (MMPA), as amended, from Quintillion Subsea Operation, LLC, propose to authorize the incidental taking by harassment of small numbers of Pacific walruses from July 15–November 15, 2016. The area specified for inclusion in the proposed authorization includes Federal waters of the northern Bering, Chukchi, and Southern Beaufort Seas, the marine waters of the State of Alaska, and coastal land adjacent to Nome, Kotzebue, Point Hope, Wainwright, Barrow, and Oliktok Point, as shown in Figure 1. The applicant has requested this authorization for its planned cable-laying activities. We anticipate no take by injury or death and include none in this proposed authorization, which if finalized, will be for take by harassment only.
We will consider comments we receive on or before July 25, 2016.
•
•
•
Please indicate whether your comments apply to the proposed incidental harassment authorization or the draft environmental assessment. We will post all hardcopy comments on
Copies of the application, the list of references used in the notice, and other supporting materials may be downloaded from the Web at:
In response to a request from Quintillion Subsea Operation, LLC (Quintillion or “the applicant”), we propose to authorize the incidental taking by harassment of small numbers of Pacific walruses from July 15–November 15, 2016, under section 101(a)(5)(D) of the Marine Mammal Protection Act of 1972 (MMPA), as amended. Quintillion has requested this authorization for its planned cable-laying activities in Federal waters of the northern Bering, Chukchi, and southwestern Beaufort Seas, the marine waters of the State of Alaska, and coastal land adjacent to Nome, Kotzebue, Point Hope, Wainwright, Barrow, and Oliktok Point, as specified in Figure 1. We anticipate no take by injury or death and include none in this proposed authorization, which, if finalized, would be for take by harassment only.
Section 101(a)(5)(D) of the MMPA (16 U.S.C. 1361
The MMPA allows the Service to authorize, upon request, the incidental take of small numbers of marine mammals as part of a specified activity within a specified geographic region. In this case, the Service may authorize the incidental, but not intentional, take by harassment of small numbers of Pacific walruses by Quintillion during the specified cable-laying project activities if we find that such harassment during each period will:
• Have no more than a “negligible impact” on the species or stock of Pacific walrus; and
• Not have an “unmitigable adverse impact” on the availability of the species or stock for taking for subsistence uses.
The Service may stipulate the permissible methods of taking and require mitigation, monitoring, and reporting of such takings, which are meant to reduce or minimize negative impacts to the Pacific walrus.
We intend that any final action resulting from this proposal will be as accurate and as effective as possible. Therefore, we request comments or suggestions on this proposed authorization. We particularly seek comments concerning:
• Whether the proposed authorization, including the proposed activities, will have a negligible impact on the species or stock of Pacific walrus.
• Whether the proposed authorization will ensure that an unmitigable adverse impact on the availability of Pacific walruses for subsistence taking does not occur.
• Whether there are any additional provisions we may wish to consider for ensuring the conservation of the Pacific walrus.
You may submit your comments and materials concerning this proposed authorization by one of the methods listed in
If you submit a comment via
Section 101(a)(5)(D) of the MMPA, as amended (16 U.S.C. 1371(a)(5)(D)), authorizes the Secretary of the Interior (the Secretary) to allow, upon request of a citizen and subject to such conditions as the Secretary may specify, the incidental but not intentional taking by harassment of small numbers of marine mammals of a species or population stock by such citizens who are engaging in a specified activity within a specified region. Incidental taking may be authorized only if the Secretary finds that such take during each period concerned will have a negligible impact on such species or stock, and will not have an unmitigable adverse impact on the availability of such species or stock for subsistence use.
Section 101(a)(5)(D) of the MMPA establishes a process by which citizens of the United States can apply for an authorization for incidental take of small numbers of marine mammals where the take will be limited to harassment during a period of not more than 1 year. We refer to these incidental harassment authorizations as “IHAs.”
The term “take,” as defined by the MMPA, means to harass, hunt, capture, or kill, or to attempt to harass, hunt, capture, or kill any marine mammal. Harassment, as defined by the MMPA, means any act of pursuit, torment, or annoyance which: (i) Has the potential to injure a marine mammal or marine mammal stock in the wild (the MMPA calls this “Level A harassment”), or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (the MMPA calls this “Level B harassment”).
The terms “small numbers,” “negligible impact,” and “unmitigable adverse impact” are defined in 50 CFR 18.27, the Service's regulations governing take of small numbers of marine mammals incidental to specified activities. “Small numbers” is defined as a portion of a marine mammal species or stock whose taking would have a negligible impact on that species or stock. However, we do not rely on that definition here, as it conflates the terms “small numbers” and “negligible impact,” which we recognize as two separate and distinct requirements. Instead, in our small numbers determination, we evaluate whether the number of marine mammals likely to be taken is small relative to the size of the overall population. “Negligible impact” is defined as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to adversely affect the species or stock through effects on annual rates of recruitment or survival. “Unmitigable adverse impact” is defined as an impact resulting from the specified activity (1) that is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by (i) causing the marine mammals to abandon or avoid hunting areas, (ii) directly displacing subsistence users, or (iii) placing physical barriers between the marine mammals and the subsistence hunters; and (2) that cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.
In order to issue an IHA, the Service must set forth the following: (1) Permissible methods of taking; (2) means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance; and (3) requirements pertaining to the monitoring and reporting of such takings. Habitat areas of significance for
On October 29, 2015, Quintillion submitted a request to the Service for the nonlethal taking by harassment of Pacific walruses and polar bears that may occur incidental to a cable-laying project. Quintillion is proposing to install 1,904 kilometers (km) (1,183 miles (mi)) of submerged fiber optic cable on the seafloor of the Bering, Chukchi, and Beaufort Seas off the northern and western coasts of Alaska during the open-water season of 2016. The Quintillion cable project or “the proposed action” consists of a main trunk line and six branching lines with links to the existing terrestrial networks of six rural Alaskan communities. An amendment with updated information was received in February 2016, and Quintillion withdrew its request for incidental take of polar bears on April 25, 2016. A complete copy of Quintillion's request and supporting documents may be obtained as specified above in
The project is most likely to encounter Pacific walruses in the Chukchi Sea in August and September. The cable-laying activities are proposed for the northern Bering Sea after mid-July when most animals have moved either northward into the Chukchi Sea or southward to Bristol Bay, where no cable-laying activities are proposed. The Southern Beaufort Sea is outside of the normal range of the species and is, therefore, considered “extralimital” to the normal range of the species, and encounters are unlikely. When Pacific walruses are encountered, they may react to the presence of Quintillion's vessels or the sounds of the cable-laying activities. Thrusters, echo sounders, and beacon transceivers that will be used by the cable-laying ships during this project may generate noise levels capable of causing acoustic harassment to Pacific walruses in the local area.
Quintillion is requesting incidental take by Level B harassment of Pacific walruses from disruption of behavioral patterns and exposure to sound levels exceeding 160 decibels (dB; all dB levels given herein are re: 1 µPa). The number of actual takes from sound exposure will depend upon the number of individuals occurring within the 160-dB ensonification zone. The “ensonification zone” is the area surrounding a sound source where received sound levels may exceed the specified threshold. Quintillion is not requesting authorization for take by Level A harassment. Quintillion does not believe that Level A take will occur because the project is not expected to generate noise levels at or above the level considered by the Service to have the potential to cause injury. Quintillion estimates that the project will generate sound levels no greater than 180 dB
Prior to issuing an IHA in response to this request, the Service must evaluate the level of activities described in the application, the associated potential impacts to Pacific walruses, and the potential effects on the availability of the species for subsistence use. The Service is tasked with analyzing the impact that the proposed lawful activities will have on Pacific walruses during normal operating procedures.
The planned Quintillion cable project will occur in the marine waters of the northern Bering, Chukchi, and southwestern Beaufort Seas, in waters of the State of Alaska, and on coastal land of Alaska (Figure 1). The main trunk line is 1,317 km (818 mi) in length. The branching lines range between 27 km (17 mi) and 233 km (145 mi) in length and extend between the trunk line and the coastal communities of Nome, Kotzebue, Point Hope, Wainwright, and Barrow. Another branching line will extend to Oliktok Point, located 260 km (162 mi) southeast of Barrow. This line will connect over land with the community of Nuiqsut and the Prudhoe Bay industrial center. Additional project details are available in Quintillion's IHA application, available online at
All activities associated with the IHA request, including mobilization, preliminary work, cable laying, post-burial work, and demobilization of survey and support crews are planned to occur June 1–October 31, 2016. Operations in the Bering Sea will begin near Nome in mid-June and follow the receding sea ice northward into the northern Bering Sea. Work in the Bering Sea between Nome and the Bering Strait is proposed to occur from mid-July to mid-August 2016. Work in the open waters of the Chukchi Sea north of the Bering Strait and in the Beaufort Sea will be done in August and September. Nearshore cable landing work near Oliktok Point, Barrow, Wainwright, and Point Hope will begin in July and will continue in August–October while work is also being conducted offshore. Work may be conducted day or night. The operations will take approximately 150 days within the work window.
Before cable is laid, a pre-lay grapnel run will be completed along the proposed cable route where burial is required. A grapnel is a small anchor with three or more flukes, used for grappling or dragging. The objective of the operation is the identification and clearance of any seabed debris. The grapnel run will employ towed grapnels and will be conducted by a tugboat. Any debris recovered during these operations will be discharged ashore and disposed of in accordance with applicable regulations. If any debris cannot be recovered, then a local reroute will be planned to avoid the debris.
The cable-laying operations will be conducted from the Cable Ship (C/S)
Support vessels include a tug and barge that will be primarily used for nearshore operations on the branch lines. Submerged cable components will include the cable, interconnecting hardware, and repeaters. The cable will be placed on the seafloor surface or will be buried. Burial method will depend on bottom substrate, water depth, and location. Echo sounders, transceivers, and transponders will be used to monitor the water depth and the position of equipment on the seafloor.
Where cable is to be laid on the seafloor surface, the cable ships will install the cable as close as possible to the planned route with the correct amount of cable slack to enable the cable to conform to the contours of the seabed without loops or suspensions. A slack plan will be developed that uses direct bathymetric data and a catenary modeling system to control the ship and the cable payout speeds to ensure the cable is accurately placed. A dive team and the tug and barge will lay cable in nearshore waters too shallow for the C/S
Burial methods will depend on water depth. In depths greater than 12 m (39.4 ft), the cable will be buried using a burial plough pulled by the cable ship. The plough is pulled by a tow wire as cable is fed through a depressor that pushes it into a trench. Burial depth is
In water depths less than 12 m (39.4 ft), burial will be by a tug-pulled jet sled, tracked Remotely Operated Vehicle (ROV), or by a dive team using hand-jetting equipment, subject to seabed conditions in the area. Burial depths will generally be 2–3 m (6.6–9.8 ft). Nearer to shore, where seasonal ice scouring occurs, the cable will be floated on the surface and then pulled through an existing horizontal directionally drilled bore pipe to the beach manhole where it will be spliced to the terrestrial cable. The floated cable portion will then be lowered to the seabed by divers and buried (using a burial method as described above) from the bore pipe seaward.
While it is expected that the cable trenches will fill in by natural current processes, it is important to ensure that cable splices and interconnections are fully buried, and that there are no plough skips at locations where burial is critical. To ensure proper burial at critical locations, the ROV will be used to conduct post-lay inspection and burial along an estimated 10 km (6.2 mi) of the burial route.
The stock of Pacific walruses is composed of a single panmictic population inhabiting the shallow continental shelf waters of the Bering and Chukchi Seas (Lingqvist
Distribution is largely influenced by the extent of the seasonal pack ice and prey densities. From April to June, most of the population migrates from the Bering Sea through the Bering Strait and into the Chukchi Sea. Pacific walruses tend to migrate into the Chukchi Sea along lead systems that develop in the sea ice. During the open-water season, Pacific walruses are closely associated with the edge of the seasonal pack ice from Russian waters to areas west of Point Barrow, Alaska. Most of these animals remain in the Chukchi Sea throughout the summer months, but a few occasionally range into the Beaufort Sea. Oil and gas industry observers reported 35 sightings east of Point Barrow (~156.5° W.) between 1995 and 2012 (Kalxdorff and Bridges 2003; AES Alaska 2015; USFWS unpublished data).
The pack ice usually advances rapidly southward in late fall, and most Pacific walruses return to the Bering Sea by mid- to late-November. During the winter breeding season, three concentration areas form in the Bering Sea where open leads, polynyas, or thin ice occur (Fay
Pacific walruses are usually found in waters of 100 m (328 ft) or less although they are capable of diving to greater depths. They use sea ice as a resting platform over feeding areas, as well as for giving birth, nursing, passive transportation, and avoiding predators (Fay 1982; Ray
Bivalve clams of the genera
Pacific walruses are social and gregarious animals. They travel and haul out onto ice or land in groups, and spend approximately 20–30 percent of their time out of the water. Hauled-out animals tend to be in close physical contact. Young animals often lie on top of adults. The size of the hauled-out groups can range from a few animals up to several thousand individuals. The largest aggregations occur at land haulouts.
Use of terrestrial haulouts in the eastern Chukchi Sea by large numbers has been common during recent years of low summer sea ice, when the edge of the pack ice has moved north into the deep Arctic Basin where Pacific walruses cannot feed (due to too great a water depth). In recent years, the barrier islands north of Point Lay, Alaska, have held large aggregations of up to 20,000–40,000 animals in late summer and fall (Monson
Polar bears are known to prey on Pacific walruses, particularly calves; killer whales (
Pacific walruses have been hunted for food and other purposes by coastal-dwelling Alaska Natives and Native peoples of Chukotka, Russian Federation for thousands of years. Combined harvest mortality from 2000–2014 for the United States and Russian Federation averaged 3,207 per year (USFWS unpublished data). This mortality estimate includes corrections for under-reported harvest (U.S. only)
Detailed information on the biology and status of the species, including a revised stock assessment report announced on April 21, 2014 (79 FR 22154), is available at
Proposed cable-laying activities in the Chukchi Sea may encounter Pacific walruses, but encounters in the Beaufort and Bering Seas are unlikely. The Southern Beaufort Sea east of 153° W. is extralimital; encounters are unlikely there. Project activities are scheduled to occur in the northern Bering Sea after mid-July, when most Pacific walruses have moved north into the Chukchi Sea or south to Bristol Bay. No project activities are planned in Bristol Bay or in the Bering Sea south of Nome.
Proposed activities in the Chukchi Sea in July–August have the greatest degree of overlap with areas used by Pacific walruses. Project activities occurring in these areas in September–November may also encounter Pacific walruses. Noise and vessel activities associated with the project have the potential to disrupt normal behavioral patterns including migration, nursing, and feeding. Use of thrusters, echo sounders, and beacon transceivers could generate noise levels capable of causing acoustic harassment near the project area and are discussed in the following section.
Pacific walruses hear sounds both in air and in water. Kastelein
Acoustic sources operating during cable laying will include thrusters, plows, jets, ROVs, echo sounders, and positioning beacons. Of these, the dominant source of radiated underwater noise at frequencies less than 200 Hz is propeller cavitation from the vessel propulsion systems (Ross 1976). The cable ships will each maintain dynamic positioning during cable-laying operations by using two 1,500-kW bow thrusters, two 1,500-kW aft thrusters, and one 1,500-kW fore thruster. Sound source measurements have not been conducted specific to the C/S
Echo sounders, transceivers, and transponders will be used to conduct hydroacoustic surveys of water depth and to guide the position of the plow and ROV. Sound levels produced by these sources can range from 210–226 dB at 1 m, but are generally at frequencies above the hearing sensitivities of Pacific walruses; typical frequencies are 24 kHz–900 kHz. Some surveys use frequencies as low as 50 Hz or as high as 2 megahertz (MHz). Pulses of sound are produced every 1 to 3 seconds in narrow downward-focused beams; there is very little horizontal propagation of noise. Commercial sonar systems may generate lower frequency side-lobes audible to marine mammals, but these are generally produced at sound levels unlikely to cause harm (Deng
Marine mammals in general have variable reactions to noise sources, particularly mobile sources such as marine vessels. Potential impacts from noise include displacement from preferred foraging areas, increased stress, energy expenditure, interference with feeding, masking of communications, or temporary hearing loss. Potential acoustic injuries from exposure to high levels of sound may manifest in the form of temporary or permanent changes in hearing sensitivity. The underwater hearing abilities of the Pacific walrus have not been studied sufficiently to develop species-specific criteria for preventing harmful exposure. Sound pressure level thresholds have been developed for other members of the pinniped taxonomic group, above which exposure is likely to cause behavioral responses and injuries (Finneran 2015).
Historically, NOAA has used 190 dB
The NOAA 190–dB
Based on these data, and applying a precautionary approach in the absence of empirical information, we assume it is possible that Pacific walruses exposed to 190–dB or greater sound levels from underwater activities could suffer injury from PTS. Pacific walruses exposed to underwater sound pressure levels greater than 180 dB could suffer temporary shifts in hearing thresholds. Repeated or continuous exposure to sound levels between 160 and 180 dB may also result in TTS, and exposures above 160 dB are more likely to elicit behavioral responses than lower level exposures.
The Service's underwater sound mitigation measures include employing “Protected Species Observers” (PSOs) to establish and monitor 160–dB, 180–dB, and 190–dB isopleth mitigation zones centered on any underwater sound source greater than 160 dB
Pacific walruses' reactions to noise sources at likely to be variable, depending on the sound levels and frequencies, individuals' prior exposure to the disturbance source, their need or desire to be in the particular habitat or area where they are exposed to the noise, location relative to the disturbance, and whether the disturbance source is visible or odorous. Pacific walruses are typically more sensitive to disturbance when hauled out on land or ice than when they are in the water. The Quintillion cable project will be carried out away from the edge of the seasonal pack ice and terrestrial haulouts. This will minimize potential interactions with large concentrations of Pacific walruses in the project area, which typically favor sea-ice habitats or land-based haulouts.
Relatively minor reactions, such as increased vigilance, are not likely to disrupt biologically important behavioral patterns and, therefore, do not constitute take by harassment, as defined by the MMPA. Reactions such as fleeing a haulout or departing a feeding area have the potential to disrupt biologically significant behavioral patterns, including nursing, feeding, and resting, and may result in decreased fitness for the affected animal. These reactions meet the criteria for Level B harassment under the MMPA. Significant reactions have been documented in response to vessel noise. For example, icebreaking activities in the Chukchi Sea were observed to displace some Pacific walrus groups up to several kilometers (Brueggeman
Cable-laying activities will occur in regions of the Chukchi Sea used by Pacific walruses for foraging. Noise from these activities may cause Pacific walruses to be displaced during feeding, and could have direct effects on food resources. Little research has been conducted on the effects of sound on invertebrates. Mussels, clams, and crabs do not have auditory systems or swim bladders that could be affected by sound pressure, but squid and other invertebrate species have complex statocysts that resemble the otolith organs of fish that may allow them to detect sounds (Budelmann 1992). Normandeau Associates, Inc. (2012) concluded that invertebrates are sensitive to local water movements and to low-frequency particle accelerations generated by sound sources in their close vicinity. Based on these results, impulsive hydroacoustic surveys could acoustically impact local marine communities, but only within a limited area. From an ecological community standpoint, these impacts are considered minor. No significant reduction in quality or availability of Pacific walrus food resources is expected.
The proposed action will include measures to prevent extreme behavioral reactions to project noise and injury from noise exposure. Measures include minimizing probability of encounters by working during times when sea ice is not present and avoiding terrestrial haulouts. Cable vessels will not operate in areas where doing so would allow animals to be exposed to simultaneous noise from more than one ship. Acoustic ensonification zones will be monitored by PSOs during cable laying to document take and during pre- and post-cable-laying activities to maintain at least an 805-m (0.5-mi) distance from Pacific walruses. These measures are expected to reduce the intensity of disturbance events and to minimize the potential for injuries to animals.
Pacific walruses may be disturbed by the sights, sounds, and smells of humans, machinery, and equipment associated with the proposed vessel-based activities during Quintillion's project. The potential responses of Pacific walruses to these types of disturbances are highly variable and may depend on the context of the encounter. Responses may include: Altered headings; increased swimming rates; increased vigilance; changes in dive, surfacing, respiration, feeding, and vocalization patterns; and hormonal stress production (
The proposed cable route is outside of the HSWUA, which will limit the number of walruses exposed to the project activities, but some Pacific walruses may be foraging outside the HSWUA and could be displaced while using these peripheral feeding areas. Pacific walruses that are displaced while foraging in peripheral feeding areas or while traveling between Hanna Shoal and coastal haulouts are likely to expend some additional energy avoiding the project activities. Effects of displacement within foraging areas and from travel routes will depend on the ability of the affected animals to reach and use alternate areas. There are no anticipated events or activities that will restrict availability of or access to other suitable foraging habitat or alternate travel routes during this project.
Pacific walruses may cross paths with cable-laying and support vessels while migrating or traveling to foraging or resting areas. The reaction of Pacific walruses to vessel traffic is dependent upon vessel type, distance, speed, and an animal's previous exposure to disturbances. For example, low-frequency diesel engines have been observed to cause fewer disturbances than high-frequency outboard engines (Fay
The Chukchi Sea contains important food resources. Trenching for cable burial will impact benthic and epibenthic invertebrates by: (1) Crushing with the plough blade, plough skid, or ROV track; (2) dislodgement onto the surface where they may die; and (3) the settlement of suspended sediment away from the trench where it may clog gills or feeding structures of sessile invertebrates or smother sensitive species (BERR 2008). Recolonization of benthic communities in northern latitudes is slow and may take 10 years or more (Conlan and Kvitek 2005; Beuchel and Gulliksen 2008). Seafloor trenching will leave a lasting impact on the seafloor within the cable corridor, but will have only a minor effect on the benthic community in a local area. Linear trenching of this scale will affect approximately 0.3 percent of each square km intersected by the cable route. This is an insignificant portion of the total seafloor available for Pacific walrus foraging. Further, none of the activity will occur in the HSWUA. The overall effects of cable laying on food resources will be inconsequential to Pacific walruses.
Disturbance that occurs while Pacific walruses are resting at a haulout may have the greatest potential for harmful impacts. Disturbance events in the Chukchi Sea have been known to cause groups to abandon land or ice haulouts and occasionally result in trampling injuries or cow-calf separations, both of which are potentially fatal (USFWS 2015a). Anecdotal observations by Pacific walrus hunters and researchers also suggest that males tend to be more tolerant of disturbances than females (Fay
Quintillion's activities are planned to avoid disturbance of haulouts. Pacific walrus densities in the Chukchi Sea are highest along the edge of the pack ice, and the proposed activities are scheduled to avoid pack ice. The probability of encountering haulouts in pack ice is, therefore, low. Operations may encounter aggregations of Pacific walruses hauled out onto sparse patches of ice or when cable branches are installed at beach landings. Cable end branches will be placed perpendicular to the coastline and adjacent to the respective village to minimize nearshore activities. Landing locations were selected with input from local residents to avoid areas where haulouts may occur. No nearshore work will be done near Point Lay, where large haulouts are likely.
Potential spills could involve fuel, oil, lubricants, solvents, and other substances used aboard the cable ships or support vessels. An oil spill or unpermitted discharge is an illegal act; IHAs do not authorize takes of marine mammals caused by illegal or unpermitted activities. If a spill did occur, the most likely impact upon Pacific walruses would be exposure to spilled oil, which may cause injury, illness, or possibly death depending on degree and duration of exposure and the characteristics of the spilled substance. A large spill could result in a range of impacts from reduced food availability to chronic ingestion of contaminated food. Spill response activities, especially use of dispersants, may increase the cumulative impact of a spill on Pacific walrus habitat by making oil more bioavailable for uptake by filter feeders and benthic invertebrates (
The Service anticipates that incidental take of Pacific walruses may occur during Quintillion's cable-laying project. Noise, vessels, and human activities could temporarily interrupt feeding, resting, and movement patterns. The project component most likely to result in take is cavitation noise produced by the thrusters during dynamic positioning of the cable-laying vessel. The elevated underwater noise levels may cause short-term, temporary, nonlethal, but biologically significant changes in behavior that the Service considers to be Level B harassment. Other proposed activities, such as the use of an ROV, tug and barge, dive team, and support vessels are considered to have a limited potential for disturbance leading to take.
For non-impulse sounds, such as those produced by the dynamic positioning thrusters during Quintillion's subsea cable-laying operation, the Service uses the 190-dB
Quintillion provided calculations to estimate take by Level B harassment based on the estimated number of Pacific walruses that may occur within the 120-dB isopleth produced by the dynamic positioning thrusters during the proposed cable-laying operation. The Service generally associates the 160-dB isopleth with Level B harassment. The estimate of take based on the 120-dB isopleth will account for all animals exposed to sound levels higher than 120 dB, including those exposed to 160 dB or greater. The Service evaluated these calculations to determine whether the necessary MMPA findings could be made per Quintillion's petition, but we expect Quintillion's calculations to overestimate the number of Pacific walruses that will be taken. Quintillion provided a full description of the methodology used to estimate take by harassment in its IHA petition, which is also provided in the following paragraphs.
The estimate of the numbers of Pacific walruses that could be taken by Level B harassment from exposure to thruster noise during cable-laying operations was determined by multiplying the maximum seasonal density of Pacific walruses by the total area in the northern Bering, Chukchi, and southwestern Beaufort Seas (to 153°W) that will be ensonified by sound levels greater than 120 dB
Various acoustic investigations have modeled distances to the 120-dB isopleth for water depths similar to where Quintillion would be operating with results ranging between 1.4–3.5 km (Samsung 2009; Deepwater Wind 2013). However, these ranges were based on conservative modeling that included
The sum total of submerged cable length is 1,904 km (1,183 mi), but total cable length within Pacific walrus habitat (west of 153° W.) is 1,691 km (1,051 mi). Assuming that the radius to the 120-dB isopleth is 2.3 km (1.4 mi), the total ensonified area encompasses an area 1,691 km (1,051 mi) in length and 4.6 km (2.8 mi) in width (4.6 = 2 × 2.3 km) or 7,780 km
The seasonal distribution of Pacific walruses in the project area is associated with the distribution and extent of broken pack ice (Fay
The best available at-sea density estimates come from Aerts
The number of Pacific walruses potentially exposed to harassment by the Quintillion cable project was estimated by multiplying the seasonal density (0.041 walrus/km
This level of take by harassment is small relative to the most recent stock abundance estimate for the Pacific walrus. A take level of 500 represents only 0.39 percent of the best available estimate of the current population size of 129,000 animals (Speckman
Although 500 Pacific walruses (~0.39 percent of the population) are estimated to be potentially taken (
Vessel-based activities could temporarily interrupt the feeding, resting, and movement of Pacific walruses. Because offshore activities are expected to move through the Chukchi Sea, impacts associated with cable laying are likely to be temporary and localized. The anticipated effects include short-term behavioral reactions and displacement of small numbers of Pacific walruses in the vicinity of active operations. Areas affected by the proposed action will be small compared to the regular movement patterns of the population indicating that animals will be capable of retreating from or avoiding the affected areas. Animals that encounter the proposed activities may exert more energy than they would otherwise due to temporary cessation of feeding, increased vigilance, and retreat from the project area, but would be expected to tolerate this without measurable effects on health or reproduction. Adoption of the measures specified in Mitigation and Monitoring are expected to reduce the intensity of disturbance events and minimize the potential for injuries to animals.
In sum, no injuries or mortalities are anticipated to occur as a result of Quintillion's subsea cable-laying operation, and none will be authorized. The takes that are anticipated and would be authorized are expected to be limited to short-term Level B harassment in the form of brief startling reactions or temporary displacement. No long-term biologically significant impacts to Pacific walruses are expected.
The MMPA allows Alaska Natives to harvest Pacific walruses for subsistence purposes or for the purposes of creating authentic Native articles of handicraft and clothing, provided this is accomplished in a non-wasteful manner. The proposed cable-laying activities will occur within the marine subsistence areas used by Alaska Natives from the villages of Nome, Wales, Diomede, Kotzebue, Kivalina, Point Hope, Point Lay, Wainwright, Barrow, and Nuiqsut, all of which annually hunt Pacific walruses, except Nuiqsut. Between 2006 and 2015, approximately 1,080 Pacific walruses were harvested annually in Alaska (USFWS unpublished data). The years 2013–2015 were low harvest years; annual harvest from 2006–2012 was 1,308 per year. These estimates are of
The villages within the project area harvested an average of 81 Pacific walruses per year from 2006–2015. The small village of Diomede (population of ~115) harvested 26 percent of these (~21 per year). Diomede is located on Little Diomede Island in the center of the Bering Strait. Twice a year the vanguard of the walrus population passes through the Strait when migrating between wintering and summering grounds providing harvest opportunities for Diomede hunters. Pacific walruses will also occasionally haul out on Little Diomede Island during the summer and fall (Garlich-Miller and Burn 1999).
Relative to the village population size (556), Pacific walruses are also an important staple for Wainwright inhabitants. From 2006–2015, approximately 26 Pacific walruses were taken annually. Wainright also harvests beluga and bowhead whales. The small village of Wales (population ~145), located on the eastern edge of the Bering Strait, harvested an average of six Pacific walruses each year (USFWS unpublished data). Nome also harvested six Pacific walruses per year, and Barrow harvested 14 per year from 2006–2015. Nome and Barrow both have populations of approximately 4,000 people, and Pacific walrus is not as important in the subsistence diet as other resources.
Kotzebue, Kivalina, Point Hope, and Point Lay each harvested fewer than five Pacific walruses annually from 2006–2015, suggesting harvest of this species in these villages is more opportunistic than focused. The communities of Savoonga, Brevig Mission, Chefornak, Elim, Gambell, Hooper Bay, King Island, Kipnuk, Shaktoolik, Shishmaref, Teller, Togiak, and Toksook Bay all harvested one or more per year on average from 2006–2015, but are outside of the geographic region of the proposed action.
There are only a few locations where the proposed project area could overlap with local subsistence harvest areas. These include the portion of the route passing between the villages of Diomede and Wales, and the branching line into Wainwright. The proposed route is expected to pass about 25 km (16 mi) east of Little Diomede Island. Presence of ice is needed for any spring Pacific walrus hunts from Diomede, and the Quintillion cable-laying vessel cannot operate in the presence of ice.
Pacific walruses are harvested from Wainwright and Barrow during July and August from drifting ice floes (Bacon
Based on the proposed cable-laying timetable relative to the seasonal timing of the various village harvest periods, an overlap in cable laying and Pacific walrus hunting is not expected. However, Quintillion will continue to work closely with the Eskimo Walrus Commission (EWC) and the affected villages to minimize any effects cable-laying activities might have on subsistence harvest, including scheduling the laying of branching lines to avoid periods when Pacific walruses are present.
In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, the Service must, where applicable, set forth the permissible methods of take and other means of effecting the least practicable impact on the Pacific walrus and its habitat, and on the availability of the species or stock for subsistence uses. Particular attention must be paid to habitat areas of importance, including haulouts and feeding areas. The Service evaluated the project, its potential impacts, and the range of avoidance, mitigation, and minimization measures that could be applied. Monitoring and mitigation measures were developed that will minimize the potential impacts and ensure the least practicable impact to Pacific walruses. As part of these mitigation measures, Quintillion will communicate closely with the EWC and the villages to ensure subsistence harvest is not disrupted. A Plan of Cooperation (POC) has been developed and will be implemented to structure and facilitate coordination with subsistence users. Work will be scheduled to minimize activities in hunting areas during subsistence harvest periods. Quintillion has also developed a Marine Mammal Monitoring and Mitigation Plan (4MP). Habitat areas where Pacific walruses engage in particularly sensitive activities (such as feeding or resting at haulouts) will be avoided. Adaptive measures, such as temporal or spatial limitations, will be applied in response to the presence of Pacific walruses. These documents will be available for public review as specified in
For the proposed Quintillion subsea cable-laying operations in the Bering, Chukchi, and Beaufort Seas and coastal lands of Alaska, the primary means of minimizing potential consequences for Pacific walrus and subsistence users is routing the cable to avoid concentration areas and important prey habitat. Most of the main trunk line will be laid 30–150 km (19–93 mi) offshore, thereby avoiding nearshore Pacific walrus concentrations and terrestrial haulouts. Where cable end branches will come ashore, landings will be conducted at right angles to the coastline and immediately adjacent to the respective village (except at Oliktok Point where no village exists) to minimize nearshore activities and avoid areas where haulouts may occur. No work will be done near Point Lay, where large haulouts are likely, or near Hanna Shoal, where feeding aggregations may occur. Cable-laying activities will not be performed by multiple vessels simultaneously where doing so would create overlapping ensonification zones. The proposed action will not occur north of the Bering Strait until July 1 to allow Pacific walruses the opportunity to disperse from the confines of the spring lead system and to minimize interactions with subsistence hunters. Quintillion's operations must avoid sea ice for safety reasons. In doing so, Quintillion will avoid ice habitat used by Pacific walruses. The cable-laying operation will occur at a slow speed of 600 m/hr (0.37 mph), and it is, therefore, highly unlikely that cable-laying activities could cause injury. Collisions between vessels and marine mammals are rare, and when they do occur, they usually involve fast-moving vessels.
Measures included in the proposed IHA to monitor and reduce the
Quintillion has proposed to employ PSOs during cable-laying operations to monitor zones of ensonification where the received sound level is 120 dB or greater. Observers will conduct vessel-based monitoring for Pacific walruses during all daylight periods of operation throughout the cable-laying operation. The duties of PSOs will include: Watching for marine mammals and identifying Pacific walruses; recording their numbers, locations, distances, and reactions to the survey operations; and documenting take by harassment. A sufficient number of trained PSOs will be required onboard each survey vessel to achieve 100 percent monitoring coverage during all periods of cable-laying operations in daylight with a maximum of 4 consecutive hours on watch and a maximum of 12 hours of watch time per day, per PSO. Nighttime observations will be made opportunistically using night-vision equipment.
Each vessel will have an experienced field crew leader to supervise the PSO team and will contain individuals with prior experience as marine mammal monitoring observers, including experience specific to Pacific walrus observations. New or inexperienced PSOs would be paired with an experienced PSO so that the quality of marine mammal observations and data recording is kept consistent. Resumes for candidate PSOs will be made available for the Service to review. All observers will have completed a training course designed to familiarize individuals with monitoring and data collection procedures. The PSOs shall be provided with Fujinon 7 × 50 or equivalent binoculars. Laser range finders (Leica LRF 1200 or equivalent) will be available to assist with distance estimation.
All location, weather, and marine mammal observation data will be recorded onto a standard field form or database. Global positioning system and weather data will be collected at the beginning and end of a monitoring period and at every half-hour in between. Position data will also be recorded at the change of an observer or the sighting of a Pacific walrus. Enough position data will be collected to map an accurate charting of vessel travel. Observations of Pacific walruses will also include group size and composition (adults/juveniles), behavior, distance from vessel, presence in any applicable ensonification zone, and any apparent reactions to the project activities. Data forms or database entries will be made available to the Service upon request.
Quintillion plans to conduct sound source verification and contribute to passive acoustic monitoring efforts. Acoustic injury to Pacific walruses can occur if received noise levels exceed 190 dB. The cable-laying activities are not expected to produce noise levels capable of acoustic injury, and Quintillion is not requesting authorization of take by Level A harassment. Therefore, no shutdown zones will be necessary for this activity. However, Level B take may occur due to exposure to sound at greater than 160-dB levels. For this reason, observers must monitor the 160-B ensonification zone for the presence of Pacific walruses. Quintillion has committed to monitoring the 120-dB zone for marine mammals. The 160-dB zone is well within the 120-dB zone and, therefore, will be included in the monitoring area.
Sound source verification will be conducted during early-season operation of one cable-lay ship and anchor-handling tug. Results will be used to calibrate the 120-dB and 160-dB ensonification zones. If sound source verification indicates that sound levels produced during operations will be higher than expected (greater than 190 dB
Passive acoustic monitoring will be conducted by the 2016 joint Arctic Whale Ecology Study (ARCWEST)/Chukchi Acoustics, Oceanography, and Zooplankton Study Extension (CHAOZ–X) with support from Quintillion. The current mooring locations for the passive acoustic monitoring portion of the joint program align closely with the proposed Quintillion cable-lay route. Acoustic data from these locations in 2016 will provide information on the distribution and composition of the marine mammal community and the acoustic effects of the cable-lay activity on the local environment where the route passes close to these stations.
When the cable ships are traveling in Alaskan waters to and from the project area (before and after completion of cable laying), and during all travel by support vessels, operators will implement the following measures:
• Avoid potential interaction with any and all Pacific walruses by taking reasonable precautions such as changing speed or course when Pacific walruses are observed within 805 km (0.5 mi). Changes in speed or course will be achieved gradually to avoid abrupt maneuvers whenever possible.
• Do not approach Pacific walruses within 805 km (0.5 mi).
• Reduce speed to less than 2.6 meters per second (m/s) (5 kn) when visibility drops (such as during inclement weather, rough seas, or at night) to avoid the likelihood of collision with Pacific walruses. During cable laying, the normal vessel travel speed is less than 2.6 m/s (5 kn).
• Vessels may not be operated in such a way as to separate members of a group of Pacific walruses from other members of the group.
• Activities are not planned near known haulouts, but if Pacific walruses are observed on land, vessels will maintain a 1.6 km (1 mi) separation distance.
• Any behavioral response indicating more than Level B take of a Pacific walrus due to project activities shall be reported to the Service within 48 hours, including separation of mother from young, stampeding haulouts, injured animals, and animals in acute distress.
The Service requires holders of an IHA to cooperate with the Service and other designated Federal, State, and local agencies to monitor the impacts of proposed activities on marine mammals and subsistence users. Quintillion has coordinated with the Service, NOAA—Fisheries, and the Army Corps of Engineers, along with communities and subsistence harvest organizations. Specifically, Quintillion has coordinated with EWC, Barrow Whaling Captains Association members and board, the Community of Wainwright, Wainwright Whaling Captains, Point Hope Community, Tikigaq Whaling Captains, the Northwest Arctic Borough, Kotzebue City Management, the Community of Kotzebue, Maniilaq Association, Kawerak Inc., the Nome Community, and Kuukpik Corporation. Communications will continue throughout the project and may include public service announcements on KBRW and KOTZ radio stations, messaging on the Alaska Rural Communications Service television network, newsletters, and 1–800
• Plan routes in offshore waters away from nearshore subsistence harvest areas.
• Schedule operations to avoid conflict with subsistence harvest.
• Develop and implement a POC to coordinate communication.
• Participate in the Automatic Identification System for vessel tracking to allow the cable-laying fleet to be located in real time.
• Distribute a daily report by email to all interested parties. Daily reports will include vessel activity, location, subsistence/local information, and any potential hazards.
Holders of an IHA must keep the Service informed of the impacts of authorized activities on Pacific walruses by: (1) Notifying the Service at least 48 hours prior to commencement of activities; (2) immediately reporting any occurrence of injury or mortality due to project activities; (3) submitting project reports; and (4) notifying the Service upon project completion or at the end of the work season.
Weekly reports will be submitted to the Service each Thursday during the weeks that cable-laying activities take place. The reports will summarize project activities, monitoring efforts conducted by PSOs, results of sound source verification, Pacific walruses detected, the number of Pacific walruses exposed to sound levels greater than 160 dB, and any behavioral reactions to project activities.
A technical report will be submitted to the Service within 90 days after the end of the project or the end of the open-water season, whichever comes first. The report will describe all monitoring activities conducted during cable-laying activity and provide results. The report will include the following:
• Summary of monitoring effort (total hours of monitoring, activities monitored, number of PSOs).
• Summary of project activities completed and additional work yet to be done.
• Analyses of the factors influencing visibility and detectability of marine mammals (
• Discussion of location, weather, ice cover, sea state, and other factors affecting the presence and distribution of Pacific walruses.
• Number, location, distance/direction from the vessel, and initial behavior of any sighted Pacific walruses upon detection.
• Dates, times, locations, heading, speed, weather, and sea conditions (including sea state and wind force), as well as description of the specific cable-laying activity occurring at the time of the Pacific walrus observation.
• Estimated distance from the animal or group at closest approach and at the end of the encounter.
• An estimate of the number of Pacific walruses that have been exposed to the thruster noise (based on visual observation) at received levels greater than or equal to 120 dB
• Estimates of uncertainty in all take estimates, with uncertainty expressed by the presentation of confidence limits, a minimum-maximum, posterior probability distribution, or another applicable method, with the exact approach to be selected based on the sampling method and data available.
• A description of the mitigation measures implemented during project activities and their effectiveness for minimizing the effects of the proposed action on Pacific walruses.
• An analysis of the effects of survey operations on Pacific walruses.
• Occurrence, distribution, and composition of Pacific walrus sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, visibility, location of the vessel, and location of the animal (or distance and direction to the animal from the vessel) in the form of electronic database or spreadsheet files.
• A discussion of any specific Pacific walrus behaviors of interest.
In the unexpected event that the specified activity causes the take of a Pacific walrus in a manner not authorized by the IHA such as an injury or mortality (
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Description of all sound sources used in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all Pacific walrus observations in the 24 hours preceding the incident;
• Description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
In the event that Quintillion discovers an injured or dead Pacific walrus, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in the IHA (
The Service has carefully evaluated Quintillion's proposed mitigation measures and considered a range of other measures of ensuring that the cable project will have the least practicable impact on Pacific walruses and their habitat. Our evaluation considered the following: (1) The manner in which, and the degree to which, the successful implementation of the measures are expected to minimize adverse impacts to Pacific walruses; (2) the proven or likely efficacy of the measures to minimize adverse impacts as planned; and (3) the practicability of the measures for applicant implementation.
The expected effects of the prescribed mitigation measures are as follows:
• Avoidance of injury or death of Pacific walruses.
• Reduction in the numbers of Pacific walruses exposed to activities expected to result in the take of marine mammals.
• Reduction in the number of times individuals would be exposed to project activities.
• A reduction in the intensity of exposures to activities expected to result in the take of Pacific walruses.
• Avoidance or minimization of adverse effects to Pacific walrus habitat, especially haulout areas, sea ice, and foraging areas.
• An increase in the probability of detecting Pacific walruses through vessel-based monitoring, allowing for
• Reduction in the likelihood of affecting Pacific walruses in a manner that would alter their availability for subsistence uses.
Based on our evaluation of the proposed mitigation measures, the Service has preliminarily determined that these measures provide the means of effecting the least practicable impact on Pacific walruses and their habitat, including feeding areas and haulouts. These measures will also minimize any effects the project will have on the availability of the species or stock for subsistence uses.
For small take analyses, the statute and legislative history do not expressly require a specific type of numerical analysis, leaving the determination of “small” to the agency's discretion. In this case, we propose a finding that the Quintillion project will affect up to 500 Pacific walruses, and that this constitutes a small number of animals. Factors considered in our small numbers determination include the number of Pacific walruses in the affected area, the size of the affected area relative to available habitat, and the expected efficacy of mitigation measures.
First, the number of Pacific walruses inhabiting the proposed impact area is small relative to the size of the Pacific walrus population. The potential exposures for the 2016 cable-laying period, based on estimated density plus an additional allowance for the clumped distribution of Pacific walruses, is approximately 500 animals. This is about 0.39 percent of the population size of 129,000 estimated by Speckman
Second, the area where the proposed activities would occur is a relatively small fraction of the available habitat of the Pacific walrus. Cable-laying activities will have temporary impacts to Pacific walrus habitat along a 1,691-km (1,051-mi) linear corridor of marine waters and coastal land of Alaska. Sound levels greater than 120 dB
Third, monitoring requirements and mitigation measures are expected to limit the number of incidental takes. The cable route will avoid sea ice, terrestrial haulouts, and important feeding habitat. Adaptive mitigation measures will be applied by the support fleet and when cable ships are in transit. These measures will include changes in speed or course when Pacific walruses could come within 805 m (0.5 mi), and are expected to help prevent take by Level A harassment and to minimize take by Level B harassment. Activities will be monitored by PSOs, and unexpected impacts and will be reported to the Service. No take by injury or death is anticipated or authorized. Monitoring and reporting will allow the Service to reanalyze and refine future take estimates and mitigation measures as activities continue in Pacific walrus habitat in the future. Should the Service determine, based on monitoring and reporting, that the effects are greater than anticipated the authorization may be modified, suspended, or revoked.
For these reasons, we propose a finding that the Quintillion project will involve takes by Level B harassment of only a small number of animals.
The Service proposes a finding that any incidental take by harassment resulting from the proposed Quintillion cable-laying operation cannot be reasonably expected to, and is not reasonably likely to, adversely affect the Pacific walrus through effects on annual rates of recruitment or survival, and would, therefore, have no more than a negligible impact on the species or stock. In making this finding, we considered the best available scientific information, including: (1) The biological and behavioral characteristics of the species; (2) the most recent information on species distribution and abundance within the area of the proposed action; (3) the potential sources of disturbance during the proposed action; and (4) the potential responses of Pacific walruses to this disturbance. In addition, we reviewed material supplied by the applicant, other operators in Alaska, our files and datasets, data acquired from NOAA—Fisheries, published reference materials, and Pacific walrus experts.
Pacific walruses are likely to respond to proposed activities with temporary behavioral modification or displacement. These reactions are unlikely to have consequences for the health, reproduction, or survival of affected animals. The major source of disturbance is likely to be production of sound by propeller cavitation during dynamic positioning by the cable-laying vessels. Sound production is not expected to reach levels capable of causing harm, and Level A harassment (harassment that has the potential to injure Pacific walruses) is not authorized. Sound source verification will be conducted to ensure that this assessment is accurate.
Responses of Pacific walruses to disturbance would most likely include diving or swimming away from the sound source, which may cause temporary interruption of foraging, resting, or other natural behaviors. Affected animals are expected to resume normal behaviors soon after exposure, with no lasting consequences. Thus, although 500 Pacific walruses (~0.39 percent of the population) are estimated to be potentially taken (
Our proposed finding of negligible impact applies to incidental take associated with the proposed activities as mitigated by the avoidance and minimization measures. These mitigation measures are designed to minimize interactions with and impacts to Pacific walruses. These measures, and the monitoring and reporting requirements, are required for the validity of our finding and are a necessary component of the IHA.
For these reasons, we propose a finding that the Quintillion project will have a negligible impact on Pacific walruses.
We propose a finding that the anticipated harassment caused by the proposed activities would not have an unmitigable adverse impact on the availability of Pacific walruses for taking for subsistence uses. In making this finding, we considered the timing and location of the proposed activities and the timing and location of subsistence harvest activities and patterns, as reported through the Service's Marking, Tagging, and Reporting Program in the area of the proposed action. We also considered the applicant's consultation with potentially affected subsistence communities and proposed measures for avoiding impacts to subsistence harvest.
We have prepared a draft Environmental Assessment (EA) (see
Under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
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, Department of the Interior Secretarial Order 3225 of January 19, 2001 (Endangered Species Act and Subsistence Uses in Alaska (Supplement to Secretarial Order 3206)), Department of the Interior Secretarial Order 3317 of December 1, 2011 (Tribal Consultation and Policy), Department of the Interior Memorandum of January 18, 2001 (Alaska Government-to-Government Policy), the Department of the Interior's manual at 512 DM 2, and the Native American Policy of the U.S. Fish and Wildlife Service, dated January 20, 2016, we acknowledge our responsibility to communicate and work directly on a Government-to-Government basis with federally recognized Alaska Natives Tribes in developing programs for healthy ecosystems, to seek their full and meaningful participation in evaluating and addressing conservation concerns for listed species, to remain sensitive to Alaska Native culture, and to make information available to Alaska Natives.
Furthermore, and in accordance with Department of the Interior Policy on Consultation with Alaska Native Claims Settlement Act of 1971 (ANCSA) Corporations, dated August 10, 2012, we likewise acknowledge our responsibility to communicate and work directly with ANCSA Corporations in evaluating and addressing conservation concerns for listed species, to remain sensitive to Alaska Native culture, and to make information available to ANSCA Corporations.
We have evaluated possible effects of the proposed activities on federally recognized Alaska Native Tribes. Through the IHA process identified in the MMPA, the applicant presented a communication process, culminating in a POC with the Native communities most likely to be affected, and engaged these communities in numerous informational meetings.
To facilitate co-management activities, the Service maintains cooperative agreements with the EWC and the Qayassiq Walrus Commission (QWC). The cooperative agreements fund a wide variety of management issues, including co-management operations, biological sampling programs, harvest monitoring, collection of Native knowledge in management, international coordination on management issues, cooperative enforcement of the MMPA, and development of local conservation plans. To help realize mutual management goals, the Service, EWC, and QWC hold meetings to discuss future expectations and outline a shared vision of co-management.
Through various interactions and partnerships, we have determined that the issuance of this proposed IHA is appropriate. We invite continued discussion about improving our coordination and information exchange, including through the IHA/POC process, as may be requested by Tribes or other Native groups.
The Service proposes to issue an IHA for the nonlethal, incidental, unintentional take by Level B harassment of small numbers of Pacific walruses during cable-laying activities in the marine waters of Alaska and impacted coastal communities, as described in this document and in the applicant's petition. We neither anticipate nor propose authorization for intentional take or take by injury or death. The final IHA would be effective immediately after the date of issuance through November 15, 2016.
The final IHA would also incorporate the mitigation, monitoring, and reporting requirements described in this proposal. The applicant would be expected and required to implement and fully comply with those requirements. If the nature or level of activity changes or exceeds that described in this proposal and in the IHA petition, or the nature or level of take exceeds that projected in this proposal, the Service will reevaluate its findings. The Secretary may modify, suspend, or revoke the authorization if the findings are not accurate or the mitigation, monitoring, and reporting requirements described herein are not being met.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on June 30, 2016. We 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
You must submit comments on or before July 25, 2016.
Send your comments and suggestions on this information collection to the Desk Officer for the Department of the Interior at OMB–OIRA at (202) 395–5806 (fax) or
To request additional information about this ICR, contact Hope Grey at
The Migratory Bird Treaty Act Protocol Amendment (1995) (Amendment) provides for the customary and traditional use of migratory birds and their eggs for subsistence use by indigenous inhabitants of Alaska. The Amendment states that its intent is not to cause significant increases in the take of species of migratory birds relative to their continental population sizes. A submittal letter from the Department of State to the White House (May 20, 1996) accompanied the Amendment and specified the need for harvest monitoring. The submittal letter stated that the Service, the Alaska Department of Fish and Game (ADF&G), and Alaska Native organizations would collect harvest information cooperatively within the subsistence eligible areas. Harvest survey data help to ensure that customary and traditional subsistence uses of migratory birds and their eggs by indigenous inhabitants of Alaska do not significantly increase the take of species of migratory birds relative to their continental population sizes.
Between 1989 and 2004, we monitored subsistence harvest of migratory birds using annual household surveys in the Yukon-Kuskokwim Delta, which is the region of highest subsistence bird harvest in the State of Alaska. In 2004, we began monitoring subsistence harvest of migratory birds in subsistence eligible areas Statewide. The Statewide harvest assessment program helps to track trends and changes in levels of harvest. The harvest assessment program relies on collaboration among the Service, the ADF&G, and a number of Alaska Native organizations.
We gather information on the annual subsistence harvest of about 60 bird species/species categories (ducks, geese, swans, cranes, upland game birds, seabirds, shorebirds, and grebes and loons) in the subsistence eligible areas of Alaska. The survey covers 11 regions of Alaska, which are further divided into subregions. We survey the regions and villages in a rotation schedule to accommodate budget constraints and to minimize respondent burden. The survey covers spring, summer, and fall harvest in most regions.
In collaboration with Alaska Native organizations, we hire local resident surveyors to collect the harvest information. The surveyors list all households in the villages to be surveyed and provide survey information and harvest report forms to randomly selected households that have agreed to participate in the survey. To ensure anonymity of harvest information, we identify households by a numeric code. The surveyor visits households three times during the survey year. At the first household visit, the surveyor explains the survey purposes and invites household participation. The surveyor returns at the end of the season of most harvest and at the end of the two other seasons combined to help the household complete the harvest report form.
We have designed the survey methods to streamline procedures and reduce respondent burden. We use the following forms for household participation:
• FWS Form 3–2380 (Tracking Sheet and Household Consent). The surveyor visits each household selected to participate in the survey to provide information on the objectives and to obtain household consent to participate. The surveyor uses this form to record consent and track subsequent visits for completion of harvest reports.
• FWS Forms 3–2381–1, 3–2381–2, 3–2381–3, and 3–2381–4 (Harvest Report). The Harvest Report has drawings of bird species most commonly available for harvest in the different regions of Alaska, with fields for writing down the numbers of birds and eggs taken. There are four versions of this form: Interior Alaska, North Slope, Southern Coastal Alaska, and Western Alaska. This form has a sheet for each season surveyed, and each sheet has fields for the household code, community name, harvest year, date of completion, and comments.
We again invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. 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 OMB and us in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
Fish and Wildlife Service, Interior.
Notice of availability; request for comment.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Renee and Kurt Mammen for a 10-year incidental take permit (ITP) under the Endangered Species Act of 1973, as amended. The application addresses the potential for “take” of the federally endangered Morro shoulderband snail likely to result incidental to the construction and maintenance of a single-family residence on an existing legal parcel, associated infrastructure, and use of an existing access road in the unincorporated community of Los Osos, San Luis Obispo County, California. We invite comments from the public on the application package, which includes a draft low-effect habitat conservation plan (HCP) and draft low-effect screening form and environmental action statement, which constitutes our proposed National Environmental Policy Act (NEPA) compliance.
To ensure consideration, please send your written comments by July 25, 2016.
You may download a copy of the draft HCP and draft low-effect screening form and environmental action statement on the internet at
Julie M. Vanderwier, Senior Fish and Wildlife Biologist, at the Ventura office address or by phone at (805) 644–1766.
We have received an application for an incidental take permit (ITP) pursuant to section 10(a)(1)(B) of the Endangered Species Act (Act; 16 U.S.C. 1531
The Morro shoulderband snail was listed as endangered on December 15, 1994 (59 FR 64613). Section 9 of the Act and its implementing regulations (16 U.S.C. 1531
The project involves the construction and maintenance of a single-family residence and associated infrastructure along with use of an existing access road to a legal parcel in the Bayview Heights subdivision of Los Osos, County of San Luis Obispo, California. The HCP provides the support necessary for the Service to issue an incidental take permit (ITP) that would authorize take, in this instance, of the Morro shoulderband snail (
The draft HCP contains two alternatives to the proposed action: “No Action” and “Project Redesign.” Under the “No Action” alternative, an ITP for the Mammen single-family residence would not be issued. The Mammen single-family residence could not legally be built and the mitigation fee would not be available to contribute to recovery actions for Morro shoulderband snail. Since the property is privately owned, there are ongoing economic considerations (
The “Project Redesign” alternative would involve design of a project that would reduce or avoid altogether take of Morro shoulderband snail. This alternative was not selected, due to the parcel's small size and marginal value to the long-term conservation of the Morro shoulderband snail of habitat on site. A reduction or redesign of the project footprint would not meet the applicants' needs and would not significantly reduce the effects of the taking of Morro shoulderband snail such that there would be a greater benefit to species survival and recovery. For these reasons, the “Project Redesign” alternative has also been rejected.
We have determined that the applicants' proposal will have a minor or negligible effect on the Morro shoulderband snail and that the HCP qualifies for processing as a low-effect plan consistent with our Habitat Conservation Planning Handbook (November 1996). Three criteria form the basis for our determination: (1) The proposed project as described in the HCP would result in minor or negligible effects on federally listed, proposed, and/or candidate species and their habitats; (2) implementation of the HCP would result in minor negligible effects on other environmental values or resources; and (3) HCP impacts, considered together with those of other past, present, and reasonably foreseeable future projects, would not result in cumulatively significant effects. It is our preliminary determination that HCP approval and ITP issuance qualify for categorical exclusion under the NEPA (42 U.S.C. 4321
We will evaluate the permit application, including the draft HCP and comments we receive, to determine whether it meets the requirements of section 10(a)(1)(B) of the Act. We will also evaluate whether issuance of the ITP would comply with section 7of the Act by conducting an intra-Service consultation pursuant to section 7(a)(2).
We request comments from the public regarding our preliminary determination that the applicant's proposal will have a minor or negligible effect on the Morro shoulderband snail and that the HCP qualifies for processing as a low-effect. We will evaluate comments received and make a final determination regarding whether the application meets the requirements of section 10(a)(1)(B) of the Act. We will incorporate the results of our intra-Service consultation, in combination with the above findings, in our final analysis to determine whether to issue the ITP. If all of our requirements are met, we will issue the ITP to the applicant. Permit issuance would not occur less than 30 days after the date of this notice.
If you wish to comment on the permit application, HCP, and associated documents, you may submit comments by any one of the methods provided in
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 view, we cannot guarantee that we will be able to do so.
We provide this notice under section 10(c) of the Act and the NEPA public involvement regulations (40 CFR 1500.1(b), 1500.2(d), and 1506.6).
Bureau of Indian Affairs, Interior.
Notice of submission to OMB.
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs (BIA) has submitted to the Office of Management and Budget (OMB) a request for renewal of the collection of information for grants under the Office of Indian Energy and Economic Development, Energy and Mineral Development Program, authorized by OMB Control Number 1076–0174. This information collection expires June 30, 2016.
Interested persons are invited to submit comments on or before July 25, 2016.
Please submit your comments to the Desk Officer for the Department of the Interior at the Office of Management and Budget, by facsimile to (202) 395–5806 or you may send an email to:
Rebecca Naragon, U.S. Department of the Interior, Office of Indian Energy and Economic Development, 1951 Constitution Avenue NW., MS–16–SIB, Washington, DC 20245; email:
The Energy Policy Act of 2005, 25 U.S.C. 3502(a)(2)(B) authorizes the Secretary of the Interior to provide grants to assist Indian Tribes in the development of energy resources and further the goal of Indian self-determination.
The Office of Indian Energy and Economic Development (IEED) administers and manages the energy resource development grant program under the Energy and Minerals Development Program (EMDP). Congress may appropriate funds to EMDP on a year-to-year basis. When funding is available, IEED may solicit proposals for energy resource development projects from Indian Tribes and Tribal energy resource development organizations for use in carrying out projects to promote the integration of energy resources, and to process, use or develop those energy resources on Indian land. The projects may be in the areas of exploration, assessment, development, feasibility, or market studies. Indian Tribes that
The Bureau of Indian Affairs (BIA) requests your comments on this collection concerning: (a) The necessity of this information collection 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 the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (c) Ways we could enhance the quality, utility, and clarity of the information to be collected; and (d) Ways we could minimize the burden of the collection of the information on the respondents.
Please note that an agency may not conduct or sponsor, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number.
It is our policy to make all comments available to the public for review at the location listed in the
Office of the Secretary, Interior.
Notice.
Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 26 nonfederal invasive species experts and stakeholders from across the nation, the purpose of the Advisory Committee is to provide advice to the National Invasive Species Council, as authorized by Executive Order 13112, on a broad array of issues related to preventing the introduction of invasive species and providing for their control and minimizing the economic, ecological, and human health impacts that invasive species cause. The Council is co-chaired by the Secretary of the Interior, the Secretary of Agriculture, and the Secretary of Commerce. The duty of the Council is to provide national leadership regarding invasive species issues.
Meeting of the Invasive Species Advisory Committee: Tuesday, July 12, 2016: 8:30 a.m. to 5:00 p.m.; Wednesday, July 13, 2016: 8:30 a.m. to 5:30 p.m.; Thursday, July 14, 2016; 8:00 a.m.–12:00 p.m.
Smithsonian Institution National Museum of the American Indian, 4th and Independence Avenue SW., Washington, DC 20560. The general session will be held in the Conference Center (4th Floor). NOTE: All meeting participants and interested members of the public must register their attendance online at
Kelsey Brantley, National Invasive Species Council Program Specialist and ISAC Coordinator, Phone: (202) 208–4122; Fax: (202) 208–4118, email:
Bureau of Land Management, Alaska State Office, Interior.
Notice of cancellation of public meeting.
The Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) has been cancelled.
The meeting was to be held June 28–30, 2016, at the Arctic Interagency Visitor Center, Dalton Highway, Coldfoot, Alaska 99701.
June Lowery, RAC Coordinator, BLM Alaska State Office, 222 W. 7th Avenue #13, Anchorage, AK 99513;
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 Alaska.
Bureau of Land Management, Interior.
Notice.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the Department of the Interior, Bureau of Land Management (BLM), Grand Staircase-Escalante National Monument Advisory Committee (GSENMAC) will meet as indicated below.
The GSENM MAC will meet Friday, August 5, 2016, (10 a.m.–4 p.m.) in Escalante, Utah.
The Committee will meet at the Escalante Interagency Visitor Center, located at 755 West Main Street, Escalante, Utah.
Larry Crutchfield, Public Affairs Officer, Grand Staircase-Escalante National Monument, Bureau of Land Management, 669 South Highway 89A, Kanab, Utah 84741; phone (435) 644–1209.
The 15-member GSENMAC was appointed by the Secretary of Interior on January 23, 2016, pursuant to the Monument Management Plan, the Federal Land Policy and Management Act of 1976 (FLPMA), and the Federal Advisory Committee Act of 1972 (FACA). As specified the Committee charter, the GSENMAC may be requested to: (1) Gather and analyze information, conduct studies and field examinations, seek public input or ascertain facts to develop recommendations concerning the use and management of the Monument; (2) Review programmatic documents including the annual Monument Manager's Reports, and Monument Science Plans to provide recommendations on the achievement of the Management Plan objectives; (3) Compile monitoring data and assess and advise the DFO of the extent to which the Plan objectives are being met; (4) Make recommendations on Monument protocols and applicable planning projects to achieve the overall objectives are being met; (5) Review appropriate research proposals and make recommendations on project necessity and validity; (6) Make recommendations regarding allocation of research funds through review of research and project proposals as well as needs identified through the evaluation process; (7) Consult and make recommendations on issues such as protocols for specific projects,
Topics to be discussed by the GSENMAC during this meeting include new member orientation (MAC Charter, By-laws, FACA committee guidelines and responsibilities), the ongoing Livestock Grazing Management Plan Amendment and Associated Environmental Impact Statement (LGMPA/AEIS), GSENM division reports, future meeting dates and other matters as may reasonably come before the GSENMAC.
The entire meeting is open to the public. Members of the public are welcome to address the Committee at 3:00 p.m., local time, on August 5, 2016. Depending on the number of persons wishing to speak, a time limit could be established. Interested persons may make oral statements to the GSENMAC during this time or written statements may be submitted for the GSENMAC's consideration. Written statements can be sent to: Grand Staircase-Escalante National Monument, Attn.: Larry Crutchfield, 669 South Highway 89A, Kanab, Utah, 84741. Information to be distributed to the GSENMAC is requested 10 days prior to the start of the GSENMAC meeting.
All meetings are open to the public; however, transportation, lodging, and meals are the responsibility of the participating public.
Bureau of Reclamation, Interior.
Notice of availability.
The Bureau of Reclamation has made available to the public the Water Management Plans for four entities. For the purpose of this announcement, Water Management Plans (Plans) are considered the same as Water Conservation Plans. Reclamation is publishing this notice in order to allow the public an opportunity to review the Plans and comment on the preliminary determinations.
Submit written comments on the preliminary determinations on or before July 25, 2016.
Send written comments to Ms. Charlene Stemen, Bureau of Reclamation, 2800 Cottage Way, MP–410, Sacramento, CA 95825; or via email at
To be placed on a mailing list for any subsequent information, please contact Ms. Charlene Stemen at the email address above or at 916–978–5281 (TDD 978–5608).
To meet the requirements of the Central Valley Project Improvement Act of 1992 and the Reclamation Reform Act of 1982, the Bureau of Reclamation developed and published the Criteria for Evaluating Water Management Plans (Criteria). Each of the four entities listed below has developed a Plan that has been evaluated and preliminarily determined to meet the requirements of these Criteria. The following Plans are available for review:
We are inviting the public to comment on our preliminary (
1. Description of the District;
2. Inventory of Water Resources;
3. Best Management Practices (BMPs) for Agricultural Contractors;
4. BMPs for Urban Contractors;
5. Plan Implementation;
6. Exemption Process;
7. Regional Criteria; and
8. Five-Year Revisions
Reclamation evaluates Plans based on these criteria. A copy of these Plans will be available for review at Reclamation's Mid-Pacific Regional Office, 2800 Cottage Way, MP–410, Sacramento, CA 95825. Our practice is to make comments, including names and home addresses of respondents, available for public review. If you wish to review a copy of these Plans, please contact Ms. Stemen.
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.
The Commission hereby gives notice of the scheduling of full reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the countervailing duty order on heavy iron construction castings from Brazil, the antidumping duty order on heavy iron construction castings from Canada, and the antidumping duty orders on iron construction castings from Brazil and China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.
Porscha Stiger (202–205–3241), 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 (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207,
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
The Commission has determined that these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the reviews period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of full reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty orders on seamless refined copper pipe and tube from China and Mexico would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.
Lawrence Jones (202–205–3358), 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 (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
The Commission has determined that these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the reviews period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty orders on carbon steel butt-weld pipe fittings from Brazil, China, Japan, Taiwan, and Thailand would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
Michael Szustakowski ((202) 205–3169), 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 (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
June 22, 2016.
11:00 a.m.
9:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205–2000.
Open to the public.
In accordance with 19 CFR 201.35(d)(2)(i), the Commission hereby gives notice that the Commission has determined to change the time of the meeting of June 22, 2016, from 11:00 a.m. to 9:30 a.m.
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. Earlier notification of this change was not possible.
By order of the Commission.
National Institute of Justice, Justice.
Notice and request for comments.
The National Institute of Justice (NIJ) seeks feedback from the public on the draft failure definition and scoring criteria (FDSC) developed for the Gun Safety Technology Challenge, published here:
Comments must be received by 5 p.m. Eastern Time on August 8, 2016.
NIJ was tasked with supporting the President's Plan to Reduce Gun Violence, specifically:
The President is directing the Attorney General to work with technology experts to review existing and emerging gun safety technologies, and to issue a report on the availability and use of those technologies. In addition, the Administration will issue a challenge to the private sector to develop innovative and cost-effective gun safety technology and provide prizes for those technologies that are proven to be reliable and effective.
In support of this Executive action, NIJ has conducted a technology assessment and market survey of existing and emerging gun safety technologies that would be of interest to the law enforcement and criminal justice communities and others with an interest in gun safety and advanced firearm technology. These firearms or firearms accessories can be understood to use integrated components that exclusively permit an authorized user or set of users to operate or fire the gun and automatically deactivate it under a set of specific circumstances, reducing the chances of accidental or purposeful use by an unauthorized user. The integrated gun safety technology may include different authentication technologies, such as radio frequency identification and fingerprint sensors.
A report published in June 2013 by NIJ entitled
NIJ now seeks an objective demonstration of the reliability of firearms available today with advanced gun safety technology integrated into the firearm. The reliability of firearms with integrated advanced safety technologies has been cited as a concern regarding the potential performance and user acceptance of products that may incorporate such technologies, as discussed in the 2013 NIJ report. It is anticipated that the results of the Challenge will provide a basis to improve the general understanding of whether the addition of a smart gun technology does or does not significantly reduce the reliability of the firearm system compared to existing firearms. It is believed that this is the first effort to apply a methodology to provide a rigorous and scientific assessment of the technical performance characteristics of these types of firearms.
With this Challenge, manufacturers and developers of (1) firearms that incorporate advanced safety technologies or (2) firearms accessories utilizing advanced safety technologies that are intended to modify firearms were able to submit their products for testing and evaluation. The Challenge is designed to proceed in an escalated manner in three stages, including an informational and safety review, light duty single product testing, and more heavy duty expanded product testing. To assess the reliability of smart gun technology, the U.S. Army Aberdeen Test Center (ATC) plans to perform firearm testing and evaluation. The Challenge was published on October 7, 2015, and closed to submissions on January 5, 2016.
NIJ hopes to better understand the effect of smart gun technology on the reliability of the firearm versus the same or similar firearms without the added safety technology. This Challenge seeks “apples to apples” comparisons to the greatest extent possible. Testing and evaluation is designed to prioritize the collection and use of data that can substantiate conclusions about the relative performance of firearms, so that firearms with and without advanced gun safety technology that are similar with respect to type, form factor, caliber, and other physical characteristics are tested and evaluated using a common methodology and equivalent ammunition. Testing and evaluation is not designed to provide comparison of test results against absolute performance requirements or safety criteria, but rather to provide a meaningful comparison of test results of one firearm against another similar firearm, or a firearm with and without a relevant safety accessory. NIJ recently sought feedback from the public on the draft test procedures developed for the Gun Safety Technology Challenge, published here:
Office of Workers' Compensation Programs, Labor.
Announcement of meeting of the Subcommittee on IH & CMC and Their Reports of the Advisory Board on Toxic Substances and Worker Health (Advisory Board) for the Energy Employees Occupational Illness Compensation Program Act (EEOICPA).
The subcommittee will meet via teleconference on July 18, 2016, from 2:00 p.m. to 4:00 p.m. Eastern Time.
The Advisory Board is mandated by Section 3687 of EEOICPA. The Secretary of Labor established the Board under this authority and Executive Order 13699 (June 26, 2015). The purpose of the Advisory Board is to advise the Secretary with respect to: (1) The Site Exposure Matrices (SEM) of the Department of Labor; (2) medical guidance for claims examiners for claims with the EEOICPA program, with respect to the weighing of the medical evidence of claimants; (3) evidentiary requirements for claims under Part B of EEOICPA related to lung disease; and (4) the work of industrial hygienists and staff physicians and consulting physicians of the Department of Labor and reports of such hygienists and physicians to ensure quality, objectivity, and consistency. The Advisory Board sunsets on December 19, 2019. This subcommittee is being assembled to gather data and begin working on advice under Area #4, IH & CMC and Their Reports.
The Advisory Board operates in accordance with the Federal Advisory
• Defining the issues and scope of the subcommittee's topic area: the work of industrial hygienists and staff physicians and consulting physicians and their reports to ensure quality, objectivity and consistency;
• Defining data and informational needs (and review) for the topic area;
• Drafting the initial work plan with a timetable.
OWCP transcribes Advisory Board subcommittee meetings. OWCP posts the transcripts on the Advisory Board Web page,
•
•
Comments must be received by July 11, 2016. OWCP will make available publically, without change, any written comments, including any personal information that you provide. Therefore, OWCP cautions interested parties against submitting personal information such as Social Security numbers and birthdates.
Electronic copies of this
You may contact Antonio Rios, Designated Federal Officer, at
This is not a toll-free number.
The Legal Services Corporation's Finance Committee will meet telephonically on June 28, 2016. The meeting will commence at 3:00 p.m., EDT, and will continue until the conclusion of the Committee's agenda.
John N. Erlenborn Conference Room, Legal Services Corporation Headquarters, 3333 K Street NW., Washington, DC 20007.
Members of the public who are unable to attend in person but wish to listen to the public proceedings may do so by following the telephone call-in directions provided below.
• Call toll-free number: 1–866–451–4981;
• When prompted, enter the following numeric pass code: 5907707348
• When connected to the call, please immediately “MUTE” your telephone.
Members of the public are asked to keep their telephones muted to eliminate background noises. To avoid disrupting the meeting, please refrain from placing the call on hold if doing so will trigger recorded music or other sound. From time to time, the Chair may solicit comments from the public.
Open.
Katherine Ward, Executive Assistant to the Vice President & General Counsel, at (202) 295–1500. Questions may be sent by electronic mail to
LSC complies with the Americans with Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to accommodate individuals with disabilities. Individuals needing other accommodations due to disability in order to attend the meeting in person or telephonically should contact Katherine Ward, at (202) 295–1500 or
Legal Services Corporation.
Postponement notice.
On June 16, 2016, the Legal Services Corporation (LSC) published a notice in the
This postponement is effective June 21, 2016.
Katherine Ward, Executive Assistant to the Vice President for Legal Affairs and General Counsel, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007; (202) 295–1500;
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92–463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Wednesday, July 20, 2016, 8:30 a.m.–4:00 p.m., and Thursday, July 21, 2016, 8:30 a.m.–4:00 p.m., Local Time.
NASA Headquarters, Room 3H42, 300 E Street SW., Washington, DC 20546.
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358–0750, fax (202) 358–2779, or
The meeting will be open to the public up to the capacity of the room. This meeting will also be available telephonically and by WebEx. Any interested person may call the USA toll free conference call number 1–877–601–4492, passcode 7555144, or call the toll number 1–773–756–4808, passcode 7555144, both days. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be required to sign a register and comply with NASA Headquarters security requirements, including the presentation of a valid picture ID before receiving access to NASA Headquarters. Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID to Security before access to NASA Headquarters. Due to the Real ID Act, Public Law 109–13, any attendees with drivers licenses issued from non-compliant states/territories must present a second form of ID. [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I–9]. Non-compliant states/territories are: American Samoa, Illinois, Minnesota, Missouri, New Mexico and Washington. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 working days prior to the meeting: Full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee; and home address to Ms. Ann Delo via email at
National Credit Union Administration (NCUA).
Notice.
The National Credit Union Administration (NCUA) will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104–13, on or after the date of publication of this notice.
Comments should be received on or before July 25, 2016 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for NCUA, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission may be obtained by emailing
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on June 20, 2016.
National Credit Union Administration (NCUA).
Notice and request for comment.
NCUA, as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on an extension of a currently approved collection, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35).
Written comments should be received on or before August 22, 2016 to be assured consideration.
Interested persons are invited to submit written comments on the information collection to Dawn Wolfgang, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314; Fax No. 703–519–8579; or Email at
Requests for additional information should be directed to the address above.
The records preservation program requirement enables FICUs to reconstruct their vital records in the event records are destroyed by a catastrophe and facilitates restoration of vital member services.
Adjustments are being made to the number of respondents due to a decline in the number of FICUs.
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on June 20, 2016.
Nuclear Regulatory Commission.
Draft NUREG; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing distribution to general licensees. The NRC is requesting public comment on draft NUREG–1556, Volume 16, Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees.” The document has been updated from the previous revision to include information on safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by applicants, licensees, and the NRC staff.
Submit comments by July 25, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to assure consideration of comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Vanessa Cox, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415–8342; email:
Please refer to Docket ID NRC–2015–0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this action by the following methods:
•
•
•
The draft NUREG–1556, Volume 16, Revision 1, is also available on the NRC's public Web site on the: (1) “Consolidated Guidance About Materials Licenses (NUREG–1556)” page at
Please include Docket ID NRC–2015–0252 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 publicly disclosed in your comment submission. The NRC will post 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 NUREG provides guidance to existing licensees that distribute generally licensed (GL) materials, products, or devices and to an applicant in preparing a license application to distribute GL materials, products, or devices. The NUREG also provides the NRC with criteria for evaluating a license application. The purpose of this notice is to provide the public with an opportunity to review and provide comments on draft NUREG–1556, Volume 16, Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees.” These comments will be considered in the final version or subsequent revisions.
For the U.S. Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Early site permit application; receipt.
On May 12, 2016, the Tennessee Valley Authority (TVA) filed with the U.S. Nuclear Regulatory Commission (NRC), an application for an early site permit (ESP) for the Clinch River Nuclear Site located in Oak Ridge, Tennessee.
The ESP application is available as of May 26, 2016.
Please refer to Docket ID NRC–2016–0119, when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Allen Fetter, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone: 301–415–8556, email:
Pursuant to Section 103 of the Atomic Energy Act, as amended, and part 52 of title 10 of the
The NRC will publish subsequent
The following table indicates the ADAMS accession number or Web site where application documents are available to interested persons.
The NRC will post publically available materials related to this application in ADAMS and on the NRC's public Web site at
For the Nuclear Regulatory Commission.
Peace Corps.
60-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 60 days for public comment in the
Submit comments on or before August 22, 2016.
Comments should be addressed to Denora Miller, FOIA/Privacy Act Officer. Denora Miller can be contacted by telephone at 202–692–1236 or email at
Denora Miller at Peace Corps address above.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202–789–6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's Web site (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
3.
4.
5.
6.
7.
8.
This notice will be published in the
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202–789–6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's Web site (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
This notice will be published in the
On April 28, 2016, the Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The FINRA Regulation By-Laws establish the composition of the NAC,
The FINRA Board appoints the NAC and its members.
The proposed rule change amends the FINRA Regulation By-Laws in three ways. First, it amends Section 5.2 of the FINRA Regulation By-Laws to expand the size of the NAC from fourteen members to fifteen members and require that the NAC have more Non-Industry Members, including at least three Public Members, than Industry Members. Accordingly, FINRA would add one Non-Industry Member seat to the current 14-member committee.
Second, the proposed rule change lengthens the term of office of future NAC members by one year, from three to four years.
Finally, the proposed rule change streamlines the NAC election process and aligns it with the process currently used for elections involving the FINRA District Committees. The proposed rule change amends Section 6.7 of the FINRA Regulation By-Laws by deleting the term “envelope” and adding language to permit ballots to be delivered by additional means.
The proposed rule change also amends Section 6.10 of the FINRA Regulation By-Laws to simplify the tabulation of ballots by the Independent Agent, by eliminating the provision in Section 6.10 of the FINRA Regulation By-Laws that permits NAC candidates and their representatives to observe the Independent Agent's accounting of ballots in contested NAC elections. The proposed rule change would align the ballot counting process used in NAC elections with the process used in FINRA District Committee elections, which does not provide candidates the ability to be present while the Independent Agent opens and counts the ballots.
One commenter supported the proposed rule change and believed that expanding the size of the NAC and requiring that the number of Non-Industry Members exceed the number of Industry Members would “clearly advance the public interest and protect investors. . . .”
Two commenters suggested that FINRA increase the number of Public Members on the NAC.
In its response, FINRA noted that the current and proposed FINRA Regulation By-Laws do not limit the ability of the Board to appoint more than three Public Members to the NAC.
In response to the commenter's concern that increasing the number of Non-Industry Members may diminish the NAC's balanced perspective and expertise, FINRA noted that the proposed rule change still maintains FINRA's custom of “substantial industry participation in the NAC's adjudication of disciplinary and other matters.” Further, FINRA represented that it is committed to appointing Non-Industry Members that are both highly qualified and provide unique perspectives in NAC deliberations, including expertise in a variety of subjects and issues important to the matters the NAC considers, such as the federal securities laws, just and equitable principals of trade, best professional practices, and corporate governance and compliance.
One commenter explicitly supported extending the terms of NAC members from three to four years.
In its response, FINRA noted that the proposed rule change would maintain the current NAC member term limit, which generally prohibits NAC members from serving consecutive terms, and staggered terms. According to FINRA, this should allow a “regular infusion of fresh ideas and knowledge and generally serve the goal of invigorating NAC deliberations” with the composition of the NAC changing each year, while allowing NAC members to be fully productive for a longer term. Further, with respect to the commenter's suggestion to re-evaluate the four-year term at a future date, FINRA noted that the NAC's decisions are generally subject to discretionary review by the FINRA Board of Governors. As a result, the FINRA Board of Governors is “well placed to conduct an ongoing evaluation of the NAC's effectiveness and the quality of its decision making” and therefore, amending the proposed rule change to establish a date for reevaluating the effectiveness of the longer member terms is unnecessary.
One commenter believed that the revised selection process for contested elections would make the process more efficient and allow for electronic balloting.
After carefully considering the proposal, the comments submitted, and FINRA's response, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities association.
The Commission believes that FINRA's proposal to add one Non-Industry Member to the NAC should enhance the independence of the NAC and continue to ensure that a diversity of expertise, experiences and views are represented on the NAC. With respect to commenters' suggestion that FINRA should increase the number of Public Members on the NAC,
The Commission also believes it is appropriate for FINRA to increase the term of NAC members from three to four years. While one commenter raised concerns about extending member terms,
The Commission also believes that the proposed changes to the NAC selection process to modernize and streamline the process and to align it with the process used in FINRA District Committee elections are appropriate.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Section 19(b) of the Act (15 U.S.C. 78s(b)) requires each self-regulatory organization (“SRO”) to file with the Commission copies of any proposed rule, or any proposed change in, addition to, or deletion from the rules of such SRO. Rule 19b–4 implements the requirements of Section 19(b) by requiring the SROs to file their proposed rule changes on Form 19b–4 and by clarifying which actions taken by SROs are subject to the filing requirement set forth in Section 19(b). Rule 19b–4(n) requires a designated clearing agency to provide the Commission advance notice (“Advance Notice”) of any proposed change to its rules, procedures, or operations that could materially affect the nature or level of risks presented by such clearing agency. Rule 19b–4(o) requires a registered clearing agency to submit for a Commission determination any security-based swap, or any group, category, type, or class of security-based swaps it plans to accept for clearing (“Security-Based Swap Submission”), and provide notice to its members of such submissions.
The collection of information is designed to provide the Commission with the information necessary to determine, as required by the Act, whether the proposed rule change is consistent with the Act and the rules thereunder. The information is used to determine if the proposed rule change should be approved, disapproved, suspended, or if proceedings should be instituted to determine whether to approve or disapprove the proposed rule change.
The respondents to the collection of information are SROs (as defined by Section 3(a)(26) of the Act),
In calendar year 2015, each respondent filed an average of approximately 57 proposed rule changes. Each filing takes approximately 39 hours to complete on average. Thus, the total annual reporting burden for filing proposed rule changes with the Commission is 86,697 hours (57 proposals per year × 39 SROs × 39 hours per filing) for the estimated future number of 39 SROs.
Designated clearing agencies have additional information collection burdens. As noted above, pursuant to Rule 19b–4(n), a designated clearing agency must file with the Commission an Advance Notice of any proposed change to its rules, procedures, or operations that could materially affect the nature or level of risks presented by such designated clearing agency. The Commission estimates that four designated clearing agencies will each submit five Advance Notices per year, with each submission taking 90 hours to complete. The total annual reporting burden for filing Advance Notices is therefore 1,800 hours (4 designated clearing agencies × 5 Advance Notices per year × 90 hours per response).
Designated clearing agencies are required to post all Advance Notices to their Web sites, each of which takes approximately four hours to complete. For five Advance Notices, the total annual reporting burden for posting them to respondents' Web sites is 80 hours (4 designated clearing agencies × 5 Advance Notices per year × 4 hours per Web site posting). Respondents are required to update the postings of those Advance Notices that become effective, each of which takes approximately four hours to complete. The total annual reporting burden for updating Advance Notices on the respondents' Web sites is 80 hours (4 designated clearing agencies × 5 Advance Notices per year × 4 hours per Web site posting).
Pursuant to Rule 19b–4(n)(5), the respondents are also required to provide copies of all materials submitted to the Commission relating to an Advance Notice to the Board of Governors of the Federal Reserve System (“Board”) contemporaneously with such submission to the Commission, which is estimated to take two hours. The total annual reporting burden for designated clearing agencies to meet this requirement is 40 hours (4 designated clearing agencies × 5 Advance Notices per year × 2 hours per response).
The Commission estimates that three security-based swap clearing agencies will each submit 20 Security-Based Swap Submissions per year, with each submission taking 140 hours to complete resulting in a total annual reporting burden of 8,400 hours (3 respondent clearing agencies × 20 Security-Based Swap Submissions per year × 140 hours per response). Respondent clearing agencies are required to post all Security-Based Swap Submissions to their Web sites, each of which takes approximately four hours to complete. For 20 Security-Based Swap Submissions, the total annual reporting burden for posting them to the three respondents' Web sites is 240 hours (3 respondent clearing agencies × 20 Security-Based Swap Submissions per year × 4 hours per Web site posting). In addition, three clearing agencies that have not previously posted Security-Based Swap Submissions, Advance Notices, and proposed rule changes on their Web sites may need to update their existing Web sites to post such filings online. The Commission estimates that each of these three clearing agencies would spend approximately 15 hours updating its existing Web site, resulting in a total one-time burden of 45 hours (3 respondent clearing agencies × 15 hours per Web site update) or 15 hours annualized over three years.
Respondent clearing agencies will also have to provide training to staff members using the Electronic Form 19b–4 Filing System (“EFFS”) to submit Security-Based Swap Submissions, Advance Notices, and/or proposed rule changes electronically. The Commission estimates that one anticipated security-based swap clearing agency will spend approximately 20 hours training all staff members who will use EFFS to submit Security-Based Swap Submissions, Advance Notices, and/or proposed rule changes electronically, or 6.7 hours annualized over three years. The Commission also estimates that one anticipated clearing agency will have a one-time burden of 130 hours to draft and implement internal policies and procedures for using EFFS to make these submissions, or 43.3 hours annualized over three years. The Commission estimates that each of the 39 respondents will spend 10 hours each year training new compliance staff members and updating the training of existing compliance staff members to use EFFS, for a total annual burden of 390 hours (39 respondent SROs × 10 hours).
In connection with Security-Based Swap Submissions, counterparties may apply for a stay from a mandatory clearing requirement under Rule 3Ca–1. The Commission estimates that each clearing agency will submit five applications for stays from a clearing requirement per year and it will take approximately 18 hours to retrieve, review, and submit each application. Thus, the total annual reporting burden for the Rule 3Ca–1 stay of clearing requirement would be 270 hours (3 respondent clearing agencies × 5 stay of clearing applications per year × 18 hours to retrieve, review, and submit the stay of clearing information).
Based on the above, the total estimated annual response burden pursuant to Rule 19b–4 and Form 19b–4 is the sum of the total annual reporting burdens for filing proposed rule changes, Advance Notices, and Security-Based Swap Submissions; training staff to file such proposals; drafting, modifying, and implementing internal policies and procedures for filing such proposals; posting each proposal on the respondents' Web sites; updating Web sites to enable posting of proposals; updating the respondents' online rulebooks to reflect the proposals that became effective; submitting copies of Advance Notices to the Board; and applying for stays from clearing requirements, which is 114,740 hours.
Compliance with Rule 19b–4 is mandatory. Information received in response to Rule 19b–4 shall not be kept confidential; the information collected is public information.
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information 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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or by sending an email to
Department of State.
Notice of the CAFTA–DR Environmental Affairs Council Meeting and request for comments.
The Department of State and the Office of the United States Trade Representative are providing notice that the parties to the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA–DR) intend to hold the tenth meeting of the Environmental Affairs Council (the Council) established under Chapter 17 (Environment) of that agreement in San Salvador, El Salvador, on July 7 and 8, 2016. The Council will commemorate the tenth anniversary of CAFTA–DR by highlighting the many environmental accomplishments of the past ten years and charting a course for the future. On July 7, the Council will meet to review implementation of Chapter 17 of CAFTA–DR and the CAFTA–DR Environmental Cooperation Agreement (ECA). All interested persons are invited to attend the Council's public session beginning at 9:00 a.m. on July 8 at the Hotel Sheraton Presidente in San Salvador.
During the July 7 Council meeting, Council members will present the progress made and challenges in implementing Chapter 17 obligations as well as the outcomes achieved through environmental cooperation in their respective countries. The Council will also receive a presentation from the CAFTA–DR Secretariat for Environmental Matters (SEM). More information on the Council is included below under
All interested persons are invited to attend the July 8 public session where they will have an opportunity to ask questions and discuss implementation of Chapter 17 and the Environmental Cooperation Agreement with Council Members. At the public session, the Council hopes to receive input from the public on current environmental challenges and ideas for future cooperation. The session will also offer the opportunity to hear directly from beneficiaries of the CAFTA–DR Environmental Cooperation Program and explore environmental progress in CAFTA–DR countries through a number of side events and interactive presentations. If you would like to attend the public session, please notify Neal Morris and Laura Buffo at the email addresses listed under the heading
The Department of State and Office of the United States Trade Representative also invite written comments or suggestions to be submitted before July 1, 2016 regarding topics to be discussed at the Council meeting. In preparing comments, we encourage submitters to refer to Chapter 17 of the CAFTA–DR, the Final Environmental Review of the CAFTA–DR, and the CAFTA–DR Environmental Cooperation Agreement (ECA)
The public session of the Council will be held on July 8, 2016, from 9:00 a.m.–4:00 p.m. at the Hotel Sheraton Presidente in San Salvador, El Salvador. We request comments and suggestions in writing no later than July 1, 2016.
Written comments or suggestions should be submitted to both:
(1) Neal Morris, U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs, Office of Environmental Quality and Transboundary Issues by email to
(2) Laura Buffo, Director for Environment and Natural Resources, Office of the United States Trade Representative by email to
If you have access to the Internet you can view and comment on this notice by going to:
Neal Morris, (202) 647–9312, or Laura Buffo, (202) 395–9424
Article 17.5 of the CAFTA–DR establishes an Environmental Affairs Council (the Council) and, unless the CAFTA–DR parties otherwise agree, requires it to meet annually to oversee the implementation of, and review progress under, Chapter 17. Article 17.5 further requires, unless the parties otherwise agree, that each meeting of the Council include a session in which members of the Council have an opportunity to meet with the public to discuss matters relating to the implementation of Chapter 17.
In Article 17.9, the parties recognize the importance of strengthening capacity to protect the environment and to promote sustainable development in concert with strengthening trade and investment relations and state their commitment to expanding their cooperative relationship on environmental matters. Article 17.9 also references the ECA, which sets out certain priority areas of cooperation on environmental activities. These priority areas include, among others: Reinforcing institutional and legal frameworks and the capacity to develop, implement, administer, and enforce environmental laws, regulations, standards and policies; conserving and managing shared, migratory and endangered species in international commercial trade and management of protected areas; promoting best practices leading to sustainable management of the environment; and facilitating technology development and transfer and training to promote clean production technologies. In preparing comments, we encourage submitters to refer to:
• Chapter 17 of the CAFTA–DR,
• The Final Environmental Review of CAFTA–DR, and
• The ECA.
These documents are available at:
Federal Aviation Administration (FAA), DOT.
Notice of Request to Release Airport Property.
The FAA proposes to rule and invite public comment on the release of land at the Monroe Regional Airport at Monroe, Louisiana 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 July 22, 2016.
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. Lacey Spriggs, Manager, Federal Aviation Administration, Southwest Region, Airports Division, Louisiana/New Mexico Airports District Office, ASW–640, 10101 Hillwood Parkway, Fort Worth, Texas 76177.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to the Mr. Ron Phillips, Airport Manager, at the following address: 5400 Operations Road, Monroe, Louisiana 71203.
Mr. Bill Bell, Lead Engineer, Federal Aviation Administration, Louisiana/New Mexico Airports District Office, ASW–640, 10101 Hillwood Parkway, Fort Worth, Texas 76177, Telephone: (817) 222–5664, email:
The request to release property may be reviewed in person at this same location.
The FAA invites public comment on the request to release property at the Monroe Regional Airport at Monroe, Louisiana under the provisions of the AIR 21.
The following is a brief overview of the request:
The City of Monroe, Louisiana requests the release of 2.2 acres of non-aeronautical airport property. The land was acquired by Deed from the United States dated September 8, 1949. The property to be released will be sold and the funds will be used for the Airport's Bermuda Release program and purchase of a new tractor.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents relevant to the application in person at the Monroe Airport, Monroe, Louisiana, telephone number (318) 329–2460.
Federal Railroad Administration (FRA), U.S. Department of Transportation.
Notice and request for comments.
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA is informing the public it has revised the Annual Positive Train Control (PTC) Progress Report Form (Form FRA F 6180.166), which the Office of Management and Budget (OMB) previously approved on March 16, 2016, for a period of 180 days, under its emergency processing procedures. FRA revised the Annual PTC Progress Report Form based on comments it received from industry stakeholders on a related information collection, the Quarterly PTC Progress Report Form (Form FRA F 6180.165). Before submitting this annual information collection request to OMB for regular clearance, FRA is soliciting public comment on specific aspects of the proposed information collection identified below.
Comments must be received no later than August 22, 2016.
Submit written comments on the following proposed activity by mail to either: Mr. Robert Brogan, Office of Safety, Planning and Evaluation Division, RRS–21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590, or Ms. Kimberly Toone, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA to acknowledge receipt of their respective comments must include a self-addressed stamped postcard stating, “Comments on OMB control number 2130–0553.” Alternatively, comments may be transmitted via facsimile to (202) 493–6216 or (202) 493–6497, or via email to Mr. Brogan at
Mr. Robert Brogan, Office of Planning and Evaluation Division, RRS–21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590 (telephone: (202) 493–6292) or Ms. Kimberly Toone, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493–6132). (These telephone numbers are not toll-free.)
The PRA and its implementing regulations require Federal agencies to provide 60-days' notice to the public for comment on information collection activities before seeking approval for reinstatement or renewal by OMB.
Under the Positive Train Control Enforcement and Implementation Act of 2015 (PTCEI Act), each railroad subject to 49 U.S.C. 20157(a) must submit an annual progress report to FRA by March 31, 2016, and annually thereafter, until PTC implementation is completed. 49 U.S.C. 20157(c)(1). The PTCEI Act specifically requires each railroad to provide certain information in the annual reports regarding its progress toward implementing a PTC system, and authorizes FRA to request that railroads provide additional information in the annual progress reports.
On March 16, 2016, OMB approved the Annual PTC Progress Report Form (Form FRA F 6180.166). However, based on industry's oral and written comments on the proposed Quarterly PTC Progress Report Form (Form FRA F 6180.165), FRA has revised the Annual PTC Progress Report Form to be as consistent with the quarterly report form as possible (where the questions overlap), thereby enabling railroads to transfer information from the quarterly report forms to the annual report forms more easily. In summary, on April 12, 2016, the Association of American Railroads (AAR) submitted comments to FRA on behalf of itself and its member railroads, and the American Public Transit Association (APTA) submitted comments to FRA on behalf of Metra, the Utah Transit Authority, the Tri-County Metropolitan Transportation District of Oregon, and the Fort Worth Transportation Authority.
On April 19, 2016, FRA held a meeting on the proposed Quarterly PTC Progress Report Form to offer the affected regulated entities a forum to provide additional comments and feedback to FRA. Representatives from, and members of, AAR, APTA, the American Short Line and Regional Railroad Association (ASLRRA), and some individual railroad representatives attended the meeting and provided feedback. FRA published minutes from the meeting on
The current Annual PTC Progress Report Form, as approved through September 30, 2016, can be accessed and downloaded in FRA's eLibrary at:
The associated collection of information is summarized below. FRA will submit this information collection request to OMB for regular clearance as required by the PRA.
Reporting Burden:
FRA notes that the 38.41-hour estimate is an average for all railroads. FRA estimated the annual reporting burden is 60 hours for Class I and large passenger railroads, 40 hours for Class II and medium passenger railroads, and 25 hours for Class III, terminal and small passenger railroads.
Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501–3520.
Maritime Administration, Department of Transportation.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before July 25, 2016.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW., Washington, DC 20503. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimate of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
Lisa Simmons, 202–366–2321, Office of Financial Approvals, Maritime Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. FAX: 202–366–7901 or email:
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.93.
Maritime Administration (MARAD), DOT.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before July 25, 2016.
Dr. David Palmer, (516) 726–5707, U.S. Merchant Marine Academy, Kings Point, NY 11024.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.93.
By Order of the Maritime Administrator.
Environmental Protection Agency (EPA).
Final rule; notice of final action on reconsideration.
This action sets forth the Environmental Protection Agency's (EPA) final decision on the issues for which it granted reconsideration on January 21, 2015, which pertain to certain aspects of the February 7, 2013, final rule titled “Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Commercial and Industrial Solid Waste Incineration Units” (CISWI rule). The EPA is finalizing proposed actions on these four topics: Definition of “continuous emission monitoring system (CEMS) data during startup and shutdown periods;” particulate matter (PM) limit for the waste-burning kiln subcategory; fuel variability factor (FVF) for coal-burning energy recovery units (ERUs); and the definition of “kiln.” This action also includes our final decision to deny the requests for reconsideration of all other issues raised in the petitions for reconsideration of the 2013 final commercial and industrial solid waste incineration rule for which we did not grant reconsideration.
The amendments in this rule to 40 CFR part 60, subpart DDDD, are effective June 23, 2016, and to 40 CFR part 60, subpart CCCC, are effective December 23, 2016. The incorporation by reference of certain publications listed in this rule was approved February 7, 2013.
The EPA has established a docket for this action on the commercial and industrial solid waste incineration rule under Docket ID No. EPA–HQ–OAR–2003–0119. All documents in the docket are listed in the
For further information, contact Dr. Nabanita Modak Fischer, Fuels and Incineration Group, Sector Policies and Programs Division (E143–05), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541–5572; fax number: (919) 541–3470; email address:
Categories and entities potentially affected by the proposed action are those that operate Commercial and Industrial Solid Waste Incineration (CISWI) units. The New Source Performance Standards (NSPS) and Emission Guidelines (EG), hereinafter referred to as “standards,” for CISWI affect the following categories of sources:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this final action. To determine whether your facility would be affected by this final action, you should examine the applicability criteria in 40 CFR 60.2010 of subpart CCCC, 40 CFR 60.2505 of subpart DDDD and 40 CFR part 241. If you have any questions regarding the applicability of this final action to a particular entity, contact the person listed in the preceding
The docket number for this final action regarding the CISWI NSPS (40 CFR part 60, subpart CCCC) and EG (40 CFR part 60, subpart DDDD) is Docket ID No. EPA–HQ–OAR–2003–0119. In addition to being available in the docket, an electronic copy of this final action is available on the World Wide Web (WWW) through the Technology Transfer Network (TTN) Web. Following signature, the EPA posted a copy of the proposed action at
Under the CAA section 307(b)(1), judicial review of this final rule is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) by August 22, 2016. Under CAA section 307(d)(7)(B), only an objection to this final rule that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, Environmental Protection Agency, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave. NW., Washington, DC 20004, with a copy to the persons listed in the preceding
On March 21, 2011, the EPA promulgated revised NSPS and EG for CISWI units. Following that action, the Administrator received petitions for reconsideration that identified certain issues that warranted further opportunity for public comment. In response to the petitions, the EPA reconsidered and requested comment on several provisions of the February 2011 final NSPS and EG for commercial and industrial solid waste incineration units. The EPA published the proposed revisions to the NSPS and EG for commercial and industrial solid waste units on December 23, 2011 (76 FR 80452).
On February 7, 2013, the EPA promulgated the final reconsidered NSPS and EG for CISWI units (78 FR 9112). The final rule made some revisions to the December 2011 proposed reconsideration rule in response to comments and additional information received. Following that action, the EPA again received petitions for reconsideration. These petitions stated certain provisions should be reconsidered and that the public lacked sufficient opportunity to comment on some of the provisions contained in the final 2013 CISWI rule. On January 21, 2015, the EPA reconsidered and requested comment on four provisions of the 2013 final NSPS and EG for CISWI units. Additionally, the EPA proposed clarifying changes and corrections to the final rule, some of which were raised in petitions for reconsideration of the 2013 CISWI rule. The EPA also proposed to amend the final rule by removing the affirmative defense provision. The EPA continued to evaluate the remaining issues raised in the petitions for reconsideration of the February 7, 2013 final CISWI reconsideration based on public comments received on the January 21, 2015, proposed reconsideration. For a more detailed background and additional information on how this rule is related to other CAA combustion rules issued under CAA section 112 and
In this document, we are finalizing amendments associated with certain issues raised by Petitioners in their petitions for reconsideration on the 2013 CISWI rule. These provisions are: (1) Definition of “CEMS data during startup and shutdown periods;” (2) particulate matter (PM) limit for the waste-burning kiln subcategory; (3) fuel variability factor (FVF) for coal-burning energy recovery units (ERUs); and (4) the definition of “kiln.” The final amendments are summarized as follows:
1. Definition of “CEMS data during startup and shutdown periods”: The EPA is revising the “CEMS data during startup and shutdown” definition to be subcategory-specific. For ERUs and waste-burning kilns, the definitions reflect provisions similar to those of the non-waste counterpart National Emission Standards for Hazardous Air Pollutants (NESHAP) to CISWI for the type of source (
2. Particulate matter limit for the waste-burning kiln subcategory: The EPA has determined that the test averages, instead of the individual test runs, should be used to establish the standards for new and existing waste-burning kilns. Based on that approach, the final PM emission limits for existing kilns is 13.5 mg/dscm and the final PM emission limit for new kilns is 4.9 mg/dscm.
3. Fuel variability factor (FVF) for coal-burning energy recovery units: The EPA is incorporating a fuel variability factor and adopting as final the emission limits discussed in the proposed rule for cadmium (Cd), hydrogen chloride (HCl), mercury (Hg), lead (Pb), filterable particulate matter (PM), and nitrogen oxides (NO
4. Definition of “kiln”: The EPA is finalizing a definition of “kiln” that is consistent with that of the Portland Cement NESHAP. The terms “in-line raw mill” and “in-line coal mill” are included in the definition, and, therefore, have been added to the definitions within the CISWI rule. Furthermore, the EPA is finalizing the proposed compliance demonstration and ongoing monitoring method for waste-burning kilns that combine emission streams from the in-line raw mill and/or the in-line coal mill and exhaust through multiple stacks. The EPA is also finalizing clarifying language that makes the monitoring requirements for waste-burning kilns consistent with those in the Portland Cement NESHAP. Specifically, we are not requiring that CEMS or PM continuous parameter monitoring systems (CPMS) be installed on separate alkali bypass or in-line coal mill stacks. Instead, as is the case with the Portland Cement NESHAP, the results of the initial and subsequent performance tests for the alkali bypass and in-line coal mill stacks can be used to determine the combined emissions to demonstrate compliance with the relevant emissions limit. However, unlike the Portland Cement NESHAP, the performance test must be conducted on an annual basis (between 11 and 13 calendar months following the previous performance test) to keep the testing schedule for these stacks consistent with the CISWI rule's annual performance testing requirements.
Section IV of this preamble discusses these issues in further detail and presents the revisions necessary to address each issue.
Additionally, the EPA is clarifying certain applicability provisions relating to incinerator units and air curtain incinerator units subject to the 2000 CISWI NSPS and is correcting various typographical errors identified in the rule as published in the CFR. Section V of this preamble discusses these issues in further detail.
The EPA is also finalizing the proposed amendments to the final rule by removing the affirmative defense provision for the reasons set forth in the proposed rule.
Section 307(d)(7)(B) of the CAA states that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. If the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within such time or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule, the Administrator shall convene a proceeding for reconsideration of the rule and provide the same procedural rights as would have been afforded had the information been available at the time the rule was proposed. If the Administrator refuses to convene such a proceeding, such person may seek review of such refusal in the United States court of appeals for the appropriate circuit (as provided in subsection (b)).”
As to the first procedural criterion for reconsideration, a petitioner must show why the issue could not have been presented during the comment period, either because it was impracticable to raise the issue during that time or because the grounds for the issue arose after the period for public comment (but within 60 days of publication of the final action). The EPA is denying the petitions for reconsideration on a number of issues because this criterion has not been met. In many cases, the petitions reiterate comments made on the proposed December 2011 rule during the public comment period for that rule. On those issues, the EPA responded to those comments in the final rule and made appropriate revisions to the proposed rule after consideration of public comments received. It is well established that an agency may refine its proposed approach without providing an additional opportunity for public comment.
In the EPA's view, an objection is of central relevance to the outcome of the rule only if it provides substantial support for the argument that the promulgated regulation should be revised.
This action includes our final decision to deny the requests for reconsideration with respect to all issues raised in the petitions for reconsideration of the final 2013 CISWI rule for which we did not grant reconsideration. These denied requests for reconsideration are discussed in detail in the “Reconsideration issues on the 2013 final rule” memorandum found in the docket to this rulemaking.
The EPA did not propose revisions to the definition of “CEMS data during startup and shutdown,” but requested comment and suggestions for provisions in this definition that would address the transitional operation period at startup. Based on our review of comments received and suggestions on provisions, we are finalizing revised subcategory-specific definitions for “CEMS data during startup and shutdown” that are operationally representative for the subcategory of unit, and more closely resemble the non-waste burning regulatory definitions of these periods of operation. This issue, and the rationale for doing so, are discussed in greater detail in section IV.A. of this preamble.
Similarly, the EPA did not propose PM emission limits for waste-burning kilns based on test average data instead of test run data, but requested comment on the appropriateness of such an approach for this set of data. Upon consideration of comments, the EPA has determined to adopt the emission limits based on test average data for PM for the waste-burning kiln subcategory, and we have discussed our rationale for this in section IV.B. of this preamble.
The EPA did not propose but requested comment and additional data concerning the need for a FVF for coal-fired ERUs. Potential emission limits based on periods of non-waste combustion and, if applicable, a FVF for coal ERUs were discussed in the proposal for coal-burning ERUs for Cd, HCl, Hg, Pb, PM, and NO
Additionally, the HCl CEMS requirements for waste-burning kilns not equipped with acid gas wet or dry scrubbers have been revised in response to comments and to be more consistent with more recently promulgated monitoring provisions included in the Portland Cement NESHAP rule. These revised provisions allow sources to use CEMS installed and operated according to either Performance Specification 15 or Performance Specification 18 to continuously monitor HCl emissions. The revised provisions also provide additional clarification and detail to sources on the procedures to use for calibrating and verifying the performance of the HCl CEMS.
This section of the preamble summarizes the major comments received regarding the reconsidered issues and the EPA's responses in support of this final rule. For other comments not discussed here, refer to the “Summary of Public Comments and Responses for Commercial and Industrial Solid Waste Incineration Units: 2015 Reconsideration and Final Amendments” in the docket.
To resolve this issue, the EPA determined that the 7 percent oxygen correction would not be required for CEMS data collected during periods of startup and shutdown, referred to and defined as “CEMS data during startup and shutdown.”
Based on data submitted for coal-burning ERUs, a new definition of “CEMS data during startup and shutdown” was proposed in the December 2011 reconsideration proposal that referred to the data collected during the first 4 hours of operation of an energy recovery unit starting up from a cold start and the hour of operation following the cessation of waste material being fed to the unit during shutdown.
The EPA received comments on the proposed definition expressing concern that the time limits included in the definition may not accurately represent all CISWI unit types. Further, commenters argued that the same logic should apply for all CEMS-measured emission limits, not just CO. They explained that, even though CEMS is a compliance alternative rather than a requirement for most CISWI standards, other air regulations and permit requirements may require the units to continue to monitor emissions using CEMS data. Therefore, in the February 2013 CISWI final rule, the definition was revised to include all pollutants measured with a CEMS, expanded to include a separate definition for waste-burning kilns, and revised to remove the 4-hour and 1-hour time limits in the
After the February 2013 CISWI final rule was promulgated, the EPA received petitions stating that stakeholders did not have the opportunity to comment on the final definition, especially the clause that defines the beginning and ending of these periods as the introduction and cessation, respectively, of waste material being fed to the combustor. Petitioners argued that, with the inclusion of the provision ending startup when waste is added to the unit, the end of startup will occur too early because units that combust waste often introduce waste before steady state operations to transition from startup fuel to waste and other primary fuel combustion. For this reason, the petitioners argued that the EPA should extend the startup period duration to include the period of time when sources are transitioning to waste combustion from the startup fuel.
On January 21, 2015, the EPA requested comment on whether the definition should be revised to extend the startup period to include this transitional period of combustor operation. In addition, the EPA requested that commenters suggest provisions that would ensure adequate application of the CEMS data during startup and shutdown definition, such as maximum allowable time limits after introduction of waste, if the agency were to allow solid waste combustion during startup.
The commenter suggested that CEMS data during startup and shutdown should be defined as follows:
As an alternative to the above definition, the commenter suggested the definition could include the period of time up to 6 hours following introduction of waste to the unit instead of tying the definition to “useful thermal energy.” The commenter noted that this might allow the definition to be applicable to incinerators and small remote incinerators.
Another commenter suggested that the first 48 hours of startup and the last 24 hours of shutdown for incinerators, small remote incinerators, and energy recovery units is adequate in most cases. This commenter stated that any time the feed to a combustion chamber is modified (
With respect to waste-burning kilns, one commenter argued that it is highly beneficial to have the definitions of startup and shutdown for kilns in the CISWI rule match the definitions in the Portland Cement NESHAP. Therefore, the commenter supported having a separate definition of CEMS data during startup and shutdown that applied to waste-burning kilns, and that this
“
We note that certain commenters indicate that reasons for changing the definitions include that the units may have greater emissions during startup and shutdown and also that pollution control equipment may not be fully operational during startup. The EPA is not revising the definitions to allow sources to violate the standard; instead the change is designed to better reflect the actual operating conditions during startup and shutdown. The oxygen correction is thus designed to allow sources to use actual stack oxygen levels during these periods instead of numbers corrected to 7 percent oxygen.
Finally, the subcategory-specific definitions of “CEMS data during startup and shutdown” in this final rule more clearly specify the beginning and end of startup and shutdown periods for each subcategory of CISWI unit. However, we realize in doing so that the previous, separate definitions of “startup period” and “shutdown” that have been held over from the 2000 CISWI rule may now cause confusion for waste-burning kilns and ERUs especially. Because the 2000 CISWI rule applied to incinerator units (and not ERUs and waste-burning kilns), we recognize the need to clarify that the “startup period” and “shutdown” definitions apply only to incinerators and small, remote incinerators. For this reason, the EPA is revising the definitions of “startup period” and “shutdown” to clarify that they are intended to apply only to incinerators and small, remote incinerators.
As noted before and by some commenters, monitoring by CEMS is an alternative, and may be useful for sources that are required by permit or for Acid Rain program requirements (40
The commenter also suggested that either using CEMS data corrected to stack oxygen or developing a mass-based standard should be investigated. In essence, though, the revised provisions allow CEMS data to be “corrected to” stack oxygen levels (that is, the numerator and denominator of the oxygen correction are equal, so the correction factor equals 1). Sources must still measure and record concentrations and stack oxygen levels during these periods, and must keep records of periods of CEMS data that are being claimed as periods of startup and shutdown (
The March 2011 CISWI final rule promulgated PM emissions limits of 6.2 milligrams per dry standard cubic meter (mg/dscm) for existing units, and 2.5 mg/dscm for new units, both corrected to 7 percent oxygen. In an action parallel to the March 21, 2011, final CISWI rule, the EPA promulgated a final rule that identifies the standards and procedures for identifying whether non-hazardous secondary materials (NHSM) are or are not solid waste when used as fuels or ingredients in combustion units. The EPA defines the NHSM that are solid waste under RCRA in the final “Identification of Non-Hazardous Secondary Materials That Are Solid Waste” rulemaking. The RCRA definition of solid waste is integral in defining the CISWI source category. Commercial and industrial units that combust solid waste are subject to standards issued pursuant to CAA section 129, rather than to standards issued pursuant to CAA section 112 that would otherwise be applicable to such units (
Following the December 2011 reconsideration proposal, the EPA learned that one of the kilns in the CISWI inventory was no longer burning waste, and another kiln that was not thought to be burning waste materials was doing so. The CISWI waste-burning kiln inventory was revised during the period between proposal and final to reflect these changes, and the database updated to include emissions data for the newly identified unit, as well as some additional test reports obtained for units within the inventory. The EPA calculated the maximum achievable control technology (MACT) floors after making the appropriate revisions to the inventory and the new NSPS and EG PM emission limits were more stringent than those proposed in the December 2011 reconsideration proposal. Table 1 of this preamble tracks the progression of the waste-burning kiln PM limits from the March 2011 final rule through the February 2013 final rule.
Throughout the CISWI rulemaking process from March 2011 through February 2013, the EPA used the same calculation methodology (
In the context of MACT analyses, as the EPA noted in the January 21, 2015 proposal, emission test averages or individual test run data can be used to determine emissions variability of best performers. We also noted that we typically use individual test runs, but for categories with data from 15
In the January 21, 2015 proposal, the EPA solicited comment on the data set used in the February 2013 final rule, as well as whether this data set warrants a different calculation approach due to its size or other factors. See the memoranda titled “Potential Emission Limits Calculation Analyses for Waste-burning Kilns and Coal ERUs,” “Approach for Applying the Upper Prediction Limit to Limited Data Sets,” and “Use of the Upper Prediction Limit for Calculating MACT Floors” in the CISWI docket for more details.
One commenter described control measures that Portland Cement NESHAP and waste-burning kilns will need to take to meet the 13.5 mg/dscm limit for existing waste-burning kilns that was discussed, noting that baghouse equipment will still need to be improved at many kilns to meet this limit. The commenter also pointed out that the performance of a baghouse on a kiln is comparable whether it is a Portland Cement NESHAP kiln or a CISWI kiln. The commenter went on to use this discussion and data from the Portland Cement NESHAP analyses to support the 13.5 mg/dscm limit (which equates to 0.075 lb/ton clinker on a production basis, as compared to the existing kiln PM limit of 0.07 lb/ton clinker in the Portland Cement NESHAP) and to demonstrate that the current beyond-the-floor analysis done for the 2013 CISWI final rule is still applicable despite the new PM emission limit.
We also note that, for this particular data set, there are distinct advantages to using this approach. One advantage is that there is a significant amount of test data for the best-performing source. These runs reflect various fuel and waste material firing conditions for the best-performing unit. By splitting the data for the best-performing source into sets of three according to the operational condition (waste or non-waste), each of the resulting averages is more representative of the fuel, waste, and operational variability demonstrated by the other 3-run test averages found in the data set for this source and for the other existing source best performers. In other words, the time periods—and variability in process inputs and operations these periods represent—are approximately equal for each data point in the average data set for existing and new sources. This approach also has the added benefit of a slightly larger time period of operations being represented by the data, since there is one additional average that can be included in the data pool (
We also reviewed the information submitted by the commenters on the costs and emission improvement requirements existing kilns will need to undertake to meet the revised emission limits, as well as our own assessment of control improvements needed, and agree with the assessment that beyond-the-floor emission standards for waste-burning kiln PM limits are unwarranted. In our analysis, the same kilns that would need improvements for the 2013 PM limits still need to add these improvements to meet the 13.5 mg/dscm standards (as well as the CISWI limits for Cd and Pb, which are not being revised but are also controlled by PM control devices). The technology most likely being used to meet the standards would be fabric filters (baghouses), which is a physical control technology. Information supplied by the industry indicate that many cement kilns will require highly efficient fabric filters to meet the 13.5 mg/dscm standards. Fabric filters do not have a variable component, such as sorbent injection rates, that can be varied easily once the system is designed and the filter media specified. Therefore, unlike other control technologies, the PM removal efficiency of fabric filters does not depend on other factors in the process and control device's performance will essentially be the same regardless of other process inputs. Therefore, the EPA is finalizing the 13.5 mg/dscm and 4.9 mg/dscm emission limits discussed at proposal for existing and new waste-burning kilns, respectively, based on the analysis of emission test average data.
The calculated PM emission limits using the test averages are presented in Table 1 of this preamble for comparison. The calculations used to support the 2015 emission limit values, analyses of impacts and discussion of beyond-the-floor considerations are available in the “Revised Emission Limits and Impacts Analyses for Waste-burning Kilns and
Further, we have determined that the data set for existing waste-burning kilns for PM is sufficient to address longer-term performance and variability among the best-performing sources and justifies the use of test average data. While the data set for new waste-burning kilns is smaller in count than that of the existing sources, it is not considered a small data set, and the EPA has concerns about not treating variability consistently between existing and new source emission limits within the same subcategory.
With respect to the commenter's arguments about the UPL calculation methodology, the EPA did not open the UPL calculation methodology for reconsideration, so we are not responding to the commenter's arguments on this issue.
Table 2 of this preamble presents a comparison of the 2013 final rule emission limits for existing coal ERUs and the emission limits calculated using all data available (
One commenter pointed out that the consideration of fuel variability is of particular importance because a CISWI unit remains a CISWI unit until it ceases to burn waste for at least 6 months. The commenter explained that estimating emission levels achieved when a unit was burning waste and coal does not reflect the level achieved when combusting only coal. Commenters also called attention to the boiler and process heater standards, which account for fuel supply variability, and contended that the EPA should do the same for CIWSI because ERUs would be subject to the boiler standards if they did not combust waste in addition to fossil fuels.
One commenter indicated that the EPA had not properly addressed fuel variability for the SO
At proposal, the agency explained our rationale for considering emission limits that incorporate a FVF for fuel-dependent pollutants (
The commenter further noted that even if it were lawful to incorporate a FVF at all, the FVF should be based on the average ratio, as opposed to the maximum ratio, because the maximum ratio does not yield a reasonable estimate of the average emissions limitation achieved by the best performing sources, yielding floors less stringent than the statute permits.
Regarding the commenter's assertions that the average ratio should be used instead of the maximum ratio in calculating the FVF, we note that, unlike situations present in the Boiler NESHAP, the best-performing units in the coal ERU subcategory (all located at the same facility) are not burning a variety of fuels. These CISWI ERU units burn coal, and periodically an industrial waste generated at the facility. Therefore, there is one fuel and one waste that is input that will influence emissions. This is not the case for the boiler best-performers in the Boiler NESHAP solid fuel subcategory, as these consisted of a “mix of biomass, coal and other solid fossil fuel” data (
The FVF accounts for fuel variability between sources using long-term fuel measurement data that represent inherent natural variations in fuel usage at the best performing unit over time. The FVF is used in conjunction with the 99 percent UPL to characterize long-term variability due to technological controls and fuel characteristics. The results are MACT floors that reasonably estimate the performance over time of the best performing sources (there are three identical units at one facility that are best performers for this subcategory of unit, with only one additional unit that may be in this subcategory). These calculations are described in more detail in the “Revised Emission Limits and Impacts Analyses for Waste-burning Kilns and Coal ERUs” memorandum found in the docket to this rulemaking.
For these reasons, the EPA is adopting the revised emission limits for coal ERUs discussed in the January 21, 2015, proposal, and the agency is also incorporating a FVF into the SO
For waste-burning kilns, the EPA proposed language in the definition of “kiln” to make it consistent with that of the Portland Cement NESHAP. The terms “in-line raw mill” and “in-line coal mill” were proposed to be included in the definition, and, therefore, were proposed to be added to the definitions within the CISWI rule.
In addition to the proposed definitional amendments in the January 21, 2015, notice, the EPA proposed a compliance demonstration and ongoing monitoring method for waste-burning kilns that combine emission streams from the in-line raw mill and in-line coal mill and exhaust through multiple stacks. The EPA is finalizing the proposed approach with some minor revisions to address comments as
In the January 21, 2015, notice, the EPA proposed to correct minor typographical errors and clarify provisions of the final rule that may have been unclear. The EPA is finalizing these corrections, which are summarized in this section of the preamble. There were some comments received on these clarifications. These comments, and responses to them, are found in the “2013 CISWI Rule Reconsideration Response to Comments.”
Following promulgation of the February 2013 CISWI final rule, the EPA received questions regarding the continued applicability of the 2000 CISWI NSPS for units that are subject to the 2000 CISWI NSPS as they are transitioned from the 2000 NSPS to the February 2013 EG with which they will eventually be required to comply. The 2000 CISWI NSPS are the same as the 2000 CISWI EG and limited in applicability to the incinerator subcategory and air curtain incinerators so only these types of CISWI units being regulated in the February 2013 CISWI final rules are affected by this applicability issue. The EPA intended, consistent with the statute and our stated intent (see 76 FR 15711, March 21, 2011), to continue to regulate these units as “new” sources under the 2000 NSPS, and then regulate them as “existing” sources under the 2013 EG once these units were covered under an approved state plan or federal plan that implements the February 2013 CISWI final EG. The language in the February 7, 2013, NSPS at 40 CFR 60.2105 and the title of Table 1 to 40 CFR part 60, subpart CCCC make the EPA's intent to do so evident. However, the applicability section in 40 CFR 60.2015 omitted the applicability provisions for incinerators and air curtain incinerators that are subject to the 2000 CISWI NSPS. In this final rule, the EPA is finalizing proposed additional language in 40 CFR 60.2015(a) and 40 CFR 60.2105(b) that clarifies that these incinerators and air curtain incinerators remain “new” units regulated under the 2000 NSPS until such time that an approved state plan or federal plan implements the February 2013 EG for those units, at which time such units will be subject to the 2013 EG to the extent those limits are more stringent than the 2000 CISWI NSPS limits, which will continue to apply if they are more stringent.
The following items are typographical errors in the final rule that we are correcting in this final action:
• References in 40 CFR 60.2020(e), 60.2020(f), 60.2555(e), and 60.2555(f) were changed from “. . . paragraphs (e)(1) through (3) . . .” to “. . . paragraphs (e)(1) through (4) . . .”.
• Restructured 40 CFR 60.2060 to add paragraph (b) that clarifies waste management plan submittal timeline for CISWI units that commence reconstruction or modification after August 7, 2013.
• References in 40 CFR 60.2020(i) and 60.2245 were revised to include 40 CFR 60.2242 in addition to 40 CFR 60.2245 through 60.2260 (
• References in 40 CFR 60.2555(i) and 60.2810 were revised to include 40 CFR 60.2805 in addition to 40 CFR 60.2810 through 60.2870 (
• References in 40 CFR 60.2110(i)(2)(i)(D) and 40 CFR 60.2675(i)(2)(i)(D) were changed from “. . . paragraphs (i)(2)(i) through (iv) . . .” to “. . . paragraphs (i)(2)(i)(A) through (i)(2)(i)(C) . . .”.
• Two references in the definitions of terms for Equation 3 in 40 CFR 60.2110(i)(2)(iv) were revised. For the `z' term, “(2)(a)” was corrected to “(2)(i)”, and for the `R' term, “Equation 3” was corrected to “Equation 2”.
• Two references in the definitions of terms for Equation 3 in 40 CFR 60.2675(i)(2)(iv) were revised. For the `z' term, “(2)(a)” was corrected to “(2)(i)”, and for the `R' term, “Equation 3” was corrected to “Equation 2”.
• The language in 40 CFR 60.2140(c) and 60.2705(c) were revised to include the phrase “commence or recommence
• Extra spaces were removed from 40 CFR 60.2145(v) and 60.2710(v).
• The reference in 40 CFR 60.2145(w)(1) was changed from “§ 60.2675” to “§ 60.2140”.
• The references in 40 CFR 60.2145(x)(1) were changed from “. . . § 60.2145(l) and (x)(1)(i) through (iii) . . .” to “. . . paragraphs (l) and (x)(1)(i) through (x)(1)(iii) . . .”
• The references in 40 CFR 60.2710(x)(1) were changed from “. . .§ 60.2710(l) and (x)(1)(i) through (iii). . .” to “. . . paragraphs (l) and (x)(1)(i) through (x)(1)(iii). . .”
• Language in 40 CFR 60.2145(x)(1)(iii), 60.2165(r)(1)(iii), 60.2710(x)(1)(iii) and 60.2730(r)(1)(iii) was revised to clarify the PM continuous parameter monitoring system (CPMS) detection limit. The phrase “of no greater than” was changed to “increments no greater than”.
• Provisions for PM CPMS in both subparts were revised to also clarify the output signals from digital monitoring devices and remove “lb/Mmbtu” typographical errors.
• The reference in 40 CFR 60.2165(q)(1) was changed from “§ 60.2675” to “§ 60.2140”.
• Text in 40 CFR 60.2165(q)(3) was corrected from “. . .paragraph (q)(4) or this section . . .” to “. . . paragraph (q)(4) of this section . . .”.
• The title of 40 CFR part 60, subpart CCCC Table 1 was revised to clarify that these emission limits apply to incinerators that were subject to the 2000 CISWI rule provisions.
• The dates in paragraphs (a)(1) and (2) of 40 CFR 60.2535 from the 2000 CISWI rule were omitted in the current CFR version of the rule, and have been reinserted.
• Added text in 40 CFR 60.2525(b) and 60.2535(b) to clarify applicability for incinerators and air curtain incinerators that were reconstructed or modified on or after June 1, 2001, but no later than August 7, 2013.
• Revised the language of 40 CFR 60.2550(b) to reflect the August 7, 2013 date for purposes of applicability with 40 CFR part 60, subpart CCCC.
• The text “over 10 MMBtu/hr but less than 250 MMBtu/hr annual average heat input rates” was added to 40 CFR 60.2730(m) for clarification and consistency.
• The definition of chemical recovery unit in 40 CFR 60.2265 was revised to be consistent with the definition provided in 40 CFR 60.2875. The following text was added: “A chemical recovery unit is not an incinerator, a waste-burning kiln, an energy recovery unit or a small, remote incinerator under this subpart.”
• Clarifying language was added to the HCl row of 40 CFR part 60, subpart DDDD Table 8. Compliance method text was changed from “. . . if a wet scrubber is not used” to “. . . if a wet scrubber or dry scrubber is not used.”
• Text in 40 CFR 60.2165(o) was corrected from “. . . you must use a continuous automated sampling system . . .” to “. . . you may substitute use of a continuous automated sampling system for the carbon monoxide annual performance test.”
• Revise the definition of “Oxygen trim system” to include draft controller and to clarify that it is a system that maintains the desired excess air level over the operating load range.
• Revise the definition of “Reconstruction” in both subparts to reflect the correct criterion that reconstruction begins on or after August 7, 2013.
• Renumbered equations in 40 CFR part 60, subpart DDDD to be in sequence within the subpart instead of being a continuation with 40 CFR part 60, subpart CCCC.
• Revised paragraphs 40 CFR 60.2030(c), 60.2210(h), 60.2220(d), 60.2235, 60.2770(h), 60.2780(d) and 60.2795 to reflect the most recent electronic reporting guidance available and to further clarify reporting requirements.
• Revised paragraphs 40 CFR 60.2145(j)(1) and 60.2710(j)(1) to reflect the most recent guidance available for HCl CEMS installed and certified in accordance to Performance Specification 15 or Performance Specification 18.
• Table footnotes were converted from alphabetical to numeric format.
• Deleted inadvertent footnote references to the following: Dioxin/furan TEQ and TMB rows of 40 CFR part 60, subpart CCCC Table 8; Dioxin/furan TMB row and Pb row of 40 CFR part 60, subpart DDDD Table 7; Dioxin/furan row of 40 CFR part 60, subpart DDDD Table 8; and dioxin/furan row of 40 CFR part 60, subpart DDDD Table 9.
Since publication of the February 7, 2013, final CISWI rule, the EPA has received stakeholder questions and requests for clarification on certain rule provisions. We are not finalizing any regulatory language changes for the following items, but are providing some clarification to these questions. Furthermore, comments received on these clarifications and responses to these comments are found in the “Response to Comments on the 2015 CISWI Reconsideration” document found in the docket:
• Mass balance as operating limits for units without certain control devices—A stakeholder has asked for clarification on whether a mass balance could be used as an operating parameter, and whether this must be measured as a 30-day rolling average instead of taking a monthly sample. Furthermore, the stakeholder also asked whether the material balance allows them to waive annual stack testing. The EPA clarifies that mass balance operating parameters do not replace annual stack testing. Stack testing and operating parameters work in tandem to ensure ongoing compliance with the standards. We do, however, accept that mass balance could be an allowable operating parameter in cases where no control device is needed to meet the pollutant's specific emission limit applicable to the unit, provided the petition for the operating parameter limits meets the requirements specified in 40 CFR 60.2115 and 40 CFR 60.2680. We also point out that these requirements also allow any source to request a different averaging time that is appropriate for the source and operating parameter.
• Clarification on who the “EPA Administrator” is and whom to contact for requests for averaging times, qualifying facility notifications, etc. We have received questions on how to contact the Administrator to submit notifications, reports and requests. The contact information is given in the General Provisions, under 40 CFR 60.4, and has addresses listed by EPA Regional Offices.
This action finalizes the proposed provisions and makes technical and clarifying corrections, but does not cause substantive changes to the impacts on the environment, energy generation and usage, and economic factors for affected sources from the February 7, 2013, final CISWI rule (78 FR 9112). The number of sources requiring improved emission control performance is the same as estimated in the final 2013 rule. While the emission limits have been relaxed slightly for PM in the waste-burning kilns, the assumed controls required to meet the final standards are still the same as those estimated for the final 2013 rule. That is, waste-burning kilns that would require additional controls to meet the final 2013 rule's PM and metals emission limits will still require those control improvements to meet the limits being finalized in this action. The main
Taken together, the revised emission limits being finalized in this action could result in allowable emission estimates, primarily in PM, that are greater than those assumed for the 2013 final rule by about 297 tpy. In other words, there could potentially be 297 fewer tpy of PM emission reductions as a result of this final rule when compared to the 2013 final rule's estimated emission reductions. We have estimated these emission impacts in the memorandum “Revised Emission Limits and Impacts Analyses for Waste-burning Kilns and Coal ERUs” available in the docket. We have not revised the regulatory impacts assessment prepared for the 2013 final rule since the expected emissions control costs are unchanged and the change in estimated emission reductions are relatively minor when compared to the 34,771 tpy overall emission reductions estimated for the February 7, 2013, final rule (
Additional information about these statues and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations (40 CFR part 60, subpart CCCC and 40 CFR part 60, subpart DDDD) and has assigned OMB control number 2060–0664 for subpart CCCC and OMB control number 2060–0662 for subpart DDDD. This action is believed to result in no changes to the information collection requirements of the February 2013 final CISWI rule, so that the information collection estimate of project cost and hour burden from the final CISWI rule have not been revised.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. This final rule will not impose any new requirements on any entities because it does not impose any additional regulatory requirements relative to those specified in the February 2013 final CISWI rule. The February 2013 final CISWI rule was certified as not having a significant economic impact on a substantial number of small entities. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
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.
This action does not have tribal implications, as specified in Executive Order 13175. The EPA is not aware of any CISWI in Indian country or owned or operated by Indian tribal governments. The CISWI aspects of this rule may, however, invoke minor indirect tribal implications to the extent that entities generating solid wastes on tribal lands could be affected. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2–202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This action does not involve technical standards.
This action is not finalizing any new incorporation by reference material, so therefore this action is not making any amendments to the incorporations by reference found in 40 CFR 60.17. The incorporation by reference of this document was already approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 for § 60.14, effective February 7, 2013. The EPA has made, and will continue to make, these documents generally available electronically through
The EPA believes the human health or environmental risk addressed by this action will
This action is subject to the CRA, and the EPA will submit a rule report to House of Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Incorporation by reference.
For the reasons stated in the preamble, the Environmental Protection Agency is amending title 40, chapter I, of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
This subpart establishes new source performance standards for commercial and industrial solid waste incineration (CISWI) units.
This subpart takes effect on August 7, 2013. Some of the requirements in this subpart apply to planning the CISWI unit (
Yes, if your incineration unit meets all the requirements specified in paragraphs (a) through (c) of this section:
(a) Your incineration unit is a new incineration unit as defined in § 60.2015;
(b) Your incineration unit is a CISWI unit as defined in § 60.2265; and
(c) Your incineration unit is not exempt under § 60.2020.
(a) A new incineration unit is an incineration unit that meets any of the criteria specified in paragraphs (a)(1) through (3) of this section:
(1) A CISWI unit that commenced construction after June 4, 2010;
(2) A CISWI unit that commenced reconstruction or modification after August 7, 2013; and
(3) Incinerators and air curtain incinerators, as defined in this subpart, that commenced construction after November 30, 1999, but no later than June 4, 2010, or that commenced reconstruction or modification on or after June 1, 2001, but no later than August 7, 2013, are considered new incineration units and remain subject to the applicable requirements of this subpart until the units become subject to the requirements of an approved state plan or federal plan that implements subpart DDDD of this part (Emission Guidelines and Compliance Times for Commercial and Industrial Solid Waste Incineration Units).
(b) This subpart does not affect your CISWI unit if you make physical or operational changes to your incineration unit primarily to comply with subpart DDDD of this part (Emission Guidelines and Compliance Times for Commercial and Industrial Solid Waste Incineration Units). Such changes do not qualify as reconstruction or modification under this subpart.
This subpart exempts the types of units described in paragraphs (a), (c) through (i), and (n) of this section, but some units are required to provide notifications. Air curtain incinerators are exempt from the requirements in this subpart except for the provisions in §§ 60.2242, 60.2250, and 60.2260.
(a)
(1) Notify the Administrator that the unit meets these criteria; and
(2) Keep records on a calendar quarter basis of the weight of pathological waste, low-level radioactive waste, and/or chemotherapeutic waste burned, and the weight of all other fuels and wastes burned in the unit.
(b) [Reserved]
(c)
(d)
(e)
(1) The unit qualifies as a small power-production facility under section 3(17)(C) of the Federal Power Act (16 U.S.C. 796(17)(C));
(2) The unit burns homogeneous waste (not including refuse-derived fuel) to produce electricity;
(3) You submit documentation to the Administrator notifying the EPA that the qualifying small power production facility is combusting homogenous waste; and
(4) You maintain the records specified in § 60.2175(w).
(f)
(1) The unit qualifies as a cogeneration facility under section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B));
(2) The unit burns homogeneous waste (not including refuse-derived fuel) to produce electricity and steam or other forms of energy used for industrial, commercial, heating, or cooling purposes;
(3) You submit documentation to the Administrator notifying the Agency that
(4) You maintain the records specified in § 60.2175(x).
(g)
(h)
(i)
(1) 100 percent wood waste;
(2) 100 percent clean lumber; and
(3) 100 percent mixture of only wood waste, clean lumber, and/or yard waste.
(j)–(l) [Reserved]
(m)
(n)
(o)
(a) This subpart can be implemented and enforced by the U.S. Environmental Protection Agency (EPA), or a delegated authority such as your state, local, or tribal agency. If the EPA Administrator has delegated authority to your state, local, or tribal agency, then that agency (as well as EPA) has the authority to implement and enforce this subpart. You should contact your EPA Regional Office to find out if this subpart is delegated to your state, local, or tribal agency.
(b) In delegating implementation and enforcement authority of this subpart to a state, local, or tribal agency, the authorities contained in paragraph (c) of this section are retained by the EPA Administrator and are not transferred to the state, local, or tribal agency.
(c) The authorities that will not be delegated to state, local, or tribal agencies are specified in paragraphs (c)(1) through (4) and (c)(6) through (11) of this section:
(1) Approval of alternatives to the emission limitations in table 1 of this subpart and operating limits established under § 60.2110;
(2) Approval of major alternatives to test methods;
(3) Approval of major alternatives to monitoring;
(4) Approval of major alternatives to recordkeeping and reporting;
(5) [Reserved]
(6) The requirements in § 60.2115;
(7) The requirements in § 60.2100(b)(2);
(8) Approval of alternative opacity emission limits in § 60.2105 under § 60.11(e)(6) through (8);
(9) Performance test and data reduction waivers under § 60.2125(j), § 60.8(b)(4) and (5);
(10) Determination of whether a qualifying small power production facility or cogeneration facility under § 60.2020(e) or (f) is combusting homogenous waste; and
(11) Approval of an alternative to any electronic reporting to the EPA required by this subpart.
These new source performance standards contain the eleven major components listed in paragraphs (a) through (k) of this section:
(a) Preconstruction siting analysis;
(b) Waste management plan;
(c) Operator training and qualification;
(d) Emission limitations and operating limits;
(e) Performance testing;
(f) Initial compliance requirements;
(g) Continuous compliance requirements;
(h) Monitoring;
(i) Recordkeeping and reporting;
(j) Definitions; and
(k) Tables.
No. You must meet the preconstruction siting analysis and waste management plan requirements before you commence construction of the CISWI unit. The operator training and qualification, emission limitations, operating limits, performance testing and compliance, monitoring, and most recordkeeping and reporting requirements are met after the CISWI unit begins operation.
(a) You must prepare a siting analysis if you plan to commence construction of an incinerator after December 1, 2000.
(b) You must prepare a siting analysis for CISWI units that commenced construction after June 4, 2010, or that commenced reconstruction or modification after August 7, 2013.
(c) You must prepare a siting analysis if you are required to submit an initial application for a construction permit under 40 CFR part 51, subpart I, or 40 CFR part 52, as applicable, for the reconstruction or modification of your CISWI unit.
(a) The siting analysis must consider air pollution control alternatives that minimize, on a site-specific basis, to the maximum extent practicable, potential risks to public health or the environment. In considering such alternatives, the analysis may consider costs, energy impacts, nonair environmental impacts, or any other factors related to the practicability of the alternatives.
(b) Analyses of your CISWI unit's impacts that are prepared to comply with state, local, or other federal regulatory requirements may be used to satisfy the requirements of this section, provided they include the consideration of air pollution control alternatives specified in paragraph (a) of this section.
(c) You must complete and submit the siting requirements of this section as required under § 60.2190(c) prior to commencing construction.
A waste management plan is a written plan that identifies both the feasibility and the methods used to reduce or separate certain components of solid waste from the waste stream in order to reduce or eliminate toxic emissions from incinerated waste.
(a) You must submit a waste management plan prior to commencing construction.
(b) For CISWI units that commence reconstruction or modification after August 7, 2013, you must submit a waste management plan prior to the commencement of modification or reconstruction.
A waste management plan must include consideration of the reduction or separation of waste-stream elements such as paper, cardboard, plastics, glass, batteries, or metals; or the use of recyclable materials. The plan must identify any additional waste management measures and implement those measures the source considers practical and feasible, considering the effectiveness of waste management measures already in place, the costs of additional measures, the emissions reductions expected to be achieved, and any other environmental or energy impacts they might have.
(a) No CISWI unit can be operated unless a fully trained and qualified CISWI unit operator is accessible, either at the facility or can be at the facility within 1 hour. The trained and qualified CISWI unit operator may operate the CISWI unit directly or be the direct supervisor of one or more other plant personnel who operate the unit. If all qualified CISWI unit operators are temporarily not accessible, you must follow the procedures in § 60.2100.
(b) Operator training and qualification must be obtained through a state-approved program or by completing the requirements included in paragraph (c) of this section.
(c) Training must be obtained by completing an incinerator operator training course that includes, at a minimum, the three elements described in paragraphs (c)(1) through (3) of this section:
(1) Training on the eleven subjects listed in paragraphs (c)(1)(i) through (xi) of this section;
(i) Environmental concerns, including types of emissions;
(ii) Basic combustion principles, including products of combustion;
(iii) Operation of the specific type of incinerator to be used by the operator, including proper startup, waste charging, and shutdown procedures;
(iv) Combustion controls and monitoring;
(v) Operation of air pollution control equipment and factors affecting performance (if applicable);
(vi) Inspection and maintenance of the incinerator and air pollution control devices;
(vii) Actions to prevent and correct malfunctions or to prevent conditions that may lead to malfunctions;
(viii) Bottom and fly ash characteristics and handling procedures;
(ix) Applicable federal, state, and local regulations, including Occupational Safety and Health Administration workplace standards;
(x) Pollution prevention; and
(xi) Waste management practices.
(2) An examination designed and administered by the instructor.
(3) Written material covering the training course topics that may serve as reference material following completion of the course.
The operator training course must be completed by the later of the three dates specified in paragraphs (a) through (c) of this section:
(a) Six months after your CISWI unit startup;
(b) December 3, 2001; and
(c) The date before an employee assumes responsibility for operating the CISWI unit or assumes responsibility for supervising the operation of the CISWI unit.
(a) You must obtain operator qualification by completing a training course that satisfies the criteria under § 60.2070(b).
(b) Qualification is valid from the date on which the training course is completed and the operator successfully passes the examination required under § 60.2070(c)(2).
To maintain qualification, you must complete an annual review or refresher course covering, at a minimum, the five topics described in paragraphs (a) through (e) of this section:
(a) Update of regulations;
(b) Incinerator operation, including startup and shutdown procedures, waste charging, and ash handling;
(c) Inspection and maintenance;
(d) Prevention and correction of malfunctions or conditions that may lead to malfunction; and
(e) Discussion of operating problems encountered by attendees.
You must renew a lapsed operator qualification by one of the two methods specified in paragraphs (a) and (b) of this section:
(a) For a lapse of less than 3 years, you must complete a standard annual refresher course described in § 60.2085; and
(b) For a lapse of 3 years or more, you must repeat the initial qualification requirements in § 60.2080(a).
(a) Documentation must be available at the facility and readily accessible for all CISWI unit operators that addresses the ten topics described in paragraphs (a)(1) through (10) of this section. You must maintain this information and the training records required by paragraph (c) of this section in a manner that they can be readily accessed and are suitable for inspection upon request:
(1) Summary of the applicable standards under this subpart;
(2) Procedures for receiving, handling, and charging waste;
(3) Incinerator startup, shutdown, and malfunction procedures;
(4) Procedures for maintaining proper combustion air supply levels;
(5) Procedures for operating the incinerator and associated air pollution control systems within the standards established under this subpart;
(6) Monitoring procedures for demonstrating compliance with the incinerator operating limits;
(7) Reporting and recordkeeping procedures;
(8) The waste management plan required under §§ 60.2055 through 60.2065;
(9) Procedures for handling ash; and
(10) A list of the wastes burned during the performance test.
(b) You must establish a program for reviewing the information listed in paragraph (a) of this section with each incinerator operator:
(1) The initial review of the information listed in paragraph (a) of this section must be conducted within 6 months after the effective date of this subpart or prior to an employee's assumption of responsibilities for operation of the CISWI unit, whichever date is later; and
(2) Subsequent annual reviews of the information listed in paragraph (a) of this section must be conducted not later than 12 months following the previous review.
(c) You must also maintain the information specified in paragraphs (c)(1) through (3) of this section:
(1) Records showing the names of CISWI unit operators who have completed review of the information in § 60.2095(a) as required by § 60.2095(b), including the date of the initial review and all subsequent annual reviews;
(2) Records showing the names of the CISWI operators who have completed the operator training requirements under § 60.2070, met the criteria for qualification under § 60.2080, and maintained or renewed their qualification under § 60.2085 or § 60.2090. Records must include documentation of training, the dates of the initial and refresher training, and the dates of their qualification and all subsequent renewals of such qualifications; and
(3) For each qualified operator, the phone and/or pager number at which they can be reached during operating hours.
If all qualified operators are temporarily not accessible (
(a) When all qualified operators are not accessible for more than 8 hours, but less than 2 weeks, the CISWI unit may be operated by other plant personnel familiar with the operation of the CISWI unit who have completed a review of the information specified in § 60.2095(a) within the past 12 months. However, you must record the period when all qualified operators were not accessible and include this deviation in the annual report as specified under § 60.2210; and
(b) When all qualified operators are not accessible for 2 weeks or more, you must take the two actions that are described in paragraphs (b)(1) and (2) of this section:
(1) Notify the Administrator of this deviation in writing within 10 days. In the notice, state what caused this deviation, what you are doing to ensure that a qualified operator is accessible, and when you anticipate that a qualified operator will be accessible; and
(2) Submit a status report to the Administrator every 4 weeks outlining what you are doing to ensure that a qualified operator is accessible, stating when you anticipate that a qualified operator will be accessible and requesting approval from the Administrator to continue operation of the CISWI unit. You must submit the first status report 4 weeks after you notify the Administrator of the deviation under paragraph (b)(1) of this section. If the Administrator notifies you that your request to continue operation of the CISWI unit is disapproved, the CISWI unit may continue operation for 90 days, then must cease operation. Operation of the unit may resume if you meet the two requirements in paragraphs (b)(2)(i) and (ii) of this section:
(i) A qualified operator is accessible as required under § 60.2070(a); and
(ii) You notify the Administrator that a qualified operator is accessible and that you are resuming operation.
(a) You must meet the emission limitations for each CISWI unit, including bypass stack or vent, specified in table 1 of this subpart or tables 5 through 8 of this subpart by the applicable date in § 60.2140. You must be in compliance with the emission limitations of this subpart that apply to you at all times.
(b) An incinerator or air curtain incinerator that commenced construction after November 30, 1999, but no later than June 4, 2010, or that commenced reconstruction or modification on or after June 1, 2001 but no later than August 7, 2013, must continue to meet the emission limits in table 1 of this subpart for units in the incinerator subcategory and § 60.2250 for air curtain incinerators until the units become subject to the requirements of an approved state plan or federal plan that implements subpart DDDD of this part (Emission Guidelines and Compliance Times for Commercial and Industrial Solid Waste Incineration Units).
(a) If you use a wet scrubber(s) to comply with the emission limitations, you must establish operating limits for up to four operating parameters (as specified in table 2 of this subpart) as described in paragraphs (a)(1) through (4) of this section during the initial performance test:
(1) Maximum charge rate, calculated using one of the two different procedures in paragraph (a)(1)(i) or (ii) of this section, as appropriate:
(i) For continuous and intermittent units, maximum charge rate is 110 percent of the average charge rate measured during the most recent performance test demonstrating compliance with all applicable emission limitations; and
(ii) For batch units, maximum charge rate is 110 percent of the daily charge rate measured during the most recent performance test demonstrating compliance with all applicable emission limitations.
(2) Minimum pressure drop across the wet particulate matter scrubber, which is calculated as the lowest 1-hour average pressure drop across the wet scrubber measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations; or minimum amperage to the wet scrubber, which is calculated as the lowest 1-hour average amperage to the wet scrubber measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations;
(3) Minimum scrubber liquid flow rate, which is calculated as the lowest 1-hour average liquid flow rate at the inlet to the wet acid gas or particulate matter scrubber measured during the most recent performance test demonstrating compliance with all applicable emission limitations; and
(4) Minimum scrubber liquor pH, which is calculated as the lowest 1-hour average liquor pH at the inlet to the wet acid gas scrubber measured during the most recent performance test demonstrating compliance with the HCl emission limitation.
(b) You must meet the operating limits established during the initial performance test 60 days after your CISWI unit reaches the charge rate at which it will operate, but no later than 180 days after its initial startup.
(c) If you use a fabric filter to comply with the emission limitations and you do not use a PM CPMS for monitoring PM compliance, you must operate each fabric filter system such that the bag leak detection system alarm does not sound more than 5 percent of the operating time during a 6-month period. In calculating this operating time percentage, if inspection of the fabric filter demonstrates that no corrective action is required, no alarm time is counted. If corrective action is required, each alarm shall be counted as a minimum of 1 hour. If you take longer than 1 hour to initiate corrective action, the alarm time shall be counted as the actual amount of time taken by you to initiate corrective action.
(d) If you use an electrostatic precipitator to comply with the emission limitations and you do not use a PM CPMS for monitoring PM compliance, you must measure the (secondary) voltage and amperage of the electrostatic precipitator collection plates during the particulate matter performance test. Calculate the average
(e) If you use activated carbon sorbent injection to comply with the emission limitations, you must measure the sorbent flow rate during the performance testing. The operating limit for the carbon sorbent injection is calculated as the lowest 1-hour average sorbent flow rate measured during the most recent performance test demonstrating compliance with the mercury emission limitations. For energy recovery units, when your unit operates at lower loads, multiply your sorbent injection rate by the load fraction, as defined in this subpart, to determine the required injection rate (
(f) If you use selective noncatalytic reduction to comply with the emission limitations, you must measure the charge rate, the secondary chamber temperature (if applicable to your CISWI unit), and the reagent flow rate during the nitrogen oxides performance testing. The operating limits for the selective noncatalytic reduction are calculated as the highest 1-hour average charge rate, lower secondary chamber temperature, and lowest reagent flow rate measured during the most recent performance test demonstrating compliance with the nitrogen oxides emission limitations.
(g) If you use a dry scrubber to comply with the emission limitations, you must measure the injection rate of each sorbent during the performance testing. The operating limit for the injection rate of each sorbent is calculated as the lowest 1-hour average injection rate or each sorbent measured during the most recent performance test demonstrating compliance with the hydrogen chloride emission limitations. For energy recovery units, when your unit operates at lower loads, multiply your sorbent injection rate by the load fraction, as defined in this subpart, to determine the required injection rate (
(h) If you do not use a wet scrubber, electrostatic precipitator, or fabric filter to comply with the emission limitations, and if you do not determine compliance with your particulate matter emission limitation with either a particulate matter CEMS or a particulate matter CPMS, you must maintain opacity to less than or equal to 10 percent opacity (1-hour block average).
(i) If you use a PM CPMS to demonstrate compliance, you must establish your PM CPMS operating limit and determine compliance with it according to paragraphs (i)(1) through (5) of this section:
(1) Determine your operating limit as the average PM CPMS output value recorded during the performance test or at a PM CPMS output value corresponding to 75 percent of the emission limit if your PM performance test demonstrates compliance below 75 percent of the emission limit. You must verify an existing or establish a new operating limit after each repeated performance test. You must repeat the performance test annually and reassess and adjust the site-specific operating limit in accordance with the results of the performance test:
(i) Your PM CPMS must provide a 4–20 milliamp output, or digital equivalent, and the establishment of its relationship to manual reference method measurements must be determined in units of milliamps;
(ii) Your PM CPMS operating range must be capable of reading PM concentrations from zero to a level equivalent to at least two times your allowable emission limit. If your PM CPMS is an auto-ranging instrument capable of multiple scales, the primary range of the instrument must be capable of reading PM concentration from zero to a level equivalent to two times your allowable emission limit; and
(iii) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, record and average all milliamp output values, or their digital equivalent, from the PM CPMS for the periods corresponding to the compliance test runs (
(2) If the average of your three PM performance test runs are below 75 percent of your PM emission limit, you must calculate an operating limit by establishing a relationship of PM CPMS signal to PM concentration using the PM CPMS instrument zero, the average PM CPMS output values corresponding to the three compliance test runs, and the average PM concentration from the Method 5 or performance test with the procedures in (i)(1) through (5) of this section:
(i) Determine your instrument zero output with one of the following procedures:
(A) Zero point data for
(B) Zero point data for extractive instruments should be obtained by removing the extractive probe from the stack and drawing in clean ambient air;
(C) The zero point can also can be established obtained by performing manual reference method measurements when the flue gas is free of PM emissions or contains very low PM concentrations (
(D) If none of the steps in paragraphs (i)(2)(i)(A) through (C) of this section are possible, you must use a zero output value provided by the manufacturer.
(ii) Determine your PM CPMS instrument average in milliamps, or the digital equivalent, and the average of your corresponding three PM compliance test runs, using equation 1:
(iii) With your instrument zero expressed in milliamps, or the digital equivalent, your three run average PM CPMS milliamp value, or its digital equivalent, and your three run average PM concentration from your three compliance tests, determine a
(iv) Determine your source specific 30-day rolling average operating limit using the mg/dscm per milliamp or digital value from equation 2 in equation 3, below. This sets your operating limit at the PM CPMS output value corresponding to 75 percent of your emission limit:
(3) If the average of your three PM compliance test runs is at or above 75 percent of your PM emission limit you must determine your operating limit by averaging the PM CPMS milliamp or digital signal output corresponding to your three PM performance test runs that demonstrate compliance with the emission limit using equation 4 and you must submit all compliance test and PM CPMS data according to the reporting requirements in paragraph (i)(5) of this section:
(4) To determine continuous compliance, you must record the PM CPMS output data for all periods when the process is operating and the PM CPMS is not out-of-control. You must demonstrate continuous compliance by using all quality-assured hourly average data collected by the PM CPMS for all operating hours to calculate the arithmetic average operating parameter in units of the operating limit (
(5) For PM performance test reports used to set a PM CPMS operating limit, the electronic submission of the test report must also include the make and model of the PM CPMS instrument, serial number of the instrument, analytical principle of the instrument (
If you use an air pollution control device other than a wet scrubber, activated carbon injection, selective noncatalytic reduction, fabric filter, an electrostatic precipitator, or a dry scrubber or limit emissions in some other manner, including material balances, to comply with the emission limitations under § 60.2105, you must petition the EPA Administrator for specific operating limits to be established during the initial performance test and continuously monitored thereafter. You must submit the petition at least sixty days before the performance test is scheduled to begin. Your petition must include the five items listed in paragraphs (a) through (e) of this section:
(a) Identification of the specific parameters you propose to use as additional operating limits;
(b) A discussion of the relationship between these parameters and emissions of regulated pollutants, identifying how emissions of regulated pollutants change with changes in these parameters and how limits on these parameters will serve to limit emissions of regulated pollutants;
(c) A discussion of how you will establish the upper and/or lower values for these parameters which will establish the operating limits on these parameters;
(d) A discussion identifying the methods you will use to measure and the instruments you will use to monitor these parameters, as well as the relative accuracy and precision of these methods and instruments; and
(e) A discussion identifying the frequency and methods for recalibrating the instruments you will use for monitoring these parameters.
(a) All performance tests must consist of a minimum of three test runs conducted under conditions representative of normal operations.
(b) You must document that the waste burned during the performance test is representative of the waste burned under normal operating conditions by
(c) All performance tests must be conducted using the minimum run duration specified in table 1 of this subpart or tables 5 through 8 of this subpart.
(d) Method 1 of appendix A of this part must be used to select the sampling location and number of traverse points.
(e) Method 3A or 3B of appendix A of this part must be used for gas composition analysis, including measurement of oxygen concentration. Method 3A or 3B of appendix A of this part must be used simultaneously with each method.
(f) All pollutant concentrations, except for opacity, must be adjusted to 7 percent oxygen using equation 5 of this section:
(g) You must determine dioxins/furans toxic equivalency by following the procedures in paragraphs (g)(1) through (4) of this section:
(1) Measure the concentration of each dioxin/furan tetra-through octa-chlorinated isomer emitted using EPA Method 23 at 40 CFR part 60, appendix A–7;
(2) Quantify isomers meeting identification criteria 2, 3, 4, and 5 in Section 5.3.2.5 of Method 23, regardless of whether the isomers meet identification criteria 1 and 7. You must quantify the isomers per Section 9.0 of Method 23. (Note: You may reanalyze the sample aliquot or split to reduce the number of isomers not meeting identification criteria 1 or 7 of Section 5.3.2.5.);
(3) For each dioxin/furan (tetra-through octa-chlorinated) isomer measured in accordance with paragraphs (g)(1) and (2) of this section, multiply the isomer concentration by its corresponding toxic equivalency factor specified in table 3 of this subpart; and
(4) Sum the products calculated in accordance with paragraph (g)(3) of this section to obtain the total concentration of dioxins/furans emitted in terms of toxic equivalency.
(h) Method 22 at 40 CFR part 60, appendix A–7 of this part must be used to determine compliance with the fugitive ash emission limit in table 1 of this subpart or tables 5 through 8 of this subpart.
(i) If you have an applicable opacity operating limit, you must determine compliance with the opacity limit using Method 9 at 40 CFR part 60, appendix A–4, based on three 1-hour blocks consisting of ten 6-minute average opacity values, unless you are required to install a continuous opacity monitoring system, consistent with §§ 60.2145 and 60.2165.
(j) You must determine dioxins/furans total mass basis by following the procedures in paragraphs (j)(1) through (3) of this section:
(1) Measure the concentration of each dioxin/furan tetra-through octa-chlorinated isomer emitted using EPA Method 23 at 40 CFR part 60, appendix A–7;
(2) Quantify isomers meeting identification criteria 2, 3, 4, and 5 in Section 5.3.2.5 of Method 23, regardless of whether the isomers meet identification criteria 1 and 7. You must quantify the isomers per Section 9.0 of Method 23. (Note: You may reanalyze the sample aliquot or split to reduce the number of isomers not meeting identification criteria 1 or 7 of Section 5.3.2.5.); and
(3) Sum the quantities measured in accordance with paragraphs (j)(1) and (2) of this section to obtain the total concentration of dioxins/furans emitted in terms of total mass basis.
You use results of performance tests to demonstrate compliance with the emission limitations in table 1 of this subpart or tables 5 through 8 of this subpart.
You must conduct a performance test, as required under §§ 60.2125 and 60.2105 to determine compliance with the emission limitations in table 1 of this subpart or tables 5 through 8 of this subpart, to establish compliance with any opacity operating limit in § 60.2110, to establish the kiln-specific emission limit in § 60.2145(y), as applicable, and to establish operating limits using the procedures in §§ 60.2110 or 60.2115. The performance test must be conducted using the test methods listed in table 1 of this subpart or tables 5 through 8 of this subpart and the procedures in § 60.2125. The use of the bypass stack during a performance test shall invalidate the performance test. You must conduct a performance evaluation of each continuous monitoring system within 60 days of installation of the monitoring system.
(a) The initial performance test must be conducted within 60 days after your CISWI unit reaches the charge rate at which it will operate, but no later than 180 days after its initial startup.
(b) If you commence or recommence combusting a solid waste at an existing combustion unit at any commercial or industrial facility, and you conducted a test consistent with the provisions of this subpart while combusting the solid waste within the 6 months preceding the reintroduction of that solid waste in the combustion chamber, you do not need to retest until 6 months from the date you reintroduce that solid waste.
(c) If you commence or recommence combusting a solid waste at an existing combustion unit at any commercial or industrial facility and you have not conducted a performance test consistent with the provisions of this subpart while combusting the solid waste within the 6 months preceding the reintroduction of that solid waste in the combustion chamber, you must conduct a performance test within 60 days from the date you reintroduce that solid waste.
(a) The initial air pollution control device inspection must be conducted within 60 days after installation of the control device and the associated CISWI unit reaches the charge rate at which it will operate, but no later than 180 days after the device's initial startup.
(b) Within 10 operating days following an air pollution control device inspection, all necessary repairs must be completed unless the owner or operator obtains written approval from the state agency establishing a date whereby all
(a)
(2) If you cease combusting solid waste, you may opt to remain subject to the provisions of this subpart. Consistent with the definition of CISWI unit, you are subject to the requirements of this subpart at least 6 months following the last date of solid waste combustion. Solid waste combustion is ceased when solid waste is not in the combustion chamber (
(3) If you cease combusting solid waste, you must be in compliance with any newly applicable standards on the effective date of the waste-to-fuel switch. The effective date of the waste-to-fuel switch is a date selected by you, that must be at least 6 months from the date that you ceased combusting solid waste, consistent with § 60.2145(a)(2). Your source must remain in compliance with this subpart until the effective date of the waste-to-fuel switch;
(4) If you own or operate an existing commercial or industrial combustion unit that combusted a fuel or non-waste material, and you commence or recommence combustion of solid waste, you are subject to the provisions of this subpart as of the first day you introduce or reintroduce solid waste to the combustion chamber, and this date constitutes the effective date of the fuel-to-waste switch. You must complete all initial compliance demonstrations for any section 112 standards that are applicable to your facility before you commence or recommence combustion of solid waste. You must provide 30 days prior notice of the effective date of the waste-to-fuel switch. The notification must identify:
(i) The name of the owner or operator of the CISWI unit, the location of the source, the emissions unit(s) that will cease burning solid waste, and the date of the notice;
(ii) The currently applicable subcategory under this subpart, and any 40 CFR part 63 subpart and subcategory that will be applicable after you cease combusting solid waste;
(iii) The fuel(s), non-waste material(s) and solid waste(s) the CISWI unit is currently combusting and has combusted over the past 6 months, and the fuel(s) or non-waste materials the unit will commence combusting;
(iv) The date on which you became subject to the currently applicable emission limits; and
(v) The date upon which you will cease combusting solid waste, and the date (if different) that you intend for any new requirements to become applicable (
(5) All air pollution control equipment necessary for compliance with any newly applicable emissions limits which apply as a result of the cessation or commencement or recommencement of combusting solid waste must be installed and operational as of the effective date of the waste-to-fuel, or fuel-to-waste switch.
(6) All monitoring systems necessary for compliance with any newly applicable monitoring requirements which apply as a result of the cessation or commencement or recommencement of combusting solid waste must be installed and operational as of the effective date of the waste-to-fuel, or fuel-to-waste switch. All calibration and drift checks must be performed as of the effective date of the waste-to-fuel, or fuel-to-waste switch. Relative accuracy tests must be performed as of the performance test deadline for PM CEMS (if PM CEMS are elected to demonstrate continuous compliance with the particulate matter emission limits). Relative accuracy testing for other CEMS need not be repeated if that testing was previously performed consistent with Clean Air Act section 112 monitoring requirements or monitoring requirements under this subpart.
(b) You must conduct an annual performance test for the pollutants listed in table 1 of this subpart or tables 5 through 8 of this subpart and opacity for each CISWI unit as required under § 60.2125. The annual performance test must be conducted using the test methods listed in table 1 of this subpart or tables 5 through 8 of this subpart and the procedures in § 60.2125. Annual performance tests are not required if you use CEMS or continuous opacity monitoring systems to determine compliance.
(c) You must continuously monitor the operating parameters specified in § 60.2110 or established under § 60.2115 and as specified in § 60.2170. Use 3-hour block average values to determine compliance (except for baghouse leak detection system alarms) unless a different averaging period is established under § 60.2115 or, for energy recovery units, where the averaging time for each operating parameter is a 30-day rolling, calculated each hour as the average of the previous 720 operating hours. Operation above the established maximum, below the established minimum, or outside the allowable range of operating limits specified in paragraph (a) of this section constitutes a deviation from your operating limits established under this subpart, except during performance tests conducted to determine compliance with the emission and operating limits or to establish new operating limits. Operating limits are confirmed or reestablished during performance tests.
(d) You must burn only the same types of waste and fuels used to establish subcategory applicability (for energy recovery units) and operating limits during the performance test.
(e) For energy recovery units, incinerators, and small remote units, you must perform an annual visual emissions test for ash handling.
(f) For energy recovery units, you must conduct an annual performance test for opacity (except where particulate matter CEMS or continuous opacity monitoring systems are used are used) and the pollutants listed in table 6 of this subpart.
(g) You may elect to demonstrate continuous compliance with the carbon monoxide emission limit using a carbon monoxide CEMS according to the following requirements:
(1) You must measure emissions according to § 60.13 to calculate 1-hour arithmetic averages, corrected to 7 percent oxygen. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must demonstrate initial compliance with the carbon monoxide emissions limit using a 30-day rolling average of these 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part; and
(2) Operate the carbon monoxide CEMS in accordance with the requirements of performance specification 4A of appendix B of this part and quality assurance procedure 1 of appendix F of this part.
(h) Coal and liquid/gas energy recovery units with average annual heat input rates greater than or equal to 250 MMBtu/hr may elect to demonstrate continuous compliance with the particulate matter emissions limit using a particulate matter CEMS according to the procedures in § 60.2165(n) instead
(i) For energy recovery units with annual average heat input rates greater than or equal to 10 MMBtu/hour and less than 250 MMBtu/hr, you must install, operate, certify and maintain a continuous opacity monitoring system (COMS) according to the procedures in § 60.2165.
(j) For waste-burning kilns, you must conduct an annual performance test for cadmium, lead, dioxins/furans and hydrogen chloride as listed in table 7 of this subpart. If you do not use an acid gas wet scrubber or dry scrubber, you must determine compliance with the hydrogen chloride emissions limit according to the requirements in paragraph (j)(1) of this section. You must determine compliance with the mercury emissions limit using a mercury CEMS according to paragraph (j)(2) of this section. You must determine compliance with nitrogen oxides, sulfur dioxide, and carbon monoxide using CEMS. You must determine compliance with particulate matter using CPMS:
(1) If you monitor compliance with the HCl emissions limit by operating an HCl CEMS, you must do so in accordance with Performance Specification 15 (PS 15) of appendix B to 40 CFR part 60, or, PS 18 of appendix B to 40 CFR part 60. You must operate, maintain, and quality assure a HCl CEMS installed and certified under PS 15 according to the quality assurance requirements in Procedure 1 of appendix F to 40 CFR part 60 except that the Relative Accuracy Test Audit requirements of Procedure 1 must be replaced with the validation requirements and criteria of sections 11.1.1 and 12.0 of PS 15. You must operate, maintain and quality assure a HCl CEMS installed and certified under PS 18 according to the quality assurance requirements in Procedure 6 of appendix F to 40 CFR part 60. For any performance specification that you use, you must use Method 321 of appendix A to 40 CFR part 63 as the reference test method for conducting relative accuracy testing. The span value and calibration requirements in paragraphs (j)(1)(i) and (ii) of this section apply to all HCl CEMS used under this subpart:
(i) You must use a measurement span value for any HCl CEMS of 0–10 ppmvw unless the monitor is installed on a kiln without an inline raw mill. Kilns without an inline raw mill may use a higher span value sufficient to quantify all expected emissions concentrations. The HCl CEMS data recorder output range must include the full range of expected HCl concentration values which would include those expected during “mill off” conditions. The corresponding data recorder range shall be documented in the site-specific monitoring plan and associated records;
(ii) In order to quality assure data measured above the span value, you must use one of the three options in paragraphs (j)(1)(ii)(A) through (C) of this section:
(A) Include a second span that encompasses the HCl emission concentrations expected to be encountered during “mill off” conditions. This second span may be rounded to a multiple of 5 ppm of total HCl. The requirements of the appropriate HCl monitor performance specification shall be followed for this second span with the exception that a RATA with the mill off is not required;
(B) Quality assure any data above the span value by proving instrument linearity beyond the span value established in paragraph (j)(1)(i) of this section using the following procedure. Conduct a weekly “above span linearity” calibration challenge of the monitoring system using a reference gas with a certified value greater than your highest expected hourly concentration or greater than 75% of the highest measured hourly concentration. The “above span” reference gas must meet the requirements of the applicable performance specification and must be introduced to the measurement system at the probe. Record and report the results of this procedure as you would for a daily calibration. The “above span linearity” challenge is successful if the value measured by the HCl CEMS falls within 10 percent of the certified value of the reference gas. If the value measured by the HCl CEMS during the above span linearity challenge exceeds 10 percent of the certified value of the reference gas, the monitoring system must be evaluated and repaired and a new “above span linearity” challenge met before returning the HCl CEMS to service, or data above span from the HCl CEMS must be subject to the quality assurance procedures established in (j)(1)(ii)(D) of this section. In this manner values measured by the HCl CEMS during the above span linearity challenge exceeding +/−20 percent of the certified value of the reference gas must be normalized using equation 6;
(C) Quality assure any data above the span value established in paragraph (j)(1)(i) of this section using the following procedure. Any time two consecutive one-hour average measured concentration of HCl exceeds the span value you must, within 24 hours before or after, introduce a higher, “above span” HCl reference gas standard to the HCl CEMS. The “above span” reference gas must meet the requirements of the applicable performance specification and target a concentration level between 50 and 150 percent of the highest expected hourly concentration measured during the period of measurements above span, and must be introduced at the probe. While this target represents a desired concentration range that is not always achievable in practice, it is expected that the intent to meet this range is demonstrated by the value of the reference gas. Expected values may include above span calibrations done before or after the above-span measurement period. Record and report the results of this procedure as you would for a daily calibration. The “above span” calibration is successful if the value measured by the HCl CEMS is within 20 percent of the certified value of the reference gas. If the value measured by the HCl CEMS is not within 20 percent of the certified value of the reference gas, then you must normalize the stack gas values measured above span as described in paragraph (j)(1)(ii)(D) of this section. If the “above span” calibration is conducted during the period when measured emissions are above span and there is a failure to collect the one data point in an hour due to the calibration duration, then you must determine the emissions average for that missed hour as the average of hourly averages for the hour preceding the missed hour and the hour following the missed hour. In an hour where an “above span” calibration is being conducted and one or more data points are collected, the emissions average is represented by the average of all valid data points collected in that hour;
(D) In the event that the “above span” calibration is not successful (
Only one “above span” calibration is needed per 24-hour period.
(2) Compliance with the mercury emissions limit must be determined using a mercury CEMS according to the following requirements:
(i) You must operate a CEMS system in accordance with performance specification 12A of 40 CFR part 60, appendix B or a sorbent trap based integrated monitor in accordance with performance specification 12B of 40 CFR part 60, appendix B. The duration of the performance test must be a calendar month. For each calendar month in which the waste-burning kiln operates, hourly mercury concentration data, and stack gas volumetric flow rate data must be obtained. You must demonstrate compliance with the mercury emissions limit using a 30-day rolling average of these 1-hour mercury concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content;
(ii) Owners or operators using a mercury CEMS must install, operate, calibrate, and maintain an instrument for continuously measuring and recording the mercury mass emissions rate to the atmosphere according to the requirements of performance specifications 6 and 12A of 40 CFR part 60, appendix B, and quality assurance procedure 6 of 40 CFR part 60, appendix F; and
(iii) The owner or operator of a waste-burning kiln must demonstrate initial compliance by operating a mercury CEMS while the raw mill of the in-line kiln/raw mill is operating under normal conditions and including at least one period when the raw mill is off.
(k) If you use an air pollution control device to meet the emission limitations in this subpart, you must conduct an initial and annual inspection of the air pollution control device. The inspection must include, at a minimum, the following:
(1) Inspect air pollution control device(s) for proper operation; and.
(2) Develop a site-specific monitoring plan according to the requirements in paragraph (l) of this section. This requirement also applies to you if you petition the EPA Administrator for alternative monitoring parameters under § 60.13(i).
(l) For each continuous monitoring system required in this section, you must develop and submit to the EPA Administrator for approval a site-specific monitoring plan according to the requirements of this paragraph (l) that addresses paragraphs (l)(1)(i) through (vi) of this section:
(1) You must submit this site-specific monitoring plan at least 60 days before your initial performance evaluation of your continuous monitoring system:
(i) Installation of the continuous monitoring system sampling probe or other interface at a measurement location relative to each affected process unit such that the measurement is representative of control of the exhaust emissions (
(ii) Performance and equipment specifications for the sample interface, the pollutant concentration or parametric signal analyzer and the data collection and reduction systems.
(iii) Performance evaluation procedures and acceptance criteria (
(iv) Ongoing operation and maintenance procedures in accordance with the general requirements of § 60.11(d);
(v) Ongoing data quality assurance procedures in accordance with the general requirements of § 60.13; and
(vi) Ongoing recordkeeping and reporting procedures in accordance with the general requirements of § 60.7(b), (c), (c)(1), (c)(4), (d), (e), (f), and (g).
(2) You must conduct a performance evaluation of each continuous monitoring system in accordance with your site-specific monitoring plan.
(3) You must operate and maintain the continuous monitoring system in continuous operation according to the site-specific monitoring plan.
(m) If you have an operating limit that requires the use of a flow monitoring system, you must meet the requirements in paragraphs (l) and (m)(1) through (4) of this section:
(1) Install the flow sensor and other necessary equipment in a position that provides a representative flow;
(2) Use a flow sensor with a measurement sensitivity at full scale of no greater than 2 percent;
(3) Minimize the effects of swirling flow or abnormal velocity distributions due to upstream and downstream disturbances; and
(4) Conduct a flow monitoring system performance evaluation in accordance with your monitoring plan at the time of each performance test but no less frequently than annually.
(n) If you have an operating limit that requires the use of a pressure monitoring system, you must meet the requirements in paragraphs (l) and (n)(1) through (6) of this section:
(1) Install the pressure sensor(s) in a position that provides a representative measurement of the pressure (
(2) Minimize or eliminate pulsating pressure, vibration, and internal and external corrosion;
(3) Use a pressure sensor with a minimum tolerance of 1.27 centimeters of water or a minimum tolerance of 1 percent of the pressure monitoring system operating range, whichever is less;
(4) Perform checks at the frequency outlined in your site-specific monitoring plan to ensure pressure measurements are not obstructed (
(5) Conduct a performance evaluation of the pressure monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than annually; and
(6) If at any time the measured pressure exceeds the manufacturer's specified maximum operating pressure range, conduct a performance evaluation of the pressure monitoring system in accordance with your monitoring plan and confirm that the pressure monitoring system continues to meet the performance requirements in your monitoring plan. Alternatively, install and verify the operation of a new pressure sensor.
(o) If you have an operating limit that requires a pH monitoring system, you must meet the requirements in paragraphs (l) and (o)(1) through (4) of this section:
(1) Install the pH sensor in a position that provides a representative measurement of scrubber effluent pH;
(2) Ensure the sample is properly mixed and representative of the fluid to be measured;
(3) Conduct a performance evaluation of the pH monitoring system in
(4) Conduct a performance evaluation (including a two-point calibration with one of the two buffer solutions having a pH within 1 of the pH of the operating limit) of the pH monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than quarterly.
(p) If you have an operating limit that requires a secondary electric power monitoring system for an electrostatic precipitator, you must meet the requirements in paragraphs (l) and (p)(1) and (2) of this section:
(1) Install sensors to measure (secondary) voltage and current to the precipitator collection plates; and
(2) Conduct a performance evaluation of the electric power monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than annually.
(q) If you have an operating limit that requires the use of a monitoring system to measure sorbent injection rate (
(1) Install the system in a position(s) that provides a representative measurement of the total sorbent injection rate; and
(2) Conduct a performance evaluation of the sorbent injection rate monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than annually.
(r) If you elect to use a fabric filter bag leak detection system to comply with the requirements of this subpart, you must install, calibrate, maintain, and continuously operate a bag leak detection system as specified in paragraphs (l) and (r)(1) through (5) of this section:
(1) Install a bag leak detection sensor(s) in a position(s) that will be representative of the relative or absolute particulate matter loadings for each exhaust stack, roof vent, or compartment (
(2) Use a bag leak detection system certified by the manufacturer to be capable of detecting particulate matter emissions at concentrations of 10 milligrams per actual cubic meter or less;
(3) Conduct a performance evaluation of the bag leak detection system in accordance with your monitoring plan and consistent with the guidance provided in EPA–454/R–98–015 (incorporated by reference,
(4) Use a bag leak detection system equipped with a device to continuously record the output signal from the sensor; and
(5) Use a bag leak detection system equipped with a system that will sound an alarm when an increase in relative particulate matter emissions over a preset level is detected. The alarm must be located where it is observed readily by plant operating personnel.
(s) For facilities using a CEMS to demonstrate compliance with the sulfur dioxide emission limit, compliance with the sulfur dioxide emission limit may be demonstrated by using the CEMS specified in § 60.2165 to measure sulfur dioxide. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must calculate a 30-day rolling average of the 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, Appendix A–7 of this part. The sulfur dioxide CEMS must be operated according to performance specification 2 in appendix B of this part and must follow the procedures and methods specified in paragraph (s) of this section. For sources that have actual inlet emissions less than 100 parts per million dry volume, the relative accuracy criterion for inlet sulfur dioxide CEMS should be no greater than 20 percent of the mean value of the reference method test data in terms of the units of the emission standard, or 5 parts per million dry volume absolute value of the mean difference between the reference method and the CEMS, whichever is greater:
(1) During each relative accuracy test run of the CEMS required by performance specification 2 in appendix B of this part, collect sulfur dioxide and oxygen (or carbon dioxide) data concurrently (or within a 30- to 60-minute period) with both the CEMS and the test methods specified in paragraphs (s)(1)(i) and (ii) of this section:
(i) For sulfur dioxide, EPA Reference Method 6 or 6C, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference,
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference,
(2) The span value of the CEMS at the inlet to the sulfur dioxide control device must be 125 percent of the maximum estimated hourly potential sulfur dioxide emissions of the unit subject to this subpart. The span value of the CEMS at the outlet of the sulfur dioxide control device must be 50 percent of the maximum estimated hourly potential sulfur dioxide emissions of the unit subject to this subpart.
(3) Conduct accuracy determinations quarterly and calibration drift tests daily in accordance with procedure 1 in appendix F of this part.
(t) For facilities using a CEMS to demonstrate continuous compliance with the nitrogen oxides emission limit, compliance with the nitrogen oxides emission limit may be demonstrated by using the CEMS specified in § 60.2165 to measure nitrogen oxides. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must calculate a 30-day rolling average of the 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part. The nitrogen oxides CEMS must be operated according to performance specification 2 in appendix B of this part and must follow the procedures and methods specified in paragraphs (t)(1) through (4) of this section:
(1) During each relative accuracy test run of the CEMS required by performance specification 2 of appendix B of this part, collect nitrogen oxides and oxygen (or carbon dioxide) data concurrently (or within a 30- to 60-minute period) with both the CEMS and the test methods specified in paragraphs (t)(1)(i) and (ii) of this section:
(i) For nitrogen oxides, EPA Reference Method 7 or 7E at 40 CFR part 60, appendix A–4 must be used; and
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B at 40 CFR part 60, appendix A–3, or as an alternative ANSI/ASME PTC 19–10.1981 (incorporated by reference,
(2) The span value of the continuous emission monitoring system must be 125 percent of the maximum estimated hourly potential nitrogen oxide emissions of the unit.
(3) Conduct accuracy determinations quarterly and calibration drift tests daily in accordance with procedure 1 in appendix F of this part.
(4) The owner or operator of an affected facility may request that
(i) The fuel factor equation in Method 3B must be used to determine the relationship between oxygen and carbon dioxide at a sampling location. Method 3A or 3B, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference,
(ii) Samples must be taken for at least 30 minutes in each hour;
(iii) Each sample must represent a 1-hour average; and
(iv) A minimum of three runs must be performed.
(u) For facilities using a CEMS to demonstrate continuous compliance with any of the emission limits of this subpart, you must complete the following:
(1) Demonstrate compliance with the appropriate emission limit(s) using a 30-day rolling average of 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part. CEMS data during startup and shutdown, as defined in the subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content; and
(2) Operate all CEMS in accordance with the applicable procedures under appendices B and F of this part.
(v) Use of the bypass stack at any time is an emissions standards deviation for particulate matter, HCl, Pb, Cd, Hg, NO
(w) For energy recovery units with a design heat input capacity of 100 MMBtu per hour or greater that do not use a carbon monoxide CEMS, you must install, operate, and maintain a oxygen analyzer system as defined in § 60.2265 according to the procedures in paragraphs (w)(1) through (4) of this section:
(1) The oxygen analyzer system must be installed by the initial performance test date specified in § 60.2140;
(2) You must operate the oxygen trim system within compliance with paragraph (w)(3) of this section at all times;
(3) You must maintain the oxygen level such that the 30-day rolling average that is established as the operating limit for oxygen is not below the lowest hourly average oxygen concentration measured during the most recent CO performance test; and
(4) You must calculate and record a 30-day rolling average oxygen concentration using equation 19–19 in section 12.4.1 of EPA Reference Method 19 of Appendix A–7 of this part.
(x) For energy recovery units with annual average heat input rates greater than or equal to 250 MMBtu/hour and waste-burning kilns, you must install, calibrate, maintain, and operate a PM CPMS and record the output of the system as specified in paragraphs (x)(1) through (8) of this section. For other energy recovery units, you may elect to use PM CPMS operated in accordance with this section. PM CPMS are suitable in lieu of using other CMS for monitoring PM compliance (
(1) Install, calibrate, operate, and maintain your PM CPMS according to the procedures in your approved site-specific monitoring plan developed in accordance with paragraphs (l) and (x)(1)(i) through (iii) of this section:
(i) The operating principle of the PM CPMS must be based on in-stack or extractive light scatter, light scintillation, beta attenuation, or mass accumulation detection of the exhaust gas or representative sample. The reportable measurement output from the PM CPMS must be expressed as milliamps or the digital signal equivalent;
(ii) The PM CPMS must have a cycle time (
(iii) The PM CPMS must be capable of detecting and responding to particulate matter concentrations increments no greater than 0.5 mg/actual cubic meter.
(2) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, you must adjust the site-specific operating limit in accordance with the results of the performance test according to the procedures specified in § 60.2110.
(3) Collect PM CPMS hourly average output data for all energy recovery unit or waste-burning kiln operating hours. Express the PM CPMS output as milliamps.
(4) Calculate the arithmetic 30-day rolling average of all of the hourly average PM CPMS output collected during all energy recovery unit or waste-burning kiln operating hours data (milliamps or their digital equivalent).
(5) You must collect data using the PM CPMS at all times the energy recovery unit or waste-burning kiln is operating and at the intervals specified in paragraph (x)(1)(ii) of this section, except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments), and any scheduled maintenance as defined in your site-specific monitoring plan.
(6) You must use all the data collected during all energy recovery unit or waste-burning kiln operating hours in assessing the compliance with your operating limit except:
(i) Any data collected during monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities conducted during monitoring system malfunctions are not used in calculations (report any such periods in your annual deviation report);
(ii) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods are not used in calculations (report emissions or operating levels and report any such periods in your annual deviation report);
(iii) Any PM CPMS data recorded during periods of CEMS data during startup and shutdown, as defined in this subpart.
(7) You must record and make available upon request results of PM CPMS system performance audits, as well as the dates and duration of periods from when the PM CPMS is out of control until completion of the corrective actions necessary to return the PM CPMS to operation consistent with your site-specific monitoring plan.
(8) For any deviation of the 30-day rolling average PM CPMS average value from the established operating parameter limit, you must:
(i) Within 48 hours of the deviation, visually inspect the air pollution control device;
(ii) If inspection of the air pollution control device identifies the cause of the deviation, take corrective action as soon as possible and return the PM CPMS measurement to within the established value;
(iii) Within 30 days of the deviation or at the time of the annual compliance test, whichever comes first, conduct a PM emissions compliance test to determine compliance with the PM emissions limit and to verify. Within 45 days of the deviation, you must re-establish the CPMS operating limit. You are not required to conduct additional testing for any deviations that occur between the time of the original deviation and the PM emissions compliance test required under paragraph (x) of this section; and
(iv) PM CPMS deviations leading to more than four required performance tests in a 12-month process operating period (rolling monthly) constitute a violation of this subpart.
(y) When there is an alkali bypass and/or an in-line coal mill that exhaust emissions through a separate stack(s), the combined emissions are subject to the emission limits applicable to waste-burning kilns. To determine the kiln-specific emission limit for demonstrating compliance, you must:
(1) Calculate a kiln-specific emission limit using equation 7:
Where:
(2) Particulate matter concentration must be measured downstream of the in-line coal mill. All other pollutant concentrations must be measured either upstream or downstream of the in-line coal mill; and
(3) For purposes of determining the combined emissions from kilns equipped with an alkali bypass or that exhaust kiln gases to a coal mill that exhausts through a separate stack, instead of installing a CEMS or PM CPMS on the alkali bypass stack or in-line coal mill stack, the results of the initial and subsequent performance test can be used to demonstrate compliance with the relevant emissions limit. A performance test must be conducted on an annual basis (between 11 and 13 calendar months following the previous performance test).
You must conduct annual performance tests between 11 and 13 months of the previous performance test.
On an annual basis (no more than 12 months following the previous annual air pollution control device inspection), you must complete the air pollution control device inspection as described in § 60.2141.
(a) You must conduct annual performance tests according to the schedule specified in § 60.2150, with the following exceptions:
(1) You may conduct a repeat performance test at any time to establish new values for the operating limits to apply from that point forward, as specified in § 60.2160. The Administrator may request a repeat performance test at any time;
(2) You must repeat the performance test within 60 days of a process change, as defined in § 60.2265;
(3) If the initial or any subsequent performance test for any pollutant in table 1 or tables 5 through 8 of this subpart, as applicable, demonstrates that the emission level for the pollutant is no greater than the emission level specified in paragraph (a)(3)(i) or (a)(3)(ii) of this section, as
(i) For particulate matter, hydrogen chloride, mercury, nitrogen oxides, sulfur dioxide, cadmium, lead and dioxins/furans, the emission level equal to 75 percent of the applicable emission limit in table 1 or tables 5 through 8 of this subpart, as applicable, to this subpart; and
(ii) For fugitive emissions, visible emissions (of combustion ash from the ash conveying system) for 2 percent of the time during each of the three 1-hour observations periods.
(4) If you are conducting less frequent testing for a pollutant as provided in paragraph (a)(3) of this section and a subsequent performance test for the pollutant indicates that your CISWI unit does not meet the emission level specified in paragraph (a)(3)(i) or (a)(3)(ii) of this section, as applicable, you must conduct annual performance tests for the pollutant according to the schedule specified in paragraph (a) of this section until you qualify for less frequent testing for the pollutant as specified in paragraph (a)(3) of this section.
(b) [Reserved]
(a) Yes. You may conduct a repeat performance test at any time to establish new values for the operating limits. The Administrator may request a repeat performance test at any time.
(b) You must repeat the performance test if your feed stream is different than the feed streams used during any performance test used to demonstrate compliance.
(a) If you are using a wet scrubber to comply with the emission limitation under § 60.2105, you must install, calibrate (to manufacturers' specifications), maintain, and operate devices (or establish methods) for monitoring the value of the operating parameters used to determine compliance with the operating limits listed in table 2 of this subpart. These devices (or methods) must measure and record the values for these operating parameters at the frequencies indicated in table 2 of this subpart at all times except as specified in § 60.2170(a).
(b) If you use a fabric filter to comply with the requirements of this subpart and you do not use a PM CPMS for monitoring PM compliance, you must install, calibrate, maintain, and continuously operate a bag leak
(1) You must install and operate a bag leak detection system for each exhaust stack of the fabric filter;
(2) Each bag leak detection system must be installed, operated, calibrated, and maintained in a manner consistent with the manufacturer's written specifications and recommendations;
(3) The bag leak detection system must be certified by the manufacturer to be capable of detecting particulate matter emissions at concentrations of 10 milligrams per actual cubic meter or less;
(4) The bag leak detection system sensor must provide output of relative or absolute particulate matter loadings;
(5) The bag leak detection system must be equipped with a device to continuously record the output signal from the sensor;
(6) The bag leak detection system must be equipped with an alarm system that will alert automatically an operator when an increase in relative particulate matter emissions over a preset level is detected. The alarm must be located where it is observed easily by plant operating personnel;
(7) For positive pressure fabric filter systems, a bag leak detection system must be installed in each baghouse compartment or cell. For negative pressure or induced air fabric filters, the bag leak detector must be installed downstream of the fabric filter; and
(8) Where multiple detectors are required, the system's instrumentation and alarm may be shared among detectors.
(c) If you are using something other than a wet scrubber, activated carbon, selective non-catalytic reduction, an electrostatic precipitator, or a dry scrubber to comply with the emission limitations under § 60.2105, you must install, calibrate (to the manufacturers' specifications), maintain, and operate the equipment necessary to monitor compliance with the site-specific operating limits established using the procedures in § 60.2115.
(d) If you use activated carbon injection to comply with the emission limitations in this subpart, you must measure the minimum mercury sorbent flow rate once per hour.
(e) If you use selective noncatalytic reduction to comply with the emission limitations, you must complete the following:
(1) Following the date on which the initial performance test is completed or is required to be completed under § 60.2125, whichever date comes first, ensure that the affected facility does not operate above the maximum charge rate, or below the minimum secondary chamber temperature (if applicable to your CISWI unit) or the minimum reagent flow rate measured as 3-hour block averages at all times; and
(2) Operation of the affected facility above the maximum charge rate, below the minimum secondary chamber temperature and below the minimum reagent flow rate simultaneously constitute a violation of the nitrogen oxides emissions limit.
(f) If you use an electrostatic precipitator to comply with the emission limits of this subpart and you do not use a PM CPMS for monitoring PM compliance, you must monitor the secondary power to the electrostatic precipitator collection plates and maintain the 3-hour block averages at or above the operating limits established during the mercury or particulate matter performance test.
(g) For waste-burning kilns not equipped with a wet scrubber or dry scrubber, in place of hydrogen chloride testing with EPA Method 321 at 40 CFR part 63, appendix A, an owner or operator must install, calibrate, maintain, and operate a CEMS for monitoring hydrogen chloride emissions, as specified in § 60.2145(j) of this subpart, discharged to the atmosphere and record the output of the system. To demonstrate continuous compliance with the hydrogen chloride emissions limit for units other than waste-burning kilns not equipped with a wet scrubber or dry scrubber, a facility may substitute use of a hydrogen chloride CEMS for conducting the hydrogen chloride annual performance test, monitoring the minimum hydrogen chloride sorbent flow rate, monitoring the minimum scrubber liquor pH, and monitoring minimum injection rate.
(h) To demonstrate continuous compliance with the particulate matter emissions limit, a facility may substitute use of either a particulate matter CEMS or a particulate matter CPMS for conducting the PM annual performance test and using other CMS for monitoring PM compliance (
(i) To demonstrate continuous compliance with the dioxin/furan emissions limit, a facility may substitute use of a continuous automated sampling system for the dioxin/furan annual performance test. You must record the output of the system and analyze the sample according to EPA Method 23 at 40 CFR part 60, appendix A–7 of this part. This option to use a continuous automated sampling system takes effect on the date a final performance specification applicable to dioxin/furan from continuous monitors is published in the
(j) To demonstrate continuous compliance with the mercury emissions limit, a facility may substitute use of a continuous automated sampling system for the mercury annual performance test. You must record the output of the system and analyze the sample at set intervals using any suitable determinative technique that can meet performance specification 12B. The owner or operator who elects to continuously sample mercury emissions instead of sampling and testing using EPA Reference Method 29 or 30B at 40 CFR part 60, appendix A–8, ASTM D6784–02 (Reapproved 2008) (incorporated by reference, see § 60.17), or an approved alternative method for measuring mercury emissions, must install, calibrate, maintain, and operate a continuous automated sampling system and must comply with performance specification 12A and quality assurance procedure 5, as well as the requirements specified in § 60.58b(p) and (q). A facility may substitute continuous mercury monitoring for the minimum sorbent flow rate, if activated carbon sorbent injection is used solely for compliance with the mercury emission limit. Waste-burning kilns must install, calibrate, maintain, and operate a mercury CEMS as specified in § 60.2145(j).
(k) To demonstrate continuous compliance with the nitrogen oxides emissions limit, a facility may substitute use of a CEMS for the nitrogen oxides annual performance test to demonstrate compliance with the nitrogen oxides emissions limits and monitoring the charge rate, secondary chamber temperature, and reagent flow for selective noncatalytic reduction, if applicable:
(1) Install, calibrate, maintain, and operate a CEMS for measuring nitrogen oxides emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 2 of appendix B of this part, the quality assurance
(2) Following the date that the initial performance test for nitrogen oxides is completed or is required to be completed under § 60.2125, compliance with the emission limit for nitrogen oxides required under § 60.52b(d) must be determined based on the 30-day rolling average of the hourly emission concentrations using CEMS outlet data. The 1-hour arithmetic averages must be expressed in parts per million by volume corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2).
(l) To demonstrate continuous compliance with the sulfur dioxide emissions limit, a facility may substitute use of a continuous automated sampling system for the sulfur dioxide annual performance test to demonstrate compliance with the sulfur dioxide emissions limits:
(1) Install, calibrate, maintain, and operate a CEMS for measuring sulfur dioxide emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 2 of appendix B of this part, the quality assurance requirements of procedure one of appendix F of this part and procedures under § 60.13 must be followed for installation, evaluation, and operation of the CEMS; and
(2) Following the date that the initial performance test for sulfur dioxide is completed or is required to be completed under § 60.2125, compliance with the sulfur dioxide emission limit may be determined based on the 30-day rolling average of the hourly arithmetic average emission concentrations using CEMS outlet data. The 1-hour arithmetic averages must be expressed in parts per million corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average emission concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2).
(m) For energy recovery units over 10 MMBtu/hr but less than 250 MMBtu/hr annual average heat input rates that do not use a wet scrubber, fabric filter with bag leak detection system, or particulate matter CEMS, you must install, operate, certify, and maintain a continuous opacity monitoring system according to the procedures in paragraphs (m)(1) through (5) of this section by the compliance date specified in § 60.2105. Energy recovery units that use a CEMS to demonstrate initial and continuing compliance according to the procedures in § 60.2165(n) are not required to install a continuous opacity monitoring system and must perform the annual performance tests for the opacity consistent with § 60.2145(f):
(1) Install, operate, and maintain each continuous opacity monitoring system according to performance specification 1 of 40 CFR part 60, appendix B;
(2) Conduct a performance evaluation of each continuous opacity monitoring system according to the requirements in § 60.13 and according to PS–1 of 40 CFR part 60, appendix B;
(3) As specified in § 60.13(e)(1), each continuous opacity monitoring system must complete a minimum of one cycle of sampling and analyzing for each successive 10-second period and one cycle of data recording for each successive 6-minute period;
(4) Reduce the continuous opacity monitoring system data as specified in § 60.13(h)(1); and
(5) Determine and record all the 6-minute averages (and 1-hour block averages as applicable) collected.
(n) For coal and liquid/gas energy recovery units, incinerators, and small remote incinerators, an owner or operator may elect to install, calibrate, maintain, and operate a CEMS for monitoring particulate matter emissions discharged to the atmosphere and record the output of the system. The owner or operator of an affected facility who continuously monitors particulate matter emissions instead of conducting performance testing using EPA Method 5 at 40 CFR part 60, appendix A–3 or, as applicable, monitor with a particulate matter CPMS according to paragraph (r) of this section, must install, calibrate, maintain, and operate a CEMS and must comply with the requirements specified in paragraphs (n)(1) through (13) of this section:
(1) Notify the Administrator 1 month before starting use of the system;
(2) Notify the Administrator 1 month before stopping use of the system;
(3) The monitor must be installed, evaluated, and operated in accordance with the requirements of performance specification 11 of appendix B of this part and quality assurance requirements of procedure two of appendix F of this part and § 60.13. Use Method 5 or Method 5I of Appendix A of this part for the PM CEMS correlation testing;
(4) The initial performance evaluation must be completed no later than 180 days after the date of initial startup of the affected facility, as specified under § 60.2125 or within 180 days of notification to the Administrator of use of the continuous monitoring system if the owner or operator was previously determining compliance by Method 5 performance tests, whichever is later;
(5) The owner or operator of an affected facility may request that compliance with the particulate matter emission limit be determined using carbon dioxide measurements corrected to an equivalent of 7 percent oxygen. The relationship between oxygen and carbon dioxide levels for the affected facility must be established according to the procedures and methods specified in § 60.2145(t)(4)(i) through (iv);
(6) The owner or operator of an affected facility must conduct an initial performance test for particulate matter emissions as required under § 60.2125. Compliance with the particulate matter emission limit, if PM CEMS are elected for demonstrating compliance, must be determined by using the CEMS specified in paragraph (n) of this section to measure particulate matter. You must calculate a 30-day rolling average of 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown, as defined in this subpart, using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7;
(7) Compliance with the particulate matter emission limit must be determined based on the 30-day rolling average calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 from the 1-hour arithmetic average CEMS outlet data;
(8) At a minimum, valid continuous monitoring system hourly averages must be obtained as specified in § 60.2170(e);
(9) The 1-hour arithmetic averages required under paragraph (n)(7) of this section must be expressed in milligrams per dry standard cubic meter corrected to 7 percent oxygen (dry basis) and must be used to calculate the 30-day rolling average emission concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2);
(10) All valid CEMS data must be used in calculating average emission concentrations even if the minimum
(11) The CEMS must be operated according to performance specification 11 in appendix B of this part;
(12) During each relative accuracy test run of the CEMS required by performance specification 11 in appendix B of this part, particulate matter and oxygen (or carbon dioxide) data must be collected concurrently (or within a 30- to 60-minute period) by both the CEMS and the following test methods:
(i) For particulate matter, EPA Reference Method 5 must be used; and
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B, as applicable, must be used; and
(13) Quarterly accuracy determinations and daily calibration drift tests must be performed in accordance with procedure 2 in appendix F of this part.
(o) To demonstrate continuous compliance with the carbon monoxide emissions limit, you may substitute use of a continuous automated sampling system for the carbon monoxide annual performance test:
(1) Install, calibrate, maintain, and operate a CEMS for measuring carbon monoxide emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 4B of appendix B of this part, the quality assurance procedure 1 of appendix F of this part and the procedures under § 60.13 must be followed for installation, evaluation, and operation of the CEMS; and
(2) Following the date that the initial performance test for carbon monoxide is completed or is required to be completed under § 60.2140, compliance with the carbon monoxide emission limit may be determined based on the 30-day rolling average of the hourly arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, using CEMS outlet data. Except for CEMS data during startup and shutdown, as defined in this subpart, the 1-hour arithmetic averages must be expressed in parts per million corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average emission concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2).
(p) The owner/operator of an affected source with a bypass stack shall install, calibrate (to manufacturers' specifications), maintain, and operate a device or method for measuring the use of the bypass stack including date, time and duration.
(q) For energy recovery units with a design heat input capacity of 100 MMBtu per hour or greater that do not use a carbon monoxide CEMS, you must install, operate, and maintain a oxygen analyzer system as defined in § 60.2265 according to the procedures in paragraphs (q)(1) through (4) of this section:
(1) The oxygen analyzer system must be installed by the initial performance test date specified in § 60.2140;
(2) You must operate the oxygen trim system within compliance with paragraph (q)(3) of this section at all times;
(3) You must maintain the oxygen level such that the 30-day rolling average that is established as the operating limit for oxygen according to paragraph (q)(4) of this section is not below the lowest hourly average oxygen concentration measured during the most recent CO performance test; and
(4) You must calculate and record a 30-day rolling average oxygen concentration using equation 19–19 in section 12.4.1 of EPA Reference Method 19 of Appendix A–7 of this part.
(r) For energy recovery units with annual average heat input rates greater than or equal to 250 MMBtu/hour and waste-burning kilns, you must install, calibrate, maintain, and operate a PM CPMS and record the output of the system as specified in paragraphs (r)(1) through (8) of this section. If you elect to use a particulate matter CEMS as specified in paragraph (n) of this section, you are not required to use a PM CPMS to monitor particulate matter emissions. For other energy recovery units, you may elect to use PM CPMS operated in accordance with this section. PM CPMS are suitable in lieu of using other CMS for monitoring PM compliance (
(1) Install, calibrate, operate, and maintain your PM CPMS according to the procedures in your approved site-specific monitoring plan developed in accordance with § 60.2145(l) and (r)(1)(i) through (iii) of this section:
(i) The operating principle of the PM CPMS must be based on in-stack or extractive light scatter, light scintillation, beta attenuation, or mass accumulation detection of PM in the exhaust gas or representative sample. The reportable measurement output from the PM CPMS must be expressed as milliamps or a digital signal equivalent;
(ii) The PM CPMS must have a cycle time (
(iii) The PM CPMS must be capable of detecting and responding to particulate matter concentration increments no greater than 0.5 mg/actual cubic meter.
(2) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, you must adjust the site-specific operating limit in accordance with the results of the performance test according to the procedures specified in § 60.2110.
(3) Collect PM CPMS hourly average output data for all energy recovery unit or waste-burning kiln operating hours. Express the PM CPMS output as milliamps or the digital signal equivalent.
(4) Calculate the arithmetic 30-day rolling average of all of the hourly average PM CPMS output collected during all energy recovery unit or waste-burning kiln operating hours data (milliamps or digital bits).
(5) You must collect data using the PM CPMS at all times the energy recovery unit or waste-burning kiln is operating and at the intervals specified in paragraph (r)(1)(ii) of this section, except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments), and any scheduled maintenance as defined in your site-specific monitoring plan.
(6) You must use all the data collected during all energy recovery unit or waste-burning kiln operating hours in assessing the compliance with your operating limit except:
(i) Any data collected during monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities conducted during monitoring system malfunctions are not used in calculations (report any such periods in your annual deviation report);
(ii) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-
(iii) Any PM CPMS data recorded during periods of CEMS data during startup and shutdown, as defined in this subpart.
(7) You must record and make available upon request results of PM CPMS system performance audits, as well as the dates and duration of periods from when the PM CPMS is out of control until completion of the corrective actions necessary to return the PM CPMS to operation consistent with your site-specific monitoring plan.
(8) For any deviation of the 30-day rolling average PM CPMS average value from the established operating parameter limit, you must:
(i) Within 48 hours of the deviation, visually inspect the air pollution control device;
(ii) If inspection of the air pollution control device identifies the cause of the deviation, take corrective action as soon as possible and return the PM CPMS measurement to within the established value;
(iii) Within 30 days of the deviation or at the time of the annual compliance test, whichever comes first, conduct a PM emissions compliance test to determine compliance with the PM emissions limit and to verify the operation of the emissions control device(s). Within 45 days of the deviation, you must re-establish the CPMS operating limit. You are not required to conduct additional testing for any deviations that occur between the time of the original deviation and the PM emissions compliance test required under this paragraph; and
(iv) PM CPMS deviations leading to more than four required performance tests in a 12-month process operating period (rolling monthly) constitute a violation of this subpart.
(s) If you use a dry scrubber to comply with the emission limits of this subpart, you must monitor the injection rate of each sorbent and maintain the 3-hour block averages at or above the operating limits established during the hydrogen chloride performance test.
For each continuous monitoring system required or optionally allowed under § 60.2165, you must collect data according to this section:
(a) You must operate the monitoring system and collect data at all required intervals at all times compliance is required except for periods of monitoring system malfunctions or out-of-control periods, repairs associated with monitoring system malfunctions or out-of-control periods (as specified in 60.2210(o)), and required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments). A monitoring system malfunction is any sudden, infrequent, not reasonably preventable failure of the monitoring system to provide valid data. Monitoring system failures that are caused in part by poor maintenance or careless operation are not malfunctions. You are required to effect monitoring system repairs in response to monitoring system malfunctions or out-of-control periods and to return the monitoring system to operation as expeditiously as practicable;
(b) You may not use data recorded during monitoring system malfunctions or out-of-control periods, repairs associated with monitoring system malfunctions or out-of-control periods, or required monitoring system quality assurance or control activities in calculations used to report emissions or operating levels. You must use all the data collected during all other periods, including data normalized for above scale readings, in assessing the operation of the control device and associated control system; and
(c) Except for periods of monitoring system malfunctions or out-of-control periods, repairs associated with monitoring system malfunctions or out-of-control periods, and required monitoring system quality assurance or quality control activities including, as applicable, calibration checks and required zero and span adjustments, failure to collect required data is a deviation of the monitoring requirements.
You must maintain the items (as applicable) as specified in paragraphs (a), (b), and (e) through (x) of this section for a period of at least 5 years:
(a) Calendar date of each record; and
(b) Records of the data described in paragraphs (b)(1) through (6) of this section:
(1) The CISWI unit charge dates, times, weights, and hourly charge rates;
(2) Liquor flow rate to the wet scrubber inlet every 15 minutes of operation, as applicable;
(3) Pressure drop across the wet scrubber system every 15 minutes of operation or amperage to the wet scrubber every 15 minutes of operation, as applicable;
(4) Liquor pH as introduced to the wet scrubber every 15 minutes of operation, as applicable;
(5) For affected CISWI units that establish operating limits for controls other than wet scrubbers under § 60.2110(d) through (g) or § 60.2115, you must maintain data collected for all operating parameters used to determine compliance with the operating limits. For energy recovery units using activated carbon injection or a dry scrubber, you must also maintain records of the load fraction and corresponding sorbent injection rate records;
(6) If a fabric filter is used to comply with the emission limitations, you must record the date, time, and duration of each alarm and the time corrective action was initiated and completed, and a brief description of the cause of the alarm and the corrective action taken. You must also record the percent of operating time during each 6-month period that the alarm sounds, calculated as specified in § 60.2110(c);
(c)–(d) [Reserved]
(e) Identification of calendar dates and times for which data show a deviation from the operating limits in table 2 of this subpart or a deviation from other operating limits established under § 60.2110(d) through (g) or § 60.2115 with a description of the deviations, reasons for such deviations, and a description of corrective actions taken;
(f) The results of the initial, annual, and any subsequent performance tests conducted to determine compliance with the emission limits and/or to establish operating limits, as applicable. Retain a copy of the complete test report including calculations;
(g) All documentation produced as a result of the siting requirements of §§ 60.2045 and 60.2050;
(h) Records showing the names of CISWI unit operators who have completed review of the information in § 60.2095(a) as required by § 60.2095(b), including the date of the initial review and all subsequent annual reviews;
(i) Records showing the names of the CISWI operators who have completed the operator training requirements under § 60.2070, met the criteria for qualification under § 60.2080, and maintained or renewed their qualification under § 60.2085 or § 60.2090. Records must include documentation of training, the dates of the initial and refresher training, and the dates of their qualification and all subsequent renewals of such qualifications;
(j) For each qualified operator, the phone and/or pager number at which
(k) Records of calibration of any monitoring devices as required under § 60.2165;
(l) Equipment vendor specifications and related operation and maintenance requirements for the incinerator, emission controls, and monitoring equipment;
(m) The information listed in § 60.2095(a);
(n) On a daily basis, keep a log of the quantity of waste burned and the types of waste burned (always required);
(o) Maintain records of the annual air pollution control device inspections that are required for each CISWI unit subject to the emissions limits in table 1 of this subpart or tables 5 through 8 of this subpart, any required maintenance, and any repairs not completed within 10 days of an inspection or the timeframe established by the state regulatory agency;
(p) For continuously monitored pollutants or parameters, you must document and keep a record of the following parameters measured using continuous monitoring systems:
(1) All 6-minute average levels of opacity;
(2) All 1-hour average concentrations of sulfur dioxide emissions;
(3) All 1-hour average concentrations of nitrogen oxides emissions;
(4) All 1-hour average concentrations of carbon monoxide emissions. You must indicate which data are CEMS data during startup and shutdown;
(5) All 1-hour average concentrations of particulate matter emissions;
(6) All 1-hour average concentrations of mercury emissions;
(7) All 1-hour average concentrations of hydrogen chloride emissions;
(8) All 1-hour average percent oxygen concentrations; and
(9) All 1-hour average PM CPMS readings or particulate matter CEMS outputs;
(q) Records indicating use of the bypass stack, including dates, times, and durations.
(r) If you choose to stack test less frequently than annually, consistent with § 60.2155(a) through (c), you must keep annual records that document that your emissions in the previous stack test(s) were less than 75 percent of the applicable emission limit and document that there was no change in source operations including fuel composition and operation of air pollution control equipment that would cause emissions of the relevant pollutant to increase within the past year.
(s) Records of the occurrence and duration of each malfunction of operation (
(t) Records of all required maintenance performed on the air pollution control and monitoring equipment.
(u) Records of actions taken during periods of malfunction to minimize emissions in accordance with § 60.11(d), including corrective actions to restore malfunctioning process and air pollution control and monitoring equipment to its normal or usual manner of operation.
(v) For operating units that combust non-hazardous secondary materials that have been determined not to be solid waste pursuant to § 241.3(b)(1) of this chapter, you must keep a record which documents how the secondary material meets each of the legitimacy criteria under § 241.3(d)(1). If you combust a fuel that has been processed from a discarded non-hazardous secondary material pursuant to § 241.3(b)(4) of this chapter, you must keep records as to how the operations that produced the fuel satisfies the definition of processing in § 241.2 and each of the legitimacy criteria of § 241.3(d)(1) of this chapter. If the fuel received a non-waste determination pursuant to the petition process submitted under § 241.3(c) of this chapter, you must keep a record that documents how the fuel satisfies the requirements of the petition process. For operating units that combust non-hazardous secondary materials as fuel per § 241.4, you must keep records documenting that the material is a listed non-waste under § 241.4(a).
(w) Records of the criteria used to establish that the unit qualifies as a small power production facility under section 3(17)(C) of the Federal Power Act (16 U.S.C. 796(17)(C)) and that the waste material the unit is proposed to burn is homogeneous.
(x) Records of the criteria used to establish that the unit qualifies as a cogeneration facility under section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B)) and that the waste material the unit is proposed to burn is homogeneous.
All records must be available onsite in either paper copy or computer-readable format that can be printed upon request, unless an alternative format is approved by the Administrator.
See table 4 of this subpart for a summary of the reporting requirements.
You must submit a notification prior to commencing construction that includes the five items listed in paragraphs (a) through (e) of this section:
(a) A statement of intent to construct;
(b) The anticipated date of commencement of construction;
(c) All documentation produced as a result of the siting requirements of § 60.2050;
(d) The waste management plan as specified in §§ 60.2055 through 60.2065; and
(e) Anticipated date of initial startup.
You must submit the information specified in paragraphs (a) through (e) of this section prior to initial startup:
(a) The type(s) of waste to be burned;
(b) The maximum design waste burning capacity;
(c) The anticipated maximum charge rate;
(d) If applicable, the petition for site-specific operating limits under § 60.2115; and
(e) The anticipated date of initial startup.
You must submit the information specified in paragraphs (a) through (c) of this section no later than 60 days following the initial performance test. All reports must be signed by the facilities manager:
(a) The complete test report for the initial performance test results obtained under § 60.2135, as applicable;
(b) The values for the site-specific operating limits established in § 60.2110 or § 60.2115; and
(c) If you are using a fabric filter to comply with the emission limitations, documentation that a bag leak detection system has been installed and is being operated, calibrated, and maintained as required by § 60.2165(b).
You must submit an annual report no later than 12 months following the submission of the information in § 60.2200. You must submit subsequent reports no more than 12 months following the previous report. (If the unit is subject to permitting requirements under title V of the Clean Air Act, you may be required by the permit to submit these reports more frequently.)
The annual report required under § 60.2205 must include the ten items listed in paragraphs (a) through (j) of this section. If you have a deviation from the operating limits or the emission limitations, you must also submit deviation reports as specified in §§ 60.2215, 60.2220, and 60.2225:
(a) Company name and address;
(b) Statement by a responsible official, with that official's name, title, and signature, certifying the accuracy of the content of the report;
(c) Date of report and beginning and ending dates of the reporting period;
(d) The values for the operating limits established pursuant to § 60.2110 or § 60.2115;
(e) If no deviation from any emission limitation or operating limit that applies to you has been reported, a statement that there was no deviation from the emission limitations or operating limits during the reporting period;
(f) The highest recorded 3-hour average and the lowest recorded 3-hour average, as applicable, for each operating parameter recorded for the calendar year being reported;
(g) Information recorded under § 60.2175(b)(6) and (c) through (e) for the calendar year being reported;
(h) For each performance test conducted during the reporting period, if any performance test is conducted, the process unit(s) tested, the pollutant(s) tested and the date that such performance test was conducted. Submit, following the procedure specified in § 60.2235(b)(1), the performance test report no later than the date that you submit the annual report;
(i) If you met the requirements of § 60.2155(a) or (b), and did not conduct a performance test during the reporting period, you must state that you met the requirements of § 60.2155(a) or (b), and, therefore, you were not required to conduct a performance test during the reporting period;
(j) Documentation of periods when all qualified CISWI unit operators were unavailable for more than 8 hours, but less than 2 weeks;
(k) If you had a malfunction during the reporting period, the compliance report must include the number, duration, and a brief description for each type of malfunction that occurred during the reporting period and that caused or may have caused any applicable emission limitation to be exceeded. The report must also include a description of actions taken by an owner or operator during a malfunction of an affected source to minimize emissions in accordance with § 60.11(d), including actions taken to correct a malfunction;
(l) For each deviation from an emission or operating limitation that occurs for a CISWI unit for which you are not using a continuous monitoring system to comply with the emission or operating limitations in this subpart, the annual report must contain the following information:
(1) The total operating time of the CISWI unit at which the deviation occurred during the reporting period; and
(2) Information on the number, duration, and cause of deviations (including unknown cause, if applicable), as applicable, and the corrective action taken.
(m) If there were periods during which the continuous monitoring system, including the CEMS, was out of control as specified in paragraph (o) of this section, the annual report must contain the following information for each deviation from an emission or operating limitation occurring for a CISWI unit for which you are using a continuous monitoring system to comply with the emission and operating limitations in this subpart:
(1) The date and time that each malfunction started and stopped;
(2) The date, time, and duration that each CMS was inoperative, except for zero (low-level) and high-level checks;
(3) The date, time, and duration that each continuous monitoring system was out-of-control, including start and end dates and hours and descriptions of corrective actions taken;
(4) The date and time that each deviation started and stopped, and whether each deviation occurred during a period of malfunction or during another period;
(5) A summary of the total duration of the deviation during the reporting period, and the total duration as a percent of the total source operating time during that reporting period;
(6) A breakdown of the total duration of the deviations during the reporting period into those that are due to control equipment problems, process problems, other known causes, and other unknown causes;
(7) A summary of the total duration of continuous monitoring system downtime during the reporting period, and the total duration of continuous monitoring system downtime as a percent of the total operating time of the CISWI unit at which the continuous monitoring system downtime occurred during that reporting period;
(8) An identification of each parameter and pollutant that was monitored at the CISWI unit;
(9) A brief description of the CISWI unit;
(10) A brief description of the continuous monitoring system;
(11) The date of the latest continuous monitoring system certification or audit; and
(12) A description of any changes in continuous monitoring system, processes, or controls since the last reporting period.
(n) If there were periods during which the continuous monitoring system, including the CEMS, was not out of control as specified in paragraph (o) of this section, a statement that there were not periods during which the continuous monitoring system was out of control during the reporting period.
(o) A continuous monitoring system is out of control in accordance with the procedure in 40 CFR part 60, appendix F of this part, as if any of the following occur:
(1) The zero (low-level), mid-level (if applicable), or high-level calibration drift exceeds two times the applicable calibration drift specification in the applicable performance specification or in the relevant standard;
(2) The continuous monitoring system fails a performance test audit (
(3) The continuous opacity monitoring system calibration drift exceeds two times the limit in the applicable performance specification in the relevant standard.
(a) You must submit a deviation report if any recorded 3-hour average parameter level is above the maximum operating limit or below the minimum operating limit established under this subpart, if the bag leak detection system alarm sounds for more than 5 percent of the operating time for the 6-month reporting period, or if a performance test was conducted that deviated from any emission limitation.
(b) The deviation report must be submitted by August 1 of that year for data collected during the first half of the calendar year (January 1 to June 30), and by February 1 of the following year for data you collected during the second half of the calendar year (July 1 to December 31).
In each report required under § 60.2215, for any pollutant or parameter that deviated from the
(a) The calendar dates and times your unit deviated from the emission limitations or operating limit requirements;
(b) The averaged and recorded data for those dates;
(c) Durations and causes of the following:
(1) Each deviation from emission limitations or operating limits and your corrective actions;
(2) Bypass events and your corrective actions; and
(d) A copy of the operating limit monitoring data during each deviation and for any test report that documents the emission levels the process unit(s) tested, the pollutant(s) tested and the date that the performance test was conducted. Submit, following the procedure specified in § 60.2235(b)(1), the performance test report no later than the date that you submit the deviation report.
(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section:
(1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section:
(i) A statement of what caused the deviation;
(ii) A description of what you are doing to ensure that a qualified operator is accessible; and
(iii) The date when you anticipate that a qualified operator will be available.
(2) Submit a status report to the Administrator every 4 weeks that includes the three items in paragraphs (a)(2)(i) through (iii) of this section:
(i) A description of what you are doing to ensure that a qualified operator is accessible;
(ii) The date when you anticipate that a qualified operator will be accessible; and
(iii) Request approval from the Administrator to continue operation of the CISWI unit.
(b) If your unit was shut down by the Administrator, under the provisions of § 60.2100(b)(2), due to a failure to provide an accessible qualified operator, you must notify the Administrator that you are resuming operation once a qualified operator is accessible.
(a) Yes. You must submit notifications as provided by § 60.7.
(b) If you cease combusting solid waste but continue to operate, you must provide 30 days prior notice of the effective date of the waste-to-fuel switch, consistent with 60.2145(a). The notification must identify:
(1) The name of the owner or operator of the CISWI unit, the location of the source, the emissions unit(s) that will cease burning solid waste, and the date of the notice;
(2) The currently applicable subcategory under this subpart, and any 40 CFR part 63 subpart and subcategory that will be applicable after you cease combusting solid waste;
(3) The fuel(s), non-waste material(s) and solid waste(s) the CISWI unit is currently combusting and has combusted over the past 6 months, and the fuel(s) or non-waste materials the unit will commence combusting;
(4) The date on which you became subject to the currently applicable emission limits; and
(5) The date upon which you will cease combusting solid waste, and the date (if different) that you intend for any new requirements to become applicable (
(a) Submit initial, annual and deviation reports electronically on or before the submittal due dates. Submit the reports to the EPA via the Compliance and Emissions Data Reporting Interface (CEDRI). (CEDRI can be accessed through the EPA's Central Data Exchange (CDX) (
(b) Submit results of each performance test and CEMS performance evaluation required by this subpart as follows:
(1) Within 60 days after the date of completing each performance test (
(i) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT Web site (
(ii) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 60.4.
(2) Within 60 days after the date of completing each continuous emissions monitoring system performance evaluation you must submit the results of the performance evaluation following the procedure specified in either paragraph (b)(2)(i) or (b)(2)(ii) of this section:
(i) For performance evaluations of continuous monitoring systems measuring relative accuracy test audit (RATA) pollutants that are supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the evaluation, you must submit the results of the performance evaluation to the EPA via the CEDRI. (CEDRI can be
(ii) For any performance evaluations of continuous monitoring systems measuring RATA pollutants that are not supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the evaluation, you must submit the results of the performance evaluation to the Administrator at the appropriate address listed in § 60.4.
If the Administrator agrees, you may change the semiannual or annual reporting dates. See § 60.19(c) for procedures to seek approval to change your reporting date.
Yes. Each CISWI unit and air curtain incinerator subject to standards under this subpart must operate pursuant to a permit issued under Section 129(e) and Title V of the Clean Air Act.
(a) An air curtain incinerator operates by forcefully projecting a curtain of air across an open chamber or open pit in which combustion occurs. Incinerators of this type can be constructed above or below ground and with or without refractory walls and floor. (Air curtain incinerators are not to be confused with conventional combustion devices with enclosed fireboxes and controlled air technology such as mass burn, modular, and fluidized bed combustors.)
(b) Air curtain incinerators that burn only the materials listed in paragraphs (b)(1) through (3) of this section are only required to meet the requirements under § 60.2242 and under “Air Curtain Incinerators” (§§ 60.2245 through 60.2260):
(1) 100 percent wood waste;
(2) 100 percent clean lumber; and
(3) 100 percent mixture of only wood waste, clean lumber, and/or yard waste.
Within 60 days after your air curtain incinerator reaches the charge rate at which it will operate, but no later than 180 days after its initial startup, you must meet the two limitations specified in paragraphs (a) and (b) of this section:
(a) Maintain opacity to less than or equal to 10 percent opacity (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values), except as described in paragraph (b) of this section; and
(b) Maintain opacity to less than or equal to 35 percent opacity (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values) during the startup period that is within the first 30 minutes of operation.
(a) Use Method 9 of appendix A of this part to determine compliance with the opacity limitation.
(b) Conduct an initial test for opacity as specified in § 60.8.
(c) After the initial test for opacity, conduct annual tests no more than 12 calendar months following the date of your previous test.
(a) Prior to commencing construction on your air curtain incinerator, submit the three items described in paragraphs (a)(1) through (3) of this section:
(1) Notification of your intent to construct the air curtain incinerators;
(2) Your planned initial startup date; and
(3) Types of materials you plan to burn in your air curtain incinerator.
(b) Keep records of results of all initial and annual opacity tests onsite in either paper copy or electronic format, unless the Administrator approves another format, for at least 5 years.
(c) Make all records available for submittal to the Administrator or for an inspector's onsite review.
(d) You must submit the results (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values) of the initial opacity tests no later than 60 days following the initial test. Submit annual opacity test results within 12 months following the previous report.
(e) Submit initial and annual opacity test reports as electronic or paper copy on or before the applicable submittal date.
(f) Keep a copy of the initial and annual reports onsite for a period of 5 years.
Terms used but not defined in this subpart are defined in the Clean Air Act and subpart A (General Provisions) of this part.
(1) For incinerators and small remote incinerators: CEMS data collected during the first hours of a CISWI unit startup from a cold start until waste is fed to the unit and the hours of operation following the cessation of waste material being fed to the CISWI unit during a unit shutdown. For each startup event, the length of time that CEMS data may be claimed as being CEMS data during startup must be 48 operating hours or less. For each shutdown event, the length of time that CEMS data may be claimed as being CEMS data during shutdown must be 24 operating hours or less;
(2) For energy recovery units: CEMS data collected during the startup or shutdown periods of operation. Startup begins with either the first-ever firing of fuel in a boiler or process heater for the purpose of supplying useful thermal energy (such as steam or heat) for heating, cooling or process purposes, or producing electricity, or the firing of fuel in a boiler or process heater for any purpose after a shutdown event. Startup ends four hours after when the boiler or process heater makes useful thermal energy (such as heat or steam) for heating, cooling, or process purposes, or generates electricity, whichever is earlier. Shutdown begins when the boiler or process heater no longer makes useful thermal energy (such as heat or steam) for heating, cooling, or process purposes and/or generates electricity or when no fuel is being fed to the boiler or process heater, whichever is earlier. Shutdown ends when the boiler or process heater no longer makes useful thermal energy (such as steam or heat) for heating, cooling, or process purposes and/or generates electricity, and no fuel is being combusted in the boiler or process heater; and
(3) For waste-burning kilns: CEMS data collected during the periods of kiln operation that do not include normal operations. Startup means the time from when a shutdown kiln first begins firing fuel until it begins producing clinker. Startup begins when a shutdown kiln turns on the induced draft fan and begins firing fuel in the main burner. Startup ends when feed is being continuously introduced into the kiln for at least 120 minutes or when the feed rate exceeds 60 percent of the kiln design limitation rate, whichever occurs first. Shutdown means the cessation of kiln operation. Shutdown begins when feed to the kiln is halted and ends when continuous kiln rotation ceases.
(1) Units burning only pulping liquors (
(2) Units burning only spent sulfuric acid used to produce virgin sulfuric acid;
(3) Units burning only wood or coal feedstock for the production of charcoal;
(4) Units burning only manufacturing byproduct streams/residue containing catalyst metals that are reclaimed and reused as catalysts or used to produce commercial grade catalysts;
(5) Units burning only coke to produce purified carbon monoxide that is used as an intermediate in the production of other chemical compounds;
(6) Units burning only hydrocarbon liquids or solids to produce hydrogen, carbon monoxide, synthesis gas, or other gases for use in other manufacturing processes; and
(7) Units burning only photographic film to recover silver.
(1) Fails to meet any requirement or obligation established by this subpart, including but not limited to any emission limitation, operating limit, or operator qualification and accessibility requirements; and
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
(1) The cumulative cost of the changes over the life of the unit exceeds 50 percent of the original cost of building and installing the CISWI unit (not including the cost of land) updated to current costs (current dollars). To determine what systems are within the boundary of the CISWI unit used to calculate these costs, see the definition of CISWI unit; and
(2) Any physical change in the CISWI unit or change in the method of operating it that increases the amount of any air pollutant emitted for which section 129 or section 111 of the Clean Air Act has established standards.
(1) A physical change (maintenance activities excluded) to the CISWI unit which may increase the emission rate of any air pollutant to which a standard applies;
(2) An operational change to the CISWI unit where a new type of non-hazardous secondary material is being combusted;
(3) A physical change (maintenance activities excluded) to the air pollution control devices used to comply with the emission limits for the CISWI unit (
(4) An operational change to the air pollution control devices used to comply with the emission limits for the affected CISWI unit (
(1) The reconstruction begins on or after August 7, 2013; and
(2) The cumulative cost of the construction over the life of the incineration unit exceeds 50 percent of the original cost of building and installing the CISWI unit (not including land) updated to current costs (current dollars). To determine what systems are within the boundary of the CISWI unit used to calculate these costs, see the definition of CISWI unit.
(1) Low-density fluff refuse-derived fuel through densified refuse-derived fuel; and
(2) Pelletized refuse-derived fuel.
(1) For a corporation: A president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation, or a duly authorized representative of such person if the representative is responsible for the overall operation of one or more manufacturing, production, or operating facilities applying for or subject to a permit and either:
(i) The facilities employ more than 250 persons or have gross annual sales or expenditures exceeding $25 million (in second quarter 1980 dollars); or
(ii) The delegation of authority to such representatives is approved in advance by the permitting authority;
(2) For a partnership or sole proprietorship: A general partner or the proprietor, respectively;
(3) For a municipality, state, federal, or other public agency: Either a principal executive officer or ranking elected official. For the purposes of this part, a principal executive officer of a federal agency includes the chief executive officer having responsibility for the overall operations of a principal geographic unit of the agency (
(4) For affected facilities:
(i) The designated representative in so far as actions, standards, requirements, or prohibitions under Title IV of the Clean Air Act or the regulations promulgated thereunder are concerned; or
(ii) The designated representative for any other purposes under part 60.
(1) Materials recovery facilities (including primary or secondary smelters) which combust waste for the primary purpose of recovering metals;
(2) Qualifying small power production facilities, as defined in section 3(17)(C) of the Federal Power Act (16 U.S.C. 769(17)(C)), or qualifying cogeneration facilities, as defined in section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B)), which burn homogeneous waste (such as units which burn tires or used oil, but not including refuse-derived fuel) for the production of electric energy or in the case of qualifying cogeneration facilities which burn homogeneous waste for the production of electric energy and steam or forms of useful energy (such as heat) which are used for industrial, commercial, heating or cooling purposes; or
(3) Air curtain incinerators provided that such incinerators only burn wood wastes, yard wastes, and clean lumber and that such air curtain incinerators comply with opacity limitations to be established by the Administrator by rule.
(1) Grass, grass clippings, bushes, shrubs, and clippings from bushes and shrubs from residential, commercial/retail, institutional, or industrial sources as part of maintaining yards or other private or public lands;
(2) Construction, renovation, or demolition wastes; and
(3) Clean lumber.
This subpart establishes emission guidelines and compliance schedules for the control of emissions from commercial and industrial solid waste incineration (CISWI) units. The pollutants addressed by these emission guidelines are listed in table 2 of this subpart and tables 6 through 9 of this subpart. These emission guidelines are developed in accordance with sections 111(d) and 129 of the Clean Air Act and subpart B of this part.
(a) If you are the Administrator of an air quality program in a state or United States protectorate with one or more existing CISWI units that meet the criteria in paragraphs (b) through (d) of this section, you must submit a state plan to U.S. Environmental Protection Agency (EPA) that implements the emission guidelines contained in this subpart.
(b) You must submit a state plan to EPA by December 3, 2001 for incinerator units that commenced construction on or before November 30, 1999 and that were not modified or reconstructed after June 1, 2001.
(c) You must submit a state plan that meets the requirements of this subpart and contains the more stringent emission limit for the respective pollutant in table 6 of this subpart or table 1 of subpart CCCC of this part to EPA by February 7, 2014 for incinerators that commenced construction after November 30, 1999, but no later than June 4, 2010, or commenced modification or reconstruction after June 1, 2001 but no later than August 7, 2013.
(d) You must submit a state plan to EPA that meets the requirements of this subpart and contains the emission limits in tables 7 through 9 of this subpart by February 7, 2014, for CISWI units other than incinerator units that commenced construction on or before June 4, 2010, or commenced modification or reconstruction after June 4, 2010 but no later than August 7, 2013.
No. You are not required to submit a state plan if there are no existing CISWI units in your state, and you submit a negative declaration letter in place of the state plan.
(a) You must include the nine items described in paragraphs (a)(1) through (9) of this section in your state plan:
(1) Inventory of affected CISWI units, including those that have ceased operation but have not been dismantled;
(2) Inventory of emissions from affected CISWI units in your state;
(3) Compliance schedules for each affected CISWI unit;
(4) Emission limitations, operator training and qualification requirements, a waste management plan, and operating limits for affected CISWI units that are at least as protective as the emission guidelines contained in this subpart;
(5) Performance testing, recordkeeping, and reporting requirements;
(6) Certification that the hearing on the state plan was held, a list of witnesses and their organizational affiliations, if any, appearing at the hearing, and a brief written summary of each presentation or written submission;
(7) Provision for state progress reports to EPA;
(8) Identification of enforceable state mechanisms that you selected for implementing the emission guidelines of this subpart; and
(9) Demonstration of your state's legal authority to carry out the sections 111(d) and 129 state plan.
(b) Your state plan may deviate from the format and content of the emission guidelines contained in this subpart. However, if your state plan does deviate in content, you must demonstrate that your state plan is at least as protective as the emission guidelines contained in this subpart. Your state plan must address regulatory applicability, increments of progress for retrofit, operator training and qualification, a waste management plan, emission limitations, performance testing, operating limits, monitoring, recordkeeping and reporting, and air curtain incinerator requirements.
(c) You must follow the requirements of subpart B of this part (Adoption and Submittal of State Plans for Designated Facilities) in your state plan.
Yes. The EPA will review your state plan according to § 60.27.
(a) If you do not submit an approvable state plan (or a negative declaration letter) by December 2, 2002, EPA will
(b) If you do not submit an approvable state plan (or a negative declaration letter) to EPA that meets the requirements of this subpart and contains the emission limits in tables 6 through 9 of this subpart for CISWI units that commenced construction on or before June 4, 2010 and incinerator or air curtain incinerator units that commenced reconstruction or modification on or after June 1, 2001 but no later than August 7, 2013, then EPA will develop a federal plan according to § 60.27 to implement the emission guidelines contained in this subpart. Owners and operators of CISWI units not covered by an approved state plan must comply with the federal plan. The federal plan is an interim action and will be automatically withdrawn when your state plan is approved.
No. The EPA has no formal review process for negative declaration letters. Once your negative declaration letter has been received, EPA will place a copy in the public docket and publish a notice in the
(a) For CISWI units in the incinerator subcategory and air curtain incinerators that commenced construction on or before November 30, 1999, your state plan must include compliance schedules that require CISWI units in the incinerator subcategory and air curtain incinerators to achieve final compliance as expeditiously as practicable after approval of the state plan but not later than the earlier of the two dates specified in paragraphs (a)(1) and (2) of this section:
(1) December 1, 2005; and
(2) Three years after the effective date of state plan approval.
(b) For CISWI units in the incinerator subcategory and air curtain incinerators that commenced construction after November 30, 1999, but on or before June 4, 2010 or that commenced reconstruction or modification on or after June 1, 2001 but no later than August 7, 2013, and for CISWI units in the small remote incinerator, energy recovery unit, and waste-burning kiln subcategories that commenced construction before June 4, 2010, your state plan must include compliance schedules that require CISWI units to achieve final compliance as expeditiously as practicable after approval of the state plan but not later than the earlier of the two dates specified in paragraphs (b)(1) and (2) of this section:
(1) February 7, 2018; and
(2) Three years after the effective date of State plan approval.
(c) For compliance schedules more than 1 year following the effective date of State plan approval, State plans must include dates for enforceable increments of progress as specified in § 60.2580.
Yes. Subpart B establishes general requirements for developing and processing section 111(d) plans. This subpart applies instead of the requirements in subpart B of this part for paragraphs (a) and (b) of this section:
(a) State plans developed to implement this subpart must be as protective as the emission guidelines contained in this subpart. State plans must require all CISWI units to comply by the dates specified in § 60.2535. This applies instead of the option for case-by-case less stringent emission standards and longer compliance schedules in § 60.24(f); and
(b) State plans developed to implement this subpart are required to include two increments of progress for the affected CISWI units. These two minimum increments are the final control plan submittal date and final compliance date in § 60.21(h)(1) and (5). This applies instead of the requirement of § 60.24(e)(1) that would require a State plan to include all five increments of progress for all CISWI units.
Yes, a state may meet its Clean Air Act section 111(d)/129 obligations by submitting an acceptable written request for delegation of the federal plan that meets the requirements of this section. This is the only other option for a state to meet its Clean Air Act section 111(d)/129 obligations.
(a) An acceptable federal plan delegation request must include the following:
(1) A demonstration of adequate resources and legal authority to administer and enforce the federal plan;
(2) The items under § 60.2515(a)(1), (2) and (7);
(3) Certification that the hearing on the state delegation request, similar to the hearing for a state plan submittal, was held, a list of witnesses and their organizational affiliations, if any, appearing at the hearing, and a brief written summary of each presentation or written submission; and
(4) A commitment to enter into a Memorandum of Agreement with the Regional Administrator who sets forth the terms, conditions, and effective date of the delegation and that serves as the mechanism for the transfer of authority. Additional guidance and information is given in EPA's Delegation Manual, Item 7–139, Implementation and Enforcement of 111(d)(2) and 111(d)/(2)/129(b)(3) federal plans.
(b) A state with an already approved CISWI Clean Air Act section 111(d)/129 state plan is not precluded from receiving EPA approval of a delegation request for the revised federal plan, providing the requirements of paragraph (a) of this section are met, and at the time of the delegation request, the state also requests withdrawal of EPA's previous state plan approval.
(c) A state's Clean Air Act section 111(d)/129 obligations are separate from its obligations under Title V of the Clean Air Act.
The authorities listed under § 60.2030(c) will not be delegated to state, local, or tribal agencies.
(a) No. This subpart does not directly affect CISWI unit owners and operators in your state. However, CISWI unit owners and operators must comply with the state plan you develop to implement the emission guidelines contained in this subpart. States may choose to incorporate the model rule text directly in their state plan.
(b) If you do not submit an approvable plan to implement and enforce the guidelines contained in this subpart for CISWI units that commenced construction before November 30, 1999 by December 2, 2002, EPA will implement and enforce a federal plan, as provided in § 60.2525, to ensure that each unit within your state reaches
(c) If you do not submit an approvable plan to implement and enforce the guidelines contained in this subpart by February 7, 2014, for CISWI units that commenced construction on or before June 4, 2010, EPA will implement and enforce a federal plan, as provided in § 60.2525, to ensure that each unit within your state that commenced construction on or before June 4, 2010, reaches compliance with all the provisions of this subpart by February 7, 2018.
(a) Your state plan must address incineration units that meet all three criteria described in paragraphs (a)(1) through (3) of this section:
(1) CISWI units and air curtain incinerators in your state that commenced construction on or before June 4, 2010, or commenced modification or reconstruction after June 4, 2010 but no later than August 7, 2013;
(2) Incineration units that meet the definition of a CISWI unit as defined in § 60.2875; and
(3) Incineration units not exempt under § 60.2555.
(b) If the owner or operator of a CISWI unit or air curtain incinerator makes changes that meet the definition of modification or reconstruction after August 7, 2013, the CISWI unit becomes subject to subpart CCCC of this part and the state plan no longer applies to that unit.
(c) If the owner or operator of a CISWI unit makes physical or operational changes to an existing CISWI unit primarily to comply with your state plan, subpart CCCC of this part does not apply to that unit. Such changes do not qualify as modifications or reconstructions under subpart CCCC of this part.
This subpart exempts the types of units described in paragraphs (a), (c) through (i), (m), and (n) of this section, but some units are required to provide notifications. Air curtain incinerators are exempt from the requirements in this subpart except for the provisions in §§ 60.2805, 60.2860, and 60.2870:
(a)
(1) Notify the Administrator that the unit meets these criteria; and
(2) Keep records on a calendar quarter basis of the weight of pathological waste, low-level radioactive waste, and/or chemotherapeutic waste burned, and the weight of all other fuels and wastes burned in the unit.
(b) [Reserved]
(c)
(d)
(e)
(1) The unit qualifies as a small power-production facility under section 3(17)(C) of the Federal Power Act (16 U.S.C. 796(17)(C));
(2) The unit burns homogeneous waste (not including refuse-derived fuel) to produce electricity;
(3) You submit documentation to the Administrator notifying the Agency that the qualifying small power production facility is combusting homogenous waste; and
(4) You maintain the records specified in § 60.2740(v).
(f)
(1) The unit qualifies as a cogeneration facility under section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B));
(2) The unit burns homogeneous waste (not including refuse-derived fuel) to produce electricity and steam or other forms of energy used for industrial, commercial, heating, or cooling purposes;
(3) You submit documentation to the Administrator notifying the Agency that the qualifying cogeneration facility is combusting homogenous waste; and
(4) You maintain the records specified in § 60.2740(w).
(g)
(h)
(i)
(1) 100 percent wood waste;
(2) 100 percent clean lumber; and
(3) 100 percent mixture of only wood waste, clean lumber, and/or yard waste.
(j)–(l) [Reserved]
(m)
(n)
(o)
(a) The model rule is the portion of these emission guidelines (§§ 60.2575 through 60.2875) that addresses the
(b) In the model rule of §§ 60.2575 to 60.2875, “you” means the owner or operator of a CISWI unit.
Use the model rule to satisfy the state plan requirements specified in § 60.2515(a)(4) and (5).
The model rule contains the eleven major components listed in paragraphs (a) through (k) of this section:
(a) Increments of progress toward compliance;
(b) Waste management plan;
(c) Operator training and qualification;
(d) Emission limitations and operating limits;
(e) Performance testing;
(f) Initial compliance requirements;
(g) Continuous compliance requirements;
(h) Monitoring;
(i) Recordkeeping and reporting;
(j) Definitions; and
(k) Tables.
If you plan to achieve compliance more than 1 year following the effective date of state plan approval, you must meet the two increments of progress specified in paragraphs (a) and (b) of this section:
(a) Submit a final control plan; and
(b) Achieve final compliance.
Table 1 of this subpart specifies compliance dates for each of the increments of progress.
Your notification of achievement of increments of progress must include the three items specified in paragraphs (a) through (c) of this section:
(a) Notification that the increment of progress has been achieved;
(b) Any items required to be submitted with each increment of progress; and
(c) Signature of the owner or operator of the CISWI unit.
Notifications for achieving increments of progress must be postmarked no later than 10 business days after the compliance date for the increment.
If you fail to meet an increment of progress, you must submit a notification to the Administrator postmarked within 10 business days after the date for that increment of progress in table 1 of this subpart. You must inform the Administrator that you did not meet the increment, and you must continue to submit reports each subsequent calendar month until the increment of progress is met.
For your control plan increment of progress, you must satisfy the two requirements specified in paragraphs (a) and (b) of this section:
(a) Submit the final control plan that includes the five items described in paragraphs (a)(1) through (5) of this section:
(1) A description of the devices for air pollution control and process changes that you will use to comply with the emission limitations and other requirements of this subpart;
(2) The type(s) of waste to be burned;
(3) The maximum design waste burning capacity;
(4) The anticipated maximum charge rate; and
(5) If applicable, the petition for site-specific operating limits under § 60.2680.
(b) Maintain an onsite copy of the final control plan.
For the final compliance increment of progress, you must complete all process changes and retrofit construction of control devices, as specified in the final control plan, so that, if the affected CISWI unit is brought online, all necessary process changes and air pollution control devices would operate as designed.
(a) If you close your CISWI unit but will restart it prior to the final compliance date in your state plan, you must meet the increments of progress specified in § 60.2575.
(b) If you close your CISWI unit but will restart it after your final compliance date, you must complete emission control retrofits and meet the emission limitations and operating limits on the date your unit restarts operation.
If you plan to close your CISWI unit rather than comply with the state plan, submit a closure notification, including the date of closure, to the Administrator by the date your final control plan is due.
A waste management plan is a written plan that identifies both the feasibility and the methods used to reduce or separate certain components of solid waste from the waste stream in order to reduce or eliminate toxic emissions from incinerated waste.
You must submit a waste management plan no later than the date specified in table 1 of this subpart for submittal of the final control plan.
A waste management plan must include consideration of the reduction or separation of waste-stream elements such as paper, cardboard, plastics, glass, batteries, or metals; or the use of recyclable materials. The plan must identify any additional waste management measures, and the source must implement those measures considered practical and feasible, based on the effectiveness of waste management measures already in place, the costs of additional measures, the emissions reductions expected to be achieved, and any other environmental or energy impacts they might have.
(a) No CISWI unit can be operated unless a fully trained and qualified CISWI unit operator is accessible, either at the facility or can be at the facility
(b) Operator training and qualification must be obtained through a state-approved program or by completing the requirements included in paragraph (c) of this section.
(c) Training must be obtained by completing an incinerator operator training course that includes, at a minimum, the three elements described in paragraphs (c)(1) through (3) of this section:
(1) Training on the eleven subjects listed in paragraphs (c)(1)(i) through (xi) of this section:
(i) Environmental concerns, including types of emissions;
(ii) Basic combustion principles, including products of combustion;
(iii) Operation of the specific type of incinerator to be used by the operator, including proper startup, waste charging, and shutdown procedures;
(iv) Combustion controls and monitoring;
(v) Operation of air pollution control equipment and factors affecting performance (if applicable);
(vi) Inspection and maintenance of the incinerator and air pollution control devices;
(vii) Actions to prevent and correct malfunctions or to prevent conditions that may lead to malfunctions;
(viii) Bottom and fly ash characteristics and handling procedures;
(ix) Applicable federal, state, and local regulations, including Occupational Safety and Health Administration workplace standards;
(x) Pollution prevention; and
(xi) Waste management practices.
(2) An examination designed and administered by the instructor.
(3) Written material covering the training course topics that can serve as reference material following completion of the course.
The operator training course must be completed by the later of the three dates specified in paragraphs (a) through (c) of this section:
(a) The final compliance date (Increment 2);
(b) Six months after CISWI unit startup; and
(c) Six months after an employee assumes responsibility for operating the CISWI unit or assumes responsibility for supervising the operation of the CISWI unit.
(a) You must obtain operator qualification by completing a training course that satisfies the criteria under § 60.2635(b).
(b) Qualification is valid from the date on which the training course is completed and the operator successfully passes the examination required under § 60.2635(c)(2).
To maintain qualification, you must complete an annual review or refresher course covering, at a minimum, the five topics described in paragraphs (a) through (e) of this section:
(a) Update of regulations;
(b) Incinerator operation, including startup and shutdown procedures, waste charging, and ash handling;
(c) Inspection and maintenance;
(d) Prevention and correction of malfunctions or conditions that may lead to malfunction; and
(e) Discussion of operating problems encountered by attendees.
You must renew a lapsed operator qualification by one of the two methods specified in paragraphs (a) and (b) of this section:
(a) For a lapse of less than 3 years, you must complete a standard annual refresher course described in § 60.2650; and
(b) For a lapse of 3 years or more, you must repeat the initial qualification requirements in § 60.2645(a).
(a) Documentation must be available at the facility and readily accessible for all CISWI unit operators that addresses the ten topics described in paragraphs (a)(1) through (10) of this section. You must maintain this information and the training records required by paragraph (c) of this section in a manner that they can be readily accessed and are suitable for inspection upon request:
(1) Summary of the applicable standards under this subpart;
(2) Procedures for receiving, handling, and charging waste;
(3) Incinerator startup, shutdown, and malfunction procedures;
(4) Procedures for maintaining proper combustion air supply levels;
(5) Procedures for operating the incinerator and associated air pollution control systems within the standards established under this subpart;
(6) Monitoring procedures for demonstrating compliance with the incinerator operating limits;
(7) Reporting and recordkeeping procedures;
(8) The waste management plan required under §§ 60.2620 through 60.2630;
(9) Procedures for handling ash; and
(10) A list of the wastes burned during the performance test.
(b) You must establish a program for reviewing the information listed in paragraph (a) of this section with each incinerator operator:
(1) The initial review of the information listed in paragraph (a) of this section must be conducted by the later of the three dates specified in paragraphs (b)(1)(i) through (iii) of this section:
(i) The final compliance date (Increment 2);
(ii) Six months after CISWI unit startup; and
(iii) Six months after being assigned to operate the CISWI unit.
(2) Subsequent annual reviews of the information listed in paragraph (a) of this section must be conducted no later than 12 months following the previous review.
(c) You must also maintain the information specified in paragraphs (c)(1) through (3) of this section:
(1) Records showing the names of CISWI unit operators who have completed review of the information in § 60.2660(a) as required by § 60.2660(b), including the date of the initial review and all subsequent annual reviews;
(2) Records showing the names of the CISWI operators who have completed the operator training requirements under § 60.2635, met the criteria for qualification under § 60.2645, and maintained or renewed their qualification under § 60.2650 or § 60.2655. Records must include documentation of training, the dates of the initial refresher training, and the dates of their qualification and all subsequent renewals of such qualifications; and
(3) For each qualified operator, the phone and/or pager number at which they can be reached during operating hours.
If all qualified operators are temporarily not accessible (
(a) When all qualified operators are not accessible for more than 8 hours, but less than 2 weeks, the CISWI unit may be operated by other plant personnel familiar with the operation of the CISWI unit who have completed a review of the information specified in § 60.2660(a) within the past 12 months. However, you must record the period when all qualified operators were not accessible and include this deviation in the annual report as specified under § 60.2770;
(b) When all qualified operators are not accessible for 2 weeks or more, you must take the two actions that are described in paragraphs (b)(1) and (2) of this section:
(1) Notify the Administrator of this deviation in writing within 10 days. In the notice, state what caused this deviation, what you are doing to ensure that a qualified operator is accessible, and when you anticipate that a qualified operator will be accessible; and
(2) Submit a status report to the Administrator every 4 weeks outlining what you are doing to ensure that a qualified operator is accessible, stating when you anticipate that a qualified operator will be accessible and requesting approval from the Administrator to continue operation of the CISWI unit. You must submit the first status report 4 weeks after you notify the Administrator of the deviation under paragraph (b)(1) of this section. If the Administrator notifies you that your request to continue operation of the CISWI unit is disapproved, the CISWI unit may continue operation for 90 days, then must cease operation. Operation of the unit may resume if you meet the two requirements in paragraphs (b)(2)(i) and (ii) of this section:
(i) A qualified operator is accessible as required under § 60.2635(a); and
(ii) You notify the Administrator that a qualified operator is accessible and that you are resuming operation.
(a) You must meet the emission limitations for each CISWI unit, including bypass stack or vent, specified in table 2 of this subpart or tables 6 through 9 of this subpart by the final compliance date under the approved state plan, federal plan, or delegation, as applicable. The emission limitations apply at all times the unit is operating including and not limited to startup, shutdown, or malfunction.
(b) Units that do not use wet scrubbers must maintain opacity to less than or equal to the percent opacity (three 1-hour blocks consisting of ten 6-minute average opacity values) specified in table 2 of this subpart, as applicable.
(a) If you use a wet scrubber(s) to comply with the emission limitations, you must establish operating limits for up to four operating parameters (as specified in table 3 of this subpart) as described in paragraphs (a)(1) through (4) of this section during the initial performance test:
(1) Maximum charge rate, calculated using one of the two different procedures in paragraph (a)(1)(i) or (ii) of this section, as appropriate:
(i) For continuous and intermittent units, maximum charge rate is 110 percent of the average charge rate measured during the most recent performance test demonstrating compliance with all applicable emission limitations; and
(ii) For batch units, maximum charge rate is 110 percent of the daily charge rate measured during the most recent performance test demonstrating compliance with all applicable emission limitations.
(2) Minimum pressure drop across the wet particulate matter scrubber, which is calculated as the lowest 1-hour average pressure drop across the wet scrubber measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations; or minimum amperage to the wet scrubber, which is calculated as the lowest 1-hour average amperage to the wet scrubber measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations.
(3) Minimum scrubber liquid flow rate, which is calculated as the lowest 1-hour average liquid flow rate at the inlet to the wet acid gas or particulate matter scrubber measured during the most recent performance test demonstrating compliance with all applicable emission limitations.
(4) Minimum scrubber liquor pH, which is calculated as the lowest 1-hour average liquor pH at the inlet to the wet acid gas scrubber measured during the most recent performance test demonstrating compliance with the HCl emission limitation.
(b) You must meet the operating limits established during the initial performance test on the date the initial performance test is required or completed (whichever is earlier). You must conduct an initial performance evaluation of each continuous monitoring system and continuous parameter monitoring system within 60 days of installation of the monitoring system.
(c) If you use a fabric filter to comply with the emission limitations and you do not use a PM CPMS for monitoring PM compliance, you must operate each fabric filter system such that the bag leak detection system alarm does not sound more than 5 percent of the operating time during a 6-month period. In calculating this operating time percentage, if inspection of the fabric filter demonstrates that no corrective action is required, no alarm time is counted. If corrective action is required, each alarm shall be counted as a minimum of 1 hour. If you take longer than 1 hour to initiate corrective action, the alarm time shall be counted as the actual amount of time taken by you to initiate corrective action.
(d) If you use an electrostatic precipitator to comply with the emission limitations and you do not use a PM CPMS for monitoring PM compliance, you must measure the (secondary) voltage and amperage of the electrostatic precipitator collection plates during the particulate matter performance test. Calculate the average electric power value (secondary voltage × secondary current = secondary electric power) for each test run. The operating limit for the electrostatic precipitator is calculated as the lowest 1-hour average secondary electric power measured during the most recent performance test demonstrating compliance with the particulate matter emission limitations.
(e) If you use activated carbon sorbent injection to comply with the emission limitations, you must measure the sorbent flow rate during the performance testing. The operating limit for the carbon sorbent injection is calculated as the lowest 1-hour average sorbent flow rate measured during the most recent performance test demonstrating compliance with the mercury emission limitations. For energy recovery units, when your unit operates at lower loads, multiply your sorbent injection rate by the load fraction, as defined in this subpart, to determine the required injection rate (
(f) If you use selective noncatalytic reduction to comply with the emission limitations, you must measure the charge rate, the secondary chamber temperature (if applicable to your CISWI unit), and the reagent flow rate during the nitrogen oxides performance testing. The operating limits for the selective noncatalytic reduction are calculated as the highest 1-hour average charge rate, lowest secondary chamber temperature,
(g) If you use a dry scrubber to comply with the emission limitations, you must measure the injection rate of each sorbent during the performance testing. The operating limit for the injection rate of each sorbent is calculated as the lowest 1-hour average injection rate of each sorbent measured during the most recent performance test demonstrating compliance with the hydrogen chloride emission limitations. For energy recovery units, when your unit operates at lower loads, multiply your sorbent injection rate by the load fraction, as defined in this subpart, to determine the required injection rate (
(h) If you do not use a wet scrubber, electrostatic precipitator, or fabric filter to comply with the emission limitations, and if you do not determine compliance with your particulate matter emission limitation with either a particulate matter CEMS or a particulate matter CPMS, you must maintain opacity to less than or equal to ten percent opacity (1-hour block average).
(i) If you use a PM CPMS to demonstrate compliance, you must establish your PM CPMS operating limit and determine compliance with it according to paragraphs (i)(1) through (5) of this section:
(1) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, record all hourly average output values (milliamps, or the digital signal equivalent) from the PM CPMS for the periods corresponding to the test runs (
(i) Your PM CPMS must provide a 4–20 milliamp output, or the digital signal equivalent, and the establishment of its relationship to manual reference method measurements must be determined in units of milliamps or digital bits;
(ii) Your PM CPMS operating range must be capable of reading PM concentrations from zero to a level equivalent to at least two times your allowable emission limit. If your PM CPMS is an auto-ranging instrument capable of multiple scales, the primary range of the instrument must be capable of reading PM concentration from zero to a level equivalent to two times your allowable emission limit; and
(iii) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, record and average all milliamp output values, or their digital equivalent, from the PM CPMS for the periods corresponding to the compliance test runs (
(2) If the average of your three PM performance test runs are below 75 percent of your PM emission limit, you must calculate an operating limit by establishing a relationship of PM CPMS signal to PM concentration using the PM CPMS instrument zero, the average PM CPMS output values corresponding to the three compliance test runs, and the average PM concentration from the Method 5 or performance test with the procedures in (i)(1)through (5) of this section:
(i) Determine your instrument zero output with one of the following procedures:
(A) Zero point data for
(B) Zero point data for extractive instruments should be obtained by removing the extractive probe from the stack and drawing in clean ambient air;
(C) The zero point can also can be established obtained by performing manual reference method measurements when the flue gas is free of PM emissions or contains very low PM concentrations (
(D) If none of the steps in paragraphs (i)(2)(i)(A) through (C) of this section are possible, you must use a zero output value provided by the manufacturer.
(ii) Determine your PM CPMS instrument average in milliamps, or the digital equivalent, and the average of your corresponding three PM compliance test runs, using equation 1:
(iii) With your instrument zero expressed in milliamps, or the digital equivalent, your three run average PM CPMS milliamp value, or its digital equivalent, and your three run average PM concentration from your three compliance tests, determine a relationship of mg/dscm per milliamp or digital signal equivalent, with equation 2:
(iv) Determine your source specific 30-day rolling average operating limit using the mg/dscm per milliamp value, or per digital signal equivalent, from equation 2 in equation 3, below. This sets your operating limit at the PM CPMS output value corresponding to 75 percent of your emission limit:
(3) If the average of your three PM compliance test runs is at or above 75 percent of your PM emission limit you must determine your operating limit by averaging the PM CPMS milliamp or digital signal output corresponding to your three PM performance test runs that demonstrate compliance with the emission limit using equation 4 and you must submit all compliance test and PM CPMS data according to the reporting requirements in paragraph (i)(5) of this section:
(4) To determine continuous compliance, you must record the PM CPMS output data for all periods when the process is operating and the PM CPMS is not out-of-control. You must demonstrate continuous compliance by using all quality-assured hourly average data collected by the PM CPMS for all operating hours to calculate the arithmetic average operating parameter in units of the operating limit (
(5) For PM performance test reports used to set a PM CPMS operating limit, the electronic submission of the test report must also include the make and model of the PM CPMS instrument, serial number of the instrument, analytical principle of the instrument (
(a) If you use an air pollution control device other than a wet scrubber, activated carbon injection, selective noncatalytic reduction, fabric filter, an electrostatic precipitator, or a dry scrubber or limit emissions in some other manner, including mass balances, to comply with the emission limitations under § 60.2670, you must petition the EPA Administrator for specific operating limits to be established during the initial performance test and continuously monitored thereafter. You must submit the petition at least sixty days before the performance test is scheduled to begin. Your petition must include the five items listed in paragraphs (a)(1) through (5) of this section:
(1) Identification of the specific parameters you propose to use as additional operating limits;
(2) A discussion of the relationship between these parameters and emissions of regulated pollutants, identifying how emissions of regulated pollutants change with changes in these parameters and how limits on these parameters will serve to limit emissions of regulated pollutants;
(3) A discussion of how you will establish the upper and/or lower values for these parameters which will establish the operating limits on these parameters;
(4) A discussion identifying the methods you will use to measure and the instruments you will use to monitor these parameters, as well as the relative accuracy and precision of these methods and instruments; and
(5) A discussion identifying the frequency and methods for recalibrating the instruments you will use for monitoring these parameters.
(b) [Reserved]
(a) All performance tests must consist of a minimum of three test runs conducted under conditions representative of normal operations.
(b) You must document that the waste burned during the performance test is representative of the waste burned under normal operating conditions by maintaining a log of the quantity of waste burned (as required in § 60.2740(b)(1)) and the types of waste burned during the performance test.
(c) All performance tests must be conducted using the minimum run duration specified in tables 2 and 6 through 9 of this subpart.
(d) Method 1 of appendix A of this part must be used to select the sampling location and number of traverse points.
(e) Method 3A or 3B of appendix A of this part must be used for gas composition analysis, including measurement of oxygen concentration. Method 3A or 3B of appendix A of this part must be used simultaneously with each method.
(f) All pollutant concentrations, except for opacity, must be adjusted to 7 percent oxygen using equation 5 of this section:
(g) You must determine dioxins/furans toxic equivalency by following the procedures in paragraphs (g)(1) through (4) of this section:
(1) Measure the concentration of each dioxin/furan tetra- through octa-isomer emitted using EPA Method 23 at 40 CFR part 60, appendix A;
(2) Quantify isomers meeting identification criteria 2, 3, 4, and 5 in Section 5.3.2.5 of Method 23, regardless of whether the isomers meet identification criteria 1 and 7. You must quantify the isomers per Section 9.0 of Method 23. [Note: You may reanalyze the sample aliquot or split to reduce the number of isomers not meeting identification criteria 1 or 7 of Section 5.3.2.5.];
(3) For each dioxin/furan (tetra- through octa-chlorinated) isomer measured in accordance with paragraph (g)(1) and (2) of this section, multiply the isomer concentration by its corresponding toxic equivalency factor specified in table 4 of this subpart; and
(4) Sum the products calculated in accordance with paragraph (g)(3) of this section to obtain the total concentration of dioxins/furans emitted in terms of toxic equivalency.
(h) Method 22 at 40 CFR part 60, appendix A–7 must be used to determine compliance with the fugitive ash emission limit in table 2 of this subpart or tables 6 through 9 of this subpart.
(i) If you have an applicable opacity operating limit, you must determine compliance with the opacity limit using Method 9 at 40 CFR part 60, appendix A–4, based on three 1-hour blocks consisting of ten 6-minute average opacity values, unless you are required to install a continuous opacity monitoring system, consistent with § 60.2710 and § 60.2730.
(j) You must determine dioxins/furans total mass basis by following the procedures in paragraphs (j)(1) through (3) of this section:
(1) Measure the concentration of each dioxin/furan tetra- through octa-chlorinated isomer emitted using EPA Method 23 at 40 CFR part 60, appendix A–7;
(2) Quantify isomers meeting identification criteria 2, 3, 4, and 5 in Section 5.3.2.5 of Method 23, regardless of whether the isomers meet identification criteria 1 and 7. You must quantify the isomers per Section 9.0 of Method 23. (Note: You may reanalyze the sample aliquot or split to reduce the number of isomers not meeting identification criteria 1 or 7 of Section 5.3.2.5.); and
(3) Sum the quantities measured in accordance with paragraphs (j)(1) and (2) of this section to obtain the total concentration of dioxins/furans emitted in terms of total mass basis.
You use results of performance tests to demonstrate compliance with the emission limitations in table 2 of this subpart or tables 6 through 9 of this subpart.
You must conduct a performance test, as required under §§ 60.2670 and 60.2690, to determine compliance with the emission limitations in table 2 of this subpart and tables 6 through 9 of this subpart, to establish compliance with any opacity operating limits in § 60.2675, to establish the kiln-specific emission limit in § 60.2710(y), as applicable, and to establish operating limits using the procedures in § 60.2675 or § 60.2680. The performance test must be conducted using the test methods listed in table 2 of this subpart and tables 6 through 9 of this subpart and the procedures in § 60.2690. The use of the bypass stack during a performance test shall invalidate the performance test. You must conduct a performance evaluation of each continuous monitoring system within 60 days of installation of the monitoring system.
(a) The initial performance test must be conducted no later than 180 days after your final compliance date. Your final compliance date is specified in table 1 of this subpart.
(b) If you commence or recommence combusting a solid waste at an existing combustion unit at any commercial or industrial facility and you conducted a test consistent with the provisions of this subpart while combusting the given solid waste within the 6 months preceding the reintroduction of that solid waste in the combustion chamber, you do not need to retest until 6 months from the date you reintroduce that solid waste.
(c) If you commence or recommence combusting a solid waste at an existing combustion unit at any commercial or industrial facility and you have not conducted a performance test consistent with the provisions of this subpart while combusting the given solid waste within the 6 months preceding the reintroduction of that solid waste in the combustion chamber, you must conduct a performance test within 60 days from the date you reintroduce solid waste.
(a) The initial air pollution control device inspection must be conducted within 60 days after installation of the control device and the associated CISWI unit reaches the charge rate at which it will operate, but no later than 180 days after the final compliance date for meeting the amended emission limitations.
(b) Within 10 operating days following an air pollution control device inspection, all necessary repairs must be completed unless the owner or operator obtains written approval from the state agency establishing a date whereby all necessary repairs of the designated facility must be completed.
(a)
(2) If you cease combusting solid waste you may opt to remain subject to the provisions of this subpart. Consistent with the definition of CISWI unit, you are subject to the requirements of this subpart at least 6 months following the last date of solid waste combustion. Solid waste combustion is ceased when solid waste is not in the combustion chamber (
(3) If you cease combusting solid waste you must be in compliance with any newly applicable standards on the effective date of the waste-to-fuel switch. The effective date of the waste-to-fuel switch is a date selected by you, that must be at least 6 months from the date that you ceased combusting solid waste, consistent with § 60.2710(a)(2). Your source must remain in compliance
(4) If you own or operate an existing commercial or industrial combustion unit that combusted a fuel or non-waste material, and you commence or recommence combustion of solid waste, you are subject to the provisions of this subpart as of the first day you introduce or reintroduce solid waste to the combustion chamber, and this date constitutes the effective date of the fuel-to-waste switch. You must complete all initial compliance demonstrations for any Section 112 standards that are applicable to your facility before you commence or recommence combustion of solid waste. You must provide 30 days prior notice of the effective date of the waste-to-fuel switch. The notification must identify:
(i) The name of the owner or operator of the CISWI unit, the location of the source, the emissions unit(s) that will cease burning solid waste, and the date of the notice;
(ii) The currently applicable subcategory under this subpart, and any 40 CFR part 63 subpart and subcategory that will be applicable after you cease combusting solid waste;
(iii) The fuel(s), non-waste material(s) and solid waste(s) the CISWI unit is currently combusting and has combusted over the past 6 months, and the fuel(s) or non-waste materials the unit will commence combusting;
(iv) The date on which you became subject to the currently applicable emission limits;
(v) The date upon which you will cease combusting solid waste, and the date (if different) that you intend for any new requirements to become applicable (
(5) All air pollution control equipment necessary for compliance with any newly applicable emissions limits which apply as a result of the cessation or commencement or recommencement of combusting solid waste must be installed and operational as of the effective date of the waste-to-fuel, or fuel-to-waste switch.
(6) All monitoring systems necessary for compliance with any newly applicable monitoring requirements which apply as a result of the cessation or commencement or recommencement of combusting solid waste must be installed and operational as of the effective date of the waste-to-fuel, or fuel-to-waste switch. All calibration and drift checks must be performed as of the effective date of the waste-to-fuel, or fuel-to-waste switch. Relative accuracy tests must be performed as of the performance test deadline for PM CEMS (if PM CEMS are elected to demonstrate continuous compliance with the particulate matter emission limits). Relative accuracy testing for other CEMS need not be repeated if that testing was previously performed consistent with section 112 monitoring requirements or monitoring requirements under this subpart.
(b) You must conduct an annual performance test for the pollutants listed in table 2 of this subpart or tables 6 through 9 of this subpart and opacity for each CISWI unit as required under § 60.2690. The annual performance test must be conducted using the test methods listed in table 2 of this subpart or tables 6 through 9 of this subpart and the procedures in § 60.2690. Opacity must be measured using EPA Reference Method 9 at 40 CFR part 60. Annual performance tests are not required if you use CEMS or continuous opacity monitoring systems to determine compliance.
(c) You must continuously monitor the operating parameters specified in § 60.2675 or established under § 60.2680 and as specified in § 60.2735. Operation above the established maximum or below the established minimum operating limits constitutes a deviation from the established operating limits. Three-hour block average values are used to determine compliance (except for baghouse leak detection system alarms) unless a different averaging period is established under § 60.2680 or, for energy recovery units, where the averaging time for each operating parameter is a 30-day rolling, calculated each hour as the average of the previous 720 operating hours over the previous 30 days of operation. Operation above the established maximum, below the established minimum, or outside the allowable range of the operating limits specified in paragraph (a) of this section constitutes a deviation from your operating limits established under this subpart, except during performance tests conducted to determine compliance with the emission and operating limits or to establish new operating limits. Operating limits are confirmed or reestablished during performance tests.
(d) You must burn only the same types of waste and fuels used to establish subcategory applicability (for ERUs) and operating limits during the performance test.
(e) For energy recovery units, incinerators, and small remote units, you must perform annual visual emissions test for ash handling.
(f) For energy recovery units, you must conduct an annual performance test for opacity using EPA Reference Method 9 at 40 CFR part 60 (except where particulate matter continuous monitoring system or continuous parameter monitoring systems are used) and the pollutants listed in table 7 of this subpart.
(g) For facilities using a CEMS to demonstrate compliance with the carbon monoxide emission limit, compliance with the carbon monoxide emission limit may be demonstrated by using the CEMS according to the following requirements:
(1) You must measure emissions according to § 60.13 to calculate 1-hour arithmetic averages, corrected to 7 percent oxygen. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must demonstrate initial compliance with the carbon monoxide emissions limit using a 30-day rolling average of the 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7.
(2) Operate the carbon monoxide continuous emissions monitoring system in accordance with the applicable requirements of performance specification 4A of appendix B and the quality assurance procedures of appendix F of this part.
(h) Coal and liquid/gas energy recovery units with annual average heat input rates greater than 250 MMBtu/hr may elect to demonstrate continuous compliance with the particulate matter emissions limit using a particulate matter CEMS according to the procedures in § 60.2730(n) instead of the continuous parameter monitoring system specified in § 60.2710(i). Coal and liquid/gas energy recovery units with annual average heat input rates less than 250 MMBtu/hr, incinerators, and small remote incinerators may also elect to demonstrate compliance using a particulate matter CEMS according to the procedures in § 60.2730(n) instead of particulate matter testing with EPA Method 5 at 40 CFR part 60, appendix A–3 and, if applicable, the continuous opacity monitoring requirements in paragraph (i) of this section.
(i) For energy recovery units with annual average heat input rates greater than or equal to 10 MMBTU/hour but less than 250 MMBtu/hr you must install, operate, certify and maintain a continuous opacity monitoring system (COMS) according to the procedures in § 60.2730.
(j) For waste-burning kilns, you must conduct an annual performance test for the pollutants (except mercury and particulate matter, and hydrogen chloride if no acid gas wet scrubber is used) listed in table 8 of this subpart. If you do not use an acid gas wet scrubber or dry scrubber, you must determine compliance with the hydrogen chloride emissions limit according to the requirements in paragraph (j)(1) of this section. You must determine compliance with the mercury emissions limit using a mercury CEMS according to paragraph (j)(2) of this section. You must determine compliance with particulate matter using CPMS:
(1) If you monitor compliance with the HCl emissions limit by operating an HCl CEMS, you must do so in accordance with Performance Specification 15 (PS 15) of appendix B to 40 CFR part 60, or, PS 18 of appendix B to 40 CFR part 60. You must operate, maintain, and quality assure a HCl CEMS installed and certified under PS 15 according to the quality assurance requirements in Procedure 1 of appendix F to 40 CFR part 60 except that the Relative Accuracy Test Audit requirements of Procedure 1 must be replaced with the validation requirements and criteria of sections 11.1.1 and 12.0 of PS 15. You must operate, maintain and quality assure a HCl CEMS installed and certified under PS 18 according to the quality assurance requirements in Procedure 6 of appendix F to 40 CFR part 60. For any performance specification that you use, you must use Method 321 of appendix A to 40 CFR part 63 as the reference test method for conducting relative accuracy testing. The span value and calibration requirements in paragraphs (j)(1)(i) and (ii) of this section apply to all HCl CEMS used under this subpart:
(i) You must use a measurement span value for any HCl CEMS of 0–10 ppmvw unless the monitor is installed on a kiln without an inline raw mill. Kilns without an inline raw mill may use a higher span value sufficient to quantify all expected emissions concentrations. The HCl CEMS data recorder output range must include the full range of expected HCl concentration values which would include those expected during “mill off” conditions. The corresponding data recorder range shall be documented in the site-specific monitoring plan and associated records; and
(ii) In order to quality assure data measured above the span value, you must use one of the three options in paragraphs (j)(1)(ii)(A) through (C) of this section:
(A) Include a second span that encompasses the HCl emission concentrations expected to be encountered during “mill off” conditions. This second span may be rounded to a multiple of 5 ppm of total HCl. The requirements of the appropriate HCl monitor performance specification shall be followed for this second span with the exception that a RATA with the mill off is not required;
(B) Quality assure any data above the span value by proving instrument linearity beyond the span value established in paragraph (j)(1)(i) of this section using the following procedure. Conduct a weekly “above span linearity” calibration challenge of the monitoring system using a reference gas with a certified value greater than your highest expected hourly concentration or greater than 75% of the highest measured hourly concentration. The “above span” reference gas must meet the requirements of the applicable performance specification and must be introduced to the measurement system at the probe. Record and report the results of this procedure as you would for a daily calibration. The “above span linearity” challenge is successful if the value measured by the HCl CEMS falls within 10 percent of the certified value of the reference gas. If the value measured by the HCl CEMS during the above span linearity challenge exceeds 10 percent of the certified value of the reference gas, the monitoring system must be evaluated and repaired and a new “above span linearity” challenge met before returning the HCl CEMS to service, or data above span from the HCl CEMS must be subject to the quality assurance procedures established in (j)(1)(ii)(D) of this section. In this manner values measured by the HCl CEMS during the above span linearity challenge exceeding +/−20 percent of the certified value of the reference gas must be normalized using equation 6;
(C) Quality assure any data above the span value established in paragraph (j)(1)(i) of this section using the following procedure. Any time two consecutive one-hour average measured concentration of HCl exceeds the span value you must, within 24 hours before or after, introduce a higher, “above span” HCl reference gas standard to the HCl CEMS. The “above span” reference gas must meet the requirements of the applicable performance specification and target a concentration level between 50 and 150 percent of the highest expected hourly concentration measured during the period of measurements above span, and must be introduced at the probe. While this target represents a desired concentration range that is not always achievable in practice, it is expected that the intent to meet this range is demonstrated by the value of the reference gas. Expected values may include above span calibrations done before or after the above-span measurement period. Record and report the results of this procedure as you would for a daily calibration. The “above span” calibration is successful if the value measured by the HCl CEMS is within 20 percent of the certified value of the reference gas. If the value measured by the HCl CEMS is not within 20 percent of the certified value of the reference gas, then you must normalize the stack gas values measured above span as described in paragraph (j)(1)(ii)(D) of this section. If the “above span” calibration is conducted during the period when measured emissions are above span and there is a failure to collect the one data point in an hour due to the calibration duration, then you must determine the emissions average for that missed hour as the average of hourly averages for the hour preceding the missed hour and the hour following the missed hour. In an hour where an “above span” calibration is being conducted and one or more data points are collected, the emissions average is represented by the average of all valid data points collected in that hour; and
(D) In the event that the “above span” calibration is not successful (
Only one “above span” calibration is needed per 24-hour period.
(2) Compliance with the mercury emissions limit must be determined using a mercury CEMS according to the following requirements:
(i) You must operate a CEMS in accordance with performance specification 12A at 40 CFR part 60, appendix B or a sorbent trap based integrated monitor in accordance with performance specification 12B at 40 CFR part 60, appendix B. The duration of the performance test must be a calendar month. For each calendar month in which the waste-burning kiln operates, hourly mercury concentration data and stack gas volumetric flow rate data must be obtained. You must demonstrate compliance with the mercury emissions limit using a 30-day rolling average of these 1-hour mercury concentrations, including CEMS data during startup and shutdown as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content;
(ii) Owners or operators using a mercury continuous emissions monitoring systems must install, operate, calibrate and maintain an instrument for continuously measuring and recording the mercury mass emissions rate to the atmosphere according to the requirements of performance specifications 6 and 12A at 40 CFR part 60, appendix B and quality assurance procedure 5 at 40 CFR part 60, appendix F; and
(iii) The owner or operator of a waste-burning kiln must demonstrate initial compliance by operating a mercury CEMS while the raw mill of the in-line kiln/raw mill is operating under normal conditions and including at least one period when the raw mill is off.
(k) If you use an air pollution control device to meet the emission limitations in this subpart, you must conduct an initial and annual inspection of the air pollution control device. The inspection must include, at a minimum, the following:
(1) Inspect air pollution control device(s) for proper operation; and
(2) Develop a site-specific monitoring plan according to the requirements in paragraph (l) of this section. This requirement also applies to you if you petition the EPA Administrator for alternative monitoring parameters under § 60.13(i).
(l) For each CMS required in this section, you must develop and submit to the EPA Administrator for approval a site-specific monitoring plan according to the requirements of this paragraph (l) that addresses paragraphs (l)(1)(i) through (vi) of this section:
(1) You must submit this site-specific monitoring plan at least 60 days before your initial performance evaluation of your continuous monitoring system:
(i) Installation of the continuous monitoring system sampling probe or other interface at a measurement location relative to each affected process unit such that the measurement is representative of control of the exhaust emissions (
(ii) Performance and equipment specifications for the sample interface, the pollutant concentration or parametric signal analyzer and the data collection and reduction systems;
(iii) Performance evaluation procedures and acceptance criteria (
(iv) Ongoing operation and maintenance procedures in accordance with the general requirements of § 60.11(d);
(v) Ongoing data quality assurance procedures in accordance with the general requirements of § 60.13; and
(vi) Ongoing recordkeeping and reporting procedures in accordance with the general requirements of § 60.7(b),(c), (c)(1), (c)(4), (d), (e), (f) and (g).
(2) You must conduct a performance evaluation of each continuous monitoring system in accordance with your site-specific monitoring plan.
(3) You must operate and maintain the continuous monitoring system in continuous operation according to the site-specific monitoring plan.
(m) If you have an operating limit that requires the use of a flow monitoring system, you must meet the requirements in paragraphs (l) and (m)(1) through (4) of this section:
(1) Install the flow sensor and other necessary equipment in a position that provides a representative flow;
(2) Use a flow sensor with a measurement sensitivity at full scale of no greater than 2 percent;
(3) Minimize the effects of swirling flow or abnormal velocity distributions due to upstream and downstream disturbances; and
(4) Conduct a flow monitoring system performance evaluation in accordance with your monitoring plan at the time of each performance test but no less frequently than annually.
(n) If you have an operating limit that requires the use of a pressure monitoring system, you must meet the requirements in paragraphs (l) and (n)(1) through (6) of this section:
(1) Install the pressure sensor(s) in a position that provides a representative measurement of the pressure (
(2) Minimize or eliminate pulsating pressure, vibration, and internal and external corrosion;
(3) Use a pressure sensor with a minimum tolerance of 1.27 centimeters of water or a minimum tolerance of 1 percent of the pressure monitoring system operating range, whichever is less;
(4) Perform checks at the frequency outlined in your site-specific monitoring plan to ensure pressure measurements are not obstructed (
(5) Conduct a performance evaluation of the pressure monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than annually; and
(6) If at any time the measured pressure exceeds the manufacturer's specified maximum operating pressure range, conduct a performance evaluation of the pressure monitoring system in accordance with your monitoring plan and confirm that the pressure monitoring system continues to meet the performance requirements in your monitoring plan. Alternatively, install and verify the operation of a new pressure sensor.
(o) If you have an operating limit that requires a pH monitoring system, you must meet the requirements in paragraphs (l) and (o)(1) through (4) of this section:
(1) Install the pH sensor in a position that provides a representative measurement of scrubber effluent pH;
(2) Ensure the sample is properly mixed and representative of the fluid to be measured;
(3) Conduct a performance evaluation of the pH monitoring system in accordance with your monitoring plan at least once each process operating day; and
(4) Conduct a performance evaluation (including a two-point calibration with one of the two buffer solutions having a pH within 1 of the pH of the operating limit) of the pH monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than quarterly.
(p) If you have an operating limit that requires a secondary electric power monitoring system for an electrostatic precipitator, you must meet the requirements in paragraphs (l) and (p)(1) and (2) of this section:
(1) Install sensors to measure (secondary) voltage and current to the precipitator collection plates; and
(2) Conduct a performance evaluation of the electric power monitoring system in accordance with your monitoring plan at the time of each performance
(q) If you have an operating limit that requires the use of a monitoring system to measure sorbent injection rate (
(1) Install the system in a position(s) that provides a representative measurement of the total sorbent injection rate; and
(2) Conduct a performance evaluation of the sorbent injection rate monitoring system in accordance with your monitoring plan at the time of each performance test but no less frequently than annually.
(r) If you elect to use a fabric filter bag leak detection system to comply with the requirements of this subpart, you must install, calibrate, maintain, and continuously operate a bag leak detection system as specified in paragraphs (l) and (r)(1) through (5) of this section:
(1) Install a bag leak detection sensor(s) in a position(s) that will be representative of the relative or absolute particulate matter loadings for each exhaust stack, roof vent, or compartment (
(2) Use a bag leak detection system certified by the manufacturer to be capable of detecting particulate matter emissions at concentrations of 10 milligrams per actual cubic meter or less;
(3) Conduct a performance evaluation of the bag leak detection system in accordance with your monitoring plan and consistent with the guidance provided in EPA–454/R–98–015 (incorporated by reference,
(4) Use a bag leak detection system equipped with a device to continuously record the output signal from the sensor; and
(5) Use a bag leak detection system equipped with a system that will sound an alarm when an increase in relative particulate matter emissions over a preset level is detected. The alarm must be located where it is observed readily by plant operating personnel.
(s) For facilities using a CEMS to demonstrate compliance with the sulfur dioxide emission limit, compliance with the sulfur dioxide emission limit may be demonstrated by using the CEMS specified in § 60.2730 to measure sulfur dioxide. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must calculate a 30-day rolling average of the 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7. The sulfur dioxide CEMS must be operated according to performance specification 2 in appendix B of this part and must follow the procedures and methods specified in paragraph (s) of this section. For sources that have actual inlet emissions less than 100 parts per million dry volume, the relative accuracy criterion for inlet sulfur dioxide CEMS should be no greater than 20 percent of the mean value of the reference method test data in terms of the units of the emission standard, or 5 parts per million dry volume absolute value of the mean difference between the reference method and the CEMS, whichever is greater:
(1) During each relative accuracy test run of the CEMS required by performance specification 2 in appendix B of this part, collect sulfur dioxide and oxygen (or carbon dioxide) data concurrently (or within a 30- to 60-minute period) with both the CEMS and the test methods specified in paragraphs (s)(1)(i) and (ii) of this section:
(i) For sulfur dioxide, EPA Reference Method 6 or 6C, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference, see § 60.17) must be used; and
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference, see § 60.17), as applicable, must be used.
(2) The span value of the CEMS at the inlet to the sulfur dioxide control device must be 125 percent of the maximum estimated hourly potential sulfur dioxide emissions of the unit subject to this subpart. The span value of the CEMS at the outlet of the sulfur dioxide control device must be 50 percent of the maximum estimated hourly potential sulfur dioxide emissions of the unit subject to this subpart.
(3) Conduct accuracy determinations quarterly and calibration drift tests daily in accordance with procedure 1 in appendix F of this part.
(t) For facilities using a CEMS to demonstrate continuous compliance with the nitrogen oxides emission limit, compliance with the nitrogen oxides emission limit may be demonstrated by using the CEMS specified in § 60.2730 to measure nitrogen oxides. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. You must calculate a 30-day rolling average of the 1-hour arithmetic average emission concentration using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7. The nitrogen oxides CEMS must be operated according to performance specification 2 in appendix B of this part and must follow the procedures and methods specified in paragraphs (t)(1) through (4) of this section:
(1) During each relative accuracy test run of the CEMS required by performance specification 2 of appendix B of this part, collect nitrogen oxides and oxygen (or carbon dioxide) data concurrently (or within a 30- to 60-minute period) with both the CEMS and the test methods specified in paragraphs (t)(1)(i) and (ii) of this section:
(i) For nitrogen oxides, EPA Reference Method 7 or 7E at 40 CFR part 60, appendix A–4 must be used; and
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference, see § 60.17), as applicable, must be used.
(2) The span value of the CEMS must be 125 percent of the maximum estimated hourly potential nitrogen oxide emissions of unit.
(3) Conduct accuracy determinations quarterly and calibration drift tests daily in accordance with procedure 1 in appendix F of this part.
(4) The owner or operator of an affected facility may request that compliance with the nitrogen oxides emission limit be determined using carbon dioxide measurements corrected to an equivalent of 7 percent oxygen. If carbon dioxide is selected for use in diluent corrections, the relationship between oxygen and carbon dioxide levels must be established during the initial performance test according to the procedures and methods specified in paragraphs (t)(4)(i) through (iv) of this section. This relationship may be reestablished during performance compliance tests:
(i) The fuel factor equation in Method 3B must be used to determine the relationship between oxygen and carbon dioxide at a sampling location. Method 3A, 3B, or as an alternative ANSI/ASME PTC 19.10–1981 (incorporated by reference, see § 60.17), as applicable, must be used to determine the oxygen concentration at the same location as the carbon dioxide monitor;
(ii) Samples must be taken for at least 30 minutes in each hour;
(iii) Each sample must represent a 1-hour average; and
(iv) A minimum of 3 runs must be performed.
(u) For facilities using a continuous emissions monitoring system to demonstrate continuous compliance with any of the emission limits of this subpart, you must complete the following:
(1) Demonstrate compliance with the appropriate emission limit(s) using a 30-day rolling average of 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown, as defined in this subpart, calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content; and
(2) Operate all CEMS in accordance with the applicable procedures under appendices B and F of this part.
(v) Use of the bypass stack at any time is an emissions standards deviation for particulate matter, HCl, Pb, Cd, Hg, NO
(w) For energy recovery units with a design heat input capacity of 100 MMBtu per hour or greater that do not use a carbon monoxide CEMS, you must install, operate, and maintain an oxygen analyzer system as defined in § 60.2875 according to the procedures in paragraphs (w)(1) through (4) of this section:
(1) The oxygen analyzer system must be installed by the initial performance test date specified in § 60.2675;
(2) You must operate the oxygen trim system within compliance with paragraph (w)(3) of this section at all times;
(3) You must maintain the oxygen level such that the 30-day rolling average that is established as the operating limit for oxygen is not below the lowest hourly average oxygen concentration measured during the most recent CO performance test; and
(4) You must calculate and record a 30-day rolling average oxygen concentration using equation 19–19 in section 12.4.1 of EPA Reference Method 19 of Appendix A–7 of this part.
(x) For energy recovery units with annual average heat input rates greater than or equal to 250 MMBtu/hour and waste-burning kilns, you must install, calibrate, maintain, and operate a PM CPMS and record the output of the system as specified in paragraphs (x)(1) through (8) of this section. For other energy recovery units, you may elect to use PM CPMS operated in accordance with this section. PM CPMS are suitable in lieu of using other CMS for monitoring PM compliance (
(1) Install, calibrate, operate, and maintain your PM CPMS according to the procedures in your approved site-specific monitoring plan developed in accordance with paragraphs (l) and (x)(1)(i) through (iii) of this section:
(i) The operating principle of the PM CPMS must be based on in-stack or extractive light scatter, light scintillation, beta attenuation, or mass accumulation of the exhaust gas or representative sample. The reportable measurement output from the PM CPMS must be expressed as milliamps or the digital signal equivalent;
(ii) The PM CPMS must have a cycle time (
(iii) The PM CPMS must be capable of detecting and responding to particulate matter concentrations increments no greater than 0.5 mg/actual cubic meter.
(2) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, you must adjust the site-specific operating limit in accordance with the results of the performance test according to the procedures specified in § 60.2675.
(3) Collect PM CPMS hourly average output data for all energy recovery unit or waste-burning kiln operating hours. Express the PM CPMS output as milliamps or the digital signal equivalent.
(4) Calculate the arithmetic 30-day rolling average of all of the hourly average PM CPMS output collected during all energy recovery unit or waste-burning kiln operating hours data (milliamps or their digital equivalent).
(5) You must collect data using the PM CPMS at all times the energy recovery unit or waste-burning kiln is operating and at the intervals specified in paragraph (x)(1)(ii) of this section, except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments), and any scheduled maintenance as defined in your site-specific monitoring plan.
(6) You must use all the data collected during all energy recovery unit or waste-burning kiln operating hours in assessing the compliance with your operating limit except:
(i) Any data collected during monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities conducted during monitoring system malfunctions are not used in calculations (report any such periods in your annual deviation report);
(ii) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods are not used in calculations (report emissions or operating levels and report any such periods in your annual deviation report);
(iii) Any PM CPMS data recorded during periods of CEMS data during startup and shutdown, as defined in this subpart.
(7) You must record and make available upon request results of PM CPMS system performance audits, as well as the dates and duration of periods from when the PM CPMS is out of control until completion of the corrective actions necessary to return the PM CPMS to operation consistent with your site-specific monitoring plan.
(8) For any deviation of the 30-day rolling average PM CPMS average value from the established operating parameter limit, you must:
(i) Within 48 hours of the deviation, visually inspect the air pollution control device;
(ii) If inspection of the air pollution control device identifies the cause of the deviation, take corrective action as soon as possible and return the PM CPMS measurement to within the established value;
(iii) Within 30 days of the deviation or at the time of the annual compliance test, whichever comes first, conduct a PM emissions compliance test to determine compliance with the PM emissions limit and to verify. Within 45 days of the deviation, you must re-establish the CPMS operating limit. You are not required to conduct additional testing for any deviations that occur between the time of the original deviation and the PM emissions compliance test required under paragraph (x) of this section; and
(iv) PM CPMS deviations leading to more than four required performance tests in a 12-month process operating period (rolling monthly) constitute a violation of this subpart.
(y) When there is an alkali bypass and/or an in-line coal mill that exhaust emissions through a separate stack(s), the combined emissions are subject to
(1) Calculate a kiln-specific emission limit using equation 7:
(2) Particulate matter concentration must be measured downstream of the in-line coal mill. All other pollutant concentrations must be measured either upstream or downstream of the in-line coal mill.
(3) For purposes of determining the combined emissions from kilns equipped with an alkali bypass or that exhaust kiln gases to a coal mill that exhausts through a separate stack, instead of installing a CEMS or PM CPMS on the alkali bypass stack or in-line coal mill stack, the results of the initial and subsequent performance test can be used to demonstrate compliance with the relevant emissions limit. A performance test must be conducted on an annual basis (between 11 and 13 calendar months following the previous performance test).
You must conduct annual performance tests between 11 and 13 months of the previous performance test.
On an annual basis (no more than 12 months following the previous annual air pollution control device inspection), you must complete the air pollution control device inspection as described in § 60.2706.
(a) You must conduct annual performance tests according to the schedule specified in § 60.2715, with the following exceptions:
(1) You may conduct a repeat performance test at any time to establish new values for the operating limits to apply from that point forward, as specified in § 60.2725. The Administrator may request a repeat performance test at any time;
(2) You must repeat the performance test within 60 days of a process change, as defined in § 60.2875; and
(3) If the initial or any subsequent performance test for any pollutant in table 2 or tables 6 through 9 of this subpart, as applicable, demonstrates that the emission level for the pollutant is no greater than the emission level specified in paragraph (a)(3)(i) or (a)(3)(ii) of this section, as applicable, and you are not required to conduct a performance test for the pollutant in response to a request by the Administrator in paragraph (a)(1) of this section or a process change in paragraph (a)(2) of this section, you may elect to skip conducting a performance test for the pollutant for the next 2 years. You must conduct a performance test for the pollutant during the third year and no more than 37 months following the previous performance test for the pollutant. For cadmium and lead, both cadmium and lead must be emitted at emission levels no greater than their respective emission levels specified in paragraph (a)(3)(i) of this section for you to qualify for less frequent testing under paragraph (a) of this section:
(i) For particulate matter, hydrogen chloride, mercury, carbon monoxide, nitrogen oxides, sulfur dioxide, cadmium, lead, and dioxins/furans, the emission level equal to 75 percent of the applicable emission limit in table 2 or tables 6 through 9 of this subpart, as applicable, to this subpart; and
(ii) For fugitive emissions, visible emissions (of combustion ash from the ash conveying system) for 2 percent of the time during each of the three 1-hour observation periods.
(4) If you are conducting less frequent testing for a pollutant as provided in paragraph (a)(3) of this section and a subsequent performance test for the pollutant indicates that your CISWI unit does not meet the emission level specified in paragraph (a)(3)(i) or (a)(3)(ii) of this section, as applicable, you must conduct annual performance tests for the pollutant according to the schedule specified in paragraph (a) of this section until you qualify for less frequent testing for the pollutant as specified in paragraph (a)(3) of this section.
(b) [Reserved]
(a) Yes. You may conduct a repeat performance test at any time to establish new values for the operating limits. The Administrator may request a repeat performance test at any time.
(b) You must repeat the performance test if your feed stream is different than the feed streams used during any performance test used to demonstrate compliance.
(a) If you are using a wet scrubber to comply with the emission limitation under § 60.2670, you must install, calibrate (to manufacturers' specifications), maintain, and operate devices (or establish methods) for monitoring the value of the operating parameters used to determine compliance with the operating limits listed in table 3 of this subpart. These devices (or methods) must measure and record the values for these operating parameters at the frequencies indicated in table 3 of this subpart at all times except as specified in § 60.2735(a).
(b) If you use a fabric filter to comply with the requirements of this subpart and you do not use a PM CPMS for monitoring PM compliance, you must install, calibrate, maintain, and continuously operate a bag leak detection system as specified in paragraphs (b)(1) through (8) of this section:
(1) You must install and operate a bag leak detection system for each exhaust stack of the fabric filter;
(2) Each bag leak detection system must be installed, operated, calibrated, and maintained in a manner consistent with the manufacturer's written specifications and recommendations;
(3) The bag leak detection system must be certified by the manufacturer to be capable of detecting particulate matter emissions at concentrations of 10 milligrams per actual cubic meter or less;
(4) The bag leak detection system sensor must provide output of relative or absolute particulate matter loadings;
(5) The bag leak detection system must be equipped with a device to continuously record the output signal from the sensor;
(6) The bag leak detection system must be equipped with an alarm system that will alert automatically an operator when an increase in relative particulate matter emission over a preset level is detected. The alarm must be located where it is observed easily by plant operating personnel;
(7) For positive pressure fabric filter systems, a bag leak detection system must be installed in each baghouse compartment or cell. For negative pressure or induced air fabric filters, the bag leak detector must be installed downstream of the fabric filter; and
(8) Where multiple detectors are required, the system's instrumentation and alarm may be shared among detectors.
(c) If you are using something other than a wet scrubber, activated carbon, selective non-catalytic reduction, an electrostatic precipitator, or a dry scrubber to comply with the emission limitations under § 60.2670, you must install, calibrate (to the manufacturers' specifications), maintain, and operate the equipment necessary to monitor compliance with the site-specific operating limits established using the procedures in § 60.2680.
(d) If you use activated carbon injection to comply with the emission limitations in this subpart, you must measure the minimum sorbent flow rate once per hour.
(e) If you use selective noncatalytic reduction to comply with the emission limitations, you must complete the following:
(1) Following the date on which the initial performance test is completed or is required to be completed under § 60.2690, whichever date comes first, ensure that the affected facility does not operate above the maximum charge rate, or below the minimum secondary chamber temperature (if applicable to your CISWI unit) or the minimum reagent flow rate measured as 3-hour block averages at all times; and
(2) Operation of the affected facility above the maximum charge rate, below the minimum secondary chamber temperature and below the minimum reagent flow rate simultaneously constitute a violation of the nitrogen oxides emissions limit.
(f) If you use an electrostatic precipitator to comply with the emission limits of this subpart and you do not use a PM CPMS for monitoring PM compliance, you must monitor the secondary power to the electrostatic precipitator collection plates and maintain the 3-hour block averages at or above the operating limits established during the mercury or particulate matter performance test.
(g) For waste-burning kilns not equipped with a wet scrubber or dry scrubber, in place of hydrogen chloride testing with EPA Method 321 at 40 CFR part 63, appendix A, an owner or operator must install, calibrate, maintain, and operate a CEMS for monitoring hydrogen chloride emissions, as specified in § 60.2710(j), discharged to the atmosphere and record the output of the system. To demonstrate continuous compliance with the hydrogen chloride emissions limit for units other than waste-burning kilns not equipped with a wet scrubber or dry scrubber, a facility may substitute use of a hydrogen chloride CEMS for conducting the hydrogen chloride annual performance test, monitoring the minimum hydrogen chloride sorbent flow rate, monitoring the minimum scrubber liquor pH.
(h) To demonstrate continuous compliance with the particulate matter emissions limit, a facility may substitute use of either a particulate matter CEMS or a particulate matter CPMS for conducting the particulate matter annual performance test and other CMS monitoring for PM compliance (
(i) To demonstrate continuous compliance with the dioxin/furan emissions limit, a facility may substitute use of a continuous automated sampling system for the dioxin/furan annual performance test. You must record the output of the system and analyze the sample according to EPA Method 23 at 40 CFR part 60, appendix A–7. This option to use a continuous automated sampling system takes effect on the date a final performance specification applicable to dioxin/furan from continuous monitors is published in the
(j) To demonstrate continuous compliance with the mercury emissions limit, a facility may substitute use of a continuous automated sampling system for the mercury annual performance test. You must record the output of the system and analyze the sample at set intervals using any suitable determinative technique that can meet performance specification 12B criteria. This option to use a continuous automated sampling system takes effect on the date a final performance specification applicable to mercury from monitors is published in the
(k) To demonstrate continuous compliance with the nitrogen oxides emissions limit, a facility may substitute use of a CEMS for the nitrogen oxides annual performance test to demonstrate compliance with the nitrogen oxides emissions limits and monitoring the charge rate, secondary chamber temperature and reagent flow for selective noncatalytic reduction, if applicable:
(1) Install, calibrate, maintain and operate a CEMS for measuring nitrogen oxides emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 2 of appendix B of this part, the quality assurance procedure 1 of appendix F of this part and the procedures under § 60.13 must be followed for installation, evaluation and operation of the CEMS; and
(2) Following the date that the initial performance test for nitrogen oxides is completed or is required to be completed under § 60.2690, compliance with the emission limit for nitrogen oxides required under § 60.52b(d) must be determined based on the 30-day rolling average of the hourly emission concentrations using CEMS outlet data. The 1-hour arithmetic averages must be expressed in parts per million by volume corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average concentrations.
(l) To demonstrate continuous compliance with the sulfur dioxide emissions limit, a facility may substitute use of a continuous automated sampling system for the sulfur dioxide annual performance test to demonstrate compliance with the sulfur dioxide emissions limits:
(1) Install, calibrate, maintain and operate a CEMS for measuring sulfur dioxide emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 2 of appendix B of this part, the quality assurance requirements of procedure 1 of appendix F of this part and the procedures under § 60.13 must be followed for installation, evaluation and operation of the CEMS; and
(2) Following the date that the initial performance test for sulfur dioxide is completed or is required to be completed under § 60.2690, compliance with the sulfur dioxide emission limit may be determined based on the 30-day rolling average of the hourly arithmetic average emission concentrations using CEMS outlet data. The 1-hour arithmetic averages must be expressed in parts per million corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average emission concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2).
(m) For energy recovery units over 10 MMBtu/hr but less than 250 MMBtu/hr annual average heat input rates that do not use a wet scrubber, fabric filter with bag leak detection system, or particulate matter CEMS, you must install, operate, certify and maintain a continuous opacity monitoring system according to the procedures in paragraphs (m)(1) through (5) of this section by the compliance date specified in § 60.2670. Energy recovery units that use a particulate matter CEMS to demonstrate initial and continuing compliance according to the procedures in § 60.2730(n) are not required to install a continuous opacity monitoring system and must perform the annual performance tests for opacity consistent with § 60.2710(f):
(1) Install, operate and maintain each continuous opacity monitoring system according to performance specification 1 at 40 CFR part 60, appendix B;
(2) Conduct a performance evaluation of each continuous opacity monitoring system according to the requirements in § 60.13 and according to performance specification 1 at 40 CFR part 60, appendix B;
(3) As specified in § 60.13(e)(1), each continuous opacity monitoring system must complete a minimum of one cycle of sampling and analyzing for each successive 10-second period and one cycle of data recording for each successive 6-minute period;
(4) Reduce the continuous opacity monitoring system data as specified in § 60.13(h)(1); and
(5) Determine and record all the 6-minute averages (and 1-hour block averages as applicable) collected.
(n) For coal and liquid/gas energy recovery units, incinerators, and small remote incinerators, an owner or operator may elect to install, calibrate, maintain and operate a CEMS for monitoring particulate matter emissions discharged to the atmosphere and record the output of the system. The owner or operator of an affected facility who continuously monitors particulate matter emissions instead of conducting performance testing using EPA Method 5 at 40 CFR part 60, appendix A–3 or, as applicable, monitor with a particulate matter CPMS according to paragraph (r) of this section, must install, calibrate, maintain and operate a CEMS and must comply with the requirements specified in paragraphs (n)(1) through (13) of this section:
(1) Notify the Administrator 1 month before starting use of the system;
(2) Notify the Administrator 1 month before stopping use of the system;
(3) The monitor must be installed, evaluated and operated in accordance with the requirements of performance specification 11 of appendix B of this part and quality assurance requirements of procedure 2 of appendix F of this part and § 60.13;
(4) The initial performance evaluation must be completed no later than 180 days after the final compliance date for meeting the amended emission limitations, as specified under § 60.2690 or within 180 days of notification to the Administrator of use of the continuous monitoring system if the owner or operator was previously determining compliance by Method 5 at 40 CFR part 60, appendix A–3 performance tests, whichever is later;
(5) The owner or operator of an affected facility may request that compliance with the particulate matter emission limit be determined using carbon dioxide measurements corrected to an equivalent of 7 percent oxygen. The relationship between oxygen and carbon dioxide levels for the affected facility must be established according to the procedures and methods specified in § 60.2710(t)(4)(i) through (iv);
(6) The owner or operator of an affected facility must conduct an initial performance test for particulate matter emissions as required under § 60.2690. Compliance with the particulate matter emission limit, if PM CEMS are elected for demonstrating compliance, must be determined by using the CEMS specified in paragraph (n) of this section to measure particulate matter. You must calculate a 30-day rolling average of 1-hour arithmetic average emission concentrations, including CEMS data during startup and shutdown, as defined in this subpart, using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, appendix A–7 of this part;
(7) Compliance with the particulate matter emission limit must be determined based on the 30-day rolling average calculated using equation 19–19 in section 12.4.1 of EPA Reference Method 19 at 40 CFR part 60, Appendix A–7 of the part from the 1-hour arithmetic average of the CEMS outlet data.
(8) At a minimum, valid continuous monitoring system hourly averages must be obtained as specified § 60.2735;
(9) The 1-hour arithmetic averages required under paragraph (n)(7) of this section must be expressed in milligrams per dry standard cubic meter corrected to 7 percent oxygen (or carbon dioxide) (dry basis) and must be used to calculate the 30-day rolling average emission concentrations. CEMS data during startup and shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2);
(10) All valid CEMS data must be used in calculating average emission concentrations even if the minimum CEMS data requirements of paragraph (n)(8) of this section are not met;
(11) The CEMS must be operated according to performance specification 11 in appendix B of this part;
(12) During each relative accuracy test run of the CEMS required by performance specification 11 in appendix B of this part, particulate matter and oxygen (or carbon dioxide) data must be collected concurrently (or within a 30-to 60-minute period) by both the CEMS and the following test methods:
(i) For particulate matter, EPA Reference Method 5 at 40 CFR part 60, appendix A–3 must be used; and
(ii) For oxygen (or carbon dioxide), EPA Reference Method 3A or 3B at 40 CFR part 60, appendix A–2, as applicable, must be used; and
(13) Quarterly accuracy determinations and daily calibration drift tests must be performed in accordance with procedure 2 in appendix F of this part.
(o) To demonstrate continuous compliance with the carbon monoxide emissions limit, a facility may substitute use of a continuous automated sampling system for the carbon monoxide annual performance test to demonstrate compliance with the carbon monoxide emissions limits:
(1) Install, calibrate, maintain, and operate a CEMS for measuring carbon monoxide emissions discharged to the atmosphere and record the output of the system. The requirements under performance specification 4B of appendix B of this part, the quality assurance procedure 1 of appendix F of this part and the procedures under § 60.13 must be followed for installation, evaluation, and operation of the CEMS; and
(2) Following the date that the initial performance test for carbon monoxide is completed or is required to be completed under § 60.2690, compliance with the carbon monoxide emission limit may be determined based on the 30-day rolling average of the hourly arithmetic average emission concentrations, including CEMS data during startup and shutdown as defined in this subpart, using CEMS outlet data. Except for CEMS data during startup and shutdown, as defined in this subpart, the 1-hour arithmetic averages must be expressed in parts per million corrected to 7 percent oxygen (dry basis) and used to calculate the 30-day rolling average emission concentrations. CEMS data collected during startup or shutdown, as defined in this subpart, are not corrected to 7 percent oxygen, and are measured at stack oxygen content. The 1-hour arithmetic averages must be calculated using the data points required under § 60.13(e)(2).
(p) The owner/operator of an affected source with a bypass stack shall install, calibrate (to manufacturers' specifications), maintain and operate a device or method for measuring the use of the bypass stack including date, time and duration.
(q) For energy recovery units with a heat input capacity of 100 MMBtu per hour or greater that do not use a carbon monoxide CEMS, you must install, operate and maintain the continuous oxygen monitoring system as defined in § 60.2875 according to the procedures in paragraphs (q)(1) through (4) of this section:
(1) The oxygen analyzer system must be installed by the initial performance test date specified in § 60.2675;
(2) You must operate the oxygen trim system within compliance with paragraph (q)(3) of this section at all times;
(3) You must maintain the oxygen level such that the 30-day rolling average that is established as the operating limit for oxygen according to paragraph (q)(4) of this section is not below the lowest hourly average oxygen concentration measured during the most recent CO performance test; and
(4) You must calculate and record a 30-day rolling average oxygen concentration using equation 19–19 in section 12.4.1 of EPA Reference Method 19 of Appendix A–7 of this part.
(r) For energy recovery units with annual average heat input rates greater than or equal to 250 MMBtu/hour and waste-burning kilns, you must install, calibrate, maintain, and operate a PM CPMS and record the output of the system as specified in paragraphs (r)(1) through (8) of this section. For other energy recovery units, you may elect to use PM CPMS operated in accordance with this section. PM CPMS are suitable in lieu of using other CMS for monitoring PM compliance (
(1) Install, calibrate, operate, and maintain your PM CPMS according to the procedures in your approved site-specific monitoring plan developed in accordance with § 60.2710(l) and (r)(1)(i) through (iii) of this section:
(i) The operating principle of the PM CPMS must be based on in-stack or extractive light scatter, light scintillation, beta attenuation, or mass accumulation of the exhaust gas or representative sample. The reportable measurement output from the PM CPMS must be expressed as milliamps or the digital signal equivalent;
(ii) The PM CPMS must have a cycle time (
(iii) The PM CPMS must be capable of detecting and responding to particulate matter concentrations increments no greater than 0.5 mg/actual cubic meter.
(2) During the initial performance test or any such subsequent performance test that demonstrates compliance with the PM limit, you must adjust the site-specific operating limit in accordance with the results of the performance test according to the procedures specified in § 60.2675.
(3) Collect PM CPMS hourly average output data for all energy recovery unit or waste-burning kiln operating hours. Express the PM CPMS output as milliamps or the digital signal equivalent.
(4) Calculate the arithmetic 30-day rolling average of all of the hourly average PM CPMS output collected during all energy recovery unit or waste-burning kiln operating hours data (milliamps or digital bits).
(5) You must collect data using the PM CPMS at all times the energy recovery unit or waste-burning kiln is operating and at the intervals specified in paragraph (r)(1)(ii) of this section, except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, required monitoring system quality assurance or quality control activities (including, as applicable, calibration checks and required zero and span adjustments), and any scheduled maintenance as defined in your site-specific monitoring plan.
(6) You must use all the data collected during all energy recovery unit or waste-burning kiln operating hours in assessing the compliance with your operating limit except:
(i) Any data collected during monitoring system malfunctions, repairs associated with monitoring system malfunctions, or required monitoring system quality assurance or quality control activities conducted during monitoring system malfunctions are not used in calculations (report any such periods in your annual deviation report);
(ii) Any data collected during periods when the monitoring system is out of control as specified in your site-specific monitoring plan, repairs associated with periods when the monitoring system is out of control, or required monitoring system quality assurance or quality control activities conducted during out-of-control periods are not used in calculations (report emissions or operating levels and report any such periods in your annual deviation report); and
(iii) Any PM CPMS data recorded during periods of CEMS data during startup and shutdown, as defined in this subpart.
(7) You must record and make available upon request results of PM CPMS system performance audits, as well as the dates and duration of periods from when the PM CPMS is out of control until completion of the corrective actions necessary to return
(8) For any deviation of the 30-day rolling average PM CPMS average value from the established operating parameter limit, you must:
(i) Within 48 hours of the deviation, visually inspect the air pollution control device;
(ii) If inspection of the air pollution control device identifies the cause of the deviation, take corrective action as soon as possible and return the PM CPMS measurement to within the established value;
(iii) Within 30 days of the deviation or at the time of the annual compliance test, whichever comes first, conduct a PM emissions compliance test to determine compliance with the PM emissions limit and to verify the operation of the emissions control device(s). Within 45 days of the deviation, you must re-establish the CPMS operating limit. You are not required to conduct additional testing for any deviations that occur between the time of the original deviation and the PM emissions compliance test required under this paragraph; and
(iv) PM CPMS deviations leading to more than four required performance tests in a 12-month process operating period (rolling monthly) constitute a violation of this subpart.
(s) If you use a dry scrubber to comply with the emission limits of this subpart, you must monitor the injection rate of each sorbent and maintain the 3-hour block averages at or above the operating limits established during the hydrogen chloride performance test.
For each continuous monitoring system required or optionally allowed under § 60.2730, you must monitor and collect data according to this section:
(a) You must operate the monitoring system and collect data at all required intervals at all times compliance is required except for periods of monitoring system malfunctions or out-of-control periods, repairs associated with monitoring system malfunctions or out-of-control periods (as specified in § 60.2770(o)), and required monitoring system quality assurance or quality control activities including, as applicable, calibration checks and required zero and span adjustments. A monitoring system malfunction is any sudden, infrequent, not reasonably preventable failure of the monitoring system to provide valid data. Monitoring system failures that are caused in part by poor maintenance or careless operation are not malfunctions. You are required to effect monitoring system repairs in response to monitoring system malfunctions or out-of-control periods and to return the monitoring system to operation as expeditiously as practicable.
(b) You may not use data recorded during the monitoring system malfunctions, repairs associated with monitoring system malfunctions or out-of control periods, or required monitoring system quality assurance or control activities in calculations used to report emissions or operating levels. You must use all the data collected during all other periods, including data normalized for above scale readings, in assessing the operation of the control device and associated control system.
(c) Except for periods of monitoring system malfunctions or out-of-control periods, repairs associated with monitoring system malfunctions or out-of-control periods, and required monitoring system quality assurance or quality control activities including, as applicable, calibration checks and required zero and span adjustments, failure to collect required data is a deviation of the monitoring requirements.
You must maintain the items (as applicable) as specified in paragraphs (a), (b), and (e) through (w) of this section for a period of at least 5 years:
(a) Calendar date of each record;
(b) Records of the data described in paragraphs (b)(1) through (6) of this section:
(1) The CISWI unit charge dates, times, weights, and hourly charge rates;
(2) Liquor flow rate to the wet scrubber inlet every 15 minutes of operation, as applicable;
(3) Pressure drop across the wet scrubber system every 15 minutes of operation or amperage to the wet scrubber every 15 minutes of operation, as applicable;
(4) Liquor pH as introduced to the wet scrubber every 15 minutes of operation, as applicable;
(5) For affected CISWI units that establish operating limits for controls other than wet scrubbers under § 60.2675(d) through (g) or § 60.2680, you must maintain data collected for all operating parameters used to determine compliance with the operating limits. For energy recovery units using activated carbon injection or a dry scrubber, you must also maintain records of the load fraction and corresponding sorbent injection rate records; and
(6) If a fabric filter is used to comply with the emission limitations, you must record the date, time, and duration of each alarm and the time corrective action was initiated and completed, and a brief description of the cause of the alarm and the corrective action taken. You must also record the percent of operating time during each 6-month period that the alarm sounds, calculated as specified in § 60.2675(c).
(c)–(d) [Reserved]
(e) Identification of calendar dates and times for which data show a deviation from the operating limits in table 3 of this subpart or a deviation from other operating limits established under § 60.2675(d) through (g) or § 60.2680 with a description of the deviations, reasons for such deviations, and a description of corrective actions taken.
(f) The results of the initial, annual, and any subsequent performance tests conducted to determine compliance with the emission limits and/or to establish operating limits, as applicable. Retain a copy of the complete test report including calculations.
(g) Records showing the names of CISWI unit operators who have completed review of the information in § 60.2660(a) as required by § 60.2660(b), including the date of the initial review and all subsequent annual reviews.
(h) Records showing the names of the CISWI operators who have completed the operator training requirements under § 60.2635, met the criteria for qualification under § 60.2645, and maintained or renewed their qualification under § 60.2650 or § 60.2655. Records must include documentation of training, the dates of the initial and refresher training, and the dates of their qualification and all subsequent renewals of such qualifications.
(i) For each qualified operator, the phone and/or pager number at which they can be reached during operating hours.
(j) Records of calibration of any monitoring devices as required under § 60.2730.
(k) Equipment vendor specifications and related operation and maintenance requirements for the incinerator, emission controls, and monitoring equipment.
(l) The information listed in § 60.2660(a).
(m) On a daily basis, keep a log of the quantity of waste burned and the types of waste burned (always required).
(n) Maintain records of the annual air pollution control device inspections that are required for each CISWI unit subject to the emissions limits in table
(o) For continuously monitored pollutants or parameters, you must document and keep a record of the following parameters measured using continuous monitoring systems:
(1) All 6-minute average levels of opacity;
(2) All 1-hour average concentrations of sulfur dioxide emissions. You must indicate which data are CEMS data during startup and shutdown;
(3) All 1-hour average concentrations of nitrogen oxides emissions. You must indicate which data are CEMS data during startup and shutdown;
(4) All 1-hour average concentrations of carbon monoxide emissions. You must indicate which data are CEMS data during startup and shutdown;
(5) All 1-hour average concentrations of particulate matter emissions. You must indicate which data are CEMS data during startup and shutdown;
(6) All 1-hour average concentrations of mercury emissions. You must indicate which data are CEMS data during startup and shutdown;
(7) All 1-hour average concentrations of hydrogen chloride emissions. You must indicate which data are CEMS data during startup and shutdown;
(8) All 1-hour average percent oxygen concentrations; and
(9) All 1-hour average PM CPMS readings or particulate matter CEMS outputs.
(p) Records indicating use of the bypass stack, including dates, times and durations.
(q) If you choose to stack test less frequently than annually, consistent with § 60.2720(a) through (c), you must keep annual records that document that your emissions in the previous stack test(s) were less than 75 percent of the applicable emission limit and document that there was no change in source operations including fuel composition and operation of air pollution control equipment that would cause emissions of the relevant pollutant to increase within the past year.
(r) Records of the occurrence and duration of each malfunction of operation (
(s) Records of all required maintenance performed on the air pollution control and monitoring equipment.
(t) Records of actions taken during periods of malfunction to minimize emissions in accordance with § 60.11(d), including corrective actions to restore malfunctioning process and air pollution control and monitoring equipment to its normal or usual manner of operation.
(u) For operating units that combust non-hazardous secondary materials that have been determined not to be solid waste pursuant to § 241.3(b)(1) of this chapter, you must keep a record which documents how the secondary material meets each of the legitimacy criteria under § 241.3(d)(1). If you combust a fuel that has been processed from a discarded non-hazardous secondary material pursuant to § 241.3(b)(4), you must keep records as to how the operations that produced the fuel satisfies the definition of processing in § 241.2 and each of the legitimacy criteria in § 241.3(d)(1) of this chapter. If the fuel received a non-waste determination pursuant to the petition process submitted under § 241.3(c), you must keep a record that documents how the fuel satisfies the requirements of the petition process. For operating units that combust non-hazardous secondary materials as fuel per § 241.4, you must keep records documenting that the material is a listed non-waste under § 241.4(a).
(v) Records of the criteria used to establish that the unit qualifies as a small power production facility under section 3(17)(C) of the Federal Power Act (16 U.S.C. 796(17)(C)) and that the waste material the unit is proposed to burn is homogeneous.
(w) Records of the criteria used to establish that the unit qualifies as a cogeneration facility under section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B)) and that the waste material the unit is proposed to burn is homogeneous.
All records must be available onsite in either paper copy or computer-readable format that can be printed upon request, unless an alternative format is approved by the Administrator.
See table 5 of this subpart for a summary of the reporting requirements.
You must submit the waste management plan no later than the date specified in table 1 of this subpart for submittal of the final control plan.
You must submit the information specified in paragraphs (a) through (c) of this section no later than 60 days following the initial performance test. All reports must be signed by the facilities manager:
(a) The complete test report for the initial performance test results obtained under § 60.2700, as applicable;
(b) The values for the site-specific operating limits established in § 60.2675 or § 60.2680; and
(c) If you are using a fabric filter to comply with the emission limitations, documentation that a bag leak detection system has been installed and is being operated, calibrated, and maintained as required by § 60.2730(b).
You must submit an annual report no later than 12 months following the submission of the information in § 60.2760. You must submit subsequent reports no more than 12 months following the previous report. (If the unit is subject to permitting requirements under title V of the Clean Air Act, you may be required by the permit to submit these reports more frequently.)
The annual report required under § 60.2765 must include the ten items listed in paragraphs (a) through (j) of this section. If you have a deviation from the operating limits or the emission limitations, you must also submit deviation reports as specified in §§ 60.2775, 60.2780, and 60.2785:
(a) Company name and address;
(b) Statement by a responsible official, with that official's name, title, and signature, certifying the accuracy of the content of the report;
(c) Date of report and beginning and ending dates of the reporting period;
(d) The values for the operating limits established pursuant to § 60.2675 or § 60.2680;
(e) If no deviation from any emission limitation or operating limit that applies to you has been reported, a statement that there was no deviation from the emission limitations or operating limits during the reporting period;
(f) The highest recorded 3-hour average and the lowest recorded 3-hour average, as applicable, for each operating parameter recorded for the calendar year being reported;
(g) Information recorded under § 60.2740(b)(6) and (c) through (e) for the calendar year being reported;
(h) For each performance test conducted during the reporting period, if any performance test is conducted, the process unit(s) tested, the pollutant(s) tested and the date that such performance test was conducted. Submit, following the procedure specified in § 60.2795(b)(1), the performance test report no later than the date that you submit the annual report;
(i) If you met the requirements of § 60.2720(a) or (b), and did not conduct a performance test during the reporting period, you must state that you met the requirements of § 60.2720(a) or (b), and, therefore, you were not required to conduct a performance test during the reporting period;
(j) Documentation of periods when all qualified CISWI unit operators were unavailable for more than 8 hours, but less than 2 weeks;
(k) If you had a malfunction during the reporting period, the compliance report must include the number, duration, and a brief description for each type of malfunction that occurred during the reporting period and that caused or may have caused any applicable emission limitation to be exceeded. The report must also include a description of actions taken by an owner or operator during a malfunction of an affected source to minimize emissions in accordance with § 60.11(d), including actions taken to correct a malfunction;
(l) For each deviation from an emission or operating limitation that occurs for a CISWI unit for which you are not using a CMS to comply with the emission or operating limitations in this subpart, the annual report must contain the following information:
(1) The total operating time of the CISWI unit at which the deviation occurred during the reporting period; and
(2) Information on the number, duration, and cause of deviations (including unknown cause, if applicable), as applicable, and the corrective action taken.
(m) If there were periods during which the continuous monitoring system, including the CEMS, was out of control as specified in paragraph (o) of this section, the annual report must contain the following information for each deviation from an emission or operating limitation occurring for a CISWI unit for which you are using a continuous monitoring system to comply with the emission and operating limitations in this subpart:
(1) The date and time that each malfunction started and stopped;
(2) The date, time, and duration that each CMS was inoperative, except for zero (low-level) and high-level checks;
(3) The date, time, and duration that each continuous monitoring system was out-of-control, including start and end dates and hours and descriptions of corrective actions taken;
(4) The date and time that each deviation started and stopped, and whether each deviation occurred during a period of malfunction or during another period;
(5) A summary of the total duration of the deviation during the reporting period, and the total duration as a percent of the total source operating time during that reporting period;
(6) A breakdown of the total duration of the deviations during the reporting period into those that are due to control equipment problems, process problems, other known causes, and other unknown causes;
(7) A summary of the total duration of continuous monitoring system downtime during the reporting period, and the total duration of continuous monitoring system downtime as a percent of the total operating time of the CISWI unit at which the continuous monitoring system downtime occurred during that reporting period;
(8) An identification of each parameter and pollutant that was monitored at the CISWI unit;
(9) A brief description of the CISWI unit;
(10) A brief description of the continuous monitoring system;
(11) The date of the latest continuous monitoring system certification or audit; and
(12) A description of any changes in continuous monitoring system, processes, or controls since the last reporting period.
(n) If there were periods during which the continuous monitoring system, including the CEMS, was not out of control as specified in paragraph (o) of this section, a statement that there were not periods during which the continuous monitoring system was out of control during the reporting period.
(o) A continuous monitoring system is out of control if any of the following occur:
(1) The zero (low-level), mid-level (if applicable), or high-level calibration drift exceeds two times the applicable calibration drift specification in the applicable performance specification or in the relevant standard;
(2) The continuous monitoring system fails a performance test audit (
(3) The continuous opacity monitoring system calibration drift exceeds two times the limit in the applicable performance specification in the relevant standard.
(p) For energy recovery units, include the annual heat input and average annual heat input rate of all fuels being burned in the unit to verify which subcategory of energy recovery unit applies.
(a) You must submit a deviation report if any recorded 3-hour average parameter level is above the maximum operating limit or below the minimum operating limit established under this subpart, if the bag leak detection system alarm sounds for more than 5 percent of the operating time for the 6-month reporting period, or if a performance test was conducted that deviated from any emission limitation.
(b) The deviation report must be submitted by August 1 of that year for data collected during the first half of the calendar year (January 1 to June 30), and by February 1 of the following year for data you collected during the second half of the calendar year (July 1 to December 31).
In each report required under § 60.2775, for any pollutant or parameter that deviated from the emission limitations or operating limits specified in this subpart, include the four items described in paragraphs (a) through (d) of this section:
(a) The calendar dates and times your unit deviated from the emission limitations or operating limit requirements;
(b) The averaged and recorded data for those dates;
(c) Durations and causes of the following:
(1) Each deviation from emission limitations or operating limits and your corrective actions; and
(2) Bypass events and your corrective actions.
(d) A copy of the operating limit monitoring data during each deviation and for any test report that documents the emission levels the process unit(s) tested, the pollutant(s) tested and the date that the performance test was conducted. Submit, following the procedure specified in § 60.2795(b)(1), the performance test report no later than the date that you submit the deviation report.
(a) If all qualified operators are not accessible for 2 weeks or more, you must take the two actions in paragraphs (a)(1) and (2) of this section:
(1) Submit a notification of the deviation within 10 days that includes the three items in paragraphs (a)(1)(i) through (iii) of this section:
(i) A statement of what caused the deviation;
(ii) A description of what you are doing to ensure that a qualified operator is accessible; and
(iii) The date when you anticipate that a qualified operator will be available.
(2) Submit a status report to the Administrator every 4 weeks that includes the three items in paragraphs (a)(2)(i) through (iii) of this section:
(i) A description of what you are doing to ensure that a qualified operator is accessible;
(ii) The date when you anticipate that a qualified operator will be accessible; and
(iii) Request approval from the Administrator to continue operation of the CISWI unit.
(b) If your unit was shut down by the Administrator, under the provisions of § 60.2665(b)(2), due to a failure to provide an accessible qualified operator, you must notify the Administrator that you are resuming operation once a qualified operator is accessible.
(a) Yes. You must submit notifications as provided by § 60.7.
(b) If you cease combusting solid waste but continue to operate, you must provide 30 days prior notice of the effective date of the waste-to-fuel switch, consistent with § 60.2710(a). The notification must identify:
(1) The name of the owner or operator of the CISWI unit, the location of the source, the emissions unit(s) that will cease burning solid waste, and the date of the notice;
(2) The currently applicable subcategory under this subpart, and any 40 CFR part 63 subpart and subcategory that will be applicable after you cease combusting solid waste;
(3) The fuel(s), non-waste material(s) and solid waste(s) the CISWI unit is currently combusting and has combusted over the past 6 months, and the fuel(s) or non-waste materials the unit will commence combusting;
(4) The date on which you became subject to the currently applicable emission limits; and
(5) The date upon which you will cease combusting solid waste, and the date (if different) that you intend for any new requirements to become applicable (
(a) Submit initial, annual and deviation reports electronically on or before the submittal due dates. Submit the reports to the EPA via the Compliance and Emissions Data Reporting Interface (CEDRI). (CEDRI can be accessed through the EPA's Central Data Exchange (CDX) (
(b) Submit results of each performance test and CEMS performance evaluation required by this subpart as follows:
(1) Within 60 days after the date of completing each performance test (
(i) For data collected using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT Web site (
(ii) For data collected using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the test, you must submit the results of the performance test to the Administrator at the appropriate address listed in § 60.4.
(2) Within 60 days after the date of completing each continuous emissions monitoring system performance evaluation you must submit the results of the performance evaluation following the procedure specified in either paragraph (b)(1) or (b)(2) of this section:
(i) For performance evaluations of continuous monitoring systems measuring relative accuracy test audit (RATA) pollutants that are supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of the evaluation, you must submit the results of the performance evaluation to the EPA via the CEDRI. (CEDRI can be accessed through the EPA's CDX.) Performance evaluation data must be submitted in a file format generated through the use of the EPA's ERT or an alternate file format consistent with the XML schema listed on the EPA's ERT Web site. If you claim that some of the performance evaluation information being submitted is CBI, you must submit a complete file generated through the use of the EPA's ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT Web site, including information claimed to be CBI, on a compact disc, flash drive, or other commonly used electronic storage media to the EPA. The electronic storage media must be clearly marked as CBI and mailed to U.S. EPA/OAQPS/CORE CBI Office, Attention: Group Leader, Measurement Policy Group, MD C404–02, 4930 Old Page Rd., Durham, NC 27703. The same ERT or alternate file with the CBI omitted must be submitted to the EPA via the EPA's CDX as described earlier in this paragraph; and
(ii) For any performance evaluations of continuous monitoring systems measuring RATA pollutants that are not supported by the EPA's ERT as listed on the EPA's ERT Web site at the time of
If the Administrator agrees, you may change the semiannual or annual reporting dates. See § 60.19(c) for procedures to seek approval to change your reporting date.
Yes. Each CISWI unit and air curtain incinerator subject to standards under this subpart must operate pursuant to a permit issued under Clean Air Act sections 129(e) and Title V.
(a) An air curtain incinerator operates by forcefully projecting a curtain of air across an open chamber or open pit in which combustion occurs. Incinerators of this type can be constructed above or below ground and with or without refractory walls and floor. (Air curtain incinerators are not to be confused with conventional combustion devices with enclosed fireboxes and controlled air technology such as mass burn, modular, and fluidized bed combustors.)
(b) Air curtain incinerators that burn only the materials listed in paragraphs (b)(1) through (3) of this section are only required to meet the requirements under § 60.2805 and under “Air Curtain Incinerators” (§§ 60.2810 through 60.2870):
(1) 100 percent wood waste;
(2) 100 percent clean lumber; and
(3) 100 percent mixture of only wood waste, clean lumber, and/or yard waste.
If you plan to achieve compliance more than 1 year following the effective date of state plan approval, you must meet the two increments of progress specified in paragraphs (a) and (b) of this section:
(a) Submit a final control plan; and
(b) Achieve final compliance.
Table 1 of this subpart specifies compliance dates for each of the increments of progress.
Your notification of achievement of increments of progress must include the three items described in paragraphs (a) through (c) of this section:
(a) Notification that the increment of progress has been achieved;
(b) Any items required to be submitted with each increment of progress (see § 60.2840); and
(c) Signature of the owner or operator of the incinerator.
Notifications for achieving increments of progress must be postmarked no later than 10 business days after the compliance date for the increment.
If you fail to meet an increment of progress, you must submit a notification to the Administrator postmarked within 10 business days after the date for that increment of progress in table 1 of this subpart. You must inform the Administrator that you did not meet the increment, and you must continue to submit reports each subsequent calendar month until the increment of progress is met.
For your control plan increment of progress, you must satisfy the two requirements specified in paragraphs (a) and (b) of this section:
(a) Submit the final control plan, including a description of any devices for air pollution control and any process changes that you will use to comply with the emission limitations and other requirements of this subpart; and
(b) Maintain an onsite copy of the final control plan.
For the final compliance increment of progress, you must complete all process changes and retrofit construction of control devices, as specified in the final control plan, so that, if the affected incinerator is brought online, all necessary process changes and air pollution control devices would operate as designed.
(a) If you close your incinerator but will reopen it prior to the final compliance date in your state plan, you must meet the increments of progress specified in § 60.2815.
(b) If you close your incinerator but will restart it after your final compliance date, you must complete emission control retrofits and meet the emission limitations on the date your incinerator restarts operation.
If you plan to close your incinerator rather than comply with the state plan, submit a closure notification, including the date of closure, to the Administrator by the date your final control plan is due.
After the date the initial stack test is required or completed (whichever is earlier), you must meet the limitations in paragraphs (a) and (b) of this section:
(a) Maintain opacity to less than or equal to 10 percent opacity (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values), except as described in paragraph (b) of this section; and
(b) Maintain opacity to less than or equal to 35 percent opacity (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values) during the startup period that is within the first 30 minutes of operation.
(a) Use Method 9 of appendix A of this part to determine compliance with the opacity limitation.
(b) Conduct an initial test for opacity as specified in § 60.8 no later than 180 days after your final compliance date.
(c) After the initial test for opacity, conduct annual tests no more than 12 calendar months following the date of your previous test.
(a) Keep records of results of all initial and annual opacity tests onsite in either paper copy or electronic format, unless the Administrator approves another format, for at least 5 years.
(b) Make all records available for submittal to the Administrator or for an inspector's onsite review.
(c) Submit an initial report no later than 60 days following the initial opacity test that includes the information specified in paragraphs (c)(1) and (2) of this section:
(1) The types of materials you plan to combust in your air curtain incinerator; and
(2) The results (as determined by the average of three 1-hour blocks consisting of ten 6-minute average opacity values) of the initial opacity tests.
(d) Submit annual opacity test results within 12 months following the previous report.
(e) Submit initial and annual opacity test reports as electronic or paper copy on or before the applicable submittal date and keep a copy onsite for a period of 5 years.
Terms used but not defined in this subpart are defined in the Clean Air Act and subparts A and B of this part.
(1) For incinerators and small remote incinerators: CEMS data collected during the first hours of operation of a CISWI unit startup from a cold start until waste is fed into the unit and the hours of operation following the cessation of waste material being fed to the CISWI unit during a unit shutdown. For each startup event, the length of time that CEMS data may be claimed as being CEMS data during startup must be 48 operating hours or less. For each shutdown event, the length of time that CEMS data may be claimed as being CEMS data during shutdown must be 24 operating hours or less;
(2) For energy recovery units: CEMS data collected during the startup or shutdown periods of operation. Startup begins with either the first-ever firing of fuel in a boiler or process heater for the purpose of supplying useful thermal energy (such as steam or heat) for heating, cooling or process purposes, or producing electricity, or the firing of fuel in a boiler or process heater for any purpose after a shutdown event. Startup ends four hours after when the boiler or process heater makes useful thermal energy (such as heat or steam) for heating, cooling, or process purposes, or generates electricity, whichever is earlier. Shutdown begins when the boiler or process heater no longer makes useful thermal energy (such as heat or steam) for heating, cooling, or process purposes and/or generates electricity or when no fuel is being fed to the boiler or process heater, whichever is earlier. Shutdown ends when the boiler or process heater no longer makes useful thermal energy (such as steam or heat) for heating, cooling, or process purposes and/or generates electricity, and no fuel is being combusted in the boiler or process heater; and
(3) For waste-burning kilns: CEMS data collected during the periods of kiln operation that do not include normal operations. Startup means the time from when a shutdown kiln first begins firing fuel until it begins producing clinker. Startup begins when a shutdown kiln turns on the induced draft fan and begins firing fuel in the main burner. Startup ends when feed is being continuously introduced into the kiln for at least 120 minutes or when the feed rate exceeds 60 percent of the kiln design limitation rate, whichever occurs first. Shutdown means the cessation of kiln operation. Shutdown begins when feed to the kiln is halted and ends when continuous kiln rotation ceases.
(1) Units burning only pulping liquors (
(2) Units burning only spent sulfuric acid used to produce virgin sulfuric acid;
(3) Units burning only wood or coal feedstock for the production of charcoal;
(4) Units burning only manufacturing byproduct streams/residue containing catalyst metals that are reclaimed and reused as catalysts or used to produce commercial grade catalysts;
(5) Units burning only coke to produce purified carbon monoxide that is used as an intermediate in the production of other chemical compounds;
(6) Units burning only hydrocarbon liquids or solids to produce hydrogen, carbon monoxide, synthesis gas, or other gases for use in other manufacturing processes; and
(7) Units burning only photographic film to recover silver.
(1) Fails to meet any requirement or obligation established by this subpart, including but not limited to any emission limitation, operating limit, or operator qualification and accessibility requirements; and
(2) Fails to meet any term or condition that is adopted to implement an applicable requirement in this subpart and that is included in the operating permit for any affected source required to obtain such a permit.
(1) The cumulative cost of the changes over the life of the unit exceeds 50 percent of the original cost of building and installing the CISWI unit (not including the cost of land) updated to current costs (current dollars). To determine what systems are within the boundary of the CISWI unit used to calculate these costs, see the definition of CISWI unit; and
(2) Any physical change in the CISWI unit or change in the method of operating it that increases the amount of any air pollutant emitted for which section 129 or section 111 of the Clean Air Act has established standards.
(1) A physical change (maintenance activities excluded) to the CISWI unit which may increase the emission rate of any air pollutant to which a standard applies;
(2) An operational change to the CISWI unit where a new type of non-hazardous secondary material is being combusted;
(3) A physical change (maintenance activities excluded) to the air pollution control devices used to comply with the emission limits for the CISWI unit (
(4) An operational change to the air pollution control devices used to comply with the emission limits for the affected CISWI unit (
(1) The reconstruction begins on or after August 7, 2013; and
(2) The cumulative cost of the construction over the life of the incineration unit exceeds 50 percent of the original cost of building and installing the CISWI unit (not including land) updated to current costs (current
(1) Low-density fluff refuse-derived fuel through densified refuse-derived fuel; and
(2) Pelletized refuse-derived fuel.
(1) For a corporation: A president, secretary, treasurer, or vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the corporation, or a duly authorized representative of such person if the representative is responsible for the overall operation of one or more manufacturing, production, or operating facilities applying for or subject to a permit and either:
(i) The facilities employ more than 250 persons or have gross annual sales or expenditures exceeding $25 million (in second quarter 1980 dollars); or
(ii) The delegation of authority to such representatives is approved in advance by the permitting authority;
(2) For a partnership or sole proprietorship: a general partner or the proprietor, respectively;
(3) For a municipality, state, federal, or other public agency: Either a principal executive officer or ranking elected official. For the purposes of this part, a principal executive officer of a Federal agency includes the chief executive officer having responsibility for the overall operations of a principal geographic unit of the agency (
(4) For affected facilities:
(i) The designated representative in so far as actions, standards, requirements, or prohibitions under Title IV of the Clean Air Act or the regulations promulgated thereunder are concerned; or
(ii) The designated representative for any other purposes under part 60.
(1) Materials recovery facilities (including primary or secondary smelters) which combust waste for the primary purpose of recovering metals;
(2) Qualifying small power production facilities, as defined in section 3(17)(C) of the Federal Power Act (16 U.S.C. 769(17)(C)), or qualifying cogeneration facilities, as defined in section 3(18)(B) of the Federal Power Act (16 U.S.C. 796(18)(B)), which burn homogeneous waste (such as units which burn tires or used oil, but not including refuse-derived fuel) for the production of electric energy or in the case of qualifying cogeneration facilities which burn homogeneous waste for the production of electric energy and steam or forms of useful energy (such as heat) which are used for industrial, commercial, heating or cooling purposes; or
(3) Air curtain incinerators provided that such incinerators only burn wood wastes, yard wastes and clean lumber and that such air curtain incinerators comply with opacity limitations to be established by the Administrator by rule.
(1) Grass, grass clippings, bushes, shrubs, and clippings from bushes and shrubs from residential, commercial/retail, institutional, or industrial sources as part of maintaining yards or other private or public lands;
(2) Construction, renovation, or demolition wastes; or
(3) Clean lumber.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.
These regulations are effective on August 22, 2016.
Marie Casey, (410) 786–7861 or Karen Reinhardt (410) 786–0189 for issues related to the local coverage determination process for clinical diagnostic laboratory tests. Valerie Miller, (410) 786–4535 or Sarah Harding, (410) 786–4001 for all other issues.
To assist readers in referencing sections contained in this document, we are providing the following Table of Contents.
Because of the many terms to which we refer by acronym in this final rule, we are listing these abbreviations and their corresponding terms in alphabetical order below:
Since 1984, Medicare has paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) under section 1833(h) of the Social Security Act (the Act). Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113–93, enacted on April 1, 2014) added section 1834A to the Act. The statute requires extensive revisions to the Medicare payment, coding, and coverage requirements for CDLTs, as well as creates a new subcategory of CDLTs called Advanced Diagnostic Laboratory Tests (ADLTs) with separate reporting and payment requirements. In this final rule, we present our policies for implementing the requirements of section 1834A of the Act.
Section 1834A of the Act significantly changes how CMS will set Medicare payment rates for CDLTs that are paid for under the CLFS. In general, with certain designated exceptions, the statute requires that the payment amount for CDLTs furnished on or after January 1, 2017, be equal to the weighted median of private payor rates determined for the test, based on certain data reported by laboratories during a specified data collection period. Different reporting and payment requirements will apply to a subset of CDLTs that are determined to be ADLTs. The most significant policies adopted in this final rule include the following (more detailed descriptions follow the bulleted list):
• The implementation date for CLFS rates based on the weighted median of private payor rates.
• The definition of “applicable laboratory”.
• The definition of “reporting entity” (the entity that must report applicable information).
• The definition of “applicable information” (the specific data that must be reported).
• The definition of ADLT.
• Data collection and data reporting schedules.
• Data integrity.
• Confidentiality and public release of limited data.
• Coding for certain CDLTs.
• The payment methodology for CDLTs.
• The local coverage determination (LCD) process and the authority to designate Medicare Administrative Contractors (MACs) for clinical diagnostic laboratory tests.
Section 1834A(b)(1)(A) of the Act requires that, for a CDLT furnished on or after January 1, 2017, the amount Medicare pays for the CDLT must be equal to the weighted median of private payor rates for the CDLT. After considering public comments recommending that we revise the implementation date of the CLFS, we have decided to move the implementation date to January 1, 2018. Thus, for a CDLT furnished on or after January 1, 2018, the amount Medicare pays will be equal to the weighted median of private payor rates for the CDLT.
Under the authority of section 1834A(a)(2) of the Act, which requires applicable laboratories to report applicable information to CMS to be used in establishing the new CLFS payment rates, we proposed to define an applicable laboratory as an entity that: (1) Reports tax-related information to the Internal Revenue Service (IRS) under a Taxpayer Identification Number (TIN) with which all of the National Provider Identifiers (NPIs) in the entity are associated; (2) is itself a laboratory, as defined in § 493.2, or, if it is not itself a laboratory, has at least one component that is a laboratory, as defined in § 493.2, for which the entity reports tax-related information to the IRS using its TIN; (3) in a data collection period, receives, collectively with its associated NPI entities, more than 50 percent of its Medicare revenues from the CLFS or Physician Fee Schedule (PFS); (4) for the data collection period from July 1, 2015 through December 31, 2015, receives, collectively with its associated NPI entities, at least $25,000 of its Medicare revenues from the CLFS; and (5) for all subsequent data collection periods receives, collectively with its associated NPI entities, at least $50,000 of its Medicare revenues from the CLFS.
After considering the comments we received, we are retaining some aspects of the proposed definition and revising others. In this final rule, the applicable laboratory is defined at the NPI level, rather than the TIN level, so we have removed the pieces of the definition that refer to the TIN-level entity. However, we are retaining the TIN-level entity as the “reporting entity” (now defined separately from the applicable laboratory), which is responsible for reporting applicable information for all of its component NPI-level entities that meet the definition of applicable laboratory. We are retaining the “majority of Medicare revenues” threshold, but it will be applied to the NPI-level entity, rather than the TIN-level entity. We are finalizing a low expenditure threshold, but we are revising the amount because the threshold will be applied at the NPI level as opposed to the TIN level and will reflect a 6-month data collection period instead of a full calendar year. Under our final policy, if a laboratory receives less than $12,500 of its Medicare revenues from the CLFS during the data collection period, it is excluded from the definition of applicable laboratory. For a single laboratory that offers and furnishes an ADLT, the $12,500 threshold will not apply with respect to the ADLT. This means, if the laboratory otherwise meets the definition of applicable laboratory, whether or not it meets the low expenditure threshold, it will be considered an applicable laboratory with respect to the ADLT it offers and furnishes, and must report applicable information for its ADLT. If it does not meet the threshold, it will not be considered an applicable laboratory with respect to all the other CDLTs it furnishes.
The statute requires the following applicable information to be reported for each test on the CLFS an applicable laboratory performs: (1) The payment rate that was paid by each private payor for each test during the data collection period; and (2) the volume of such tests for each such payor. We proposed to use the term “private payor rate” in the context of applicable information, instead of “payment rate,” to minimize confusion because we typically use the term payment rate to generically refer to the amount paid under the CLFS. We also proposed that the private payor rate reflect the price for a test prior to application of any deductible or coinsurance amounts owed by the patient. In this final rule we are adopting these policies as final. We proposed that only applicable laboratories may report applicable information. We are also finalizing that requirement, but rephrasing it in the regulation to conform to our final policy that reporting entities, rather than applicable laboratories, will be reporting applicable information.
Section 1834A(d)(5) of the Act specifies criteria for defining an ADLT and authorizes the Secretary to establish additional criteria. We proposed to apply the criteria specified in statute, but not any additional criteria under the statutory authority conferred upon the Secretary, and are finalizing that proposal in this final rule. In addition, in the proposed rule, we defined an ADLT, in part, to be a molecular pathology analysis of multiple biomarkers of deoxyribonucleic acid (DNA), or ribonucleic acid (RNA). However, in response to public comments, we are removing the requirement that the test be a molecular pathology analysis and permitting protein-only based tests to also qualify for ADLT status.
We proposed that the initial data collection period would be July 1, 2015, through December 31, 2015, and that all subsequent data collection periods would be a full calendar year, from January 1 through December 31. After consideration of the comments we received, and because we no longer need to implement a shortened time frame for the initial data reporting period in light of our moving the implementation date of the revised CLFS to January 1, 2018, we are adopting the policy that all data collection periods are 6 months long, from January 1 through June 30. Further, we proposed that all applicable information, except applicable information for new ADLTs, would be reported to us in a data reporting period that would begin on January 1 and end on March 31 of the year following the data collection period. We are finalizing this policy in this final rule. However, because we are finalizing that reporting entities, and not applicable laboratories, must report applicable information, we have revised the final data reporting requirements regulation accordingly.
We proposed that the applicable information for new ADLTs must be reported initially to us by the end of the second quarter of the new ADLT initial period, which we are finalizing. We also proposed that the new ADLT initial period would be a period of 3 calendar quarters that begins on the first full calendar quarter following the first day on which a new ADLT is performed. After consideration of public comments, we are revising this policy and
The statute specifies that if, after a new ADLT initial period, the Secretary determines the payment amount that was applicable during the initial period (the test's actual list charge) was greater than 130 percent of the payment amount that is applicable after such period (based on private payor rates), the Secretary shall recoup the difference between those payment amounts for tests furnished during the initial period. We proposed to recoup the entire amount of the difference between the actual list charge and the weighted median private payer rate. After consideration of public comments, we are revising our proposed policy so that, for tests furnished during the new ADLT initial period, we will pay up to 130 percent of the weighted median private payor rate. That is, if the actual list charge is subsequently determined to be greater than 130 percent of the weighted median private payor rate, we will recoup the difference between the actual list charge and 130 percent of the weighted median private payer rate.
We proposed to apply a civil monetary penalty (CMP) to an applicable laboratory that fails to report or that makes a misrepresentation or omission in reporting applicable information. We proposed to require all data to be certified by the President, Chief Executive Officer (CEO), or Chief Financial Officer (CFO) of an applicable laboratory before it is submitted to CMS. As required by section 1834A(a)(10) of the Act, certain information disclosed by a laboratory under section 1834A(a) of the Act is confidential and may not be disclosed by the Secretary or a Medicare contractor in a form that reveals the identity of a specific payor or laboratory, or prices, charges or payments made to any such laboratory, with several exceptions. We are revising the certification and CMP policies in the final rule to require that the accuracy of the data be certified by the President, CEO, or CFO of the reporting entity, or an individual who has been delegated to sign for, and who reports directly to such an officer. Similarly, the reporting entity will be subject to CMPs for the failure to report or the misrepresentation or omission in reporting applicable information. Additionally, we are updating the CMP amount to reflect changes required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Pub. L. 114–74, November 2, 2015).
We proposed to use G codes, which are part of the Healthcare Common Procedure Coding System (HCPCS) we use for programmatic purposes, to temporarily identify new ADLTs and new laboratory tests that are cleared or approved by the Food and Drug Administration (FDA). The temporary codes would be in effect for up to 2 years until a permanent HCPCS code is established except if the Secretary determines it is appropriate to extend the use of the temporary code. We are finalizing this policy in this final rule.
As required by section 1834A(b) of the Act, payment amounts for laboratory tests on the CLFS will be determined by calculating a weighted median of private payor rates using reported private payor rates and associated volume (number of tests). For tests that were paid on the CLFS prior to the implementation of section 1834A of the Act, PAMA requires that any reduction in payment amount be phased in over the first 6 years of payment under the new system. For new ADLTs, initial payment will be based on the actual list charge of the test for 3 calendar quarters; thereafter, the payment rate will be determined using the weighted median of private payor rates and associated volume (number of tests) reported every year. For new and existing tests for which we receive no applicable information to calculate a weighted median, we proposed that payment rates be determined by using crosswalking or gapfilling methods. These methods of determining payment were discussed in the proposed rule (80 FR 59404). We are finalizing these policies in this final rule.
Section 1834A(g)(2) of the Act authorizes the Secretary to designate one or more (not to exceed four) MACs to establish coverage policies, or establish coverage policies and process claims, for CDLTs. As noted in section II.I of the proposed rule, we requested public comment on the benefits and disadvantages of implementing this discretionary authority before making proposals on this topic. While we proposed no changes to the CDLT LCD development and implementation processes or claims processing functions in this final rule, our review of the comments received and our response to comments is contained in section II.I below.
In section VI. of this final rule, we provide a regulatory impact analysis that, to the best of our ability, describes the expected impact of the policies we are adopting in this final rule. These policies, which implement section 1834A of the Act, include a process for collecting the applicable information of applicable laboratories for CDLTs. We note that, because such data are not yet available, we are limited in our ability to provide estimated impacts of the payment policies under different scenarios. However, we believe this final rule is an economically significant rule because we believe that the changes to how CLFS payment rates will be developed will overall decrease payments to entities paid under the CLFS. Accordingly, in section IV., we have prepared a Regulatory Impact Analysis that, to the best of our ability, presents the costs and benefits of the rulemaking.
Currently, under sections 1832, 1833(a), (b), and (h), and 1861 of the Act, CDLTs furnished on or after July 1, 1984 in a physician's office, by an independent laboratory, or in limited circumstances by a hospital laboratory for its outpatients or non-patients are paid under the Medicare CLFS, with certain exceptions. Under these sections, tests are paid the lesser of (1) the billed amount, (2) the local fee schedule amount established by the Medicare contractor, or (3) a National Limitation Amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests are paid at the NLA.
Under the current system, the CLFS amounts are updated for inflation based on the percentage change in the Consumer Price Index for all urban consumers (CPI–U) and reduced by a multi-factor productivity adjustment (see section 1833(h)(2)(A) of the Act). For CY 2015, under section 1833(h)(2)(A)(iv)(II) of the Act, we also reduced the update amount by 1.75 percentage points. In the past, we have implemented other adjustments or did not apply the change in the CPI–U to the CLFS for certain years in accordance with statutory mandates. We do not otherwise have authority to update or change the payment amounts for tests on the CLFS. Generally, coinsurance and deductibles do not apply to CDLTs paid under the CLFS.
For any CDLT for which a new or substantially revised HCPCS code has been assigned on or after January 1, 2005, we determine the basis for and
In 2014, Medicare paid approximately $7 billion for CDLTs. As the CLFS has grown from approximately 400 tests to over 1,300 tests, some test methods have become outdated and some tests may no longer be priced appropriately. For example, some tests have become more automated and cheaper to perform, with little need for manual interaction by laboratory technicians, while more expensive and complex tests have been developed that bear little resemblance to the simpler tests that were performed at the inception of the CLFS.
Section 1834A of the Act, as added by section 216(a) of PAMA, requires extensive revisions to the Medicare payment, coding, and coverage requirements for CDLTs. In this section, we describe the major provisions of section 1834A of the Act, which we are implementing in this final rule.
Section 1834A(a)(1) of the Act requires reporting of private payor payment rates for CDLTs made to applicable laboratories to establish Medicare payment rates for tests paid under the CLFS. Applicable information must be reported to the Secretary, at a time specified by the Secretary and for a designated data collection period, for each CDLT an applicable laboratory furnishes during such period for which Medicare payment is made. Section 1834A(a)(2) of the Act defines the term “applicable laboratory” to mean a laboratory that receives a majority of its Medicare revenues from sections 1834A or 1833(h) of the Act (the statutory authorities under which CLFS payments are or will be made), or section 1848 of the Act (the authority under which PFS payments are made). Section 1834A(a)(2) of the Act also provides that the Secretary may establish a low volume or low expenditure threshold for excluding a laboratory from the definition of an applicable laboratory, as the Secretary determines to be appropriate.
Section 1834A(a)(3)(A) of the Act defines the term “applicable information” as the payment rate that was paid by each private payor for each CDLT and the volume of such tests for each such payor for the data collection period. Under section 1834A(a)(5) of the Act, the payment rate reported by a laboratory must reflect all discounts, rebates, coupons, and other price concessions, including those described in section 1847A(c)(3) of the Act regarding the average sales price for Part B drugs or biologicals. Section 1834A(a)(6) of the Act further specifies that, where an applicable laboratory has more than one payment rate for the same payor for the same test, or more than one payment rate for different payors for the same test, each such payment rate and the volume for the test at each such rate must be reported. The paragraph also provides that, beginning January 1, 2019, the Secretary may establish rules to aggregate reporting in situations where a laboratory has more than one payment rate for the same payor for the same test, or more than one payment rate for different payors for the same test. Under section 1834A(a)(3)(B) of the Act, information about laboratory tests for which payment is made on a capitated basis or other similar payment basis is not considered “applicable information” and is therefore excluded from the reporting requirements.
Section 1834A(a)(4) of the Act defines the term “data collection period” as a period of time, such as a previous 12-month period, specified by the Secretary. Section 1834A(a)(7) of the Act requires that an officer of each laboratory must certify the accuracy and completeness of the applicable information reported. Section 1834A(a)(8) of the Act defines the term “private payor” as a health insurance issuer and a group health plan (as such terms are defined in section 2791 of the Public Health Service Act), a Medicare Advantage plan under Medicare Part C, or a Medicaid managed care organization (as defined in section 1903(m) of the Act).
Section 1834A(a)(9)(A) of the Act authorizes the Secretary to apply a CMP in cases where the Secretary determines that an applicable laboratory has failed to report, or made a misrepresentation or omission in reporting, applicable information under section 1834A(a) of the Act for a CDLT. In these cases, the Secretary may apply a CMP in an amount of up to $10,000 per day for each failure to report or each such misrepresentation or omission. Section 1834A(a)(9)(B) of the Act further provides that the provisions of section 1128A of the Act (other than subsections (a) and (b)) shall apply to a CMP under this paragraph in the same manner as they apply to a CMP or proceeding under section 1128A(a) of the Act. Section 1128A of the Act governs CMPs that apply in general under federal health care programs. Thus, the provisions of section 1128A of the Act (specifically sections 1128A(c) through 1128A(n) of the Act) apply to a CMP under section 1834A(a)(9) of the Act in the same manner as they apply to a CMP or proceeding under section 1128A(a) of the Act. That is, the existing CMP provisions apply to the laboratory data collection process under 1834A of the Act, just as the CMP provisions are applied now to other processes, such as the Medicare Part B and Medicaid drug data collection processes under sections 1847A and 1927 of the Act.
Section 1834A(a)(10) of the Act addresses the confidentiality of the information reported to the Secretary. Specifically, the paragraph provides that, notwithstanding any other provision of law, information disclosed under the data reporting requirements is confidential and shall not be disclosed by the Secretary or a Medicare contractor in a form that discloses the identity of a specific payor or laboratory, or prices charged, or payments made to any such laboratory, except: (1) As the Secretary determines to be necessary to carry out this section; (2) to permit the Comptroller General to review the information provided; (3) to permit the Director of the Congressional Budget Office to review the information
Section 1834A(a)(12) of the Act requires the Secretary to establish parameters for the data collection under section 1834A(a) of the Act through notice and comment rulemaking no later than June 30, 2015.
Section 1834A(b) of the Act establishes a new methodology for determining Medicare payment rates for CDLTs. Section 1834A(b)(1)(A) of the Act provides that, in general, the payment amount for a CDLT (except for new ADLTs and new CDLTs) furnished on or after January 1, 2017, shall be equal to the weighted median determined under section 1834A(b)(2) of the Act for the test for the most recent data collection period. Section 1834A(b)(1)(B) of the Act specifies that the payment amounts established under this methodology shall apply to a CDLT furnished by a hospital laboratory if the test is paid for separately, and not as part of a bundled payment under the hospital outpatient prospective payment system (OPPS) (section 1833(t) of the Act). Section 1834A(b)(2) of the Act provides that the Secretary shall calculate a weighted median for each test for the data collection period by arraying the distribution of all payment rates reported for the period for each test weighted by volume for each payor and each laboratory. Section 1834A(b)(4)(A) of the Act states that the payment amounts established under this methodology for a year following a data collection period shall continue to apply until the year following the next data collection period. Moreover, section 1834A(b)(4)(B) of the Act specifies that the payment amounts established under section 1834A of the Act shall not be subject to any adjustment (including any geographic adjustment, budget neutrality adjustment, annual update, or other adjustment).
Section 1834A(b)(3) of the Act requires a phase-in of any reduction in payment amounts for a CDLT for each year from 2017 through 2022. Specifically, section 1834A(b)(3)(A) of the Act requires that the payment amounts determined under the new methodology for a CDLT for each of 2017 through 2022 shall not result in a reduction in payments for that test for the year that is greater than the “applicable percent” of the payment amount for the test for the preceding year. Section 1834A(b)(3)(B) of the Act defines these maximum applicable percent reductions as follows: For each of 2017 through 2019, 10 percent; and for each of 2020 through 2022, 15 percent. However, section 1834A(b)(3)(C) of the Act specifies that this payment reduction limit shall not apply to a new CDLT under section 1834A(c)(1) of the Act, or to a new ADLT, as defined in section 1834A(d)(5) of the Act.
Section 1834A(b)(5) of the Act increases by $2 the nominal fee that would otherwise apply under section 1833(h)(3)(A) of the Act for a sample collected from an individual in a Skilled Nursing Facility (SNF) or by a laboratory on behalf of a Home Health Agency (HHA). This provision has the effect of raising the sample collection fee from $3 to $5 when the sample is being collected from an individual in a SNF or by a laboratory on behalf of an HHA.
Section 1834A(d)(5) of the Act defines an ADLT to mean a CDLT covered under Medicare Part B that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria: (1) The test is an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins combined with a unique algorithm to yield a single patient-specific result; (2) the test is cleared or approved by the FDA; or (3) the test meets other similar criteria established by the Secretary.
Section 1834A(d)(1)(A) of the Act provides that, in the case of an ADLT for which payment has not been made under the CLFS prior to April 1, 2014 (PAMA's enactment date), during an initial 3 quarters, the payment amount for the test shall be based on the actual list charge for the test. Section 1834A(d)(1)(B) of the Act defines the term “actual list charge” for purposes of this provision to mean the publicly available rate on the first day at which the test is available for purchase by a private payor. For the reporting requirements for such tests, under section 1834A(d)(2) of the Act, an applicable laboratory will initially be required to comply with the data reporting requirements under section 1834A(a) of the Act by the last day of the second quarter (Q2) of the initial 3 quarter period. Section 1834A(d)(3) of the Act requires that, after this initial period, the data reported under paragraph 1834A(d)(2) of the Act shall be used to establish the payment amount for an ADLT described in section 1834A(d)(1)(A) of the Act using the payment methodology for CDLTs under section 1834A(b) of the Act. This payment amount shall continue to apply until the year following the next data collection period.
Section 1834A(d)(4) of the Act addresses recoupment of payment for new ADLTs if the actual list charge exceeds the subsequently established payment amount based on market rates. Specifically, it provides that, if the Secretary determines after the initial period that the payment amount for a new ADLT based on the actual list charge was greater than 130 percent of the payment rate that is calculated using the payment methodology for CDLTs under section 1834A(b) of the Act, the Secretary shall recoup the difference for tests furnished during that initial period.
Section 1834A(c) of the Act provides for payment of new tests that are not ADLTs. Specifically, section 1834A(c)(1) of the Act provides that, in the case of a CDLT that is assigned a new or substantially revised HCPCS code on or after April 1, 2014 (PAMA's enactment date), and which is not an ADLT (as defined in section 1834A(d)(5) of the Act), during an initial period until payment rates under section 1834A(b) of the Act are established for the test, payment for the test shall be determined on the basis of crosswalking or gapfilling. Section 1834A(c)(1)(A) of the Act requires application of the crosswalking methodology described in § 414.508(a) (or any successor regulation) to the most appropriate existing test under the CLFS during that period. Section 1834A(c)(1)(B) of the Act provides that, if no existing test is comparable to the new test, the gapfilling process described in section 1834A(c)(2) of the Act shall be applied. Section 1834A(c)(2) of the Act states that this gapfilling process must take into account the following sources of information to determine gapfill amounts, if available: charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payors; charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and other criteria the Secretary determines to be appropriate. Section 1834A(c)(3) of the Act further requires that, in determining the payment amount under crosswalking or gapfilling processes, the Secretary must consider recommendations from the panel
Section 1834A(e) of the Act sets out coding requirements for certain new and existing tests. Specifically, section 1834A(e)(1)(A) of the Act requires the Secretary to adopt temporary HCPCS codes to identify new ADLTs (as defined in section 1834A(d)(5) of the Act) and new laboratory tests that are cleared or approved by the FDA. Section 1834A(e)(1)(B) of the Act addresses the duration of these temporary new codes. Section 1834A(e)(1)(B)(i) of the Act requires the temporary code to be effective until a permanent HCPCS code is established (but not to exceed 2 years), subject to an exception under section 1834A(e)(1)(B)(ii) of the Act that permits the Secretary to extend the temporary code or establish a permanent HCPCS code, as the Secretary determines appropriate.
Section 1834A(e)(2) of the Act addresses coding for certain existing tests. This section requires that, not later than January 1, 2016, the Secretary shall assign a unique HCPCS code and publicly report the payment rate for each existing ADLT (as defined in section 1834A(d)(5) of the Act) and each existing CDLT that is cleared or approved by the FDA for which payment is made under Medicare Part B as of April 1, 2014 (PAMA's enactment date), if such test has not already been assigned a unique HCPCS code. In addition, section 1834A(e)(3) of the Act requires the establishment of unique identifiers for certain tests. Specifically, for purposes of tracking and monitoring, if a laboratory or a manufacturer requests a unique identifier for an ADLT or a laboratory test that is cleared or approved by the FDA, the Secretary shall use a means to uniquely track such test through a mechanism such as a HCPCS code or modifier.
Section 1834A(f) of the Act addresses requirements for input from clinicians and technical experts on issues related to CDLTs. In particular, section 1834A(f)(1) of the Act requires the Secretary to consult with an expert outside advisory panel that is to be established by the Secretary no later than July 1, 2015. This advisory panel must include an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in clinical laboratory science or health economics, or in issues related to CDLTs, which may include the development, validation, performance, and application of such tests. Under section 1834A(f)(1)(A) of the Act, this advisory panel is required to provide input on the establishment of payment rates under section 1834A of the Act for new CDLTs, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test, and the factors to be used in determining coverage and payment processes for new CDLTs. Section 1834A(f)(1)(B) of the Act states that the panel may provide recommendations to the Secretary under section 1834A of the Act. Section 1834A(f)(2) of the Act requires the panel to comply with the requirements of the Federal Advisory Committee Act (5 U.S.C. App.). A notice announcing the establishment of the Advisory Panel on CDLTs and soliciting nominations for members was published in the October 27, 2014
Section 1834A(f)(3) of the Act requires that the Secretary continue to convene the annual meeting described in section 1833(h)(8)(B)(iii) of the Act after the implementation of section 1834A of the Act, for purposes of receiving comments and recommendations (and data on which the recommendations are based) on the establishment of payment amounts under section 1834A of the Act.
Section 1834A(g) of the Act addresses issues related to coverage of CDLTs. Section 1834A(g)(1)(A) of the Act requires that coverage policies for CDLTs, when issued by a MAC, be issued in accordance with the LCD process, which we have outlined in Chapter 13 of the Medicare Program Integrity Manual.
In addition, section 1834A(g)(1)(A) of the Act states that the processes governing the appeal and review of CDLT-related LCDs shall continue to follow the general rules for LCD review established by CMS in regulations at 42 CFR part 426.
Section 1834A(g)(1)(B) of the Act states that the CDLT-related LCD provisions referenced in section 1834A(g) of the Act do not apply to the national coverage determination (NCD) process (as defined in section 1869(f)(1)(B) of the Act). Section 1834A(g)(1)(C) of the Act specifies that the provisions pertaining to the LCD process for CDLTs, including appeals of LCDs, shall apply to coverage policies issued on or after January 1, 2015.
In addition, section 1834A(g)(2) of the Act authorizes the Secretary to designate one or more (not to exceed four) MACs to either establish LCDs for CDLTs, or to both establish CDLT-related LCDs and process Medicare claims for payment for CDLTs, as determined appropriate by the Secretary.
Section 1834A(h)(1) of the Act states that there shall be no administrative or judicial review under sections 1869, 1878, or otherwise, of the establishment of payment amounts under section 1834A of the Act. Section 1834A(h)(2) of the Act provides that the Paperwork Reduction Act in chapter 35 of title 44 of the U.S.C. shall not apply to information collected under section 1834A of the Act.
Section 1834A(i) of the Act states that during the period beginning on the date of enactment of section 1834A of the Act (April 1, 2014) and ending on December 31, 2016, the Secretary shall use the methodologies for pricing, coding, and coverage for ADLTs in effect on the day before this period. This may include crosswalking or gapfilling methods.
We received approximately 1,300 public comments from individuals, health care providers, corporations, government agencies, trade associations, and major laboratory organizations. The following are the proposed provisions, a summary of the public comments we received related to each proposal, and our responses to the comments.
Section 1834A(a)(1) of the Act requires an “applicable laboratory” to report applicable information for a data collection period for each CDLT the laboratory furnishes during the period for which payment is made under Medicare Part B. The statute requires reporting to begin January 1, 2016, and to take place every 3 years thereafter for CDLTs, and every year thereafter for ADLTs. Section 1834A(a)(2) of the Act defines an applicable laboratory as a laboratory that receives a majority of its Medicare revenues from section 1834A and section 1833(h) (the statutory authorities for the CLFS) or section 1848 (the statutory authority for the PFS) of the Act. Section 1834A(a)(2) of the Act
In establishing a regulatory definition for “applicable laboratory,” we considered the following issues: (1) How to define “laboratory;” (2) what it means to receive a majority of Medicare revenues from sections 1834A, 1833(h), or 1848 of the Act; (3) how to apply the majority of Medicare revenues criterion; and (4) whether to establish a low volume or low expenditure threshold to exclude an entity from the definition of applicable laboratory.
First, we considered what a laboratory is, and we incorporated our understanding of that term in our proposed definition of applicable laboratory. The CLFS applies to a wide variety of laboratories (for example, national chains, physician offices, hospital laboratories, etc.), and we believed it was important that we define laboratory broadly enough to encompass every laboratory type that is subject to the CLFS.
We searched for existing statutory definitions of “laboratory” that could be appropriate to use for the revised CLFS. However, section 1834A of the Act does not define laboratory, nor is it defined elsewhere in the Medicare statute. So we looked to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a definition. CLIA applies to all laboratories performing testing on human specimens for a health purpose, including but not limited to those seeking payment under the Medicare and Medicaid programs (§ 493.1). To be paid under Medicare, a laboratory must be CLIA-certified (§ 410.32(d) and part 493). Therefore, we believed it was appropriate to use the CLIA definition of laboratory at § 493.2 for our purposes of defining laboratory within the term applicable laboratory. We did not consider alternative definitions of laboratory as we were not able to identify alternative definitions that would be appropriate for consideration under section 1834A of the Act.
CLIA defines a laboratory as a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both), or only serving as a mailing service and not performing testing, are not considered laboratories, which we believed was also appropriate for our purposes. The services of those facilities that only collect or prepare specimens or serve as a mailing service are not paid on the CLFS. We proposed to incorporate the CLIA regulatory definition of laboratory into our proposed definition of applicable laboratory in § 414.502 by referring to the CLIA definition at § 493.2 to indicate what we mean by laboratory.
We indicated in the proposed rule that, under the revised payment system for CDLTs, an applicable laboratory is the entity that reports applicable information to CMS. However, not all entities that meet the CLIA regulatory definition of laboratory would be applicable laboratories under our proposal. Here, we discuss which entities we believe should be required to report applicable information.
Laboratory business models vary throughout the industry. For example, some laboratories are large national networks with multiple laboratories under one parent entity. Some laboratories are single, independent laboratories that operate individually. Some entities, such as hospitals or large practices, include laboratories as well as other types of providers and suppliers. We proposed that an applicable laboratory is an entity that itself is a laboratory under the CLIA definition or is an entity that includes a laboratory (for example, a health care system that is comprised of one or more hospitals, physician offices, and reference laboratories). Within our proposed definition of applicable laboratory, we indicated that if the entity is not itself a laboratory, it has at least one component that is a laboratory, as defined in § 493.2.
We proposed that, whether an applicable laboratory is itself a laboratory or is an entity that has at least one component that is a laboratory, the applicable laboratory would be required to report applicable information. Entities that enroll in Medicare must provide a TIN, which we use to identify the entity of record that is authorized to receive Medicare payments. The TIN-level entity is the entity that reports tax-related information to the Internal Revenue Service (IRS). When an entity reports to the IRS, the entity and its components are all associated with that entity's TIN. We would rely on the TIN as the mechanism for defining the entity we consider to be the applicable laboratory. Therefore, we proposed that the TIN-level entity is the applicable laboratory.
We explained that each component of the TIN-level entity that is a covered health care provider under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations will have an NPI. The NPI is the HIPAA standard unique health identifier for health care providers adopted by HHS (§ 162.406). Health care providers, which include laboratories that transmit any health information in electronic form in connection with a HIPAA transaction for which the Secretary has adopted a standard, are required to obtain NPIs and use them according to the NPI regulations at 45 CFR part 162, subpart D. When the TIN-level entity reports tax-related information to the IRS, it does so for itself and on behalf of its component NPI-level entities. We indicated this in the proposed definition of applicable laboratory by stating that the applicable laboratory is the entity that reports tax-related information to the IRS under a TIN with which all of the NPIs in the entity are associated. We also proposed to define TIN and NPI in § 414.502 by referring to definitions already in the Code of Federal Regulations.
We considered defining an applicable laboratory at the NPI level instead of the TIN level. Some stakeholders indicated that, because they bill Medicare by NPI and not TIN, the NPI would be the most appropriate level for reporting applicable information to Medicare. However, because the purpose of the revised Medicare payment system is to base CLFS payment amounts on private payor rates for CDLTs, which we expect would be negotiated at the level of the entity's TIN, as described previously, and not by individual laboratory locations at the NPI level, we proposed that an applicable laboratory be defined at the level of a TIN. Further, numerous stakeholders suggested that the TIN represents the entity negotiating pricing and is the entity in the best position to compile and report applicable information across its multiple NPIs when there are multiple NPIs associated with a TIN. We stated in the proposed rule that we believed defining an applicable laboratory by TIN rather than by NPI would result in the same applicable information being reported, and would require reporting by fewer entities, and therefore, would be less burdensome to applicable laboratories. In addition, we stated that we did not believe reporting at the TIN level would affect or diminish the quality of the applicable information reported. To the
We also considered whether to separate the mechanics of reporting from the definition of an applicable laboratory. For example, we considered allowing or requiring a corporate entity with multiple TINs to provide applicable information for all of its TINs along with a list of component TINs. Under this approach, the corporate entity would report each distinct private payor rate and the associated volume across all component TINs instead of each component TIN reporting separately. Thus, if the same rate was paid by a private payor in two or more of the corporate entity's component TINs, the entity would report the private payor rate once and the associated sum of the volume of that test across the component TINs. We stated in the proposed rule that we believed this approach may be operationally less burdensome than submitting separate data files by TIN or NPI. We also stated that we did not believe such reporting would affect the quality of the applicable information because we should still arrive at the same weighted median for each test. We opted not to propose this option, however, because we are not familiar enough with the corporate governance of laboratories to know whether this even higher level of reporting would be a desirable or practical option for the industry and whether it would affect the quality of the applicable information we would receive.
Next, we considered what it means for an applicable laboratory to receive a majority of Medicare revenues from sections 1834A, 1833(h), or 1848 of the Act. We proposed to define Medicare revenues to be payments received from the Medicare program, which would include fee-for-service payments under Medicare Parts A and B, as well as Medicare Advantage payments under Medicare Part C, and prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance amounts for Medicare services furnished during the data collection period. We applied the standard meaning of “majority,” which is more than 50 percent. Under our proposal, in deciding whether an entity meets the majority criterion of the applicable laboratory definition, it would examine its Medicare revenues from sections 1834A, 1833(h), and 1848 of the Act to determine if those revenues (including any beneficiary deductible and coinsurance amounts), whether from only one or a combination of all three sources, constitute more than 50 percent of its total revenues under the Medicare program for the data collection period. In determining its Medicare revenues from sections 1834A, 1833(h), and 1848 of the Act, the entity would not include Medicare payments made to hospital laboratories for tests furnished for admitted hospital inpatients or registered hospital outpatients because payments for these patient care services are made under the statutory authorities of section 1886(d) of the Act (for the Hospital Inpatient Prospective Payment System (IPPS)) and section 1833(t) of the Act (for the OPPS), respectively, not sections 1834A, 1833(h), or 1848 of the Act. In other words, an entity would need to determine whether its Medicare revenues from laboratory services billed on Form CMS 1500 (or its electronic equivalent) and paid under the current CLFS (section 1833(h) of the Act), the CLFS under PAMA (section 1834A of the Act), and the PFS (section 1848 of the Act) constitute more than 50 percent of its total Medicare revenues for the data collection period.
Moreover, for the entity evaluating whether it is an applicable laboratory, the “majority of Medicare revenues” determination would be based on the collective amount of its Medicare revenues received during the data collection period, whether the entity is a laboratory under § 493.2 or is a larger entity that has at least one component that is a laboratory. We proposed that the determination of whether an entity is an applicable laboratory would be made across the entire entity, including all component NPI entities, and not just those NPI entities that are laboratories. We proposed to specify in the definition of applicable laboratory that an applicable laboratory is an entity that receives, collectively with its associated NPI entities, more than 50 percent of its Medicare revenues from one or a combination of the following sources: 42 CFR part 414, subpart G; and 42 CFR part 414, subpart B. The regulatory citations we proposed to include in the definition are the regulatory payment provisions that correspond to the three statutory provisions named in section 1834A(a)(2), that is, sections 1834A, 1833(h), and 1848 of the Act.
We noted that section 1834A(a)(1) of the Act only mandates reporting from entities meeting the definition of an applicable laboratory. We stated in the proposed rule that we believed the purpose of only mandating applicable laboratories to report applicable information is to ensure we use only their applicable information to determine payment rates under the CLFS beginning January 1, 2017, and not information from entities that do not meet the definition of applicable laboratory. We believed that, by specifying that only applicable laboratories must report applicable information, and specifying in the definition of applicable laboratory that an applicable laboratory must receive the majority of its Medicare revenues from PFS or CLFS services, the statute limits reporting primarily to independent laboratories and physician offices (other than those that meet the low expenditure or low volume threshold, if established by the Secretary) and does not include other entities (such as hospitals or other health care providers) that do not receive the majority of their revenues from PFS or CLFS services. For this reason, we proposed to prohibit any entity that does not meet the definition of applicable laboratory from reporting applicable information to CMS, which we reflect in paragraph (g) of the proposed data reporting requirements in § 414.504.
We stated that we expected most entities that fall above or below the “majority of Medicare revenues” threshold will tend to maintain that status through the course of their business. However, it is conceivable that an entity could move from above to below the threshold, or vice-versa, through the course of its business so that, for example, for services furnished in one data collection period, an entity might be over the “majority of Medicare revenues” threshold, but below the threshold in the next data collection period. We proposed that an entity that otherwise meets the criteria for being an applicable laboratory, would have to report applicable information if it is above the threshold in the given data collection period. Some entities will not know whether they exceed the threshold until after the data collection period is over; in that case, they would have to retroactively assess their Medicare revenues during the 3-month data reporting period. However, we expected that most entities will know whether they exceed the threshold long before the end of the data collection period. Under our proposal, an entity would need to reevaluate its status as to whether it falls above or below the “majority of Medicare revenues” threshold for every data collection period, that is, every year for ADLTs and every 3 years for all other CDLTs. We proposed this requirement would be
Finally, we proposed to establish a low expenditure threshold for excluding an entity from the definition of applicable laboratory, as permitted under section 1834A(a)(2) of the Act, and we included that threshold in our proposed definition of applicable laboratory in § 414.502. We stated in the proposed rule that we believed it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a test, and minimizing the reporting burden for entities that receive a relatively small amount of revenues under the CLFS. We expected many of the entities that meet the low expenditure threshold will be physician offices and will have relatively low revenues for laboratory tests paid under the CLFS.
For purposes of determining the low expenditure threshold, we reviewed Medicare payment amounts for physician office laboratories and independent laboratories from CY 2013 Medicare CLFS claims data. In the proposed rule, we noted that, although the statute uses the term “expenditure,” in this discussion, we would use the term “revenues” because, from the perspective of applicable laboratories, payments received from Medicare are revenues rather than expenditures, whereas expenditures refer to those same revenues, but from the perspective of Medicare (that is, to Medicare, those payments are expenditures). In our analysis, we assessed the number of billing physician office laboratories and independent laboratories that would otherwise qualify as applicable laboratories, but would be excluded from the definition under various revenue thresholds. We did not include in our analysis hospitals whose Medicare revenues are generally under section 1833(t) of the Act for outpatient services and section 1886(d) of the Act for inpatient services, as these entities are unlikely to meet the proposed definition of applicable laboratory.
We found that, with a $50,000 revenue threshold, the exclusion of data from physician office laboratories and independent laboratories with total CLFS revenues below that threshold, did not materially affect the quality and sufficiency of the data we needed to set rates. In other words, we were able to substantially reduce the number of entities that would be required to report (94 percent of physician office laboratories and 52 percent of independent laboratories) while retaining a high percentage of Medicare utilization (96 percent of CLFS spending on physician office laboratories and more than 99 percent of CLFS spending on independent laboratories) from applicable laboratories that would be required to report. In the proposed rule, we indicated that we did not believe excluding certain entities with CLFS revenues below a $50,000 threshold would have a significant impact on the weighted median private payor rates.
With this threshold, using Medicare utilization data, we estimated that only 17 tests would have utilization completely attributed to laboratories not reporting because they fell below a $50,000 threshold. We understand that Medicare claims data are not representative of the volume of laboratory tests furnished in the industry as a whole; however, we believed this was the best information available to us for the purpose of determining a low expenditure threshold for the proposed rule. Therefore, we proposed that any entity that would otherwise be an applicable laboratory, but that receives less than $50,000 in Medicare revenues under section 1834A and section 1833(h) of the Act for laboratory tests furnished during a data collection period, would not be an applicable laboratory for the subsequent data reporting period. In determining whether its Medicare revenues from sections 1834A and 1833(h) are at least $50,000, the entity would not include Medicare payments made to hospital laboratories for tests furnished for hospital inpatients or hospital outpatients. In other words, an entity would need to determine whether its Medicare revenues from laboratory tests billed on Form CMS 1500 (or its electronic equivalent) and paid under the current CLFS (under section 1833(h) of the Act) and the revised CLFS (under section 1834A of the Act) are at least $50,000. We proposed that if an applicable laboratory receives, collectively with its associated NPI entities (which would include all types of NPI entities, not just laboratories), less than $50,000 in Medicare revenues for CLFS services paid on Form CMS 1500 (or its electronic equivalent), the entity would not be an applicable laboratory.
As discussed in the proposed rule (80 FR 59399), we proposed an initial data collection period of July 1, 2015, through December 31, 2015 (all subsequent data collection periods would be a full calendar year). In conjunction with the shortened data collection period for 2015, we proposed to specify that, during the data collection period of July 1, 2015, through December 31, 2015, to be an applicable laboratory, an entity must have received at least $25,000 of its Medicare revenues from the CLFS, as set forth in 42 CFR part 414, subpart G. During each subsequent data collection period, to be an applicable laboratory, an entity would have to receive at least $50,000 of its Medicare revenues from the CLFS, as set forth in 42 CFR part 414, subpart G.
We stated that, as with the “majority of Medicare revenues” threshold, some entities will not know whether they meet the low expenditure threshold, that is, if they receive at least $50,000 in Medicare CLFS revenues in a data collection period (or $25,000 during the initial data collection period) until after the data collection period is over; in that case, they would have to retroactively assess their total Medicare CLFS revenues during the subsequent 3-month data reporting period. However, for many entities, it will be clear whether they exceed the low expenditure threshold even before the end of the data collection period. Under our proposal, an entity would need to reevaluate its status as to the $50,000 low expenditure threshold during each data collection period, that is, every year for ADLTs and every three years for all other CDLTs. We proposed to codify the low expenditure threshold requirement as part of the definition of applicable laboratory in § 414.502.
We did not propose a low volume threshold. As indicated in the proposed rule, once we obtain applicable information under the new payment system, we may decide to reevaluate the threshold options in future years and propose different or revised policies, as necessary, which we would do through notice and comment rulemaking.
In summary, we proposed to define an applicable laboratory to mean an entity that reports tax-related information to the IRS under a TIN with which all of the NPIs in the entity are associated. An applicable laboratory would either itself be a laboratory, as defined in § 493.2, or, if it is not itself a laboratory, have at least one component that is. In a data collection period, an applicable laboratory must have received, collectively with its associated NPI entities, more than 50 percent of its Medicare revenues from either the CLFS or PFS. For the data collection period from July 1, 2015 through December 31, 2015, for purposes of calculating CY 2017 payment rates, the applicable laboratory must have received, collectively with its associated NPI entities, at least $25,000 of its Medicare revenues from the CLFS, and for all subsequent data collection periods, at least $50,000 of its Medicare revenues from the CLFS. We proposed to codify
A discussion of the comments we received on our proposed definition of applicable laboratory and our responses to those comments are provided below.
Many commenters expressed particular concern about the exclusion of hospital outreach laboratories under our proposed definition of applicable laboratory. Commenters asserted that hospital outreach laboratories, which do not provide laboratory services to hospital patients, are direct competitors of the broader independent laboratory market, and excluding them from the definition of applicable laboratory would result in incomplete and inappropriate applicable information, which would skew the CLFS payment rates. Commenters maintained that, if the majority of all laboratories are not permitted to report private payor rate information, CMS's policy would ignore the intent of Congress to include all sectors of the laboratory market in establishing the new Medicare rates for clinical diagnostic laboratory services. Commenters stressed that, in order to set accurate market-based rates, CMS needs to ensure reporting by a broad scope of the laboratory market.
We agree with commenters, however, that hospital outreach laboratories should be accounted for in the new CLFS payment rates. Hospital outreach laboratories are laboratories that furnish laboratory tests for patients that are not admitted hospital inpatients or registered outpatients of the hospital. They are distinguishable from hospital laboratories in that they are enrolled in Medicare separately from the hospital of which they are a part, that is, they can be enrolled as independent laboratories that do not serve hospital patients. We believe it is important not to prevent private payor rates from being reported for hospital outreach laboratories so that we may have a broader representation of the national laboratory market to use in setting CLFS payment amounts. We address below how we are revising our definition of applicable laboratory to account for hospital outreach laboratories.
If we used the commenters' suggested approach to define an applicable laboratory by CLIA certificate, the majority of Medicare revenues criterion would be applied only to the revenues received by the laboratory (as identified by its CLIA certificate) and not to the entire organization, if the laboratory is part of an organization that provides laboratory and other services. For example, in the case of a hospital laboratory, the numerator of the majority of Medicare revenues ratio would be the revenues the hospital received for the CLFS and PFS services furnished in its laboratory, and the denominator would be all of the revenues the hospital received for the
The CLIA certificate is used to certify that a laboratory meets applicable health and safety regulations in order to furnish laboratory services. CLIA certificates are not associated with Medicare billing so, unlike for example, the NPI, with which revenues for specific services can easily be identified, the CLIA certificate cannot be used to identify revenues for specific services. The TIN, like the NPI, can be used to determine revenues and costs for tax purposes where revenues for CLFS or PFS services can be distinguished from other Medicare revenues. We do not see how a hospital would determine whether its laboratories would meet the majority of Medicare revenues threshold (and the low expenditure threshold) using the CLIA certificate as the basis for defining an applicable laboratory. In addition, given the difficulties many hospitals would have in determining whether their laboratories are applicable laboratories, we also believe hospitals may object to using the CLIA certificate as commenters advocate.
As discussed previously in this section, given that the purpose of the revised Medicare payment system is to base CLFS payment amounts on private payor rates, which we expect would be negotiated at the level of the entity's TIN and not by individual laboratory locations at the NPI level, we proposed that an applicable laboratory be defined at the TIN level instead of the NPI level. In addition, while we were developing the proposed rule, many stakeholders suggested that the TIN-level entity is the one that negotiates pricing and is in the best position to collect private payor rates and report applicable information for its multiple NPI-level entities when there are multiple NPI-level entities associated with a TIN. Defining applicable laboratory in terms of the NPI rather than the TIN, however, is consistent with our view that the statute supports limiting reporting to primarily independent laboratories and physician office laboratories. That is, the statute defines an applicable laboratory as a laboratory that receives a majority of its
However, we proposed to define applicable laboratory in terms of the TIN rather than the NPI, in part, to minimize the reporting burden on the laboratory industry. We have concerns about the administrative burden the reporting requirement may place on applicable laboratories by defining applicable laboratories in terms of the NPI. We believe that defining applicable laboratory by the NPI, while retaining the reporting requirement at the TIN level, will result in the same applicable information being reported to CMS, but will require reporting by fewer entities, which will be less burdensome to the laboratory industry. Therefore, although we are changing the definition of applicable laboratory to apply at the NPI level, we are retaining the requirement to report applicable information at the TIN level. Under this approach, the TIN-level entity will still be required to report applicable information to CMS for all of its component NPI-level entities that meet the definition of applicable laboratory. We are calling these TIN-level entities “reporting entities” and are establishing a definition in § 414.502, which we discuss in more detail in this section.
We are not prescribing how a reporting entity should coordinate with its component applicable laboratories to collect and prepare applicable information for submission. The TIN-level entity and any NPI-level entities that are applicable laboratories will establish their own approach for ensuring that the TIN-level entity reports applicable information for laboratory services provided by the NPI-level entities. However, in deciding how to collect applicable information and prepare it for reporting, entities may want to consider that, in this final rule, data integrity will be certified for the reporting entity under § 414.504(d) (as discussed in section II.E.2), and the reporting entity will be the entity to which civil penalties may be applied under § 414.504(e) (as discussed in section II.E.1). We will provide the details for how applicable information is to be reported to CMS through subregulatory guidance.
In light of the changes described above, we are modifying our proposed definition of applicable laboratory at § 414.502. Specifically, we are removing the first two requirements from the proposed definition that pertained to the TIN-level entity. Because all NPI-level entities that qualify as applicable laboratories will be laboratories, we are specifying that an applicable laboratory is a laboratory as defined in § 493.2 that bills Medicare part B under its own NPI. Because we are defining applicable laboratory in terms of the NPI rather than the TIN, we are specifying in the definition of applicable laboratory that the majority of Medicare revenues threshold is to be applied by the NPI-level entity, that is, the applicable laboratory, rather than by the TIN-level entity collectively with all its associated NPIs.
In addition, as discussed later in this section, we are revising the dollar amount for the low expenditure threshold from $50,000 to $12,500, which is also reflected in the revised definition of applicable laboratory. And, because the initial data collection period will no longer be shorter than the subsequent data collection periods (as discussed further below), the definition of applicable laboratory will no longer reflect a different low expenditure threshold for the initial data collection period. Additionally, as discussed later in this section, we are also not applying the low expenditure threshold to the single laboratory that offers and furnishes an ADLT with respect to that laboratory's ADLTs, so we are adding a provision to that effect.
While many commenters supported our proposal for reporting applicable information at the TIN level, some commenters also suggested that we be flexible in allowing applicable information to be reported at the TIN level, the NPI level, or the CLIA certificate level.
We believe that reporting at the TIN level will require reporting from fewer entities overall and will therefore be less burdensome to all types of applicable laboratories—that is independent laboratories, physician office laboratories, and hospital outreach laboratories—than would requiring applicable laboratories to report. We indicated in the proposed rule (80 FR 59392) that we do not believe reporting at the TIN level would affect or diminish the quality of the applicable information reported, and we noted that reporting at the higher level should produce exactly the same applicable information as reporting at the lower level. We still believe that to be the case even though we are no longer defining applicable laboratory to be the TIN-level entity.
We do not agree with the comments suggesting we allow applicable information to be reported at the TIN level, the NPI level, or the CLIA certificate level. We believe such flexibility could result in confusion among applicable laboratories as to which entity will be reporting for a given data reporting period. For example, under the commenters' suggested approach, for an organization in which a TIN-level entity is comprised of multiple NPI-level entities that meet the definition of applicable laboratory, the organization might designate an NPI-level entity to report applicable information for the initial data reporting period, but might decide to shift the reporting responsibility to the another NPI-level entity or the TIN-level entity for the next. We are concerned about the possibility of confusion as to which entity has reporting responsibilities, which could result in duplicative or no reporting.
For these reasons, we are finalizing our proposal that applicable information must be reported by the TIN-level entity. We believe section 1834A(a)(1) of the Act supports this final policy. A fundamental requirement of the statute is that the applicable information of
The commenters suggested we establish a POL-dependent test CLFS revenue threshold to address POLs performing tests that are performed primarily or exclusively in the POL setting. Specifically, they proposed that CMS identify test codes for which POLs perform the test 50 percent or more of the time (by procedure volume). The commenters suggested that CMS could identify any POL that would not otherwise meet the definition of applicable laboratory (because the laboratory is below the low expenditure threshold) but that performs more than a significant threshold percentage, as determined by CMS, of the POL-dependent test. The commenters stated that CMS would contact such POLs and require that they report applicable information solely for those POL-dependent tests, so POL laboratories would not report applicable information for any test codes other than for POL-dependent tests that meet the criteria suggested. Furthermore, the POL could decline to report if it did not perform the test during the data collection period. Additionally, the commenter suggested for the purpose of reporting POL-dependent tests, a data collection period should be limited to no more than 3 months (or some other appropriate timeframe that balances the benefit of enhanced data collection with avoiding unnecessary reporting burden on physician offices). Moreover, the commenter requested that POL test-dependent laboratories not be liable for the civil monetary penalties outlined in the statute for good-faith errors in reporting. Under the suggested approach, for each POL-dependent test code, CMS would combine the data reported by applicable laboratories together with the data from POLs meeting the POL-dependent test CLFS revenue threshold for that test to determine the weighted median private payor amount.
As noted by the commenter, we would not receive private payor rate data from laboratories offering and furnishing an ADLT that have CLFS revenues below the low expenditure threshold, which means we would need to use crosswalking or gapfilling methodologies to develop a payment amount for the test after the new ADLT initial period. Given that the statute contemplates private payor rates being reported for ADLTs by the end of the second quarter of the new ADLT initial period, we do not believe it is appropriate to apply a discretionary threshold if it excludes the single laboratory that offers and furnishes an ADLT from the definition of an applicable laboratory. If the single laboratory offering and furnishing an ADLT is excluded, we would not receive any private payor rate data for the test. For this reason, we agree with the commenter that the low expenditure threshold should not be applied to single laboratories offering and furnishing ADLTs. Therefore, we are finalizing a policy to exclude laboratories offering and furnishing ADLTs from the low-expenditure threshold, but only with respect to the ADLTs offered and furnished by the single laboratory. If the single laboratory offering and furnishing an ADLT otherwise meets the definition of applicable laboratory, but does not meet the low expenditure threshold, that is, even if it receives less than $12,500 in Medicare revenues from the CLFS during a data collection period, the single laboratory would be an applicable laboratory with respect to its ADLT, which means its applicable information for the ADLT must be reported. However, because we want to minimize the data collection and reporting burden for laboratories to the extent we can, with respect to the other CDLTs the single laboratory furnishes that are not ADLTs, the low expenditure threshold will still apply. This means that the single laboratory offering and furnishing an ADLT that does not receive at least $12,500 in Medicare CLFS revenues is not an applicable laboratory with respect to its CDLTs that are not ADLTs, and it may not report information for those other CDLTs. For example, if the single laboratory that offers and furnishes an ADLT receives greater than 50 percent of its Medicare revenue from the CLFS and PFS during a data collection period but only receives $10,000 in revenues from the CLFS during the data collection period, it would be an applicable laboratory only for the purpose of reporting applicable information for the ADLT. The single laboratory that offers and furnishes an ADLT would not be an applicable laboratory for purposes of the other CDLTs it furnishes that are not ADLTs.
As discussed in the proposed rule (80 FR 59393 through 59394), we established a low expenditure threshold to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a test, and minimizing the reporting burden for laboratories that receive a relatively small amount of revenues under the CLFS. The proposed low expenditure threshold would have required an entity to receive at least $50,000 of its Medicare revenue from the CLFS for a data collection period to be considered an applicable laboratory. We established that threshold based on CY 2013 TIN-level Medicare CLFS claims. We also proposed an initial data collection period of July 1, 2015, through December 31, 2015 (with all subsequent data collection periods being a full calendar year). In conjunction with the shortened initial data collection period, we proposed a $25,000 low expenditure threshold, whereas for all subsequent data collection periods, we proposed a low expenditure threshold of $50,000.
Although we are not revising the low expenditure threshold in response to the public comments we received on the issue, we are revising it in conjunction with our decisions to define applicable laboratory in terms of the NPI rather than the TIN and, as discussed in section III.D., to make the data collection period 6 months rather than a full calendar year.
To establish the new low expenditure threshold amount, we repeated the analysis we used for the proposed rule, but using NPI-level claims data rather than TIN-level claims data. We reviewed Medicare payment amounts from CY 2013 Medicare CLFS claims for physician office laboratories and independent laboratories at the NPI level. We assessed the number of billing physician office laboratories and independent laboratories that would otherwise qualify as applicable laboratories based on the majority of Medicare revenues threshold, but that would be excluded from the definition under various low expenditure revenue thresholds. Consistent with our analysis for the proposed low expenditure threshold, we did not include hospitals whose Medicare revenues were primarily under section 1833(t) of the Act for outpatient services and section 1886(d) of the Act for inpatient services, as these entities are unlikely to meet the definition of applicable laboratory. We found that, with a $25,000 annual
Additionally, because we are changing the data collection period from a full calendar year to 6 months in this final rule, we reduced the $25,000 annual low expenditure threshold by 50 percent, which resulted in a $12,500 low expenditure threshold for the 6-month data collection period. Accordingly, any laboratory that would otherwise be an applicable laboratory, but that receives less than $12,500 in CLFS revenues in a data collection period would not be an applicable laboratory (with the exception of single laboratories that offer and furnish ADLTs, which would be considered applicable laboratories only with respect to the ADLTs that they offer and furnish). As discussed previously in this section, we are finalizing the low expenditure threshold criterion as part of the definition of applicable laboratory in § 414.502. In addition, because the initial data collection period will no longer be shorter than subsequent ones, it is no longer necessary for us to apply a different low expenditure threshold to the initial data collection period. Therefore, we are removing the provision in the definition of applicable laboratory that would have distinguished the initial data collection period low expenditure threshold.
As with the proposed low expenditure threshold of $50,000, in determining whether its CLFS revenues in a data collection period are at least $12,500, a laboratory would not include Medicare payments made to hospital laboratories for tests furnished for hospital inpatients or hospital outpatients. In other words, a laboratory would need to determine whether its Medicare revenues from laboratory tests billed on Form CMS 1500 (or its electronic equivalent) and paid under the current CLFS (under section 1833(h) of the Act) and the revised CLFS (under section 1834A of the Act) are at least $12,500 for the data collection period. If a laboratory receives less than $12,500 in Medicare revenues for CLFS services paid on Form CMS 1500 (or its electronic equivalent) during a data collection period, the laboratory would not be an applicable laboratory.
Some laboratories will not know whether they meet the low expenditure threshold, that is, if they receive at least $12,500 in Medicare CLFS revenues in a data collection period, until after the data collection period is over; in that case, they would have to assess their total Medicare CLFS revenues during the 6-month window between the end of the data collection period and the beginning of the data reporting period. However, for many laboratories, it will be clear whether they exceed the low expenditure threshold even before the end of the data collection period. A laboratory would need to reevaluate its status as to the $12,500 low expenditure threshold for each data collection period, that is, every year for ADLTs and every 3 years for all other CDLTs.
Section 1834A(a)(3) of the Act defines the term “applicable information” as (1) the payment rate that was paid by each private payor for a test during the data collection period, and (2) the volume of such tests for each such payor during the data collection period. Under section 1834A(a)(5) of the Act, the payment rate reported by a laboratory must reflect all discounts, rebates, coupons, and other price concessions, including those described in section 1847A(c)(3) of the Act relating to a manufacturer's average sales price for drugs or biologicals. Section 1834A(a)(6) of the Act states that if there is more than one payment rate for the same payor for the same test, or more than one payment rate for different payors for the same test, the applicable laboratory must report each payment rate and corresponding volume for the test. Section 1834A(a)(3)(B) of the Act provides that applicable information must not include information about a laboratory test for which payment is made on a capitated basis or other similar payment basis during the data collection period.
We proposed to define applicable information in § 414.502 as, for each CDLT for a data collection period, each private payor rate, the associated volume of tests performed corresponding to each private payor rate, and the specific HCPCS code associated with the test, but not information about a test for which payment is made on a capitated basis.
Several terms and concepts in our proposed definition required explanation. First, we addressed the term “private payor rate.” The statutory definition of applicable information refers to “payment rate” as opposed to private payor rate; however, we often use payment rate generically to refer to the amount paid by Medicare under the CLFS. For the proposed rule, we believed it could be confusing to the public if we used the term “payment rate” as it related to both applicable information and the amount paid under the CLFS. Because the statute says the payment rate is the amount paid by private payors, we believed “private payor rate” could be used in the context of applicable information rather than payment rate. Therefore, we referred to the private payor rate in regard to applicable information, and we did so even when we were referring to the statutory language that specifically references payment rate. When we used the term “payment rate,” unless we indicated otherwise, we were referring to the Medicare payment amount under the CLFS. In our proposed definition of private payor rate, we attempted to be clear that we were limiting the term to its use in the definition of applicable information. We continue to use the term private payor rate with regard to applicable information in this final rule.
Regarding the definition of “private payor rate,” the statute indicates that applicable laboratories are to report the private payor rate “that was paid by each private payor,” and that the private payor rate must reflect all price concessions. The private payor rate, as we noted previously, is the amount that was paid by a private payor for a CDLT, and we proposed to incorporate that element into our proposed definition of private payor rate. To calculate a CLFS amount, we believed it was necessary to include in private payor rates patient deductible and coinsurance amounts. (Note: In the discussion below, “patient” refers to a privately insured individual while “beneficiary” refers to a Medicare beneficiary.) For example, if a private payor paid a laboratory $80 for a particular test, but the payor required the patient to pay the laboratory 20 percent of the cost of that test as coinsurance, meaning the private payor actually paid the laboratory only $64, the laboratory would report a private payor rate of $80 (not $64), to reflect the patient coinsurance. The alternative would be for private payor rates to not include patient deductibles and coinsurance (such policy would yield $64 in the above example). Thus, the issue of whether to include or exclude
With regard to price concessions, section 1834A of the Act is clear that the private payor rate is meant to reflect the amount paid by a private payor less any price concessions that were applied to a CDLT. For example, there may be a laboratory that typically charges $10 for a particular test, but offers a discount of $2 per test if a payor exceeds a certain volume threshold for that test in a given time period. If the payor exceeds the volume threshold, the private payor rate for that payor for that test, taking into account the $2 discount, is $8. The statute lists specific price concessions in section 1834A(a)(5) of the Act—discounts, rebates, and coupons; and in section 1847A(c)(3) of the Act—volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase requirement, chargebacks, and rebates (except for Medicaid rebates under section 1927 of the Act). These lists are examples of price concessions, and, we believed, were not meant to be exhaustive. We indicated that other price concessions that are not specified in section 1834A of the Act might be applied to the amounts paid by private payors, and we would expect those to be accounted for in the private payor rate. Within our definition of private payor rate, we proposed that the amount paid by a private payor for a CDLT must be the amount after all price concessions were applied.
We proposed to codify the definition of private payor rate in § 414.502. Specifically, we proposed that the private payor rate, for applicable information, is the amount that was paid by a private payor for a CDLT after all price concessions were applied, and includes any patient cost-sharing amounts, if applicable.
Next, we addressed the definition of “private payor.” Section 1834A(a)(3)(i) of the Act specifies that applicable information is the private payor rate paid by each private payor. Section 1834A(a)(8) of the Act defines private payor as (A) a health insurance issuer and a group health plan (as such terms are defined in section 2791 of the Public Health Service Act), (B) a Medicare Advantage plan under part C, and (C) a Medicaid managed care organization (as defined in section 1903(m) of the Act).
A health insurance issuer is defined in section 2791(b)(2) of the Public Health Service (PHS) Act, in relevant part, as an insurance company, insurance service, or insurance organization (including a health maintenance organization) which is licensed to engage in the business of insurance in a state and which is subject to state law which regulates insurance (within the meaning of section 514(b)(2) of the Employee Retirement Income Security Act of 1974 (ERISA)). We incorporated this definition of health insurance issuer into our proposed definition of private payor by referring to the definition at section 2791(b)(2) of the PHS Act.
Section 2791(a)(1) of the PHS Act defines a group health plan, in relevant part, as an employee welfare benefit plan (as defined in section 3(1) of ERISA to the extent that the plan provides medical care and including items and services paid for as medical care) to employees or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise. We incorporated this definition of group health plan into our definition of private payor by referring to the definition at section 2791(a)(1) of the PHS Act.
A Medicare Advantage plan under part C is defined in section 1859(b)(1) of the Act as health benefits coverage offered under a policy, contract, or plan by a Medicare+Choice organization under, and in accordance with, a contract under section 1857 of the Act. In the proposed rule we incorporated this definition of Medicare Advantage plan into our definition of private payor by referring to the definition in section 1859(b)(1) of the Act.
A Medicaid managed care organization is defined in section 1903(m)(1)(A) of the Act, in relevant part, as a health maintenance organization, an eligible organization with a contract under section 1876 of the Act or a Medicare+Choice organization with a contract under Medicare Part C, a provider sponsored organization, or any other public or private organization, which meets the requirement of section 1902(w) of the Act and (i) makes services it provides to individuals eligible for benefits under Medicaid accessible to such individuals, within the area served by the organization, to the same extent as such services are made accessible to individuals (eligible for medical assistance under the State plan) not enrolled with the organization, and (ii) has made adequate provision against the risk of insolvency, which provision is satisfactory to the state, meets the requirements under section 1903(m)(1)(C)(i) of the Act (if applicable), and which assures that individuals eligible for benefits under Medicaid are in no case held liable for debts of the organization in case of the organization's insolvency. An organization that is a qualified health maintenance organization (as defined in section 1310(d) of the PHS Act) is deemed to meet the requirements of clauses (i) and (ii). We incorporated this definition of Medicaid managed care organization into our definition of private payor by referring to the definition at section 1903(m)(1)(A) of the Act.
We proposed to codify the definition of “private payor” in § 414.502 as a health insurance issuer, as defined in section 2791(b)(2) of the PHS Act; a group health plan, as defined in section 2791(a)(1) of the PHS Act; a Medicare Advantage plan under Medicare Part C, as defined in section 1859(b)(1) of the Act; or a Medicaid managed care organization, as defined in section 1903(m)(1)(A) of the Act.
Next, section 1834A(a)(3) of the Act requires that applicable information include the private payor rate for each test and the “volume of such tests” for each private payor. Regarding the volume reporting requirement, we are aware that sometimes laboratories are paid different amounts for the same CDLT by a payor. Also, sometimes laboratories are paid different amounts for the same CDLT by different payors. Section 1834A(a)(6) of the Act specifies that an applicable laboratory must report each such private payor rate and associated volume for the CDLT. Accordingly, we proposed that each applicable laboratory must report each private payor rate for each CDLT and its corresponding volume. For example, an applicable laboratory and private payor may agree on a volume discount for a particular test whereby the first 100 tests will be reimbursed at $100. The 101st test (and all thereafter) will be reimbursed at $90. In reporting to CMS, the laboratory would report two different private payor rates for this private payor. The first would be 100 tests at a private payor rate of $100 per test, and the second, $90 for all tests reimbursed thereafter. We proposed to implement the volume reporting requirement by including in the proposed definition of applicable
In the proposed rule we discussed the need to be able to identify the particular test for which private payor information is being reported. As CLFS tests are identified by HCPCS codes (see 80 CFR 59403 to 59404 for discussion of coding), applicable laboratories will need to report a HCPCS code for each test that specifically identifies the test being reported. We proposed to include in § 414.502 that applicable information includes the specific HCPCS code associated with each CDLT. Some laboratory tests are currently billed using unlisted CPT codes or HCPCS level II miscellaneous/not otherwise classified (NOC) codes. Because NOC codes and unlisted CPT codes do not describe a single test and may be used to bill and pay for multiple types of tests, we would not be able to determine the specific laboratory test corresponding to a reported private payor rate if either was used for reporting. To ensure that applicable laboratories do not report applicable information with a NOC code or an unlisted CPT code, we also proposed to define “specific HCPCS code” in § 414.502 as a HCPCS code that does not include an unlisted CPT code, as established by the American Medical Association, or a NOC code, as established by the CMS HCPCS Workgroup. Therefore, data on tests that are billed using unlisted CPT codes or NOC codes would not be considered applicable information and would not be reported.
Finally, the statute specifies that applicable information does not include certain information listed in section 1834A(a)(3)(B) of the Act—information for a laboratory test for which payment is made on a capitated basis or other similar payment basis during the data collection period. A capitated payment is made for health care services based on a set amount for each enrolled beneficiary in the plan for a given period of time, regardless of whether the particular beneficiary receives services during the period covered by the payment. Payment is typically made on a capitated basis under a managed care arrangement. As there is no way to determine payment specifically for a given test, it cannot be reported as applicable information. Therefore, we proposed to specify in the definition of applicable information in § 414.502 that the term does not include information about a test for which payment is made on a capitated basis. We stated that we do not believe providing a discount based on volume of tests furnished is an example of a payment made on a capitated basis or other similar payment basis.
A discussion of the public comments we received on the definition of applicable information and our responses to those comments appears below.
• Hard copy (manual) remittances where HCPCS-level payment data are not captured or the formatting of the hard copy remittance advice is not conducive to optical character recognition (OCR) scanning;
• Manual remittances where the payor has grouped test-level payments into an encounter-level (claim-level) payment;
• Payments that were made in error, which are often not corrected until months after the incorrect payment was received;
• Bulk settlements;
• Payments that include post-payment activity such as recoupments;
• Payments from secondary insurance payors;
• Payments that do not reflect specific HCPCS code-level amounts; and
• Other similar payments.
The commenters requested that we permit some measure of flexibility for applicable laboratories to exclude reporting the aforementioned items from applicable information where the administrative burden of collecting and reporting applicable information exceeds any potential to influence the final payment rate. To that end, the commenters requested that we issue subregulatory guidance after publication of the final rule to specify the information that laboratories may exclude from reporting.
First, the commenters' specific requests that certain information be excluded from the definition of applicable information indicate to us that we need to provide clarification about what we meant by the term “paid” in the proposed definition of private payor rate. We clarify here that an amount has been paid if the laboratory received final payment for the test. Many of the items commenters requested to be excluded would not be considered applicable information because final payment would not have been made for the test. For instance, a private payor pays a laboratory for a test, but subsequent post-payment activities may change that initial payment amount. Some examples of post-payment activity that could change the initial payment amount are the correction of an initial payment made in error or recoupment of payment. Where those types of activities result in a final payment, the resulting payment amount would be considered for purposes of the private payor rate if it is made to the laboratory in the data collection period. For example, if an initial claim was paid in error 3 months before a data collection period and then corrected, with final payment being made by the private payor during the data collection period, the final corrected payment amount for the test would be considered for purposes of the private payor rate. If a test is performed during a data collection period, but a final payment is not made until after the data collection period, that payment amount would not be a private payor rate for purposes of applicable information and, therefore, would not be reported to CMS. Final payments from secondary insurance payors would also be considered in calculating private payor rates if the final payment was made during the data collection period.
Second, commenters asked whether payment rates can be excluded from the
Third, commenters asked about excluding from applicable information manual remittances where the payor has grouped test-level payments into an encounter (claim-level) payment. The proposed rule specified that, for each CDLT, the associated volume of tests performed corresponding to each private payor rate is a component of the definition of applicable information. Where the associated volume of tests performed corresponding to each private payor rate cannot be discerned by a laboratory from the private payors' remittance, those payment amounts would not be considered applicable information and should not be reported to CMS. Therefore, where a private payor groups test-level payments into a claim-level payment, instead of by individual HCPCS code, those rates would not be applicable information.
Commenters also asked that we allow stakeholders to decide whether the burden of collecting and reporting certain payment rates outweighs the potential influence those rates would have on final payment rates and, when that is the case, stakeholders would not have to report it as applicable information. We cannot permit stakeholders to exercise that discretion. The statute is clear that applicable information, which is used to set CLFS payment amounts, must be reported for applicable laboratories for a data collection period, and it defines applicable information, in part, as the payment rate that was paid by each private payor for the test during a data collection period and the volume of such tests for each such payor for the data collection period. As such, we believe the statute does not support selective reporting of applicable information for applicable laboratories. If the laboratory meets the definition of applicable laboratory, the applicable information for that laboratory must be reported.
Where a laboratory test claim is still under review by the private payor or is under appeal during a data collection period, the amount that has already been paid would not be considered a final payment rate and would therefore not be used to determine a private payor rate. Payment rates for claims under appeal would only be private payor rates if the final payment amount is determined and paid during the data collection period. For example, if a laboratory filed an appeal for a test furnished prior to a data collection period, and the appeal was resolved so that final payment for the test was made during the data collection period, the final rate paid would be used to calculate the private payor rate. However, if the appeal was settled during the data collection period, but final payment was not made by the private payor until after the data collection period, the payment amount could not be used for a private payor rate and would therefore be excluded from applicable information.
Some commenters asked whether denials, which they referred to as zero payments, would need to be reported as applicable information because no private payor payment amount was made for the laboratory test(s). We assume commenters are suggesting that when a claim is denied, the payment amount for the test could be said to be zero dollars, so commenters want to know if, in those instances, they should report zero dollars as the private payor rate. Laboratories should not report zero dollars for CDLTs where a private payor has denied payment within a data collection period. We are revising the definition of private payor rate in § 414.502 to specify that it does not include information about denied payments.
Finally, in response to the commenters' request for clarification as to whether private payor rate includes non-contracted amounts for out-of-network laboratories or services, we clarify that applicable information includes private payor rates for out-of-network laboratories, as long as the final payment for the laboratory test was made by the private payor during the data collection period. As the statutory definition of applicable information does not distinguish between contracted and non-contracted amounts paid by private payors, we believe it is appropriate for the private payor rate to include non-contracted amounts paid to laboratories.
We are modifying the definition of applicable information in § 414.502 to clarify that, with respect to each CDLT, applicable information includes each private payor rate for which final payment has been made in the data collection period. We are also renumbering the provisions within the definition to make the requirements clearer; these are non-substantive changes that do not affect the final policy. In addition, we are modifying the definition of private payor rate in § 414.502 to clarify two points: (1) The private payor rate is the “final amount” that was paid by a private payor for a CDLT and; (2) as noted above, the private payor rate does not include information about denied payments.
We are clarifying here that the price concessions to be applied are only those applied by the private payor. We do not intend that concessions applied by a laboratory, such as, for example, the waiver of patient coinsurance, copayments, or deductibles due to a patient's financial hardship, would be a price concession for purposes of the definition of private payor rate. The statute envisions that CLFS payment rates under the new system are based on the rates paid by private payors. Although laboratories may provide concessions to patients, we do not believe it is appropriate to factor those concessions into a system that is required to be based on the rates paid by private payors. We understand, however, that we may have created some confusion about which price concessions are to be applied and which are not. Unfortunately, we provided an example in the proposed rule of a discount provided by a laboratory, as opposed to a private payor, that would be considered to be a price concession. This example did not reflect our intent that, for the private payor rate, only price concessions made by the private payor are to be applied.
To be clear, concessions applied by a laboratory are not price concessions for purposes of the private payor rate. To clarify that only private payor price concessions apply in calculating the private payor rate and not those applied by the laboratory, we are modifying the definition of private payor rate in § 414.502 to indicate that, for purposes of applicable information, private payor rate is the final amount that was paid by a private payor for a CDLT after all private payor price concessions are applied, and does not include price concessions applied by a laboratory.
The statute applies different reporting and payment requirements to ADLTs than to other CDLTs, and further distinguishes a subset of ADLTs called “new ADLTs.” In this section, we discuss our definitions for the terms “advanced diagnostic laboratory test” and “new advanced diagnostic laboratory test.”
Section 1834A(d)(5) of the Act defines an ADLT as a CDLT covered under Medicare Part B that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and that meets one of the following criteria: (1) The test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result; (2) the test is cleared or approved by the FDA; (3) the test meets other similar criteria established by the Secretary. Sections 1834A(d)(1) and (2) of the Act recognize special reporting and payment requirements for ADLTs for which payment has not been made under the CLFS prior to April 1, 2014 (PAMA's enactment date). In establishing a regulatory definition for ADLT, we considered each component of the statutory definition at section
We believe that, by including these provisions for ADLTs, the statute seeks to establish special payment status for tests that are unique and are provided only by the laboratory that developed the test, or a subsequent owner of that laboratory. In other words, we view the statute as intending to award special payment status to the one laboratory that is expending the resources for all aspects of the test—developing it, marketing it to the public, performing it, and selling it. It is with this understanding that we developed our proposed policies for defining ADLTs.
First, to be an ADLT, a test must meet the requirements specified in the first part of the definition at section 1834A(d)(5) of the Act, that is, it must be a CDLT covered under Medicare Part B that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner). For the meaning of “single laboratory,” we believed the statute intends to ensure that we grant ADLT status to the one laboratory that offers and furnishes the particular test, to the exclusion of all other laboratories. To ensure this is the case, we proposed to require the laboratory to be a facility with a single CLIA certificate as described in § 493.43(a) and (b) because we believed, in most instances, the laboratory's single CLIA certificate would correspond to one laboratory location or facility. Under our proposal, an entity with multiple CLIA certificates would not be a single laboratory. For example, a test offered by a health system consisting of multiple entities, including physician offices and independent laboratories, and that has multiple CLIA certificates associated with its multiple testing locations, would not be eligible for ADLT status, even if the test met all other ADLT criteria. Section 493.43(b) includes several narrow exceptions for certain types of laboratories that may have multiple locations.
Next, the statute directs that the test must be “offered and furnished” by a laboratory seeking ADLT status for the test. It also requires that the test be “not sold for use by a laboratory other than the original developing laboratory.” We interpreted the original developing laboratory referenced in the statute to be the same laboratory that offers and furnishes the test. This interpretation was consistent with our understanding that the statute intends for special payment status to be awarded to the one laboratory that is expending the resources for all aspects of the test. Within the two requirements—(1) that a laboratory seeking ADLT status must offer and furnish the test and (2) that the test is not sold for use by a laboratory other than the original developing laboratory—there were several components for us to parse, and we did so consistent with our view of the statutory intent. First, we stated that we believed a laboratory offers and furnishes a test when it markets and performs the test. The laboratory that markets and performs the test must also be the only one to sell it, that is, to receive remuneration in exchange for performing the test. In addition, we believed that laboratory must also be the one that developed the test, which means the laboratory designed it. We are aware that, in certain circumstances, a referring laboratory may bill for a test under section 1833(h)(5)(A) of the Act. The referring laboratory is a laboratory that receives a specimen to be tested and refers it to another laboratory, the reference laboratory, to perform the test. We explained that, in these situations, because the reference laboratory performed the test, it would be the laboratory that offered and furnished the test for purposes of the ADLT definition.
Accordingly, under our proposal, only one laboratory could design, market, perform, and sell the test. If more than one laboratory engages in any of those activities, the test would not meet the criteria to be an ADLT. Under our proposal, we would not expect to see more than one applicable laboratory report applicable information for a given ADLT.
Next, the statute permits a successor owner to the original developing laboratory to sell the test without disqualifying the test from ADLT status. We proposed to define successor owner as a laboratory that has assumed ownership of the original developing laboratory, and meets all other aspects of the ADLT definition (except for being the original developing laboratory). This means the successor owner is a single laboratory that markets, performs, and sells the ADLT.
In considering how to define successor owner, we looked to our regulations at § 489.18(a), which describe what constitutes a change of ownership for Medicare providers. Although laboratories are suppliers and not providers, we believed the language in this regulation appropriately applied to the wide range of potential changes in ownership for laboratories. Specifically, we proposed to incorporate the scenarios described in § 489.18(a) as discussed in the proposed rule, 80 FR 59397, as follows. A successor owner, for purposes of an ADLT, would mean a single laboratory that has assumed ownership of the laboratory that designed the test through any of the following circumstances:
• Partnership. In the case of a partnership, the removal, addition, or substitution of a partner, unless the partners expressly agree otherwise, as permitted by applicable state law, constitutes change of ownership.
• Unincorporated sole proprietorship. Transfer of title and property to another party constitutes change of ownership.
• Corporation. The merger of the original developing laboratory corporation into another corporation, or the consolidation of two or more corporations, including the original developing laboratory, resulting in the creation of a new corporation constitutes change of ownership. However, a transfer of corporate stock or the merger of another corporation into the original developing laboratory corporation does not constitute change of ownership.
• Leasing. The lease of all or part of the original developing laboratory facility constitutes change of ownership of the leased portion. In the case of a lease, all of or part of the original developing laboratory is leased by the owner(s) of the original developing laboratory to another entity who takes over the continued production of the test, and the owner(s) of the original developing laboratory becomes the lessor of the laboratory where it formerly provided laboratory tests. In this situation, there would be a change of ownership of the leased portion of the laboratory, and the lessee would become the successor owner that could be paid for performing an ADLT, provided the test meets all other criteria for being an ADLT.
As we noted, the successor owner would need to be a single laboratory and meet all other aspects of the ADLT definition. For example, under our proposal, if an original developing
Next, in addition to meeting the first part of the ADLT definition at section 1834A(d)(5) of the Act, the statute requires that an ADLT must meet one of the criteria described in paragraphs (5)(A), (5)(B), or (5)(C). Criterion A of section 1834A(d)(5) of the Act states that the test is an analysis of multiple biomarkers of DNA, RNA, or proteins combined with a unique algorithm to yield a single patient-specific result. We interpreted this provision to require that the test analyze, at a minimum, biomarkers of DNA or RNA. Tests that analyze nucleic acids (DNA or RNA) are molecular pathology analyses. Therefore, we proposed that, under criterion A, a test must be a molecular pathology analysis of DNA or RNA. Examples of such tests include those that analyze the expression of a gene, the function of a gene, or the regulation of a gene. The statute also requires that the test analyze “multiple” biomarkers of DNA, RNA, or proteins. Therefore, we stated that an ADLT might consist of one test that analyzes multiple biomarkers or it might consist of multiple tests that each analyzes one or more biomarkers.
That the analysis of the biomarkers must be “combined with a unique algorithm to yield a single patient-specific result” indicated to us that the algorithm must be empirically derived, and that the ultimate test result must be diagnostic of a certain condition, a prediction of the probability of an individual developing a certain condition, or the probability of an individual's response to a particular therapy. Furthermore, the statute requires the result to be a single patient-specific one, so we proposed that the test must diagnose a certain condition for an individual, or predict the probability that a specific individual patient will develop a certain condition(s) or respond to a particular therapy. We also proposed that the test must provide new clinical diagnostic information that cannot be obtained from any other existing test on the market or combination of tests (for example, through a synthesis of the component molecular pathology assays included in the laboratory test in question). We considered requiring that a new ADLT be clinically useful, as well as new, but decided against such a policy due to statutory limitations. These proposed policies for implementing criterion A were based on our view that ADLTs that meet the criterion are innovative tests that are new and different from any prior test already on the market and provide the individual patient with valuable genetic information to predict the trajectory of the patient's disease process or response to treatment of the patient's disease that could not be gained from another test or tests on the market. Finally, we stated that we expected an ADLT could include assays in addition to the biomarker assay(s) described above. For example, in addition to an analysis of a DNA biomarker, an ADLT might also include a component that analyzes proteins. We would not disqualify a test from ADLT status consideration if that is the case. In summary, we proposed that to qualify as an ADLT under criterion A of section 1834A(d)(5) of the Act, a test: (i) Must be a molecular pathology analysis of multiple biomarkers of DNA, or RNA; (ii) when combined with an empirically derived algorithm, yields a result that predicts the probability a specific individual patient will develop a certain condition(s) or respond to a particular therapy(ies); (iii) provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests; and (iv) may include other assays. We included this proposed requirement in paragraph (1) of the ADLT definition in § 414.502.
Criterion B of section 1834A(d)(5) of the Act states that the test is cleared or approved by the FDA. The FDA considers CDLTs to be medical devices, and has two main application processes for clearing and approving medical devices. To receive FDA clearance to market a new device, a Premarket Notification submission, also referred to as a 510(k), is submitted to FDA for review at least 90 days before introducing, or delivering for introduction, the device into interstate commerce. Before FDA can clear a 510(k) and allow a device to be commercialized, the 510(k) submitter must demonstrate that their medical device is “substantially equivalent” to a device that is legally marketed for the same intended use and for which a Premarket Approval Application (PMA) is not required. A request for FDA approval of a device is typically submitted through a PMA, which is the most stringent type of device marketing application required by FDA. A PMA refers to the scientific and regulatory review necessary to evaluate the safety and effectiveness of devices that have not been found to be substantially equivalent through the 510(k) [Premarket Notification] process or devices for which insufficient information exists to determine that general controls either alone (Class I) or together with special controls (Class II) would provide a reasonable assurance of their safety and effectiveness. To obtain FDA approval of a device, an applicant must submit a PMA which includes valid scientific evidence to assure that the device is safe and effective for its intended use(s). We further noted that FDA regulations or orders exempt many Class I and certain Class II devices from premarket notification and allow them to be legally marketed immediately without premarket clearance. Since criterion B of section 1834A(d)(5) of the Act requires FDA approval or clearance, we stated that we did not intend for this criterion to cover any devices that are, by regulation or order, exempt from premarket notification and that have not received FDA approval or clearance. We proposed that a laboratory test can be considered an ADLT if it is cleared or approved by the FDA and meets all other aspects of the ADLT definition. Under criterion B, laboratories would have to submit documentation of their FDA clearance or approval for the test. We stated that this process would be outlined through subregulatory processes prior to January 1, 2016.
To implement criteria A and B, we stated that we would establish guidelines for laboratories to apply for ADLT status and submit documentation to support their application. For example, we indicated that if our proposed definition of criterion A is finalized, laboratories would have to submit to CMS evidence of their empirically derived algorithms and show how their test provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests. As we noted in section II.F. of the proposed rule (80 FR 59402), section 1834A(a)(10) of the Act provides for confidentiality of the information disclosed by a laboratory under section 1834A(a) of the Act. As this statutory provision is limited to “this section” (that is, section (a)), we believed it does not apply to section (d) of section 1834A of the Act, which relates to information provided to the Secretary to determine whether a test is an ADLT. While we stated that we do
Criterion C of section 1834A(d)(5) of the Act gives the Secretary the authority to establish and apply other similar criteria by which to determine that a test is an ADLT. We did not propose to exercise this authority; however we indicated that if we do so in the future, it would be through notice and comment rulemaking.
Section 1834A(d) of the Act is titled “Payment for New Advanced Diagnostic Laboratory Tests.” As previously discussed in this section, section 1834A(d)(1)(A) of the Act provides special payment rules for ADLTs for which payment has not been made under the CLFS prior to April 1, 2014, the enactment date of PAMA. Section 1834A(i) of the Act, titled “Transitional Rule,” provides that during the period beginning on April 1, 2014, PAMA's enactment date, and ending on December 31, 2016, for ADLTs paid under Medicare Part B, the Secretary shall use the methodologies for pricing, coding, and coverage in effect on the day before April 1, 2014, which may include crosswalking or gapfilling methods. We interpreted section 1834A(i) of the Act to mean that we must use the current CLFS payment methodologies for ADLTs that are furnished between April 1, 2014, and December 31, 2016.
Accordingly, we proposed to define a new ADLT as an ADLT for which payment has not been made under the CLFS prior to January 1, 2017. Any ADLT paid for under the CLFS prior to January 1, 2017, would be an existing ADLT and would be paid in accordance with the current regulations at 42 CFR part 414, subpart G, including gapfilling and crosswalking methodologies. In other words, there would be no new ADLTs until January 1, 2017, and they would be first paid on the CLFS using the payment methodology for new ADLTs proposed in § 414.522. We proposed to codify the definition of “new ADLT” at § 414.502 to mean an ADLT for which payment has not been made under the CLFS prior to January 1, 2017.
A discussion of the public comments we received on the definitions of ADLT and new ADLT and our responses to those comments appears below.
In the proposed rule, we explained that we considered “marketing” to be an appropriate illustration of how we interpreted the term “offer.” Nonetheless, we agree that some marketing activities, such as developing and implementing a promotional strategy, may go beyond “offering” a test. What we were attempting to achieve with our proposal that the single laboratory must be the only laboratory to market and perform the test, was to ensure that the single laboratory was the entity expending the resources for all aspects of the test, in other words, the entity responsible for administering all aspects of the test. We are using the term “offer” rather than “market” in this final rule because we are convinced by commenters that the terms are not synonymous and, in fact, marketing goes beyond the scope of offering. If a laboratory offers a test, it is presenting the test for sale, which is consistent with our view that a single laboratory is the entity expending the resources and is responsible for administering all aspects of the test.
In addition, we used the term “performed” in the proposed rule to illustrate what we believe it means for a laboratory to furnish a test. While it is important for the industry to know how we interpret the term “furnish,” we understand the industry prefers we use the term “furnish” in the regulatory definition of ADLT. Therefore, we are revising our proposed definition of ADLT in § 414.502 to include the statutory terms “offered and furnished” rather than “marketed and performed.”
For these reasons, we are not adopting our proposal to define single laboratory as a facility with a single CLIA certificate. For purposes of an ADLT, we are revising the definition of single laboratory to mean a laboratory as defined in § 493.2 which furnishes the test, and that may also design, offer, and sell the test. The definition also includes the entities that own the laboratory or that the laboratory owns, which may design, offer, and sell the test; this includes other laboratories that may be owned by the single entity.
We believe this revised approach will allow a corporate entity that owns multiple laboratories to furnish a new ADLT at each laboratory site, and will enable other parts of the single laboratory organization to be involved with aspects of the ADLT such as research and development. It will also allow an original developing laboratory that meets the definition of a single laboratory to continue to be a single laboratory if it chooses to expand its organization by acquiring new laboratory sites to meet increased demand for laboratory testing. Revising the definition of single laboratory to allow multiple laboratories located in different locations throughout the country, under common ownership, to furnish the test could also improve beneficiary access to innovative laboratory tests.
Although our revised definition will enable parts of the single laboratory organization other than its component laboratories to assume responsibilities such as developing (as we discuss above, we believe when a laboratory develops a test, it means the laboratory designs it), offering, and selling the test, only the laboratory parts of the single laboratory organization may perform the test. Therefore, our revised definition specifies that only laboratories, as defined in § 493.2, may furnish the ADLT.
We are revising the definition of single laboratory in § 414.502 to indicate that a single laboratory, for purposes of an ADLT, means the laboratory, as defined in § 493.2, which furnishes the test, and that may also design, offer, or sell the test and the entity that owns the laboratory and the entity that is owned by the laboratory which may design, offer, or sell the test.
Additionally, as discussed previously in this section, we proposed that a successor owner for purposes of an ADLT, means a single laboratory that has assumed ownership of the laboratory that designed the test through any of the following circumstances: Partnership; unincorporated sole proprietorship; corporation; or leasing. Under our revised definition of single laboratory, because each successor owner is an entity that assumes ownership of a single laboratory, the successor owner becomes the owner of the entire single laboratory organization, that is, the laboratory and the other entities the laboratory owns or is owned by. For example, if the single laboratory owns multiple laboratories and other entities, then a change in partnership or sole proprietorship, as described in the definition of successor owner, would have to apply to the entire single laboratory organization to qualify as successor ownership. In the case of a merger of the single laboratory into another corporation or its consolidation with two or more corporations that results in a new corporation, the entire single laboratory organization would need to be included in the corporate merger to qualify as successor ownership.
For changes in ownership resulting from leasing, we proposed (80 FR 59397) that the lease of all or part of the single laboratory organization would constitute a change in ownership of the leased portion. However, we cannot reconcile leasing a portion of a single laboratory with our final policy that a single laboratory includes the laboratory and the other entities that own or are owned by the laboratory. Therefore, we are removing leasing from the definition of successor owner as a circumstance under which there can be a successor owner.
In addition, in the proposed rule we indicated that a successor owner for purposes of an ADLT means a single laboratory that has assumed ownership of the laboratory that designed the test. We recognize that successor ownership is not limited to just the successor of the original developing laboratory. There can be successor owners to successor owners. Therefore, we are revising the definition of successor owner to clarify, for purposes of an ADLT, a successor owner means a single laboratory that has assumed ownership of the single laboratory that designed the test or of the single laboratory that is a successor owner to the single laboratory that designed the test, through any of the following circumstances:
(1) Partnership—the removal, addition, or substitution of a partner, unless the partners expressly agree otherwise, as permitted by applicable state law;
(2) Unincorporated sole proprietorship—the transfer of title and property to another party;
(3) Corporation—the merger of the single laboratory corporation into another corporation, or the consolidation of two or more corporations, including the single laboratory, resulting in the creation of a new corporation. We also specify that a transfer of corporate stock or the merger of another corporation into the single laboratory corporation does not constitute change of ownership.
The commenter describes a situation wherein an academic institution licenses the intellectual property to another entity that further develops the test for commercialization. We believe that by “discovering” the test, the academic institution partially develops the test. For instance, a laboratory that purchases the intellectual property of the test may rely on the academic institution to develop a method the test utilizes or a particular reagent the academic institution has patented. In such situations, the laboratory that purchased the intellectual property would not be expending its own resources on all aspects of the development of the test and therefore, could not be considered an original developing laboratory of the test. It also could not be a successor owner if the academic institution is not the original developing laboratory or a single laboratory. As such, the test would not qualify for ADLT status.
In addition, we are not finalizing our proposal under criterion A that a test must be a molecular pathology analysis of multiple biomarkers of DNA or RNA. In the proposed rule (80 FR 59397 through 59398) we stated that tests that analyze nucleic acids (DNA or RNA) are molecular pathology analyses, and we therefore proposed that, under criterion A, a test must be a molecular pathology analysis of RNA or DNA. Because we are now including protein-only tests under criterion A, and protein-only tests are not molecular pathology tests, we are removing the requirement that an ADLT must be a molecular pathology test. The definition of ADLT in § 414.502(1)(i) is revised to state that it is an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins.
For the reasons discussed previously in this section, we are finalizing our proposal for the unique algorithm, and will reflect it in the definition of ADLT under criterion A as proposed.
The proposed definition of new ADLT correlated to the proposed implementation date of the private payor rate-based CLFS, January 1, 2017. However, as we discuss in this final rule, in response to comments, we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018. We believe it is also appropriate to adopt a corresponding change for new ADLTs because the statute requires new ADLTs to be paid based on private payor rates after the new ADLT initial period. If we were to retain the proposed implementation date for new ADLTs, it could result in a new ADLT receiving payment based on the median private payor rate before January 1, 2018. For example, if the initial period for a new ADLT were to end on September 30, 2017, payment would then be based on the weighted median private payor rate beginning October 1, 2017, which would be prior to the January 1, 2018 implementation schedule for the new private payor rate-based CLFS. Therefore, the January 1, 2018 implementation date will apply to CDLTs (that are not ADLTs), as well as new ADLTs. In conjunction with this change, the payment amount for existing ADLTs will be determined based on crosswalking and gapfilling for ADLTs furnished through December 31, 2017, instead of December 31, 2016.
We are revising the definition of new ADLT in § 414.502 to reflect that a new ADLT is an ADLT for which payment has not been made under the CLFS prior to January 1, 2018. We are also making a conforming revision to § 414.507(h) to indicate that the payment amount for ADLTs that are furnished between April 1, 2014, and December 31, 2017, is based on the crosswalking or gapfilling methods described in § 414.508(a).
Specifically, we indicated that, although the statute does not explicitly protect ADLT application information from release under FOIA (as it does under section 1834A(a)(11) of the Act for applicable information), FOIA does include an exemption for trade secrets and commercial and financial information obtained from a person that is privileged or confidential. While we do not have the authority to provide automatic protection from public disclosure under this FOIA exemption, (b)(4), if an applicant submits an ADLT application that includes trade secrets or certain commercial or financial information, specified above, it is possible the information could be withheld from public disclosure under FOIA exemption (b)(4). An applicant that wishes to protect the information submitted in an ADLT application would mark it proprietary and confidential, and substantiate that statement by expressly claiming substantial competitive harm if the information is disclosed, and demonstrating such in a separate statement by explaining how the release would cause substantial competitive harm pursuant to the process in E.O. 12600 for evaluation by us. Because there is no guarantee such information will be withheld, however, laboratories will have to decide for themselves whether to apply for ADLT status and risk the possibility of public disclosure of information they do not want to be publicly disclosed. However, we note that we would only be requiring information relevant to determining whether a test qualifies as an ADLT. Please see additional comments and responses related to confidentiality and
Section 1834A(a) of the Act requires applicable laboratories to report applicable information. The information is gathered or collected during a “data collection period” and then reported to the Secretary during a “data reporting period.” Under the statute, the Secretary is to specify the period of time for the data collection period and the timeframe for the data reporting period. In this section, we proposed to define the terms “data collection period” and “data reporting period.” In determining what the proposed data collection and data reporting periods should be, we considered our objectives to: (1) Provide applicable laboratories sufficient notice of their obligation to collect and report applicable information to CMS; (2) allow applicable laboratories enough time to collect and report applicable information; (3) give CMS enough time to process applicable information to determine a CLFS payment rate for each laboratory test; and (4) publish new CLFS payment rates at least 60 days in advance of January 1 so laboratories will have sufficient time to review the data used to calculate CLFS payment rates and prepare for implementation of the new CLFS rates on January 1.
Section 1834A(a)(4) of the Act defines the term “data collection period” as a period of time, such as a previous 12-month period, specified by the Secretary. We believed the data collection period should be a full calendar year, for example, January 1 through December 31, because a full calendar year of applicable information would provide a comprehensive set of data for calculating CLFS rates. In addition, we chose to define a data collection period as a calendar year as opposed to, for example, a federal fiscal year (October through September), so the data collection period would coordinate with the timing of the CLFS payment schedule, wherein updated CLFS payment rates are in effect on January 1 of each year. We also believed the data collection period should immediately precede the data reporting period, which is the time period during which applicable laboratories must report applicable information to us. For example, the data reporting period for the 2018 data collection period (January 1, 2018, through December 31, 2018) would begin on January 1, 2019. We believed that having the data collection period immediately precede the data reporting period would result in more accurate reporting by laboratories and, thus, more accurate rate setting by us, because laboratories would have more recent experience, and therefore, be more familiar with the information they are reporting. Further, we believed that starting the data reporting period immediately after the data collection period would limit the lag time between reporting applicable information and the use of that applicable information to determine Medicare CLFS payments, thus ensuring that we are using the most recent data available to set CLFS payment rates. For these reasons, we proposed to codify in § 414.502 that the data collection period is the calendar year during which an applicable laboratory collects applicable information and that immediately precedes the data reporting period.
We proposed a different timeline for the 2015 data collection period, which would have begun July 1, 2015, and ended December 31, 2015. While our preference would have been for the data collection period to be a full calendar year, as we proposed for subsequent data collection periods, and for it to begin after publication of proposed and final rules implementing section 1834A of the Act, we believed the statute contemplated the possibility that the first data collection period would begin prior to publication of regulations establishing the parameters for data collection. Given that the statute, which was enacted on April 1, 2014, required us to establish the parameters for data collection through rulemaking by June 30, 2015, the first data collection period that would allow for reporting in 2016 and implementation of the new payment system on January 1, 2017, would have to have been in 2015. As the statute indicates that a data collection period could be a 12-month period, and data collection requirement regulations did not have to be complete until June 30, 2015, we believed the statute anticipated that the first data collection period would begin prior to publication of the June 30, 2015 regulations, that is, 6 months prior to a final regulation. In addition, section 1834A(a)(4) of the Act does not require the data collection period to be a 12-month period, but rather, suggests that it could be, and provides us the authority to determine the length of the period. Therefore, although we could have chosen to make the 2015 data collection period a full calendar year, given that laboratories would not have notice of the data collection period until our regulations were proposed and finalized, we believed it was reasonable to limit the time period of the first data collection period to 6 months, which would have been consistent with the length of time the data collection period would have been in effect prior to a final rule if we had adopted a full calendar year data collection period in 2015 and published regulations specifying that to be the case on June 30, 2015. While we believed a full calendar year of data would be the most robust and comprehensive for setting CLFS payment rates, we stated in the proposed rule that we believed the 6-month data collection period in 2015 would still provide sufficient, reliable data with which to set rates that accurately reflect private payor rates. Therefore, we proposed to include in the definition of data collection period in § 414.502 that the data collection period for 2015 would be July 1, 2015 through December 31, 2015.
Under section 1834A(a)(1) of the Act, beginning January 1, 2016, and every 3 years thereafter (or annually in the case of an ADLT), each applicable laboratory must report applicable information to the Secretary at a time specified by the Secretary. We believed applicable laboratories should have 3 months during which to submit applicable information from the corresponding data collection period, that is, the calendar year immediately preceding the data reporting period. For example, for purposes of calculating CY 2017 CLFS rates, the data collection period would have begun on July 1, 2015, and ended on December 31, 2015, and the data reporting period would have been January 1, 2016 through March 31, 2016. We believed a 3-month data reporting period would be a sufficient amount of time for applicable laboratories to report applicable information to us. As we explained in the proposed rule, it would give us adequate time to calculate CLFS payment amounts, upload the CLFS rates on Medicare's claims processing systems, and make that data publicly available (preliminarily in September and then a final version in November) before the CLFS rates would go into effect on the following January 1. Given the magnitude of the potential changes in CLFS payment rates, to give the industry sufficient time to prepare for the next year's fee schedule, we believed final CLFS rates for the following year should be published at least 60 days prior to the beginning of the next calendar year, or no later than November 1. For these reasons, we proposed that the definition of “data reporting period” in § 414.502 be the 3-month period during which an applicable laboratory reports applicable information to CMS and that
Table 1 illustrates the proposed data collection period, data reporting period, and CLFS rate year for which the data would have been used for CDLTs.
As indicated in this section, we proposed that applicable information must be reported annually for ADLTs and follow the above proposed data collection schedule on an annual basis after the first data collection period, which would be for the first and second quarters of the new ADLT initial period, and reported to us by the end of the second quarter of the new ADLT initial period (described in more detail later in this section).
Section 1834A(a)(1) of the Act requires applicable laboratories, beginning January 1, 2016, to report applicable information on CDLTs that are not ADLTs every 3 years, and every year for ADLTs, at a time specified by the Secretary. As we discussed previously, we proposed that the data collection period during which applicable laboratories collect applicable information would be the calendar year immediately prior to the data reporting period. Thus, the data reporting period is a 3-month period that would occur each year for ADLTs, from January 1 through March 31, and every third year, from January 1 through March 31, for all other CDLTs (for example, 2016, 2019, 2022, etc.). We proposed to establish these data reporting requirements in § 414.504(a).
Section 1834A(a)(3)(A) of the Act requires applicable information to be the rate paid by each private payor for the test and the associated volume of such tests for each such payor during the data collection period. In addition, section 1834A(a)(6) of the Act specifies that, in the case where an applicable laboratory has more than one payment rate for the same payor for the same test or more than one payment rate for different payors for the same test, the applicable laboratory must report each such payment rate and the volume for the test at each such rate. Furthermore, section 1834A(a)(6) of the Act provides that, beginning January 1, 2019, the Secretary may establish rules to aggregate reporting, that is, permit applicable laboratories to combine the prices and volumes for individual tests. We explained that we understand this to mean that, absent rules set by the Secretary (in 2019 or later), applicable laboratories may not aggregate data by laboratory test in reporting applicable information. Taken together, these provisions indicated to us that an applicable laboratory must report applicable information for every test it performs for each private payor, including both the amounts paid and volume. This means, should a rate for a private payor change during the data collection period, an applicable laboratory would report both the old and new rates and the volume of tests associated with each rate. We realized the amount of applicable information could be voluminous for those applicable laboratories that offer a large number of tests. However, we believed the statute requires comprehensive reporting of applicable information so the Medicare CLFS rates accurately reflect the rates paid by private payors to laboratories. Our proposed definition of applicable information in § 414.502 states that applicable information, with respect to each CDLT for a data collection period, includes each private payor rate and the associated volume of tests performed corresponding to each private payor rate, so our proposed requirement at § 414.504(a) covers the requirement for applicable laboratories to report the private payor rate for every laboratory test it performs, and to account for the volume of tests furnished at each rate. We explained that this requirement means an applicable laboratory that has more than one payment rate for the same payor for the same test, or more than one payment rate for different payors for the same test, must report each such payment rate and the volume for the test at each such rate.
To minimize the reporting burden on applicable laboratories and to avoid collecting personally identifiable information, we proposed that we would only require applicable laboratories to report the minimum information necessary to enable us to set CLFS payment rates. We indicated that we would specify the form and manner for reporting applicable information in guidance prior to the first data reporting period, but generally, in reporting applicable information, we would expect laboratories to report the specific HCPCS code associated with each laboratory test, the private payor rate or rates associated with the HCPCS code, and the volume of laboratory tests performed by the laboratory at each private payor rate. We would not permit applicable laboratories to report individual claims because claims include more information than we need to set payment rates and they contain personally identifiable information. We also would not permit applicable laboratories to report private payor names because section 1834A(a)(11) of the Act prohibits a payor from being identified on information reported by the applicable laboratory. Our guidance would reflect these instructions. Accordingly, we proposed to include in our data reporting requirements at § 414.504(b), that applicable information must be reported in the form and manner specified by CMS.
Section 1834A(d)(1)(A) of the Act requires the payment amount for new ADLTs to be based on actual list charge for an “initial period” of 3 quarters, but does not specify when this initial period of 3 quarters begins. We believed the initial period should start and end on the basis of a calendar quarter, so that the first day of the initial period would be the first day of a calendar quarter, and the last day of the initial period would be the last day of a calendar quarter (for example, January 1 and March 31, April 1 and June 30, July 1 and September 30, or October 1 and December 31). We proposed this policy to be consistent with how applicable information would be reported for CDLTs (on the basis of a calendar year, that is, 4 quarters of applicable information) and how CLFS payment rates would be updated (also on the basis of a calendar year). We explained in the proposed rule that this
Section 1834A(d)(2) of the Act requires applicable laboratories to report applicable information for new ADLTs not later than the last day of the Q2 of the initial period. The applicable information will be used to determine the CLFS payment amount (using the weighted median methodology; see our discussion of the proposed CDLT payment methodology at 80 FR 59404 through 59406) for a new ADLT after the new ADLT initial period. We proposed to codify the reporting requirement for new ADLTs in § 414.504(a)(3).
We provided the following as an example of the proposed reporting and payment schedule for a new ADLT: A new ADLT that is first performed by an applicable laboratory during the Q1 of 2017 (for example, February 4, 2017) would start its initial period on the first day of the Q2 of 2017 (April 1, 2017). The new ADLT initial period would last for 3 full quarters, until the end of the Q4 of 2017 (December 31, 2017). The applicable laboratory would be required to report applicable information for the new ADLT by the end of the Q2 of the new ADLT initial period, which would be, in this example, the end of the Q3 of 2017 (September 30, 2017). These data would be used to calculate the payment amount for the new ADLT, which would be applied after the end of the new ADLT initial period, or starting Q1 2018 (January 1, 2018). This payment amount would last through the remainder of CY 2018. The new ADLT would then follow the annual reporting schedule for existing ADLTs, that is, CY 2017 applicable information would be reported between January 1, 2018 through March 31, 2018, and the applicable information would then be used to establish the payment amount for the ADLT that takes effect on January 1, 2019.
Table 2 illustrates the proposed data collection and reporting periods for a new ADLT using the above example.
A summary of the comments we received on the proposals for data collection and reporting and our responses are discussed below.
The commenters suggested that a January 1, 2018 implementation date would provide applicable laboratories sufficient notice of their obligation to collect and report applicable information and adequate time to collect and report the information to us. They asserted that moving the implementation date out by 1 year would also allow us enough time to process the private payor data and calculate and publish the new CLFS rates at least 60 days prior to implementation. In addition, many commenters stated that the recommendation to move the implementation date of the new system to January 1, 2018 is consistent with PAMA, which required us to publish a final rule by June 30, 2015 to enable new rates to be in effect on January 1, 2017, thereby contemplating an 18-month period from the date of the final rule to the implementation of the new rates.
After we begin to obtain applicable information under the new private payor rate-based CLFS, we will evaluate the quality and quantity of applicable information reported in a 6-month data collection period. We will also evaluate whether a 6-month window before the reporting period continues to be necessary once the laboratory industry has more experience with the new CLFS. If we determine that a longer data collection period is necessary or appropriate, or that a 6-month period after the data collection period is no longer needed, we may propose modifications to our policies, which we would do through notice and comment rulemaking.
We are finalizing a 6-month data collection period, from January 1 through June 30, for all data collection periods, initial and subsequent. Because we are moving the implementation of the new CLFS to January 1, 2018, we no longer need to provide a shortened time frame for the initial data collection period, so we are no longer distinguishing the initial data collection period from subsequent data collection periods in the definition of data collection period in § 414.502. We are also finalizing the proposed 3-month data reporting period, from January 1 through March 31, for a data reporting period following a data collection period. This means entities will have six months between the end of the data collection period and the beginning of the data reporting period. We are revising the definition of data collection period in § 414.502 to read: Data collection period is the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data reporting period.
Table 3 illustrates the final data collection and reporting periods, as described above, and the CLFS rate year for which the data will be used for CDLTs.
Some commenters suggested the new ADLT initial period should only begin once Medicare coverage is available for that particular test. Other commenters suggested that the CMS approval date for ADLT status should trigger the start date for the new ADLT initial period. For example, if a test is first performed on February 4, 2017, and CMS does not confer ADLT status until March 14, 2018, then it would be March 14, 2018, and not February 4, 2017, that would trigger the start of the new ADLT initial period.
Other commenters pointed out that CMS's proposed approach requires, before an ADLT can be paid at the actual list charge rate, that the laboratory has first sought and been granted ADLT status for its laboratory test and that Medicare coverage in the form of an initial claim determination or a local coverage policy has occurred. As such, some commenters believed we should clarify our proposed policy, while others suggested we should adopt a new policy, that when the agency says the initial period starts on the first day of the next calendar quarter following the first day on which the new ADLT is performed, that means the agency has already deemed the test to be an ADLT and Medicare coverage has been established.
We recognize that our proposed policy to tie the start of the new ADLT initial period to the date the test is first performed could mean new ADLTs will not be paid actual list charge. We understand that a Medicare coverage determination could be a lengthy process for the types of tests that are likely to qualify as ADLTs and that, consequently, a test may be available on the market and paid by private payors before Medicare covers and pays for it. Under our proposed policy, if the test has been available to private payors long before we grant ADLT status and provide Medicare coverage, the new ADLT initial period may have expired and the actual list charge rate would no longer apply.
We believe making the start of the new ADLT initial period contingent upon us making a Medicare Part B coverage determination for the test and approving the test for ADLT status will address stakeholder concerns that the new ADLT initial period might expire before Medicare makes payment at the actual list charge. We are revising our proposal accordingly. The new ADLT initial period will begin only when the test has been both covered under Medicare Part B and approved for ADLT status, regardless of the order in which the events take place. To ensure that both events have occurred, the date that triggers the date on which the new ADLT initial period begins will be the later of the two.
For example, if we approve a single laboratory's request for ADLT status on March 4, 2018, and a coverage determination for that test is made on August 10, 2018, the date that triggers the new ADLT initial period is August 10, 2018. The new ADLT initial period would begin October 1, 2018 because that is the first day of the first full calendar quarter following August 10, 2018. In another example, if a coverage determination for the test is made on April 6, 2018, and we approve a single laboratory's request for ADLT status on May 1, 2018, the date that triggers the new ADLT initial period would be May 1, 2018. The new ADLT initial period would begin July 1, 2018 because that is the first day of the first full calendar quarter following May 1, 2018.
To reflect this change to the start date of a new ADLT initial period, we are revising the definition of new ADLT initial period in § 414.502 to mean a period of 3 calendar quarters that begins on the first day of the first full calendar quarter following the later of the date a Medicare Part B coverage determination is made or ADLT status is granted by us. In light of this change, we are also revising the data reporting requirements in § 414.504(c) to no longer require a laboratory seeking new ADLT status for its test to attest to the date the new ADLT is first performed as this information is no longer relevant for determining the start date of the new ADLT initial period.
Additionally we clarify here that the start date of a new ADLT initial period is separate and distinct from the date that corresponds to the definition of the actual list charge. As discussed in this final rule, the actual list charge is the publicly available rate on the first day the new ADLT is obtainable by a patient who is covered by private insurance, or
We also recognize that if private payors do not cover and pay for a test until after the second quarter of the new ADLT initial period, no private payor data may be reported for the test. In that case, we would use crosswalking and gapfilling methodologies to determine pricing for the new ADLT after the new ADLT initial period. We note that the use of crosswalking and gapfilling for determining pricing for ADLTs in such circumstances is consistent with how we will price other CDLTs for which no applicable information is reported in a data reporting period. We believe the requirement for laboratories to collect and report private payor rate data annually for ADLTs would mitigate most concerns about prolonged reliance on crosswalking and gapfilling to price ADLTs rather than private payor rates. We note that under the recoupment of payment for new ADLTs if actual list charge exceeds the market rate provision (section 1834A(d)(4) of the Act), the weighted median private payor rate determined during the new ADLT initial period is compared to the actual list charge. If no private payor rate data is reported during the new ADLT initial period, there would be no weighted median private payor rate to compare the actual list charge to and the recoupment provision would not be applicable. For more information on the recoupment of payment for new ADLTs, please refer to section II.H in this final rule.
Table 4 illustrates the final data collection and reporting period for a new ADLT, using the example above, where a test receives a Medicare Part B coverage determination on April 6, 2018 and ADLT status is granted by CMS on May 1, 2018.
Table 5 illustrates the final data collection and reporting periods for new ADLTs after the new ADLT initial period, using the example above, where the new ADLT initial period ends on March 31, 2019.
Section 1834A(a)(9)(A) of the Act authorizes the Secretary to apply a CMP if the Secretary determines that an applicable laboratory has failed to report, or has made a misrepresentation or omission in reporting, information under section 1834A(a) of the Act for a CDLT. In these cases, the Secretary may apply a CMP in an amount of up to $10,000 per day for each failure to report or each such misrepresentation or omission. Section 1834A(a)(9)(B) of the Act further provides that the provisions of section 1128A of the Act (other than sections (a) and (b)) shall apply to a CMP under this paragraph in the same manner as they apply to a CMP or proceeding under section 1128A(a) of the Act. Section 1128A of the Act governs CMPs that apply to all federal health care programs. Thus the provisions of section 1128A of the Act (specifically sections 1128A(c) through 1128A(n) of the Act) apply to a CMP under section 1834A(a)(9) of the Act in the same manner as they apply to a CMP or proceeding under section 1128A(a) of the Act. We noted that a similar provision is included in the law under section 1847A(d)(4) of the Act with regard to the reporting of average sales price by the manufacturer of a drug or biological. Given the similarity between sections 1834A(a)(9)(A) and 1847A(d)(4) of the Act, we proposed to adopt a provision in § 414.504(e) for implementing section 1834A(a)(9)(A) of the Act that is similar to § 414.806, the regulation governing drug manufacturers' reporting of Part B drug
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
We note that this amount was recently amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, November 2, 2015) (the 2015 Act), which amends the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) (Pub. L. 101–410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)). The Inflation Adjustment Act required all agencies, including HHS, to adjust any CMPs within their jurisdiction by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment. The 2015 Act was enacted to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. Among other things, it revises the method of calculating inflation adjustments so that, instead of the significant rounding methodology applied under the Inflation Adjustment Act, penalty amounts are now simply rounded to the nearest $1. Accordingly, in applying the requirements of the Inflation Adjustment Act, as amended, to the penalty amounts specified in section 1834A(a)(9) of the Act, the Secretary may assess CMPs of up to $10,017 per day per violation beginning on the effective date of this rule. We have revised § 414.504(e) to reflect this statutory adjustment. The 2015 Act also requires agencies to publish annual adjustments not later than January 15 of every year after publication of the initial adjustment. Therefore, subsequent to this initial adjustment, CMP adjustments applicable to section 1834A of the Act will be updated annually through regulations published by the Secretary no later than January 15 of every year.
Section 1834A(a)(7) of the Act requires that an officer of each laboratory must certify the accuracy and completeness of the reported information required by section 1834A(a) of the Act. We proposed to implement this provision by requiring in § 414.504(d) that the President, CEO, or CFO of an applicable laboratory or an individual who has been delegated authority to sign for, and who reports directly to, the laboratory's President, CEO, or CFO, must sign a certification statement and be responsible for assuring that the applicable information provided is accurate, complete, and truthful, and meets all the reporting parameters. We stated that we would specify the processes for certification in subregulatory guidance prior to January 1, 2016.
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
Section 1834A(a)(10) of the Act addresses the confidentiality of the information disclosed by a laboratory under section 1834A(a) of the Act. Specifically, the paragraph provides that, notwithstanding any other provision of law, information disclosed by a laboratory under section 1834A(a) of the Act is confidential and must not be disclosed by the Secretary or a Medicare contractor in a form that discloses the identity of a specific payor or laboratory, or prices charged or payments made to any such laboratory, except as follows:
• As the Secretary determines to be necessary to carry out section 1834A of the Act;
• To permit the Comptroller General to review the information provided;
• To permit the Director of the Congressional Budget Office (CBO) to review the information provided; and
• To permit MedPAC to review the information provided.
These confidentiality provisions apply to information disclosed by a laboratory under section 1834A(a) of the Act, the paragraph that addresses reporting of applicable information for purposes of establishing CLFS rates, and we interpreted these protections as applying to the applicable information that applicable laboratories report to CMS under proposed § 414.504(a). We did not interpret section 1834A(a)(10) of the Act as applying to other information laboratories may submit to CMS that does not constitute applicable information, for example, information regarding an applicable laboratory's business structure, such as its associated NPI entities, or information submitted in connection with an application for ADLT status under section 1834A(d) of the Act, including evidence of a laboratory's empirically derived algorithms and how the test provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests.
In section II.H of this final rule, we discuss in more detail how we will use the applicable information reported under § 414.504 to set CLFS payment rates, and intend to make available to the public a list of test codes and the CLFS payment rates associated with those codes, which is the same CLFS information we currently make available. This information would not reveal the identity of a specific payor or laboratory, or prices charged or
As noted above, section 1834A(a)(10) of the Act lists four instances when the prohibition on disclosing information reported by laboratories under section 1834A(a) of the Act would not apply, the first being when the Secretary determines disclosure is necessary to carry out section 1834A of the Act. We believe certain disclosures will be necessary for us to administer and enforce the new Medicare payment system for CDLTs. For example, it may be necessary to disclose to the HHS OIG confidential data needed to conduct an audit, evaluation, or investigation or to assess a CMP, or to disclose to other law enforcement entities such as the Department of Justice confidential data needed to conduct law enforcement activities. Therefore, we proposed to add those entities to the list of entities in § 414.504(f) to which we may disclose applicable information that is otherwise confidential. Additionally, there may be other circumstances that require the Secretary to disclose confidential information regarding the identity of a specific laboratory or private payor. If we determine that it is necessary to disclose confidential information for other circumstances, we would notify the public of the reasons through a
Also, we believed that codes and associated CLFS payment rates published for ADLTs may indirectly disclose the identity of the specific laboratories selling those tests, and, for new ADLTs, payments made to those laboratories. As explained in this section, ADLTs are offered and furnished only by a single laboratory. Thus, in the proposed rule, we believed publishing the test code and associated CLFS payment rate for an ADLT would indirectly reveal the identity of the laboratory because only a single laboratory would be offering and furnishing that test. Moreover, because Medicare will pay actual list charge for a new ADLT during the new ADLT initial period, publishing the test code and associated CLFS rate for a new ADLT would, we believe, reveal the payments made to the laboratory offering and furnishing that test. We believe section 1834A(a)(10)(A) of the Act authorizes us to publish the test codes and associated CLFS payment rates for ADLTs and we do not believe we can do so without indirectly revealing ADLT laboratory identities and payments made to those laboratories. However, because the actual list charge for a new ADLT would already be publicly available, we do not believe laboratories will be harmed by our publishing the CLFS rates for new ADLTs. We indicated that we would not publish information that directly discloses a laboratory's identity, but we could not prevent the public from associating CLFS payment information for an ADLT with the single laboratory offering and furnishing the test.
Section 1834A(a)(10) of the Act also prohibits a Medicare contractor from disclosing information under section 1834A(a) of the Act in a form that reveals the identity of a specific payor or laboratory, or prices charged or payments made to any such laboratory. We stated in the proposed rule that we did not expect this prohibition to be problematic as applicable laboratories would be reporting applicable information to CMS and not the MACs. When a MAC sets rates under our new policies, we expect the MAC will follow its current practice for pricing when developing a local payment rate for an item or service that does not have a national payment rate, that is, it would only disclose pricing information to the extent necessary to process and pay a claim.
We proposed to implement the confidentiality requirements of section 1834A(a)(10) of the Act in § 414.504(f).
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
A few commenters requested that CMS protect all reported information from public disclosure. One commenter requested assurance that disclosures made as the Secretary determines to be necessary to carry out the requirements of the law are made judiciously and without revealing more information than is truly necessary.
A commenter indicated that the form and manner specified for reporting applicable information should ensure that private payor names are not reported. Along those same lines, another commenter suggested that language be added to § 414.504(b) to explicitly state that private payor names are to be omitted from or otherwise obscured in all reporting materials. The commenter opined that including this instructive language solely in separate subregulatory guidance materials would be insufficient and that it needs to be included in the regulation to make the requirements clear, eliminate any uncertainty regarding confidentiality for clinical laboratories subject to the new law, and protect price competition in the marketplace.
Although we appreciate the commenter's suggestion for adding language to the regulations to explicitly state that private payor identities are not to be revealed in reporting applicable information, we do not believe it is necessary. Section 1834A(a)(11) of the Act specifies that a payor shall not be identified on applicable information. In our data reporting requirements at
As indicated above in this section, we intend to make available to the public a list of test codes and the CLFS payment rates (that is, the weighted median of private payor rates) associated with those codes, which is the same CLFS information we currently make available to the public annually in November. However, under the new process, we expect to release this file earlier than November so the public will have more opportunity to review and comment on the payment rates before they are implemented. In addition, to address commenters' concerns about data transparency, we also intend to make available to the public, a file that includes summary or aggregate-level private payor rate and volume data for each test code such as, the unweighted median private payor rate, the range of private payor rates, the total, median and mean volume, and the number of laboratories reporting. Such information will also be released to the public before the final rates are published to better enable the public to comment on the general accuracy of the reported data. In providing this information, we will not release any information that identifies a payor or a laboratory.
In addition to publishing the aggregate-level private payor rate and volume data, we are also exploring whether we can make available a file of the raw data, that is, the actual, un-aggregated data that is reported as applicable information for an applicable laboratory. We believe this process could provide even more transparency for the public to review and comment on the new CLFS payment rates before they are made effective. Details of this process, if we decide we can release the raw data, would be provided in subregulatory guidance.
Although we noted in the proposed rule that we cannot prevent the public from associating applicable information for an ADLT with the single laboratory offering and furnishing the test (80 FR 59402), we have given further consideration to how we may protect the identity of such laboratories from public disclosure. Although we believe we could release the applicable information for ADLTs in raw or aggregate form under the authority of section 1834A(a)(10)(A) of the Act, we recognize and appreciate that commenters are especially concerned about confidentiality and risk of disclosure of propriety information. Therefore, we have decided, for tests we consider to be uncommon or that we know to be provided only by a single laboratory (such as for new ADLTs), we will not release applicable information in aggregate form, or raw form if we decide we can release the raw data. However, we will provide the HCPCS code and CLFS rate associated with those tests consistent with our current annual publication of the CLFS file. We consider a test to be “uncommon” if it is offered or furnished by only a few laboratories or if it is paid by only a few private payors. We will clarify further what we mean by “a few laboratories” and “a few private payors” after we evaluate the private payor data we receive in the first data reporting period of January 1, 2017 through March 31, 2017, and we will publish that clarification along with the public files we discussed above in this section.
FOIA includes an exemption for trade secrets and commercial and financial information obtained from a person that is privileged or confidential. While we do not have the authority to provide automatic protection from public disclosure under FOIA Exemption 4, if an applicant submits an ADLT application that includes trade secrets or certain commercial or financial information, specified above, it is possible the information could be withheld from public disclosure under the FOIA exemption. An applicant that wishes to protect the information submitted in an ADLT application would mark it proprietary and confidential, and substantiate that statement by expressly claiming substantial competitive harm if the information is disclosed, and demonstrating such in a separate statement by explaining how the release would cause substantial competitive
Section 1834A(e) of the Act includes coding requirements for certain new and existing ADLTs and laboratory tests that are cleared or approved by the FDA. In this section, we describe our current coding system for the CLFS and how we proposed to utilize aspects of this system to implement the coding provisions in section 1834A(e) of the Act.
Currently, new tests on the CLFS receive HCPCS level I codes (CPT) from the American Medical Association (AMA). The CPT is a uniform coding system consisting of descriptive terms and codes that are used primarily to identify medical services and procedures furnished by physicians, suppliers, and other health care professionals. Decisions regarding the addition, deletion, or revision of CPT codes are made by the AMA, and published and updated annually by the AMA. Level II of the HCPCS is a standardized coding system used primarily to identify products, supplies, and services not included in the CPT codes, such as ambulance services and durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). Because Medicare and other insurers cover a variety of services, supplies, and equipment that are not identified by CPT codes, the HCPCS level II codes were established for submitting claims for these items.
Within CMS, the CMS HCPCS Workgroup, which is comprised of representatives of major components of CMS and consultants from pertinent Federal agencies, is responsible for all revisions, deletions, and addition to the HCPCS level II codes. As part of its deliberations, the CMS HCPCS Workgroup may develop temporary and permanent national alpha-numeric HCPCS level II codes. Permanent HCPCS level II codes are established and updated annually, whereas temporary HCPCS level II codes are established and updated on a quarterly basis. Temporary codes are useful for meeting, in a short time frame, the national program operational needs of a particular insurer that are not addressed by an already existing national code. For example, Medicare may need additional codes before the next annual HCPCS update to implement newly issued coverage policies or legislative requirements.
Temporary HCPCS level II codes do not have established expiration dates; however, a temporary code may be replaced by a CPT code, or the CMS HCPCS Workgroup may decide to replace a temporary code with a permanent HCPCS level II code. For example, a laboratory may request a code for a test in the middle of a year. Because permanent codes are assigned only once a year, the CMS HCPCS Workgroup may assign the laboratory test a temporary HCPCS level II code. The temporary code may be used indefinitely or until a permanent code is assigned to the test. Whenever the CMS HCPCS Workgroup establishes a permanent code to replace a temporary code, the temporary code is cross-referenced to the new permanent code and removed.
“G codes” are temporary HCPCS level II codes that we use to identify professional health care procedures and services, including laboratory tests, that would otherwise be identified by a CPT code, but for which there is no CPT code. We have used G codes for laboratory tests that do not have CPT codes but for which we make payment, or in situations where we want to treat the codes differently from the CPT code descriptor for Medicare payment purposes.
Section 1834A(e) of the Act includes three provisions that relate to coding: (a) Temporary codes for certain new tests; (b) coding for existing tests; and (c) establishment of unique identifiers for certain tests. The effect of section 1834A(e) of the Act is to require the Secretary to establish codes, whereas prior to the enactment of PAMA, the Secretary had discretion to establish codes, but was not required to do so. Before we discussed each of the three provisions in the proposed rule, we addressed several specific references in the statute that we believed needed clarification.
In the three coding provisions, the statute requires us to “adopt,” “assign,” and “establish” codes or identifiers. We believe those terms to be interchangeable. There is no practical difference between them for purposes of CMS's obligation under section 1834A(e) of the Act, which is, essentially, to ensure that certain laboratory tests can be identified by a HCPCS code, or in the case of section 1834A(e)(3) of the Act, a unique identifier. The statute also refers to “new laboratory tests” and “existing clinical diagnostic laboratory test[s]” in sections 1834A(e)(1)(A) and (2), respectively. We believe new laboratory tests here refers to CDLTs (that are cleared or approved by the FDA) paid under the CLFS on or after January 1, 2017, and existing CDLTs refers to CDLTs (that are cleared or approved by the FDA) paid under the CLFS prior to that date.
Section 1834A(e)(1)(A) of the Act requires the Secretary to adopt temporary HCPCS codes to identify new ADLTs and new laboratory tests that are cleared or approved by the FDA. As discussed previously, we proposed a definition for new ADLTs, and we also discussed what it means for a laboratory test to be cleared or approved by the FDA. We applied those interpretations in this section. We understood the statute to be requiring us to adopt temporary HCPCS level II codes for these two types of laboratory tests if they have not already been assigned a HCPCS code. Therefore, we stated we would use the existing HCPCS coding
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
Section 1834A(e)(2) of the Act stipulates that not later than January 1, 2016, for each existing ADLT and each existing CDLT that is cleared or approved by the FDA for which payment is made under Medicare Part B as of PAMA's enactment date (April 1, 2014), if such test has not already been assigned a unique HCPCS code, the Secretary shall (1) assign a unique HCPCS code for the test and (2) publicly report the payment rate for the test.
As with the requirement for us to adopt codes for certain new tests under section 1834A(e)(1) of the Act, we discussed in the proposed rule that we believed our existing coding process is consistent with the requirements of section 1834A(e)(2) of the Act. Accordingly, we stated that we would use the existing HCPCS coding process for these tests, meaning, if an existing ADLT or existing CDLT is not already assigned a CPT code or a HCPCS level II code, we would assign a G code to the test.
One aspect of section 1834A(e)(2) of the Act (applying to existing tests) that is different than section 1834A(e)(1) of the Act (applying to certain new tests) is the requirement for us to assign a “unique” HCPCS code. We explained in the proposed rule that we understand a unique HCPCS code to describe only a single test. An ADLT is a single test, so each existing ADLT would be assigned its own G code. However, it is possible that one HCPCS code may be used to describe more than one existing CDLT that is cleared or approved by the FDA. For instance, explained in the proposed rule, we understand there are different versions of laboratory tests for the Kirsten rat sarcoma viral oncogene homolog (KRAS)—one version that is FDA-approved and others that are not FDA-cleared or -approved. Currently, the same HCPCS code is used for both the FDA-approved laboratory test for KRAS and the non-FDA-cleared or -approved versions of the test. Thus, the current HCPCS code is not unique in describing only the FDA-approved version of the KRAS test. Under section 1834A(e)(2) of the Act, we are required to ensure that FDA-cleared or -approved versions of the KRAS test are assigned their own unique codes.
As we discussed in the proposed rule, section 1834A(e)(2)(B) of the Act requires us to publicly report the payment rate for existing ADLTs or tests that are cleared or approved by the FDA by January 1, 2016. We noted that we did not meet the deadline for this requirement as we would have established by January 1, 2016 the final definition of an ADLT, an ADLT application process, and a process for identifying FDA-cleared or -approved tests. In section II.D. of this final rule we stated, in response to comments, that we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018. Consistent with this change in implementing the new CLFS payment rates, we believe it is appropriate to adopt a corresponding change in assigning and publicly reporting the payment rates for existing ADLTs and tests that are cleared or approved by the FDA. Therefore, by January 1, 2017, we will assign and publish payment rates for existing ADLTs and tests cleared or approved by the FDA. We will publish the ADLT application process and the process for specifying that a test is cleared or approved by the FDA in subregulatory guidance.
It is possible there are existing ADLTs or CDLTs cleared or approved by the FDA that are currently being priced under our existing regulations using crosswalking or gapfilling. For instance, some tests are currently being priced using gapfilling (see
To alleviate commenters' concerns that we will automatically assign a unique HCPCS code for an ADLT or an FDA-cleared or -approved test, we note that laboratories must first indicate to the agency that its test requires a unique code. We may not be aware of existing ADLTs or CLDTs that are cleared or approved by the FDA that do not already have a unique HCPCS code. Details regarding how laboratories must notify us will be specified in subregulatory guidance.
Section 1834A(e)(3) of the Act requires the establishment of a unique identifier for certain tests. Specifically, section 1834A(e)(3) of the Act provides that, for purposes of tracking and monitoring, if a laboratory or a manufacturer requests a unique identifier for an ADLT or a laboratory test that is cleared or approved by the FDA, the Secretary shall use a means to uniquely track such test through a mechanism such as a HCPCS code or modifier. Section 1834A(e)(3) of the Act applies only to those laboratory tests that are addressed by sections 1834A(e)(1) and (2) of the Act, that is, new and existing ADLTs and new and existing CDLTs that are cleared or approved by the FDA.
The statute does not define “tracking and monitoring.” However, in the context of a health insurance program like Medicare, tracking and monitoring would typically be associated with enabling or facilitating the obtaining of information included on a Medicare claim for payment to observe such factors as: Overall utilization of a given service; regional utilization of the service; where a service was provided (for example, office, laboratory, hospital); who is billing for the service (for example, physician, laboratory, other supplier); which beneficiary received the service; and characteristics of the beneficiary receiving the service (for example, male/female, age, diagnosis). As the HCPCS code is the fundamental variable used to identify an item or service, and can serve as the means to uniquely track and monitor many various aspects of a laboratory test, we believed the requirements of this section would be met by the existing HCPCS coding process. Therefore, we proposed to implement section 1834A(e)(3) of the Act using our current HCPCS coding system, which we are finalizing in this final rule. If a laboratory or manufacturer specifically requests a unique identifier for tracking and monitoring an ADLT or an FDA-cleared or -approved CDLT, we will assign it a unique HCPCS code if it does not already have one.
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
Section 1834A(b) of the Act establishes a new methodology for determining Medicare payment amounts for CDLTs on the CLFS. Section 1834A(b)(1)(A) of the Act establishes the general requirement that the Medicare payment amount for a CDLT furnished on or after January 1, 2017, shall be equal to the weighted median determined for the test for the most recent data collection period. Section 1834A(b)(2) of the Act requires the Secretary to calculate a weighted median for each laboratory test for which information is reported for the data collection period by arraying the distribution of all private payor rates reported for the period for each test weighted by volume for each private payor and each laboratory. As discussed later in this section, the statute includes special payment requirements for new ADLTs and new CDLTs that are not ADLTs.
To illustrate how we proposed to calculate the weighted median for CDLTs, we provided examples of several different scenarios in the proposed rule (80 FR 59404 through 59406). These examples showed how we planned to determine the weighted median and were not exhaustive of every possible pricing scenario. In the first example, as depicted in Table 6, we supposed that the following private payor rate and volume information for three different CDLTs was reported for applicable laboratories.
In this example, there are five different private payor rates for each test. Table 6 is shown again as Table 7 with each test arrayed by order of the lowest to highest private payor rate, with each private payor rate appearing one time only so as to not reflect volume weighting.
With five different private payor rates for each test, the unweighted median is the middle value or the third line in the table where there are an equal number of private payor rates listed above and below the third line in the table. The
• Test 1 = $5.00
• Test 2 = $23.50
• Test 3 = $41.00
These results are obtained by arraying the distribution of all private payor rates reported for the period for each test without regard to the volume reported for each private payor and each laboratory. To obtain the weighted median, we would do a similar array to the one in Table 7 except we would list each distinct private payor rate repeatedly by the same number of times as its volume. This is illustrated for Test 1 in Table 8.
Thus, for Test 1, the array would show the lowest private payor rate of $2.50 five thousand times. The ellipsis (“. . .”) represents the continuation of the sequence between lines 2 and 4,999. The next private payor rate in the sequence ($4.00) would appear on line 5,001 and would be listed 3,000 times until we get to line 8,000. This process would continue with the remaining private payor rates listed as many times as the associated volumes, with the continuing sequence illustrated by ellipses. Continuing the array, the next highest private payor rate in the sequence would be: $5.00 listed 1,000 times; $6.00 listed 900 times; and $9.00 listed 1,100 times. The total number of lines in the array would be 11,000, as that is the total volume for Test 1 furnished for the five applicable laboratories. Because the total volume for Test 1 is 11,000, the weighted median private payor rate would be the
Repeating this process for Test 2 (see Table 9), the total volume for Test 2 is 7,600 units; therefore, the weighted median private payor rate would be the average of the 3,800th and 3,801st entry, which would be $18.00.
For Test 3 (see Table 10), the total volume is 3,550 units; therefore, the weighted median private payor rate would be the average of the 1,775th and 1,776th entry, which would be $41.00.
In this example, weighting changed the median private payor rate from $5.00 to $4.00 for Test 1, from $23.50 to $18.00 for Test 2, and resulted in no change ($41.00 both unweighted and weighted) for Test 3.
For simplicity, the above example shows only one private payor rate per test. We expect laboratories commonly have multiple private payor rates for each CDLT they perform. For each test performed by applicable laboratories having multiple private payor rates, we would use the same process shown above in this section, irrespective of how many different private payor rates there are for a given test. That is, we would list each private payor rate and its volume at that private payor rate, and determine the median as we did above for each payor and each laboratory, and then compute the volume-weighted median rate. The following example in Table 11 illustrates how we proposed to calculate the weighted median rate for a test under this scenario:
To calculate the weighted median for Test 4, we would array all private payor rates, listed the number of times for each respective test's volume, and then determine the median value (as illustrated in Table 12).
The total volume for Test 4 is 195. Therefore, the median value would be at the 98th entry, which would be $4.75. We proposed to describe this process in § 414.507(b).
Section 1834A(b)(1)(B) of the Act states that the Medicare payment amounts established under section 1834A of the Act shall apply to a CDLT furnished by a hospital laboratory if such test is paid for separately, and not as part of a bundled payment under section 1833(t) of the Act (the statutory section pertaining to the OPPS). In CY 2014, we finalized a policy to package certain CDLTs in the OPPS (78 FR 74939 through 74942 and § 419.2(b)(17)). Under current policy, certain CDLTs that are listed on the CLFS are packaged in the OPPS as integral, ancillary, supportive, dependent, or adjunctive to the primary service or services provided in the hospital outpatient setting on the same date of service as the laboratory test. Specifically, we conditionally package laboratory tests and only pay separately for a laboratory test when (1) it is the only service provided to a beneficiary on a given date of service or (2) it is conducted on the same date of service as the primary service, but is ordered for a different purpose than the primary service and ordered by a practitioner different than the practitioner who ordered the other OPPS services. Also excluded from this conditional packaging policy are molecular pathology tests described by CPT codes in the ranges of 81200 through 81383, 81400 through 81408, and 81479 (78 FR 74939 through 74942). When laboratory tests are not packaged under the OPPS and are listed on the CLFS, they are paid at the CLFS payment rates outside the OPPS under Medicare Part B. Section 1834A(b)(1)(B) of the Act would require us to pay the CLFS payment amount determined under section 1834A(b)(1)(B) of the Act for CDLTs that are provided in the hospital outpatient department and not packaged into Medicare's OPPS payment. This policy would apply to any tests currently paid separately in the hospital outpatient department or in the future if there are any changes to OPPS packaging policy.
Next, section 1834A(b)(4)(A) of the Act states that the Medicare payment amounts under section 1834A(b) shall continue to apply until the year following the next data collection period. We proposed to implement this requirement in proposed § 414.507(a) by stating that each payment rate will be in effect for a period of 1 calendar year for ADLTs and 3 calendar years for all other CDLTs, until the year following the next data collection period.
Section 1834A(b)(4)(B) of the Act states that the Medicare payment amounts under section 1834A of the Act shall not be subject to any adjustment (including any geographic adjustment, budget neutrality adjustment, annual
A discussion of the public comments we received regarding the calculation of the weighted median private rate, and our responses to those comments, appears below.
Independent laboratories that exceed the majority of Medicare revenues threshold and the low expenditure threshold will meet the definition of applicable laboratory and their applicable information will be reported to us for determining the weighted median private payor rate. Although the low expenditure threshold will exclude many independent laboratories and physician office laboratories from reporting private payor rates, based on our analysis of CY 2013 CLFS claims data, we found with a $12,500 threshold for a 6-month data collection period, we can retain a high percentage of Medicare FFS utilization data under the CLFS from applicable laboratories. We note that because CLFS payments will be based on the weighted median of private payor rates, additional reporting may not be likely to change the weighted median private payor rate, irrespective of how many additional smaller laboratories are required to report, if, as our analysis suggests, the largest laboratories dominate the market and therefore most significantly affect the payment rate. For more information regarding the definition of applicable laboratory, please see section II.A. of this final rule.
Section 1834A(b)(3) of the Act limits the reduction in payment amounts that may result from implementation of the new payment methodology under section 1834A(b) of the Act within the first 6 years. Specifically, section 1834A(b)(3)(A) of the Act states that the payment amounts determined for a CDLT for a year cannot be reduced by more than the applicable percent from the preceding year for each of 2017 through 2022. Under section 1834A(b)(3)(B) of the Act, the applicable percent is 10 percent for each of 2017 through 2019, and 15 percent for each of 2020 through 2022. These provisions do not apply to new ADLTs, or new CDLTs that are not ADLTs.
In the proposed rule (80 FR 59407), we provided the following example. If a test that is not a new ADLT or new CDLT has a CY 2016 Medicare payment amount of $20.00, the maximum reduction in the Medicare payment amount for CY 2017 is 10 percent, or $2. Following the CY 2016 data reporting period, CMS calculates a weighted median of $15.00 (a reduction of 25 percent from a Medicare payment amount of $20.00) based on the applicable information reported for the test. Because the maximum payment reduction permitted under the statute for 2017 is 10 percent, the Medicare payment amount for CY 2017 will be $18.00 ($20.00 minus $2.00). The following year, a 10 percent reduction from the CY 2017 payment of $18.00 would equal $1.80, lowering the total Medicare payment amount to $16.20 for CY 2018. In a second example we provided, if a test that is not a new ADLT or new CDLT has a CY 2016 Medicare payment amount of $17.00, the maximum reduction for CY 2017 is 10 percent or $1.70. Following the CY 2016 data reporting period, we calculated a weighted median of $15.00 (a reduction of 11.8 percent from the CY 2016 Medicare payment amount of $17). Because the maximum reduction is 10 percent, the Medicare payment amount for CY 2017 will be $15.30 or the maximum allowed reduction of $1.70 from the preceding year's (CY 2016) Medicare payment amount of $17.00. The following year (CY 2018), the Medicare payment amount will be reduced to $15.00, or $0.30 less, which is less than a 10 percent reduction from the prior year's (CY 2017) Medicare payment amount of $15.30. We believed applying the maximum applicable percentage reduction from the prior year's Medicare payment amount, rather than from the weighted median rate for CY 2016, was most consistent with the statute's mandate that the reduction “for the year” (that is, the calendar year) not be “greater than the applicable percent . . . of the amount of payment for the test for the preceding year.”
We explained in the proposed rule that, to apply the phase-in reduction provisions beginning in CY 2017, we must look at the CLFS rates established for CY 2016 under the payment methodology set forth in sections 1833(a), (b), and (h) of the Act. Previously discussed, CDLTs furnished on or after July 1, 1984, and before January 1, 2017, in a physician's office, by an independent laboratory, or, in limited circumstances, by a hospital laboratory for its outpatients or non-patients, are paid under the Medicare CLFS, with certain exceptions. Payment is the lesser of:
• The amount billed;
• The state or local fee schedule amount established by Medicare contractors; or
• An NLA, which is a percentage of the median of all the state and local fee schedules.
The NLA is 74 percent of the median of all local Medicare payment amounts for tests for which the NLA was established before January 1, 2001. The NLA is 100 percent of the median of the local fee schedule amount for tests for which the NLA was first established on or after January 1, 2001 (see section 1833(h)(4)(B)(viii) of the Act). Medicare typically pays either the lower of the local fee schedule amount or the NLA, as it uncommon for the amount billed to be less than either of these amounts. As the local fee schedule amount may be lower than the NLA, Medicare payment amounts for CDLTs are not uniform across the nation. Thus, in the proposed rule we evaluated which CY 2016 CLFS payment amounts to consider—the lower of the local fee schedule amount or the NLA, or just the NLA—when applying the phase-in reduction provisions to the CLFS rates for CY 2017 (80 FR 59407). Under option 1, we explained we would apply the 10 percent reduction limitation to the lower of the NLA or the local fee schedule amount. This option would retain some of the features of the current payment methodology under sections 1833(a), (b), and (h) of the Act and, we believed, would be the most consistent with the requirement in section 1834A(b)(3)(A) of the Act to apply the applicable percentage reduction limitation to the “amount of payment for the test” for the preceding year. As noted above, for each of CY 2018 through 2022, we explained we would apply the applicable percentage reduction limitation to the Medicare payment amount for the preceding year. Under this option, though, the Medicare payment amounts may be local fee schedule amounts, so there could continue to be regional variation in the Medicare payment amounts for CDLTs.
Alternatively, under option 2, we explained would consider only the NLAs for CY 2016 when applying the 10 percent reduction limitation. This option would eliminate the regional variation in Medicare payment amounts for CDLTs, and, we believed, would be more consistent with section 1834A(b)(4)(B) of the Act, which, as noted above, prohibits the application of any adjustments to CLFS payment amounts determined under section 1834A of the Act, including any geographic adjustments.
We proposed option 2 (NLAs only) for purposes of applying the 10 percent reduction limit to CY 2017 payment amounts because we believed the statute intends CLFS rates to be uniform nationwide, which is why it precludes any geographic adjustment. That is, we proposed that if the weighted median calculated for a CDLT based on applicable information for CY 2017 would be more than 10 percent less than the CY 2016 NLA for that test, we would establish a Medicare payment amount for CY 2017 that is no less than 90 percent of the NLA (that is, no more than a 10 percent reduction). For each of CY 2018 through 2022, we would apply the applicable percentage reduction limitation to the Medicare payment amount for the preceding year.
We proposed to codify the phase-in reduction provisions in § 414.507(d) to specify that for years 2017 through 2022, the payment rates established under this section for each CDLT that is not a new ADLT or new CDLT, may not be reduced by more than the following amounts for—
• 2017—10 percent of the NLA for the test in 2016.
• 2018—10 percent of the payment rate established in 2017.
• 2019—10 percent of the payment rate established in 2018.
• 2020—15 percent of the payment rate established in 2019.
• 2021—15 percent of the payment rate established in 2020.
• 2022—15 percent of the payment rate established in 2021.
Table 13 illustrates the proposed phase-in reduction for the two hypothetical examples presented above:
As discussed in section II.D., we are moving the implementation date of the private payor-based rates for the CLFS to January 1, 2018. We are finalizing our proposed policy for the phase-in of payment reductions, but we believe it is appropriate to make a corresponding change to the phase-in payment reduction timetable, which will permit laboratories to get the full benefit of the payment reduction limitations we believe the statute intended. Accordingly, we are revising the phase-in of the payment reductions timetable to reflect the January 1, 2018 implementation date of the revised CLFS. We are reflecting this change in § 414.507(d) by indicating that a maximum payment reduction per year of 10 percent applies for years 2018 through 2020 and a maximum payment reduction per year of 15 percent applies for years 2021 through 2023.
A discussion of the comments we received on the phase-in payment reduction, and our responses to those comments, appears below.
Section 1834A(d)(1)(A) of the Act provides that the payment amount for a new ADLT shall be based on the actual list charge for the laboratory test during an initial period of 3 quarters. Section 1834A(d)(2) of the Act requires applicable information to be reported for a new ADLT not later than the last day of the Q2 of the initial period. Section 1834A(d)(3) of the Act requires the Secretary to use the weighted median methodology under section (b) to establish Medicare payment rates for new ADLTs after the initial period. Under section 1834A(d)(3) of the Act, such payment rates continue to apply until the year following the next data collection period.
In this section, we discussed our proposal to require the initial period, which we proposed to call the “new ADLT initial period,” to begin on the first day of the first full calendar quarter following the first day on which a new ADLT is performed. In accordance with section 1834A(d)(1)(A) of the Act, we proposed that the payment amount for the new ADLT would equal the actual list charge, as defined below in this section, during the new ADLT initial period. Accordingly, we proposed to codify § 414.522(a)(1) to specify the payment rate for a new ADLT during the new ADLT initial period is equal to its actual list charge.
Section 1834A(d)(1)(B) of the Act states that actual list charge means the publicly available rate on the first day at which the test is available for purchase by a private payor for a laboratory test. We believed the “publicly available rate” is the amount charged for an ADLT that is readily accessible in such forums as a company Web site, test registry, or price listing, to anyone seeking to know how much a patient who does not have the benefit of a negotiated rate would pay for the test. We noted that this interpretation of publicly available rate is distinguishable from a private payor rate in that the former is readily available to a consumer, while the latter may be negotiated between a private payor and
We explained in the proposed rule that, in our view, the first day a new ADLT is available for purchase by a private payor is the first day an ADLT is offered to a patient who is covered by private insurance. The statutory phrase “available for purchase” suggested to us that the test only has to be available to patients who have private insurance even if the test has not actually been performed yet by the laboratory. That is, it is the first day the new ADLT is obtainable by a patient, or marketed to the public as a test that a patient can receive, even if the test has not yet been performed on that date. We proposed to incorporate this interpretation into our proposed definition of actual list charge in § 414.502 to specify actual list charge is the publicly available rate on the first day the new ADLT is obtainable by a patient who is covered by private insurance, or marketed to the public as a test a patient can receive, even if the test has not yet been performed on that date.
Because we cannot easily know the first date on which a new ADLT is performed or the actual list charge amount for a new ADLT, we proposed to require the laboratory seeking ADLT status for its test to inform us of both the date the test is first performed and the actual list charge amount. Accordingly, we proposed in § 414.504(c), that, in its new ADLT application, the laboratory seeking new ADLT status for its test must attest to the actual list charge and the date the new ADLT is first performed. We also indicated that we would outline the new ADLT application process in detail in subregulatory guidance prior to the effective date of the private payor rate based CLFS.
Because the new ADLT initial period starts on the first day of the next calendar quarter following the first day on which a new ADLT is performed, there will be a span of time between when the test is first performed and when the test is paid the actual list charge amount. We indicated in the proposed rule that we need to establish a payment amount for the test during that span of time. We explained that, similar to how we pay for a test under the PFS, the CLFS, or other payment systems, for a service that does not yet have a national payment amount, the MAC would work with a laboratory to develop a payment rate for a new ADLT for the period of time before we pay at actual list charge. We provided the following example in the proposed rule (80 FR 59408). If an ADLT is first performed on February 4, 2017, the new ADLT initial period would begin on April 1, 2017. While the new ADLT would be paid the actual list charge amount from April 1 through December 31, 2017, the MAC would determine the payment amount for the test from February 4 through March 31, 2017, as it does currently for tests that need to be paid prior to having a national payment amount. We proposed to specify at § 414.522(a)(2) that the payment amount for a new ADLT prior to the new ADLT initial period is determined by the MAC based on information provided by the laboratory seeking new ADLT status for its laboratory test.
According to section 1834A(d)(3) of the Act, the weighted median methodology used to calculate the payment amount for CDLTs that are not new ADLTs will be used to establish the payment amount for a new ADLT after the new ADLT initial period; we explained that the payment amount would be based on applicable information reported by an applicable laboratory before the last day of the second quarter of the new ADLT initial period, per section 1834A(d)(2) of the Act. We proposed to codify these provisions in § 414.522(b) as follows: After the new ADLT initial period, the payment rate for a new ADLT is equal to the weighted median established under the payment methodology described in § 414.507(b).
The payment rate based on the first 2 quarters of the new ADLT initial period would continue to apply until the year following the next data collection period, per section 1834A(d)(3) of the Act. The following is the example we provided in the proposed rule (80 FR 59408 through 59409) of how the various time frames for new ADLT payment rates would work. If the first day a new ADLT is available for purchase by a private payor is in the middle of Q1 of 2017, the new ADLT initial period would begin on the first day of Q2 of CY 2017. The test would be paid actual list charge through the end of Q4 of CY 2017. The applicable laboratory that furnishes the test would collect applicable information in Q2 and Q3 of CY 2017, and report it to us by the last day of Q3 of CY 2017. We would calculate a weighted median based on that applicable information and establish a payment rate that would be in effect from January 1, 2018, through the end of 2018. The applicable laboratory would report applicable information from the CY 2017 data collection period to us during the January through March data reporting period in 2018, which would be used to establish the payment rate that would go into effect on January 1, 2019.
A discussion of the comments we received on payment for new ADLTs, and our responses to those comments, appears below.
Section 1834A(d)(4) of the Act requires that, if the Medicare payment amount during the new ADLT initial period (that is, the actual list charge) is determined to be more than 130 percent of the Medicare payment amount based on the weighted median of private payor rates that applies after the new ADLT initial period, the Secretary shall recoup the difference between such payment amounts for tests furnished during such period.
In the proposed rule, we interpreted this to mean that the Secretary should recoup the entire amount of the difference between the Medicare
The statute refers to “such payment amounts” which we interpreted to mean the Medicare payment amount based on actual list charge and the Medicare payment amount based on the weighted median rate. We believed that the statute directed recoupment of the full amount of that difference as the 130 percent is only being used in making the threshold determination of whether the recoupment provision will apply. For this reason, we proposed at § 414.522(c) to specify that if the Medicare payment amount for an ADLT during the new ADLT initial period (based on actual list charge) was more than 130 percent of the weighted median rate, we would recoup the entire amount of the difference between the two amounts. We further noted that if the 130 percent statutory threshold is not exceeded, we would not make any recoupment at all. Thus, for instance, if the weighted median private payor rate is $100 and the Medicare payment amount during the initial period is $130 or lower, the statutory threshold of 130 percent would not be exceeded and we would not pursue any recoupment of payment.
However, if the actual list charge for a new ADLT was more than 130 percent of the weighted median rate (as calculated from applicable information received during the first reporting period), claims paid during the new ADLT initial period would be re-priced using the weighted median rate. To that end, we proposed that we would issue a Technical Direction Letter instructing the MACs to re-price claims previously paid during the new ADLT initial period at the weighted median rate (instead of the actual list charge for the new ADLT). We also noted that we intended to issue further guidance on the operational procedures for recoupment of payments for the new ADLTs that exceed the 130 percent threshold.
A discussion of the comments we received on our proposed recoupment of payment for new ADLTs and our responses to those comments, appears below.
Other stakeholders stated that our proposed recoupment policy would provide a disincentive for laboratories offering new ADLTs to negotiate price concessions with private payors. For example, they believe that if laboratories performing new ADLTs negotiate price concessions with commercial payors, it will lower the weighted median private payor rate and make it more likely that the ADLT will reach the 130 percent recoupment threshold. Therefore, laboratories offering new ADLTs may refuse to negotiate price concessions with commercial payors to avoid the recoupment threshold.
After review of the public comments, we recognize our proposed policy would create a disparity in the application of recoupment of payments. Under our proposal, if the difference between the actual list charge and the weighted median private payor rate is not greater than 130 percent (for example, if it is exactly 130 percent), then there would be no recoupment, but if the difference between the actual list charge and the weighted median private payor rate is greater than 130 percent (for example, if it is 131 percent), then the entire amount of the difference between actual list charge and the weighted median private payor rate would be recouped.
In section II.D. of this final rule, we indicated that we understand a Medicare coverage determination could be a lengthy process for the types of tests that are likely to qualify as ADLTs and that, consequently, a test may be available on the market and paid by private payors before Medicare covers and pays for it. If a test is available to the public long before a Medicare Part B coverage determination is made and ADLT status is granted, the actual list charge could be significantly higher than the weighted median private payor rate based on applicable information reported during the new ADLT initial period. If the actual list charge is greater than 130 percent of the weighted median private payor rate determined during the new ADLT initial period, under our proposed recoupment policy, we would have recouped the entire difference between the actual list charge and the weighted median private payor rate, in which case the single laboratory that develops, offers and furnishes the ADLT would not have been awarded any special payment status during the new ADLT initial period, as contemplated by the statute. Furthermore, we agree our proposed recoupment policy could have been a disincentive for laboratories and private payors to negotiate price concessions because it could have increased the likelihood that the recoupment threshold would have been met.
For these reasons, we are revising our proposed interpretation of the recoupment provision so that during the new ADLT initial period, new ADLTs will be paid up to 130 percent of their weighted median private payor rate. To determine whether the recoupment provision applies, we will compare the
Additionally, as discussed in section II.D., we revised the definition of new ADLT initial period to mean a period of 3 calendar quarters that begins on the first day of the first full calendar quarter following the later of the date a Medicare Part B coverage determination is made and ADLT status is granted by us. See section II.D. for a discussion of the new ADLT initial period.
Section 1834A(i) of the Act requires the Secretary, for the period of April 1, 2014, through December 31, 2016, to use the methodologies for pricing, coding, and coverage for ADLTs in effect on the day before the enactment of PAMA (April 1, 2014), and provides that those methodologies may include crosswalking or gapfilling. Thus, we explained that section 1834A(i) of the Act authorizes us to use crosswalking and gapfilling to pay for existing ADLTs, that is, those ADLTs that are paid for under the CLFS prior to January 1, 2017. The methodologies in effect on March 31, 2014 were gapfilling and crosswalking. Therefore, we proposed to use crosswalking and gapfilling to establish the payment amounts for existing ADLTs. We proposed to reflect this requirement at § 414.507(h) to state that for ADLTs that are furnished between April 1, 2014 and December 31, 2016, payment is made based on crosswalking or gapfilling methods described in proposed § 414.508(a).
A discussion of the comments we received on payment for existing ADLTs, and our responses to those comments, appears below.
As we discuss in section II.D. of this final rule, in response to comments, we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018. In conjunction with the revised implementation date, we are also adopting a corresponding change for new ADLTs to reflect that a new ADLT is an ADLT for which payment has not been made under the CLFS prior to January 1, 2018. Therefore, the payment amount for existing ADLTs will be determined based on crosswalking and gapfilling for ADLTs furnished through December 31, 2017, instead of December 31, 2016, which is reflected in revised § 414.507(h).
Section 1834A(c) of the Act includes special provisions for determining payment for new CDLTs that are not ADLTs. Section 1834A(c)(1) of the Act states that payment for a CDLT that is assigned a new or substantially revised HCPCS code on or after the April 1, 2014 enactment date of PAMA, which is not an ADLT, will be determined using crosswalking or gapfilling during an initial period until payment rates under section 1834A(b) of the Act are established. The test must either be crosswalked (as described in § 414.508(a) or any successor regulation) to the most appropriate existing test on the CLFS or, if no existing test is comparable, paid according to a gapfilling process that takes into account specific sources of information, which we describe later in this section.
We developed our current procedures for crosswalking and gapfilling new CDLTs pursuant to section 1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the Secretary to establish by regulation procedures for determining the basis for, and amount of, payment for any CDLT for which a new or substantially revised HCPCS code is assigned on or after January 1, 2005. Section 1833(h)(8)(B) of the Act specifies the annual public consultation process that must take place before the Secretary can determine payment amounts for such tests, and section 1833(h)(8)(C) of the Act requires the Secretary to implement the criteria for making such determinations and make available to the public the data considered in making such determinations. We implemented these provisions in the CY 2007 PFS final rule (71 FR 69701 through 69704) published in the
We interpreted section 1834A(c) of the Act to generally require us to use the existing procedures we implemented in 42 CFR part 414, subpart G. However, we explained that we needed to make some changes to our current regulations to reflect specific provisions in section 1834A(c) of the Act, as well as other aspects of section 1834A of the Act and the proposed rule. In this section, we describe those proposed changes and how they would affect our current process for setting payment rates for new CDLTs. To incorporate section 1834A of the Act within the basis and scope of payment for CDLTs, we proposed to add a reference to 42 CFR part 414, subpart A, entitled “General Provisions,” in § 414.1.
In addition, we proposed to change the title of 42 CFR part 414, subpart G, to reflect that it applies to payment for all CDLTs, not just new CDLTs. We also proposed to add a reference to section 1834A of the Act in § 414.500. To reflect that § 414.500 would apply to a broader scope of laboratory tests than just those covered by section 1833(h)(8) of the Act, we proposed to remove “new” and “with respect to which a new or substantially revised Healthcare Common Procedure Coding System code is assigned on or after January 1, 2005.”
As previously noted, section 1834A(c) of the Act addresses payment for a CDLT that is not an ADLT and that is assigned a new or substantially revised HCPCS code on or after April 1, 2014, PAMA's enactment date. Our current regulations apply throughout to a “new test,” which we currently define in § 414.502 as any CDLT for which a new or substantially revised HCPCS code is assigned on or after January 1, 2005. We proposed to replace “new test” with “new CDLT” in § 414.502 and to make conforming changes throughout the regulations to distinguish between the current requirements that apply to new tests and the proposed requirements that would apply to new CDLTs. Our proposed definition specified that a new CDLT means a CDLT that is assigned a new or substantially revised Healthcare Common Procedure Coding System (HCPCS) code, and that does not meet the definition of an ADLT. Section 1834A(c)(1) of the Act uses the same terminology as section 1833(h)(8)(A) of the Act, “new or substantially revised HCPCS code,” which we incorporated into the definition of new test in § 414.502. We also defined “substantially revised HCPCS code” in
We did not receive any comments on our proposed payment for new CDLTs that are not ADLTs or the proposed definitions discussed above.
• Charges for the test and routine discounts to charges;
• Resources required to perform the test;
• Payment amounts determined by other payors; and
• Charges, payment amounts, and resources required for other tests that may be comparable (although not similar enough to justify crosswalking) or otherwise relevant.
During the first year a new test code is paid using the gapfilling method, contractors are required to establish contractor-specific amounts on or before March 31. Contractors may revise their payment amounts, if necessary, on or before September 1, based on additional information. After the first year, the contractor-specific amounts are used to calculate the NLA, which is the median of the contractor-specific amounts, and under § 414.508(b)(2), the test code is paid at the NLA in the second year. We instruct MACs to use the gapfilling method through program instruction, which lists the specific new test code and the timeframes to establish contractor-specific amounts.
In the CY 2007 PFS final rule with comment period (71 FR 69702), we also described the timeframes for determining the amount of and basis for payment for new tests. The codes to be included in the upcoming year's fee schedule (effective January 1) are available as early as May. We list the new clinical laboratory test codes on our Web site, usually in June, along with registration information for the public meeting, which is held no sooner than 30 days after we announce the meeting in the
Section 1834A(c)(1) of the Act refers to payment for CDLTs for which a new or substantially revised HCPCS code is assigned on or after the April 1, 2014 PAMA enactment date. We noted in the proposed rule (80 FR 59410) that the annual crosswalking and gapfilling process had already occurred for codes on the 2015 CLFS, and was currently underway for codes on the 2016 CLFS. We proposed to continue using the current crosswalking and gapfilling processes for CDLTs assigned new or substantially revised HCPCS codes prior to January 1, 2017 because:
• Section 1834A(c)(1)(A) of the Act refers to our existing crosswalking process under § 414.508(a);
• We would not be able to finalize new crosswalking requirements as of PAMA's April 1, 2014 enactment date; and
• The current payment methodology involving NLAs and local fee schedule amounts would remain in effect until January 1, 2017.
We proposed to update § 414.508 by changing the introductory language to limit paragraphs (a) and (b) (which would be redesignated as paragraphs (a)(1) and (2)) to tests assigned new or substantially revised HCPCS codes “between January 1, 2005 and December 31, 2016,” and adding introductory language preceding new proposed paragraphs (b)(1) and (2) to reflect our proposal to pay for a CDLT that is assigned a new or substantially revised HCPCS code on or after January 1, 2017 based on either crosswalking or gapfilling.
For CDLTs that are assigned a new or substantially revised HCPCS codes on or after January 1, 2017, we proposed to use comparable crosswalking and gapfilling processes that were modified to reflect the new market-based payment system under section 1834A of the Act. We noted in the proposed rule that, beginning January 1, 2017, the payment methodology established under section 1834A(b) of the Act would replace the current payment methodology under sections 1833(a), (b), and (h) of the Act, including NLAs and local fee schedule amounts. Thus, we proposed to establish § 414.508(b)(1) and (2) to describe crosswalking and gapfilling processes that do not involve NLAs or local fee schedule amounts.
Regarding the crosswalking process, because section 1834A(c)(1)(A) of the Act specifically references our existing process under § 414.508(a), we did not propose to change the circumstances when we use crosswalking, that is, when we determine the new CDLT is
Crosswalking is used if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code.
• We assign to the new CDLT code, the payment amount established under § 414.507 for the existing test.
• Payment for the new CDLT code is made at the payment amount established under § 414.507 for the existing test.
Regarding the gapfilling process, section 1834A(c)(2) of the Act requires the use of gapfilling if no existing test is comparable to the new test. Section 1834A(c)(2) of the Act specifies that this gapfilling process must take into account the following sources of information to determine gapfill amounts, if available:
• Charges for the test and routine discounts to charges.
• Resources required to perform the test.
• Payment amounts determined by other payors.
• Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
• Other criteria the Secretary determines appropriate.
The first four criteria are identical to the criteria currently specified in § 414.508(b)(1). For this reason did not propose any substantive changes to the factors that must be considered in the gapfilling process. The fifth criterion authorizes the Secretary to establish other criteria for gapfilling as the Secretary determines appropriate. We did not propose any additional factors to determine gapfill amounts. We noted that, if we decided to establish additional gapfilling criteria, we would do so through notice and comment rulemaking.
We proposed to establish a gapfilling process for CDLTs assigned a new or substantially revised HCPCS code on or after January 1, 2017, that would be similar to the gapfilling process currently included in § 414.508(b), but would eliminate the reference to the NLA in § 414.508(b)(2), as that term would no longer be applicable, and would substitute “Medicare Administrative Contractor” (MAC) for “carrier,” as MACs are now Medicare's claims processing contractors. To determine a payment amount under this gapfilling process, we proposed to pay the test code at an amount equal to the median of the contractor-specific payment amounts, consistent with the current gapfilling methodology at § 414.508(b). We proposed § 414.508(b)(2) would state that gapfilling is used when no comparable existing CDLT is available. We proposed in § 414.508(b)(2)(i) that, in the first year, Medicare Administrative Contractor-specific amounts would be established for the new CDLT code using the following sources of information to determine gapfill amounts, if available:
• Charges for the test and routine discounts to charges;
• Resources required to perform the test;
• Payment amounts determined by other payors; and
• Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
• Other criteria CMS determines appropriate.
We noted that section 1834A(c)(1) of the Act requires the crosswalked and gapfilled payment amounts for new CDLTs to be in effect “during an initial period” until payment rates under section 1834A(b) of the Act are established. As discussed, we typically list new CDLT codes on our Web site by June, and by January 1 of the following calendar year, we have either established payment amounts using crosswalking or indicated that a test is in its first year of the gapfilling process. Because we proposed to largely continue our existing gapfilling and crosswalking processes, for CDLTs assigned new or substantially revised HCPCS codes on or after January 1, 2017, we believed the initial period should be the period of time until applicable information is reported for a CDLT and can be used to establish a payment amount using the weighted median methodology in § 414.507(b). We proposed to continue to permit reconsideration of the basis and amount of payment for CDLTs as we currently do under § 414.509. For a new CDLT for which a new or substantially revised HCPCS code was assigned on or after January 1, 2008, we accept reconsideration requests in written format for 60 days after making a determination of the basis for payment (either crosswalking or gapfilling) or the payment amount assigned to the new test code, per § 414.509(a)(1), (b)(1)(i) and (b)(2)(ii). The requestor may also request to present its reconsideration request at the next annual public meeting, typically convened in July of each year under § 414.509(a)(2)(i) and (b)(1)(ii)(A). Under § 414.509(a)(1), if a requestor recommends that the basis for payment should be changed from gapfilling to crosswalking, the requestor may also recommend the code or codes to which to crosswalk the new test. We noted that we might reconsider the basis for payment under § 414.509(a)(3) and (b)(1)(iii) or its determination of the amount of payment, which could include a revised NLA for the new code under § 414.509(b)(2)(v) based on comments. However, as noted in this section, we explained in the proposed rule that the NLA would no longer be applicable on or after January 1, 2017, and we would instead refer to the national payment amount under crosswalking or gapfilling as the median of the contractor-specific payment amounts. Therefore, we proposed to revise § 414.509 to replace references to the “national limitation amount” with “median of the Medicare Administrative Contractor-specific payment amount” in § 414.509(b)(2)(iv) and (b)(2)(v). We also proposed to replace “carrier-specific amount” where it appears in § 414.509 with “Medicare Administrative Contractor-specific payment amount” because we now refer to our Medicare Part B claims processing contractors as Medicare Administrative Contractors.
As we discuss in this final rule, in response to comments, we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018. We believe it is also appropriate for us to adopt corresponding changes to several timeframes we proposed in § 414.508. We are replacing December 31, 2016, with December 31, 2017 in the introductory paragraph of § 414.508(a) to indicate, for a new CDLT that is assigned a new or substantially revised code between January 1, 2005 and December 31, 2017, we determine the payment amount based on either crosswalking or gapfilling, as specified in paragraph (a)(1) or (2). We are also replacing January 1, 2017, with January 1, 2018 in the introductory paragraph of § 414.508(b) to indicate, for a new CDLT that is assigned a new or substantially revised HCPCS code on or after January 1, 2018, we determine the payment amount based on either crosswalking or
A discussion of the comments we received on crosswalking and gapfilling and our responses to those comments appears below.
Our current procedures for public consultation for payment for a new test are addressed in § 414.506. Section 1834A(c)(3) of the Act requires the Secretary to consider recommendations from the expert outside advisory panel established under section 1834A(f)(1) of the Act when determining payment using crosswalking or gapfilling processes. In this section, we describe the Advisory Panel on CDLTs (the Panel). We proposed to specify that the public consultation process regarding payment for new CDLTs on or after January 1, 2017, must include the Panel's recommendations by adding § 414.506(e) to specify that we will consult with an expert outside advisory panel, called the Advisory Panel on CDLTs, composed of an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics in issues related to CDLTs . We proposed that this advisory panel would provide input on the establishment of payment rates under § 414.508 and provide recommendations to CMS under this subpart.
A discussion of the comments we received on the Panel is included in section II.J.1. of this final rule.
Section 1834A(c)(4) of the Act requires the Secretary to make available to the public an explanation of the payment rate for a new CDLT, including an explanation of how the gapfilling criteria are applied and how the recommendations of the Advisory Panel on CDLTs are applied. Currently, § 414.506(d) provides that, considering the comments and recommendations (and accompanying data) received at the public meeting, we develop and make available to the public (through a Web site and other appropriate mechanisms) a list of:
• Proposed determinations of the appropriate basis for establishing a payment amount for each code, with an explanation of the reasons for each determination, the data on which the determinations are based, and a request for public written comments within a specified time period on the proposed determinations; and
• Final determinations of the payment amounts for tests, with the rationale for each determination, the data on which the determinations are based, and responses to comments and suggestions from the public.
Section 414.506(d) already indicates that we will provide an explanation of the payment rate determined for each new CDLT and the rationale for each determination. As described above, under our current process, we make available to the public proposed payment rates with accompanying rationales and supporting data, as well as final payment rates with accompanying rationales and supporting data. However, this process has been used almost exclusively for new tests that are crosswalked. For tests that are gapfilled, we generally post the contractor-specific amounts in the first year of gapfilling on the CMS Web site and provide for a public comment period, but do not typically provide explanations of final payment amounts. Based on section 1834A(c)(4) of the Act, we proposed to amend § 414.506 to explicitly indicate that, for a new CDLT on or after January 1, 2017, we would provide an explanation of gapfilled payment amounts and how we took into account the Panel's recommendations. Specifically, we proposed to add paragraphs (3) and (4) to § 414.506(d). In § 414.506(d)(3), we proposed to specify that, for a new CDLT, in applying paragraphs (d)(1) and (2), we will provide an explanation of how we took into account the recommendations of the Advisory Panel on CDLTs. In § 414.506(d)(4), we proposed to specify that, for a new CDLT, in applying paragraphs (d)(1) and (2) and § 414.509(b)(2)(i) and (iii) when we use the gapfilling method described in § 414.508(b)(2), we will make available to the public an explanation of the payment rate for the test.
Under these provisions, we proposed to publish the Medicare payment amounts for new CDLTs along with an explanation of the payment rate and how the gapfilling criteria and recommendations by the Advisory Panel on CDLTs were applied via the CMS CLFS Web site as we currently do for new tests. The CMS CLFS Web site may be accessed at:
As we discuss in this final rule, we are moving the implementation date of the private payor rate-based CLFS until January 1, 2018. We believe it is also appropriate for us to adopt corresponding changes to several timeframes we proposed in § 414.506. Accordingly, in § 414.506(d)(3) and (4), we are replacing January 1, 2017 with January 1, 2018 to identify our obligations with respect to procedures for public consultation for payment for new CDLTs beginning January 1, 2018.
While sections 1834A(b), (c), and (d), of the Act, respectively, address payment for CDLTs and ADLTs as of January 1, 2017, the statute does not address how we must pay for a laboratory test when no applicable information is reported for applicable laboratories.
There are several possible reasons why no applicable information would be reported for a laboratory test. For example:
•
•
•
•
In the event we do not receive applicable information for a laboratory test that is paid under the CLFS, we would need to determine a payment amount for the test in the year following the data collection period. The statute does not specify the methodology we must use to establish the payment rate for an ADLT or CDLT for which we receive no applicable information in a data reporting period but for which we need to establish a payment amount. In such circumstances, we proposed to use crosswalking and gapfilling using the requirements we proposed for those methodologies in § 414.508(b)(1) and (2) to establish a payment rate on or after January 1, 2017 (which will now be January 1, 2018, in accordance with the change to the implementation date of the revised CLFS), which would remain in effect until the year following the next data reporting period. We proposed this policy would include the situation where we receive no applicable information for tests that were previously priced using gapfilling or crosswalking or where we had previously priced a test using the weighted median methodology. If we receive no applicable information in a subsequent data reporting period, we propose to use crosswalking or gapfilling methodologies to establish the payment amount for the test. That is, if in a subsequent data reporting period, no applicable information is reported, we would reevaluate the basis for payment, —crosswalking or gapfilling— and the payment amount for the test.
In exploring what we would do if we receive no applicable information for a CDLT, we alternatively considered carrying over the current payment amount for a test under the current CLFS, the payment amount for a test (if one was available) using the weighted median methodology based on applicable information from the previous data reporting period, or the gapfilled or crosswalked payment amount. However, we did not propose this approach because we believed carrying over previous payment rates would not reflect changes in costs or pricing for the test over time. We understood the purpose of section 1834A of the Act to be update the CLFS rates to reflect changes in market prices over time.
As noted above, the statute does not address situations where we price a test using crosswalking or gapfilling because we received no applicable information with which to determine a CLFS rate. We believed reconsidering rates for tests in these situations would be consistent with the purpose of section 1834A of the Act, which requires us to periodically reconsider CLFS payment rates. In the case of tests for which we previously received applicable information to determine payment rates, section 1834A of the Act requires Medicare to follow changes in the market rates for private payors. Our proposal served an analogous purpose by having us periodically reconsider the payment rate of a test using gapfilling or crosswalking. We stated in the proposed rule that we expected to continue to evaluate our proposed approach to setting rates for laboratory tests paid on the CLFS with no reported applicable information as we gained more programmatic experience under the new CLFS. We indicated that any revisions to how we determine a rate for laboratory tests without reported applicable information would be addressed in the future through notice and comment rulemaking.
In summary, we proposed that for a CDLT, including ADLTs, for which we receive no applicable information in a data reporting period, we would determine the payment amount based on either crosswalking or gapfilling. We proposed to add paragraph (g) to § 414.507 to specify that for CDLTs for which we receive no applicable information, payment would be made based on the crosswalking or gapfilling methods described in § 414.508(b)(1) and (2).
A discussion of the comments we received on Medicare payment for tests where no applicable information is reported, and our responses to those comments, appears below.
As we discussed previously, because we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018, we are also adopting a corresponding change to the use of crosswalking and gapfilling methodologies for tests where no applicable information is reported. That is, we are revising § 414.508(a) to reflect that we will use the crosswalking and gapfilling methodologies specified in that section to establish payment rates before January 1, 2018, and we are revising § 414.508(b) to reflect that we will use the crosswalking and gapfilling methodologies specified under § 414.508(b) to establish payment rates beginning January 1, 2018.
In summary, we are revising our proposed policy for recouping payment for new ADLTs if the actual list charge paid during the new ADLT initial period exceeds 130 percent of the market-based rate as discussed above in this section. If the actual list charge is greater than 130 percent of the weighted median private payor rate determined during the new ADLT initial period, we will recoup the difference between the actual list charge and 130 percent of the weighted median private payor rate. We are also making changes corresponding to the January 1, 2018 implementation date of the private payor rate-based CLFS as discussed in this section. We are finalizing all other payment methodology policies in this section as proposed.
Section 1834A(g) of the Act addresses issues related to coverage of CDLTs. Section 1834A(g)(1)(A) of the Act requires that coverage policies for CDLTs, when issued by a MAC, be issued in accordance with the LCD process. The current LCD development and implementation process is set forth in agency guidance. Section 1869(f)(2)(B) of the Act defines an LCD as a determination by a MAC under part A or part B, as applicable, respecting whether or not a particular item or service is covered on a MAC jurisdiction-wide basis under such parts, in accordance with section 1862(a)(1)(A) of the Act.
While the LCD development process is not enumerated in statute, CMS' Internet-Only Manual 100–08, Medicare Program Integrity Manual, Chapter 13, lays out the process for establishing LCDs. The manual outlines the steps in LCD development including: The posting of a draft LCD with a public comment period, a public meeting and presentation to an expert advisory committee, and, after consideration of comments, issuance of a final LCD followed by at least a 45-day notice period prior to the policy becoming effective. This LCD development process has been used by the MACs since 2003.
In addition to addressing LCD development and implementation, section 1834A(g)(1)(A) of the Act states that the processes governing the appeal and review of LCDs for CDLTs must be consistent with the general LCD appeal and review rules that we have issued at 42 CFR part 426. The LCD appeals process allows an “aggrieved party” to challenge an LCD or LCD provisions in effect at the time of the challenge. An aggrieved party is defined as a Medicare beneficiary, or the estate of a Medicare beneficiary, who is entitled to benefits under Part A, enrolled under Part B, or both (including an individual enrolled in fee-for-service Medicare, in a Medicare+Choice plan, or in another Medicare managed care plan), and is in need of coverage for an item or service that would be denied by an LCD, as documented by the beneficiary's treating physician, regardless of whether the service has been received.
Section 1834A(g)(1)(B) of the Act provides that the CDLT-related LCD provisions referenced in section 1834A(g) do not apply to the NCD process (as defined in section 1869(f)(1)(B) of the Act). The NCD process is outlined in section 1862(l) of the Act and further articulated in the August 7, 2013
Section 1834A(g)(1)(C) of the Act specifies that the provisions pertaining to the LCD process for CDLTs, including appeals, shall apply to coverage policies issued on or after January 1, 2015.
Beyond specifying how the Medicare LCD process will relate to CDLTs, section 1834A(g)(2) of the Act provides the Secretary the discretion to designate one or more (not to exceed four) MACs to either establish LCDs for CDLTs or to both establish LCDs and process Medicare claims for payment for CDLTs. Currently, there are 12 MACs that have authority to establish LCDs and process claims for CDLTs. We believe the statute authorizes us to reduce the number of MACs issuing LCDs for CDLTs, which would result in fewer contractors issuing policies for larger geographic areas. If we were to exercise only the authority to reduce the number of MACs issuing LCDs for CDLTs, such a change could likely be finalized within the next 2 to 4 years. However, reducing the number of MACs processing claims for CDLTs would involve significantly more complex programmatic and operational issues. For instance, the consolidation of Medicare claims processing for CDLTs would require complex changes to Medicare's computer systems. Thus, such a transition could take several years to implement. To be consistent with the statute, we believe the agency would need to conduct various analyses to determine the feasibility and program desirability of moving forward with consolidating the number of MACs making coverage policies and processing claims for CDLTs. We believe that the medical complexity of many tests and the volume of tests overall would require serious consideration of several factors before the agency could decide whether to consolidate all MAC CDLT processes into 1–4 MACs. For instance, if only coverage policies were to be developed by a smaller number of MACs, issues could arise for the other MACs that would need to implement policies, edit claims and defend LCD policies that they did not author. Moreover, the same policy may be implemented differently among MACs based on the ability of their individual claims processing systems to support certain types of editing and/or their differing assessment of risk and technical solutions. Finally, if both LCD development and claims processing were combined and consolidated, we would need to consider that the MAC processing the laboratory claim (in most cases) would not be the same MAC that processes the claim of the ordering physician. This could complicate the development of a full profile of the ordering physician's practice patterns for quality and medical necessity assessment purposes.
The timing for implementation of section 1834A(g)(2) of the Act (if we chose to exercise this authority) would be largely dependent on the time it would take the agency to develop new MAC statements of work, modify existing or develop new MAC contracts, and address the policy, information technology and technical aspects of the claims processing environment including the potential development of a new system. Implementing the fullest scope of the authority granted by this section, by which we would reduce both the number of MACs writing coverage policies for CDLT services and the number of MACs processing CDLT claims, could take at least 5 to 6 years and involve considerable costs. For example, to establish centralized LCDs for all CDLTs would probably involve an initial build-up and then a steady-state investment of several million dollars per year. To create regional lab test claims processors (in addition to development of LCDs) would involve higher set-up costs, and some steady-state costs.
We received 27 comments on these proposals. Of those comments, two commenters were in favor of consolidating both LCD development and claims processing for CDLTs. Five commenters were in favor of only MAC LCD consolidation for CDLTs. Of those five comments, four commenters said we may want to consider having MACs consolidate their LCDs for CDLTs but also raised concerns about such consolidation. Seven commenters were not in favor of having the MACs consolidate their LCDs for CDLTs. In regard to designating 1–4 MACs to
A discussion of the comments we received on the benefits and risks of implementing the various scenarios authorized by this section of the statute, and our response to those comments, appears below.
Two commenters indicated that consolidating claims processing functions under 1–4 MACs may be problematic unless consolidation of claims processing functions applies only to independent labs. One commenter offered an alternative of using the Master Edit File to address CMS' concerns about the complexities of consolidating CDLT claims processing. This file, designed to function similarly to the Part B Drug Crosswalk Pricing file and the National Correct Coding Initiative edit file, could standardize processing across the MACs. Tools such as the Integrated Data Repository could also facilitate the necessary data analysis and payment review processes being performed at a single contractor.
Two commenters indicated that CMS should consider designating a single contractor. One of these commenters believes a single contractor should be designated that has expertise in laboratory and precision medicine with the responsibility for coverage determinations for such tests. The commenter believes it would be difficult as well as inefficient for each MAC to develop this substantial and specialized expertise in laboratory medicine. The other commenter disagreed that it would take years to implement a national LCD process, and provided some suggestions on the LCD development process so that all MACs could release CDLT LCDs at the same time.
Four commenters indicated that if CMS were to move forward with fewer MACs developing LCDs it may put some MACs in a position of having to defend and/or abide by LCDs they did not develop. This could also create regional differences in how the same LCD would be enforced because a MAC's claims processing systems and editing capabilities differ.
Section 1834A(f) of the Act sets out several requirements for input from clinicians and technical experts on issues related to CDLTs. Section 1834A(f)(1) of the Act requires the Secretary to consult with an expert outside advisory panel that is to be established by the Secretary no later than July 1, 2015. This advisory panel must be composed of an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics, in issues related to CDLTs, which may include the development, validation, performance, and application of such tests.
Section 1834A(f)(1)(A) of the Act provides that the advisory panel will generally provide input on the establishment of payment rates for new CDLTs, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test and the factors used in determining coverage and payment processes for new CDLTs. Section 1834A(f)(1)(B) of the Act provides that the panel will provide recommendations to the Secretary under section 1834A of the Act. Section 1834A(f)(2) of the Act mandates that the panel comply with the requirements of the Federal Advisory Committee Act (5 U.S.C. App.) (FACA). We proposed to add § 414.506(e) to codify the establishment of the Advisory Panel on CDLTs.
In the October 27, 2014
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
In addition, a commenter noted that much of the discussion during the
Section 1834A(h)(1) of the Act states there shall be no administrative or judicial review under sections 1869 and 1878 of the Act, or otherwise, of the establishment of payment amounts under section 1834A of the Act. We proposed to codify this provision in § 414.507(e).
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
Section 1834A(b)(5) of the Act increases by $2 the nominal fee that would otherwise apply under section 1833(h)(3)(A) of the Act for a sample
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
As stated in section 1834A(h)(2) of the Act, Chapter 35 of title 44, United States Code, shall not apply to the information collection requirements contained in section 1834A of the Act. Consequently, the information collection requirements contained in this final rule need not be reviewed by the Office of Management and Budget.
We ordinarily publish a notice of proposed rulemaking in the
We are finalizing the CMP amounts adjusted in accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Pub. L. 114–74) (the 2015 Act) without public notice and comment. The 2015 Act is very prescriptive in the formula that we must apply in adjusting the civil monetary penalties, leaving us no flexibility to exercise discretion in calculating the inflation adjustments to the CMP amounts. Therefore, we find good cause to waive notice and comment procedures as unnecessary.
This final rule is necessary to establish a methodology for implementing the requirements in section 1834A of the Act, including a process for data collection and reporting, a weighted median calculation methodology, and requirements for how and to whom these policies would apply.
We have examined the impacts of this final 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 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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This final rule is an economically significant rule because we believe that the changes to how CLFS payment rates will be developed will overall decrease payments to entities paid under the CLFS. We estimate that this final rule is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that, to the best of our ability, presents the costs and benefits of the rulemaking.
Our analysis presents the projected effects of our implementation of new section 1834A of the Act. As described earlier in this final rule, a part of this rule describes a schedule and process for collecting the private payor rate information of certain laboratories. Until such time that these data are available, we are limited in our ability to estimate effects of our CLFS payment policies under different scenarios.
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, we estimate that most of the entities paid under the CLFS are small entities as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). The great majority of hospitals and most other health care providers and suppliers are small
For purposes of the RFA, we estimate that most entities furnishing laboratory tests paid under the CLFS are considered small businesses according to the Small Business Administration's size standards with total revenues of $32.5 million or less in any 1 year: $32.5 million for medical laboratories and $11 million for doctors. Individuals and states are not included in the definition of a small entity. Using the codes for laboratories in the North American Industry Classification System (NAICS), more than 90 percent of medical laboratories would be considered small businesses. This final rule will have a significant impact on a substantial number of small businesses or other small entities even with an exception for low expenditure laboratories.
In the proposed rule (80 FR 59391through 59394), we proposed to define applicable laboratory at the TIN level. Approximately 68,000 unique TIN entities are enrolled in the Medicare program as a laboratory and paid under the CLFS. Of these unique TIN entities, 94 percent are enrolled as a physician office laboratory, 3 percent are enrolled as independent laboratories while the remaining 3 percent are attributed to other types of laboratories such as those operating within a rural health clinic or a skilled nursing facility. In section II.A. of this final rule, we discussed that after considering commenters' suggestions, we have revised the proposal and, as a final policy, we are defining applicable laboratory at the NPI level. Approximately 266,000 unique NPI-level entities are enrolled in the Medicare program as a laboratory and paid under the CLFS. Of these unique NPI-level entities, 93 percent are enrolled as a physician office laboratory, 1 percent are enrolled as independent laboratories while the remaining 6 percent are attributed to other types of laboratories such as those operating within a rural health clinic or a skilled nursing facility. Given that well over 90 percent of Medicare enrolled laboratories paid under the CLFS are physician-owned laboratories, we estimate the majority of Medicare-enrolled laboratories would meet the SBA definition of a small business. While the NPI-level entity will be the applicable laboratory, the TIN-level entity will be responsible for reporting applicable information for all the NPIs in its organization that are applicable laboratories. We believe that reporting at the TIN level will require reporting from fewer entities and will, therefore, be less burdensome to all types of applicable laboratories—that is independent laboratories, physician office laboratories, and hospital outreach laboratories—than would requiring applicable laboratories to report.
As discussed in section II.B of this final rule, the applicable information required to be reported to CMS includes each private payor rate, the associated volume of tests performed corresponding to each private payor rate, and the specific HCPCS code associated with the test. We specifically intended to minimize the reporting burden by only requiring the minimum information necessary to enable us to set CLFS payment rates. We are not requiring (or permitting) individual claims to be reported because claims include more information than we need to set payment rates (and also raises concerns about reporting personally identifiable information). We believe that each of these policies, which are finalized in this rule, will substantially reduce the reporting burden for reporting entities in general and small businesses in particular.
Given that we have never collected information about private payor rates for tests from laboratories, we do not have the specific payment amounts from the weighted median of private payor rates that will result from implementation of section 1834A of the Act. For this reason, it is not possible to determine an impact at the level of the individual laboratory or physician office laboratory much less distinctly for small and other businesses. While the information provided elsewhere in this impact statement provide the aggregate level of changes in payments, these estimates were done by comparing the differences in payment amounts for laboratory tests from private payers with the Medicare CLFS payment adjusted for changes expected to occur by CY 2018. While this methodology can be used to estimate an overall aggregate change in payment for services paid using the CLFS, the impact on any individual laboratory will depend on the mix of laboratory services provided by the individual laboratory or physician office.
A final regulation is generally deemed to have a significant impact on small businesses if the rule is estimated to have an impact greater than a 3 to 4 percentage change to their revenue. As discussed previously in this section, we estimate that most entities furnishing laboratory tests paid under the CLFS would be considered a small business. Therefore, we believe our accounting statement provides a reasonable representation of the impact of the changes to the CLFS on small businesses (see Table 14). As illustrated in Table 14, the effect on the Medicare program is expected to be $390 million less in Part B program payments for CLFS tests furnished in FY 2018. The 5-year impact is estimated to be $1.71 billion less and the 10-year impact is expected to result in $3.93 billion less in program payments. As discussed previously, overall, Medicare pays approximately $7 billion a year under the current CLFS for CDLTs. Using our estimated amount of changes in CLFS spending, we estimate an overall percentage reduction in revenue of approximately −5.6 percent for FY 2018 (−$390 million/$7 billion = −5.6 percent); a 5-year percentage reduction of about 4.9 percent (−$1.71 billion/$35 billion = −4.9 percent) and a 10-year percentage reduction of approximately 5.6 percent (−$3.93 billion/$70 billion = −5.61percent). As such, we estimate that the revisions to the CLFS as authorized by PAMA will have a significant impact on small businesses.
We note that the above estimates differ from the estimates indicated in the regulatory impact analysis section of the proposed rule. The difference is due to the move in implementation from January 1, 2017, to January 1, 2018. The move not only eliminated a year of potential savings but resulted in less future savings as another year of productivity adjustments will take effect and essentially narrow the gap between private payor rates and Medicare rates.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This final rule will not have a significant impact on small rural hospitals because the majority of entities paid under the CLFS and affected by the policies are independent laboratories and physician offices. To the extent that rural hospitals own independent laboratories and to the extent that rural hospitals are paid under the CLFS, there could be a significant impact on those facilities. Since most payments for laboratory tests to hospitals are bundled in Medicare Severity Diagnosis Related Group payments under Part A, the Secretary has determined that this final rule will not have a significant impact on the operations of a substantial number of
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 2016, that is approximately $146 million. This final rule does not contain mandates that will impose spending costs on State, local, or tribal governments in the aggregate, or by the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have examined the CLFS provisions included in this final rule in accordance with Executive Order 13132, Federalism, and have determined that they will not have a substantial direct effect on state, local or tribal governments, preempt state law, or otherwise have a Federalism implication. While we have limited information about entities billing the CLFS with government ownership, the limited amount of information we currently have indicates that the number of those entities, as well as CLFS payment amounts associated with them, are minimal. Based on 2013 claims data, we received only 21,627 claims for CLFS services from a total of 50 state or local public health clinics (0.1 percent of total laboratories that billed under the CLFS). However, we note that this final rule will potentially affect payments to a substantial number of laboratory test suppliers, and some effects may be significant.
Section 1834A of the Acts requires that the payment amount for tests on the CLFS, beginning January 1, 2017, be based on private payor rates. As discussed in the proposed rule (80 FR 59416), we estimated the effect on the Medicare program is expected to be $360 million less in program payments for CLFS tests furnished in FY 2017. However, as discussed in section II.D of this final rule, we are moving the implementation date of the private payor rate-based CLFS to January 1, 2018. As a result, we revised the estimated amount of change in CLFS spending to reflect the revised implementation date.
The effect on the Medicare program is expected to be $390 million less in program payments for CLFS tests furnished in FY 2018. We first established a baseline difference between Medicare CLFS payment rates and private payor rates based on a study by the Office of Inspector General, “Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings”, OEI–07–11–00010, June 2013. The OIG study showed that Medicare paid between 18 and 30 percent more than other insurers for 20 high-volume and/or high-expenditure lab tests. We assumed the private payor rates to be approximately 20 percent lower than the Medicare CLFS payment rates for all tests paid under the CLFS in CY2010. We then accounted for the legislated 5 years of 1.75 percent cuts to laboratory payments, as required by section 1833(h)(2)(A)(iv)(II) of the Act, as well as 8 years of multi-factor productivity adjustments, as required by section 1833(h)(2)(A) of the Act, to establish a new baseline difference between private payor rates and Medicare CLFS payment rates of approximately 5.8 percent in 2018. The new baseline difference between Medicare CLFS payment rates and private payor rates (5.8 percent) results in an approximate savings to the Medicare program of $390 million in FY 2018. We projected the FY 2018 Medicare savings of $390 million forward by assuming a rate of growth proportional to the growth in the CLFS (that is approximately 8.2 percent annually over the projection window FY 2016 through FY 2025) after adjusting for additional productivity adjustments to determine a 10-year cost savings estimate (as illustrated in Table 14). We note that the 1-year move in implementation of this final rule reduces the 10-year estimated amount of change in CLFS spending by approximately $790 million. The effect on the Medicaid program is expected to be limited to payments that Medicaid may make on behalf of Medicaid recipients who are also Medicare beneficiaries. We note that section 6300.2 of the CMS State Medicaid Manual states that Medicaid reimbursement for CDLTs may not exceed the amount that Medicare recognizes for such tests.
A discussion of the comments we received on this topic, and our responses to those comments, appears below.
As discussed previously, the applicable information of applicable laboratories must be collected, and reporting entities will be required to report that information to CMS. Section II.E.1. addresses penalties for non-reporting. We believe there could be substantial costs associated with compliance with section 1834A. As we had only limited information upon which to develop a cost estimate for collecting and reporting applicable information, we did not propose an estimate of the cost of data collection and reporting. As discussed below, we provided an illustrative example of the potential magnitude of collecting and reporting applicable information under the revised private payor rate based CLFS.
As noted previously, the CLFS has grown from approximately 400 tests to over 1,300 tests. For the proposed rule, we were not able to ascertain how many private payors and private payor rates there are for each applicable laboratory, and therefore, provided a hypothetical
To better understand the projected reporting, recordkeeping or other compliance requirements, we specifically requested comments on the following questions concerning applicable laboratories:
• How many tests on the CLFS does the applicable laboratory perform?
• For each test, how many different private payor rates does the applicable laboratory have in a given period (for example, calendar year or other 12 month reporting period)?
• Does the applicable laboratory receive more than one rate from a private payor in a given period (for example, calendar year or other 12 month reporting period)?
• Is the information that laboratories are required to report readily available in the applicable laboratories' record systems?
• How much time does the applicable laboratory expect will be required to assemble and report applicable information?
• What kind of personnel will the applicable laboratory be using to report applicable information?
• What is the salary per hour for these staff?
• Is there other information not requested in the above questions that will inform the potential reporting burden being imposed by section 1834A of the Act?
We believed that these items would be important factors to consider before projecting data reporting and record-keeping requirements. A discussion of the comments we received on this topic and our responses to those comment, appears below.
According to the National Association of Insurance Commissioners, there were 859 domestic insurers in the United States in 2015.
Additionally, although we expect applicable information (that is, private payor rates and associated volume) to be reported by applicable laboratories on nearly all of the approximately 1300 tests on the CLFS, it seems likely that most applicable laboratories will not have private payor rates for each test on the CLFS and that a small number of tests will have the highest volume and more associated private payor rates. For instance, based on 2013 Medicare claims data, 25 tests accounted for over 85 percent of the total allowed services paid on the CLFS. Assuming that all of the estimated applicable laboratories (approximately 13,600) would report a single private payor rate for each of the most common 25 laboratory tests paid on the CLFS, we estimate there would be approximately 37,500 data points reported per applicable laboratory (25 laboratory test rates × 1,500 private payors) and approximately 510 million total data points reported for all applicable laboratories (13,600 estimated applicable laboratories × estimated 37,500 data points per applicable laboratory). As these 510 million data points are for the 25
Additionally, we recognize that requirements set forth by section 1834A of the Act may necessitate changes to IT systems and other administrative changes for laboratories to implement the reporting requirements of section 1834A of the Act. One commenter indicated that IT systems changes resulting from the data collection and reporting requirements could cost $300,000 and as much as $600,000 to implement. We presume that the majority of applicable laboratories would have IT systems and would not need to rely extensively on a manual payment remittance process. Although the information we received from the comments regarding the cost of IT changes was insightful, it was insufficient to develop a cost estimate for data collection and reporting activities for the entire laboratory industry.
This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding sections of this final rule provide descriptions of the statutory provisions that are addressed, identify policies where the statute recognizes the Secretary's discretion, present the rationale for our policies and, where relevant, alternatives that were considered.
In developing this final rule, we considered numerous alternatives to the final policies. Key areas where we considered alternatives include the organizational level associated with an applicable laboratory, authority to develop a low volume or low expenditure threshold to reduce reporting burden for small businesses, whether to include coinsurance amounts as part of the applicable information, the definition of the initial reporting period for ADLTs, and how to set rates for CDLTs for which the agency receives no applicable information. Below, we discuss alternative policies considered. We recognize that all of the alternatives considered could have a potential impact on the cost or savings under the CLFS. However, we do not have any private payor rate information with which to price these alternative approaches.
As discussed previously in this section, we proposed to define an applicable laboratory at the TIN level rather than the NPI level because we believed that reporting applicable information would be less burdensome for applicable laboratories. However, as discussed in detail in section II.A of this final rule, in response to public comments, we revised our proposal and, as a final policy adopted in this final rule, we are defining applicable laboratory at the NPI level while maintaining that the TIN-level entity will be the reporting entity. We believe that having the TIN-level entity report applicable information for all of the NPI-level entities in its organization that are applicable laboratories will not affect or diminish the quality of the applicable information reported and should produce the same applicable information as reporting individually at the NPI level.
We proposed to exercise our authority to develop a low expenditure threshold to exclude small businesses from having to report applicable information. Specifically, we proposed that any entity that would otherwise be an applicable laboratory, but that received less than $50,000 in Medicare revenues under sections 1834A and 1833(h) of the Act (the CLFS) for tests furnished during a data collection period, would not be an applicable laboratory. We considered the alternative of not proposing a low volume or low expenditure threshold which would require all entities meeting the definition of applicable laboratory to report applicable information to us. However, by proposing a low expenditure threshold we were able to substantially reduce the number of entities required to report applicable information to us (94 percent of physician office laboratories and 52 percent of independent laboratories would not be required to report applicable information) while retaining a high percentage of Medicare utilization (that is, 96 percent of CLFS spending on physician office laboratories and more than 99 percent of CLFS spending on independent laboratories) from applicable laboratories that would be required to report. We did not pursue a low volume threshold because we believed it could potentially exclude laboratories that perform a low volume of very expensive tests from reporting applicable information.
As discussed section II.A of this final rule, we are revising the low expenditure threshold consistent with defining an applicable laboratory at the NPI level rather than the TIN level. We are also revising the low expenditure threshold consistent with our decision in this final rule to change the data collection period from 12 months to 6 months, which will also reduce the reporting burden for reporting entities (see detailed discussion in section II.D. of this final rule). With these changes, the low expenditure threshold is reduced from $50,000 in the proposed rule to $12,500 in this final rule. As we found for the proposed rule, the application of the low expenditure threshold will significantly reduce the number of laboratories qualifying as applicable laboratories and substantially reduce the reporting burden for small businesses. We estimate that the low expenditure threshold of $12,500 adopted in this final rule will exclude approximately 95 percent of physician office laboratories and approximately 55 percent of independent laboratories from having to report applicable information, while retaining a high percentage of Medicare utilization (that is, approximately 92 percent of CLFS spending on physician office laboratories and approximately 99 percent of CLFS spending on independent laboratories). Additionally, as discussed in section II.A., for a single laboratory that offers and furnishes an ADLT, the $12,500 threshold will not apply with respect to the ADLT. This means, if the laboratory otherwise meets the definition of applicable laboratory, whether or not it meets the low expenditure threshold, it will be
As explained in section II.D. of this final rule, section 1834A(d)(1)(A) of the Act requires an “initial period” of three quarters during which payment for new ADLTs is based on the actual list charge for the laboratory test. The statute does not specify when this initial period of three quarters is to begin. Section 1834A(d)(2) of the Act requires reporting of applicable information not later than the last day of the Q2 of the new ADLT initial period. These private payor rates will be used to determine the CLFS rate after the new ADLT initial period ends. We considered starting the new ADLT initial period on the day the new ADLT is first performed (which in most cases would be after a calendar quarter begins). However, as noted previously in this final rule, if we were to start the new ADLT initial period after the beginning of a calendar quarter, the 2nd quarter would also begin in the midst of a calendar quarter, requiring the laboratory to report applicable information from the middle of the calendar quarter rather than on a calendar quarter basis. Further, if a new ADLT initial period of three quarters would also end during a calendar quarter, the laboratory would start getting paid the weighted median rate in the middle of the calendar quarter rather at the beginning of a calendar quarter. This may be burdensome and confusing for laboratories. As such, we believe that the new ADLT initial period should start and end on the basis of a calendar quarter (for example, January 1 through March 31, April 1 through June 30, July 1 through September 30, or October 1 through December 31) for consistency with how private payor rates will be reported and determined for CDLTs (on the basis of a calendar year which is four quarters aggregated) and how CLFS rates will be paid (also on the basis of a calendar year). As discussed in section II.D., we are revising the definition of new ADLT initial period in § 414.502 to mean a period of 3 calendar quarters that begins on the first day of the first full calendar quarter following the later of the date a Medicare Part B coverage determination is made or ADLT status is granted by us.
As discussed in section II.H.4. of this final rule, the statute specifies that if, after a new ADLT initial period, the Secretary determines the payment amount that was applicable during the initial period (the test's actual list charge) was greater than 130 percent of the payment amount that is applicable after such period (based on private payor rates), the Secretary shall recoup the difference between those payment amounts for tests furnished during the initial period. We proposed to recoup the entire amount of the difference between the actual list charge and the weighted median private payer rate. After consideration of public comments, we revised our proposed policy so that, for tests furnished during the new ADLT initial period, we will pay up to 130 percent of the weighted median private payor rate. That is, if the actual list charge is subsequently determined to be greater than 130 percent of the weighted median private payor rate, we will recoup the difference between the actual list charge and 130 percent of the weighted median private payer rate. As we currently do not have information upon which to develop a cost estimate for this final recoupment policy, we cannot estimate how this policy will impact future payments under the CLFS. We do not anticipate many laboratory tests will meet the criteria for being an ADLT, therefore, we do not expect this final recoupment policy will have a significant impact on total CLFS spending.
As discussed in section II.B of this final rule, in the event we do not receive applicable information for a laboratory test that is provided to a Medicare beneficiary, we will use crosswalking and gapfilling using the definitions in § 414.508(b)(1) and (2) to establish a payment rate on or after January 1, 2018, which will remain in effect until the year following the next data reporting period. This policy includes the situation where we receive no applicable information for tests that were previously priced using gapfilling or crosswalking or where we had previously priced a test using the weighted median methodology. If we receive no applicable information in a subsequent data reporting period, we will use crosswalking or gapfilling methodologies to establish the payment amount for the test. That is, if in a subsequent data reporting period, no applicable information is reported, we will reevaluate the basis for payment, of crosswalking or gapfilling, and the payment amount for the test.
In exploring what we would do if we receive no applicable information for a CDLT, we alternatively considered carrying over the current payment amount for a test under the current CLFS, the payment amount for a test (if one was available) using the weighted median methodology based on applicable information from the previous data reporting period, or the gapfilled or crosswalked payment amount. However, we did not adopt this approach because we believe carrying over previous payment rates would not reflect changes in costs or pricing for the test over time. As noted previously, we believe reconsidering payment rates for tests in these situations is consistent with the purpose of section 1834A of the Act, which requires us to periodically reconsider CLFS payment rates. In this final rule, we finalized our proposal for using crosswalking and gapfilling in the event we do not receive applicable information for a laboratory test.
As discussed previously, we proposed to use the NLAs for purposes of applying the 10 percent reduction limit to CY 2017 payment amounts instead of using local fee schedule amounts. As previously explained, we believed the statute intends CLFS rates to be uniform nationwide, which is why it precludes any geographic adjustment. We proposed that if the weighted median calculated for a CDLT based on applicable information for CY 2017 would be more than 10 percent less than the CY 2016 NLA for that test, we would establish a Medicare payment amount for CY 2017 that is no less than 90 percent of the NLA (that is, no more than a 10 percent reduction). We proposed, for each of CY 2017 through 2022, we would apply the applicable percentage reduction limitation to the Medicare payment amount for the preceding year. The alternative would have been to apply the 10 percent reduction limitation to the lower of the NLA or the local fee schedule amount. This option would retain some of the features of the current payment methodology. Under this option, though, the Medicare payment amounts may be local fee schedule amounts, so there could continue to be regional variation in the Medicare payment amounts for CDLTs. We believe that Medicare infrequently pays less than the NLA and there would be significant burden for CMS to establish systems logic to establish transition payment
As discussed in section II.D of this final rule, we are moving the implementation date of the private payor-based rates for the CLFS by one year, to January 1, 2018. Therefore we are making a corresponding change to the phase-in of payment reductions timetable to reflect the January 1, 2018 implementation date. We are codifying this change from the proposed rule in § 414.507(d) to indicate that a maximum payment reduction per year of 10 percent applies for years 2018 through 2020 and a maximum payment reduction per year of 15 percent applies for years 2021 through 2023.
We did not receive comments on the proposed rule regarding the phased-in reduction provisions. Therefore, we adopted our proposal for phased-in reduction, along with the above changes to the timetable, as final policy.
As required by OMB Circular A–4 (available on the Office of Management and Budget Web site at:
We are creating a data collection system, developing HCPCS codes for laboratory tests when needed, convening a FACA advisory committee to make recommendations on how to pay for new CDLTs including reviewing and making recommendations on applications for ADLTs, and undertaking other implementation activities. To implement these new standards, we anticipate initial federal start-up costs to be approximately $4 million per year. Once implemented, ongoing costs to collect data, review ADLTs, maintain data collection systems, and provide other upkeep and maintenance services will require an estimated $3 million annually in federal costs. We will continue to examine and seek comment on the potential impacts to both Medicare and Medicaid.
The changes we adopt in this final rule will affect suppliers who receive payment under the CLFS, primarily independent laboratories and physician offices. We are limited in our ability to determine the specific impact on different classes of suppliers at this time due to the data limitations noted earlier in this section. However, we anticipate that the updated information through this data collection process in combination with the exclusion of adjustments (geographic adjustment, budget neutrality adjustment, annual update, or other adjustment that may apply under other Medicare payment systems), as described in section 1834A(b)(4)(B) of the Act, will reduce aggregate payments made through the CLFS, and therefore, some supplier level payments. We note that this final rule includes changes that may affect different laboratory test suppliers differently, based on the types of tests they provide.
The previous analysis, together with the remainder of the preamble, provides a Regulatory Flexibility Analysis. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amend 42 CFR chapter IV as set forth below:
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
This subpart implements provisions of 1833(h)(8) of the Act and 1834A of the Act—procedures for determining the basis for, and amount of, payment for a clinical diagnostic laboratory test (CDLT).
(1) The test—
(i) Is an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins;
(ii) When combined with an empirically derived algorithm, yields a result that predicts the probability a specific individual patient will develop a certain condition(s) or respond to a particular therapy(ies);
(iii) Provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests; and
(iv) May include other assays.
(2) The test is cleared or approved by the Food and Drug Administration.
(1) Means—
(i) Each private payor rate for which final payment has been made during the data collection period;
(ii) The associated volume of tests performed corresponding to each private payor rate; and
(iii) The specific Healthcare Common Procedure Coding System (HCPCS) code associated with the test.
(2) Does not include information about a test for which payment is made on a capitated basis.
(1) Is a laboratory, as defined in § 493.2 of this chapter;
(2) Bills Medicare Part B under its own National Provider Identifier (NPI);
(3) In a data collection period, receives more than 50 percent of its Medicare revenues, which includes fee-for-service payments under Medicare Parts A and B, Medicare Advantage payments under Medicare Part C, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period from one or a combination of the following sources:
(i) This subpart G.
(ii) Subpart B of this part.
(4) Receives at least $12,500 of its Medicare revenues from this subpart G. Except, for a single laboratory that offers and furnishes an ADLT, this $12,500 threshold—
(i) Does not apply with respect to the ADLTs it offers and furnishes; and
(ii) Applies with respect to all the other CDLTs it furnishes.
(1) A health insurance issuer, as defined in section 2791(b)(2) of the Public Health Service Act.
(2) A group health plan, as defined in section 2791(a)(1) of the Public Health Service Act.
(3) A Medicare Advantage plan under Medicare Part C, as defined in section 1859(b)(1) of the Act.
(4) A Medicaid managed care organization, as defined in section 1903(m)(1)(A) of the Act.
(1) Is the final amount that is paid by a private payor for a CDLT after all private payor price concessions are applied and does not include price concessions applied by a laboratory.
(2) Includes any patient cost sharing amounts, if applicable.
(3) Does not include information about denied payments.
(1) The laboratory, as defined in 42 CFR 493.2, which furnishes the test, and that may also design, offer, or sell the test; and
(2) The following entities, which may design, offer, or sell the test:
(i) The entity that owns the laboratory.
(ii) The entity that is owned by the laboratory.
(1)
(2)
(3)
(a) In a data reporting period, a reporting entity must report applicable information for each CDLT furnished by its component applicable laboratories during the corresponding data collection period, as follows—
(1) For CDLTs that are not ADLTs, every 3 years beginning January 1, 2017.
(2) For ADLTs that are not new ADLTs, every year beginning January 1, 2017.
(3) For new ADLTs—
(i) Initially, no later than the last day of the second quarter of the new ADLT initial period; and
(ii) Thereafter, every year.
(b) Applicable information must be reported in the form and manner specified by CMS.
(c) A laboratory seeking new ADLT status for its test must, in its new ADLT application, attest to the actual list charge.
(d) To certify data integrity, the President, CEO, or CFO of a reporting entity, or an individual who has been delegated authority to sign for, and who reports directly to, such an officer, must sign the certification statement and be responsible for assuring that the data provided are accurate, complete, and truthful, and meets all the reporting parameters described in this section.
(e) If the Secretary determines that a reporting entity has failed to report applicable information for its applicable laboratories, or made a misrepresentation or omission in reporting applicable information for its applicable laboratories, the Secretary may apply a civil monetary penalty to a reporting entity in an amount of up to $10,000 per day, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act of 2015, Pub. L. 114–74, November 2, 2015), for each failure to report or each such misrepresentation or omission. The provisions for civil monetary penalties that apply in general to the Medicare program under 42 U.S.C. 1320a–7b apply in the same manner to the laboratory data reporting process under this section.
(f) CMS or its contractors will not disclose applicable information reported to CMS under this section in a manner that would identify a specific payor or laboratory, or prices charged or payments made to a laboratory, except to permit the Comptroller General, the Director of the Congressional Budget Office, and the Medicare Payment Advisory Commission, to review the information, or as CMS determines is necessary to implement this subpart, such as disclosures to the HHS Office of Inspector General or the Department of Justice for oversight and enforcement activities.
(g) Applicable information may not be reported for an entity that does not meet the definition of an applicable laboratory. For a single laboratory that offers and furnishes an ADLT that is not an applicable laboratory except with respect to its ADLTs, the applicable information of its CDLTs that are not ADLTs may not be reported.
For a new CDLT, CMS determines the basis for and amount of payment after performance of the following:
(d) * * *
(1) Proposed determinations with respect to the appropriate basis for establishing a payment amount for each code, with an explanation of the reasons for each determination, the data on which the determinations are based, including recommendations from the Advisory Panel on CDLTs described in paragraph (e) of this section, and a request for written public comments within a specified time period on the proposed determination; and
(3) On or after January 1, 2018, in applying paragraphs (d)(1) and (2) of this section, CMS will provide an explanation of how it took into account the recommendations of the Advisory Panel on CDLTs described in paragraph (e) of this section.
(4) On or after January 1, 2018, in applying paragraphs (d)(1) and (2) of this section and § 414.509(b)(2)(i) and (iii) when CMS uses the gapfilling method described in § 414.508(b)(2), CMS will make available to the public an explanation of the payment rate for the test.
(e) CMS will consult with an expert outside advisory panel, called the Advisory Panel on CDLTs, composed of an appropriate selection of individuals with expertise, which may include molecular pathologists researchers, and individuals with expertise in laboratory science or health economics, in issues related to CDLTs. This advisory panel will provide input on the establishment of payment rates under § 414.508 and provide recommendations to CMS under this subpart.
(a)
(b)
(c) The payment amounts established under this section are not subject to any adjustment, such as geographic, budget
(d)
(1) 2018—10 percent of the national limitation amount for the test in 2017.
(2) 2019—10 percent of the payment rate established in 2018.
(3) 2020—10 percent of the payment rate established in 2019.
(4) 2021—15 percent of the payment rate established in 2020.
(5) 2022—15 percent of the payment rate established in 2021.
(6) 2023—15 percent of the payment rate established in 2022.
(e) There is no administrative or judicial review under sections 1869 and 1878 of the Social Security Act, or otherwise, of the payment rates established under this subpart.
(f) Effective April 1, 2014, the nominal fee that would otherwise apply for a sample collected from an individual in a Skilled Nursing Facility (SNF) or by a laboratory on behalf of a Home Health Agency (HHA) is $5.
(g) For a CDLT for which CMS receives no applicable information, payment is made based on the crosswalking or gapfilling methods described in § 414.508(b)(1) and (2).
(h) For ADLTs that are furnished between April 1, 2014 and December 31, 2017, payment is based on the crosswalking or gapfilling methods described in § 414.508(a).
(a) For a new CDLT that is assigned a new or substantially revised code between January 1, 2005 and December 31, 2017, CMS determines the payment amount based on either of the following:
(1)
(i) CMS assigns to the new CDLT code, the local fee schedule amounts and national limitation amount of the existing test.
(ii) Payment for the new CDLT code is made at the lesser of the local fee schedule amount or the national limitation amount.
(2)
(i) In the first year, Medicare Administrative Contractor-specific amounts are established for the new CDLT code using the following sources of information to determine gapfill amounts, if available:
(A) Charges for the CDLT and routine discounts to charges;
(B) Resources required to perform the CDLT;
(C) Payment amounts determined by other payors; and
(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(ii) In the second year, the test code is paid at the national limitation amount, which is the median of the contractor-specific amounts.
(iii) For a new CDLT for which a new or substantially revised HCPCS code was assigned on or before December 31, 2007, after the first year of gapfilling, CMS determines whether the contractor-specific amounts will pay for the test appropriately. If CMS determines that the contractor-specific amounts will not pay for the test appropriately, CMS may crosswalk the test.
(b) For a new CDLT that is assigned a new or substantially revised HCPCS code on or after January 1, 2018, CMS determines the payment amount based on either of the following until applicable information is available to establish a payment amount under the methodology described in § 414.507(b):
(1)
(i) CMS assigns to the new CDLT code, the payment amount established under § 414.507 of the comparable existing CDLT.
(ii) Payment for the new CDLT code is made at the payment amount established under § 414.507.
(2)
(i) In the first year, Medicare Administrative Contractor-specific amounts are established for the new CDLT code using the following sources of information to determine gapfill amounts, if available:
(A) Charges for the test and routine discounts to charges;
(B) Resources required to perform the test;
(C) Payment amounts determined by other payors;
(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and
(E) Other criteria CMS determines appropriate.
(ii) In the second year, the CDLT code is paid at the median of the Medicare Administrative Contractor-specific amounts.
For a new CDLT, the following reconsideration procedures apply:
(b) * * *
(2) * * *
(i) By April 30 of the year after CMS makes a determination under § 414.506(d)(2) or paragraph (a)(3) of this section that the basis for payment for a CDLT will be gapfilling, CMS posts interim Medicare Administrative Contractor-specific amounts on the CMS Web site.
(ii) For 60 days after CMS posts interim Medicare Administrative Contractor-specific amounts on the CMS Web site, CMS will receive public comments in written format regarding the interim Medicare Administrative Contractor-specific amounts.
(iii) After considering the public comments, CMS will post final Medicare Administrative Contractor-specific amounts on the CMS Web site.
(iv) For 30 days after CMS posts final Medicare Administrative Contractor-specific payment amounts on the CMS Web site, CMS will receive reconsideration requests in written format regarding whether CMS should reconsider the final Medicare Administrative Contractor-specific payment amount and median of the Medicare Administrative Contractor-specific payment amount for the CDLT.
(v) Considering reconsideration requests received, CMS may reconsider its determination of the amount of payment. As the result of a reconsideration, CMS may revise the median of the Medicare Administrative Contractor-specific payment amount for the CDLT.
(a) The payment rate for a new ADLT—
(1) During the new ADLT initial period, is equal to its actual list charge.
(2) Prior to the new ADLT initial period, is determined by the Medicare Administrative Contractor based on information provided by the laboratory
(b) After the new ADLT initial period, the payment rate for a new ADLT is equal to the weighted median established under the payment methodology described in § 414.507(b).
(c) If, after the new ADLT initial period, the actual list charge of a new ADLT is greater than 130 percent of the weighted median established under the payment methodology described in § 414.507, CMS will recoup the difference between the ADLT actual list charge and 130 percent of the weighted median.
(d) If CMS does not receive any applicable information for a new ADLT by the last day of the second quarter of the new ADLT initial period, the payment rate for the test is determined either by the gapfilling or crosswalking method as described in § 414.508(b)(1) and (2).
Office of Acquisition Policy, General Services Administration.
Final rule.
The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to include clauses that require vendors to report transactional data from orders placed against certain Federal Supply Schedule (FSS) contracts, Governmentwide Acquisition Contracts (GWACs), and Governmentwide Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts.
Transactional data refers to the information generated when the Government purchases goods or services from a vendor. It includes specific details such as descriptions, part numbers, quantities, and prices paid for the items purchased. GSA has experimented with collecting transactional data through some of its contracts and found it instrumental for improving competition, lowering pricing, and increasing transparency. Accordingly, GSA will now test these principles on a broader base of its contracting programs. This move supports the Government's shift towards category management by allowing it to centrally analyze what it buys and how much it pays, and thereby identify the most efficient solutions, channels, and sources to meet its mission critical needs.
GSA will introduce a new Transactional Data Reporting clause to its FSS contracts in phases, beginning with a pilot for select Schedules and Special Item Numbers. Participating vendors will no longer be subject to the existing requirements for Commercial Sales Practices (CSP) disclosures and Price Reductions clause (PRC) basis of award monitoring, resulting in a substantial burden reduction. Stakeholders have identified the CSP and PRC requirements as some of the most burdensome under the Schedules program. These actions represent the most significant change to the Schedules program in the past two decades. GSA has also created a Transactional Data Reporting clause for all new GWACs and Governmentwide IDIQ contracts and may apply the clause to any existing contracts in this class that do not contain other transactional data requirements.
This rule is effective June 23, 2016.
Mr. Matthew McFarland, Senior Policy Advisor, GSA Acquisition Policy Division, at 202–690–9232 or
The purpose of the Transactional Data Reporting rule is to transform price disclosure and related policies for GSA's Federal Supply Schedule (FSS) contracts, Governmentwide Acquisition Contracts (GWACs), and Governmentwide Indefinite-Delivery, Indefinite Quantity (IDIQ) contracts, in order to improve the value taxpayers receive when purchases are made using these vehicles. The rule contains new clauses that require vendors to electronically report certain specific details on transactions under these GSA contracts, such as the descriptions of goods or services acquired, part numbers, quantities, and prices paid. GSA will use this added market intelligence to make smarter buying decisions and share the information with its agency customers so they can also make smarter buying decisions when utilizing GSA's contract vehicles.((
The rule also seeks to eliminate burden associated with current pricing disclosure and tracking requirements for thousands of entities, particularly small businesses that sell to agencies through the FSS program, the Government's largest purchasing channel for commercial products and services. In Fiscal Year 2015 alone, GSA's FSS contracts accounted for $33 billion in sales, or more than 7 percent of all federal contract spending. Accordingly, the rule provides for a measured and managed phase-out of disclosures and tracking currently required by the Commercial Sales Practices (CSP) format and the Price Reductions clause (PRC), and the associated practice of negotiating pricing based on a model where the Government strives to secure the vendor's most favored pricing and maintain this position for the life of the contract. Instead, GSA is adopting a more dynamic market driven pricing model, where vendors submit prices paid by Government customers through a new Transactional Data Reporting clause
The Transactional Data Reporting clause is being implemented under the Schedules program on a pilot basis, to begin not less than 60 days after the publication date of the rule. Participation in the pilot will initially be voluntary for existing Schedule contract holders, and those who participate and comply with the Transactional Data Reporting requirements will not provide CSPs or be subject to the PRC basis of award tracking customer provision. The pilot will involve eight Schedules, including the information technology Schedule 70 and the Professional Services Schedule (Schedule 00CORP), and will reach approximately 30 percent of GSA's FSS contracts that account for more than 40 percent of GSA the FSS sales volume.
FSS contracts managed by the Department of Veterans Affairs are not included in the pilot and therefore will not be impacted by changes made by this rule to waive application of the CSP and PRC tracking customer provision.
For GSA's non-FSS Governmentwide vehicles, a Transactional Data Reporting
The Transactional Data Reporting final rule follows a proposed rule published by GSA in the
After careful review of the public comments, which are discussed in greater detail in Section V of this document,
Transactional Data Reporting is an attempt to embrace modern technology while moving away from outmoded practices. When first introduced in the 1980s, the CSP and PRC helped GSA and its customer agencies maintain advantageous pricing from original equipment manufacturers that held the vast majority of FSS contracts. However, changes in what the Government buys and shifts in the federal marketplace have eroded the effectiveness of these tools over time. Additionally, vendors repeatedly single out these pricing tools as among the most complicated and burdensome requirements in federal contracting. By contrast, Transactional Data Reporting provides a less burdensome alternative. The rule adds a total of $15 million a year in costs for two classes of contracts, FSS ($12 million a year) and non-FSS ($3 million a year). FSS vendors are currently subject to the CSP and PRC reporting requirements that are being eliminated, resulting in a $44 million a year burden reduction. Factoring in the $12 million a year increase for new reporting requirements, this equates to a $32 million a year net burden reduction for those FSS vendors ($12 million−$44 million = −$32 million). However, non-FSS vendors are not subject to the CSP and PRC requirements and therefore are not receiving any burden reduction, but are seeing a $3 million a year reporting burden for the new requirements. As a result, the net burden reduction reduces to $29 million a year when accounting for all vendors subject to the rule ($12 million + $3 million−$44 million = −$29 million).
In all, the Transactional Data Reporting rule will result in an estimated burden reduction of $29 million a year, which consists of a projected $15 million a year compliance burden
Equally important, GSA's experience using horizontal pricing techniques, where it compares a vendor's offered price to those offered by other vendors, has proved to be a more effective model. This includes a growing body of experience with transactional data that points to improved acquisition outcomes, from smarter demand management, to better pricing and reduced price variation, and opportunities to develop more effective buying strategies. Section II.B of this document provides several examples of how the Government has successfully employed transactional data-fueled horizontal pricing techniques.
To ensure a measured and manageable transition to use of transactional data in lieu of the CSP and PRC, the final rule will be implemented through a multi-layered phase-in process built around the pilot as follows:
• First, the pilot will be evaluated against a series of metrics that will include, but not be limited to, changes in price, sales volume, and small business participation, as well as macro use of transactional data by category managers and teams to create smarter buying strategies such as consumption policies. GSA's Senior Procurement Executive will regularly evaluate progress against these metrics in consultation with the Administrator for Federal Procurement Policy and other interested stakeholders to determine whether to expand, limit, or discontinue the program. No expansion of the pilot or action to make Transactional Data Reporting a permanent fixture on the Schedules will occur prior to the careful evaluation of at least one year of experience with the pilot.
• Second, Schedules will enter the pilot on a rolling basis. At least thirty days prior to applying the pilot to a Schedule or Special Item Number, vendors will be given notice on Interact, GSA's platform for exchanging information with Schedule vendors.
• Third, the new Transactional Data Reporting requirements will be mandatory only for new Schedule contracts awarded after the Schedule becomes subject to the pilot and at the time to extend the term of the Schedule contract. Initially, vendors holding existing contracts under pilot Schedules will be encouraged to enter via a bilateral contract modification so they can begin to take advantage of the
• Fourth, use of the transactional data will be introduced to federal buyers in stages, starting with category managers to provide them with insight into the assorted options available for satisfying common requirements and support smarter buying strategies, such as demand management, that promote the most efficient methods for meeting the Government's needs. The data will then be shared with FSS contracting officers, followed by agency ordering offices. Each of these buying groups will receive tailored training on the proper use of transactional data. In all cases, training will emphasize that prices paid information is just one information point that must be considered in conjunction with other factors such as total cost, quantity discounts, desired performance levels, unique terms and conditions or product attributes, delivery schedule, customer satisfaction, and other relevant information. Contracting officers will be encouraged to discuss with the offeror perceived variances between offered prices, transactional data, and existing contract-level prices, in order to evaluate whether other attributes (
Finally, GSA is amending its pricing instructions in the General Services Administration Acquisition Manual (GSAM) to place greater emphasis on price analysis when negotiating prices with Schedule vendors and, in particular, the need to specifically consider (i) offered prices on FSS contracts or Governmentwide contracts for the same or similar items or services, (ii) prices paid, as it becomes available under this rule, and (iii) commercial data sources providing publicly available pricing information. The GSAM guidance will also reiterate that the contracting officer is responsible for ensuring pricing is fair and reasonable. Accordingly, if a contracting officer is unable to make this determination based on data available to them through GSA's tools or available commercial pricing information, they will retain the right, as the Federal Acquisition Regulation (FAR) has always provided, to request additional pricing information, such as data other than certified cost and pricing data.
A fuller discussion of these issues is presented in the following sections of this document, including GSA's analysis of alternatives, an overview of the rule's implementation, a discussion of public comments, and an examination of the reporting burden.
GSA's primary statutory authorities for the FSS program are 41 U.S.C. 152(3), Competitive Procedures, and 40 U.S.C. 501, Services for Executive Agencies. For GWACs, GSA is an executive agent designated by the Office of Management and Budget pursuant to 40 U.S.C. 11302(e). Furthermore, 40 U.S.C. 121(c) authorizes GSA to prescribe regulations for its other multi-agency contracts, including Governmentwide IDIQ contracts. Finally, this rule is included in GSA's report under Executive Order 13563, Improving Regulation and Regulatory Review, which directs each federal agency to consider “how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome.” GSA's retrospective plan and updates to the plan can be found at
Currently, the Federal Government acquires goods and services worth hundreds of billions in dollars through millions of individual transactions conducted by thousands of contracting units across hundreds of federal agencies and commissions. Most buying offices operate independently, conducting procurements without regard to the experiences of their counterparts. Functions such as industry outreach, market research, requirements development, negotiations, and contract award are repetitively performed, without coordination, across the acquisition landscape. Ongoing contract duplication leaves vendors navigating a diverse array of procedures and requirements, driving up administrative costs that ultimately manifest in higher prices.
In response, the Office of Federal Procurement Policy (OFPP) introduced a new vision for federal purchasing to fundamentally shift managing individual purchases and prices across thousands of procurement units to buying as one through category management.
1. Optimizing existing contract vehicles (including replacement or elimination of duplicate or underperforming contracts) and driving more optimal use of contract vehicles.
2. Improving data collection efforts and analysis to drive improvements in categories of spend to increase savings and reduce duplication.
3. Leveraging industry/commercial intelligence and key partner relationships.
4. Maximizing customer insights and relationships to bring more spend under management and improve offerings and value.
5. Growing and sharing expertise.
The CMLC has identified the following ten first-tier, or Level 1, categories that account for $270 billion, or approximately two-thirds, of total contract spending:
• Information Technology (IT).
• Professional Services.
• Security and Protection.
• Facilities & Construction.
• Industrial Products and Services.
• Office Management.
• Transportation and Logistics Services.
• Travel and Lodging.
• Human Capital.
• Medical.
To ensure Governmentwide harmonization, Level 1 categories will be led by a manager responsible for developing category-specific strategies. Within each Level 1 category are several Level 2 categories. For example, the Level 1 IT category includes Level 2 categories such as IT Software and IT Consulting. In concert with their respective category manager, Level 2 category teams will provide expert analysis, identify best-in-class sourcing solutions, and facilitate the dissemination of best practices, leading to smarter buying across the Government.
For example, OFPP issued
1. Standardize laptop and desktop configurations for common requirements. Through an extensive data analysis, the category team determined five standard configurations could satisfy 80 percent of the Government's laptop needs.
2. Reduce the number of contracts for laptops and desktops by consolidating purchasing and using a few number of high-performing—or best in class—contracts. With limited exceptions, all agencies are prohibited from issuing new solicitations for laptops and desktops, and civilian agencies must use NASA Solutions for Enterprise-Wide Procurement (SEWP), GSA Schedule 70, or National Institutes of Health (NIH) Chief Information Officer-Commodities and Solutions (CIO–CS).
3. Develop and modify demand management processes to optimize price and performance. Agencies are encouraged to adopt smarter buying strategies, such as adopting uniform refresh cycles and aggregating demand to support leveraged buying events.
In another example, the Professional Services category team within GSA consolidated its offerings in two areas, the Professional Services Schedule (PSS) and the One Acquisition Solution for Integrated Services (OASIS) vehicle. The PSS is the result of combining eight separate Schedules under one umbrella, and in the process eliminating more than 700 duplicative contracts. This promotes efficiency in a number of ways. GSA can now focus its resources on improving the user experience under its contracts. Vendors, especially small businesses, now need to manage fewer contracts to fully access the professional services market, lowering their administrative burden. Finally, customers can meet their mission needs through a less fragmented purchasing channel. Likewise, OASIS provides flexibility for federal buyers seeking to streamline their acquisition strategies by eliminating duplicative contracts. In Fiscal Year 2015, GSA supported the Army and Air Force in moving more than $350 million in combined contract sales under the OASIS vehicle. OASIS has also allowed the Air Force to forgo extending five of its IDIQ contracts and the Department of Homeland Security has chosen OASIS as the successor to its Technical, Acquisition, and Business Support Services (TABSS) IDIQ contract.
The reduction in duplicative and inefficient contracts also removes barriers to entry into the federal marketplace, especially for small businesses. The Government Accountability Office (GAO) reports the costs of being on multiple contract vehicles ranged from $10,000 to $1,000,000 due to increased bid and proposal, and administrative costs.
Nevertheless, as category management continues to permeate the acquisition landscape, a critical ingredient for its success must be obtained: Transactional data.
A critical component of category management, and smarter buying in general, is the availability of transactional data, which shows the details of purchases at the line-item level. It includes details such as descriptions, quantities, and prices paid for the items purchased. More than providing leverage for Government buyers to negotiate lower prices, transactional data underlies the business intelligence used to inform smarter buying strategies.
Transactional data provides the Government insight into its purchasing patterns, allowing it to identify the most efficient solutions, channels, and sources to meet mission critical needs. As previously noted, two key category management principles are optimizing existing contract vehicles and reducing contract duplication.
Category managers will also use transactional data to develop demand management strategies that offer more optimal solutions for satisfying common requirements. For example, GSA's Domestic Delivery Services 2 (DDS2) program illustrates how transactional data can provide valuable insight into purchasing patterns and offer opportunities to develop more effective procurement strategies. In Fiscal Year 2009, 90 percent of revenue through the Domestic Delivery Services contracts was for more expensive, express air shipments, with less costly ground shipments accounting for the remaining 10 percent. However, after analyzing the actual buying practices through transactional data, the Government was able to change its consumption behavior to spend less by foregoing unnecessary express air shipments. By Fiscal Year 2015, air shipments shrank to 60 percent of revenue and 46 percent of total shipments, while ground shipments grew to 40 percent of revenue and 54 percent of total shipments.
Transactional data can also be leveraged to reduce price variation and lower costs. As exhibited by the 300 percent laptop price variance, Government buyers often rely on asymmetric information, which results from one party possessing better information than the other. In response, GSA began pioneering transactional data reporting on several of its contract vehicles. Combined with sourcing strategies and enhanced competition, GSA successfully instituted dynamic pricing models, where prices are continually adjusted based on transactional data, resulting in less variation and lower prices. Examples of this success include:
• Office Supplies 2 (OS2) and Office Supplies 3(OS3), with direct savings increasing from 10 percent in Fiscal Year 2010 to nearly 30 percent by Fiscal Year 2015.
• Federal Strategic Sourcing Initiative (FSSI) Wireless: This contract delivered
• Commercial Satellite Communications (COMSATCOM): Customers save an average of 34 percent compared to GSA Schedule contract prices and better understand spend details. The availability of transactional data under COMSATCOM is already contributing to a reduction in duplicative contracts.
However, transactional data does not transform the federal acquisition system into a lowest-price procurement model. The Federal Acquisition Regulation (FAR) has a stated vision “to deliver on a timely basis the best value product or service to the customer, while maintaining the public's trust and fulfilling public policy objectives.”
In Fiscal Year 2015, Government agencies ordered nearly $40 billion in goods and services through GSA's Federal Supply Schedules, Governmentwide Acquisition Contracts (GWACs), and Governmentwide Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts. GSA's Federal Supply Schedule program, commonly known as GSA Schedules or Multiple Award Schedules (MAS), accounted for approximately $33 billion of those sales, making it the Government's most used commercial-item purchasing channel. Consistent with the broader effort to transform the federal marketplace, GSA is innovating its suite of Governmentwide contract vehicles.
While GSA has a number of policies in place to help its buyers and agency users to secure best value for the taxpayer, and other regulatory actions in process to improve the Schedules program, two limitations in current pricing practices make achievement of this goal unnecessarily challenging: (1) Insufficient attention to “horizontal pricingI”—the ability to compare one vendor's pricing to that of other vendors—and (2) lack of visibility into prices paid by other customers.
Until recently, when vendors first submitted an FSS offer, minimal consideration was given to the relative competitiveness of the vendor's prices to other vendors (
Pricing disclosures, such as the CSP and its predecessors, along with the PRC, have served as the bedrock of the Schedules program pricing approach for at least as far back as the 1980s. With limited other means of data collection available, they served as a way to ensure fair and reasonable pricing through the life of a contract with the goal of achieving most favored customer pricing. For many years, CSP disclosures and the PRC tracking customer feature were critical mechanisms for achieving advantageous pricing from original equipment manufacturers (OEMs) that held the vast majority of FSS contracts. However, these tools predate the Federal Acquisition Streamlining Act of 1994 (FASA)
Moreover, a number of factors have eroded the effectiveness of these tools over time, including: (i) The significant growth of contracts held by resellers with little or no commercial sales against which to negotiate most favored customer pricing; (ii) the prevalence of sales for commercial-off-the-shelf products or other commercial items for which the Government is not a market driver; and (iii) the fact that these practices tie pricing for reductions to sales of single items and play little role in blanket purchase agreements and other higher-volume leveraged buying by agencies to achieve greater savings and reduce administrative costs.
When it comes to contract administration, the Government, and other customers in the category to which the Government is most typically aligned under the PRC, tends to receive voluntary price reductions from the vendor as a result of general market forces. In other words, prices are reduced under the voluntary provisions of the PRC as a result of competitive market forces, not under the mandatory tracking customer provisions.
Vendors have also singled out these pricing tools as among the most complicated and burdensome requirements in federal contracting, including during a 2014 national online dialogue sponsored by the Chief Acquisition Officers Council to identify ways of improving how the Government does business with its contractors. A number of contractors contended that the one-size-fits all application of these tools to all Schedules runs counter to
GSA recognized the deficiencies of its vertical pricing model and has begun implementing horizontal pricing initiatives for its FSS contracts. For example, over the past year GSA has launched the Competitive Pricing Initiative (CPI) and the Contract Awarded Labor Category Tool (CALC):
• CPI aims to identify and address price variability across the Schedules program. The initiative is built around a Formatted Product Tool (FPT) that identifies pricing outside a range determined to be acceptable for identical items; vendors whose prices exceed the acceptable range are then notified of their comparative pricing. Currently, this initiative applies only to products, while services will be addressed at a later date. Moving forward, FSS contracting officers will utilize available horizontal pricing data from the FPT for certain categories of supplies when conducting price analysis, in addition to other price analysis techniques already employed in compliance with the FAR and GSAR. The FSS contracting officer's final determination will also take into account non-price elements, such as materially different terms, quantities, and market and economic factors. CPI will also allow FSS contracting officers to identify where a vendor's offered pricing is outside the range determined to be acceptable for identified products and services. After a vendor has been notified, they will be given the opportunity to use this market intelligence to make their offered pricing more competitive. Equally important, vendors will have the chance to advise if they have a unique value proposition, such as speedier deliveries, guarantees, or quantity that warrants a higher price.
• CALC is a market research tool that searches a database of awarded FSS contract prices for 48,000 labor categories from more than 5,000 FSS contracts under the Professional Services Schedule. Rather than sifting through contract files or searching GSA Advantage!® for comparable pricing, Government contracting professionals can now use CALC to return a multitude of comparable contract prices within a matter of seconds. Additionally, these search results can be filtered by relevant criteria such as years of experience and education level. Over time, greater enhancements are anticipated, such as adding geographic filters.
GSA has made tremendous progress on the horizontal price analysis front over the past year, but tools such as CPI and CALC only support segments of the FSS program and only analyze contract-level prices. Although GSA establishes fair and reasonable prices on its Governmentwide contracts, the program is designed with the intent of ordering activities negotiating further discounts at the time of the instant requirement. While in many respects this is a significant strength of the program, at times, the absence of good pricing information contributes to negative perceptions of the program, and as result, contract duplication. Consequently, transactional data is needed to perform a horizontal analysis of the actual prices paid for goods and services acquired through GSA contract vehicles.
Though the specifics vary, several of GSA's non-FSS contracts now require vendors to report transactional data, including Alliant, Alliant Small Business, Connections II, Custom SATCOM Solutions (CS2), Custom SATCOM Solutions—Small Business (CS2–SB), Office Supply Third Generation (OS3), and One Acquisition Solution for Integrated Services (OASIS). However, these requirements are applied through their respective solicitations without the benefit of a dedicated, standard GSAR clause, resulting in inconsistency.
Continuous innovation is imperative for the FSS program. In 2010, the Multiple Award Schedule (MAS) Blue Ribbon Advisory Panel, which included representatives from the Government's largest buying agencies—the Department of the Defense, Department of Homeland Security, Department of the Interior, Department of the Treasury, and Department of Education—and industry, recommended that “the GSA Administrator remove the Price Reduction Clause from the MAS program supply contracts for products in phases as the GSA Administrator implements recommendations for competition and price transparency at the Schedule contract level and the order level.” That same year, the Government Accountability Office (GAO) issued a report recommending GSA collect “prices paid” data on FSS orders and make this information available to FSS contract negotiators and customer agencies.
On March 4, 2015, GSA issued a proposed rule to require transactional data reporting on its FSS contracts and non-FSS contract vehicles—Governmentwide Acquisition Contracts (GWACs) and Governmentwide Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts. The rule proposed for non-FSS contracts would have been immediately implemented but rolled out on a pilot basis for the FSS program under select Schedules. For FSS contracts, the requirement would be paired with an alternate Price Reductions clause that did not include the tracking customer feature, although GSA would have had the right to request CSP disclosures at any time.
On April 17, 2015, a public meeting was held at GSA headquarters in Washington, DC, to discuss the proposed rule. Nearly 200 companies, organizations, Government agencies, and interest groups were represented. In general, industry representatives opposed the transactional data reporting requirement but supported the proposed PRC changes. Government procurement representatives supported the rule, while oversight entities expressed concern with the potential reporting burden and PRC changes.
Following an extension to the public comment period,
GSA is adopting new requirements for transactional data reporting on its FSS, GWAC, and Governmentwide IDIQ vehicles:
• For FSS contracts, a new transactional data reporting clause, GSAR Alternate I, 552.238–74 Industrial Funding Fee and Sales Reporting (Federal Supply Schedule), will be paired with changes to FSS pricing disclosure requirements. Specifically, FSS vendors subject to the Transactional Data Reporting rule will no longer provide CSP disclosures and will no longer be subject to the PRC tracking customer provision. These changes will be initially implemented for select Schedules and Special Item Numbers on a pilot basis.
• For GWACs and Governmentwide IDIQs, a new clause, GSAR 552.216–75 Transactional Data Reporting, will apply to all new GWACs and Governmentwide IDIQs and may be applied to any existing contracts in this class that do not contain other transactional data clauses.
The following is a summary of changes made in response to public comments regarding the proposed rule:
GSA has also concluded the horizontal pricing ability afforded by Transactional Data Reporting would not only exceed the PRC tracking customer provision benefits, it could also alleviate the need for CSP disclosures when combined with automated commercial data sources, new data analytic tools, and improved price analysis policy. For the Schedules pilot, pairing Transactional Data Reporting with a removal of CSP disclosures and the PRC tracking customer provision will result in an average annual burden reduction of approximately $32 million for participating FSS vendors.
GSA increased the monthly reporting window from 15 to 30 calendar days in response to comments stating the proposed 15-day window did not allow enough time to compile, analyze, and report transactional data. GSA opted to not require monthly IFF remittance because doing so would disproportionately harm small businesses, many of whom remit fees based on accrued billings before they actually receive payments from their Government customers. The non-FSS clause (552.216–75) does not specify CAF remittance frequency—those instructions will be provided within 60 days after award or inclusion of the clause in the contract—but ensures contractors have at least 30 days after the last day of the month to remit the CAF.
GSA determined it is necessary to obtain and analyze transactional data for purchases made through its contract vehicles in order to support the Government's category management vision and improve acquisition outcomes in general. However, following the April 17, 2015 public meeting and subsequent receipt of the public comments, GSA was compelled to further evaluate the spectrum of alternatives for Transactional Data Reporting, ranging from withdrawing the rule in favor of different approaches for obtaining the data to applying the new reporting clauses without corresponding changes to existing disclosure requirements. Ultimately, the decision to proceed hinged on considerations including, but not limited to, alternatives for collecting transactional data; the burden associated with reporting transactional data; opportunities to reduce burden through changes to existing disclosure requirements, and the associated
The Initial Regulatory Flexibility Analysis published with the proposed rule included an evaluation of alternatives for obtaining transactional data—internal applications; GSA ordering platforms such as eBuy and GSA Advantage!®; the SmartPay credit card purchase program; and upgrades to the Federal Procurement Data System. GSA previously concluded these options would not provide the breadth of data needed to support the Government's objectives or would be unable to do so in the foreseeable future. Since the publication of the proposed rule, GSA reevaluated those alternatives and reached similar conclusions. Additionally, the Government's electronic invoicing initiative
The most common concern, in terms of the number of respondents to the proposed rule, regarded the associated burden of reporting transactional data. In general, commenters felt the burden was underestimated and/or the requirement was too burdensome. To address the concerns with its Transactional Data Reporting burden estimates, GSA reevaluated its methodology and significantly increased its burden estimates.
A notable concern expressed by industry stakeholders was the retention, and potential increase, of CSP disclosures. GSA noted in the proposed rule it “. . . would maintain the right throughout the life of the FSS contract to ask a vendor for updates to the disclosures made on its commercial sales format (which is used to negotiate pricing on FSS vehicles) if and as necessary to ensure that prices remain fair and reasonable in light of changing market conditions.”
In the summer of 2015, GSA also began preparing its request to renew the PRC information collection, which is identified under OMB Control Number 3090–0235. The Paperwork Reduction Act requires federal agencies to seek public comment on proposed collections of information from the public and then submit an information collection request (ICR) to the OMB Office of Information and Regulatory Affairs (OIRA). After receiving clearance to proceed, federal agencies must seek public comment and OIRA approval for renewal of these information collections, typically every three years. Since the PRC information collection was last approved in 2012, GSA needed to begin preparing its request to renew the information collection shortly after publishing the Transactional Data Reporting proposed rule. While GSA would have proceeded with a renewal request regardless, the timing did allow for the consideration of the Transactional Data Reporting comments. In particular, GSA agreed with the general industry comment that burdens of the PRC and CSP are related and therefore decided to include CSP disclosure burden estimates with the PRC ICR. GSA also opted to change the name of Information Collection 3090–0235 from “Price Reductions Clause” to “Federal Supply Schedule Pricing Disclosures” to more accurately reflect the scope of the information collected.
Following two
Streamlining the existing pricing disclosure requirements is particularly beneficial for small businesses. The current CSP and PRC disclosure requirements are constant, meaning vendors, especially those with a higher number of FSS contract offerings, must bear the burden even if they have little to no sales through their FSS contracts. Thus, small businesses are disproportionately impacted because they account for the bulk of lower volume contracts. Moreover, small businesses, which generally have fewer resources to devote to contract management, will no longer be subjected to the complex CSP and PRC pricing disclosure requirements.
Unlike the existing CSP and PRC disclosure requirements, Transactional Data Reporting imposes a progressive burden—one that increases with a vendor's sales volume. Namely, monthly reporting time will increase with a vendor's applicable sales volume, as vendors with lower to no reportable sales will spend little time on monthly reporting, while those businesses with more reportable sales with will face a higher reporting burden. Likewise, setup costs will be a major driver of the new reporting burden, but vendors with little to no activity on their FSS contracts will likely forgo investments in new reporting systems because the reporting burden will not be significantly more than that of the current quarterly sales reporting requirements. Thus, tying the burden to sales volume is particularly beneficial for small businesses, as they hold 80 percent of the total contracts but account for only about 39 percent of the sales.
Finally, consideration was given to whether Transactional Data Reporting should be applied to all of GSA's Governmentwide contract vehicles. Most of GSA's non-FSS Governmentwide vehicles currently have transactional data reporting requirements that exceed those created through this rule, but the new applicable Transactional Data Reporting clause (GSAR clause 552.216–75) will provide a consistent reporting mechanism for future non-FSS vehicles, or for current vehicles that adopt the new clause. For FSS contracts, an analysis was conducted to determine whether Transactional Data Reporting should be considered for all FSS contracts, or only those that include products or services that would allow straightforward comparisons, such as commodities with standard part numbers. The second-most common comment area questioned the utility of collecting transactional data for Schedules where “apples-to-apples” comparisons cannot be made, such as contracts for professional services and complex solutions. While transactional data is most useful for price analysis when comparing like items, it does not mean the data is not useful when perfect comparisons cannot be made. Government buyers and FSS contracting officers will use the data for price analysis and market research, and category managers will use the data for consumption analysis to form demand management strategies, regardless of whether the data can be used for perfect comparisons. An example is the ability to compare labor rates across contract vehicles, which is beginning to bear fruit in the form of reduced contract duplication. Consequently, GSA decided not to limit the prescription of Transactional Data Reporting to certain Schedules or Special Item Numbers.
GSAR clause 552.216–75 Transactional Data Reporting is immediately available for GSA's GWACs and non-FSS Governmentwide IDIQ contracts. It will be applied to all new vehicles in this class—those vehicles with solicitations issued on or after the effective date of this rule—but the current contract vehicles with alternative transactional data provisions may opt to continue using existing reporting requirements. The clause requires contractors to report eleven standard data elements and includes a “fill-in” for additional data elements. However, GSA's Senior Procurement Executive must approve any data elements beyond the standard elements in order for them to be included with a tailored version of the clause. The determination regarding additional data elements will consider the benefits, alternatives, burden, and need for additional rulemaking.
The new FSS Transactional Data Reporting clause (GSAR clause 552.238–74, Alternate I), along with the corresponding changes to existing pricing disclosure requirements, will be introduced in phases, beginning with a pilot for select Schedules and Special Item Numbers (SINs). The clause requires vendors to report eleven standard data elements and includes a “fill-in” for additional data elements. However, GSA's Senior Procurement Executive must approve any data elements beyond the standard elements in order for them to be included with a tailored version of the clause. The determination regarding additional data elements will consider the benefits, alternatives, burden, and need for additional rulemaking.
The pilot will begin no sooner than July 1, 2016—details will be released at a later date—and will include the following Schedules and SINs:
• Schedule 03FAC, Facilities Maintenance and Management: All SINs.
• Schedule 51 V, Hardware Superstore: All SINs.
• Schedule 58 I, Professional Audio/Video, Telemetry/Tracking, Recording/Reproducing and Signal Data Solutions: All SINs.
• Schedule 72, Furnishing and Floor Coverings: All SINs.
• Schedule 73, Food Service, Hospitality, Cleaning Equipment and Supplies, Chemicals and Services: All SINs.
• Schedule 75, Office Products: All SINs.
• Schedule 00CORP, The Professional Services Schedule: Professional Engineering Services (PES) SINs.
• Schedule 70, General Purpose Information Technology Equipment, Software, and Services: SINs 132 8 (Purchase of New Equipment); 132 32, 132 33, and 132 34 (Software); and 132 54 and 132 55 (Commercial Satellite Communications (COMSATCOM)).
The new reporting clause and corresponding pricing disclosure changes will be applied to newly-awarded contracts for the applicable Schedules/SINs. Existing contracts for the pilot Schedules/SINs will adopt the new reporting clause and corresponding pricing disclosure changes after the execution of a bilateral modification between the vendor and Government.
For the two pilot Schedules that include only select SINs—The Professional Services Schedule and Schedule 70—contracts subject to the Transactional Data Reporting that include those SINs will report transactional data for all SINs under those contracts. For example, a vendor holding a Schedule 70 contract consisting of SINs 132 33 (Perpetual Software License), 132 34 (Maintenance of Software as a Service), and 132 51 (Information Technology Professional Services) will be subject to the Transactional Data Reporting pilot because of the inclusion of Software SINs 132 33 and 132 34. However, this vendor will report transactional data for all SINs—132 33, 132 34, and 132 51. Likewise, vendors holding Professional Services Schedule contracts that include a Professional Engineering Services SIN in conjunction with other SINs under that Schedule (
The initial pilot will reach approximately 30 percent of GSA's FSS contracts, including Schedules/SINs covering a wide array of goods and services that account for approximately 43 percent of the GSA Schedules sales volume. This scope will enable GSA to evaluate the effectiveness of Transactional Data Reporting before deciding whether to expand, limit, or discontinue the program. Evaluation
Vendors subject to the new Transactional Data Reporting clauses will be required to electronically report the data, as outlined in the applicable clauses, thirty (30) days after the end of the preceding month; reporting instructions will be posted on the Vendor Support Center Web site (
• A single sign-on for all contracts. The current system requires a different sign-on for each contract.
• Electronic Data Interchange (EDI) upload capability.
• A spreadsheet template that can be downloaded, filled, and uploaded in lieu of manual data entry.
• Vendors with $0 sales during a reporting period can now click a single field to complete the report, as opposed to the current 72A requirement of submitting $0 for each SIN.
The new FSS Transactional Data Reporting clause (552.238–74 Alternate I) requires monthly reporting but quarterly fee remittance, which will also be processed through the new portal. As sales are reported, the portal will calculate a running balance and remind users to submit payment within 30 days after the end of the quarters ending March 31, June 30, September 30, and December 31. However, vendors will have the option to pay-as-you-go, meaning they can voluntarily remit the fees as sales are reported, rather than doing so on a quarterly basis. Portal instructions and training will be posted to GSA's Vendor Support Center.
Transactional data collected through the portal will be accessible only by authorized users and protected in accordance with GSA's information technology security policies. Additionally, GSA intends to share transactional data to the maximum extent allowable to promote transparency and competition while respecting that some data could be exempt from disclosure. Accordingly, a public data extract, containing information that would otherwise be releasable under the Freedom of Information Act (FOIA), will be created for use by the general public;
GSA, like other agencies, will use transactional data to support its contracting officers in making smarter decisions when purchasing goods and services. However, GSA's FSS contracting officers will also take this data into consideration when awarding FSS contracts and evaluating requests to adjust pricing and add new items to current contracts. As a result, GSA is developing training for Government buyers and implementing new procedures for its FSS contracting officers. Training and guidance deployed in connection with this rule emphasizes the importance of considering the best overall value (not just unit price) for each procurement, taking into account desired terms and conditions, performance levels, past customer satisfaction, and other relevant information.
Additionally, FAS also has an internal training course aimed at GSA contracting officers awarding and administering FSS contracts—this course will be updated to educate contracting officers on how to conduct analysis on transactional data, as well as how to use these analyses to achieve better pricing on the contracts.
In addition to the regulatory changes made through this final rule, non-regulatory instructions for GSA category managers and FSS contracting officers are being incorporated into the GSAM. The category manager guidance will include instructions to use transactional data for category analysis, as well as approval requirements for adding data elements to the new Transactional Data Reporting clauses, including approvals by the head of contracting activity and GSA's Senior Procurement Executive and coordination with the applicable category manager. The FSS contracting officer guidance will give instructions for evaluating offers for FSS contracts when transactional data is available.
One of the objectives of the new FSS contracting officer guidance is to align
The new guidance will include an order of preference for information to be used when evaluating FSS offers and establishing negotiating objectives, including the following:
1. Using data that is readily available, in accordance with FAR 15.404–1(b)(2)(ii),
2. Performing market research to compare prices for the same or similar items in accordance with FAR 15.404–1(b)(2)(vi).
3. Requesting additional pricing information such as “data other than certified cost or pricing data” (as defined at FAR 2.101
Traditionally, GSAR section 538.270, Evaluation of multiple award schedule (MAS) offers, has instructed FSS contracting officers to require pricing information through the CSP format and seek the offeror's best price. As these instructions are included in the regulatory portion of the GSAM, this case includes new language for these instructions to specify their use only when the CSP format is included in the solicitation (
GSA received 26 comment letters in response to the proposed rule.
All comments filed were considered, many of which led to the changes described in Section III of this document.
Nineteen commenters provided comments related to the compliance burden.
The proposed rule contained burden estimates in accordance with the Paperwork Reduction Act, including a one-time average initial setup burden of 6 hours and an average monthly reporting burden of approximately .52 of an hour, or 31 minutes. The ongoing reporting burden for FSS vendors, following a first-year burden for implementation, was estimated to $7.6 million a year. However, the proposed rule coupled the new reporting requirement with the removal of the PRC tracking customer provision, which would have resulted in an estimated burden reduction of $51 million a year if applied to the entire GSA Schedules program.
Most of the commenters weighing in on the burden stated the estimates were significantly underestimated. For example, one association compared the proposed rule's burden estimates with the results of a survey it conducted among some of its members to assess the costs of implemented the requirements set forth in the proposed rule. It reported the following for setup time:
When asked about the estimated number of hours that their company would require for initial startup to comply with the proposed rule, small business respondents reported that it would take on average 232 hours. Large and medium size contractors estimated that it would take on average 1192 hours. In the context of an average work week, small businesses estimated that it would take nearly 6 weeks for initial setup, which would require limited resources to be diverted to this effort. Large and medium size businesses reported that it would take nearly 8 months on average to setup these systems. The proposed rule suggests that contractors should undertake this compliance burden at “no cost to the government.”
That association also reported much higher figures for its monthly reporting estimates:
In the survey contractors also report a significantly higher number of hours required to do the monthly transactional data reporting than estimated in the proposed rule. Respondents were asked in the survey to estimate the number of hours it would take their company to report the transactional data on a monthly basis. GSA estimated that it would only take 31 minutes per month. However, small businesses reported that it would take 38 hours per month on average. Large and medium size businesses estimated that it would take an average of 68 hours per month—nearly 2 weeks to conduct the reporting.
One commenter also questioned GSA's and ordering agencies' ability to use the data, and GSA's capability to enforce the reporting requirements.”
Finally, multiple commenters stated Government is shifting the burden of gathering transactional data onto vendors. Some commenters said this will force industry to charge higher prices to recoup their costs, while others argued vendors should be directly reimbursed for reporting costs.
The likelihood of a vendor adopting an automated system increases with their applicable sales volume. Vendors with little to no reportable data are unlikely to expend the effort needed to establish an automated reporting system since it will be relatively easy to identify and report a limited amount of data. In Fiscal Year 2015, 32 percent of FSS vendors reported $0 sales, while another 34 percent reported average sales between $1 and $20,000 per month. If the rule were applied to the entire Schedules program, approximately two-thirds, or nearly 11,000 vendors, would have a lower reporting burden. However, as a vendor's applicable average monthly sales increase, they will be increasingly likely to establish an automated system to reduce the monthly reporting burden. Consequently, vendors with higher reportable sales will likely bear a higher setup burden to create an automated system, or absorb a high monthly reporting burden if they choose to rely on manual reporting methods.
This renewed analysis led GSA to increase its burden estimates.
• The projected setup time for an automated system increased from an average of 6 hours
• The projected monthly reporting time range grew from 0.3 minutes–4 hours to 0.25 hours–48 hours.
However, GSA's estimates are still considerably lower than the estimates provided through the public comments,
• At least two-thirds of the potential Transactional Data Reporting participants will have a relatively lower burden (
• Vendors with higher reporting volume will face lower setup times with a higher monthly reporting burden, or higher setup times with a lower monthly reporting burden. In other words, vendors will not face a higher setup burden and a higher monthly reporting burden to comply with the rule.
This increase in the burden estimates reinforced the need to evaluate existing pricing disclosure requirements that could be rendered obsolete once transactional data is collected. After evaluating these comments and submitting the Federal Supply Schedule Pricing Disclosures information collection request (OMB control number 3090–0235),
Regarding the ability of GSA and ordering agencies to use the data, new systems are being deployed to leverage the information. Transactional data reported in accordance with the new clauses will be shared with authorized users to craft smarter buying strategies. GSA is also developing data visualization tools to make the data more user friendly. Within GSA, FAS has established a data analytics team that will assist in the establishment and ongoing analysis of contract-level prices. In terms of oversight, FAS will use many of the same resources it currently deploys to ensure compliance with the existing GSAR clause 552.238–74, Industrial Funding Fee and Sales Reporting.
GSA is pursuing this initiative because obtaining transactional data from its industry partners is the most feasible path the Government can take to implement smarter buying strategies and promote taxpayer value. GSA recognizes the burden that comes with this rule and will continually evaluate ways to minimize the data collection. However, this rule will not lead to higher costs and subsequently higher prices because the changes to the CSP and PRC requirements provide a net burden reduction. To the contrary,
Fifteen commenters provided comments related to whether transactional data is useful for making imperfect comparisons.
Commenters expressed concern that transactional data would eventually be collected and used for goods and services that do not lend themselves to perfect comparisons. Multiple commenters noted it will be difficult, and in some cases impossible, to make one-to-one comparisons for professional services and complex or customizable products, such as laptops. For example, one commenter noted complex service offerings are “priced according to very specific circumstances related to risk, security requirements, geographic area of performance, and the qualifications of the individuals performing the work.”
Multiple commenters stated concerns with how the Government will use prices paid data when conducting a horizontal price analysis. One commenter noted FAR section 15.404–1(b)(2)(ii) allows the “comparison of proposed prices to historical prices paid . . . for the same or similar items” but that paragraph (A) of this FAR section states:
The prior price must be a valid basis for comparison. If there has been a significant time lapse between the last acquisition and the present one, if the terms and conditions of the acquisition are significantly different, or if the reasonableness of the prior price is uncertain, then the prior price may not be a valid basis for comparison.
Other commenters gave examples of other factors that should be taken into account when making comparisons, such as differing quantities or terms and conditions. For example, one commenter was concerned the data would create a false expectation for the lowest reported prices, as deep discounts can be offered on a one-time based or in response to special promotions, ease of service, volume, or geographic location.
Transactional data will assist Government buyers and FSS contracting officers in using the price analysis techniques found in FAR section 15.404–1(b)(2)(ii), as transactional data is necessary to make a comparison of “proposed prices to historical prices paid . . . for the same or similar items.” Although paragraph (A) of FAR section FAR section 15.404–1(b)(2)(ii) notes the prior price is not a valid basis of comparison if “there has been a significant time lapse between the last acquisition and the present one, if the terms and conditions of the acquisition are significantly different, or if the reasonableness of the prior price is uncertain . . . ,” it does allow for some variance in factors when making comparisons. Furthermore, paragraph (B) of FAR section 15.404–1(b)(2)(ii) not only allows, but requires, a prior price to “be adjusted to account for materially differing terms and conditions, quantities and market and economic factors.” In other words, when there has been no significant time lapse, the terms and conditions of an acquisition are similar to previous purchases, and the reasonableness of the prior price is certain, transactional data is valid for comparisons of, if not identical, at least similar items and can be adjusted to account for materially different terms and conditions, quantities, and market and economic factors.
Transactional data will also be instrumental for informing buying decisions and crafting overarching demand management strategies, regardless of whether the data is too dissimilar for price comparisons. For instance, the availability of transactional data will provide buyers visibility into the variables that drive costs, which is key to defining requirements and developing accurate cost estimates. Likewise, category managers will gain insight into the assorted options available for satisfying common requirements, and then use the lessons learned to form demand management strategies that promote the most efficient methods for meeting the Government's needs.
Regarding the differences between the Schedules program and OS2, GSA agrees that the success of the Federal Strategic Sourcing Initiative (FSSI), which includes OS2, was an important factor in GSA's decision to pursue Transactional Data Reporting for the larger Schedules program. While GSA anticipates Transactional Data Reporting will be successful, it recognizes its assumptions should be tested, and therefore opted to begin with a pilot. GSA does not expect this pilot to replicate or exceed the discounts achieved through FSSI—often up to 30 percent lower than the comparable Schedule prices—partly because of the
In response to the suggestion that a professional services Schedule be included in the pilot before expanding the requirements across the program, GSA has decided to include the Professional Engineering Services SINs from the Professional Services Schedule in the pilot. The pilot will also now include software SINs under Schedule 70, in order to collect data for more complex solutions. The initial pilot will now reach approximately 30 percent of GSA's FSS contracts, including Schedules/SINs covering a wide array of goods and services that account for 43 percent of the Schedules sales volume. This scope will enable GSA to evaluate the effectiveness of Transactional Data Reporting before deciding whether to expand, limit, or discontinue the program.
Finally, GSA recognizes the complexities of employing horizontal price analysis, whether it is through Transactional Data Reporting or other initiatives. For example, the new CPI initiative is built around a tool that identifies contract-level pricing outside a range determined to be acceptable for identical items; vendors whose prices exceed the acceptable range are then notified of their comparative pricing. It is important to reiterate that a range is identified because GSA appreciates the varying circumstances that can contribute to price variation. For CPI, the FSS contracting officer's final determination will take into account non-price elements, such as materially different terms, quantities, and market and economic factors. The GSAM guidance for FSS contracts, which will be viewable on
Thirteen parties provided comments related to public disclosure of transactional data.
One commenter asked whether GSA will share the transactional data with vendors,
Transparency will support a dynamic marketplace by providing vendors with the business intelligence needed to identify customers, determine which products should be included on their contract pricelists, and ascertain whether their prices are competitive. This will be particularly beneficial for small businesses, which often do not have the resources to invest in dedicated business development staff or acquire business intelligence through third-parties.
However, GSA recognizes some information may be protected from public release, which led to the decision to create a public data extract, as opposed to allowing the public the same access as authorized users. The data extract will provide the public a filtered view of the data, including information that is releasable under FOIA, while protecting information that is not.
Finally, GSA is not including remedies in this rule for unauthorized disclosure of data. GSA is taking precautions to prevent unauthorized disclosures of data, but in the event of such an occurrence, GSA will address remedies at that time based on the specific circumstances and in accordance with applicable statutes and regulations.
Thirteen commenters stated the Government already possesses this data.
Transactional data is generated when a transaction is made between a buyer and seller. As such, the parties of the transaction will produce and possess this data. For federal contracting, these parties are the Government ordering agency and the vendor. On the Government side, this data is often found in contract writing systems and financial systems. However, these systems are not shared across agencies; in fact, many agencies use multiple versions of these systems. Moreover, systems that do provide transactional data tend to cover a narrow scope of federal spending. For instance, GSA possesses data for transactions
Several commenters objected to GSA requiring vendors to report data that originates from the Government. For example, one commenter stated the Government needs to make investments in automated systems that can provide the data without burdening vendors, and that this rule only delays those eventual investments.
Commenters also stated it will not be easier for vendors to provide the data. One commenter stated many vendors do not keep this type of data as a matter of practice, but for the vendors that do, their reporting systems may not be compatible with GSA's reporting site.
Finally, commenters suggested alternatives to vendor-provided transactional data. Two commenters stated GSA should obtain data from the Federal Procurement Data System (FPDS);
Additionally, the Government's electronic invoicing initiative
Lastly, GSA will consider changes, or even rescind Transactional Data Reporting, as new data systems come online that improve the Government's ability to aggregate and analyze its purchasing data. Also, GSA is exploring ways to synchronize its transactional data intake system with other applications that share common attributes in order to reduce the number of vendor-reported data elements.
Nine commenters stated GSA should rely on order-level competition to ensure the Government is receiving the best value.
The Government, and other customers in the category to which the government is most typically aligned under the price reductions clause, tend to receive voluntary price reductions from the vendor as a result of general market forces (
Six of those commenters expressed support for the proposed PRC changes in the context of the general statement that order-level competition is the most effective method for driving down prices.
Nine parties submitted comments related to the proposed rule's retention of CSP disclosures.
[V]endors would still be subject to the commercial sales disclosure requirements, including the requirement to disclose commercial sales practices when requesting a contract modification for additional items or additional Special Item Numbers. In addition, GSA would maintain the right throughout the life of the FSS contract to ask a vendor for updates to the disclosures made on its commercial sales format (which is used
Nine commenters stated removing the PRC tracking customer feature does not relieve vendors of the burden of tracking commercial pricing, which will still be necessary to provide CSP disclosures.
As noted in Section III of this document, GSA also began preparing its routine renewal request for the PRC information collection, identified under OMB Control Number 3090–0235, in the summer of 2015.
Following two
Transactional Data Reporting negates the need for CSP disclosures when used in conjunction with automated commercial data sources, new data analytic tools, and improved price analysis policy. As discussed in Section IV of this document,
1. Use data that is readily available, in accordance with FAR 15.404–1(b)(2)(ii),
2. Perform market research to compare prices for the same or similar items in accordance with FAR 15.404–1(b)(2)(vi).
3. Request additional pricing information such as “data other than certified cost or pricing data” (as defined at FAR 2.101
Multiple commenters addressed small businesses in other comments, but six commenters stated there are certain aspects of the rule are especially impactful on small business.
Three commenters noted that this rule will make it more difficult for small businesses to compete against other-than-small businesses in the federal marketplace,
GSA intends to share transactional data to the maximum extent allowable to promote transparency and competition while respecting that some data could be exempt from disclosure. The data will serve as valuable market intelligence for vendors to use for crafting more efficient, targeted business development strategies that incur lower administrative costs. This will be particularly beneficial for small businesses, which often do not have the resources to invest in dedicated business development staff or acquire business intelligence through third-parties.
Nevertheless, GSA will be mindful of Transactional Data Reporting's small business impacts. The initiative is being phased in on a pilot basis. GSA's Senior Procurement Executive will regularly evaluate progress against metrics, including small business participation, in consultation with the Administrator for Federal Procurement Policy and other interested stakeholders to determine whether to expand, limit, or discontinue the program. No expansion of the pilot or action to make Transactional Data Reporting a permanent fixture on the Schedules will occur prior to the careful evaluation of at least one year of experience with the pilot.
With respect to the burden analysis, GSA did not differentiate between small businesses and other-than-small businesses in its burden estimates because Transactional Data Reporting imposes a progressive burden—one that increases with a vendor's sales volume. Namely, monthly reporting time will increase with a vendor's applicable sales volume, as vendors with lower to no reportable sales will spend little time on monthly reporting, while those businesses with more reportable sales will face a higher reporting burden. Likewise, setup costs will be a major driver of the new reporting burden, but vendors with little to no activity on their FSS contracts will likely forgo investments in new reporting systems because the reporting burden will not be significantly more than that of the current quarterly sales reporting requirements.
Finally, in regards to the legal framework of the new system, GSA will be implementing the Transactional Data Reporting clauses through bilateral modifications on existing contracts, meaning vendors must agree to the changes before GSA can insert a new clause in a contract. New contracts awarded under the pilot Schedules/SINs or future Governmentwide IDIQ vehicles will include the new Transactional Data Reporting clauses, but vendors will have an opportunity to view the requirements before agreeing to a contract. For the Schedules, GSA is instituting this program to meet its obligations under 41 U.S.C. 152(3)(b), which states that orders and contracts awarded under the FSS program must result in “the lowest overall cost alternative to meet the needs of the Federal Government.”
Six commenters stated Transactional Data Reporting will lead to a counterproductive fixation on lower prices.
FSS contracting officers will be instructed to evaluate the data in the context of each offer, taking into account not only cost and quantity discounts, but desired terms and conditions, unique attributes, socio-economic considerations, and other relevant information. Contracting officers will further be encouraged to discuss with the offeror perceived variances between offered prices, transactional data, and existing contract-level prices, in order to evaluate whether other attributes (
More importantly, transactional data provides benefits beyond better pricing. For instance, it supports the key category management principles of optimizing existing contract vehicles and reducing contract duplication.
Lastly, GSA recognizes the costs for compliance with the Transactional Data Reporting requirements make it necessary to alleviate the burden of other compliance requirements. Therefore, this rule removes CSP disclosures and the PRC tracking customer provision for FSS vendors subject to the new Transactional Data Reporting clause, resulting in an average annual burden reduction of approximately $32 million for FSS pilot vendors.
Four parties submitted comments relating to increased business liability risks.
Transactional Data Reporting will also provide greater ease of compliance with the removal of CSP disclosures and the PRC tracking customer provision. Reporting transactional data is based upon data used to generate a standard invoice. On the other hand, navigating the PRC and CSP requirements is complex because they require industry partners to track their GSA pricing relative to all of their commercial customers, and monitor and control all of their commercial sale transactions.
Four parties submitted comments related to the Government's procedures for using transactional data.
GSA will offer training and guidance for category managers and contracting officers. The Category Management Leadership Council has released a guidance document for category managers. The document provides “guidance for the governance, management and operations of category management, taking into consideration the inherent complexities of a Federal-wide initiative.”
To address erroneous data, the new Transactional Data Reporting site will allow vendors more leeway to correct mistakes than the current 72A Reporting System. While sales adjustments submitted through the 72A system must be approved by the assigned IOA, vendors will be able to submit data corrections through the new site on their own, although IOAs will be notified of corrections over a certain dollar threshold.
As for evaluating rapidly changing data, GSA opted to require monthly, rather than quarterly, data reporting to improve the recency of the data. However, GSA acknowledges prices may fluctuate for reasons including, but not limited to, changing and cyclical demand. This is why, among other reasons such as varying attributes, that GSA does not have an expectation to always receive the lowest reported price.
Finally, GSA does not intend to continually renegotiate all prices based on transactional data; doing so would be an administrative burden for all parties involved. However, GSA is beginning to employ automated analysis techniques for its contract-level prices to reduce variability. For example, the new Formatted Product Tool (FPT) identifies pricing outside a range determined to be acceptable for identical items; vendors whose prices exceed the acceptable range are then notified of their comparative pricing. Currently, this initiative applies only to products, while services will be addressed at a later date. However, whether it be the FPT or other tools, it is important to note GSA intends to view pricing in a range, so renegotiations will not be triggered merely because a vendor does not meet the lowest-reported price.
Two commenters stated GSA should not pair Transactional Data Reporting with the removal of the PRC tracking customer provision. The first commenter stated prices paid by the Government do not necessarily equate to the best price,
GSA currently establishes price reasonableness on its FSS contracts by comparing a contractor's prices and price-related terms and conditions with those offered to their other customers. Through analysis and negotiations, GSA establishes a favorable pricing relationship in comparison to one of the contractor's customers or category of customers. Contractors are then required, under the PRC, to monitor their pricing over the life of the contract and provide the Government with the same price reductions they give to the class of commercial customers upon which the original contract award was predicated.
In the proposed rule, GSA moved to couple the FSS Transactional Data Reporting clause with a new alternate version of the PRC that did not include the tracking customer provision. This new alternate PRC would only retain the Government's right to request price reductions and the contractor's right to offer them. The rationale for this idea was explained in the proposed rule
GSA believes the collection and use of transactional data may be a more efficient and effective way for driving price reductions on FSS buys than through use of the tracking customer mechanism. In addition to avoiding the challenges associated with the tracking customer mechanism described above, the transactional data reporting clause would allow for greater reliance on horizontal pricing in the FSS program so that GSA and its customers can easily evaluate the relative competitiveness of prices between FSS vendors. Moreover, the transactional data reporting clause, if used as an alternative to tracking customer mechanism, could significantly reduce contractor burden. The Chief Acquisition Officers Council recently conducted an Open Dialogue through an online platform on improving how to do business with the Federal Government. Contractors pointed to the price reductions clause as one of the most complicated and burdensome requirements in Federal contracting, and GSA's own estimates suggest FSS contractors spend over 860,000 hours a year (at a cost of approximately $58.5 million) on compliance with this clause.
One commenter acknowledged the benefits of transactional data to impact pricing but stated the new Transactional Data Reporting clause will not require vendors to offer price reductions based upon transactional data, in contrast to the PRC, which has protections to require FSS vendors to offer price reductions following a triggering event. In the proposed rule, GSA also stated it found only 3 percent of price reduction modifications were tied to the tracking customer feature, while approximately 78 percent of those modifications were voluntary, resulting from commercial pricelist adjustments and market rate changes.
Using transactional data will be a more efficient and effective way for driving price reductions. In addition to avoiding the challenges associated with the tracking customer mechanism described above, the transactional data reporting clause would allow for greater reliance on horizontal pricing in the FSS program so that GSA and its customers can easily evaluate the relative competitiveness of prices between FSS vendors. Although this rule removes the PRC's price protection provision, order-level competition and transparency will proactively achieve the same objective without relying on retroactive enforcement. Companies seeking to win Schedules business will offer discounts or better value than their
However, initiating Transactional Data Reporting in conjunction with the existing PRC and CSP disclosure requirements would be unduly burdensome and likely counterproductive. For example, performance under the Office Supplies 3 (OS3) vehicle began in Fiscal Year 2015. Like its predecessor, OS2, OS3 relies on transactional data and horizontal pricing techniques to drive savings. But unlike the Schedules-based OS2, OS3 is a standalone IDIQ that does not include the traditional FSS CSP and PRC requirements. As such, OS3's pricing is 17 percent lower than its predecessor's prices.
To preserve its link to the commercial marketplace, GSA is posting new GSAM guidance for FSS contracting officers to use when relying on transactional data in lieu of CSP disclosures and the basis of award enforced by the PRC. The new guidance will include an order of preference for that includes prices paid information on contracts for the same or similar items; contract-level prices on other FSS contracts or Government-wide contracts for the same or similar items; and commercial data sources providing publicly available pricing information. FSS contracting officers will also still have the ability to request additional pricing information such as “data other than certified cost or pricing data” (as defined at FAR 2.101
With respect to the 2012 survey sample size, GSA acknowledges this concern but did not base its projections solely on the survey. The PRC projections were recently reevaluated for the renewal of the related information collection request and increased from $59 million
Two parties submitted comments related to the proposed reporting frequency. GSA proposed for non-FSS vendors subject to the rule to report sales monthly within 15 calendar days after the end of the calendar month and to remit any Contract Access Fee (CAF) due within 15 calendar days after the end of the calendar month. For FSS vendors, GSA proposed that they report sales monthly within 15 calendar days after the end of the calendar month and to remit any Industrial Funding Fee (IFF) due within 30 calendar days after the end of each quarter.
The first commenter stated the proposed 15-day reporting window did not provide vendors enough time to prepare and review the data to be reported. This commenter also stated the inconsistency between monthly reporting and quarterly payments may be unnecessarily confusing for vendors.
With respect to monthly reporting versus quarterly payment, GSA opted to not require monthly payment for the FSS clause (GSAR 552.238–74 Alternate I) because doing so would be disproportionately harmful for small businesses, many of whom remit fees based on accrued billings before they actually receive payments from their Government customers. Payment frequency is not addressed in the non-FSS clause (GSAR 552.216–75) but vendors will have at least 30 days after the last day of the month to remit fees, as applicable.
Finally, GSA chose not to require less frequent reporting because doing so would lessen the impact of transactional data, which becomes less actionable as time passes.
Two commenters provided suggested changes to GSA's regulatory text. The first commenter stated GSA must update GSAR Figure 515.4–2
The second commenter suggested two changes to the regulatory text. The first change would replace “Offerors must include the CAF in their prices” with “The CAF will be charged as a separate and distinct line item on every order”
As for the suggested updates to GSAR clause 552.216–75, GSA no longer instructs offerors to include the CAF in their prices because many non-FSS programs include the CAF as a separate line item. However, GSA wants its non-FSS contract programs to have the flexibility to structure the CAF to meet their business needs, so it is instead choosing to provide the contractor with relevant instructions within 60 days of award or inclusion of this clause in the contract.
With respect to the suggestions to paragraph (a)(1) for GSAR clause 552.238–74 Alternate I, GSA has removed the definition for “contract sale” and instead included similar language in paragraph (c)(3).
“Contract sale” was removed from the definitions because this clause requires contractors to report transactional data, not “contract sales” as required by the basic version of GSAR clause 552.238–74.
The following are comments submitted by a single party and GSA's corresponding responses.
Finally, GSA recognizes fixed price data will have limited value compared to data reported for other contract types, but there are still numerous benefits. The Government can use fixed price data to analyze its consumption patterns, evaluate and compare purchasing channels, and identify best-in-class solutions. Thereafter, the Government can leverage its buying power and demand management strategies to achieve taxpayer savings as it concentrates its purchases through fewer channels, while vendors realize lower administrative costs. Fixed price data will also be useful for market research; for example, the data will be especially useful when combined with information from the eBuy statement of work (SOW) library.
(1) GSA concurs. It is pursuing this objective with its Formatted Product Tool (FPT), which identifies pricing outside a range determined to be acceptable for identical items; vendors whose prices exceed the acceptable range are then notified of their comparative pricing.
(2) As noted by the commenter in their full comment, GSA requires offerors to submit letters of supply/commitment. GSA works to remedy situations when it is notified that a vendor is not an authorized reseller.
(3) GSA currently encourages vendors to maintain accurate GSA Advantage!® catalogs. GSA is also working on implementing updates to GSA Advantage!® that will make it easier for vendors to maintain current catalogs.
(4) GSA is updating relevant courseware on the Federal Acquisition Institute (FAI) and Defense Acquisition University (DAU) portals to educate both customers and GSA contracting officers on how to use the data. Similarly, the courseware on how to use the FSS program and other non-FSS GWACs and multi-agency IDIQs will be updated to educate customers on the new requirements and how they can use the data collected to buy smarter. The external courseware will also highlight the additional value transactional data offers to GSA's FSS and non-FSS contracting programs and emphasize it must be viewed in the context of each procurement, taking into account desired terms and conditions, performance levels, past customer satisfaction, and other relevant information.
(5) GSA considered relying on data from transactions completed through GSA Advantage!®, but it only accounts for about 1 percent of Schedule sales. Thus, the breadth of data is not adequate to meet the Government's objectives.
(6) As noted previously, GSA is removing the PRC tracking customer provision and CSP disclosures for vendors subject to the Transactional Data Reporting requirements, in part to reduce costs and simplify procedures for industry partners.
GSA has the authority to issue regulations relating to its contracting programs. GSA's primary statutory authorities for the FSS program are 41 U.S.C. 152(3), Competitive Procedures, and 40 U.S.C. 501, Services for Executive Agencies. For GWACs, GSA is an executive agent designated by the Office of Management and Budget pursuant to 40 U.S.C. 11302(e). Furthermore, 40 U.S.C. 121(c) authorizes GSA to prescribe regulations for its other multi-agency contracts, including Governmentwide IDIQ contracts. This rule is not an unwarranted expansion of the former alternation of rates doctrine and is not a violation of antitrust principles.
Lastly, the rule is not creating a new Contract Access Fee (CAF). Currently, GSA charges ordering activities a CAF on many of its Governmentwide Acquisition Contracts (GWACs) and Governmentwide Indefinite-Delivery, Indefinite-Quantity (IDIQ) contracts, such as Alliant and OASIS. The CAF serves a similar purpose for those contracts as the Industrial Funding Fee (IFF) does for the FSS program. These fees are generally remitted by vendors on behalf of the ordering activity but are not actually paid by the vendor. Future contracts including GSAR clause 552.216–75 may apply a CAF, but the CAF will not be applied primarily because of the clause's inclusion.
Executive Order (E.O.) 12866 of September 30, 1993, Regulatory
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.”
E.O. 13563 of January 18, 2011, Improving Regulation and Regulatory Review, supplements and reaffirms the principles of E.O. 12866 of September 30, 1993. Section 1(c) of E.O. 13563 directs agencies to “use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” Accordingly, GSA offers the following summary of the costs and benefits associated with this final rule.
The total costs associated with this rule are $15 million per year for participating vendors and $2 million per year for the Federal Government.
• For FSS contracts, the new reporting requirements will be initially implemented for select Schedules and Special Item Numbers on a pilot basis. GSA estimates the costs associated with these requirements to be $12 million per year for vendors participating in the FSS pilot.
• Non-FSS Governmentwide IDIQs, including GWACs, will be subject to GSAR clause 552.216–75 Transactional Data Reporting. GSA estimates the costs for vendors holding these contracts to be up to almost $3 million per year.
The estimated costs for vendors affected by this rule are limited to the time needed to implement reporting procedures and fulfill monthly reporting obligations. Implementation costs include the time to configure systems, train personnel, and institute procedures. Monthly reporting costs include the time needed for identifying reportable data, performing quality assurance checks, and transmitting the data. GSA's burden estimates account for vendors that may want to hire personnel and update information technology systems to meet the reporting requirements. Existing FSS vendors participating in the Transactional Data Reporting pilot will initially be the only ones that will absorb new reporting burdens in the course of their current contract performance. However, these vendors will not necessarily need to hire additional personnel because the rule provides a net burden reduction with the removal of the CSP and PRC disclosure requirements. Likewise, the rule does not require vendors to acquire information technology tools, although some vendors, particularly those with higher sales volume, may choose to adopt automated systems to meet the reporting requirement. Nevertheless, the new FSS reporting clause will be incorporated into existing contracts through bilateral modifications, so vendors may choose not to participate. Otherwise, the new Transactional Data Reporting clauses will apply to new contracts awarded under the pilot Schedules and Special Item Numbers and new contracts awarded under non-FSS Governmentwide IDIQ programs. As such, these new vendors will have an opportunity to evaluate the costs associated with meeting these reporting requirements prior to entering into the contract.
This rule will save taxpayer dollars because it supports smarter buying practices and will improve pricing. Transactional Data Reporting supports the Government's shift towards category management and provides vendors with a more open marketplace.
GSA has found transactional data to be instrumental for improving competition, lowering pricing, and increasing transparency through its Federal Strategic Sourcing Initiative (FSSI) contracts. GSA does not expect this pilot to replicate or exceed the discounts achieved through FSSI—often up to 30 percent lower than the comparable Schedule prices—mostly because of the diversity of offerings in the greater Schedules program. Yet, GSA does anticipate lower prices in addition to other key benefits. For instance, it supports the category management principles of optimizing existing contract vehicles and reducing contract duplication. The Government can use transactional data to analyze its consumption patterns, evaluate and compare purchasing channels, and identify best-in-class solutions. Thereafter, the Government can leverage its buying power and demand management strategies to achieve taxpayer savings as it concentrates its purchases through fewer channels, which will in turn provide lower administrative costs for vendors.
Today, vendors incur heavy upfront costs when submitting an offer for an FSS contract, which is frequently the
Lastly, the transactional data released to the public will provide valuable market intelligence that can be used by vendors for crafting more efficient, targeted business development strategies that incur lower administrative costs. This will be particularly beneficial for small businesses, which often do not have the resources to invest in dedicated business development staff or acquire business intelligence through third-parties.
GSA expects this final 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,
Following receipt of the public comments in response to the proposed rule, GSA concluded the horizontal pricing ability afforded by Transactional Data Reporting would not only exceed the PRC tracking customer provision benefits, it could also alleviate the need for CSP disclosures when combined with automated commercial data sources, new data analytic tools, and improved price analysis policy. For the Schedules pilot, pairing Transactional Data Reporting with a removal of CSP disclosures and the PRC tracking customer provision will result in an average annual burden reduction of approximately $32 million for participating FSS vendors.
Providing the required transactional data will impose significant economic impact on all vendors, both small and other than small, doing business on GSA-managed contracts. Therefore, Final Regulatory Flexibility Analysis (FRFA) has been prepared consistent with 5 U.S.C. 603, and is summarized as follows:
The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to require vendors to report transactional data generated from orders placed against certain contracts. The primary changes are the creation of three clauses: 552.216–75 Sales Reporting and Fee Remittance; 552.238–74 Industrial Funding Fee (IFF) and Sales Reporting, Alternate I; and 552.238–75 Price Reductions, Alternate II.
Clauses 552.238–74, Alternate I and 552.216–75 will require vendors to provide transactional data from orders placed against GSA's Governmentwide contracts. Clause 552.238–74, Alternate I applies to orders placed against Federal Supply Schedule (FSS) contract vehicles. FSS vendors that agree to the new transactional data reporting requirement will have their contracts modified to include clause 552.238–75 Price Reductions, Alternate II, which removes the basis of award tracking requirement found in the basic Price Reductions clause (PRC). These vendors will also no longer be required to provide Commercial Sales Practices (CSP) disclosures, as required by GSAR section 515.408. Removing these two disclosure requirements in favor of a new transactional data reporting clause will provide a net burden reduction for FSS vendors.
The other transactional data reporting clause, 552.216–75, applies to GSA's non-FSS contract vehicles—Governmentwide Acquisition Contracts (GWACs) and Multi-Agency Contracts (MACs). Most of these contracts already contain transactional data reporting requirements and are not subject to the FSS PRC and CSP disclosure requirements. Once implemented, the new GSAR reporting clauses will further the objective of using actual transactional data in order to negotiate better pricing for GSA's Governmentwide contracting programs and enable GSA to provide federal agencies with market intelligence and expert guidance in procuring goods and services from GSA acquisition vehicles. Additionally, collecting transactional data will allow customers to analyze spending patterns and develop new acquisition strategies to fully leverage the Government's spend. Finally, reducing FSS pricing disclosure requirements will provide vendors a net burden reduction, make FSS contracts easier to administer, and improve accessibility for new vendors.
GSA received 26 comment letters on the proposed rule, including comments from industry associations, vendors, individuals, Government stakeholders, and other interested groups. Commenters representing industry interests cited the high reporting burden imposed by the rule, while stating GSA was underestimating the potential burden. However, these commenters supported the removal of the PRC basis of award tracking customer requirement.
Other areas with significant industry concern included:
• The retention, and potential increase, of CSP disclosures.
• Releasability of the transactional data to the public.
• Using transactional data for other than one-to-one comparisons.
To address concerns with its Transactional Data Reporting burden estimates, GSA reevaluated its Paperwork Reduction Act burden estimation methodology and substantially increased its burden estimates. These higher burden projections were a significant concern and they reinforced the need to couple Transactional Data Reporting with other significant forms of burden reductions.
However, Transactional Data Reporting could negate that disclosure burden because not only does it exceed the PRC tracking customer provision benefits, it could also alleviate the need for CSP disclosures when combined with automated commercial data sources, new data analytic tools, and
GSA intends to share transactional data to the maximum extent allowable to promote transparency and competition while respecting that some data could be exempt from disclosure. Accordingly, a data extract will be created for use by the general public, containing information otherwise releasable under the Freedom of Information Act; details about the public data extract will be released through a forthcoming notice in the
Finally, GSA gave consideration as to whether Transactional Data Reporting should be considered for all FSS contracts or only those that include products or services that would allow straightforward comparisons, such as commodities with standard part numbers. GSA agrees transactional data is most useful for price analysis when comparing like items, but that does not mean the data is not useful when perfect comparisons cannot be made. Government buyers and FSS contracting officers will use the data for price analysis and market research, and category managers will use the data for consumption analysis to form demand management strategies, regardless of whether the data can be used for perfect comparisons.
The Chief Counsel for Advocacy of the Small Business Administration provided comments in response to the proposed rule; the following is a summary of those comments and GSA's responses:
However, GSA was especially mindful of small business concerns when forming this rule. For instance, tying the reporting burden to sales volume is particularly beneficial for small businesses, as they hold 80 percent of the total contracts but only account for approximately 39 percent of the sales.
The public data extract will also benefit small businesses. GSA intends to share transactional data to the maximum extent allowable to promote transparency and competition while respecting that some data could be exempt from disclosure. The data will serve as valuable market intelligence for vendors to use for crafting more efficient, targeted business development strategies that incur lower administrative costs. This will be particularly beneficial for small businesses, which often do not have the resources to invest in dedicated business development staff or acquire business intelligence through third-parties. Details about the public data extract will be released in a forthcoming
The likelihood of a vendor adopting an automated system increases with their applicable sales volume. Vendors with little to no reportable data are unlikely to expend the effort needed to establish an automated reporting system since it will be relatively easy to identify and report a limited amount of data. In fiscal year 2015, 32 percent of FSS vendors reported $0 sales, while another 34 percent reported average sales between $1 and $20,000 per month. If the rule were applied to the entire Schedules program, approximately two-thirds, or nearly 11,000 vendors, would have a lower reporting burden. However, as a vendor's applicable average monthly sales increase, they will be increasingly likely to establish an automated system to reduce the monthly reporting burden. Consequently, vendors with higher reportable sales will likely bear a higher setup burden to create an automated system, or absorb a high monthly reporting burden if
This renewed analysis led GSA to increase its burden estimates. For FSS contracts in particular—
• The projected setup time for an automated system increased from an average of 6 hours
• The projected monthly reporting time range grew from 0.3 minutes–4 hours to 0.25 hours–48 hours.
However, GSA's estimates are still considerably lower than the estimates provided through the public comments,
• At least two-thirds of the potential Transactional Data Reporting participants will have a relatively lower burden (
• Vendors with higher reporting volume will face lower setup times with a higher monthly reporting burden, or higher setup times with a lower monthly reporting burden. In other words, vendors will not face a higher setup burden and a higher monthly reporting burden to comply with the rule.
Transparency will support a dynamic marketplace by providing contractors with the business intelligence needed to identify customers, determine which products should be included on their contract pricelists, and ascertain whether their prices are competitive. This will be particularly beneficial for small businesses, which often do not have the resources to invest in dedicated business development staff or acquire business intelligence through third-parties.
However, GSA recognizes some information may be protected from public release, which led to the decision to create a public data extract, as opposed to allowing the public the same access as authorized users. The data extract will provide the public a filtered view of the data, including information that is releasable under FOIA while protecting information that is not.
The reporting clauses created by this rule will initially apply to a subset of the GSA's
This rule may eventually apply to all contractors who hold GSA Federal Supply Schedule contracts and other GSA Governmentwide contract vehicles. This population consists of 20,323 contracts, 16,308 (80 percent) of which are held by small businesses. The vast majority of these small businesses contracts (15,837) are under GSA's FSS program.
Vendors subject to the rule will be required to report transactional data and remit fees paid by ordering activities to GSA. The data reporting responsibilities are new for FSS vendors, but most of GSA's Governmentwide non-FSS contracts already contain transactional data reporting requirements.
The reporting aspect of the rule requires vendors to identify, compile, and report transactional data—historical information encompassing the products and services delivered during the performance of a task or delivery order placed against this contract. Furnishing electronic reports is an existing requirement for all affected vendors but FSS vendors will be required to furnish more detailed information than currently required under their FSS contracts. The clauses require vendors to report data once a month—within 30 days after the last day of the end of the month.
Vendors will be responsible for remitting applicable fees paid by ordering activities to GSA. FSS vendors must remit fees four times a year (30 days after the end of the last day of each quarter) and non-FSS vendors may have to remit fees up to, but no more than, once a month. These fee remittance requirements are generally the same as what is currently required under these contracts.
The reporting clauses created by this rule will initially apply to a subset of the GSA's Federal Supply Schedule program on a pilot basis and will be available for use for all of GSA's non-FSS Governmentwide IDIQ contracts; this population consists of 6,017 contracts, of which 4,852 (81 percent) are held by small business concerns. This rule may eventually apply to all contractors who hold GSA Federal Supply Schedule contracts and other GSA Governmentwide contract vehicles; this population consists of 20,323 contracts, 16,308 (80 percent) of which are held by small businesses. These small business contract holders include SBA certified 8(a) firms; SBA certified small disadvantaged businesses; HUBZone firms; service disabled veteran-owned small businesses; veteran-owned small businesses; economically disadvantaged women-owned small businesses; and women-owned small businesses.
The professional skills needed to comply with these requirements are generally the same as those needed to comply with existing FSS and non-FSS reporting requirements and invoicing functions. Generally, reporting personnel must have an understanding of the reporting system and the transactional data they are reporting.
•
•
GSA determined it is necessary to obtain and analyze transactional data for purchases made through its contract vehicles in order to support the Government's category management vision and improve acquisition outcomes in general. For the Schedules, GSA is instituting this program to meet its obligations under 41 U.S.C. 152(3)(b), which states that orders and contracts awarded under the FSS program must result in “the lowest overall cost alternative to meet the needs of the Federal Government.”
Following the April 17, 2015 public meeting and subsequent receipt of the public comments, GSA was compelled to further evaluate the spectrum of alternatives for Transactional Data Reporting, ranging from withdrawing the rule in favor of different approaches for obtaining the data to applying the new reporting clauses without corresponding changes to existing disclosure requirements. Ultimately, the decision to proceed hinged on considerations including, but not limited to, alternatives for collecting transactional data; the burden associated with reporting transactional data; opportunities to reduce burden through changes to existing disclosure requirements, and the associated impacts of those changes; effects on small businesses; and the benefits of collecting transactional data for non-standard products and services.
GSA's Initial Regulatory Flexibility Analysis included an evaluation of alternatives for obtaining transactional data—internal applications; GSA ordering platforms such as eBuy and GSA Advantage!®; the SmartPay credit card purchase program; and upgrades to the Federal Procurement Data System. GSA previously concluded these options would not provide the breadth of data needed to support the Government's objectives or would be unable to do so in the foreseeable future. Since the publication of the proposed rule, GSA reevaluated those alternatives and reached similar conclusions. Additionally, the Government's electronic invoicing initiative
The most common concern, in terms of the number of respondents, regarded the associated burden of reporting transactional data. In general, commenters felt the burden was underestimated and/or the requirement was too burdensome. To address the concerns with its Transactional Data Reporting burden estimates, GSA reevaluated its methodology and substantially increased its burden estimates. These higher burden projections were a significant concern and they reinforced the need to couple Transactional Data Reporting with other significant forms of burden reductions.
A notable concern expressed by industry stakeholders was the retention, and potential increase, of CSP disclosures. GSA noted in the proposed rule it “. . . would maintain the right throughout the life of the FSS contract to ask a vendor for updates to the disclosures made on its commercial sales format (which is used to negotiate pricing on FSS vehicles) if and as necessary to ensure that prices remain fair and reasonable in light of changing market conditions.”
In 2015, GSA also began preparing its request to renew the PRC information collection request (ICR) in accordance with the Paperwork Reduction Act of 1995.
Following two
Streamlining the existing pricing disclosure requirements is particularly beneficial for small businesses. The current CSP and PRC disclosure requirements are constant, meaning vendors, especially those with a higher number of FSS contract offerings, must bear the burden even if they have little to no sales through their FSS contracts. Thus, small businesses are disproportionately impacted because they account for the bulk of lower volume contracts. Moreover, small businesses, which generally have fewer resources to devote to contract management, will no longer be subjected to the complex CSP and PRC pricing disclosure requirements.
The Regulatory Secretariat has submitted a copy of the Final Regulatory Flexibility Analysis (FRFA) to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the FRFA may be obtained from the Regulatory Secretariat.
The Paperwork Reduction Act (44 U.S.C. Chapter 35) applies to this final rule because it contains information collection requirements. Accordingly, the Regulatory Secretariat submitted a request for approval of a new information collection requirement concerning this rule to the Office of Management and Budget under 44 U.S.C. 3501,
GSA has increased its burden estimates for the final rule. For the proposed rule, GSA chose to estimate the burden for the entire population of contracts that may ultimately be affected by this rule. However, as this rule will only initially apply to select Schedules and SINs under the FSS program on a pilot basis, GSA is now estimating the burden impact for vendors participating in the FSS pilot and those holding other GSA Governmentwide contracts that may include the Transactional Data Reporting clause (552.216–75). Although the burden estimates have increased, the final rule will still provide a net burden reduction based on the difference between the CSP and PRC disclosure requirements and the new reporting requirements (
The new reporting clauses require vendors to report transactional data elements such as item descriptions and prices paid to a GSA Web site. This data must be reported monthly within 30 calendar days after the of each calendar month, meaning vendors will furnish 12 reports over the course of a year for each contract containing one of these clauses.
The reporting clauses created by this rule will initially apply to a subset of the FSS program on a pilot basis and will be available for use for all of GSA's non-FSS Governmentwide IDIQ contracts. The pilot population may include up to 4,978 FSS vendors and 537 non-FSS vendors, for a total of 5,515 vendors. However, this number may be lower depending on the number of FSS vendors that accept the bilateral modification to include GSAR clause 552.238–74 Alternate I, or whether existing non-FSS Governmentwide contracting programs opt not to use GSAR clause 552.216–75.
GSA separated vendors into categories based on average monthly sales volume
• Category 1: No sales activity (average monthly sales of $0).
• Category 2: Average monthly sales between $0 and $20,000.
• Category 3: Average monthly sales between $20,000 and $200,000.
• Category 4: Average monthly sales between $200,000 and $1 million.
• Category 5: Average monthly sales over $1 million.
The distribution by sales category of vendors initially impacted by this rule (
The likelihood of a vendor adopting an automated system increases with their applicable sales volume. Vendors with little to no reportable data are unlikely to expend the effort needed to establish an automated reporting system since it will be relatively easy to identify and report a limited amount of data. In fiscal year 2015, 32 percent of FSS vendors reported $0 sales, while another 34 percent reported average sales between $1 and $20,000 per month. If the rule were applied to the entire Schedules program, approximately two-thirds, or nearly 11,000 vendors, would have a lower reporting burden. However, as a vendor's applicable average monthly sales increase, they will be increasingly likely to establish an automated system to reduce the monthly reporting burden. Consequently, vendors with higher reportable sales will likely bear a higher setup burden to create an automated system, or absorb a high monthly reporting burden if they choose to rely on manual reporting methods.
The following chart depicts the likelihood of the pilot population of vendors initially impacted by this rule adopting manual and automated reporting systems:
The following table shows GSA's projected monthly reporting times per sales category and system type:
The time and cost estimates for vendors initially impacted by the rule (
• FSS estimates are made on a 20-year contract life cycle because the maximum length of an FSS contract is 20 years. The estimates include a one-time setup burden for all 4,978 FSS pilot vendors in Year 1. For each year thereafter, the estimates include the one-time setup burden for new FSS vendors under the pilot Schedules and SINs
• Non-FSS estimates are made on a 10-year contract life cycle because the maximum length of a non-FSS contract is 10 years. The estimates include a one-time setup burden for all 537 non-FSS vendors in Year 1. For each year thereafter, the estimates only include the monthly reporting burden because contracts are typically not added to a non-FSS program following the initial awards. The total Year 1 hours and costs were added to the aggregate hours and costs from Years 2 through 10 to arrive at the total life cycle figures, and then those figures were divided by 10 to arrive at the average annual figures.
Based on this methodology, the average annual time burden for vendors initially complying with this rule is 205,900 hours:
The average annual cost burden for vendors initially complying with this rule is $15,208,326.84:
The Government also incurs costs through this rule when collecting data and performing quality assurance functions. Cost estimates use an hourly rate of $41.48, which is derived from a GS–12, Step 5 salary in the Washington, DC locality area.
•
•
•
Combining the costs for FSS contracts, non-FSS contracts, and information technology systems, the total annualized cost to the Government for the reporting clauses would be $3,881,670.77 if the rule were implemented across the FSS program.
Nineteen commenters provided comments related to the compliance burden.
The proposed rule contained burden estimates in accordance with the Paperwork Reduction Act, including a one-time average initial setup burden of 6 hours and an average monthly reporting burden of approximately .52 of an hour, or 31 minutes. The ongoing reporting burden for FSS vendors, following a first-year burden for implementation, was estimated to $7.6 million a year. However, the proposed rule coupled the new reporting requirements with the removal of the PRC tracking customer provision, which was projected to provide an estimated burden reduction of approximately $51 million a year if the rule were applied
Coincidentally, GSA began preparing its request to renew Information Collection 3090–0235 in the summer of 2015, as it was due to be renewed three years after its 2012 approval. While GSA would have proceeded with a renewal request regardless, the timing did allow for consideration of the Transactional Data Reporting comments. In particular, GSA agreed with the general industry comment that the burdens of the PRC and CSP are related, and GSA therefore decided to include CSP disclosure burden estimates in its information collection request. Following two
To address the concerns with the Transactional Data Reporting proposed rule burden estimates, GSA reevaluated its methodology and substantially increased its burden estimates. For the proposed rule, GSA's public burden estimates included an average initial setup time of 6 hours and average ongoing monthly reporting times ranging from 2 minutes to 4 hours, depending on a vendor's sales volume.
These higher burden projections, coupled with the increased Transactional Data Reporting burden estimates calculated in response to the public comments, were a significant concern and reinforced the need to pair Transactional Data Reporting with other significant forms of burden reductions. Consequently, the FSS Transactional Data Reporting clause (552.238–74 Alternate I) is now coupled with the removal of the CSP and PRC burdens shown in Information Collection 3090–0235, resulting in an overall annual public burden reduction of approximately $32 million for the initial implementation of the rule.
Requesters may obtain a copy of the supporting statement from the General Services Administration, Regulatory Secretariat Division (MVCB), ATTN: Ms. Flowers, 1800 F Street NW., 2nd Floor, Washington, DC 20407. Please cite OMB Control Number 3090–0306, Transactional Data Reporting, in all correspondence.
Government procurement.
For the reasons described in the preamble, GSA amends 48 CFR parts 501, 515, 516, 538, and 552 as follows:
40 U.S.C. 121(c).
40 U.S.C. 121(c).
The revisions read as follows:
(a) Use Alternate IV of the FAR provision at 52.215–20, Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data, for MAS solicitations to provide the format for submission of information other than cost or pricing data for MAS solicitations. To provide uniformity in requests under the MAS program, insert the following in paragraph (b) of the provision:
(2)
(b) When the contract contains the basic clause 552.238–74 Industrial Funding Fee and Sales Reporting, insert the following format for commercial sales practices in the exhibits or attachments section of the solicitation and resulting contract (see FAR 12.303).
(c) When the contract contains the basic clause 552.238–74 Industrial Funding Fee and Sales Reporting, include the instructions for completing the commercial sales practices format in Figure 515.4–2 in solicitations issued under the MAS program.
(d) When the contract contains the basic clause 552.238–74 Industrial Funding Fee and Sales Reporting, insert the clause at 552.215–72, Price Adjustment—Failure to Provide Accurate Information, in solicitations and contracts under the MAS program.
(e) Use Alternate IV of FAR 52.215–21, Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data—Modifications, to provide for submission of information other than cost or pricing data for MAS contracts. To provide for uniformity in requests under the MAS program, insert the following in paragraph (b) of the clause:
(1) Information required by the clause at 552.238–81, Modifications (Multiple Award Schedule).
40 U.S.C. 121(c).
(d) The Contracting Officer may insert clause 552.216–75 in solicitations and GSA-awarded IDIQ contracts, not including Federal Supply Schedule (FSS) contracts. This clause should be included in all GSA-awarded Governmentwide acquisition contracts and multi-agency contracts. See 538.273 for clauses applicable to FSS contracts.
40 U.S.C. 121(c).
(a)
(b) When offerors have commercial catalogs, negotiate concessions from established catalogs, including price and non-price terms and conditions.
(c) The Government will seek to obtain the offeror's best price (the best price given to the most favored customer). However, the Government recognizes that the terms and conditions of commercial sales vary and there may be legitimate reasons why the best price is not achieved.
(d) Establish negotiation objectives based on a review of relevant data and determine price reasonableness.
(e) When establishing negotiation objectives and determining price reasonableness, compare the terms and conditions of the MAS solicitation with the terms and conditions of agreements with the offeror's commercial customers. When determining the Government's price negotiation objectives, consider the following factors:
(1) Aggregate volume of anticipated purchases.
(2) The purchase of a minimum quantity or a pattern of historic purchases.
(3) Prices taking into consideration any combination of discounts and concessions offered to commercial customers.
(4) Length of the contract period.
(5) Warranties, training, and/or maintenance included in the purchase price or provided at additional cost to the product prices.
(6) Ordering and delivery practices.
(7) Any other relevant information, including differences between the MAS solicitation and commercial terms and conditions that may warrant differentials between the offer and the discounts offered to the most favored commercial customer(s). For example, an offeror may incur more expense selling to the Government than to the customer who receives the offeror's best price, or the customer (
(f) You may award a contract containing pricing which is less favorable than the best price the offeror extends to any commercial customer for similar purchases if you make a determination that both of the following conditions exist:
(1) The prices offered to the Government are fair and reasonable, even though comparable discounts were not negotiated.
(2) Award is otherwise in the best interest of the Government.
(g) State clearly in the award document the price/discount relationship between the Government and the identified commercial customer (or category of customers) upon which the award is based.
The revision reads as follows:
(a) MAS awards will be for commercial items as defined in FAR 2.101.
(a)
(b) The basic clause and Alternate I of 552.238–75, Price Reductions, requires the contractor to maintain during the contract period the negotiated price/discount relationship (and/or term and condition relationship) between the eligible ordering activities and the offeror's customer or category of customers on which the contract award was predicated (see 538.271(c)). If a change occurs in the contractor's commercial pricing or discount arrangement applicable to the identified commercial customer (or category of customers) that results in a less advantageous relationship between the eligible ordering activities and this customer or category of customers, the change constitutes a “price reduction.”
(c) Ensure that the contractor understands the requirements of section 552.238–75 and agrees to report all price reductions to the Contracting Officer as provided for in the clause.
(b)
(1)
(2)
(A) Federal Supply Schedule 70;
(B) The Consolidated Schedule containing information technology Special Item Numbers;
(C) Federal Supply Schedule 84; and
(D) Federal Supply Schedules for recovery purchasing (see 538.7102).
(ii) Use Alternate II for Federal Supply Schedules with Transactional Data Reporting requirements. This alternate clause is used when vendors agree to include clause 552.238–74 Alternate I in the contract.
(3)
(ii) Use Alternate II for Federal Supply Schedules with Transactional Data Reporting requirements. This alternate clause is used when vendors agree to include clause 552.238–74 Alternate I in the contract.
40 U.S.C. 121(c).
As prescribed in 516.506(d), insert the following provision:
(a)
(b)
(1) The Contractor must electronically report transactional data by utilizing the automated reporting system at an Internet Web site designated by the General Services Administration (GSA) or by uploading the data according to GSA instructions. GSA will post registration instructions and reporting procedures on the Vendor Support Center Web site,
(2) The Contractor must provide, at no additional cost to the Government, the following transactional data elements, as applicable:
(i) Contract or Blanket Purchase Agreement (BPA) Number.
(ii) Delivery/Task Order Number/Procurement Instrument Identifier (PIID).
(iii) Non Federal Entity.
(iv) Description of Deliverable.
(v) Manufacturer Name.
(vi) Manufacturer Part Number.
(vii) Unit Measure (each, hour, case, lot).
(viii) Quantity of Item Sold.
(ix) Universal Product Code.
(x) Price Paid per Unit.
(xi) Total Price.
Note to paragraph (b)(2): The Contracting Officer may add data elements to the standard elements listed in paragraph (b)(2) of this section with the approvals listed in GSAM 507.105(c)(3).
(3) The Contractor must report transactional data within 30 calendar days from the last calendar day of the month. If there was no contract activity during the month, the Contractor must submit a confirmation of no reportable transactional data within 30 calendar days of the last calendar day of the month.
(4) The Contractor must report the price paid per unit, total price, or any other data elements with an associated monetary value listed in (b)(2) of this section, in U.S. dollars.
(5) The Contractor must maintain a consistent accounting method of transactional data reporting, based on the Contractor's established commercial accounting practice.
(6)
(A) Issuance of an invoice; or
(B) Receipt of payment.
(ii) The Contractor must determine whether to report transactional data on the basis of invoices issued or payments received.
(7) The Contractor must continue to furnish reports, including confirmation of no transactional data, through physical completion of the last outstanding task or delivery order issued against the contract.
(8) Unless otherwise expressly stated by the ordering activity, orders that contain classified information or other information that would compromise national security are exempt from this reporting requirement.
(9) This clause does not exempt the Contractor from fulfilling existing reporting requirements contained elsewhere in the contract.
(10) GSA reserves the unilateral right to change reporting instructions following 60 calendar days' advance notification to the Contractor.
(c)
(2) Within 60 calendar days of award or inclusion of this clause in the contract, a GSA representative will provide the Contractor with specific written procedural instructions on remitting the CAF, including the deadline by which the Contractor must remit the CAF. The deadline specified in the written procedural instructions will be no less than 30 calendar days after the last calendar day of the month. GSA reserves the unilateral right to change remittance instructions following 60 calendar days' advance notification to the Contractor.
(3) The Contractor must remit the CAF to GSA in U.S. dollars.
(4) The Contractor's failure to remit the full amount of the CAF within the specified deadline constitutes a contract debt to the United States Government under the terms of FAR Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or offsetting payments and interest on the debt (see FAR clause 52.232–17, Interest). If the Contractor fails to submit the required sales reports, falsifies them, or fails to timely pay the CAF, these reasons constitute sufficient cause for the Government to terminate the contract for cause.
(a)
(b)
(1) The Contractor must electronically report transactional data by utilizing the automated reporting system at an Internet Web site designated by the General Services Administration (GSA) or by uploading the data according to GSA instructions. GSA will post registration instructions and reporting procedures on the Vendor Support Center Web site,
(2) The Contractor must provide, at no additional cost to the Government, the following transactional data elements, as applicable:
(i) Contract or Blanket Purchase Agreement (BPA) Number.
(ii) Delivery/Task Order Number/Procurement Instrument Identifier (PIID).
(iii) Non Federal Entity.
(iv) Description of Deliverable.
(v) Manufacturer Name.
(vi) Manufacturer Part Number.
(vii) Unit Measure (each, hour, case, lot).
(viii) Quantity of Item Sold.
(ix) Universal Product Code.
(x) Price Paid per Unit.
(xi) Total Price.
Note to paragraph (b)(2): The Contracting Officer may add data elements to the standard elements listed in paragraph (b)(2) of this section with the approvals listed in GSAM 507.105(c)(3).
(3) The contractor must report transactional data within 30 calendar days from the last calendar day of the month. If there was no contract activity during the month, the Contractor must submit a confirmation of no reportable transactional data within 30 calendar days of the last calendar day of the month.
(4) The Contractor must report the price paid per unit, total price, or any other data elements with an associated monetary value listed in (b)(2) of this section, in U.S. dollars.
(5) The reported price paid per unit and total price must include the Industrial Funding Fee (IFF).
(6) The Contractor must maintain a consistent accounting method of transactional data reporting, based on the Contractor's established commercial accounting practice.
(7)
(A) Issuance of an invoice; or
(B) Receipt of payment.
(ii) The Contractor must determine whether to report transactional data on the basis of invoices issued or payments received.
(8) The Contractor must continue to furnish reports, including confirmation of no transactional data, through physical completion of the last outstanding task or delivery order of the contract.
(9) Unless otherwise expressly stated by the ordering activity, orders that contain classified information or other or information that would compromise national security are exempt from this reporting requirement.
(10) This clause does not exempt the Contractor from fulfilling existing
(11) GSA reserves the unilateral right to change reporting instructions following 60 calendar days' advance notification to the Contractor.
(c)
(2) GSA has the unilateral right to change the fee amount at any time, but not more than once per year; GSA will provide reasonable notice prior to the effective date of any change. GSA will post notice of the current IFF on the Vendor Support Center Web site at
(3) Offerors must include the IFF in their prices. The fee is included in the awarded price(s) and reflected in the total amount charged to ordering activities. The fee will not be included in the price of non-contract items purchased pursuant to a separate contracting authority, such as a Governmentwide Acquisition Contract (GWAC); a separately awarded Federal Acquisition Regulation (FAR) Part 12, FAR Part 13, FAR Part 14, or FAR Part 15 procurement; or a non-FAR contract.
(4) The Contractor must remit the IFF to GSA in U.S. dollars within 30 calendar days after the last calendar day of the reporting quarter; final payment must be remitted within 30 calendar days after physical completion of the last outstanding task order or delivery order issued against the contract.
(5) GSA reserves the unilateral right to change remittance instructions following 60 calendar days' advance notification to the Contractor.
(d) The Contractor's failure to remit the full amount of the IFF within 30 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of FAR Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or offsetting payments and interest on the debt (see FAR clause 52.232–17, Interest). If the Contractor fails to submit the required transactional data reports, falsifies them, or fails to timely pay the IFF, these reasons constitute sufficient cause for the Government to terminate the contract for cause.
(a) The Government may request from the Contractor, and the Contractor may provide to the Government, a temporary or permanent price reduction at any time during the contract period.
(b) The Contractor may offer the Contracting Officer a voluntary price reduction at any time during the contract period.
The revisions and addition read as follows:
(b)
(1)
(i) Information about the new item(s) or the item(s) under the new SIN(s) must be submitted in accordance with the instructions in the solicitation.
(ii) Delivery time(s) for the new item(s) or the item(s) under the new SIN(s) must be submitted in accordance with the request for proposal.
(iii) Production point(s) for the new item(s) or the item(s) under the new SIN(s) must be submitted if required by FAR 52.215–6, Place of Performance.
(iv) Hazardous Material information (if applicable) must be submitted as required by FAR 52.223–3 (Alternate I), Hazardous Material Identification and Material Safety Data.
(v) Any information requested by FAR 52.212–3(f), Offeror Representations and Certifications-Commercial Items, that may be necessary to assure compliance with FAR 52.225–1, Buy American Act-Balance of Payments Programs-Supplies.
(2)
On August 21, 2015, Investors' Exchange, LLC (“IEX” or “IEX Exchange”) submitted to the Securities and Exchange Commission (“Commission”) a Form 1 application (“Form 1”) under the Securities Exchange Act of 1934 (“Act”), seeking registration as a national securities exchange pursuant to Section 6 of the Act.
On September 9, 2015, IEX submitted Amendment No. 1 to its Form 1.
On March 18, 2016, the Commission issued an order (“Order Instituting Proceedings” or “OIP”) that provided public notice of the significant changes IEX proposed to its application in Amendment Nos. 2, 3, and 4, and solicited comment on the amended Form 1, while simultaneously instituting proceedings under Section 19(a)(1)(B) of the Act
For the reasons set forth below, and based on the representations set forth in IEX's Form 1, as amended, as supplemented in IEX's responses to comments included in the public comment file, this order approves IEX's Form 1 application, as amended, for registration as a national securities exchange.
Pursuant to Sections 6(b) and 19(a) of the Act,
As discussed in greater detail below, the Commission finds that IEX Exchange's application, as amended, for exchange registration meets the requirements of the Act and the rules and regulations thereunder. Further, the Commission finds that the proposed rules of IEX Exchange are consistent with Section 6 of the Act in that, among other things, they are designed to: (1) Assure fair representation of the exchange's members in the selection of its directors and administration of its affairs and provide that, among other things, one or more directors shall be representative of investors and not be associated with the exchange, or with a
IEX Group, Inc. (“IEXG”), a Delaware corporation, will own 100% of IEX Exchange as well as IEX Services LLC (“IEXS”), a registered broker-dealer that currently operates an alternative trading system (“IEX ATS”). Following the launch of operations of IEX Exchange, IEXS would be a facility of IEX Exchange and would provide outbound order routing services to IEX Exchange.
The board of directors of IEX Exchange (“Exchange Board”) will be its governing body and will possess all of the powers necessary for the management of its business and affairs, including governance of IEX Exchange as a self-regulatory organization (“SRO”).
Under the Amended and Restated Operating Agreement of Investors' Exchange LLC (“IEX Exchange Operating Agreement”):
• The Exchange Board will initially be composed of seven directors;
• One director will be the Chief Executive Officer of IEX Exchange;
• The number of Non-Industry Directors,
• At least twenty percent of the directors on the Exchange Board will be Member Representative Directors;
• A majority of the Board of Directors will be Independent Directors.
In addition, during such time as IEX Exchange operates a listings business, the Exchange Board must have one Director who is an officer or director of an issuer and one Director who is a representative of investors, and in each case, such Director must not be associated with a member.
As discussed further below, the initial Directors of the Exchange Board shall be appointed by IEXG and shall serve until the first annual meeting of holders of LLC interests of Investors' Exchange LLC, of which IEX Group, Inc. is the sole holder (“LLC Member”). In its Form 1 application, IEX committed to hold its first annual meeting as a registered exchange within 90 days after the date of final action by the Commission on IEX's application for registration as a national securities exchange (“Approval Date”).
The Nominating Committee will nominate candidates for each director position, and IEXG, as the sole LLC Member, will elect those directors. For Member Representative Director
Thereafter, the Member Nominating Committee will nominate a final slate of candidates to the Nominating Committee, and the Nominating Committee must accept those candidates and submit them to the LLC Member.
In addition, with respect to the requirement that the number of Non-Industry Directors, including at least two Independent Directors, will equal or exceed the sum of the number of Industry Directors and Member Representative Directors, the Commission believes that the proposed composition of the Exchange Board satisfies the requirements in Section 6(b)(3) of the Act,
The Commission believes that the IEX Exchange governance provisions are consistent with the Act. In particular, the Commission believes that the requirement in the IEX Exchange Operating Agreement that 20% of the directors be Member Representative Directors and the means by which they will be chosen by IEX Exchange members provide for the fair representation of members in the selection of directors and the administration of IEX Exchange and therefore are consistent with Section 6(b)(3) of the Act.
IEXG will appoint an interim Exchange board of directors (“Interim Exchange Board”) at a special meeting, which will include interim Member Representative Directors. The interim Member Representative Directors will be selected by the Buy-Side Trading Advisory Committee (“TAC”) of IEXG from a list of potential candidates submitted by current subscribers of the IEX ATS.
The Interim Exchange Board will serve until the first annual meeting of the LLC Member, which will take place within 90 days after the Approval Date, when the Exchange Board will be elected pursuant to the full nomination, petition, and voting process set forth in the IEX Exchange Operating Agreement.
The Commission believes that the process for electing the Interim Exchange Board, as proposed, is consistent with the requirements of the Act, including that the rules of the exchange assure fair representation of the exchange's members in the selection of its directors and administration of its affairs.
In the IEX Exchange Operating Agreement, IEX Exchange has proposed to establish several committees of the Exchange Board. Specifically, IEX Exchange has proposed to establish the following committees of the Exchange Board that would be appointed by the Chairman of the Exchange Board, with the approval of the Exchange Board: An Appeals Committee and a Regulatory Oversight Committee.
The Appeals Committee will consist of two Independent Directors, and one Member Representative Director.
Because the Executive Committee will have the powers and authority of the Exchange Board in the management of the business and affairs of the IEX Exchange between meetings of the Exchange Board, its composition must reflect that of the Exchange Board. Accordingly, if established, the number of Non-Industry Directors on the Executive Committee must equal or exceed the number of Industry Directors and the percentages of Independent Directors and Member Representative Directors must be at least as great as the corresponding percentages on the Exchange Board as a whole.
As discussed above, the Nominating and Member Nominating Committees will have responsibility for, among other things, nominating candidates for election to the Exchange Board. On an annual basis, the members of these committees will nominate candidates for the succeeding year's respective committees to be elected by IEXG, as the sole LLC Member.
The Commission believes that IEX Exchange's proposed committees, which are similar to the committees maintained by other exchanges,
When IEX Exchange commences operations as a national securities exchange, IEX Exchange will have all the attendant regulatory obligations under the Act. In particular, IEX Exchange will be responsible for the operation and regulation of its trading system and the regulation of its members. The Commission believes that certain provisions in the IEX Exchange and IEXG governance documents are designed to facilitate the ability of IEX Exchange and the Commission to fulfill their regulatory obligations. The discussion below summarizes some of these key provisions.
IEX Exchange will be structured as a Delaware limited liability company (“LLC”), which will be wholly owned by the sole member of the LLC, IEXG. The proposed Third Amended and Restated Certificate of Incorporation of IEX Group, Inc. (“IEXG Certificate”) includes restrictions on the ability to own and vote shares of capital stock of IEXG.
In particular, for so long as IEXG directly or indirectly controls IEX Exchange, no person, either alone or together with its related persons,
Any person that proposes or attempts to own shares of capital stock in excess of the 40% ownership limitation, or vote or grant proxies or consents with respect to shares of capital stock in excess of the 20% voting limitation, must deliver written notice to the IEXG board of directors (“IEXG Board”) to notify the IEXG Board of its intention.
The IEXG Certificate also contains provisions that are designed to further safeguard the ownership and voting limitations described above, or are otherwise related to direct and indirect changes in control. Specifically, any person that, either alone or together with its related persons owns, directly or indirectly, of record or beneficially, 5% or more of the capital stock of IEXG will be required to immediately notify the IEXG Board in writing upon acquiring knowledge of such ownership.
The IEX Exchange Operating Agreement does not include change of control provisions that are similar to those in the IEXG Certificate; however the IEX Exchange Operating Agreement explicitly provides that IEXG is the sole LLC Member of IEX Exchange.
Although IEXG is not directly responsible for regulation, its activities with respect to the operation of IEX Exchange must be consistent with, and must not interfere with, the self-regulatory obligations of IEX Exchange. As described above, the provisions applicable to direct and indirect changes in control of IEXG and IEX Exchange, as well as the voting limitation imposed on owners of IEXG who also are IEX Exchange members, are designed to help prevent any owner of IEXG from exercising undue influence or control over the operation of IEX Exchange and to help ensure that IEX Exchange retains a sufficient degree of independence to effectively carry out its regulatory obligations under the Act. In addition, these limitations are designed to address the conflicts of interests that might result from a member of a national securities exchange owning interests in the exchange. As the Commission has noted in the past, a member's ownership interest in an entity that controls an exchange could become so large as to cast doubt on whether the exchange may fairly and objectively exercise its self-regulatory responsibilities with respect to such member.
The Commission believes that IEX's and IEXG's proposed governance provisions are consistent with the Act, including Section 6(b)(1), which requires, in part, an exchange to be so organized and have the capacity to carry out the purposes of the Act.
Although IEXG will not itself carry out regulatory functions, its activities with respect to the operation of IEX Exchange must be consistent with, and must not interfere with, IEX Exchange's self-regulatory obligations. In this regard, IEX Exchange and IEXG propose to adopt certain provisions in their respective governing documents that are designed to help maintain the independence of the regulatory functions of IEX Exchange. These proposed provisions are substantially similar to those included in the governing documents of other exchanges that recently have been granted registration.
• The directors, officers, employees, and agents of IEXG must give due regard to the preservation of the independence of the self-regulatory function of IEX Exchange and to its obligations to investors and the general public and must not take actions that would interfere with the effectuation of decisions by the Exchange Board relating to its regulatory functions or that would interfere with IEX Exchange's ability to carry out its responsibilities under the Act.
• IEXG must comply with federal securities laws and the rules and regulations promulgated thereunder, and agrees to cooperate with the Commission and IEX Exchange pursuant to, and to the extent of, their respective regulatory authority. In addition, IEXG's officers, directors, employees, and agents must comply with federal securities laws and the rules and regulations promulgated thereunder and are deemed to agree to cooperate with the Commission and IEX Exchange in respect of the Commission's oversight responsibilities regarding IEX Exchange and the self-regulatory functions and responsibilities of IEX Exchange and IEXG shall take reasonable steps necessary to cause its officers, directors, employees and agents to so cooperate.
• IEXG, and its officers, directors, employees, and agents submit to the jurisdiction of the U.S. federal courts, the Commission, and IEX Exchange, for purposes of any action, suit, or proceeding pursuant to U.S. federal securities laws, and the rules and regulations thereunder, arising out of, or relating to, IEX Exchange activities.
• All books and records of IEX Exchange reflecting confidential information pertaining to the self-regulatory function of IEX Exchange (including but not limited to disciplinary matters, trading data, trading practices, and audit information) shall be retained in confidence by IEX Exchange and its personnel, including its directors, officers, employees and agents, and will not be used by IEX Exchange for any non-regulatory purposes and shall not be made available to any person (including, without limitation, any IEX Exchange member) other than to personnel of the Commission, and those personnel of IEX Exchange, members of committees of the Exchange Board, members of the Exchange Board, or hearing officers and other agents of IEX Exchange, to the extent necessary or appropriate to properly discharge the self-regulatory responsibilities of IEX Exchange.
• The books and records of IEX Exchange and IEXG must be maintained in the United States
• Furthermore, to the extent they relate to the activities of IEX Exchange, the books, records, premises, officers, directors, employees, and agents of IEXG will be deemed to be the books, records, premises, officers, directors, employees, and agents of IEX Exchange, for purposes of, and subject to oversight pursuant to, the Act.
• IEXG will take reasonable steps necessary to cause its officers, directors, employees, and agents, prior to accepting a position as an officer, director, employee or agent (as applicable) to consent in writing to the applicability of provisions regarding books and records, confidentiality, jurisdiction, and regulatory obligations, with respect to their activities related to IEX Exchange.
• The IEXG Certificate and By-Laws require that, so long as IEXG controls IEX Exchange, any changes to those documents must be submitted to the
The Commission believes that the provisions discussed in this section, which are designed to help ensure the independence of IEX Exchange's regulatory function and facilitate the ability of IEX Exchange to carry out its responsibility and operate in a manner consistent with the Act, are appropriate and consistent with the requirements of the Act, particularly with Section 6(b)(1), which requires, in part, an exchange to be so organized and have the capacity to carry out the purposes of the Act.
Further, Section 19(h)(1) of the Act
The Commission also notes that, even in the absence of the governance provisions described above, under Section 20(a) of the Act any person with a controlling interest in IEX Exchange would be jointly and severally liable with and to the same extent that IEX Exchange is liable under any provision of the Act, unless the controlling person acted in good faith and did not directly or indirectly induce the act or acts constituting the violation or cause of action.
The regulatory operations of IEX Exchange will be monitored by the Regulatory Oversight Committee of the Exchange Board. The Regulatory Oversight Committee will consist of at least two members, all of whom must be Independent Directors. The Regulatory Oversight Committee will be responsible for overseeing the adequacy and effectiveness of IEX Exchange's regulatory and SRO responsibilities, assessing IEX Exchange's regulatory performance, and assisting the Exchange Board (and committees of the Exchange Board) in reviewing IEX Exchange's regulatory plan and the overall effectiveness of IEX Exchange's regulatory functions.
Further, a Chief Regulatory Officer (“CRO”) of IEX Exchange will have general supervision over IEX Exchange's regulatory operations, including responsibility for overseeing IEX Exchange's surveillance, examination, and enforcement functions and for administering any regulatory services agreements with another self-regulatory organization to which IEX Exchange is a party.
As a prerequisite for the Commission's granting of an exchange's application for registration, an exchange must be organized and have the capacity to carry out the purposes of the Act.
To help ensure that IEX has and will continue to have adequate funding to be able to meet its responsibilities under the Act, IEX Exchange represents that, if the Commission approves IEX's application for registration as a national securities exchange, IEXG will allocate sufficient assets to IEX Exchange to enable the exchange's operation.
IEX Exchange also represents that such cash and in-kind contributions from IEXG will be adequate to operate IEX Exchange, including the regulation of the exchange, and that IEXG and IEX Exchange will enter into an agreement that requires IEXG to provide adequate funding over time for the exchange's operations, including the regulation of IEX Exchange.
Further, any “Regulatory Funds” received by IEX Exchange will not be used for non-regulatory purposes or distributed to IEXG, but rather will be applied to fund the regulatory operations of IEX Exchange, or, as applicable, used to pay restitution and disgorgement to customers as part of a regulatory proceeding.
Although IEX Exchange will be an SRO with all of the attendant regulatory obligations under the Act, it has represented to the Commission that it intends to enter into a Regulatory Services Agreement (“RSA”) with FINRA, under which FINRA will perform certain regulatory functions on IEX Exchange's behalf.
The Commission believes that it is consistent with the Act for IEX Exchange to contract with FINRA to perform certain examination, enforcement, and disciplinary functions.
Section 19(g)(1) of the Act,
A 17d–2 plan that is declared effective by the Commission relieves the specified SRO of those regulatory responsibilities allocated by the plan to another SRO.
Because IEX Exchange anticipates entering into these 17d–2 agreements, it has not made provision to fulfill the regulatory obligations that would be undertaken by FINRA and other SROs under these agreements with respect to common members.
Numerous comment letters the Commission received on IEX's Form 1 application focused on IEX's proposed trading rules and the operation of its system. Much of the public comment centered on issues related to specific features of IEX's proposed trading system—namely, its “Point-of-Presence” (“POP”) and “coil” infrastructure (sometimes referred to as IEX's “speed bump”) and the manner in which IEX originally proposed (prior to Amendment Nos. 2, 3, and 4) to provide outbound routing services through its affiliated routing broker-dealer. IEX submitted several response letters to address these issues before amending its Form 1 in Amendment Nos. 2, 3, and 4 to propose a fundamentally different approach to outbound routing. As detailed in the Order Instituting Proceedings, in these amendments IEX proposed a material change to its approach to outbound routing through its affiliated routing broker-dealer. In the Order Instituting Proceedings, the Commission provided public notice of IEX's amendments and solicited commenters' views as to whether IEX's proposed revisions, including the changes to its outbound routing functionality, were consistent with the Act. The outbound routing issue, other issues related to IEX's POP and coil infrastructure, and other issues that are relevant to IEX's proposed trading system in the context of the Commission's consideration of IEX's Form 1 are addressed below.
The Commission received letters in support,
Among the commenters who were critical of aspects of IEX's proposal, most focused on issues surrounding the coil, the operation of and advantages that IEX initially proposed to be provided to IEX's affiliated outbound router, and IEX's proposed order types, which are discussed in detail below.
IEX will operate a fully automated electronic order book, and will not maintain or operate a physical trading floor. Only broker-dealer members of IEX and entities that enter into market access arrangements with members (collectively, “Users”) will have access to the IEX system.
With respect to the price of executions that would occur on IEX, the IEX system is designed to comply with the order protection requirements of Rule 611 of Regulation NMS,
Limit orders that a User marks as non-displayed will not be displayed to anyone and will be ranked in the IEX system at their specified price, subject to the “Midpoint Price Constraint,” which is a price sliding process that prevents non-displayed limit orders from being ranked in the IEX system at a price that is more aggressive than the midpoint of the NBBO.
Due to IEX's Midpoint Price Constraint functionality, IEX has proposed a “Book Recheck” functionality that is activated in response to a change to the NBBO, the IEX order book, or when IEX receives inbound messages. When Book Recheck is activated, certain resting, non-displayed orders become “active”
In addition, IEX proposed several pegged order types—primary peg, midpoint peg, and discretionary peg—all of which would be non-displayed with prices that are automatically adjusted by the IEX system in response to changes in the national best bid and offer (“NBBO”) (subject to a limit price, if any).
IEX's proposed discretionary peg order type is a non-displayed, pegged order that, upon entry, is priced by the IEX system to be equal to the less aggressive of the midpoint of the NBBO or the order's limit price, if any. Any unexecuted portion of the order is posted non-displayed on the order book and ranked at the less aggressive of the near-side primary quote (
Quote “stability” or “instability” is an assessment that the IEX system makes in what IEX describes as real-time, based on a pre-determined, objective set of conditions that are detailed in IEX's proposed rule.
Certain commenters that criticized IEX's discretionary peg order assert that IEX's determination of quote stability and the resulting implications for resting discretionary peg orders amounts to IEX performing services that are typically performed by broker-dealers exercising discretion over customer orders.
With regard to its discretionary peg order, IEX states that any action taken with respect to such an order is based on system logic and entirely automated, like other pegged orders.
The Commission does not believe that its disapproval of the Nasdaq benchmark order proposal is apposite here. In contrast to IEX's proposed discretionary peg order, Nasdaq's proposed “benchmark orders” were not actually exchange orders that would
The Commission also notes that existing exchanges offer both discretion and pegging functionalities, including the combination of both of those features in a single order type.
More generally, some commenters contend that IEX's order types are not adequately described in IEX's rulebook, or suggest that they are uniquely complex.
The Commission believes that IEX constructed its proposed order type rules in a manner that is reasonably designed to present sufficient and comprehensive information on the available options and possible combinations. While IEX is responsible for ensuring that its rules fully and accurately reflect its systems capabilities and operations, the Commission believes that IEX has structured many of its rules using a template-like approach that is designed to provide basic information about fundamental combinations and system functionality. In addition, the Commission does not believe that IEX's order type rules are uniquely complex in light of existing exchange order type offerings. Accordingly, the Commission believes that IEX's order type rules are consistent with the Act and, in particular, the Section 6(b)(5) requirement that an exchange's rules be designed to promote just and equitable principles of trade, remove impediments to and perfect the mechanisms of a free and open market and a national market system, and protect investors and the public interest.
In addition, one commenter noted that IEX proposes not to display odd-lot orders and suggests that the Commission should consider whether this would systematically disadvantage smaller orders that might be submitted by retail investors.
IEX's Point-of-Presence (“POP”) and “coil” infrastructure (collectively referred to as the “POP/coil delay”) is how IEX Users will connect to IEX, and is one of the most widely commented upon features of IEX. As described in the Order Instituting Proceedings, several commenters expressed concern, among other things, that IEX's initially-published Form 1 lacked specific detail about how the POP/coil structure would work, including what messages and activity would—and would not—be subject to the delay.
Access to IEX by all Users will be obtained through a POP,
Further, under IEX's Form 1 as amended, there is one type of inbound message and one type of outbound message that would
1. Inbound proprietary market data feeds from other trading centers as well as the SIP feed to the IEX system would
2. Outbound transaction and quote messages sent from IEX to the applicable securities information processor (“SIP”) would
In addition, updates to resting pegged orders on IEX would be processed within the IEX trading system and would not require that separate messages be transmitted from outside the trading system, which would otherwise traverse the POP/coil, for each update.
Accordingly, IEX imposes an intentional delay on Users' ability to access IEX's matching engine but the delay does not apply to IEX's adjustment of resting pegged order prices on its book.
In other words, the purpose of IEX's coil is to provide an intentional buffer that slows down incoming orders to allow IEX's matching engine to update the prices of resting “pegged” orders when away prices change to protect resting pegged orders from the possibility of adverse selection when the market moves to a new midpoint price.
Aside from whether the POP/coil delay affects IEX's ability to have an “automated” and thus “protected” quotation under Regulation NMS, discussed below,
The Commission first considers IEX's POP/coil delay as applied to outbound data. The POP/coil delay applies to IEX's outbound proprietary market data, other than the data it sends to the SIP. Doing so allows market participants to execute on IEX while slightly delaying the news of that execution to IEX's proprietary market data feed and to the participants to the trade (through not to the applicable SIP), which in effect allows the order sender to avoid the potential for information leakage when subsequently accessing liquidity on other markets before news of its execution on IEX could affect resting liquidity on those markets (
The Commission similarly concludes that IEX's inbound POP/coil delay is not unfairly discriminatory and does not impose an unnecessary or inappropriate burden on competition. The delay imposed on inbound messages benefits resting pegged orders on IEX because that delay, together with the fact that IEX takes in direct data feeds from other exchanges unencumbered by the delay, allows IEX to update the prices of resting pegged orders in response to changes in the NBBO (which may include displayed orders on IEX) as quickly as IEX is able to receive data and calculate it before incoming messages, including incoming orders seeking to execute against pegged orders, reach the matching engine. At the same time, the POP/coil delay appears to provide no protection or benefits for displayed orders or non-displayed orders at fixed limit prices.
Another commenter recommended that IEX be approved as a “manual” market without a protected quote, unless it developed and offered a “bypass” order type that “that foregoes potential price improvement associated with interacting with hidden mid-point peg orders to by-pass the delay and interact with protected quotes.”
Other commenters believed that IEX's proposed re-pricing of resting pegged orders without any POP/coil delay would not be problematic.
In response, IEX represented that it will provide a “powerful incentive” for Users to submit displayed orders because displayed orders will have priority over non-displayed orders at the same price.
The Commission does not believe that the advantage IEX provides to pegged orders is unfairly discriminatory or imposes an unnecessary or inappropriate burden on competition. Rather, it is designed to ensure that pegged orders on IEX operate as designed and as reflected in IEX's rules by accurately tracking the NBBO, and that users of pegged orders on IEX can better achieve their goals when their pegged orders operate efficiently. To accomplish this, IEX slows down incoming order messages by 350 microseconds to allow it to update resting pegged orders when the NBBO changes, so that the resting pegged orders are accurately pegged to current market prices. Without this protection, pegged orders resting on IEX have the potential to be subject to “latency arbitrage” by those market participants using very sophisticated latency-sensitive technology, who can rapidly aggregate market data feeds and react faster than IEX to NBBO updates. In such case, pegged orders on IEX could be executed at disadvantageous “stale” prices that have not been updated to reflect the new NBBO. Further, because non-displayed pegged order types will be available to all Users of IEX, all Users will be able to benefit from this order type on IEX and thus utilize the POP/coil delay.
IEX's proposed POP/coil delay is thus narrowly designed to allow IEX to update the prices of non-displayed resting pegged orders so that they can achieve their intended purpose—pricing that is accurately benchmarked to the NBBO. Though the POP/coil delay does not benefit displayed limit orders or non-pegged non-displayed limit orders, such orders would not benefit from the symmetrical POP/coil delay because their purpose is to post or execute consistent with their fixed limit price. The Commission thus finds that IEX's ability to update the prices of resting pegged orders during the POP/coil delay is not designed to unfairly discriminate among members to the detriment of investors or the public interest and is intended to benefit investors that post pegged orders.
The Commission is engaged in an ongoing broad-based review of equity market structure, including whether there are appropriate incentives to display trading interest and whether the level of undisplayed liquidity may be impairing price discovery.
Finally, the Commission notes that the POP/coil delay applies to all IEX Users equally, and may not be bypassed, for a fee or otherwise.
As noted above, IEXS, IEX's affiliated single-purpose outbound routing broker-dealer, will provide outbound routing services for IEX. As detailed in the Order Instituting Proceedings, under the initially published version of IEX's Form 1 (prior to Amendment No. 2), orders routed from IEX through IEXS to away trading centers for execution (as well as reports back to IEX from those away trading centers) would not have traversed the POP/coil (though reports communicated from IEX back to members would have traversed the coil). Several commenters expressed concern that this design would provide an unfair competitive advantage to IEXS over other routing brokers to most quickly and efficiently route to away markets,
In response to these comments, IEX submitted Amendment Nos. 2, 3, and 4 to propose a complete redesign of the way its trading system will handle outbound routing by bifurcating its handling of non-routable and routable orders once they initially exit the coil and reach IEX.
Given the additional POP/coil delay, Users submitting
In the Order Instituting Proceedings, the Commission noted that it was particularly interested in commenters' views as to whether the changes to IEX's outbound routing process set forth in IEX's Form 1, as amended by Amendment Nos. 2, 3 and 4, are consistent with the Act, in light of commenters' concerns that, under IEX's Form 1 prior to Amendment No. 2, IEX's proposed routing functionality and IEXS would have an advantage over other routing broker-dealers that would be unfairly discriminatory and an inappropriate burden on competition. Several commenters stated the changes to IEX's proposed routing functionality have sufficiently addressed these concerns and eliminated the advantage IEXS would have had over other routing broker-dealers under the original proposal.
The Commission notes that it carefully scrutinizes exchange-affiliated routing brokers, and has scrutinized with particularity IEX's proposed operation of IEXS, both as initially proposed and as amended by Amendment Nos. 2, 3, and 4.
Thus, unique access or preferences that an exchange provides to its outbound order routing function must be taken into account in the analysis of whether an exchange provides outbound routing in a manner consistent with the Act, and in particular, the requirement that an exchange's rules be designed not to permit unfair discrimination and not impose an unnecessary or undue burden on competition.
The Commission believes that the revisions to IEX's outbound routing structure set forth in Amendment Nos. 2, 3, and 4 have eliminated any such improper advantage that may have been provided to IEXS under IEX's initial proposal. The Commission notes that, following these amendments, certain commenters that criticized IEX's initially-proposed outbound routing structure expressed support for IEX's amended outbound routing structure.
The Commission believes that IEX has directly responded to the comments on this point through the changes it proposed in Amendment Nos. 2, 3, and 4. Specifically, by inserting an additional POP/coil delay for routable orders between the IEX routing logic and IEX matching engine, the Commission believes that IEX's ability to provide outbound routing services will now be on substantively comparable terms to a third party routing broker that is a member of IEX. Both the IEX routing logic and a third-party routing broker-dealer would experience 350 microseconds of latency in sending order messages to the IEX matching engine (assuming that the third-party routing broker-dealer sends a non-routable order, which would bypass the IEX routing logic and instead proceed to the IEX matching engine) and 350 microseconds of latency in receiving fill and quote information back from the IEX matching engine. Thus, if the IEX routing logic were to pursue a serial routing strategy, it would do so based on a view of the IEX book that is subject to the POP/coil delay, it would experience the same 350 microsecond latency in the transmission of the order to the IEX book that a routing broker-dealer would experience with its non-routable order, and it would experience the same 350 microsecond latency in waiting to determine what, if any, remainder is left to be routed to away destinations. The Commission believes that these are the same conditions that a third-party routing broker-dealer would experience when pursuing a serial routing strategy involving IEX.
IEX's new router design provides flexibility to its routing functionality to employ either a “spray” approach to routing or a “serial” approach.
Thus, under IEX's amended outbound routing rule, IEX's affiliated broker-dealer does not have any structural or informational advantages in its provision of routing services as compared to a third-party broker-dealer member of IEX performing a similar function for itself or others. Thus, the Commission believes that IEX's proposed routing structure, as amended, would not be unfairly discriminatory and would not impose an inappropriate burden on competition.
Accordingly, for the reasons stated above, the Commission believes that the outbound routing functionality of IEX, as amended by Amendment Nos. 2, 3,
In light of the POP/coil delay, the issue of whether IEX would operate as an automated trading center, in compliance with Rule 600(b)(4) of Regulation NMS,
As noted above, according to IEX, all
Several commenters asserted that this 700 microsecond delay would not be
Other commenters did not believe that protecting IEX's quotations despite IEX's POP/coil would have a detrimental impact on market quality,
In response to commenters that argued that the POP/coil delay would negatively affect market transparency, degrade the NBBO, or cloud price discovery, the Commission notes that Rule 600(b)(3)(v) requires trading centers to immediately update their displayed quotations to reflect material changes. Market participants today already experience very short delays in receiving updates to displayed quotations, as a result of geographic and technological latencies, similar to those experienced when accessing protected quotations. Indeed, the NBBO is an amalgamation of individual protected quotations from different markets located in different places, and is already subject to geographic, network, computational, and other technological latencies.
In addition, the Commission published notice of a proposed interpretation regarding the permissibility of intentional access
Consequently, IEX is a trading center whose quotations can be “automated quotations” under Rule 600(b)(3). In turn, IEX is designed to be an “automated trading center” under Rule 600(b)(4) whose best-priced, displayed quotation would be a “protected quotation” under Rules 600(b)(57) and 600(b)(58), and for purposes of Rule 611.
As a result, following the issuance of this order and IEX having met the conditions to begin operating as an automated trading center in a particular symbol, market participants will be required to have reasonably designed policies and procedures to treat IEX's best bid and best offer in such symbol as a protected quotation.
As noted above, one prerequisite for the Commission's grant of an exchange's application for registration is that a proposed exchange must be so organized and have the capacity to be able to carry out the purposes of the Act.
The IEX Amended and Restated Operating Agreement and IEX rules provide that the Exchange has disciplinary jurisdiction over its members so that it can enforce its members' compliance with its rules and the federal securities laws and rules.
The Commission received one comment on this topic, from a commenter that encouraged IEX to adopt a rule similar to BATS Rule 8.17 (Expedited Client Suspension Proceeding) concerning expedited suspension proceedings with respect to alleged violations of IEX's disruptive quoting and trading rule.
Once IEX begins operations as a national securities exchange, a security will be considered for listing on IEX only if such security is registered pursuant to Section 12(b) of the Act
The Commission notes that IEX's proposed initial and continuing listing standards for securities to be listed and traded on the IEX Exchange are virtually identical to the current rules for the Nasdaq Global Select Market of The NASDAQ Stock Market.
The Commission notes that IEX's proposed corporate governance standards in connection with securities to be listed and traded on the IEX Exchange are virtually identical to the current rules of Nasdaq and the NYSE.
While IEX does not intend to list securities upon becoming an exchange, it has expressed an intent to do so in the future.
As an exchange, IEX will be permitted by Section 12(f) of the Act
Section 11(a)(1) of the Act
In a letter to the Commission, IEX requested that the Commission concur with IEX's conclusion that IEX members that enter orders into the IEX trading system satisfy the requirements of Rule 11a2–2(T).
The Rule's first requirement is that orders for covered accounts be transmitted from off the exchange floor. In the context of automated trading systems, the Commission has found that the off-floor transmission requirement is met if a covered account order is transmitted from a remote location directly to an exchange's floor by electronic means.
Second, the Rule requires that the member and any associated person not participate in the execution of its order after the order has been transmitted. IEX represented that at no time following the submission of an order is a member or an associated person of the member able to acquire control or influence over the result or timing of the order's execution.
Third, Rule 11a2–2(T) requires that the order be executed by an exchange member who is unaffiliated with the member initiating the order. The Commission has stated that this requirement is satisfied when automated exchange facilities, such as the IEX trading system, are used, as long as the design of these systems ensures that members do not possess any special or unique trading advantages in handling their orders after transmitting them to the exchange.
Fourth, in the case of a transaction effected for an account with respect to which the initiating member or an associated person thereof exercises investment discretion, neither the initiating member nor any associated person thereof may retain any compensation in connection with effecting the transaction, unless the person authorized to transact business for the account has expressly provided otherwise by written contract referring to Section 11(a) of the Act and Rule 11a2–2(T) thereunder.
IEX Exchange proposes to incorporate by reference certain FINRA rules as IEX rules. Thus, for certain IEX rules, Exchange members will comply with an IEX rule by complying with the FINRA rule referenced.
Using its authority under Section 36 of the Act,
A.
B.
C.
D.
E.
F.
By the Commission (Chair WHITE and Commissioner STEIN; Commissioner PIWOWAR concurring in part and dissenting with respect to Sections III.C.7 and III.C.8).
Comment Letters Received Regarding Investors' Exchange LLC's Application for Registration as a National Securities Exchange under Section 6 of the Securities Exchange Act of 1934 (File No. 10–222)