I. Public Participation

On October 31, 2011, the Department published in the Federal Register a rule proposing to amend EOIR's regulations by removing the mandatory submission of all asylum applications to DOS. See 76 FR 67099 (Oct. 31, 2011). The comment period ended December 30, 2011. The Department received three public comments. As explained below, the Department is adopting all amendments in the proposed rule, as well as making several non-substantive, technical corrections.

The current regulations require that EOIR send a copy of all defensive asylum applications to DOS. 1 The Department is amending the regulations at 8 CFR 1208.11, 1240.11, 1240.33, and 1240.49 in order to remove this mandatory requirement. Under this rule, an immigration court has the discretion to forward a defensively filed asylum application to DOS, but is not required to do so. For example, EOIR may forward an application in order to ascertain whether DOS has information relevant to the adjudication of a particular case or type of claims. By consolidating certain paragraphs, the final rule also removes redundant references to the types of information that DOS may provide to EOIR. These amendments increase the efficiency of DOS' review of asylum applications and are consistent with similar changes USCIS has already made. See 74 FR 15367 (Apr. 6, 2009).

EOIR's changes to the regulations do not require additional resources, either in the hiring of personnel at EOIR or DOS or in the expenditure of material or financial resources. Amending the regulations permits both EOIR and DOS to conserve resources. EOIR will no longer be required to expend resources on mailing to DOS every properly filed defensive asylum application it receives. Rather, an immigration judge may request, in his or her discretion, specific comments from DOS regarding individual cases or types of claims under consideration, or other information the immigration judge deems appropriate. By focusing on select cases forwarded by EOIR, DOS officers can better utilize their time and resources toward accomplishing their asylum responsibilities. These regulatory changes will also result in resource savings for asylum applicants, as an applicant will no longer be required to make an extra copy of his or her application for EOIR to forward to DOS, pursuant to current instructions to the Form I-589, Application for Asylum and for Withholding of Removal.

Under this rule, the types of comments that DOS may provide will not change. At its option, DOS may provide detailed country conditions information relevant to the applicant's eligibility for asylum and withholding of removal. DOS may also provide an assessment of the accuracy of the applicant's assertions about conditions in the applicant's country of nationality or habitual residence and the applicant's particular situation, information about whether persons who are similarly situated to the applicant are persecuted or tortured in the applicant's country of nationality or habitual residence and the frequency of such persecution or torture, or such other information as DOS deems relevant.

Additionally, these regulatory amendments are consistent with changes effected by implementation of the Homeland Security Act of 2002. The Homeland Security Act authorized the creation of DHS and transferred the functions of the former Immigration and Naturalization Service (INS) to DHS, while retaining EOIR under the authority of the Attorney General. In order to accommodate these changes, title 8 of the Code of Federal Regulations was reorganized into separate chapters, chapter I for DHS and chapter V for the Department of Justice. See 68 FR 9824, 9834 (Feb. 28, 2003). The provisions governing procedures for asylum and withholding of removal in part 208 were duplicated into a new part 1208. As a result, part 208 governs asylum adjudications before DHS's USCIS and part 1208 governs asylum adjudications before EOIR. As this final rule only addresses submissions of asylum applications from EOIR to DOS, it is limited to amending 8 CFR 1208.11, 1240.11, 1240.33, and 1240.49. To be consistent with changes that effected implementation of the Homeland Security Act, references in EOIR's regulations to “The Service” and USCIS “asylum officers” forwarding asylum applications to DOS are removed, as those matters are now governed by the DHS regulations at 8 CFR 208.11.

This rule also includes several technical corrections. The regulations currently refer to 8 U.S.C. 1101 and Title VII of Public Law 110-229 as authority for 8 CFR part 1208. The proposed rule that was published on October 31, 2011, inadvertently omitted citations to 8 U.S.C. 1101 and Title VII of Public Law 110-229 in the authority section of 8 CFR part 1208. The proposed rule did not intend to remove those references. This final rule corrects these typographical omissions and includes citations to 8 U.S.C. 1101 and Title VII of Public Law 110-229 in the authority section of 8 CFR part 1208. The regulations currently refer to 8 U.S.C. 1224, 1251, 1252a, 1228 as authority for 8 CFR part 1240, but 8 U.S.C. 1224 is no longer directly applicable to part 1240 following the creation of DHS and related changes in the regulations. Sections 1251 and 1252a have been transferred to 8 U.S.C. 1227 and 1228, respectively, and 8 U.S.C. 1252b has been repealed. Additionally, the regulations currently do not include the following authorities, which are applicable to part 1240: 8 U.S.C. 1158, 1186b, 1229a, 1229b, 1229c, and 1361. This final rule updates the authority for 8 CFR part 1240 to reflect these changes. This final rule also includes two minor, non-substantive changes to 8 CFR 1208.11(a): Deleting the words “such” and “as an” and inserting the word “the” before “immigration judge.” Additionally, 8 CFR 1208.11(b)(3) is revised to duplicate 8 CFR 208.11(b)(3) by deleting the words “their respective” and inserting the words “the applicant's.” 8 CFR 1208.11(c) is also revised to change the word “the” to the word “an” before “applicable Executive Order.” The regulations at 8 CFR 1240.11(c)(2), 1240.33(b), and 1240.49(c)(3) are also revised to change the word “the” to the word “an” before “applicable Executive Order.” As announced in the proposed rule, the Department is also amending part 1240 to cite to the correct regulatory provision regarding filing of an asylum application as provided in 8 CFR 1208.4(b). The regulations at 8 CFR 1240.11(c)(2) and 8 CFR 1240.33(b) are corrected to cite to 8 CFR 1208.4(b). This change is consistent with 8 CFR 1240.49(c)(3). These amendments are technical corrections and do not make any substantive changes to parts 1208 and 1240.

The Department of Justice provided an opportunity for comment, which ended on December 30, 2011. The Department received three comments: One from an anonymous individual; one from a candidate for a Master of Social Work degree; and one from a candidate for a juris doctor degree. The Department considered these comments in preparing this final rule. The comments are numbered one through three in order of receipt. All comments and other docket materials are available for viewing by making arrangements with the EOIR Office of the General Counsel as discussed above.

The first comment is general in nature and expresses the view that the United States should withdraw from its international protection obligations towards applicants for asylum and withholding of removal and should, instead, impose a general immigration moratorium. As this comment does not address the changes set forth in the proposed rule, the comment does not require a response.

The second commenter supports this rulemaking initiative. The commenter notes that while the DOS serves as an informational resource tool for immigration judges, the information provided by DOS is not normally dispositive of the outcome of a given case. This commenter recognizes EOIR's proposed regulatory changes will allow both the Department and the DOS to utilize DOS as an information resource and “not as a storage locker for thousands of filed defensive applications; many of which they are unable to review in a reasonably timely manner.” The commenter also expresses concern that the existing regulatory construct requiring DOS mandatory review of all defensive asylum and withholding applications filed with EOIR creates system inefficiencies, duplication of effort, and delays that may inadvertently extend the time an asylum applicant must remain in immigration detention during his or her immigration proceedings before EOIR. The commenter notes that the efficiencies to be gained by these regulatory changes outweigh possible negative considerations. Finally, the commenter notes that the direct and indirect cost savings to the government agencies directly affected by the regulation, as well as the cost savings to the public, allow for “a redirecting of tax dollars to other areas in need.” The Department agrees with this commenter that the proposed regulatory changes will make the DOS asylum application review process more economical and efficient.

The third commenter opposes this rulemaking initiative. The commenter asserts that the proposed cost savings do not outweigh the possible harm to defensive asylum and withholding applicants. This commenter views the mandatory submission to DOS of all defensively received applications for asylum and withholding of removal as a safeguard against possible abuses of discretion by immigration judges making credibility determinations on asylum applicants' protection claims. The commenter notes that asylum applicants often suffer from some form of post-traumatic stress or depression that affects long-term memory, making credibility determinations very difficult and prone to error. The commenter further notes that DOS' cultural and country condition information may safeguard against immigration judges making incorrect adverse credibility determinations based upon asylum applicants' behavior and information that does not easily transfer across cultures.

The Department appreciates this commenter's concerns. However, EOIR provides training to its adjudicators on cultural sensitivity and makes available numerous resources on country condition information, which more directly address the commenter's concerns. Moreover, continuing the current mandatory submission of all defensively filed asylum and withholding applications is not sustainable. DOS is tasked with numerous reporting and country condition responsibilities. DOS' review and comment on defensive asylum and withholding applications is a small part of its overall mission. Revising the regulations to allow for immigration judges to exercise their discretion to request DOS review and comment on specific protection claims will allow DOS to better focus its limited resources. The existing process is neither efficient nor efficacious in producing the results originally contemplated by the regulation. In a time of dwindling resources, both human and monetary, the Department has determined that it is best to amend the regulations to provide immigration judges with the discretion to determine when and for which cases to seek DOS review. The final rule also provides DOS with the ability to focus its resources on providing review and comment for the cases that immigration judges have identified as most in need of DOS' expertise. Additionally, DOS is required to provide to Congress annually Country Reports on Human Rights Practices and International Religious Freedom Reports, which provide world-wide country conditions information that continue to be useful to the adjudication of asylum applications. This rule does not alter these DOS responsibilities, nor affect how immigration judges utilize these DOS country condition resources.

Accordingly, the Department is adopting as a final rule the proposed rule amending 8 CFR parts 1208 and 1240 that was published on October 31, 2011, including the non-substantive, technical corrections discussed in this rule.

The Department has reviewed this regulation in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)) and has determined that this rule will not have a significant economic impact on a substantial number of small entities for the following reason: This rule affects only the process by which EOIR forwards and DOS receives asylum applications. The rule will not regulate “small entities” as that term is defined in 5 U.S.C. 601(6).

This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets.

The Department has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and Executive Order 13563. Accordingly, this rule has not been submitted to the Office of Management and Budget for review. Nevertheless, the Department certifies that this regulation has been drafted in accordance with the principles of Executive Order 12866, section 1(b), and Executive Order 13563.

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320, apply to this rule. The information collection requirement (Form I-589, Application for Asylum and for Withholding of Removal) discussed in this rule has been previously approved by the Office of Management and Budget (OMB. No. 1615-0067) as provided by the Paperwork Reduction Act. This rule will require revisions to the existing information collection. The Form I-589 instructions will be revised to reduce the number of form copies that must be submitted by applicants on and after the effective date of these regulations. Once a final rule is issued, EOIR and USCIS will work to modify the instructions to the Form I-589 to reflect the changes.

Accordingly, for the reasons set forth in the preamble, part 1208 and part 1240 of chapter V of title 8 of the Code of Federal Regulations are amended as follows:

The Animal and Plant Health Inspection Service (APHIS) regulations in title 9 of the Code of Federal Regulations (CFR), parts 93, 94, and 95, govern the importation into the United States of specified animals and animal products and byproducts to prevent the introduction of various animal diseases, including Newcastle disease and highly pathogenic avian influenza (HPAI). These are dangerous and destructive communicable diseases of birds and poultry. The regulations in § 94.6 restrict the importation of carcasses, parts of products of carcasses, and eggs (other than hatching eggs)  1 of poultry, game birds, and other birds, from all regions where Newcastle disease or any subtype of HPAI are considered to exist.

On July 19, 2011, we published in the Federal Register (76 FR 42595-42602, Docket No. APHIS-2009-0094) a proposal  2 to amend the regulations governing the importation of live birds and poultry, and poultry meat and products, by recognizing 25 Member States of the European Union (EU) as the APHIS-defined EU poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We also determined that the region meets our requirements for being considered free of HPAI. In addition, we proposed to establish requirements for the importation of live birds and poultry, including hatching eggs, and poultry meat and products to the United States from the APHIS-defined EU poultry trade region.

We solicited comments concerning our proposal for 60 days ending September 19, 2011, and received four comments by that date. They were from an organization representing zoo veterinarians, an association representing zoos and aquariums, a foreign government, and a private citizen. Three of the commenters were in favor of recognizing the APHIS-defined EU poultry trade region as a region free of Newcastle disease and HPAI and establishing requirements governing the importation of live birds and poultry, including hatching eggs, and poultry meat and products from that region. One of those commenters also offered a recommendation regarding zoo ruminants from Canada that we determined to be outside the scope of the proposed rule. One commenter generally opposed our proposal but did not offer any specific comments on any aspect of the proposed rule. We are not making any changes to the proposed provisions based on the comments we received.

We are, however, making one change in this final rule after additional consideration of industry practices and regulations within the EU regarding the transport of hatching eggs. In proposed § 94.28, we included conditions for the importation from the APHIS-defined EU poultry trade region of live birds and poultry, including hatching eggs, to the United States. The proposed conditions included a requirement that live birds and poultry, including hatching eggs, imported from the APHIS-defined EU poultry trade region must not have been in any region in which Newcastle disease or HPAI is considered to exist, except for the APHIS-defined EU poultry trade region. We also proposed that within the APHIS-defined EU poultry trade region itself, live birds and poultry intended for importation to the United States, including hatching eggs, must not have been in a restricted zone established because of detection of Newcastle disease or HPAI in commercial poultry from the time of detection until the designation of the zone as a restricted zone is removed by the competent veterinary authority of the Member State, or until 3 months following depopulation of the poultry on affected premises in the restricted zone and the cleaning and disinfection of the last affected premises in the zone, whichever is later.

Since publication of the proposed rule, an official representing the European Commission, the executive body of the EU, commented on another APHIS rulemaking  3 that placed restrictions on the importation of bird and poultry products from regions where any subtype of HPAI is considered to exist. The commenter noted that EU regulations  4 allow transit of live poultry, including day-old chicks and hatching eggs, through zones within the EU under restrictions due to HPAI on the condition that transport takes place on roads or rail without unloading or stopping and that the shipment is kept under strictly controlled, biosecured, and air-conditioned circumstances at all times while in transit.

While we maintain that importation should remain prohibited for live birds, poultry, and day-old chicks that have been moved through zones restricted for HPAI within the APHIS-defined EU poultry trade region, we have determined that the risk of exposure of hatching eggs to HPAI while transiting such zones is very low when secure means of shipping are employed, such as transporting the hatching eggs under the official requirements specified in the Council directive.

Therefore, we have decided to allow the importation of hatching eggs from the APHIS-defined EU poultry trade region that have transited a restricted zone established because of detection of HPAI within that region as long as all control measures in the import permit issued by APHIS are followed and the shipment travels under seal issued by the veterinary competent authority. The seal number must be listed on the health certificate that accompanies the shipment and the veterinarian who places the seal is required to sign his or her name under the seal number. Seals are not to be broken until the shipment reaches its U.S. port of entry. Hatching egg shipments with seals that are not intact will be rejected upon inspection at the U.S. port of entry.

APHIS-issued import permits accompanying hatching eggs from the APHIS-defined EU poultry trade region will include specific information regarding the route and means of shipment, listing all other countries that will be involved before arrival in the United States and all ports or other points in the route, as well as the types of transportation that will be used for moving the shipment to the United States. Import permits issued by APHIS for importation of hatching eggs to the United States require certified veterinarians to verify the authenticity of seals used in such shipments.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule with the change discussed in this document.

This is a substantive rule that relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, may be made effective less than 30 days after date of publication in the Federal Register . Based on a risk evaluation that we prepared, we determined that the APHIS-defined EU poultry trade region meets our requirements for being considered free of Newcastle disease and that it is therefore no longer necessary to impose Newcastle disease and HPAI-related restrictions on the importation of live birds and poultry, including hatching eggs, and poultry meat and products from that region.

Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective 15 days after publication in the Federal Register .

This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see footnote 2 in this document for a link to Regulations.gov).

We expect this rule to have negligible economic effects on U.S. entities, large or small, because of the relatively small quantities of poultry and poultry products likely to be imported from the APHIS-defined EU poultry trade region. In addition, the poultry industry in the United States is highly concentrated and vertically integrated, with extensive use of contractual agreements for production, an industry structure that will tend to mitigate any economic effects of the rule on small entities. The United States is the world's largest producer and second-largest exporter of poultry meat; about 20 percent of U.S. poultry production was exported in 2010. Imports from the APHIS-defined EU poultry trade region will face a highly competitive U.S. market.

The EU is a large producer of live poultry, poultry meat, and other poultry products, but two-thirds of the region's trade in poultry and poultry products is between EU Member States; 13 of the 25 Member States had a within-region trade in poultry and poultry products of 70 percent or more. More than half of the Member States are net importers of live poultry and poultry products (13 are net importers of live poultry, 16 of poultry meat) and 17 of hatching eggs.

Nine EU Member States are currently recognized by APHIS as free of Newcastle disease; however, quantities of poultry or poultry products exported to the United States in recent years have been negligible. U.S. imports of live poultry and hatching eggs from EU-25 Member States have been sporadic and at insignificant levels.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the recognition of 25 Member States of the EU as the APHIS-defined EU poultry trade region will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov Web site. 5 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT .

This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, we are amending 9 CFR parts 53, 71, 82, 93, 94, 95, and 104 as follows:

Discussion

We issued a second supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That second SNPRM was published in the Federal Register on December 10, 2012 (77 FR 73340). That second SNPRM proposed to correct an unsafe condition for the specified products. The Mandatory Continuing Airworthiness Information (MCAI) states:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

Airbus requested that the service information referenced in the second SNPRM (77 FR 73340, December 10, 2012) be updated to include recently added service information. Airbus stated that EASA has issued AD 2012-0236R1, dated December 17, 2012. In addition, Airbus stated that Thales Avionics has issued Service Bulletin C16291A-34-007, Revision 04, dated October 11, 2012.

We partially agree with Airbus' request regarding using the most recent service information. Since the second SNPRM (77 FR 73340, December 10, 2012) was issued, we have reviewed Thales Avionics Service Bulletin C16291A-34-007, Revision 04, dated October 11, 2012. The actions in that service information remain unchanged from the previous service information. We have revised paragraphs (g), (i), and (k) of this AD accordingly to reflect the most current Thales Avionics service information.

In addition, we have reviewed EASA AD 2012-0236, dated November 9, 2012 (corrected November 12, 2012), and EASA AD 2012-0236R1, dated December 17, 2012. We have determined that no subsequent changes are required in this final rule as done to the EASA AD. We have not changed this final rule in this regard.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously-and minor editorial changes. We have determined that these changes:

• Are consistent with the intent that was proposed in the second SNPRM (77 FR 73340, December 10, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM (77 FR 73340, December 10, 2012).

We estimate that this AD will affect 755 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $128,350, or $170 per product.

In addition, we estimate that any necessary follow-on actions would take about 3 work-hours and require parts costing $0, for a cost of $255 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the second SNPRM (77 FR 73340, December 10, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on January 3, 2013 (78 FR 275). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 275, January 3, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 275, January 3, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 275, January 3, 2013).

We estimate that this AD will affect 7 products of U.S. registry. We also estimate that it will take about 4 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,380, or $340 per product.

In addition, we estimate that any necessary follow-on actions will take about 2.5 work-hours and require parts costing $1,900, for a cost of $2,112.50 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (78 FR 275, January 3, 2013), the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on October 16, 2012 (77 FR 63272). That NPRM proposed to correct an unsafe condition for the specified products. The Mandatory Continuing Airworthiness Information (MCAI) states:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on January 19, 2012 (77 FR 2666). That NPRM proposed to require doing a general visual inspection of the housing assembly of the packboard release mechanism to determine if its surface treatment has been sealed, and if unsealed, replacing the housing assembly with a new or serviceable housing assembly.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (77 FR 2666, January 19, 2012), and the FAA's response to each comment. Boeing supported the NPRM. American Airlines stated that it has incorporated the requirements of the NPRM into its maintenance program and will continue to do so. United Airlines (United) did not object to the proposed compliance time.

United requested that we revise the NPRM (77 FR 2666, January 19, 2012) to provide instructions for inspecting for the accomplishment of Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010, by verifying the stencil of the “Inspected and/or Mod per S.B. 777 107-25-30” on the girt assembly and upper lacing cover. United also requested that we revise the NPRM to permit operators to demonstrate compliance by means of a technical records review for the accomplishment of Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010.

We agree because, if the modification has been accomplished before the issuance of the AD, there is no need to duplicate it. We have revised paragraph (g) of this final rule to specify only slides/rafts that have not been modified using Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010, require the replacement of the housing assembly. We also have added a new paragraph (h) to this final rule (and re-identified subsequent paragraphs accordingly) to state that verifying the stencil or a review of technical or maintenance records is acceptable for determining if the modification has been accomplished.

Delta Airlines (Delta) requested that we revise the NPRM (77 FR 2666, January 19, 2012) to provide instructions stating how to inspect for discrepant unsealed components. Delta stated that the instructions are referenced within a note in Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010. (Boeing Special Attention Service Bulletin 777-25-0507, dated June 30, 2011, references Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010, as an additional source of guidance for inspecting and installing a new housing assembly of the door-mounted slide/raft packboard release mechanism.) Delta stated that it is not recommended to have important instructions listed only within a note.

We disagree with the commenter's request to revise the AD to provide inspection instructions. We reference the Air Cruisers Service Bulletin as an additional source of guidance for accomplishing the actions. To delay this AD so manufacturer service information could be revised would be inappropriate, in light of the identified unsafe condition. We have not changed the AD in this regard.

Delta expressed concern that the 42-month compliance time would be difficult to meet if replacement part kits were not available upon the issuance of the AD. We infer from this comment that Delta is requesting that the 42-month compliance time be extended to allow the part supplier adequate time to make part kits available.

We disagree with the request to extend the compliance time because we have confirmed that the supplier has prepared to have parts available and also to support the compliance time of the AD. If adequate parts are not available as planned approaching the end of the compliance period, paragraph (j) of this AD provides operators the opportunity to request approval of an alternative compliance time if data are presented that prove that the alternative compliance time will provide an acceptable level of safety. We have not changed this AD regarding this issue.

United requested that we allow credit for work done prior to the effective date of the AD using Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010, since Air Cruisers Service Bulletin 777 107-25-30 is now at Revision 1.

We find that no change is necessary because this AD requires that actions be done in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-25-0507, dated June 30, 2011, which references Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010, as an additional source of guidance for inspecting and installing a new housing assembly of the door-mounted slide/raft packboard release mechanism. Boeing has not revised its service bulletin and, therefore, this AD references the original issue of Air Cruisers Service Bulletin 777 107-25-30, dated September 30, 2010. We have not changed this AD in this regard.

We have changed Note 1 to paragraph (g) of the NPRM (77 FR 2666, January 19, 2012), which defined a general visual inspection, to new paragraph (i) in the regulatory text of this AD, and re-identified subsequent paragraphs and notes accordingly.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously—and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 2666, January 19, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 2666, January 19, 2012).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 161 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

History

On November 30, 2012, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to amend Class E airspace for the Middletown, OH, area, creating additional controlled airspace at Middletown Regional/Hook Field Airport (77 FR 71364) Docket No. FAA-2012-0651. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9W dated August 8, 2012, and effective September 15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface to ensure that required controlled airspace exists from the 6.5-mile radius of the airport to 12.3 miles northeast of the airport, 11.2 miles southwest of the airport, and 7 miles southwest of the Hook Field NDB navigation aid, to contain aircraft executing new standard instrument approach procedures at Middletown Regional/Hook Field Airport, Middletown, OH. This action enhances the safety and management of IFR operations at the airport. The geographic coordinates of the Middletown Regional/Hook Field airport, formerly known as Hook Field Airport, and the Hook Field NDB are also updated to coincide with the FAA's aeronautical database.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Middletown Regional/Hook Field Airport, Middletown, OH.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

On November 30, 2012, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace for the West Ranch Airport, Round Mountain, TX (77 FR 71367) Docket No. FAA-2012-0771. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9W dated August 8, 2012, and effective September 15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface to ensure that required controlled airspace exists for departing aircraft under instrument flight rules, and arriving aircraft utilizing new standard instrument approach procedures at West Ranch Airport, Round Mountain, TX. This action enhances the safety and management of IFR operations at the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at West Ranch Airport, Round Mountain, TX.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The Department of Labor (the Department) published the Wage Methodology for the Temporary Non-agricultural Employment H-2B Program final rule (the Wage Rule) on January 19, 2011, 76 FR 3452. The Wage Rule revised the methodology by which the Department calculates the prevailing wages to be paid to H-2B workers and United States (U.S.) workers recruited in connection with a temporary labor certification for use in petitioning the Department of Homeland Security to employ a nonimmigrant worker in H-2B status. The Department originally set the effective date of the Wage Rule for January 1, 2012. However, as a result of litigation and following notice-and-comment rulemaking, we issued a final rule, 76 FR 45667 (Aug. 1, 2011), revising the effective date of the Wage Rule to September 30, 2011, and a second final rule, 76 FR 59896 (Sept. 28, 2011), further revising the effective date of the Wage Rule to November 30, 2011.

Thereafter, the Department extended the effective date of the Wage Rule until January 1, 2012, in light of the enactment on November 18, 2011 of the Consolidated and Further Continuing Appropriations Act, 2012, which provided that “[n]one of the funds made available by this or any other Act for fiscal year 2012 may be used to implement, administer, or enforce, prior to January 1, 2012 the [Wage Rule].” Public Law 112-55, 125 Stat. 552, Div. B, Title V, § 546 (Nov. 18, 2011) (the November 2011 Appropriations Act). In delaying the Wage Rule's effective date, the Department stated that although the November 2011 Appropriations Act “prevent[ed] the expenditure of funds to implement, administer, or enforce the Wage Rule before January 1, 2012, it [did] not prohibit the Wage Rule from going into effect, which [was] scheduled to occur on November 30, 2011. When the Wage Rule goes into effect, it will supersede and make null the prevailing wage provisions at 20 CFR 655.10(b) of the Department's existing H-2B regulations, which were promulgated under Labor Certification Process and Enforcement for Temporary Employment in Occupations Other Than Agriculture or Registered Nursing in the United States (H-2B Workers), and Other Technical Changes; Final Rule, 73 FR 78020, Dec. 19, 2008 (the H-2B 2008 Rule).” 76 FR 73508, 73509 (Nov. 29, 2011).

Accordingly, the Department determined that it was necessary in light of the November 2011 Appropriations Act to delay the effective date of the Wage Rule in order to avoid the replacement of the H-2B 2008 Rule with a new rule that the Department lacked appropriated funds to implement. As a result, the Department issued a final rule, 76 FR 73508, that delayed the effective date of the Wage Rule until January 1, 2012. Subsequent appropriations legislation 1 containing the same restriction prohibiting the Department's use of appropriated funds to implement, administer, or enforce the Wage Rule necessitated subsequent extensions of the effective date of that rule. See 76 FR 82115 (Dec. 30, 2011) (extending the effective date to Oct. 1, 2012); 77 FR 60040 (Oct. 2, 2012) (extending the effective date to Mar. 27, 2013).

In light of the anticipated enactment of the Consolidated and Further Continuing Appropriations Act, 2013, which establishes the Department's appropriations through September 30, 2013, and also continues the prohibition of the expenditure of the Department's appropriated funds to implement, administer, or enforce the Wage Rule through September 30, 2013, see Sec. 1101, the Department again must delay the effective date of the Wage Rule. Delaying the effective date of the Wage Rule will ensure an orderly transition and prevent further disruption in light of the U.S. District Court for the Eastern District of Pennsylvania's March 21, 2013 ruling in Comite de Apoyo a los Trabajadores Agricolas et al. v. Solis, 09-cv-00240, 2013 WL 1163426 (E.D. Pa. Mar. 21, 2013), in which the court vacated and granted a permanent injunction against the operation of one provision of the H-2B 2008 Rule, 20 CFR 655.10(b)(2). Under the now-vacated provision, prevailing wage determinations issued by the Department for a job opportunity for which the employer seeks H-2B workers must be based on the arithmetic mean of the wages of workers similarly employed at the skill level in the area of intended employment. Pursuant to that now-vacated regulation, the Department established a four-tier wage structure by dividing the Bureau of Labor Statistics Occupational Employment Statistics Survey (OES survey) wage applicable to the occupation in question into four tiers. The court vacated 20 CFR 655.10(b)(2) and remanded to the Department, giving the Department thirty days to come into compliance with the court's order.

As a result of the court's order, if a prevailing wage determination is sought based on the OES survey, the Department currently is unable to issue a prevailing wage determination under the now-vacated wage provision of the 2008 rule because the court has held invalid the four-tiered OES wage. Most of the Department's prevailing wage determinations in the H-2B program are based on the invalidated four-tiered OES wage. However, if an employer's request for a prevailing wage determination is covered by a collective bargaining agreement, the Department still may issue that prevailing wage determination because the issuance of such determinations is unaffected by the court's order. See 20 CFR 655.10(b)(1). Similarly, the Department still may issue prevailing wage determinations based on the employer's submission of a private wage survey (if approved by the Department), or its voluntary use of wages set under the Davis-Bacon Act, 40 U.S.C. 276a et seq., 29 CFR part 1, or the McNamara-O'Hara Service Contract Act, 41 U.S.C. 351 et seq. See 20 CFR 655(b)(4), (b)(5). These alternative methodologies would be barred, however, were the 2011 Wage Rule to take effect.

Consistent with the court's ruling and order, the Department intends to promulgate a revised wage rule within 30 days of the date of that ruling that complies with the court's interpretation of what the statutory and regulatory framework require. Doing so will allow the Department to resume the normal operation of the H-2B program. Were the 2011 Wage Rule to take effect in this short time period during which DOL is preparing a revised wage rule, not only would it prevent the Department from continuing to issue the small but meaningful percentage of H-2B labor certifications that are not based on the vacated portion of the 2008 rule, but it would lead to disruption and confusion about the governing regulatory framework, as the 2011 rule would be in place and govern submissions made to the Department, but the Department would lack funds to implement that governing structure. Therefore, we are again postponing the effective date of the 2011 Wage Rule, which the Department is unable to implement as a result of Congressional action and which, if permitted to become effective, would further limit the Department's current ability to issue prevailing wage determinations.

The Department considers this situation an emergency warranting the publication of a final rule under the good cause exception of the Administrative Procedure Act. See 5 U.S.C. 553(b)(B), (d)(3). We are currently experiencing a significant suspension in program operations as a result of the court's order and until we promulgate a new regulation, which we intend to do in short order. In order to avoid a complete operational suspension of the H-2B program while we promulgate a new regulation (due to the continued defunding of the 2011 Wage Rule), as well as the confusion and disruption that would result from the 2011 Wage Rule briefly taking legal effect pending that new regulation, the Department finds good cause to adopt this rule, effective immediately, and without prior notice and comment. See 5 U.S.C. 553(b)(B), (d)(3). Any delay in promulgating this extension of the Wage Rule's effective date as the result of notice-and-comment rulemaking would significantly disrupt the program.

The final regulations addressing non-agricultural surface leasing of Indian land, and redesignating certain sections related to agricultural leases, failed to direct changes to the indefinite article preceding “agricultural lease,” resulting in the regulatory language now stating “a agricultural lease” rather than “an agricultural lease” in several instances. The final regulations also inadvertently omitted insurance as a mandatory provision for WEELs and the standard language that BIA may treat any provision of a lease document that violates Federal law as a violation of the lease. This document corrects those errors.

Accordingly, 25 CFR part 162 is corrected by making the following correcting amendments:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive necessary information about the event until February 11, 2013. As a result, the Coast Guard did not have sufficient time to publish an NPRM and to receive public comments prior to the event. Immediate action is needed to minimize potential danger to the race participants, participant vessels, spectators and the general public.

Under 5 U.S.C. 553(d)(3), for the same reasons mentioned above, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register because immediate action is needed to minimize potential danger to the race participants, participant vessels, spectators and the general public.

From April 18, 2013, until April 21, 2013, Charleston Ocean Racing Association will host three sailboat races on Charleston Harbor in Charleston, South Carolina during Charleston Race Week. Approximately 300 sailboats will be participating in the three races. It is anticipated that at least 15 spectator vessels will be present during the races.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to ensure safety of life on navigable waters of the United States during three Charleston Race Week sailboat races.

The rule establishes a special local regulation on certain waters of Charleston Harbor in Charleston, South Carolina. The special local regulation will be enforced daily from 7:30 a.m. until 5:30 p.m. on April 18, 2013, through April 21, 2013. The special local regulation consists of the following three race areas.

1. Race Area #1. All waters encompassed within an 800 yard radius of position 32°46′39″ N, 79°55′10″ W.

2. Race Area #2. All waters encompassed within a 900 yard radius of position 32°45′48″ N, 79°54′46″ W.

3. Race Area #3. All waters encompassed within a 900 yard radius of position 32°45′44″ N, 79°53′32″ W.

Except for those persons and vessels participating in the sailboat races, persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within any of the race areas unless specifically authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within any of the race areas may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the race areas is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) Although persons and vessels will not be able to enter, transit through, anchor in, or remain within the regulated areas without authorization from the Captain of the Port Charleston or a designated representative, they may operate in the surrounding area during the enforcement periods; (2) persons and vessels may still enter, transit through, anchor in, or remain within the regulated areas if authorized by the Captain of the Port Charleston or a designated representative; and (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within the waters of Charleston Harbor encompassed within the three regulated areas between 7:30 a.m. and 5:30 p.m., from April 18, 2013, until April 21, 2013. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard did not receive the request for an escort and safety zone nor a confirmed itinerary, from the Office of Puerto Rican Secretary of State with sufficient time to publish an NPRM and to receive public comments prior to the event. Any delay in the effective date of this rule would be impracticable because immediate action is needed to minimize potential danger to high ranking officials and the general public.

Under 5 U.S.C. 553(d)(3), for the same reasons as above, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On April 6, 2013, the Spanish Navy School Ship San Sebastian El Cano, a public vessel will be transiting in with high ranking officials to honor and return the remains of Captain Ramon Power y Giralt, a famous and respected Puerto Rican Navy Captain. The escort will be held on the waters of Bahia de San Juan, San Juan, Puerto Rico of the Spanish Navy School Ship San Sebastian El Cano, and will include a 21 gun salute near the Bar Channel entrance.

The purpose of the rule is to protect high ranking officials on board the Spanish Navy School Ship San Sebastian El Cano and the public from the hazards associated with the 21 gun salute over navigable waters of the United States.

The legal basis for the rule is the U. S. Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

The safety zone encompasses certain waters of Bahia de San Juan, San Juan, Puerto Rico. The safety zone will be enforced from 8 a.m. to 9:30 a.m. on April 6, 2013, and from 8 a.m. to 10 a.m. on April 10, 2013.

Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port San Juan or a designated representative. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the safety zone by contacting the Captain of the Port San Juan by telephone at (787) 289-2041, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the Captain of the Port San Juan or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port San Juan or a designated representative. The U. S. Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only one and a half hours on the first day, and two hours four days later; (2) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port San Juan or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone during the enforcement period if authorized by the Captain of the Port San Juan or a designated representative; and (4) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of Bahia de San Juan encompassed within the safety zone from 8 a.m. until 9:30 a.m. on April 6, 2013, and from 8 a.m. until 10 a.m. on April 10, 2013. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INTFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will be enforced for a maximum of three and a half hours. This rule is categorically excluded, under, paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Tariff of Tolls (Schedule of Fees and Charges in Canada) in their respective jurisdictions. The Tariff sets forth the level of tolls assessed on all commodities and vessels transiting the facilities operated by the SLSDC and the SLSMC. The SLSDC is revising 33 CFR 402.10, “Schedule of tolls”, to reflect the fees and charges levied by the SLSMC in Canada. The changes affect the tolls for commercial vessels and are applicable only in Canada. The collection of tolls by the SLSDC on commercial vessels transiting the U.S. locks is waived by law (33 U.S.C. 988a(a)). Accordingly, no notice or comment is necessary on these amendments.

Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-19478) or you may visit www.regulations.gov.

This regulation involves a foreign affairs function of the United States and therefore Executive Order 12866 does not apply and evaluation under the Department of Transportation's Regulatory Policies and Procedures is not required.

I certify this regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Tariff of Tolls primarily relate to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.

This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, et seq.) because it is not a major federal action significantly affecting the quality of the human environment.

The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and has determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment.

The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives.

This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review.

Accordingly, the Saint Lawrence Seaway Development Corporation is amending 33 CFR part 402, Tariff of Tolls, as follows:

Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The Program has subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board is currently made up of:

• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• The Alaska Regional Director, U.S. Fish and Wildlife Service;

• The Alaska Regional Director, U.S. National Park Service;

• The Alaska State Director, U.S. Bureau of Land Management;

• The Alaska Regional Director, U.S. Bureau of Indian Affairs; and

• The Alaska Regional Forester, U.S. Forest Service.

Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Regional Advisory Council. The Regional Advisory Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation * * * .” Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications, along with some administrative corrections, were published in the Federal Register as follows:

The Departments published a proposed rule on February 2, 2012 (77 FR 5204), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on March 30, 2012. The Departments advertised the proposed rule by mail, radio, and newspaper. During that period, the Regional Councils met and, in addition to other Regional Council business, received suggestions for proposals from the public. The Board received a total of 25 proposals for changes to subparts C and D; this included 3 proposals that the Board had deferred from previous regulatory cycles. After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also available online. The public then had an additional 30 days in which to comment on the proposals for changes to the regulations.

The 10 Regional Advisory Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Regional Advisory Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board meeting of January 22-24, 2013. These final regulations reflect Board review and consideration of Regional Advisory Council recommendations and public comments. The public received extensive opportunity to review and comment on all changes.

Of the 25 proposals, 21 were on the Board's regular agenda and 4 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Subsistence Regional Advisory Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Any Board member may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus (regular) agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals. Of the proposals on the consensus agenda, the Board adopted one and rejected three. Analysis and justification for each action are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management Web site ( http://alaska.fws.gov/asm/index.cfml ). Of the proposals on the regular agenda, the Board adopted two; adopted five with modification; rejected six; deferred two; and took no action on six.

The Board rejected, deferred, or took no action on 14 non-consensus proposals. The rejected proposals were recommended for rejection by one or more of the Regional Advisory Councils unless noted below.

The Board rejected a proposal to establish harvest and possession limits for northern pike in a section of the Yukon River. This action would have been unnecessarily restrictive to subsistence users and there are no conservation concerns to warrant harvest/possession limits. This action was supported by two Councils and contrary to the recommendations of two Councils.

The Board took no action on six proposals dealing with customary trade in the Yukon-Northern Area. This decision was based on its earlier action on a customary trade proposal and to allow time to review the results of this action. The Board encouraged the Regional Advisory Councils and the public to continue to participate and work toward a solution on this important issue and is open to future proposals on this matter.

The Board deferred a proposal to revise the definitions of king and Tanner crab pots, marking requirements, and crab pot limits per vessel in the Kodiak area. This action allows additional time for the Council and State to address new data and work to clarify and define affected areas.

The Board rejected a proposal to reduce household limits for steelhead on the Klawock River in the Southeast Alaska Area based on its action on a similar proposal.

The Board rejected a proposal to restrict designated fishers on the Klawock River in Southeast Alaska. This proposal was unnecessarily restrictive to subsistence users.

The Board deferred a proposal, until January 2014, to eliminate the subsistence sockeye salmon annual guideline harvest level on the Stikine River in Southeast Alaska pending consideration by the Transboundary River Panel and the Pacific Salmon Commission.

The Board rejected a proposal limiting gear types for eulachon in Southeast Alaska. This proposal was unnecessarily restrictive to subsistence users.

The Board rejected a proposal establishing an annual harvest limit for eulachon in Southeast Alaska. This proposal was unnecessarily restrictive to subsistence users.

The Board rejected a proposal to close Federal public waters to non-Federally qualified users in the Makhnati Island area to the harvest of herring and herring spawn. This closure was unnecessary for conservation concerns or to protect Federally qualified users.

The Board adopted or adopted with modification seven non-consensus proposals. Modifications were suggested by the affected Regional Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Regional Councils unless noted below.

The Board adopted a proposal to rescind the permit requirement for Chinook salmon in the drift gillnet fishery within the Yukon River subdistricts 4B and 4C. This action was less restrictive to subsistence users and would align with other remote (non-road accessible) subsistence fisheries along the Yukon River.

The Board adopted a proposal with modification to limit customary trade for Yukon River Chinook salmon. This action will restrict customary trade so that transactions may only occur between Federally qualified rural residents who have customary and traditional use of that resource as defined in Federal regulations (see 36 CFR 242.4 and 50 CFR 100.4). This action only affects customary trade within this region. These modifications responded to recommendations made by a subcommittee composed of members of each of the three Councils that submitted proposals. Four Councils made recommendations on this proposal; two supported; one opposed; and one took no action.

The Board adopted with modification a proposal to revise the gear types, open areas, and require a Federal permit on the Chignik River. This action differed in approach, yet met the intent of the Council's recommendation.

The Board adopted a proposal to rescind the expiration date for the Ninilchik community fish wheel fishery on the Kasilof River. This action provided additional opportunity for subsistence users.

The Board adopted a proposal with modification to rescind the requirement to remove the tail fins of subsistence caught salmon in the Southeastern Alaska Area, but retained the requirement to clip fins in the Yakutat Area. This action was taken to reduce the burden on subsistence users.

The Board adopted with modification a proposal limiting harvest on individual streams for steelhead within the Prince of Wales/Kosciusko Islands. This action was based on conservation concerns.

The Board adopted a proposal with modification to expand the permit requirements for the harvest of eulachon to all of District 1. This action was taken to better track the harvest of eulachon.

These final regulations reflect Board review and consideration of Regional Council recommendations and public and Tribal comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the Federal Register , participation in multiple Regional Council meetings, additional public review and comment on all proposals for regulatory change, and opportunity for additional public comment during the Board meeting prior to deliberation. Additionally, an administrative mechanism exists (and has been used by the public) to request reconsideration of the Board's decision on any particular proposal for regulatory change (36 CFR 242.20 and 50 CFR 100.20). Therefore, the Board believes that sufficient public notice and opportunity for involvement have been given to affected persons regarding Board decisions.

In the more than 20 years the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in DATES to ensure continued operation of the subsistence program.

A Draft Environmental Impact Statement (DEIS) for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. That document described the major issues associated with Federal subsistence management as identified through public meetings, written comments, and staff analyses and examined the environmental consequences of four alternatives. Proposed regulations (subparts A, B, and C) that would implement the preferred alternative were included in the DEIS as an appendix. The DEIS and the proposed administrative regulations presented a framework for a regulatory cycle regarding subsistence hunting and fishing regulations (subpart D). The Final Environmental Impact Statement (FEIS) was published on February 28, 1992.

Based on the public comments received, the analysis contained in the FEIS, and the recommendations of the Federal Subsistence Board and the Department of the Interior's Subsistence Policy Group, the Secretary of the Interior, with the concurrence of the Secretary of Agriculture, through the U.S. Department of Agriculture-Forest Service, implemented Alternative IV as identified in the DEIS and FEIS (Record of Decision on Subsistence Management for Federal Public Lands in Alaska (ROD), signed April 6, 1992). The DEIS and the selected alternative in the FEIS defined the administrative framework of a regulatory cycle for subsistence hunting and fishing regulations. The final rule for subsistence management regulations for public lands in Alaska, subparts A, B, and C, implemented the Federal Subsistence Management Program and included a framework for a regulatory cycle for the subsistence taking of wildlife and fish. The following Federal Register documents pertain to this rulemaking:

An environmental assessment was prepared in 1997 on the expansion of Federal jurisdiction over fisheries and is available from the office listed under FOR FURTHER INFORMATION CONTACT . The Secretary of the Interior with the concurrence of the Secretary of Agriculture determined that the expansion of Federal jurisdiction did not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the following collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100: Subsistence hunting and fishing applications, permits, and reports, Federal Subsistence Regional Advisory Council Membership Application/Nomination and Interview Forms (OMB Control No. 1018-0075).

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value Statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq. ), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.

The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies and there is no cost imposed on any State or local entities or tribal governments.

The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board will provide Federally recognized Tribes and Alaska Native corporations an opportunity to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”

The Secretaries, through the Board, will provide a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Regional Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

On January 22, 2013, the Board provided Federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.

This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.

Theo Matuskowitz drafted these regulations under the guidance of Kathleen M. O'Reilly-Doyle of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by

• Daniel Sharp, Alaska State Office, Bureau of Land Management;

• Sandy Rabinowitch and Nancy Swanton, Alaska Regional Office, National Park Service;

• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

• Jerry Berg and Jack Lorrigan, Alaska Regional Office, U.S. Fish and Wildlife Service; and

• Steve Kessler, Alaska Regional Office, U.S. Forest Service.

For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This SUPPLEMENTARY INFORMATION section is arranged as follows:

Ohio sought SIP approval of its revision of Ohio Administrative Code (OAC) Chapter 3745-17 to clarify and amend its PM rules in an August 22, 2008, submission. EPA approved nine sections, partially approved another section, and approved the rescission of another section of the OAC 3745-17 PM rules in an October 26, 2010, direct final rule (75 FR 65567). EPA conditionally approved OAC 3745-17-11 in the October 26, 2010, rule, conditioned on Ohio making specified revisions to the rule. The rule that EPA conditionally approved established work practice requirements for coating sources in lieu of PM emission limits. As written when submitted on August 22, 2008, OAC 3745-17-11 would have authorized Ohio to exempt coating sources that are too large to meet the work practice requirements of the rule from complying with those requirements. No EPA approval of the exemption was required, thus the state could have unilaterally exempted coating sources from the work practice requirements. EPA conditionally approved OAC 3745-17-11 based on a commitment by Ohio to revise the rule to require that any exemption of large coating sources from the work practice requirements be submitted to EPA as a request for revision to the SIP.

Pursuant to its commitment, Ohio revised OAC 3475-17-11, Restrictions on Particulate Emissions from Industrial Sources, on December 13, 2011. The revised rule was effective on December 23, 2011. Ohio revised OAC 3745-17-11 (A)(1)(l) to provide that any exemption from the surface coating PM work practice requirements for sources coating large size items, which the state may grant when emission control would be technically infeasible, economically unreasonable, or both, must be submitted to EPA for SIP approval. The added language makes clear that state action to grant such an exemption does not exempt the source from Federal enforcement of the work practice requirements in the SIP unless and until EPA approves the exemption.

The version of OAC 3745-17-11 that EPA conditionally approved included other revisions from the PM rules EPA approved into the Ohio SIP on November 8, 2006 (71 FR 65417). Section (A)(5) states that sources can be subject to both fugitive dust and stationary source PM restrictions if that facility emits PM through its stacks as well as emits fugitive dust. Section (A)(1)(m) exempts jet engine test stands from the PM emission limits.

EPA finds the revisions to OAC 3745-17-11 submitted on February 23, 2012, to be approvable.

Although the primary emissions of concern from surface coating are the volatile organic compound emissions that arise from solvent evaporation, OAC 3745-17-11 establishes a particulate emission limit for coating operations simply because OAC 3745-17-11 establishes generic emission limits for any process handling material such as coatings and objects being coated. However, testing of particulate emissions from coating operations is difficult, making it difficult to determine whether particular control measures provide for compliance. Therefore, Ohio exempted surface coating operations from the generic emission limits in OAC 3745-17-11 and subjected these sources instead to a set of rules requiring a specific set of work practices that will limit the emissions as well as an emission limit. The exemptions for surface coaters are provided in OAC 3745-17-11 (A)(1)(h) to (l).

As noted in Section I., Ohio revised OAC 3745-17-11 (A)(1)(l) to require EPA approval, as a SIP revision, for all large item exemptions. This satisfies EPA's concerns with director's discretion previously expressed to Ohio regarding the August 22, 2008, submission. Therefore, EPA is now approving OAC 3745-17-11 (A)(1)(l), as submitted on February 23, 2012, into the Ohio SIP.

OAC 3745-17-11 (A)(1)(m) grants an exemption from the rule's PM emission limits for jet engine testing. PM emissions resulting from this exemption are expected to be small given that a small number of engines will be tested at once and only for a limited time. Ohio stated that the maximum PM emissions rate resulting from this exemption will be 10 pounds per hour. EPA finds that this exemption will have de minimis impact and thus finds OAC 3745-17-11 (A)(1)(m) approvable.

Another addition to OAC 3745-17-11 is section (A)(5), which states that source can be subject to both OAC 3745-17-08 and OAC 3745-17-11. This section applies to a source that is a fugitive dust source, as defined by OAC 3745-17-01 (B)(7), and emits PM through one or more stacks. Restrictions on emissions of fugitive dust are given in OAC 3745-17-08. It is logical that a source emitting PM as fugitive dust and also through stack emissions would be subject to the PM emission restrictions for both fugitive sources and for stationary sources. Thus, EPA is approving this addition to the Ohio SIP.

A final important element of Ohio's submittal is OAC 3745-17-11 (C), the requirements for surface coating processes that are exempt under OAC 3745-17-11 (A)(1)(h) to (l). Surface coating processes are required by OAC 3745-17-11 (C)(1) to use a dry particulate filter, waterwash, or equivalent control device to limit PM emission. Subject facilities must follow the work practice requirements given in OAC 3745-17-11 (C)(2) including maintaining documentation, properly operating the control device, and conducting periodic inspections of the control device. This section also requires a surface coating source to comply with any PM emission limits given in a facility's permit instead of the previous listed requirement of OAC 3745-17-11 (C)(1) and (2). EPA finds these requirements to be a suitable equivalent to subjecting these sources to the generic emission limit in Ohio's process weight rate rule.

EPA is converting its prior conditional approval to full approval because Ohio submitted revisions to OAC 3745-17-11 that satisfy the conditions listed in EPA's conditional approval. EPA is approving all of OAC 3745-17-11, as effective on December 23, 2011, into the Ohio SIP.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective May 28, 2013 without further notice unless we receive relevant adverse written comments by April 29, 2013. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective May 28, 2013.

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

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

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 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 addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 28, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0860 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 28, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0860, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-9328-8) and September 28, 2012 (77 FR 59578) (FRL-9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions ((PP) 1E7923 and 2F8008) by IR-4, IR-4 Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540 and Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596, respectively. The petitions requested that 40 CFR 180.586 be amended by establishing tolerances for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruit, citrus, group 10-10; citrus, dried pulp; pistachio; strawberry and tea, fresh at 0.60, 1.0, 0.01, 1.50 and 70 parts per million (ppm), respectively, 1E7923; and vegetable, fruiting group 8-10, except pepper/eggplant, subgroup 8-10B; and pepper/eggplant subgroup 8-10B at 0.20, and 0.7 ppm, respectively, 2F8008. In addition, PP 2F8008 requested that 40 CFR 180.586(a) be amended by deleting the tolerance for residues of clothianidin in or on the vegetable, fruiting group 8 at 0.2 ppm, upon approval of vegetables, fruiting, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm; and replacing the tolerance for residues of clothianidin in or on fruit, pome at 1.0 ppm with fruit, pome group 11-10 at 1.0 ppm due to EPA expansion of the crop group. The above-mentioned Federal Register documents referenced a summary of the petition prepared by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

At this time, EPA is only establishing tolerances for tea, dried and is increasing the tolerance level for pepper to support PHI for an existing registration. In addition, EPA is re-defining the crop group tolerance expression “vegetable, fruiting, group 8” as “vegetable, fruiting, group 8, except pepper.” EPA is not prepared to establish tolerances for the remaining petitioned-for clothianidin tolerances until the potential ecological and environmental risks can be assessed. EPA will make a final determination on the other petitioned-for tolerances at a later date. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for clothianidin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with clothianidin follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

EPA considered the toxicity of clothianidin as well as several metabolites and degradates in conducting this risk assessment. EPA assumed that clothianidin's metabolites/degradates that are similar in structure to clothianidin are toxicologically equivalent to clothianidin with respect to the endpoints being used for risk assessment.

The available data indicate that there are no consistent target organs in mammals; however, some effects noted in the liver, hematopoietic system and kidney are similar to effects from other neonicotinoid insecticides. In subchronic oral studies, the dog seemed to be more sensitive to clothianidin than the rat. In addition to decreases in body weight and body weight gains observed in both animals, dogs also displayed decreased white blood cells, albumin and total protein, as well as some anemia. Long-term dietary administration of clothianidin did not result in a wider spectrum of effects in the dog; in contrast, the chronic feeding studies in rats showed additional effects in the liver, ovaries and kidneys. In the mouse chronic oral study, increases in vocalization and decreases in body weight and body weight gain were noted.

Based on the lack of significant tumor increases in two adequate rodent carcinogenicity studies, EPA has classified clothianidin as “not likely to be carcinogenic to humans.” A bone marrow micronucleus assay in mice showed that clothianidin is neither clastogenic nor aneugenic up to a toxic oral dose. Additionally, a study on the livers of Wistar male mice showed no induction of unscheduled DNA synthesis up to the limit dose; therefore, mutagenicity is not of concern.

Clinical signs of neurotoxicity were exhibited in both rats (decreased arousal, motor activity and locomotor activity) and mice (decreased spontaneous motor activity, tremors and deep respirations) in acute neurotoxicity studies following exposure by gavage; however, no indications of neurotoxicity were observed following dietary exposure in the subchronic neurotoxicity study in rats.

There was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses following in utero exposure to clothianidin in developmental studies; however, increased quantitative susceptibility of rat pups was seen in both the reproduction and developmental neurotoxicity studies. In the rat reproduction study, offspring toxicity (decreased body weight gains and absolute thymus weights in pups, delayed sexual maturation and an increase in stillbirths) was observed in the absence of maternal effects. In the developmental neurotoxicity study in rats, offspring effects (decreased body weights, body weight gains, motor activity and acoustic startle response amplitude) were noted at doses lower than those resulting in maternal toxicity.

Decreased absolute and relative thymus and spleen weights were observed in multiple studies; these studies showed possible evidence of effects on the immune system. In addition, juvenile rats in the rat reproduction study appeared to be more susceptible to these effects. However, a guideline immunotoxicity study showed no evidence of clothianidin-mediated immunotoxicity in adult rats and a developmental immunotoxicity study demonstrated no increased susceptibility for offspring with regard to immunotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by clothianidin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: “Clothianidin—Aggregate Human Health Risk Assessment of New Uses on Strawberry, Pistachio, and Citrus; New Tolerance for Tea; and Revised PHI and Tolerance for Pepper and Eggplant (Crop Subgroup 8-10B),” dated September 27, 2012 at page 32, and additional information on pome fruit can be found in document: “Clothianidin—Human Health Risk Assessment for Requested Foliar Uses on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome Fruit,” dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-0860.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for clothianidin used for human risk assessment is discussed in Unit II of the final rule published in the Federal Register of August 29, 2012 (77 FR 52246) (FRL-9360-4).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to clothianidin, EPA considered exposure for all of the petitioned-for tolerances as well as all existing clothianidin tolerances in 40 CFR 180.586. EPA assessed dietary exposures from clothianidin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for clothianidin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA used maximum field trial values, empirical processing factors and assumed 100 percent crop treated (PCT) for all commodities. Clothianidin is a major metabolite of thiamethoxam, and there are a number of crops for which uses of both clothianidin and thiamethoxam have been registered. The labels for the various end-use products containing these active ingredients prohibit the application of both active ingredients to the same crop during a growing cycle. Due to that restriction and the assumption of 100 PCT, a single value reflecting the greatest clothianidin residue from either active ingredient has been used for crops listed for use with both active ingredients (versus combined estimates from clothianidin and thiamethoxam). Generally, this assessment uses the established or recommended clothianidin tolerance for crops having tolerances for both compounds (the exception being low-growing berry, subgroup 13-07G, which is based on observed clothianidin residues in thiamethoxam strawberry field trials). For foods with thiamethoxam tolerances but without clothianidin tolerances, maximum residues of clothianidin observed in thiamethoxam field trials have been used in these assessments. Foods falling into this category include meats, meat by-products, artichoke, tropical fruits, coffee, hop, mint, and rice.

In relying on maximum field trial residues of clothianidin, EPA has adjusted the field trial values upward to account for metabolites of concern for leafy and root and tuber vegetables and for ruminants and poultry. Details on these adjustments are provided in document: “Clothianidin—Human Health Risk Assessment for Requested Foliar Uses on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome Fruit,” dated February 1, 2012, in docket ID number EPA-HQ-OPP-2011-0860.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assessed chronic dietary exposure using the same residue information and assumptions regarding metabolites/degradates as in the acute exposure analysis.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that clothianidin does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue information. EPA used anticipated residue (maximum field trial residues) in the dietary assessment for clothianidin.

Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for clothianidin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of clothianidin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

The Agency modeled estimated drinking water concentrations (EDWC) of clothianidin in surface and groundwater using the Tier 1 Rice Model, the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST), and the Screening Concentrations in Groundwater model (SCI-GROW). The Tier 1 Rice Model produced the greatest value of any of the models used to predict EDWCs for acute and chronic exposures. The Tier 1 Rice Model EDWC of 72 parts per billion (ppb) was entered directly into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Clothianidin is currently registered for the following uses that could result in residential exposures: Turf, ornamental plants, and/or indoor use to control bed bugs. EPA assessed residential exposure using the following assumptions: Exposures may occur during application of products containing clothianidin (handler exposure) as well as following application (post-application exposure) and are expected to be of short-term (1-30 days) duration.

Adults were assessed for potential short-term dermal and inhalation handler exposure from applying clothianidin to residential turf/home lawns and for short-term post-application dermal exposure from contact with treated residential and recreational turf home lawns and golf courses. There is also potential for post-application dermal and inhalation exposure for adults and children resulting from use of clothianidin on residential turf, ornamentals ( i.e., trees), and indoor surfaces, as well as, potential for incidental oral post-application exposure for children.

Although there is potential for adult exposure resulting from both applying the product and post-application activities, the Agency did not combine exposure estimates from adult handler and post-application activities because of the conservative assumptions and inputs within each exposure scenario. The children's combined exposure includes only the hand-to-mouth exposure for the incidental oral exposure component. To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth would overestimate incidental oral exposures for purposes of estimating combined residential exposure. Further, because the level of concern for dermal exposures (MOEs less than 100) and inhalation exposure (MOEs less than 1,000) are different, a total aggregate risk index (ARI) approach was used instead of the MOE approach. ARIs of greater than 1 indicate risks are not of concern.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Clothianidin is a member of the neonicotinoid class of pesticides and is a metabolite of another neonicotinoid, thiamethoxam. Structural similarities or common effects do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events. Although clothianidin and thiamethoxam bind selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, and the other neonicotinoids are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a noncompetitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nAChRs, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. While the insecticidal action of the neonicotinoids is neurotoxic, the most sensitive regulatory endpoint for clothianidin is based on unrelated effects in mammals, including changes in body and thymus weights, delays in sexual maturation, and stillbirths. Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids (such as testicular tubular atrophy with thiamethoxam, and mineralized particles in thyroid colloid with imidaclopid). Thus, there is currently no evidence to indicate that neonicotinoids share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the neonicotinoids. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism released by OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no residual concern for increased qualitative or quantitative susceptibility in the rat or rabbit developmental toxicity studies. Since there is evidence of increased quantitative susceptibility of the young following exposure to clothianidin in the rat reproduction study and the DNT study, EPA performed a degree of concern analysis to:

i. Determine the level of concern for the effects observed when considered in the context of all available toxicity data; and,

ii. Identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the clothianidin risk assessment.

Considering the overall toxicity profile and the endpoints and doses selected for the clothianidin risk assessment, EPA characterized the degree of concern for the effects observed in the clothianidin 2-generation reproduction and DNT studies as low, noting that there are clear NOAELs for the offspring effects and regulatory doses were selected to be protective of these effects. No other residual uncertainties were identified with respect to susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X in assessing risks from dermal and oral exposure pathways. However, EPA does not have reliable data to support reduction of the FQPA SF in assessing risks from the inhalation exposure pathway and thus is retaining the 10X FQPA SF for these assessments. That decision is based on the following findings:

i. The toxicity database for clothianidin is complete with the exception of a required 28-day inhalation study.

ii. There are no residual concerns regarding potential prenatal and postnatal toxicity in the young. A rat developmental neurotoxicity study is available and shows evidence of increased quantitative susceptibility of offspring. However, EPA considers the degree of concern for the developmental neurotoxicity study to be low for prenatal and postnatal toxicity because the NOAEL and LOAEL were well characterized, and the doses and endpoints selected for risk assessment are protective of the observed susceptibility. While the rat multi-generation reproduction study showed evidence of increased quantitative susceptibility of offspring compared to adults, the degree of concern is low because the study NOAEL has been selected as the POD for risk assessment purposes for relevant exposure routes and durations. In addition, the potential immunotoxic effects observed in the study have been further characterized with the submission of a developmental immunotoxicity study that showed no evidence of susceptibility. As a result, there are no concerns or residual uncertainties for pre- and postnatal toxicity after establishing toxicity endpoints and traditional UFs to be used in the risk assessment for clothianidin.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on assumptions that were judged to be highly conservative and health-protective for all durations and population subgroups, including maximum field trial residues, adjustment factors from metabolism data, empirical processing factors, and 100 PCT for all commodities. The exposure databases (dietary food, drinking water, and residential) are complete. The risk assessment for each potential exposure scenario includes all metabolites and/or degradates of concern and does not underestimate potential exposure and risk for infants or children. Additionally, EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to clothianidin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by clothianidin.

In conclusion, there are reliable data showing that, with the exception of scenarios involving inhalation exposure, the risk to infants and children can be safely assessed without an additional 10X safety factor. However, in the absence of the required inhalation toxicity study, EPA is retaining the 10X FQPA factor as a database uncertainty factor for assessing inhalation exposure and risk only, for both adults and children.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute Population adjusted dose (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to clothianidin will occupy 28% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to clothianidin from food and water will utilize 28% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of clothianidin is not expected; therefore, the chronic aggregate risk estimates are equivalent to the dietary risk estimates and are below EPA's level of concern.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

For purposes of performing an aggregate assessment, the EPA selected the worst-case adult and children exposure scenarios. The treatment of tree trunks using a manually-pressurized handwand presents the worst-case exposure estimate for adults, while the bed bug scenario presents the worst-case exposure estimates for children 1 to <2 yrs old.

For short- and intermediate-term “worst-case” aggregate exposure estimates, the ARI for adults is 6.5 and for children 1 to <2 years old, the ARI is estimated at 1.2. ARI estimated values greater than 1.0 indicate risks are not of concern.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, clothianidin was classified as “not likely to be carcinogenic to humans,” and is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to clothianidin residues.

Adequate enforcement methodologies, based on solvent extraction and Liquid chromatography—mass spectrometry/mass spectrometry (LC-MS/MS) separation, identification, and quantification, are available for plant (Morse Method #Meth 164—modified, RM-39C-1, or Bayer Method 00552) and livestock (Bayer Method 00624) matrices. The (LOQ) for clothianidin in plant commodities is 0.01 ppm, except for wheat straw (0.02 ppm), and the validated LOQs are 0.01 ppm in milk and 0.02 ppm in animal tissues. Clothianidin and its major metabolites are not adequately recovered using any of the United States Food and Drug Administration (FDA) multiresidue methods.

The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for clothianidin in or on tea, fresh at 0.7 ppm and fruiting vegetables other than cucurbits at 0.050 ppm. The residue field trial submitted to support the U.S. tolerances results in higher clothianidin residues than the maximum residue levels established by Codex and therefore, the U.S. tolerances cannot be harmonized with the Codex MRLs.

EPA received one comment on the notice of filing for petition, 1E7923, in which the commenter requested that EPA deny IR-4's petition to establish a tolerance for residues of clothianidin on food crops because it is toxic to humans.

When new or amended tolerances are requested for the presence of the residues of a pesticide and its toxicologically significant metabolite(s) in food or feed, the Agency, as is required by section 408 of the FFDCA, estimates the risk of the potential exposure to these residues by performing an aggregate risk assessment. As discussed in Unit III, EPA's assessment for clothianidin concludes that there is a reasonable certainty that no harm will result from exposure to clothianidin residues of interest. Therefore, the tolerances established by this action are found to be acceptable. The commenter submitted no evidence or argument that addresses this statutory finding.

In this action EPA is only establishing tolerances for tea, dried and pepper and will make a final determination on the remaining petitioned for tolerances at a later date. Though EPA is able to make the required safety finding under FFDCA and the human health risk assessments support all of the petitioned-for uses, what must still be considered for the additional uses to be registered in the United States are potential ecological and environmental risks associated with clothianidin. Therefore, at this time EPA is only prepared to establish a tolerance on dried tea (without a U.S. registration; i.e., an “import tolerance”) and to increase the tolerance on pepper to support a shorter pre-harvest interval (PHI).

EPA is still in the process of assessing the potential ecological concerns identified with the additional exposures expected from the registration of the proposed pome fruit group 11-10, pepper/eggplant subgroup 8-10B, citrus fruit group 10-10, pistachio, and strawberry uses. However, in order to support an effort to establish tolerances for residues of pesticides on tea, to ensure a safe supply of tea for the U.S. consumer, EPA has determined it will move forward with establishing the tolerance for clothianidin on tea prior to finalizing the decision on the remaining petitioned for uses. Additionally, there is an existing tolerance for residues of clothianidin on fruiting vegetable group 8 at 0.20 ppm and residue field trial data were submitted for pepper to support a lower PHI which results in a recommended higher tolerance. Though EPA is not prepared to allow the expansion of the Fruiting Vegetable Group 8 at this time to include the additional commodities in Pepper/eggplant Subgroup 8-10B, shortening the PHI on pepper is not expected to result in any additional environmental exposure. Therefore, the EPA has determined that it will establish a higher tolerance for clothianidin on pepper in this action and a final determination on the petition for the pepper/eggplant subgroup 8-10B tolerance will be made at a later date.

As to the tolerance levels, the proposed tea, fresh tolerance at 50 ppm will be established on tea, dried at 70 ppm. The commodity listing is changed from tea, fresh to tea, dried to reflect the commodity from which residue data were collected and to reflect the principal tea commodity that is in the channels of trade. The value of the tolerance is changed based on the output from the Organisation for Economic Cooperation and Development (OECD) calculation procedures. EPA is also establishing the separate tolerance on pepper at 0.80 ppm which is different than the requested tolerance at 0.7 ppm for pepper/eggplant subgroup 8-10B. EPA based the 0.80 tolerance level on the non-bell-pepper residue data and OECD Calculation Procedures.

Finally, to account for the establishment of a “separate” pepper tolerance, EPA re-defined the existing crop group tolerance expression “vegetable, fruiting, group 8” as “vegetable, fruiting, group 8, except pepper”.

Therefore, tolerances are established for residues of clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on tea, dried at 70 ppm, pepper at 0.80 ppm, and vegetable, fruiting, group 8, except pepper at 0.20 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

The Moving Ahead for Progress in the 21st Century Act (MAP-21, Pub. L. 112-141) authorized the Public Transportation Emergency Relief Program at 49 U.S.C. 5324. The Emergency Relief Program allows FTA to make grants for eligible public transportation capital and operating costs in the event of a catastrophic event, such as a natural disaster, that affects a wide area, as a result of which the Governor of a State has declared an emergency and the Secretary of Transportation has concurred, or the President has declared a major disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act, 42 U.S.C. 5121-5207).

The Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), enacted on January 29, 2013, provides $10.9 billion for FTA's Emergency Relief Program solely for recovery, relief and resiliency efforts in areas affected by Hurricane Sandy. The law provides that not more than $2 billion shall be made available no later than March 30, 2013. On February 6, 2013, FTA issued a notice of availability of emergency relief funds for the first $2 billion (78 FR 8691). In accordance with the statute, the remainder of the appropriated funds will be made available only after FTA enters into a Memorandum of Agreement (MOA) with the Federal Emergency Management Agency (FEMA) as required by section 20017(b) of MAP-21, and FTA issues interim regulations for the Emergency Relief Program. FTA entered into an MOA with FEMA on March 4, 2013 (available at http://www.fta.dot.gov/documents/FTA_FEMA_MOA.pdf ). This interim final rule meets the requirement for interim regulations.

Projects funded through the Disaster Relief Appropriations Act of 2013 are subject to section 904(c) of that Act, which requires expenditure of funds within 24 months of grant obligation, unless this requirement is waived for this program in accordance with guidance to be issued by the Office of Management and Budget. In all cases, oversight procedures will be put in place to ensure that projects are implemented in accordance with the project schedule.

This interim final rule applies to FTA's Emergency Relief Program, authorized at 49 U.S.C. 5324, and is not limited to Hurricane Sandy response. The rule includes a description of eligible projects, the criteria FTA will use to identify projects for funding, and additional details on how FTA will administer the program. As with FTA's recent Federal Register notice of availability of emergency relief funds for Hurricane Sandy (78 FR 8691, Feb. 6, 2013), FTA will set priorities regarding the type of projects that will most likely receive funding for each specific emergency, based on the facts of the emergency and the type of relief most needed, as well as the availability of annual and supplemental appropriations. FTA seeks public comment on this interim final rule.

Section 5324(a)(2) of title 49, United States Code, defines an “emergency” as follows:

Section 5324(b) of title 49, United States Code, authorizes the Secretary to make awards for FTA's Emergency Relief (Emergency Relief) Program as follows:

In addition, section 5324(d) provides that a grant awarded under section 5324 shall be subject to the terms and conditions the Secretary determines are necessary, and made only for expenses that are not reimbursed under the Stafford Act. Accordingly, FTA will not fund project expenses that FEMA has funded.

This section states the purpose of the rule, which is to establish policy and provide program requirements for the administration of emergency relief funds for emergency public transportation services, and the protection, replacement, repair or reconstruction of public transportation equipment and facilities which have suffered or are in danger of suffering serious damage by a natural disaster over a wide area or a catastrophic failure from an external cause.

This section specifies that part 602 applies to entities that provide public transportation services and that are impacted by emergencies and major disasters.

This section provides definitions that apply to terms used in part 602. Some of the definitions are statutory, such as “emergency,” which is found in 49 U.S.C. 5324, “major disaster,” found in the Stafford Act, and “net project cost,” found in 49 U.S.C. 5302. Other definitions, such as “catastrophic failure,” “emergency repairs,” “external cause,” “heavy maintenance,” and “serious damage” are included in the Federal Highway Administration's (FHWA) emergency relief rule (23 CFR part 668). For consistency, FTA has incorporated these definitions into the FTA Emergency Relief Program.

The definition of “emergency operations” is consistent with the definition in 49 U.S.C. 5324. Eligible emergency operating assistance expenses are for operating costs outside the scope of a recipient's typical service or operations, and include but are not limited to: costs to assist with evacuations prior to an emergency and to assist with rescue operations; the net project cost of providing temporary public transportation service, such as bus or ferry service around inoperable rail lines, or additional service to meet the needs of an influx of evacuees; and the net project costs related to reestablishing, expanding, or relocating public transportation service before, during, or after an emergency or major disaster.

Section 5324 provides that capital projects to “protect” equipment and facilities in danger of suffering serious damage are an eligible expense. FTA has included two definitions that address these types of projects. First, “emergency protective measures” are actions taken immediately before, during or after an emergency to protect public health and safety, and to protect property from immediate damage or from further immediate damage. Such actions eliminate or lessen immediate threats to public health or safety, or eliminate or lessen the immediate threat of significant damage or additional damage to an affected recipient's property through measures that are cost effective. This definition is consistent with FEMA's description of emergency protective measures in 44 CFR 206.225. Some examples of emergency protective measures include, but are not limited to: moving rolling stock to protect it from damage, for example, to higher ground in order to protect it from storm surges; emergency communications; security forces; sandbagging; bracing/shoring damaged structures; debris removal; dewatering; and removal of health and safety hazards.

Second, for this rule, we have defined the term “resilience” to mean a capability to anticipate, prepare for, respond to, and recover from significant multi-hazard threats with minimum damage to social well-being, the economy, and the environment. This definition of “resilience” is consistent with the definition in the 2010 Interagency Climate Change Adaptation Task Force Progress Report to the President and America's Climate Choices: Adapting to the Impacts of Climate Change by the National Academy of Sciences. A “resiliency project” is a project designed and built to address future vulnerabilities to a public transportation facility or system due to future recurrence of emergencies or major disasters that are likely to occur again in the geographic area in which the public transportation system is located; or projected changes in development patterns, demographics, or extreme weather or other climate patterns. “Permanent repairs” are defined as those repairs undertaken following the disaster occurrence for the purpose of repairing, replacing or reconstructing seriously damaged public transportation system elements, including rolling stock, equipment, facilities and infrastructure to a state of good repair. For all capital projects, the cost to perform the work, whether by in-house or contracted personnel, is an eligible cost. FTA seeks public comment on these definitions.

This section describes FTA's policies related to the Emergency Relief Program. FTA's first goal in the Emergency Relief Program is to assist public transportation agencies in restoring public transportation service and in repairing and reconstructing transit assets to a state of good repair as expeditiously as possible. FTA has not defined the term “state of good repair” in this rule. This summer, FTA plans to issue interim policy guidance on the definition of the term state of good repair, and also plans to issue an advance notice of proposed rulemaking for the transit asset management program authorized by 49 U.S.C. 5326. In conjunction with repair and reconstruction activities, a second goal is to increase the resiliency of affected public transportation systems in order to help protect those systems from damage due to future emergencies and major disasters.

Grants awarded with section 5324 funds, as well as grants awarded under sections 5307 and 5311 for emergency relief purposes, may be made only for expenses that are not reimbursed by FEMA under the Stafford Act, or by other Federal agencies, or by insurance proceeds. If an applicant has already received FEMA or other Federal agency funding or insurance proceeds, the applicant may not apply for FTA emergency relief funding for the same project expenses. However, partial compensation for a loss by such other sources will not preclude FTA participation for the part of the loss not compensated. For example, insurance proceeds may only cover the value of a vehicle at the time it was destroyed, and not the cost to replace that vehicle. Consistent with FTA Circular 5010.1D, FTA may participate in the replacement cost beyond what the insurance proceeds may cover.

If FTA makes a grant and the recipient subsequently receives compensation from another source, the funds received from the other source must be used to reduce FTA's share of the project cost. FTA seeks public comment on the aforementioned policies and other policies for ensuring emergency relief funds are expended efficiently and consistent with the law's purposes.

The language in FTA's Emergency Relief Program at 49 U.S.C. 5324 is the same as the FHWA's Emergency Relief Program at 23 U.S.C. 125, in that assets must have “suffered serious damage.” FHWA's Emergency Relief Program rule provides that the Emergency Relief Program “is not intended to fund heavy maintenance or routine emergency repair activities which should normally be funded as contingency items in the State and local road programs.” 23 CFR 668.105(j). Therefore, FHWA has determined that eligible Emergency Relief repair activities in a State in the range of $700,000 (Federal share) or more are usually significant enough to justify approval of Emergency Relief funds.

FTA has not included such a provision in this interim final rule, but has included a definition of heavy maintenance and § 602.13 provides that heavy maintenance is not an eligible activity. FTA seeks public comment on whether and how, in a final rule, FTA should establish a similar policy that sets a minimum monetary damage threshold for FTA participation in the cost of repair, reconstruction, or replacement activities for public transportation systems after an emergency. Similarly, FTA seeks comment on whether there should be a minimum monetary cost threshold for emergency protective measures or emergency operations. Further, on what basis should FTA establish minimum cost thresholds for FTA participation, given that the size of public transportation systems and the resources of entities that operate them vary? In other words, should such a threshold vary based on the size of public transportation systems, as measured by annual revenue miles, directional miles, number of vehicles, unlinked passenger trips, budget, or some other basis?

This section of the interim final rule provides that the Federal share for emergency relief project funds made available under 49 U.S.C. 5324, for both operating and capital projects, shall be for up to 80 percent of the project cost, unless the Secretary waives the local share requirement. This section also provides that when a recipient chooses to use funds available to it under 49 U.S.C. 5307 or 5311 for emergency projects, the Federal share will be 80 percent for capital projects and 50 percent for operating projects, which is consistent with the Federal share requirements of those sections. FTA seeks public comment on these Federal share requirements.

This section describes the conditions under which FTA will grant pre-award authority. The purpose of pre-award authority is to allow affected recipients to respond to critical needs in preparation for, or in the immediate aftermath of, an emergency or major disaster, and in advance of receiving a grant from FTA under the Emergency Relief Program. Generally, pre-award authority will be effective beginning on the effective date of the declared emergency or major disaster, and subject to the appropriation of Emergency Relief Program funds. In expected weather events, such as hurricanes, pre-award authority for evacuations and activities to protect public transportation vehicles, equipment and facilities, shall be effective within a reasonable period of time in advance of the event, such as during the period the storm is forecast with some certainty to hit the affected area. FTA seeks comment on whether the language “forecast with some certainty to hit the affected area” is specific enough, or if FTA should adopt a policy with more specificity. FEMA Policy FP 010-4, May 18, 2012, ( pre_disaster_emergency_declaration_requests_policy_fp010_4[2].pdf ) provides the conditions under which FEMA will fund pre-disaster emergency protective measures. For example, a Federal agency must determine or affirm that a potential major disaster is imminent, the Governor must take action under State law and direct execution of the State emergency plan, and Direct Federal Assistance must be needed to meet critical emergency protection requirements before impact that are beyond the capability or capacity of the State, tribal or local governments; or the appropriate State, tribal, or local governments must have issued evacuation orders for three or more areas or for a geographical area with a combined population of more than 100,000 individuals. Adopting text similar to this in the final rule would provide affected recipients with some certainty as to when FTA would fund emergency protective measures, evacuations, etc.

Pre-award authority shall be subject to a maximum amount as determined by FTA. Except as provided in section 602.15 of this interim final rule, all applicable Federal grant requirements must be met for the project to remain eligible for Federal funding. As with pre-award authority for FTA's other programs, pre-award authority is not a legal or implied commitment that the project will be approved for FTA assistance or that FTA will obligate Federal funds, and affected recipients expend local funds at their own risk. Furthermore, pre-award authority is not a legal or implied commitment that all activities undertaken by the applicant will be eligible for inclusion in the project. In other words, not all activities undertaken by the applicant may be eligible for Federal assistance, even if the project is otherwise eligible. FTA seeks public comment on the use of pre-award authority for the Emergency Relief Program.

This section describes the eligible activities under 49 U.S.C. 5324, as well as activities ineligible for emergency relief funding. An affected recipient may apply for section 5324 emergency relief funds on behalf of itself as well as affected subrecipients.

Emergency operations, emergency protective measures, emergency repairs, permanent repairs and resiliency projects, as those terms are defined in section 602.5 of this rule, are eligible for emergency relief funding. Affected recipients should repair, replace or reconstruct seriously damaged public transportation system elements as necessary to restore the elements to a state of good repair taking into account current as well as future conditions and risks. For example, replace destroyed rolling stock with new rolling stock, replace older seriously damaged elements with new ones, incorporate current design standards, replace a destroyed facility at a different location when replacing at the existing location is not practical or feasible, or when doing so will eliminate vulnerabilities to future disasters, incorporate additional required features resulting from the environmental review process, and incorporate or add protective features or design standards in order to protect the equipment or facilities from future damage. In other words, FTA does not expect affected recipients to replace old, destroyed rolling stock, equipment, and elements of facilities with similarly-aged rolling stock, equipment, and elements of facilities. Instead, affected recipients should replace these destroyed elements with new ones. New rolling stock acquired to replace destroyed rolling stock should be fully compliant with current safety and other design standards, including the Americans with Disabilities Act (ADA), as well as Buy America requirements. Facilities damaged by the emergency or disaster that require substantial work to bring into a state of good repair should be similarly brought up to current design standards, including the ADA. In addition, where feasible, resiliency projects should be incorporated into replacement and repairs such that equipment, facilities and infrastructure will be protected from future disasters.

It is not the intent or purpose of the Emergency Relief Program to provide substitute funding for regular capital maintenance that is not a result of an emergency or major disaster. Therefore, heavy maintenance and projects for which funds were obligated in an FTA grant prior to the declared emergency or major disaster are not eligible expenses under the Emergency Relief Program. In addition, FTA will not fund project costs for which the recipient has received funding through FEMA, another Federal agency or through insurance proceeds. In general, projects that change the function of the original infrastructure, and do not enhance or otherwise improve system resiliency—for example, a change from a bus rapid transit system to light rail, or a replacement of bus shelters with intermodal facilities, or projects that significantly upgrade a maintenance facility—do not qualify for Emergency Relief funding. However, formula and other funds available to the recipient may be used in conjunction with Emergency Relief Program funds to make substantial changes or improvements to an affected transit asset during the course of an Emergency Relief project.

Replacing damaged diesel buses with compressed natural gas or other clean fuel buses is eligible under the Emergency Relief Program, but any costs associated with new alternative fueling stations or maintenance facilities is not eligible for Emergency Relief funds. Those associated costs are eligible, however, under FTA's formula programs, and recipients and subrecipients may use funds apportioned under sections 5307 or 5311 formula funds for those costs. Lost revenue as a result of service disruptions is not an eligible expense. Finally, project costs associated with the replacement or replenishment of stockpiles of materials that are not the property of the affected recipient and have not yet been integrated into the public transportation system are not eligible. This would include contractor-owned property on a construction site that has not yet been installed, and would be covered by the contractor's insurance company. This is distinguished from the cost to replace spare parts and other maintenance items necessary for the operation of the system that are seriously damaged or destroyed as a result of an emergency, which is an eligible expense. FTA seeks public comment on the list of eligible and ineligible activities.

FTA also requests comment on the extent of the benefit-cost analysis that is appropriate to carry out in the context of emergency repairs, permanent repairs, and resiliency projects. Because the benefits of resiliency projects include a reduction in the risk of damage from future emergencies, FTA particularly requests comments on the extent of risk analysis that should be conducted for resiliency projects. Similarly, factoring in the full cost of the loss of the function or service provided by critical transit infrastructure can affect how benefit-cost analyses should be addressed. For example, damage to rail and transit infrastructure can result in additional costs to transit riders who would use alternative modes of travel or forgo a trip, and result in decreases in business productivity because employees cannot get to work. Similarly, the transit system serves to help move people and goods before, during and after an emergency, a function that is very detrimental to lose and expensive to replace once lost. FTA welcomes comment on how these costs should be taken into account in a benefit-cost analysis.

Section 5324(d) of title 49, United States Code provides that a grant awarded under sections 5324, 5307 and 5311 that is made to address an emergency shall be subject to the terms and conditions the Secretary determines are necessary. In general, projects will be subject to the requirements of chapter 53 of title 49, United States Code, as well as cross-cutting requirements, including but not limited to those outlined in FTA's Master Agreement.

This section provides information as to when FTA may determine the inapplicability of Federal requirements in order to expedite restoration of service through delivery of Emergency Relief Program funds. FTA will determine the terms and conditions of Emergency Relief grants based on the circumstances of a specific emergency or major disaster for which funding is available under the Emergency Relief Program.

FTA may determine the inapplicability of requirements associated with public transportation programs as necessary and appropriate for emergency repairs, permanent repairs, and emergency operating expenses that are incurred within 45 days of the emergency or major disaster, or longer as determined by FTA. This 45-day period is consistent with FTA's charter rule at 49 CFR 604.2(f), which provides that the charter rule does not apply to a recipient for actions directly responding to an emergency or major disaster. If FTA determines that any requirement does not apply, this determination shall apply to all eligible activities undertaken with funds authorized under 49 U.S.C. 5324 within the 45-day period, as well as funds authorized under 49 U.S.C. 5307 and 5311 and used for eligible emergency relief activities.

In the event an affected recipient or subrecipient finds that FTA requirements would limit the recipient's or subrecipient's ability to respond to an emergency or major disaster, the affected recipient or subrecipient may request that applicable requirements be waived in accordance with the emergency relief docket process as outlined below. Affected recipients and subrecipients should never assume that a waiver will be granted.

Under 49 CFR part 601, subpart D, FTA establishes an emergency relief docket each calendar year. The purpose of the docket is to allow recipients affected by national or regional emergencies to request relief from FTA administrative requirements set forth in FTA policy statements, circulars, guidance documents, and regulations. As stated above, 49 U.S.C. 5324(d) provides that a grant awarded under section 5324 or under section 5307 or 5311 to address an emergency shall be subject to the terms and conditions the Secretary determines are necessary. Effective with calendar year 2013, recipients affected by an emergency or major disaster may request waivers of chapter 53 requirements when the requirement(s) will limit a recipient's or subrecipient's ability to respond to an emergency or major disaster. Recipients must follow the procedures as set forth in 49 CFR part 601, subpart D when requesting a waiver of statutory or administrative requirements. FTA seeks public comment on the types of requirements that FTA should prospectively determine inapplicable or waived in the event of an emergency or major disaster.

Executive Order 11988, Floodplain Management, requires Federal agencies to avoid to the extent possible the long and short-term adverse impacts associated with the occupancy and modification of floodplains and to avoid direct and indirect support of floodplain development wherever there is a practicable alternative. The Executive Order provides an eight-step process that agencies should carry out as part of their decision-making on projects that have potential impacts to or within the floodplain. Executive Order 11988 is further implemented by DOT Order 5650.2, Floodplain Management and Protection.

Since this rule addresses natural disasters, including weather events that can produce serious flooding, FTA has included a provision in this rule that addresses Executive Order 11988. Specifically, recipients shall not use grant funds for any activity in an area delineated as a `special flood hazard area' or equivalent, as labeled in the Federal Emergency Management Administration's (FEMA) most recent and current data source, unless, prior to seeking FTA funding for such action, the recipient designs or modifies its actions in order to minimize potential harm to or within the floodplain, in accordance with Executive Order 11988. To guide decision making, recipients shall use the “best available information” as identified by FEMA, which includes advisory data (such as Advisory Base Flood Elevations), preliminary and final Flood Insurance Rate Maps (FIRMs), and Flood Insurance Studies (FISs). If FEMA data is mutually determined by FTA and the recipient to be unavailable or insufficiently detailed, other Federal, State, or local data may be used as the “best available information” in accordance with Executive Order 11988.

The final determination on “best available information” shall be used to establish such reconstruction requirements as a project's minimum elevation. In certain situations, notably where a project or activity is located within a special flood hazard area, use of FTA funds will require that a project and activity shall be designed and constructed in accordance with specific and additional reconstruction terms, such as elevated minimums for project elevations (e.g. best available data plus one foot in elevation), as determined necessary to adequately enhance long-term structural resilience, and mitigate against the reoccurrence of flood-related damages. Additionally, in scenarios where higher minimum elevations are required by either State or locally adopted building codes or standards, the higher of the competing minimums would apply. This standard does not necessarily mean that transit agencies will be required to move existing facilities to a higher elevation; however, in order to minimize potential harm within the floodplain in accordance with Executive Order 11988, recipients should consider updated design features or added protective features (resiliency projects) in order to reduce the risk of damage from future disasters. A base flood elevation from an interim or preliminary or non-FEMA source cannot be used if it is lower than the current FIRM. Recipients shall also consider the best available data on sea-level rise, storm surge, scouring and erosion before rebuilding. In all instances, FTA retains the authority to award funds in direct alignment with recipient acceptance of and continued compliance with Federal determinations regarding increased standards for floodplain management. FTA seeks public comment on this provision.

Applications for Emergency Relief funding must include a detailed damage assessment report to support the request for assistance for capital projects. Typically, a damage assessment involves on-the-ground visits to the damaged sites to verify the extent of the damage and to estimate the cost of repairs. The damage assessment report should be coordinated with FEMA, if appropriate, to avoid duplication of effort. FTA seeks comment on how to maximize harmonization of FTA and FEMA requirements for damage assessment reports. The damage assessment report should include, by political subdivision or other generally recognized administrative or geographic boundaries, a description of the types and extent of damage to public transportation systems and a preliminary estimate of cost of restoration, replacement, or reconstruction for seriously damaged systems in each jurisdiction. Pictures showing the kinds and extent of damage and sketch maps detailing the damaged areas should be included, as appropriate, in the damage assessment report. In addition, the damage assessment report should include recommendations for resiliency projects to protect equipment and facilities from future emergencies and disasters.

FTA is requesting public comment regarding whether, with respect to requests for Emergency Relief funding for permanent repairs or resiliency projects relating to damaged or destroyed facilities, it is appropriate to incorporate requirements of Section 1315(b) of MAP-21 such that the damage assessment report should include an evaluation of whether such damaged or destroyed facilities have repeatedly required repair or reconstruction in the past. If so, FTA seeks comment as to whether the applicant should evaluate whether there are reasonable alternatives that could reduce the need for Federal funds to be expended on such repair or reconstruction activities in the future, better protect public safety, health and the environment, and/or meet transportation needs as described in relevant and applicable Federal, State, local and tribal plans.

Generally, a damage assessment report should be completed within six weeks of the emergency or major disaster. For large disasters where extensive damage to public transportation systems is readily evident, the appropriate FTA Regional Administrator may approve a grant application under section 602.17(f) prior to submission of the damage assessment report. In these cases, the applicant shall prepare and submit to the appropriate FTA Regional Administrator an abbreviated or preliminary damage assessment report, summarizing eligible repair costs by jurisdiction, after the damage inspections have been completed.

The applicant shall include the damage assessment report as an appendix to the grant application. In addition to the report, an applicant shall submit a copy of the Governor's declaration or a Presidential declaration; a list of projects which describes emergency operations, emergency protective measures, and emergency repairs completed as well as permanent work needed to repair or replace the damaged or destroyed rolling stock, equipment, facilities, and infrastructure; and supporting documentation showing other sources of funding available, including insurance policies, agreements with other Federal agencies, and any other source of funds available to address the damage resulting from the emergency or major disaster.

Applications for emergency operating expenses must include the dates, hours, number of vehicles, and total fare revenues received (if any) for the emergency service. Only net project costs may be reimbursed.

Applicants that apply for and/or receive funding from another Federal agency, including FEMA, for operating expenses and also seek funding from FTA for operating costs must include a copy of the agreement with the other Federal agency, including the scope of the agreement, the amount funded, and the dates the other Federal agency funded operating costs, as well as the scope of service and dates for which the applicant is seeking FTA funding. Applicants that apply for and/or receive funding from another Federal agency, including FEMA, for emergency or permanent repairs or emergency protective measures and also seek funding from FTA for emergency or permanent repairs or emergency protective measures must include a copy of the agreement with the other Federal agency, including the scope of the agreement, the amount funded, and a list of projects included in the other Federal agency's application.

Each applicant is responsible for preparing and submitting a grant application, and the appropriate FTA regional office may provide technical assistance to the applicant in preparing a list of projects for the grant application. This work may involve joint site inspections to view damage and reach tentative agreement on the type of permanent corrective work the applicant will undertake. The data collected must be sufficient to make a determination of eligibility of the proposed work. The FTA Regional Administrator's approval of the grant application constitutes a finding of eligibility under 49 U.S.C. 5324. FTA seeks public comment on the application procedures.

All comments received on or before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket at the above address. Comments received after the comment closing date will be filed in the docket and will be considered to the extent practicable. A final rule may be published at any time after close of the comment period.

As required by the Disaster Relief Appropriations Act of 2013, FTA is issuing this interim final rule in order to implement the Emergency Relief Program and to provide information regarding the application procedures for Emergency Relief Program grants in response to Hurricane Sandy. This interim final rule is effective immediately. In addition, FTA requests comments on the rule, given that its requirements will apply to the Emergency Relief Program in general, and not only to grant funds disbursed in response to Hurricane Sandy.

The Administrative Procedure Act (5 U.S.C. 553(d)) requires that a rule be published 30 days prior to its effective date unless one of three exceptions applies. One of these exceptions is when the agency finds good cause for a shorter period. Here, FTA has determined that good cause exists for immediate effectiveness of this rule because the rule is expected to address the immediate need to repair transit system facilities, infrastructure and equipment damaged by Hurricane Sandy. Hurricane Sandy affected mid-Atlantic and northeastern states in October 2012, and particularly devastated transit operations in New Jersey and New York. Through immediate promulgation of the interim final rule, many of the much-needed Hurricane Sandy recovery efforts can occur in a more expeditious manner. Thus, it is in the public interest for this final rule to have an immediate effective date.

FTA will publish a notice responding to any comments received and, if appropriate, will amend provisions of the rule. If FTA subsequently establishes criteria or conditions for grants made under the Emergency Relief Program that are different from those in this interim final rule, the different criteria or conditions will not be applied retroactively to applications submitted or grants awarded consistent with this interim final rule, unless the change benefits the applicant.

FTA has determined preliminarily that this action is a significant regulatory action within the meaning of Executive Order 12866 and is significant within the meaning of Department of Transportation regulatory policies and procedures because of substantial congressional, State and local government, and public interest. Those interests include restoring public transportation service as quickly as possible after an emergency or major disaster, the receipt of Federal financial support for repairing and replacing public transportation investments damaged or destroyed by emergencies and major disasters as expeditiously as possible, and the receipt of Federal financial support for emergency operations before, during and after emergencies and major disasters.

FTA has determined that this is an economically significant rule within the meaning in Executive Order 12866 because of the amount of funding FTA reasonably expects to distribute as a result of Hurricane Sandy. FTA was appropriated $10.9 billion for the Emergency Relief Program in response to Hurricane Sandy, and FTA expects to distribute more than $100 million to entities impacted by the hurricane in the upcoming year. The Obama Administration's budget request included $25 million for fiscal year 2013 for the Emergency Relief program, and the authorization in 49 U.S.C. 5338(f) is for “such sums as are necessary to carry out section 5324.” Congress did not appropriate any funds for the Emergency Relief Program in the 2013 Continuing Appropriations Resolution (Pub. L. 112-175). Hurricane Sandy was an extraordinary event resulting in historical damage to public transportation systems. While it is impossible to predict how much funding Congress might appropriate for the Emergency Relief Program for extraordinary events such as Hurricane Sandy, in a typical year without an extraordinary event such as Hurricane Sandy, FTA does not expect this rule to have an economic impact greater than $100 million.

The purpose of this interim final rule is to provide grant application procedures and describe eligible activities as directed by statute. The rule itself does not affect the total amount of grant funds available to States or local governmental authorities. That amount will be specified in annual or supplemental appropriations acts of Congress. FTA will distribute funds through the Emergency Relief Program consistent with the requirements of this rule to those States and local governmental authorities that have experienced emergencies or major disasters.

Through the Emergency Relief Program, FTA will reimburse affected recipients for eligible operating and capital costs incurred as a result of an emergency or major disaster. MAP-21 generally prescribes the criteria and types of projects eligible for emergency relief grants, and FTA has exercised limited discretion in this rulemaking to implement the statute.

While complying with the application procedures set forth in this rule is a requirement for receiving grant funds, the rule does not impose any mandate on States or governmental authorities to submit an application. However, should a State or local governmental authority choose to submit an application, there are some costs and burdens associated with the application process. FTA received emergency clearance from OMB under the Paperwork Reduction Act (PRA) for funds made available by the Disaster Relief Appropriations Act, and included in this notice is a request for comment for the information collection required by this rule. Interested persons should consult the Paperwork Reduction Act section of this document for further information.

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612), FTA has evaluated the effects of this interim final rule on small entities and has determined the interim final rule will not have a significant economic impact on a substantial number of small entities. Recipients of Emergency Relief Program funds are generally States and local governmental authorities. The only burden placed upon local governments by this rule is the small paperwork burden associated with the application process, which is addressed in the Paperwork Reduction Act section of this notice and is designed to minimize the paperwork burdens of the rule. For this reason, FTA certifies that this action will not have a significant economic impact on a substantial number of small entities.

This interim final rule will not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). The Federal share for grants made under the Emergency Relief Program is 80 percent, and the Secretary may waive all or part of the non-Federal share. This interim final rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $143.1 million or more in any one year (2 U.S.C. 1532).

This interim final rule has been analyzed in accordance with the principles and criteria established by Executive Order 13132, and FTA has determined that this interim final rule will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. FTA has also determined that this interim final rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions.

The regulations effectuating Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this interim final rule.

On February 6, 2013, in compliance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ) and the Office of Management and Budget (OMB) implementing regulation at 5 CFR 1320.13, FTA received emergency approval from OMB for an Information Collection for funds appropriated by the Disaster Relief Appropriations Act (Information Collection number 2132-0575). The approval for this information collection will expire on August 13, 2013.

In compliance with the PRA and OMB implementing regulation at 5 CFR 1320.8(d), FTA is seeking longer-term approval from OMB for Information Collection number 2132-0575, for which FTA received emergency approval, as abstracted below. The Information Collection includes not only funds specific to Hurricane Sandy but for the Emergency Relief Program in its entirety. In order to receive emergency relief funds, applicants will be required to fill out and submit a grant application. This is the same grant application used by FTA recipients for other FTA programs and will be submitted electronically through the Transportation Electronic Award and Management (TEAM) system. In addition to the grant application, applicants will be required to develop a damage assessment report. FTA is seeking comment on whether the information collected will have practical utility; whether its estimation of the burden of the proposed information collection is accurate; whether the burden can be minimized through the use of automated collection techniques or other forms of information technology; and for ways in which the quality, utility, and clarity of the information can be enhanced.

Type of Review: OMB Clearance. Updated information collection request.

Respondents: In any given year, FTA estimates that as many as 20 recipients may experience an emergency that is declared by a Governor of a State or the President. The PRA estimate was based on a total of 20 recipients seeking emergency relief funds per year.

Frequency: Information will be collected periodically whenever an applicant applies for emergency relief funding.

Estimated Total Annual Burden Hours: 3,600. FTA estimates the average annual time burden per applicant is 180 hours. This estimate includes: (1) 50 hours for preparation of a grant application, including any supplemental emergency relief forms (49 CFR 602.17(b)); (2) 50 hours per grant recipient to develop a damage assessment report (49 CFR 602.17(a)); and 80 hours for project management, including submission of Milestone Progress Reports, Federal Financial Reports and other required reports.

Additional documentation detailing FTA's Paperwork Reduction Act Information Collection Request, including FTA's Justification Statement, may be accessed from OMB's Web site at http://www.reginfo.gov/public/do/PRASearch, Information Collection number 2132-0575. OMB is required to file comments or make a decision concerning the proposed information rule within 60 days after receiving the information collection request submission from FTA. FTA will summarize and respond to any comments on the proposed information collection request from OMB and the public in the preamble to the final rule.

The National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), requires Federal agencies to analyze the potential environmental effects of their proposed actions either through a Categorical Exclusion, an Environmental Assessment or an Environmental Impact Statement. This interim final rule is categorically excluded under FTA's NEPA implementing procedures at 23 CFR 771.118(c)(4), which covers planning and administrative activities which do not involve or lead directly to construction, such as the promulgation of rules, regulations and directives. FTA has determined that no unusual circumstances exist and that this Categorical Exclusion is applicable.

Executive Order 12898 directs every Federal agency to make environmental justice part of its mission by identifying and addressing the effects of all programs, policies, and activities on minority populations and low-income populations. The DOT's environmental justice initiatives accomplish this goal by involving the potentially affected public in developing transportation projects that fit harmoniously within their communities without sacrificing safety or mobility. FTA has developed a program circular addressing environmental justice in transit projects, C 4703.1, Environmental Justice Policy Guidance for Federal Transit Administration Recipients. The Circular is designed to provide a framework to assist recipients as they integrate principles of environmental justice into their transit decision-making process. The Circular contains recommendations for State DOTs, MPOs and transit providers on (1) How to fully engage environmental justice populations in the transportation decision-making process; (2) how to determine whether environmental justice populations would be subjected to disproportionately high and adverse human health or environmental effects of a public transportation project, policy, or activity; and (3) how to avoid, minimize, or mitigate these effects.

This action will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This action meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

FTA has analyzed this action under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. FTA certifies that this interim final rule will not cause an environmental risk to health or safety that may disproportionately affect children.

FTA has analyzed this action under Executive Order 13175 (Nov. 6, 2000), and believes that it will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. Therefore, a tribal summary impact statement is not required.

FTA has analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). FTA has determined that it is not a significant energy action under that order since it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review U.S. DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477).

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN set forth in the heading of this document can be used to cross-reference this action with the Unified Agenda.

For the reasons set forth in the preamble, FTA amends Chapter VI of Title 49, Code of Federal Regulations, by adding Part 602, as set forth below.