This proposed rule is issued under the Potato Research and Promotion Plan (Plan) (7 CFR part 1207). The Plan is authorized under the Potato Research and Promotion Act (Act) (7 U.S.C. 2611-2627).

Executive Order 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated as “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 311 of the Act (7 U.S.C. 2620), a person subject to a plan may file a petition with USDA stating that such plan, any provision of such plan, or any obligation imposed in connection with such plan, is not in accordance with law and request a modification of such plan or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which such person is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided that a complaint is filed not later than 20 days after date of the entry of the ruling.

This proposed rule invites comments on amending the structure of the Committee of the Board and to delete the Board's mailing address from the Plan. The Plan is administered by the Board with oversight by USDA. Under the Plan, assessments are collected from handlers and importers and used for projects to promote potatoes and potato products.

This proposed rule modifies the structure of the Board's Administrative Committee as prescribed in the Plan by increasing the number of Vice-Chairperson positions on the Committee from seven to nine. These additional positions would be allocated, as provided in the Board's bylaws, to the Northwest and North Central caucuses. The Northwest district includes Alaska, Idaho, Montana, Oregon and Washington. The North Central district includes Illinois, Indiana, Iowa, Michigan, Missouri, Minnesota, North Dakota, Ohio, South Dakota, and Wisconsin. With this action, Board representation at the executive level for potato producers in the Northwest district increases from 28.5 percent to 33 percent and in the North Central district from 14 percent to 22 percent.

Section 1207.327(b) of the Plan provides the authority to the Board to make rules and regulations, with USDA approval, to effectuate the terms and conditions of the Plan. Section 1207.328(a) of the Plan provides the authority to the Board to select from its members such officers as may be necessary and to adopt such rules for the conduct of its business as the Board may deem advisable.

Section 1207.507(a) of the Plan's administrative rules delineates the structure of the Board's Administrative Committee. The Committee is selected from among Board members, and is composed mostly of producer members, with one or more importer member(s), and the public member. The Board, through the adoption of its bylaws, may prescribe the manner of selection and the number of members; except that the regulations mandate that the Committee shall include a Chairperson and a fixed number of Vice-Chairpersons. The proposed change is intended to facilitate increased involvement in the Board's leadership opportunities from the Northwest and North Central caucuses and possibly increase diversity at higher positions on the Board.

Prior to this change, the Plan provided for seven Vice-Chairperson positions on the Committee. Vice-Chairperson positions are allocated in the Board's bylaws to represent production districts as determined by the Board. This action increases the number of Vice-Chairperson positions to nine. The additional Vice-Chairpersons would be allocated to the Northwest and North Central caucuses, which historically have been the caucuses with the greatest production.

The second proposed change would delete the Board's mailing address from the Plan's rules and regulations. Section 1207.501 of the Plan specifies that all communications in connection with the Plan shall be addressed to: National Potato Promotion Board, 7555 East Hampden Avenue, Suite 412, Denver, Colorado, 80231. The Board is in the process of moving to a new location within Denver, Colorado. Therefore, this section would need to be amended. However, USDA is recommending that this section be deleted so no further amendment would be required if the Board moves its office in the future. Interested persons wanting to contact the Board can reach them through their Web site, Facebook, or smartphone application.

The Board met on March 14, 2013, and unanimously recommended amending the Committee structure of the Board and amending the Board's mailing address from the Plan. This action would contribute to effective administration of the program.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of the proposed rule on small entities. Accordingly, AMS has considered the economic impact of this action on small entities.

According to the Board, it is estimated that in 2013 there are about 2,500 producers, 1,030 handlers and 240 importers of potatoes and potato products who are subject to the provisions of the Plan.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (domestic handlers and importers) as those having annual receipts of no more than $7.0 million. Under these definitions, the majority of the handlers, producers and importers that would be affected by this rule would be considered small entities.

This proposed rule invites comments on amending the structure of the Administrative Committee of the Board and deleting the Board's mailing address from the Plan. The Plan is administered by the Board with oversight by the U.S. Department of Agriculture (USDA). Under the Plan, there are seven Committee Vice-Chairperson positions. The Board has recommended that these positions be increased to nine Vice-Chairpersons. This proposed change is intended to facilitate increased involvement in the Board's leadership opportunities. The deletion of the Board's mailing address would require no further amendment to the Plan if the Board's office is relocated. The Board's office is being relocated so an amendment change was necessary to the Plan.

This proposed rule would amend section 1207.507(a) of the Plan by changing the number of Vice-Chairperson positions from seven to nine. Also, the Board's office address would be removed from 1207.501 of the Plan.

Regarding the economic impact of this proposed rule on affected entities, this action would impose no costs on producers, handlers, and importers as a result of this action. Both changes are administrative in nature; it would merely provide additional opportunities for increased involvement by producers in the Board's leadership opportunities from the larger production areas.

Regarding alternatives, one option to the proposed action would be to maintain the status quo and not change the Administrative Committee structure. This would not alleviate the concerns voiced by the Northwest and North Central caucuses for more representation and leadership opportunities. The Board also considered combining the Southwest caucus into the Northwest caucus. The Board concluded that this would cause the Southwest producers to lose their representation as there are more Northwest producers and the available seats could possibly be absorbed by all Northwest producers. Therefore, the proposed recommendation was approved, as it would allow greater opportunity for producers from the Board's two largest caucus districts to become engaged in the Board's leadership structure. This action would also make the representation on the Board more equitable according to production.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are imposed by the Order have been approved previously under OMB control number 0581-0093. This proposed rule would not result in a change to the information collection and recordkeeping requirements previously approved and would impose no additional reporting and recordkeeping burden on potato producers, handlers and importers.

As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Regarding outreach efforts, this action was discussed by the Board at meetings over the past year. Board members discussed the changes with their respective regions. The Board met in March 2013 and unanimously made its recommendation. All of the Board's meetings, including meetings held via teleconference, are open to the public and interested persons are invited to participate and express their views.

We have performed this initial RFA regarding the impact of this proposed action on small entities and we invite comments concerning potential effects of this action on small businesses.

A 15-day comment period is provided to allow interested persons to respond to this proposal. Fifteen days is deemed appropriate because this rule would need to be in place as soon as possible so the additional Vice-Chairperson can participate in Committee meetings. In addition, the Board's office has already relocated so the address needs to be deleted promptly. All written comments timely received will be considered before a final determination is made on this matter.

For the reasons set forth in the preamble, 7 CFR part 1207 is proposed to be amended as follows:

This Federal Register document is also accessible via the Internet at http://www.access.gpo.gov/su-docs/aces/aces140.html.

The National Marine Sanctuaries Act (NMSA or Act, 16 U.S.C. 1431 et seq.) authorizes the Secretary of Commerce to, among other things, identify and designate as national marine sanctuaries areas of the marine environment, including the Great Lakes, which are of special national significance; to manage these areas as the National Marine Sanctuary System (NMSS); and to provide for the comprehensive and coordinated conservation and management of these areas and the activities affecting them in a manner which complements existing regulatory authorities. Section 1433 of the NMSA provides sanctuary designation standards and factors to consider in determining whether an area qualifies for consideration as a potential sanctuary, and section 1434 establishes procedures for sanctuary designation and implementation. Day-to-day management of the NMSS has been delegated by the Secretary to the ONMS. Regulations implementing the NMSA and each sanctuary are codified in Title 15 Part 922 of the Code of Federal Regulations (CFR).

NOAA first developed a formal process for identifying and evaluating sites for consideration as potential national marine sanctuaries in the late 1970s. In 1983, NOAA replaced this process with the Site Evaluation List (SEL) (48 FR 24295). As described in NOAA regulations at 15 CFR 922.3, the SEL was a list of natural and historical marine resource sites selected by the Secretary as qualifying for further evaluation for possible designation as national marine sanctuaries. The SEL included detailed criteria, relied on regional review panels, and was intended to be reviewed and updated every five years. When it was published in 1983, the SEL included 29 sites (48 FR 35568), four of which were subsequently designated as sanctuaries: Flower Garden Banks (1991), Stellwagen Bank (1992), Western Washington Outer Coast (renamed Olympic Coast, 1994), and Thunder Bay (2000) national marine sanctuaries (NMS). The list of sites on the SEL can be found at http://sanctuaries.noaa.gov/management/fr/54_fr_53432.pdf.

When the SEL was established, the criteria for nominating sites to the list focused primarily on the natural resource qualities that made an area eligible for sanctuary designation. The Marine Sanctuaries Amendments Act of 1984 (Pub. L. 98-496) added historical, research and educational qualities to the list of designation criteria. In 1988, NOAA issued a final rule (53 FR 43801) reflecting these amendments and, in 1989, announced that it would consider new sites for the SEL consistent with these revised criteria (54 FR 53432).

In 1995, the ONMS Director deactivated the SEL (60 FR 66875) to focus on management of the existing sanctuaries, which at that time there were a total of twelve national marine sanctuaries. Since then, only one national marine sanctuary, Thunder Bay National Marine Sanctuary, has been added to the NMSS. Public interest in the designation of new national marine sanctuaries has, however, remained strong. A variety of individuals, local, state, and tribal governments, academic institutions, citizen groups, and non-government organizations from coastal communities around the country have requested NOAA, the Department of Commerce, and the President to consider designating additional sanctuaries. These requests often reference the many and diverse benefits that coastal communities realize from an adjacent national marine sanctuary, including, but not limited to: Meaningful protection of nationally significant marine resources; significant social and economic benefits from expanded travel, tourism, and recreation, as well as ocean-related jobs; increased opportunity for, and access to, federal research focused on local marine resources; education programs to promote ocean literacy, sustainable uses, and stewardship; and community-driven problem solving for a myriad of ocean issues.

The purpose of this proposed rulemaking is to:

(1) Provide public notice that NOAA is re-establishing the public process to nominate areas of the marine and Great Lakes environments for consideration as national marine sanctuaries;

(2) Seek public comment on proposed changes to various sections of the ONMS regulations at 15 CFR 922; and

(3) Seek public comment on the criteria and process NOAA proposes using to evaluate new sanctuary nominations.

This proposed rule proposes criteria, process, and regulatory changes necessary to provide the American public an opportunity to nominate marine areas that NOAA may consider for designation as a national marine sanctuary. This new sanctuary nomination process intends to focus on proposals generated and driven by local and regional community groups and coalitions. As such, it would replace the old SEL process—which tended towards an agency-driven, “top-down” approach—with a more grassroots, “bottom-up” approach to sanctuary nominations. NOAA is, therefore, proposing to remove all terminology referencing the SEL in order to ensure that the sanctuary nomination process ultimately implemented by NOAA is more community driven, open to public input and analysis, and that any sites ultimately designated as national marine sanctuaries have widespread community support. NOAA will begin accepting new nominations following issuance of a final rule, which will be published after consideration of public comment on the proposed criteria and regulations below. NOAA is not accepting nominations for new national marine sanctuaries at this time, nor is it considering evaluation of sites from the deactivated SEL. If NOAA determines that a nominated site meets the final criteria, the agency may then choose to begin the public process for national marine sanctuary designation.

The public may re-nominate sites from the deactivated SEL, per the final evaluation criteria, and resubmit these areas for NOAA's consideration. The final criteria will be consistent with the existing standards in section 303(b) of the NMSA, but they may not mirror them exactly. In deciding to pursue an eligible site for designation, NOAA can, and will, contemplate additional criteria or clarifications of existing criteria, such as the ONMS' fiscal capability to manage any area as a national marine sanctuary. Ultimately, the agency seeks to have the most robust means possible for designating areas of special national significance as new national marine sanctuaries.

NOAA requests public comment on: (1) The completeness and utility of the following twelve criteria for evaluating areas of the marine environment as possible new national marine sanctuaries; (2) NOAA's proposed process steps for receiving sanctuary nominations; and (3) proposed amendments to ONMS regulations.

NOAA will analyze the comments on these criteria and any additional criteria proposed by the public and publish the final evaluation criteria in its final rule on this process. The twelve criteria NOAA proposes to evaluate ares of the marine environment as possible new national marine sanctuaries are:

(1) The area's natural resource and ecological qualities, including its contribution to biological productivity, maintenance of ecosystem structure, maintenance of ecologically or commercially important or threatened species or species assemblages, maintenance of critical habitat of endangered species, and the biogeographic representation of the site.

(2) The area's historical, cultural, archaeological, or paleontological significance.

(3) The present and potential uses of the area that depend on maintenance of the area's resources, including commercial and recreational fishing, subsistence uses, other commercial and recreational activities, and research and education.

(4) The present and potential activities that may adversely affect the significance, values, qualities, resources and uses identified above.

(5) The existing State and Federal regulatory and management authorities applicable to the area and the adequacy of those authorities to fulfill the purposes and policies of the NMSA.

(6) The manageability of the area, including such factors as its size, its ability to be identified as a discrete ecological unit with definable boundaries, its accessibility, and its suitability for monitoring and enforcement activities.

(7) The public benefits to be derived from sanctuary status, with emphasis on the benefits of long-term protection of nationally significant resources, vital habitats, and resources which generate tourism.

(8) The negative impacts produced by management restrictions on income-generating activities such as living and nonliving resources development.

(9) The socioeconomic effects of sanctuary designation.

(10) The area's scientific value and value for monitoring the resources and natural processes that occur there.

(11) The feasibility of employing innovative management approaches to protect sanctuary resources or to manage compatible uses.

(12) The value of the area as an addition to the System.

As part of the new sanctuary nomination process, NOAA is contemplating the following procedures and protocols:

(1) A nomination must have broad community support, including a combination of such entities as local government organizations, elected officials, tribes, stakeholder groups (e.g., industry or non-governmental organizations), or academia.

(2) In nominating an area for national marine sanctuary consideration, a coalition of advocates should strive to provide documentation and/or analyses that address as many of the final evaluation criteria as possible. (NOAA will publish the final evaluation criteria in its final rule on this process.)

(3) NOAA will maintain a publically transparent inventory on the ONMS Web site of those nominations that have successfully demonstrated eligibility for national marine sanctuary designation. These nominations would not automatically equate to sanctuary designation.

(4) NOAA would implement any new sanctuary designation as a separate process from the nomination process, and under the highly participatory standards enacted by the NMSA and the National Environmental Policy Act (NEPA).

In this rulemaking, NOAA proposes to revise 15 CFR 922.10 to codify a statement that NOAA is once again accepting nominations for national marine sanctuary designation. NOAA is also proposing to eliminate all regulations related to the SEL by removing 15 CFR 922.21 and 922.23, and removing SEL from the Definitions section at 15 CFR 922.3.

Note that, through a separate rulemaking action (78 FR 5998, January 28, 2013), NOAA is also proposing to revise regulations regarding the SEL as part of a comprehensive regulatory review pursuant to Executive Order 13563. NOAA will resolve any inconsistencies between these two rules in the respective final rules.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. A description of this action, its purpose, and its legal basis are described in the preamble to this proposed rule and is not repeated here. The factual basis for this certification is as follows:

This rule proposes administrative changes to the regulations. The proposed action will only modify the procedural regulations to reactivate the sanctuary nomination process and set forth the nomination process and evaluation criteria for evaluating areas of the marine environment as possible new national marine sanctuaries.

The types of small entities that may be impacted by this rulemaking are local government organizations, tribes, stakeholder groups (e.g., industry or non-governmental organizations), or academia who wish to nominate areas of the marine environment for consideration as a national marine sanctuary. The agency, however, does not currently have data reflecting how many of these entities would submit nominations for possible designation as a new national marine sanctuary, but it anticipates that it would be a very small number. The impacts of this rulemaking would also be very small, as the proposed provisions merely set forth the proposed nomination process and evaluation criteria. The submission of nominations is purely voluntary, and this rulemaking does not impose any costs or requirements beyond those related to the preparation of documentation in support of the nomination. This action does not include any decisions or determinations on future sanctuary site designations. The impact of future potential national marine sanctuary designations will be evaluated individually on a case-by-case basis and will be subject to a Regulatory Flexibility Act review at that time. Therefore, it is not expected that the modifications of the regulations at 15 CFR 922.10 will have a significant economic impact on a substantial number of small entities.

This proposed rule does not establish any new reporting, record-keeping, or other compliance requirements.

This proposed rule has been determined to not be significant within the meaning of Executive Order 12866.

Accordingly, for the reasons set forth above, NOAA proposes to amend 15 CFR part 922 as follows:

1. Pursuant to section 215(d) of the Federal Power Act (FPA),1 the Commission proposes to approve the retirement of 34 requirements within 19 Reliability Standards identified by the North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization (ERO). The proposed retirements meet the benchmarks set forth in the Commission's March 15, 2012 order that requirements proposed for retirement either: (1) Provide little protection for Bulk-Power System reliability or (2) are redundant with other aspects of the Reliability Standards.2 Consistent with the Commission's proposal in the March 2012 Order, we believe that the requirements proposed for retirement can “be removed from the Reliability Standards with little effect on reliability and an increase in efficiency of the ERO compliance program.” 3 We seek comment on our proposal to approve the retirement of the 34 requirements identified by NERC.

2. In addition, we propose to withdraw 41 outstanding Commission directives that NERC develop modifications to Reliability Standards. In Order No. 693 and subsequent final rules, the Commission has identified various issues and directed NERC to develop modifications to the Reliability Standards or take other action to address those issues.4 While NERC has addressed many of these directives, over 150 directives remain outstanding. Some of the outstanding directives may no longer warrant action to assure reliability of the Bulk-Power System and should be withdrawn. We have identified 41 outstanding directives to withdraw based on the following three guidelines: (1) Whether the reliability concern underlying the outstanding directive has been addressed in some manner, rendering the directive stale; (2) whether the outstanding directive provides general guidance for standards development rather than a specific directive; and (3) whether the outstanding directive is redundant with another directive. The 41 outstanding directives we propose to withdraw are listed in Attachment A to this Notice of Proposed Rulemaking (NOPR). The withdrawal of these directives will enhance the efficiency of the Reliability Standards development process, with little or no impact on Bulk-Power System reliability.

3. Pursuant to Executive Order 13579, the Commission issued a plan to identify regulations that warrant repeal or modification, or strengthening, complementing, or modernizing where necessary or appropriate.5 In the Plan, the Commission also stated that it voluntarily and routinely, albeit informally, reviews its regulations to ensure that they achieve their intended purpose and do not impose undue burdens on regulated entities or unnecessary costs on those entities or their customers. The proposal in this NOPR is a part of the Commission's ongoing effort to review its requirements and reduce unnecessary burdens by eliminating requirements that are not necessary to the performance of the Commission's regulatory responsibilities.

4. Section 215 of the FPA requires the Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. Once approved, the Reliability Standards may be enforced in the United States by the ERO subject to Commission oversight, or by the Commission independently.6 Pursuant to the requirements of FPA section 215, the Commission established a process to select and certify an ERO 7 and, subsequently, certified NERC as the ERO.8

5. In the March 2012 Order, the Commission accepted, with conditions, NERC's “Find, Fix, Track and Report” (FFT) initiative. The FFT process, inter alia, provides NERC and the Regional Entities the flexibility to address lower-risk possible violations through an FFT informational filing as opposed to issuing and filing a Notice of Penalty. In addition, the Commission raised the prospect of revising or removing requirements of Reliability Standards that “provide little protection for Bulk-Power System reliability or may be redundant.” 9 Specifically, the Commission stated:

6. In its February 28, 2013 petition, NERC seeks Commission approval of the retirement of 34 requirements within 19 Reliability Standards. NERC asserts that the 34 requirements proposed for retirement “are redundant or otherwise unnecessary” and that “violations of these requirements . . . pose a lesser risk to the reliability of the Bulk-Power System.” 11 In addition, NERC states that it is not proposing to retire any Reliability Standard in its entirety, and the remaining requirements of each affected Reliability Standard will remain in continuous effect. NERC maintains that the requirements proposed for retirement “can be removed [from the Reliability Standards] with little to no effect on reliability.” 12 NERC also asserts that the proposed retirement of the 34 requirements “will allow industry stakeholders to focus their resources appropriately on reliability risks and will increase the efficiency of the ERO compliance program.” 13

7. In addition, in its petition, NERC provides a description of the collaborative process adopted by industry stakeholders to respond to the Commission's proposal in paragraph 81 of the March 2012 Order. NERC maintains that the “scope of the P 81 project was limited solely to the removal of requirements in their entirety that would not otherwise compromise the integrity of the specific Reliability Standard or impact the reliability of the BES.” 14 Further, NERC states that the criteria adopted to identify potential requirements for retirement “were designed so that no rewriting or consolidation of requirements would be necessary.” 15

8. NERC states that the “P 81 Team” developed three criteria for its review:

9. Specifically, the seven questions adopted for Criterion C are:

10. NERC maintains that the project team focused on the identification of “lower-level facilitating requirements that are either redundant with other requirements or where evidence retention is burdensome and the requirement is unnecessary” because the reliability goal is achieved through other standards or mechanisms.17 NERC asserts that the proposed retirement of documentation requirements will not create a gap in reliability because “NERC and the Regional Entities can enforce reporting obligations pursuant to section 400 of NERC's Rules of Procedure and Appendix 4C to ensure that necessary data continues to be submitted for compliance and enforcement purposes.” 18 NERC asserts that although the P 81 project proposes to retire requirements associated with data retention or documentation, “the simple fact that a requirement includes a data retention or documentation element does not signify that it should be considered for retirement or is otherwise inappropriately designated as a requirement.” 19

11. Based on this approach, NERC identified the following 34 requirements within 19 Reliability Standards for potential retirement:

12. NERC also requests that the Commission approve the implementation plan, provided as Exhibit C to NERC's petition, which provides that the identified requirements will be retired immediately upon Commission approval.

13. NERC states that it will apply the “concepts” from the P 81 project to improve the drafting of Reliability Standards going forward. Specifically, NERC explains that Reliability Standards development projects “will involve stronger examination for duplication of requirements across the NERC body of Reliability Standards and the technical basis and necessity for each and every requirement will continue to be evaluated.” 21 According to NERC, requirements that were proposed and ultimately not included in the immediate filing will be mapped for consideration as part of addressing existing standards projects and five-year reviews of standards that have not been recently revised.

14. Pursuant to section 215 of the FPA, we propose to approve the retirement of the 34 requirements within 19 Reliability Standards identified by NERC as just, reasonable, not unduly discriminatory or preferential, and in the public interest. In the March 2012 Order, the Commission explained that “some current requirements likely provide little protection for Bulk-Power System reliability or may be redundant. The Commission is interested in obtaining views on whether such requirements could be removed from the Reliability Standards with little effect on reliability and an increase in efficiency of the ERO compliance program.” 22 In general, the proposed retirements satisfy the expectations set forth in the March 2012 Order; namely, the requirements proposed for retirement either: (1) Provide little protection for Bulk-Power System reliability or (2) are redundant with other aspects of the Reliability Standards.

15. We agree with NERC that the elimination of certain requirements that pertain to the information collection or documentation will not result in a reliability gap. Section 400 and Appendix 4C (Uniform Compliance Monitoring and Enforcement Program) of the NERC Rules of Procedure provide NERC and the Regional entities the authority to enforce reporting obligations necessary to support reliability.23 This authority, used in the appropriate manner, justifies retiring certain documentation-related requirements that provide limited, if any, support for reliability. We anticipate that the retirement of such requirements will enhance the efficiency of the ERO compliance program, as well as the efficiency of individual registered entity compliance programs.

16. The specific requirements, NERC's rationale supporting retirement, and the Commission's proposed approval of the retirements are outlined below.

17. BAL-005-0.2b, Requirement R2—Automatic Generation Control:

18. NERC states that the reliability purpose of BAL-005-0.2b is “to establish requirements for Balancing Authority Automatic Generation Control (“AGC”) necessary to calculate Area Control Error (“ACE”) and to routinely deploy the Regulating Reserve.” 24 NERC asserts that the reliability purpose and objectives of BAL-005-0.2b will not be affected by the retirement of Requirement R2.25 Specifically, NERC states that BAL-005 is related to BAL-001—Real Power Balancing Control Performance, and a “Balancing Authority must use AGC to control its Regulating Reserves to meet the Control Performance Standards (“CPS”) as set forth in BAL-001-0.1a Requirements R1 and R2.” 26 According to NERC, the “primary purpose of Requirement R2 is to specify how a Balancing Authority must meet [the Control Performance Standards], i.e., through the use of [Automatic Generation Control].” 27

19. NERC states that, although the Commission has previously rejected an argument regarding the potential redundancy of Requirement R2, “this Requirement is redundant in an operational sense.” 28 NERC asserts that, while a balancing authority may be able to meet its Control Performance Standard without automatic generation control, “it cannot do so for any extended period of time, and, therefore, Balancing Authorities must use [Automatic Generation Control] to control Regulating Reserves to satisfy obligations under BAL-001-0.1a Requirements R1 and R2.” 29 NERC concludes that “Balancing Authorities must still have Regulating Reserves that can be controlled by [Automatic Generation Control] to satisfy the [Control Performance Standards] in BAL-001-0.1a Requirements R1 and R2” if BAL-005-0.2b, Requirement R2 is retired.30

20. We propose to approve the retirement of BAL-005-0.2b, Requirement R2 based on NERC's assertion that the requirement is redundant with BAL-001-0.1a, Requirements R1 and R2. Specifically, we propose to accept NERC's explanation that the obligation to maintain regulating reserves controlled by automatic generation control under BAL-005-0.2b, Requirement R2 is redundant from an operational perspective with the obligation to meet the Control Performance Standards in BAL-001-0.1a, Requirements R1 and R2. As NERC notes, although a balancing authority can meet the Control Performance Standards without automatic generation control, it is reasonable to assume that it cannot operate in that manner for an extended period of time and that a balancing authority must ultimately rely on regulating reserves controlled by automatic generation control.

21. CIP-003-3, -4, Requirement R1.2—Cyber Security—Security Management Controls:

22. NERC states that CIP-003 requires responsible entities to have minimum security management controls in place to protect critical cyber assets. According to NERC, the “reliability purpose and objectives of CIP-003 are unaffected by the proposed retirement of Requirement R1.2.” 31 NERC states that “CIP-003 Requirement R1.2 is an administrative task that requires Responsible Entities to ensure that their cyber security policy is readily available to personnel” and that retirement of Requirement R1.2 will not create a gap in reliability.32

23. We propose to approve the retirement of CIP-003-3, -4, Requirement R1.2 based on NERC's explanation that it is an administrative provision that provides little protection for Bulk-Power System reliability. As NERC explains, the training, procedures, and process related requirements of the CIP standards render having the cyber security policy readily available an unnecessary requirement.33 Thus, we agree that CIP-003-3, -4, Requirement R1.2 may be viewed as redundant with the training obligations imposed under CIP-004-3a that require specific training for all employees, including contractors and service vendors, who have access to critical cyber assets. We also agree with NERC that CIP-003-3, -4, Requirement R1.2 creates a compliance burden that outweighs the reliability benefit of requiring a responsible entity to ensure that its general cyber security policy is readily available.

24. CIP-003-3, -4, Requirements R3, R3.1, R3.2, and R3.3—Cyber Security—Security Management Controls:

25. NERC states that CIP-003 requires Responsible Entities to have minimum security management controls in place to protect critical cyber assets. NERC asserts that the “reliability purpose and objectives of CIP-003 are unaffected by the proposed retirement of Requirements R3, and R3.1 through R3.3.” 34 NERC characterizes CIP-003-3, -4, Requirements R3, R3.1, R3.2, and R3.3 as administrative tasks and indicates that the proposed retirement of these requirements presents no reliability gap. NERC explains that the requirements at issue “only apply to exceptions to internal corporate policy, and only in cases where the policy exceeds a Reliability Standards requirement or addressees an issue that is not covered in a Reliability Standard.” 35 NERC maintains that the retirement of Requirements R3, R3.1, R3.2, and R3.3 “would not impact an entity's ability to maintain such an exception process within its corporate policy governance procedures, if it is so desired.” 36

26. NERC explains that CIP-003-3, -4, Requirement R3, R3.1, R3.2, and R3.3 “have proven not to be useful and have been subject to misinterpretation.” 37 Specifically, NERC states that entities may be interpreting CIP-003-3, -5, Requirement R3 and its sub-requirements as allowing for an exemption from compliance with one or more requirements of a Reliability Standard. NERC explains that this misinterpretation has created an unnecessary burden because entities have “allocate[d] time and resources to tasks that are misaligned with the [CIP] requirements themselves.” 38 In addition, NERC notes that the misunderstanding of the requirements has affected the efficiency of the ERO compliance program due to “the amount of time and resources needed to clear up the misunderstanding and coach entities on the meaning of the CIP exception requirements.” 39

27. We propose to approve the retirement of CIP-003-3, -4, Requirements R3, R3.1, R3.2, and R3.3 based on NERC's explanation that Requirements R3, R3.1, R3.2, and R3.3 impose administrative tasks that provide little protection for Bulk-Power System reliability. As NERC notes, the exception process outlined under CIP-003-3, -4, Requirements R3, R3.1, R3.2, and R3.3 only applies to a responsible entity's internal corporate policy, and only in situations where a responsible entity's internal corporate policy exceeds a CIP Reliability Standard requirement. The retirement of CIP-003-3, -4, Requirements R3, R3.1, R3.2, and R3.3 will not affect a responsible entity's compliance with the body of the CIP Reliability Standards.

28. CIP-003-3, -4, Requirement R4.2—Cyber Security—Security Management Controls:

29. NERC states that CIP-003, Requirement R4.2 requires responsible entities to classify information based on its “sensitivity.” NERC characterizes this task as an “administrative task” that is redundant with CIP-003-3, -4, Requirement R4. According to NERC, Requirement R4 already requires a Responsible Entity to classify critical cyber information and the “only difference between Requirements R4 and R4.2 is that the subjective term `based on sensitivity' has been added [to Requirement R4.2], thus, making it essentially redundant.” 40 NERC maintains that the retirement of R4.2 presents no reliability gap.

30. We propose to approve the retirement of CIP-003-3, -4, Requirement R4.2 based on NERC's explanation that Requirement R4.2 is redundant with CIP-003-3, -4, Requirement R4. Specifically, the only distinction between CIP-003-3, -4, Requirement R4.2 and Requirement R4 is the subjective term “based on the sensitivity.” The obligation in Requirement R4 that a responsible entity must identify, classify, and protect Critical Cyber Asset information remains even with the retirement of Requirement R4.2.

31. CIP-005-3a, -4a, Requirement R2.6—Cyber Security—Electronic Security Perimeter(s):

32. NERC states that the general purpose of CIP-005-3a, -4a is to ensure a proper or secure access point configuration. NERC asserts that the “implementation of an appropriate use banner . . . on a user's screen for all interactive access attempts into the Electronic Security Perimeter . . . is an activity or task that is administrative.” 41 NERC states that the implementation of an appropriate use banner does not support the general purpose of CIP-005-3a, -4a and, thus, retirement of the provision presents no reliability gap.42

33. NERC explains that Requirement R2.6 has also been the subject of numerous technical feasibility exceptions for devices that cannot support such a banner and, thus, has diverted resources from more productive efforts. NERC avers that “the ERO's compliance program would become more efficient if CIP-005-3a, -4a [Requirement] R2.6 was retired, because ERO time and resources could be reallocated to monitor compliance with the remainder of CIP-005-3a, -4a, which provides for more effective controls of electronic access at all electronic access points into the ESP.” 43

34. We propose to approve the retirement of CIP-005-3a, -4a, Requirement R2.6 based on NERC's explanation that Requirement R2.6 represents an administrative task that provides little protection for Bulk-Power System reliability. As NERC notes, the implementation of an appropriate use banner as required under CIP-005-3a, -4a, Requirement R2.6 does not further the general goal of controlling electronic access at all electronic access points to the Electronic Security Perimeter(s). In addition, Requirement R2.6 has been the subject of numerous technical feasibility exceptions due to the fact that not all devices can support an appropriate use banner.

35. CIP-007-3, -4, Requirement R7.3—Cyber Security—Systems Security Management:

36. NERC states that Requirement R7.3 requires the maintaining of records for the purpose of demonstrating compliance with disposing of or redeploying Cyber Assets in accordance with documented procedures. NERC asserts, however, that it and the Regional Entities can require the production of records to demonstrate compliance under section 400 of the NERC Rules of Procedure. Therefore, NERC maintains that “Requirement R7.3 is redundant and unnecessary.” 44

We propose to approve the retirement of CIP-007-3, -4, Requirement R7.3. The retirement of Requirement R7.3 will not relieve a responsible entity of the obligation to dispose of or redeploy a Cyber Asset in the manner set forth in CIP-007-3, -4, Requirement R7. Should NERC or the Regional Entities seek to confirm that a responsible entity is complying with the substantive obligations in CIP-007-3, -4, Requirement R7, they can invoke their authority under section 400 of the NERC Rules of Procedure.

37. EOP-005-2, Requirement R3.1—System Restoration from Blackstart Services:

38. NERC states that the reliability purpose of EOP-005-2 is to ensure that plans, Facilities, and personnel are prepared to enable system restoration from blackstart resources to assure that reliability is maintained during restoration and priority is placed on restoring the Interconnection. According to NERC, the reliability purpose of EOP-005 will be unaffected by the retirement of Requirement R3.1.

39. NERC explains that “EOP-005-2 Requirement R3 currently requires the Transmission Operator to submit its restoration plan to its Reliability Coordinator, whether or not the plan includes changes.” 45 NERC maintains that, since a transmission operator is already obligated to review and submit its restoration plan to its reliability coordinator annually whether or not there has been a change, “EOP-005-2 Requirement R3.1 only adds a separate, duplicative administrative burden for the entity to also confirm that there were no changes[.]” 46

40. We propose to approve the retirement of EOP-005-2, Requirement R3.1 based on NERC's explanation that Requirement R3.1 is redundant with EOP-005-2, Requirement R3. Specifically, Requirement R3 requires a responsible entity to review its restoration plan and submit the plan to its reliability coordinator annually. As NERC notes, Requirement R3.1 adds a separate, duplicative administrative burden requiring a transmission operator to confirm whether or not the restoration plan reflects any changes. The retirement of Requirement R3.1 will not remove the transmission operator's obligation to review and submit its restoration plan to its reliability coordinator on an annual basis.

41. FAC-002-1, Requirement R2—Coordination of Plans for New Facilities:

42. NERC states that the reliability purpose of FAC-002 is to avoid adverse impacts on reliability by requiring generator owners and transmission owners and electricity end-users to meet facility connection and performance requirements. Specifically, NERC maintains that “Responsible Entities have an existing obligation to produce the same information required by Requirement R2 to demonstrate compliance with Requirement R1 and its sub-requirements, thus making Requirement R2 redundant.” 47 NERC concludes that the retirement of Requirement R2 presents no reliability gap. NERC asserts that the reliability purpose of FAC-002 will be unaffected by the retirement of Requirement R2.

43. We propose to approve the retirement of FAC-002-1, Requirement R2 based on NERC's explanation that Requirement R2 is redundant with the compliance obligations imposed by FAC-002-1, Requirement R1 and its sub-requirements. While FAC-002-1, Requirement R2 requires a responsible entity to retain documentation of the evaluation of the reliability impact of new facilities and their connections to the interconnected transmission systems for three years, Requirement R1 and its sub-requirements require a responsible entity to have evidence and documentation of the evaluation in order to show that it is in compliance. We also note that Part D, Section 1.4 of FAC-002-1 separately specifies a data retention period of three years for this evaluation. The retirement of Requirement R2 should not result in a reliability gap on account of the need to maintain evidence and documentation to show compliance with FAC-002-1, Requirement R1.

44. FAC-008-3, Requirements R4 and R5—Facility Ratings:

45. NERC states that “the reliability objective [of FAC-008 is] that facility ratings produced by the methodologies of the Transmission Owner or Generator Owner shall equal the most limiting applicable equipment rating, and consider, for example, emergency and normal conditions, historical performance, nameplate ratings, etc.” 48 NERC asserts that this reliability objective “is not significantly or substantively advanced by FAC-008-3 R4 (available for inspection) and R5 (comment and responsive comments).” 49 NERC states that the retirement of FAC-008-03, Requirements R4 and R5 will not create a reliability gap “because Transmission Owners and Generator Owners must comply with the substantive requirements of FAC-008-3 regarding their facility rating methodologies whether or not the exchange envisioned by FAC-008-3 R4 and R5 occurs.” 50

46. NERC states further that “neither FAC-008-3 R4 nor R5 require that the Transmission Owner and Generator Owner change its methodology, rather FAC-008-3 R4 and R5 are designed as an exchange of comments that may be an avenue to advance commercial interests.” 51 Therefore, NERC asserts that FAC-008-3, Requirements R4 and R5 represent “an administrative task that does little, if anything, to benefit or protect the reliable operation of the BES, and has the potential to implicate commercially sensitive issues.” 52 NERC concludes that “the ERO compliance program would gain efficiencies by no longer having to track whether requests for technical review had occurred, comments provided and reallocate time and resources to monitoring the Transmission Owner's or Generator Owner's adherence to substantive requirements of FAC-008-3.” 53

47. We propose to approve the retirement of FAC-008-03, Requirements R4 and R5 based on NERC's explanation that Requirements R4 and R5 impose an administrative task that provides little protection for Bulk-Power System reliability. The retirement of Requirements R4 and R5 will not relieve a transmission owner or generator owner of the obligation to have documentation supporting its facility ratings methodology.

Requirements R4 and R5, therefore, impose a compliance burden with little attendant reliability benefit.

48. FAC-010-2.1, Requirement R5—System Operating Limits Methodology for the Planning Horizon:

49. NERC states that the reliability purpose of FAC-010-2.1 is to ensure that system operating limits used in the reliable planning of the bulk electric system are determined based on an established methodology.54 NERC asserts that the reliability purpose of FAC-010-2.1 will be unaffected by the retirement of Requirement R5. NERC states that “[t]he retirement of FAC-010-2.1 R5 does not create a reliability gap, because the Planning Authority must comply with the substantive requirements of FAC-010-2.1 whether or not the exchange envisioned by FAC-010-2.1 R5 occurs.” 55

50. NERC states that “FAC-010- 2.1 R5 sets forth an administrative task that does little, if anything, to benefit or protect the reliable operation of the BES, and has the potential to implicate commercially sensitive issues.” 56 According to NERC, “a Planning Authority's time and resources would be better spent complying with the substantive requirements of FAC-010-2.1.” 57 NERC concludes that “the ERO compliance program would gain efficiencies by no longer having to track whether requests for technical review had occurred, comments provided and reallocate time and resources to monitoring the Planning Authority's adherence to substantive requirements of FAC-010-2.1.” 58

51. We propose to approve the retirement of FAC-010-2.1, Requirement R5 based on NERC's explanation that Requirement R5 imposes an administrative task that provides little protection for Bulk-Power System reliability. The retirement of Requirement R5 will not relieve a planning authority of the obligation to document its system operating limits methodology under the remaining provisions of FAC-010-2.1. In addition, the retirement of Requirement R5 will not relieve a planning authority from its obligation pursuant to Requirement R4 of the standard to provide its system operating limits methodology, including any changes to the methodology, to the appropriate entities prior to the effective date of any such change. Based on the explanation in NERC's petition, Requirement R5 imposes a compliance burden with little attendant reliability benefit.

52. FAC-011-2.1, Requirement R5—System Operating Limits Methodology for the Operations Horizon:

53. NERC states that FAC-011-2 Requirement R5 requires that, when a reliability coordinator receives comments on its system operating limit methodology, the reliability coordinator must respond and indicate whether it has changed its methodology. According to NERC, the “retirement of FAC-011-2 R5 does not create a reliability gap, because the Reliability Coordinator must comply with the substantive requirements of FAC-011-2 R5 [sic] whether or not the exchange envisioned by FAC-011-2 R5 occurs.” 59 NERC maintains that “FAC-011-2 R5 may support an avenue to advance commercial interests.” 60

54. NERC states that FAC-011-2, Requirement R5 sets forth an administrative task that does little, if anything, to benefit or protect the reliable operation of the BES. NERC asserts that “[i]nstead of spending time and resources on FAC-011-2 R5 a Reliability Coordinator's time and resources would be better spent complying with the substantive requirements” of FAC-011-2.61 NERC concludes that “the ERO compliance program would gain efficiencies by no longer having to track whether requests for technical review had occurred, comments provided and reallocate time and resources to monitoring the Reliability Coordinator's adherence to substantive requirements” of FAC-011-2.62

55. We propose to approve the retirement of FAC-011-2, Requirement R5 based on NERC's explanation that Requirement R5 imposes an administrative task that provides little protection for Bulk-Power System reliability. The retirement of Requirement R5 will not relieve a reliability coordinator of the obligation to document its system operating limits methodology under the remaining provisions of FAC-011-2. In addition, the retirement of Requirement R5 will not relieve a reliability coordinator from its obligation pursuant to Requirement R4 of the standard to provide its system operating limits methodology, including any changes to the methodology, to the appropriate entities prior to the effective date of any such change. Based on the explanation in NERC's petition, Requirement R5 imposes a compliance burden with little attendant reliability benefit.

56. FAC-013-2, Requirement R3—Assessment of Transfer Capability for the Near-term Transmission Planning Horizon:

57. NERC states that FAC-013-2, Requirement R3 is a needlessly burdensome administrative task that does little, if anything, to benefit or protect the reliable operation of the BES. NERC explains FAC-013-2, Requirement R1 and its associated sub-requirements set forth the information that each Planning Authority must include when developing its transfer capability methodology. NERC explains further “FAC-013-2 R3 sets forth a requirement that if an entity comments on this methodology, the Planning Authority must respond and indicate whether or not it will make a change to its Transfer Capability methodology.” 63 NERC concludes, “while R1 sets forth substantive requirements, R3 sets forth more of an administrative task of the Planning Authority responding to comments on its methodology.” 64

58. NERC states that “it would seem unnecessarily burdensome to engage in the exchange of comments, given there is no nexus between the exchange and compliance with the substantive requirements of FAC-013-2.” 65 According to NERC, issues regarding an entity's transfer capability methodology should be raised in the context of the receipt of transmission services, not the Reliability Standards.66 NERC asserts that time and resources would be better spent complying with the substantive requirements of FAC-013-2. NERC concludes that “the ERO compliance program would gain efficiencies by no longer having to track whether requests for technical review had occurred, comments provided and reallocate time and resources to monitoring the Reliability Coordinator's adherence to substantive requirements of FAC-013-2.” 67

59. We propose to approve the retirement of FAC-013-2, Requirement R3 based on NERC's explanation that Requirement R3 imposes an administrative task that provides little protection for Bulk-Power System reliability. The retirement of Requirement R3 will not relieve a planning coordinator of the obligation to document its transfer capability methodology under the remaining provisions of FAC-013-2. In addition, the retirement of Requirement R3 will not relieve a planning coordinator from its obligation pursuant to Requirement R2 of the standard to provide its transfer capability methodology, including any changes to the methodology, to the appropriate entities prior to the effective date of any such change. Based on the explanation in NERC's petition, Requirement R3 imposes a compliance burden with little attendant reliability benefit.

60. INT-007-1, Requirement R1.2—Interchange Confirmation:

The FD&C Act establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR Part 807).

On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended the device reclassification procedures under section 513(e) of the FD&C Act, changing the process for reclassifying a device from rulemaking to an administrative order. Prior to the enactment of FDASIA, FDA published a proposed rule under section 513(e) proposing the reclassification of implanted blood access devices for hemodialysis (77 FR 36951; June 20, 2012). FDA is issuing this proposed administrative order to comply with the new procedural requirement created by FDASIA when reclassifying a preamendments class III device. Also as required by section 513(e) of the FD&C Act, FDA has scheduled a panel meeting to discuss the proposed reclassification for June 27, 2013 (78 FR 25747; May 2, 2013). The three comments submitted in response to the proposed rule on implanted blood access devices for hemodialysis will be considered under this proposed administrative order and do not need to be resubmitted. No objections to the proposed reclassification were submitted. This action is intended solely to fulfill the procedural requirements for reclassification implemented by FDASIA. FDA is also issuing the draft guidance, “Implanted Blood Access Devices for Hemodialysis,” which provides recommendations on how to comply with the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.

Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Dep't of Health, Educ., & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in “medical science.” (See Upjohn v. Finch supra, 422 F.2d at 951.) Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)

FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the valid scientific evidence upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA). (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by the Food and Drug Administration Modernization Act of 1997 (FDAMA), provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved. This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device, but does not include descriptions of methods of manufacture or product composition and other trade secrets.

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payors, and providers. In addition, the proposed order must set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including the public health benefits of the use of the device, and the nature and incidence (if known) of the risk of the device. (See section 513(e)(1)(A)(i) of the FD&C Act.)

FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device.

As discussed in the preamble to the proposed rule (46 FR 7616; January 23, 1981), the Gastroenterology-Urology Devices Panel recommended that both implanted and nonimplanted blood access devices be classified into class II. Although FDA agreed with the panel recommendation for nonimplanted blood access devices, FDA disagreed with the panel for implanted blood access devices and proposed that implanted blood access devices be classified into class III because FDA believed that the device presented a potential unreasonable risk of illness or injury to the patient. FDA also noted that the implanted blood access device is part of a life-supporting and life-sustaining system and that general controls and performance standards were insufficient to provide reasonable assurance of the safety and effectiveness of implanted blood access devices.

In 1983, FDA classified implanted blood access devices into class III, but the accessories to these devices into class II (48 FR 53012; November 23, 1983). In 1987, FDA published a clarification by inserting language in the codified language stating that no effective date had been established for the requirement for premarket approval for implanted blood access devices (52 FR 17732 at 17738; May 11, 1987).

In 2009, FDA published an order for the submission of information on implanted blood access devices (74 FR 16214; April 9, 2009). In response to that order, FDA received information in support of reclassification from 15 device manufacturers who all recommended that implanted blood access devices be reclassified to class II. The manufacturers stated that safety and effectiveness of these devices may be assured by bench testing, biocompatibility testing, sterility testing, expiration date testing, labeling, and standards.

On June 20, 2012, FDA published a proposed rule proposing the reclassification of implanted blood access devices for hemodialysis from class III to class II (77 FR 36951) and announced the availability of a draft Special Controls Guidance Document that, when finalized, would serve as a special control, if FDA reclassified these devices. FDA believed that the special controls as described in the guidance document entitled “Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis” would be sufficient to mitigate the risks to health associated with implanted blood access devices for hemodialysis.

The proposed rule provided for a comment period that was open until September 18, 2012. FDA received three comments that suggested modifications to the proposed Special Controls Guidance Document. These were considered by FDA.

On July 9, 2012, FDASIA was enacted, which amended the device reclassification procedures under sections 513 and 515 of the FD&C Act (21 U.S.C. 360c and 360e, respectively), changing the process for taking final administrative action for these devices. Accordingly, FDA is issuing a proposed administrative order to comply with the new procedural requirement created by FDASIA when reclassifying a preamendments class III device. Further, FDA intends to codify the proposed special controls within the § 876.5540(b)(1) (21 CFR 876.5540(b)(1)) classification regulation.

Implanted blood access devices include various flexible or rigid tubes, such as catheters or cannulae. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff” for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles.

FDA is proposing in this order to modify the identification language from how it is presently written in § 876.5540(a)(1) for additional clarification. FDA is clarifying in the identification that these are prescription devices and modifying the examples of devices (e.g., catheter, cannulae) in the identification language to be consistent with existing legally marketed devices covered by this classification.

FDA is proposing that implanted blood access devices for hemodialysis be reclassified from class III to class II. In this proposed order, the Agency has identified special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls (including prescription-use restrictions) applicable to the devices, would provide reasonable assurance of their safety and effectiveness. Absent the special controls identified in this proposed order, general controls applicable to the device are insufficient to provide reasonable assurance of the safety and effectiveness of the device. FDA believes that this new information is sufficient to demonstrate that the proposed special controls can effectively mitigate the risks to health identified in the next section, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for implanted blood access devices.

FDA believes that these devices can be utilized to provide access to a patient's blood for hemodialysis or other chronic uses for 30 days or more. When used in hemodialysis, the device is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis.

FDA has considered implanted blood access devices in accordance with the reserved criteria set forth in section 510(l) and decided that the device requires premarket notification (510(k) of the FD&C Act). Therefore, the Agency does not intend to exempt this proposed class II device from premarket notification (510(k)) submission as provided under section 510(m) of the FD&C Act.

After considering available information for the classification of these devices, FDA has evaluated the risks to health associated with the use of implanted blood access devices for hemodialysis and determined the following risks to health are associated with its use:

• Thrombosis in patient and catheter occlusion, or central venous stenosis. Inadequate blood compatibility of the materials used in this device, blood pooling between dialysis sessions, or turbulent blood pathways could lead to potentially debilitating or fatal thromboembolism.

• Adverse tissue reaction. Inadequate tissue compatibility of the materials used in this device could cause an immune reaction.

• Infection and pyrogen reactions. An improperly sterilized device could cause a skin or bloodstream infection.

• Device failure. Weakness of connections or materials could lead to blood loss or device fragment embolization.

• Cardiac arrhythmia, hemorrhage, embolism, nerve injury, or vessel perforation. Improper placement into the heart or blood vessel could damage tissues and result in injuries.

• Hemolysis. Turbulence or high pressure created by narrow openings or changes in blood flow paths could cause the destruction of red blood cells.

• Accidental withdrawal or catheter migration. A catheter's cuff may not allow adequate ingrowth from the surrounding subcutaneous tissue, which could cause the device to dislodge or fall out with subsequent blood loss.

FDA believes that implanted blood access devices for hemodialysis should be reclassified from class III to class II because special controls, in addition to general controls, can be established to provide reasonable assurance of the safety and effectiveness of the device, and because general controls themselves are insufficient to provide reasonable assurance of its safety and effectiveness. In addition, there is now sufficient information to establish special controls to provide such assurance.

While current clinical practice guidelines recommend avoiding implanted blood access devices, such as catheters, if possible, they are still a necessary treatment option, and are used in a significant number of hemodialysis patients. While the risks are frequently cited, there are many advantages of implanted blood access devices, which lead to their relatively frequent use, as described previously. In many cases, vascular access for hemodialysis is needed urgently, and the alternatives, such as the arteriovenous fistula or the arteriovenous graft require weeks and months, respectively, before they can be used. Implanted blood access devices are frequently used as the immediate hemodialysis vascular access and also as a bridge to a more permanent vascular access. Additionally, some patients may have inadequate vascular anatomy to establish a more permanent vascular access and may require continued implanted blood access device use.

FDA believes that the identified special controls, in addition to general controls, are necessary to provide reasonable assurance of safety and effectiveness of these devices. Therefore, in accordance with sections 513(e) and 515(i) of the FD&C Act and § 860.130, based on new information with respect to the device and taking into account the public health benefit of the use of the device and the nature and known incidence of the risk of the device, FDA, on its own initiative, is proposing to reclassify this preamendments class III device into class II. The Agency has identified special controls that would provide reasonable assurance of their safety and effectiveness. Implanted blood access devices for hemodialysis are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device (proposed § 876.5540(a); § 801.109 (21 CFR 801.109) (Prescription devices.)).

Since 1983 when FDA classified implanted blood access devices into class III, sufficient evidence has been developed to support a reclassification to class II with special controls. FDA has been reviewing these devices for many years and their risks are well known. The risks to health are identified in section V, and FDA believes these risks can be adequately mitigated by special controls. Catheters continue to evolve over time with improved materials and insertion techniques to mitigate the risks. A review of 15 publications shows a decrease in infections and an increase in patency over three decades (1980 to 2011) (Refs. 1 to 15). The decrease in occurrence of serious adverse events as evidenced through FDA's Manufacturer and User Facility Device Experience (MAUDE) database, the valid scientific evidence to support implanted blood access devices for hemodialysis provided in the referenced publications, and FDA's review experience with these devices, supports FDA's conclusion that the identified special controls, including performance testing demonstrating that the device performs as intended under anticipated conditions of use, is appropriately designed, and includes adequate safeguards and labeling to inform users of inappropriate use conditions, in addition to general controls, provide reasonable assurance of the safety and effectiveness of implanted blood access devices.

FDA believes that the following special controls, together with general controls (including applicable prescription-use restrictions and continuing 510(k) notification requirements), are sufficient to mitigate the risks to health described in section V for implanted blood access devices:

1. Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.

2. Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

a. Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 ml/min increments, must be established. The fluid and its viscosity used during testing must be stated.

b. Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.

c. Priming volumes must be established.

d. Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.

e. Air leakage testing and liquid leakage testing must be conducted.

f. Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the catheter must be conducted, and retested for leakage.

g. Mechanical hemolysis testing must be conducted.

h. Chemical tolerance of the catheter to repeated exposure to commonly used disinfection agents must be established.

3. Performance data must demonstrate the sterility of the device.

4. Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.

5. Labeling must bear all information required for the safe and effective use of implanted blood access devices for hemodialysis including the following:

a. Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format.

b. Labeling must provide the arterial and venous priming volumes.

c. Labeling must specify the forward and reverse recirculation rates.

d. Labeling must specify an expiration date.

e. Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.

f. Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively a label can be provided that can be affixed to the patient's medical record with this information.

g. The labeling must contain the following information: Comprehensive instructions for the preparation and insertion of the hemodialysis catheter, including recommended site of insertion, method of insertion, a reference on the proper location for tip placement, a method for removal of the catheter, anticoagulation, guidance for management of obstruction and thrombus formation, and site care.

h. The labeling must identify any coatings or additives and summarize the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.

6. For subcutaneous devices, the recommended type of needle for access must be described, stated in the labeling, and test results on repeated use of the ports must be provided.

7. Coated devices must include a description of the coating or additive material, duration of effectiveness, how the coating is applied, and testing to adequately demonstrate the performance of the coating.

In addition, implanted blood access devices are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device. (Proposed § 876.5540(a); § 801.109 (Prescription devices.)). Under 21 CFR 807.81, the device would continue to be subject to 510(k) notification requirements. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document entitled “Implanted Blood Access Devices for Hemodialysis,” that, when finalized, would provide recommendations on how to comply with the special controls proposed in this order, if FDA reclassifies this device (Ref. 16).

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This proposed order refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR Part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR Part 801 have been approved under OMB control number 0910-0485.

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this proposed order we are proposing to revoke the requirements in § 876.5540(b)(1) related to the classification of implanted blood access devices as class III devices and to codify the reclassification of implanted blood access devices into class II (special controls).

FDA is proposing that any final order based on this proposed order become effective on the date of its publication in the Federal Register or at a later date if stated in the final order.

Comments submitted to the previous dockets (2012-N-0303) have been officially noted and do not need to be resubmitted. FDA will consider previous docket comments in issuing any final orders for these devices. Interested persons may submit either electronic comments regarding this document or the associated guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR Part 876 be amended as follows:

A notice of proposed rulemaking and a notice of public hearing that appeared in the Federal Register on Friday, March 8, 2013 (78 FR 14939) announced that a public hearing was scheduled for July 2, 2013, at 10 a.m. in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue NW., Washington, DC. The subject of the public hearing is under section 6708 of the Internal Revenue Code.

The public comment period for these regulations expired on June 6, 2013. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed by June 10, 2013. As of Monday, June 24, 2013, no one has requested to speak. Therefore, the public hearing scheduled for July 2, 2013, is cancelled.

Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA. Information is organized as follows:

In the Clean Air Act (CAA) Amendments of 1977, Congress established a program to protect and improve visibility in the Nation's national parks and wilderness areas. See CAA section 169A. Congress amended the visibility provisions in the CAA in 1990 to focus attention on the problem of regional haze. See CAA section 169B. The EPA promulgated regional haze regulations (RHR) in 1999 to implement sections 169A and 169B of the Act. These regulations require states to develop and implement plans to ensure reasonable progress toward improving visibility in mandatory Class I Federal areas 1 (Class I areas). 64 FR 35714 (July 1, 1999); see also 70 FR 39104 (July 6, 2005) and 71 FR 60612 (October 13, 2006).

Regional haze is impairment of visual range or colorization caused by air pollution, principally fine particulate, produced by numerous sources and activities, located across a broad regional area. The sources include but are not limited to, major and minor stationary sources, mobile sources, and area sources including non-anthropogenic sources. These sources and activities may emit fine particles (PM2.5) (e.g., sulfates, nitrates, organic carbon, elemental carbon, and soil dust), and their precursors (e.g., sulfur dioxide (SO2), nitrogen oxides (NOX), and in some cases, ammonia and volatile organic compounds). Fine particulate can also cause serious health effects and mortality in humans, and contributes to environmental effects such as acid deposition and eutrophication. See 64 FR at 35715.

Data from the existing visibility monitoring network, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) monitoring network, show that visibility impairment caused by air pollution occurs virtually all the time in most national parks and wilderness areas. The average visual range in many Class I areas in the western United States is 100-150 kilometers, or about one-half to two-thirds the visual range that would exist without manmade air pollution.2 Visibility impairment also varies day-to-day and by season depending on variations in meteorology and emission rates. The deciview (dv) is the metric by which visibility is measured in the regional haze program. A change of 1 dv is generally considered the change in visual range that the human eye can perceive.

The RHR requires each State's regional haze implementation plan to contain emission limitations representing BART and schedules for compliance with BART for each source subject to BART, unless the State demonstrates that an emissions trading program or other alternative will achieve greater reasonable progress toward natural visibility conditions. A State may opt to implement or require participation in an emission trading program or other alternative measure rather than require sources subject to BART to install, operate, and maintain BART.

On April 16, 2007, Idaho submitted to the EPA for approval new and revised rules that provide the Idaho Department of Environmental Quality (IDEQ) the regulatory authority to address regional haze and to implement BART (BART Authority rule). The EPA approved these rules on June 9, 2011. 76 FR 33651. Idaho submitted its Regional Haze State Implementation Plan as meeting the requirements of 40 CFR 51.308 to the EPA on October 25, 2010 (2010 RH SIP submittal). The 2010 RH SIP submittal covers the planning period of 2008 through 2018 and, among the other required elements, includes a BART determination for the TASCO facility in Nampa, Idaho. On June 22, 2011, the EPA approved the BART related provisions of Idaho's 2010 RH SIP submittal, including the final BART determination for the TASCO facility.3 76 FR 36329. That approval incorporated by reference the September 7, 2010, TASCO Tier II Operating Permit No. T2-2009.0105 (2010 TASCO Tier II Operating Permit) that contained the emission limitations representing BART for TASCO. On November 8, 2012, EPA took final action to approve the remaining elements in the Idaho Regional Haze SIP. 77 FR 66929. Thus, Idaho's 2010 RH SIP is fully approved.

On June 29, 2012, Idaho submitted revisions (2012 RH SIP submittal) to the 2010 RH SIP that includes: a revised NOX BART determination; a more stringent particulate matter (PM) emission limitation; and an alternative control measure to replace the SO2 BART determination for TASCO's fossil fuel-fired Riley Boiler. This alternative control measure is also referred to as the BART Alternative. In addition to the new NOX and PM emission limitations on the Riley Boiler, the alternative control measure relies on control of NOX emissions from two other boilers at the TASCO facility in Nampa, that are not BART eligible emission units (non-BART boilers). The alternative measure also takes into account emission reductions resulting from the permanent shutdown of three coal fired pulp-dryers. The revised NOX BART determination, more stringent PM emission limitation, and the BART Alternative are contained in a revised Tier II Operating Permit, T2-2009.0105 issued to TASCO December 23, 2011 (2011 TASCO Tier II Operating Permit). As explained below this alternative measure and revised permit result in greater reasonable progress toward natural visibility conditions than the improvement expected from the BART determination previously approved.

The RHR contains provisions whereby a state may choose to implement an alternative measure as an alternative to BART, if the state can demonstrate that the alternative measure achieves greater reasonable progress toward achieving natural visibility conditions than would be achieved through the installation, operation and maintenance of BART. The requirements for alternative measures are established at 40 CFR 51.308(e)(2). As explained in the RHR, the state must demonstrate that all necessary emission reductions will take place during the first long term strategy period (i.e., by 2018) and that the emissions reductions resulting from the alternative measure will be surplus to those reductions resulting from measures adopted to meet requirements of the CAA as of the baseline date of the SIP.

The Idaho rules provide IDEQ authority to consider and adopt alternative measures as an alternative to BART. See IDAPA 58.01.01.668.06.4 The EPA approved this BART Alternative rule when it approved the Idaho BART Authority rule. 76 FR 33652 (June 9, 2011).

Sources subject to BART must be in compliance with the BART emission limitations as soon as practical but no later than 5 years after EPA approves the implementation plan revision. 40 CFR 51.308(e)(1)(iv). The EPA approval of Idaho's BART provisions became effective July 22, 2011, thus TASCO must be in compliance with the BART requirements no later than July 22, 2016. Under the BART Alternative, as specified in the revised permit, TASCO must comply with the emission limitations by July 22, 2016, which is well within the first long term strategy period which ends December, 2018.

TASCO operates a sugar beet processing facility in Nampa, Idaho, that includes a fossil fuel fired boiler referred to as the “Riley Boiler”. The Riley Boiler is a BART eligible source and is subject to BART. In the final action on the BART provisions in the 2010 RH SIP submittal, the EPA approved IDEQ's BART determination for the Riley Boiler. 76 FR 36329. The approved BART level technology and emission limitations identified for the Riley Boiler and contained in the 2010 TASCO Tier II Operating Permit are:

PM: 14 pounds per hour (lbs/hr) and requires the emissions to be controlled using a baghouse;

SO2: 115 lbs/hr and requires the emissions to be controlled with spray-dry flue gas desulfurization (spray-dry FGD); and

NOx: 186 lbs/hr and requires the NOX emissions to be controlled using low NOX burners with overfire air (LNB-OFA).

Subsequent to the 2010 RH SIP submission and approval, TASCO submitted to IDEQ additional site-specific engineering analyses and a proposal for an alternative measure to replace the SO2 BART determination for its facility. Dispersion modeling was conducted to compare the visibility improvement expected from the alternative control measure to visibility improvement expected from implementation of BART. Based on the new information and proposal, IDEQ revised portions of Chapter 10 of the 2010 RH SIP and submitted the revisions, along with supporting technical documentation, to the EPA. The 2012 RH SIP submittal contains, among other elements, a new NOX BART determination for the Riley Boiler and the 2011 TASCO Tier II Operating Permit for the Riley Boiler.

The 2012 RH SIP submittal revises the NOX BART determination for the Riley Boiler. The 2010 RH SIP submittal identified low NOX burners (LNB), LNB with overfire air (OFA), and selective catalytic reduction (SCR) as all technically feasible NOX controls for the Riley Boiler. The State evaluated the cost effectiveness of each technology and determined that: LNB is cost effective at $921/ton; LNB-OFA is cost effective at $1270/ton with an incremental cost over LNB at $2431/ton. At that time, the State determined that SCR had a cost effectiveness value of $3768/ton and an incremental cost over LNB-OFA of $10,245/ton. In the 2010 RH SIP submittal, Idaho determined that SCR is not cost effective based on the incremental cost of SCR over the cost of LNB-OFA. In the final action on Idaho's 2010 RH SIP submittal, the EPA approved the State's BART determination. As explained, based on additional on-site engineering analysis conducted by TASCO, Idaho subsequently determined that neither LNB-OFA nor SCR are technically feasible at this facility. See 2012 RH SIP submittal, Chapter 10, Section 10.5. In the detailed engineering analysis conducted for installation of LNB-OFA, TASCO determined that there is insufficient space in the combustion chamber for LNB-OFA for adequate combustion and flame management. As also explained, TASCO and the State now consider SCR to be technically infeasible due to inadequate space between the boiler and baghouse and concerns about catalyst fouling and erosion. The analysis also determined that installation after the baghouse would not provide adequate exhaust temperature for SCR to function properly. Id. Thus, the 2012 RH SIP submittal finds that LNB is the only technically feasible NOX control technology for the Riley Boiler.

Regardless of the revised determination of what NOx control is technically feasible for the Riley Boiler, new, more stringent, BART emission limitations for NOx were included in the State's revised BART determination and the new, more stringent, NOx and PM emission limitations are included in the revised 2011Tier II Operating Permit. See 2012 RH SIP submittal Chapter 10, Section 10.5 Table 3, and 2011 TASCO Tier II Operating Permit Condition 3.4. The revised NOx BART determination is based on LNBs for NOx control. The revised NOx BART determination for the Riley Boiler strengthens the emission limitations from 186 lbs/hr to 147 lbs/hr, and results in a 21% reduction in NOx emissions from the original BART determination for the Riley Boiler. It also changes the identified control technology for NOx upon which the BART emission limitation is based, from LNB-OFA to LNBs. As explained below, this new BART determination and more stringent emission limitations were used in the demonstration that the BART Alternative provides for greater reasonable progress to achieve natural visibility conditions than BART.

The 2012 RH SIP submittal also proposes as a BART Alternative an alternative measure to the SO2 BART determination for the Riley Boiler. This alternative measure covers six emission units at the TASCO facility: the Riley Boiler, the Babcock & Wilcox (B&W) Boilers #1 and #2, and the South, Center, and North Pulp dryers. The alternative measure replaces the spray-dry FGD SO2 control on the Riley Boiler with LNB NOx control on the B&W Boilers #1 & #2 and takes into account the emission reductions resulting from the shutdown of the three pulp dryers. Thus, the retrofit of the coal-fired low-NOx burners on the B&W Boilers and resulting NOx reductions and credit for the permanent shutdown of the three pulp dryers are intended to replace the BART SO2 emission limitation for the Riley Boiler. The controls for the B&W Boilers #1 & #2 and shutdown requirements for the South Pulp Dryer in the 2011 TASCO Tier II Operating Permit, (Condition 4.1) will become Federally enforceable upon final approval of this proposal. The permanent shutdown of the Center and North pulp dryers is Federally enforceable, as required by the September 30, 2002, TASCO Tier II permit currently in the Federally approved SIP. The 2011 TASCO Tier II Operating Permit also includes a revised PM limitation for the Riley Boiler, reducing the PM emission limitation from 14 lbs/hr to 12.4 lbs/hr. The strengthened PM emission limitation results in an 11% reduction in PM emissions from the emissions expected from the BART determination previously approved.

TASCO conducted air quality dispersion modeling to estimate visibility improvement in affected Class I areas in accordance with the three-state, Washington, Idaho, and Oregon BART Modeling Protocol to demonstrate greater reasonable progress in achieving natural visibility conditions. This protocol underwent extensive review and approval and formed the basis for much of the BART modeling for regional haze conducted in the Pacific Northwest, including modeling in Idaho's 2010 RH SIP submittal. In the 2012 RH SIP submittal, the State demonstrated the visibility improving advantages of the BART Alternative by comparing the visibility improvement of the revised BART for the Riley Boiler in the 2012 RH SIP submittal with the improvement resulting from the BART Alternative. The model input emissions for SO2, NOx and PM were determined for all six emission units included in the alternative measure: the Riley Boiler (SO2, NOx, and PM), B&W Boilers #1 and #2 (NOx), and the three coal-fired pulp dryers (SO2, NOx and PM). Three scenarios were modeled for all six emission units: baseline (pre-BART), revised BART for Riley Boiler, and the BART Alternative.

Emissions from the TASCO facility impairs visibility at seven mandatory Class I areas within 300 kilometers (km): Eagle Cap Wilderness Area, Oregon; Craters of the Moon National Monument, Idaho; Hells Canyon Wilderness Area, Oregon; Jarbidge Wilderness Area, Nevada; Sawtooth Wilderness Area, Idaho; Selway-Bitteroot Wilderness Area, Idaho; and the Strawberry Wilderness Area, Oregon. The results of this modeling effort for all seven Class I areas are presented in the 2012 RH SIP submittal, Chapter 10, Section 10.5, Table 6. The deciview impact for the 22nd highest day over the 2003 to 2005 time period is presented for each of the seven Class I areas. The submittal shows the number of days with impairment greater than 0.5 dv in the 2003 to 2005 time period.

The Table below presents the modeled visibility, at all Class I areas within 300 km of the TASCO facility at baseline conditions (2003 to 2005), under the revised BART, and under the proposed BART Alternative. As shown, the proposed BART Alternative achieves greater reasonable progress toward natural conditions than would be achieved through the installation, operation and maintenance of BART.

The provisions of 40 CFR part 51, Appendix Y, followed by Idaho, set forth the process used to identify control technologies and to consider the five statutory factors that must be evaluated as part of a BART determination. After site specific consideration of the factors, the best achievable retrofit technology is identified and the BART emission limitation is specified.

As discussed previously in this notice, based on a revised analysis conducted and provided by TASCO, Idaho determined that SCR is technically infeasible for the Riley Boiler. This new finding does not affect the State's final BART determination because, as the EPA previously agreed, Idaho's determination found that even if SCR was technically feasible it was not cost effective and thus, would not qualify as BART. 76 FR 3632. Thus, the 2012 RH SIP submittal determination that SCR is technically infeasible does not change the EPA's previous agreement that SCR is not BART for this facility. The EPA previously approved the NOX BART emission limitation for the Riley Boiler of 186 lbs/hr, based on LNB-OFA control technology. However, TASCO's further engineering analysis determined that while there is insufficient space in the combustion chamber for LNB-OFA for adequate combustion and flame management, LNB alone could achieve greater NOX control than the LNB-OFA control. Accordingly, Idaho revised its NOX BART determination to reflect the technology change, greater control and tighter emission limitations. The compliance date of July 22, 2016 remains unchanged.

In the 2012 RH SIP submittal, Idaho strengthened the NOX BART emission limitation to 147 lbs/hr based on TASCO's reassessment of LNB performance for the Riley Boiler. In light of TASCO's revised analysis that the original BART determination is not technically feasible and because the revised BART determination results in a more stringent NOX BART emission limitation, the EPA is proposing to vacate our original BART determination and approve the revised NOX BART determination and this new limitation for the TASCO facility.

The EPA previously approved Idaho's PM BART emission limitation for the Riley Boiler of 14 lbs/hr, based on baghouse control technology as provided in the 2010 RH SIP submittal. In the 2012 RH SIP submittal, Idaho strengthened the PM emission limitation to 12.4 lbs/hr, based on TASCO's analysis of the performance of the baghouse. The revised PM emission limitation is more stringent than the limitation previously approved and therefore the EPA is proposing to approve this revised PM limitation as a SIP strengthening measure.

The 2012 RH SIP submittal includes a proposed alternative measure to the previously approved SO2 BART determination for Riley Boiler. This alternative measure is intended to replace the SO2 BART emission limitation of 115 lb/hr for the Riley Boiler 5 with a combined NOX emission limitation on the B&W Boilers #1 and #2 of 103 lbs/hr, and takes into account the emission reductions resulting from the permanent shutdown of three coal-fired pulp dryers. The baseline emissions for all three pulp dryers are: NOX—191.2 lbs/hr; SO2—17.9 lbs/hr; and PM-927 lbs/hr. These emissions were permanently eliminated when the pulp dryers were shutdown.

Installation of LNB control and establishing emission limitations on the B&W Boilers, along with permanently eliminating the emissions associated with the three pulp dryers, result in a total reduction in NOX of 221 t/y, SO2 of 20.6 t/y, and PM of 113 t/y. The B&W Boilers are non-BART units. The pulp dryers were shutdown because installation of a drying process using waste steam from the boilers instead of the pulp dryers reduced the fuel demand that resulted in a lower cost operation, eliminating the need for the pulp dryers. The shutdown of the pulp dryers is not required under the CAA. Thus, these emission reductions may be considered surplus. The total emissions are reduced under the BART Alternative measure compared to both the original 2010 RH SIP approved BART determination and the revised BART determination in the 2012 RH SIP submittal.

As presented in Table 1 above, dispersion modeling of visibility in all Class I areas within 300 km of the TASCO facility demonstrates there is overall greater progress towards achieving natural conditions under the BART Alternative. In particular, there is greater progress in the Eagle Cap Wilderness Area (the Class I area most impacted by emissions from the TASCO facility) of 0.101 dv under the BART alternative than under the revised BART determination and in the Strawberry Mountain Wilderness Area of 0.159 dv.

The 2011 TASCO Tier II Operating Permit, Permit Condition 3.3 requires compliance with the BART Alternative by July 22, 2016, the same compliance date as the approved BART. Additionally, the permit provides that unless LNBs have been installed and operating, as required in Permit Condition 3.7, on and after July 22, 2016, the Riley Boiler may be fired only using natural gas, and that on, and after July 22, 2016, the Riley Boiler may not be fired with coal until such date that the coal-fired LNBs are installed and operated in accordance with the permit. See 2011 TASCO Tier II Operating Permit, Permit Condition 3.9. Permit condition 14.9 of TASCO's Tier I Operating Permit T1-050020, issued May 23, 2006, required the North and Central pulp dryers to be permanently shut down and Permit Condition 4.1 of the 2011 TASCO Tier II Operating Permit, requires the South Pulp Dryer to be permanently shutdown. Thus, there is no delay in compliance with BART requirements under the BART Alternative.

The 2011 TASCO Tier II Operating Permit contains the emission limitations discussed above. See 2011 TASCO Tier II Operating Permit, Permit Condition 3.4 and 3.5. The permit also contains requirements for a non-visibility impairing pollutant, specifically carbon monoxide (CO). Permit Condition 3.12 requires performance testing for CO. The EPA proposes no action on this permit condition, as it does not pertain to visibility.

The second paragraph of Condition 3.3 of the Permit allows TASCO to submit a request to obtain IDEQ approved alternatives to BART and to revise the Permit and explains that IDEQ will process the request in accordance with its permitting rules. The condition further provides that the request must be submitted in time for any such revision to the permit and the corresponding revision to the RH SIP to be approved prior to July 22, 2016. This provision is administrative in nature and addresses the State's procedure for possible future revisions to the permit. As such it is not necessary or appropriate for EPA to act on this provision. Nevertheless, we note that a revision to a Federally approved permit must meet applicable Federal requirements before it could be incorporated into the Federally approved SIP. The EPA cannot assure Idaho or TASCO that any submitted BART Alternative measure will be approved until that measure has been thoroughly evaluated by the EPA as meeting Federal requirements.

The EPA is proposing to vacate our previous BART determination for the TASCO facility and to approve Idaho's 2012 RH SIP submittal including the revised NOX BART determination for the TASCO Riley Boiler and the 2011 TASCO Tier II Operating Permit containing the BART Alternative conditions 1.2 including the table of Regulated Emission Point Sources Table, 3.2, 3.3 (first paragraph only), 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.11, 3.13, 3.14, 3.15, 3.16, and 4.1. Specifically, the EPA proposes to approve new BART emission limitations for NOX, the revised PM emission limitations and the BART Alternative at the TASCO facility because they provide greater overall reasonable progress toward achieving natural conditions in affected Class I areas than the previously approved BART determination for the TASCO facility.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In response to requests from industry representatives and environmental groups, the EPA is extending the public comment period for an additional 15 days. The public comment period will end on July 23, 2013, rather than July 8, 2013.

This NPRM proposes a regulation that would require each Class I railroad, intercity passenger railroad, and commuter railroad to establish and implement a critical incident stress plan for certain employees of the railroad who are directly involved in, witness, or respond to, a critical incident. FRA seeks comment on all aspects of this proposal.

Although FRA has never regulated critical incident stress plans, many railroads have had some form of critical incident stress plan in place for many years. This rulemaking responds to the Rail Safety Improvement Act of 2008 (Public Law 110-432, Div. A) (RSIA) mandate that the Secretary of Transportation establish regulations to define “critical incident” and to require certain railroads to develop and implement critical incident stress plans.

As discussed in detail below, FRA reviewed the applicable science and information received through the Railroad Safety Advisory Committee (RSAC), and as required by Congress, FRA proposes a definition for “critical incident” and proposes a set of minimum standards for critical incident stress plans. This approach provides covered employees with options for relief following a critical incident, yet allows for substantial flexibility within the regulatory framework so that railroads may adapt their plans commensurate with their needs. The proposal defines a “critical incident” as either — (1) An accident/incident reportable to FRA under 49 CFR part 225 that results in a fatality, loss of limb, or a similarly serious bodily injury; or (2) A catastrophic accident/incident reportable to FRA under part 225 that could be reasonably expected to impair a directly-involved employee's ability to perform his or her job duties safely. The proposed set of minimum standards for critical incident stress plans include allowing a directly-involved employee to obtain relief from the remainder of the tour of duty, providing for the directly-involved employee's transportation to the home terminal (if applicable), and offering a directly-involved employee appropriate support services following a critical incident. The proposed rule would require each applicable railroad to submit its plan to FRA for approval.

FRA has analyzed the economic impacts of this proposed rule against a “status quo” baseline that reflects present conditions (i.e. primarily what applicable railroads are already doing with respect to critical incident policy). Based on both RSAC meetings and discussions with the rail industry, FRA's analysis assumes that all railroads affected by the proposed rule currently have policies that include a critical incident stress plan, thereby reducing the costs of compliance associated with the proposed rule. In estimating these compliance costs, FRA included costs associated with training supervisors on how to interact with railroad employees who have been affected by a critical incident, employee training, counseling, and other support services, and costs associated with the submission of the critical incident stress plan to FRA for approval. FRA estimates that the costs of the proposed rule for a 20-year period would total $1,943,565. Using a 7 percent and a 3 percent discount rate, the total discounted costs will be $1,337,830 and $1,615,519, respectively.

The proposed rule contains minimum standards for employee training, leave, counseling, and other support services. These standards would help create benefits by providing employees with knowledge, coping skills, and services that would help them: (1) Recognize and cope with symptoms of normal stress reactions that commonly occur as a result of a critical incident; (2) reduce their chance of developing a disorder such as depression, Post-Traumatic Stress Disorder (PTSD), or Acute Stress Disorder (ASD) as a result of a critical incident; and (3) recognize symptoms of psychological disorders that sometimes occur as a result of a critical incident and know how to obtain prompt evaluation and treatment of any such disorder, if necessary. FRA anticipates that implementation of the proposed rule would yield benefits by reducing long-term healthcare costs associated with treating PTSD, ASD, and other stress reactions; and costs that accrue either when an employee is unable to return to work for a significant period of time or might leave railroad employment due to being affected by PTSD, ASD, or another stress reaction. In addition, safety risk posed by having a person who has just been involved in a critical incident performing safety critical functions is also reduced. The majority of the quantifiable benefits identified by FRA's analysis are associated with railroad employee retention and a reduction of long-term healthcare costs associated with PTSD cases that were not treated appropriately after a critical incident. FRA expects that the proposed rule would decrease the number of employees who leave the railroad industry due to PTSD, ASD, or other stress reactions, as early treatment for potential PTSD cases following exposure to a critical incident would reduce both the likelihood of developing PTSD and the duration of PTSD or another stress reaction. The proposed rule would therefore increase the early identification of PTSD and provide more immediate healthcare to the cases that develop. FRA estimates that the present value of the quantifiable benefits for a 20-year period would total $2,630,000. Using a 7 percent and a 3 percent discount rate, the total discounted benefits would be $1,505,622 and $2,023,548, respectively. Overall, FRA finds that the value of the anticipated benefits would justify the cost of implementing the proposed rule. FRA seeks comments on all aspects of the economic impacts of its proposal.

On October 16, 2008, the RSIA was enacted. Section 410 of the RSIA (Section 410) mandates that the Secretary of Transportation (Secretary) require “each Class I railroad carrier, each intercity passenger railroad carrier, and each commuter railroad carrier to develop and submit for approval to the Secretary a critical incident stress plan that provides for debriefing, counseling, guidance, and other appropriate support services to be offered to an employee affected by a critical incident.” See Section 410(a). RSIA mandates that the plans include provisions for relieving employees who are involved in, or who witness, critical incidents from their tours of duty, and for providing leave for such employees from their normal duties as may be necessary and reasonable to receive preventive services and treatment related to the critical incident. See Section 410(b). The Secretary is specifically required to define the term “critical incident” for purposes of this rulemaking. See Section 410(c). The Secretary has delegated his responsibilities under the RSIA to the Administrator of FRA. See 49 CFR 1.89(b). In the Section-by-Section Analysis below, FRA discusses how the proposed regulatory text addresses each portion of the Section 410 mandates. This proposed rule is also issued pursuant to FRA's general rulemaking authority at 49 U.S.C. 20103.

As required by Section 410(c), within 30 days after enactment of the RSIA, FRA initiated action within the DOT to commence a rulemaking to define the term “critical incident.” Additionally, as required by Section 410(a), FRA consulted with the Department of Health and Human Services (HHS) and the Department of Labor (DOL) in preparing this proposed rule. Specifically, in addition to consulting with representatives of HHS and DOL, FRA provided those departments with an advance copy of this proposed regulation and requested input on FRA's approach. FRA has incorporated the suggestions provided by both HHS's Substance Abuse and Mental Health Services Administration (SAMHSA) and DOL's Wage and Hour Division.

Highway-rail grade crossing accidents and trespasser incidents along the railroad right-of-way are an unfortunate reality for employees in the railroad industry. Railroad work carries the risk that a covered employee will be directly involved in a critical incident, often outside the control of the railroad employees, which can lead to severe emotional and psychological distress, including Post Traumatic Stress Disorder (PTSD) and the more immediate Acute Stress Disorder (ASD).2 There are concerns about the impact of exposure to traumatic incidents on employees in safety-sensitive jobs, most notably engineers and conductors.

Until this proposed rule, a national, uniform approach to critical incident response in the railroad industry did not exist, with only a handful of States taking action through statutes or regulations to aid critical incident response in the railroad industry. With this proposed rule, FRA seeks to define the term “critical incident” in the railroad setting, which if met, would trigger the requirement that appropriate support services be offered to railroad employees affected by such incidents.

PTSD and ASD can develop following any traumatic event that threatens personal safety or the safety of others, or causes serious physical, cognitive or emotional harm. While such disorders are most often initiated by a threat to one's life or the witnessing of brutal injury or traumatic death—in combat situations, for example, or during violent accidents or disasters—any overwhelming life experience can trigger the disorders, especially if the event is perceived as unpredictable and uncontrollable. Individuals exposed to traumatic events experience alterations in their neurologic, endocrine, and immune systems, which have been linked to adverse changes in overall health.3 These changes and symptoms can be ameliorated if treated appropriately, usually with psychotherapy and/or medications. However, PTSD and ASD often go undiagnosed, as few primary care providers routinely assess for it and more often than not, attribute the symptoms to less serious forms of depression, anxiety, and general emotional distress.4

In recent years approximately 2,500 highway-rail crossing accidents and 900 casualties to persons trespassing on railroad property (trespassers) have occurred in the United States annually. Each one of these incidents, as well as other traumatic events such as railroad accidents or incidents resulting in serious injury or death to railroad employees, hold potential for causing ASD, PTSD, or other health and safety-related problems, in any railroad employee who is present. Some locomotive engineers and conductors have had the misfortune of experiencing multiple potential PTSD/ASD-invoking events over the course of their careers.5

Exposure of railroad employees, particularly locomotive engineers and conductors, to prototypical potentially traumatic exposures is well established. Incursion events, such as vehicular accidents at highway-rail grade crossings and pedestrian incursions onto the railroad right-of-way (frequently as a method of suicide) often involve fatalities and the injuries sustained may be gruesome. Locomotive engineers and conductors, because of their proximity to the accident scene, must often tend to the injured and secure the scene, compounding the extent and the duration of exposure. In particular, locomotive engineers may be alone in the cab when an on-the-track accident occurs. Further, train crews are required to report the incident, secure the train, and often leave the train and examine the victims. Crew members may even provide first aid if victims are alive, and wait, sometimes for long periods, for assistance or instructions.

Systematic empirical studies of the health impact on railroad personnel of this kind of experience are limited. The best designed studies have been European and show clinically diagnosed PTSD in 7 to 14 percent of those exposed. FRA has found no empirical studies of treatment efficacy and impact within the U.S. railroad population, presumably due to the relatively small population annually treated and the different locations and systems involved in railroad employees' identification and care.

If left untreated, mental health conditions carry significant costs for employers in the form of “presenteeism,” when employees come to work, but have lowered productivity.6 Presenteeism can have catastrophic safety consequences for railroads. Symptoms such as sleep difficulties, trouble concentrating, hypervigilance and exaggerated sensory reactions—often leading sufferers to misuse alcohol to reduce the stress—compromise workers' safety at work and the safety of others, and lower employees' productivity on the job. One study revealed that employees are more likely to engage in workplace presenteeism than calling in sick (absenteeism).7

Most major railroads have plans to provide their employees with assistance and intervention following traumatic events. Most of these programs have been in existence for a number of years, usually as part of a railroad's “Employee Assistance Program” (EAP). The descriptions of interventions, timing, and delivery in these programs are often “transplanted” from programs created for fire, rescue, and emergency services personnel in the 1980s and 1990s. These approaches, particularly those built around “critical incident stress debriefing” and related interventions, have come under increasing scrutiny as independent research has reported such interventions to not be helpful in certain situations and even to paradoxically inhibit the natural recovery of certain vulnerable participants. Accordingly, most authoritative guidelines now caution against the routine application of these approaches and some now list them as directly contraindicated.

While there are variations among railroads' existing programs, there are also substantial similarities reflected with respect to critical elements mandated by statute.8 For example, many railroads provide assistance and intervention following critical incidents, often through the use of the railroad's EAP. The majority of existing plans allow for immediate relief from duty upon request for the remainder of the tour of duty, as well as transportation to the home terminal for affected employees. Finally, many plans allow for additional leave following the tour of duty upon request, often involving contact with occupational medicine or EAP representatives.9 Therefore, several of these common elements are incorporated into this proposed rule.

In March 1996, FRA established RSAC, which provides a forum for developing consensus recommendations to the Administrator of FRA on rulemakings and other safety program issues. 61 FR 9740 (Mar. 11, 1996). RSAC's charter under the Federal Advisory Committee Act (Pub. L. 92-463) was most recently renewed in 2012. 77 FR 28421 (May 14, 2012).

RSAC includes representation from all of FRA's major stakeholders, including railroads, labor organizations, suppliers and manufacturers, and other interested parties. An alphabetical list of RSAC members includes the following:

When appropriate, FRA assigns a task to RSAC, and after consideration and debate, RSAC may accept or reject the task. If the task is accepted, RSAC establishes a working group that possesses the appropriate expertise and representation of interests to develop recommendations to FRA for action on the task. These recommendations are developed by consensus. A working group may establish one or more task forces to develop facts and options on a particular aspect of a given task. The task force then provides that information to the working group for consideration.

If a working group comes to a unanimous consensus on recommendations for action, the proposal is presented to the full RSAC for a vote. If the proposal is accepted by a simple majority of RSAC, the proposal is formally recommended to FRA. FRA then determines what action to take on the recommendation. Because FRA staff members play an active role at the working group level in discussing the issues and options and in drafting the language of the consensus proposal, FRA is often favorably inclined toward the RSAC recommendation.

However, FRA is in no way bound to follow the RSAC recommendation, and the agency exercises its independent judgment on whether the recommended rule achieves the agency's regulatory goal, is soundly supported, and is in accordance with policy and legal requirements. Often, FRA varies in some respects from the RSAC recommendation in developing the actual regulatory proposal or final rule. Any such variations would be noted and explained in the rulemaking document issued by FRA. If the working group or RSAC is unable to reach consensus on recommendations for action, FRA will proceed to resolve the issue through traditional rulemaking proceedings.

The Critical Incident Task Force (Task Force) was formed as part of the Medical Standards Working Group, and its task statement (Task No. 09-02) was accepted by RSAC on September 10, 2009. On July 2, 2010, FRA solicited bids for a grant to assess the current knowledge of post-traumatic stress interventions and to advance evidence-based recommendations for controlling the risks associated with traumatic exposures in the railroad setting. On March 11, 2011, FRA awarded the grant to the National Fallen Firefighters Foundation. On May 20, 2011, the Task Force was reformulated into an independent working group, the Critical Incident Working Group (CIWG). Task No. 09-02 (amended to reflect the new independent working group) specifies that the purpose of the CIWG is to provide advice regarding the development of implementing regulations for Critical Incident Stress Plans as required by the RSIA. The Task further assigns the CIWG to do the following: (1) Define what a “critical incident” is that requires a response; (2) review available data, literature, and standards of practice concerning critical incident programs to determine appropriate action when a railroad employee is involved in, or directly witnesses, a critical incident; (3) review any evaluation studies available for existing railroad critical incident programs; (4) describe program elements appropriate for the rail environment, including those requirements set forth in the RSIA; (5) provide an example of a suitable plan (template); and (6) assist in the preparation of an NPRM.

The CIWG met on June 24, 2011; September 8-9, 2011; October 11-12, 2011; and December 13, 2011. At the conclusion of the December 2011 meeting, an informal task force was formed to consider the substantive agreements made by the CIWG and to draft regulatory language around those agreements for the CIWG's consideration and vote. The small task force presented the language to the full CIWG for an electronic vote on August 6, 2012. The CIWG reached a consensus on all but one item 10 and forwarded a proposal to the full RSAC on August 21, 2012. RSAC voted to approve the CIWG's recommended text on September 27, 2012 and that recommended text provided the basis for this NPRM. While the CIWG did discuss a general template flow chart of a suitable critical incident stress plan, as recommended by the Grantee's Final Report, a specific model plan that could be adapted and adopted by railroads was not developed by the CIWG. Instead, the CIWG focused its efforts on the definition of critical incident and the program elements essential for the proposed regulatory text.

In addition to FRA staff, the members of the CIWG include the following:

AAR, including members from BNSF Railway Company (BNSF), Canadian National Railway (CN), Canadian Pacific Railway (CP), CSX Transportation, Inc. (CSX), The Kansas City Southern Railway Company (KCS), Norfolk Southern Railway Company (NS), Northeast Illinois Regional Commuter Railroad Corporation (Metra), and Union Pacific Railroad Company (UP);

Amtrak;

APTA, including members from Greater Cleveland Regional Transit Authority; Long Island Rail Road (LIRR); MTA—Metro-North Railroad; and Southern California Regional Rail Authority (SCRRA);

ASLRRA (representing short line and regional railroads);

ATDA;

BLET;

BMWED;

BRC/TCIU;

BRS;

NRCMA; and

UTU.

Staff from DOT's John A. Volpe National Transportation Systems Center attended all of the meetings of the CIWG and contributed to the technical discussions.

FRA has greatly benefited from the open, informed exchange of information during the meetings. In developing this NPRM, FRA relied heavily upon the work of the CIWG.

In this NPRM, FRA proposes a definition for the term “critical incident” and proposes minimum criteria that must be addressed by each railroad's critical incident stress plan. The proposed regulatory text would allow a railroad to utilize its existing critical incident stress plan as a base, making modifications as necessary to ensure compliance with the minimum standards proposed in this NPRM. The proposed rule would provide each railroad with the opportunity to conform its critical incident stress plan's screening and intervention components to current best practices and standards for evidence-based care. This flexible, standards-based approach allows for innovation and plan modification in response to new scientific developments in this field.

Subpart A of the proposal contains the general provisions of the rule, including a statement of the rule's purpose, an application section, a statement of general duty, the critical incident stress plan coverage section, a definitions section that includes the central definition of a “critical incident,” and a statement pertaining to penalties. As discussed further in the definitions section, § 272.9, this proposal defines a “critical incident” as either—(1) An accident/incident reportable to FRA under 49 CFR Part 225 that results in a fatality, loss of limb, or a similarly serious bodily injury; or (2) A catastrophic accident/incident reportable to FRA under part 225 that could be reasonably expected to impair a directly-involved employee's ability to perform his or her job duties safely.

Proposed paragraph (a) of section 272.1 includes a formal statement of the rule's purpose. Proposed paragraph (b) of this section effectively explains that the proposed rule would set a minimum standard for critical incident stress plans and that the rule would not constrain a railroad from implementing a critical incident stress plan containing provisions beyond those proposed, provided that any additional provisions are not inconsistent with the rule.

Consistent with Section 410(a), proposed section 272.3 provides that the requirements of this part only apply to each Class I railroad, including the National Railroad Passenger Corporation, each intercity passenger railroad, and each commuter railroad. However, FRA encourages other railroads to implement critical incident stress plans and procedures consistent with this proposed regulation. FRA understands that many Class II and Class III railroads that would not be subject to this rule in fact do have critical incident stress plans in place. FRA notes that critical incident stress plans would be particularly useful for Class II and Class III railroads that are located in geographical locations prone to critical incidents, such as those locations with a large number of highway-rail grade crossings.

This proposed paragraph provides that a railroad subject to this part must adopt a written critical incident stress plan approved by the FRA under § 272.103 and must comply with that plan. Should a railroad subject to this part make a material modification to the approved plan, the railroad is required to adopt the modified plan approved by the FRA under § 272.103 and to comply with that plan as revised. As discussed in the section-by-section analysis of § 272.103 below, a material modification is a substantive change to a plan, not a minor update such as an address or similar change.

A large percentage of critical incidents occur where persons intentionally place themselves in front of a moving train (suicides) or drive around highway grade crossing warning signs, shortly before a train approaches, and a train crew is unable to stop the train in time to avoid hitting them. The crewmembers involved may be traumatized after such an event, even though there was nothing they could have done to prevent the collision. The purpose of this proposed rule is to effectuate the intent of the RSIA that train crews will be assisted following such events. After extensive discussions in the CIWG, FRA believes that other railroad-related accidents, such as those that occur in car shops, maintenance-of-way situations, or other non-main-track locations involving railroad operations, should also be covered by this proposed regulation. This extension provides additional benefits, but with little additional cost, as many railroad critical incident stress plans already extend beyond the grade crossing and trespasser context. Thus, as explained below FRA intends in this proposal that railroads make use of these critical incident stress plans to aid directly involved employees in situations other than suicides and trespassers.

To make it clear which railroad employees would be covered by this regulation, FRA is proposing language similar to the RSIA for safety-related employees and similar to existing regulatory language pertaining to railroad employees who perform safety sensitive functions. See 49 U.S.C. 20102(4) (defining “safety-related railroad employee”) and 49 CFR 209.303. As proposed, this part would cover railroad employees subject to the hours of services laws or regulations (49 U.S.C. 21103, 21104, 21105 or 49 CFR Part 228, subpart F), railroad employees that inspect, repair, or maintain railroad right-of-way or structures, and railroad employees who inspect, repair, or maintain locomotives, passenger cars, or freight cars, when directly involved in a critical incident.

Thus, this regulation would include an employee who performs work covered under the hours of service laws or regulations, as well as an employee who performs work that is not typically subject to the hours of service laws, but during a tour of duty, performs work covered by the hours of service laws. This regulation would also cover employees who are responsible for inspecting, repairing, and maintaining the right-of-way of a railroad, such as a person who would be included in the definitions of “roadway worker” and “railroad bridge worker” found in 49 CFR 214.7. Also included would be railroad employees who inspect, install, repair, or maintain track, roadbed, and signal and communication systems of a railroad and railroad employees who inspect, repair, or maintain locomotives, passenger cars, or freight cars. Paragraph (c) of this section was adjusted from the consensus CIWG language to maintain consistency with 49 CFR Part 209, as suggested during the full RSAC meeting on September 27, 2012. The words “inspect, install, repair, or” were added to the original phrase “[r]ailroad employees who maintain the right-of-way or structures.”

In this manner, FRA proposes to cover other employees besides locomotive engineers and conductors who could be psychologically affected or even traumatized by a critical incident as a result of railroad operations. But, by including a coverage section that would be more limited than the entire field of railroad employees, FRA is reducing the costs to railroads while ensuring that those employees who could most benefit from the regulation are included. For example, a railroad track maintainer is welding track on a siding and sees a train collide with an automobile at a nearby highway-rail grade crossing. Since the track maintainer witnessed the incident while performing his or her job duties arising from railroad operations (maintaining track), as proposed, the maintainer would be covered by the rule. In contrast, a railroad administrative assistant who works in a railroad's headquarters building would not be specifically covered by this proposed regulation if he or she witnesses an injury in the office. Although FRA does not propose to cover office injuries or accidents, FRA encourages railroads to apply their critical incident stress plans in any situation where it could be beneficial to the railroad and its employees, even if this proposed regulation would not cover the particular situation at issue or the specific railroad employee involved.

Proposed § 272.9 defines a number of terms used in this proposed part. A few of these terms have definitions that are similar to, but may not exactly mirror, definitions of the same terms used elsewhere in FRA's regulations. Definitions may differ from those in other FRA regulations because a particular word or phrase used in the definition in another FRA regulation does not have context within this proposed part.

FRA proposes to define the term accident/incident to mean an accident/incident that is reportable under FRA's accident/incident reporting regulations at 49 CFR Part 225 (Part 225). While substantially the same as the consensus CIWG definition, “an accident or incident reportable under part 225 of this chapter,” the phrasing was altered for clarity to say that accident/incident has the meaning assigned to that term by part 225 of this chapter.

The definitions of Administrator and Associate Administrator are standard definitions used in other parts of this chapter of the Code of Federal Regulations. Consistent with its use in other parts of FRA's regulations, in this part, the term Associate Administrator means the Associate Administrator for Railroad Safety/Chief Safety Officer.

FRA proposes to define Class I to have the same meaning as assigned to the term by the regulations of the Surface Transportation Board (49 CFR Part 1201; General Instructions 1-1). This instruction states that for purposes of accounting and reporting, Class I railroads have “annual carrier operating revenues of $250 million or more after applying the railroad revenue deflator formula shown in Note A.” Note A states that “[t]he railroad revenue deflator formula is based on the Railroad Freight Price Index developed by the Bureau of Labor Statistics. The formula is as follows: Current Year's Revenues × (1991 Average Index/Current Year's Average Index).” This proposed definition of “Class I” is similar to the definitions of “Class I” found elsewhere in FRA's regulations. See, e.g., 49 CFR 217.4; 219.5; and 244.9. See also 49 U.S.C. 20102(1).

FRA proposes to define commuter railroad to mean a railroad, as described by 49 U.S.C. 20102(2), including public authorities operating passenger train service, that provides regularly-scheduled passenger service in a metropolitan or suburban area and commuter railroad service that was operated by the Consolidated Rail Corporation on January 1, 1979. In this manner, FRA proposes to mirror the applicability language in 49 CFR 239.3. See also 49 CFR Part 209, Appendix A.

Railroads operated entirely by contract operators, such that the contractor organization itself meets the definition of a Class I railroad, intercity passenger railroad, or commuter railroad, would be subject to this rule. In these circumstances, FRA assumes that the contract operator would utilize the critical incident stress plan developed by the reporting railroad.

FRA proposes to define critical incident to reflect the recommendations made by the CIWG. By limiting the definition of “critical incident” to a subset of those accidents/incidents that are reportable under Part 225, FRA proposes to exclude from the definition all incidents that do not arise from the operation of the railroad. This language is consistent with the CIWG language, but was modified to replace “accident/incident” with “accident/incident reportable to FRA under part 225 of this chapter” to enhance the understanding of that term. To clarify FRA's position, FRA provides the following examples. If a train crewmember that is being transported in a van (i.e., the crewmember is in deadhead status and on duty) is directly involved in an accident/incident that results in a fatality, loss of limb, or a similarly serious bodily injury, that crewmember would be included in the scope of this proposed regulation, as that event arose from the operation of a railroad, and would be reportable under Part 225. In contrast, if a deadheading crewmember riding in the van sees a motor-vehicle accident on a public highway that does not otherwise involve the van, this incident would not be an accident/incident arising from railroad operations nor would it be reportable under Part 225, and thus would be excluded from the scope of the proposed definition of “critical incident.” While a reportable accident/incident could cover many incidents that relate to railroad operations, this proposed definition of “critical incident” includes only an accident/incident that results in a fatality, loss of limb, or a similarly serious bodily injury or a catastrophic accident/incident reportable to FRA under part 225 of this chapter that could be reasonably expected to impair a directly-involved employee's ability to perform his or her job duties safely. Accordingly, minimal injuries in the railroad workplace would not be included in the scope of this proposed definition. Similarly, as explained below, “near miss” scenarios (i.e., situations which when seen in hindsight could have resulted in an accident, but did not) would not be included.

Paragraph (1) of the definition is designed to reflect the presumed statutory intent to include an event that results in a fatality, loss of limb, or a similarly serious bodily injury. This element is intended to encompass the typical events that occur along the railroad right-of-way, involving highway-rail grade crossing accidents and trespasser incursions that could affect a directly-involved employee. This element also includes events resulting from railroad operations such as those in a railroad shop where an employee witnesses a workplace accident that results in another person's death or extreme injury.

Paragraph (2) of the definition expands the definition beyond an accident/incident leading to another person's actual physical harm, to include a catastrophic accident/incident reportable to FRA under part 225 of this chapter that could be reasonably expected to impair a directly-involved employee's ability to perform his or her job duties safely. FRA understands this paragraph to mean an accident/incident that had the potential for catastrophic consequences (i.e., could have caused a fatality, loss of limb, or other similarly serious bodily injury), that could be reasonably expected to impair a directly-involved employee's ability to perform his or her job duties safely. In this manner, a critical incident is intended to include an event, such as a serious derailment or accident that could have caused a fatality, loss of limb, or similarly serious bodily injury, but fortunately did not. The following examples are meant to clarify the meaning of the definition.

Additionally, this proposed rule does not directly apply to “near miss” scenarios. A “near miss” is an event, seen in hindsight, in which an accident could have occurred, but was narrowly avoided. For example, an automobile is rendered inoperable on the railroad tracks at a highway-rail grade crossing, but the automobile is able to get out of the way of the oncoming train, so that a collision is averted. While a “near miss” event could cause a negative stress-reaction in the train crew in the example above, research demonstrates that such reaction would typically only occur in situations where, for example, an individual had been involved in a prior similar incident which had catastrophic consequences or there were other issues at play. FRA believes that such “near miss” issues should be handled by each railroad on an individual basis, as the applicable science does not appear to support including “near miss” scenarios in the rule generally. Although FRA requests comment on all aspects of this proposed rule, FRA specifically requests comment on this proposed definition of “critical incident.” In particular, FRA requests comment as to whether the proposed definition should contain explicit language excluding “near miss” scenarios.

FRA proposes that a directly-involved employee mean a railroad employee covered in proposed § 272.7 who falls into any of three stated subcategories: (1) Whose actions are closely connected to the critical incident; (2) who witnesses the critical incident in person as it occurs or who witnesses the immediate effects of the critical incident in person; or (3) who is charged to directly intervene in, or respond to, the critical incident (excluding railroad police officers or investigators who routinely respond to and are specially trained to handle emergencies). The first subcategory would include an employee covered under § 272.7 whose actions are closely connected to the critical incident, such as the locomotive engineer or the conductor who operates the train that hits a car or pedestrian at a crossing. The second subcategory is an employee covered under § 272.7 who is a witness to the critical incident, such as an employee who is working alongside the track when the highway-rail grade crossing collision occurs, and either sees the incident happen or comes upon the casualties of the incident. The phrase “witnesses . . . in person” is intended to exclude employees who only hear about the accident/incident (such as over the radio) and are not otherwise directly involved in the accident/incident. The third subcategory would include an employee covered under § 272.7 who is charged to directly intervene in, or respond to, the highway-rail grade crossing accident/incident, such as craft and supervisory employees who are called out to the scene. In this way, a first line or second line railroad supervisor, or a shop or other railroad employee who responds to a critical incident, is able to seek counseling and guidance as outlined in the critical incident stress plan if needed. Consistent with the intent of the CIWG, specific regulatory language was added to clarify that this definition is not intended to cover non-railroad emergency responders, such as emergency medical technicians, local police officers, or local firefighters. Nor is the proposed rule intended to cover railroad police officers and railroad investigators who routinely respond to such incidents and are specially trained to handle such emergency matters.

FRA proposes to define FRA as the Federal Railroad Administration, 1200 New Jersey Ave. SE., Washington, DC 20590.

FRA proposes that home terminal mean an employee's regular reporting point at the beginning of the tour of duty.

FRA proposes that intercity passenger railroad mean a railroad, as described by 49 U.S.C. 20102(2), including public authorities operating passenger train service, which provides regularly-scheduled passenger service between large cities. In this manner, FRA proposes to mirror the applicability language in 49 CFR 239.3. See also 49 CFR Part 209, Appendix A.

Consistent with other FRA regulations, the proposed rule lists the penalties that may be imposed for noncompliance. This section provides minimum and maximum civil penalty amounts determined in accordance with 49 U.S.C. 21301 and 21304 and the Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat. 890, 28 U.S.C. 2461, note, as amended by Section 31001(s)(1) of the Debt Collection Improvement Act of 1996, Public Law 104-134, 110 Stat. 1321-373, April 26, 1996.

This subpart contains the basic components of the critical incident stress plan required by this proposed rule and the elements of the approval process. This proposed rule affords railroads considerable discretion in the administration of their critical incident stress plans.

The objective of the regulation is to allow each railroad to utilize its existing critical incident stress plan (if any) as a base, making modifications as necessary to ensure compliance with the minimum standards proposed and to enhance conformity of the plan's screening and intervention components to current best practices and standards for evidence-based care. Each plan to be presented to FRA for review and approval should document that the railroad has taken sufficient steps to establish how each element of the plan can be satisfactorily executed in covered critical incidents.

Proposed § 272.101 would require that a railroad's critical incident stress plan contain at least provisions for carrying out the objectives described in paragraphs (a)-(g) of the section. Among these designated objectives are allowing a directly-involved employee to obtain relief from the remainder of the tour of duty, providing for the directly-involved employee's transportation to the home terminal (if applicable), and offering a directly-involved employee appropriate support services following a critical incident. The specific details of each plan may vary, but the plans must be consistent with this section.

Under proposed paragraph (a) of the section, the plan must provide for “[i]nforming each directly-involved employee as soon as practicable of the stress relief options that he or she may request[.]” Paragraph (a) would require that a critical incident stress plan contain a provision that the railroad will notify directly-involved employees as soon as it is practicable after the critical incident in question that they may choose to be relieved from the remainder of the tour of duty. Although all employees covered under § 272.7 should already be cognizant of the opportunity to request relief following a critical incident, directly-involved employees must be reminded of this option for relief as soon as it is practicable after the occurrence of an incident. FRA's intent with this provision is to emphasize that an employee's opportunity for relief from service must be effectively communicated to covered employees. Of course, if a covered employee has been seriously injured and has already been relieved from duty for the remainder of the tour, it is not necessary to notify the employee of the opportunity to be relieved.

FRA recommends that a typical plan specify an appropriate time to notify affected employees of the option to seek relief, such as, “employees must be notified at the incident site of their opportunity to be relieved.” This reminder of the option to seek relief must be made during the early communications between the employee and the dispatcher and/or railroad management, before the employee has already continued on his or her tour of duty or much time has elapsed.

Under proposed paragraph (b) of the section, the plan must provide for “[o]ffering timely relief from the balance of the duty tour for each directly-involved employee, after the employee has performed any actions necessary for the safety of persons and contemporaneous documentation of the incident.” In accordance with proposed paragraph (a), FRA would expect directly-involved employees to be informed of their opportunity for relief from service. Consistent with that notification, in accordance with proposed paragraph (b), employees that choose to avail themselves of that opportunity for relief must be relieved of duty in a timely fashion. A directly-involved employee may have to perform certain actions following a critical incident, such as rendering aid to injured persons, tending to important safety issues, securing the train, notifying appropriate personnel, and assisting in documenting the circumstances of the critical incident. FRA recommends that critical incident stress plans outline an instructive protocol that explains what tasks and responsibilities the employee is expected to perform following a critical incident. For example, this instructive protocol might establish the proper points of contact and other communication procedures (both within the organization and official emergency responders), identify tasks that must be completed, and describe how to evaluate the incident.

While it may not be feasible to relieve employees within the first few minutes following a critical incident, relief should be provided as soon as possible. Directly-involved employees should be relieved in an efficient manner, without jeopardizing the safety of persons (themselves, other employees, and any victims of a critical incident, whether or not they are employees). If the directly-involved employees are waiting for an essential railroad official or a coroner to arrive on the scene, relief may not be feasible until such official arrives, but directly-involved employees should not have to remain at a critical incident site for any time beyond what is necessary. FRA recognizes that bad weather or other circumstances could delay the safe transportation of employees. However, directly-involved employees must be relieved without delay to the extent practicable.

FRA notes that not every employee will take advantage of the relief that must be offered. However, each plan must allow for the directly-involved employee to request relief even if the employee initially stated after the event that he or she wished to continue on with the tour of duty. FRA expects the option to seek relief to remain available for the duration of the directly-involved employee's tour of duty.

Finally, there are some instances where the immediate relief of an employee is not the most constructive aid. Many employees simply want to get to their home terminal without having to wait for the train to be re-crewed. Although relief must be offered to all directly-involved covered employees, and the railroad must not deny a request for relief, this part does not require an employee to avail him or herself to this option. If leave from the tour of duty were mandated by this part, it could hinder some instances where an employee's continuation of duty serves as a coping mechanism, which has been shown, at least in some instances, to provide certain benefits to the employee. However, FRA does not intend for this option to supersede a railroad's authority to decide that an employee should not continue his or her tour of duty and must be relieved for safety-reasons, for the well-being of the employee, or for other reasons.

Under proposed paragraph (c) of the section, the plan must provide for “offering timely transportation to each directly-involved employee's home terminal, if necessary.” As outlined in proposed paragraph (b), FRA intends to convey with the proposed term “timely relief” that the directly-involved employee must be relieved as soon as practicable following the critical incident, provided that all essential tasks have been performed. Similarly, FRA understands that it may take some time to arrange and provide transportation to an employee's home terminal. Railroads must make a good faith, reasonable effort to transport directly-involved employees safely from the incident site as soon as possible after their request for such relief, with the understanding that this transportation may not be immediate (a directly-involved employee may need to wait for a van to arrive). Directly-involved employees must not, however, be required to remain at the critical incident site for any time beyond what is necessary.

Under proposed paragraph (d) of the section, the plan must provide for “offering counseling, guidance, and other appropriate support services to each directly-involved employee.” For purposes of this paragraph, the statutory term “appropriate support services” means early and proximal intervention according to evidence-based standards. This interpretation allows providers to adapt their work as necessary, without any single, limiting approach being required.

The railroad's plan should contain elements that have been demonstrated to help mitigate, attenuate, and limit stressful impacts as well as provide intervention and treatment after the fact. The phrase “other appropriate support services” is designed to be flexible to account for new approaches. Research shows that five basic principles hold a demonstrated positive impact on resiliency and resolution: (1) Restoring a sense of safety; (2) calming anxiety and agitation; (3) enhancing self-efficacy; (4) building connectedness; and (5) facilitating hope.11 As suggested by the Grantee's final report, railroad plans should consider an evidence-based approach to early assistance designed to facilitate resiliency and establish a basis for subsequent intervention based on systematic screening and stepped care employing evidence-based treatment as indicated. A series of well researched, public domain resources is available to support each step of early intervention and stepped care, including the following: (1) Several approaches have been developed around the principles of “psychological first aid,” evidence-informed approaches to early interactions with those affected by potentially traumatic events intended to facilitate these basic principles (e.g., Psychological First Aid, a manual on early assistance developed by the National Center for Post Traumatic Stress Disorder (NCPTSD) and the Substance Abuse and Mental Health Services Administration (SAMHSA); 12 Curbside Manner: Stress First Aid for the Street from the National Fallen Firefighters Foundation Everyone Goes Home project; Mental Health First Aid from the National Council for Behavioral Health Centers); (2) Trauma Screening Questionnaire, a 10-item quick screen with documented sensitivity, specificity, and efficiency to identify those for whom further assessment and treatment may be indicated; 13 and (3) Web-based approaches to clinician training to enable journeyman providers open access at little or no cost to training and consultation in evidence-based treatments for PTSD, anxiety, and depression.14

Taken together, these resources provide a foundation for the adaptation of any analogous existing railroad programs to meet current standards of care. For example, programs for fire and emergency medical services personnel have been substantially redesigned to be more consistent with empirical evidence respecting variability in individual reactivity and resilience; organizational roles in preparation, response, and recovery; and implementation of standards respecting screening, assessment, and specialty care.15 Similar adaptations are underway in other workplace settings.16

FRA notes that the specific intervention element of “critical stress debriefing” in the scientific literature is contraindicated, as it has not been shown to be effective and may actually be harmful in some instances. “Critical stress debriefing” is an intervention approach that requires a participant, through a formal interview process, to relive and discuss the traumatic experience, shortly following a traumatic event. The intent of “critical stress debriefing” is to resolve the emotional aftermath of the incident. According to current research, however, “critical stress debriefing,” the central intervention of most critical incident programs, shows no preventive efficacy and well-controlled studies suggests risk of impaired recovery for some participants, especially the most severely symptomatic.17 Thus, FRA interprets the RSIA requirement in Section 410(a) that critical incident stress plans “provide for debriefing, counseling, guidance, and other appropriate services” to require services that provide effective, appropriate guidance and support, rather than requiring a rigid application of “critical stress debriefing” intervention methods. FRA expects that the questioning and investigatory purposes involved in “debriefing” will still occur as part of any response to a critical incident, but that the specific intervention element of “critical stress debriefing” will not be a component of a railroad's plan as an appropriate support service.

Further, by including “appropriate support services” in the regulatory text, mirroring the statutory text, it is not FRA's intent to assess or approve the clinical quality of services or providers. However, if a railroad's plan proposes to utilize a method that is shown to be contraindicated and may cause harm, the plan will not be approved. For example, if a plan requires “critical stress debriefing,” FRA will disapprove the plan, as this would not be an “appropriate support service.” While volunteer “peer-to-peer” support services and psychoeducation services may be helpful, they lack direct empirical demonstrations of efficacy and, in some settings, have also raised concern.18 Thus, if a peer support program is utilized, it should follow specific protocols: it should complement but not supplant professional roles, the definition of roles and boundaries should be emphasized, and the relationship to occupational medicine and/or EAP should be specified in the plan.

Under proposed paragraph (e) of the section, the plan must provide for “[p]ermitting relief from the duty tour(s) subsequent to the critical incident, for an amount of time to be determined by each railroad, if requested by a directly-involved employee as may be necessary and reasonable[.]” In this provision, FRA proposes that railroad plans address how much additional time off an employee affected by a critical incident may receive at the employee's option and what procedures must be followed in that event. Many railroads currently offer relief from the immediate tour of duty along with transportation to the employee's home terminal, then provide up to three days off along with consultation with an EAP, if any, and/or occupational medicine staff. This section would provide directly-involved employees with an opportunity, away from the railroad environment, to cope with having experienced a critical incident. This is an amount of time to be determined by each railroad to allow for a reasonable amount of rest and time following a critical incident (without necessitating a clinical diagnosis). This proposed part is neutral on the amount of additional relief a railroad should permit beyond the tour of duty during which the critical incident occurred. The specific language in this proposal was modified from the RSAC-approved language to include a qualifier on the requirement: “for an amount of time to be determined by each railroad . . . as may be necessary and reasonable” to add context and clarity on the intent of the provision.

Under paragraph (f) of the section, the plan must provide for “[p]ermitting each directly-involved employee such additional leave from normal duty as may be necessary and reasonable to receive preventive services or treatment related to the incident or both.” Beyond an initial “coping” period, as specified in paragraph (e), additional time must be provided to affected employees for preventive services and treatment as needed for the adverse effects of the critical incident. Many railroads' plans currently permit leave in addition to the duty tour(s) subsequent to the critical incident discussed in paragraph (e) if a clinical diagnosis supports the need to fulfill the employee's request. Paragraph (f) reinforces that each railroad's critical incident stress plan must provide for additional relief to be provided as necessary and reasonable to receive the preventive services or treatment related to the incident, as required by the RSIA.

Under proposed paragraph (g) of this section, the plan must provide for “[a]ddressing how the railroad's employees operating or otherwise working on track owned by or operated over by a different railroad will be afforded the protections of the plan.” This proposal was not discussed specifically in the CIWG, but was added to ensure that situations where railroad employees operate or otherwise work on track owned by or operated over by a different railroad are addressed. FRA recognizes that there may be instances where a critical incident occurs while one railroad's employees are operating over another railroad's track. For example, if track maintainers employed by Railroad A witness a critical incident involving Railroad B's train, both Railroad A's track maintainers and Railroad B's train crew must be covered by an approved critical incident stress plan. In this example, provided that this proposed regulation applies to Railroad A, Railroad A's employees would logically be covered by Railroad A's critical incident stress plan, even if the critical incident did not specifically occur with Railroad A's equipment. As such, each railroad's plan must address how the critical incident stress plan would be implemented to account for situations where multiple railroads are involved.

FRA encourages railroads to which this part would apply and labor organizations representing employees to whom this part would apply to discuss the railroad's proposed critical incident stress plan prior to formal submission of the plan to FRA for approval. This collaborative discussion should help ensure that plans are drafted and adapted to meet the needs of all potentially affected by the plan. This proposed section envisions that at a minimum, potentially-affected employees would have an opportunity to comment and to discuss the contents of the plan at an early stage, prior to implementation. Because collaborative efforts will likely benefit railroad employees and railroad management, each railroad required to submit a critical incident stress plan should aspire to consult with, employ good faith, and use its best efforts to reach agreement with all of its covered employees on the contents of the plan. However, such endeavors would not be required by this proposed regulation.

In paragraphs (b) and (c) of this section, the railroad must provide the international/national president of any non-profit employee labor organization representing a class or craft of the railroad's employees subject to this part with a copy of the railroad's critical incident stress plan and any material modification thereof. This requirement is intended to be consistent with other proposed and final FRA regulations, such as the NPRM on training standards (77 FR 6412, Feb. 7, 2012) and the final rule on conductor certification (76 FR 69802, Nov. 9, 2011). FRA encourages the union officials to distribute the notice broadly within each organization, so that all covered employees are made aware of the elements of the railroad's plan.

FRA notes that some members of the CIWG expressed their wish that this part require each railroad to notify not only the international/national president, but also the general chairpersons, of any non-profit employee labor organization representing a class or craft of the railroad's employees subject to this part. The issue of whether to require notification of the general chairpersons (in addition to the international/national president) was a point of contention in the CIWG, and a consensus was not reached. Labor representatives argued that general chairpersons are the designated collective bargaining representatives, and in many cases, the international/national presidents do not have standing on railroad property. For these reasons, labor representatives believe notifications should be sent to the general chairpersons because each plan is an on-property issue unique to each railroad and because a railroad would not be unduly burdened by contacting the relevant general chairpersons.

In response, railroad representatives and AAR argue that nothing in the RSIA requires that each railroad send a copy of its plans to each general chairperson, and they do not want to set a precedent that might be cited in a future rulemaking. Prior FRA regulations have required informing only the international/national presidents, rather than general chairpersons. Railroad and AAR representatives expressed the view that it would be less burdensome for each railroad to notify a single person at each organization, who can then pass along the information to the most relevant persons. There are many general chairpersons in each organization,19 which would add to the cost of compliance of the proposed rule, if FRA proposed to require each railroad to notify general chairpersons directly. FRA notes that the recent publication of the System Safety Program NPRM, 77 FR 55372 (Sept. 7, 2012), includes a consultation requirement, in proposed § 270.102(b)(4), and “a service list containing the names and contact information for the international/national president and general chairperson of any non-profit employee labor organization representing a class or craft of the railroad's directly affected employees.” The RSIA mandate for system safety and risk reduction programs specifically required consultation. The RSIA mandate for critical incident stress plans does not. FRA seeks comments on this issue.

The proposal contemplates that railroads may submit existing critical incident stress plans to FRA for approval that have previously been established through any applicable collective bargaining agreement. However, FRA proposes that, in order to satisfy the eventual final rule, any preexisting critical incident stress plan would have to contain all prescribed elements of the plan as set forth in the regulation, and such a plan would have to be submitted to FRA pursuant to this section for review. Thus, FRA would approve critical incident stress plans previously vetted through the collective bargaining agreement process, provided that those plans meet the criteria specified in the final regulation. As proposed, FRA's regulation would constitute a minimum standard and would not negate any higher standards set by a collective bargaining agreement.

Under paragraph (e) of proposed § 272.103, “[a]fter FRA's initial approval of a railroad's critical incident stress plan, if the railroad makes a material modification of the plan, the railroad shall submit to FRA for approval a copy of the plan as it has been revised to reflect the material modification within 30 days of making the material modification.” The plan should be reviewed periodically for effectiveness and updated when it is prudent to do so. When material modifications are made, the railroad must submit the materially modified plan to FRA for approval. “Material modification” refers to substantive changes made to the plan, and is not intended to refer to minor updates, such as address modifications, or the like.

Under paragraph (f) of proposed § 272.103, “[u]pon FRA approval of a railroad's critical incident stress plan and any material modification of the critical incident stress plan, the railroad must make a copy of the railroad's plan and the material modification available to the railroad's employees identified in § 272.7.” This paragraph is intended to ensure that all relevant employees of the railroad are aware of the railroad's critical incident stress plan and the specific requirements of the plan. For a railroad to implement its critical incident stress plan so as to fulfill the objective of the plan, which is to aid employees who experience critical incidents, all relevant employees of the railroad, from managers at headquarters to employees at the local level, must be made aware of the railroad's critical incident stress plan and the specific requirements of the plan and must be trained on how to implement the requirements of the plan relevant to the employee.20

Under paragraph (g) of proposed § 272.103, “[e]ach railroad subject to this part must make a copy of the railroad's plan available for inspection and reproduction by the Federal Railroad Administration.” This section addresses FRA's specific authority to inspect and enforce the proposed regulation, as is stated in other FRA regulations.

This section proposes the option for each railroad to which this part applies to file any plan submissions electronically. FRA intends to create a secure document submission site and will need basic information from each railroad before setting up the user's account. The points of contact information in proposed paragraph (b) are necessary in order to provide secure access.

Proposed paragraphs (c), (e), and (f) are intended to allow FRA to make the greatest use of an electronic database. It is anticipated that FRA may be able to approve or disapprove all or part of a critical incident stress plan and generate automated notifications by email to a railroad's points of contact. Thus, FRA wants each point of contact to understand that by providing any email addresses, the railroad is consenting to receive approval and disapproval notices from FRA by email. Railroads that allow notice from FRA by email would gain the benefit of receiving such notices quickly and efficiently.

Proposed paragraph (d) is necessary to provide FRA's mailing address for those railroads that need to submit something in writing to FRA. For those railroads, requesting electronic submission, the list of information specified in proposed paragraph (b) is required. Otherwise, those railroads that choose to submit printed materials to FRA must deliver them directly to the specified address. Some railroads may choose to deliver a CD, DVD, or other electronic storage format to FRA rather than requesting access to upload the documents directly to the secure electronic database; although this will be an acceptable method of submission, FRA would encourage each railroad to utilize the electronic submission capabilities of the system. Of course, if FRA does not have the capability to read the type of electronic storage format sent, FRA can reject the submission.

Finally, FRA is considering whether to mandate electronic submission. FRA is strongly leaning toward finalizing this option because the agency will be devoting significant resources to develop the electronic submission process. It will be more costly for the agency to develop the electronic submission process and have to upload written submissions into the electronic database itself. FRA expects that there are few, if any, railroads who do not have Internet access and an email address, or who cannot otherwise meet the minimum requirements for electronic submission. FRA requests comments on whether mandatory electronic submission is objectionable to any railroad.

In the final rule, Appendix A will contain a detailed penalty schedule similar to that FRA has issued for most of its existing rules. Because such penalty schedules are statements of policy, notice and comment are not required prior to their issuance. See 5 U.S.C. 553(b)(3)(A). Nevertheless interested parties are invited to submit their views on what penalties may be appropriate.

This proposed rule has been evaluated in accordance with existing policies and procedures and determined to be non-significant under both Executive Orders 12866 and 13563 and DOT policies and procedures. See 44 FR 11034, February 26, 1979. FRA has prepared and placed in the docket a Regulatory Impact Analysis (RIA) addressing the economic impact of this proposed rule. As part of the RIA, FRA has assessed the quantitative costs and benefits from the implementation of this proposed rule.

The purpose of the proposed rule is to enhance safety by mandating that certain railroads (each Class I railroad, intercity passenger railroad, and commuter railroad) have a critical incident stress plan intended to mitigate the long-term negative effects of critical incidents upon railroad employees. Specifically the proposal would help ensure that every railroad employee covered by the rule who works for these railroads and who is affected by a critical incident can receive the support services needed.

The Railroad Safety Advisory Committee (RSAC) formed a working group to provide advice and recommendations on the regulatory matters involving critical incident stress plans.21 Based on both RSAC meetings and discussions with the rail industry, FRA's analysis in the RIA assumes that all railroads affected by the proposed rule currently have policies that include a critical incident stress plan, thereby reducing the costs of compliance associated with the proposed rule. FRA requests comments on this assumption.

FRA's analysis follows DOT's revised “Guidance on the Economic Value of a Statistical Life in US Department of Transportation Analyses,” published in March 2013. Based on real wage growth forecasts from the Congressional Budget Office, DOT's guidance estimates that there will be an expected 1.07 percent annual growth rate in median real wages over the next 20 years (2013-2033) and assuming an income elasticity of 1.0 adjusts the Value of Statistical Life (VSL) in future years in the same way. Real wages represent the purchasing power of nominal wages. VSL is the basis for valuing avoided casualties. FRA's analysis further accounts for expected wage growth by adjusting the taxable wage component of labor costs. Other non-labor hour based costs and benefits are not impacted. FRA estimates that the costs of the proposed rule for a 20-year period would total $1.9 million, with a present value (PV, 7%) of $1.3 million and (PV, 3%) of $1.6 million. In estimating these compliance costs, FRA included costs associated with training supervisors on how to interact with railroad employees who have been affected by a critical incident, additional costs associated with greater use of Employee Assistance Programs, and costs associated with the submission of critical incident stress plans to FRA. FRA also estimates that the quantifiable benefits of the proposed rule for a 20-year period would total $2.6 million, with a present value (PV, 7%) of $1.5 million and (PV, 3%) of $2.0 million. FRA is confident that potential benefits of the proposed rule would exceed the total costs.

The RIA also explains the likely benefits of this proposed rule, providing quantified estimates of the benefits where feasible. The proposed rule contains minimum standards for employee training, leave, counseling, and other support services. These standards would help create benefits by providing employees with knowledge, coping skills, and services that would help them: (1) Recognize and cope with symptoms of normal stress reactions that commonly occur as a result of a critical incident; (2) reduce their chance of developing a disorder such as depression, Post-Traumatic Stress Disorder (PTSD), or Acute Stress Disorder (ASD) as a result of a critical incident; and (3) recognize symptoms of psychological disorders that sometimes occur as a result of a critical incident and know how to obtain prompt evaluation and treatment of any such disorder, if necessary.

Specifically, FRA anticipates that implementation of the proposed rule would yield benefits by reducing long-term healthcare costs associated with treating PTSD, ASD, and other stress reactions; and costs that accrue either when an employee is unable to return to work for a significant period of time or might leave railroad employment due to being affected by PTSD, ASD, or another stress reaction.

The majority of the quantifiable benefits identified are associated with railroad employee retention and a reduction of long-term healthcare costs associated with PTSD cases that were not treated appropriately after a critical incident. FRA estimates that one-half of one percent of railroad employees who develop PTSD exit the railroad industry. According to this estimate, one railroad employee would leave the railroad industry due to PTSD every ten years. If an employee is unable to return to work, the railroad not only loses an experienced employee, but also must train a new employee. FRA expects that the proposed rule would decrease the number of new employees that have to be trained to backfill for those who leave the railroad industry due to PTSD, ASD, or other stress reactions, as early treatment for potential PTSD cases following exposure to a critical incident by reducing both the likelihood of developing and the duration of PTSD or another stress reaction. The proposed rule would also increase the early identification and treatment of PTSD thus reducing long-term healthcare costs. Overall, FRA finds that the value of the anticipated benefits would justify the cost of implementing the proposed rule.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) and Executive Order 13272 (67 FR 53461; August 16, 2002) require agency review of proposed and final rules to assess their impact on small entities. FRA developed the proposed rule in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) to ensure potential impacts of rules on small entities are properly considered.

The Regulatory Flexibility Act requires an agency to review regulations to assess their impact on small entities. An agency must prepare an initial regulatory flexibility analysis (IRFA) unless it determines and certifies that a rule, if promulgated, would not have a significant economic impact on a substantial number of small entities (SEIOSNOSE). FRA has not determined whether this proposed rule would have a SEIOSNOSE. Therefore, FRA is publishing this IRFA to aid the public in commenting on the potential small business impacts of the requirements in the proposed rule. FRA invites all interested parties to submit data and information regarding the potential economic impact on small entities that would result from the adoption of the proposed rule. FRA will consider all comments received in the public comment process when making a final determination.

The proposed rule would apply to each Class I railroad, intercity passenger railroad, and commuter railroad as defined by this part. Based on information currently available, FRA estimates that no small entities would be required to create a critical incident stress plan, and therefore, no small business would be negatively impacted by the proposed rule. FRA estimates that the total cost of the proposed rule for the railroad industry over a 20-year period would be $1,943,565, with a present value (PV, 7) of $1,337,830 and (PV, 3) of $1,615,519. Based on information currently available as noted above, FRA estimates that zero percent of the total railroad costs associated with implementing the proposed rule would be borne by small entities. The total regulatory cost in the RIA for this proposed rule is the basis for the estimates in this IRFA, and the RIA has been placed in the docket for public review. It provides extensive information about the total costs of the proposed regulation.

Based on the railroad reporting data from 2011, there are 719 Class III railroads. Due to the applicability of the proposed rule, however, none of these railroads would be impacted. The railroad reporting data also shows that there are 30 intercity passenger and commuter railroads.22 Although two of these railroads are considered small entities, they do not fall within the proposed rule's definition of a “commuter railroad,” which means a railroad, as described by 49 U.S.C. 20102(2), including public authorities operating passenger train service, that provides regularly-scheduled passenger service in a metropolitan or suburban area and commuter railroad service that was operated by the Consolidated Rail Corporation on January 1, 1979. Therefore FRA finds that there are 28 intercity passenger and commuter railroads that will incur additional costs by the proposed rule. FRA requests comments on the finding that no small entities would be impacted by this proposed regulation.

In accordance with the Regulatory Flexibility Act, an IRFA must contain:

(1) A description of the reasons why the action by the agency is being considered.

(2) A succinct statement of the objectives of, and legal basis for, the proposed rule.

(3) A description—and, where feasible, an estimate of the number—of small entities to which the proposed rule will apply.

(4) A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirements and the types of professional skills necessary for preparation of the report or record.

(5) An identification, to the extent practicable, of all relevant Federal rules that may duplicate, overlap, or conflict with the proposed rule.

This rulemaking responds to requirements in the Rail Safety Improvement Act of 2008 (RSIA) (Pub. L. 110-432, Div. A) that the Secretary of Transportation, as delegated to the Administrator of FRA (49 CFR 1.89(b)), establish regulations to define critical incident, and to require certain railroads to develop and implement critical incident stress plans.

The purpose of this proposed rule is to enhance safety by mandating that railroads have a critical incident stress plan that may help mitigate the long-term negative effects of critical incidents upon covered railroad employees. One of the most important assets to the railroad industry is its labor force. The railroads spend significant resources training their workforces. Although all of the railroads potentially affected by the proposed rule have policies that include critical incident stress plans, the proposed rule would promote implementation as intended to every applicable employee covered by a critical incident stress plan and also ensure that all such plans meet certain minimum Federal requirements.

After reviewing the critical incident stress plans of various railroads, FRA determined that the most cost efficient and beneficial way to help ensure implementation of the plan for railroad employees covered who witness a critical incident was to implement the requirements found in this proposed rule. FRA anticipates that the railroad industry will accept the proposed requirements.

The purpose of the proposed rule is to require each Class I, intercity passenger, and commuter railroad to develop a critical incident stress plan. This plan would cover every applicable railroad employee who witnessed a critical incident while working.

Section 410 of RSIA requires the Secretary of Transportation, as delegated to the Administrator of the Federal Railroad Administration, to prescribe a regulation mandating that certain railroads develop and implement critical incident stress plans. A Railroad Safety Advisory Committee (RSAC) working group was formed and tasked to define a critical incident, which made sure that the railroad industry and labor unions were included in the rulemaking process. The working group reached a consensus on all but one item 23 and forwarded a proposal to the full RSAC on August 21, 2012. The full RSAC voted to approve the working group's recommended text on September 27, 2012, and that recommended text provided the basis for this NPRM. This proposed regulation would be codified in Title 49, Code of Federal Regulations, part 272.

The universe of entities that must be considered in an IRFA generally includes only those small entities that are reasonably expected to be directly regulated by the proposed action. This proposed rule would affect Class I railroads (including the National Railroad Passenger Corporation (“Amtrak”)), intercity passenger railroads, and commuter railroads as defined in the scope of the proposed rule.

“Small entity” is defined in 5 U.S.C. 601. Section 601(3) defines a “small entity” as having the same meaning as “small business concern” under section 3 of the Small Business Act. This includes any small business concern that is independently owned and operated, and is not dominant in its field of operation. Section 601(4) likewise includes within the definition of “small entities” not-for-profit enterprises that are independently owned and operated, and are not dominant in their field of operation.

The Small Business Administration (SBA) stipulates in its size standards that the largest a railroad business firm that is “for profit” may be and still be classified as a “small entity” is 1,500 employees for “line haul operating railroads” and 500 employees for “switching and terminal establishments.” Additionally, 5 U.S.C. 601(5) defines as “small entities” governments of cities, counties, towns, townships, villages, school districts, or special districts with populations less than 50,000.

Federal agencies may adopt their own size standards for small entities in consultation with the SBA and in conjunction with public comment. Pursuant to that authority, FRA has published a final statement of agency policy that formally establishes “small entities” or “small businesses” as being railroads, contractors, and hazardous materials shippers that meet the revenue requirements of a Class III railroad as set forth in 49 CFR 1201.1-1, which is $20 million or less in inflation-adjusted annual revenues; and commuter railroads or small governmental jurisdictions that serve populations of 50,000 or less. See 68 FR 24891, May 9, 2003, codified at 49 CFR part 209, Appendix C. The $20 million-limit is based on the Surface Transportation Board's revenue threshold for a Class III railroad. Railroad revenue is adjusted for inflation by applying a revenue deflator formula in accordance with 49 CFR 1201.1-1. FRA is proposing to use this definition of “small entity” for this rulemaking. Any comments received pertinent to its use will be addressed in the final rule.

FRA finds that there are 7 Class I and 28 intercity passenger and commuter railroads, including Amtrak and the Alaska Railroad, affected by this proposed rule. Amtrak, the Alaska Railroad, and the 7 Class I railroads are not considered to be small entities. All of the affected commuter railroads are part of larger public transportation agencies that receive Federal funds and serve major jurisdictions with populations greater than 50,000; based on the definition, therefore, they are not considered small entities.

For a thorough presentation of cost estimates, please refer to the RIA, which has been placed in the docket for this rulemaking.

As FRA believes that no small entities will be affected by this proposed rule, there would also be no cost impacts on small businesses. Railroads operated entirely by contract operators, such that the contractor organization itself meets the definition of a commuter railroad, Class I, or intercity passenger railroad, would be subject to this rule. In these circumstances, FRA assumes that the contract operator would utilize the critical incident stress plan developed by the reporting railroad. FRA will hold the reporting railroads responsible for defects or deficiency, not the contracted operators. Therefore, FRA does not expect that the proposed rule will directly impact any contractors that are considered to be small entities.

FRA is not aware of any relevant Federal rules that may duplicate, overlap, or conflict with the proposed rule.

FRA invites all interested parties to submit comments, data, and information demonstrating the potential economic impact that would result from adoption of the proposals in this NPRM. FRA will consider all comments received in the public comment period for this NPRM when making a final determination of the rulemaking's economic impact on small entities.

FRA analyzed this proposed rule in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”).

Because this rule does not significantly or uniquely affect tribes and does not impose substantial and direct compliance costs on Indian tribal governments, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.

The information collection requirements in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The sections that contain the new information collection requirements and the estimated time to fulfill each requirement are as follows:

All estimates include the time for reviewing instructions; searching existing data sources; gathering or maintaining the needed data; and reviewing the information. Pursuant to 44 U.S.C. 3506(c)(2)(B), FRA solicits comments concerning: Whether these information collection requirements are necessary for the proper performance of the functions of FRA, including whether the information has practical utility; the accuracy of FRA's estimates of the burden of the information collection requirements; the quality, utility, and clarity of the information to be collected; and whether the burden of collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology, may be minimized. For information or a copy of the paperwork package submitted to OMB, contact Mr. Robert Brogan, Information Clearance Officer, at 202-493-6292, or Ms. Kimberly Toone at 202-493-6137.

Organizations and individuals desiring to submit comments on the collection of information requirements should direct them to Mr. Robert Brogan or Ms. Kimberly Toone, Federal Railroad Administration, 1200 New Jersey Avenue SE., 3rd Floor, Washington, DC 20590. Comments may also be submitted via email to Mr. Brogan or Ms. Toone at the following address: Robert.Brogan@dot.gov; Kim.Toone@dot.gov.

OMB is required to make a decision concerning the collection of information requirements contained in this proposed rule between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposal.

FRA is not authorized to impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for any new information collection requirements resulting from this rulemaking action prior to the effective date of the final rule. The OMB control number, when assigned, will be announced by separate notice in the Federal Register.

FRA has evaluated this proposed rule in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this action is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review pursuant to section 4(c)(20) of FRA's Procedures. 64 FR 28547, May 26, 1999. In accordance with section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this final rule that might trigger the need for a more detailed environmental review. As a result, FRA finds that this proposed rule is not a major Federal action significantly affecting the quality of the human environment.

Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation.

FRA has analyzed this proposed rule in accordance with the principles and criteria contained in Executive Order 13132. If adopted, this proposed rule would not have a substantial direct effect on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. FRA has also determined that this proposed rule would not impose substantial direct compliance costs on State and local governments. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

Moreover, FRA notes that RSAC, which endorsed and recommended the majority of this proposed rule, has as permanent members, two organizations representing State and local interests: AASHTO and ASRSM. Both of these State organizations concurred with the RSAC recommendation made in this rulemaking. RSAC regularly provides recommendations to the Administrator of FRA for solutions to regulatory issues that reflect significant input from its State members. To date, FRA has received no indication of concerns about the federalism implications of this rulemaking from these representatives or from any other representatives of State government.

However, this proposed rule could have preemptive effect by operation of law under 49 U.S.C. 20106 (Section 20106). Section 20106 provides that States may not adopt or continue in effect any law, regulation, or order related to railroad safety or security that covers the subject matter of a regulation prescribed or order issued by the Secretary of Transportation (with respect to railroad safety matters) or the Secretary of Homeland Security (with respect to railroad security matters), except when the State law, regulation, or order qualifies under the “local safety or security hazard” exception to Section 20106.

In sum, FRA has analyzed this proposed rule in accordance with the principles and criteria contained in Executive Order 13132. As explained above, FRA has determined that this proposed rule has no federalism implications, other than the possible preemption of State laws under Section 20106. Accordingly, FRA has determined that preparation of a federalism summary impact statement for this proposed rule is not required.

Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) [currently $140,800,000] in any 1 year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and tribal governments and the private sector. This proposed rule will not result in the expenditure, in the aggregate, of $140,800,000 or more in any one year, and thus preparation of such a statement is not required.

Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” See 66 FR 28355 (May 22, 2001). Under the Executive Order a “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: (1)(i) that is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA has evaluated this proposed rule in accordance with Executive Order 13211. FRA has determined that this proposed rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Consequently, FRA has determined that this final rule is not a “significant energy action” within the meaning of the Executive Order.

FRA wishes to inform all interested parties that anyone is able to search the electronic form of any written communications and comments received into any agency docket by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Interested parties may also review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477) or visit http://www.regulations.gov/#!privacyNotice.

For the reasons discussed in the preamble, FRA proposes to amend chapter II, subtitle B of Title 49 of the Code of Federal Regulations as follows:

Public Comments

We will accept written comments and information during the reopened comment period and public hearings on our proposed listing and designation of critical habitat for the Eriogonum codium (Umtanum desert buckwheat) and Physaria douglasii subsp. tuplashensis (White Bluffs bladderpod) that was published in the Federal Register on May 15, 2012 (77 FR 28704). We will consider all information and recommendations from all interested parties.

As to the proposed listing determination, we are particularly interested in comments concerning:

(1) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to these species and regulations that may be addressing those threats.

(2) Additional information concerning the historical and current status, range, distribution, and population size of these species, including the locations of any additional populations.

(3) Any information on the biological or ecological requirements of the species, and ongoing conservation measures for the species and their habitats.

(4) Current or planned activities in the areas occupied by these species and possible impacts of these activities on these species.

As to the proposed critical habitat determination, we are particularly interested in comments concerning:

(5) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Act, including whether there are threats to the species from human activity, the degree of which can be expected to increase due to the designation, and whether that increase in threat outweighs the benefit of designation such that the designation of critical habitat is not prudent.

(6) Specific information on:

(a) The amount and distribution of the species' habitat;

(b) What areas occupied by the species at the time of listing that contain features essential for the conservation of the species we should include in the designation and why;

(c) Special management considerations or protection that may be needed in critical habitat areas we are proposing, including managing for the potential effects of climate change; and

(d) What areas not occupied at the time of listing are essential to the conservation of the species and why.

(7) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.

(8) Any foreseeable economic, national security, or other relevant impacts that may result from designating any area that may be included in the final designation. We are particularly interested in any impacts on small entities and the benefits of including or excluding areas from the proposed designation that are subject to these impacts.

(9) Whether our approach to designating critical habitat could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments.

If you submitted comments or information on the proposed rule (77 FR 28704) during the initial comment period from May 15, 2012, to July 16, 2012, please do not resubmit them. We have incorporated them into the public record as part of the original comment period, and we will fully consider them in our final determinations.

You may submit your comments and materials concerning the proposed rules by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. We will post all hardcopy comments on http://www.regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov at Docket No. FWS-R1-ES-2012-0017 for the proposed listing action and at Docket No. FWS-R1-ES-2013-0012 for the proposed critical habitat designation, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

On May 15, 2012, we published a proposed rule to list Eriogonum codium (Umtanum desert buckwheat) and Physaria douglasii subsp. tuplashensis (White Bluffs bladderpod) as threatened and to designate critical habitat for these species (77 FR 28704). We proposed to designate a total of approximately 344 acres (139 hectares) of critical habitat for Eriogonum codium in Benton County, Washington, and approximately 2,861 acres (1,158 hectares) of critical habitat for Physaria douglasii subsp. tuplashensis in Franklin County, Washington. That proposal had a 60-day comment period, ending July 16, 2012.

On April 23, 2013, we published final rules for these proposed actions. We published the final listing rule under Docket No. FWS-R1-ES-2012-0017 (78 FR 23984) and the final critical habitat rule under Docket No. FWS-R1-ES-2013-0012 (78 FR 24008). The provisions of the final rules did not change from what was proposed. Both final rules had an effective date of May 23, 2013.

On May 23, 2013, we published a notice reopening the comment period on our May 15, 2012, proposed listing and designation of critical habitat (78 FR 30839) and published a document to delay the effective date of the April 23, 2013 final rules for an additional 6 months—until November 22, 2013 (May 23, 2013; 78 FR 30772). We delayed the effective date of the final rules and reopened the comment period on the proposed rules to allow us time to follow proper procedure in accordance with 16 U.S.C. 1533(b)(5). If, after review of any comments received during this reopened comment period, we determine that we should revise the final rules, we will announce this decision and our course of action in a document published in the Federal Register.

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

We will accept written comments and information during this comment period on our proposed designation of critical habitat for Arctostaphylos franciscana that was published in the Federal Register on September 5, 2012 (77 FR 54517), the revisions to that proposed designation of critical habitat that are described in this document, our DEA of the proposed designation, and the amended required determinations provided in this document. We will consider information and recommendations from all interested parties. We are particularly interested in comments concerning:

(1) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Act (16 U.S.C. 1531 et seq.), including whether there are threats to the species from human activity, the degree of which can be expected to increase due to the designation, and whether that increase in threat outweighs the benefit of designation such that the designation of critical habitat may not be prudent.

(2) Specific information on:

(a) Areas containing the physical and biological features essential to the conservation of A. franciscana that we should include in the final critical habitat designation and why. Include information on the distribution of these essential features and what special management considerations or protections may be required to maintain or enhance them;

(b) Areas proposed as revised critical habitat that do not contain the physical and biological features essential for the conservation of the species and that should not be designated as critical habitat;

(c) Areas not occupied or not known to be occupied at the time of listing that are essential for the conservation of the species and why; and

(d) Information on the projected and reasonably likely impacts of climate change on A. franciscana and proposed critical habitat and whether the critical habitat may adequately account for these potential effects.

(3) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.

(4) Information on the new areas that we are proposing for critical habitat designation in this document.

(5) Information that may assist us identifying or clarifying the physical and biological features essential to the conservation of A. franciscana.

(6) Whether any specific areas being proposed as critical habitat for A. franciscana should be considered for exclusion under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any specific area outweigh the benefits of including that area under section 4(b)(2) of the Act. See the Exclusions section of the September 5, 2012, proposed rule (77 FR 54517) for further discussion. We have not proposed to exclude any areas from critical habitat. However, we have received requests from the Presidio Trust and the National Park Service (NPS) to exclude some areas within the proposed Units 1, 2, and some areas within proposed Subunits 3A, 4B, and 5A and all of Subunit 3A at the Presidio. We will examine conservation actions for A. franciscana, including current management planning documents, in our consideration of these areas for exclusion from the final designation of critical habitat for A. franciscana, under section 4(b)(2) of the Act. We specifically solicit comments on the inclusion or exclusion of these areas.

(7) Any foreseeable economic, national security, or other relevant impacts that may result from designating any area that may be included in the final designation. We are particularly interested in any impacts on small entities, and the benefits of including or excluding areas from the proposed designation that are subject to these impacts.

(8) Information on the extent to which the description of probable economic impacts in the DEA is complete and accurate, and specifically:

(a) Whether there are incremental costs of critical habitat designation (for example, costs attributable solely to the designation of critical habitat for A. franciscana) that have not been appropriately identified or considered in our economic analysis, including costs associated with future administrative costs or project modifications that may be required by Federal agencies related to section 7 consultation under the Act; and

(b) Whether there are additional project modifications that may result from the designation of critical habitat for A. franciscana and what those potential project modifications might represent.

(9) Whether our approach to designating critical habitat could be improved or modified in any way to provide for greater public participation and understanding, or to assist us in accommodating public concerns and comments.

If you submitted comments or information on the proposed rule (77 FR 54517) during the initial comment period from September 5, 2012, to November 5, 2012, please do not resubmit them. We will incorporate them into the public record as part of this comment period, and we will fully consider them in the preparation of our final determination. Our final determination concerning critical habitat will take into consideration all written comments and any additional information we receive during both comment periods. On the basis of public comments, we may, during the development of our final determination, find that areas proposed are not essential, are appropriate for exclusion under section 4(b)(2) of the Act, or are not appropriate for exclusion.

You may submit your comments and materials concerning the proposed revised rule or DEA by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. We will post all hardcopy comments on http://www.regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, this document, and the DEA, will be available for public inspection on http://www.regulations.gov at Docket No. FWS-R8-ES-2012-0067, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Sacramento Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT). You may obtain copies of the proposed rule (77 FR 54517), this document, and the DEA on the Internet at http://www.regulations.gov at Docket No. FWS-R8-ES-2012-0067, or by mail from the Sacramento Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

It is our intent to discuss only those topics directly relevant to the designation of critical habitat for Arctostaphylos franciscana in this document. For more information on previous Federal actions concerning A. franciscana, refer to the proposed designation of critical habitat published in the Federal Register on September 5, 2012 (77 FR 54517). For more information on the taxonomy or biology of A. franciscana or its habitat, refer to the final listing rule published in the Federal Register on September 5, 2012 (77 FR 54434), which is available online at http://www.regulations.gov (at Docket No. FWS-R8-ES-2010-0049 or from the Sacramento Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT). More information on A. franciscana and its habitat is also available in the Recovery Plan for Coastal Plants of the Northern San Francisco Peninsula (Service 2003), which is available from the Environmental Conservation Online System (ECOS) (http://ecos.fws.gov/ecos) and the Sacramento Fish and Wildlife Office Web site (http://www.fws.gov/sacramento/).

On September 5, 2012, we published a final rule to list A. franciscana (77 FR 54434) and a proposed rule to designate critical habitat for A. franciscana (77 FR 54517). We proposed to designate as critical habitat approximately 318 acres (ac) (197 hectares (ha)) that we have now corrected to 197 ac (80 ha) in 11 units located in the City and County of San Francisco, California. That proposal had a 60-day comment period, ending November 5, 2012. We will submit for publication in the Federal Register a final critical habitat designation for A. franciscana after we receive public comment on the revisions to the proposed critical habitat described in this document, the DEA, and the amended required determinations provided in this document.

Section 3 of the Act defines critical habitat as the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features essential to the conservation of the species and that may require special management considerations or protection, and specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. If the proposed rule is made final, section 7 of the Act will prohibit destruction or adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions affecting critical habitat must consult with us on the effects of their proposed actions, under section 7(a)(2) of the Act.

We have corrected the acreage calculations for our September 5, 2012, proposal (77 FR 54517) due to a mapping error. The September 5, 2012, proposal identified 318 ac (129 (ha); the corrected total acreage is 197 ac (80 ha) for the 11 units proposed (see Revisions to Proposed Critical Habitat). We are providing corrected acreage because we have learned that our original acreage calculations were inadvertently made using a map projection that is used for web-based mapping (WGS84) rather than the local area projection used as a standard by the Service (UTM NAD83). The WGS84 projection is not designed for accurate local area measurement and resulted in inflated acreages, which have been corrected. The total acreage that we proposed has been recalculated, resulting in a total acreage of 197 ac (80 ha) proposed in the September 5, 2012, proposed rule (77 FR 54517). Please see Table 1 for revised acreages for each of these units.

On September 5, 2012, we proposed 11 units, consisting of approximately 318 ac (129 ha) in City and County of San Francisco, California, as critical habitat for Arctostaphylos franciscana (77 FR 54517). As stated above, we are correcting the acreage of the original proposal to a total of 197 ac (80 ha).

We are now proposing to increase the designation by approximately 73 ac (30 ha) to a total of approximately 270 ac (109 ha) in 13 critical habitat units in the City and County of San Francisco, California. We propose this increase based on additional information on habitat suitability that San Francisco Parks and Recreation Department (SFPRD) staff provided to us. The additional areas include: Two subunits in Unit 9 (Diamond Heights) so that the unit now consists of three subunits; and two new units at McLaren Park: Unit 12 (McLaren Park East), which consists of two subunits, and Unit 13 (McLaren Park West). Below, under Revised Proposed Critical Habitat: Additional Units, we provide an updated unit description for proposed Unit 9 and unit descriptions for proposed Units 12 and 13. We also modified the methods we used to delineate the proposed critical habitat; see “Methods” below.

As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. We review available information pertaining to the habitat requirements of the species. In accordance with the Act and its implementing regulations at 50 CFR 424.12(e), we consider whether designating additional areas—outside those currently occupied as well as those occupied at the time of listing, if listing occurs before the designation of critical habitat—are necessary to ensure the conservation of the species. We are proposing to designate critical habitat in areas within the geographical area currently occupied by the species (see final listing determination published in the Federal Register on September 5, 2012 (77 FR 54434)). We also are proposing to designate specific areas outside the geographical area occupied by the species at the time of listing (in this case, the geographical area currently occupied by the species), which were historically occupied but are presently unoccupied, because such areas are essential for the conservation of the species.

This section provides details of the criteria and process we used to delineate the proposed critical habitat for Arctostaphylos franciscana. The areas being proposed for critical habitat within this document and previous proposed rule are based largely on habitat characteristics identified from the “rediscovery site” near Doyle Drive, the currently occupied transplantation site, and historically occupied areas identified in voucher specimens and historical records. We also used the Recovery Plan for Coastal Plants of the Northern San Francisco Peninsula (Service 2003, pp. 1-322); the Conservation Plan for Arctostaphylos franciscana (the Franciscan Manzanita) (Chasse et al. 2009, pp. 1-44); the Raven's Manzanita Recovery Plan (Service 1984, pp. 1-73), which provide habitat characteristics of the historically co-occurring species; and information received from peer reviewers and the public on our proposed listing for A. franciscana (76 FR 55623; September 8, 2011). Due to the rapid development of the San Francisco peninsula and limited historical information on plant location and distribution, it is difficult to determine the exact range of the species. Given the amount of remaining habitat available with the appropriate characteristics, we looked at all areas within the vicinity of San Francisco that met our criteria as potential habitat. Based on this information, we propose to designate critical habitat in areas within the geographical area currently occupied by A. franciscana (which is the same as the geographical area occupied by the species at the time of listing) and unoccupied areas that are essential for the conservation of the species (see the Distribution and Habitat section in the September 5, 2012, proposed designation (77 FR 54517) for more information on the range of the species.

Although a recovery plan for Arctostaphylos franciscana has not been developed, the species is discussed along with the endangered A. hookeri ssp. ravenii (Raven's manzanita) in the Recovery Plan for Coastal Plants of the Northern San Francisco Peninsula (Service 2003). The taxonomic name for Raven's manzanita has been changed to A. montana ssp. ravenii. The recovery plan calls for a three-part strategy in conserving A. montana ssp. ravenii, as well as additional recommendations for establishment in areas outside the Presidio at historic and other rock outcrop sites in conjunction with A. franciscana (Service 2003, pp. 75-77). The strategy includes: (1) Protecting the existing plant and surrounding habitat; (2) increasing the number of independent populations throughout suitable habitat within the Presidio; and (3) restoring the natural ecological interactions of the species with its habitat, including allowing gene flow with A. franciscana. As mentioned above, the recovery plan also identifies establishing additional areas, along with populations of A. franciscana, within rock outcrops throughout suitable habitat. We believe that a recovery strategy for A. franciscana would be similar to the recovery strategy for A. montana ssp. ravenii in many aspects, based on: (1) The existence of only one “wild” individual of each species; (2) the species' co-occurrence in similar habitat within the Presidio and elsewhere at historical locations; and (3) the seeming dependence of A. montana ssp. ravenii on A. franciscana to produce viable seed and maintain gene flow with A. franciscana in the absence of more than the single individual or clones of A. montana ssp. ravenii. In order to accomplish portions of this strategy, we have identified areas we believe are essential to the conservation of A. franciscana through the following criteria:

(1) Determine, in accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, the physical or biological habitat features essential to the conservation of the species and which may require special management considerations or protection.

(2) Identify multiple independent sites for A. franciscana. These sites should be throughout the historic range of the species (generally on the San Francisco peninsula north of Mount Davidson) within or near rock outcrops of various origins but especially on ridges or slopes within serpentine or greenstone formations along the Franciscan fault zone between Potrero Hills and the Golden Gate (see Figure 2 in the September 5, 2012, proposed rule at 77 FR 54517).

(3) In accordance with section 2(b) of the Act, select areas that would conserve the ecosystem upon which the species depends. This includes areas that contain the natural ecological interactions of the species with its habitat or areas with additional management that may be enhanced. The conservation of A. franciscana is dependent on several factors including, but not limited to, selection of areas of sufficient size and configuration to sustain natural ecosystem components, functions, and processes (such as full sun exposure, summer fog, natural fire and hydrologic regimes, intact mycorrhizal or edaphic interactions); protection of existing substrate continuity and structure; connectivity among groups of plants of this species within geographic proximity to facilitate gene flow among the sites through pollinator activity and seed dispersal; and sufficient adjacent suitable habitat for vegetative reproduction and population expansion.

(4) In selecting areas to propose as critical habitat, consider factors such as size, connectivity to other habitats, and rangewide recovery considerations. We rely upon principles of conservation biology, including: (a) Resistance and resiliency, to ensure sufficient habitat is protected throughout the range of the species to support population viability (e.g., demographic parameters); (b) redundancy, to ensure multiple viable populations are conserved throughout the species' range; and (c) representation, to ensure the representative genetic and life history of A. franciscana are conserved.

We have determined that the additional units and subunits we are proposing as critical habitat in this document are essential for the conservation and recovery of A. franciscana because they provide the physical or biological features necessary for the reestablishment of wild populations of A. franciscana within the species' historical range. Due to the small number of individual plants and low population size, suitable habitat and space for expansion or reintroduction are essential to achieving population levels that would be necessary for recovery.

We have identified the additional units and subunits in part because of information indicating that some critical habitat units may be or may become unsuitable for A. franciscana because of soilborne pathogens or plant diseases. Therefore, it is important to identify as many independent units as feasible to increase the odds that at least some of these would remain free of these pathogens into the foreseeable future (Swiecki 2013, p. 3). The additional units proposed below provide further resistance, resiliency, and redundancy. Additionally, the McLaren Park West and McLaren Park East units would provide connectivity between the Bayview Park and Diamond Heights units.

In order to identify the physical or biological features on the ground based on our criteria outlined above, we used the following methods to delineate the proposed critical habitat:

(1) We compiled and reviewed all available information on A. franciscana habitat and distribution from historic voucher specimens, literature, and reports.

(2) We also compiled and reviewed all available information on A. montana ssp. ravenii habitat and distribution from similar sources, as these two species have similar habitat requirements and often occurred together historically.

(3) We reviewed available information on rock outcrops, bedrock, and areas identified as serpentine, greenstone, or of Franciscan formation within the San Francisco peninsula and surrounding areas south of Mount Davidson and north into Marin County to determine the extent of these features on the landscape.

(4) We compiled species occurrence information including historic record locations, the current occupied site within the Presidio, and information on the “rediscovery site” near Doyle Drive.

(5) We then compiled all this information into a Geographic Information System (GIS) database using ESRI ArcMap 10.0.

(6) We screen digitized and mapped the specific areas on which are found those physical or biological features essential to the conservation of the species or other areas determined to be essential for the conservation of the species.

Additionally, in the analysis for the additional areas we are proposing as critical habitat in this document, we used the following methods to delineate the proposed critical habitat:

(1) We used additional information we received about the suitability of habitat through our November 15, 2012, site visit and discussions with SFPRD staff. In our analysis for the proposed rule we had missed portions of Diamond Heights and McLaren Park as appropriate habitat.

(2) We examined higher-resolution imagery (0.3 meter pixel resolution versus 1.0 meter pixel resolution that was used in the September 5, 2012, proposed critical habitat). We used U.S. Geological Survey High Resolution Orthoimage USNG 10SEG325910. Orthoimage are remotely sensed image data in which the displacement of features in the image caused by terrain relief and sensor orientation have been mathematically removed. The natural color orthoimages were produced at 0.3-meter (approximately 1-foot) pixel resolution. We reviewed the remaining habitat available with the appropriate characteristics. We looked at all additional areas within San Francisco City and County that met our criteria as potential critical habitat. We double-checked suitable habitat we located against imagery that was used in the September 5, 2012, critical habitat.

(3) We mapped critical habitat. The image data were acquired between October 20, 2003, and January 21, 2004, using North American Datum (NAD) 83 Universal Transverse Mercator Zone 10N coordinates.

When determining proposed critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical and biological features for A. franciscana. The scale of the maps we prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed lands, especially within such an urbanized area as San Francisco. Any such lands inadvertently left inside critical habitat boundaries shown on the maps of the proposed rule have been excluded by text in the proposed rule and are not proposed for designation as critical habitat. Therefore, if the critical habitat is finalized as proposed, a Federal action involving these lands would not trigger section 7 consultation with respect to critical habitat and the requirement of no adverse modification unless the specific action would affect the physical and biological features in the adjacent critical habitat.

The units of critical habitat are proposed for designation based on sufficient elements of physical or biological features being present to support life-history processes for A. franciscana. Some units contain all of the identified elements of physical or biological features and support multiple life-history processes. Some units contain only some elements of the physical or biological features necessary to support the use of that habitat by A. franciscana.

The critical habitat designation is defined by the maps, as modified by any accompanying regulatory text, presented at the end of this document in the Proposed Regulation Promulgation section. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates or plot points, or both, on which each map is based available to the public on http://www.regulations.gov at Docket No. FWS-R8-ES-2012-0067, on our Internet site at http://www.fws.gov/sacramento, and at the Fish and Wildlife office responsible for the designation (see FOR FURTHER INFORMATION CONTACT above).

We are now proposing to increase the proposed critical habitat designation for Arctostaphylos franciscana by: Adding two subunits to Unit 9 (Diamond Heights) so that the unit now consists of three subunits; and by adding two additional units at McLaren Park: Unit 12 (McLaren Park East), which consists of two subunits, and Unit 13 (McLaren Park West). The additional units provide an increase of approximately 73 ac (30 ha) above the September 5, 2012, proposed designation (77 FR 54517). We have updated the unit description for proposed Unit 9, and we have added unit descriptions for proposed Units 12 and 13. Please refer to the September 5, 2012, proposed designation (77 FR 54517) for information on the other proposed units. Table 2 shows the occupancy status of the newly proposed subunits of Unit 9, and Units 12, and 13, while Table 3 provides the acreage of each of those areas, by subunit.

Unit 9 consists of a total of approximately 38 ac (16 ha) and is located near Diamond Heights Boulevard (Blvd.) south of Turquoise Way, and O'Shaughnessy Blvd. This unit is comprised of three subunits. Subunit 9A (22 ac (9 ha)), which is located near Diamond Heights Blvd. south of Turquoise Way, was proposed as Unit 9 in the proposed rule published on September 5, 2012 (77 FR 54517). Subunit 9B (6 ac (2 ha)) is located east of O'Shaughnessy Blvd., and subunit 9C (11 ac (4 ha)) is located west of O'Shaughnessy Blvd. Unit 9 is currently unoccupied. The unit is within an area that: Experiences summer fog; is located on sloping terrain; and contains Franciscan Complex (greenstone) bedrock outcrops of chert, volcanic, and sedimentary materials, as well as soils derived from these formations; and open grassland habitat. The unit represents one of several areas identified for the species within the Mount Davidson area. Mount Davidson is the only site still remaining that was known to be previously occupied by the species. The units in this area would assist in establishing populations of A. franciscana outside the Presidio. The additional subunits provide additional rock outcrop areas within the matrix of natural land. As a result, we have determined that the area is essential for the conservation of the species, because it provides for one of multiple independent sites for A. franciscana and contains some of the last remaining appropriate habitat within the area.

Unit 12 consists of a total of approximately 27 ac (11 ha) and is located at McLaren Park south of Mansell Street (St.) near Visitacion Avenue (Ave.). This unit is comprised of two subunits. Subunit 12A (14 ac (6 ha)) is located south of Mansell St. and west of Visitacion Ave. Subunit 12B (12 ac (5 ha)) is located south of Mansell St. and east of Visitacion Ave. This unit is currently unoccupied. The unit is within an area that experiences summer fog and is located on sloping terrain. It contains Franciscan Complex (greenstone) bedrock and serpentine outcrops, soils derived from these formations, and open grassland habitat. This unit would assist in establishing an additional population of A. franciscana outside the Presidio and Mount Davidson areas. This unit and Unit 13 (McLaren Park West) are located roughly midway between the remaining appropriate habitat at Diamond Heights and Bayview Park and thereby provide increased connectivity between these units. As a result, we have determined that the area is essential for the conservation of the species, because it provides for one of multiple independent sites for A. franciscana, contains some of the last remaining appropriate habitat within the area, and provides additional connectivity between Unit 9 (Diamond Heights) and Unit 11 (Bayview Park).

Unit 13 consists of approximately 30 ac (12 ha) and is located at McLaren Park between Geneva Ave. and Sunnydale Ave. This unit is currently unoccupied. The unit is within an area that experiences summer fog; is located on sloping terrain; and contains Franciscan Complex (greenstone) bedrock outcrops of volcanic materials, soils derived from these formations, and open grassland habitat. Including this unit would assist in establishing additional populations of A. franciscana outside the Presidio and Mount Davidson areas. This unit and Unit 12 (McLaren Park East) are located roughly midway between remaining appropriate habitat at Diamond Heights and Bayview Park. As a result, we have determined that the area is essential for the conservation of the species, because it provides for one of multiple independent sites for A. franciscana, contains some of the last remaining appropriate habitat within the area, and provides connectivity between Unit 9 (Diamond Heights) and Unit 11 (Bayview Park).

Section 4(b)(2) of the Act requires that we designate or revise critical habitat based upon the best scientific data available, after taking into consideration the economic impact, impact on national security, or any other relevant impact of specifying any particular area as critical habitat. We may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area as critical habitat, provided such exclusion will not result in the extinction of the species.

When considering the benefits of inclusion for an area, we consider the additional regulatory benefits that area would receive from the protection from adverse modification or destruction as a result of actions with a Federal nexus (activities conducted, funded, permitted, or authorized by Federal agencies), the educational benefits of mapping areas containing essential features that aid in the recovery of the listed species, and any benefits that may result from designation due to State or Federal laws that may apply to critical habitat.

When considering the benefits of exclusion, we consider, among other things, whether exclusion of a specific area is likely to result in conservation; the continuation, strengthening, or encouragement of partnerships; or implementation of a management plan. In the case of A. franciscana, the benefits of critical habitat include public awareness of the presence of A. franciscana and the importance of habitat protection, and, where a Federal nexus exists, increased habitat protection for A. franciscana due to protection from adverse modification or destruction of critical habitat. In practice, situations with a Federal nexus exist primarily on Federal lands or for projects undertaken by Federal agencies.

We have not proposed to exclude any areas from critical habitat. However, we will review the requests from NPS, the Presidio Trust, and the public to exclude some areas within proposed Units 1, and 2, and some areas within proposed Subunits 3B, 4B, and 5A, as well as all of Subunit 3A at the Presidio. NPS wrote in support of an exclusion for portions of Units 1 and 2 where NPS plans remediation of contaminated soils and other cultural resource management. NPS and the Presidio Trust requested an exclusion for portions of Subunit 3B and all of Subunit 3A because of concerns that designating these subunits will impair their abilities to manage habitat for the federally endangered A. montana ssp. ravenii (Ravens' manzanita), threatened Hesperolinon congestum (Marin dwarf-flax), and endangered Presidio clarkia (Clarkia franciscana); H. congestum and C. franciscana require a more open serpentine grassland habitat than does A. franciscana. The Presidio Trust requested an exclusion for portions of Subunits 4B and 5A due to their designations as an historic forest zone within their vegetation management plan, the lack of suitable soils for A. franciscana, and/or concerns that designating these subunits will impair the Trust's abilities to manage habitat for H. congestum and C. franciscana. The final decision on whether to exclude any areas will be based on the best scientific data available at the time of the final designation, including information obtained during the comment period and information about the economic impact of designation. Accordingly, we have prepared a DEA concerning the proposed critical habitat designation, which is available for review and comment (see ADDRESSES).

The purpose of the DEA is to identify and analyze the potential economic impacts associated with the proposed critical habitat designation for A. franciscana. The DEA describes the economic impacts of all potential conservation efforts for A. franciscana; some of these costs will likely be incurred regardless of whether we designate critical habitat. The economic impact of the proposed critical habitat designation is analyzed by comparing scenarios both “with critical habitat” and “without critical habitat.” The “without critical habitat” scenario represents the baseline for the analysis, considering protections already in place for the species (e.g., under the Federal listing and other Federal, State, and local regulations). The baseline, therefore, represents the costs incurred regardless of whether critical habitat is designated. The “with critical habitat” scenario describes the incremental impacts associated specifically with the designation of critical habitat for the species. The incremental conservation efforts and associated impacts are those not expected to occur absent the designation of critical habitat for the species. In other words, the incremental costs are those attributable solely to the designation of critical habitat, above and beyond the baseline costs; these are the costs we may consider in the final designation of critical habitat when evaluating the benefits of excluding particular areas under section 4(b)(2) of the Act. The analysis looks retrospectively at baseline impacts incurred since the species was listed, and forecasts both baseline and incremental impacts likely to occur if we finalize the proposed critical habitat designation. For a further description of the methodology of the analysis, see Chapter 2, “Methodology,” of the DEA.

The DEA provides estimated costs of the foreseeable potential economic impacts of the proposed critical habitat designation for A. franciscana over the next 20 years (2013 to 2032), which was determined to be the appropriate period for analysis because limited planning information is available for most activities to forecast activity levels for projects beyond a 20-year timeframe. It identifies potential incremental costs as a result of the proposed critical habitat designation; these are those costs attributed to critical habitat over and above those baseline costs attributed to listing.

The DEA quantifies economic impacts of A. franciscana conservation efforts associated with the following categories of activity: (1) NPS and Presidio Trust management and habitat restoration activities; (2) NPS and Presidio Trust soil remediation activities; (3) road maintenance and construction activities; (4) broadcast facility maintenance and construction activities; and (5) other activities, such as SFPRD trail maintenance and species reintroduction. The DEA considers both economic efficiency and distributional effects that may result from efforts to protect A. franciscana and its habitat. Economic efficiency effects generally reflect the “opportunity costs” associated with the commitment of resources required to accomplish species and habitat conservation. The DEA also addresses how potential economic impacts are likely to be distributed.

The DEA concludes that incremental impacts resulting from the critical habitat designation would be limited to additional administrative costs of section 7 consultation. Estimating the impact of a regulation on future outcomes is inherently uncertain. Administrative time for consultations and other additional costs are project dependent and exhibit wide variability. The timing of future projects affects the present value of the cost estimates because of the time value of money, but the precise timing is uncertain. The quantity and type of future consultations will be influenced by economic, demographic, political, and biological variables that cannot be forecast precisely.

The DEA estimates total potential incremental economic impacts in areas proposed as critical habitat over the next 20 years (2013 to 2032) to be approximately $28,222 ($1,411 annualized) in present-value terms applying a 7 percent discount rate (RTI International 2013, pp. ES-2 and 3-2). NPS and the Presidio Trust manage lands within the four proposed unoccupied critical habitat units (Units 1, 2, 3, and 4) and the one proposed occupied critical habitat unit (Unit 5) on Federal lands at the Presidio. The remaining proposed critical habitat units (Units 6 through 13) occur on non-Federal lands unoccupied by A. franciscana. The primary incremental economic impacts are administrative costs associated with section 7 consultations with NPS and the Presidio Trust on their activities within proposed Units 1, 2, 3, and 4.

Administrative costs associated with section 7 consultations on a variety of NPS and Presidio Trust activities (including NPS and Presidio Trust management plans, soil remediation, and unspecified activities) on Federal lands in proposed occupied and unoccupied critical habitat (Units 1, 2, 3, 4, and 5) account for approximately 91 percent of the forecast undiscounted incremental impacts (RTI International 2013, pp. ES-2 and 3-2). Within these administrative costs, the largest incremental economic impacts are associated with section 7 consultations with NPS and the Presidio Trust for unspecified activities within Units 1, 2, 3, 4, and 5; these unspecified consultations represent approximately 75 percent of the total undiscounted incremental costs and are expected to total $32,672 (undiscounted) over the 20-year period, with costs of formal consultations distributed evenly among all 5 units and costs of informal consultations distributed evenly among the 4 unoccupied units (RTI International 2013, pp. ES-2 and p. 3-2).

The second largest incremental economic impact is associated with section 7 consultations with NPS and the Presidio Trust for soil remediation activities within Units 1 and 2. These consultations represent approximately 19 percent of the total undiscounted incremental costs and are expected to total $8,083 over the 20-year period distributed evenly between the two units (RTI International 2013, p. ES-2) (all soil remediation activities are anticipated to occur within the first year, and, therefore are not discounted) (RTI International 2013, p. 3-5).

The third largest incremental economic impact is associated with section 7 consultations on federally funded trail maintenance on SFRPD lands within proposed unoccupied critical habitat Units 12 and 13. These consultations represent approximately 6 percent of the total undiscounted incremental costs and are expected to total $2,690 (undiscounted) over the next 20 years distributed evenly between the two units (RTI International 2013, p. ES-2). The SFRPD is estimated to incur costs of approximately $363 from these consultations, with the remaining costs accruing to the Service and the Federal action agency (RTI International 2013, p. ES-3).

The fourth largest incremental economic impact is associated with the reinitiation of section 7 consultation with NPS and the Presidio Trust for their management plans within proposed critical habitat Units 1 through 5. This consultation represents approximately 0.4 percent of the total incremental costs and is expected to total $115 over the 20-year period, distributed evenly among the five units (the reinitiation of consultation on the NPS and Presidio Trust management plans is anticipated to occur within the first year and, therefore, is not discounted).

With regard to other activities on non-Federal lands, the potential for Federal nexus is very low. Therefore, no consultations were estimated for miscellaneous activities on non-Federal land within Units 6 through 11. Thus, there are no anticipated incremental economic impacts associated with the designation of critical habitat within Units 6 through 11. The only other consultations that may be anticipated on non-Federal lands include reintroduction of A. franciscana into areas where other endangered species, such as the mission blue butterfly (Icaricia icarioides missionensis), are present. Reintroduction consultations are likely to be intra-Service, and costs are likely to be minimal and administrative in nature. Furthermore, the costs would be considered baseline costs.

Regarding road maintenance and construction, the California Department of Transportation indicated in a personal communication that any projects on the roads adjacent to the proposed units would not likely affect the A. franciscana or the proposed critical habitat; additionally, no projects are anticipated (RTA International 2013, pp. 3-1, 3-6). Similarly, no maintenance and construction projects related to radio and broadcast towers are expected to affect A. franciscana or the proposed critical habitat (RTA International 2013, pp. 3-1, 3-6). Lastly, any consultation regarding species reintroduction would be considered intra-Service consultation and consist of little (if any) administrative effort.

As stated earlier, we are soliciting data and comments from the public on the DEA, as well as on all aspects of the proposed rule, the revisions to that proposed rule that are described in this document, and our amended required determinations. We may revise the proposed rule or supporting documents to incorporate or address information we receive during the public comment period. In particular, we may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area, provided the exclusion will not result in the extinction of this species.

In our September 5, 2012, proposed rule (77 FR 54517), we indicated that we would defer our determination of compliance with several statutes and executive orders until the information concerning potential economic impacts of the designation and potential effects on landowners and stakeholders became available in the DEA. We have now made use of the DEA data to make these determinations. In this document, we affirm the information in our proposed rule concerning Executive Orders (E.O.s) 12866 and 13563 (Regulatory Planning and Review), E.O. 13132 (Federalism), E.O. 12988 (Civil Justice Reform), E.O. 13211 (Energy, Supply, Distribution, and Use), the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the National Environmental Policy Act (42 U.S.C. 4321 et seq.), and the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951). However, based on the DEA data, we are amending our required determination concerning the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and E.O. 12630 (Takings).

Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA; 5 U.S.C. 801 et seq.), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities. Based on our DEA of the proposed designation, we provide our analysis for determining whether the proposed rule would result in a significant economic impact on a substantial number of small entities. Based on comments we receive, we may revise this determination as part of our final rulemaking.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

To determine if the proposed designation of critical habitat for A. franciscana would affect a substantial number of small entities, we considered the number of small entities affected within particular types of economic activities, such as habitat restoration activities; road maintenance and construction; broadcast facility maintenance and construction; and trail maintenance. In order to determine whether it is appropriate for our agency to certify that this proposed rule would not have a significant economic impact on a substantial number of small entities, we considered each industry or category individually. In estimating the numbers of small entities potentially affected, we also considered whether their activities have any Federal involvement. Critical habitat designation will not affect activities that do not have any Federal involvement; designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies. In areas where A. franciscana is present, Federal agencies already are required to consult with us under section 7 of the Act on activities they fund, permit, or implement that may affect the species. If we finalize this proposed critical habitat designation, consultations to avoid the destruction or adverse modification of critical habitat would be incorporated into the existing consultation process.

In the DEA, we evaluated the potential economic effects on small entities resulting from implementation of conservation actions related to the proposed designation of critical habitat for A. franciscana. Because the Service, Presidio Trust, NPS, and the SFRPD are the only entities with expected direct compliance costs and are not considered small entities, this rule would not result in any impact to small entities. Please refer to the DEA of the proposed critical habitat designation for a more detailed discussion of potential economic impacts.

The Service's current understanding of recent case law is that Federal agencies are only required to evaluate the potential impacts of rulemaking on those entities directly regulated by the rulemaking; therefore, they are not required to evaluate the potential impacts to those entities not directly regulated. The designation of critical habitat for an endangered or threatened species only has a regulatory effect where a Federal action agency is involved in a particular action that may affect the designated critical habitat. Under these circumstances, only the Federal action agency is directly regulated by the designation, and, therefore, consistent with the Service's current interpretation of RFA and recent case law, the Service may limit its evaluation of the potential impacts to those identified for Federal action agencies. Under this interpretation, there is no requirement under the RFA to evaluate potential impacts to entities not directly regulated, such as small businesses. However, Executive Orders 12866 and 13563 direct Federal agencies to assess the costs and benefits of available regulatory alternatives in quantitative (to the extent feasible) and qualitative terms. Consequently, it is the current practice of the Service to assess to the extent practicable these potential impacts, if sufficient data are available, whether or not this analysis is believed by the Service to be strictly required by the RFA. In other words, while the effects analysis required under the RFA is limited to entities directly regulated by the rulemaking, the effects analysis under the Act, consistent with the E.O. regulatory analysis requirements, can take into consideration impacts to both directly and indirectly impacted entities, where practicable and reasonable.

In summary, we have considered whether the proposed designation would result in a significant economic impact on a substantial number of small entities. Information for this analysis was gathered from the Small Business Administration, stakeholders, and the Service. Because the Service, Presidio Trust, NPS and SFRPD are the only entities with expected direct compliance costs and are not considered small entities, this rule would not result in a significant impact on a substantial number of small entities. For the above reasons and based on currently available information, we certify that, if promulgated, the proposed critical habitat designation would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.

In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for Arctostaphylos franciscana in a takings implications assessment. Critical habitat designation does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to allow actions that do require Federal funding or permits to go forward. The takings implications assessment concludes that this proposed designation of critical habitat does not pose significant takings implications for lands within or affected by the designation. However, we will further evaluate this issue as we complete our final economic analysis, and review and revise this assessment as appropriate.

A complete list of all references we cited in the September 5, 2012, proposed rule and in this document is available on the Internet at http://www.regulations.gov under Docket No. FWS-R8-ES-2012-0067 or by contacting the Sacramento Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

The primary authors of this notice are the staff members of the Sacramento Fish and Wildlife Office, Region 8, U.S. Fish and Wildlife Service.

Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, which was proposed to be amended at 77 FR 54517, September 5, 2012, as set forth below:

These revisions and additions read as follows: