Animal and Plant Health Inspection Service
Food Safety and Inspection Service
Forest Service
National Institute of Food and Agriculture
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Air Force Department
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
Transportation Security Administration
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
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National Park Service
Occupational Safety and Health Administration
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Surface Transportation Board
Transportation Security Administration
Comptroller of the Currency
Internal Revenue Service
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National Aeronautics and Space Administration.
Final rule.
NASA has adopted as final, with no change, a proposed rule to extend coverage of non-procurement suspension and debarment to all tiers of procurement and non-procurement actions under all grants and cooperative agreements. The revisions herein are part of NASA's retrospective plan under EO 13563 completed in August 2011. NASA's full plan can be accessed at:
Leigh Pomponio, NASA, Office of Procurement, Contract Management Division (Suite 5G84); (202) 358–0592; email:
On August 31, 2005 (70 FR 51865), the Office of Management and Budget promulgated guidelines to Federal agencies on the governmentwide debarment and suspension system for nonprocurement programs. The OMB guidance to Federal Agencies was amended on November 15, 2006 (71 FRN 664320). These two notices resulted in the governmentwide regulation at 2 CFR part 180. Specifically, at § 180.220(c), OMB offered Federal agencies flow down options for application of nonprocurement suspension and debarment regulations to procurement actions under covered transactions. OMB permitted Agencies to flow down requirements to just the first-tier or to all lower-tier participants.
On April 20, 2007, NASA promulgated a final rule (72 FR 19783) which established a new Part 1880 in Title 2 of the Code of Federal Regulations (CFR) on nonprocurement debarment and suspension. This rule implemented and supplemented the Office of Management and Budget's (OMB) guidance provided at 2 CFR part 180. It included agency-specific regulations related to nonprocurement suspension and debarment. At the time of that action, NASA elected to limit the flow down of nonprocurement suspension and debarment applicability to only first-tier procurement contacts thereunder. However, NASA has since reconsidered its position on flow down and this final rule revises 2 CFR 1880.220 to apply to all participants at all tiers, and to procurement and non-procurement actions at any dollar amount, under Agency grants and cooperative agreements. NASA will not permit any subawards to individuals or entities that are listed on the Excluded Parties List Service (EPLS).
To extend the suspension and debarment exclusions, NASA published a proposed rule on October 29, 2012. The due date for public comments in response to the proposed rule was December 28, 2012. NASA did not receive any comments.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866. This rule is not a major rule under 5 U.S.C. 804.
NASA certifies that this rule will not 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
The Paperwork Reduction Act (Pub. L. 104–13) is not applicable because the changes do not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.
Government procurement; Federal Grant program.
Accordingly, 2 CFR part 1880 is amended as follows:
Sec. 2455, Pub. L. 103–355, 108 Stat. 3327; E.O. 12549, 3 CFR, 1986 Comp., p. 189; E.O. 12689, 3 CFR, 1989 Comp., p. 235; 42 U.S.C. 2473(c)(1). 2
NASA extends coverage of nonprocurement suspension and debarment requirements beyond first-tier procurement contracts under a covered nonprocurement action, to all lower tier subcontracts, at all dollar values, consistent with OMB guidance at 2 CFR 180.220(c) and the figure in the appendix at 2 CFR part 180. NASA does not permit subcontracting to suspended
National Credit Union Administration (NCUA).
Final rule.
The NCUA Board (Board) is amending its investment regulation to allow federal credit unions (FCUs) to purchase Treasury Inflation Protected Securities (TIPS). This final rule adds TIPS to the list of permissible investments for FCUs in part 703. TIPS will provide FCUs with an additional investment portfolio risk management tool that can be useful in an inflationary economic environment.
The final rule is effective on March 29, 2013.
John H. Brolin, Staff Attorney, or Frank Kressman, Associate General Counsel, Office of General Counsel, at 1775 Duke Street, Alexandria, VA 22314 or telephone: (703) 518–6438; or J. Owen Cole, Jr., Director, Division of Capital Markets, Office of Examination and Insurance, at the above address or telephone: (703) 518–6360.
TIPS are securities issued by the U.S. Department of the Treasury, Bureau of Public Debt, and are readily available to investors. TIPS differ from other securities by providing protection against inflation. The principal amount of TIPS increases with inflation and decreases with deflation, as measured by the Bureau of Labor Statistic's Consumer Price Index (CPI). When TIPS mature, holders are paid the adjusted principal or original principal, whichever is greater. TIPS pay interest twice a year at a fixed rate. The rate is applied to the adjusted principal, so, like the principal, interest payments rise with inflation and fall with deflation. In a deflationary period, it is possible to experience a contractual decline in the principal balance, which is not an event of default.
TIPS are currently a prohibited investment under part 703 because they reprice their value in response to changes in the CPI, and the CPI is a prohibited index for variable rate instruments. Under § 703.14(a), an FCU is permitted to invest in a variable rate instrument as long as the rate is tied to a domestic interest rate.
The Board issued a proposed rule in September 2012 to amend § 703.14(a) to add TIPS to the list of permissible investments for FCUs in part 703.
The NCUA received eight comment letters on the September 2012 proposal: two from FCU trade associations and six from state credit union leagues. The Board has considered these comments in adopting this final rule.
All of the commenters agreed that the authority to invest in TIPS will help FCUs manage inflation risk. Several commenters noted that TIPS are guaranteed by the U.S. Government, and the benefits to TIPS investors are widely recognized. One state credit union league noted that certain state-chartered institutions already have the authority to invest in TIPS, which they argued demonstrates that such securities can be utilized safely. Moreover, several commenters noted that FCUs now have greater access to advanced asset-liability management tools that can help identify and measure basis risk.
In addition to supporting the proposal, several commenters also made other recommendations that were outside the scope of the proposal. In general, the commenters asked the Board to take additional steps in the future to provide increased flexibility and additional investment powers to FCUs. Several commenters also urged NCUA to work closely with state regulators to facilitate the ability of well-managed state credit unions to invest in TIPS, where permissible under state law.
As discussed, the Board is adopting this final rule to provide FCUs with an additional investment portfolio risk management tool that can be useful in an inflationary economic environment.
Historically, the Board has prohibited FCUs from investing in variable rate instruments tied to non-domestic rate indices, such as TIPS, because of the basis risk for FCUs. The Board remains concerned about basis risk. However, the Board generally agrees with commenters who noted that FCUs now have greater access to advanced asset-liability management tools that can identify and measure basis risk, and are, therefore, better equipped to manage the risks associated with investing in TIPS. Moreover, the Board agrees with commenters that allowing FCUs to hold TIPs in their investment portfolios adds no credit risk and allows them the option of minimizing the need for
While the Board believes the authority to invest in TIPS can be a valuable part of an effective risk management program for those FCUs that understand the risks, TIPS may not be appropriate for all FCUs. As with any investment, the decision to purchase TIPS should be based on sound due diligence and a demonstrated effectiveness in managing risk. However, other than the due diligence and risk management requirements already required by NCUA for investments under § 703.14(a), this final rule does not impose any new TIPS-specific due diligence or risk management requirements on FCUs.
This final rule authorizes FCUs to purchase TIPS only. Other similar securities based on inflation indices currently available or available in the future that are not issued by the United States Treasury Department are not authorized by this rule. While several commenters requested the Board provide increased flexibility and additional investment powers to qualified FCUs, such requests are outside the scope of this rulemaking and will be considered separately by the Board.
The TIPS pilot program will be terminated as of the effective date of this final rule.
The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact a rule may have on a substantial number of small entities (primarily those under $50 million in assets). This final rule extends regulatory relief while maintaining existing safety and soundness standards. NCUA has determined this final rule will not have a significant economic impact on a substantial number of small credit unions.
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden on regulated entities or modifies an existing burden.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. This final rule will not have a substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The rule only adds to the list of permissible investments for FCUs. NCUA has determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.
NCUA has determined that this final rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999.
The Small Business Regulatory Enforcement Fairness Act of 1996
Credit unions, Investments.
For the reasons discussed above, the Board amends 12 CFR part 703 as follows:
12 U.S.C. 1757(7), 1757(8), 1757(15).
(a)
Federal Energy Regulatory Commission.
Final rule.
Under section 215 of the Federal Power Act (FPA), the Federal Energy Regulatory Commission (Commission) approves regional Reliability Standard PRC–006–NPCC–1 (Automatic Underfrequency Load Shedding), submitted to the Commission for approval by the North American Electric Reliability Corporation (NERC). Regional Reliability Standard PRC–006–NPCC–1 applies to generator owners, planning coordinators, distribution providers, and transmission owners in the Northeast Power Coordinating Council
1. Under section 215 of the Federal Power Act (FPA),
2. Section 215 of the FPA requires a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards that are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by NERC (the Commission-certified ERO), subject to Commission oversight, or by the Commission independently.
3. A Regional Entity may develop a Reliability Standard for Commission approval to be effective in that region only.
4. On April 19, 2007, the Commission accepted delegation agreements between NERC and each of the eight Regional Entities.
5. NERC's Commission-approved and currently-effective Reliability Standard PRC–006–1 establishes continent-wide design and documentation requirements for UFLS programs that arrest declining frequency and assist recovery of frequency following system events leading to frequency degradation.
6. On May 4, 2012, NERC petitioned the Commission to approve regional Reliability Standard PRC–006–NPCC–1 and the related violation risk factors, violation severity levels, effective dates, and implementation plan.
7. In the petition, NERC proposed violation risk factors and violation severity levels for each requirement of the regional Reliability Standard, an implementation plan, and effective dates. NERC stated that these proposals were developed and reviewed for consistency with NERC and Commission guidelines. NERC proposed two effective dates for the regional Reliability Standard. NERC stated that Requirements R1 through R7 would become effective on the first day of the first calendar quarter following applicable regulatory approval but no earlier than January 1, 2016. For Requirements R8 through R23, NERC stated that they will become effective the first day of the first calendar quarter
8. On September 20, 2012, the Commission issued a Notice of Proposed Rulemaking (NOPR) proposing to approve regional Reliability Standard PRC–006–NPCC–1 as just, reasonable, not unduly discriminatory or preferential, and in the public interest.
9. While proposing to approve regional Reliability Standard PRC–006–NPCC–1, the NOPR sought comment on two issues: (1) The technical basis for the 57.8 Hz maximum tripping limit for existing nuclear units established in Requirement R19; and (2) the time-frame for actions that result in changes to the NPCC UFLS program.
10. In response to the NOPR, initial comments were filed by NERC, NPCC, New York Independent System Operator (NYISO), PSEG Companies (PSEG),
11. Pursuant to FPA section 215(d)(2), we approve regional Reliability Standard PRC–006–NPCC–1 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. Regional Reliability Standard PRC–006–NPCC–1 is designed to operate in conjunction with the NERC continent-wide UFLS Reliability Standard PRC–006–1 by mitigating the consequences of underfrequency events, while accommodating differences in system transmission and distribution topology among NPCC planning coordinators. Regional Reliability Standard PRC–006–NPCC–1 includes requirements that are not found in the corresponding NERC Reliability Standard PRC–006–1 and that are more stringent than Reliability Standard PRC–006–1 while accommodating differences in system transmission and distribution topology among NPCC planning coordinators due to historical design criteria, makeup of load demands, and generation resources.
12. We address below the following issues raised in the NOPR and/or comments: (A) Requirement R19—nuclear generating plants; (B) Time-frame for completion of actions; (C) Compensatory load shedding requirements; and (D) violation risk factors and violations severity levels.
13. In the NOPR, the Commission sought comments on the technical basis for the 57.8 Hz maximum tripping limit for existing nuclear units established in Requirement R19. The NOPR observed that Requirement R19 provides that:
14. The NOPR stated that the NERC petition did not explain the technical basis for establishing 57.8 Hz as the maximum frequency at which existing nuclear units may trip pursuant to Requirement R19.1, other than to state that the regional Reliability Standard was based on the work of an NPCC working group.
15. NPCC states that its UFLS program is designed to arrest frequency decline at or above 58.0 Hz while incorporating the performance characteristics of regional generation. In determining the 57.8 Hz limit for existing nuclear units within the NPCC Region, NPCC states that it “considered the minimum program frequency of 58.0 Hz, the existing maximum trip settings of the nuclear units (gathered through surveys) within NPCC's footprint, system response, and credible islands as determined by the NPCC Planning Coordinators.”
16. NERC states that it supports the comments submitted by NPCC regarding the technical basis for the 57.8 Hz limit. NERC also states that the requirements in regional Reliability Standard PRC–006–NPCC–1 are consistent with the continent-wide UFLS Reliability Standard PRC–006–1.
17. The Commission finds that NPCC has provided an adequate technical basis for the 57.8 Hz maximum frequency threshold trip setting for existing nuclear units, as set forth in Requirement R19. As explained by NPCC, a maximum frequency threshold trip setting of 57.8 Hz for existing nuclear units provides a margin of 0.2 Hz above the highest frequency at which the nuclear units in NPCC's footprint are expected to trip by low coolant flow or underfrequency protection. Adherence to the 57.8 Hz limit should also result in islands with a 25% generation deficiency being able to survive and maintain automatic UFLS program requirements.
18. In the NOPR, the Commission sought comments on the time-frames for actions that result in changes to the NPCC UFLS program. The NOPR observed that NERC's Reliability Standard PRC–006–1, Requirement R3, requires the planning coordinator to set the schedule for distribution providers and transmission owners to implement the UFLS program and that regional Reliability Standard PRC–006–NPCC–1, Requirements R5, R16.2, and R19.3, require distribution providers, transmission owners, and generator owners to provide, inform, and transmit exceptions to the UFLS program and justifications for the exceptions to the planning coordinator. The NOPR stated that these Requirements in regional Reliability Standard PRC–006–NPCC–1 do not specify a time-frame for the completion of these actions. The NOPR indicated that Requirements R5, R16.2, and R19.3 address actions that can result in changes to the UFLS program and should occur before the UFLS program is implemented, thus making it necessary for entities to provide the required information to the planning coordinator within a specified period of time. The NOPR further observed that other Requirements in regional Reliability Standard PRC–006–NPCC–1 require actions of distribution providers, transmission owners, and generator owners that should occur before the UFLS program is implemented and that those actions include specific time-frames for completion.
19. NPCC states that Requirement R5 addresses a limited set of non-conforming circumstances and places the burden on entities to demonstrate that such non-conforming circumstances do not degrade the overall performance of the UFLS program. NPCC states that the absence of time-frames for completion of the required actions in Requirement R5 means that responsible entities are required to notify the NPCC planning coordinator “upon identification of any non-conformance with Requirement R5.”
20. NPCC states that Requirement R16 addresses an existing class of non-nuclear units that “trip above the threshold curve for setting underfrequency trip protection for generators and which already provide compensatory load shedding in accordance with existing procedures.”
21. NPCC states that Requirement R19.3, similar to the requirements regarding non-nuclear units in Requirement R16.2, requires responsible entities to provide planning coordinators with the current operating parameters of an existing class of nuclear units that trip above the threshold curve for setting underfrequency trip protection for generators units. NPCC further states that like Requirement R16.2, Requirement 19.3 requires responsible entities to transmit changes to the underfrequency settings to the planning coordinator. NPCC maintains that, in the absence of time-frames, responsible entities must notify the planning coordinator “immediately upon identification of such change.”
22. NPCC also states that there is a limited number of existing nuclear and non-nuclear units that trip above the curve in Figure 1. NPCC notes that Requirement R15 requires that all new units conform to the curve in Figure 1. According to NPCC, the number of units that must comply with Requirement R16 and Requirement R19 is limited to the existing set of units described above and thus the inclusions of time-frames is unnecessary.
23. NERC states that it supports the comments submitted by NPCC on this issue.
24. The Commission finds that NPCC has provided adequate justification for not including specific time-frames in Requirements R5, R16.2, and R19.3. NPCC states that these Requirements apply to a limited number of existing nuclear and non-nuclear units whose performance characteristics are already incorporated in the regional UFLS program, and that planning coordinators within NPCC have the existing technical parameters necessary to incorporate existing unit attributes and compensatory load shedding information into their assessment. NPCC further states that the absence of specific time-frames in these Requirements means that responsible entities must immediately notify planning coordinators upon identification of any non-conformance or changes to underfrequency settings pursuant to these Requirements. The Commission determines that this satisfies the concern raised in the NOPR.
25. Reliability Standard PRC–006–NPCC–1, Requirements R3, R16 and R18, address compensatory load
26. Dominion states that there are technical difficulties associated with Requirements R16.3 and R18. Dominion states that shedding additional load equivalent to a non-conforming generator would be extremely difficult to design and coordinate and that the design would have to account for the real-time status and output of the generator. Dominion also states that Requirements R16.3 and R18 are unreasonable because they require non-conforming generators to procure compensatory load shedding service for which Dominion has found no willing provider. Dominion maintains that, as a result, the regional Reliability Standard cannot be practically implemented and may have an adverse impact on the Bulk-Power System. Dominion further states that NPCC's assertion that generators in NPCC are already following these procedures as part of NPCC Directory #12 is misleading because only NPCC Full Members are required to follow the existing criteria. Dominion maintains that the regional Reliability Standard will impact a number of generators that are not NPCC Full Members. In addition, Dominion observes that several entities raised concerns with the compensatory load shedding provisions during the regional Reliability Standard drafting process. Dominion also maintains that Order No. 763,
27. PSEG states that it is inappropriate for planning coordinators to assign responsibility for compensatory load shedding, asserting that it is inconsistent with Order No. 763. PSEG also contends that the regional Reliability Standard contravenes the prohibition in FPA section 215 against setting standards for “adequacy or safety of electric facilities or services” because the regional Reliability Standard requires generator owners with existing non-conforming units to construct additional capacity or acquire off-setting UFLS at their expense.
28. In reply to Dominion's and PSEG's comments, NPCC states that the regional Reliability Standard drafting team considered comments regarding the difficulty of designing and coordinating the shedding of load equivalent to a non-conforming generator, but that the overarching reliability objective of re-establishing a balance between load and generation during possible islanding events made shedding additional load necessary. NPCC states that it is impractical to expect an exact match between compensatory load shedding and unit output but maintains that compensatory load shedding based on an average megawatt output, as provided in Attachment B, aligns the amount of compensatory load shedding with the unit output most likely to be lost when the unit trips prematurely. NPCC further states that requiring compensatory load shedding based on a two year average net generator megawatt output is an effective approach to integrating small non-conforming generators into the design of a UFLS program. In addition, NPCC observes that that Regional Criteria requiring non-conforming generation to secure compensatory load shedding preexist the development of the regional Reliability Standard and that it is a cost effective alternative for generators. With respect to Order No. 763, NPCC states that the regional Reliability Standard is consistent with the Commission's determination that it is appropriate for planning coordinators to consider generators that trip outside of the UFLS set points.
29. NPCC maintains that the regional Reliability Standard Requirements R1 and R3 are “only intended to communicate the results of locational assessments, and there is no obligation to obtain compensatory load shedding based solely on this information nor does the Planning Coordinator determine whether mitigation is necessary or who will be responsible for providing mitigation.”
30. NPCC further notes that the existing compensatory load shedding requirements are presently contained in NPCC Directory #12 and “have been successfully implemented within the region * * * and non-conforming generators that are already interconnected either have existing contracts to provide compensatory load shedding or have mitigated the conditions that would trip the unit above the performance curve in order to comply with the Regional
31. In reply to Dominion's and PSEG's comments, NERC states it never intended to suggest that it is inappropriate for planning coordinators to determine whether mitigation is necessary and who will provide mitigation with respect to generators that trip outside the UFLS set points in UFLS programs. NERC states that “[o]n the contrary, the Planning Coordinator is one of the functional entities with responsibility for maintaining the reliability of the Bulk-Power System.”
32. Further, NERC claims that the technical concerns raised in the comments are overstated. NERC states that concerns “regarding potential overfrequency excursions due to overcompensating when a generating unit with non-conforming trip setting is off-line would be appropriate if compensatory loadshedding was applied to large generating units or if the provision was open-ended with applicability to future generating units not studied by the Planning Coordinator.”
33. The Commission rejects the protests made by Dominion and PSEG regarding the compensatory load shedding provisions of regional Reliability Standard PRC–006–NPCC–1. Based on the record before us, we are not persuaded that the compensatory load shedding option for existing, non-conforming units in Requirement R16 presents a technical barrier to implementation of the regional Reliability Standard. NPCC states that generators already comply with the compensatory load shedding requirements in NPCC Directory #12, which is not disputed by Dominion and PSEG. While Dominion maintains that the regional Reliability Standard will require more generators (i.e., non-NPCC Full Members) to comply with the compensatory load shedding requirement, the fact that there are generators who do so now refutes the assertion that the requirement is technically or practically infeasible.
34. We agree with NPCC that the NERC Reliability Functional Model does not preclude the assignment of a new or revised task in a Reliability Standard, such as to generator owners. The NERC Reliability Functional Model provides that:
35. We disagree with Dominion and PSEG that the regional Reliability Standard is inconsistent with Order No. 763. In the context of the rulemaking addressing the continent-wide UFLS Reliability Standard PRC–006–1, Order No. 763 explained that it would be inappropriate to include in Reliability Standard PRC–006–1 specific requirements as to how to mitigate generators that tripped outside of the UFLS program (e.g., by procuring load to shed).
36. Finally, we reject the claim that the compensatory load shedding provisions in regional Reliability Standard PRC–006–NPCC–1 contravene FPA section 215. As discussed above, the compensatory load shedding option for existing, non-conforming, non-nuclear units is one option for such generators. Generator owners may instead choose to bring their units into compliance rather than secure compensatory load shedding. We do not find that the regional Reliability Standard implicates the proscription in FPA section 215 against ordering the
37. In the NOPR, the Commission proposed to approve NERC's proposed violation risk factors and violation severity levels for regional Reliability Standard PRC–006–NPCC–1 as consistent with the Commission's established guidelines.
38. No comments were received that specifically addressed the violation risk factors, violation severity levels, implementation plan, and effective dates proposed by NERC.
39. The Commission approves the violation risk factors, violation severity levels, implementation plan, and effective dates proposed by NERC.
40. The Office of Management and Budget (OMB) regulations require that OMB approve certain reporting and recordkeeping (collections of information) imposed by an agency.
41. The Commission is submitting these reporting and recordkeeping requirements to OMB for its review and approval under section 3507(d) of Paperwork Reduction Act of 1995. The Commission solicited comments on the need for and the purpose of the information contained in regional Reliability Standard PRC–006–NPCC–1 and the corresponding burden to implement the regional Reliability Standard. The Commission received comments on specific requirements in the regional Reliability Standard, which we address in this Final Rule. However, the Commission did not receive any comments on our reporting burden estimates. The Final Rule approves regional Reliability Standard PRC–006–NPCC–1. As noted previously, this is the first time NERC has requested Commission approval of regional Reliability Standard PRC–006–NPCC–1. Regional Reliability Standard PRC–006–NPCC–1 is designed to work with and augment the NERC continent-wide UFLS Reliability Standard PRC–006–1 by mitigating the consequences of underfrequency events, while accommodating differences in system transmission and distribution topology among NPCC planning coordinators due to historical design criteria, makeup of load demands, and generation resources. Regional Reliability Standard PRC–006–NPCC–1 is only applicable to generator owners, planning coordinators, distribution providers, and transmission owners in the NPCC Region. To properly account for the burden on respondents, the Commission will treat the burden resulting from NERC-approved Reliability Standard PRC–006–NPCC–1 as pertaining to entities within the NPCC Region.
42.
Total Annual Cost (Reporting + Record Retention)
43. 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:
For submitting comments concerning the collection(s) of information and the associated burden estimate(s), please send your comments to the Commission and to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission, phone: 202–395–4638, fax: 202–395–7285]. For security reasons, comments to OMB should be submitted by email to:
44. 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.
45. The Regulatory Flexibility Act of 1980 (RFA)
46. Regional Reliability Standard PRC–006–NPCC–1 establishes a coordinated, comprehensive UFLS region-wide consistent program with the NPCC region to achieve and facilitate the broader program characteristics contained in the requirements of the continent-wide PRC–006–1.
47. Further, NERC explains that the cost for smaller entities to implement regional Reliability Standard PRC–006–NPCC–1 was considered during the development process. NERC states that regional Reliability Standard PRC–006–NPCC–1 provides an opportunity for smaller entities to aggregate their load with other such entities in the same electrical island. This allows each smaller entity's respective planning coordinator to achieve the desired aggregate outcome within that island according to program characteristics.
48. Based on this understanding, the Commission certifies that the regional Reliability Standard will not have a significant economic impact on a substantial number of small entities. Accordingly, no regulatory flexibility analysis is required.
49. In addition to publishing the full text of this document in the
50. From FERC'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 excluding the last three
51. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at 202–502–6652 (toll free at 1–866–208–3676) or email at
52. These regulations are effective April 29, 2013. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996.
By the Commission.
Internal Revenue Service (IRS), Treasury.
Final regulations and removal of temporary regulations.
This document contains final regulations under section 6654 of the Internal Revenue Code (Code) relating to reduced estimated income tax payments for qualified individuals with small business income for any taxable year beginning in 2009 and does not apply to any taxable years beginning before or after 2009. The final regulations implement changes to section 6654 made by the American Recovery and Reinvestment Act of 2009. The final regulations provide guidance for qualified individuals with small business income to certify that they satisfy the statutory gross income requirement for purposes of the reduction in their required 2009 estimated income tax payments.
Janet Engel Kidd at (202) 622–4940 (not a toll-free number).
This document contains final amendments to the Income Tax Regulations (26 CFR part 1) under section 6654(d) of the Code relating to the addition to tax for failure by an individual to pay estimated income tax. Section 6654(d)(1)(D) was added by section 1212 of Division B of the American Recovery and Reinvestment Act of 2009, Public Law 111–5 (123 Stat. 336 (2009)), effective for taxable years beginning in 2009. It does not apply to any taxable years beginning before or after 2009.
Section 6654 imposes an addition to tax in the case of an individual taxpayer's underpayment of estimated tax. Estimated tax is payable in four installments throughout the taxable year, and the amount of each required installment is generally 25 percent of the required annual payment of estimated tax. Under section 6654(d)(1)(B), the required annual payment is the lesser of (i) 90 percent of the tax shown on the income tax return for the taxable year (or, if no return is filed, 90 percent of the tax for the year), or (ii) 100 percent of the tax shown on the taxpayer's return for the preceding taxable year (or 110 percent if the taxpayer's adjusted gross income for the preceding taxable year exceeded $150,000). The provision allowing for the payment of 100 (or 110) percent of the tax shown on the taxpayer's return for the preceding taxable year does not apply if the preceding taxable year was less than 12 months or if the taxpayer did not file a return for that year.
Section 6654(d)(1)(D) provides a “[s]pecial rule for 2009.” Under this provision, the applicable percentage of tax shown on the return for the preceding taxable year (either 100 or 110 percent) is reduced to 90 percent for qualified individuals for taxable years that begin in 2009. In other words, for taxable years that begin in 2009, a qualified individual's annual required payment of estimated tax is the lesser of (i) 90 percent of the tax shown on the return for the 2009 taxable year (or, if no return is filed, 90 percent of the tax for the year), or (ii) 90 percent of the tax shown on the individual's return for taxable year 2008.
To implement the special rule for 2009, the Treasury Department and the IRS published in the
The IRS received one written public comment responding to the proposed regulations. The comment is available for public inspection at
The final regulations adopt the proposed regulations without change. The final regulations explain who is a qualified individual under section 6654(d)(1)(D) and how a taxpayer establishes that the taxpayer is a qualified individual. A qualified individual is any individual (1) whose adjusted gross income shown on the individual's return for the preceding taxable year (prior to the taxable year that begins in 2009) is less than $500,000, and (2) who certifies that more than 50 percent of the gross income shown on that return was income from a small business. See section 6654(d)(1)(D)(ii). If an individual is married within the meaning of section 7703, and files a separate return for a taxable year that begins in 2009, then to qualify, the individual's adjusted gross income shown on the preceding year's return must be less than $250,000, rather than $500,000. See section 6654(d)(1)(D)(iv). Pursuant to section 6654(d)(1)(D)(ii)(II), the Secretary shall prescribe by regulation the form, manner, and time for filing a certification. Additionally, section 6654(m) authorizes the Secretary to prescribe regulations as necessary to carry out the purposes of section 6654.
Income from a small business is defined in general terms in section 6654(d)(1)(D)(iii) as income from a trade or business the average number of employees of which was less than 500 for calendar year 2008. The final regulations specify that the trade or business must be a bona fide trade or business of which the individual was an owner. The final regulations provide that a trade or business may be organized as, or take the legal form of, a corporation, partnership, limited
The final regulations also provide that a qualified individual shall file a certification with the IRS in the manner and at the time prescribed in forms, publications, or other guidance, such as Form 2210, “Underpayment of Estimated Tax by Individuals, Estates, and Trusts” (or any successor form and its instructions).
The final regulations will be applicable for taxable years that begin in 2009. The reduced percentage in section 6654(d)(1)(D) is limited to taxable years that begin in 2009 and does not apply to taxable years that begin before or after 2009.
It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking that preceded these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business and no comments were received.
The principal author of these regulations is Janet Engel Kidd, Office of the Associate Chief Counsel, Procedure and Administration.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
Section 1.6654–2 also issued under 26 U.S.C. 6654(m).
(a)
(1) * * *
(ii)
(A)
(B)
(C) The trade or business may be organized as, or take the legal form of, a corporation, partnership, limited liability company, or sole proprietorship.
(D) A qualified individual shall file a certification of the individual's qualification in the manner and at the time prescribed by the Internal Revenue Service in forms, publications, or other guidance.
(f)
Occupational Safety and Health Administration, Labor.
Interim final rule; request for comments.
This document provides the interim final regulations governing the employee protection (whistleblower) provision of section 1558 of the Affordable Care Act, which added section 18C of the Fair Labor Standards Act, to provide protections to employees of health insurance issuers or other employers who may have been subject to retaliation for reporting potential violations of the law's consumer protections (
This interim final rule is effective on February 27, 2013. Comments and additional materials must be submitted (post-marked, sent or received) by April 29, 2013.
You may submit comments and attachments electronically at
The Patient Protection and Affordable Care Act, Public Law 111–148, 124 Stat. 119, was signed into law on March 23, 2010 and was amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111–152, 124 Stat. 1029, that was signed into law on March 30, 2010. The terms “Affordable Care Act” or “Act” are used in this rulemaking to refer to the final, amended version of the law. The Affordable Care Act contains various provisions designed to make health care more affordable and accountable.
Among the policies to achieve its goals, the Affordable Care Act's section 1558 amended the Fair Labor Standards Act (FLSA) to add section 18C, 29 U.S.C. 218C (section 18C), which provides protection to employees against retaliation by an employer for engaging in certain protected activities.
Under section 18C, an employer may not retaliate against an employee for receiving a credit under section 36B of the Internal Revenue Code of 1986 or a cost-sharing reduction (referred to as a “subsidy” in section 18C) under section 1402 of Affordable Care Act. These provisions allow employees to receive tax credits or cost-sharing reductions while enrolled in a qualified health plan through an exchange, if their employer does not offer a coverage option that is affordable and provides a basic level of value (
Section 18C also protects employees against retaliation because they provided or are about to provide to their employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of, any provision of or amendment made by title I of the Affordable Care Act; testified or are about to testify in a proceeding concerning such violation; assisted or participated, or are about to assist or participate, in such a proceeding; or objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee reasonably believed to be in violation of any provision of title I of the Act (or amendment), or any order, rule, regulation, standard, or ban under title I of the Act (or amendment). Title I includes a range of insurance company accountability policies such as: The prohibition of lifetime dollar limits on coverage, the requirement for most plans to cover recommended preventive services with no cost sharing, and, starting in 2014, guaranteed availability (also known as guaranteed issue) protections so that individuals and employers will be able to obtain coverage that currently can be denied due to a pre-existing condition, and the prohibition on the use of factors such as health status, medical history, gender, and industry of employment to set premium rates.
Section 18C became effective on the date the health care law was enacted, March 23, 2010. On January 1, 2014, the scope of coverage of section 18C will be expanded by section 2706(b) of the Public Health Service Act (PHSA), 42 U.S.C. 300gg
These interim rules establish procedures for the handling of whistleblower complaints under section 18C of the FLSA; these procedures are very similar to those used for whistleblower complaints in other industries.
Section 18C(b)(1) adopts the procedures, notifications, burdens of proof, remedies, and statutes of limitation in the Consumer Product Safety Improvement Act of 2008 (CPSIA), 15 U.S.C. 2087(b). Accordingly, a covered employee may file a complaint with the Secretary of Labor (Secretary) within 180 days of the alleged retaliation. Upon receipt of the complaint, the Secretary must provide written notice to the person or persons named in the complaint alleged to have violated the Act (respondent) of the filing of the complaint, the allegations contained in the complaint, the substance of the evidence supporting the complaint, and the rights afforded the respondent throughout the investigation. The Secretary must then, within 60 days of receipt of the complaint, afford the complainant and respondent an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation.
The Secretary may conduct an investigation only if the complainant has made a prima facie showing that the protected activity was a contributing factor in the adverse action alleged in the complaint and the respondent has not demonstrated, through clear and convincing evidence, that the respondent would have taken the same adverse action in the absence of that activity.
After investigating a complaint, the Secretary will issue written findings. If, as a result of the investigation, the Secretary finds there is reasonable cause to believe that retaliation has occurred, the Secretary must notify the respondent of those findings, along with a preliminary order that requires the respondent to, where appropriate: Take affirmative action to abate the violation; reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages to the complainant, as well as all costs and expenses (including attorney fees and expert witness fees) reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.
The complainant and the respondent then have 30 days after the date of the Secretary's notification in which to file objections to the findings and/or preliminary order and request a hearing before an ALJ. The filing of objections under section 18C of the FLSA will stay any remedy in the preliminary order except for preliminary reinstatement. If a hearing before an ALJ is not requested within 30 days, the preliminary order becomes final and is not subject to judicial review.
If a hearing is held, the statute requires the hearing to be conducted “expeditiously.” The Secretary then has 120 days after the conclusion of any hearing in which to issue a final order, which may provide appropriate relief or deny the complaint. Until the Secretary's final order is issued, the Secretary, the complainant, and the respondent may enter into a settlement agreement that terminates the proceeding. Where the Secretary has determined that a violation has occurred, the Secretary, where appropriate, will assess against the respondent a sum equal to the total amount of all costs and expenses, including attorney's and expert witness fees, reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the Secretary issued the order. The Secretary also may award a prevailing respondent a reasonable attorney's fee, not exceeding $1,000, if the Secretary finds that the complaint is frivolous or has been brought in bad faith. Within 60 days of the issuance of the final order, any person adversely affected or aggrieved by the Secretary's final order may file an appeal with the United States Court of Appeals for the circuit in which the violation occurred or the circuit where the complainant resided on the date of the violation.
The statute permits the employee to seek de novo review of the complaint by a United States district court in the event that the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination. The court will have jurisdiction over the action without regard to the amount in controversy, and the case will be tried before a jury at the request of either party.
Finally, section 18C(b)(2) of the FLSA provides that nothing in section 18C shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement, and the rights and remedies in section 18C may not be waived by any agreement, policy, form, or condition of employment.
The regulatory provisions in this part have been written and organized to be consistent with other whistleblower regulations promulgated by OSHA to the extent possible within the bounds of the statutory language of section 18C of the FLSA and 15 U.S.C. 2087(b) of CPSIA. Responsibility for receiving and investigating complaints under section 18C has been delegated to the Assistant Secretary for Occupational Safety and Health. Secretary's Order 1–2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012). Hearings on determinations by the Assistant Secretary are conducted by the Office of Administrative Law Judges, and appeals from decisions by ALJs are decided by the ARB. Secretary's Order 1–2010 (Jan. 15, 2010), 75 FR 3924 (Jan. 25, 2010).
This section describes the purpose of the regulations implementing section 18C of the FLSA and provides an overview of the procedures covered by these regulations.
This section includes general definitions for the Affordable Care Act whistleblower provision codified at section 18C of the FLSA. The definitions of the terms “employer,” “employee,” and “person” from section 3 of the FLSA, 29 U.S.C. 203, apply to these rules and are included here.
The FLSA defines “employer” as including “any person acting directly or indirectly in the interest of an employer in relation to an employee and includes a public agency, but does not include any labor organization (other than when acting as an employer) or anyone acting in the capacity of officer or agent of such labor organization.” 29 U.S.C. 203(d). The FLSA defines “person” to mean “an individual, partnership, association, corporation, business trust, legal representative, or any organized group of persons.” 29 U.S.C. 203(a).
The FLSA defines “employee” to mean “any individual employed by an employer.” 29 U.S.C. 203(e)(1). In the case of an individual employed by a public agency, the term employee means any individual employed by the Government of the United States: As a civilian in the military departments (as defined in section 102 of the U.S. Code at title 5), in any executive agency (as
Consistent with the Secretary's interpretation of the term “employee” in the other whistleblower statutes administered by OSHA
This section describes the activities that are protected under section 18C of the FLSA, and the conduct that is prohibited in response to any protected activities. Section 18C(a)(1) protects any employee from retaliation “because the employee received a credit under section 36B of the Internal Revenue Code of 1986 or a subsidy under section 1402 of this Act.” The reference to “a subsidy under section 1402 this Act” in section 18C(a)(1) refers to receipt of a cost-sharing reduction under section 1402 of the Affordable Care Act. 42 U.S.C. 18071.
Under section 18C(a)(2), an employer may not retaliate against an employee because the employee “provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of, any provision of this title (or an amendment made by this title).” Section 18C also protects employees who testify, assist or participate in proceedings concerning such violations. Sections 18C(a)(3) and (4), 29 U.S.C. 218C(a)(3) and (4). Finally, section 18C(a)(5) prohibits retaliation because an employee “objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this title (or amendment), or any order, rule, regulation, standard, or ban under this title (or amendment).” References to “this title” in section 18C(a)(2) and (5) refer to Title I of the Affordable Care Act. This includes health insurance reforms such as providing guaranteed availability (also known as guaranteed issue) protections so that individuals and employers will be able to obtain coverage when it currently can be denied, continuing current guaranteed renewability protections, prohibiting the use of factors such as health status, medical history, gender, and industry of employment to set premium rates, limiting age rating, and prohibiting issuers from dividing up their insurance pools within markets.
In order to have a “reasonable belief” under sections 18C(a)(2) and (5), a complainant must have both a subjective, good faith belief and an objectively reasonable belief that the complained-of conduct violates one of the listed categories of law.
This section explains the requirements for filing a retaliation complaint under section 18C. To be timely, a complaint must be filed within 180 days of when the alleged violation occurs. Under
OSHA notes that a complaint of retaliation filed with OSHA under the Affordable Care Act is not a formal document and need not conform to the pleading standards for complaints filed in federal district court articulated in
This section describes the procedures that apply to the investigation of complaints under section 18C. Paragraph (a) of this section outlines the procedures for notifying the parties and appropriate Federal agencies of the complaint and notifying the respondent of its rights under these regulations. Paragraph (b) describes the procedures for the respondent to submit its response to the complaint. Paragraph (c) specifies that throughout the investigation the Agency will provide to the complainant (or the complainant's legal counsel if the complainant is represented by counsel) a copy of respondent's submissions to the Agency that are responsive to the complainant's whistleblower complaint and the complainant will have an opportunity to respond to those submissions. Before providing such materials to the complainant, the Agency will redact them in accordance with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. Paragraph (d) of this section discusses confidentiality of information provided during investigations. Paragraph (e) of this section sets forth the applicable burdens of proof. Paragraph (f) describes the procedures the Assistant Secretary will follow prior to the issuance of findings and a preliminary order when the Assistant Secretary has reasonable cause to believe that a violation has occurred.
Section 18C of the FLSA incorporates the burdens of proof set forth in CPSIA. 15 U.S.C. 2087(b). That statute requires that a complainant make an initial prima facie showing that protected activity was “a contributing factor” in the adverse action alleged in the complaint,
If the complainant does not make the required prima facie showing, the investigation must be discontinued and the complaint dismissed.
Assuming that an investigation proceeds beyond the gatekeeping phase, the statutory burdens of proof require an employee to prove that the alleged protected activity was a “contributing factor” in the alleged adverse action. If the employee proves that the alleged
The statutory burdens of proof do not address the evidentiary standard that applies to a complainant's proof that protected activity was a contributing factor in an adverse action. Rather, they simply provide that the Secretary may find a violation only “if the complainant demonstrates” that protected activity was a contributing factor in the alleged adverse action.
Section 18C also incorporates the authorities in the FLSA sections 9 and 11, 29 U.S.C. 209 and 211, to issue subpoenas and conduct investigations. Such authorities under section 18C are delegated and assigned to the Assistant Secretary for Occupational Safety and Health.
This section provides that, on the basis of information obtained in the investigation, the Assistant Secretary will issue, within 60 days of the filing of a complaint, written findings regarding whether or not there is reasonable cause to believe that the complaint has merit. If the findings are that there is reasonable cause to believe that the complaint has merit, the Assistant Secretary will order appropriate relief, including preliminary reinstatement, affirmative action to abate the violation, back pay with interest, and compensatory damages. The findings and, where appropriate, preliminary order, advise the parties of their right to file objections to the findings of the Assistant Secretary and to request a hearing. The findings and, where appropriate, preliminary order, also advise the respondent of the right to request an award of attorney's fees not exceeding $1,000 from the ALJ, regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. If no objections are filed within 30 days of receipt of the findings, the findings and any preliminary order of the Assistant Secretary become the final decision and order of the Secretary. If objections are timely filed, any order of preliminary reinstatement will take effect, but the remaining provisions of the order will not take effect until administrative proceedings are completed.
In ordering interest on back pay under section 18C, the Secretary has determined that interest due will be computed by compounding daily the Internal Revenue Service interest rate for the underpayment of taxes, which under 26 U.S.C. 6621 is generally the Federal short-term rate plus three percentage points. The Secretary believes that daily compounding of interest achieves the make-whole purpose of a back pay award. Daily compounding of interest has become the norm in private lending and recently was found to be the most appropriate method of calculating interest on back pay by the National Labor Relations Board.
In appropriate circumstances, in lieu of preliminary reinstatement, OSHA may order that the complainant receive the same pay and benefits that he or she received prior to his termination, but not actually return to work. Such “economic reinstatement” is akin to an order for front pay and frequently is employed in cases arising under section 105(c) of the Federal Mine Safety and Health Act of 1977, 30 U.S.C. 815(c), which protects miners from retaliation.
To be effective, objections to the findings of the Assistant Secretary must be in writing and must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, within 30 days of receipt of the findings. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of the filing; if the objection is filed in person, by hand-delivery or other means, the objection is filed upon receipt. The filing of objections also is considered a request for a hearing before an ALJ. Although the parties are directed to serve a copy of their objections on the other parties of record, as well as the OSHA official who issued the findings and order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards, the failure to serve copies of the objections on the other parties of record does not affect the ALJ's jurisdiction to hear and decide the merits of the case.
The timely filing of objections stays all provisions of the preliminary order, except for the portion requiring reinstatement. A respondent may file a motion to stay OSHA's preliminary order of reinstatement with the Office of Administrative Law Judges. However, such a motion will be granted only based on exceptional circumstances. The Secretary believes that a stay of the Assistant Secretary's preliminary order of reinstatement under section 18C of the FLSA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief,
This section adopts the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges at 29 CFR part 18 subpart A. It specifically provides for hearings to be consolidated if both the complainant and respondent object to the findings and/or order of the Assistant Secretary. This section provides that the hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo on the record. As noted in this section, formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.
The Assistant Secretary, at his or her discretion, may participate as a party or amicus curiae at any time in the administrative proceedings under section 18C of the FLSA. For example, the Assistant Secretary may exercise his or her discretion to prosecute the case in the administrative proceeding before an ALJ; petition for review of a decision of an ALJ, including a decision based on a settlement agreement between the complainant and the respondent, regardless of whether the Assistant Secretary participated before the ALJ; or participate as amicus curiae before the ALJ or in the ARB proceeding. Although OSHA anticipates that ordinarily the Assistant Secretary will not participate, the Assistant Secretary may choose to do so in appropriate cases, such as cases involving important or novel legal issues, large numbers of employees, alleged violations that appear egregious, or where the interests of justice might require participation by the Assistant Secretary. The Internal Revenue Service of the United States Department of the Treasury, the United States Department of Health and Human Services, and the Employee Benefits Security Administration of the United States Department of Labor, if interested in a proceeding, also may participate as amicus curiae at any time in the proceedings.
This section sets forth the requirements for the content of the decision and order of the ALJ, and includes the standard for finding a violation under section 18C. Paragraph (c) of this section further provides that the Assistant Secretary's determination to dismiss the complaint without an investigation or without a complete investigation under section 1984.104 is not subject to review. Thus, section 1984.109(c) clarifies that the Assistant Secretary's determinations on whether to proceed with an investigation under section 18C and whether to make particular investigative findings are discretionary decisions not subject to review by the ALJ. The ALJ hears cases de novo and, therefore, as a general matter, may not remand cases to the Assistant Secretary to conduct an investigation or make further factual findings. A full discussion of the burdens of proof used by the Department of Labor to resolve whistleblower cases under this part is described above in the discussion of section 1984.104. Paragraph (d) notes the remedies that the ALJ may order under section 18C and, as discussed under section 1984.105 above, provides that interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. Paragraph (e) requires that the ALJ's decision be served on all parties to the proceeding, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. Paragraph (e) also provides that any ALJ decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other
Upon the issuance of the ALJ's decision, the parties have 14 days within which to petition the ARB for review of that decision. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing of the petition; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt.
The appeal provisions in this part provide that an appeal to the ARB is not a matter of right but is accepted at the discretion of the ARB. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. The ARB has 30 days to decide whether to grant the petition for review. If the ARB does not grant the petition, the decision of the ALJ becomes the final decision of the Secretary. If a timely petition for review is filed with the ARB, any relief ordered by the ALJ, except for that portion ordering reinstatement, is inoperative while the matter is pending before the ARB. When the ARB accepts a petition for review, the ALJ's factual determinations will be reviewed under the substantial evidence standard.
This section also provides that, based on exceptional circumstances, the ARB may grant a motion to stay an ALJ's preliminary order of reinstatement under section 18C, which otherwise would be effective, while review is conducted by the ARB. The Secretary believes that a stay of an ALJ's preliminary order of reinstatement under section 18C would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief,
If the ARB concludes that the respondent has violated the law, it will issue a final order providing relief to the complainant. The final order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney's and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney's fee, not exceeding $1,000.
This section provides the procedures and time periods for withdrawal of complaints, the withdrawal of findings and/or preliminary orders by the Assistant Secretary, and the withdrawal of objections to findings and/or orders. It permits complainants to withdraw their complaints orally and provides that, in such circumstances, OSHA will confirm a complainant's desire to withdraw in writing. It also provides for approval of settlements at the investigative and adjudicative stages of the case.
This section describes the statutory provisions of CPSIA, incorporated into section 18C of the FLSA, for judicial review of decisions of the Secretary and requires, in cases where judicial review is sought, the ARB to submit the record of proceedings to the appropriate court pursuant to the rules of such court.
This section describes the Secretary's authority under section 18C to obtain judicial enforcement of orders and the terms of settlement agreements. Section 18C incorporates the procedures, notifications, burdens of proof, remedies, and statutes of limitations set forth in CPSIA, 15 U.S.C. 2087(b), which expressly authorizes district courts to enforce orders, including preliminary orders of reinstatement, issued by the Secretary.
This section sets forth provisions that allow a complainant to bring an original de novo action in district court, alleging the same allegations contained in the complaint filed with OSHA, under certain circumstances. By incorporating the procedures, notifications, burdens of proof, remedies, and statutes of limitations set forth in CPSIA, 15 U.S.C.
Under section 18C of the FLSA, the Assistant Secretary's written findings become the final order of the Secretary, not subject to judicial review, if no objection is filed within 30 days.
This section also requires that, within seven days after filing a complaint in district court, a complainant must provide a file-stamped copy of the complaint to the Assistant Secretary, the ALJ, or the ARB, depending on where the proceeding is pending. A copy of the complaint also must be provided to the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. This provision is necessary to notify the Agency that the complainant has opted to file a complaint in district court. This provision is not a substitute for the complainant's compliance with the requirements for service of process of the district court complaint contained in the Federal Rules of Civil Procedure and the local rules of the district court where the complaint is filed. The section also incorporates the statutory provisions which allow for a jury trial at the request of either party in a district court action, and which specify the remedies and burdens of proof in a district court action.
This section provides that in circumstances not contemplated by these rules or for good cause the ALJ or the ARB may, upon application and notice to the parties, waive any rule as justice or the administration of section 18C of the FLSA requires.
This rule contains a reporting provision (filing a retaliation complaint, section 1984.103) which was previously reviewed as a statutory requirement of section 18C of the FLSA, 29 U.S.C. 218C, and approved for use by the Office of Management and Budget (“OMB”), and was assigned OMB control number 1218–0236 under the provisions of the Paperwork Reduction Act of 1995, Public Law 104–13, 109 Stat. 163 (1995). A non-material change has been submitted to OMB to include the regulatory citation.
The notice and comment rulemaking procedures of section 553 of the Administrative Procedure Act (APA) do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This is a rule of agency procedure, practice and interpretation within the meaning of that section. Therefore, publication in the
Furthermore, because this rule is procedural and interpretative rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule be effective 30 days after publication in the
The Office of Management and Budget has concluded that this rule is a “significant regulatory action” within the meaning of section 3(f)(4) of Executive Order 12866. Executive Order 12866, reaffirmed by Executive Order 13563, requires a full economic impact analysis only for “economically significant” rules, which are defined in section 3(f)(1) of Executive Order 12866 as rules that may “[h]ave 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.” Because the rule is procedural and interpretative in nature, it is expected to have a negligible economic impact. Therefore, no economic impact analysis has been prepared. For the same reason, the rule does not require a section 202 statement under the Unfunded Mandates Reform Act of 1995. 2 U.S.C. 1531
The Department has determined that the regulation will not have a significant economic impact on a substantial number of small entities. The regulation simply implements procedures necessitated by enactment of section 18C of the FLSA. Furthermore, no certification to this effect is required and no regulatory flexibility analysis is required because no proposed rule has been issued.
Administrative practice and procedure, Employment, Health care, Investigations, Reporting and recordkeeping requirements, Whistleblower.
This document was prepared under the direction and control of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health.
Accordingly, for the reasons set out in the preamble, 29 CFR part 1984 is added to read as follows:
29 U.S.C. 218C; Secretary's Order 1–2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012); Secretary's Order 1–2010 (Jan. 15, 2010), 75 FR 3924 (Jan. 25, 2010).
(a) This part implements procedures under section 1558 of the Patient Protection and Affordable Care Act, Public Law 111–148, 124 Stat. 119, which was signed into law on March 23, 2010 and was amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111–152, 124 Stat. 1029, signed into law on March 30, 2010. The terms “Affordable Care Act” or “the Act” are used in this part to refer to the final, amended version of the law. Section 1558 of the Act amended the Fair Labor Standards Act, 29 U.S.C. 201
(b) This part establishes procedures under section 18C of the FLSA for the expeditious handling of retaliation complaints filed by employees, or by persons acting on their behalf. These rules, together with those codified at 29 CFR part 18, set forth the procedures under section 18C of the FLSA for submission of complaints, investigations, issuance of findings and preliminary orders, objections to findings and orders, litigation before administrative law judges (ALJs), post-hearing administrative review, and withdrawals and settlements.
As used in this part:
(a)
(b)
(c)
(d)
(e)(1)
(2) The term
(i) Any individual who volunteers to perform services for a public agency which is a State, a political subdivision of a State, or an interstate governmental agency, if the individual receives no compensation or is paid expenses, reasonable benefits, or a nominal fee to perform the services for which the individual volunteered—and such services are not the same type of services which the individual is employed to perform for such public agency;
(ii) Any employee of a public agency which is a State, political subdivision of a State, or an interstate governmental agency that volunteers to perform services for any other State, political subdivision, or interstate governmental agency, including a State, political subdivision or agency with which the employing State, political subdivision, or agency has a mutual aid agreement; or
(iii) Any individual who volunteers their services solely for humanitarian purposes to private non-profit food banks and who receive groceries from the food banks.
(3) The term employee includes former employees and applicants for employment.
(f)
(g)
(h)
(i)
(j)
(k) Any future statutory amendments that affect the definition of a term or terms listed in this section will apply in lieu of the definition stated herein.
(a) No employer may discharge or otherwise retaliate against, including, but not limited to, intimidating, threatening, restraining, coercing, blacklisting or disciplining, any employee with respect to the employee's compensation, terms, conditions, or privileges of employment because the employee (or an individual acting at the request of the employee), has engaged in any of the activities specified in paragraphs (b)(1) through (5) of this section.
(b) An employee is protected against retaliation because the employee (or an individual acting at the request of the employee) has:
(1) Received a credit under section 36B of the Internal Revenue Code of 1986, 26 U.S.C. 36B, or a subsidy under section 1402 of the Affordable Care Act, 42 U.S.C. 18071;
(2) Provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of, any provision of title I of the Affordable Care Act (or an amendment made by title I of the Affordable Care Act);
(3) Testified or is about to testify in a proceeding concerning such violation;
(4) Assisted or participated, or is about to assist or participate, in such a proceeding; or
(5) Objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of title I of the Affordable Care Act (or amendment), or any order, rule, regulation, standard, or ban under title I of the Affordable Care Act (or amendment).
(a)
(b)
(c)
(d)
(a) Upon receipt of a complaint in the investigating office, the Assistant Secretary will notify the respondent of the filing of the complaint, of the allegations contained in the complaint, and of the substance of the evidence supporting the complaint. Such materials will be redacted, if necessary, in accordance with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. The Assistant Secretary will also notify the respondent of its rights under paragraphs (b) and (f) of this section and paragraph (e) of § 1984.110. The Assistant Secretary will provide an unredacted copy of these same materials to the complainant (or complainant's legal counsel if complainant is represented by counsel) and to the appropriate office of the Federal agency charged with the administration of the general provisions of the Affordable Care Act under which the complaint is filed: Either the Internal Revenue Service of the United States Department of the Treasury (IRS), the United States Department of Health and Human Services (HHS), or the Employee Benefits Security Administration of the United States Department of Labor (EBSA).
(b) Within 20 days of receipt of the notice of the filing of the complaint provided under paragraph (a) of this section, the respondent and the complainant each may submit to the Assistant Secretary a written statement and any affidavits or documents substantiating its position. Within the same 20 days, the respondent and the complainant each may request a meeting with the Assistant Secretary to present its position.
(c) Throughout the investigation, the Agency will provide to the complainant (or the complainant's legal counsel if complainant is represented by counsel) a copy of all of respondent's submissions to the Agency that are responsive to the complainant's whistleblower complaint. Before providing such materials to the complainant, the Agency will redact them, if necessary, in accordance with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. The Agency will also provide the complainant with an opportunity to respond to such submissions.
(d) Investigations will be conducted in a manner that protects the confidentiality of any person who provides information on a confidential
(e)(1) A complaint will be dismissed unless the complainant has made a prima facie showing that protected activity was a contributing factor in the adverse action alleged in the complaint.
(2) The complaint, supplemented as appropriate by interviews of the complainant, must allege the existence of facts and evidence to make a prima facie showing as follows:
(i) The employee engaged in a protected activity;
(ii) The respondent knew or suspected that the employee engaged in the protected activity;
(iii) The employee suffered an adverse action; and
(iv) The circumstances were sufficient to raise the inference that the protected activity was a contributing factor in the adverse action.
(3) For purposes of determining whether to investigate, the complainant will be considered to have met the required burden if the complaint on its face, supplemented as appropriate through interviews of the complainant, alleges the existence of facts and either direct or circumstantial evidence to meet the required showing, i.e., to give rise to an inference that the respondent knew or suspected that the employee engaged in protected activity and that the protected activity was a contributing factor in the adverse action. The burden may be satisfied, for example, if the complaint shows that the adverse action took place shortly after the protected activity, giving rise to the inference that it was a contributing factor in the adverse action. If the required showing has not been made, the complainant (or the complainant's legal counsel, if complainant is represented by counsel) will be so notified and the investigation will not commence.
(4) Notwithstanding a finding that a complainant has made a prima facie showing, as required by this section, an investigation of the complaint will not be conducted or will be discontinued if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of the complainant's protected activity.
(5) If the respondent fails to make a timely response or fails to satisfy the burden set forth in the prior paragraph, the Assistant Secretary will proceed with the investigation. The investigation will proceed whenever it is necessary or appropriate to confirm or verify the information provided by the respondent.
(f) Prior to the issuance of findings and a preliminary order as provided for in § 1984.105, if the Assistant Secretary has reasonable cause, on the basis of information gathered under the procedures of this part, to believe that the respondent has violated section 18C of the FLSA and that preliminary reinstatement is warranted, the Assistant Secretary will again contact the respondent (or the respondent's legal counsel if respondent is represented by counsel) to give notice of the substance of the relevant evidence supporting the complainant's allegations as developed during the course of the investigation. This evidence includes any witness statements, which will be redacted to protect the identity of confidential informants where statements were given in confidence; if the statements cannot be redacted without revealing the identity of confidential informants, summaries of their contents will be provided. The complainant will also receive a copy of the materials that must be provided to the respondent under this paragraph. Before providing such materials to the complainant, the Agency will redact them, if necessary, in accordance with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. The respondent will be given the opportunity to submit a written response, to meet with the investigators, to present statements from witnesses in support of its position, and to present legal and factual arguments. The respondent must present this evidence within 10 business days of the Assistant Secretary's notification pursuant to this paragraph, or as soon thereafter as the Assistant Secretary and the respondent can agree, if the interests of justice so require.
(a) After considering all the relevant information collected during the investigation, the Assistant Secretary will issue, within 60 days of the filing of the complaint, written findings as to whether or not there is reasonable cause to believe that the respondent has retaliated against the complainant in violation of section 18C of the FLSA.
(1) If the Assistant Secretary concludes that there is reasonable cause to believe that a violation has occurred, the Assistant Secretary will accompany the findings with a preliminary order providing relief to the complainant. The preliminary order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney's and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily.
(2) If the Assistant Secretary concludes that a violation has not occurred, the Assistant Secretary will notify the parties of that finding.
(b) The findings and, where appropriate, the preliminary order will be sent by certified mail, return receipt requested, to all parties of record (and each party's legal counsel if the party is represented by counsel). The findings and, where appropriate, the preliminary order will inform the parties of the right to object to the findings and/or order and to request a hearing, and of the right of the respondent to request an award of attorney's fees not exceeding $1,000 from the ALJ, regardless of whether the respondent has filed objections, if respondent alleges that the complaint was frivolous or brought in bad faith. The findings and, where appropriate, the preliminary order also will give the address of the Chief Administrative Law Judge, U.S. Department of Labor. At the same time, the Assistant Secretary will file with the Chief Administrative Law Judge a copy of the original complaint and a copy of the findings and/or order.
(c) The findings and any preliminary order will be effective 30 days after receipt by the respondent (or the respondent's legal counsel if the respondent is represented by counsel), or on the compliance date set forth in the preliminary order, whichever is later, unless an objection and/or a request for hearing has been timely filed as provided at § 1984.106. However, the portion of any preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and the preliminary order, regardless of any objections to the findings and/or the order.
(a) Any party who desires review, including judicial review, of the findings and/or preliminary order, or a respondent alleging that the complaint was frivolous or brought in bad faith
(b) If a timely objection is filed, all provisions of the preliminary order will be stayed, except for the portion requiring preliminary reinstatement, which will not be automatically stayed. The portion of the preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and preliminary order, regardless of any objections to the order. The respondent may file a motion with the Office of Administrative Law Judges for a stay of the Assistant Secretary's preliminary order of reinstatement, which shall be granted only based on exceptional circumstances. If no timely objection is filed with respect to either the findings or the preliminary order, the findings and/or the preliminary order will become the final decision of the Secretary, not subject to judicial review.
(a) Except as provided in this part, proceedings will be conducted in accordance with the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges, codified at subpart A of part 18 of this title.
(b) Upon receipt of an objection and request for hearing, the Chief Administrative Law Judge will promptly assign the case to an ALJ who will notify the parties, by certified mail, of the day, time, and place of hearing. The hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo on the record. ALJs have broad discretion to limit discovery in order to expedite the hearing.
(c) If both the complainant and the respondent object to the findings and/or order, the objections will be consolidated and a single hearing will be conducted.
(d) Formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.
(a)(1) The complainant and the respondent will be parties in every proceeding and must be served with copies of all documents in the case. At the Assistant Secretary's discretion, the Assistant Secretary may participate as a party or as amicus curiae at any time at any stage of the proceeding. This right to participate includes, but is not limited to, the right to petition for review of a decision of an ALJ, including a decision approving or rejecting a settlement agreement between the complainant and the respondent.
(2) Copies of documents must be sent to the Assistant Secretary, and to the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, only upon request of the Assistant Secretary, or where the Assistant Secretary is participating in the proceeding, or where service on the Assistant Secretary and the Associate Solicitor is otherwise required by these rules.
(b) The IRS, HHS, and EBSA, if interested in a proceeding, may participate as amicus curiae at any time in the proceeding, at those agencies' discretion. At the request of the interested Federal agency, copies of all documents in a case must be sent to the Federal agency, whether or not the agency is participating in the proceeding.
(a) The decision of the ALJ will contain appropriate findings, conclusions, and an order pertaining to the remedies provided in paragraph (d) of this section, as appropriate. A determination that a violation has occurred may be made only if the complainant has demonstrated by a preponderance of the evidence that protected activity was a contributing factor in the adverse action alleged in the complaint.
(b) If the complainant has satisfied the burden set forth in the prior paragraph, relief may not be ordered if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of any protected activity.
(c) Neither the Assistant Secretary's determination to dismiss a complaint without completing an investigation pursuant to § 1984.104(e) nor the Assistant Secretary's determination to proceed with an investigation is subject to review by the ALJ, and a complaint may not be remanded for the completion of an investigation or for additional findings on the basis that a determination to dismiss was made in error. Rather, if there otherwise is jurisdiction, the ALJ will hear the case on the merits or dispose of the matter without a hearing if the facts and circumstances warrant.
(d)(1) If the ALJ concludes that the respondent has violated the law, the ALJ will issue an order that will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney's and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily.
(2) If the ALJ determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ALJ determines that a complaint was frivolous or was brought in bad faith, the ALJ may award to the respondent a reasonable attorney's fee, not exceeding $1,000.
(e) The decision will be served upon all parties to the proceeding, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor. Any ALJ's decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the Administrative Review Board (ARB), U.S. Department of Labor. The
(a) Any party desiring to seek review, including judicial review, of a decision of the ALJ, or a respondent alleging that the complaint was frivolous or brought in bad faith who seeks an award of attorney's fees, must file a written petition for review with the ARB, which has been delegated the authority to act for the Secretary and issue final decisions under this part. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. A petition must be filed within 14 days of the date of the decision of the ALJ. The date of the postmark, facsimile transmittal, or electronic communication transmittal will be considered to be the date of filing; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt. The petition must be served on all parties and on the Chief Administrative Law Judge at the time it is filed with the ARB. Copies of the petition for review must be served on the Assistant Secretary, and on the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.
(b) If a timely petition for review is filed pursuant to paragraph (a) of this section, the decision of the ALJ will become the final order of the Secretary unless the ARB, within 30 days of the filing of the petition, issues an order notifying the parties that the case has been accepted for review. If a case is accepted for review, the decision of the ALJ will be inoperative unless and until the ARB issues an order adopting the decision, except that any order of reinstatement will be effective while review is conducted by the ARB, unless the ARB grants a motion by the respondent to stay that order based on exceptional circumstances. The ARB will specify the terms under which any briefs are to be filed. The ARB will review the factual determinations of the ALJ under the substantial evidence standard. If no timely petition for review is filed, or the ARB denies review, the decision of the ALJ will become the final order of the Secretary. If no timely petition for review is filed, the resulting final order is not subject to judicial review.
(c) The final decision of the ARB will be issued within 120 days of the conclusion of the hearing, which will be deemed to be 14 days after the date of the decision of the ALJ, unless a motion for reconsideration has been filed with the ALJ in the interim. In such case, the conclusion of the hearing is the date the motion for reconsideration is ruled upon or 14 days after a new decision is issued. The ARB's final decision will be served upon all parties and the Chief Administrative Law Judge by mail. The final decision will also be served on the Assistant Secretary, and on the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, even if the Assistant Secretary is not a party.
(d) If the ARB concludes that the respondent has violated the law, the ARB will issue a final order providing relief to the complainant. The final order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to the complainant's former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney's and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily.
(e) If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney's fee, not exceeding $1,000.
(a) At any time prior to the filing of objections to the Assistant Secretary's findings and/or preliminary order, a complainant may withdraw his or her complaint by notifying the Assistant Secretary, orally or in writing, of his or her withdrawal. The Assistant Secretary then will confirm in writing the complainant's desire to withdraw and determine whether to approve the withdrawal. The Assistant Secretary will notify the parties (and each party's legal counsel if the party is represented by counsel) of the approval of any withdrawal. If the complaint is withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section. A complainant may not withdraw his or her complaint after the filing of objections to the Assistant Secretary's findings and/or preliminary order.
(b) The Assistant Secretary may withdraw the findings and/or preliminary order at any time before the expiration of the 30-day objection period described in § 1984.106, provided that no objection has been filed yet, and substitute new findings and/or a new preliminary order. The date of the receipt of the substituted findings or order will begin a new 30-day objection period.
(c) At any time before the Assistant Secretary's findings and/or order become final, a party may withdraw objections to the Assistant Secretary's findings and/or order by filing a written withdrawal with the ALJ. If the case is on review with the ARB, a party may withdraw a petition for review of an ALJ's decision at any time before that decision becomes final by filing a written withdrawal with the ARB. The ALJ or the ARB, as the case may be, will determine whether to approve the withdrawal of the objections or the petition for review. If the ALJ approves a request to withdraw objections to the Assistant Secretary's findings and/or order, and there are no other pending objections, the Assistant Secretary's findings and/or order will become the final order of the Secretary. If the ARB approves a request to withdraw a petition for review of an ALJ decision, and there are no other pending petitions for review of that decision, the ALJ's decision will become the final order of the Secretary. If objections or a petition for review are withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section.
(d)(1)
(2)
(e) Any settlement approved by the Assistant Secretary, the ALJ, or the ARB will constitute the final order of the Secretary and may be enforced in United States district court pursuant to § 1984.113.
(a) Within 60 days after the issuance of a final order under §§ 1984.109 and 1984.110, any person adversely affected or aggrieved by the order may file a petition for review of the order in the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit in which the complainant resided on the date of the violation.
(b) A final order is not subject to judicial review in any criminal or other civil proceeding.
(c) If a timely petition for review is filed, the record of a case, including the record of proceedings before the ALJ, will be transmitted by the ARB or the ALJ, as the case may be, to the appropriate court pursuant to the Federal Rules of Appellate Procedure and the local rules of such court.
Whenever any person has failed to comply with a preliminary order of reinstatement, or a final order, including one approving a settlement agreement, issued under section 18C of the FLSA, the Secretary or a person on whose behalf the order was issued may file a civil action seeking enforcement of the order in the United States district court for the district in which the violation was found to have occurred. The Secretary also may file a civil action seeking enforcement of the order in the United States district court for the District of Columbia.
(a) The complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which will have jurisdiction over such an action without regard to the amount in controversy, either:
(1) Within 90 days after receiving a written determination under § 1984.105(a) provided that there has been no final decision of the Secretary; or
(2) If there has been no final decision of the Secretary within 210 days of the filing of the complaint.
(3) At the request of either party, the action shall be tried by the court with a jury.
(b) A proceeding under paragraph (a) of this section shall be governed by the same legal burdens of proof specified in section 1984.109. The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including:
(1) Reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;
(2) The amount of back pay, with interest; and
(3) Compensation for any special damages sustained as a result of the discharge or discrimination, including litigation costs, expert witness fees, and reasonable attorney fees.
(c) Within seven days after filing a complaint in federal court, a complainant must file with the Assistant Secretary, the ALJ, or the ARB, depending on where the proceeding is pending, a copy of the file-stamped complaint. A copy of the complaint also must be served on the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.
In special circumstances not contemplated by the provisions of these rules, or for good cause shown, the ALJ or the ARB on review may, upon application, after three- days notice to all parties, waive any rule or issue such orders that justice or the administration of section 18C of the FLSA requires.
Office of the Secretary, Department of Defense.
Final rule.
This final rule implements Section 713 of the Duncan Hunter National Defense Authorization Act (NDAA) for Fiscal Year 2009. Section 713 states the Secretary shall establish a smoking cessation program under the TRICARE program. The smoking cessation program under TRICARE shall, at a minimum, include the following: The availability, at no cost to the beneficiary, of pharmaceuticals used for smoking cessation, with the limitation on the availability of such pharmaceuticals to the mail-order pharmacy program under the TRICARE program; smoking cessation counseling; access to a toll-free quit line 24 hours a day, 7 days a week; access to print and Internet web-based tobacco cessation material. Per the statute, Medicare-eligible beneficiaries are excluded from the TRICARE smoking cessation program.
Ms. Ginnean Quisenberry, Population Health, Medical Management, and Patient Centered Medical Home Division, Office of the Chief Medical Officer, TRICARE Management Activity, telephone (703) 681–6717.
The purpose of this final rule is to implement the provisions of the Duncan Hunter NDAA for FY 2009 (Pub. L. 110–417) that establishes a smoking cessation program under the TRICARE program. Establishment of the TRICARE smoking cessation program attempts to reduce the number of TRICARE beneficiaries who are nicotine dependent, thereby improving the health of the TRICARE beneficiary population and reducing Department of Defense costs, in particular those related to the adverse effects of smoking. The legal authority for the Final Rule is Section 713 of the Duncan Hunter NDAA FY09 (Pub. L. 110–417).
Section 713 of the Duncan Hunter NDAA for FY 2009 stipulates the following key features for inclusion in the TRICARE smoking cessation program:
1.
Smoking cessation medications will be covered by TRICARE through the Mail Order Pharmacy program, as well
2.
In person smoking cessation counseling from a TRICARE authorized provider as detailed in the TRICARE Policy Manual for is a covered TRICARE benefit for those beneficiaries that are not eligible for Medicare.
3.
Beneficiaries will have access to a toll-free smoking cessation quit line that will be available 24 hours a day, 7 days a week.
4.
TRICARE will provide access to both print and web-based tobacco cessation materials for any beneficiary who is interested in quitting using tobacco products.
5.
All of those in the chain of command are expected to provide their support to the program and to any member who wishes to quit smoking. There is no intent for any reporting requirements to the chain of command related to any member's participation.
The cost for these changes is estimated to be 24 million dollars for a one year period. The benefits are that TRICARE will be in compliance with its statutory provisions and health of beneficiaries who quit smoking will be improved.
The Duncan Hunter NDAA for FY 2009 (Pub. L. 110–417) provides authority for establishment of a smoking cessation program under the TRICARE program. Prior to enactment of Section 713 of the Duncan Hunter NDAA FY09 (Pub. L. 110–417), all supplies and services related to “stop smoking” programs were excluded from TRICARE coverage per the regulation, 32 CFR 199.4(g)(65).
Smoking is the number one cause of
Smoking causes respiratory diseases such as emphysema, bronchitis, and chronic airway obstruction. It also causes several types of cancers including, but not limited to, esophageal, oral cavity, uterine, and lung cancer. In fact, the CDC estimates that 90 percent of lung cancer deaths in men and 80 percent in women are caused by smoking.
Smoking also puts individuals at increased risk for several other types of diseases and adverse health outcomes such as coronary artery disease, chronic obstructive lung diseases, peripheral vascular disease, heart attack, and stroke. In addition, it increases the risk of infertility, preterm delivery, stillbirth, low birth weight, and sudden infant death syndrome.
Smoking and its related adverse effects pose a significant challenge for many TRICARE beneficiaries. Establishment of the TRICARE smoking cessation program attempts to reduce the number of TRICARE beneficiaries who are nicotine dependent, thereby improving the health of the TRICARE beneficiary population and reducing Department of Defense costs, in particular those related to the adverse effects of smoking. For further information on TRICARE and the benefits provided under the TRICARE program, please visit
This final rule implements Section 713 of the Duncan Hunter NDAA for FY 2009. Section 713 stipulates the following key features for inclusion in the TRICARE smoking cessation program:
(1) The availability, at no cost to the beneficiary, of pharmaceuticals used for smoking cessation, with a limitation on the availability of such pharmaceuticals to the national mail-order pharmacy program under the TRICARE program if appropriate.
(2) Counseling.
(3) Access to a toll-free quit line that is available 24 hours a day, 7 days a week.
(4) Access to print and Internet web-based tobacco cessation material.
(5) Chain of command involvement by officers in the chain of command of participants in the program who are on active duty.
Additionally, Section 713 of NDAA FY 2009 stated the TRICARE smoking cessation program shall not be made available to Medicare-eligible beneficiaries. The statutory language further stated that refunds of copayments paid by Medicare-eligible beneficiaries are available during fiscal year 2009, subject to the specific availability of appropriations for this purpose. However, this authority was not extended beyond FY 2009; consequently, no action is required by TRICARE regarding this provision.
This final rule establishes a smoking cessation program under the TRICARE program. The TRICARE smoking cessation program will be available to all TRICARE beneficiaries who reside in one of the 50 United States or the District of Columbia who are not eligible for Medicare benefits authorized under Title XVIII of the Social Security Act. In general, the TRICARE smoking cessation program will not be available to TRICARE beneficiaries who reside overseas except that under authority of 32 CFR 199.17, active duty service members and active duty dependents residing overseas including the U.S. territories of Guam, Puerto Rico, and the Virgin Islands who are enrolled in TRICARE Prime at a military treatment facility may have access to those services that the ASD(HA) has determined may be reasonably provided overseas.
It is the intent of the Department to provide access to smoking cessation pharmaceuticals and web based smoking cessation materials overseas where feasible. However, beneficiaries residing in certain areas overseas may not have easy access to the mail services, equipment or technology needed to receive these smoking cessation benefits and in those areas there is no requirement to make them available. For example, there is no intent by the Department to make the web based services available in areas where there are no web based carriers to provide such a service. Additionally, the laws and our treaties with various countries restrict the mailing of pharmaceuticals into the country. If such laws or treaties do not allow the delivery of the pharmaceuticals through the TRICARE Mail Order Pharmacy (TMOP), it is not the intent of the Secretary to provide the pharmaceutical benefit in those areas through this mechanism.
At this time, it is not the intent of the Department to provide access to the toll free quit line overseas due to the technological barriers and cost involved in providing this service. In addition, it is not the intent of the Department at this time to make face-to-face smoking
There will be no requirement for an eligible beneficiary to be diagnosed with a smoking related illness in order to access benefits under the TRICARE smoking cessation program. Benefits under this program will include, at no cost to the beneficiary, pharmaceuticals used for smoking cessation available through the TRICARE mail-order pharmacy program and at Military Treatment Facilities. The program will include smoking cessation counseling; access to a toll-free quit line 24 hours a day, 7 days a week; and access to printed and Internet web-based tobacco cessation material. Like other pharmaceuticals, smoking cessation pharmaceuticals may also be available at no cost to the beneficiary at an MTF; however, smoking cessation pharmaceuticals are not a covered benefit under the TRICARE Retail Pharmacy program.
The proposed rule was published in the
All but one of the public comments was positive and supported the provisions of the proposed rule. Fifteen of the respondents approved of the new coverage of smoking cessation medications with no copay, however there were two comments questioning the limitation of availability to the Mail Order Pharmacy Program. There was concern that TRICARE had not explained the reasoning for this decision and some were concerned that this limitation would be a barrier to those seeking treatment. We appreciate the comments and acknowledge the concern. However, we do not believe that limiting availability of smoking cessation pharmaceuticals to the mail order pharmacy will be a barrier to seeking care by the majority of beneficiaries. Mail order is a more cost effective venue than retail pharmacy and this limitation is a way of controlling the cost of providing these pharmaceuticals at no cost to the beneficiary. We believe that providing these pharmaceuticals at no cost has a greater influence on a beneficiary's decision to seek care than the fact that the care is limited to a specific venue. We believe this to be a prudent, fair, and reasonable approach to providing the pharmaceutical component of the benefit.
Additionally, one respondent, representing the National Community Pharmacists Association felt that since some retail pharmacists provide smoking cessation counseling, it would be more convenient for beneficiaries to be able to get their medications at the retail pharmacy where they might possibly be going for smoking cessation counseling, so that both activities could occur in one location. We appreciate the respondent's comment and the suggestion that would seemingly offer greater convenience to TRICARE beneficiaries; however, consistent with Center for Medicare and Medicaid Services (CMS), pharmacists are not recognized as authorized TRICARE independent providers. Although TRICARE currently recognizes pharmacies as providers for purposes of the pharmacy benefits program under 32 CFR 199.21, which includes providing immunizations to our beneficiaries, the individual pharmacist is not recognized as an independent provider. Therefore, pharmacist counseling services are not currently a covered benefit under TRICARE and pharmacists cannot be reimbursed for this service. Therefore, beneficiaries who obtain smoking cessation products in a retail pharmacy may not receive counseling from the pharmacist as a covered benefit. In addition, as mentioned above, providing these products in the retail venue would significantly increase the cost of this program. The respondents were also concerned that if medications for smoking cessation are mailed to a patient's home, they will not have the opportunity to ask questions of a pharmacist before taking them. Unlike the majority of retail pharmacies, the mail order pharmacy program provides access to pharmacists 24/7 via a toll free number. Consistent with most pharmacy services, the mail order program provides complete written information including instructions for use, side effects, adverse effects, doses, warnings, and telephone numbers for questions.
Five respondents expressed concern that these new benefits were only available CONUS and not OCONUS. One respondent suggested a change to the language that deals with OCONUS availability. The commentor would prefer that it say that TRICARE is required to make the smoking cessation program available overseas unless the ASD(HA) determines it is not possible to provide the program in specific overseas locations or situations, instead of stating that the benefits are not available overseas unless the Assistant Secretary of Defense for Health Affairs [ASD(HA)] determines they can be reasonably provided. We appreciate the respondent's comments and acknowledge the respondent's suggestion, however during the implementation of this benefit the ability to provide the benefit overseas was extensively explored. The Department found significant barriers and elected not to implement at this time. The language gives the Assistant Secretary the ability to expand the benefit as technology and other innovations make the delivery of these benefits feasible. Additionally the current federal regulations relating to the implementation of TRICARE overseas states that the program is not implemented overseas without affirmative action by the Department, thus the language used is consistent with our current regulatory framework.
One person commented that the smoking cessation program should include provisions to assist with tobacco cessation as well. We appreciate the comment; however, the language in section 713 of the NDAA 2009 limits us to providing a smoking cessation program with one exception. That exception allows the Department to provide printed and Internet web-based tobacco cessation materials.
One respondent was concerned that the language in the summary statement that says that there is a “limitation on the availability of such pharmaceuticals to the mail-order pharmacy” will cause the beneficiaries to believe that they cannot get these medications at the MTF pharmacies. We appreciate the respondent's comment and concern, and would like to assure the respondent that this was unintentional. To correct this and assure clarity, the language in Section III, the Summary, concerning the availability of smoking cessation pharmaceuticals has been revised to include a reference to the availability of pharmaceuticals at the MTFs. The language in the regulation itself reflects the correct availability of these pharmaceutical agents.
The statement in the proposed rule that says, “the Secretary of Defense shall provide for involvement by officers in the chain of command of participants in the program who are on active duty” caused concern for one responder. This commentor took this statement to mean that those active duty members who took advantage of the program would
There were several comments related to the number of quit attempts available to participants in the program. One respondent did not think that a beneficiary should get more than three attempts total. The commenter was opposed to having three possible attempts per year and felt it would be a waste of TRICARE resources to continue to pay for additional attempts for someone who was not successful within a year of trying. We acknowledge the respondent's comments and appreciate the concerns. TRICARE is dedicated to the appropriate and judicious use of taxpayers' money and the decision to allow more than three quit attempts in total was the result of extensive research concerning smoking cessation. This research revealed that, on average, it takes smokers seven attempts to quit. Allowing more than three total attempts will give TRICARE beneficiaries who want to quit smoking the best opportunity to do so. This will result in a healthier beneficiary population; and as this population becomes healthier and more individuals choose to quit, TRICARE health care costs associated with treating diseases that are either caused by or exacerbated by smoking will be reduced.
Another respondent had the opposite view, believing that since “tobacco dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit”, patients should not be limited in their attempts and should have access to tobacco cessation services throughout the year. We acknowledge and respect this respondent's point of view; however, believe it would be fiscally irresponsible not to impose a limit on quit attempts. Furthermore, while our research revealed that the average person requires multiple attempts at quitting before they are successful, our research did not support a conclusion that allowing unlimited quit attempts results in improved success rates.
This respondent also requested that the DoD Pharmacy and Therapeutics Committee, when deciding which specific smoking cessation medications TRICARE will cover, will choose to include all FDA-approved tobacco cessation medications. We appreciate this respondent's comment and suggestion. The Pharmacy and Therapeutics Committee has a mandate to review and recommend drugs based on their clinical and cost effectiveness. After this formal process, these recommendations will then go to the TMA Director, who will make the final decision. At this point, we do not know which of the smoking cessation medications will, or will not be on the formulary.
Another comment requested that TRICARE providers be made aware of the available cessation benefits and be trained in smoking cessation counseling. We appreciate the respondent's comments and suggestions and want to assure this respondent that once the final rule is published and this becomes a TRICARE benefit, information concerning it will be well publicized. This publicity will include information for TRICARE providers and our beneficiaries. Information concerning this new benefit will also be available on the TRICARE Web site (
Another comment recommended an expansion of the TRICARE smoking cessation program to include a reduction of tobacco advertising in military literature and increasing the cost of tobacco products on military bases. We appreciate this respondent's comment and suggestions; however, the authority to take the actions suggested is beyond the scope of the requirements of the law that TRICARE was tasked to implement.
Unrelated to the Proposed Rule on Smoking Cessation, one comment was received from a retiree who was upset that he might be forced to pay more for TRICARE Prime as a part of DoD cutbacks. We appreciate this respondent's comments; however, we cannot address these here as they are outside the scope of the law that implements the TRICARE smoking cessation benefits.
Section 801 of title 5, United States Code, and Executive Orders 12866 and 13563 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. This final rule is not a significant regulatory action.
Public Law 96–354, “Regulatory Flexibility Act” (RFA) (5 U.S.C. 601), requires that each Federal agency prepare a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule will not have a significant impact on a substantial number of small entities. Therefore, this final rule is not subject to the requirements of the RFA.
This rule does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96–511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).
Section 202 of Public Law 104–4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any federal mandate may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100 million in any one year. This final rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year, and thus this final rule is not subject to this requirement.
Executive Order 13132, “Federalism,” requires that an impact analysis be performed to determine whether the rule has federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States,
Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Military personnel.
Accordingly, 32 CFR Part 199 is amended as follows:
5 U.S.C. 301; 10 U.S.C. Chapter 55.
The revisions and additions read as follows:
(d) * * *
(3) * * *
(vi)
(C) Over-the-counter (OTC) drugs (drugs that by United States law do not require a prescription), in general, are not covered. However, insulin is covered for a known diabetic even in states that do not require a prescription for its purchase. In addition, OTC drugs used for smoking cessation are covered when all requirements under the TRICARE smoking cessation program are met as provided in paragraph (e)(30) of this section.
(e) * * *
(30)
(i)
(ii)
(A)
(B)
(C)
(D)
(iii)
(g) * * *
(39)
(i) Services provided by a certified marriage and family therapist, pastoral
(ii) Diabetes self-management training (DSMT) as specifically provided in paragraph (d)(3)(ix) of this section.
(iii) Smoking cessation counseling and education as specifically provided in paragraph (e)(30) of this section.
(iv) Services provided by alcoholism rehabilitation counselors only when rendered in a CHAMPUS-authorized treatment setting and only when the cost of those services is included in the facility's CHAMPUS-determined allowable cost rate.
(65) [Reserved]
The additions and revisions read as follows:
(a) * * *
(2)
(ii)
(h) * * *
(2)
(iii) Pharmaceutical agents prescribed for smoking cessation are not available for coverage when obtained through a retail pharmacy. This includes network and non-network retail pharmacies.
(i) * * *
(2) * * *
(v) * * *
(D) $0.00 co-payment for smoking cessation pharmaceutical agents covered under the smoking cessation program.
Coast Guard, DHS.
Final rule.
The Coast Guard is removing the existing drawbridge operation regulation for the Kansas City Southern (KCS) Railroad drawbridge across Sabine River, mile 36.2, between Newton County, TX and Calcasieu Parish, LA. The drawbridge was converted to a fixed bridge in 2012 and the operating regulation is no longer applicable or necessary.
This rule is effective February 27, 2013.
Documents mentioned in this preamble are part of docket USCG–2012–1065. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Jim Wetherington, Bridge Administration Branch, Coast Guard; telephone 504–671–2128, email
The Coast Guard is issuing this 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 a notice of proposed rulemaking (NPRM) with respect to this rule because the Kansas City Southern Railroad Bridge over the Sabine River, mile 36.2, that once required draw operations in 33 CFR 117.493(b), was converted to a fixed bridge in 2012. Therefore, the regulation is no longer applicable and shall be removed from publication. It is unnecessary to publish an NPRM because this regulatory action does not purport to place any restrictions on mariners but rather removes a restriction that has no further use or value.
Under 5 U.S.C. 553(d)(1), a rule that relieves a restriction is not required to provide the 30 day notice period before its effective date. This rule removes the Kansas City Southern (KCS) Railroad Bridge over the Sabine River, mile 36.2, draw operation requirements under 33 CFR 117. 493(b), thus removing a regulatory restriction on the public.
The KCS Railroad Bridge across the Sabine River, mile 36.2, was converted to a fixed bridge in 2012 after 20 years of not being required to open, by regulation, and being effectively fixed with the removal of all operations equipment by the owner. It has come to the attention of the Coast Guard that the governing regulation for this drawbridge was never removed subsequent to the coversion of the existing bridge to a fixed bridge. The conversion of this drawbridge necessitates the removal of the parts of the drawbridge operation regulation, 33 CFR 117.493(b), that are pertaining to the former drawbridge.
The purpose of this rule is to remove the parts of the paragraph of 33 CFR 117.493(b) that refer to the KCS Railroad Drawbridge at mile 36.2, from the Code of Federal Regulations since it governs a bridge that is no longer able to be opened.
The Coast Guard is changing the regulation in 33 CFR 117.493(b) by removing restrictions and the regulatory burden related to the draw operations for this bridge that is no longer a drawbridge. The change removes the part of the paragraph of the regulation governing the KCS Railroad Bridge, mile 36.2, since the bridge has been converted to a fixed bridge. This Final Rule seeks to update the Code of Federal Regulations by removing language that governs the operation of the KCS Railroad Bridge, mile 36.2, which in fact is no longer a drawbridge. This change does not affect waterway or land traffic. This change does not affect nor does it alter the operating schedules in 33 CFR 117.493(a), the remainder of 33 CFR 117.493(b) that governs the remaining active drawbridge listed in this paragraph nor the remaining active drawbridges on the Sabine River.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
The Coast Guard does not consider this rule to be “significant” under that Order because it is an administrative change and does not affect the way vessels operate on the waterway.
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 rule will have no effect on small entities since this drawbridge has been converted to a fixed bridge and the regulation governing draw operations for this bridge is no longer applicable. There is no new restriction or regulation being imposed by this rule; therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 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 it does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to 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.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b) (2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 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.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have concluded 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 rule involves the removal of the parts of the paragraph of 33 CFR 117.493 (b) that refer to the KCS Railroad Drawbridge at mile 36.2, from the Code of Federal Regulations since it governs a bridge that has been converted to a fixed bridge. This rule is categorically excluded, under figure 2–1, paragraph (32) (e), of the Instruction.
Under figure 2–1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05–1; Department of Homeland Security Delegation No. 0170.1.
(b) The draw of the S12 Bridge, mile 40.8, at Starks, need not be opened for the passage of vessels.
Coast Guard, DHS.
Final rule.
Many of the Coast Guard's regulations incorporate by reference consensus standards that are developed by organizations other than the Coast Guard. This final rule updates references to standards developed by ASTM International, that have been reapproved, without change, since their incorporation into Coast Guard regulation. This rule does not address standards that have changed substantively, and it will not have any substantive impact on the regulated public.
This rule is effective March 29, 2013. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register on March 29, 2013.
Documents mentioned in this preamble as being available in the docket are part of docket USCG–2012–0866 and are available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this rule, call or email Mr. Roger K. Butturini, PE, U.S. Coast Guard Office of Standards Evaluation and Development; telephone 202–372–1494, email
The Coast Guard is issuing this final rule without prior notice and opportunity to comment, pursuant to section 4(a) of the Administrative Procedure Act (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.” As discussed in more detail in this final rule, the industry standards adopted in this rule are merely reapproved editions of the previously incorporated standards. Reapproving a
The purpose of this rule is to update references to incorporated industry standards that have been reapproved, without change, by the standards organization that developed them. In this rule, we focus on standards developed by ASTM International (ASTM). We also are standardizing usage of ASTM's name, which was formerly the American Society for Testing and Materials, updating the listed contact information for publishers, and reformatting certain sections for ease of use.
In updating our references, we ensure that the publications we have incorporated by reference are reasonably available to the public as required by 1 CFR part 51. The Coast Guard's authority to revise its regulations is outlined in 33 CFR 1.05–1, as well as in the authority citations for each part of the Code of Federal Regulations (CFR) amended by this rule. Incorporation by reference is governed by 5 U.S.C. 552(a), 15 U.S.C. 272 note, and 1 CFR part 51.
Voluntary consensus standards are technical standards that are developed or adopted by voluntary consensus standards bodies. They may include specifications for materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices. The Coast Guard has actively participated in the development of industry standards for the safety of marine equipment at the International Maritime Organization, the International Organization for Standardization, ASTM, the American Society of Mechanical Engineers, and other standards development bodies. The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or would otherwise be impractical.
When appropriate, the Coast Guard incorporates industry standards, and particularly voluntary consensus standards, into its regulations. This process, known as incorporation by reference, gives the content of incorporated standards the same force as regulations published in the CFR. Incorporation by reference occurs as part of a rulemaking and is governed by specific rules, which are available at 1 CFR part 51. Under these rules the Coast Guard may only incorporate a specific edition of a standard, and that standard must be reasonably available to the class of persons affected by it. Because standards organizations revise and replace standards over time, the specific edition incorporated by the Coast Guard eventually may become outdated, unavailable, or both. This can lead to conflicts between domestic and international requirements, or between regulatory requirements and modern best practices. Therefore, the Coast Guard reviews its incorporations by reference and updates them if necessary.
Standards organizations sometimes “reapprove” standards without modifying them. Reapproving a standard is a maintenance activity that confirms to the reader that the standard in question is not outdated or superseded as of the year of reapproval. For example, the standard known as ASTM A 575–96, “Standard Specification for Steel Bars, Carbon, Merchant Quality, M-Grades,” was originally published in 1996; when it was reapproved in 2002, it became known as ASTM A 575–96 (Reapproved 2002). It was reapproved again in 2007 as ASTM A 575–96 (Reapproved 2007). The substantive content remains the same as in the 1996 edition.
Because the Coast Guard must incorporate a specific edition, however, reapproval can cause the Coast Guard's incorporation to become outdated or confusing even if the substance of the incorporated standard is unchanged. For example, the Coast Guard incorporated ASTM A 575–96. Although the content of the standard has not changed since the Coast Guard incorporated it, the current version is ASTM A 575–96 (Reapproved 2007) and the incorporated ASTM A 575–96 has been superseded. In some cases, superseded standards are no longer readily available.
This rule updates regulatory references to certain incorporated ASTM standards that have been reapproved without change. We chose to focus on ASTM standards in this rule because we had recently verified that several such standards had been reapproved without change. The Coast Guard is aware that standards developed by other organizations may also have been reapproved and may also require updating, and that some of the Coast Guard's other incorporations may require updating for other reasons. The Coast Guard intends to address those incorporations in future publications in the
The following table lists the title of each standard affected by this rule, the version previously incorporated, the more recent version to be incorporated, and the locations in the CFR where these references occur.
All of the incorporated standards in Table 1 have been reapproved without change. For that reason, incorporating the most recent versions does not change the substantive regulatory requirements and will have no substantive impact on the regulated public.
The Coast Guard is also standardizing usage of the name “ASTM International,” formerly known as the American Society for Testing and Materials, as well as reformatting the reapproved document titles to match the capitalization and punctuation used in the most current publications. These changes are administrative in nature, and will not affect the regulated public in a substantive manner.
Some of the reapproved ASTM standards appear in older sections of the CFR that did not include paragraph designations. The lack of paragraph designations makes reading and cross-referencing these sections more difficult. This rule reformats those sections using the Office of the Federal Register's preferred paragraph designation format. The reformatted sections are 46 CFR 32.01–1, 76.01–2, 153.4, 160.077–5, 160.176–4, and 162.027–1. This rule also updates publisher contact information in these sections when appropriate.
Although these reformatted sections contain incorporated standards other than reapproved ASTM standards, this rule does not update those references, incorporate newer versions, or make any other substantive change to those references. With the exception of the reapproved ASTM standards discussed above, the content of the reformatted sections remains the same as it was prior to this rule. Suggestions for updates to these sections may be submitted to the Coast Guard using the contact information in
In developing this rule, the Coast Guard became aware that 33 CFR 155.140(c)(3) indicated standard ASTM F 722–82 was incorporated by reference in Appendices A and B of 33 CFR part 155. Appendices A and B do not contain any reference to ASTM F 722–82, however, and subsequent research determined this reference to be a typographical error. This rule removes the reference to ASTM F 722–82 from § 155.140. As there is no regulatory requirement in Part 155 associated with the standard, the removal can have no substantive impact on the public.
The Director of the
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders.
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
This final rule makes non-substantive changes throughout Titles 33 and 46 of the CFR. As discussed in more detail in Section V (Discussion of Changes) of this preamble, the industry standards adopted in this rule are merely reapproved editions of the previously incorporated standards. Reapproving a standard is a maintenance activity that confirms to the reader that the standard in question is not outdated or superseded as of the year of reapproval. Therefore, this rule does not change any substantive regulatory requirements and will have no substantive effect on the public. As a result, we expect no additional cost to the industry. No additional labor or resources would be required by the regulated public.
We expect this final rule to be beneficial to the public and to the maritime industry because it will make the Coast Guard's references to these standards consistent with the current standards available for use by industry and will ensure that the publications we have incorporated by reference are reasonably available to the public.
This rule is not preceded by a notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act (5 U.S.C. 601–612). The Regulatory Flexibility Act does not apply when the agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), we want to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
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).
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if the rule 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 it does not have implications for federalism.
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.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 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.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The NTTAA (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This rule uses the following voluntary consensus standards:
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321–4370f), and have concluded 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 rule is categorically excluded under section 2.B.2, figure 2–1, paragraph (34)(a) of the Instruction. This rule falls under the category of editorial or procedural regulations since it involves the adoption of voluntary consensus standards already in effect. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under
Explosives, Harbors, Hazardous substances, Incorporation by reference, Reporting and recordkeeping requirements.
Fire prevention, Harbors, Hazardous substances, Incorporation by reference, Natural gas, Reporting and recordkeeping requirements, Security measures.
Alaska, Fire prevention, Hazardous substances, Incorporation by reference, Oil pollution, Reporting and recordkeeping requirements.
Alaska, Hazardous substances, Incorporation by reference, Oil pollution, Reporting and recordkeeping requirements.
Cargo vessels, Fire prevention, Incorporation by reference, Marine safety, Navigation (water), Occupational safety and health, Reporting and recordkeeping requirements, Seamen.
Cargo vessels, Fire prevention, Incorporation by reference, Marine safety.
Cargo vessels, Fire prevention, Hazardous materials transportation, Incorporation by reference, Marine safety, Occupational safety and health, Reporting and recordkeeping requirements.
Incorporation by reference, Reporting and recordkeeping requirements, Vessels.
Fire prevention, Incorporation by reference, Marine safety, Passenger vessels.
Cargo vessels, Fire prevention, Incorporation by reference, Marine safety.
Fire prevention, Incorporation by reference, Marine safety, Occupational safety and health, Oil and gas exploration, Vessels.
Administrative practice and procedure, Cargo vessels, Hazardous materials transportation, Incorporation by reference, Marine safety, Reporting and recordkeeping requirements, Water pollution control.
Incorporation by reference, Marine safety, Reporting and recordkeeping requirements.
Fire prevention, Incorporation by reference, Marine safety, Oil pollution, Reporting and recordkeeping requirements.
Fire prevention, Incorporation by reference, Marine safety, Oceanographic research vessels.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 126, 127, 154, and 155, and 46 CFR parts 32, 34, 39, 54, 56, 76, 95, 108, 153, 160, 162, and 193 as follows:
33 U.S.C. 1231; 49 CFR 1.46.
(b) * * *
33 U.S.C. 1231; 46 U.S.C. Chapter 701; Department of Homeland Security Delegation No. 0170.1.
(b) * * *
33 U.S.C. 1231, 1321(j)(1)(C), (j)(5), (j)(6), and (m)(2); sec. 2, E.O. 12777, 56 FR 54757; Department of Homeland Security Delegation No. 0170.1. Subpart F is also issued under 33 U.S.C. 2735.
(d) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(3) ASTM F722–82 (Reapproved 2008), Standard Specification for Welded Joints for Shipboard Piping Systems, (approved November 1, 2008), incorporation by reference approved for Appendix A and Appendix B.
33 U.S.C. 1231, 1321(j); 46 U.S.C. 3703; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1. Sections 155.100 through 155.130, 150.350 through 155.400, 155.430, 155.440, 155.470, 155.1030(j) and (k), and 155.1065(g) are also issued under 33 U.S.C. 1903(b). Section 155.490 also issued under section 4110(b) of Pub. L. 101–380. Sections 155.1110 through 155.1150 also issued under 33 U.S.C. 2735.
(c)
(3) [Reserved].
46 U.S.C. 2103, 3306, 3703, 3719; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1; Subpart 32.59 also issued under the authority of Sec. 4109, Pub. L. 101–380, 104 Stat. 515.
(b) American Bureau of Shipping (ABS), ABS Plaza, 16855 Northchase Drive, Houston, TX 77060, 281–877–5800,
(1) Rules for Building and Classing Steel Vessels, 1989, incorporation by reference approved for §§ 32.15–15; 32.60–10; 32.65–40.
(2) [Reserved]
(c) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM D4986–98, Standard Test Method for Horizontal Burning Characteristics of Cellular Polymeric Materials, incorporation by reference approved for § 32.57–10.
(2) ASTM F1273–91 (Reapproved 2007), Standard Specification for Tank Vent Flame Arresters (approved December 1, 2007), incorporation by reference approved for § 32.20–10.
46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F1121–87 (Reapproved 2010), Standard Specification for International Shore Connections for Marine Fire Applications, (approved March 1, 2010), incorporation by reference approved for § 34.10–15 (“ASTM F 1121”).
33 U.S.C. 1231; 46 U.S.C. 3306, 3703, 3715(b); 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
(b) * * *
33 U.S.C. 1509; 43 U.S.C. 1333; 46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
(c)
(2) ASTM A 203/A 203M–97 (Reapproved 2007)
33 U.S.C. 1321(j), 1509; 43 U.S.C. 1333; 46 U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.
(e)
(6) ASTM A134–96 (Reapproved 2012), Standard Specification for Pipe, Steel, Electric-Fusion (Arc)-Welded (Sizes NPS 16 and Over) (“ASTM A 134”), (approved March 1, 2012), incorporation by reference approved for § 56.60–1;
(10) ASTM A179/A179M–90a (Reapproved 2012), Standard Specification for Seamless Cold-Drawn Low-Carbon Steel Heat-Exchanger and Condenser Tubes (“ASTM A 179”), (approved March 1, 2012), incorporation by reference approved for § 56.60–1;
(17) ASTM A214/A214M–96 (Reapproved 2012), Standard Specification for Electric-Resistance-Welded Carbon Steel Heat-Exchanger and Condenser Tubes (“ASTM A 214”), (approved March 1, 2012), incorporation by reference approved for § 56.60–1;
(40) ASTM A 536–84 (Reapproved 2009), Standard Specification for Ductile Iron Castings (“ASTM A 536”), (approved May 1, 2009), incorporation by reference approved for § 56.60–1;
(41) ASTM A 575–96 (Reapproved 2007), Standard Specification for Steel Bars, Carbon, Merchant Quality, M-Grades (“ASTM A 575”), (approved September 1, 2005), incorporation by reference approved for § 56.60–2;
(42) ASTM A576–90b (Reapproved 2012), Standard Specification for Steel Bars, Carbon, Hot-Wrought, Special Quality (“ASTM A576”), (approved March 1, 2012), incorporation by reference approved for § 56.60–2;
(69) ASTM F682–82a (Reapproved 2008), Standard Specification for Wrought Carbon Steel Sleeve-Type Pipe Couplings (“ASTM F 682”), (approved November 1, 2008), incorporation by reference approved for § 56.60–1;
(70) ASTM F1006–86 (Reapproved 2008), Standard Specification for Entrainment Separators for Use in Marine Piping Applications (“ASTM F 1006”), (approved November 1, 2008), incorporation by reference approved for § 56.60–1;
(71) ASTM F1007–86 (Reapproved 2007), Standard Specification for Pipeline Expansion Joints of the Packed Slip Type for Marine Application (“ASTM F 1007”), (approved December 1, 2007), incorporation by reference approved for § 56.60–1;
(72) ASTM F1020–86 (Reapproved 2011), Standard Specification for Line-Blind Valves for Marine Applications (“ASTM F 1020”), (approved April 1, 2011), incorporation by reference approved for § 56.60–1;
(73) ASTM F1120–87 (Reapproved 2010), Standard Specification for Circular Metallic Bellows Type Expansion Joints for Piping Applications (“ASTM F 1120”), (approved May 1, 2010), incorporation by reference approved for § 56.60–1;
(74) ASTM F1123–87 (Reapproved 2010), Standard Specification for Non-Metallic Expansion Joints (“ASTM F 1123”), (approved March 1, 2010), incorporation by reference approved for § 56.60–1;
(75) ASTM F1139–88 (Reapproved 2010), Standard Specification for Steam Traps and Drains (“ASTM F 1139”), (approved March 1, 2010), incorporation by reference approved for § 56.60–1;
(76) ASTM F1172–88 (Reapproved 2010), Standard Specification for Fuel Oil Meters of the Volumetric Positive Displacement Type (“ASTM F 1172”), (approved March 1, 2010), incorporation by reference approved for § 56.60–1;
(78) ASTM F1199–88 (Reapproved 2010), Standard Specification for Cast (All Temperatures and Pressures) and Welded Pipe Line Strainers (150 psig and 150 °F Maximum) (“ASTM F 1199”), (approved March 1, 2010), incorporation by reference approved for § 56.60–1;
(79) ASTM F1200–88 (Reapproved 2010), Standard Specification for Fabricated (Welded) Pipe Line Strainers (Above 150 psig and 150 °F) (“ASTM F 1200”), (approved March 1, 2010), incorporation by reference approved for § 56.60–1;
(80) ASTM F1201–88 (Reapproved 2010), Standard Specification for Fluid Conditioner Fittings in Piping Applications above 0 °F (“ASTM F 1201”), (approved May 1, 2010), incorporation by reference approved for § 56.60–1;
46 U.S.C. 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F1121–87 (Reapproved 2010), Standard Specification for International Shore Connections for Marine Fire Applications (“ASTM F 1121”), (approved March 1, 2010), incorporation by reference approved for § 76.10–10.
(2) [Reserved]
(c) National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA 02169–7471, 617–770–3000,
(1) NFPA 13–1996, Standard for the Installation of Sprinkler Systems (“NFPA 13”), incorporation by reference approved for §§ 76.25–1; 76.25–90.
(2) [Reserved]
(d) Underwriters Laboratories Inc. (UL), 12 Laboratory Drive, Research Triangle Park, NC 27709–3995, 919–549–1400,
(1) UL 19 Standard for Safety, Lined Fire Hose and Hose Assemblies (“UL 19”) (2001), incorporation by reference approved for § 76.10–10.
(2) [Reserved]
46 U.S.C. 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277;
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F1121–87 (Reapproved 2010), Standard Specification for International Shore Connections for Marine Fire Applications, (approved March 1, 2010), incorporation by reference approved for § 95.10–10.
43 U.S.C. 1333; 46 U.S.C. 3102, 3306; Department of Homeland Security Delegation No. 0170.1.
24. In § 108.101, in the table in paragraph (b), revise the first, second, and fifth entry to read as follows:
(b) * * *
46 U.S.C. 3703; Department of Homeland Security Delegation No. 0170.1. Section 153.40 issued under 49 U.S.C. 5103. Sections 153.470 through 153.491, 153.1100 through 153.1132, and 153.1600 through 153.1608 also issued under 33 U.S.C. 1903 (b).
(b) American National Standards Institute (ANSI), 25 West 43rd Street, 4th Floor, New York, NY 10036,
(1) ANSI B16.5, Pipe Flanges and Flanged Fittings, 1988, incorporation by reference approved for § 153.940.
(2) ANSI B16.24, Bronze Pipe Flanges and Flanged Fittings, 1979, incorporation by reference approved for § 153.940.
(3) ANSI B16.31, Non-Ferrous Flanges, 1971, incorporation by reference approved for § 153.940.
(c) American Society for Testing and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F 1122–87 (1992), Standard Specification for Quick Disconnect Couplings, incorporation by reference approved for § 153.940.
(2) ASTM F1271–90 (Reapproved 2012), Standard Specification for Spill Valves for Use in Marine Tank Liquid Overpressure Protections Applications (approved May 1, 2012), incorporation by reference approved for § 153.365.
46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; 49 CFR 1.46.
(a) Certain material is incorporated by reference into this part with the approval of the Director of the
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM B 117–97, Standard Practice for Operating Salt Spray (Fog) Apparatus, into § 160.077–11.
(2) ASTM D 751–95, Standard Test Methods for Coated Fabrics, incorporation by reference approved for § 160.077–19.
(3) ASTM D1434–82 (Reapproved 2009)
(c) DLA Document Services, 700 Robbins Avenue, Building 4/D, Philadelphia, PA 19111–5094, 215–697–6396,
(1) In Federal Test Method Standard No. 191 the following test methods:
(i) Method 5100, Strength and Elongation, Breaking of Woven Cloth; Grab Method.
(ii) Method 5132, Strength of Cloth, Tearing; Falling-Pendulum Method.
(iii) Method 5134, Strength of Cloth, Tearing; Tongue Method.
(iv) Method 5804.1, Weathering Resistance of Cloth; Accelerated Weathering Method.
(v) Method 5762, Mildew Resistance of Textile Materials; Soil Burial Method.
(2) Federal Standard No. 751, Stitches, Seams, and Stitching.
(3) MIL–L–24611(SH), Life Preserver Support Package for Life Preserver, MK 4.
(d) National Institute of Standards and Technology (NIST) (formerly National Bureau of Standards), 100 Bureau Drive, Stop 1070, Gaithersburg, MD 20899–1070, 301–975–6478,
(1) “The Universal Color Language” and “The Color Names Dictionary” in
(2) [Reserved.]
(e) Underwriters Laboratories Inc. (UL), 12 Laboratory Drive, Research Triangle Park, NC 27709–3995, 919–549–1400,
(1) UL 1191, Components for Personal Flotation Devices.
(2) UL 1517, Standard for Hybrid Personal Flotation Devices (November 12, 1984), incorporation by reference approved for 46 CFR 160.077–5(e)(2); 160.077–11(a)(5)(ii) and(g)(1); 160.077–15(b)(12); 160.077–17(b)(9); 160.077–19(a)(5) and (b)(1) through (18); 160.077–21(c)(1) through (5); 160.077–23(h)(4) through (7); 160.077–27(e)(1) and (4); and 160.077–29(c)(5), (7), and (9), and (d)(1) and (5).
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a). To enforce any edition other than that specified in paragraph (b) of this section, the Coast Guard must publish a notice of change in the
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM B 117–97, Standard Practice for Operating Salt Spray (Fog) Apparatus, incorporation by reference approved for §§ 160.176–8; 160.176–13.
(2) ASTM D 751–95, Standard Test Methods for Coated Fabrics, incorporation by reference approved for § 160.176–13.
(3) ASTM D 975–98, Standard Specification for Diesel Fuel Oils, incorporation by reference approved for § 160.176–13.
(4) ASTM D1434–82 (Reapproved 2009)
(c) Federal Aviation Administration, Aircraft Certification Service, 800 Independence Avenue SW., Washington, DC 20591, 202–385–6346,
(1) TSO–C13d, Federal Aviation Administration Standard for Life Preservers, January 3, 1983, incorporation by reference approved for § 160.176–8.
(2) [Reserved]
(d) DLA Document Services, 700 Robbins Avenue, Building 4/D, Philadelphia, PA 19111–5094, 215–697–6396,
(1) In Federal Test Method Standard No. 191A (dated July 20, 1978) the following methods:
(i) Method 5100, Strength and Elongation, Breaking of Woven Cloth; Grab Method, incorporation by reference approved for § 160.176–13.
(ii) Method 5132, Strength of Cloth, Tearing; Falling-Pendulum Method, incorporation by reference approved for § 160.176–13.
(iii) Method 5134, Strength of Cloth, Tearing; Tongue Method, incorporation by reference approved for § 160.176–13.
(iv) Method 5804.1, Weathering Resistance of Cloth; Accelerated Weathering Method, incorporation by reference approved for § 160.176–8.
(v) Method 5762, Mildew Resistance of Textile Materials; Soil Burial Method, incorporation by reference approved for § 160.176–8.
(2) Federal Standard No. 751a, Stitches, Seams, and Stitching, January 25, 1965, incorporation by reference
(3) MIL–L–24611—Life Preserver Support Package For Life Preserver, MK 4, dated May 18, 1982, incorporation by reference approved for § 160.176–8.
(e) National Institute of Standards and Technology (NIST) (formerly National Bureau of Standards), c/o Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, 202.512.1800,
(1) Special Pub. 440,
(2) [Reserved]
(f) Underwriters Laboratories Inc. (UL), 12 Laboratory Drive, Research Triangle Park, NC 27709–3995, 919–549–1400,
(1) UL 1191, “Components for Personal Flotation Devices”, November 11, 1984, incorporation by reference approved for §§ 160.176–8; 160.176–13.
(2) [Reserved]
33 U.S.C. 1321(j), 1903; 46 U.S.C. 3306, 3703, 4104, 4302; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1.
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F1546/F1546 M–96 (Reapproved 2012), Standard Specification for Fire Hose Nozzles (ASTM F 1546) (approved May 1, 2012), incorporation by reference approved for §§ 162.027–2; 162.027–3.
(2) [Reserved]
46 U.S.C. 2213, 3102, 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; Department of Homeland Security Delegation No. 0170.1.
(b) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, 877–909–2786,
(1) ASTM F1121–87 (Reapproved 2010), Standard Specification for International Shore Connections for Marine Fire Applications, (approved March 1, 2010), incorporation by reference approved for § 193.10–10.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of pyroxasulfone
This regulation is effective February 27, 2013. Objections and requests for hearings must be received on or before April 29, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0308, is available at
Kathryn Montague, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–1243; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ–OPP–2012–0308 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 29, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP–2012–0308, by one of the following methods:
•
•
•
In the
Based upon review of the data supporting the petition, EPA is establishing tolerances for residues of the herbicide pyroxasulfone and its metabolites as requested by the petitioner, except that the tolerance for residues in or on soybean, forage is lowered to 1.0 ppm and the tolerance for residues in or on soybean, seed is lowered to 0.06 ppm. The reasons for these changes are explained in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyroxasulfone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyroxasulfone follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Pyroxasulfone acute toxicity to mammals is low by all routes of exposure. Subchronic and chronic oral toxicity testing of pyroxasulfone in mice, rats, and dogs produced a variety of adverse effects in several target organs. Effects seen in animal studies included cardiac toxicity (increased cardiomyopathy in mice and rats), liver toxicity (centrilobular hepatocellular hypertrophy, histopathological, and/or clinical pathological indicators), neurotoxicity characterized by axonal/myelin degeneration in the sciatic nerve (dog, mouse, and rat) and spinal cord sections (dog), skeletal muscle myopathy, kidney toxicity (increased incidence of chronic progressive nephropathy in dogs and retrograde nephropathy in mice), urinary bladder mucosal hyperplasia, inflammation, and urinary bladder transitional cell papillomas (rats). Decreased body weight and enzyme changes were noted in some studies. Immunotoxicity studies in rats and mice showed no evidence of immunotoxic effects from pyroxasulfone.
Pyroxasulfone was moderately toxic to rats following a 4-week dermal exposure producing local inflammation and systemic effects of minimal to mild cardiac myofiber degeneration at the limit dose. No adverse effects were noted in a 28-day inhalation study at the highest-dose tested.
Pyroxasulfone did not exhibit developmental toxicity in the rat developmental toxicity study and exhibited only slight developmental toxicity in rabbits (reduced fetal weight and resorptions) at the limit dose. However, developmental effects were noted in post-natal day (PND) 21 offspring in the rat developmental neurotoxicity (DNT) study characterized as decreased brain weight and morphometric changes. Developmental effects in the rabbit developmental study and DNT study occurred in the absence of maternal toxicity, indicating potential increased quantitative susceptibility of offspring. In a reproductive toxicity in rats reduced pup weight and body weight gains during lactation occurred at similar or higher doses causing pronounced maternal toxicity (reduced body weight, body weight gain, and food consumption and increased kidney weight, cardiomyopathy, and urinary bladder mucosal hyperplasia with inflammation).
In cancer studies in mice and rats, renal tubular adenomas were observed in male mice and urinary bladder transitional cell papillomas were observed in male rats. The kidney adenomas in male mice were determined to be spontaneous and not treatment-related based on the following considerations:
1. Absence of any cytotoxicity (degeneration or individual cell necrosis) in studies ranging from 14 days to 18 months at doses up to 15,000 ppm.
2. Absence of cell regeneration leading to precursor lesions such as atypical tubular hyperplasia at all time points and doses up to 15,000 ppm.
3. Lack of exacerbation of chronic progressive nephropathy, a spontaneous disease in rodents that results in cell regeneration which can result in renal tubule tumors in chronic studies.
4. Lack of a clear dose response in the distribution of tumors between test substance treated groups.
The urinary bladder tumors seen in male rats were determined to be a threshold effect. Pyroxasulfone exposure causes the growth of crystals in the urinary tract with subsequent calculi formation resulting in cellular damage. Crystal formation in the absence of calculi is not associated with hyperplasia or urinary bladder tumors; therefore, the formation of urinary bladder calculi is the prerequisite for subsequent hyperplasia and neoplasia. In other words, urinary bladder tumors do not develop at doses too low to produce calculi. There is also a clear threshold of 1,000 ppm (42.55 milligrams/kilogram/day (mg/kg/day)) for development of calculi and tumorigenesis. The point of departure (POD) of 50 ppm (2.0 mg/kg/day) selected for chronic risk assessment is not expected to result in urinary bladder calculi formation, which is a prerequisite for subsequent hyperplasia and neoplasia. Therefore, the Agency has determined that the quantification of risk using a non-linear approach (i.e., Reference dose (RfD)) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to pyroxasulfone. There is no concern for mutagenicity.
Specific information on the studies received and the nature of the adverse effects caused by pyroxasulfone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies the toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a RfD—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the
A summary of the toxicological endpoints for pyroxasulfone used for human risk assessment is discussed in Unit III.B. of the final rule published in the
1.
i.
Such effects were identified for pyroxasulfone. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100% of the crop was treated with pyroxasulfone and that residues of the parent and the relevant metabolites of concern on soybeans are present at tolerance levels.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of pyroxasulfone for acute exposures are estimated to be 17 parts per billion (ppb) for surface water and 210 ppb for ground water. EDWCs of pyroxasulfone for chronic exposures for non-cancer assessments are estimated to be 3.2 ppb for surface water and 174 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 210 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 174 ppb was used to assess the contribution to drinking water.
3.
4.
EPA has not found pyroxasulfone to share a common mechanism of toxicity with any other substances, and pyroxasulfone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyroxasulfone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
i. The increased susceptibility is occurring at high doses.
ii. NOAELs and LOAELs have been identified for all effects of concern, and thus a clear dose response has been well defined.
iii. The PODs selected for risk assessment are protective of the fetal/offspring effects.
3.
i. The toxicity database for pyroxasulfone is complete.
ii. Pyroxasulfone is a neurotoxic chemical and there is evidence of increased susceptibility of offspring with regard to neurotoxic effects in the rat DNT study. There is also evidence of increased susceptibility of fetuses/offspring with regard to non-neurotoxic effects in the rabbit developmental toxicity study. However, the concern for the increased susceptibility is low for the reasons stated in Unit III.D.2., and EPA did not identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors (UFs) to be used in the risk assessment for pyroxasulfone.
iii. There are no residual uncertainties in the exposure database. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues), and EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pyroxasulfone in drinking water. These assessments will not underestimate the exposure and risks posed by pyroxasulfone.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
4.
5.
6.
Adequate enforcement methodology (a liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) method) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for pyroxasulfone.
EPA has revised the tolerance levels for soybean, forage and soybean, seed as based on analysis of the field trial data using the tolerance MRL calculator in accordance with the Organization for Economic Cooperation and Development's “MRL Calculator User Guide Standard Operating Procedure (SOP).” Soybean, forage was decreased from 1.5 ppm to 1.0 ppm for residues of pyroxasulfone and its metabolites M–1, M–3, and M–25 and soybean, seed was decreased from 0.07 ppm to 0.06 ppm for residues of pyroxasulfone and its metabolites M–3, M–25, and M–28.
Therefore, tolerances are established for residues of the herbicide pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1
This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions read as follows.
(a) * * *
(2) * * *
(3) Tolerances are established for residues of the herbicide pyroxasulfone, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of pyraflufen-ethyl in or on multiple commodities which are identified and discussed later in this document. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective February 27, 2013. Objections and requests for hearings must be received on or before April 29, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2011–1002, is available at
Bethany Benbow, Registration Division
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ–OPP–2011–1002 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 29, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP–2011–1002, by one of the following methods:
•
•
•
In the
Based upon review of the data supporting the petition, EPA is establishing tolerances for peanut and peanut, hay but not establishing tolerances for hop, dried cone; peanut, meal; or peanut, refined oil. In addition, the current time-limited tolerances established for combined residues of pyraflufen-ethyl and metabolite E–1 in milk and the meat by-products of cattle, goat, horse, and sheep at 0.02 ppm are being revised to permanent tolerances for combined residues of pyraflufen-ethyl and metabolites E–1 and E–9 at 0.03 ppm. Finally, permanent tolerances for combined residues of pyraflufen-ethyl and metabolites E–1 and E–9 are also being set for the fat and meat of cattle, goat, horse, and sheep at 0.03 ppm. The reasons for these changes are explained in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pyraflufen-ethyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraflufen-ethyl follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Pyraflufen-ethyl exhibits relatively low acute toxicity from oral, dermal, and inhalation exposure. It produces moderate eye
Since the last risk assessment, the neurotoxicity battery was reviewed and determined to be negative for both acute and subchronic neurotoxicity. Additionally, the Agency reviewed an immunotoxicity study that showed a decreased immune response (decreases of anti-sheep red blood cell (SRBC) antibody forming cell (AFC) response in male rats), only at a dose level approaching the limit dose.
Specific information on the studies received and the nature of the adverse effects caused by pyraflufen-ethyl as well as the no observed adverse effect levels (NOAELs) and the lowest observed adverse effect levels (LOAELs) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for pyraflufen-ethyl used for human risk assessment is shown in Table 1 of this unit.
1.
i.
ii.
iii.
All exposure inputs for the cancer assessment were the same as for the chronic dietary exposure assessment, except the estimated drinking water concentrations (EDWC). A Tier 2 drinking water (surface water) of a (30-year average) estimate for pyraflufen-ethyl and its metabolic products, E–1, E–2, and E–3, was incorporated directly into the dietary assessment to estimate chronic carcinogenic risk from drinking water containing pyraflufen-ethyl.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI–GROW) models, the estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl acute exposures are estimated to be 0.640 parts per billion (ppb) for surface water and 0.0018 ppb for ground water. The estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl for non-cancer chronic exposures are estimated to be 0.295 ppb for surface water and 0.0018 ppb for ground water. The EDWCs of pyraflufen-ethyl for chronic exposures for cancer assessments are estimated to be 0.268 ppb for surface water and 0.0018 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.295 ppb was used to assess the contribution to drinking water. For cancer dietary risk assessment, the water concentration of value 0.268 ppb was used to assess the contribution to drinking water.
3.
Pyraflufen-ethyl is currently registered for the following uses that could result in residential exposures: Established ornamental turf lawns (residential, industrial, and institutional), parks, cemeteries, athletic fields, golf courses, sod farms, nurseries, ornamental plantings, and Christmas trees. EPA assessed residential handler exposure using the following assumptions: (1) Most residential uses will result in short-term (1–30 day) exposures, (2) residential handlers are assumed to be wearing short-sleeved shirts, short pants, shoes, and socks during pyraflufen-ethyl application, (3) various application methods may be used such as manually pressurized handwands, backpack sprayers, and hose-end sprayers.
When determining the potential for residential post-application exposure, the Agency considers residues from leaf to skin/hand residue transfer, children's hand-to-mouth transfer, and exposure time. Because exposure to treated gardens and turf could be expected within the same day, adult post-application cancer exposure to treated trees and retail plants and turf were combined. The exposure assessment for treated plants is considered extremely conservative in that the plants are assumed to be treated the same day that residential post-application contact occurs, with no residue transfer between treatment and purchase of the plants. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
1.
2.
3.
i. The toxicity database for pyraflufen-ethyl is complete.
ii. There is no indication that pyraflufen-ethyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that pyraflufen-ethyl results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated (CT) and tolerance-level residues for the proposed commodities, and residue inputs of
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined chronic dietary and short-term residential exposures result in an adult (inhalation) non-cancer aggregate MOE of 290,000. The aggregate MOE for children 1–2 years old, including incidental oral exposures from treated turf, is 9,600. Because EPA's level of concern for pyraflufen-ethyl is a MOE of 100 or below, these MOEs are not of concern.
4.
5.
6.
Adequate enforcement methodology (gas chromatography-mass spectrometry (GC/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for pyraflufen-ethyl.
Based on a lack of adequate residue data, the Agency is not granting tolerances for hops at this time. As permitted under 40 CFR 180.8, the petitioner has withdrawn its request for hop, dried cone tolerances.
In addition, the requested tolerances for peanut, meal and peanut, refined oil are not being granted since those residues will be covered by the proposed tolerance for peanut. Because peanut hay is fed to livestock and may affect residue levels, upon review of the data supporting the petitions, EPA determined that several livestock tolerances should be revised (from residues of the parent and metabolite E-1 in milk and meat by-products of cattle, goat, horse, and sheep at 0.02 ppm to residues of the parent and metabolites E-1 and E-9 at 0.03 ppm) and several new livestock tolerances should be established (residues of the parent and metabolites E-1 and E-9 in the fat and meat of cattle, goat, horse and sheep at 0.03 ppm). The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation.
Finally, based on data submitted with this petition, EPA is removing the time-limitations for these tolerances.
Therefore, permanent tolerances are established for the combined residues of pyraflufen-ethyl, metabolite E-1, and metabolite E-9 in or on (cattle, goat, horse, sheep) fat, meat, and meat by-products at 0.03 ppm; milk at 0.03 ppm; and new tolerances are established for the combined residues of pyraflufen-ethyl and metabolite E-1 in or on peanut at 0.01 ppm; and peanut, hay at 0.07 ppm.
This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR part 180 is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a)
Environmental Protection Agency (EPA).
Final rule.
This regulation amends inadvertent tolerances for residues of acetochlor in or on crop groups 15 and 16 for cereal grains by dropping the exclusion for rice grain and straw. Monsanto Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective February 27, 2013. Objections and requests for hearings must be received on or before April 29, 2013 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0302, is available at
Hope Johnson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–5410; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ–OPP–2012–0302 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 29, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP–2012–0302, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Specifically the petition requested that crop groups 15 and 16 be amended
Monsanto sought the removal of the exception for rice and rice straw for the acetochlor tolerances for crop groups 15 and 16 so that rice crops could be rotated to fields previously treated with acetochlor. EPA determined that this revision to these tolerances was appropriate without modifying the tolerance value based upon translation of residue data reflecting analysis for residues of acetochlor and its metabolites in/on wheat and sorghum commodities planted after treatment with acetochlor. Residues in the wheat and sorghum grain were non-quantifiable, whereas finite residues that were below the existing crop group tolerance were reported in the straw.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acetochlor including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acetochlor follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Acetochlor has low acute toxicity by the oral, dermal, and inhalation routes of exposure and is mildly irritating to the eyes. The results of two dermal irritation studies indicate that it is a mild to strong skin irritant. Acetochlor is also a strong dermal sensitizer.
Evidence of neurotoxicity was observed in acute and subchronic neurotoxicity screening studies in rats, developmental toxicity studies in rats, and subchronic and chronic studies in dogs. In addition to the nervous system, the major target organs affected in subchronic and chronic studies in rats, dogs, and mice exposed to acetochlor are the liver, thyroid (secondary to liver), kidney, testes, and erythrocytes. Species-specific target organs include the nasal olfactory epithelium in rats and the lungs in mice.
There is no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring to acetochlor exposure in the developmental and reproduction toxicity studies in rats and rabbits. In two developmental toxicity studies in rats, fetal effects (increased early resorptions, post-implantation loss, and decreased fetal weight) occurred at doses that also resulted in maternal toxicity (mortality, clinical signs of toxicity, and decreased maternal body weight gain). In two rabbit developmental toxicity studies there were no adverse fetal effects at the highest doses tested (HDT) (190 milligrams/kilograms/day (mg/kg/day) and 300 mg/kg/day); whereas maternal toxicity (body weight loss) was seen at 50 mg/kg/day in one study. In three reproduction toxicity studies in rats, offspring effects (decreased pup weights in the first two studies; decreased pup weights, decreased F2 litter size at birth, and focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study) occurred at the same or higher doses than those resulting in parental toxicity (decreased body weight or weight gain in the first two studies; focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study). There was no evidence of reproductive toxicity observed at any dose tested in two of the three reproductive toxicity studies in rats. The third reproduction study in rats showed a decreased number of implantations at the HDT of 1,750 parts per million (ppm).
EPA has determined that quantification of carcinogenic risk on a linear, non-threshold basis is not appropriate for the mouse tumors. There are acceptable mode of action data for the rat tumors (nasal olfactory epithelial tumors and thyroid follicular cell tumors) which are adequate to support a non-linear, threshold approach for assessment of cancer risk. The rat nasal tumors are the most sensitive effect for cancer risk. However, because rat nasal tumors are not the most sensitive chronic effect, EPA has not conducted a separate cancer-only risk assessment but performed a single, chronic risk assessment that will be protective of both non-cancer and cancer effects, including rat nasal tumors, thyroid tumors, and mouse tumors.
Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some
A summary of the toxicological endpoints for acetochlor used for human risk assessment is discussed in Unit III.A of the final rule published in the
1.
i.
Such effects were identified for acetochlor. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, entitled “What We Eat in America” (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA assumed tolerance level residues and 100 percent crop treated (PCT) for all commodities. Experimentally derived processing factors were used for cereal grain commodities. Default processing factors were used for all other commodities.
ii.
iii.
iv.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
2.
Acetochlor parent residue exposure is generally higher and more widespread through surface water sources than ground water, therefore, the Agency generated the surface water concentrations using the PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis Modeling System). The estimated drinking water concentrations (EDWCs) of acetochlor for acute exposures are estimated to be 75 parts per billion (ppb) for drinking water. For chronic exposures for non-cancer assessments are estimated to be 4.8 ppb for drinking water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 75 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 4.8 ppb was used to assess the contribution to drinking water.
3.
Acetochlor is not registered for any specific use patterns that would result in residential exposure.
4.
The chloroacetanilides have been evaluated by the Agency and the Federal Insecticides, Fungicides, and Rodenticides Act (FIFRA) Scientific Advisory Panel (SAP) as a related group of chemicals for this purpose. Acetochlor is included in a Cumulative Assessment Group (CAG) of chloroacetanilide pesticides. Structurally related chloroacetanilides include acetochlor, alachlor, butachlor, metolachlor, and propachlor. For purposes of a cumulative risk assessment, it was determined that the common mechanism of toxicity group consists of alachlor, acetochlor, and butachlor. Butachlor is excluded from the group for risk assessment purposes at present because there are no registered uses or tolerances for this chemical in the United States. The group was selected based on common endpoints of:
• Nasal turbinate tumors in rats, and a known mechanism of toxicity for development of these tumors.
• Induction of hepatic Uridine Diphosphate-Glucuronosyl Transferase (UDPGT), which results in increased incidence of thyroid follicular cell tumors secondary to disruption of pituitary-thyroid homeostasis.
Thyroid effects were not included in the final cumulative assessment of the chloroacetanilide herbicides because they were determined to occur at excessively toxic dose levels, and therefore were not considered relevant to human risk assessment. Nasal tumors represent the most sensitive endpoint for both compounds.
An updated cumulative risk assessment of the chloroacetanilide (CAG) pesticides acetochlor and alachlor conducted in April 2007 provides an assessment of existing and new uses of those chemicals to date. Based on the most recent chloroacetanilide CAG cumulative risk assessment, cumulative risk is not of concern. A revised quantitative cumulative assessment was not conducted because the proposed amended use would not affect the cumulative risk results. Not only is acetochlor a very minor contributor to chloroacetanilide cumulative risk when compared to alachlor, but removing the exception for rotation to rice will only have a minor impact on acetochlor exposure since finite residues on grains, including rice, are unlikely. In the residue data cited/translated to support this petition, non-quantifiable residues were reported in wheat and sorghum grains.
1.
2.
3.
i. The toxicity database for acetochlor is now complete. An immunotoxicity study has been reviewed and is acceptable/guideline. Immunotoxicity was not observed at the highest dose tested. The acute neurotoxicity (ACN) and subchronic neurotoxicity (SCN) studies have also been upgraded to acceptable/guideline based on acceptable positive control data and functional observational battery measures.
ii. Furthermore, EPA has determined that a developmental neurotoxicity study is not required since:
a. There is no evidence of increased susceptibility in the rat and rabbit in the prenatal and 2-generation reproduction postnatal studies.
b. Developmental effects were observed in the presence of maternal effects.
c. The effects observed in the neurotoxicity studies were only at high doses.
iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues or average residue levels derived from reliable field trials. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acetochlor in drinking water. These assessments will not underestimate the exposure and risks posed by acetochlor.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Because no short-term adverse effect was identified, acetochlor is not expected to pose a short-term risk.
4.
Because no intermediate-term adverse effect was identified, acetochlor is not expected to pose an intermediate-term risk.
5.
6.
Adequate enforcement methodology (high performance liquid chromatography (HPLC) method with oxidative coulometric electrochemical detection (OCED)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).
The Codex has not established a MRL for acetochlor.
Therefore, the acetochlor tolerances for crop groups 15 and 16 are amended to drop the exception for rice and rice straw, respectively.
This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(d) * * *
Federal Maritime Commission.
Final rule.
The Federal Maritime Commission amends its rules regarding the establishment of passenger vessel financial responsibility for nonperformance of transportation. The amount of coverage required for performance is modified to increase the cap on required performance coverage to $30 million over a two year period and thereafter adjust the cap every two years using the Consumer Price Index; adjust the amount of coverage required for smaller passenger vessel operators by providing for consideration of alternative forms of protection; remove the application form for issuance of certificates of financial responsibility from the Commission's regulations and make it available at its Web site; add an expiration date to the Certificate (Performance); and make technical adjustments to the regulations.
The Final Rule is effective: April 2, 2013.
Karen V. Gregory, Secretary, Federal Maritime Commission, 800 North
By Notice of Proposed Rulemaking (NPRM) published on September 20, 2011, 76 FR 58227, the Federal Maritime Commission (Commission or FMC) proposed to amend its rules regarding the establishment of passenger vessel financial responsibility under 46 U.S.C. 44102 (formerly contained in section 3(a) of Pub. L. 89–777).
The Commission adopts the Final Rule as set forth below. Also the Chairman of the Commission certifies below pursuant to section 5 U.S.C. 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 601
The Commission's current rules provide that “[n]o person in the United States may arrange, offer, advertise or provide passage on a vessel unless a Certificate (Performance) has been issued to or covers such person,” 46 CFR 540.3. Such persons must apply for a Certificate (Performance), 46 CFR 540.4, and provide financial responsibility “in an amount determined by the Commission to be no less than 110 percent of the unearned passenger revenue of the [PVO] applicant” for the two immediately preceding years, “reflect[ing] the greatest amount of unearned passenger revenue,” 46 CFR 540.5.
Whereas the Supplementary Information of the NPRM provided for notice to be given of any increase in the cap, the proposed rule omitted the notice requirement. The attached final rule includes a formal notice, requiring the Bureau of Certification and Licensing (BCL) to calculate the adjusted cap amount and transmit that information to the Commission's Office of the Secretary (Secretary). The Secretary will then publish the notice of the new amount and the date on which it is to become effective on the Commission's Web site (
The final rule also provides that PVOs with unearned passenger revenue (UPR) that is no more than 150% of the cap (i.e., UPR of $45,000,000 or less) may request relief from coverage requirements by means of substituting alternative forms of protection. The Final Rule requires that requests be submitted to the Bureau of Certification and Licensing and authorizes the Director of BCL to grant requests based upon the already existing protections applicable to credit card receipts for PVOs whose payment policies provide for final payment by passengers to be made within 60 days of the vessel sailing.
Sections 540.4(b) and 540.23(a) have been modified to direct applicants to file application form FMC–131 directly with the Bureau of Certification and Licensing, rather than the Office of the Secretary, reflecting actual practice over many years. The Final Rule removes form FMC–131 from the Commission's regulations, instead it will be made available on the Commission's web site (
The sample surety bond, guaranty, and escrow agreements that are set forth in the Commission's regulations are also amended and were included in the NPRM for public comment.
Section 540.7 is revised to require that each Certificate (Performance) expires 5 years from the date of issuance. This varies from the current rule that provides that the certificate continues in effect for an indeterminate time. The Final Rule also provides that, for good cause shown, the Commission may issue a certificate with an expiration date less than 5 years.
Cruise Lines International Association, Inc. (CLIA) submitted comments on behalf of its members, sixteen of which are PVOs currently in the Commission's program. All sixteen have UPR exceeding the current $15 million cap. CLIA opined that the
Lindblad Expeditions, Inc., an operator of U.S. flag passenger vessels under the program, supports increasing the cap “commensurate with the UPR exposure of all PVOs” but indicates that such exposure “would best be accomplished by eliminating the cap altogether.” Linblad supported the adjustment of Part 540 financial responsibility coverage to take into consideration overlapping financial protection provided by credit card issuers. Specifically, Lindblad recommended the Commission take into account PVO bonds with the U.S. Tour Operator Association and private trip insurance.
American Cruise Lines, Inc. (ACL) (an operator of U.S. flag vessels), InnerSea Discoveries, LLC (InnerSea) (an operator of U.S. flag vessels), Congressman Andy Harris, M.D., the Passenger Vessel Association (PVA) (the national trade association representing owners and operators of U.S. flagged passenger vessels), the National Association of Surety Bond Producers (NASBP) oppose increasing the cap to $30 million. The Surety & Fidelity Association of America (SFAA) neither supports nor opposes the increase.
ACL, Lindblad, InnerSea, PVA, and Congressman Harris assert that the current cap and increased cap unfairly discriminate against smaller U.S. flagged PVOs as they must devote a large portion of their capital to comply with the financial responsibility requirement of 110% UPR. In contrast, the larger, foreign-flagged PVOs have to cover a much smaller percentage of their UPR. ACL and InnerSea consider their financial responsibility burden to be disproportionate to their risk of non-performance.
NASBP and SFAA advise that, because sureties demand reimbursement for losses, sureties conduct a thorough financial assessment of each PVO in order to assure the PVO has sufficient financial strength for the bond amount sought. NASBP and SFAA expressed concern that a PVO faced with a higher bond amount due to an increase in the cap may not be able to demonstrate financial strength necessary to obtain a bond. NASBP recommends that the Commission eliminate any cap and that a flat 15 percent of UPR be set as the financial responsibility level for all PVOs, regardless of size. NASBP calculates that the flat rate would produce $555 million in financial responsibility industry-wide (in comparison to the amount indicated in the Commission's NPRM).
InnerSea proposes that regulations be adopted that concentrate on a PVO's financial stability, regardless of size. InnerSea recommends that financial responsibility be tied to familiar financial ratios, such as debt to equity ratios, when setting coverage levels.
PVA suggests that a two-tier cap be implemented; one that applies a $15 million cap to PVOs with UPR between $15 million and $30 million and a $30 million cap for those PVOs with UPR of greater than $30 million. PVA indicates that such a two-tier cap approach would protect small U.S. flagged operators from the adverse impact of the cap increase.
ACL, Lindblad, PVA, Royal Caribbean and CLIA all support the concept of alternative protection in order to take into consideration duplicative coverage derived from sources other than the Part 540 financial responsibility. ACL and CLIA assert that such alternative protection should include consideration of credit card sales, given that additional financial protections exist for credit card purchasers under the Fair Credit Billing Act (FCBA), 15 U.S.C 1666(a). CLIA also suggests, in its response to the NPRM, that the U.S. Bankruptcy Code protects passengers. CLIA points to protections provided to unsecured creditors under the Bankruptcy Code priority set out in section 503(a)(7), 11 U.S.C. 503(a)(7), which covers money paid for services that are not delivered. ACL and Lindblad suggest that the Commission needs to consider factors other than credit cards with respect to alternative forms of protection. Lindblad suggests that travel insurance be considered as alternative protection.
ACL supports reliance upon credit card refunds but cautions that credit card issuers may require increased collateral as further protection. ACL cites an American Express letter dated May 29, 2003 indicating that if the Commission offset bond amounts based upon refunds from credit card sales, then card issuers would “require PVOs to post collateral that covers all UPR charges [made] with the company's credit cards.” PVA expressed a similar concern that if credit card companies perceive increased risk they would alter the terms of their agreements with PVOs. Lindblad indicates that PVOs are required to pay fees and establish cash reserves with a third party which exceeds 10 percent of high UPR.
With respect to the requirement establishing the limitation for making a request at 150 percent of the highest UPR, ACL asserts that such a limit would create a disincentive to growth as smaller PVOs will attempt to assure that their UPR not reach $45 million in order to continue qualifying for alternative protection consideration. CLIA likewise suggests that the 150 percent limitation is too low and will provide a disincentive for small cruise lines to embark passengers at U.S. ports as their UPR approaches the 150 percent mark.
Congressman Harris and InnerSea oppose reliance upon credit card refunds or travel insurance as sources for alternative financial protection. Echoing other PVOs, cited
Congressman Harris asserts that offsetting travel insurance and credit card payments would not eliminate the discriminatory effect against smaller, U.S. flag PVOs. Instead, the likely effect of recognizing such alternative methods is to substitute credit card issuers in place of the Commission as the party demanding increased financial security.
As indicated above, SFAA asserts that because sureties demand reimbursement for losses they conduct a thorough financial assessment of each PVO in order to assure it has sufficient financial strength to reimburse the surety. SFAA suggests that, in analyzing any alternative financial security, the Commission should consider whether the alternative security includes a process that performs a similar prequalification function (as that provided by sureties) as well as providing sufficient financial protection in the event the PVO defaults.
ACL and CLIA both recommend eliminating the 10 percent “administrative fee” for PVOs below the $30 million cap. ACL asserts that it should be eliminated as it “is intended to cover the cost of administration” of the Commission's “nonperformance financial security program” and that there is no sound basis for it being imposed on smaller U.S. flag coastwise trade PVOs and not on the larger PVOs that meet the cap. Similarly, CLIA suggests the “administrative fee” be
The NPRM also requested comment as to whether a model similar to PVO casualty requirements employing the number of berths on a PVO's largest vessel might be appropriate for the nonperformance program. ACL supports the idea from the standpoint that it would appear to eliminate the cap but is concerned whether it would foster growth in the industry. CLIA opposes a casualty model, asserting that Congress specifically created a model of financial security for death or injury and created a very different model for nonperformance. CLIA points out that Congress created the casualty provisions at the same time it created the nonperformance requirements of Public Law 89–777 and, in doing so, manifested a clear intention that the claims be treated differently.
Carnival suggests that financially sound PVOs that have a number of cruise brands be treated as a single applicant for purposes of the financial responsibility requirements. Carnival recommends that such applicants be covered by a single $50 million bond backed by the parent company's guaranty. Carnival explains that such a bond and parental guaranty would provide greater security by assuring that the parent stands behind its group of companies.
Those opposing the increase in the cap are ACL and the PVA, which represents U.S. flag passenger vessel operators, including ACL, InnerSea and Lindblad. Their comments focus on the disparity between the 110 percent of UPR that they must secure versus the large PVOs, with UPR exceeding the current and increased cap limitations. Commission-mandated coverage for large PVOs has been capped for 20 years at $15 million and, under the final rule, will rise to $30 million. The comments underscore that small U.S. flag PVOs are particularly disadvantaged because they must operate vessels meeting U.S. build limitations and must hire U.S. crews, neither of which burden the large foreign flag PVOs. Congressman Harris shares this concern.
These comments accurately reflect that the large PVOs that qualify for the current cap have enjoyed unchanging financial responsibility burdens for all of their UPR above $15 million for 20 years. In contrast, smaller PVOs' financial responsibility requirements have been subject to increases during those 20 years, as their high two-year reported UPR increased. Those opposing the new cap do not see the increase as a change that meaningfully narrows the gap between the 110% financial responsibility requirements applicable to small PVOs vis-a-vis the small fraction of financial responsibility required of much larger PVOs.
It is clear that the larger PVOs with UPR exceeding the current cap have had the benefit of an unchanging burden of financial responsibility for the past twenty years; during this same period the PVO industry's highest UPR quadrupled from $1 billion to approximately $4 billion. In effect, the overall financial burdens of the Commission's requirements have diminished over time as the percentage of the UPR covered by financial responsibility dropped from 25% to 7.9% of UPR.
The $30 million cap will result in a significant increase in the UPR covered by PVOs' financial responsibility, with the preponderance of the increase falling on large PVOs. Based upon the recent reported UPR of PVOs providing nonperformance coverage, it appears that coverage requirements for fifteen of the large PVOs would increase to $30 million, increasing total coverage for the industry by $225 million. This would increase industry-wide coverage requirements to approximately 13.5 percent of outstanding UPR.
Without recognition of alternative forms of coverage, three of the commenting PVOs that benefit from the current cap would be immediately impacted by adoption of the rule, as they would be subject to increasing their financial responsibility. However, alternative forms of coverage, discussed below, would potentially reduce their coverage requirements below the $15 million currently maintained by these PVOs.
Adoption of the $30 million cap on the basis of the quadrupling of UPR for the largest PVOs over the past 20 years is sufficient reason for increasing the cap. However, the Commission has, in the past, found the effects of inflation are relevant to increasing the cap.
The Commission adopts the increased cap based upon the large increase of UPR of large PVOs over the last twenty years with no increase in the cap. The Commission also adopts the requirement that the $30 million cap will be adjusted every two years based upon the CPI–U. Based on past history, the use of the CPI–U would not account for all of the increase in UPR of the largest PVOs, but will serve to capture some of the increases in large PVOs' UPR.
As described above, the final rule is amended to provide notice of each biennial cap adjustment. The final rule provides that: (1) the Bureau of Certification and Licensing will calculate the adjusted cap amount and transmit that information to the Secretary; and (2) the Secretary will then publish in the
The suggestions by NASBP (that a flat 15% of UPR financial responsibility requirement be set for all PVOs), by InnerSea (that all PVOs' financial responsibility be established using familiar financial ratios such as debt/equity), and by PVA (that a two-tier cap system be put in place) create concerns and uncertainty that the final rule avoids. Application of the NASBP's flat 15% would apply a low and potentially inadequate percentage to all PVOs that do not meet the current $15 million cap. Inasmuch as 12 of the 15 PVOs that have ceased operations since September 2000 were PVOs whose UPR was below that threshold, the Commission's experience is that smaller PVOs have greater risks that performance coverage will be required to reimburse passengers for losses. Without current coverage requirements, many passengers would have suffered significant losses.
InnerSea's suggestion that regulations should concentrate on a PVO's financial stability, regardless of size, would seem similarly problematic. The Commission
Those suggestions would require the Commission to continuously monitor the financial health of every PVO. Financial reports not required to be filed currently would of necessity be mandated. The Commission's previous experience with American Classic Voyages Company (American Classic), when it ceased operating, demonstrated the short comings of reporting requirements as well as the inadequacy of self-insurance as a means for PVOs to meet their financial responsibility requirements.
PVA's suggestion of a two-tier cap system would leave the $15 million cap in place for those PVOs with up to $30 million in UPR. While this would provide greater certainty, it would also necessitate a significant increase in requirements at the point $30 million UPR is reached. A PVO would move immediately from a $15 million cap to a $30 million cap. The Commission's final rule allows for alternative forms of coverage for those whose UPR is less than $45 million and provides greater relief to smaller operators, such as those represented by PVA.
The Commission's experience with respect to PVOs that have ceased operation is relevant to consideration of the $30 million cap and to consideration of individual proposals for alternative financial protection, provided the PVO's UPR is less than 150% of the cap. For example, American Classic had UPR of $51 million.
CLIA indicated, in its response to the NOI, that it understood most of American Classic's passengers received full “Fair Credit Billing Act * * * refunds” and refunds via the bankruptcy process. CLIA stated that the passengers of one American Classic vessel received “100 percent of their fare payments through the bankruptcy process within 17–18 months after the [American Classic] bankruptcy filing.” However, according to the bankruptcy plan administrator's office, the 40% of passengers who paid by cash or check were classified as priority claimants in the bankruptcy proceeding and received only the maximum amount available under the bankruptcy code for that category of customer deposits, which was $2100 per person at that time. If any individual passengers' deposit equaled more than $2100 per person, they would not have been fully reimbursed via the American Classic bankruptcy proceeding. With respect to passengers of the American Classic vessel M.S. PATRIOT, a compromise was structured after extensive negotiations whereby the passengers received reimbursements of 26% of their initial deposits.
The final rule provides a process by which a PVO whose UPR is less than 150% of the $30 million cap (i.e., $45 million) may request relief from the Commission by seeking recognition of additional financial protection(s) in substitution for coverage otherwise required by the Commission's regulations. This case-by-case process is supported broadly by the vessel interests that submitted comments. Alternative sources suggested include recognition of existing credit card refund requirements (whether under the Fair Credit Billing Act or not), Bankruptcy Code priorities that allow recovery of consumer deposits made for services rendered but not performed, private travel insurance, and U.S. Tour Operator Association (USTOA) performance bonds that are purchased by some PVOs.
Several commenters indicate, however, that reliance on credit card refunds can be problematic in that, if the Commission grants a request, the credit card companies could increase security to cover some or all of the UPR relief granted. This could include hold-backs or letters of credit to protect the credit card company in the event of nonperformance. One commenter, InnerSea, indicates this outcome is a near-certainty.
The Commission has rarely recognized alternative forms of financial responsibility. The Commission decided to grant a request by a PVO for relief from the otherwise applicable financial responsibility requirements pursuant to 46 CFR 540.5. The Commission accepted credit card receipts and the PVO's USTOA performance bond in recognition of the increased collateralization by its credit card company requiring funds to be held back to cover nonperformance. Since credit card issuers had set up a separate escrow type fund to protect its cardholders, it was deemed unnecessary to mandate a duplicate escrow set up under Commission regulations. A concern with the relief given to the PVO, however, was that the “hold-back” funds also would be available to be used to reimburse the passenger for services unrelated to the ocean transportation, including air fare, shore excursions, port transfer and baggage charges.
Comments responding to the NOI, NPRM and RFI indicate that PVO credit card receipts account for 50 percent to 94 percent of passenger fares. The concern was expressed that credit card sales in effect result in double coverage because some are required by the card companies to provide collateral and pay extra fees in addition to the costs associated with obtaining financial responsibility to comply with the Commission's regulations in Part 540. Though the extra collateral and fees may be used to refund unearned revenues that fall under the Commission's regulations, credit card refunds are not limited to payment of the unearned revenues covered by Part 540.
With respect to the consumer protections under the Fair Credit Billing Act, the cardholder must give written notice of non-performance to the card issuer within sixty days after the credit card issuer mailed the statement containing the charges.
As indicated in comments, common PVO industry practice requires full payment of cruise fares from 60 to 90 days prior to sailing, though booking usually occurs months before the sailing date. Passengers may be required to make substantial initial deposits at the time of booking. Such booking deposits may account for up to 30 percent of the total fare. Hence, booking deposits made by credit cards normally do not fall within the 60 day window of the FCBA. CLIA indicates in its response to the NOI, however, that approximately 50 percent of cruise fares are paid within the 60-day FCBA window.
Notwithstanding that credit card companies have consistently reimbursed cardholders, even where nonperformance occurred beyond the 60-day window, the increased reliance on credit card refunds as an alternative form of protection can present other concerns. For example, credit cardholder contracts vary by card issuer and cardholder, and are subject to unilateral changes by the card issuer; the Commission has no authority to assure that credit card issuers will make Part 540 refunds in preference to other non-statutory claims associated with passengers' broader travel plans (e.g., hotels, airfare, land-side excursions, etc.). There is no assurance that the card issuer will make such reimbursements in certain circumstances or, as a general matter, continue to make such refunds. Nonetheless, recognition of credit card protection may serve, on a case-by-case basis, as the primary source of alternative financial responsibility.
Credit card reimbursement requirements and policies exist regardless of Commission requirements. Such requirements may be imposed by statute, regulation or policies of credit card issuers. Consideration of credit card protections by the Commission does not change those requirements. However, it is true that credit card issuers may require collateral based upon a risk assessment of a PVO or other company. Nonetheless, imposition of such a requirement presumably is based on the perceived risk of failure of the enterprise. That risk would exist whether or not the Commission required additional coverage.
Private travel insurance policies differ widely. For example, some policies only reimburse passengers in the event the PVO formally declares bankruptcy. Others will reimburse passengers only after the PVO officially announces that it has suspended operations due to insolvency or bankruptcy. Still others may not cover nonperformance by the PVO, but only the inability of the passenger to travel as scheduled. Some PVOs offer travel insurance that have portions of coverage which are not in fact underwritten by insurance providers, with the passenger protected only to the extent of the PVO's ability to reimburse.
The wide variability of travel insurance policies makes it difficult for the Commission to assure that the proceeds are adequately and reliably targeted to reimburse passengers for their unperformed water transportation. Therefore, it appears to the Commission that private travel insurance as a form of alternative financial responsibility is not sufficiently reliable at this time to support a request to provide substitute financial responsibility.
The performance bonds that PVOs purchase from the U.S. Tour Operators Association are also suggested as a source of substitute financial responsibility. The Commission has had some experience with respect to the USTOA bond performance. Unlike private travel insurance, the USTOA bond is an agreement between the PVO and the association, not the individual passenger. Also, the USTOA bond varies less from bond to bond and appears to have been administered with consistent results. The USTOA bond may merit consideration with respect to a request for relief, provided the bond text were amended to provide specifically for coverage of Part 540 unearned revenues; or if amended to provide a mechanism whereby passengers are paid directly, not via the insolvent PVO.
As indicated by passenger experience with respect to the American Classic bankruptcy, it would appear that the Bankruptcy Code priority for services not performed is a source of last resort for refund of unearned passenger revenues. Not only did some American Classic passengers have to wait almost ten years for refunds, some received refunds of only 26 percent. Bankruptcy would, therefore, be an unreliable source of passenger protection. Bankruptcy likely would not be anticipated and, even if a bankruptcy were to occur, there would be no assurance of sufficient assets to reimburse any passenger, much less fully reimburse all of them.
The process provided in the final rule enables the Commission, on a case-by-case basis, to consider additional protections submitted by an applicant. The rule provides that PVOs with UPR not exceeding 150% of the cap may submit requests for relief from coverage requirements by substituting alternative forms of protection. ACL and CLIA both suggest that the 150% level is too low, and that more small PVOs would be able to take advantage of the process if the level were higher. The most significant effect of increasing the percentage would be to lessen the amount of UPR that is covered by established financial instruments under the Commission's nonperformance program in substitution for security that is not as certain, such as credit card refunds.
Currently, 28 of the 40 PVOs in the Commission's program have UPR below $45,000,000 and each therefore may qualify for lowering their current coverage requirements. However, raising it to 200% would allow consideration of only one additional PVO. Accordingly, the Commission adopts the 150% threshold for submission of requests for relief.
ACL commented that the Commission did not indicate what criteria governed the process. This point is well taken. Accordingly, the final rule has been amended to set out criteria the Commission will use in considering such requests.
The final rule requires that requests be submitted to the Bureau of Certification and Licensing. PVOs must include their most recently available annual and quarterly reports, irrespective of the alternative financial responsibility upon which a request may be based.
For requests based upon the already existing protections applicable to credit card receipts, the PVO must, for voyages
The final rule provides that the Commission may permit a reduction in financial responsibility to be based upon credit card receipts. The amount of such a reduction is determined by halving the proportion of credit card receipts to the PVO's total receipts, and applying the resulting percentage to the PVO's highest two-year UPR. For example, where the total credit card receipts for the twelve-month period equals 30 percent of the total receipts for the period, the PVO would receive a 15 percent reduction off of its highest UPR. Such requests ordinarily will be granted for PVOs whose payment policies provide for payment within 60 days of the vessel's sailing date and financial condition appears to be sound. Requests based upon payment policies that require final payment more than 60 days from the date of sailing may be granted for a lower percentage reduction. The Director of BCL, may, however, refer such requests to the Commission for decision.
The final rule also provides that the alternative financial responsibility granted will remain in effect until its Certificate (Performance) expires pursuant to 540.7(b) unless the Commission determines otherwise based upon paragraph 5 of this section.
Additionally, BCL may request additional information, at the time of the initial request, from the PVO. Such requests are made now by BCL when, for example, it receives information that may bear on a PVO's ability to perform. Similarly, the final rule adds a provision enabling the BCL to request such information from PVOs after their requests are granted. Of course, the PVO may provide any other information related to the alternative financial responsibility or its financial condition that it considers relevant to its request.
ACL and CLIA each suggest elimination of the 10% “administrative fee.” They refer to the last ten percent in the 110% of UPR required of PVOs that do not qualify for the cap. ACL asserts that the 10% is used to administer the Commission's nonperformance program. To clarify, the 10% is not an “administrative fee” in any sense and the Commission does not receive any of the 10%. All 110 percent of a PVO's financial responsibility is devoted to refunds in the event of nonperformance and, in some instances, to cover costs associated with payment of reimbursements, such as standard check processing fees by banks.
Further, in promulgating the original regulations implementing section 3 of Public Law 89–777 in 1967, the Commission established the requirement that PVOs provide financial responsibility equal to 110% of UPR. The Commission stated that the rule is designed to recover 100% of unearned revenue based on two years' performance “to give an indication of the general operating condition of the applicant, plus a safety factor of 10 percent.” 32 FR 3986 (March 11, 1967). In short, this 10 percent “safety factor” assures reimbursement where the actual amount of UPR at the time a PVO fails to perform is greater than the amount last reported.
For example, as reflected in the Regulatory Flexibility Act Threshold Analysis described below, escrow agreements are obtained more often by smaller PVOs. Such PVOs may have difficulty obtaining a bond or guaranty or have seasonal services or operations that otherwise experience drastic change in the amount of UPR through the year. Escrow agreements require a fixed 10% to be kept in escrow during the slow season and require that funds received from voyage deposits and final fare payments be deposited on a timely basis into the escrow account. Among other requirements, escrow PVOs are required to submit reports of monies received and deposited on a weekly and monthly basis so that the Commission can confirm that the rapidly accumulating funds have, in fact, been deposited. Most escrow agreements provide that “the Customer may, at any time, deposit additional funds consisting exclusively of UPR and the Fixed Amount into the Escrow Account.” Hence, the 10 percent safety factor helps bridge gaps between the most recent report of weekly deposits and amounts received but not yet deposited.
As described by ACL and CLIA, their suggestion would result in an “across the board” cut for all PVOs that do not qualify for the cap. The recognition of alternative coverage to reduce current coverage requirements, however, negates the need to consider eliminating the 10% safety factor, as fewer small PVOs may be submitting coverage of 110% of UPR. Therefore in light of the Commission's experience that significant shortfalls in UPR (deposited and revenue received but not yet deposited) frequently occur with respect to escrow agreements, the 110% coverage requirement remains unchanged for all PVOs, except those that qualify for the $30 million cap or who receive relief under the new rule providing for substitution of alternative financial responsibility. In any event, escrow agreements will continue to require a minimum of 10 percent to be held in escrow at all times; even where an escrow PVO obtains relief to provide alternative financial responsibility for the remaining 90% of its UPR.
The Commission also requested comment as to whether nonperformance financial responsibility levels might be established using a methodology similar to that for the casualty program for PVO financial responsibility. CLIA commented in response to this suggestion and strongly opposes it, asserting that the casualty methodology was established by statute at the same time, and in the same statute, as the nonperformance provisions, which CLIA asserts indicates that Congress intended separate and distinct systems for casualty and performance coverage. CLIA's comments imply that new statutory authority would be needed to make such a change. ACL indicated that the idea had some merit but that they would need more information on such a proposal. As the Commission adopts the rule as proposed, there is no need to consider the use of a methodology similar to that for establishing financial responsibility under the Commission's casualty program.
As described above, Carnival suggests that financially sound PVOs that have a number of cruise brands be treated as a single applicant for purposes of the financial responsibility requirements. Carnival recommends that such applicants be covered by a single $50 million bond backed by the parent company's guaranty. Carnival explains that such a bond and parental guaranty would provide greater security by assuring that the parent stands behind its group of companies. The adoption of the final rule also obviates the need to consider a financial responsibility methodology that would potentially reduce the financial responsibility requirements of larger PVOs.
The Commission also adopts certain technical changes to its passenger vessel financial responsibility regulations in Part 540. Those changes include the revision of the definition of “unearned passenger revenue” in section 540.2(i) to clarify that UPR “includes port fees and taxes paid” by passengers but excludes “items as airfare, hotel
The changes to section 540.4(b) and section 540.23(a) are also adopted. Applicants will file their applications directly with the Bureau of Certification and Licensing instead of with the Office of the Secretary. Form FMC–131 will be deleted from the Code of Federal Regulations and instead made available on the Commission's web site (www.fmc.gov) or directly from the Bureau of Certification and Licensing.
The revision to section 540.7 is adopted and requires that each Certificate (Performance) expire 5 years from the date of issuance. The current rule provides that the certificate may continue in effect indefinitely. The Final Rule does not, however, require expiration of the underlying financial responsibility instruments.
This revision will assist the U.S. Customs and Border Protection to verify the validity of a certificate under 46 U.S.C. 44105, and ensure that the Commission periodically confirms PVO information previously submitted. This change harmonizes the Commission's PVO certificates with domestic and international certificates (e.g., the U.S. Coast Guard's Certificate of Inspection, those issued under The Safety of Life at Sea Convention, and the International Convention on Load Lines).
NASBP supports expiration dates for each Certificate (Performance), indicating that surety bonds were not meant to be indefinite. The final rule, however, is not intended to affect the underlying financial responsibility. Rather the certificate expiration provides the opportunity for the updating of each PVO's information with the Commission as well as the broader reasons indicated. However, should the PVO and its surety include an expiration date less than five years for the underlying security, the certificate could be issued with that expiration date.
The sample surety bond, guaranty, and escrow agreement are amended as contained in the NPRM and will continue to be set out in the Commission's regulations.
The Regulatory Flexibility Act of 1980 (RFA),
The threshold analysis considered the economic impact on small businesses of the rule changes in Docket 11–16:
Based upon the following factual basis, the threshold analysis concludes that none of the PVOs in the Commission's program that are identified as small entities under the Small Business Act (SBA)
The Commission issued a Request for Additional Information and Comments (RFI) on February 22, 2012. Comments were submitted by four PVOs: Royal Caribbean, Carnival, American Cruise Lines, and InnerSeas Discoveries. The analysis compiles confidential data provided in response to the Commission's questions about their companies' operations and demonstrates the huge differences in operational scale among the respondents.
The industry regulated under Part 540 of the Commission's regulations consists of “persons” in the U.S. who arrange, offer, advertise or provide passage on a vessel having berth or state room accommodations for 50 or more passengers and embark passengers at U.S. ports.
As of June 30, 2012, the FMC Passenger Vessel Operator program had 40 participants. The threshold analysis reviewed each of the 40 program participants along with their 2-year high UPR, amount of performance coverage, the type of instrument used, percentage of UPR protected by bonds or escrows, and the primary market segment in which they operate. The analysis determined whether a PVO meets or exceeds the SBA size standard for the NAICs codes indentified.
The SBA defines a small business as any firm that is independently owned and operated and not dominant in its field of operation. The SBA size standard for a small company in the U.S. cruise industry is 500 or fewer employees. For the purposes of this analysis, any operator in the PVO program that is affiliated with, or a subsidiary of, a larger entity is considered to exceed the SBA size standard. For example, a PVO that operates one vessel in the Commission's PVO program, has a 2-year high UPR of less than $1 million, and may have fewer than 500 employees in the U.S. However, it is considered to have exceeded the SBA size standard because it is a subsidiary of a large global enterprise. Such a single vessel operator does not meet the “independently owned and operated” criteria for a small business. A total of nine operators in the PVO program are considered to have exceeded the SBA size standard by the same reasoning.
Seven PVOs were eliminated from this analysis because they have either no UPR or no financial responsibility instrument (performance) on file with the Commission. These PVOs maintain a casualty certificate and many embark passengers from U.S. ports on a very limited basis (i.e., embark very few passengers at one U.S. port on a rare occasion or perform several short-term chartered cruises once a year or every 2 or 3 years). Historically, UPR for these seven PVOs has been well under the $15 million cap.
Staff identified nine PVOs in the program that meet the SBA size standard and are considered to be small businesses. Six of the nine small PVOs are exploration/soft adventure operators which operate U.S. flag vessels in Alaska, U.S. coastal waters, or on inland waterways. These operators would be classified in the NAICS codes of 483112-Deep Sea Passenger Transportation, 483114-Coastal and Great Lakes Passenger Transportation, and 483212-Inland Water Passenger Transportation. Because they are U.S. flag operators, they are required to have U.S. ownership, use U.S.-built ships, and use U.S. citizens as crew members. The remaining three small PVOs are foreign flag operators operating in various U.S./foreign cruise and ferry markets using Panamanian and Bahamian flag vessels, and they are classified in NAICS code 483112-Deep Sea Passenger Transportation.
Assessing economic impact involves estimating the cost of any increased financial performance coverage. On a per-passenger basis, the cost of financial coverage can vary significantly depending on the size of the PVO. For example, the cost per passenger for a large PVO whose coverage is capped at $15 million level can be very small. In contrast, a small PVO's coverage can be many times that of the large operator for the same time period.
The economic impact on small PVOs depends upon the instrument used to establish financial responsibility. Five of the program's small PVOs have bonds. Based on conversations with a surety association, BCL finds that the least risky PVOs would probably pay about 0.5 percent of the instrument's face value, while the most risky would probably pay about 3 percent. These estimates were used for the baseline estimate of economic impact of the current rule. The threshold analysis shows the range of possibilities for those small PVOs using bonds. The level of coverage based on 110% UPR with the increased cap also was calculated as was the range of annual premiums. Differences in anticipated annual premiums under the current and proposed rules were calculated. Only one operator with UPR exceeding the $15 million cap would be expected to have increased premium costs.
One commenter provided the percentage of the bond amount that it must pay to its surety as an annual premium and advised that the surety requires it to obtain a letter of credit in an amount that is a percentage of the bond value. The PVO also provided the amount of its current letter of credit and advised that the process of obtaining the surety bond and letter of credit also incurs additional bank and legal fees.
The threshold analysis reviewed the estimated cost of increasing financial responsibility to $30 million on the five small PVOs using bonds in comparison to their costs under the current rule using each PVO's current 2 year high UPR, its current performance coverage, the estimated cost of coverage using the .5 and 3 percentages provided by the surety association. One small PVO commented that one of the most important additional costs would be the opportunity cost of tying up additional credit availability to secure its bond.
The threshold analysis, however, indicated that the cost of coverage when the cap increases to $30 million for one PVO may increase the average ticket price by less than one percent. The other four PVOs using bonds would experience no increase in their surety bonds as a result of the cap increase.
The threshold analysis also reviewed the remaining four small PVOs that use escrow accounts. Balances in these accounts change weekly as additional fares are deposited; cruises are completed; and the “unearned” revenue associated with the completed cruise becomes “earned” and is withdrawn from the account. Escrow account holders are assessed administrative fees, unlike PVOs using surety bonds or guarantees that are charged premiums linked to the amount of the instrument. Administrative fees, on the other hand, are generally not based on the value of the account. Rather escrow agents or managers have fee schedules which are dependent upon the number and types of transactions or services provided. These include deposits, wire transfers, number of checks processed and issued, number of transfer payments, and documentation preparation. In addition, escrow agents may charge a monthly service fee. The new rule would not affect the basis on which administrative fees are assessed.
To determine the economic impact for these operators, the “opportunity cost”
Because these four small PVOs have UPR levels well below the current $15 million cap, they will not be required to obtain additional performance coverage under the regulations. As a result, these small PVOs would not be subject to any immediate additional economic impact.
With respect to the new provision contained in the Final Rule at 46 CFR 540(j)(ii), based on the current levels of their 2-year high UPR with respect to the required cap (both existing and proposed), it appears that all nine small PVOs may be able to demonstrate the existence of additional forms of protection. To the extent that those proposals are acceptable to the Commission, it would be expected that the elimination of coverage duplication would result in no additional economic impact for any small PVO, and may even reduce it in some cases.
Forty operators participate in the FMC's PVO program. Nine are small PVOs as defined by the SBA's small business size standards for NAICS codes of 483112-Deep Sea Passenger Transportation, 483114-Coastal and Great Lakes Passenger Transportation, and 483212-Inland Water Passenger Transportation.
With one exception, all small operators will be left unaffected economically by the rule changes, even without consideration of alternative forms of coverage. The amount of required coverage should remain the same for these operators. After the evaluation reflected in the threshold analysis, the economic impact on the one small operator does not appear likely to be significantly adverse. Should that operator not avail itself of a reduction under the alternative form of coverage provided in the Final Rule, the compliance cost increase brought about by the rule change would increase costs per passenger by a small amount. If this cost is passed on in its entirety to the cruise passengers, it would raise that operator's average fare by less than one percent and still leave the cruise line profitable. It does not seem likely that this level of impact will drive a small PVO out of business or decrease its ability to make future capital investments or harm its competitiveness against larger firms.
However, the Final Rule would allow the Commission, on a case-by-case basis, to recognize additional protections submitted by small PVOs with UPR not exceeding 150 percent of the $30 million cap. Most likely, the one operator that would be affected by the increased cap, should it choose to avail itself of this provision, would be required to produce less coverage and incur less cost than it does now. Consequently, the threshold analysis does not indicate that the Final Rule in this proceeding will have a significant economic impact on a substantial number of small business entities.
Even without recognition of alternative forms of coverage, the threshold analysis concludes that this rule will not have a significant economic impact on a substantial number of small entities and, therefore, the analysis recommends that the Chairman so certify pursuant to section 605(b) of the RFA.
This rule is not a “major rule” under 5 U.S.C. 804(2).
As described in the NPRM, the collection of information requirements contained in the rule have been submitted to the Office of Management and Budget for review under section 3504(h) of the Paperwork Reduction Act of 1980, as amended. OMB has withheld approval of the forms affected by the rule pending receipt of a summary of comments pertaining to information collection burden imposed by the rule or change made in response to comments. No comments were received relating to information collection burden of the rule.
Inasmuch as the PVOs that are subject to the Commission's passenger vessel financial responsibility regulations at 46 CFR part 540 are already subject to requirements to submit application forms, financial responsibility instruments and periodic reports of their unearned passenger revenues, the final rule does not impose any new recordkeeping or reporting requirements on PVOs that would be “collection of information” requiring approval under the Paperwork Reduction Act, 44 U.S.C. 3501
Administrative practice and procedure, Authority delegations, Organization and functions, Seals and insignia.
Insurance, Maritime carriers, Reporting and recordkeeping requirements, Surety bonds.
For the reasons stated in the supplementary information, the Federal Maritime Commission amends 46 CFR Parts 501 and 540 as follows.
5 U.S.C. 551–557, 701–706, 2903 and 6304; 31 U.S.C. 3721; 41 U.S.C. 414 and 418; 44 U.S.C. 501–520 and 3501–3520; 46 U.S.C. 301–307, 40101–41309, 42101–42109, 44101–44106; Pub. L. 89–56, 70 Stat. 195; 5 CFR Part 2638; Pub. L. 104–320, 110 Stat. 3870.
(g) * * *
(2) Through the Office of Passenger Vessels and Information Processing, has responsibility for reviewing applications for certificates of financial responsibility with respect to passenger vessels, reviewing requests for substitution of alternative forms of financial protection, managing all activities with respect to evidence of financial responsibility for OTIs and passenger vessel owner/operators, and for developing and maintaining all Bureau database and records of OTI applicants and licensees.
(d) Authority to the Director, Bureau of Certification and Licensing to grant requests to substitute alternative financial responsibility pursuant to § 540.9(l) of this chapter based upon existing protection available to purchases of passenger vessel transportation by credit card by an amount up to fifty (50) percent of the passenger vessel operator's highest two-year unearned passenger revenues.
5 U.S.C. 552, 553; 31 U.S.C. 9701; 46 U.S.C. 305, 44101–44106.
(b) * * * Vessels operating without the proper certificate may be denied clearance by the Department of Homeland Security and their owners may also be subject to a civil penalty of not more than $5,000 in addition to a civil penalty of $200 for each passage
(a)
(i)
(a) In order to comply with section 3 of Public Law 89–777 (46 U.S.C. 44101–44102, 44104–44106) enacted November 6, 1966, there must be filed with the Federal Maritime Commission an application on Form FMC–131 for a Certificate of Financial Responsibility for Indemnification of Passengers for Nonperformance of Transportation. Copies of Form FMC–131 may be obtained from the Commission's Web site at
(b) An application for a Certificate (Performance) shall be filed with the Bureau of Certification and Licensing, Federal Maritime Commission, by the vessel owner or charterer at least 60 days in advance of the arranging, offering, advertising, or providing of any water transportation or tickets in connection therewith except that any person other than the owner or charterer who arranges, offers, advertises, or provides passage on a vessel may apply for a Certificate (Performance). Late filing of the application will be permitted without penalty only for good cause shown.
(c) All applications and evidence required to be filed with the Commission shall be in English, and any monetary terms shall be expressed in terms of U.S. currency.
(d) The Commission shall have the privilege of verifying any statements made or any evidence submitted under the rules of this subpart.
(e) An application for a Certificate (Performance), excluding an application for the addition or substitution of a vessel to the applicant's fleet, shall be accompanied by a filing fee remittance of $2,767. An application for a Certificate (Performance) for the addition or substitution of a vessel to the applicant's fleet shall be accompanied by a filing fee remittance of $1,382. Administrative changes, such as the renaming of a vessel will not incur any additional fees.
(f) The application shall be signed by a duly authorized officer or representative of the applicant with a copy of evidence of his or her authority.
(g) In the event of any material change in the facts as reflected in the application, an amendment to the application shall be filed no later than fifteen (15) days following such change. For the purpose of this subpart, a material change shall be one which:
(1) Results in a decrease in the amount submitted to establish financial responsibility to a level below that required to be maintained under the rules of this subpart, or
(2) Requires that the amount to be maintained be increased above the amount submitted to establish financial responsibility.
(h) Notice of the application for issuance, denial, revocation, suspension, or modification of any such Certificate will be published on the Commission's web site at
(a) * * *
(1) * * * (i) Until notice in writing has been given to the assured or to the insurer and to the Bureau of Certification and Licensing at its office in Washington, DC 20573, by certified mail or courier service, * * *
(c) * * * Copies of Form FMC–133A may be obtained from the Commission's Web site at
(a) * * * Copies of Form FMC–132A may be obtained from the Commission's Web site at
Where satisfactory proof of financial responsibility has been established:
(a) A Certificate (Performance) covering specified vessels shall be issued evidencing the Commission's finding of adequate financial responsibility to indemnify passengers for nonperformance of water transportation.
(b) The period covered by the Certificate (Performance) shall be five (5) years, unless another termination date has been specified thereon.
(a) Prior to the denial, revocation, suspension, or modification of a Certificate (Performance), the Commission shall notify the applicant of its intention to deny, revoke, suspend, or modify and shall include with the notice the reason(s) for such action. If the applicant, within 20 days after the receipt of such notice, requests a hearing to show that the evidence of financial responsibility filed with the Commission does meet the rules of this subpart, such hearing shall be granted by the Commission. Regardless of a hearing, a Certificate (Performance) shall become null and void upon cancellation or termination of the surety bond, evidence of insurance, guaranty, or escrow account.
(b) * * *
(3) Failure to comply with or respond to lawful inquiries, requests for information, rules, regulations, or orders of the Commission pursuant to the rules of this subpart.
(c) The Commission's bond (Form FMC–132A), guaranty (Form FMC–
(e) Each applicant, insurer, escrow agent and guarantor shall furnish a written designation of a person in the United States as legal agent for service of process for the purposes of the rules of this subpart. Such designation must be acknowledged, in writing, by the designee and filed with the Commission. In any instance in which the designated agent cannot be served because of death, disability, or unavailability, the Secretary, Federal Maritime Commission, will be deemed to be the agent for service of process. A party serving the Secretary in accordance with the above provision must also serve the certificant, insurer, escrow agent, or guarantor, as the case may be, by certified mail or courier service at the last known address of them on file with the Commission.
(h) Every person who has been issued a Certificate (Performance) must submit to the Commission a semi-annual statement of any changes with respect to the information contained in the application or documents submitted in support thereof or a statement that no changes have occurred. Negative statements are required to indicate no change. These statements must cover the 6-month period of January through June and July through December, and include a statement of the highest unearned passenger vessel revenue accrued for each month in the 6-month reporting period. Such statements will be due within 30 days after the close of every such 6-month period. The reports required by this paragraph shall be submitted to the Bureau of Certification and Licensing at its office in Washington, DC 20573 by certified mail, courier service, or electronic submission.
(j) The amount of: the insurance as specified in § 540.5(a), the escrow account as specified in § 540.5(b), the guaranty as specified in § 540.5(c), or the surety bond as specified in § 540.6 shall not be required to exceed $15 million for one year after April 2, 2013. Twelve (12) months after April 2, 2013, the amount shall not exceed $22 million, and twenty four (24) months after April 2, 2013, the amount shall not exceed $30 million. Every two years, on the anniversary after the cap on required financial responsibility reaches $30 million, the cap shall automatically adjust to the nearest $1 million based on changes as reflected in the U.S. Bureau of Labor Statistics' Consumer Price Index. The Bureau of Certification and Licensing will determine the amount of each adjustment and transmit that information to the Secretary of the Federal Maritime Commission for publication on the Commission's Web site (
(k) Every person in whose name a Certificate (Performance) has been issued shall be deemed to be responsible for any unearned passage money or deposits held by its agents or any other person authorized by the certificant to sell the certificant's tickets. Certificants shall promptly notify the Commission of any arrangements, including charters and subcharters, made by it or its agent with any person pursuant to which the certificant does not assume responsibility for all passenger fares and deposits collected by such person or organization and held by such person or organization as deposits or payment for services to be performed by the certificant. If responsibility is not assumed by the certificant, the certificant also must inform such person or organization of the certification requirements of Public Law 89–777 and not permit use of its vessel, name or tickets in any manner unless and until such person or organization has obtained the requisite Certificate (Performance) from the Commission. Failure to follow the procedures in this paragraph means the certificant shall retain full financial responsibility for indemnification of passengers for nonperformance of the transportation.
(l)
(2) The Commission will consider such requests on a case-by-case basis.
(3) The request must include copies of the requesting PVO's most recently available annual and quarterly financial and income statements. Other documents and information in support of its request may also be submitted.
(4) For requests based upon the already existing protections available to credit card purchases of passenger vessel transportation, the requesting PVO must supply the following information for the most recent twelve months preceding the request: Total deposits and payments received for passenger vessel transportation; Credit card receipt totals; Copy of the PVO's policy(ies) governing payments by passengers (i.e., deposits and the number of days prior to sailing the passenger must make final payment).
(5) In determining whether and to what level to reduce the required amount, the Commission may consider the extent to which other statutory requirements provide relevant protections, the certificant's financial data, and other specific facts and circumstances.
(6) For PVOs with payment policies that provide for final payment for the passenger vessel transportation no later than 60 days before the vessel's sailing date, requests based upon credit card receipts may be granted by the Commission permitting a reduction in the financial responsibility otherwise required under this Part. The amount of such a reduction will be established by determining the proportion that the PVO's total credit card receipts bears to its total receipts and applying one half of that percentage to the PVO's highest two-year UPR.
(7) The Bureau of Certification and Licensing may request additional information as may assist it in considering the request.
(8) Where a request is granted, the alternative financial responsibility shall remain in effect until the PVO's Certificate (Performance) expires under § 540.7(b) or until the Director, Bureau of Certification and Licensing determines otherwise based upon changing information pursuant to this paragraph or paragraph (l)(5) of this section. Additional information may be requested at any time by the Commission or BCL from a PVO whose request under this section has been granted.
Know all men by these presents, that we __________ (Name of
Whereas this bond is written to assure compliance by the Principal as an authorized holder of a Certificate (Performance) pursuant to subpart A of part 540 of title 46, Code of Federal Regulations, and shall inure to the benefit of any and all passengers to whom the Principal may be held legally liable for any of the damages herein described. Now, therefore, the condition of this obligation is such that if the Principal shall pay or cause to be paid to passengers any sum or sums for which the Principal may be held legally liable by reason of the Principal's failure faithfully to provide such transportation and other accommodations and services in accordance with the ticket contract made by the Principal and the passenger while this bond is in effect for the supplying of transportation and other services pursuant to and in accordance with the provisions of subpart A of part 540 of title 46, Code of Federal Regulations, then this obligation shall be void, otherwise, to remain in full force and effect.
The liability of the Surety with respect to any passenger shall not exceed the passage price paid by or on behalf of such passenger. The liability of the Surety shall not be discharged by any payment or succession of payments hereunder, unless and until such payment or payments shall amount in the aggregate to the penalty of the bond, but in no event shall the Surety's obligation hereunder exceed the amount of said penalty. The Surety agrees to furnish written notice to the Federal Maritime Commission forthwith of all suits filed, judgments rendered, and payments made by said Surety under this bond.
This bond is effective the ______ day of ________, 20__, 12:01 a.m., standard time at the address of the Principal as stated herein and shall continue in force until terminated as hereinafter provided. The Principal or the Surety may at any time terminate this bond by written notice sent by certified mail, courier service, or other electronic means such as email and fax to the other and to the Federal Maritime Commission at its office in Washington, DC, such termination to become effective thirty (30) days after actual receipt of said notice by the Commission, except that no such termination shall become effective while a voyage is in progress. The Surety shall not be liable hereunder for any refunds due under ticket contracts made by the Principal for the supplying of transportation and other services after the termination of this bond as herein provided, but such termination shall not affect the liability of the Surety hereunder for refunds arising from ticket contracts made by the Principal for the supplying of transportation and other services prior to the date such termination becomes effective.
The underwriting Surety will promptly notify the Director, Bureau of Certification and Licensing, Federal Maritime Commission, Washington, DC 20573, of any claim(s) or disbursements against this bond.
In witness whereof, the said Principal and Surety have executed this instrument on ______ day of ________, 20__.
(Signature and title)
(Signature and title)
Only corporations or associations of individual insurers may qualify to act as surety, and they must establish to the satisfaction of the Federal Maritime Commission legal authority to assume the obligations of surety and financial ability to discharge them.
1. Whereas ________ (Name of applicant) (Hereinafter referred to as the “Applicant”) is the Owner or Charterer of the passenger Vessel(s) specified in the annexed Schedule (“the Vessels”'), which are or may become engaged in voyages to or from United States ports, and the Applicant desires to establish its financial responsibility in accordance with section 3 of Pub. L. 89–777, 89th Congress, approved November 6, 1966 (“the Act”) then, provided that the Federal Maritime Commission (“FMC”) shall have accepted, as sufficient for that purpose, the Applicant's application, supported by this Guaranty, and provided that FMC shall issue to the Applicant a Certificate (Performance) (“Certificate”), the undersigned Guarantor hereby guarantees to discharge the Applicant's legal liability to indemnify the passengers of the Vessels for nonperformance of transportation within the meaning of section 3 of the Act, in the event that such legal liability has not been discharged by the Applicant within 21 days after any such passenger has obtained a final judgment (after appeal, if any) against the Applicant from a United States Federal or State Court of competent jurisdiction, or has become entitled to payment of a specified sum by virtue of a compromise settlement agreement made with the Applicant, with the approval of the Guarantor, whereby, upon payment of the agreed sum, the Applicant is to be fully, irrevocably and unconditionally discharged from all further liability to such passenger for such nonperformance.
2. The Guarantor's liability under this Guaranty in respect to any passenger shall not exceed the amount paid by such passenger; and the aggregate amount of the Guarantor's liability under this Guaranty shall not exceed $______.
3. The Guarantor's liability under this Guaranty shall attach only in respect of events giving rise to a cause of action against the Applicant, in respect of any of the Vessels, for nonperformance of transportation within the meaning of Section 3 of the Act, occurring after the Certificate has been granted to the Applicant, and before the expiration
(a) The date whereon the Certificate is withdrawn, or for any reason becomes invalid or ineffective; or
(b) The date 30 days after the date of receipt by FMC of notice in writing delivered by certified mail, courier service or other electronic means such as email and fax, that the Guarantor has elected to terminate this Guaranty except that: (i) If, on the date which would otherwise have been the expiration date under the foregoing provisions (a) or (b) of this Clause 3, any of the Vessels is on a voyage whereon passengers have been embarked at a United States port, then the expiration date of this Guaranty shall, in respect of such Vessel, be postponed to the date on which the last passenger on such voyage shall have finally disembarked; and (ii) Such termination shall not affect the liability of the Guarantor for refunds arising from ticket contracts made by the Applicant for the supplying of transportation and other services prior to the date such termination becomes effective.
4. If, during the currency of this Guaranty, the Applicant requests that a vessel owned or operated by the Applicant, and not specified in the annexed Schedule, should become subject to this Guaranty, and if the Guarantor accedes to such request and so notifies FMC in writing or other electronic means such as email and fax, then, provided that within 30 days of receipt of such notice, FMC shall have granted a Certificate, such Vessel shall thereupon be deemed to be one of the Vessels included in the said Schedule and subject to this Guaranty.
5. The Guarantor hereby designates ______, with offices at ______, as the Guarantor's legal agent for service of process for the purposes of the Rules of the Federal Maritime Commission, subpart A of part 540 of title 46, Code of Federal Regulations, issued under Section 3 of Pub. L. 89–777 (80 Stat. 1357, 1358), entitled “Security for the Protection of the Public.”
THIS ESCROW AGREEMENT, made as of this __ day of (month & year), by and between (Customer), a corporation/company having a place of business at (“Customer”) ________ _________ and (Banking Institution name & address) a banking corporation, having a place of business at (“Escrow Agent”).
Witnesseth:
WHEREAS, Customer wishes to establish an escrow account in order to provide for the indemnification of passengers in the event of non-performance of water transportation to which such passengers would be entitled, and to establish Customer's financial responsibility therefore; and
WHEREAS, Escrow Agent wishes to act as Escrow Agent of the escrow account established hereunder;
NOW, THEREFORE, in consideration of the premises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows:
1. Customer has established on (month, & year) (the “Commencement Date”) an escrow account with the Escrow Agent which escrow account shall hereafter be governed by the terms of this Agreement (the “Escrow Account”). Escrow Agent shall maintain the Escrow Account in its name, in its capacity as Escrow Agent.
2. Customer will determine, as of the date prior to the Commencement Date, the amount of unearned passenger revenue, including any funds to be transferred from any predecessor Escrow Agent. Escrow Agent shall have no duty to calculate the amount of unearned passenger revenue. Unearned Passenger Revenues are defined as that passenger revenue received for water transportation and all other accommodations, services and facilities relating thereto not yet performed. 46 C.F.R. 540.2(i).
3. Customer will deposit on the Commencement Date into the Escrow Account cash in an amount equal to the amount of Unearned Passenger Revenue determined under Paragraph 2 above plus a cash amount (“the Fixed Amount”) equal to (10 percent of the Customer's highest Unearned Passenger Revenue for the prior two fiscal years. For periods on or after (year of agreement (2009)), the Fixed Amount shall be determined by the Commission on an annual basis, in accordance with 46 CFR Part 540.
4. Customer acknowledges and agrees that until such time as a cruise has been completed and Customer has taken the actions described herein, Customer shall not be entitled, nor shall it have any interest in any funds deposited with Escrow Agent to the extent such funds represent Unearned Passenger Revenue.
5. Customer may, at any time, deposit additional funds consisting exclusively of Unearned Passenger Revenue and the Fixed Amount, into the Escrow Account and Escrow Agent shall accept all such funds for deposit and shall manage all such funds pursuant to the terms of this Agreement.
6. After the establishment of the Escrow Account, as provided in Paragraph 1, Customer shall on a weekly basis on each (identify day of week), or if Customer or Escrow Agent is not open for business on (identify day of week) then on the next business day that Customer and Escrow Agent are open for business recompute the amount of Unearned Passenger Revenue as of the close of business on the preceding business day (hereinafter referred to as the “Determination Date”) and deliver a Recomputation Certificate to Escrow Agent on such date. In each such weekly recomputation Customer shall calculate the amount by which Unearned Passenger Revenue has decreased due to (i) the cancellation of reservations and the corresponding refund of monies from Customer to the persons or entities canceling such reservations; (ii) the amount which Customer has earned as revenue as a result of any cancellation fee charged upon the cancellation of any reservations; (iii) the amount which Customer has earned due to the completion of cruises; and (iv) the amount by which Unearned Passenger Revenue has increased due to receipts from passengers for future water transportation and all other accommodations, services and facilities relating thereto and not yet performed.
The amount of Unearned Passenger Revenue as recomputed shall be compared with the amount of Unearned Passenger Revenue for the immediately preceding period to determine whether there has been a net increase or decrease in Unearned Passenger Revenue. If the balance of the Escrow Account as of the Determination Date exceeds the sum of the amount of Unearned Passenger Revenue, as recomputed, plus the Fixed Amount then applicable, then Escrow Agent shall make any excess funds in the Escrow Account available to Customer. If the balance in the Escrow Account as of the Determination Date is less than the sum of the amount of Unearned Passenger Revenue, as recomputed, plus an amount equal to the Fixed Amount, Customer shall deposit an amount equal to such deficiency with the Escrow Agent. Such deposit shall be made in immediately available funds via wire transfer or by direct transfer from the Customer's U.S. Bank checking account before the close of business on the next business day following the day on which the Recomputation Certificate is received by Escrow Agent. The Escrow Agent shall promptly notify the Commission within two business days any time a deposit required by a Recomputation Certificate delivered to the Escrow Agent is not timely made.
7. Customer shall furnish a Recomputation Certificate, in substantially the form attached hereto as Annex 1, to the Federal Maritime
Within fifteen (15) days after the end of each calendar month, Escrow Agent shall provide to Customer and to the Commission at the addresses provided in Paragraph 25 below, a comprehensive statement of the Escrow Account. Such statement shall provide a list of assets in the Escrow Account, the balance thereof as of the beginning and end of the month together with the original cost and current market value thereof, and shall detail all transactions that took place with respect to the assets and investments in the Escrow Account during the preceding month.
8. At the end of each quarter of Customer's fiscal year, Customer shall cause the independent auditors then acting for it to conduct an examination in accordance with generally accepted auditing standards with respect to the weekly Recomputation Certificates furnished by Customer of the Unearned Passenger Revenues and the amounts to be deposited in the Escrow Account and to express their opinion within forty-five (45) days after the end of such quarter as to whether the calculations at the end of each fiscal quarter are in accordance with the provisions of Paragraph 6 of this Agreement. The determination of Unearned Passenger Revenue of such independent auditors shall have control over any computation of Unearned Passenger Revenue by Customer in the event of any difference between such determinations. To the extent that the actual amount of the Escrow Account is less than the amount determined by such independent auditors to be required to be on deposit in the Escrow Account, Customer shall immediately deposit an amount of cash into the Escrow Account sufficient to cause the balance of the Escrow Account to equal the amount determined to be so required. Such deposit shall be completed no later than the business day after receipt by the Escrow Agent of the auditor's opinion containing the amount of such deficiency.
The opinion of such independent auditors shall be furnished by such auditors directly to Customer, to the Commission and to the Escrow Agent at their addresses contained in this Agreement. In the event that a required deposit to the Escrow Agent is not made within one Business Day after receipt of an auditor's report or a Recomputation Certificate, Escrow Agent shall send notification to the Commission within the next two Business Days.
9. Escrow Agent shall invest the funds in the Escrow Account in Qualified Investments as directed by Customer in its sole and absolute discretion. “Qualified Investments” means, to the extent permitted by applicable law:
(a) Government obligations or obligations of any agency or instrumentality of the United States of America;
(b) Commercial paper issued by a United States company rated in the two highest numerical “A” categories (without regard to further gradation or refinement of such rating category) by Standard & Poor's Corporation, or in the two highest numerical “Prime” categories (without regard to further gradation or refinement of such rating) by Moody's Investor Services, Inc.;
(c) Certificates of deposit and money market accounts issued by any United States bank, savings institution or trust company, including the Escrow Agent, and time deposits of any bank, savings institution or trust company, including the Escrow Agent, which are fully insured by the Federal Deposit Insurance Corporation;
(d) Corporate bonds or obligations which are rated by Standard & Poor's Corporation or Moody's Investors Service, Inc. in one of their three highest rating categories (without regard to any gradation or refinement of such rating category by a numerical or other modifier); and
(e) Money market funds registered under the Federal Investment Company Act of 1940, as amended, and whose shares are registered under the Securities Act of 1933, as amended, and whose shares are rated “AAA”, “AA+” or “AA” by Standard & Poor's Corporation.
10. All interest and other profits earned on the amounts placed in the Escrow Account shall be credited to Escrow Account.
11. This Agreement has been entered into by the parties hereto, and the Escrow Account has been established hereunder by Customer, to establish the financial responsibility of Customer as the owner, operator or charterer of the passenger vessel(s) (see Exhibit A), in accordance with Section 3 of Public Law 89–777, 89th Congress, approved November 6, 1966 (the “Act”). The Escrow Account shall be held by Escrow Agent in accordance with the terms hereof, to be utilized to discharge Customer's legal liability to indemnify the passengers of the named vessel(s) for non-performance of transportation within the meaning of Paragraph 3 of the Act. The Escrow Agent shall make indemnification payments pursuant to written instructions from Customer, on which the Escrow Agent may rely, or in the event that such legal liability has not been discharged by Customer within twenty-one (21) days after any such passenger has obtained a final judgment (after appeal, if any) against Customer from a United States Federal or State Court of competent jurisdiction the Escrow Agent is authorized to pay funds out of the Escrow Account, after such twenty-one day period, in accordance with and pursuant to the terms of an appropriate order of a court of competent jurisdiction on receipt of a certified copy of such order.
As further security for Customer's obligation to provide water transportation to passengers holding tickets for transportation on the passenger vessel(s) (see Exhibit A) Customer will pledge to each passenger who has made full or partial payment for future passage on the named vessel(s) an interest in the Escrow Account equal to such payment. Escrow Agent is hereby notified of and acknowledges such pledges. Customers' instructions to Escrow Agent to release funds from the Escrow Account as described in this Agreement shall constitute a certification by Customer of the release of pledge with respect to such funds due to completed, canceled or terminated cruises. Furthermore, Escrow Agent agrees to hold funds in the Escrow Account until directed by Customer or a court order to release such funds as described in this Agreement. Escrow Agent shall accept instructions only from Customer, acting on its own behalf or as agent for its passengers, and shall not have any obligations at any time to act pursuant to instructions of Customer's passengers or any other third parties except as expressly described herein. Escrow Agent hereby waives any right of offset to which it is or may become entitled with regard to the funds on deposit in the Escrow Account which constitute Unearned Passenger Revenue.
12. Customer agrees to provide to the Escrow Agent all information necessary to facilitate the administration of this Agreement and the Escrow Agent may rely upon any information so provided.
13. Customer hereby warrants and represents that it is a corporation in good standing in its State of organization and that is qualified to do business in the State of . Customer further warrants and represents that (i) it possesses full power and authority to enter into this Agreement and fulfill its obligations hereunder and (ii) that the execution, delivery and performance of this Agreement have been authorized and approved by all required corporate actions.
14. Escrow Agent hereby warrants and represents that it is a national banking association in good standing. Escrow Agent further warrants and represents that (i) it has full power and authority to enter into this Agreement and fulfill its obligations hereunder and (ii) that the execution, delivery and performance of this Agreement have been authorized and approved by all required corporate actions.
15. This Agreement shall have a term of one (1) year and shall be automatically renewed for successive one (1) year terms unless notice of intent not to renew is delivered to the other party to this Agreement and to the Commission at least 90 days prior to the expiration of the current term of this Agreement. Notice shall be given by certified mail to the parties at the addresses provided
16. (a) Customer hereby agrees to indemnify and hold harmless Escrow Agent against any and all claims, losses, damages, liabilities, cost and expenses, including litigation, arising hereunder, which might be imposed or incurred on Escrow Agent for any acts or omissions of the Escrow Agent or Customer, not caused by the negligence or willful misconduct of the Escrow Agent. The indemnification set forth herein shall survive the resignation or removal of the Escrow Agent and the termination of this agreement.
(b) In the event of any disagreement between parties which result in adverse claims with respect to funds on deposit with Escrow Agent or the threat thereof, Escrow Agent may refuse to comply with any demands on it with respect thereto as long as such disagreement shall continue and in so refusing, Escrow Agent need not make any payment and Escrow Agent shall not be or become liable in any way to Customer or any third party (whether for direct, incidental, consequential damages or otherwise) for its failure or refusal to comply with such demands and it shall be entitled to continue so to refrain from acting and so refuse to act until such conflicting or adverse demands shall finally terminate by mutual written agreement acceptable to Escrow Agent or by a final, non-appealable order of a court of competent jurisdiction.
17. Escrow Agent shall be entitled to such compensation for its services hereunder as may be agreed upon from time to time by Escrow Agent and Customer and which shall initially be set forth in a separate letter agreement between Escrow Agent and Customer. This Agreement shall not become effective until such letter agreement has been executed by both parties hereto and confirmed in writing to the Commission.
18. Customer may terminate this Agreement and engage a successor escrow agent, after giving at least 90 days written termination notice to Escrow Agent prior to terminating Escrow Agent if such successor agent is a commercial bank whose passbook accounts are insured by the Federal Deposit Insurance Corporation and such successor agrees to the terms of this agreement, or if there is a new agreement then such termination shall not be effective until the new agreement is approved in writing by the Commission. Upon giving the written notice to Customer and the Commission, Escrow Agent may terminate any and all duties and obligations imposed on Escrow Agent by this Agreement effective as of the date specified in such notice, which date shall be at least 90 days after the date such notice is given. All escrowed funds as of the termination date specified in the notice shall be turned over to the successor escrow agent, or if no successor escrow agent has been named within 90 days after the giving of such notice, then all such escrowed funds for sailing scheduled to commence after the specified termination date shall be returned to the person who paid such passage fares upon written approval of the Commission. In the event of any such termination where the Escrow Agent shall be returning payments to the passengers, then Escrow Agent shall request from Customer a list of passenger names, addresses, deposit/fare amounts and other information needed to make refunds. On receipt of such list, Escrow Agent shall return all passage fares held in the Escrow Account as of the date of termination specified in the notice to the passengers, excepting only amounts Customer is entitled to receive pursuant to the terms of this Agreement for cruises completed through the termination date specified in the notice, and all interest which shall be paid to Customer.
In the event of termination of this Agreement and if alternative evidence of financial responsibility has been accepted by the Commission and written evidence satisfactory to Escrow Agent of the Commission's acceptance is presented to Escrow Agent, then Escrow Agent shall release to Customer all passage fares held in the Escrow Account as of the date of termination specified in the notice. In the event of any such termination where written evidence satisfactory to Escrow Agent of the Commission's acceptance has not been presented to Escrow Agent, then Escrow Agent shall request from Customer a list of passenger names, addresses, deposit/fare amounts and other information needed to make refunds. On receipt of such list, Escrow Agent shall return all passage fares held in the Escrow Account as of the date of termination specified in the notice to the passengers, excepting only amounts Customer is entitled to receive pursuant to the terms of this Agreement for cruises completed through the termination date specified in the notice, and all interest which shall be paid to Customer. Upon termination, Customer shall pay all costs and fees previously earned or incurred by Escrow Agent through the termination date.
19. Neither Customer nor Escrow Agent shall have the right to sell, pledge, hypothecate, assign, transfer or encumber funds or assets in the Escrow Account except in accordance with the terms of this Agreement.
20. This Agreement is for the benefit of the parties hereto and, accordingly, each and every provision hereof shall be enforceable by any or each or both of them. Additionally, this Agreement shall be enforceable by the Commission. However, this Agreement shall not be enforceable by any other party, person or entity whatsoever.
21. (a) No amendments, modifications or other change in the terms of this Agreement shall be effective for any purpose whatsoever unless agreed upon in writing by Escrow Agent and Customer and approved in writing by the Commission.
(b) No party hereto may assign its rights or obligations hereunder without the prior written consent of the other, and unless approved in writing by the Commission. The merger of Customer with another entity or the transfer of a controlling interest in the stock of Customer shall constitute an assignment hereunder for which prior written approval of the Commission is required, which approval shall not be unreasonably withheld.
22. The foregoing provisions shall be binding upon undersigned, their assigns, successors and personal representative.
23. The Commission shall have the right to inspect the books and records of the Escrow Agent and those of Customer as related to the Escrow Account. In addition, the Commission shall have the right to seek copies of annual audited financial statements and other financial related information.
24. All investments, securities and assets maintained under the Escrow Agreement will be physically located in the United States.
25. Notices relating to this Agreement shall be sent to Customer at (address) and to Escrow Agent at (address) or to such other address as any party hereto may hereafter designate in writing. Any communication sent to the Commission or its successor organization shall be sent to the following address: Bureau of Certification and Licensing, Federal Maritime Commission, 800 North Capitol NW., Washington, DC 20573–0001.
26. This agreement may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which when taken together shall constitute one and the same instrument.
27. This Agreement is made and delivered in, and shall be construed in accordance with the laws of the State ____ of without regard to the choice of law rules.
IN WITNESS WHEREOF, the undersigned have each caused this Agreement to be executed on their behalf as of the date first above written.
ESCROW AGREEMENT, dated _______ by and between (Customer) and (Escrow Agent).
The undersigned, the Controller of __________ hereby furnishes this Recomputation Certificate pursuant to the terms of the Escrow Agreement dated ________ , between the Customer and (“Bank”). Terms herein shall have the same definitions as those in such Escrow Agreement and Federal Maritime Commission regulations.
By the Commission.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; accountability measures.
NMFS implements accountability measures (AMs) for commercial greater amberjack in the Gulf of Mexico (Gulf) reef fish fishery for the 2013 fishing year through this temporary final rule. This rule reduces the Gulf greater amberjack 2013 commercial annual catch target (ACT) (equal to the commercial quota) to 338,157 lb (153,385 kg) and reduces the 2013 commercial annual catch limit (ACL) to 410,157 lb (186,044 kg), based on the 2012 commercial ACL overage. These actions are necessary to reduce overfishing of the Gulf greater amberjack resource.
This rule is effective February 27, 2013, through December 31, 2013.
Electronic copies of Amendment 35 to the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP), which includes an environmental assessment, an initial regulatory flexibility analysis, and a regulatory impact review, may be obtained from the Southeast Regional Office Web site at
Rich Malinowski, telephone: 727–824–5305, or email:
NMFS manages the reef fish fishery of the Gulf, which includes greater amberjack, under the FMP. The Gulf of Mexico Fishery Management Council (Council) prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All greater amberjack weights discussed in this temporary rule are in round weight.
The 2006 reauthorization of the Magnuson-Stevens Act established new requirements including ACLs and AMs to end overfishing and prevent overfishing from occurring. AMs are management controls to prevent ACLs from being exceeded, and correct or mitigate overages of the ACL if they occur. Section 303(a)(15) of the Magnuson-Stevens Act mandates the establishment of ACLs at a level such that overfishing does not occur in the fishery, including measures to ensure accountability.
On November 13, 2012, NMFS published a final rule for Amendment 35 (77 FR 67574). That final rule established the Gulf greater amberjack stock ACL equal to the greater amberjack stock allowable biological catch (ABC) at 1,780,000 lb (807,394 kg), with the greater amberjack stock ACT at 1,539,000 lb (698,079 kg) based on the ACT Control Rule developed in the Generic Annual Catch Limits/Accountability Measures Amendment (Generic ACL Amendment) (76 FR 82044, December 29, 2011).
Sector allocations were established in Amendment 30A to the FMP (73 FR 38139, July 3, 2008) with 27 percent of the ACL allocated to the commercial sector and 73 percent of the ACL allocated to the recreational sector. Based on these allocations, the final rule for Amendment 35 established a greater amberjack commercial ACL of 481,000 lb (218,178 kg) and the commercial ACT (equivalent to the commercial quota) of 409,000 lb (185,519 kg). The commercial ACT is set 15 percent below the ACL to account for management uncertainty.
Accountability measures for Gulf greater amberjack were also revised by the final rule for Amendment 35. In accordance with regulations at 50 CFR 622.49(a)(1)(i), when the commercial ACT (commercial quota) is reached, or projected to be reached, the Assistant Administrator for Fisheries, NOAA, (AA), will file a notification with the Office of the Federal Register to close the commercial sector for the remainder of the fishing year. If despite such closure, commercial landings exceed the commercial ACL, then during the following fishing year, both the commercial ACT (commercial quota) and the commercial ACL will be reduced by the amount of the prior year's commercial ACL overage.
Additionally, the final rule for Amendment 35 established a commercial trip limit for greater amberjack of 2,000 lb (907 kg). This trip limit is applicable until the commercial ACT (commercial quota) is reached or projected to be reached during a fishing year and the commercial sector is closed.
In 2012, the commercial sector of greater amberjack was closed on March 1, when the adjusted commercial quota of 237,438 (107,700 kg), based on the 2011 quota overage, was determined to be reached. Finalized 2012 commercial landings data indicated the adjusted 2012 commercial quota of 237,438 lb (107,700 kg) was exceeded by 29.8 percent, or 70,843 lb (32,134 kg). Therefore, the reduced 2013 commercial ACT (commercial quota) for Gulf greater amberjack is 338,157 lb (153,385 kg) (
The 2014 commercial ACT (commercial quota) for greater amberjack will return to 409,000 lb (185,519 kg), as specified at 50 CFR 622.42(a)(1)(v), and the commercial ACL for greater amberjack will return to 481,000 lb (218,178 kg), as specified in 50 CFR 622.49(a)(1)(i)(C), unless AMs are implemented due to a commercial ACL overage, or the Council takes subsequent regulatory action to adjust the commercial ACT (commercial quota) and commercial ACL.
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the Gulf greater amberjack component of the Gulf reef fish fishery and is consistent with the Magnuson-Stevens Act, the FMP, and other applicable laws.
The temporary rule has been determined to be not significant for purposes of Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the AMs established by Amendment 35 and located at 50 CFR 622.49(a)(1)(i) authorize the AA to file a notification with the Office of the Federal Register to reduce the commercial ACT (commercial quota) and commercial ACL the following fishing year when the commercial ACL is exceeded. The proposed rule for Amendment 35 (77 FR 42476, July 19, 2012) that implemented these AMs was already subject to notice and comment and all that remains is to notify the public of the 2013 commercial ACT (commercial quota) and commercial ACL for Gulf greater amberjack.
Additionally, prior notice and opportunity for public comment would be contrary to the public interest. Given the ability of the commercial sector to rapidly harvest fishery resources, there is a need to immediately implement the reduced commercial ACT (commercial quota) and commercial ACL for the 2013 fishing year. Taking time to provide prior notice and opportunity for public comment creates a higher likelihood of the reduced commercial ACT (commercial quota) and commercial ACL being exceeded.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend our regulations regarding genetically engineered organisms regulated by the United States Department of Agriculture by adding provisions for sharing certain business information with State and Tribal government agencies. The proposed provisions would govern the sharing of certain information contained in permit applications and notifications for importations, interstate movements, or releases into the environment of regulated articles. The procedures would allow the Animal and Plant Health Inspection Service (APHIS) to share certain business information with State and Tribal governments without impairing our ability to protect confidential business information from disclosure. APHIS currently withholds such information when it shares applications with non-Federal Government agencies. This action would improve our collaborative and cooperative efforts with State and Tribal governments as well as improve the effectiveness of our notification and permitting procedures as APHIS continues to regulate certain genetically engineered organisms.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
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Supporting documents and any comments we receive on this docket may be viewed at
Ms. Chessa Huff-Woodard, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737–1236; (301) 851–3943.
The Animal and Plant Health Inspection Service (APHIS) regulates the introduction (importation, interstate movement, or release into the environment) of organisms altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests under 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests” (referred to below as the regulations or as part 340). The regulations refer to such genetically engineered (GE) organisms and products as “regulated articles.” The purpose of the regulations is to prevent the dissemination of plant pests.
With certain limited exceptions, the regulations prohibit the introduction (importation, interstate movement, or release into the environment) of any regulated article unless APHIS has issued a permit for the introduction in accordance with § 340.4, or unless APHIS has been notified in accordance with § 340.3 for certain GE plants that meet specified eligibility requirements and performance standards. Before APHIS authorizes the introduction, APHIS makes a determination on whether the actions under notification or permit are likely to result in the risk of introduction of a plant pest. In order to make that determination, APHIS requires applicants to provide essential information, some of which is designated by the applicant as confidential business information (CBI).
As provided in §§ 340.3 and 340.4, APHIS shares notifications and applications for permits for introductions, minus any information designated as confidential business information identified by the submitter, with State regulatory officials in the States of introduction. We now propose to share certain business information with State and Tribal regulatory officials. APHIS proposes to share certain business information only with those specific State or Tribal agencies that have legal jurisdiction over genetically engineered agricultural crops and/or products. No other State or Tribal agencies would have any access to the shared CBI. This information sharing would allow APHIS to share issues of concern with the officials of the State where the introduction is planned and would also enable the States to better review and comment on notifications and permits and provide information, advice, and recommendations to APHIS. APHIS would also share certain business information in notifications and applications for permits with Tribal government officials when introductions of regulated articles are proposed for Tribal lands.
Permit applications, notifications, and other information submitted to APHIS under the regulations frequently contain business information designated by the submitter to be confidential in nature and marked as such on the submission. CBI is protected from mandatory public disclosure under the Freedom of Information Act (FOIA), exemption 4 (5 U.S.C. 552(b)(4)). Exemption 4 covers two broad categories of information in Federal agency records: (1) Trade secret information and (2) information that is commercial or financial, obtained from a person and privileged or confidential. It has been APHIS policy
APHIS' notification and permit procedures require that if an applicant claims submitted information to be CBI, that information must be clearly designated as such. In accordance with the regulations and guidance documents,
Currently, APHIS shares only “CBI-deleted” copies of notification or permit submissions with appropriate State or Tribal regulatory officials. State and Tribal officials may provide comments on the applications sent them, but are not required to do so.
Historically, applicants have claimed a wide range of information that they have to submit to APHIS as being CBI. For example, applicants have claimed the exact location of an introduction (facility address or GPS coordinates for an environmental release) as CBI. Applicants have also claimed confidentiality for genes, the gene donor, production details, and particular details about phenotype of the regulated article. Permit applications generally have more material designated as CBI than do notifications because permit applications have more detailed descriptions of the phenotype of the regulated article (described in § 340.4(b)(5)) than do notifications (described in § 340.3(d)(2)). Permit applications also contain a description of the methods for confinement of the regulated article during the introduction. Other material often claimed as CBI in permit applications specifically for release into the environment includes the purpose of the environmental release, descriptions of the release, proposed procedures and confinement methods, and other safeguards and mitigation measures to prevent dissemination or persistence following the environmental release.
Currently, if a State or Tribal official desires to see information from notification or permit applications, acknowledged notifications, or issued permits and that information has been designated as CBI by the applicant, the official would need to contact the applicant for the information. However, APHIS has not always withheld designated CBI from State or Tribal regulatory officials. Around 1988, APHIS began sharing certain business information designated by submitters as CBI with State authorities if the State's attorney general submitted a letter to APHIS agreeing to protect the confidentiality of the information to be shared. Only a few States were authorized to receive designated CBI from APHIS using this mechanism. In 2001, this policy was discontinued because of concerns that sharing designated CBI with States could be deemed to constitute a waiver of the applicable exemption from disclosure under FOIA. During the period when we shared designated CBI with the States, the only shared records were paper documents, and there were no reports that a State's process to protect designated CBI shared with them by APHIS had failed, or that any such business information had been released to unauthorized persons.
On June 7, 2004, APHIS convened a meeting with the National Association of State Directors of Agriculture (NASDA). One of the main purposes of the meeting was to evaluate the quality of interactions between APHIS and State governments, especially with respect to biotechnology issues. At that meeting, State officials expressed the view that cooperation and collaboration between APHIS and the States in regulatory activities for agricultural biotechnology may not be as effective as possible because information withheld as CBI from notification and permit applications often appeared to be important to the State's review. State officials expressed concern about the adequacy of reviews conducted when important information was not available to them.
The discussions regarding sharing of designated CBI information initiated at the 2004 NASDA meeting have continued over time, along with discussions covering a range of regulatory activities and compliance and enforcement issues arising within agricultural biotechnology. These discussions focused on methods of sharing designated CBI with the States that would be consistent with the ability of the States to prevent disclosure under State FOIA laws and other applicable disclosure statutes or policies of the States. As a result of these discussions, APHIS has developed this proposed rule to allow the sharing of certain business information desired by State and Tribal government authorities.
This proposed rule would establish a mechanism for APHIS to share certain information designated as CBI with State and Tribal government agencies. This sharing would provide benefits to APHIS, and to the States and Tribal governments, and strengthen the relationship between the Federal and other governments. For APHIS, a provision to share certain business information will benefit compliance activities, improve the efficiency of the permit and notification processes, and facilitate inspections by State regulators under the supervision of APHIS. For the State and Tribal governments, the proposed changes would enhance participation in the assessment process and encourage these entities to be more fully informed and involved. The proposed sharing of certain business information would be accomplished without compromising the protection afforded CBI under FOIA's Exemption 4.
Sharing certain business information with State and Tribal governments would support better contingency planning and disaster responses. In the event of a local emergency, such as a hurricane, tornado, or flooding, there may be a need to assess and potentially remediate locations where regulated articles were present as part of an environmental release or were in a containment facility that became damaged. In these events, State and Tribal government officials in proximity to the area of concern may be better prepared to respond to this situation if they already have knowledge of the regulated article, the location of the site, and the identities of the personnel responsible for the site. Because such business information is often designated as CBI, and if APHIS could not share certain CBI with the appropriate State and Tribal authorities, participation of the State or Tribes may be hampered,
The ability to share CBI would aid APHIS and State and Tribal governments by improving the efficiency of the notification and permitting processes. The proposed sharing of certain business information would help avoid the delays that frequently occur in the current APHIS permitting and notification process. These delays may occur when a State or Tribal government decides it must ask the developer of the regulated article for business information about a proposed introduction of the regulated article. The business information requested is often part of the CBI information the developer submitted in its application to APHIS, but deleted when the application was forwarded to the State or Tribal government. From previous experience, APHIS understands that such requests by State agencies or Tribal officials for certain business information from applicants can sometimes be lengthy processes. Because the applicant may not have a routine procedure to respond to a State or Tribal agency, requests for information may not be processed in a timely manner by the applicant.
Under this proposed rule, only the appropriate State and Tribal agencies would be able to review the conditions assigned by APHIS for introduction of a regulated article and also to confer with APHIS on any additional issues related to a permit or notification. For example, feedback provided by State and Tribal agencies about the site of an environmental release or nearby areas may help APHIS to further review assigned confinement conditions. The goal of these conditions is to prevent possible unauthorized dissemination of plant pests. State and Tribal agencies may wish to discuss with APHIS any information regarding activities, commerce, and traffic in the area of an environmental release. Such local information may further inform APHIS about appropriate confinement conditions for an environmental release, ensure better compliance with the conditions of the permit, or help the applicant meet the performance standards for notifications.
In some cases, a State or Tribal regulatory official could assess citizen, consumer, or grower concerns about introductions at certain locations, and then convey these issues to APHIS. In these situations, APHIS would receive valuable inputs from the State and Tribal agencies that would be used to confirm confinement protocols and advise product developers. Yet other activities might be facilitated by sharing of certain business information about the regulated crop and its planting location. In other cases, by working closely with State agencies or Tribal nations in possession of authorized shared CBI, APHIS may obtain certain information about environmental releases to assist in complying with other Federal statutes, e.g., the Endangered Species Act.
This proposal would improve Federal transparency because the appropriate State and Tribal government agencies receiving certain business information from APHIS would be better informed about introductions within their jurisdictions. Furthermore, when the State or Tribal agencies have accurate and detailed information about introductions, they would be better prepared to explain to their citizens the proposed introduction of genetically engineered organisms at publicly undisclosed sites within their jurisdiction. Consequently, the proposed sharing could increase public confidence in Federal, State and Tribal oversight of introductions of regulated articles.
Recent APHIS experience has demonstrated the value of sharing certain business information with States and Tribal governments. In 2005, APHIS initiated an ongoing pilot inspection project with some State plant regulatory agencies. APHIS evaluated whether State inspectors could supplement APHIS officers by performing inspections of environmental release sites for regulated articles. For this pilot project, State inspectors received the same training as APHIS officers, and then were to conduct inspections on behalf of APHIS. In the course of this pilot project, APHIS' lack of authority to share CBI with State cooperators prevented full employment of State inspectors to accomplish APHIS' regulatory objectives. Because CBI-deleted documents may not contain certain business information crucial to inspections, such as the contact information for the applicant's site cooperator, or the exact location of the environmental release, State inspectors had to obtain this information from the applicant. This extra step added time and uncertainty to the necessary inspections, which are scheduled to correspond with the timing of certain biological and business activities related to the regulated article (pollination, harvest, etc.). This step of requesting information from the applicant may cause unacceptable delays that potentially interfere with timely completion of inspections.
Overall, APHIS anticipates that this new sharing activity for certain business information would benefit APHIS' compliance activities, enhance the effectiveness and efficiency of the permitting process, and allow the fullest use of State-employed inspectors. Increased participation by the States and Tribal governments in the permitting and notification processes would allow them to engage APHIS in mutually beneficial and constructive collaborations. By informing these governments about introductions into their State or Tribal lands, the sharing of certain business information will initiate a new level of transparency for APHIS with State and Tribal government stakeholders and enhance their ability to represent the interests of the public they represent
Despite the benefits of this proposed activity, APHIS is required to choose a procedure that does not publicly disclose CBI submitted by the applicant. Except for the brief period 1988–2001, APHIS' communication with the States and Tribal governments generally had the same status as communication with any member of the public. In accordance with 5 U.S.C. 552(a)(3)(A), any record of the Agency that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public.
There are times when public disclosure of information would undermine legitimate private rights and governmental responsibilities. As discussed above, FOIA Exemption 4 (5 U.S.C. 552(b)(4)) states that disclosure requirements do not apply to “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” This exemption applies to all notification and permit information that applicants designate as CBI and that APHIS accepts and treats as CBI as required by applicable Federal laws. Another FOIA exemption that is applicable to some or all of this material is Exemption 5 (5 U.S.C. 552(b)(5)), “inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with
Our proposed provisions for the sharing of certain business information would include a statement that the appropriate State and Tribal agencies receiving the shared information are not members of the public for purposes of disclosure of designated CBI submitted to APHIS by notification or permit applicants as required by part 340. Accordingly, disclosure of the authorized information by APHIS to the State or Tribal government would not constitute a waiver of any FOIA exemption protection.
APHIS proposes to establish a new § 340.10 that would contain requirements for safeguarding shared business information and would also describe what types of CBI could be shared with States and Tribal governments. We propose that if any of this information is to be retained by the State or Tribal governments, only paper copies would be authorized for retention. Currently, APHIS is examining various electronic options to share certain business information, but a method for doing so has not been selected. We considered allowing regulators in authorized States and Tribal governments to share certain business information that was downloaded to a secure APHIS server, and then granting access to the authorized government entities. However, providing a new and separate secure system was not likely to be economically viable for APHIS. Although secured access to electronic records containing certain business information is not possible at this time, APHIS will continue to explore the possibility of sharing this information with authorized State or Tribal government officials by this means in the future. If APHIS finds an electronic means to share certain business information with these agencies, APHIS will deploy a system that conforms to all appropriate Federal cyber security requirements and ensures the confidentiality and integrity of the CBI data. Also, as part of the implementation plan for this rule, APHIS will survey State and Tribal government agencies 6 and 12 months after initiating that system to determine whether the electronic means of sharing CBI meets the needs of the appropriate State and Tribal regulatory officials.
The Administrator may authorize sharing of information under proposed § 340.10 provided that five conditions are met by the appropriate State or Tribal government authority desiring the shared information, as stated in a written agreement between the State or Tribal governments and APHIS. Proposed § 340.10 (a)(1) would require the State or Tribal government officials to state their authority to protect from public disclosure permit and compliance information that has been designated CBI in the written agreement. Based on our preliminary review of State authorities, APHIS realizes that only some States have the legal authority to protect the specified types of business information from public disclosures. For example, the four States currently participating in the APHIS pilot program in 2009—Arkansas, Florida, Kansas, and North Carolina—were able to provide letters indicating that shared confidential business information could be protected if disclosed to State inspectors by the applicant. However, we particularly invite comments on whether limits to statutory authority in any State would preclude its participation in the proposed information sharing program.
Proposed § 340.10(a)(2) would require the State or Tribal government to have in place suitable procedures to ensure the security of the shared confidential business information and to specify and restrict which specific State or Tribal agency or agencies and their respective officials are allowed access to it. These officials would be required to complete the same annual “Confidential Business Information and Records Management” training that APHIS requires of employees handling CBI. State and Tribal procedures would have to be equivalent to those currently used by APHIS, which are specified in APHIS' “Policy Statement on the Protection of Privileged or Confidential Business Information” cited above. At this time, APHIS would not allow State or Tribal agencies to store in electronic form or otherwise create any records of any CBI received from APHIS. Nevertheless, APHIS is exploring and seeking input on sharing certain business information with State and Tribal government agencies by electronic means. This issue is discussed further in the first paragraph of this section above.
The goal of these security measures would be to safeguard documents containing information disclosed under the proposed provisions, i.e., to account for the location of documents at all times, control access to documents, and provide for secure transmittal, destruction, or return of documents to APHIS. If State or Tribal agencies employ methods equivalent to those used by APHIS, we are confident that they can review this information while effectively maintaining document security. Adaptations of these procedures that achieve an equivalent effect would be specified in the required written agreement between APHIS and a State or Tribal government agency.
Proposed § 340.10(a)(3) would require a commitment in the written agreement between APHIS and the State or Tribal government not to disclose CBI without the written permission of the submitter or written confirmation from APHIS that the information is no longer considered CBI as determined by APHIS pursuant to the applicable Federal laws. Proposed § 340.10(a)(4) would require a commitment in the written agreement by the State or Tribal government that all persons authorized to have access to CBI provided by APHIS will be trained by the State or Tribal authority on how to maintain the security of the shared CBI before having access to it. APHIS would provide the content of the required training.
This training requirement would also apply to situations where a State or Tribal authority needs to share certain business information with State or Tribal employees who are not regulatory officials (such as faculty of State universities) and APHIS agrees to allow the non-regulatory State or Tribal employees access to the shared CBI. Such persons would need training to protect this information from disclosure and in these cases, the parties would need to establish additional safeguards within the written agreement before those non-regulatory State or Tribal employees were allowed access to the shared CBI. For example, the State or Tribal authority would have to agree to appoint regulatory officials to oversee confidentiality rules and responsibilities for safeguarding business information shared with these other employees.
Each government agency entering into a written agreement with APHIS to receive certain business information would be obligated under the terms of the written agreement to safeguard the entrusted information. If a State or Tribal government intentionally or even
The final provision for the written agreement, proposed § 340.10(a)(5), would require inclusion of other needed terms agreed to by APHIS and the State or Tribal government regarding the shared information. This provision could take into account and incorporate administrative procedures or authorities that are unique to a State or Tribe.
Proposed § 340.10(b) describes the types of CBI from notifications and permit applications, acknowledged notifications, or issued permits that APHIS proposes to share with States and Tribal governments. APHIS developed these information categories based on our experience working with States and Tribes and our observations of what types of information prevented optimal cooperation from States or Tribes in application review, inspection, and other activities under the regulations. APHIS also used responses to a questionnaire developed and distributed by NASDA that identified information needs perceived by State regulatory officials. Respondents identified the following information as useful during their State review: Information about the regulated article and its phenotype, the location and contact information of any cooperators for the introduction, activity dates during the introduction (e.g., planting, inoculation, harvest dates for environmental releases), and protocols used during the introduction.
When information sharing is requested by the State or Tribal government agency, APHIS proposes to share:
• Information about the regulated article(s) being used during the introduction, including information in the notification or permit application, the acknowledged notification, or the issued permit regarding the phenotypic designation, and the phenotypic description of anticipated expression of the altered genetic material in the regulated article compared to the expression in the non-modified parental organism;
• The location(s) of the introduction identified by the applicant within the territory of the State or Tribal nation of the requester, including the cooperator's address; GPS coordinates corresponding to multiple sites within the particular State or Tribe; and the number of acres for an environmental release;
• The dates of activity during the environmental release, including planting dates and termination dates for the release;
• The methods of confinement as they are approved by APHIS at the time of application (for permits, APHIS would share the mandatory and supplemental conditions required by APHIS and those cited in the permit application; for notifications, APHIS would provide design protocols for the regulated articles); and
• The name and contact information for the responsible person for the introduction.
The regulations in § 340.4(b) and (c) currently state that when APHIS determines that a permit application is complete, we will submit to the State department of agriculture of the State where an introduction is planned a copy of the initial review along with the application marked “CBI Deleted” or “No CBI” for State notification and review. Because proposed § 340.10 would allow us to share CBI with the appropriate State or Tribal officials, we would amend § 340.4(b) and (c) to state that when an application contains designated CBI, the State or Tribal government will be provided a “CBI deleted” copy of the application unless the disclosure of certain business information to the State or Tribal government has been authorized in accordance with § 340.10 and is requested by the State or Tribal government.
The current regulations identify the procedures for a permit applicant to identify and mark CBI information in § 340.4(a). CBI information submitted in notification applications is identified and marked exactly the same way as such information is marked and identified in permit applications. However, APHIS neglected to include parallel language in the notifications section at the time the notifications procedure was added to part 340. APHIS proposes to take this opportunity to remedy that oversight by adding a reference in § 340.3(d) for submission of CBI in notifications. The section “Procedural requirements for notifying APHIS” will contain parallel language to that in § 340.4(a) addressing CBI in permit applications.
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, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.
APHIS has prepared an economic analysis for this proposed rule, which is set out below. The analysis provides a cost-benefit analysis, as required by Executive Order 12866, and an analysis of the potential economic effects of this proposed rule on small entities, as required by the Regulatory Flexibility Act.
This proposal would amend APHIS' part 340 regulations regarding regulated articles to add provisions concerning the sharing of certain business information but only with certain officials of State and Tribal government agencies. The proposed provisions would create mechanisms for sharing certain business information contained in permit applications and notifications that are submitted to APHIS under the regulations, while continuing to allow APHIS to protect the confidentiality of the information.
The benefits of the proposed rule include improving the effectiveness and efficiency of the notification and permitting processes of part 340. At the same time, the rule will enhance and maintain the rigorous regulation of regulated articles. Specifically, State and Tribal government officials could receive information from APHIS that APHIS would withhold as CBI under current procedures and that applicants may choose not to disclose if requested directly by States or Tribes. This would allow those State and Tribal government officials to provide more timely and more pertinent information to APHIS regarding site-specific issues related to notifications or permits. Although APHIS does not envision any efficiencies gained from reduced paper handling, efficiencies will derive from
There would be minimal costs to the States and Tribes associated with sharing certain business information between these agencies and APHIS. Costs would be the resources required to draft and sign a written agreement, and the resources it would take to share the information, provide for the appropriate training of those State or Tribal officials that would have access to the CBI, and provide the appropriate mechanisms for safeguarding the shared CBI. State agencies and Tribal officials not currently equipped to handle CBI would incur costs of updating or equipping their facilities with secure filing systems, provided that they entered into a written agreement with APHIS. Because only the storage of paper documents would be authorized, not the storage of electronic documents, no computer security costs would be incurred. There would be no cost to the biotechnology industry as we expect the required measures will protect sensitive information. Costs to assess the business information proposed for sharing by APHIS are discretionary; if the information is not requested, APHIS would not provide it to the States and Tribal governments.
The cost to APHIS would consist mainly of salary for staff to implement the procedures and to carry them out on a continuing basis. This should entail less than one full-time staff year during implementation, and decrease later as the procedures become routine for APHIS, States, and Tribes. We expect the benefits of sharing certain business information with State and Tribal agencies would outweigh the costs to the Federal government. The proposed rule would add transparency to the APHIS review process, as State and Tribal officials would have additional information about introductions conducted within their jurisdictions. Also, State citizens and Tribal members would have greater confidence in their regulatory officials and their ability to review permit and notification applications, and APHIS would have an additional means to strengthen its regulatory effort through improved process efficiency and effectiveness.
There are no unavoidable costs for States and Tribes under either the current application review process or the CBI sharing provisions that would be added by this proposed rule because APHIS does not require States or Tribes to reply to permit and notification review information shared with them. However, the States and Tribes involved have indicated they value the opportunity to do so. Frequently, information provided to APHIS during these reviews has allowed us to improve permit conditions and reduce risks, or to forestall operational or administrative problems that might have arisen during a permit period due to local conditions that State or Tribal officials explained to APHIS. Permit and notification review also allows States to better plan their logistics and workloads from year to year. If CBI information is shared as described in this proposal, States and Tribes would know more about the exact location of planned introductions, the methods for confinement of the regulated article, and other planned safeguards and mitigation measures. This would allow States to do better advance planning of the activities and movements of their inspectors who inspect and monitor release sites in accordance with a Memorandum of Understanding with APHIS. It would also allow them to be better prepared for responses during emergency situations, e.g., tornadoes or floods, because they would know well in advance what locations they might have to visit to assess possible releases and what types of confinement and mitigation systems they will encounter at the sites.
APHIS considered a “no action” alternative under which we would continue to delete CBI information from notification and permit applications, and then share only the CBI-deleted documents with States and Tribal governments. This alternative would avoid the implementation costs identified for this proposal, but would not accrue any of the benefits identified for sharing certain business information. The no action alternative could also result in continuing costs to the Federal government through reduced effectiveness of the regulatory program.
APHIS also considered various additional alternatives for how APHIS could share business information with the State or Tribal governments. These alternatives are discussed in detail above under the heading “
In the selected alternative, APHIS proposes to allow sharing of paper documents by only certain States or Tribal governments which are capable of preventing disclosure of such paper records to the public. These States or Tribal governments must also be able to comply with the requirements set forth in the proposed rule.
APHIS has not identified any private entities, large or small, that would be affected by this proposed rule. APHIS would share certain business information from both large and small entities with State agencies and Tribal officials, as the written agreement would provide. There would be no direct economic effect on entities submitting CBI. Some such entities might accrue minor savings in time they currently spend responding to State or Tribes' requests for information, if States or Tribes instead obtain the information through APHIS.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service determined that this action would not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) No State or local laws or regulations will be preempted by this rule; (2) no retroactive effect will be
This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.
APHIS, in compliance with the National Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4321
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This proposed rule contains certain information collection and recordkeeping requirements that would apply to regulatory officials of the States that receive APHIS submissions of notifications and permits for importations, interstate movements, and environmental releases that occur within the State or Tribal lands. The limited information presently shared with the States is authorized under §§ 340.3(e) and 340.4(b). The majority of the proposed requirements would apply to persons engaged in regulatory activities of regulated articles in the States or on Tribal Lands. The reporting burden for these officials under the proposed rule would be similar to the burden under the current regulations, except in those cases in which the State or Tribe desired more information about the details of introductions in the States or Tribes beyond that which they have historically been provided. Thus, all additional information received would be elective. The information is shared because APHIS desires to have States and Tribes better informed about introductions that occur in the States or Tribes, and because the States or Tribes may be able to provide additional assistance to APHIS in issuing the permit or acknowledging the notification. In some cases, the additional information would be shared with the State's or Tribe's inspectors when they are working with APHIS to conduct inspections, or when APHIS requests a State or a Tribe's assistance to aid with compliance and mitigation efforts. Major emergencies sometimes threaten confinement of a regulated article, and APHIS may require assistance in these circumstances.
Under proposed §§ 340.3(d)(2)(vi) and 340.4(b) and (c), State or Tribe officials would have available additional information to complete their reviews of APHIS notifications and permits. However, responses to APHIS would remain voluntary, as they are presently under § 340.3(e). Additional reading, assessment, and review writing may be required if the official desires to provide comments and information to APHIS on the business information shared under this proposed rule.
For those States or Tribes whose statutes authorize keeping business information confidential, and which have signed agreements with APHIS to protect the authorized data, additional recordkeeping requirements would be needed. As noted in the analysis of costs, safeguarding the information would require expenses of time and resources to update or establish approved systems to store certain business information as well as training the regulatory officials that would have access to the CBI. Some States may already have an approved mechanism for storing this information, and no additional burden would be imposed on them.
One goal in proposing this rule is to create an efficient and streamlined system for information sharing with the State and Tribal governments and to ensure that the review process is conducted in a timely and effective manner. Permit applications for environmental releases may take up to 120 days to assess and review before APHIS decides to either issue or deny a permit, while movements (importations and interstate movements) alone may take up to 60 days prior to a decision. Notifications for environmental releases may take up to 30 days to assess and review before APHIS decides to either acknowledge or deny the notification, movements, importations, or interstate movements under notifications may require 10 days after application for an APHIS decision regarding them. Certain business information may be provided by APHIS directly to the States or Tribal agencies after a written agreement is in effect, replacing the necessity that information useful to the States or Tribal governments be provided by the applicant. Based on this sharing, the States and Tribal governments would review and provide comment to APHIS, and APHIS could complete the review process for permits and notifications in a timely manner.
We are soliciting comments from the public (as well as the affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).
Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851–2908.
The Animal and Plant Health Inspection Service is committed to compliance 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. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851–2908.
Administrative practice and procedure, Biotechnology, Genetic engineering, Imports, Packaging and containers, Plant diseases and pests, Transportation.
Accordingly, we propose to amend 7 CFR part 340 as follows:
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
(d) * * *
(2) * * *
(vi) If there are portions of the notification deemed to contain trade secret or confidential business information (CBI), and if submitted through ePermits, then all information entered into the forms that is designated CBI should be enclosed in brackets and all subsequent copies will be automatically labeled with appropriate CBI notations. If submitted on paper, two copies of the written notification shall be submitted. On one copy, each page of the application containing trade secret or CBI should be marked “CBI Copy.” In addition, those portions of the notifications which are deemed “CBI” shall be so designated. The second copy shall have all such CBI deleted and shall be marked on each page of the application where CBI was deleted, “CBI Deleted.” If a notification does not contain CBI, then the first page of both copies shall be marked “No CBI.” When it is determined that a notification is complete, APHIS shall submit to the State department of agriculture of the State or the appropriate Tribal official of the Tribal land where the introduction is planned a copy of the notification for State or Tribal notification and review. When the application contains certain business information, the State or Tribal government will be provided a CBI deleted copy of the notification unless the disclosure of certain business information to the State or Tribal government has been authorized in accordance with § 340.10.
a. In paragraph (b), introductory text, by removing the sixth sentence and by adding in its place two new sentences to read as set forth below.
b. In paragraph (c), introductory text, by removing the last sentence and by adding in its place two new sentences to read as set forth below.
(b) * * * When it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State or the appropriate Tribal official of the Tribal land where the release is planned a copy of the initial review and a copy of the application for State or Tribal notification and review. When the application contains confidential business information (CBI), the State or Tribal government will be provided a CBI deleted copy of the application unless the disclosure of certain business information to the State or Tribal government has been authorized in accordance with § 340.10. * * *
(c) * * * When it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State of destination or to the appropriate Tribal official of the Tribal land of destination of the regulated article a copy of the initial review and a copy of the application for State or Tribal notification and review. When the application contains confidential business information (CBI), the State or Tribal government will be provided a CBI deleted copy of the application unless the disclosure of certain business information to the State has been authorized in accordance with § 340.10.
The Administrator may authorize in accordance with the provisions of this section the disclosure of certain business information (CBI) to State or Tribal government agencies that has been submitted to APHIS or incorporated into Agency-prepared records.
(a) Certain business information submitted to APHIS in notifications and applications for permits under this part may be disclosed to State or Tribal government agencies provided that the State or Tribal government agency has entered into a written agreement with APHIS that includes:
(1) A statement establishing the State's or Tribe's authority to protect certain business information from public disclosure;
(2) A statement by the State or Tribal government agency that it has suitable procedures in place to ensure the security of the business information, and the means to specify and restrict their respective officials allowed access to such information. Such procedures must be equivalent to those specified in APHIS' policy
(3) A statement that the State or Tribal government agency will not disclose any business information provided by APHIS without the written permission of the submitter of the information or written confirmation by APHIS that the information no longer has confidential status;
(4) A statement that all persons with access to business information provided by APHIS will be trained by the State or Tribal authority on how to maintain the security of the shared APHIS documents before having access to the CBI;
(5) Any other terms as agreed to by APHIS and the State or Tribal government agency.
(b) The “certain business information” that APHIS may authorize to be shared under paragraph (a) of this section may include information about the regulated article, including details about the phenotype as provided by the applicant; the site(s) of the introduction including provision of accurate details of the location, acreage (for environmental releases), and purpose of the introduction if provided; dates of activities, including proposed planting and termination dates for the regulated article, actual dates when available; methods of confinement, including design protocols if available, and description of disposition if provided; and site cooperator, including contact information for the responsible person or cooperator, depending upon what information the applicant has provided to APHIS. APHIS intends that the disclosure of information will be for the purpose of facilitating the State or Tribal agency review. In addition, the exchange of information may also be made in certain emergency situations with States or Tribal government agencies to support better disaster responses and maintain confinement of regulated articles. Also, information sharing will help facilitate participation in the inspection and compliance programs established between the States and Tribes and APHIS under specific agreements.
(c) Information APHIS discloses under this section is not a disclosure of information to the public. Disclosures made under this section do not waive any FOIA exemption protection.
Board of Governors of the Federal Reserve System (Board).
Proposed rule; extension of comment period.
On December 28, 2012, the Board published in the
Due to the range and complexity of the issues addressed in the rulemaking, the Board has determined that an extension of the public comment period until April 30, 2013, is appropriate. This action will allow interested persons additional time to analyze the proposed rules and prepare their comments.
The comment period for the proposed rule published December 28, 2012 (77 FR 76628) is extended from March 31, 2013 to April 30, 2013.
You may submit comments by any of the methods identified in the proposed rule.
Molly E. Mahar, Adviser, (202) 973–7360, Division of Banking Supervision and Regulation; Ann Misback, Associate General Counsel, (202) 452–3788, or Christine Graham, Senior Attorney, (202) 452–3005, Legal Division.
On December 28, 2012, the Board published in the
In recognition of the complexities of the issues addressed and the variety of considerations involved with implementation of the proposal, the Board requested that commenters respond to numerous questions. The proposed rule stated that the public comment period would close on March 31, 2013.
The Board has received a request from the public for an extension of the comment period to allow for additional time for comments related to the provisions of the proposed rule.
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before March 29, 2013.
Submit your comments, identified by the docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
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A contact person, with telephone number and email address, is listed at the end of each pesticide petition summary. You may also reach each contact person by mail at Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed at the end of the pesticide petition summary of interest.
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i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
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EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), (21 U.S.C. 346a), requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that
As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petitions so that the public has an opportunity to comment on the requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition's summary referenced in this unit.
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Environmental protection, Agricultural commodities, Feed
Office of the Secretary (OST), U.S. Department of Transportation (DOT).
Notice.
The DOT is seeking comments to help conduct a review of some of the requirements of the Americans with Disabilities Act of 1990 (ADA) implementing regulations for over-the-road bus (OTRB) operators. The DOT will review regulations specified in the
Please send your comments by April 29, 2013.
Interested persons are invited to submit written comments to assist in our review of 49 CFR part 37 subpart H to the Office of General Counsel. Mail or hand deliver comments to the Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590; submit electronically at
Jill Laptosky, Attorney–Advisor, Office of Regulation and Enforcement (C–50), U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, 202–493–0308 (telephone), 202–366–9313 (fax),
On September 28, 1998, the U.S. Department of Transportation (DOT or the Department) issued final regulations, in response to the ADA (Pub. L. 101–336, 104 Stat. 327, 42 U.S.C. 225 and 611), which required the accessibility of new over-the-road buses (OTRBs) and accessible OTRB service. An OTRB is defined as “a bus characterized by an elevated passenger deck located over a baggage compartment.” 49 CFR 37.3. The regulations require commercial OTRB operators to ensure that passengers with disabilities have access to OTRB transportation. The DOT is required by 49 CFR 37.215 to review various requirements within the ADA regulations for OTRB operators. These requirements include the following: the purchase and lease requirements of new OTRBs by operators of fixed-route systems (§ 37.183), the fleet accessibility requirements for OTRB fixed-route systems of large operators (§ 37.185), the interline service requirements (§ 37.187), the service requirement for OTRB demand-responsive systems (§ 37.189), the special provision for small mixed-service operators (§ 37.191), and the interim service requirements for fixed-route operators (§ 37.193(a)). We are not reviewing any other requirements in the ADA regulations for OTRB operators
As part of this review, DOT is required to consider certain factors, including the percentage of accessible OTRBs in the fleets of OTRB operators, the success of such operators at meeting the requests of passengers with disabilities for accessible OTRBs in a timely manner, ridership of OTRBs by passengers with disabilities, volume of complaints by passengers with disabilities, and the cost and service impacts of these requirements. After the review, DOT will decide whether it is appropriate to revise the part 37 ADA regulations for OTRB operators or retain the current regulations without change. The DOT will publish a notice, after the review is complete, that announces our decision and our justification.
To this end, DOT requests comments and information so the Department can better review such ADA regulations and make an informed decision on whether to initiate a rulemaking to propose revisions to any of the regulations involving OTRBs and, if so, how to develop a notice of proposed rulemaking. Specifically, comments about OTRB fleet accessibility, fulfillment of accessible OTRB service requests, and ridership and volume of complaints by passengers with disabilities, would be helpful. The DOT welcomes comments from the public, including OTRB operators and individuals with disabilities, on any aspect of this notice. The Department is particularly interested in comments from OTRB operators, both large and small, on the following:
1.
2.
3.
• Inquiries regarding whether your company owns or leases an accessible OTRB,
• Inquiries regarding whether your company can provide accessible OTRB service,
• Requests for accessible OTRB service that were received with a minimum of 48-hour advance notice and satisfied according to the requested provisions,
• Number of passengers with disabilities who have used your company's accessible OTRB service, and
• Complaints regarding denial of accessible OTRB service to an individual with a disability.
4.
5.
Your comments will help the Department conduct a review of its ADA regulations for OTRB operators and decide whether to propose any regulatory revisions. At this time, there are no pending proposed revisions to DOT's ADA regulations for OTRB operators.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations for the importation of certain fruits and vegetables into the United States.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of fruits and vegetables, contact Mr. Tony Román, Regulatory Policy Specialist, PHP, PPQ, 4700 River Road Unit133, Riverdale, MD 20737; (301) 851–2242. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851–2908.
Under these regulations, certain fruits and vegetables may be imported into the United States under specific conditions to prevent the introduction of plant pests into the United States. These conditions involve the use of information collection activities, including the issuance of phytosanitary certificates, trapping surveys, inspections by the exporting country, labeling of boxes, and recordkeeping. An additional information collection is the completion of the U.S. Department of Agriculture, APHIS, Plant Protection and Quarantine (PPQ), Application for Permit to Import Plants or Plant Products (PPQ Form 587).
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the regulations for the importation of live fish, fertilized eggs, and gametes to prevent the introduction of spring viremia of carp into the United States.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the regulations for the importation of live fish, fertilized eggs, and gametes, contact Dr. Christa Speekmann, Import/Export Specialist-Aquatic Animals, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 39, Riverdale MD 20737; (301) 851–3365. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851–2908.
In accordance with the regulations, APHIS restricts the importation of live fish, fertilized eggs, and gametes of SVC-susceptible species and the importation of diagnostic specimens or research materials containing viable SVC virus. The regulations involve information collection activities, including an Application for Import or in Transit Permit (Animals, Animal Semen, Animal Embryos, Birds, Poultry, or Hatching Eggs) (VS Form 17–129), Application for Permit to: Import or Transport Controlled Material or Organisms or Vectors (VS Form 16–3), Refusal of Entry and Order to Dispose of Fish (VS Form 17–136), and Declaration of Importation (Animals, Animal Semen, Animal Embryos, Birds, Poultry, or Hatching Eggs) (VS Form 17–29). In addition to the listed forms, additional information collection activities include a health certificate, cleaning and disinfection certificate, and 72-hour notification to APHIS before arrival of a shipment in the United States. Lastly, recordkeeping is also required.
Since the last extension of approval for these information collection activities, APHIS has refined the number of respondents and number of responses collected, resulting in a decrease of the estimated annual number of respondents from 462 to 76. In addition, APHIS has also improved estimates of the time necessary for completion of these activities, as well as the number of recordkeepers, which was adjusted from 12,010 to 1,072. The estimated total annual burden hours has now decreased from 2,018.21 hours to 1,016 hours.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public of our determination that a corn line developed by the Syngenta Biotechnology, Inc., designated as event SYN–05307–1, which has been genetically engineered for resistance to corn rootworm, an insect pest of corn, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Syngenta Biotechnology, Inc., in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
You may read the documents referenced in this notice and the comments we received in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799–7039 before coming. Those documents are also available on the Internet at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3954, email:
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.”
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS received a petition (APHIS Petition Number 10–336–01p) from Syngenta Biotechnology, Inc., (Syngenta) of Research Triangle Park, NC, seeking a determination of nonregulated status of corn (
In a notice
APHIS received 86 comments during the comment period, with 14 commenters expressing support of the EA's preferred alternative to make a determination of nonregulated status and the remaining 72 commenters expressing opposition. One of the comments opposing a determination of nonregulated status included submitted electronic attachments that consisted of many signed letters containing identical material (4,601 letters). Issues raised during the comment period included adequacy of the EA, effects on nontarget organisms, and potential effects on human and animal health. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact.
To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status of Syngenta's corn event SYN–05307–1, an EA has been prepared. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Based on APHIS' analysis of field and laboratory data submitted by Syngenta, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, comments provided by the public, and information provided in APHIS' response to those public comments, APHIS has determined that Syngenta's corn event SYN–05307–1 is unlikely to pose a plant pest risk and therefore is no longer subject to our regulations governing the introduction of certain genetically engineered organisms.
Copies of the signed determination document, as well as copies of the petition, PPRA, EA, finding of no significant impact, and response to comments are available as indicated in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has prepared a preliminary decision regarding a request from Stine Seed Farm, Inc., to extend to maize line HCEM485, which has been genetically engineered to be tolerant to the herbicide glyphosate, our determination of nonregulated status of Roundup Ready® corn line GA21. We are seeking comment on whether this genetically engineered corn is likely to pose a plant pest risk. We are making available for public comment our plant pest risk assessment and draft environmental assessment for the proposed determination of nonregulated status.
We will consider all comments that we receive on or before March 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The extension request, draft environmental assessment, and plant pest risk assessment are also available on the APHIS web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737–1236; (301) 851–3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Further, the regulations in § 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.
In a notice published in the
As described in the extension request, maize line HCEM485 has been genetically engineered by a 6.0 kb corn genomic fragment, originally isolated from a bacterial chromosome library derived from the corn inbred line B73, containing a modified form of the endogenous
Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine whether the new variety poses a plant pest risk.
In section 403 of the PPA, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS prepared a plant pest risk assessment (PPRA) and has concluded that maize line HCEM485 is similar to the antecedent organism and is unlikely to pose a plant pest risk.
APHIS has also prepared a draft environmental assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Stine Seed, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of maize line HCEM485 and it would continue to be a regulated article, or (2) make a determination of nonregulated status of maize line HCEM485.
The draft EA has been prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status of maize line HCEM485. The draft EA was prepared in accordance with (1) the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Based on APHIS' analysis of field and laboratory data submitted by Stine Seed, references provided in the extension request, peer-reviewed publications, information analyzed in the EA, and the similarity of maize line HCEM485 to the antecedent organism, Roundup Ready® corn line GA21, APHIS has determined that maize line HCEM485 is unlikely to pose a plant pest risk. We have therefore reached a preliminary decision to approve the request to extend the determination of nonregulated status of Roundup Ready® corn line GA21 to maize line HCEM485, whereby maize line HCEM485 would no longer be subject to our regulations governing the introduction of certain genetically engineered organisms.
Paragraph (e) of § 340.6 provides that APHIS will publish a notice in the
APHIS will accept written comments on the draft EA and PPRA regarding a determination of nonregulated status of maize line HCEM485 for a period of 30 days from the date this notice is published in the
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All comments received regarding the EA and PPRA will be available for public review. After reviewing and evaluating the comments on the EA and PPRA, APHIS will furnish a response to the petitioner regarding our final regulatory determination. APHIS will also publish a notice in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public of our decision to begin issuing permits for the importation into the continental United States of fresh strawberry fruit from Egypt. Based on the findings of a pest risk analysis, which we made available to the public for review and comment through a previous notice, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh strawberry fruit from Egypt.
Mr. Marc Phillips, Regulatory Policy Specialist, Regulations, Permits, and Manuals, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737–1231; (301) 851–2114.
Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56–1 through 319.56–58, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.
Section 319.56–4 of the regulations contains a performance-based process for approving the importation of commodities that, based on the findings of a pest risk analysis (PRA), can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. Under that process, APHIS publishes a notice in the
In accordance with that process, we published a notice
In the PRA, APHIS determined that three plant pests have a high risk potential of being introduced into the United States via the pathway of fresh strawberry fruit from Egypt. Those pests are:
We acknowledge the risk that this plant pest could potentially evade detection and be introduced into the United States in the manner referred to by the commenter. However, while the pest itself may potentially evade detection by its small size, its presence can be detected by visible signs of discoloration and damage to fruits and leaves. Additionally, good agricultural practices can effectively suppress or eliminate this pest from fields or prevent infestation. Successful control programs typically include monitoring, cultural, biological, and chemical components, all of which are used as part of Egypt's standard pre- and post-harvest practices for the production of export strawberries. Moreover, APHIS has permitted the entry of commercial strawberries from several countries in Asia, Europe, and South America where this pest of concern occurs. Over several decades, there has only been one interception of
Another commenter stated that the PRA does not provide for adequate phytosanitary security against any tetranychid mite.
In the risk assessment portion of the PRA, the only tetranychid species identified as likely to follow the importation pathway was
The third commenter recommended that we adopt specific phytosanitary measures to address the pest risks discussed in the PRA.
APHIS has permitted the entry of commercial strawberries from several countries in Asia, Europe, and South America with similar lists of pests of concern (e.g., Jordan and Israel). Based on our knowledge and experience in relation to importation of fresh strawberry fruit from these countries with similar pest lists, we are confident of the efficacy of the designated measures in mitigating the phytosanitary risks posed by the importation of strawberry from Egypt.
Finally, the commenter added that we should intensively monitor fresh strawberry from Egypt at the port of entry.
An integral part of standard APHIS phytosanitary practices is inspection at the port of entry.
For these reasons, together with Egypt's use of integrated pest management practices in the production of commercial strawberries, APHIS has concluded that commercial strawberries for export from Egypt are unlikely to contain the identified quarantine pests. Accordingly, we have determined that no changes to the PRA are necessary based on these comments.
Therefore, in accordance with the regulations in § 319.56–4(c)(2)(ii), we are announcing our decision to begin issuing permits for the importation into the continental United States of fresh strawberry fruit from Egypt subject to the following phytosanitary measures:
• The fresh strawberry fruit may be imported into the continental United States in commercial consignments only;
• Each consignment of fresh strawberry fruit must be inspected by the national plant protection organization of Egypt and accompanied by a phytosanitary certificate that includes an additional declaration stating that the consignment was inspected and found free of
• The fresh strawberry fruit is subject to inspection upon arrival at the U.S. port of entry.
These conditions will be listed in the Fruits and Vegetables Import Requirements database (available at
7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Syngenta Seeds, Inc., and Bayer CropScience AG seeking a determination of nonregulated status of soybean designated as event SYHTOH2, which has been genetically engineered for tolerance to the herbicides glufosinate and mesotrione. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Syngenta Seeds, Inc., and Bayer CropScience AG petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition is also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 12–215–01p) from Syngenta Seeds, Inc., and Bayer CropScience (BCS) AG of Research Triangle Park, NC, seeking a determination of nonregulated status of soybean designated as event SYHTOH2, which has been genetically engineered to tolerate exposure to the herbicides glufosinate and mesotrione. Glufosinate tolerance is not a new engineered trait in GE soybean, while mesotrione tolerance is a new trait. The petition states that this soybean event is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.
As described in the petition, soybean event SYHTOH2 has been genetically engineered for tolerance to herbicides that inhibit
Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.
Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the
In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under
We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues,
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Dow AgroSciences LLC (DAS) seeking a determination of nonregulated status of soybean designated as DAS–81419–2, which has been genetically engineered for resistance to certain lepidopteran pests. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the DAS petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition is also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 12–272–01p) from Dow AgroSciences LLC of Indianapolis, IN, seeking a determination of nonregulated status of soybean (
As described in the petition, soybean event DAS–81419–2 has been genetically engineered to express two insecticidal proteins, Cry1Ac and Cry1F, and phosphinothricin acetyltransferase, or PAT, protein. Soybean event DAS–81419–2 is currently regulated under 7 CFR part 340. Interstate movements and field tests of soybean event DAS–81419–2
Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.
Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the
In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under
We are interested in receiving comments regarding potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. We are particularly interested in receiving comments regarding biological, cultural, or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as soybean growth, crop management, and crop utilization may vary considerably by geographic region.
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company (Monsanto) seeking a determination of nonregulated status of cotton designated as MON 88701, which has been genetically engineered for tolerance to the herbicides dicamba and glufosinate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition is also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 12–185–01p) from the Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of cotton designated as event MON 88701, which has been genetically engineered for tolerance to the herbicides dicamba and glufosinate. The petition states that this cotton is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.
As described in the petition, cotton event MON 88701 has been genetically engineered to allow in-crop applications of dicamba herbicide for the control of broadleaf weeds from preemergence to 7 days preharvest and glufosinate herbicide for broad spectrum weed control from emergence through early bloom growth stage. Cotton event MON 88701 provides dicamba tolerance that allows for the in-crop application of dicamba beyond the current preplant uses in cotton and also provides glufosinate tolerance equivalent to current commercial glufosinate-tolerant cotton events. Cotton event MON 88701 is currently regulated under 7 CFR part 340. Interstate movements and field tests of cotton event MON 88701 have been conducted under notifications acknowledged by APHIS.
Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.
Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the
In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will follow our published process for soliciting public comment (see footnote 1) and publish a separate notice in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from ArborGen Inc. seeking a determination of nonregulated status of Freeze Tolerant Eucalyptus lines designated 427 and 435, which have been genetically engineered (GE) to be more tolerant of cold conditions. The incorporation of the GE trait allows these eucalyptus hybrid trees to be grown in a broader geographic area than non-GE eucalyptus hybrid trees. The petition has been submitted in accordance with our regulations concerning the introduction of certain
We will consider all comments that we receive on or before April 29, 2013. We will also consider comments made at virtual public meetings that will be held during the comment period.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition is also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1238; (301) 851–3954. To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851–851–3882, email:
Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 11–019–01p) from ArborGen Inc. of Summerville, SC, seeking a determination of nonregulated status of two Freeze Tolerant Eucalyptus (FTE) lines designated 427 and 435. The petition states that these eucalyptus trees are unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340. These regulations are authorized by the PPA to prevent the introduction or dissemination of plant pests, and the decision on whether or not to grant the petition will be based on this standard.
As described in the petition, FTE lines 427 and 435 have been genetically engineered to express the CBF2 gene to be more tolerant of cold conditions and a gene expression cassette that prevents pollen development. FTE lines 427 and 435 are currently regulated under 7 CFR part 340. Field tests of FTE lines 427 and 435 have been conducted under permits issued by APHIS at multiple sites representing both freeze stress and freeze stress-free environments in the southeastern United States, Alabama, Florida, Georgia, Louisiana, Mississippi, South Carolina, and Texas.
APHIS has conducted three separate environmental assessments (EA) on actions related to permitting confined field releases of FTE trees under conditions designed to prevent spread of the trees outside the field test area, and in each case announced the availability of the EA in the
In accordance with § 340.6(d) of the regulations and our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All comments received will be available for public review. Any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of the comments will be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a plant pest risk assessment to assess its plant pest risk and the appropriate environmental documentation—either an EA or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
Under the provisions of NEPA, Federal agencies must examine the potential environmental impacts of proposed Federal actions before actions are taken. In accordance with NEPA, regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500–1508), U.S. Department of Agriculture (USDA) regulations implementing NEPA (7 CFR part 1b) and APHIS' NEPA Implementing Procedures (7 CFR part 372), APHIS has considered how to properly examine these potential environmental impacts. In each of the previous three APHIS actions concerning FTE trees, we determined that an EA was the appropriate means to consider and document environmental impacts. Also, in response to a legal challenge to the adequacy of these EAs and the NEPA process, the United States District Court for the Southern District of Florida granted summary judgment affirming the APHIS actions (Case No. 10–14175–ClV–MOORE/LYNCH).
An EA might also be used in this case, where the relevant Federal action would be determination of nonregulated status of two FTE lines. However, APHIS is choosing the option of preparing an EIS to analyze the potential environmental impacts of responding to this petition request.
APHIS is exercising its option to prepare an EIS rather than an EA to address unresolved proposed or adopted local, regional, State, interstate, or Federal land use plans or policies that may result in adverse environmental impacts. In preparing an EIS, APHIS would be responsive to other agencies that have an interest in the possible future establishment of FTE trees in forest areas. Federal and State agencies have expressed interest in this issue from several perspectives. The USDA Forest Service has agreed to serve as a cooperating agency in the preparation of this EIS and will provide expertise in hydrology, to assess the effects of eucalyptus on water resources, and economic modeling, to predict where in the United States FTE trees may be adopted. The United States Department of Energy considers eucalyptus as a candidate bioenergy feedstock. The United States Fish and Wildlife Service has expressed interest in studies of the impacts of eucalyptus tree plantations on wildlife diversity and ecosystem sustainability. Various States, including Georgia and Florida, have conducted studies or hearings on the possible use of tree plantations as sources of bioenergy feedstocks. APHIS believes that choosing to prepare an EIS rather than an EA would allow us to fully consider potential environmental impacts of the Federal action under consideration and would also provide, in an efficient way, data that could address a wide variety of government interests and could shed light on issues relevant to possible future actions under the jurisdiction of interested agencies. By preparing an EIS at this time, APHIS may provide agencies with an opportunity to adopt all or part of the EIS for future actions in accordance with the adoption provisions of the Council on Environmental Quality's NEPA implementing regulations (40 CFR 1506.3).
This notice identifies reasonable alternatives and potential issues that may be studied in the EIS. We are requesting public comments to further delineate the scope of alternatives and environmental impacts and issues. We will be hosting two virtual meetings during the comment period to discuss the scope of the EIS (see
The EIS will consider a range of reasonable alternatives. APHIS is considering including a “no action” and “approve the petition request” alternatives. Under the ”no action” alternative, in accordance with 7 CFR part 340, FTE would continue to be regulated and the environmental release and interstate movement of FTE lines 427 and 435 would require permits issued or notifications acknowledged by APHIS. APHIS might choose this alternative if there was insufficient evidence to demonstrate that the regulated eucalyptus events were not plant pests or the lack of plant pest risk from the unconfined cultivation of FTE lines 427 and 435. Under the “approve the petition request” alternative, FTE lines 427 and 435 would no longer be regulated articles under the regulations at 7 CFR part 340.
We have also identified the following potential environmental issues for consideration in the EIS:
• Alteration in susceptibility to disease or insects—Potential of FTE lines 427 and 435 to harbor plant pests or diseases and the impacts of these pests or diseases on natural resources, forestry, or agriculture within the range of FTE lines 427 and 435.
• Alteration in weediness characteristics—Potential of FTE lines 427 and 435 to be invasive in certain environments and the impacts to natural resources and sociocultural resources if it is invasive.
• Potential impacts of growing FTE lines 427 and 435 on soil hydrology and water resources and how potential changes in soil hydrology or water use may affect natural resources and sociocultural resources.
• Potential impacts of FTE lines 427 and 435 on fire incidence and ecology and how this may affect natural resources and sociocultural resources.
• Potential impacts of allelopathy of FTE lines 427 and 435 on forestry practices or land use.
• Potential direct or indirect effects of FTE lines 427 and 435 on human health.
• Potential direct or indirect effects of FTE lines 427 and 435 on wildlife and their habitats.
In considering reasonable alternatives, the EIS will also study whether these potential environmental issues pose any potential plant pest risks that FTE may exhibit. In addition to plant pest risks that may be posed by characteristics of an individual GE eucalyptus, like allelopathy (suppression of growth of nearby plants due to toxin release), the EIS will also examine potential plant pest risks associated with environmental issues arising from the potential scale of nonregulated GE eucalyptus plantings. Plantings under the earlier permits were of small scale and limited duration. A decision to approve the petition would allow for larger sized plantings, closer together, over a longer period of time. Additionally, it is the first time APHIS has received a petition for deregulation for a GE tree like eucalyptus, where the species tends to be the dominant species in many forest areas, and the engineered change will increase the range of the species. These changes in scope from the small trials require analysis of the potential environmental and plant pest risk effects of large-scale FTE planting of local hydrology, fire ecology, and other potential issues discussed above.
While the EIS will consider a comprehensive range of potential environmental impacts that FTE eucalyptus may cause, impacts that are not plant pest risks will not affect APHIS' decision as to whether or not to make a determination of nonregulated status of FTE. As explained above, under the PPA, APHIS must make a determination of nonregulated status based on the GE organism's potential to pose a plant pest risk and nothing more.
Comments that identify other issues or alternatives that should be considered for examination in the EIS would be especially helpful. All comments received during the comment period will be carefully considered in developing the final scope of the EIS. Upon completion of the draft EIS and the plant pest risk assessment for FTE lines 427 and 435, a notice announcing their availability and an opportunity to comment on them will be published in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Pioneer Hi-Bred International, Inc., (Pioneer) seeking a determination of nonregulated status of maize designated as maize event DP–ØØ4114–3, which has been genetically engineered to be resistant to certain lepidopteran and coleopteran pests and tolerant to the herbicide glufosinate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are soliciting comments on whether this genetically engineered maize is likely to pose a plant pest risk. We are making available for public comment the Pioneer petition, our plant pest risk assessment, and our draft environmental assessment for the proposed determination of nonregulated status.
We will consider all comments that we receive on or before April 29, 2013.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition, draft environmental assessment, and plant pest risk assessment are also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 851–3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 11–244–01p) from Pioneer Hi-Bred International, Inc., (Pioneer) of Johnston, IA, seeking a determination of nonregulated status of maize (
As described in the petition, event 4114 has been genetically engineered to produce the Cry proteins Cry1F, Cry34Ab1, and Cry35Ab1, as well as the herbicide tolerance protein phosphinothricin acetyltransferase (PAT). The Cry1F protein confers resistance to certain lepidopteran pests, including European corn borer; the Cry34Ab1 and Cry35Ab1 proteins confers resistance to certain coleopteran pests, including the western corn rootworm; and the PAT protein confers tolerance to the herbicidal active ingredient glufosinate-ammonium at current labeled rates. Event 4114 is currently regulated under 7 CFR part 340. Interstate movements and field tests of event 4114 have been conducted under permits issued or notifications acknowledged by APHIS.
Field tests conducted under APHIS oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These and other data are used by APHIS to determine if the new variety poses a plant pest risk.
In section 403 of the Plant Protection Act, “plant pest” is defined as any
APHIS has also prepared a draft environmental assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Pioneer, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of maize event 4114 and it would continue to be a regulated article, or (2) make a determination of nonregulated status of event 4114.
The draft EA has been prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status of event 4114. The draft EA was prepared in accordance with (1) the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
Paragraph (d) of § 340.6 provides that APHIS will publish a notice in the
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All comments received regarding the petition, draft EA, and plant pest risk assessment will be available for public review. After reviewing and evaluating the comments on the petition, the draft EA, plant pest risk assessment, and other data, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will also publish a notice in the
7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Office of the Under Secretary for Food Safety, USDA.
Notice of public meeting and request for comments.
The Office of the Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA), U.S. Department of Health and Human Services, are sponsoring a public meeting on March 12, 2013. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions that will be discussed at the 7th Session of the Codex Committee on Contaminants in Foods (CCCF) of the Codex Alimentarius Commission (Codex), which will be held in Moscow, Russian Federation, April 8–12, 2013. The Under Secretary for Food Safety and FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 7th Session of the CCCF and to address items on the agenda.
The public meeting is scheduled for Tuesday, March 12, 2013, from 10:00 a.m. to 12:00 noon.
The public meeting will be held at the Harvey W. Wiley Federal Building, Room 1A–001, FDA, Center for Food Safety and Applied Nutrition (CFSAN), 5100 Paint Branch Parkway, College Park, MD 20740. Documents related to the 7th Session of the CCCF will be accessible via the World Wide Web at
Nega Beru, U.S. Delegate to the 7th Session of the CCCF invites interested U.S. parties to submit their comments electronically to the following email address
Henry Kim, Ph.D., Office of Food Safety, CFSAN/FDA, HFS–317, 5100 Paint Branch Parkway, College Park, MD 20740, Telephone: (240) 402–2023, Fax: (301) 436–2632, email:
Henry Kim, Ph.D., Office of Food Safety, CFSAN/FDA, HFS–317, 5100 Paint Branch Parkway, College Park, MD 20740, Telephone: (240) 402–2023, Fax: (301) 436–2632, email:
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).
The CCCF is responsible for:
(a) Establishing or endorsing permitted maximum levels, and where necessary revising existing guideline levels for contaminants and naturally occurring toxicants in food and feed;
(b) Preparing priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA);
(c) Considering and elaborating methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed;
(d) Considering and elaborating standards or codes of practice for related subjects; and
(e) Considering other matters assigned to it by Codex in relation to contaminants and naturally occurring toxicants in food and feed.
The Committee is chaired by The Netherlands.
The following items on the Agenda for the 7th Session of the CCCF will be discussed during the public meeting:
Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat prior to the meeting. Members of the public may access or request copies of these documents (see
At the March 12, 2013 public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Dr. Henry Kim for the 7th Session of the CCCF (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at
The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs).
Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at 202–720–2600 (voice and TTY).
To file a written complaint of discrimination, write USDA Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250–9410 or call 202–720–5964 (voice and TTY). USDA is an equal opportunity provider and employer.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Forest Service is preparing an environmental impact statement (EIS) to document the potential effects of the Teton to Snake Fuels Management Project. The analysis will evaluate and disclose the effects of treating National Forest land to reduce the potential fire behavior within the wildland-urban interface to better protect threatened values, to improve firefighter safety, and to allow fire to play a more natural role in the ecosystem. Treatments include understory thinning and prescribed fire some of which are located within the Palisades Wilderness Study Area (WSA) and Inventoried Roadless Areas (IRAs). Connected actions necessary to implement the proposed treatments include road maintenance, reconstruction, temporary road and landing construction and obliteration, and construction of fire control lines where needed to contain prescribed fire treatments. No road work or commercial vegetation treatments would occur within the WSA. Road maintenance would occur in a small portion of the Phillips Ridge IRA but no reconstruction would occur. The project is located in Teton and Lincoln Counties, Wyoming, west of the Jackson Hole valley and Snake River corridor, and east of the Caribou-Targhee National Forest.
The Teton to Snake Fuels Management Project was previously scoped and anyalyzed through an environmental assessment (EA) process. The EIS alternatives developed to date are the same as those in the EA. Public comments received on the original Proposed Action, Alternative 2, included support of the project as proposed, but also concerns that the proposed treatments constitute human manipulation in the WSA which could adversely affect wildlife, wilderness character, and eligibility for future designation in the National Wilderness Preservation System. Concern about proposed thinning treatments in the IRAs was also expressed. Requested modifications included reducing the amount of prescribed burning and eliminating all thinning treatments in the WSA and IRAs. Additionally concern was expressed that the proposed action could have adverse effects to habitat for boreal owls and goshawks, as well as reduce old growth habitat. The Forest Service responded to these concerns by developing a new alternative (Alternative 3—Reduce Potential Impacts to Special Areas and Wildlife Habitat), which reduces activities in the WSA and IRAs and avoids goshawk habitat, whitebark pine, boreal forest, and old growth habitat. Changes include dropping, reconfiguring, and reducing the size of units, and changing treatment prescriptions. In addition to the above resource concerns, units were modified or dropped if they also had potential impacts to visual quality, implementation difficulty, or topography that could slow an advancing wildfire. Also considered was the proximity of hazardous fuels to homes and to other fuel reduction projects that could contribute to reducing fire behavior in the project area. The Jackson Ranger District may be contacted for specific treatment unit revisions made in developing Alternative 3.
Comments submitted during the scoping period for the environmental assessment (EA) beginning in 2010 will be brought forward into the EIS analysis so there is no need to re-submit them. New comments would be most useful if they present new information or describe specific unwanted effects of implementing Alternative 3. Comments concerning the scope of the analysis must be received by April 1st, 2013. The draft environmental impact statement is expected in July 2013 and the final environmental impact statement is expected September 2013.
Send written comments to Dale Deiter, District Ranger, USDA Forest Service, Bridger-Teton National Forest, 25 Rosencrans Lane, P.O. Box 1689, Jackson, WY 83001. Comments may also be sent via email to
Visit our projects Web site at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The purpose of this project is to (1) reduce wildland fire threat to residential areas, (2) allow Forest managers to transition from suppressing most fires to a more natural fire regime, and (3) improve firefighter and public safety.
The project area lies within the wildland-urban interface (WUI) as identified by Teton County's Community Wildfire Protection Plan. As per the National Fire Plan, the National Cohesive Wildland Fire Management Strategy, and the Healthy Forests Restoration Act, the Forest Service has made the commitment to protect human communities from wildfires originating on public lands by implementing hazardous fuel reduction projects on Federal lands within the WUI. A fire behavior assessment conducted in 2010 revealed that 42 percent of the area within one-quarter mile of residential areas and the Bonneville Power Administration powerline could produce flame lengths over 4 feet, and 25 percent of this same area could produce crown fires and potential spotting up to a mile ahead of the fire. Wildfires are difficult to suppress under these conditions, particularly with the prevailing winds pushing fire toward the resdiential areas bordering the project area on the east. Additionally, there is a need to remove some snags in close proximity to homes, where firefighters would be located, to promote safety during firefighting activities.
Wilderness policy dictates that the Forest Service shall “reduce, to an acceptable level, the risks and consequences of wildfire within wilderness or escaping from wilderness.” Most of the project area is located within the Palisades Wilderness Study. There is a need to reduce potential fire behavior along the National Forest boundary to reduce the threat of wildfire spreading to residential areas, and to provide the opportunity for wildfire to play a more natural role in the ecosytem. The Wyoming Wilderness Act requires that the Palisades WSA be managed to preserve wilderness character, which includes allowing natural processes of ecological change, such as fire, to operate freely to the extent possible. However, this can only occur if fire managers feel they have a reasonable chance of keeping the fire from escaping off of National Forest System lands.
Alternative 3 proposes to treat 35 units totalling 14,281 acres through thinning (1,757 acres) and prescribed burning (12,524 acres). Thinning would favor large tree retention using the general priority order of whitebark and limber pine, aspen, Douglas-fir, lodgepole pine, Engelmann spruce, and subalpine fir. Thinning would leave 70 to 200 trees per acre in the non-commercial units, and 60 to 140 trees per acre in the commercial units. Conifers in and around aspen clones would be thinned to release suppressed aspen. Residual branches, logs, and other resulting debris would be hand- or machine-piled and burned in the units or on the landings, or scattered to further reduce fuel concentrations in the project area. Ladder fuels would be pruned in some units. Snags would be removed as needed for firefighter safety in portions of 27 units located in close proximity to residential areas. Road reconstruction would occur on 1.3 miles of National Forest roads and a total of 1 mile of temporary road would be constructed and then obliterated after use. Routine maintenance would occur on 11.7 miles of roads. Approximately 27 landings would be used.
Prescribed fire would reduce fire potential while creating a mosaic of burned and unburned areas. Ground and aerial ignition techniques would adhere to site-specific burn plans that identify parameters for weather, air quality, contingency resources, other resource concerns, equipment needs, and responses for potential escapes. Fire managers would use, and subsequently rehabilitate, up to seven miles of low-impact fire control lines if needed to contain prescribed fire. Natural barriers to fire spread would be used where possible.
Alternative 3 includes extensive project design features and best practices to avoid or reduce impacts to cultural resources, water resources, range, recreation, scenery, sensitive plants, air quality, soils, special areas, and wildlife.
At this time it is planned that the EIS will examine Alternative 1 (No Action), Alternative 2 (Proposed Action originally scoped in December 2010 and modified after further analysis), and Alternative 3—Reduce Potential Impacts to Special Areas and Wildlife Habitat (developed to address public concerns after original scoping period).
Key issues identified during the original public scoping include effects to the WSA, IRAs, and wildlife habitat. Additional public concerns addressed in the analysis include potential effects related to unauthorized motorized use, standing trees, spread of noxious weeds, road use, smoke, heavy equipment, and biodiversity.
In March 2012, the Palisades WSA map used by the Forest Service for analysis of the Teton to Snake Fuels Management Project was questioned. In July 2012, Jackson District Ranger Dale Deiter put the project on hold until more clarity was obtained regarding the WSA boundary. Since then extensive record searches have occurred uncovering many valuable maps and memos. In addition, two public meetings were held with people interested in the boundary issue. Based on the best information available at this time, the Forest Service is proceeding with the RARE II map from 1977 (Roadless Area and Review Evalaution process). The map package is expected to be assembled in March 2013 and will be submitted to the Regional and Washington Offices of the Forest Service for review and approval. Upon approval, a certified boundary and legal description will be prepared by the Forest Service lands office with final approval from the Regional Forester. A decision on the Teton to Snake Fuels Management Project would only be made after the Palisades WSA boundary is approved.
Dale Deiter, District Ranger, Jackson Ranger District, Bridger-Teton National Forest
The District Ranger will decide whether to implement one of the alternatives designed to meet the purpose and need for the project, or take no action.
A permit would be required from the State of Wyoming prior to any prescribed burning. The appropriate regulatory agencies will be consulted regarding national or state required permits associated with roads used in project implementation, and required permits obtained prior to implementation.
This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. As noted above, comments submitted during the scoping period beginning in 2010 will be brought forward in the EIS so there is no need to re-submit them. New information and concerns describing site-specific unwanted effects related to Alternative 3 would be useful.
It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.
Include the following information with your comments: Your name, address, email (optional), and telephone number; the project name: Teton to Snake Fuels Management Project; and site-specific comments, along with supporting information you believe will help identify issues, develop alternatives, or predict environmental effects of this proposal. The most useful comments provide new information or describe unwanted environmental effects potentially caused by the proposed action. If you reference scientific literature in your comments, you must provide a copy of the entire reference you have cited and include the predicted site-specific effects supported by the literature.
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered; however anonymous comments will not provide the agency with the ability to provide you with project updates.
Forest Service, USDA.
Notice of issuance of agency proposed directives; request for comment.
The Forest Service has issued proposed directives to Forest Service Handbook (FSH 1909.12) and Manual (FSM 1920) establishing procedures and responsibilities for implementing the
Comments must be received in writing by April 29, 2013.
Submit comments concerning the proposed directives through one of the following methods:
1.
2.
3.
Annie Eberhart Goode, Planning Specialist, Ecosystem Management Coordination Staff, 202–205–1056 or 703–605–4478.
The Forest Service has issued proposed directives to Forest Service Handbook (FSH 1909.12) and Manual (FSM 1920) establishing procedures and responsibilities for implementing the National Forest System (NFS) land management planning regulation set out at 36 CFR part 219. This promulgated rule was published in the
Please note that the Forest Service will not be able to receive hand-delivered comments. In addition, please note that all comments, including names and addresses when provided, will be placed in the record and available for public inspection and copying. The Agency cannot confirm receipt of comments. Individuals wishing to inspect comments should call Jody Sutton at 801–517–1020 to schedule an appointment.
These proposed directives are a revision of Forest Service Handbook (FSH) 1919.12 and Forest Service Manual (FSM) 1920. Copies of the proposed directives are available on the World Wide Web/Internet at
Readers are encouraged to obtain a copy of the proposed directives to formulate their comments and provide input for the development of the final planning directives.
On April 9, 2012, the U. S. Department of Agriculture (Department or USDA) adopted final planning regulations for the NFS at 36 CFR part 219 (77 FR 21161). These regulations, known collectively as the 2012 Planning Rule, provide broad programmatic direction in developing and carrying out land management planning. The rule explicitly directs the Chief of the Forest Service to establish planning procedures in the Forest Service Directives System (36 CFR 219.1(c)).
The Forest Service is implementing the 2012 Planning Rule. Those responsible officials that are implementing the 2012 Planning Rule must follow the regulations at 36 CFR 219 and applicable existing Forest Service Directives until they are superseded.
The Forest Service Directives System consist of the Forest Service Manual (FSM) and the Forest Service Handbook (FSH), which contain the Agency's policies, practices, and procedures, and serves as the primary basis for the internal management and control of programs and administrative direction to Forest Service employees. The directives for all Agency programs are set out on the World Wide Web/Internet at
Specifically, the FSM contains legal authorities, objectives, policies, responsibilities, instructions, and guidance needed on a continuing basis by Forest Service Line Officers and primary staff to plan and execute programs and activities. The FSH is the principal source of specialized guidance and instruction for carrying out the policies, objectives, and responsibilities contained in the FSM.
For these proposed directives, both the FSM and the FSH provide policy direction, objectives, instructions, and guidance for Forest Service Line Officers and primary staff to plan and execute the process of developing, revising, amending, and making administrative changes to plans.
The following is an overview of the contents of the proposed directives.
This Forest Service Manual describes a process for developing, revising, amending, and making administrative changes to land management plans for the National Forest System (NFS). It includes authorities and responsibilities. It should be used in conjunction with the FSH.
This FSH provides policy direction, objectives, instructions and guidance for the process of developing, revising, amending, and making administrative changes to plans for the NFS. It includes authorities and responsibilities.
The section known as the zero code contains authorities, responsibilities, and select definitions applicable to subsequent chapters.
This chapter describes the procedures for writing an assessment for development, amendment, or revision of land management plans.
This chapter describes the land management plan under the 2012 Planning Rule and explains the procedures for developing, amending, and revising land management plans.
This chapter describes the plan monitoring program, broader-scale monitoring strategy, and biennial evaluation of the monitoring information for land management planning.
This chapter describes the adaptive management framework, use of best available scientific information, public participation and the role of collaboration, and tribal consultation as it relates to land management plans.
This chapter describes the process for the public to seek administrative review of plans, plan revisions, and plan amendments before their approval. This process is referred to as the objection process.
This chapter provides procedures for developing plan components and other plan content to meet National Forest Management Act (NFMA) and planning rule requirements for identifying lands that are not suitable for timber production, plan components for timber harvest for timber production or other purposes, limitations on timber harvest, and display of the planned timber sale program.
This chapter describes the process for identifying and evaluating lands that may be suitable for inclusion in the National Wilderness Preservation System and determining whether to recommend any such lands for wilderness designation.
This chapter describes the process for identifying and evaluating potential additions to the National Wild and Scenic Rivers System. This chapter also addresses interim management of river segments determined to be eligible and suitable, documentation of study results, as well as the process for notifying Congress of agency wild and scenic river recommendations.
This chapter contains exhibits or references not easily found electronically.
This notice has been reviewed under USDA procedures and Executive Order (E.O.) 12866, Regulatory Planning and Review. The Office of Management and Budget (OMB) has reviewed this notice and has determined that it is a significant action. The proposed directives would not have an annual effect of $100 million or more on the economy nor adversely affect productivity, competition, jobs, the environment, public health or safety, nor State or local governments. The proposed directives would not interfere with an action taken or planned by another agency nor raise new legal or policy issues. Finally, the proposed directives would not alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients of such programs.
Moreover, the proposed directives have been considered in light of E.O. 13272 regarding proper consideration of small entities and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which amended the Regulatory Flexibility Act (5 U.S.C. 601
These proposed directives provide the detailed direction to agency employees necessary to carry out the provisions of the final 2012 Planning Rule adopted at 36 CFR part 219 governing land management planning. Forest Service Handbook 1909.15, section 31.12 (57 FR 43208; September 18, 1992) excludes from documentation in an environmental assessment or impact statement “rules, regulations, or policies to establish Service-wide administrative procedures, program processes, or instructions.” The Agency's conclusion is that these proposed directives fall within this category of actions and that no extraordinary circumstances exist as currently defined that require preparation of an environmental assessment or an environmental impact statement.
These proposed directives have been analyzed in accordance with the principles and criteria contained in E.O. 12360, Governmental Actions and Interference with Constitutionally Protected Property Rights, and it has been determined that they would not pose the risk of a taking of private property as they are limited to the establishment of administrative procedures.
These proposed directives have been analyzed under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that they do not constitute a significant energy action as defined in the Executive Order.
These proposed directives have been reviewed under E.O. 12988, Civil Justice Reform. These proposed directives will direct the work of Forest Service employees and are not intended to preempt any State and local laws and regulations that might be in conflict or that would impede full implementation of these directives. The directives would not retroactively affect existing permits, contracts, or other instruments authorizing the occupancy and use of NFS lands and would not require the institution of administrative proceedings before parties may file suit in court challenging their provisions
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538), which the President signed into law on March 22, 1995, the effects of these proposed directives on State, local, and Tribal governments, and on the private sector have been assessed and do not compel the expenditure of $100 million or more by any State, local, or Tribal government, or anyone in the private sector. Therefore, a statement under section 202 of the act is not required.
The Agency has considered these proposed directives under the requirements of E.O. 13132, Federalism. The Agency has made a preliminary assessment that they conform with the federalism principles set out in this Executive Order; would not impose any significant compliance costs on the States; and would 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. Moreover, these proposed directives address the land management planning process on National Forests, Grasslands or other units of the NFS, which do not directly affect the States. Based on comments received on these proposed directives, the Agency will consider if any additional consultation will be needed with State and local governments prior to adopting final directives.
The Forest Service will conduct government-to-government consultation on the planning directives. The Forest Service considers tribal consultation as an ongoing, iterative process that encompasses development of the proposed directives through the issuance of final directives. During development of the 2012 Planning Rule, between September 23, 2010, and publication of the final rule on April 9, 2012, the Agency held 16 consultation meetings across the Country. In addition, Forest Service leaders held one-on-one meetings, as requested, with tribal leaders throughout the time period of development of the rule.
The Agency will contact all federally recognized Tribes and Alaska Native Corporations by mail to formally initiate consultation on the proposed directives and seek comments within 120 days.
These proposed directives do not contain any record keeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 and, therefore, impose no paperwork burden on the public. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and implementing regulations at 5 CFR part 1320 do not apply.
Chapter 50 of these proposed directives contains information collection requirements as defined in 5 CFR part 1320. The information collection requirements have been approved by the Office of Management and Budget and assigned control number 0596–0158.
The Forest Service has developed these planning directives to set forth the legal authorities, objectives, policy, responsibilities, direction, and overall guidance for Forest Service Line Officers, agency employees, and others to use the 2012 Planning Rule. The proposed directives provide consistent interpretation of the 2012 Planning Rule for Line and Staff Officers, and interdisciplinary teams.
The 2012 Planning Rule and the proposed FSM and FSH sections together provide requirements and guidance for the Agency to adaptively manage the NFS to maintain and restore NFS land and water ecosystems and protect species while providing for ecosystem services and multiple uses. The proposed directives are intended to guide the development, revision, and amendment of land management plans to provide for the sustainability of ecosystems and resources; meet the need for forest restoration and conservation, watershed protection, and species diversity and conservation; and assist the Agency in providing a sustainable flow of benefits, services, and uses of NFS lands that provide jobs and contribute to the economic and social sustainability of communities.
By seeking public notice and comment on these proposed directives, the Agency is continuing its commitment to improve public involvement and transparency in decisionmaking associated with developing, amending, or revising a land management plan.
When the Agency offers the opportunity for public notice and comment on a proposed revision of a Forest Service Manual or Handbook revision, the Agency publishes a notice of a proposed revision with a minimum 60-day comment period. The Agency then considers the comments, makes any changes, drafts, and publishes a final
The Forest Service is committed to providing adequate opportunities for the public to comment on administrative directives that are of substantial public interest or controversy, as provided in the regulations at 36 CFR part 216. All comments on these proposed directives will be considered in the development of the final directives. The full text of these proposed directives are available on the World Wide Web/Internet at
National Institute of Food and Agriculture, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations (5 CFR part 1320) which implement the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the intention of the National Institute of Food and Agriculture (NIFA) to request an extension for a currently approved information collection (OMB No. 0524–0026) for Form NIFA–666, “Organizational Information.”
Submit comments on or before April 29, 2013.
You may submit comments, identified by NIFA–2013–0008, by any of the following methods:
Robert Martin, Records Officer, Information Policy, Planning and Training; Office of Information Technology; NIFA; USDA; Email:
They were asked to give an estimate of the time it took them to complete each form. This estimate was to include such things as: (1) Reviewing the instructions; (2) searching existing data sources; (3) gathering and maintaining the data needed; and (4) actual completion of the forms. The average time it took each respondent was calculated from their responses.
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 the Nevada Advisory Committee (Committee) to the Commission will be held on March 21, 2013, at the Department of Employment, Training and Rehabilitation, 2800 East St. Louis Ave., Las Vegas, Nevada 89104. The meeting is scheduled to begin at 3:00 p.m. and adjourn at approximately 4:30 p.m. The purpose of the meeting is to discuss the Committee's report on peer-to-peer bullying in public schools and discuss other Committee projects.
Members of the public are entitled to submit written comments. The comments must be received in the Western Regional Office of the Commission by April 21, 2013. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments, or to present their comments verbally at the meeting, or who desire additional information should contact Angelica Trevino, Office Manager, Western Regional Office, at (213) 894–3437, (or for hearing impaired TDD 913–551–1414), or by email to
Records generated from this meeting may be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's Web site,
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Port of South Louisiana, grantee of Foreign-Trade Zone 124, requesting authority to reorganize the zone to expand its service area under the alternative site framework (ASF) adopted by the Board (15 CFR 400.2(c)). The ASF is an option
FTZ 124 was approved by the Board on December 20, 1985 (Board Order 319, 50 FR 53351, December 31,1985), and was reorganized under the ASF on January 31, 2012 (Board Order 1814, 77 FR 6059, February 7, 2012). The zone currently has a service area that includes St. Charles, St. John the Baptist, St. James, La Fourche and St. Mary Parishes, Louisiana.
The applicant is now requesting authority to expand the service area of the zone to include Tangipahoa Parish, as described in the application. If approved, the grantee would be able to serve sites throughout the expanded service area based on companies' needs for FTZ designation. The proposed expanded service area is adjacent to the Gramercy Customs and Border Protection port of entry.
In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 29, 2013. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to May 13, 2013.
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 Board's Web site, which is accessible via
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) is conducting an administrative review of the antidumping duty order on silicon metal from the People's Republic of China (“PRC”) for the period of review (“POR”) June 1, 2011, through May 31, 2012. This review covers one PRC company, Shanghai Jinneng International Trade Co., Ltd. (“Shanghai Jinneng”).
Lori Apodaca, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–4551.
On June 1, 2012, the Department published a notice of an opportunity to request an administrative review of the antidumping duty order on silicon metal from the PRC.
As explained in the memorandum from the Assistant Secretary for Import Administration, the Department has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from October 29 through October 30, 2012.
Imports covered by the order are shipments of silicon metal containing at least 96.00 but less than 99.99 percent of silicon by weight. Also covered by the order is silicon metal from the PRC containing between 89.00 and 96.00 percent silicon by weight but which contain a higher aluminum content than the silicon metal containing at least 96.00 percent but less than 99.99 percent silicon by weight. Silicon metal is currently provided for under subheadings 2804.69.10 and 2804.69.50 of the Harmonized Tariff Schedule of the United States (“HTSUS”) as a chemical product, but is commonly referred to as a metal. Semiconductor-grade silicon (silicon metal containing by weight not less than 99.99 percent of silicon and provided for in subheading 2804.61.00 of the HTSUS) is not subject to the order. Although the HTSUS
As noted in the “Background” section above, Shanghai Jinneng has submitted a timely-filed certification indicating that it had no shipments of subject merchandise to the United States during the POR. In addition, in response to our no-shipments inquiry, CBP did not provide any evidence contradicting Shanghai Jinneng's claim of no shipments. Further, on November 9, 2012, the Department released to interested parties the results of the CBP query that it used for corroboration of Shanghai Jinneng's no-shipments claim.
Based on the certification of Shanghai Jinneng and our analysis of CBP information, we preliminarily determine that Shanghai Jinneng did not have any reviewable transactions during the POR. In addition, consistent with the Department's recently announced refinement to its assessment practice in non-market economy (“NME”) cases, the Department finds that it is appropriate not to rescind the review in these circumstances but rather, to complete the review with respect to Shanghai Jinneng and issue appropriate instructions to CBP based on the final results of the review.
Interested parties are invited to comment on the preliminary results and may submit case briefs and/or written comments within 30 days of the date of publication of this notice, pursuant to 19 CFR 351.309(c)(1)(ii). Rebuttal briefs, limited to issues raised in the case briefs, will be due five days after the due date for case briefs, pursuant to 19 CFR 351.309(d). Written argument should be filed electronically using Import Administration's Antidumping and Countervailing Duty Centralized Electronic Service System (“IA ACCESS”).
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Import Administration, U.S. Department of Commerce. The request must be filed electronically using IA ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, IA ACCESS, by 5:00 p.m. Eastern Standard Time, within 30 days after the date of publication of this notice.
The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.
Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review. The Department intends to issue assessment instructions to CBP within 15 days after the publication date of the final results of this review. Pursuant to the recently announced refinement to its assessment practice in NME cases, if the Department continues to determine that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For Shanghai Jinneng, which claimed no shipments, the cash deposit rate will remain unchanged from the rate assigned to the company in the most recently completed review of the company; (2) for previously investigated or reviewed PRC and non-PRC exporters who are not under review in this segment of the proceeding but who have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate the cash deposit rate will be the PRC-wide rate of 139.49 percent;
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this 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.
These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) has determined that a request for a new shipper review of the antidumping duty order on wooden bedroom furniture from the People's Republic of China (“PRC”) meets the statutory and regulatory requirements for initiation. The period of review (“POR”) for the new shipper review is January 1, 2012 through December 31, 2012.
Lori Apodaca, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–4551.
The antidumping duty order on wooden bedroom furniture from the PRC was published on January 4, 2005.
Dongguan Chengcheng stated that it is both the exporter and producer of the subject merchandise upon which its request for a new shipper review is based. Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Dongguan Chengcheng certified that it did not export wooden bedroom furniture to the United States during the period of investigation (“POI”). In addition, pursuant to section 751(a)(2)(B)(i)(II) of the Act and 19 CFR 351.214(b)(2)(iii)(A), Dongguan Chengcheng certified that, since the initiation of the investigation, it has never been affiliated with any PRC exporter or producer who exported wooden bedroom furniture to the United States during the POI, including those not individually examined during the investigation. As required by 19 CFR 351.214(b)(2)(iii)(B), Dongguan Chengcheng also certified that its export activities were not controlled by the central government of the PRC.
In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2)(iv), Dongguan Chengcheng submitted documentation establishing the following: (1) the date on which it first shipped wooden bedroom furniture for export to the United States and the date on which the wooden bedroom furniture was first entered, or withdrawn from warehouse, for consumption; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.
The Department conducted a CBP database query and confirmed by examining the results of the CBP data query that Dongguan Chengcheng's subject merchandise entered the United States during the POR specified by the Department's regulations.
Pursuant to section 751(a)(2)(B) of the Act, 19 CFR 351.214(b), and based on the information on the record, the Department finds that Dongguan Chengcheng meets the threshold requirements for initiation of a new shipper review of its shipment(s) of wooden bedroom furniture from the PRC.
It is the Department's usual practice, in cases involving non-market economies, to require that a company seeking to establish eligibility for an antidumping duty rate separate from the country-wide rate provide evidence of
We will instruct CBP to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for certain entries of the subject merchandise from Dongguan Chengcheng in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Dongguan Chengcheng stated that it both produces and exports the subject merchandise, the sales of which form the basis for its new shipper review request, we will instruct CBP to permit the use of a bond only for entries of subject merchandise which the respondent both produced and exported.
Interested parties requiring access to proprietary information in this new shipper review should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.
This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) has received information sufficient to warrant reconsideration of a completed changed circumstances review (“CCR”) of the antidumping duty order on certain frozen warmwater shrimp from the People's Republic of China (“PRC”) originally conducted in 2007.
Effective February 27, 2013.
Kabir Archuletta, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482–2593.
Yelin was formally dissolved on December 12, 2006.
On December 5, 2012, we determined that we would reconsider this CCR determination in light of certain evidence discovered in AR6.
On December 31, 2012, the Department received comments from Petitioner on the documents placed on the record of this CCR.
The merchandise that is subject to the order is certain frozen warmwater shrimp from the PRC. The products subject to the order at the time of this CCR was originally conducted
For a full description of our findings in this preliminary reconsideration, please see the Preliminary Reconsideration Memorandum.
For the reasons detailed in the Preliminary Reconsideration Memorandum, we preliminarily determine that Hilltop is not the successor-in-interest to Yelin and is considered part of the PRC-wide entity. In making this determination we have relied on adverse facts available, in accordance with section 776(a) and (b) of the Tariff Act of 1930, as amended (“the Act”).
Any interested party may request a hearing within 14 days of publication of this notice in accordance with 19 CFR 351.310(c). Interested parties may submit case briefs no later than 14 days after the date of publication of this notice, in accordance with 19 CFR 351.309(c)(1)(ii). Rebuttal briefs, which must be limited to issues raised in the case briefs, may be filed no later than five days after the case briefs, in accordance with 19 CFR 351.309(d)(1). Any hearing, if requested, will normally be held two days after rebuttal briefs are due, in accordance with 19 CFR 351.310(d)(1).
The Department will issue its final results of review within 270 days after the date on which the preliminary reconsideration of this CCR is published in the
The current requirement for a cash deposit of estimated antidumping duties on all subject merchandise will continue unless and until it is modified pursuant to the final results of this CCR. We note that Hilltop was determined to be part of the PRC-wide entity in AR6 and is currently subject to the cash deposit requirements applicable to the PRC-wide entity.
This notice is published in accordance with sections 751(b) and 777(i) of the Act and 19 CFR 351.216.
Import Administration, International Trade Administration, Department of Commerce.
Eric Greynolds or Christopher Hargett, AD/CVD Operations, Office 8, Import Administration, U.S. Department of Commerce, Room C–100, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202–482–6071 and 202–482–4161, respectively.
On January 17, 2013, the Department of Commerce (the Department) initiated countervailing duty investigations of certain frozen warmwater shrimp from the People's Republic of China, Ecuador, India, Indonesia, Malaysia, Thailand, and the Socialist Republic of Vietnam.
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires the Department to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which the Department initiated the investigation. However, if the petitioner makes a timely request for an extension, section 703(c)(1)(A) of the Act allows the Department to postpone making the preliminary determination until no later than 130 days after the date on which the administering authority initiated the investigation.
On February 8, 2013, the Coalition of Gulf Shrimp Industries, the petitioner in these investigations, requested that the deadline for the preliminary determination in each of these cases be extended to 130 days from the date of initiation in accordance with 19 CFR § 351.205(b)(2). Therefore, in accordance with section 703(c)(1)(A) of the Act, we are fully extending the due date for the preliminary determinations to no later than 130 days after the day on which the investigations were initiated. However, as that date falls on a federal holiday (
This notice is issued and published pursuant to section 703(c)(2) of the Act.
National Institute of Standards and Technology (NIST), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before April 29, 2013.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Kathryn Butler, 100 Bureau Drive, Mailstop 8662, Gaithersburg, MD
NIST's research on elevators has primarily focused on the technical aspects of ensuring safe and reliable evacuation for the occupants of tall buildings. In addition, the International Code Council and the National Fire Protection Association provide requirements for the use of elevators for both occupant evacuation and fire fighter access into the building. However, there still is little understanding of how occupants use elevator systems during fire emergencies.
The focus of this research effort is two-fold: (1) To gain an understanding of how building occupants with mobility impairments currently evacuate multi-story buildings in the United States during fire emergencies, and (2) to learn about the concerns of persons with mobility impairments on using elevators during fire evacuations. This research aims to provide guidance to designers and building managers on aspects of fire evacuation that concern occupants with mobility impairments and on how to improve elevator design and usage during fire emergencies. The research includes four opportunities for participation:
(a) Building managers and designated safety personnel from a sample of four to ten existing and new federal high-rise buildings in the United States will be contacted to fill out a questionnaire requesting information on the emergency plans and procedures for the building, including how the buildings' evacuation plans incorporate the use of the existing elevator system to evacuate occupants with mobility impairments during fire emergencies. The building emergency plan will be requested from either the General Services Administration (GSA) or from the building manager.
(b) Occupants with mobility impairments in the buildings identified in part (a) will be asked for basic information on their mobility with regard to evacuation, previous evacuation experiences, and preferences on how to evacuate during a fire emergency. At the end of the questionnaire, they will be invited to participate in a one-on-one interview to discuss these issues in more detail.
(c) Occupants with mobility impairments identified in part (b) will participate in a one-on-one interview requesting more detailed information on previous evacuation experiences, awareness of emergency procedures, and views and preferences on using an elevator to evacuate during a fire emergency.
(d) Professionals involved with emergency planning (e.g., GSA, USDA, DHS, building emergency managers, researchers) and building occupants with mobility impairments, if willing, will be invited to participate in one of two focus groups. A preliminary analysis of the data resulting from parts (a) through (c) will be summarized in the form of two sets of potential plans for the use of elevators during fire evacuation by occupants with mobility impairments: One for existing buildings and one for new buildings. Members of the focus groups will review both of these potential plans. They will then participate in a discussion that will lead to guidance for designers and building managers on aspects of fire evacuation that concern occupants with mobility impairments and on how to improve elevator design and usage during fire emergencies. The order of the discussion of plans for existing and new buildings will be switched for the two focus groups to ensure that each plan receives the same amount of attention overall.
The data from questionnaire (a) will be collected electronically. The questionnaire will be made available on a secured Web site and the link to this Web site will be distributed by NIST staff to building property managers and designated safety personnel.
The data from questionnaire (b) will be collected electronically. The questionnaire will be made available on a secured Web site and the link to this Web site will be distributed by NIST staff to occupants with mobility impairments in the buildings identified in part (a).
The data from the one-on-one interviews will be audiotaped if permission is granted or recorded in written notes if not. Participants will identify their interest in the questionnaire from part (b). Each interview will be conducted by a member of the NIST research team at the participant's workplace or by phone.
The data from the focus groups will be audio taped and recorded in written notes. Professionals involved with emergency planning (e.g., GSA, USDA, DHS, building emergency managers, researchers) and building occupants with mobility impairments, if willing, will be invited to participate.
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; (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 and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Tuesday, March 19, 2013 at 9 a.m.
The meeting will be held at the Hawthorne Hotel, 18 Washington Square, Salem, MA 01970; telephone: (978) 744–4080; fax: (978) 745–9842.
Paul J. Howard, Executive Director, New England Fishery Management Council; telephone: (978) 465–0492.
The Habitat Committee will continue development of management alternatives for Omnibus EFH Amendment 2. Regarding Dedicated Habitat Research Areas, the Committee will review PDT recommendations about: (1) Implementing dedicated habitat research areas (e.g. defining “use” in relation to sunset provisions), (2) goals and objectives for specific research areas, and (3) boundaries for Eastern Maine and Georges Bank DHRAs. Regarding gear modifications, the Committee will (1) review PDT information about gear modifications for scallop dredges, (2) discuss other gear modification options as needed, and (3) discuss a gear modification research agenda and data collection program. The Committee will also review recommended boundaries for a single Habitat Management Area in the Great South Channel. Other business may be discussed as necessary.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard, Executive Director, at (978) 465–0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
Bureau of Consumer Financial Protection.
Notice and request for information.
This notice requests information from the public to determine options that would increase the availability of affordable payment plans for borrowers with existing private student loans. Section 1035 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) establishes an ombudsman for student loans (Ombudsman) within the Consumer Financial Protection Bureau (Bureau). Among other things, the Ombudsman is responsible for making “appropriate recommendations” to the Director of the Bureau, the Secretary of the Treasury, the Secretary of Education, and Congress.
In October 2012, the Ombudsman presented a report, which recommended that policymakers identify opportunities to spur refinance and modification activity in the private student loan market. This notice seeks information from market participants, consumers, and other stakeholders in order to provide more detailed information on ways to encourage the development of more affordable loan repayment mechanisms for private student loan borrowers.
Comments must be received on or before April 8, 2013.
You may submit responsive information and other comments, identified by Docket No. CFPB–2013–0004, by any of the following methods:
•
•
All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Sensitive personal information, such as account numbers or Social Security numbers, should not be included. Submissions will not be edited to remove any identifying or contact information.
For general inquiries, submission process questions or any additional information, please contact Monica Jackson, Office of the Executive Secretary, at 202–435–7275.
12 U.S.C. 5511(c).
There are more than 38 million student loan borrowers with over $1.1 trillion in outstanding debt. The majority of the market consists of loans originated under Title IV of the Higher Education Act. The remainder of the market consists of private student loans. In July 2012, the Director of the Bureau and the Secretary of Education submitted a report to Congress detailing the private student loan market. The report
The Dodd-Frank Act requires the Secretary of the Treasury to designate an Ombudsman within the Bureau. The Dodd-Frank Act requires that the Ombudsman present an annual report describing the activities of the Ombudsman during the prior year, compile and analyze data on borrower complaints regarding private educational loans, and make appropriate recommendations to policymakers. In October 2012, the Ombudsman released an annual report.
Some policymakers have sought changes to the treatment of private student loans in the bankruptcy code. This policy option is not the primary subject of this Request for Information. Rather, this request seeks information on options to increase the level of affordable repayment options for both pre-default and post-default borrowers in distress who wish to repay their loans but may be lacking near-term ability to service their obligations.
For the purposes of this request, a loan modification refers to a restructuring of a debt obligation agreed to by the creditor and debtor where the creditor agrees to a concession. In recent years, many homeowners have sought more affordable repayment options for mortgage obligations to avoid foreclosure. In such situations, some creditors may have an economic incentive to modify the loan, as the net present value (NPV) of the restructured debt may be greater in value than the value of the collateral after foreclosure costs. However, in other situations, with respect to securitized debt obligations secured by residential real estate, subordinated note holders might be unwilling to approve a change in terms. Given the potential impact foreclosures can have on the financial system and local economies, many policymakers pursued policies designed to encourage alternative repayment options for mortgage borrowers.
The private student loan market might also benefit from further loan modification activity. Even with concessions, creditors might increase the NPV of distressed loans through such modifications. However, the market for private student loans differs from the market for residential mortgages. Private student loans are not secured by collateral and have generally lower outstanding balances relative to mortgages. These differences might fundamentally impact creditors' economic calculus for determining whether to offer a change in repayment terms.
There are also some important similarities between the two markets. As with mortgage origination, student loan originators often access funding through the asset-backed securities (ABS) market. In 2012, public filings reveal that more than $4 billion of private student loan asset-backed securities were issued. Like in the mortgage market, private student loan underwriting practices have significantly improved since the economic downturn, which may limit the level of distress for future borrowers. Another notable similarity is the employment of third-party loan servicers unaffiliated with the original lender, though this practice is less prevalent in the private student loan market than in the mortgage market.
Borrowers of federal student loans have a number of options to modify the terms of their obligations to ensure an affordable payment plan. For example, borrowers with a partial financial hardship can elect the Income-Based Repayment plan, which caps payments on eligible student loans as a percentage of income above 150% of the poverty line. Borrowers in default can rehabilitate many federal student loans by making “reasonable and affordable” payments in a consistent, timely fashion for a specified period. There are also provisions to adjust the status of a rehabilitated federal student loan on a consumer's credit report.
Available data indicate that, in recent years, there has been limited modification activity in the private student loan market. There are a number of potential impediments to offering alternative repayment options. Some of these may include: (a) Accounting guidelines that add complexity when offering alternative repayment options without charging off the loan;
Policymakers have employed various measures to prevent foreclosures among American homeowners and to mitigate resulting risks to the public and the broader economy. Examples of these risks include increased stress on insured depository institutions and decreased home values of properties proximate to foreclosed homes—both of which can lead to further distress. Given the relative size of the private student loan market and the nature of the product, private student borrower distress is unlikely to contribute to similar, significant systemic risk. However, distress among borrowers with all types of student loans may cause other negative effects in the broader economy. For example, the Department of Treasury's Office of Financial Research described in its recent annual report that student loan debt might dampen consumption.
The Ombudsman seeks information in order to provide policymakers with further details on potential ways to increase payment affordability for private student loan borrowers in distress and on the risks of failing to do so. The deadline for submission of comments is April 8, 2013.
The Bureau encourages comments from the public, including:
• Consumers;
• Financial institutions, including lenders and loan servicers;
• Nationally recognized statistical rating organizations (NRSROs);
• Private student loan asset-backed trust administrators;
• Institutions of higher education;
• Credit reporting agencies;
• Debt collectors;
• Housing finance professionals;
• Manufacturers of automobiles and other financed goods;
• Brokers and service providers in the residential real estate industry;
• Professional associations, such as those representing health professionals and teachers;
• Providers of financial counseling; and
• Other interested parties.
The Bureau is interested in responses in the following general areas, as well as specific questions below. Please feel free to respond to any of the questions outlined below.
1 What are the primary drivers of private student loan borrower distress?
a What characteristics might predict distress at loan origination?
b What characteristics might predict distress for borrowers who complete a program of study?
c What characteristics might predict distress during repayment?
d What are typical debt-to-income ratios of borrowers in distress?
2 How do borrowers in distress typically stay current with their private student loans? To what extent do borrowers reduce consumption or adjust living arrangements to meet obligations?
a Do borrowers seek to reduce payments on federal student loans in order to make payments on private student loans?
b To what extent do borrowers in distress accrue other debt (credit cards, family loans) to meet private student loan obligations?
c To what extent do borrowers in distress forego “other nonessential expenses” to meet private student loan obligations?
3 What options currently exist for borrowers to permanently or temporarily lower monthly payments on private student loan obligations? To what extent have these affordable repayment options cured delinquencies?
4 How do lenders typically evaluate whether or not a borrower qualifies for these affordable repayment options? If lenders make use of financial models, what are the key drivers of these models?
5 Do lenders work directly with co-signers to modify terms? If so, how?
6 What is the incidence or expectation of re-default rates among restructured private student loans?
7 What are some examples of loan modification programs sponsored by a public entity or the private sector that have been successful? Which features of these programs might be applicable to a student loan affordability program? Which features of these programs might not be appropriate for a student loan affordability program?
8 Is the servicing infrastructure utilized by major lenders flexible enough to process loan modifications at scale? What are the limitations of these servicing platforms? Are those limitations capable of being overcome? What are the estimated costs of overcoming those limitations?
9 What are the key differences between servicing of student loans compared to servicing of residential mortgages that must be considered when crafting an affordability program?
10 How are payments plans for defaulted private and federal student loans currently reported to consumer reporting agencies? How are rehabilitated federal student loans reported by consumer reporting agencies, and how does that reporting affect credit scores?
11 How might an affordability program sponsored by a public entity mitigate moral hazard and selection bias?
12 What are some examples of modification or refinance initiatives that successfully made borrowers aware of a new program? Which features of these programs are applicable in the private student loan market?
13 What are the most effective communication mechanisms to reach borrowers in distress?
14 How do student loan payments impact access to mortgage credit? How does student debt impact a consumer's ability to accumulate a down payment? How does student debt impact a consumer's ability to meet debt-to-income requirements for FHA-insured and private sector mortgages?
15 To what extent does student loan debt impact the market for automobiles? How does student loan debt impact a consumer's ability to secure an auto loan?
16 What evidence exists about the impact of student loan debt on consumption, savings, homeownership, household formation, entrepreneurship, and other indicators of economic health?
U.S. Air Force Academy Board of Visitors.
Meeting notice.
In accordance with 10 U.S.C. 9355, the U.S. Air Force Academy (USAFA) Board of Visitors (BoV) will hold a meeting in Harmon Hall at the United States Air Force Academy in Colorado Springs, Colorado on March 15–16, 2013. The meeting will begin at 2:30 p.m. on March 15 and 9:00 a.m. on March 16. The purpose of this meeting is to review morale and discipline, social climate, curriculum, instruction, infrastructure, fiscal affairs, academic methods, and other matters relating to the Academy. Specific topics for this meeting include a Forthclassmen Cadet Focus Group, an Upperclassmen Cadet Focus Group, an Athletic Department Update, a Superintendent's Update, a Character Update, an Impact of NDAA Requirements brief and the Subcommittee Chair Updates. In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102–3.155, three sessions of this meeting shall be closed to the public because they involve matters covered by subsection (c)(6) of 5 U.S.C. 552b. Public attendance at the open portions of this USAFA BoV meeting shall be accommodated on a first-come, first-served basis up to the reasonable and safe capacity of the meeting room. In addition, any member of the public wishing to provide input to the USAFA BoV should submit a written statement in accordance with 41 CFR 102–3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act and the procedures described in this paragraph. Written statements must address the following details: The issue, discussion, and a recommended course of action. Supporting documentation may also be included as needed to establish the appropriate historical context and provide any necessary background information. Written statements can be submitted to the Designated Federal Officer (DFO) at the Air Force address detailed below at any time. However, if a written statement is
If after review of timely submitted written comments and the BoV Chairman and DFO deem appropriate, they may choose to invite the submitter of the written comments to orally present the issue during an open portion of the BoV meeting that is the subject of this notice. Members of the BoV may also petition the Chairman to allow specific personnel to make oral presentations before the BoV. In accordance with 41 CFR 102–3.140(d), any oral presentations before the BoV shall be in accordance with agency guidelines provided pursuant to a written invitation and this paragraph. Direct questioning of BoV members or meeting participants by the public is not permitted except with the approval of the DFO and Chairman.
For additional information or to attend this BoV meeting, contact Capt Bobby Hale, Accessions and Training Division, AF/A1PT, 1040 Air Force Pentagon, Washington, DC 20330, (703) 695–4066.
Department of Education (ED), Federal Student Aid (FSA).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before March 29, 2013.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
Electronically mail
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
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 December 19, 2012, by Pangea LNG (North America) Holdings, LLC (Pangea), requesting long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in an amount up to the equivalent of 398.5 billion cubic feet (Bcf) per year (Bcf/y) of natural gas (equal to 1.09 Bcf/day of natural gas), the equivalent of 8 million metric tons per annum (mtpa), from its proposed South Texas LNG Export Project (ST LNG Project) located at the Port of Corpus Christi in Ingleside, Texas. Pangea requests this authorization for a 25-year term commencing on the earlier of the date of first export or seven years from the date the requested authorization is granted. The LNG would be exported to any country (1) with which the United States does not have a free trade agreement (FTA) requiring national treatment for trade in natural gas, (2) that has developed or in the future develops the capacity to import LNG via ocean-going carrier, and (3) with which trade is not prohibited by U.S. law or policy. Pangea is requesting this authorization to export LNG both on its own behalf and as agent for other parties who hold title to the LNG at the point of export. The Application was filed under section 3 of the Natural Gas Act (NGA). 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, April 29, 2013.
Electronic Filing by email:
Regular Mail: U.S. Department of Energy (FE–34), Office of Natural Gas Regulatory Activities, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026–4375.
Hand Delivery or Private Delivery Services (e.g., FedEx, UPS, etc.): U.S. Department of Energy (FE–34), Office of Natural Gas Regulatory Activities, Office of Fossil Energy, Forrestal Building, Room 3E–042, 1000 Independence Avenue SW., Washington, DC 20585.
Pangea is a Delaware limited liability company with its principal place of business in The Woodlands, Texas. Pangea is a wholly owned subsidiary of Pangea LNG B.V. (Pangea LNG), a Netherlands-based company that is developing floating LNG liquefaction and storage solutions around the globe. Pangea LNG's ordinary shares are owned by Daewoo Shipbuilding & Marine Engineering Co., Ltd. (DSME) (70%), D&H Solutions AS (20%), and NextDecade International Coöperatief U.A. (NextDecade International) (10%).
DSME is a South Korea-based company whose major shareholders consist of Korea Development Bank (31.27%) and Korea Asset Management Corporation (19.11%), with the remaining shares being widely-held (with no individual entities holding five (5) percent or more of DSME's shares).
Pangea states that consistent with an executed Letter of Intent, it is working with Statoil North America, Inc. on the development of the ST LNG Project. Statoil North America, Inc. is a subsidiary of Statoil ASA (Statoil), a Norwegian upstream oil and gas company listed on the Oslo and New York stock exchanges. Pangea states that headquartered in Stavanger, Norway, Statoil is an international energy company with 40 years of offshore oil and gas production experience on the Norwegian Continental Shelf and currently has operations in 36 countries. Pangea states that Statoil's LNG activities include being the operator of the Snøhvit, and LNG export facility in Norway; exercising its capacity holder rights with respect to the Cove Point import and regasification terminal (in the U.S.); and producing, transporting and marketing LNG worldwide. Pangea states that Statoil has been active in the U.S. oil and gas industry for 25 years. Pangea states that over the past decade, Statoil has increased its North American business substantially through upstream positions in the Gulf of Mexico, acreages in the Marcellus shale gas play, the Eagle Ford shale gas play, the Bakken shale oil play and oil sands acreages in Alberta, Canada. Pangea further states that it and Statoil are in active negotiations with respect to Statoil procuring up to a 50% equity stake in the ST LNG Project and utilizing up to 50% of the liquefaction and export capacity of the ST LNG Project.
In the instant Application, Pangea seeks long-term, multi-contract authorization to export domestically produced LNG in an amount up to the equivalent of 398.5 billion cubic feet (Bcf) per year (Bcf/y) of natural gas (equal to 1.09 Bcf/day of natural gas), the equivalent of 8 million metric tons per annum (mtpa), for a period of 25 years beginning on the earlier of the date of first export or seven years from the date the authorization is granted by DOE/FE. Pangea seeks to export this LNG to any nation with which the United States does not have an FTA requiring national treatment for trade in natural gas or LNG with which trade is not prohibited by United States law or policy. Pangea is seeking this export authorization in conjunction with its proposal to construct, own, and operate the ST LNG Project.
Pangea states that the ST LNG Project has been proposed, in part, due to the markedly improved outlook for domestic natural gas reserves and production. Pangea states that improved drilling techniques and extraction technologies have contributed to the rapid growth in new supplies from unconventional gas-bearing formations across the U.S. and have been utilized to enhance production in some conventional fields. Pangea states that such developments have completely changed the complexion of the U.S. natural gas industry and radically expanded the resource base.
Pangea states that LNG exports via the ST LNG Project represents a market-driven path toward deploying the country's vast energy reserves in a manner that will meaningfully contribute to the public interest through a variety of benefits, including: (1) More jobs
Pangea submits that these benefits, and others discussed in this Application, demonstrate that Pangea's export proposal is not inconsistent with the public interest. Pangea states that this stance is now buttressed by the independent NERA Report, which key findings related to the macroeconomic impacts of LNG exports are overwhelmingly positive.
Further discussion of the public interest and analysis of the impact of LNG exports is included in the Application and Appendix A of the Application.
Pangea states that it will request NGA Section 3 authorization from FERC so that it may site, construct, and operate the ST LNG Project. Pangea states that it intends to commence the FERC's mandatory pre-filing process in Spring 2013 and then file its final application to obtain Section 3 authorization in the Fall 2013. Pangea states that its affiliate developing the ST Pipeline will file an application for NGA Section 7(c) authorization to construct, own, and operate the South Texas Pipeline.
Pangea states that the potential environmental impacts of the ST LNG Project will be reviewed by FERC under the National Environmental Policy Act (NEPA). Pangea further states that consistent with the NEPA scheme applicable to applications for authorizations under NGA Section 3 delineated by Congress in the Energy Policy Act of 2005,
The Application will be reviewed pursuant to section 3 of the NGA, as amended, and the authority contained in DOE Delegation Order No. 00–002.00L (April 29, 2011) and DOE Redelegation Order No. 00–002.04E (April 29, 2011). In reviewing this LNG export Application, DOE will consider any issues required by law or policy. To the extent determined to be relevant or appropriate, these issues will include the impact of LNG exports associated with this Application, and the cumulative impact of any other application(s) previously approved, on domestic need for the gas proposed for export, adequacy of domestic natural gas supply, U.S. energy security, and any other issues, including the impact on the U.S. economy (GDP), consumers, and industry, job creation, U.S. balance of trade, international considerations, and 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. Parties that may oppose this Application should comment in their responses on these issues, as well as any other issues deemed relevant to the Application.
NEPA requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.
Due to the complexity of the issues raised by the Applicants, interested persons will be provided 60 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. Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention, as applicable. The filing of comments or a protest with respect to the Application
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. A party seeking intervention may request that additional procedures be provided, such as additional written comments, an oral presentation, a conference, or trial-type hearing. Any request to file additional written comments should explain why they are necessary. Any request for an oral presentation should identify the substantial question of fact, law, or policy at issue, show that it is material and relevant to a decision in the proceeding, and demonstrate why an oral presentation is needed. Any request for a conference should demonstrate why the conference would materially advance the proceeding. Any request for a trial-type hearing must show that there are factual issues genuinely in dispute that are relevant and material to a decision and that a trial-type hearing is necessary for a full and true disclosure of the facts.
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 on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.
The Application filed by Pangea is available for inspection and copying in the Office of Natural Gas Regulatory Activities 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. Energy Information Administration (EIA), Department of Energy (DOE).
Agency Information Collection Activities: Information Collection Extension; Notice and Request for Comments.
The EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years with the Office of Management and Budget (OMB), Form FE–746R, “Natural Gas Imports and Exports.” 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 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 regarding this proposed information collection must be received on or before April 29, 2013. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Send comments to Lisa Tracy. To ensure receipt of the comments by the due date, submission by email (
Requests for additional information or copies of the information collection instrument and instructions should be directed to Lisa Tracy at the contact information given above. Forms and instructions are also available on the Internet at:
This information collection request contains:
(1)
(2)
(3)
(4)
The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), provides the general public and other Federal agencies with opportunities to comment on collections of energy information conducted by or in conjunction with the EIA. Also, the EIA will later seek approval by the Office of Management and Budget (OMB) under Section 3507(a) of the Paperwork Reduction Act of 1995.
DOE's Office of Fossil Energy (FE) is delegated the authority to regulate natural gas imports and exports under section 3 of the Natural Gas Act of 1938, 15 U.S.C. 717b. In order to carry out its delegated responsibility, FE requires those persons seeking to import or export natural gas to file an application providing basic information on the
(4a)
FE proposes to include two additional reporting sections for the collection and identification of new types of natural gas transactions related to:
(a) Exports of compressed natural gas by truck; and
(b) Exports of liquefied natural gas by vessel in ISO containers;
(5)
(6)
(7)
(8)
Section 13(b) of the Federal Energy Administration Act of 1974, Public Law 93–275, codified at 15 U.S.C. 772(b) and Section 3 of the Natural Gas Act of 1938, codified at 15 U.S.C. 717b.
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:
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:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric reliability 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
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Environmental Protection Agency (EPA).
Notice.
EPA has received a specific exemption request from the Wyoming Department of Agriculture to use the pesticide diflubenzuron (CAS No. 35367–38–5) to treat up to 26,000 acres of alfalfa to control grasshoppers and Mormon crickets. The applicant proposes a use which is supported by the Interregional (IR)-4 program and has been requested in 5 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. EPA is soliciting public comment before making the decision whether or not to grant the exemption.
Comments must be received on or before March 14, 2013.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2013–0092, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Andrea Conrath, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 308–9356; fax number: (703) 605–0781; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
Under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the EPA Administrator determines that emergency conditions exist which require the exemption. The Wyoming Department of Agriculture has requested the EPA Administrator to issue a specific exemption for the use of diflubenzuron on alfalfa to control grasshoppers and Mormon crickets. Information in accordance with 40 CFR part 166 was submitted as part of this request.
As part of this request, the applicant asserts that projected population levels for these damaging insect pests are higher than normal for the 2013 season. The applicant claims that registered alternatives will not provide adequate control to avert significant economic losses from occurring.
The Applicant proposes to make no more than two applications of diflubenzuron, at a rate of 0.032 lbs. active ingredient (a.i.) (equivalent to 2 fl. oz. of product containing 2 lbs. a.i. per gallon). Application could be made on up to 26,000 acres of alfalfa, from the date of approval, if granted, until October 31, 2013, in the state of Wyoming. If the maximum proposed acreage were treated at the maximum rate, a total of 814 lbs. active ingredient (407 gallons formulated product) could be applied.
This notice does not constitute a decision by EPA on the application itself. The regulations governing FIFRA section 18 require publication of a notice of receipt of an application for a specific exemption proposing use which is supported by the Inter-Regional Project Number 4 (IR–4) program and has been requested in 5 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. The notice provides an opportunity for public comment on the application.
The Agency will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the Wyoming Department of Agriculture.
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's receipt of an application 71049–EUP–L from KIM–C1, LLC, requesting an experimental use permit (EUP) for the plant growth regulator, forchlorfenuron. The Agency has determined that the permit may be of regional and national significance. Therefore, because of the potential significance, EPA is seeking comments on this application.
Comments must be received on or before March 29, 2013.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2013–0010, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Cynthia Giles-Parker, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7740; email address:
This action is directed to the public in general. Although this action may be of particular interest to those persons who conduct or sponsor research on pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action.
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
Under section 5 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136c, EPA can allow manufacturers to field test pesticides under development. Manufacturers are required to obtain an EUP before testing new pesticides or new uses of pesticides if they conduct experimental field tests on 10 acres or more of land or one acre or more of water.
Pursuant to 40 CFR 172.11(a), the Agency has determined that the following EUP application may be of regional and national significance, and therefore is seeking public comment on the EUP application.
A copy of the application and any information submitted is available for public review in the docket established for this EUP application.
Following the review of the application and any comments and data received in response to this solicitation, EPA will decide whether to issue or deny the EUP request, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the
Environmental protection, Experimental use permits.
Environmental Protection Agency (EPA).
Notice.
An Exposure Modeling Public Meeting (EMPM) will be held for one day on March 19, 2013. This notice announces the location and time for the meeting and sets forth the tentative agenda topics.
The meeting will be held on March 19, 2013 from 9:00 a.m. to 4:00 p.m. Requests to participate in the meeting must be received on or before March 11, 2013.
To request accommodation of a disability, please contact the person listed under
The meeting will be held at the Environmental Protection Agency, Office of Pesticide Programs (OPP), One Potomac Yard (North Building), Fourth Floor Conference Center (N–4830), 2777 S. Crystal Drive, Arlington, VA 22202.
Gabe Rothman, Environmental Fate and Effects Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8011; fax number: (703) 305–6309; email address:
You may be potentially affected by this action if you are required to conduct testing of chemical substances under the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Agriculture, Forestry, Fishing and Hunting NAICS code 11
• Utilities NAICS code 22
• Professional, Scientific and Technical NAICS code 54
The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2009–0879, is available at
On a biannual interval, an Exposure Modeling Public Meeting will be held for presentation and discussion of current issues related to modeling pesticide fate, transport, and exposure of risk assessment in a regulatory
You may submit a request to participate in this meeting to the person listed under
Environmental protection, pesticide exposure assessment, exposure modeling, pesticide monitoring, groundwater, PRZM–GW, SAM, PFAM, DWI PCA.
Environmental Protection Agency (EPA).
Notice of Settlement.
Under 122(h) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency has entered into a settlement with 2238 NW. 86th Street Inc. concerning the Florida Petroleum Reprocessors Site located in Davie, Broward County, Florida. The settlement addresses the PRP's Site-wide liability on an Ability-to-Pay basis.
The Agency will consider public comments on the settlement until March 29, 2013. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate.
Copies of the settlement are available from Ms. Paula V. Painter. Submit your comments by Site name Florida Petroleum Reprocesssors Site by one of the following methods:
•
•
• U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303.
Paula V. Painter at 404/562–8887.
Environmental Protection Agency (EPA).
Notice. Proposal To Approve Maine's National Pollutant Discharge Elimination System (NPDES) Permitting Program.
In 1999 the State of Maine applied to implement its NPDES program under the Clean Water Act in the state, including the territories of the Aroostook Band of Micmacs and the Houlton Band of Maliseet Indians. Today, EPA is proposing to act on the state's application as it applies in those Indian territories and is inviting comment.
Interested persons may submit comments on the approval of Maine's NPDES Permitting Program in these territories as part of the administrative record to EPA—Region 1, at the address given below, no later than midnight through April 29, 2013.
Submit comments by one of the following methods:
•
•
• No facsimiles (faxes) will be accepted.
Additional information concerning the proposed approval of Maine's program in these territories may be obtained between the hours of 9 a.m. and 5 p.m. Monday through Friday excluding holidays from: Glenda Vélez, USEPA-Region 1, 5 Post Office Square–OEP06–01, Boston, MA 02109–3912, Telephone: 617–918–1677,
On December 17, 1999, EPA determined that the State of Maine had submitted a complete application to administer the National Pollutant Discharge Elimination System (NPDES) permitting program in the state under the Clean Water Act (CWA). 33 U.S.C. 1251,
On January 12, 2001, EPA approved the State of Maine's application to administer the NPDES program for all areas of the state other than Indian country. At that point EPA did not take any action on Maine's application to administer the program within the territories of the federally-recognized Indian tribes in Maine. EPA published notice of its action on February 28, 2001. 56 FR 12791. As described in the
On October 31, 2003, EPA approved the State of Maine's application to administer the NPDES program in the
On March 26, 2012, EPA approved Maine's NPDES program to apply to tribally owned and operated discharges in the territories of the Penobscot Nation and Passamaquoddy Tribe (the “southern tribes”), pursuant to the decision of the Federal Court of Appeals for the First Circuit. 77 FR 23481 (April 19, 2012). The court had found that such discharges did not qualify as internal tribal matters and were, therefore, subject to the laws of the state.
In the process leading up to EPA's 2003 partial approval of the state's program in Indian country, EPA had invited comment on the state's jurisdiction under MICSA to implement its program in the territories of all the Indian tribes in Maine, including the northern tribes. Since EPA's initial decision to defer action on the state's application as it applies to the northern tribes, the Federal Court of Appeals for the First Circuit has issued several opinions which clarify the operation of MICSA's jurisdictional provisions as they apply to those tribes. Therefore, EPA is again inviting comment on Maine's application to administer its program in the northern tribes' territories so that interested parties can address those opinions and any other aspects of Maine's NPDES program relevant to authorizing the state's NPDES program in these tribes' territories. In this way, EPA can respond to comments that more accurately reflect the current state of the law and program implementation, rather than comments from 2000 and 2001.
In brief, there are three decisions from the First Circuit that EPA expects will guide the Agency's analysis of the jurisdictional issues in acting on Maine's application as it applies to the northern tribes. The first is
Second, in
Employment decisions by tribal governments qualify as an internal tribal matter with respect to the southern tribes and, therefore, are beyond the reach of state regulation under MICSA.
Accordingly, EPA proposes to approve the state to implement its NPDES program in the territories of the Houlton Band of Maliseet Indians and the Aroostook Band of Micmacs, provided Maine submits and EPA approves a program addressing the requirements of CWA section 316(b) as described below. EPA invites comment on both the determination of the state's jurisdiction to implement the program in these tribes' territories and the respective roles of the state, tribes, and EPA in the context of a state implementing the NPDES program in the territories of federally recognized tribes in Maine.
Note that in 2001 when EPA first approved the state's program, Maine did not have authority to regulate cooling water intake structures under CWA section 316(b). The state has since granted Maine DEP that authority, and EPA is working with DEP to develop the state regulations necessary for Maine to implement that program. Once Maine submits that program, EPA will publish a separate notice inviting comment on the adequacy of Maine's section 316(b) program before taking final action to approve the state's NPDES program, including the section 316(b) program, in these territories. The Agency is inviting comment now on the balance of the
This action is proposed to be taken under the authority of Section 402 of the Clean Water Act as amended, 42 U.S.C. 1342.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, 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 revision of an existing information collection, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). On December 18, 2012 (77 FR 74847), the FDIC requested comment for 60 days on a proposal to revise its Purchaser Eligibility Certification information collection, which is currently approved under OMB Control No. 3064–0135. No comments were received on the proposal. The FDIC hereby gives notice of its plan to submit to OMB a request to approve revision of the collection.
Comments must be submitted on or before March 29, 2013.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
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•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Leneta G. Gregorie, at the FDIC address above.
Proposal to revise the following currently approved collection of information:
Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, 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 information collection on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the
By Order of the Federal Maritime Commission.
The Commission gives notice that the following applicants have filed an application for an Ocean Transportation Intermediary (OTI) license as a Non-Vessel-Operating Common Carrier (NVO) and/or Ocean Freight Forwarder (OFF) pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101). Notice is also given of the filing of applications to amend an existing OTI license or the Qualifying Individual (QI) for a licensee.
Interested persons may contact the Office of Ocean Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573, by telephone at (202) 523–5843 or by email at
By the Commission.
The Commission gives notice that the following Ocean Transportation Intermediary licenses have been reissued pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101) effective on the date shown.
The Commission gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. 40101) effective on the date shown.
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 March 14, 2013.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261–4528:
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639–7570 or send an email to
Prevalence Survey of Healthcare-Associated Infections (HAIs) in Acute Care Hospitals in the United States—Extension—(0920–0852 exp.5/31/13)—National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC).
Preventing healthcare-associated infections (HAIs) is a CDC priority. An essential step in reducing the occurrence of HAIs is to estimate accurately the burden of these infections in U.S. hospitals, and to describe the types of HAIs and causative organisms. The scope and magnitude of HAIs in the United States were last directly estimated in the 1970s by CDC's Study on the Efficacy of Nosocomial Infection Control (SENIC), in which comprehensive data were collected from a sample of 338 hospitals; 5% of hospitalized patients acquired an infection not present at the time of admission. Because of the substantial resources necessary to conduct hospital-wide surveillance in an ongoing manner, most of the more than 4,500 hospitals now reporting to the CDC's current HAI surveillance system, the National Healthcare Safety Network (NHSN 0920–0666 expires 1/31/15), focus instead on device-associated and procedure-associated infections in a selected patient locations, and do not report data on all types of HAIs occurring hospital-wide. Periodic assessments of the magnitude and types of HAIs occurring in all patient populations within acute care hospitals are needed to inform decisions by local and national policy makers and by hospital infection control personnel regarding appropriate targets and strategies for HAI prevention. Such assessments can be obtained in periodic national prevalence surveys, such as those that have been conducted in several European countries.
In 2008–2009, CDC developed a pilot protocol for a HAI point prevalence survey, conducted over a 1-day period at each of 9 acute care hospitals in one U.S. city. This pilot phase was followed in 2010 by a phase 2, limited roll-out HAI and antimicrobial use prevalence survey, conducted during July and August in 22 hospitals across 10 Emerging Infections Program sites (in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee). Experience gained in the phase 1 and phase 2 surveys was used to conduct a full-scale, phase 3 survey in 2011, involving 183 hospitals in the 10 EIP sites. Over 11,000 patients were surveyed, and analysis of HAI and antimicrobial use data is ongoing at this time. Preliminary HAI prevalence results were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (San Francisco, CA, September 8–12, 2012) and preliminary antimicrobial use results were presented at the 2012 IDWeek conference (San Diego, CA, October 17–21, 2012).
An extension of the prevalence survey's existing OMB approval is sought, to allow a repeat HAI and antimicrobial use prevalence survey to be performed in 2014. A repeat survey will allow further refinement of survey methodology and assessment of changes over time in prevalence, HAI distribution, and pathogen distribution. It will also allow for a re-assessment of the burden of antimicrobial use, at a time when antimicrobial stewardship is an area of active engagement in many acute care hospitals. The 2014 survey will be performed in a sample of up to 500 acute care hospitals, drawn from the acute care hospital populations in each of the 10 EIP sites (and including participation from many hospitals that participated in prior phases of the survey). Infection prevention personnel in participating hospitals and EIP site personnel will collect demographic and clinical data from the medical records of a sample of eligible patients in their hospitals on a single day in 2014, to identify CDC-defined HAIs. The surveys will provide data for CDC to make estimates of the prevalence of HAIs across this sample of U.S. hospitals as well as the distribution of infection types and causative organisms. These data can be used to work toward reducing and eliminating healthcare-associated infections—a DHHS Healthy People 2020 objective (
The total burden is 9,375 hours, which represents an increase of 250 hours over the previously approved burden. The increase is requested because the median number of responses per respondent in the 2011 phase 3 survey was 75. Previously, we had estimated 73 responses per respondent. There are no costs to respondents. The total estimated annualized burden is 9,375.
*Assumptions: One respondent per hospital, collection of data on median of 75 patients per hospital, average data collection time of 15 minutes per patient.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to
Requirements for the Importation of Nonhuman Primates into the United States (formerly Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States) (OMB Control No. 0920–0263 Exp.6/30/2014)—Revision—National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Since May 1990, CDC has monitored the arrival and/or uncrating of certain shipments of non-human primates imported into the United States under a special permit program specific to Cynomolgus, African Green, or Rhesus Monkeys. CDC has monitored compliance with this special permit through the collection of information focused on determining whether or not importers conduct adequate disease control practices. Importers were required to renew their special permit every 180 days.
In February 2013, CDC promulgated two regulations pertaining to the importation of nonhuman primates. The first rule rule, Requirements for Importers of Nonhuman Primates (2/15/2013, Vol. 78, No. 32/p. 11522) consolidates into 42 CFR 71.53 the requirements previously found in 42 CFR part 71.53 with those found in the Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States. It also extended the time period for registration/permit renewal from 180 days to 2 years. The Special Permit has been withdrawn. The requirements found therein are now incorporated into the revised final rule for 42 CFR 71.53. The second rule, Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples (2/12/2013, Vol.78, No. 29, p.9828), outlines a process by which importers can send liver tissues to CDC from primates that die during importation from reasons other than trauma. CDC performs these tests due to the absence of a private sector option. CDC feels these regulatory changes balance the public health risks posed by the importation of nonhuman primates with the burden imposed on regulating their importation.
These rule changes have prompted CDC to modify how it administers the information collected from the public in the enforcement of nonhuman primate regulations. CDC is requesting the following changes:
1. CDC requests that this information collection request be re-named “Requirements for the Importation of Nonhuman Primates into the United States” to more accurately reflect the type of information that is requested from respondents.
2. To streamline administration of this information collection request, CDC requests that CDC form 75.10A Application for Registration as an Importer of Nonhuman Primates and the Recordkeeping requirement currently approved under OMB Control Number 0920–0134 Foreign Quarantine Regulations, be moved and included in this revision to OMB Control Number 0920–0263. This action places all nonhuman primate information collection requirements and requests into one information collection request administered by CDC.
3. CDC is renaming the different portions of the information collected in this information collection to more accurately list the types of forms and documentation CDC collects from importers of nonhuman primates. Therefore, the former information categories of Businesses (limited permit), Businesses (extended permit), and Organizations (extended permit) are being renamed and reorganized. The information contained in these categories will now be accounted for in the Documentation sections of the burden table. This categorization will more accurately reflect CDC's interaction with the importers.
4. CDC also requests additional burden hours to account for notification to CDC from importers of shipment arrivals and requests for release from quarantine.
5. CDC further requests the addition of the Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials, which will be used to collect all of the necessary information from nonhuman primate importers to test nonhuman primate liver samples for filovirus and communicate the results of this test. This action adds approximately 50 hours of burden to this information collection request.
This information collection involves minimal personally identifiable information and should have limited impact on an individual's privacy. There are no costs to respondents other than their time.
The total burden requested for this information collection is 146.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting date and time, location, and format change.
This notice announces changes to the meeting date and time, location, and format of the first semi-annual public meeting of 2013 that was announced and published in the
Monday, March 11, 2013, from 1 p.m. to 5 p.m. Eastern Daylight Time (EDT).
Chuck Braver, (410) 786–3985.
On November 26, 2012, we published a notice in the
The November 26, 2012, notice announced an in-person meeting to be held over two days, March 11 through 12, 2013. Since the publication of that notice, the date and time, location, and format of the Panel meeting has changed. Therefore, we are publishing this notice to provide the public with the necessary information related to this upcoming public Panel meeting.
First, the November 26, 2012, notice included the published date of the Panel meeting as Monday, March 11, 2013, from 1 p.m. to 5 p.m. EDT and Tuesday, March 12, 2013, from 9 a.m. to 5 p.m. EDT. The Panel meeting date and time has been changed and will only take place on March 11, 2013, from 1 p.m. to 5 p.m. EDT.
Second, the November 26, 2012 notice included, the published meeting location as the CMS Central Office Auditorium, 7500 Security Boulevard, Woodlawn, Maryland 21244–1850. The Panel meeting format has been changed to Teleconference, Webcast, and Webinar. Therefore, there will no longer be an in-person meeting location for this public Panel meeting. Participants should view the CMS Web site at:
Participants who have registered to attend the in-person meeting based on the November 26, 2012 notice do not have to re-register. The teleconference dial-in instructions, and related webcast and webinar details will be posted on the CMS Web site approximately 1 week prior to the meeting at:
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays.
On April 26, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, Conference Management Staff, at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the
Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301–796–4627, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area). Please call the Information Line for up-to-date information on this meeting.
In the
1. On page 6332, in the third column, the
2. On page 6333, in the first column, the
3. On page 6333, in the second column, in the
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.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Minh Doan at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the
There are no capital, operating, or maintenance costs to report.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments contact: Dr. Sonia Arteaga, NIH, NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892–7936, or call non-toll free number (301) 435–0377 or Email your request, including your address to:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
The game will be incorporated with a larger initiative to provide information about clinical research (
National Institutes of Health, Public Health Service, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301–496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
National Institutes of Health, Public Health Service, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301–496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
CD22 is a cell surface protein that is expressed on a large number of B-cell lineage hematological cancers, such as leukemia and lymphoma. Several promising therapies are being developed which target CD22, including therapeutic antibodies and immunotoxins. This technology concerns the use of a high affinity antibody binding fragment to CD22 (known as m971), as the targeting moiety of a CAR. The resulting CAR can be used in adoptive cell therapy treatment for cancer.
1. Song L, et al. The Chlamydia trachomatis plasmid-encoded Pgp4 is a transcriptional regulator of virulence associated genes. Infect Immun. 2013 Jan 14 (Epub ahead of print). [PMID 23319558]
2. Kari L, et al. A live-attenuated chlamydial vaccine protects against trachoma in nonhuman primates. J Exp Med. 2011 Oct 24;208(11):2217–23. [PMID 21987657]
Collaborative Research Opportunity: The NIAID Laboratory of Intracellular Parasites is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize chlamydia vaccine. For collaboration opportunities, please contact Harlan D. Caldwell, Ph.D. at
There is growing awareness that a wide variety of synthetic and natural compounds that may lead to adverse health effects are present in water sources, such as streams, wells, and ground water; however, these compounds are often difficult to measure and thus are not commonly monitored. Even low concentrations of these compounds are of concern, as they may have biological effects at concentrations of parts per billion (PPB) or less. The presence of EDCs in the environment, in particular, is under examination for potential adverse effects on human health and on wildlife, such as cancer, immune suppression, impaired fertility, and increased incidence of diabetes and obesity.
Inventors at NCI have discovered a novel assay methodology for detecting endocrine EDCs in contaminated water. The assay utilizes fluorescently-labeled nuclear receptors in a high-throughput, cell-based format, and has the capability to detect very low concentrations of EDCs in water or other liquid samples. The inventors have already demonstrated proof of concept for this technology by using this assay to test for the presence of glucocorticoid and androgen receptor disruptors in water samples from 14 U.S. states, and also plan future studies for other types of EDCs. A product or service based on this technology could fulfill an unmet need for a high-throughput, rapid method for screening water samples for contaminants with potential endocrine-disrupting effects.
Researchers at the NIH have developed a vaccine technology that stimulates the immune system to selectively destroy metastasizing cells. Brachyury, a master transcription factor that governs the epithelial-mesenchymal transition, was shown to be significantly overexpressed in primary and metastasizing tumors relative to normal human tissues. Stimulation of T cells with the Brachyury peptide promoted a robust immune response and the targeted lysis of invasive tumor cells. Brachyury overexpression has been demonstrated in a range of human tumors (breast, lung, colon and prostate, among others) suggesting that a therapeutic vaccine derived from this technology would be broadly applicable for the treatment of cancer.
Development Stage:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the Board of Scientific Counselors, Lister Hill Center for Biomedical Communications.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301–594–3163,
Michael M. Sveda, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD 20892, 301–435–3565,
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the Board of Scientific Counselors, National Center for Biotechnology Information.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the National Library of Medicine, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Ghenima Dirami, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7814, Bethesda, MD 20892, 240–498–7546,
Richard Ingraham, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 20892, 301–496–8551,
National Institutes of Health, Public Health Service, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive patent license to practice the inventions embodied in:
HHS Ref. No. E–093–1997/0 “Food Quality Indicator;”
Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before March 29, 2013 will be considered.
Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., CLP, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435–5019; Facsimile: (301) 402–0220; Email:
The patent applications (including any patents issuing therefrom or claiming priority thereto) intended for licensure describe and claim indicator strips for monitoring food quality and freshness in real time. The major factor for food spoilage is the release of volatile gases due to the action of enzymes contained within the food or produced by microorganisms growing in the food. The rate of release of such gases depends on food's storage history. In this technology, a reactive dye locked in a water-repellent material reacts with the gases released during food decomposition, and changes color. Thus a rapid and informed decision can be made about quality of food and its shelf life under the storage conditions used. Since the detection is based on biological processes that are the root cause for food spoilage, these indicators are much more reliable. This technology provides an alternative to the current methods for assessing food quality that cannot accurately estimate shelf life of food products due to unreliable storage history. These indicators have been successfully tested on seafood and meats and can be easily adapted to dairy products.
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
National Protection and Programs Directorate, DHS.
60-day notice and request for comments; New Information Collection Request: 1670–NEW.
The Department of Homeland Security (DHS), National Protection and Programs Directorate, (NPPD), Protective Security Coordination Division (PSCD), Office for Bombing Prevention (OBP) 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 (Pub. L. 104–13, 44 U.S.C. Chapter 35).
Comments are encouraged and will be accepted until April 29, 2013. This process is conducted in accordance with 5 CFR 1320.1.
Written comments and questions about this Information Collection Request should be forwarded to Department of Homeland Security (Attn: NPPD/PSCD/OBP) 245 Murray Lane SW., Mail Stop 0612, Arlington, VA 20598–0612. Emailed requests should go to
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OMB is particularly interested in comments that:
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, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; or
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
The Technical Resource for Incident Prevention (TRIPwire) is OBP's online, collaborative, information-sharing network for bomb squad, law enforcement, and other emergency services personnel to learn about current terrorist improvised explosive device (IED) tactics, techniques, and procedures, including design and emplacement considerations. TRIPwire was established as an IED information-sharing resource under Homeland Security Presidential Directive 19 (HSPD–19), which calls for a unified national policy for the prevention and detection of, protection against, and response to terrorist use of explosives in the United States. Users from Federal, state, local, and tribal government entities, as well as business and for-profit industries can register through the TRIPwire Secure Portal. The TRIPwire portal contains sensitive information related to terrorist use of explosives and therefore user information is needed to verify eligibility and access to the system. TRIPwire applicants must provide their full name, assignment, citizenship, job title, employer name, professional address and contact information, as well as an Employment Verification Contact and their contact information. The system does not store sensitive personally identifiable information (PII) such as social security numbers. The collection of PII by TRIPwire to establish user accounts occurs in accordance with the DHS Privacy Impact Assessment PIA–015, “DHS Web Portals,” DHS/ALL–004—General Information Technology Access Account Records System (GITAARS) September 29, 2009, 74 FR 49882, and DHS/ALL–002—Department of Homeland Security Mailing and Other Lists System November 25, 2008, 73 FR 71659. The TRIPwire User Registration is a voluntary registration designed to measure users' suitability to access the secure environment.
The information collected during the TRIPwire user registration process is reviewed electronically by the project team to vet the user's “need to know,” which determines their eligibility for and access to TRIPwire. Memberships are re-verified annually based on the information users provide upon registration or communication with the TRIPwire help desk analysts. The information collected is for internal TRIPwire and OBP use only.
Transportation Security Administration, DHS.
30-day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652–0027, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a
Send your comments by March 29, 2013. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Susan Perkins, TSA PRA Officer, Office of Information Technology (OIT), TSA–11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598–6011; telephone (571) 227–3398; email
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement 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;
(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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
TSA proposes to amend the application to collect minor additional information, such as legal status document information and whether the driver is a new applicant or renewing or transferring the HME. This will enable TSA to better understand and forecast driver retention, transfer rate, and drop-rate, thus improving customer service, reducing program costs, and enhancing comparability with other Federal background checks, including the Transportation Workers Identification Credential (TWIC).
30-day notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. 3501
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 29, 2013. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and suggestions regarding items contained in this notice, and especially with regard to the estimated public burden and associated response time should be directed to the OMB USCIS Desk Officer via email at
Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
The address listed in this notice should only be used to submit comments concerning this information collection. Please do not submit requests for individual case status inquiries to this address. If you are seeking information about the status of your individual case, please check “My Case Status” online at:
DHS, USCIS invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act of 1995, the information collection notice is published in the
For Forms I–765 and I–765WS, USCIS is especially interested in the public's experience, input, and estimate of the burden in terms of time and money incurred by applicants for the following aspects of this information collection:
• The time burden incurred by preparers (persons who assist the respondent with the preparation of the form) who are not paid by the respondent.
• For preparers who are paid, the time and expense to the respondent to find and secure such preparers for assistance.
• The amount that paid preparers charge for their services.
• The time required to obtain supporting documents for Forms I–765 and I–765WS.
• The monetary costs incurred to secure supporting documents from sources such as a landlord, church, utility, public agency (housing, social services, law enforcement, local/state governments), school, medical care provider, advocacy group, law firm, or military service.
• The average time required and cost incurred to secure secondary evidence such as an affidavit or a statement.
• The percentage of total applicants who require English translations of their supporting documents.
• The percentage of supporting documents for each individual applicant that require translation into English.
• The time required to find, hire or otherwise obtain translations of supporting documents for immigration benefit requests.
• The average out of pocket monetary cost if any to obtain translations of supporting documents when required.
USCIS requested input on these questions in its 60-day notice and received no comments. If no comments are received from knowledgeable individuals, USCIS will perform its own analysis using information from other sources to estimate these costs for its next submission to OMB for this information collection.
In addition, to be helpful in the improvement of this form and the program associated with this information collection, written comments and suggestions are requested to provide USCIS with clear and specific suggestions on the data elements captured through these forms and the evidence required to be submitted with a focus on one or more of the following four points:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) How to enhance the quality, utility, and clarity of the information to be collected; and
(4) How to reduce or minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(1)
(2)
(3)
(4)
(5)
(6)
If you need a copy of the information collection instrument with instructions, or additional information, please visit the Federal eRulemaking Portal site at:
30-day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting 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. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 29, 2013. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to DHS, and to the OMB USCIS Desk Officer. Comments may be submitted to: DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529–2140. Comments may also be submitted to DHS via email at
All submissions received must include the agency name, OMB Control Number and Docket ID. Regardless of the method used for submitting comments or material, all submissions
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(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 agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(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, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(1)
(2)
(3)
(4)
(5)
• 65,000 respondents averaging 2.26 hours (2 hours 16 minutes) per response (enrollment time includes review and signing of the MOU, registration, new user training, and review of the user guides); plus
• 425,000, the number of already-enrolled respondents receiving training on new features and system updates averaging 1 hour per response; plus
• 425,000, the number of respondents submitting E-Verify cases averaging .129 hours (approximately 8 minutes) per case.
(6)
If you need a copy of the information collection instrument with supplementary documents, or need additional information, please visit
30-day notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L.104–13, 44 U.S.C. 3501
USCIS will be submitting the following information collection request to OMB for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 29, 2013. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to DHS, and to the OMB USCIS Desk Officer. Comments may be submitted to: DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529–2140. Comments may also be submitted to DHS via email at
All submissions received must include the agency name, OMB Control Number and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
The address listed in this notice should only be used to submit comments concerning this information collection. Please do not submit requests for individual case status inquiries to this address. If you are seeking information about the status of your individual case, please check “My Case Status” online at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(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 agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(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, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(1)
(2)
(3)
(4)
1. Were under the age of 31 as of June 15, 2012;
2. Came to the United States before reaching their 16th birthday;
3. Have continuously resided in the United States since June 15, 2007, up to the present time;
4. Were present in the United States on June 15, 2012, and at the time of making their request for consideration of deferred action with USCIS;
5. Entered without inspection before June 15, 2012, or their lawful immigration status expired as of June 15, 2012;
6. Are currently in school, have graduated or obtained a certificate of completion from high school, have obtained a general education development certificate, or are an honorably discharged veteran of the Coast Guard or Armed Forces of the United States; and
7. Have not been convicted of a felony, significant misdemeanor, three or more other misdemeanors, and do not otherwise pose a threat to national security or public safety.
These individuals will be considered for relief from removal from the United States or from being placed into removal proceedings as part of the deferred action for childhood arrivals process. Those who submit requests with USCIS and demonstrate that they meet the threshold guidelines may have removal action in their case deferred for a period of two years, subject to renewal (if not terminated), based on an individualized, case by case assessment of the individual's equities. Only those individuals who can demonstrate, through verifiable documentation, that they meet the threshold guidelines will be considered for deferred action for childhood arrivals, except in exceptional circumstances.
(5)
(6)
On August 15, 2012, in a 30-day notice in the
• The time burden incurred by preparers (persons who assist the respondent with the preparation of the form) who are not paid.• For preparers who are paid, the time and expense to the respondent to find and secure such preparers for assistance.
• The amount that paid preparers charge for their services.
• The time required to obtain supporting documents for Form I–821D.
• The monetary costs incurred to obtain supporting documents from sources such as a landlord, church, utility, public agency (housing, social services, law enforcement), school, medical care provider, advocacy group, law firm, or military service.
• The average time required and money expended to secure secondary evidence such as an affidavit.
• The percentage of total applicants who require English translations of their supporting documents.
• The percentage of supporting documents for each individual applicant that require translation into English.
• The time required to find, hire, or otherwise obtain translations of supporting documents for immigration benefit requests.
• The average out of pocket monetary cost if any to obtain translations of supporting documents when required.
No commenter provided input on these questions. Thus DHS and USCIS is again requesting estimates and/or data that would support our analysis of this burden during the 30-day comment period provided under this notice.
If you need a copy of the information collection instrument with supplementary documents, or need additional information, please visit
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of August 1, 2012.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202–344–1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, Camin Cargo Control, Inc., 218 Centaurus St., Corpus Christi, TX 78405, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344–1060. The inquiry may also be sent to
Office of the Assistant Secretary for Housing, 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: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., L'Enfant Plaza Building, Room 9120, Washington, DC 20410 or the number for the Federal Relay Service (1–800–877–8339).
Catherine M. Brennan, Director, Office of Housing Assistance and Grant Administration, Office of Housing, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410, telephone (202) 708–3000 (this is not a toll free number) for copies of the proposed forms and other available information.
The Department is submitting 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).
This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection 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 the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
This Notice also lists the following information:
The Paperwork Reduction Act of 1995, 44 U.S.C., Chapter 35, as amended.
Office of the Secretary, Interior.
Notice of meeting.
In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., 2, the U.S. Department of the Interior, Office of the Secretary, Wildland Fire
The next meeting will be held on March 19–20, 2013.
The meetings will be held from 8:30 a.m. to 2:30 p.m. on March 19 and from 10:00 a.m. to 11:00 a.m. on March 20 at the Peppermill Resort, 2707 South Virginia Street, Reno, NV 89502.
Shari Eckhoff, Designated Federal Officer, 300 E Mallard Drive, Suite 170, Boise, Idaho 83706; telephone (208) 334–1552; fax (208) 334–1549; or email
The WFEC is established as a discretionary advisory committee under the authorities of the Secretary of the Interior and Secretary of Agriculture, in furtherance of 43 U.S.C. 1457 and provisions of the Fish and Wildlife Act of 1956 (16 U.S.C. 742a–742j), the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701
The purpose of the WFEC is to provide advice on coordinated national-level wildland fire policy and to provide leadership, direction, and program oversight in support of the Wildland Fire Leadership Council. Questions related to the WFEC should be directed to Shari Eckhoff (Designated Federal Officer) at
Questions about the agenda or written comments may be emailed or submitted by U.S. Mail to: Department of the Interior, Office of the Secretary, Office of Wildland Fire, Attention: Shari Eckhoff, 300 E. Mallard Drive, Suite 170, Boise, Idaho 83706–6648. WFEC requests that written comments be received by the Friday preceding the scheduled meeting. Attendance is open to the public, but limited space is available. Persons with a disability requiring special services, such as an interpreter for the hearing impaired, should contact Ms. Eckhoff at (202) 527–0133 at least seven calendar days prior to the meeting.
Bureau of Land Management, Interior.
Notice of availability.
This notice announces the availability of the Bureau of Land Management's (BLM) first Rapid Ecoregional Assessment (REA) covering land in four western states. The Colorado Plateau REA includes parts of Arizona, Colorado, New Mexico and Utah. It has an area of 32,387 square miles and includes all or portions of 16 BLM field offices.
The REA, and its associated data, are available through the BLM Web site at:
Karen Prentice, Natural Resource Specialist, 202–912–7223,
This notice announces the availability of the first REA issued by the BLM covering land in four western states. Although the BLM is publishing this Notice for the first REA, subsequent REAs will be made available on the Web site listed in the
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Sierra Front-Northwestern Great Basin Resource Advisory Council (RAC), will hold two meetings in Nevada in fiscal year 2013. The meetings are open to the public.
April 4–5 at the BLM Carson City District Office, 5665 Morgan Mill Road in Carson City, Nevada and a field trip on April 5; August 8–9 at the BLM Winnemucca District Office, 5100 East Winnemucca Blvd. and a field trip on August 9. Approximate meeting times are 8 a.m. to 4 p.m. However, meetings could end earlier if discussions and presentations conclude before 4 p.m. All meetings will include a public comment period at approximately 2 p.m.
Lisa Ross, Public Affairs Specialist, Carson City District Office, 5665 Morgan Mill Road, Carson City, NV 89701, telephone: (775) 885–6107, email:
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 Nevada. Topics for discussion at each meeting will include, but are not limited to:
• April 4–5 (Carson City)—rangeland health assessments, Carson City Resource Management Plan, greater sage-grouse/Bi State conservation, recreation, and fire restoration (field trip on April 5).
• August 8–9 (Winnemucca)—landscape vegetative management and ongoing monitoring, recreation/wilderness management and Emergency Stabilization and Restoration (field trip on August 9).
Managers' reports of field office activities will be given at each meeting. The Council may raise other topics at the meetings.
Final agendas will be posted on-line at the BLM Sierra Front-Northwestern Great Basin RAC Web site at
Individuals who need special assistance such as sign language interpretation or other reasonable accommodations, or who wish to receive a copy of each agenda, may contact Lisa Ross no later than 10 days prior to each meeting.
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Mojave-Southern Great Basin Resource Advisory Council (RAC), will hold three meetings in Nevada in fiscal year 2013. The meetings are open to the public.
March 21–22 in Las Vegas, Nevada, location to be determined; July 11 in Las Vegas, Nevada, location to be determined; and Sept. 12 via video teleconference. Meeting times will be published in local and regional media sources at least 14 days before each meeting. All meetings will include a public comment period.
Chris Hanefeld, Public Affairs Specialist, Ely District Office, 702 North Industrial Way, HC 33 Box 33500, Ely, NV 89301, telephone: (775) 289–1842, email:
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 Nevada. Topics for discussion at each meeting will include, but are not limited to:
• March 21–22 (Las Vegas)—Southern Nevada Public Land Management Act (SNPLMA), Battle Mountain District and Southern Nevada District resource management plans, and permitted recreation (date of field trip to be determined).
• July 11 (Las Vegas)—Energy and transmission, Battle Mountain District and Southern Nevada District resource management plans, and permitted recreation.
• September 12 (video teleconference)—Energy and transmission, and desert tortoise.
Managers' reports of field office activities will be given at each meeting. The Council may raise other topics at the meetings.
Final agendas will be posted on-line at the BLM Mojave-Southern Great Basin RAC Web site at
Individuals who need special assistance such as sign language interpretation or other reasonable accommodations, or who wish to receive a copy of each agenda, may contact Chris Hanefeld no later than 10 days prior to each meeting.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) 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 March 31, 2013. 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 number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.
You must submit comments on or before March 29, 2013.
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 Deborah Harvey, Acting Chief, Commercial Services Program, 1201 I Street, NW., Washington, DC 20005. You may send an email to
The public solicitation process begins with the issuance of a prospectus to invite the general public to submit proposals for the contract. The prospectus describes the terms and conditions of the concession contract to be awarded, the procedures to be followed in the selection of the best proposal, and the information that must be provided. Information that we collect includes, but is not limited to:
• Description of how respondent will conduct operations to minimize disturbance to wildlife.
• Specific actions, steps, or programs that respondent will implement to protect park resources.
• Steps that respondent will take to provide visitors with a consistent, high quality, safe, and enjoyable visitor experience at a reasonable rate.
• Organizational structure and history.
• Experience with similar operations.
• Details on violations or infractions and how they were handled.
• Financial information and demonstration that respondent has credible, proven track record of meeting obligations.
• Ability to obtain funds for start-up costs.
• How respondent will communicate an environmental ethic to employees and visitors.
We use this information to objectively evaluate offers received for a particular business opportunity, assure that the park resources will be adequately protected, and determine which respondent will provide the best service to visitors.
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 in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
National Park Service, Interior.
Notice of Intent.
Pursuant to Section 102(2)(C) the National Environmental Policy Act of 1969 and the Council on Environmental Quality regulations, the National Park Service (NPS) is preparing a Chronic Wasting Disease Management Plan and Environmental Impact Statement (CWD Management Plan/EIS) for Shenandoah National Park, Virginia. Action is needed at this time prevent the establishment of CWD in the white-tailed deer population of Shenandoah National Park and, should the disease become established, to slow the spread of the disease. To ensure that all significant issues are identified and considered, all interested parties are invited to comment on the proposed scope of the project, the purpose, need, and objectives of the plan, and draft alternatives.
The National Park Service will accept comments from the public for a period of 60 days after the date of publication in the
The preferred method of comment is to submit comments electronically through the NPS PEPC Web site (
Erin Flanagan, National Park Service, Denver Service Center, at (303) 969–2327.
A long-range CWD Management Plan is needed at this time because: CWD is established and spreading within the region and represents a threat to white-tailed deer, which are an important park resource; the risk of CWD introduction and amplification is high because of high deer population density in certain areas of the park and deer movement in and out of the park; there is no known treatment to eliminate CWD once it is established in the population; a variety of management options must be considered to limit the prevalence and minimize spread; and CWD is a nonnative disease process, therefore, NPS policy states that CWD should be managed or eliminated, if prudent and feasible.
To date, Shenandoah National Park has prepared a CWD Detection and Assessment Plan and Environmental Assessment which, when completed and approved, will guide future actions for detecting and responding to initial CWD cases within the park. The next step is to comprehensively evaluate alternative approaches for long-term management of CWD, which is the purpose of the proposed CWD Management Plan/EIS.
The objectives of the long-range CWD management plan are to: Prevent CWD establishment and, should CWD become established, slow the spread of CWD within the park; monitor disease progression and impacts on park resources; provide a framework to assess or evaluate the success of the management actions and for the NPS to cooperate with other state and federal agencies on the management of CWD; develop public support for CWD management through education; minimize disruption to visitor use and experience from management actions; and minimize the potential for health and safety issues for park staff and visitors during CWD management activities.
The NPS has begun development of two action alternatives that will be made available for public comment as part of the scoping process. The first action alternative proposes a phased approach to CWD management and would be implemented when CWD is identified within a specified distance from the park. In slight contrast, the second alternative would initiate management actions immediately, rather than in response to proximity of CWD detection to the boundaries of the park. The NPS will also evaluate a no action alternative, under which current management approaches would continue, including implementation of the approved CWD detection and assessment plan.
To ensure that all significant issues are identified and considered, all interested parties are invited to comment on the proposed scope of the project; the purpose, need and objectives of the plan; and draft alternatives. These materials will be available for review and comment on the NPS PEPC Web site (
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.
National Park Service, Interior.
Notice of availability.
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of a Draft Environmental Impact Statement (EIS) for the Cottonwood Cove and Katherine Landing Development Concept Plans, Lake Mead National Recreation Area. The Draft EIS identifies and analyzes three alternatives, as follows. Alternative 1
The National Park Service will accept comments on the Draft EIS from the public for 60 days after the date the Environmental Protection Agency publishes its notice in the
Respondents may submit comments by one of two methods. You may mail written comments to Lake Mead National Recreation Area, Attn: DCP–DEIS, 601 Nevada Highway, Boulder City, NV 89005. You may also submit comments electronically via the Internet at
Mr. Jim Holland, Park Planner, Lake Mead National Recreation Area, 601 Nevada Highway, Boulder City, NV 89005 (702) 293–8986.
The purpose of the development concept plans is to reevaluate the implementation strategies for these two areas that were identified in the 1986
The general management plan addressed the need to provide recreational opportunities while preserving and protecting natural and cultural resources. It established land-based management zones and included development concept plans for Cottonwood Cove and Katherine Landing that identified limits on the development, established the number and type of facilities, and addressed flood hazards. The general management plan's vision for both areas was to accommodate increasing use, enhance the visitor experience, and mitigate flood hazards. The lake management plan established water-based management zones and provided further guidance for the long-term protection of park resources while allowing a range of recreational opportunities to support visitor needs. A number of the management actions identified in both approved plans require more site-specific development planning. There are also a number of management issues that have not been adequately addressed or resolved in the previous planning efforts and that require a more detailed examination of development and operational needs.
The primary issues affecting the management of the Cottonwood Cove and Katherine Landing developed areas are as follows:
National Park Service, Interior.
Notice of meeting.
Notice is hereby given in accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix (1988), that a teleconference meeting of the Landmarks Committee of the National Park System Advisory Board will be held beginning at 1:00 p.m. on April 9, 2013, at the following location. Members of the public may attend the meeting in person in Washington, DC, or may participate via teleconference.
The meeting will be held on April 9, 2013, from 1:00 p.m. to 3:30 p.m., Eastern Daylight Time.
The committee may also consider the following historic trail:
Patricia Henry, National Historic Landmarks Program, National Park Service; 1201 Eye Street NW., 8th Floor; Washington, DC 20005; Telephone (202) 354–2216; Email:
The purpose of the meeting of the Landmarks Committee of the National Park System Advisory Board is to evaluate nominations of historic properties in order to advise the National Park System Advisory Board of the qualifications of each property being proposed for National Historic Landmark (NHL) designation, and to make recommendations regarding the possible designation of those properties as National Historic Landmarks to the National Park System Advisory Board at a subsequent meeting at a place and time to be determined. The members of the committee, with exception of the Chair, will be participating remotely at this meeting. The members of the Landmarks Committee are:
The meeting will be open to the public at the location provided above or via teleconference. Due to the limited scope of this meeting, the NPS has determined that a teleconference will be the most efficient way to convene the Committee members. The Committee meeting will be open to the public in the same way that other Committee meetings have been open to the public in the past. Space and facilities to accommodate the public are limited and attendees will be accommodated on a first-come basis. Opportunities for oral comment will be limited to no more than 3 minutes per speaker and no more than 15 minutes total per property. The Committee Chairman will determine how time for oral comments will be allotted. To participate via teleconference interested parties must provide their name and email address to the Program by Friday, April 5; submit the requested contact information to Ms. Patty Henry at (202) 354–2216, or via email at
Pursuant to 36 CFR Part 65, any member of the public may file, for consideration by the Landmarks Committee of the National Park System Advisory Board, written comments concerning the National Historic Landmarks nominations. Comments should be submitted to J. Paul Loether, Chief, National Register of Historic Places and National Historic Landmarks Program, National Park Service; 1201 Eye Street NW., 8th Floor; Washington, DC 20005; Email:
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.
Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before January 19, 2013. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation. Comments may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202–371–6447. Written or faxed comments should be submitted by March 14, 2013. 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.
In the interest of preservation a request to shorten the comment period to three days has been made for the following resource:
National Park Service, Interior.
Notice of availability.
Pursuant to the provisions of Section 2 of the Act of September 28, 1976, 16 U.S.C. 1902, and in accordance with the provisions of 36 C.F.R. 9.17, notice is hereby given that Thomas and Kathryn Lamal have filed a proposed plan of operations to conduct a mining operation on lands embracing the Shamrock (AA026813) and Tony M (AA026810) unpatented placer claims within Wrangell-St. Elias National Park and Preserve.
Rick Obernesser, Superintendent, and Danny Rosenkrans, Senior Management Analyst, Wrangell-St. Elias National Park and Preserve, P.O. Box 439, Copper Center, Alaska 99573; telephone (907) 822–5234.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping investigation Nos. 731–TA–1202–03 (Final) under section 735(b) of the Tariff Act of 1930 (19 U.S.C. 1673d(b)) (the Act) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of less-than-fair-value imports from Austria and/or China of xanthan gum, provided for in subheading 3913.90.20 of the Harmonized Tariff Schedule of the United States.
Xanthan gum that has been blended with other product(s) is included in this scope when the resulting mix contains 15 percent or more of xanthan gum by dry weight. Other products with which xanthan gum may be blended include, but are not limited to, sugars, minerals, and salts.
Xanthan gum is a polysaccharide produced by aerobic fermentation of
Merchandise covered by the scope of this investigation is classified in the Harmonized Tariff Schedule of the United States at subheading 3913.90.20. This tariff classification is provided for convenience and customs purposes; however, the written description of the scope is dispositive.”
For further information concerning the conduct of this phase of the investigations, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Cynthia Trainor (202–205–3354), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202–205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202–205–2000. General information concerning the Commission may also be obtained by accessing its internet server (
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 investigations must be served on all other parties to the investigations (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 investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of full reviews pursuant to section 751(c)(5) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(5)) (the Act) to determine whether revocation of the antidumping duty orders on silicomanganese from India, Kazakhstan, and Venezuela would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. 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 through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Angela M. W. Newell (202–708–5409), 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 (
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.
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.
60-day notice of information collection under review.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, 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 of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for 60 days until April 29, 2013. This process is conducted in accordance with 5 CFR 1320.10.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Brian A. Reaves, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW., Washington, DC 20531 (phone: 202–616–3287).
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, “Trade Adjustment Assistance Program Reserve Funding Request,” to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Submit comments on or before March 29, 2013
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site,
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
The DOL requires financial data for the Trade Adjustment Assistance (TAA) and North America Free Trade Agreement-TAA programs administered by States. The required data are necessary in order to meet statutory requirements prescribed in the Trade Act of 1974, as amended by the Trade Adjustment Assistance Act of 2002, the American Recovery and Reinvestment Act of 2009 (Division B, Title I, Subtitle I), the Omnibus Trade and Competitiveness Act of 1988, and the North American Free Trade Act. Using Form ETA–9117, States may request reserve funds before the final distribution to cover training costs, job search allowances, relocation allowances, employment and case management services, and State administration of these benefits.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Notice.
On February 28, 2013, the Department of Labor (DOL) will submit the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, “Standard Job Corps Contractor Information Gathering,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Submit comments on or before March 29, 2013.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site,
Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email:
Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authorization for standard operating and/or reporting forms for the operation of a Job Corps Center. The ICR includes Forms ETA 3–28; ETA–6–131 A, B, and C; ETA 6–61; ETA–640; ETA–2110; and ETA–2181.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Office of Procurement, National Aeronautics and Space Administration.
Notice of Public Availability of the FY 2012 Service Contract Inventory, PSC codes selected for FY12 SCI Analysis, and FY 2011 Service Contract Inventory Analysis.
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111–117), the National Aeronautics and Space Administration (NASA) is publishing this notice to advise the public of the availability of its analysis of FY 2011 Service Contract Inventory and its FY 2012 Service Contract Inventory. This inventory provides information on service contract actions
Point of contact for this initiative is Craig Bowers (202) 358–2235,
In accordance with the Federal Advisory Committee Act (Pub. L. 92–463, as amended), the National Science Foundation announces the following meeting:
9:30 a.m., Tuesday, March 12, 2013.
NTSB Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594.
The one item is open to the public.
8469
Telephone: (202) 314–6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314–6305 or by email at
The public may view the meeting via a live or archived Webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates including weather-related cancellations are also available at
Candi Bing, (202) 314–6403 or by email at
Peter Knudson, (202) 314–6100 or by email at
FirstEnergy Nuclear Operating Company (FENOC, the licensee) is the holder of Renewed Facility Operating License Nos. DPR–66 and NPF–73 issued by the U.S. Nuclear Regulatory Commission (NRC) pursuant to part 50 of Title 10 of the
On December 22, 2005, FENOC notified the NRC of its intent to transition the facility to the National Fire Protection Association (NFPA) Standard 805 fire protection program in accordance with 10 CFR 50.48(c). Under this initiative, the NRC has exercised enforcement discretion for most fire protection noncompliances that are identified during the licensee's transition to NFPA 805, and for certain existing identified noncompliances that reasonably may be resolved at the completion of transition. NFPA 805 was adopted in 10 CFR 50.48(c) as an alternative fire protection rule, which is one path to resolving longstanding fire protection issues. To receive enforcement discretion for these noncompliances, the licensee must meet the specific criteria, as stated in Section 9.1, “Enforcement Discretion for Certain Fire Protection Issues (10 CFR 50.48),” of the “NRC Enforcement Policy,” dated June 7, 2012, and submit an acceptable license amendment application by the date, as specified in the licensee's commitment letter. In a letter dated June 29, 2011, FENOC committed to submit their license amendment application by September 30, 2012.
In a public meeting held on August 1, 2012, between the NRC and FENOC, the licensee described its progress for transitioning Beaver Valley to NFPA 805. FENOC also notified the NRC that the development of a high-quality application will require more time than originally anticipated and that they will be unable to meet their previously committed submittal date of September 30, 2012. FENOC expressed a desire to continue enforcement discretion, and a willingness to commit to the new submittal date.
In a letter dated August 29, 2012, FENOC reiterated the current transition strategy for Beaver Valley, and notified the NRC that FENOC will submit its license amendment request (LAR) no
By letter dated October 18, 2012, the NRC requested that FENOC provide additional justification for the proposed submittal date. This requested information was further discussed with FENOC in a public teleconference that was held on October 18, 2012. FENOC provided the requested supplemental information in a letter dated November 2, 2012, as discussed more fully below.
The staff reviewed and evaluated the Beaver Valley NFPA 805 transition progress and milestones, as described in the licensee's submittals dated August 29, 2012, and November 2, 2012. In its review and evaluation, the staff considered the key transition activities discussed by FENOC, as they relate to Classical Fire Protection, Nuclear Safety Capability Assessment, Probabilistic Risk Assessment, and Non-Power Operations, as well as the licensee's parallel efforts to address identified fire protection non-compliances to reduce fire risk, ahead of the staff's review of an NFPA 805 LAR. Based on the licensee's current status, scheduled key activities, and planned modifications, the NRC staff has determined that the licensee has provided adequate justification for revising the LAR submittal date. Therefore, the NRC has determined that the date for submitting an acceptable NFPA 805 LAR should be extended. This Order is being issued to revise the original Beaver Valley LAR submittal date of September 30, 2012, to December 31, 2013. The new submittal date supports FENOC's continued progress in activities related to the transition to NFPA 805, as described in the letter dated August 29, 2012.
FENOC may, at any time, cease its transition to NFPA 805 and comply with Beaver Valley's existing licensing basis and the regulations set forth in 10 CFR 50.48, as applicable. As indicated in the Enforcement Policy, if FENOC decides not to complete the transition to 10 CFR 50.48(c), it must submit a letter stating its intent to retain its existing licensing basis and withdrawing its letter of intent to comply with 10 CFR 50.48(c). If FENOC fails to meet the new LAR submittal date and fails to comply with its existing licensing basis, the NRC will take appropriate enforcement action, consistent with its Enforcement Policy.
On February 13, 2013, FENOC consented to issuing this Order, as described in Section V below. FENOC further agreed that this Order will be effective upon issuance and that it has waived its rights to a hearing.
Based on the licensee's current status, scheduled key activities, and planned modifications, the NRC has determined that the licensee has provided adequate justification for its commitment given in Section V, and, thus, for the extension of enforcement discretion. Because the licensee will continue to perform modifications to reduce current fire risk in parallel with the development of its NFPA 805 LAR, the staff finds this acceptable to ensure public health and safety. Based on the above and FENOC's consent, this Order is effective upon issuance.
Accordingly, pursuant to Sections 103, 161b, 161i, 161o, 182, and 186 of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations in 10 CFR 2.202, “Orders,”
A. FENOC will submit an acceptable license amendment request for Beaver Valley Power Station, Units 1 and 2, to adopt NFPA Standard 805 by no later than December 31, 2013.
B. FENOC will continue to receive enforcement discretion until December 31, 2013. If the NRC finds that the LAR is not acceptable, the NRC will take steps consistent with the Enforcement Policy.
The Director of the Office of Enforcement, in consultation with the Director of the Office of Nuclear Reactor Regulation, may, in writing, relax or rescind any of the above conditions upon demonstration by the licensee of good cause.
In accordance with 10 CFR 2.202, the licensee must, and any other person adversely affected by this Order may, submit an answer to this Order within 30 days from the date of this Order. In addition, any other person adversely affected by this Order may request a hearing on this Order within 30 days from the date of this Order. Where good cause is shown, consideration will be given to extending the time to answer or request a hearing. A request for extension of time must be directed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, and include a statement of good cause for the extension.
If a hearing is requested by a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearings. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.
All documents filed in the NRC adjudicatory proceedings, including a request for a hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with NRC E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a web browser plug-in from the NRC's Web site. Further information on the web-based submission form, including the installation of the web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for a hearing or petition for leave to intervene. Submissions should be in portable document format (PDF) in accordance with the NRC guidance available on the NRC's public Web site at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk thorough the “Contact Us” link located on the NRC's Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an extension request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party using E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is available to the public at
If a person other than the licensee requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.309(d) and (f).
In the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions specified in Section V above shall be final 30 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section V shall be final when the extension expires if a hearing request has not been received.
For the Nuclear Regulatory Commission
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94–409, that the Securities and Exchange Commission will hold a Closed Meeting on Friday, March 1, 2013 at 12:30 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matters at the Closed Meeting.
Commissioner Gallagher, as duty officer, voted to consider the items listed for the Closed Meeting in a closed session.
The subject matter of the Closed Meeting will be:
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551–5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to reduce the exposure period for Directed Orders from three seconds to one second. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's Internet Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Rules [sic] 8040(d)(6) (Obligations of Market Makers) to reduce the exposure period for Directed Orders from three seconds to one second.
Currently, upon receipt of a Directed Order, an Executing Participant (“EP”) must either submit the Directed Order to the Price Improvement Period (“PIP”)
The EP's pending quote will not be released until either (i) the Directed Order is modified by the submitting OFP;
When the EP does not submit the Directed Order to the PIP, but rather, releases it to the BOX Book, the Directed Order immediately executes against the BOX Book if the BOX Best Bid or Offer is equal to or better than the NBBO and GDO. Any remaining quantity not executed is exposed to BOX Participants at the better of the NBBO or GDO price for three (3) seconds, during which time any Options Participant, except for the EP as outlined above, may submit an order to the BOX Book in response. Any orders submitted to the BOX Book during the three second exposure period execute immediately against any remaining quantity of the Directed Order, in time priority. The Exchange proposes to reduce this exposure and response period to one second as the three second processing time is unnecessary.
If a Directed Order is not executable against the current NBBO, then the Trading Host exposes the order at the better GDO price for three (3) seconds. During the exposure period when the Directed Order is executable against the current NBBO, the EP must not decrement the size, worsen the price of his GDO or submit a contra order. Because the Trading Host automatically creates the GDO and shelves the EP's quote, it does not process such changes
When approving the existing one second exposure periods on the BOX Book and in the PIP, the Commission concluded that, in the electronic environment of BOX, reducing these time periods to one second was fully consistent with the electronic nature of the BOX market.
BOX believes that further reducing its Directed Order exposure period from three seconds to one second will benefit all market participants. BOX believes it is in all participants' best interests to minimize the time of any exposure period while continuing to allow Participants adequate time to electronically respond, as both the order being exposed and Participants responding are subject to market risk during the exposure period of an order. Indeed, most participants wait until the end of the last second of the current three second period before responding to exposed orders so as to minimize market risk. BOX believes that even reducing the Directed Order exposure period to one second will continue to provide market participants with sufficient time to respond and compete for Directed Orders sent to the BOX Book. Additionally, a one second exposure period will provide investors and other market participants with more timely executions, thereby reducing their market risk. BOX believes that reducing the Directed Order exposure period from three seconds to one second will provide all market participants sufficient time for effective interaction with Directed Orders. BOX Participants are able to respond to orders in fractions of a second and BOX does not believe it is necessary or beneficial to orders being exposed to continue to subject them to market risk for three seconds.
After the notice of effectiveness of the proposed rule change, and at least one week prior to the operative date, the Exchange will issue a regulatory circular to inform BOX Participants of the operative date for the reduction of the Directed Order exposure period from three seconds to one second. BOX believes this will give Participants an opportunity to change any system settings to coincide with the implementation date so as to comply with the requirement in Rule 8040(d)(6)(i) that an EP not submit to BOX a contra order to the Directed Order for his proprietary account during the 1 second following his submission of the Directed Order to BOX.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
Additionally, the proposed change will reduce market risk for BOX Participants submitting and responding to Directed Orders. As such, BOX believes the proposed rule change would help perfect the mechanism for a free and open national market system, and generally help protect investors' and the public interest. The Exchange believes the proposed rule change is not unfairly discriminatory because the exposure time period for responding to Directed Orders would be the same for all Participants. All Participants on BOX have today, and will continue to have, an equal opportunity to respond to Directed Orders exposed on BOX.
The Exchange believes the proposed change will reduce market risk for BOX Participants submitting and responding to Directed Orders, and that the proposed rule change is not unfairly discriminatory because the exposure time period for responding to Directed Orders would be the same for all Participants. All Participants on BOX have today, and will continue to have, an equal opportunity to respond to Directed Orders exposed on BOX. As such, the Exchange believes that a reduction in the Directed Order exposure period on BOX would not be unfairly discriminatory and would benefit investors. For these reasons, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) Impose any significant burden on competition; and
(iii) Become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the
The Commission notes that the Exchange asserted in its filing that
The proposed change brings the Directed Order exposure period closer in line with the exposure periods already in existence on BOX. The time period for Participants to respond in the BOX Solicitation Auction and Facilitation Auction is one second. [footnote omitted] Additionally, the PIP duration is 100 milliseconds. [footnote omitted] The BOX trading system that processes Directed Orders is the same BOX system that processes Solicitation and Facilitation Auctions and the PIP. The proposed rule change makes no substantive change to the operation of BOX, or the execution of Directed Orders on BOX, other than reducing the Directed Order exposure period to be more in line with the time periods already in existence in other mechanisms on BOX.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
All submissions should refer to File Number SR–BOX–2013–08. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend its Rules relating to Market-Maker continuous quoting obligations. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to add language to Exchange Rules 8.5 and 8.17 to exclude intra-day add-on series (“Intra-day Adds”) on the day during which such series are added for trading from Market-Makers'
Intra-Adds are series that are be added to the Exchange system after the opening of the Exchange. These series
Currently, Exchange Rules 8.5 and 8.17 impose certain obligations on Market-Makers and DPMs, respectively, including obligations to provide continuous quotes as follows
• Rule 8.5 requires that Market-Makers provide a continuous two-sided market in 60% of the non-adjusted option series of the Market-Maker's appointed class that have a time to expiration of less than nine months;
• Rule 8.17(a)(1) requires DPMs to provide continuous quotes in at least the lesser of 99% or 100% minus one call-put pair
Exchange Rule 8.19 provides that DPMs generally will receive the participation entitlements in their assigned classes when quoting at the best price if they satisfy their obligations and other conditions set forth in the rules. Specifically, Rule 8.19 provides that the DPM participation entitlement will be 50% when there is one Market-Maker also quoting at the best price on the Exchange and 40% when there are two Market-Makers also quoting at the best price on the Exchange.
In order to comply with their continuous quoting obligations, Exchange Market-Makers have automated systems in place that use complex calculations based on a variety of market factors to compute quotes in their appointed classes and transmit these quotes to the Exchange's System (the “System”).
Intra-day Adds make it extremely difficult for Market-Makers to comply with their obligation to quote in a substantial percentage of series in their appointed classes during a trading day on which Intra-day Adds are added in those classes. For example, if there are 1,000 series listed in a DPM's appointed class and the DPM is quoting in 990 of these series, the DPM is in compliance with the current minimum requirement to quote in 99% of series in its appointed class (assuming the DPM quotes in this number of series 90% of the trading day). However, if an Intra-day Add is added in the DPM's appointed class during the trading day, and the DPM's system does not automatically quote in this series, then the DPM would not comply, as it would be quoting in 990 of 1,001 series. This noncompliance would be compounded if more than one Intra-day Add is listed in a class during the same trading day. Further, if these Market-Makers turned their systems off to quote in Intra-day Adds on the trading day during which those series are added, then the Market-Makers could satisfy the standard to quote in a minimum percentage of series in their appointed classes but would then risk violating their obligation to quote for minimum percentage of the trading day as, theoretically, these Market-Makers might need to repeatedly turn their systems off to accommodate the Intra-day Adds.
The Exchange believes that it would be impracticable, particularly given that a number of Market-Makers use their systems to quote on multiple markets and not solely on the Exchange, for Market-Makers to turn off their entire systems to accommodate quoting in Intra-day Adds on the day during which those series are added on the Exchange. In addition, the Exchange believes this would interfere with the continuity of its market and reduce liquidity, which would ultimately harm investors and contradicts the purpose of the Market-Maker continuous quoting obligation.
This proposed rule change excludes Intra-day Adds from these continuous quoting obligations to address this conflict. Specifically, the Exchange is proposing to add text to Rules 8.5 and 8.17 to exclude Intra-day Adds on the day during which such series are added for trading from Market-Makers' quoting obligations. Based on communications from Market-Makers, the Exchange is concerned that Market-Makers may withdraw from the DPM program and that other market participants may be discouraged from requesting Market-Maker appointments or applying to the DPM program if they are required to quote Intra-day Adds on the trading day during which those series are added. The Exchange believes that withdrawals from, and reduced applications for, Market-Maker appointments would negatively impact liquidity and volume on the Exchange in those classes. The Exchange believes that providing Market-Makers with relief from their quoting obligations with respect to Intra-day Adds on the trading day during which they are added for trading will prevent these withdrawals and encourage market participants to apply for or continue their Market-Maker class appointments.
The Exchange does not believe this relief will result in any material decrease in liquidity. As mentioned above, it is the Exchange's understanding that several Market-Makers currently do not quote Intra-day Adds on the trading day during which they are added, so the Exchange believes this proposed relief would result in a minimal reduction, if any, in liquidity in these series. These Market-Makers' systems would add these series the next trading day, so if there is any slight reduction in liquidity in these few series, it would only last for a short period of time (until the following trading day). Additionally, this potential small reduction in liquidity would be far outweighed by the reduction in liquidity that the Exchange believes
The current quoting obligation in Intra-day Adds is a minor part of a Market-Maker's overall obligations. Specifically, Intra-day Adds represent only approximately 0.10% of the number of series listed on the Exchange, so Market-Makers will still be obligated to provide continuous two-sided markets in a substantial number of series in their appointed classes.
The Exchange believes the proposed rule change will continue to ensure that Market-Makers create a fair and orderly market in the option classes to which they are assigned, as it does not absolve Market-Makers from providing continuous quotes in a significant percentage of series of each class for a substantial portion of the trading day. Market-Makers must engage in activities that constitute a course of dealings reasonably calculated to contribute to the maintenance of a fair and orderly market, including (1) competing with other Market-Makers to improve markets in all series of options classes comprising their appointments, (2) making markets that, absent changed market conditions, will be honored in accordance with firm quote rules, and (3) updating market quotations in response to changed market condition in their appointed options classes and to assure that any market quote it causes to be disseminated is accurate.
The relief proposed in this filing is mitigated by a Market-Maker's other obligations. For example, the proposed rule change would not excuse a Market-Maker from its obligation to submit a single quote or maintain continuous quotes in one or more series of a class to which the Maker-Maker is appointed when called upon by an Exchange official if, in the judgment of such official, it is necessary to do so in the interest of maintaining a fair and orderly market.
The proposed rule change also clarifies in the Exchange Rules that while Market-Makers are not required to provide continuous quotes in Intra-day Adds on the day during which such series are added for trading, a Market-Maker may still receive a participation entitlement in such series if it elects to quote in that series and otherwise satisfies the other entitlement requirements set forth in accordance with the Rules. Specifically, the Exchange is proposing to add language to Rule 8.19 clearly stating that DPMs may still receive participation entitlements pursuant to those Rules in all Intra-day Adds on the day during which such series are added for trading in which they are quoting provided that Market-Maker meets all other entitlement requirements as set forth in Rule 8.19(b).
Market-Makers already receive participation entitlements in series they are not required to quote. For example, a DPM is currently required to provide continuous quotes in at least 99% of the non-adjusted option series or 100% of the non-adjusted series minus one call-put pair of each option class allocated to it for 90% of the trading day.
The Exchange does not believe that the proposed rule change would adversely affect the quality of the Exchange's markets or lead to a material decrease in liquidity. Rather, the Exchange believes that its current market structure, with its high rate of participation by Market-Makers, permits the proposed rule change without fear of losing liquidity. The Exchange also believes that market-making activity and liquidity could materially decrease without the proposed rule change to exclude Intra-day Adds from Market-Maker continuous quoting obligations on the trading day during which they are added for trading. The Exchange believes that this proposed relief will encourage Market-Makers to continue appointments and other TPHs to request Market-Maker appointments, and, as a result, expand liquidity in options classes listed on the Exchange to the benefit of the Exchange and its TPHs and public customers. The Exchange believes that its Market-Makers would be disadvantaged without this proposed relief, and other TPHs and public customers would also be disadvantaged if Market-Makers withdrew from appointments in options classes, resulting in reduced liquidity and volume in these classes. Additionally, the Exchange believes that the proposed rule change to clarify that Market-Makers may receive participation entitlements in Intraday Adds on the day during which such series are added for trading if it satisfies the other entitlement requirements as set forth in Exchange Rules, even if the Rules do not require the Market-Makers to continuously quote in those series, will incent Market-Makers to quote in series in which they are not required to quote, which may increase liquidity in their appointed classes.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes the proposed rule change to exclude Intra-day Adds during the day which such series are added for trading from Market-Makers' quoting obligations promotes just and equitable principles of trade because it promotes liquidity and continuity in the marketplace and would prevent interruptions in quoting or reduced liquidity that may otherwise result. The Exchange also believes that the proposed rule change supports the quality of the Exchange's markets because it does not significantly change the current quoting obligations of Market-Makers. Market-Makers must still provide continuous quotes for a significant part of the trading day in a substantial number of series of each appointed class. Even if a Market-Maker does not quote Intra-day Adds on the trading day during which they are added, this would be offset by the Market-Maker's continued other obligations. The proposed relief is further offset by a Market-Maker's obligation to quote in these series beginning the next trading day. Accordingly, the proposed rule change supports the quality of the Exchange's trading markets by helping to ensure that Market-Makers will continue to be obligated to quote in Intra-day Adds if, and when, the need arises and on an ongoing basis following the trading day during which the series are added. The Exchange believes this proposed change is reasonable and is offset by Market-Makers' continued responsibilities to provide significant liquidity to the market to the benefit of market participants.
The Exchange believes this proposed rule change, on balance, is a minor change and should not impact the quality of the Exchange's trading markets. Among other things, Intra-day Adds represent an insignificant percentage of series listed on the Exchange each day. The Exchange further believes that the potential small reduction in liquidity in Intra-day Adds that may result from the proposed relief would be far outweighed by the significant reduction in liquidity in appointed classes that the Exchange believes could occur from withdrawals from and reductions in applications for Market-Maker appointments without the proposed relief. The proposed rule change also removes impediments to and allows for a free and open market, while protecting investors, by promoting additional transparency regarding Market-Makers' obligations and benefits in the Exchange Rules. In addition, the Exchange believes that the proposed rule change is designed to not permit unfair discrimination among Market-Makers, as the proposed rule change provides the proposed relief for all Market-Makers.
The proposed rule change to clarify that Market-Makers may receive participation entitlements in Intra-day Adds in their appointed classes in which they are quoting, even though they are not required to quote, if the other requirements set forth in the Rules are satisfied, further supports the quality of the Exchange's trading markets because it encourages Market-Makers to quote in as many series as possible, which ultimately benefits all investors. This benefit is offset by the Market-Makers' continued quoting obligations and the fact that their quotes in these “non-required” series must still satisfy all of the Market-Makers' other obligations under the Rules. The Exchange also believes that this proposed change is consistent with its current practice, pursuant to which Market-Makers receive participation entitlements in additional series in which they elect to quote above the minimum percentage of series in which they are required to continuously quote under the Rules.
For the foregoing reasons, the Exchange believes that the proposed rule change is appropriate and consistent with the Act.
C2 does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change to exclude Intra-day Adds during the day which such series are added for trading from Market-Makers' quoting obligations will cause any unnecessary burden on intramarket competition because it provides the same relief to a group of similarly situated market participants—Market-Makers. The Exchange does not believe the proposed change will cause any unnecessary burden on intermarket competition because Intra-day Adds are a very small portion of series on the Exchange. Exchange further believes that the potential small reduction in liquidity in Intra-day Adds that may result from the proposed relief would be far outweighed by the significant reduction in liquidity in appointed classes that the Exchange believes could occur from withdrawals from and reductions in applications for Market-Maker appointments without the proposed relief. In addition, the Exchange believes that the proposed rule change will in fact relieve any burden on, or otherwise promote, competition. The Exchange believes that excluding Intra-day Adds on the day during which they are added for trading from Market-Maker obligations will promote trading activity on the Exchange to the benefit of the Exchange, its TPHs, and market participants.
The Exchange does not believe the proposed rule change to clarify that Market-Makers may receive participation entitlements in Intra-day Adds in their appointed classes in which they are quoting, even though they are not required to quote, if the other requirements set forth in the Rules are satisfied, will cause any unnecessary burden on intramarket competition because it too provides the same relief to a group of similarly situated market participants—Market-Makers. The Exchange does not believe the proposed change will cause any unnecessary burden on intermarket competition because Market-Makers are currently entitled to receive participation entitlements on series they are not obligated to quote in under the Rules. In addition, the Exchange believes that the proposed rule change will in fact relieve any burden on, or otherwise promote, competition. The Exchange believes allowing Market-Makers to receive a participation entitlements in Intra-day Adds will promote trading activity on the Exchange because it will incentivize Market-Makers to quote in such series though not obligated to do so to the benefit of the Exchange, its TPHs, and market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
Within 45 days of the date of publication of this notice in the
A. By order approve or disapprove such proposed rule change, or
B. Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Mississippi (FEMA–4101–DR), dated 02/19/2013.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 02/19/2013, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 13496C and for economic injury is 13497C.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Mississippi (FEMA–4101–DR), dated 02/13/2013.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416
The notice of the Presidential disaster declaration for the State of Mississippi, dated 02/13/2013 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to March 29, 2013.
Keith Miller, Department of State, Office of Overseas Schools, A/OPR/Os, Room H328, SA–1, Washington, DC 20522–0103, who is reachable on 202–261–8200. Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Wanda Lyles, Department of State, Office of Overseas Schools, A/OPR/OS, Room H328, SA–1, Washington, DC 20522–0103, who is reachable on 202–261–8200 or
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to March 29, 2013.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Martha Allen at 2401 E Street NW., Fourteenth Floor, Washington, DC 20522, who may be reached on 202–261–8800 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Federal Aviation Administration (FAA), DOT.
Notice of availability and request for comments.
The FAA announces the availability and request for comments of a draft ANILCA Section 810 Subsistence Evaluation for proposed improvements to the runway safety areas at the Kodiak Airport, Kodiak, Alaska.
Comments must be received on or before March 29, 2013.
You may submit comments or request for copies or more information by any of the following methods:
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4.
5.
Leslie Grey, AAL–614, Federal Aviation Administration, Alaskan Region, Airports Division, 222 W. 7th Avenue, Box #14, Anchorage, AK 99513. Ms. Grey may be contacted during business hours at (907) 271–5453 (phone) and (907) 271–2851 (Fax) or email
Alternatives proposed as part of the Draft EIS as published in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT)
Meeting Notice of RTCA Special Committee 223, Airport Surface Wireless Communications
The FAA is issuing this notice to advise the public of the meeting of the RTCA Special Committee 223, Airport Surface Wireless Communications.
The meeting will be held March 19–21, 2013, from 9:00 a.m.—5:00 p.m. daily.
The meeting will be held at Booze, Allen, Hamilton Offices, 1201 Maryland Avenue SW., Suite 5140, Washington, DC 20036.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330–0662/(202) 833–9339, fax (202) 833–9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. No. 92–463, 5 U.S.C., App.), notice is hereby given for a meeting of Special Committee 223. The agenda will include the following:
• Plenary: Welcome, Introductions, Administrative Remarks.
• Agenda Overview.
• Review and Approve prior Plenary Meeting Summary.
• Profile CCB Status.
• Detailed MOPS Review:
• Convergence Sub-layer.
• Security.
• MAC Layer.
• Physical Layer.
• PICS.
• CRSL.
• Review/Approval of MOPS for FRAC.
• Review of Meeting Summary Report.
• Finalize date of next meeting:
• Adjourn.
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT)
Meeting Notice of RTCA Special Committee 159, RTCA Special Committee 159, Global Positioning Systems (GPS)
The FAA is issuing this notice to advise the public of the eighty-ninth meeting of the RTCA Special Committee 159, Global Positioning Systems (GPS).
The meeting will be held March 12–15, 2013 from 9:00 a.m.–4:30 p.m.
The meeting will be held at RTCA, Inc., 1150 18th Street NW., Suite 910, Washington, DC 20036.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 330–0652/(202) 833–9339, fax at (202) 833–9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. No. 92–463, 5 U.S.C., App.), notice is hereby given for a meeting of Special Committee 159. The agenda will include the following:
• Working Group 2, GPS/SBAS, MacIntosh-NBAA Room and Colson Board Room.
• 9:00 a.m.–12:00 p.m., Working Group 2, GPS/SBAS, A4A Room.
• 1:00 p.m.–5:00 p.m., Working Group 4, Precision Landing Guidance, GPS/GBAS, MacIntosh-NBAA Room and Colson Board Room.
• Working Group 4, Precision Landing Guidance, GPS/GBAS, MacIntosh-NBAA Room and Colson Board Room.
• 1:00 p.m–5:00 p.m., Working Group 7, GPS/Antennas, A4A Room.
• Chairman's Introductory Remarks.
• Approval of Summary of the Eighty-Ninth Meeting held October 5, 2012.
• Review Working Group (WG) Progress and Identify Issues for Resolution.
• GPS/3nd Civil Frequency (WG–1).
• GPS/WAAS (WG–2).
• GPS/GLONASS (WG–2A).
• GPS/Inertial (WG–2C).
• GPS/Precision Landing Guidance (WG–4).
• GPS/Airport Surface Surveillance (WG–5).
• GPS/Interference (WG–6).
• GPS/Antennas (WG–7).
• Review of EUROCAE Activities.
• Assignment/Review of Future Work.
• Other Business.
• Date and Place of Next Meeting.
• Adjourn.
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Surface Transportation Board (Board), Transportation.
Notice of vacancies on the Railroad-Shipper Transportation Advisory Council (RSTAC) and solicitation of nominations.
The Board hereby gives notice of one vacancy on RSTAC for a small shipper representative. The Board is soliciting suggestions for candidates to fill this vacancy.
Suggestions of candidates for membership on RSTAC are due on March 25, 2013.
Suggestions may be submitted either via the Board's e-filing format or in the traditional paper format. Any person using e-filing should attach a document and otherwise comply with the instructions at the E–FILING link on the Board's Web site, at
Gabriel Meyer at 202–245–0150. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1–800–877–8339.
The Board, created by Congress in 1996 to take over many of the functions previously performed by the Interstate Commerce Commission, exercises broad authority over transportation by rail carriers, including regulation of railroad rates and service (49 U.S.C. 10701–10747, 11101–11124), as well as the construction, acquisition, operation, and abandonment of rail lines (49 U.S.C. 10901–10907) and railroad line sales, consolidations, mergers, and common control arrangements (49 U.S.C. 10902, 11323–11327).
RSTAC was established upon the enactment of the ICC Termination Act of 1995 (ICCTA), on December 29, 1995, to advise the Board's Chairman, the Secretary of Transportation, the
RSTAC consists of 19 members. Of this number, 15 members are appointed by the Chairman of the Board, and the remaining 4 members are comprised of the Secretary of Transportation and the Members of the Board, who serve as
RSTAC is required by statute to meet at least semi-annually. In recent years, RSTAC has chosen to meet 4 times a year, with the first meeting each February. Meetings are generally held at the Board's headquarters in Washington, DC, although some may be held in other locations.
RSTAC members receive no compensation for their services and are required to provide for the expenses incidental to their service, including travel expenses, as the Board cannot provide for these expenses. The RSTAC Chairman, however, may request funding from the Department of Transportation to cover travel expenses, subject to certain restrictions in ICCTA. RSTAC also may solicit and use private funding for its activities, again subject to certain restrictions in ICCTA. RSTAC members currently have elected to submit annual dues to pay for RSTAC expenses.
RSTAC members must be citizens of the United States and represent as broadly as practicable the various segments of the railroad and rail shipper industries. They may not be full-time employees of the United States. Further, RSTAC members appointed or reappointed after June 18, 2010, are prohibited from serving as federally registered lobbyists during their RSTAC term.
The members of RSTAC are appointed for a term of 3 years. A member may serve after the expiration of his or her term until a successor has taken office. No member will be eligible to serve in excess of 2 consecutive terms.
Due to an unanticipated resignation, one vacancy currently exists for a small shipper representative. Upon appointment by the Chairman, the small shipper representative will serve until December 31, 2014. Suggestions for candidates to fill this vacancy should be submitted in letter form, identify the name of the candidate, provide a summary of why the candidate is qualified to serve on RSTAC, and contain a representation that the candidate is willing to serve as a member of RSTAC effective immediately upon appointment and continuing until December 31, 2014. RSTAC candidate suggestions should be filed with the Board by March 25, 2013. Members selected to serve on RSTAC are chosen at the discretion of the Board's Chairman. Please note that submissions will be available to the public at the Board's offices and posted on the Board's Web site under Docket No. EP 526 (Sub-No. 4).
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
49 U.S.C. 726.
By the Board, Rachel D. Campbell, Office of Proceedings.
The Department of the Treasury 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 March 29, 2013 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestion for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission(s) may be obtained by calling (202) 927–5331, email at
The Department of the Treasury 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 March 29, 2013 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestion for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission(s) may be obtained by calling (202) 927–5331, email at
Departmental Offices, Treasury.
Notice of open meeting.
This notice announces that the Department of the Treasury's Federal Advisory Committee on Insurance will convene a meeting on Wednesday, March 13, 2013, in Room 4125, 1500 Pennsylvania Avenue NW., Washington, DC, 20220, beginning at 9:00 a.m. Eastern Time. The meeting is open to the public, and the site is accessible to individuals with disabilities. The Federal Advisory Committee on Insurance will convene its meeting.
The meeting will be held on Wednesday, March 13, 2013, commencing at 9:00 a.m. Eastern Time.
The Federal Advisory Committee on Insurance meeting will be held in the Room 4125, 1500 Pennsylvania Avenue NW., Washington, DC 20220. The meeting will be open to the public. Because the meeting will be held in a secured facility, members of the public who plan to attend the meeting must contact the Federal Insurance Office (Office), at (202) 622–6910, by 5:00 p.m. Eastern Time on Friday, March 8, 2013, to inform the Office of the desire to attend the meeting and to provide the information that will be required to facilitate entry into the building.
James P. Brown, Senior Policy Advisor to the Federal Insurance Office, Room 2100, Department of the Treasury, 1425 New York Avenue NW., Washington, DC 20220, at (202) 622–6910 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877–8339.
Notice of this meeting is provided in accordance with the Federal Advisory Committee Act, 5 U.S.C. App. II, 10(a)(2), through implementing regulations at 41 CFR 102–3.150.
• Send electronic comments to
• Send paper statements in triplicate to the Federal Advisory Committee on Insurance, Room 2100, Department of the Treasury, 1425 New York Avenue NW., Washington, DC 20220.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, 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 a continuing information collection, as required by the Paperwork Reduction Act of 1995.
Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning renewal of its information collection titled, “Disclosure of Financial and Other Information by National Banks.”
Comments must be submitted on or before April 29, 2013.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557–0182, 400 7th Street SW., Suite 3E–218, Mail Stop 9W–11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465–4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not enclose any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
You may request additional information or a copy of the collection from Johnny Vilela or Mary H. Gottlieb, OCC Clearance Officers, (202) 649–5490, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E–218, Mail Stop 9W–11, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
This program of periodic financial disclosure is needed not only to facilitate informed decision making by existing and potential customers and investors, but also to improve public understanding of, and confidence in, the financial condition of individual national banks and the national banking system. Further, financial disclosure reduces the likelihood that the market will overreact to incomplete information.
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the information collection burden;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Notice is hereby given that on December 28, 2012, the Office of the Comptroller of the Currency (OCC) approved the application of Bank 360, Beresford, South Dakota, to convert to the stock form of organization. Copies of the application are available for inspection on the OCC Web site at the FOIA Reading Room
By the Office of the Comptroller of the Currency.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning certain transfers of stock or securities by U.S. persons to foreign corporations and related reporting requirements; and stock transfer rules.
Written comments should be received on or before April 29, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Katherine Dean, at (202) 622–3186, or at Internal Revenue Service, Room 6242, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8453–PE, U.S. Partnership Declaration for an IRS e-file Return.
Written comments should be received on or before April 29, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Katherine Dean,
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the election not to apply look-back method in de minimis cases.
Written comments should be received on or before April 29, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6516, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to R. Katherine Dean, 202–622–3186, Internal Revenue Service, Room 6516, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet at
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (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 estimate 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 of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information
Written comments should be received on or before April 29, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of information collection should be directed to Katherine Dean at Internal Revenue Service, room 6242, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622–3186, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Department of Health and Human Services.
Final rule.
This final rule implements provisions related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans, consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The final rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This final rule also amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the federal rate review program, and revises the timeline for states to propose state-specific thresholds for review and approval by the Centers for Medicare & Medicaid Services (CMS).
Jacob Ackerman, (410) 786–1565 (or by email:
The Department of Health and Human Services (HHS) published proposed standards to implement the 2014 market reform provisions of the Affordable Care Act and to amend the federal rate review program in a November 26, 2012
This final rule: (1) Provides that health insurance issuers may vary the premium rate for health insurance coverage in the individual and small group markets only based on family size, geography, and age and tobacco use within limits; (2) directs health insurance issuers to offer coverage to and accept every employer or individual who applies for coverage in the group and individual market, subject to certain exceptions; (3) directs health insurance issuers to renew or continue in force coverage in the group and individual market, subject to certain exceptions; (4) codifies the requirement that issuers maintain a single risk pool for the individual market and a single risk pool for the small group market (unless a state decides to merge the markets into a single risk pool); and (5) outlines standards for enrollment in catastrophic plans for young adults and people who cannot otherwise afford health insurance.
Finally, this rule amends the standards under the rate review program in 45 CFR part 154. The amendments revise the timeline for states to propose state-specific thresholds for review and approval by CMS. The amendments also direct health insurance issuers to submit data relating to proposed rate increases in a standardized format specified by the Secretary of HHS (the Secretary), and modify criteria and factors for states to have an effective rate review program. These changes are necessary to reflect the new market reform provisions discussed above and to fulfill the statutory requirement beginning in 2014 that the Secretary, in conjunction with the states, monitor premium increases of health insurance coverage offered through an Exchange and outside of an Exchange. The provisions are also designed to streamline data collection for issuers, states, Exchanges, and HHS.
The substantive authority for these final rules is generally sections 2701, 2702, 2703, 2723 and 2794 of the Public Health Service Act (PHS Act) and sections 1302(e), 1312(c), and 1560(c) of the Affordable Care Act. PHS Act section 2792 authorizes rulemaking as necessary or appropriate to carry out the provisions of title XXVII of the PHS Act, including sections 2701, 2702, 2703, 2723, and 2794. Section 1321(a) of the
The Patient Protection and Affordable Care Act (Pub. L. 111–148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) was enacted on March 30, 2010. We refer to the two statutes collectively as the “Affordable Care Act” in this final rule.
Subtitles A and C of title I of the Affordable Care Act reorganized, amended, and added to the provisions of part A of title XXVII of the PHS Act relating to health insurance issuers in the group and individual markets and to group health plans that are non-federal governmental plans.
Section 2701(a)(1) of the PHS Act regarding fair health insurance premiums provides that the premium rate charged by a health insurance issuer for health insurance coverage offered in the individual or small group market may vary with respect to a particular plan or coverage only based on the following factors: (1) Whether the plan or coverage covers an individual or family; (2) rating area; (3) age (within a ratio of 3:1 for adults); and (4) tobacco use (within a ratio of 1.5:1). Section 2701(a)(2) directs each state to establish one or more rating areas and charges the Secretary with reviewing the adequacy of state-established rating areas. If the Secretary determines that a state's rating areas are not adequate, or that a state does not establish such areas, the statute authorizes the Secretary to establish rating areas for that state. Section 2701(a)(3) directs the Secretary, in consultation with the National Association of Insurance Commissioners (NAIC), to define permissible age bands for rating purposes. Section 2701(a)(4) provides that, for purposes of family coverage, any rating variation for age and tobacco use must be applied based on the portion of the premium attributable to each family member.
Section 2702 of the PHS Act directs a health insurance issuer offering health insurance coverage in the group or individual market in a state to accept every employer and individual in the state that applies for the coverage, subject to certain exceptions. These exceptions allow issuers to restrict enrollment in coverage: (1) To open and special enrollment periods as described in section 2702(b); (2) to employers with eligible individuals who live, work, or reside in the service area of a network plan as described in section 2702(c)(1)(A); and (3) in certain situations involving limited network capacity and limited financial capacity as described in section 2702(c)(1)(B) and (d).
Section 2703 of the PHS Act requires a health insurance issuer to renew or continue in force any coverage in the group or individual market at the option of the plan sponsor or the individual. Exceptions to this requirement described in section 2703(b) allow the issuer to nonrenew or discontinue coverage for nonpayment of premiums, fraud, or violation of participation or contribution rules under state law. The law also permits an issuer to cease to offer either a particular type of product or all coverage in a particular market, to refuse to renew coverage if all of the plan's enrollees leave the service area of a network plan, or if group health plan coverage is provided through a bona fide association and the employer's association membership ends. Finally, an exception outlined in section 2703(d) permits a health insurance issuer, at the time of coverage renewal, to modify the coverage offered to a group health plan in the large group market, or in the small group market if, for coverage that is available in such market other than through one or more bona fide associations, the modification is consistent with state law and effective on a uniform basis among group health plans with that product.
Section 2701 applies to health insurance issuers offering health insurance coverage in the individual and small group markets, and in the large group market if a state, beginning in 2017, allows health insurance issuers in the large group market to offer qualified health plans (QHPs) in such market through an Exchange pursuant to section 1312(f)(2)(B) of the Affordable Care Act.
Section 1302 of the Affordable Care Act specifies levels of coverage or “actuarial values” that health plans in the individual and small group markets, both inside and outside of an Exchange, will meet as part of the requirement to cover an essential health benefits (EHB) package beginning in 2014. These plans will provide a bronze, silver, gold, or platinum level of coverage as described in section 1302(d), or a catastrophic plan in the individual market as described in section 1302(e) for young adults and people who cannot otherwise afford health insurance.
Section 1312(c)(1) and (2) of the Affordable Care Act directs a health insurance issuer to consider all enrollees in all health plans (other than grandfathered health plans) offered by such issuer to be members of a single risk pool for a market (the individual market or small group market). Section 1312(c)(3) gives states the option to merge the individual and small group markets within the state into a single risk pool. Section 1312(c) applies to health plans offered both inside and outside of an Exchange for plan years (in the individual market, policy years) beginning on or after January 1, 2014. It does not apply to grandfathered health plans, and explicitly preempts state law
Section 1003 of the Affordable Care Act adds a new section 2794 of the PHS Act, which directs the Secretary, in conjunction with the states, to establish a process for the annual review of “unreasonable increases in premiums for health insurance coverage.” The statute provides that health insurance issuers must submit to the Secretary and the applicable state justifications for unreasonable premium increases prior to the implementation of the increases. Section 2794(b)(2) also specifies that in plan years beginning in 2014, the Secretary, in conjunction with the states, shall monitor premium increases of health insurance coverage offered through an Exchange and outside of an Exchange. Section 2794 of the PHS Act does not, by its own terms, apply to grandfathered health insurance coverage or to self-funded plans. Regulations at 45 CFR 154.101(b) further limit the scope of review to small group and individual market coverage.
Section 1563 of the Affordable Care Act amended the Health Insurance Portability and Accountability Act of 1996 (HIPAA) enforcement provision that previously governed group health insurance coverage and non-federal governmental group health plans by expanding its scope to include individual health insurance coverage and by renumbering the provision as section 2723 of the PHS Act.
The preemption provisions of PHS Act section 2724(a)(1) apply so that the requirements of part A of title XXVII of the PHS Act are not to be “construed to supersede any provision of state law which establishes, implements, or continues in effect any standard or requirement solely relating to health insurance issuers in connection with individual or group health insurance coverage except to the extent that such standard or requirement prevents the application of a requirement” of part A of title XXVII of the PHS Act. Section 1321(d) of the Affordable Care Act applies the same preemption principle to the requirements of title I of the Affordable Care Act.
The regulations outlined in this final rule are codified in 45 CFR parts 144, 147, 150, 154, and 156. Part 144 outlines standards regarding the basis, scope, and applicability of 45 CFR parts 144 through 148. Part 147 outlines standards for health insurance issuers in the group and individuals markets related to health insurance reforms. Part 150 outlines standards regarding enforcement. Part 154 outlines standards for health insurance issuers in the small group and individual markets with respect to rate increase disclosure and review. Part 156 outlines standards for issuers of QHPs, including with respect to participation in an Exchange.
HHS published standards under the statutory provisions discussed in section I.A. of the preamble in a November 26, 2012
This section summarizes the provisions of the November 26, 2012 proposed rule and discusses and provides responses to the comments.
HHS proposed technical changes in § 144.101 and § 144.102 to clarify enforcement of the health insurance reform requirements added by the Affordable Care Act and implemented in 45 CFR part 147. In § 144.102(c), HHS also proposed to clarify how to determine whether insurance coverage sold through associations is group or individual coverage under the PHS Act.
Comments received regarding HHS's enforcement processes and regarding bona fide associations are addressed in other sections of the preamble that we deemed to be more relevant to the substance of the comments.
Section 147.102 of this final rule implements section 2701 the PHS Act, which specifies that the only rating factors that may be used to vary premium rates for health insurance coverage in the individual and small group markets are (1) Family size; (2) geographic rating area; (3) age (within a ratio of 3:1 for adults); and (4) tobacco use (within a ratio of 1.5:1).
In § 147.102(c)(1), we proposed that issuers develop premiums for family coverage by adding up the rate of each covered family member.
We noted that rating based on specified family tiers, and other family rating practices that fail to apply the age and tobacco use factors proportionately to individual family members, would generally be impermissible pursuant to PHS Act section 2701(a)(4), which requires that any rating variation for age and tobacco use be apportioned to each family member's premium. However, in § 147.102(c)(2), we proposed flexibility for community rated states that do not permit rating based on age or tobacco use to require issuers to use a standard family-tier methodology with corresponding multipliers. We solicited comment on whether instead of permitting such flexibility, states with pure community rating should also use the per-member approach that would be used in states that allow rating for age and tobacco use.
We noted that health insurance issuers currently have flexibility in determining how to set rates for family policies and in defining which family members may be on the same policy, subject to federal and state laws requiring coverage of certain individuals. We solicited comment on whether to set standards governing the minimum categories of family members that issuers must include in setting rates for family policies or to defer to states and issuers to make this determination. We also solicited comment on the types of individuals who are typically included under family coverage, including types of covered individuals who would not meet the classification of tax dependents under the Code.
In § 147.102(c)(3), we proposed that issuers in the small group market calculate rates for employee and dependent coverage on a per-member basis, and calculate the group premium by totaling the premiums attributable to each covered individual. States may require issuers to base small group
In § 147.102(b), we proposed that each state establish rating areas, which would be presumed adequate if they meet one of the following options: one rating area for the entire state, or no more than seven rating areas based on counties, three-digit zip codes (that is, areas in which all zip codes share the same first three digits), or metropolitan statistical areas (MSAs) and non-MSA geographic divisions.
The November 26, 2012 proposed rule requested comment on various aspects concerning the proposed geographic rating area standards, namely comments concerning the use of other geographic divisions or factors; the maximum number of rating areas within a state that would be presumed adequate; whether states with existing rating areas would have to make changes to conform to the proposed standards; whether to establish minimum geographic size and population requirements; and the appropriate schedules and procedures for states to modify their rating areas in the future.
Section 147.102(b)(3) of this final rule provides that a state's rating areas must be based on one the following geographic divisions: Counties, three-digit zip codes, or MSAs and non-MSAs, and will be presumed adequate if they meet either of the following conditions: (1) As of January 1, 2013, the state had established by law, rule, regulation, bulletin, or other executive action uniform geographic rating areas for the entire state; or (2) After January 1, 2013, the state establishes by law, rule, regulation, bulletin, or other executive action for the entire state no more geographic rating areas than the number of MSAs in the state plus one. Under these standards, geographic rating areas may be noncontiguous, but the area encompassed by a geographic rating area must be separate and distinct from areas encompassed by other geographic rating areas. As mentioned, rating areas must be based on counties, three-digit zip codes, or MSAs/non-MSAs. While we proposed the possibility that HHS might approve rating areas based on other existing geographic divisions, we have determined that these are the only geographic boundaries that would be feasible for purposes of implementing the premium tax credit under Code section 36B. We note that if a state had established geographic rating areas on or before January 1, 2013 that did not follow these geographic boundaries, the state would have an opportunity to adjust their proposed rating areas before the default rating area is applied.
We recognize that a greater number of rating areas than the number of MSAs in the state plus one may in some cases be actuarially justified. Therefore, states have the option pursuant to § 147.102(b)(4) of this final rule to seek approval from HHS of a greater number of rating areas as long as the areas are based on counties, three-digit zip codes, or MSAs and non-MSAs. We will review such state proposals to ensure they are actuarially justified and non-discriminatory as discussed below.
In 147.102(a)(1)(iii), we proposed that the premium rate charged by a health insurance issuer for non-grandfathered health insurance coverage in the individual or small group market may vary by age, except that such rate may not vary by more than 3:1 for adults, as set forth by the statute. We proposed to
After consulting with the NAIC, we proposed the following standard age bands for use in all states and markets subject to section 2701 of the PHS Act:
• Children: A single age band for children ages 0 through 20.
• Adults: One-year age bands for adults ages 21 through 63.
• Older adults: A single age band for adults ages 64 and older.
Finally, we proposed that health insurance issuers in a state and market use a uniform age rating curve established by the state, specifying the relative distribution of rates across all age bands. We proposed an HHS standard default age curve that would apply in both the individual and small group markets in states that do not exercise the option to establish their own age curve. We requested comment on the default age rating curve, including comment on the premium impact of the transition from the child age curve to the adult age curve.
HHS will establish in guidance a default age rating curve that will apply in both the individual and small group markets in states that do not exercise the option to establish their own age curve (or that do not provide information to CMS about their age curve in accordance with the state reporting requirements discussed in section II.B.2. of the preamble). We intend to adopt in guidance the default age curve as proposed in the November 26, 2012 proposed rule for states that allow a maximum 3:1 ratio for age rating. For states that adopt narrower ratios for age rating, the default age curve established by HHS would take into account the permissible rating variation for age under state law. We intend to revise the default age curve periodically, but no more frequently than annually, to reflect market patterns in the individual and small group markets following implementation of the 2014 market reforms.
In § 147.102(a)(1)(iv), we proposed that the premium rate charged by a health insurance issuer for non-grandfathered health insurance coverage offered in the individual or small group market may vary for tobacco use, except that such rate may not vary by more than 1.5:1, as set forth by the statute. States or issuers would have flexibility within these limits to determine the appropriate tobacco rating factor for different age groups (for example, younger enrollees could be charged a lower tobacco use factor than older enrollees provided the tobacco use factor does not exceed 1.5:1 for any age group).
Further, we proposed to coordinate application of the tobacco rating rules of PHS Act section 2701 with the nondiscrimination and wellness program rules of PHS Act section 2705. Specifically, we proposed that a health insurance issuer in the small group market would be required to offer a tobacco user the opportunity to avoid paying the full amount of the tobacco rating factor permitted under PHS Act section 2701 if he or she participates in a wellness program meeting the standards of section 2705 of the PHS Act and its implementing regulations.
We proposed that the definition of “tobacco use” for purposes of section 2701 be consistent with the approach taken with respect to health-contingent wellness programs designed to prevent or reduce tobacco use under section 2705. We noted that a common definition of “tobacco use” does not currently exist among the states, resulting in wide variation in how health insurance issuers define and assess tobacco use in insurance applications. We solicited comment on how to define “tobacco use” for purposes of both section 2701 and section 2705 and suggested several possible approaches, such as reliance on self-reporting, a defined amount of tobacco use within a specified look-back period, regular tobacco use, or tobacco use of sufficient frequency so as to be addicted to nicotine. We also solicited comment on use of the single streamlined application under 45 CFR 155.405 to collect information on tobacco use.
In various provisions throughout proposed § 147.102, we proposed that
• The use of a narrower age rating ratio than 3:1 for adults age 21 and older.
• The use of a narrower tobacco rating ratio than 1.5:1 for individuals who use tobacco.
• State-established rating areas.
• State-established age rating curves.
• In states with community rating, the use of uniform family tiers and corresponding multipliers.
• A requirement that premiums be based on average enrollee amounts in the small group market.
In addition, in § 156.80(c), we proposed that a state inform CMS of its decision to merge the individual and small group markets in a state into a single risk pool.
We received no comments about the proposed reporting process. Accordingly, we are finalizing the state reporting process as proposed. However, for organization and clarity, we are consolidating these reporting requirements in a new § 147.103 of this final rule. Section 147.103(a) provides that for the 2014 plan or policy year, states will submit information no later than 30 days following publication of the final rule, in a form and manner specified by the Secretary. Section 147.103(b) provides for the Secretary to issue future guidance that would establish a process and timeline for states to submit information for plan or policy years after 2014 (or for updating a state standard that applies in 2014). As described in § 156.80(c), states will follow the same process with respect to a state decision to merge the individual and small group markets in a state into a single risk pool.
In § 147.104, we proposed that a health insurance issuer offering health insurance coverage in the individual or group market in a state must offer to any individual or employer in the state all of the issuer's products that are approved for sale in the applicable market, and accept any individual or employer that applies for those products.
We also proposed that issuers establish enrollment periods during which they would allow individuals and employers to purchase health insurance coverage. We proposed to align the initial and annual open enrollment periods outside the Exchanges with those inside the Exchanges. Specifically, we proposed a continuous open enrollment period in the group market and a fixed open enrollment period in the individual market based on a calendar policy year, consistent with the Exchange and SHOP standards outlined in 45 CFR 155.410 and 155.725. Effective dates of coverage would also follow those in the Exchange and SHOP. We solicited comment on how to address the open enrollment needs of individual market enrollees whose coverage renews on a non-calendar year basis.
We proposed that issuers in the individual and group markets establish special enrollment periods for individuals and plan participants and beneficiaries to enroll in coverage outside of the annual open enrollment period as a result of qualifying events triggering eligibility for COBRA continuation coverage under section 603 of ERISA.
We proposed that a participant, beneficiary, or enrollee would have 30 calendar days from the date of a qualifying event (generally consistent with the HIPAA standard) to request special enrollment, but invited comment on whether to establish a longer election period, such as 60 calendar days (generally consistent with the Exchange standard). We proposed special enrollment period effective dates that followed the effective dates of coverage for QHP special enrollment periods in § 155.420(b). We noted that a notice of special enrollment rights is currently required to be provided to group health plan participants and beneficiaries under HIPAA and solicited comment on whether issuers in the individual market should provide a similar notice to individual market enrollees.
Additionally, we proposed rules governing the circumstances under which issuers are permitted to deny coverage to individuals and employers. These rules would allow issuers to deny coverage to an employer whose eligible individuals do not live, work, or reside in the service area of a network plan (or to an individual who does not live or reside in the service area of a network plan) and in certain situations involving limited network capacity and limited financial capacity.
We also proposed that issuers in the small group market would be permitted to require small employers to satisfy minimum contribution or group participation requirements, to the extent allowed by state law or, in the case of a QHP offered in the SHOP, as permitted by § 156.285(c), and to decline to offer coverage if these standards were not met. This policy was intended to prevent adverse selection. Specifically, we were concerned that a small employer could take advantage of the continuous open enrollment opportunity under the proposed rule to wait to purchase a group policy.
We also addressed the issue of whether there could be an exception from the guaranteed availability requirements allowing coverage sold through bona fide associations to be limited to members of the association. We contrasted the existing provisions in section 2703(b) (which retained a guaranteed renewability exception permitting coverage to be limited to members of a bona fide association) with the provisions in section 2702 (where the exception had not been included in the statute), and proposed that there was no basis for an exception from the guaranteed availability requirement for coverage sold through bona fide associations. We invited comment, however, on whether and how a transition or exception process for bona fide association coverage could be structured to minimize disruption.
To ensure consistency in the marketing of health plans inside and outside of the Exchange and to minimize adverse selection, we proposed to extend to the entire health insurance market the Exchange marketing standard applicable to QHPs under § 156.225. This standard requires that an issuer comply with state marking standards and not employ
Finally, we solicited comment about how to prevent potential gaming of guaranteed availability rights and about strategies to minimize the risk of adverse selection.
While section 2702 contains no exception to guaranteed availability based on a failure to meet contribution or minimum participation requirements, section 2702(b)(1) permits an issuer to limit enrollment in coverage to open and special enrollment periods. Under our authority in section 2702(b)(3) to define “open enrollment periods,” we are providing in this final rule that, in the case of a small employer that fails to meet contribution or minimum participation requirements, an issuer may limit its offering of coverage to an annual open enrollment period, which we set forth in this final rule as the period beginning November 15 and extending through December 15 of each year. As such, the group market will have continuous open enrollment, except for small employers that fail to meet contribution or minimum participation requirements, for which the enrollment period may be limited to the annual enrollment period described above, from November 15 through December 15. This approach addresses concerns about adverse selection in a manner that is consistent with the statutory provisions. We do not extend this provision to the large group market because large employers generally do not present the same adverse selection risk as small employers.
Accordingly, in § 147.104(b)(2) of this final rule, we cross-reference the enrollment periods in § 155.420(d) of the March 27, 2012 Exchange finale rule
• An individual and any dependents losing minimum essential coverage.
• An individual gaining or becoming a dependent through marriage, birth, adoption, or placement for adoption.
• An individual experiencing an error in enrollment.
• An individual adequately demonstrating that the plan or issuer substantially violated a material provision of the contract in which he or she is enrolled.
• An individual becoming newly eligible or newly ineligible for advance payments of the premium tax credit or experiencing a change in eligibility for cost-sharing reductions.
• New coverage becoming available to an individual or enrollee as a result of a permanent move.
Additionally, the final rule provides that an individual enrolled in a non-calendar year plan is entitled to a limited open enrollment period beginning 30 calendar days prior to the individual's policy renewal date outside the open enrollment period for 2014. This one-time limited open enrollment period will allow individuals with non-calendar year policies in the individual market to transition to a calendar year policy that complies with 2014 market reform requirements of the Affordable Care Act.
We clarify that loss of minimum essential coverage triggering a limited open enrollment period does not include failure to pay premiums on a timely basis, including COBRA premiums prior to expiration of COBRA coverage, or situations allowing for a rescission as specified in 45 CFR 147.128.
We also note that these limited open enrollment periods do not include the events described in paragraphs (d)(3), (d)(8), or (d)(9) of § 155.420 of the March 27, 2012 Exchange final rule (concerning citizenship status, Indians, and exceptional circumstances). The enrollment periods for events described in paragraphs (d)(3) and (d)(8) are related to specific Exchange eligibility criteria and therefore are not appropriate for the broader market. The enrollment periods in paragraph (d)(9) arising from exceptional circumstances are not similar enough to those discussed in the November 26, 2012 proposed rule for HHS to include in the final rule. We would initiate future rulemaking if we were to establish a limited open enrollment period based on the triggering event in paragraph (d)(9) of § 155.420. With the exception of these triggering events, limited open enrollment periods are the same inside and outside the Exchange in the individual and the small group market. We note that states may create special enrollment periods or limited open enrollment periods in addition to those established by this final rule.
In § 147.106, we proposed to implement the guaranteed renewability provisions of section 2703 of the PHS Act. We proposed that an issuer offering health insurance coverage in the group or individual market must renew or continue in force such coverage at the option of the plan sponsor or individual. The exceptions to this requirement include: (1) Nonpayment of premiums; (2) fraud; (3) violation of minimum employer participation or contribution rules, as permitted under applicable state law; (4) termination of a particular type of product or all coverage in a market; (5) enrollees' movement outside the service area of a
We also proposed standards governing the discontinuance of a particular product or all health insurance coverage in the group or individual market, consistent with the statute.
Finally, we proposed that issuers in the group market may uniformly modify coverage at the time of coverage renewal and noted that parallel provisions in section 2742 of the PHS Act allow for the uniform modification of coverage in the individual market. We stated that the uniform modification of coverage provisions would allow issuers to make cost-sharing adjustments and benefit design changes to come into compliance with the requirements of the Affordable Care Act that become effective in 2014 and requested comment on whether such interpretation should be incorporated explicitly into regulation text.
We proposed technical changes in 45 CFR part 150 to reflect that the HIPAA enforcement standard, as originally codified in PHS Act section 2722 and redesignated as section 2723 by the Affordable Care Act, applies to the market reform provisions of the PHS Act created by the Affordable Care Act. Pursuant to section 2723, states have the primary enforcement authority with respect to health insurance issuers in the group and individual markets. HHS has secondary enforcement authority and will enforce a provision in a state only if the state advises us that it does not have authority to enforce the provision or if the state fails to substantially enforce a provision.
In § 154.200(a)(2) and (b), we proposed that states seeking state-specific thresholds submit proposals to CMS by August 1 of each year. The Secretary would publish a
Section 2794(b)(2(A) of the PHS Act directs that beginning in 2014, the Secretary, in conjunction with the states, shall monitor premium increases of health insurance coverage offered through an Exchange and outside an Exchange. To enable the Secretary to carry out this new monitoring function and to streamline data collection for programs beginning in 2014, we proposed revisions in § 154.215 that would direct health insurance issuers to submit data and documentation regarding rate increases on a standardized form determined by the Secretary. We also proposed that the rate review standards be modified by extending the requirement that health insurance issuers report information about rate increases to all rate increases, not just those above the review threshold. States would continue to have the authority to collect additional information above this baseline to conduct more thorough reviews or rate monitoring. Furthermore, the review threshold in § 154.200 would continue to be used to determine which rates must be reviewed rather than just reported.
Under the Paperwork Reduction Act of 1995 (PRA) process (44 U.S.C. chapter 35), we proposed a “unified rate review” template for health insurance issuers to use for submitting data for rate increases. In this final rule, we have revised the text of § 154.215 to reflect the “unified rate review” terminology. We also have added language explicitly reflecting the fact that the premium rates subject to rate review reporting are shaped by the premium rating standards implemented under the single risk pool requirement and the applicability of the guaranteed availability and renewability requirements. We clarify that states are not specifically required to use the unified rate review template in order to have an effective rate review program.
To account for the market reform changes in 2014, we proposed to modify the standards in § 154.301(a)(3) for
We also proposed to revise § 154.301(a)(4) by adding additional factors that states would take into consideration when conducting their examinations, including (1) in reviewing the impact of cost-sharing changes, the impact on the actuarial value of the health plan in light of the requirement under section 1302(d) of the Affordable Care Act that a plan meet one of the AV levels; and (2) in reviewing benefit changes to a plan, the impact of the changes on the plan's essential health benefits and non-essential health benefits.
Additionally, we proposed that states take into account, to the extent possible, the following additional factors when conducting an examination of a rate review filing:
• Other standardized ratio tests (in addition to the medical loss ratio) recommended or required by statute, regulation, or best practices;
• The impact of geographic factors and variations;
• The impact of changes within a single risk pool to all products or plans within the risk pool; and
• The impact of reinsurance and risk adjustment payments and charges.
Finally, we proposed revisions in § 154.301(b) to ensure that a state with an effective rate review program make available on its Web site, at a minimum, the same amount of information in Parts I, II, and III of each Rate Filing Justification that CMS makes available on its Web site. We proposed that a state may, instead of providing access to the information contained in Parts I, II, and III or each Rate Filing Justification, provide a link to CMS's Web site where consumers can find such information.
This approach strikes the appropriate balance between maintaining state flexibility and allowing CMS to carry out functions related to: (1) The monitoring of premium increases of health insurance coverage offered through an Exchange and outside an Exchange as required by section 2794(b)(2)(A) of the PHS Act; (2) Exchanges such as QHP certification and premium tax credit and cost-sharing reduction verification; and (3) the risk adjustment and reinsurance programs. We note that even without the administrative efficiencies associated with using the information collected through rate review authority for the second and third functions listed above, the same data would be needed and collected to carry out the first function by itself. We also clarify that we will use the information collected only for these specified purposes and will initiate future rulemaking if we intend to use the data for any other purpose.
We proposed to amend § 154.225 and § 154.330 by replacing the term “Preliminary Justification” with the term “Rate Filing Justification,” to reflect more appropriately the rate filing information that would be reported. We received no comments regarding this proposed change. Accordingly, we are finalizing proposed § 154.225 and § 154.330 without modification.
In § 156.80, we proposed standards to implement the requirement in section 1312(c) of the Affordable Care Act that an issuer use a single risk pool for a market (the individual market, small group market, or merged market) when developing rates and premiums for coverage effective beginning in 2014.
We proposed that an issuer develop a market-wide index rate (average rate) based on the total combined EHB claims experience of all enrollees in all non-grandfathered plans in the risk pool. After setting the index rate, the issuer would make a market-wide adjustment based on the expected aggregated payments and charges under the risk adjustment and reinsurance programs in a state. The premium rate for any given plan could not vary from the resulting adjusted market-wide index rate, except for the following factors: The actuarial value and cost-sharing structure of the plan; the plan's provider network, delivery system characteristics, and utilization management practices; plan benefits in addition to EHB; and with respect to catastrophic plans, the expected impact of specific eligibility categories for those plans. The index rate, the market-wide adjustment to the index rate, and the plan-specific adjustments would have to be actuarially justified and implemented transparently, consistent with federal and state rate review processes.
We invited comment on the set of allowable plan-specific adjustments and whether to allow flexibility in product pricing in 2016 after issuers had gained sufficient experience with the reformed market. Additionally, in the “HHS Notice of Benefit and Payment Parameters for 2014” proposed rule (77 FR 73118), we solicited comment on whether Exchange user fees or other administrative costs should be spread across all plans in a market as a market-wide adjustment to the index rate.
As for distribution costs and other administrative costs (other than Exchange user fees), we believe that issuers should be allowed to make actuarially justified adjustments to the market-wide index rate at the individual plan level for those costs. This will allow pricing to vary among individual plans by administrative costs reasonably allocable to those plans, ensuring that administrative efficiencies are priced accurately and promoting market competition. The final rule therefore includes administrative costs (other than Exchange user fees) as an additional factor that issuers may use to modify the market-wide index rate at the individual plan level.
Additionally, we would expect issuers to proportionally allocate anticipated reinsurance and risk adjustment payments and charges based on plan premium by applying the risk adjustment/reinsurance adjustment factor as a constant multiplicative factor across plans. We believe that this modification would prevent issuers from differentially allocating risk adjustment and reinsurance payments and charges across plans in a manner that would reintroduce risk selection differences into plan premiums.
Finally, with respect to catastrophic plans, we clarify that issuers may make a plan-specific adjustment to the market-wide index rate that accounts for differences between catastrophic and non-catastrophic plans in expected average enrollee gross spending and expected average risk adjustment payment transfers. This plan-specific adjustment would be uniform across all of an issuer's catastrophic plans (that is, risk across all catastrophic plans must be pooled). This adjustment for catastrophic plans should not include plan liability differences due to actuarial value, because actuarial value differences should be accounted for in the actuarial value adjustment.
In § 156.155, we proposed standards for catastrophic plans offered in the individual market, consistent with section 1302(e) of the Affordable Care Act. Specifically, we proposed that a health plan is a catastrophic plan if it: (1) Meets all applicable requirements for health insurance coverage in the individual market; (2) does not offer coverage at the bronze, silver, gold, or platinum levels of coverage described in section 1302(d) of the Affordable Care Act; (3) does not provide coverage of essential health benefits until the enrolled individual reaches the annual limitation in cost sharing in section 1302(c)(1) of the Affordable Care Act; and (4) covers at least three primary care visits per year before reaching the deductible. Further, we proposed that a catastrophic plan may not impose any cost-sharing requirements for preventive services identified in section 2713 of the PHS Act.
We also proposed to codify the statutory criteria identified in section 1302(e)(2) of the Affordable Care Act listing the two categories of individuals eligible to enroll in a catastrophic plan. The first category includes individuals who are younger than age 30 before the beginning of the plan year. The second category includes individuals who have been certified as exempt from the individual responsibility payment because they cannot afford minimum essential coverage or because they are eligible for a hardship exemption. Finally, we proposed that if a catastrophic plan covers more than one person (such as a catastrophic family plan), each individual enrolled must satisfy at least one of these two eligibility criteria.
Section 1560(c) of the Affordable Care Act provides that nothing in title I of the Affordable Care Act, or an amendment made by title I, “shall be construed to prohibit an institution of higher education (as such term is defined for purposes of the Higher Education Act of 1965) from offering a student health insurance plan, to the extent that such requirement is otherwise permitted under applicable federal, state, or local law.” HHS has interpreted section 1560(c) to mean that if particular requirements of the Affordable Care Act would have, as a practical matter, the effect of prohibiting an institution of higher education from offering a student health plan otherwise permitted under federal, state, or local law, these requirements would be inapplicable pursuant to section 1560(c).
HHS published a final rule in the March 21, 2012
Consistent with that policy, the November 26, 2012 proposed rule outlined similar exemptions for student health insurance coverage from the guaranteed availability and guaranteed renewability requirements of PHS Act sections 2702 and 2703 added by the Affordable Care Act to ensure that enrollment in student health insurance plans may be limited only to students and their dependents. Further, we solicited comment on whether issuers should be permitted to maintain a separate risk pool for student health insurance coverage and whether different premium rating rules should apply.
Student health insurance is subject under these final rules to the premium rating requirements of section 2701 of the PHS Act. We note, however, that given the exemption from single risk pool requirement, the premium rate charged by an issuer offering student health insurance coverage may be based on a school-specific group community rate if, consistent with section 2701, the issuer offers the coverage without rating for age or tobacco use. This provides flexibility to student health insurance issuers with respect to the per-member-rating provisions of PHS Act section 2701(a)(4) and § 147.102(c)(1), while ensuring that student enrollees and their dependents are not charge more based on their health status or gender.
The treatment of student health insurance coverage under these final rules will serve as a transitional policy. We intend to monitor student health insurance coverage as the insurance market transitions to the 2014 market reforms and revisit this policy in the future.
As mentioned above, we proposed, consistent with PHS Act section 2702, that non-grandfathered health insurance coverage made available in the individual or group market through a bona fide association must be guaranteed available to all individuals or employers in a state and market. These proposed rules represented a change from existing law permitting coverage sold through bona fide associations to be limited only to association members; therefore, we invited comment on whether and how a transition or exception process for bona fide association coverage could be structured to minimize disruption.
The Congressional Review Act, 5 U.S.C. 801(a)(3), ordinarily requires that the effective date of a “major rule” such as this final rule be at least 60 days from the date of publication. However, 5 U.S.C. 808(2) permits the federal agency promulgating the rule to determine an effective date, notwithstanding this otherwise applicable 60-day requirement, when an agency “for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rule issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” While this final rule is generally effective 60 days from the date of publication, we have determined for 45 CFR 147.103, which specifies the timing for state reporting of rating factors, and the amendments to 45 CFR part 154 governing rate review, an effective date 30 days from the date of publication of this rule.
Section 147.103 directs states to report to HHS within 30 days after publication of this rule certain rating factors required by § 147.102, including but not limited to: the age rating ratio if a state adopts a ratio narrower than 3:1 for adults; the tobacco rating ratio if a state adopts a ratio narrower than 1.5 to 1; a uniform age rating curve if a state adopts any; and geographical rating areas if the state establishes any. It is imperative that HHS receive these data from the states within 30 days of publication of this final rule in order to implement timely the risk adjustment methodology set forth in section 1343 of the Affordable Care Act and its implementing regulations. Should these data not be received within 30 days of publication of this final rule, HHS's risk adjustment scores for use on January 1, 2014 would have to be calculated using assumed rating factors based on the limitations set forth in this final rule, which could result in inaccurate risk adjustment payments to health insurance issuers in states that have developed different rating factors. This may in turn lead to imbalance in the insurance markets in those states with different rating factors. Furthermore, health insurance issuers are required to submit their applications by April 30, 2013 to the Exchanges to be certified as QHPs in 2014. In order to submit accurate information on their applications, the issuers will need to know what rating factors in a state will be effective starting January 1, 2014.
The amendments to 45 CFR part 154 revise the timeline for states to propose state-specific thresholds for review and approval by HHS. The amendments also direct health insurance issuers to submit data relating to proposed rate increases in a standardized format specified by the Secretary of HHS, and modify criteria and factors for states to have an effective rate review program. These changes are necessary to reflect the new market reform provisions and to fulfill the statutory requirement beginning in 2014 that the Secretary, in conjunction with the states, monitor premium increases of health insurance coverage offered through an Exchange and outside of an Exchange. The provisions are also designed to streamline data collection for issuers, states, Exchanges, and HHS. Since health insurance issuers will be submitting their 2014 rate filings in states starting April 1, 2013, these amendments must be effective at that point for consumers to experience the full benefits in 2014 of the rate review process both inside and outside the Exchanges.
Furthermore, HHS and the states must have the ability to collect, beginning April 1, 2013, rate data from health insurance issuers relating to the 2014 market reforms to ensure effective implementation of the market reforms starting January 1, 2014. For example, if the data submission requirement for all rate increases is not in place by April 1, 2013, states and HHS will have very little ability to gauge whether issuers have combined all of their products into a single risk pool in either the individual or small group markets. Issuers could, therefore, implement different index rates and allowable modifiers without fear of being observed by a regulator for some time, which would have the potential effect of issuers continuing to rate for health status in 2014.
Accordingly, for the reasons stated above, 45 CFR 147.103 of this final rule and the amendments to 45 CFR part 154 are effective 30 days after publication of this final rule.
For the most part, this final rule incorporates the provisions of the proposed rule. Those provisions of this final rule that differ from the proposed rule are as follows:
• Clarifies that tobacco use means use of tobacco on average four or more times per week within no longer than the past six months, including all tobacco products but excluding religious and ceremonial uses of tobacco. Further, tobacco use must be defined in terms of when a tobacco product was last used. Additionally, clarifies that issuers may vary rates for tobacco use only with respect to individuals who may legally use tobacco under federal and state law.
• Gives states additional flexibility to establish geographic rating areas that would be presumed adequate.
• Modifies the default rating area standard such that there would be one rating area for each metropolitan statistical area and one rating area comprising all non-metropolitan statistical areas in the state.
• Clarifies the criteria that HHS will use to determine whether proposed state rating areas are adequate.
• Clarifies that the cap on the number of individuals under age 21 taken into account when computing the family premium applies to the three oldest “covered children” under age 21.
• Deletes language in paragraphs (a)(1)(iii) and (a)(1)(iv) providing that states may use narrower age and tobacco use factors to avoid confusion.
• Consolidates state reporting requirements in a new § 147.103.
• Adds events triggering limited open enrollment periods in the individual market, consistent with Exchange special enrollment periods, as well as a one-time limited open enrollment period for the 2014 calendar year for individuals with non-calendar year individual policies.
• Establishes 60-day special and limited open enrollment periods in the individual market; maintains 30-day special enrollment periods in the group market.
• Ensures consistency of the prohibition against employing discriminatory marketing practices and benefit designs with the prohibition on discrimination with respect to EHB in § 156.125 and the non-discrimination standards applicable to QHPs under § 156.200(e).
• Exempts student health insurance coverage from the single risk pool requirements of Affordable Care Act section 1312(c).
• Clarifies that if any product is subject to a rate increase, an issuer must submit a Rate Filing Justification for all products in the single risk pool, including new or discontinuing products.
• Replaces the term “standardized data template” with “unified rate review template” each place it appears.
• Clarifies that the index rate for the single risk pool must be adjusted on a market-wide basis for Exchange user fees and may be adjusted at the plan-level for distribution costs and other administrative costs.
• Makes a technical correction in paragraph (c) of this section that each enrolled individual in the case of a catastrophic plan covering multiple individuals must meet the eligibility criteria outlined in paragraph “(a)(5)” of this section.
In the November 26, 2012 proposed rule (77 FR 70584), we solicited public comments on each of the sections identified as containing information collection requirements (ICRs). In this final rule, we are restating our summary of the information collection requirements and providing summaries of the comments received and our responses to those comments. Regarding wage data, we generally used data from the Bureau of Labor Statistics to derive average labor costs (including fringe benefits) for estimating the burden associated with the ICRs.
The final rule directs states to submit to CMS certain information as applicable about their rating and risk pooling requirements. A state will inform CMS if it adopts a narrower age rating ratio than 3:1 or adopts a narrower rating ratio for tobacco use than 1.5:1. A state will also submit information to CMS regarding state-established geographic rating areas and state-established uniform age rating curves. A state with pure community rating will submit information to CMS about its uniform family tiers and corresponding multipliers, if any. A state will also inform CMS if it requires premiums to be based on average enrollee amounts in the small group market (§ 147.103). Finally, a state will inform CMS if it elects to merge its individual and small group market risk pools (§ 156.80(c)). Because we do not know how many states will choose to establish their own geographical rating areas, age rating curves, and family tier structures; adopt narrower age or tobacco rating factors; require premiums to be based on average enrollee amounts in the small group market; or merge their individual and small group market risk pools, we have estimated the burden for one state.
The burden associated with this requirement is the time involved for states to provide to CMS information on the rating factors and requirements applicable to their small group and individual markets. If a state adopts narrower rating ratios for age or tobacco use, or chooses to merge their individual and small group market risk pools, the state will inform CMS. We estimate that it will take 20 minutes for a state to prepare and submit a report to CMS for each of these disclosures, for a total burden of one hour and a cost of approximately $31 for all three reports combined.
This final rule provides that a state's rating areas must be based on the geographic divisions of counties, three-digit zip codes, or MSAs and non-MSAs and will be presumed adequate if either of the following conditions are met: (1) As of January 1, 2013, the state had established by law, rule, regulation, bulletin, or other executive action uniform geographic rating areas for the entire state; or (2) After January 1, 2013, the state establishes by law, rule, regulation, bulletin, or other executive action for the entire state no more geographic rating areas than the number of MSAs in the state plus one. We anticipate that states that currently have geographical rating areas will retain them. For states that establish rating areas, we estimate that it will take one hour for a state to prepare and submit a report to CMS on its geographical rating areas, for a burden of one hour and a cost of approximately $31.
If a state develops an age rating curve, the state will report the state's age rating curve to CMS. We anticipate that HHS's default standard age rating curve will apply in most states. Only one state commented that it would establish its own age rating curve. For states that designate their own curve, we estimate that it will take three hours for each state to prepare and submit a report on its age rating curve, for a burden of three hours and a cost of $93.
If a state is community rated and designates a uniform family tier structure with corresponding multipliers, the state will report family tier structure information to CMS. We estimate that very few states will designate family tier structures and that it will take one hour to prepare and submit a report to CMS. The burden for reporting family tier structure information is estimated to be one hour, and a cost of approximately $31.
If a state requires premiums in the small group market to be based on average enrollee amounts, it will submit that information to CMS. We estimate that it will take one hour for a state to prepare and submit the report on small group market premiums to CMS, for a burden of one hour and a cost of approximately $31.
We assume that each report will be prepared by clerical staff (at a cost of approximately $31 per hour) and will be reviewed by a senior manager (using 1 hour of labor at approximately $65 per hour) prior to submission to CMS. The total burden for all disclosures is eight hours (seven by clerical staff and one by a senior manager) and approximately $279 per state, if a state needs to prepare and submit a report in all of these areas.
We expect that states that already have established a narrower age or tobacco rating ratio, family tier structure and requirements for small group market premiums to be based on average enrollee amounts, will retain them and simply incur the burden of reporting them. Based on our interactions with state officials and review of publicly available studies prepared by actuarial firms on the impact of the Affordable Care Act on the health insurance market in various states, we believe that many states have already studied the issue of merging their individual and small group market risk pools and would only incur the burden of reporting. We anticipate that few states will choose to establish their own age rating curve or establish new geographical rating areas and incur related administrative costs. If a state chooses to establish its own age rating curve (§ 147.102(e)), it is likely to engage an actuarial consultant. We estimate that it will require approximately 100 hours of effort by an actuary (at a cost of $225 per hour) and 23 hours of combined labor by state actuaries (10 hours at a cost of approximately $50 per hour) and senior management (13 hours at a cost of approximately $65 an hour) to establish an age curve. The total burden will be 123 hours and approximately $24,000. If a state chooses to establish geographical rating areas (§ 147.102(b)), if they haven't already done so, staff actuaries are likely to conduct an analysis and prepare a report for management (30 hours at a cost of approximately $50 per hour) and senior management will review the reports and make a decision (2 hours at a cost of approximately $65 an hour). The total burden would be 32 hours and approximately $1,600.
This final rule directs that health insurance issuers use a unified rate review template, as specified by the
Health insurance issuers seeking rate increases will submit data using the unified rate review template and will incur administrative costs to prepare and submit the data. Based on CMS's experience with the 2011 MLR reporting year, there are 2,010 health insurance issuers (company/state combinations, including territories) offering coverage in the individual market in all states and 1,050 issuers offering coverage in the small group market in all states, while there are 2,294 unique issuers offering products in one or both markets. Most issuers already have to provide this information to their respective states. We anticipate a total of 7,650 submissions for rate review increases annually in both markets. Based on past experience, we anticipate that approximately 1,200 of these submissions will be for rate increases at or above the subject to review threshold and the remaining 6,450 submissions will be for rate increases below the review threshold. We assume that each submission will require 11 hours of work by an actuary (at a cost of $225 per hour), including minimal time required for recordkeeping. The total cost for all submissions will be approximately $19 million. Therefore, the increase in administrative costs for all issuers seeking rate increases below the review threshold will be approximately $16 million, with an average of $7,000 per issuer. It should be noted that there are administrative efficiencies gained by helping issuers to avoid significant duplication of effort for filings subject to review by using the same standardized template for all issuers offering health insurance coverage in the small group or individual markets across all states, and because the vast majority of states currently require all rate increases to be filed. These efficiencies are not quantified in this rule.
A few commenters remarked that the costs related to rate review template submission have been underestimated. An industry group also provided estimates of the number of submissions and related costs. According to industry feedback received by CMS, the current rate review template being used requires only one to four hours of actuarial labor to complete. The unified rate review template includes more data and we estimate that it would take an actuary 11 hours, on average, to complete. Issuers will have to submit only one consolidated report for all their products in a market, unlike the current template in use which requires a separate submission for each product.
Additionally, issuers seeking rate increases may need to adjust their systems to provide the data required in the unified rate review template and incur one-time costs. One commenter provided a range of anticipated costs obtained from an industry survey. However, we do not expect many issuers to undertake major systems changes to prepare the rate review submissions. Most of the data elements specified in the new template are currently captured by issuers and most of the changes will involve categorizing the data into new categories and aggregating the information to the market level. We estimate that an issuer would need, on average, 40 hours of work by a programmer (at a cost of approximately $50 per hour) to develop a program that will extract the necessary data from its systems. The total one-time cost to all issuers for developing a program to extract the necessary data will be approximately $4.6 million, with an average cost of approximately $2,000 per issuer.
For filings subject to review, states with effective rate review programs may use the data submissions in their reviews; however, this is not expected to increase review costs.
Based on comments received and discussions with issuers and states, we have made changes to the proposed template to address concerns that have been raised. We have both removed data elements from the uniform rate review template and identified information that will be optional in the first two years of applicability. We estimate that through these changes we have reduced the number of required data elements by approximately 45 percent. States may collect additional information above this baseline. We expect that the unified rate review template will not significantly increase the burden on states or industry; rather, the data requested in the template will assist states and industry in complying with the market rules.
In addition, the final rule gives states with effective rate review programs the discretion to choose whether to incorporate the unified rate review template in their rate review processes or whether to use their own rate review templates. Issuers in states with effective rate review programs that do not require the federal template will still be required to submit information about all rate increases to CMS on the template.
We have submitted an information collection request to OMB for review and approval of the ICRs contained in this final rule. The requirements are not effective until approved by OMB and assigned a valid OMB control number.
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.
As stated earlier in this preamble, this final rule implements the Affordable Care Act's requirements on health insurance coverage related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans. These provisions are generally effective for plan or policy years beginning on or after January 1, 2014. In addition, this final rule amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the rate review program.
CMS has crafted this final rule to implement the protections intended by Congress in an economically efficient manner. We have examined the effects of this final rule as required by Executive Order 13563 (76 FR 3821, January 21, 2011), Executive Order 12866 (58 FR 51735, September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)). In accordance with OMB Circular A–4, CMS has quantified the benefits, costs, and transfers where possible, and has also provided a qualitative discussion of the benefits, costs, and transfers that may stem from this final rule.
Executive Order 12866 (58 FR 51735) directs 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 (76 FR 3821, January 21, 2011) is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866.
Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a final rule—(1) Having an annual effect on the economy of $100 million or more in any one 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 rules with economically significant effects (for example, $100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the OMB. OMB has designated this final rule as a “significant regulatory action.” Even though it is uncertain whether it is likely to have economic impacts of $100 million or more in any one year, CMS has provided an assessment of the potential costs, benefits, and transfers associated with this final regulation.
Sections 1302(e) and 1312(c) of the Patient Protection and Affordable Care Act (Affordable Care Act), and sections 2701, 2702, and 2703 of the Public Health Service Act (PHS Act), as added and amended by the Affordable Care Act, create certain standards related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans applicable to non-grandfathered health insurance coverage starting in 2014. These final regulations provide the necessary guidance to implement these important consumer protections. The current individual and small group health insurance markets generally are viewed as dysfunctional, placing consumers at a disadvantage due to the high cost of health insurance coverage, resulting from factors such as lack of competition, adverse selection, and limited transparency. In addition to affordability concerns, many people have difficulty finding and enrolling in coverage options. If employer-based coverage is not available, a person may find that affordable individual market coverage is not available due to medical underwriting. The provisions of this final rule, combined with other provisions in the Affordable Care Act, will improve the functioning of both the individual and the small group markets and make insurance affordable and accessible to millions of Americans who currently do not have affordable options available to them. In addition, this final rule would amend the existing rate review standards to reflect the new market conditions in 2014.
In accordance with OMB Circular A–4, Table VI.1 below depicts an accounting statement summarizing CMS's assessment of the benefits, costs, and transfers associated with this regulatory action. The period covered by the RIA is 2013–2017.
CMS anticipates that the provisions of these final regulations would ensure increased access and improve affordability of health insurance coverage in the individual and small group markets. Individuals who are currently unable to obtain affordable coverage because of their medical history, health status, gender, or age will be able to obtain such coverage under these final rules, along with other provisions of the Affordable Care Act, leading to an increase in the number of people with health insurance. Newly insured individuals and individuals with expanded coverage will have increased access to health care, improving utilization of preventive care and health outcomes and protection from the risk of catastrophic medical expenditures, leading to financial security. In addition, an issuer seeking a rate increase will submit data and documentation about the rate increase using a unified rate review template, which will provide CMS the data necessary for monitoring rate increases. In accordance with Executive Order 12866, CMS expects that the benefits of this final regulatory action justify the costs.
In developing this final rule, CMS carefully considered its potential effects including both costs and benefits. One commenter suggested providing additional quantitative estimates of benefits, costs and transfers. Because of data limitations, CMS did not attempt to quantify all of the benefits, costs, and transfers resulting from this final rule. Nonetheless, CMS was able to identify several potential impacts which are discussed qualitatively below.
There are diverse state laws and industry practices currently in place that result in wide variation in premium rates (henceforth referred to as “rates”) and coverage for individual and group health insurance markets. Regarding the individual market, only five states have both guaranteed availability for at least some products and modified or pure community rating requirements, while in other states, issuers can deny health insurance coverage or charge higher premiums to people with medical conditions.
Currently, only five states have guaranteed availability in the individual market. Studies show that 48 states require guaranteed renewability in the small group market while all 50 states provide some level of guaranteed renewability in the individual market. In addition, HIPAA already provides guaranteed renewability of coverage to individuals and employers, irrespective of state law. Therefore, this provision is not expected to have any significant effect in that regard.
Starting in 2014, issuers in the individual and small group markets will only be allowed to vary rates based on age and tobacco use within specified ranges, family size, and geography (the fair health insurance premium requirement). Issuers generally will accept every individual and employer that applies for health insurance coverage (the guaranteed availability requirement), and, subject to certain exceptions, must also renew or continue health insurance coverage at the option of the plan sponsor or individual (the guaranteed renewability requirement). In addition, issuers must have single risk pools for each of the individual and small group markets, or a single merged risk pool, if a state so elects, which will include all individuals enrolled in non-grandfathered plans in the applicable market (the single risk pool requirement).
The provisions of the final rule will affect the characteristics of enrollees, enrollment, and premium rates in the individual and small group markets. In addition, several other related provisions of the Affordable Care Act that will be effective in 2014, such as establishment of the Exchanges, premium tax credits, and the minimum essential coverage provision, will improve access to and affordability of health insurance coverage. The Congressional Budget Office (CBO) estimates that, by 2017, the number of uninsured will be reduced by 27 million.
A few commenters referred to actuarial studies that include estimates of premium changes in different states and markets.
This final rule directs that health insurance issuers use a unified rate review template, as specified by the Secretary, to report information about a proposed rate increase to CMS. States will continue to have the authority to collect additional information above this baseline to conduct more thorough reviews or rate monitoring.
In 2011, 48.6 million people in the United States were uninsured.
The provisions of this final rule and other changes implemented by the Affordable Care Act will increase enrollment in the individual and small group markets. According to CBO, there will be approximately 26 million enrollees in Exchange coverage by 2017. CBO estimates that, by 2017, the number of uninsured will be reduced by 27 million.
Research shows that individuals in relatively poor health experience difficulty obtaining health insurance coverage. This results in lack of adequate access to health care and higher out-of-pocket expenses for these individuals. According to a recent study by U.S. Government Accountability Office (GAO), between 36 million and 122 million adults age 19 to 64 years old (or between 20 and 66 percent of the adult population) have medical conditions that could result in issuers denying them coverage or charging higher premiums.
The provisions of this final rule and other changes implemented by the Affordable Care Act will increase enrollment in the individual market. An analysis by CBO and the staff of the Joint Committee on Taxation (JCT)
Currently, health insurance issuers may maintain several blocks of business, or “pools,” for their individual and small group market business. Most states place some restrictions on the number of small group blocks of business. However, the individual market generally has not been subject to similar restrictions. In the past, some issuers used separate pools to segment risks, resulting in large rate increases for less-healthy enrollees. A single risk pool will tend to lower rates for relatively unhealthy participants in the individual market by including younger, healthier individuals in the pool and ensuring that newer and more long-term policyholders are pooled together. In the small group market, a single risk pool will stabilize rates.
The guaranteed availability provision may result in some adverse selection—individuals with poor health who would have been denied coverage before in some states will now be able to obtain health insurance. However, according to CBO and JCT,
Administrative costs for issuers will be lowered because of the elimination of medical underwriting and the ban on coverage exclusions. Costs should decrease for processing new applications for coverage and implementing the coverage exclusions in the individual and small group markets. This, in turn, could contribute to lower premium rates.
The final rule also requires all health insurance issuers marketing group or individual health insurance coverage to comply with the same marketing standards as issuers offering QHPs within the Exchanges. This minimizes the potential for the adverse selection that could result if plans sold through Exchanges were subject to different marketing standards from plans sold outside of the Exchanges. A common standard covering the entire insurance market will also ensure consistency in market oversight, increase competition, and reduce search costs for consumers.
The amendments to the rate review standards will help avoid significant issuer duplication of effort for filings subject to review by using the same standardized template for all issuers offering health insurance coverage in the small group or individual markets. Additionally, the use of the unified rate review template will provide the necessary information to conduct the review and approval of products sold inside and outside an Exchange, monitor rates to detect patterns that could signal market disruption, and oversee the market-wide rules.
Under the final rule, issuers will likely incur some one-time, fixed costs in order to comply with the provisions of this final rule, including administrative expenditures for systems and software updates and changes in marketing. In addition, states may incur costs in order to establish geographic rating areas and uniform age rating curves. We do not anticipate that many states will establish their own age curve: Only one state has indicated that it would establish its own age rating curve. As discussed in section V. of the preamble, we estimate that a state would incur approximately $24,000 in costs to establish its own age curve. The final rule provides that a state's rating areas must be based on the geographic divisions of counties, three-digit zip codes, or MSAs and non-MSAs and will be presumed adequate if either of the following conditions are met: (1) As of January 1, 2013, the state had established by law, rule, regulation, bulletin, or other executive action uniform geographic rating areas for the entire state; or (2) After January 1, 2013, the state establishes by law, rule, regulation, bulletin, or other executive action for the entire state no more geographic rating areas than the number of MSAs in the state plus one. States have the option to seek approval from CMS of a greater number of rating areas as long as the areas are based on counties, three-digit zip codes, or MSAs and non-MSAs. We anticipate that few states will incur costs related to establishing rating areas and estimate that related costs will be approximately $1,600 each for those that do.
In addition to these administrative costs, insurance coverage can lead to increased utilization of health services for individuals who become newly insured. While a portion of this increased utilization may be economically inefficient, studies that estimated the effects of Medicare found that the cost of this inefficiency is likely more than offset by the benefit of risk reduction.
The final rule also directs states to provide information to CMS about their rating and risk pooling practices in several key areas, as applicable. They include: Age and tobacco rating factors, age rating curves, family tier structure, composite rating in the small group market, geographical rating areas, and combined individual and small group market risk pools. As discussed in section V. of the preamble, we estimate a total burden of approximately $279 for a state to submit information in all seven areas. This estimate does not include the costs of establishing age curves and geographical rating areas, which are discussed above.
Health insurance issuers seeking rate increases below the subject to review threshold will submit data using the unified rate review template and incur administrative costs to prepare and submit the data. As discussed in section V. of the preamble, we estimate that the increase in administrative costs for all issuers seeking rate increases below the review threshold will be approximately $16 million, with an average of $7,000 per issuer. It should be noted that the vast majority of states currently require all rate increases to be filed and that administrative efficiencies can be gained by avoiding significant issuer duplication of effort for filings subject to review by using the same standardized template for all issuers offering health insurance coverage in the small group or individual markets across all states, and because the vast majority of states currently require all rate increases to be filed. These efficiencies are not quantified in this rule.
Additionally, issuers seeking rate increases may need to adjust their systems to provide the data required in the standardized template format. The total one-time cost to all issuers for developing a program to extract the necessary data from their systems is estimated at approximately $4.6 million, with an average cost of approximately $2,000 per issuer.
For filings subject to review, states with effective rate review programs may use the data submissions in their reviews; however, it is not expected to increase review costs.
As discussed elsewhere in the preamble, most aspects of rating methodologies today are left to the discretion of health insurance issuers, subject to oversight by the states. In most states, issuers may vary premium rates based on a number of factors such as age, health status, and gender. In 2010, 60 percent of non-elderly adults who shopped for insurance coverage in the individual market had difficulty finding affordable coverage.
As people who were previously uninsured obtain coverage, their out-of-pocket expenses are expected to decrease while the issuers' spending will increase, which is expected to be mitigated by an increase in premium collections. Expansion in health insurance coverage will also reduce the amount of uncompensated care for providers that treat the uninsured. Millions of people without health insurance now use health care services for which they do not fully pay, shifting the uncompensated cost of their care to health care providers, people who do have insurance (in the form of higher premiums), and state and local governments.
Under Executive Order 12866, CMS is required to consider alternatives to issuing rules and alternative regulatory approaches.
Under the final rule, all issuers in a state and market will use a uniform age rating curve. CMS considered the alternative of allowing issuers to set their own rating curve. Under the alternative, issuers would have more flexibility and might incur lower upfront, fixed costs (for example, systems and software updates) to comply with the final rule. A uniform age rating curve, however, improves the accuracy of risk adjustment, provides for easier price comparisons between different plans, and simplifies identification of the second lowest cost silver plan for purposes of determining premium tax credits.
CMS also considered the alternatives of including a tobacco component for the rating curve and keeping the rating factor for tobacco use separate from the wellness program rules. These alternatives would reduce flexibility for the issuers with respect to rating for tobacco use and would provide no alternative to the tobacco surcharge which could discourage disclosure of tobacco use. Under the final rule, a health insurance issuer in the small group market may implement the tobacco use surcharge only in connection with a wellness program that effectively allows tobacco users to reduce their premiums to the level of non-tobacco users by participating in a tobacco cessation program or satisfying another reasonable alternative. This provision will help to alleviate underreporting of tobacco use and promote tobacco cessation strategies that improve health and reduce health care costs.
CMS believes that the provisions of this final rule strike the best balance of extending protections of the Affordable Care Act to consumers while preserving the availability of such coverage and minimizing market disruptions to the extent possible.
The Regulatory Flexibility Act (RFA) requires agencies that issue a rule to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as—(1) A proprietary firm meeting the size standards of the Small Business Administration (SBA), (2) a nonprofit organization that is not dominant in its field, or (3) a small government jurisdiction with a population of less than 50,000 (states and individuals are not included in the definition of “small entity”). CMS uses as its measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3 to 5 percent.
As discussed in the Web Portal final rule published on May 5, 2010 (75 FR 24481), CMS examined the health insurance industry in depth in the Regulatory Impact Analysis we prepared for the final rule on establishment of the Medicare Advantage program (69 FR 46866, August 3, 2004). In that analysis it was determined that there were few, if any, insurance firms underwriting comprehensive health insurance policies (in contrast, for example, to travel insurance policies or dental discount policies) that fell below the size thresholds for “small” business established by the SBA (currently $7 million in annual receipts for health issuers).
In addition, CMS used the data from Medical Loss Ratio (MLR) annual report submissions for the 2011 MLR reporting year to develop an estimate of the number of small entities that offer comprehensive major medical coverage. These estimates may overstate the actual number of small health insurance issuers that would be affected, since they do not include receipts from these companies' other lines of business. It is estimated that there are 22 small entities each with less than $7 million in earned premiums that offer individual or group health insurance coverage and would therefore be subject to the requirements of this final regulation. These small entities account for less than five percent of the estimated 466 companies offering health insurance coverage in the individual or group markets in different states that would be affected by the provisions of this rule. Thirty six percent of these small entities belong to holding groups, and many if not all of these small entities are likely to have other lines of business that would result in their revenues exceeding $7 million. For these reasons, CMS expects that this final rule will not affect small issuers.
The requirements in this final rule may affect health insurance premiums in the small group market. We expect that many employers that purchase health insurance coverage in the small group market would meet the SBA standard for small entities. As mentioned earlier in the impact analysis, the impact on premiums is likely to be small and may even lead to lower rates in the small group market. CMS will monitor premium changes in the small group market through the rate review program.
Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 requires that agencies assess anticipated costs and benefits before issuing any final rule that includes a federal mandate that could result in any expenditure in any one year by state, local or tribal governments, in the
UMRA does not address the total cost of a final rule. Rather, it focuses on certain categories of cost, mainly those “federal mandate” costs resulting from—(1) imposing enforceable duties on state, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, state, local, or tribal governments under entitlement programs.
This final rule gives state governments the option to establish rating areas within the state and uniform age rating curves. There are no mandates on local or tribal governments. State governments may incur administrative cost related to the option of establishing rating areas and uniform age rating curves. However, if the state government does not act, CMS will establish the rating areas and uniform age rating curve in that state. State governments will also incur administrative costs related to disclosure of rating and pooling requirements to CMS, which are estimated to be $279 per state. The private sector (for example, health insurance issuers) will incur administrative costs related to the implementation of the provisions in this final rule. This final rule does not impose an unfunded mandate on local or tribal governments. However, consistent with policy embodied in UMRA, this final rule has been designed to be low-burden alternative for state, local and tribal governments, and the private sector while achieving the objectives of the Affordable Care Act.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications.
As discussed earlier in the preamble, states are the primary regulators of health insurance coverage. States will continue to apply state laws regarding health insurance coverage. However, if any state law or requirement prevents the application of a federal standard, then that particular state law or requirement would be preempted. If CMS determines that a state does not meet the criteria for an effective rate review program, then CMS will review a rate increase subject to review to determine whether it is unreasonable. If a state does meet the criteria, then CMS will adopt that state's determination of whether a rate increase is unreasonable. States will continue to apply state law requirements regarding rate and policy filings. State requirements that are more stringent than the federal requirements would be not be preempted by this final rule. Accordingly, states have significant latitude to impose requirements with respect to health insurance coverage that are more restrictive than the federal law.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policymaking discretion of the states, CMS has engaged in efforts to consult with and work cooperatively with affected states, including consulting with National Association of Insurance Commissioners.
Throughout the process of developing this final rule, CMS has attempted to balance the states' interests in regulating health insurance issuers and Congress's intent to provide uniform protections to consumers in every state. By doing so, it is CMS's view that it has complied with the requirements of Executive Order 13132. Under the requirements set forth in section 8(a) of Executive Order 13132, and by the signatures affixed to this rule, HHS certifies that the CMS Center for Consumer Information and Insurance Oversight has complied with the requirements of Executive Order 13132 for the attached final rule in a meaningful and timely manner.
This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801,
Health care, Health insurance, Reporting and recordkeeping requirements.
Health care, Health insurance, Reporting and recordkeeping requirements, and State regulation of health insurance.
Administrative practice and procedure, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Claims, Health care, Health insurance, Health plans, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interest, Consumer protection, Grant programs-health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs-health, Organization and functions (Government agencies), Medicaid, Public assistance programs, Reporting and recordkeeping requirements, Safety, State and local governments, Sunshine Act, Technical Assistance, Women, and Youth.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR parts 144, 147, 150, 154, and 156 as set forth below:
Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg–63, 300gg–91, and 300gg–92).
(d) * * *
(1) States that fail to substantially enforce one or more provisions of part 146 concerning group health insurance, one or more provisions of part 147 concerning group or individual health insurance, or the requirements of part 148 of this subchapter concerning individual health insurance.
(2) Insurance issuers in States described in paragraph (d)(1) of this section.
(a) For purposes of 45 CFR parts 144 through 148, all health insurance coverage is generally divided into two markets—the group market and the individual market. The group market is further divided into the large group market and the small group market.
(b) The protections afforded under 45 CFR parts 144 through 148 to individuals and employers (and other sponsors of health insurance offered in connection with a group health plan) are determined by whether the coverage involved is obtained in the small group market, the large group market, or the individual market.
(c) Coverage that is provided to associations, but not related to employment, and sold to individuals is not considered group coverage under 45 CFR parts 144 through 148. If the coverage is offered to an association member other than in connection with a group health plan, or is offered to an association's employer-member that is maintaining a group health plan that has fewer than two participants who are current employees on the first day of the plan year, the coverage is considered individual health insurance coverage for purposes of 45 CFR parts 144 through 148. The coverage is considered coverage in the individual market, regardless of whether it is considered group coverage under state law. If the health insurance coverage is offered in connection with a group health plan as defined at 45 CFR 144.103, it is considered group health insurance coverage for purposes of 45 CFR parts 144 through 148.
(d) Provisions relating to CMS enforcement of parts 146, 147, and 148 are contained in part 150 of this subchapter.
Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg–63, 300gg–91, and 300gg–92), as amended.
(a)
(1) The rate may vary with respect to the particular plan or coverage involved only by determining the following:
(i) Whether the plan or coverage covers an individual or family.
(ii) Rating area, as established in accordance with paragraph (b) of this section.
(iii) Age, except that the rate may not vary by more than 3:1 for like individuals of different age who are age 21 and older and that the variation in rate must be actuarially justified for individuals under age 21, consistent with the uniform age rating curve under paragraph (e) of this section. For purposes of identifying the appropriate age adjustment under this paragraph and the age band under paragraph (d) of this section applicable to a specific enrollee, the enrollee's age as of the date of policy issuance or renewal must be used.
(iv) Subject to section 2705 of the Public Health Service Act and its implementing regulations (related to prohibiting discrimination based on health status and programs of health promotion or disease prevention) as applicable, tobacco use, except that such rate may not vary by more than 1.5:1 and may only be applied with respect to individuals who may legally use tobacco under federal and state law. For purposes of this section, tobacco use means use of tobacco on average four or more times per week within no longer than the past 6 months. This includes all tobacco products, except that tobacco use does not include religious or ceremonial use of tobacco. Further, tobacco use must be defined in terms of when a tobacco product was last used.
(2) The rate must not vary with respect to the particular plan or coverage involved by any other factor not described in paragraph (a)(1) of this section.
(b)
(2) If a state does not establish rating areas as provided in paragraphs (b)(3) and (b)(4) of this section or provide information on such rating areas in accordance with § 147.103, or CMS determines in accordance with paragraph (b)(5) of this section that a state's rating areas under paragraph (b)(4) of this section are not adequate, the default will be one rating area for each metropolitan statistical area in the state and one rating area comprising all non-metropolitan statistical areas in the state, as defined by the Office of Management and Budget.
(3) A state's rating areas must be based on the following geographic boundaries: Counties, three-digit zip codes, or metropolitan statistical areas and non-metropolitan statistical areas, as defined by the Office of Management and Budget, and will be presumed adequate if either of the following conditions are satisfied:
(i) The state established by law, rule, regulation, bulletin, or other executive action uniform rating areas for the entire state as of January 1, 2013.
(ii) The state establishes by law, rule, regulation, bulletin, or other executive action after January 1, 2013 uniform rating areas for the entire state that are no greater in number than the number of metropolitan statistical areas in the state plus one.
(4) Notwithstanding paragraph (b)(3) of this section, a state may propose to CMS for approval a number of rating areas that is greater than the number described in paragraph (b)(3)(ii) of this section, provided such rating areas are based on the geographic boundaries specified in paragraph (b)(3) of this section.
(5) In determining whether the rating areas established by each state under paragraph (b)(4) of this section are adequate, CMS will consider whether the state's rating areas are actuarially justified, are not unfairly discriminatory, reflect significant differences in health care unit costs, lead to stability in rates over time, apply uniformly to all issuers in a market, and are based on the geographic boundaries of counties, three-digit zip codes, or metropolitan statistical areas and non-metropolitan statistical areas.
(c)
(1)
(2)
(3)
(d)
(1)
(2)
(3)
(e)
(f)
(g)
(h)
(a)
(1) A ratio narrower than 3:1 in connection with establishing rates for individuals who are age 21 and older, pursuant to § 147.102(a)(1)(iii).
(2) A ratio narrower than 1.5:1 in connection with establishing rates for individuals who use tobacco legally, pursuant to § 147.102(a)(1)(iv).
(3) Geographic rating areas, pursuant to § 147.102(b).
(4) In states that do not permit rating based on age or tobacco use, uniform family tiers and corresponding multipliers, pursuant to § 147.102(c)(2).
(5) A requirement that that issuers in the small group market offer to a group premiums that are based on average enrollee amounts, pursuant to paragraph § 147.102(c)(3).
(6) A uniform age rating curve, pursuant to § 147.102(e).
(b)
(c)
(a)
(b)
(1)
(ii)
(2)
(3)
(4)
(5)
(c)
(i) Limit the employers that may apply for the coverage to those with eligible individuals in the group market who live, work, or reside in the service area for the network plan, and limit the individuals who may apply for the coverage in the individual market to those who live or reside in the service area for the network plan.
(ii) Within the service area of the plan, deny coverage to employers and individuals if the issuer has demonstrated to the applicable state authority (if required by the state authority) the following:
(A) It will not have the capacity to deliver services adequately to enrollees of any additional groups or any additional individuals because of its obligations to existing group contract holders and enrollees.
(B) It is applying paragraph (c)(1) of this section uniformly to all employers and individuals without regard to the claims experience of those individuals, employers and their employees (and their dependents) or any health status-related factor relating to such individuals, employees, and dependents.
(2) An issuer that denies health insurance coverage to an individual or an employer in any service area, in accordance with paragraph (c)(1)(ii) of this section, may not offer coverage in the individual or group market, as applicable, within the service area to any individual or employer, as applicable, for a period of 180 calendar days after the date the coverage is denied. This paragraph (c)(2) does not limit the issuer's ability to renew coverage already in force or relieve the issuer of the responsibility to renew that coverage.
(3) Coverage offered within a service area after the 180-day period specified in paragraph (c)(2) of this section is subject to the requirements of this section.
(d)
(i) It does not have the financial reserves necessary to offer additional coverage.
(ii) It is applying this paragraph (d)(1) uniformly to all employers or individuals in the group or individual market, as applicable, in the state consistent with applicable state law and without regard to the claims experience of those individuals, employers and their employees (and their dependents) or any health status-related factor relating to such individuals, employees, and dependents.
(2) An issuer that denies health insurance coverage to any employer or individual in a state under paragraph (d)(1) of this section may not offer coverage in the group or individual market, as applicable, in the state before the later of either of the following dates:
(i) The 181st day after the date the issuer denies coverage.
(ii) The date the issuer demonstrates to the applicable state authority, if required under applicable state law, that the issuer has sufficient financial reserves to underwrite additional coverage.
(3) Paragraph (d)(2) of this section does not limit the issuer's ability to renew coverage already in force or relieve the issuer of the responsibility to renew that coverage.
(4) Coverage offered after the 180-day period specified in paragraph (d)(2) of this section is subject to the requirements of this section.
(5) An applicable state authority may provide for the application of this paragraph (d) on a service-area-specific basis.
(e)
(f)
(g)
(a)
(b)
(1)
(2)
(3)
(i) The term “employer contribution rule” means a requirement relating to the minimum level or amount of employer contribution toward the premium for enrollment of participants and beneficiaries.
(ii) The term “group participation rule” means a requirement relating to the minimum number of participants or beneficiaries that must be enrolled in relation to a specified percentage or number of eligible individuals or employees of an employer.
(4)
(5)
(6)
(c)
(1) The issuer provides notice in writing to each plan sponsor or individual, as applicable, provided that particular product in that market (and to all participants and beneficiaries covered under such coverage) of the discontinuation at least 90 calendar days before the date the coverage will be discontinued.
(2) The issuer offers to each plan sponsor or individual, as applicable, provided that particular product the option, on a guaranteed availability basis, to purchase all (or, in the case of the large group market, any) other health insurance coverage currently being offered by the issuer to a group health plan or individual health insurance coverage in that market.
(3) In exercising the option to discontinue that product and in offering the option of coverage under paragraph (c)(2) of this section, the issuer acts uniformly without regard to the claims experience of those sponsors or individuals, as applicable, or any health status-related factor relating to any participants or beneficiaries covered or new participants or beneficiaries who may become eligible for such coverage.
(d)
(i) The issuer provides notice in writing to the applicable state authority and to each plan sponsor or individual, as applicable, (and all participants and beneficiaries covered under the coverage) of the discontinuation at least 180 calendar days prior to the date the coverage will be discontinued; and
(ii) All health insurance policies issued or delivered for issuance in the state in the applicable market (or markets) are discontinued and not renewed.
(2) An issuer that elects to discontinue offering all health insurance coverage in a market (or markets) in a state as described in this paragraph (d) may not issue coverage in the applicable market (or markets) and state involved during the 5-year period beginning on the date of discontinuation of the last coverage not renewed.
(e)
(1) Large group market.
(2) Small group market if, for coverage available in this market (other than only through one or more bona fide associations), the modification is consistent with state law and is effective uniformly among group health plans with that product.
(f)
(g)
(h)
(b)
(ii) For purposes of section 2702(a) of the Public Health Service Act, a health insurance issuer that offers student health insurance coverage is not required to accept individuals who are not students or dependents of students in such coverage.
(iii) For purposes of section 2703(a) of the Public Health Service Act, a health insurance issuer that offers student health insurance coverage is not required to renew or continue in force coverage for individuals who are no longer students or dependents of students.
(3)
Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg–63, 300gg–91, and 300gg–92), as amended.
(a)
(b) * * *
(2)
The revision and addition read as follows:
(1) Issued to an association that makes coverage available to individuals other than in connection with one or more group health plans; or
(2) Administered, or placed in a trust, and is not sold in connection with a group health plan subject to the provisions of parts 146 and 147 of this subchapter.
Section 2794 of the Public Health Service Act (42 U.S.C. 300gg–94).
(a) * * *
(2) * * * A state-specific threshold shall be based on factors impacting rate increases in a state to the extent that the data relating to such state-specific factors is available by August 1. States interested in proposing a state-specific threshold for approval are required to submit a proposal to the Secretary by August 1.
(b) The Secretary will publish a notice no later than September 1 of each year, to be effective on January 1 of the following year, concerning whether a threshold under paragraph (a)(1) or (a)(2) of this section applies to the state; except that, with respect to the 12-month period that begins on September 1, 2011, the threshold under paragraph (a)(1) of this section applies.
(a) If any product is subject to a rate increase, a health insurance issuer must submit a Rate Filing Justification for all products in the single risk pool, including new or discontinuing products, on a form and in a manner prescribed by the Secretary.
(b) The Rate Filing Justification must consist of the following Parts:
(1) Unified rate review template (Part I), as described in paragraph (d) of this section.
(2) Written description justifying the rate increase (Part II), as described in paragraph (e) of this section.
(3) Rating filing documentation (Part III), as described in paragraph (f) of this section.
(c) A health insurance issuer must complete and submit Parts I and III of the Rate Filing Justification described in paragraphs (b)(1) and (b)(3) of this section to CMS and, as long as the applicable state accepts such submissions, to the applicable state. If a rate increase is subject to review, then the health insurance issuer must also complete and submit to CMS and, if applicable, the state Part II of the Rate Filing Justification described in paragraph (b)(2) of this section.
(d) Content of unified rate review template (Part I): The unified rate review template must include the following as determined appropriate by the Secretary:
(1) Historical and projected claims experience.
(2) Trend projections related to utilization, and service or unit cost.
(3) Any claims assumptions related to benefit changes.
(4) Allocation of the overall rate increase to claims and non-claims costs.
(5) Per enrollee per month allocation of current and projected premium.
(6) Three year history of rate increases for the product associated with the rate increase.
(e) Content of written description justifying the rate increase (Part II): The written description of the rate increase must include a simple and brief narrative describing the data and assumptions that were used to develop the rate increase and including the following:
(1) Explanation of the most significant factors causing the rate increase, including a brief description of the relevant claims and non-claims expense increases reported in the rate increase summary.
(2) Brief description of the overall experience of the policy, including historical and projected expenses, and loss ratios.
(f) Content of rate filing documentation (Part III): The rate filing documentation must include an actuarial memorandum that contains the reasoning and assumptions supporting the data contained in Part I of the Rate Filing Justification. Parts I and III must be sufficient to conduct an examination satisfying the requirements of § 154.301(a)(3) and (4) and determine whether the rate increase is an unreasonable increase. Instructions concerning the requirements for the rate filing documentation will be provided in guidance issued by CMS.
(g) If the level of detail provided by the issuer for the information under paragraphs (d) and (f) of this section does not provide sufficient basis for CMS to determine whether the rate increase is an unreasonable rate increase when CMS reviews a rate increase subject to review under § 154.210(a), CMS will request the additional information necessary to make its determination. The health insurance
(h) Posting of the disclosure on the CMS Web site:
(1) CMS promptly will make available to the public on its Web site the information contained in Part II of each Rate Filing Justification.
(2) CMS will make available to the public on its Web site the information contained in Parts I and III of each Rate Filing Justification that is not a trade secret or confidential commercial or financial information as defined in HHS's Freedom of Information Act regulations, 45 CFR 5.65.
(3) CMS will include a disclaimer on its Web site with the information made available to the public that explains the purpose and role of the Rate Filing Justification.
(4) CMS will include information on its Web site concerning how the public can submit comments on the proposed rate increases that CMS reviews.
A health insurance issuer must submit a Rate Filing Justification for all rate increases that are filed in a state on or after April 1, 2013, or effective on or after January 1, 2014 in a state that does not require the rate increase to be filed, as follows:
(a) If a state requires that a proposed rate increase be filed with the state prior to the implementation of the rate, the health insurance issuer must submit to CMS and the applicable state the Rate Filing Justification on the date on which the health insurance issuer submits the proposed rate increase to the state.
(b) For all other states, the health insurance issuer must submit to CMS and the state the Rate Filing Justification prior to the implementation of the rate increase.
(a) * * *
(3) * * *
(iii) The reasonableness of assumptions used by the health insurance issuer to estimate the rate impact of the reinsurance and risk adjustment programs under sections 1341 and 1343 of the Affordable Care Act.
(iv) The health insurance issuer's data related to implementation and ongoing utilization of a market-wide single risk pool, essential health benefits, actuarial values and other market reform rules as required by the Affordable Care Act.
(4) * * *
(iii) The impact of cost-sharing changes by major service categories, including actuarial values.
(iv) The impact of benefit changes, including essential health benefits and non-essential health benefits.
(v) The impact of changes in enrollee risk profile and pricing, including rating limitations for age and tobacco use under section 2701 of the Public Health Service Act.
(xiii) The impacts of geographic factors and variations.
(xiv) The impact of changes within a single risk pool to all products or plans within the risk pool.
(xv) The impact of reinsurance and risk adjustment payments and charges under sections 1341 and 1343 of the Affordable Care Act.
(b)
Title I of the Affordable Care Act, sections 1301–1304, 1311–1312, 1321, 1322, 1324, 1334, 1342–1343, and 1401–1402, Pub. L. 111–148, 124 Stat. 119 (42 U.S.C. 18042).
(a)
(b)
(c)
(d)
(2)
(i) The actuarial value and cost-sharing design of the plan.
(ii) The plan's provider network, delivery system characteristics, and utilization management practices.
(iii) The benefits provided under the plan that are in addition to the essential health benefits. These additional benefits must be pooled with similar benefits within the single risk pool and the claims experience from those benefits must be utilized to determine rate variations for plans that offer those benefits in addition to essential health benefits.
(iv) Administrative costs, excluding Exchange user fees.
(v) With respect to catastrophic plans, the expected impact of the specific eligibility categories for those plans.
(e)
(f)
(a)
(1) Meets all applicable requirements for health insurance coverage in the individual market (including but not limited to those requirements described in parts 147 and 148 of this subchapter), and is offered only in the individual market.
(2) Does not provide a bronze, silver, gold, or platinum level of coverage described in section 1302(d) of the Affordable Care Act.
(3) Provides coverage of the essential health benefits under section 1302(b) of the Affordable Care Act once the annual limitation on cost sharing in section 1302(c)(1) of the Affordable Care Act is reached.
(4) Provides coverage for at least three primary care visits per year before reaching the deductible.
(5) Covers only individuals who meet either of the following conditions:
(i) Have not attained the age of 30 prior to the first day of the plan or policy year.
(ii) Have received a certificate of exemption for the reasons identified in section 1302(e)(2)(B)(i) or (ii) of the Affordable Care Act.
(b)
(c)