Need for Correction

In amending § 124.3, definition for “Primary industry classification” SBA intended the time period to consist of three years not the two years provided for in the definition. This change from two years to three years was made in other portions of the rule but was inadvertently not changed in 124.3. Correction of this oversight would make the section consistent with related provisions of the rule.

As stated in the preamble of the final rule, SBA intended to make the provisions pertaining to Tribes, ANCs, NHOs, and CDCs consistent. The section addresses when a subsidiary is eligible for award of a follow on contract. The change was inadvertently only made to the Tribes and ANC provisions. Therefore, SBA is correcting § 124.110(e) and § 124.111(d) to make these provisions, relating to Native Hawaiian Owned (NHO) entities and Certified Development Companies (CDCs) respectively, consistent with the same language pertaining to tribally and Alaskan Native Corporation (ANC) and NHO owned entities. Additionally, SBA is changing § 124.111(d) which contains a reference to SIC instead of NAICS.

In §§ 124.112(b)(6) and (d)(1) SBA is correcting typographical errors that result in the wrong word choice. The word “contacts” is replaced with the word “contracts” in (b)(6) and the word “though” is replaced with the word “through” in (d)(1)

In § 124.513(c)(4) SBA omitted the word “populated”, which is necessary for the public to be able to distinguish the treatment of profit distribution between populated and unpopulated joint ventures. This section will be corrected to insert the missing word.

With regard to § 124.519, SBA provided incorrect instructions to theFederal Registerfor the amendments to paragraph (a) that was inconsistent with the intended amendment as discussed in the preamble for the final rule. Specifically, SBA intended to amend only the introductory text of § 124.519(a) but provided instructions that amended the entire paragraph (a) resulting in the unintended removal of paragraphs (1) through (3). SBA is making the correction here to reinsert those paragraphs.

Finally, to avoid confusion for the public, SBA is correcting awkward language in § 124.520(c)(3) to clearly articulate the standards, as discussed in the preamble, for permitting a protégé firm to have more than one mentor.

Accordingly, 13 CFR part 124 is corrected by making the following correcting amendments:

Discussion

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 theFederal Registeron October 5, 2011 (76 FR 61641). That NPRM proposed to require correct an unsafe condition for the specified products. The MCAI states:

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

US Airways stated that there currently is no fly-back allowance in the NPRM (76 FR 61641, October 5, 2011). US Airways also stated that this makes it difficult for airlines to schedule the inspection quickly, which is the most desirable situation.

We infer that US Airways is requesting a ferry flight permit. We partially agree with this request. Unless otherwise specified in the AD, special flight permits are currently allowed under section 39.23 of the Federal Aviation Regulations (14 CFR 39.23). No change is therefore necessary to the AD regarding this issue.

US Airways stated that it asked Airbus to provide an SRM repair for expected findings, and that it has been informed by Airbus that a repair design was expected to be published in the February 2012 revision of the SRM. US Airways requested that a statement in the final rule be added to acknowledge that published SRM repairs are a FAA-approved corrective action for the proposed AD (76 FR 61641, October 5, 2011).

We partially agree with US Airways' request. We understand US Airways' concern regarding the unavailability of repair procedures and its effect on their scheduling of repairs since a discrepancy requires repair before further flight. However, we cannot provide approval of future SRM repairs in an AD by using the phrase, “or later FAA-approved revisions,” because it violates the Office of the Federal Register regulations for approving materials that are incorporated by reference. However, we consider that service information (including SRM repair) approved by EASA (or its delegated agent) is equivalent to FAA-approved corrective action for this AD, if it meets the certification basis of the affected airplanes and mitigates the unsafe condition addressed in this AD. We have not changed this AD in this regard.

United Airlines requested that the “Costs of Compliance” section of the NPRM (76 FR 61641, October 5, 2011) be revised. United Airlines stated that under the “Costs of Compliance” section in the NPRM, an estimate of 6 work-hours is specified to comply with the NPRM. United Airlines stated that Airbus Service Bulletin A320-57-1152, dated June 14, 2010, specifies a total of 12.5 work-hours to accomplish this inspection. United Airlines stated that Airbus Service Bulletin A320-57-1152, dated June 14, 2010, provides a more accurate representation of the work-hours required for this task, and it requests that the FAA justify its proposed estimate of 6 work-hours required to comply with the NPRM.

In addition, United Airlines stated that, when accomplishing paragraph (g)(2) of the NPRM (76 FR 61641, October 5, 2011), which requires performing a general visual inspection for corrosion if the resistance value is greater than 10 milliOhms, the operator is directed to section. 3.C.(2) of the Accomplishment Instructions, Subtask 571152-832-401-001—Removal of Primer—Inspection for Corrosion, of Airbus Service Bulletin A320-57-1152, dated June 14, 2010. United Airlines stated that this subtask's “Manpower Resources” chart specifies that it takes “5 man-hours and 2.5 hours elapsed time” to complete that part of that service bulletin, and that under this subtask, Step (a), among other actions, requires defueling and venting of the two fuel tanks. United Airlines also stated that operator experience has shown that this procedure alone takes about “8 man-hours and 4 hours of elapsed time.” United Airlines stated it understands that it is not standard practice to propose manufacturers' service bulletin changes through the FAA, but it would like to offer a more accurate estimate of at least “10 man-hours and 6 hours elapsed time,” in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1152, dated June 14, 2010.

We agree with United Airlines' request to revise the “Costs of Compliance” section of this AD. We have clarified the “Costs of Compliance” section by estimating that it would take about 2 work-hours to perform the initial action (electrical bonding test). In addition, we have estimated that it would take about 12 work-hours to perform the follow-on actions (inspection for corrosion and repair). We have changed this AD accordingly.

We reviewed the available data, including the comments received, 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 (76 FR 61641, October 5, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 61641, October 5, 2011).

We estimate that this AD will affect 67 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements (electrical bonding test) 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 $11,390, or $170 per product.

In addition, we estimate that any necessary follow-on actions (inspection for corrosion and repair) would take about 12 work-hours and require parts costing $0, for a cost of $1,020 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 athttp://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 docketcontains the NPRM (76 FR 61641, October 5, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. 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:

Discussion

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 theFederal Registeron September 27, 2011 (76 FR 59590). That NPRM proposed to require repetitive inspections for cracking of the aft pressure bulkhead at station (STA) 1582, repair or replacement of any cracked bulkhead, and eventual replacement of the aft pressure bulkhead at STA 1582 with a new bulkhead. That proposed AD specified that accomplishing the replacement would terminate the repetitive inspections specified in the NPRM.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and the FAA's response to each comment.

American Airlines has no objection to the NRPM (76 FR 59590, September 27, 2011), and noted that it will incorporate the requirements into its maintenance program.

Boeing and Airborne Express (ABX) asked that the requirements in AD 2004-14-19, Amendment 39-13728 (69 FR 42549, July 16, 2004), be added to the affected ADs section and the related requirements of the NPRM (76 FR 59590, September 27, 2011). Boeing stated that this would ensure that the initial actions in paragraphs (b), (c), and (d) of AD 2004-14-19 begin 50,000 flight cycles after the aft pressure bulkhead has been replaced. ABX recommend that we add a paragraph that allows a 50,000 flight cycle threshold on a new aft pressure bulkhead for the inspections required by AD 2004-14-19.

We do not agree to include AD 2004-14-19, Amendment 39-13728 (69 FR 42549, July 16, 2004), in the affected ADs section and related requirements of this AD. We have determined that an unsafe condition exists, and that the actions this AD requires are adequate to ensure the continued safety of the affected fleet. The commenter's suggested changes would alter the actions currently required by this AD, so additional rulemaking would be required. We find that delaying this action would be inappropriate in light of the identified unsafe condition. We have not changed this final rule regarding this issue. However, operators can always request approval of an alternative method of compliance (AMOC) for AD 2004-14-19.

Boeing asked that we change paragraph (g) of the NPRM (76 FR 59590, September 27, 2011) to remove the terminating action for the repetitive inspections specified in paragraph (b) of AD 2004-05-16, Amendment 39-13511 (69 FR 10917, March 9, 2004). Boeing stated that the inspections required by paragraph (b) of AD 2004-05-16 are not terminated by doing the inspections required by paragraph (g) of the NPRM. Boeing added that the inspections required by AD 2004-05-16 are for cracking of the web of the aft pressure bulkhead at the web y-chord joint. Boeing noted that this cracking pattern, location, and growth rate are not covered by the inspection in paragraph (g) of the NPRM.

We agree with the commenter for the reasons provided. We have removed the terminating action for the repetitive inspections required by AD 2004-05-16 (69 FR 10917, March 9, 2004) from paragraph (g) of this AD.

Boeing also requested that we revise paragraph (g) of the NPRM (76 FR 59590, September 27, 2011) to specify that accomplishing the inspections in paragraph (g) of the NPRM terminates the “initial” and repetitive inspections required by paragraphs (f) “and (h)” of AD 2005-03-11, Amendment 39-13967 (70 FR 7174, February 11, 2005), corrected on March 11, 2005 (70 FR 12119).

We partially agree with the commenter. Doing the inspections required by paragraph (g) of this AD replaces the inspections (repetitive) required by paragraph (f) of AD 2005-03-11, Amendment 39-13967 (70 FR 7174, February 11, 2005), corrected on March 11, 2005 (70 FR 12119). We have revised paragraph (g) of this AD accordingly. However, the inspection required by paragraph (h) of AD 2005-03-11 is a one-time inspection of the “oil can” locations of the aft pressure bulkhead web, which is not in the same location as the inspections required by paragraph (g) of the NPRM (76 FR 59590, September 27, 2011). Therefore the requirements in paragraph (h) of AD 2005-03-11 cannot be terminated by the inspections required by paragraph (g) ofthis AD. However, under the provisions of paragraph (i) of this AD, we will consider requests to provide such relief through approval of an AMOC if sufficient data are submitted to substantiate that the terminating action would also provide an acceptable level of safety.

Boeing also asked that we revise paragraph (h) of the NPRM (76 FR 59590, September 27, 2011) to specify that doing the replacement specified in paragraph (h) of the NPRM terminates the actions required by paragraphs (a) and (b) of AD 2004-05-16, Amendment 39-13511 (69 FR 10917, March 9, 2004) and the actions required by paragraphs (f) and (h) of AD 2005-03-11, Amendment 39-13967 (70 FR 7174, February 11, 2005), corrected on March 11, 2005 (70 FR 12119).

We agree with the commenter. Once the replacement required by paragraph (h) of this AD is done, it is not necessary to do the inspections required by paragraphs (a) and (b) of AD 2004-05-16, Amendment 39-13511 (69 FR 10917, March 9, 2004) and paragraphs (f) and (h) of AD 2005-03-11, Amendment 39-13967 (70 FR 7174, February 11, 2005), corrected on March 11, 2005 (70 FR 12119). We have revised paragraph (h) of this AD accordingly.

ABX asked that we add a new paragraph following paragraph (h) of the NPRM (76 FR 59590, September 27, 2011), which allows synchronizing the maintenance program and the AD requirements for all airplanes equipped with improved aft pressure bulkheads. ABX added that we should mandate the airworthiness limitations (AWLs) for the maintenance on aft pressure bulkheads that have been replaced, in order to relieve the burden of requesting AMOCs. ABX added that the improved aft pressure bulkhead should have the same maintenance requirements whether it was installed on an airplane in production or in service.

We partially agree with the commenter. We agree that the actual dimensional and material configuration of the modified aft pressure bulkhead is identical to the later production airplanes. However, although the configuration is identical, the fatigue life of the bulkhead is not. All Model 767 airplanes, including the fatigue test airplanes, are subject to limit test pressurization loads during production. This limit loading substantially enhances the fatigue life of the structure. We have made no change to the AD in this regard.

We have added new Note 1 to paragraph (c) of this AD to state that supplemental type certificate (STC) ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/082838ee177dbf62862576a4005cdfc0/$FILE/ST01920SE.pdf) does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01920SE is installed, a “change in product” AMOC approval request is not necessary to comply with the requirements of 14 CFR 39.17.

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. 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 83 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

History

The FAA is adjusting the geographic location of Baltimore VORTAC, Baltimore, MD, to be in concert with the FAAs aeronautical database, which shows the correct coordinates. This is an administrative change and does not affect the boundaries or operating requirements of the airspace; therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary.

The Class D and E airspace designations are published in Paragraphs 5000, 6002 and 6004 of FAA order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends the geographic coordinates in the legal description of Class D airspace and Class E surface airspace, for Martin State Airport, Baltimore, MD. This update brings the geographic coordinates in concert with the FAA's Aeronautical Products 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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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 United States Code. 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.

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 Martin State Airport, Baltimore, MD.

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

History

On December 13, 2011, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to amend Class E airspace for the Omaha, NE, area, creating additional controlled airspace at Eppley Airfield (76 FR 77448) Docket No. FAA-2011-1126. 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 7400.9V dated August 9, 2011, and effective September 15, 2011, 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 accommodate new standard instrument approach procedures at Eppley Airfield, Omaha, NE. This action is necessary for 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 amends controlled airspace at Eppley Airfield, Omaha, NE.

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

History

On March 2, 2012, the FAA published in theFederal Registera notice of proposed rulemaking to amend Class E airspace at Tullahoma, TN (77 FR 12759). 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 7400.9V dated August 9, 2011, and effective September 15, 2011, 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 amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface at Tullahoma, TN. Airspace reconfiguration is necessary due to the closing of Arnold Air Force Base, and supports new standard instrument approach procedures developed at Tullahoma Regional Airport/Wm Northern Field. Controlled airspace is necessary for the continued safety and management of IFR operations within the Tullahoma, TN, area. This action also adjusts the geographic coordinates of the Tullahoma Regional Airport/Wm Northern Field to be in concert with the FAAs 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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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 United States Code. 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.

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 in the Tullahoma, TN area.

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:

History

On December 13, 2011, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to amend Class E airspace for the Decatur, IL, area, creating additional controlled airspace at Decatur Airport (76 FR 77450) Docket No. FAA-2011-1105. 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 7400.9V dated August 9, 2011, and effective September 15, 2011, 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 accommodate new standard instrument approach procedures at Decatur Airport, Decatur, IL. This action is necessary for the safety and management of IFR operations at the airport. This action also adjusts the geographic coordinates of the airport 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 Decatur Airport, Decatur, IL.

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Acting Administrator, including the authority to issue, rescind, and revise regulations. 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, Chapter 401, Section 40103 (b), which allows the Acting Administrator to regulate the use of the navigable airspace as necessary to ensure the safety of aircraft and the efficient use of airspace. Additionally, Subtitle VII, Part A, Subpart III, Chapter 447, Section 44701 (c) authorizes the Acting Administrator to carry out functions in this chapter in a way that helps to reduce or eliminate the possibility or recurrence of accidents in air transportation.

In January 1990, the National Transportation Safety Board (NTSB) recommended that the FAA take action to address safety issues involving runway incursions and near-collision ground incidents.1 That recommendation followed several high-profile incidents, including a 1990 ground collision at Atlanta Hartsfield Airport between an Eastern B727 and a King Air (resulting in one fatality and one injury).

On August 15, 2007, an FAA “Call to Action” committee issued several recommendations to address improving runway safety across the National Airspace System (NAS). The committee identified taxi clearances as a key area of concern. Following the committee's recommendations, the FAA convened a Safety Risk Management (SRM) panel of subject matter experts to review the committee's recommendations, including the NTSB recommendation to eliminate the issuance of a “taxi to” clearance found in 14 CFR 91.129(i).

NTSB Safety Recommendations A-00-67 and A-00-68 were reiterated in an NTSB Safety Recommendation, dated August 28, 2007, following the 2006 crash of Comair flight 5191, CL-600, which crashed during takeoff from Blue Grass Airport (LEX), Lexington, KY. The NTSB determined that a contributor to the probable cause of that accident, in which the flight crew was instructed to take off from runway 22 but began its takeoff roll on runway 26, was the FAA's failure to require that all runway crossings be authorized only by ATC clearances specific to the runway.

On September 11, 2008, the SRM panel issued its “Explicit Runway Crossing Clearances Safety Risk Management Document (SRMD),” which contained a proposal “to implement explicit runway crossing clearances per NTSB recommendation A-00-67.”

In response to the NTSB's recommendation and effective June 30, 2010, the FAA implemented changes to the procedures for issuing taxi and ground movement instructions. The changes subsequently were incorporated into FAA Orders, JO 7110.65 Air Traffic Control and JO 7210.3 Facility Operation and Administration.

This action revises paragraph (i) of § 91.129 by removing the sentences that describe a “clearance to `taxi to' the takeoff runway assigned to the aircraft.” This language is contradictory to current air traffic control procedures and could lead to confusion and incorrect pilot expectations. Removing this provision does not alter the requirement to have an appropriate ATC clearance. The FAA will continue to require all aircraft to receive an ATC clearance prior to entering any taxiway or runway.

The FAA finds, under 5 U.S.C. 553(b), that notice and public comment are impracticable and contrary to the public interest. Furthermore, the FAA finds that good cause exists under 5 U.S.C. 553(d) to make this rule effective upon publication. The changes to this section align the rule with current air traffic procedures and will not adversely affect the flow of taxiing aircraft. As this rule does not change the requirement to have an ATC clearance prior to taxiing, this amendment will not adversely impact safety and will avoid confusion that can be caused between contradictory regulations and ATC procedures. Nonetheless, the FAA invites parties to comment on this proceeding. A separatenotice will be issued by the FAA addressing any comments received.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this rule.

Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the cost and benefits is not prepared. Such a determination has been made for this rule. The reasoning for this determination follows:

The changes to this section align the rule with current air traffic procedures and will not adversely affect the flow of taxiing aircraft. As this rule does not change the requirement to have an ATC clearance prior to taxiing, this amendment will not adversely impact safety and will avoid confusion that can be caused between contradicting regulations and ATC procedures. Further this rule responds to NTSB recommendations and to the August 15, 2007 FAA “Call to Action” Committee recommendations to address improving runway safety across the National Airspace System. That committee identified taxi clearances as a key area of concern. This action improves safety at no additional cost.

The FAA has, therefore, determined that this rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear. This rule aligns the agency's regulations with current practice, responds to NTSB Safety Recommendation Numbers A-00-67 and A-00-68, and with no change in existing procedures there are no additional costs.

Therefore as the FAA Acting Administrator, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this rule and determined that it will have only a domestic impact and therefore has no effect on international trade.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $143.1 million in lieu of $100 million. This rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this immediately adopted final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.

The FAA analyzed this immediately adopted final rule under the principles and criteria of Executive Order 13132,Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications.

The FAA analyzed this immediately adopted final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not a “significant energy action” under the executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

An electronic copy of a rulemaking document may be obtained by using the Internet—

1. Search the Federal eRulemaking Portal (http://www.regulations.gov);

2. Visit the FAA's Regulations and Policies Web page athttp://www.faa.gov/regulations_policies/or

3. Access the Government Printing Office's Web page athttp://www.gpo.gov/fdsys/.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under theFOR FURTHER INFORMATION CONTACTheading at the beginning of the preamble. To find out more about SBREFA on the Internet, visithttp://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

On April 18, 2012, BIS published the final rule, “Addition of Certain Persons on the Entity List: Addition of Persons Acting Contrary to the National Security or Foreign Policy Interests of the United States” in theFederal Register(77 FR 23114). This amendment corrects two spelling errors: one error in the name and one error in the address of a person who was added to the Entity List in the April 18 final rule under the destination of Jordan.

The name and address of this person should have been listed as follows:

(1)Masoud Est. for Medical and Scientific Supplies,74 First Floor, Tla'a Al Ali Khali Al Salim Street, Amman, Jordan 11118.

On April 27, 2012, BIS published the final rule, “Addition of Certain Persons to the Entity List” in theFederal Register(77 FR 25055). This amendment corrects the spelling of the city of Sharjah, which was incorrectly spelled in the addresses for three of the persons added to the Entity List under the destination of United Arab Emirates. Lastly, this rule removes a hyphen from the address of a person who was added under the destination of Pakistan to clarify the text is the address of this person and not an alias.

The name and address of these four persons should have been listed as follows:

(1)Jalaluddin Haqqani,a.k.a., the following seven aliases:

(1)Al Maskah Used Car and Spare Parts,Maliha Road, Industrial Area 6, Sharjah, U.A.E.;

(2)Feroz Khan,a.k.a., the following three aliases:

Maliha Road, Industrial Area 6, Sharjah, U.A.E.;and

(3)Zurmat General Trading,Office No. 205, Platinum Business Center, Baghdad Street, Al-Nahda 2, Al-Qusais, Dubai, U.A.E.;andP.O. Box No. 171452, Dubai, U.A.E.;and1st Street, Industrial Area 4th, Sharjah, U.A.E. (Behind the Toyota Showroom),andP.O. Box 35470, Sharjah, U.A.E.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 12, 2011, 76 FR 50661 (August 16, 2011), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by the OMB under control numbers 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email toJasmeet_K._Seehra@omb.eop.gov,or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to the Administrative Procedure Act (5 U.S.C. 553), BIS finds that there is good cause to waive the opportunity for public comment and delay in effective date for this correction. This action merely corrects clerical errors in the previous text that have no substantive affect. Because the corrections do not affect the substantive rights or obligations of any party, the public has little interest in the rule, and so prior notice and opportunity for comment are unnecessary. Accordingly, prior notice and opportunity for comment, as well as the delay in effectiveness of this rule, are hereby waived. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq.,are not applicable.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

Teva Animal Health, Inc., 3915 South 48th St. Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-391 for Griseofulvin Powder, ANADAs 200-146 and 200-247 for Oxytetracycline Hydrochloride Soluble Powder, and ANADAs 200-313 and 200-386 for Levamisole Hydrochloride Soluble Pig Wormer and Drench Powder to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. Accordingly, the agency is amending the regulations in part 520 (21 CFR part 520) to reflect the transfer of ownership and a current format.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

Regulatory Information

On February 10, 2012, we published a notice of proposed rulemaking (NPRM) entitled “Safety Zones; America's Cup World Series, East Passage, Narragansett Bay, RI” in theFederal Register(77 FR 7025). We received one comment on the proposed rule.

The legal basis for this rule is 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; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define safety zones.

This rule is necessary to provide for the safety of life and navigation for both participants and spectators involved with the America's Cup World Series in the vicinity of Newport, RI.

One comment was received, supporting this rule. The commenter believed the safety zones established by this rule will improve navigation safety for all mariners and facilitate a safe America's Cup World Series event. No changes were made to the language contained in the NPRM.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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

We expect the economic impact of this rule to be minimal. Although this regulation may have some impact on the public, the potential impact will be minimized for the following reasons: Vessels will only be restricted from the East Passage of Narragansett Bay by the designated safety zone for a maximum of six hours per day for a maximum of 10 days; there is an alternate route, the West Passage of Narragansett Bay, that does not add substantial transit time, is already routinely used by mariners, and will not be affected by these safety zones; many vessels, especially recreational vessels, may transit in allportions of the affected waterway except for those areas covered by the safety zones; and vessels may enter or pass through the affected waterway with the permission of the Captain of the Port (COTP) or the COTP's representative.

Notifications of the ACWS and associated safety zones will be made to mariners through the Rhode Island Port Safety Forum, local Notice to Mariners, event sponsors, and local media well in advance of the event.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. 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 would not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which might be small entities: Owners or operators of vessels intending to transit, fish, or anchor in the East Passage of Narragansett Bay, Rhode Island, during the ACWS races.

The rule will not have a significant economic impact on a substantial number of small entities for the following reasons: Vessels will only be restricted from the designated safety zone for a maximum of six hours per day for a maximum of 10 days; vessels may transit in all portions of the affected waterway except for those areas covered by the safety zones, and vessels may enter or pass through the affected waterway with the permission of the COTP or the COTP's representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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 calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

This rule would 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 would not create an environmental risk to health or risk to safety that might disproportionately affect children.

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g.,specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule 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. Any comments made in response to the previously published Notice of Proposed Rulemaking for thisaction were also considered in arriving at this conclusion. This rule is categorically excluded, under figure 2-1, paragraphs (34)(g) and (34)(h) of the Instruction since it involves establishment of safety zones for marine related events. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

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

Regulatory Information

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 using the NPRM process. On April 10, 2012, the Coast Guard received notice that a marine casualty caused damage to a railway bridge on April 9, 2012. Immediate repairs are now required for the bridge. This short notice did not allow for the time needed to publish a NPRM and provide for a comment period. Delaying this rule by publishing a NPRM would be contrary to the public interest by unnecessarily delaying the bridge repairs and the safety zone needed to protect repair workers and vessels transiting the area on the Upper Mississippi River. Additionally, delaying the repairs and inspections for the NPRM process would unnecessarily impede the flow of commercial river traffic and railroad traffic. This rule is needed to protect repair workers and vessels transiting this area on the Upper Mississippi River.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Delaying this rule by providing 30 days notice would be contrary to the public interest by unnecessarily delaying the bridge repairs and the safety zone needed to protect repair workers and vessels transiting the area on the Upper Mississippi River.

On April 9, 2012, a marine casualty involving a down bound crane barge striking the Merchants Bridge resulted in structural damage to the bridge, reduced vertical clearance, hanging wreckage, and a North-side railroad track closure. Initial repairs to the bridge started immediately with Saint Louis Bridge Construction performing a series of repairs and inspections on the Merchants Bridge in the vicinity of mile 183.0 to 183.5 on the Upper Mississippi River. After initial repairs, ongoing and intermittent inspections and full repairs will continue and the Coast Guard determined that a temporary safety zone is necessary to protect repair workers and marine traffic. Establishing this safety zone around the Merchants Bridge and repair personnel and equipment is intended to safeguard against disruption of positioned repair equipment, potential large falling debris, and possible hazards related to ongoing repairs in and around commercial traffic in the vicinity of mile 183.0 to 183.5 on the Upper Mississippi River.

The Coast Guard is establishing a temporary safety zone for all waters of the Upper Mississippi River, from mile 183.0 to 183.5, in the vicinity of Merchants Bridge and extending the entire width of the river. Entry into this zone is prohibited to all vessels and persons unless specifically authorized by the Captain of the Port Upper Mississippi River. This rule is effective from 7 a.m. on April 10, 2012 through 7 p.m. on December 31, 2012, but will only be enforced during intermittent repair and inspection operation periods that will be announced by broadcast notices to mariners with the greatest advance notice possible. Due to the unpredictability of the Upper Mississippi River, National Weather Service's forecasts will be used to determine the most suitable conditions for bridge repairs and inspections. Advanced notice will be given to the maximum extent possible, but despite best efforts, the safety zone may be established with minimal notice when ideal work conditions are identified. The Captain of the Port Upper Mississippi River will inform the public and maritime industry through broadcast notice to mariners of the enforcement periods and changes to the safety zone and its enforcement.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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

Although this rule will be effective until December 31, 2012 unless repairs and inspections are completed sooner, it will only be enforced for limited time periods during days scheduled for repair work or bridge inspections. By enforcing this safety zone for limited periods of time throughout the effective period, marine traffic will not be significantly impacted. Entry into or passage through the safety zone will be considered on a case-by-case basis by the Captain of the Port Upper Mississippi or designated representative. Notifications of, and changes to, the enforcement period will be made via broadcast notice to mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Upper Mississippi River, mile 183.0 to 183.5 during enforcement periods. The enforcement periods will be for a limited duration. By enforcing this safety zone for a limited duration of time intermittently throughout the effective period, marine traffic will not be significantly impacted. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule will only be enforced during limited periods of time throughout the effective period.

If you are a small business entity and are significantly affected by this regulation, please contact Chief Petty Officer Ryan Christensen, Sector Upper Mississippi River Response Department at telephone 314-269-2721, emailRyan.D.Christensen@uscg.mil.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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 businesses. 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 calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501—3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. This rule establishes a safety zone related to effecting bridge repairs and is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because this rule is not expected to result in any significant adverse environmental impact as described in the National Environmental Policy Act of 1969 (NEPA).

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

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

An interim final rule amending VA's medical regulations concerning the copayment required for certain medications was published in theFederal Registeron December 20, 2011 (76 FR 78824). Interested persons were invited to submit comments to the interim final rule on or before February 21, 2012, and we received no comments. Therefore, based on the rationale set forth in the interim final rule, VA is adopting the interim final rule as a final rule with no changes.

This document affirms as final, without change, the interim final rule that is already in effect. In accordance with 5 U.S.C. 553(b)(3)(B) and (d)(3), the Secretary of Veterans Affairs concluded that there was good cause to dispense with the opportunity for advance notice and opportunity for public comment and good cause to publish this rule with an immediate effective date. The Secretary found that it was impracticable, unnecessary, and contrary to the public interest to delay this regulation for the purpose of soliciting advance public comment or to have a delayed effective date. Increasing the copayment amount on January 1, 2012, might have caused a significant financial hardship for some veterans. Nevertheless, the Secretary invited public comment on the interim final rule but did not receive any comments.

Title 38 of the Code of Federal Regulations, as revised by this rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

This final rule contains no collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C.601-612. This final rule will temporarily freeze the copayments that certain veterans are required to pay for prescription drugs furnished by VA. This final rule affects individuals and has no impact on small entities. Therefore, under 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule will have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance program number and title for this rule are as follows: 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on May 7, 2012 for publication.

The Postal Service is taking this action to bring its international mailing standards into compliance with international standards for the acceptance of dangerous goods in international mail.

International standards have recently been the subject of discussion by the International Civil Aviation Organization (ICAO) and the Universal Postal Union (UPU), and the Postal Service anticipates that on January 1, 2013, customers will be able to mail specific quantities of lithium batteries internationally (including to and from an APO, FPO, or DPO location) when the batteries are properly installed in the personal electronic devices they are intended to operate.

Until such time that a less restrictive policy can be implemented consistent with international standards, and in accordance with UPU Convention, lithium batteries are not permitted in international mail. The UPU Convention and regulations are consistent with the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions). The Technical Instructions concerning the Transport of Dangerous Goods by Post do not permit “dangerous goods” as defined by the ICAO Technical Instructions in international mail. The prohibition on mailing lithium batteries and cells internationally also applies to mail sent by commercial air transportation to and from an APO, FPO, or DPO location.

This final rule describes the prohibitions established for mailpieces containing lithium metal or lithium-ion cells or batteries and applies regardless of quantity, size, watt hours, and whether the cells or batteries are packedinequipment,withequipment, or without equipment.

We will also revise and renumber Exhibit 601.10.20.7 to reflect “watt-hour ratings” instead of “lithium content” for secondary lithium-ion batteries when describing maximum quantity limits. In addition, the Postal Service has moved the lithium battery standards as it relates to international, APO, FPO or DPO locations to the International Mail Manual (IMM®).

The Postal Service will also make parallel changes to other USPS publications that make reference to the mailing of lithium batteries such as Publication 52,Hazardous, Restricted, and Perishable Mail.

Accordingly, 39 CFR part 111 is amended as follows:

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. On January 20, 2012 (77 FR 2937), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed approval of a SIP revision pertaining to preconstruction permitting requirements under Pennsylvania's nonattainment NSR program. The formal SIP revision was submitted by the Pennsylvania Department of Environmental Protection (PA DEP) on August 9, 2007.

The history of this SIP, the NSR Reform Program, andSouth Coast Air Quality Management Districtv.EPA 1 (South Coast)decision regarding antibacksliding provisions of the Eight-Hour Ozone National Ambient Air Quality Standard (69 FR 23951), are described in the NPR. The purpose of this SIP revision is to incorporatechanges to Pennsylvania's nonattainment NSR rules made as a result of EPA's 2002 NSR Reform, and to address the antibacksliding provisions of theSouth Coastdecision.

In summary, the current NSR Reform Rules: (1) Provide a new method for determining baseline actual emissions; (2) adopt an actual-to-projected actual methodology for determining whether a major modification has occurred; and (3) allow major stationary sources to comply with Plantwide Applicability Limits (PALs) to avoid having a significant emissions increase that triggers the requirements of the major NSR program (68 FR 63021 and 72 FR 32526). The 2002 NSR Reform Rules require that state agencies adopt and submit revisions to their SIP permitting programs implementing the minimum program elements of the 2002 NSR Reform Rules no later than January 2, 2006. In addition, as a result of theSouth Coastdecision, all one-hour ozone NAAQS major NSR requirements must remain in place where classifications under the newer eight-hour ozone standard imposed less stringent NSR requirements.

The SIP submittal consists of changes to 25 Pa. Code Chapter 121, General Provisions, and 25 Pa. Code Chapter 127, Construction, Modification, Reactivation, and Operation of Sources. This action will update Pennsylvania's nonattainment NSR regulations as previously approved on December 9, 1997 (62 FR 64722). It will incorporate for the first time the 2002 “NSR Reform” provisions into Pennsylvania's nonattainment NSR program, and will satisfy the requirements of the DC Circuit Court decision inSouth Coastregarding antibacksliding. The proposed regulations were adopted by Pennsylvania and became effective on May 19, 2007. Other specific requirements of the regulations and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

EPA is approving the August 9, 2007 SIP revision, amending Pennsylvania's NSR construction, modification, reactivation and operation permit programs at 25 Pa. Code Section 121.1 and 25 Pa. Code Chapter 127, as a revision to the Pennsylvania SIP.

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

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

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et 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. 601et 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 CAA; and

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

In addition, 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 Pennsylvania, 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. 801et 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 13, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to Pennsylvania' nonattainment NSR program 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. What action is EPA taking? II. What is the effect of this action? III. Summary of Public Comment and EPA Response IV. Statutory and Executive Order Reviews I. What action is EPA taking?

EPA is making a final determination that the Steubenville-Weirton Area has attained the 24-hour 2006 PM2.5NAAQS. This determination is based upon complete, quality assured, and certified ambient air monitoring data showing that this area has monitored attainment of the 2006 PM2.5NAAQS based on data for 2008-2010.

On October 4, 2011 (76 FR 61291), EPA proposed its determination of attainment for the Steubenville-Weirton Area. A discussion of the rationale behind this determination and the effect of the determination were included in the notice of proposed rulemaking (NPR). One adverse comment was submitted in response to EPA's October 4, 2011 NPR (76 FR 61291). A summary of the comment and EPA's response is provided in section III of this document.

Under the provisions of EPA's PM2.5implementation rule (40 CFR 51.1004(c)), the requirements for the States of Ohio and West Virginia to submit, for the Steubenville-Weirton Area, an attainment demonstration and associated RACM (including reasonably available control technology (RACT)), a reasonable further progress plan, contingency measures, and any other planning SIPs related to attainment of the 2006 PM2.5NAAQS are suspended for so long as the Area continues to meet the 24-hour 2006 PM2.5NAAQS. If EPA subsequently determines that this Area violates the 24-hour 2006 PM2.5NAAQS, the basis for the suspension of the specific requirements, set forth at 40 CFR 51.1004(c), would no longer exist and this area would thereafter have to address the pertinent requirements.

This action, does not constitute a redesignation of the Steubenville-Weirton Area to attainment of the 24-hour 2006 PM2.5NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further, this action does not involve approving maintenance plans for the Area as required under section 175A of the CAA, nor does it find that the Area has met all other requirements for redesignation. Even after a determination of attainment by EPA, the designation status of the Steubenville-Weirton Area remains nonattainment for the 24-hour 2006 PM2.5NAAQS until such time as EPA determines that the Area meets the CAA requirements for redesignation to attainment and takes action to redesignate the Steubenville-Weirton Area.

Comment:An Ohio resident expressed concern for the air quality in the Steubenville-Weirton Area. The resident perceives the air quality to be poor and thus questioned how this Area will be free from requirements to create plans for air quality improvement. The resident also proposed that areas with air quality problems should be subject to more stringent standards.

Response:Since 2006, the States of Ohio and West Virginia, as well as the Federal government, have implemented various measures that have resulted in cleaner air in the Steubenville-Weirton Area, including, the nitrogen oxides (NOX) SIP Call which addressed pollutants that can result in acid rain; mobile source engine standards leading to a decrease in NOXand direct PM2.5; fuel standards decreasing sulfur dioxide (SO2); as well as rules affecting SO2andNOXfrom power plants. These and other measures have resulted in a decrease in monitored PM2.5concentrations in the Steubenville-Weirton Area. Questions regarding the stringency of existing air standards are not relevant to this determination. The sole concern of this determination is whether the Area has attained the 2006 PM2.524-hour standard. Since 2008, based on complete, quality assured and certified data, this Area has monitored attainment of that standard, set by EPA to protect human health and the environment. The Area continues to attain the standard. At this time, therefore, no additional attainment planning or measures related to attainment of the 2006 PM2.524-hour standard are needed. In the future, should EPA determine that a violation of the standard occurs, the States of Ohio and West Virginia will then be required to submit an attainment demonstration, associated RACM, a reasonable further progress plan, contingency measures, and other planning SIPs related to attainment of the standard.

This action merely makes an attainment determination based on air quality data and does not impose any additional requirements. 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. 3501et 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. 601et 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 CAA; and

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

The Congressional Review Act, 5 U.S.C. 801et 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 13, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This clean data determination for the 24-hour 2006 PM2.5NAAQS for the Steubenville-Weirton Area 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. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.To access the OCSPP test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

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-2008-0039 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 July 13, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2008-0039, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof February 6, 2008 (73 FR 6966) (FRL-8350-9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 7E7239) by Whitmire Micro-Gen (now affiliated with BASF Corp.; 3568 Tree Court Industrial Blvd., St. Louis, MO 63112). The petition requested that 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of acetone (Cas Reg. No. 67-64-1) when used as an inert ingredient as a solvent or co-solvent in pesticide formulations applied to animals. That notice referenced a summary of the petition prepared by Whitmire Micro-Gen (now affiliated with BASF Corp.; 3568 Tree Court Industrial Blvd., St. Louis, MO 63112), the petitioner, which is available in the docket,http://www.regulations.gov.Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit V.C.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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 * * *.”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 acetone including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with acetone 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. Specific information on the studies received and the nature of the adverse effects caused by acetone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The toxicity data base for acetone includes data relative to acetone per se as well as to isopropanol. Since isopropanol readily metabolizes to acetone in the body, the Agency has concluded that the data regarding isopropanol may be used in conjunction with the data regarding acetone to characterize the toxicity of acetone.

Acetone has low acute toxicity. It is not a skin irritant or sensitizer but is a defatting agent to the skin. Acetone is an eye irritant.

The toxicity of acetone was evaluated in several subchronic toxicity studies in mice and rats via drinking water, gavage and inhalation. The most notable findings in subchronic studies were increased liver and kidney weights, and decreased spleen weights. In mice administered acetone via drinking water, adverse effects (liver and kidney toxicity) were observed at doses ≥1,600 milligrams/kilogram/bodyweight/day (mg/kg/bw/day). Rats treated with acetone via gavage for 90 days exhibited decreased body weight and increased relative kidney and liver weights, hemosiderosis of the spleen and an increased incidence and severity of nephropathy at 1,700 mg/kg/day. The NOAEL in rats was 900 mg/kg/day. In a subchronic toxicity study in rats via gavage, acetone resulted in kidney weight changes and lesions at 500 mg/kg/day. The NOAEL in this study was 100 mg/kg/day. Male Sprague-Dawley rats were exposed to acetone via inhalation at a concentration of 19,000 ppm (45,106 mg/m3) for 3 hours/day, 5 days/week, for 8 weeks. Groups were sacrificed after 2, 4, and 8 weeks and 2 weeks post-exposure. No treatment related effects were observed in this study at exposure concentrations of 19,000 ppm (equal to 11,703 mg/kg/day). No dermal toxicity studies were available.

Acetone was evaluated in a reproduction screening test with mice via gavage at a dose of 3,500 mg/kg/day and controls receiving no test compound. Toxicity was manifested as decreased reproductive index, increased gestation length, reduced birth weights, decreased neonatal survival and increased neonatal weight gain at 3,500 mg/kg/day. In a 2-generation reproduction study conducted in rats with isopropanol, the maternal NOAEL was 500 mg/kg/day based on increased in liver and kidney weights (absolute and relative) seen at the LOAEL of 1,000 mg/kg/day. The offspring toxicity NOAEL was 500 mg/kg/day based on reduced pup body weights and a slight increase in pup mortality seen at the LOAEL of 1,000 mg/kg/day. No reproductive parameters were altered at doses up to 1,000 mg/kg/day. Two developmental toxicity studies in rodents exposed to acetone via the inhalation route of exposure were also available for review. In mice, maternal (increased incidence of late resorptions) and fetal (reduced weight) toxicities were observed at the same dose, 6,600 ppm (approximately 4,066 mg/kg/day). No teratogenic effects were observed in mice. The NOAEL was 2,200 ppm (equivalent to 1,348 mg/kg/day). In rats, maternal (reduction in body weight, uterine weight and extra-gestational weight gain) and fetal (malformations) toxicities were observed at the same dose, 11,000 ppm (approximately 6,773 mg/kg/day). The NOAEL was 2,200 ppm (equivalent to 1,348 mg/kg/day). In a developmental toxicity study in rats via gavage with isopropanol, the NOAELs for maternal and developmental toxicities were 400 mg/kg/day based onslightly increased mortality at 800 mg/kg/day and reduced gestational body weight and reduced gravid uterine weights at 1,200 mg/kg/day. Reduced fetal body weights were observed at 800 and 1,200 mg/kg/day. There was also a developmental toxicity study in rabbits treated with isopropanol via gavage. Maternal toxicity was manifested as reduced body weight and food consumption at 480 mg/kg/day. The NOAEL was 240 mg/kg/day. There were no treatment related effects observed in fetuses up to the highest dose tested (480 mg/kg/day). In a developmental neurotoxicity study in rats with isopropanol, no developmental neurotoxicity was observed at doses up to 1,200 mg/kg/day.

Subchronic neurotoxicity studies were available in rats administered acetone via the inhalation or dietary routes of exposure. Repeated daily exposures up to 14,240 mg/m3of acetone produced an inhibition of avoidance behavior but did not produce any signs of motor imbalance. Following acetone administered via inhalation, rats exhibited transient ataxia at >28,480 ppm (approximately 17,544 mg/kg/day). When acetone was administered in the diet for 14 weeks, neurotoxicity was not observed at concentrations up to 1.0% (approximately 5,000 mg/kg/day).

Information on the carcinogenicity of acetone is available from dermal studies performed with acetone used as a vehicle. An increased incidence of tumor formation was not observed up to 0.2 milliliter (ml) of acetone in mice. Carcinogenicity studies in rodents administered isopropanol via inhalation, did not exhibit an increased incidence of tumor formation up to 5,000 ppm (approximately 3,086 mg/kg/day).

Acetone is normally eliminated mainly by enzymatic metabolism (70-80% of the total body burden) or excreted via urine or exhaled following inhalation exposure (human volunteer study). The first step includes the oxidation to acetol by acetone monooxygenase, associated with cytochrome P450IIE1. This step is followed by two different pathways that both lead to the formation of pyruvate which—as a key product of intermediary metabolism—can enter various pathways, e.g. gluconeogenesis or the citric acid cycle. Acetone is excreted mainly via the lung both unchanged and, following metabolism, as carbon dioxide.

Specific information on the studies received and the nature of the adverse effects caused by acetone as well as the NOAEL and the LOAEL from the toxicity studies can be found athttp://www.regulations.govin the document “Acetone—Decision Document for Pesticide Petition 7E7239, Acetone, CAS No. 67-64-1; PC Code 844101”, in docket ID number EPA-HQ-OPP-2008-0039.

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

Acetone is currently permitted for use as an inert ingredient in pesticide formulations applied pre and post harvest under 40 CFR 180.910. Acetone occurs or is found in a variety of foods and consumer products. Acetone has been approved by FDA as a secondary direct food additive (21 CFR 173.210). The available toxicity studies indicate that acetone has very low toxicity. The NOAELs were 900 mg/kg/day and above except one 90-day toxicity study in rats via gavage in which the NOAEL of 100 mg/kg/day was based on kidney toxicity seen at the LOAEL of 500 mg/kg/day. Differences in the observed effect level between the drinking water/dietary study and the gavage study may relate to the metabolism of acetone. EPA's Integrated Risk Information System (IRIS) concluded that the drinking water route is considered to more closely mimic potential long-term human exposure scenarios. For this reason, EPA concluded that the results of gavage study in the case of acetone may not be appropriate for the long term risk assessments. As indicated in this Unit, the lowest NOAEL identified in the database is 900 mg/kg/bw/day. For all practical purposes, that is the Agency's identified limit dose. For materials that show no signs of toxicity at or above the limit dose, quantitative risk assessment is not necessary. Since no endpoint of concern was identified for the acute and chronic dietary exposure assessment and short and intermediate dermal and inhalation exposure, a quantitative risk assessment for acetone is not necessary.

No hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term dermal and inhalation residential assessments, therefore, acute and chronic dietary and short-, intermediate-,and long-term dermal and inhalation residential exposure assessments are not necessary.

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.”

EPA has not found acetone to share a common mechanism of toxicity with any other substances, and acetone does not appear to produce a toxic metabolite produced by other substances, however, isopropanol is readily metabolized to acetone in humans. For both isopropanol and its metabolite, acetone, no endpoint of concerns were identified for various dietary and non-dietary exposure scenarios. For the purposes of this tolerance action, therefore, EPA has assumed that acetone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

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 thecompleteness 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.

The toxicity database is sufficient for acetone and potential exposure is adequately characterized given the low toxicity of the chemical. In terms of hazard, there are no concerns and no residual uncertainties regarding prenatal and/or postnatal toxicity. The lowest NOAEL identified in the database for risk assessment is 900 mg/kg/day. No evidence of increased susceptibility was observed in the available reproduction studies, developmental studies and developmental neurotoxicity study (isopropanol). In these studies developmental toxicity was observed in the presence maternal toxicity and at or above the limit dose of 1,000 mg/kg/day. Therefore, a safety factor analysis has not been used to assess risk. Accordingly, there is no reason to apply an additional safety factor to protect infants and children.

Given the lack of concern for hazard posed by acetone, EPA concludes that there are no dietary or aggregate dietary/non-dietary risks of concern as a result of exposure to acetone in food and water or from residential exposure. As discussed in this unit, EPA expects aggregate exposure to acetone to pose no appreciable dietary risk given that the data show a lack of systemic toxicity at doses ≥900 mg/kg/day and a lack of any increased susceptibility of infants and children. Taking into consideration of all available information on acetone, 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 acetone residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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 Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for acetone.

The Agency received one comment from a private citizen who opposed the proposed exemption. The Agency understands the commenter's concerns and recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by section 408 of the FFDCA, EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by the statute.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.930 for acetone (67-64-1) when used as an inert ingredient (as solvent or co-solvent) in pesticide formulations applied to animals.

This final rule establishes an exemption from the requirements of a tolerance 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. 3501et 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA willsubmit 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please gohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

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-2010-0421 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 July 13, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0421, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof June 23, 2010 (75 FR 35803) (FRL-8831-3), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7709) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide, in or on multiple commodities. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket,http://www.regulations.gov. There were no comments received in response to the notice of filing. Based on EPA's review of the data supporting the petition, BASF Company revised their petition (PP 0F7709) by:

1. Proposing tolerances for corn, pop, grain; corn, sweet kernels plus cobs with husks removed; and wheat, grain;

2. Decreasing or increasing the proposed tolerances for various commodities;

3. Deleting the proposed tolerance for vegetable, root, subgroup 1A and proposing a tolerance for beet, sugar; and

4. Proposing a tolerance for oilseeds, group 20.

The reasons for these changes are explained in Unit IV.C.

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

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

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

Fluxapyroxad is of low acute toxicity by the oral, dermal and inhalation routes, is not irritating to the eyes and skin, and is not a dermal sensitizer. The primary target organ for fluxapyroxad exposure via the oral route is the liver with secondary toxicity in the thyroid for rats only. Liver toxicity was observed in rats, mice, and dogs, with rats as the most sensitive species for all durations of exposure. In rats, adaptive effects of hepatocellular hypertrophy and increased liver weights and changes in liver enzyme activities were first observed. As the dose or duration of exposure to fluxapyroxad increased, clinical chemistry changes related to liver function also occurred, followed by hepatocellular necrosis, neoplastic changes in the liver, and tumors. Thyroid effects were observed only in rats. These effects were secondary to changes in liver enzyme regulation, which increased metabolism of thyroid hormone, resulting changes in thyroid hormones, thyroid follicular hypertrophy and hyperplasia, and thyroid tumor formation. Tumors were not observed in species other than rats or in organs other than the liver and thyroid.

In accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), fluxapyroxad is classified as “Not likely to be Carcinogenic to Humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range:

• No treatment-related tumors were seen in male or female mice when tested at doses that were adequate to assess carcinogenicity (including the Limit Dose);

• Treatment-related liver tumors were seen in male rats at doses ≥250 parts per million (ppm) (11 milligrams/kilogram/day (mg/kg/day)) and in female rats at doses ≥1,500 ppm (82 mg/kg/day);

• Treatment-related thyroid follicular cell tumors were seen in male rats only at doses ≥1,500 ppm (68 mg/kg/day);

• There is no mutagenicity concern fromin vivoorin vitroassays;

• The hypothesized mode of action (i.e., a non-genotoxic) for each tumor type (i.e., the liver and thyroid) was supported by adequate studies that clearly identified the sequence of key events, dose-response concordance and temporal relationship to the tumor types. The mode of action met the criteria established by the Agency.

The Agency has determined that the chronic population adjusted dose (cPAD) will adequately account for all chronic effects, including carcinogenicity, that could result from exposure to fluxapyroxad.

No evidence of neurotoxicity was observed in response to repeated administration of fluxapyroxad. An acute neurotoxicity study showed decreased rearing and motor activity. This occurred on the day of dosing only and in the absence of histopathological effects or alterations in brain weights.This indicated that any neurotoxic effects of fluxapyroxad are likely to be transient and reversible due to alterations in neuropharmacology and not from neuronal damage. There were no neurotoxic effects observed in the subchronic dietary toxicity study. No evidence of reproductive toxicity was observed. Developmental effects observed in both rats and mice (thyroid follicular hypertrophy and hyperplasia in rats and decreased defecation, food consumption, body weight/body weight gain, and increased litter loss in rabbits) occurred at the same doses as those that caused adverse effects in maternal animals, indicating no quantitative susceptibility. Since the maternal toxicities of thyroid hormone perturbation in rats and systemic toxicity in rabbits likely contributed to the observed developmental effects there is low concern for qualitative susceptibility. An immunotoxicity study in mice showed no evidence of immunotoxic effects from fluxapyroxad.

Subchronic oral toxicity studies in rats, developmental toxicity studies in rabbits, andin vitroandin vivogenotoxicity studies were performed for fluxapyroxad metabolites F700F001, M700F002, and M700F048. Like fluxapyroxad, no genotoxic effects were observed for any of these metabolites. All three metabolites displayed lower subchronic toxicity via the oral route than fluxapyroxad, with evidence of non-specific toxicity (decreased body weight) observed only for M700F0048 at the limit dose. Only M700F0048 exhibited developmental toxicity at doses similar to those that caused developmental effects in rabbits with fluxapyroxad treatment. However, these effects (abortions and resorptions) were of a different nature than for fluxapyroxad (paw hyperflexion) and are considered secondary to maternal toxicity. The Agency considers these studies sufficient for hazard identification and characterization and concludes that these metabolites do not have hazards that exceed those of fluxapyroxad in nature, severity, or potency.

Specific information on the studies received and the nature of the adverse effects caused by fluxapyroxad 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 athttp://www.regulations.govin document “Fluxapyroxad: Human Health Risk Assessment for Use of New Active Ingredient on Cereal Grains, Legume Vegetables (Succulent and Dry), Oil Seed Crops (Canola and Sunflower), Peanuts, Pome Fruit, Stone Fruit, Root and Tuber Vegetables (Potatoes and Sugar Beets), Fruiting Vegetables, and Cotton,” at page 39 in docket ID number EPA-HQ-OPP-2010-0421-0005.

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluxapyroxad used for human risk assessment is shown in the following Table.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to fluxapyroxad, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from fluxapyroxad 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 fluxapyroxad. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, tolerance level residues adjusted to account for metabolites of concern, 100 percent crop treated (PCT) assumptions, and Dietary Exposure Evaluation Model (DEEM) default and empirical processing factors were used.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, a moderately refined chronic dietary exposure analysis was performed. An assumption of 100 PCT, and DEEM default and empirical processing factors were used for the chronic dietary analysis. Highest average field trial (HAFT) residues for parent plus metabolite were used for all plant commodities. For livestock commodities, tolerance level residues adjusted to account for metabolites of concern were used.

iii.Cancer.EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to fluxapyroxad. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.,chronic exposure.

iv.Anticipated residue and percent crop treated (PCT) information.EPA did not use anticipated residue or PCT information in the acute dietary assessment for fluxapyroxad. Tolerance level residues and 100 PCT information were assumed for all food commodities. For the chronic dietary assessment tolerance level residues and 100 PCT information were assumed for livestock commodities. HAFT residues for parent plus metabolite were used for all plant commodities.

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 fluxapyroxad in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluxapyroxad. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST), and the Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluxapyroxad for acute exposures are estimated to be 14.1 parts per billion (ppb) for surface water and 0.087 ppb for ground water. For chronic exposures the EDWCs are estimated to be 6.7 ppb for surface water and 0.087 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The EDWCs of 14.1 ppb for surface water and 0.087 ppb for ground water were used for the acute and the chronic dietary assessments, respectively.

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). Fluxapyroxad is not registered for any specific use patterns that would result in residential exposure.

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.”

EPA has not found fluxapyroxad to share a common mechanism of toxicity with any other substances, and fluxapyroxad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluxapyroxad does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://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.No evidence of quantitative susceptibility was observed in a reproductive and developmental toxicity study in rats or in developmental toxicity studies in rats and rabbits. Developmental toxicity data in rats showed decreased body weight and body weight gain in the offspring at the same dose levels that caused thyroid follicular hypertrophy/hyperplasia in parental animals. Effects in rabbits were limited to paw hyperflexion, a malformation that is not considered to result from a single exposure and that usually reverses as the animal matures. Developmental effects observed in both rats and rabbits occurred at the same doses as those that caused adverse effects in maternal animals, indicatingno quantitative susceptibility. The Agency has low concern for developmental toxicity because the observed effects were of low severity, were likely secondary to maternal toxicity, and demonstrated clear NOAELs. Further, the NOAELs for these effects were at dose levels higher than the points of departure selected for risk assessment for repeat-exposure scenarios. Therefore, based on the available data and the selection of risk assessment endpoints that are protective of developmental effects, there are no residual uncertainties with regard to prenatal and/or postnatal toxicity.

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. That decision is based on the following findings:

i. The toxicity database for fluxapyroxad is complete.

ii. There is no indication that fluxapyroxad is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Neither the acute or the subchronic neurotoxicity studies indicated specific neurotoxicity responses to fluxapyroxad. Because fluxapyroxad can disrupt thyroid hormone levels, the Agency considered the potential for fluxapyroxad to cause developmental neurotoxicity as a result of thyroid hormone disruption, which is more sensitive endpoint than the endpoints used in a developmental neurotoxicity study. Based on its evaluation of thyroid hormone data submitted for fluxapyroxad and the ontogeny of thyroid hormone metabolism, the Agency has determined that adverse thyroid hormone disruptions in the young are unlikely to occur at dose levels as low as the points of departure chosen for risk assessment. The Agency has low concern for neurotoxic effects of fluxapyroxad at any life stage.

iii. Based on the developmental and reproductive toxicity studies discussed in Unit III.D.2., there are no residual uncertainties with regard to prenatal and/or postnatal toxicity.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues or field trial residue data. The dietary risk assessment is based on reliable data, is conservative and will not underestimate dietary exposure to fluxapyroxad. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluxapyroxad in drinking water. These assessments will not underestimate the exposure and risks posed by fluxapyroxad.

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

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluxapyroxad will occupy 6% 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 fluxapyroxad from food and water will utilize 48% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for fluxapyroxad.

3.Short-term risk.Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluxapyroxad is not registered for any use patterns that would result in short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD.

4.Intermediate-term risk.Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluxapyroxad is not registered for any use patterns that would result in intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD.

5.Aggregate cancer risk for U.S. population.In accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), EPA classified fluxapyroxad as “Not likely to be Carcinogenic to Humans” based on convincing evidence that carcinogenic effects are not likely below a defined dose range. The Agency has determined that the quantification of risk using the cPAD for fluxapyroxad will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluxapyroxad. As noted above, chronic exposure to fluxapyroxad from food and water will utilize 48% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

6.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 fluxapyroxad residues.

A Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC/MS/MS) method is available as an enforcement method. This method uses reversed-phase High Pressure Liquid Chromatography (HPLC) with gradient elution, and includes 2 ion transitions to be monitored for the parent and the metabolites M700F008 and M700F048, so the method also serves as the confirmatory method.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: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 not established MRLs for fluxapyroxad.

Based on EPA's review, BASF Company revised their petition (PP 0F7709) by:

1. Proposing tolerances for corn, pop, grain; corn, sweet kernels plus cobs with husks removed; and wheat, grain. Tolerances for these commodities were originally proposed as part of the respective crop group tolerances, but the Agency determined that separate tolerances are needed because of differences between the needed tolerances and the proposed crop group tolerances.

2. Decreasing or increasing the proposed tolerances for various commodities.

3. Deleting the proposed tolerance for vegetable, root, subgroup 1A and proposing a tolerance for beet, sugar. The submitted data are not sufficient to support a tolerance for the proposed subgroup 1A, but it supports a tolerance for beet, sugar.

4. Deleting tolerances that the Agency determined are not needed and/or are covered by other proposed tolerances.

5. Proposing a tolerance for oilseeds, group 20. The registrant had proposed tolerances for all the representative commodities for crop group 20 and the submitted data supports establishment of the group tolerance.

The Agency concluded that based on the residue data these changes are required to support the proposed uses. The Agency analyzed the field trial data for the respective commodities using the Organization for Economic Cooperation and Development tolerance calculation procedures to determine the appropriate tolerances.

Therefore, tolerances are established for residues of fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide, as requested in the revised petition.

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. 3501et 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please gohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

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-2010-0425 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 July 13, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0425, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail:Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Delivery:OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, OnePotomac Yard (South Bldg.), 2777 S. Crystal Dr. Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof September 8, 2010 (75 FR 54631) (FRL-8843-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7711) by Bayer CropScience, 2 T.W. Alexander Drive P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the penflufen,N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-1H-pyrazole-4-carboxamide, in or on alfalfa, forage; alfalfa, hay; vegetable, tuberous and corm, subgroup 1C; vegetable, legume, group 6; vegetable, foliage of legume, group 7; grain, cereal, group 15, grain, cereal, forage, fodder and straw, group 16; oilseed, group 19; cotton, gin by-products at 0.01 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket,http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has made some minor modifications to some commodity definitions for consistency with EPA naming-conventions for those commodities. The reason for these changes is 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 section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 penflufen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with penflufen follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Penflufen is an alkylamide fungicide belonging to the chemical class of carboxamides. The reported pesticidal mode of action is as an inhibitor of mitochondrial respiration by inhibiting succinate dehydrogenase, an enzyme in the electron transport system.

The liver and thyroid are target organs for penflufen. Increased liver weight, alterations in clinical chemistry parameters relevant to effects on the liver, and an increase in the incidence of hepatocellular hypertrophy were consistent findings across species and duration of exposure (28-day, 90-day, and 1- to 2-year exposure periods). The hepatic total cytochrome P-450 content, and benzoxyresorufin (BROD) and pentoxyresorufin (PROD) enzyme activities, were shown to be increased in rats of both sexes following subchronic oral exposure. Additionally, increased incidence of thyroid follicular cell hypertrophy/hyperplasia was observed across studies and species (no data provided on thyroid hormone levels). The liver and thyroid findings were mostly reversible after a 3-month recovery period in the rat. In the rat and mouse, following 104 week/78 week exposure periods at dose levels up to and/or greater than the limit dose, there was no increase in the incidence of liver or thyroid tumors.

Reproductive toxicity was observed in the 2-generation reproduction study in rats. Delayed sexual maturation was observed in females in both generations, and magnitude of the associated decline in body weight was not considered to be a factor in the delay in sexual maturation. Developmental toxicity was not observed in the rat or rabbit, although the dose levels in both studies were not considered adequate to assess developmental toxicity potential of penflufen. However, there is little concern that new studies would identify a developmental endpoint with a no-observed-adverse-effect-level (NOAEL) lower than the NOAEL selected for risk assessment.

Decreased motor/locomotor activity was observed in both sexes of rats following acute and in female rats following subchronic oral exposure, although neuropathological lesions were not observed in either study.

There are no mutagenicity concerns. Carcinogenicity studies with penflufen found a statistically significant increase in histiocytic sarcomas in male rats; a marginal increase in brain astrocytomas, a fatal tumor, in male rats at the high dose; and ovarian adenomas in female rats at the high dose. Although these three tumors were considered treatment-related, they provided weak evidence of carcinogenicity due to the marginal nature of the tumor responses. There was no evidence of carcinogenicity in male or female mice. Given the weak evidence indicating any potential for carcinogenicity, EPA has determined that quantification of risk using a non-linear approach reference dose (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to penflufen. The NOAEL (38 milligram/kilogram/day (mg/kg/day)) used for establishing the Chronic RfD is approximately 10-fold lower than the dose (approximately 300 mg/kg/day) that induced a marginal tumor response. The EPA has determined that the chronic population adjusted dose is protective of all long-term effects, including potential carcinogenicity.

Specific information on the studies received and the nature of the adverse effects caused by penflufen as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document “Penflufen. Human Health Risk Assessment to Support New Uses on Potato (Crop Subgroup 1C), Legume Vegetables (Crop Group 6 and Crop Group 7), Cereal Grains (Crop Group 15 and Crop Group 16), Oilseeds (Crop Group 20), and Alfalfa” in docket ID number EPA-HQ-OPP-2010-0425.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) 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 the NOAEL and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a RfD and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for penflufen used for human risk assessment is shown in the Table of this unit.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to penflufen, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from penflufen 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 penflufen. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance-level residues, default dietary exposure evaluation model (DEEM) processing factors for dried potatoes and assumed 100 percent crop treated (PCT) for all commodities.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EP used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance-level residues, default DEEM processing factors for dried potatoes and assumed 100 PCT for all commodities.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance-level residues, default DEEM processing factors for dried potatoes and assumed 100 PCT for all commodities.

iii.Cancer.EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or non-linear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used based on an earlier non-cancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a non-linear RfD approach is appropriate for assessing cancer risk to penflufen. Cancer risk was assessed using the sameexposure estimates as discussed in Unit III.C.1.ii.

iv.Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for penflufen. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

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

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of penflufen for acute exposures are estimated to be 11.4 parts per billion (ppb) for surface water and 16.6 ppb for ground water. The EDWC of penflufen for chronic exposures for non-cancer assessments are estimated to be 1.8 ppb for surface water and 16.6 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 16.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 16.6 ppb was used to assess the contribution to drinking water.

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).

Penflufen is not registered for any specific use patterns that would result in residential exposure.

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.”

EPA has not found penflufen to share a common mechanism of toxicity with any other substances, and penflufen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that penflufen does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://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.In the rat multi-generation reproduction study there was slight decrease in litter size, delayed sexual maturation, decreased body weight/gain, decreased brain, spleen, and thymus weights were noted in the offspring. At the same dose level the adults exhibited decreased body weight/gain, alteration in food consumption, decreased thymus weight, and decrease spleen weights. In the rat developmental toxicity study, the maternal findings (decreased body weight gain) at the highest dose tested (HDT) are considered minimal. No adverse effects were observed on the foetuses. In the rabbit developmental toxicity study, the maternal findings (decreased body weight gain) at the HDT are considered minimal. No adverse effects were observed at the HDT.

3.Conclusion.The Agency recommends that the 10X FQPA safety factor for the protection of infants and children, be reduced to 1X. The risk assessments conducted for penflufen were based on the most sensitive endpoints in the toxicity database, and the NOAELs selected for risk assessment are considered protective of potential developmental, neurotoxic, and immunotoxic effects for infants and children. Highly conservative exposure estimates were incorporated into the risk assessment for penflufen. There are no residual uncertainties with regard to pre- and/or postnatal toxicity or neurotoxicity, and exposure; therefore, reduction of the 10X FQPA safety factor for penflufen to 1X is appropriate based on the following findings:

i. The toxicity database for penflufen is complete for consideration of estimated risks for all populations of concern.

ii. Although decreased motor activity was observed following acute oral exposure, no neuropathological lesions were observed and there is little concern for neurotoxicity. There is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. Although there is some evidence of qualitative sensitivity of the young (delayed sexual maturation and decreased litter size), the effects are well characterized, and there is a clear NOAEL. The dose level where offspring effects were identified in the reproduction study is comparable to the high dose used in the rat developmental toxicity study where no effects were identified in either the maternal or fetal rat. Since minimal/no effects were observed in the developmental toxicity studies following exposure of the maternal animals to dose levels equal to and greater than those tested in the studies used for risk assessment, there is little concern that new studies would identify a developmental endpoint with a NOAEL lower than the NOAELs selected for risk assessment.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to penflufen in drinking water. These assessments will not underestimate the exposure and risks posed by penflufen.

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

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. A highly conservative acute dietary exposure assessment demonstrated that penflufen does not pose an unacceptable aggregate risk.

2.Chronic risk.There are no residential uses for penflufen; therefore, the chronic aggregate risk assessment includes exposures from dietary consumption of food and water only. A highly conservative chronic aggregate dietary exposure assessment demonstrated that penflufen does not pose an unacceptable aggregate chronic risk.

3.Short-term risk.There are no residential uses of penflufen; therefore a short-term aggregate risk assessment was not conducted for this chemical.

4.Intermediate-term risk.There are no residential uses of penflufen; therefore an intermediate-term aggregate risk assessment was not conducted for this chemical.

5.Aggregate cancer risk for U.S. population.In a rat carcinogenicity study with penflufen a statistically significant increase in histiocytic sarcomas with a positive trend in male rats only (but in the absence of a dose response and lack of pre-neoplastic lesions) were seen. A marginal increase in brain astrocytomas was also observed in males at the high dose; however, this effect was not dose-related, did not reach statistical significance, and there was no overall trend. In addition, there were no pre-neoplastic lesions, such as glial proliferations, which are a good indicator of chemical tumor induction (i.e.,there will be changes in the cells prior to transformation to a neoplasm). The ovarian adenomas observed at the high dose also showed no dose response, no pair-wise significance, no decrease in latency, and there were no pre-neoplastic lesions such as hyperplasia of the epithelial cells of the endometrium. Additionally, there was no evidence of carcinogenicity in male or female mice (at doses that were judged to be adequate to assess the carcinogenic potential), no concern for mutagenicity (in vivoorin vitro)for the parent molecule or the two metabolites, and there were no other lines of evidence (such as structure-activity relationship). Although these three tumors were considered treatment-related, they provided weak evidence of carcinogenicity due to the marginal nature of the tumor responses and the other factors mentioned in this unit. Given the weak evidence indicating any potential for carcinogenicity, EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to penflufen. The NOAEL (38 mg/kg/day) used for establishing the chronic RfD is approximately 10-fold lower than the dose (approximately 300 mg/kg/day) that induced a marginal tumor response. The EPA has determined that the chronic population adjusted dose is protective of all long-term effects, including potential carcinogenicity.

6.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 penflufen residues.

Adequate enforcement methodology is available to enforce the tolerance expression. The method involves extraction of samples with acetonitrile/water, cleanup using solid phase extraction, and analysis of penflufen by liquid chromatography/mass spectrometry (LC/MS/MS) (EL-002-P09-03).

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 U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for penflufen.

Some minor modifications to commodity definitions initially submitted were made to be consistent with the updated EPA naming-conventions for commodities.

Therefore, tolerances are established for residues of penflufen, in or on alfalfa, forage; alfalfa, hay; vegetable, tuberous and corm, subgroup 1C; vegetable, legume, group 6; vegetable, foliage of legume, group 7; grain, cereal, group 15, grain, cereal, forage, fodder and straw, group 16; oilseed, group 19; cotton, gin by-products at 0.01 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA 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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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 section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 section 408(n)(4) of FFDCA. 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 Indiantribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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) (Pub. L. 104-4).

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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. Does this action apply to me?

A list of potentially affected entities is provided in theFederal Registerissue of March 16, 2012 (77 FR 15609) (FRL-9335-6). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.

In the March 16, 2012Federal Register, EPA issued a revocation of some or all of the TSCA section 4 testing requirements for 10 chemical substances by direct final rule. In accordance with the procedures described in the March 16, 2012Federal Registerdocument, EPA is withdrawing the revocation of certain testing requirements for C.I. Pigment Blue 61 and also restoring the original testing requirements found in the CFR, because the Agency received an adverse comment concerning this chemical substance. The final rule revoking testing requirements for the other 9 chemical substances described in the March 16, 2012Federal Registerdocument is otherwise unaffected by the withdrawal of the revocation for C.I. Pigment Blue 61. Elsewhere in today'sFederal Register, EPA is proposing a rule to revoke certain test rule requirements for C.I. Pigment Blue 61.

The docket identification (ID) number for the test rule concerning this chemical substance was established at EPA-HQ-OPPT-2005-0033. That docket includes information considered by the Agency in developing those rules and the adverse comment.

To access the docket, please go tohttp://www.regulations.govand follow the online instructions using the docket ID number EPA-HQ-OPPT-2005-0033. Additional information about the Docket Facility is also provided underADDRESSESin the March 16, 2012Federal Registerdocument. If you have questions, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.

Therefore, 40 CFR chapter I is amended as follows:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in theFederal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will besuspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act.This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act.The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification.This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism.This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform.This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act.This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501et seq.

Accordingly, 44 CFR part 64 is amended as follows:

FRA is issuing this final rule to amend the regulatory requirements contained in 49 CFR part 236, subpart I, related to a railroad's ability to remove track segments from the necessity of implementing PTC systems as mandated by Section 104 of the Railroad Safety Improvement Act of 2008, Public Law 110-432, 122 Stat. 4854 (Oct. 16, 2008) (codified at 49 U.S.C. 20157) (hereinafter “RSIA”) based on the track segments not carrying PIH traffic as of December 31, 2015.

For years, FRA has supported the implementation of positive train control (PTC) systems, forecasting substantial benefits of advanced train control technology in supporting a variety of business and safety purposes. However, FRA repetitively noted that an immediate regulatory mandate for PTC system implementation could not be justified based upon normal cost-benefit principals relying on direct safety benefits. In 2005, FRA promulgated regulations providing for the voluntary implementation of processor-based signal and train control systems.See70 FR 11,052 (Mar. 7, 2005) (codified at 49 CFR part 236, subpart H).

As a consequence of the number and severity of certain very public accidents, coupled with a series of other less publicized accidents, Congress passed RSIA mandating the implementation of PTC systems on lines meeting certain thresholds. RSIA requires PTC system implementation on all Class I railroad lines that carry PIH materials and 5 million gross tons or more of annual traffic, and on any railroad's main line tracks over which intercity or commuter rail passenger train service is regularly provided. In addition, RSIA provided FRA with the authority to require PTC system implementation on any other line.

In accordance with its statutory authority, FRA's subsequent final rule, issued January 15, 2010, and amended on September 27, 2010, potentially required PTC system implementation on certain track segments that carried PIH traffic and 5 million gross tons or more of annual traffic in 2008 but that will not, as of December 31, 2015, carry PIH traffic, and will not be used for intercity or commuter rail passenger transportation that otherwise requires PTC installation under the rule. Per the regulation, the determination would be based upon whether the subject track segment would pass what has been called the alternative route analysis and the residual risk analysis (the “two qualifying tests”), which are described below.

Upon issuance of the PTC final rule, the Association of American Railroads (AAR) filed suit in the U.S. Court of Appeals for the District of Columbia Circuit challenging the two qualifying tests provisions of the final rule. After the parties filed their briefs, they executed a settlement agreement (Settlement Agreement). In the Settlement Agreement, FRA agreed to issue a notice of proposed rulemaking (NPRM) proposing to amend the PTC rule to eliminate the two qualifying tests and to also issue a separate NPRM that will address the issues of how to handle en route failures of PTC-equipped trains, circumstances under which a signal system may be removed after PTC system installation, and whether yard movements and certain other train movements should qualify for ade minimisexception to the PTC rule. The Settlement Agreement further provided that FRA would consider public comments on the NPRMs in determining whether to amend the PTC rule. The Settlement Agreement also provides that upon conclusion of the current rulemaking, the parties will determine whether to file a joint motion to dismiss with prejudice or advise the Court that they are unable to resolve all issues involved in the court suit.

Consistent with the Settlement Agreement, FRA issued an NPRM in this proceeding on August 24, 2011, proposing to eliminate the two qualifying tests. Having considered the public comments on the NPRM, FRA is promulgating this final rule eliminating the two qualifying tests. FRA is in the process of developing the second NPRM which will address other possible amendments to the PTC rule.

For the first 20-years of this final rule, the estimated quantified benefits to the rail industry due to the regulatory relief total approximately $620 million discounted at 7 percent and $818 million discounted at 3 percent. Substantial cost savings will accrue largely from not installing PTC system wayside components along approximately 10,000 miles of track. Although these rail lines would forego some risk reduction, the reductions will likely be relatively small since these lines pose a much lower risk of accidents because they generally do not carry passenger trains or PIH materials, and generally have lower accident exposure. The analysis shows that if the assumptions are correct, the savings of the proposed action far outweigh the cost. The following table presents the expected quantified benefits:

For the same 20-year period, the estimated quantified cost totals $26.7 million discounted at 7 percent and $39.3 million discounted at 3 percent. The costs associated with the regulatory relief result from accidents that will not be prevented due to the affected track segments not being equipped with a PTC system. A substantial part of the accident reduction that FRA expects from PTC systems required under prior rules comes from reducing high-consequence accidents involving passenger trains or the release of PIH materials. FRA believes that the lines impacted by this final rule pose significantly less risk because they generally do not carry passenger trains or PIH materials and generally have lower accident exposure. The following tables present the expected total costs of the final rule as well as the breakdown of the costs by element:

FRA has also performed a sensitivity analysis for a high case (14,000 miles), expected case (10,000 miles), and low case (7,000 miles).

The net amounts for each case, subtracting the costs from the benefits, provide the following results:

NMFS and the Council manage the snapper-grouper fishery of the South Atlantic under the FMP. The Council prepared the FMP and NMFS implements the FMP through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The Magnuson-Stevens Act provides the legal authority for the promulgation of emergency regulations under section 305(c) (16 U.S.C. 1855(c)).

The final rule for Amendment 17B to the FMP (75 FR 82280, December 30, 2010), effective on January 31, 2011, implemented ACLs and accountability measures (AMs) to end overfishing of black sea bass and prevent future overfishing from occurring, as required by National Standard 1 of the Magnuson-Stevens Act. The ACLS and AMs implemented through Amendment 17B for black sea bass resulted in in-season closures for the commercial and recreational sectors as well as a reduction in the recreational ACL for the 2011-2012 fishing year.

A new stock assessment for black sea bass was completed in October 2011, and indicates the stock is no longer overfished, but is not yet fully rebuilt. According to 2009 and 2010 data, black sea bass were undergoing overfishing “to a minor degree.” Although the black sea bass stock is increasing in magnitude, too many black sea bass were being removed from the population too quickly in 2009 and 2010. As overfishing ends for black sea bass, and its biomass increases, the commercial ACL is likely to be met earlier each fishing season as a result of the increased amount of the stock available for harvest. This result could increase the likelihood of derby-style harvesting, which is undesirable from economic, vessel safety, and social perspectives. Derby-style harvesting, also termed “the race for fish,” consists of a short duration of increased effort where harvest is maximized prior to reaching an ACL. Additionally, in 2009 and 2010, vessels increased their fishing effort into the black sea bass segment of the commercial snapper-grouper sector as other snapper-grouper species became subject to more stringent restrictions. This increase in effort resulted in the commercial ACL being reached relatively early in the fishing season. During the June 2009 to May 2010 fishing year, the commercial quota was met in December 2009. During the June 2010 to May 2011 fishing year, the commercial quota was met in October 2010, and during the June 2011 to May 2012 fishing year, the commercial quota was met in July 2011.

Currently, the black sea bass rebuilding plan specifies a constant catch rebuilding strategy as the stock rebuilds, which also contributes to increased rates of harvest and early in-season closures as more fish become available through rebuilding efforts. In an effort to extend fishing opportunities for black sea bass further into the fishing year, and to improve fisheries data reporting in the for-hire sector of the snapper-grouper fishery, the Council voted to approve Amendment 18A at its December 2011 meeting.

The Council submitted Amendment 18A for Secretarial Review on January 5, 2012. Amendment 18A was partially approved on May 2, 2012. The Secretary of Commerce (Secretary) disapproved one management measure in Amendment 18A regarding the transferability of black sea bass pot endorsements. The Council and NMFS will address this action in a separate amendment.

Amendment 18A contains a new ABC for black sea bass, which takes into account the degree to which the 2011 stock assessment report indicates overfishing was occurring in 2009 and 2010, as well as the magnitude of landings during the 2011-2012 fishing year. The Council's Scientific and Statistical Committee (SSC) was provided with data from the NMFS Southeast Fisheries Science Center (SEFSC), in November 2011, from the 2011-2012 fishing year (June-August data), which indicated the commercial ACL of 309,000 lb (140,160 kg), gutted weight, had been exceeded by at least 5 percent, and the recreational ACL of 409,000 lb (185,519 kg), gutted weight, had been exceeded by at least 10 percent. Since recreational data received by the SSC at that time was still incomplete (the recreational quota was reached in October, and September and October data were not yet available), the SSC supported a new ABC for black sea bass which assumes the commercial and recreational combined ACL was exceeded by 50 percent in the 2011-2012 fishing year. Furthermore, the SSC stated the ABC should be specified for only the 2012-2013 and 2013-2014 fishing seasons, and indicated an assessment update should be conducted before any adjustments are made to the ACL after the 2013-2014 fishing season.

Currently, commercial black sea bass fishermen harvest black sea bass with great efficiency as biomass has increased under rebuilding efforts, and effort in the black sea bass pot segment of the snapper-grouper fishery has grown. These factors lead to the fishery reaching the commercial ACL very quickly once the season opens. When fish are landed quickly, there is a greater chance the fishery will exceed its ACL, and overfishing can occur. Because black sea bass are undergoing overfishing and are currently subject to a rebuilding plan, maintaining landings below the ACL is imperative to allow biomass to increase to target levels within the rebuilding timeframe. Under the rebuilding plan, the black sea bass stock must be rebuilt by 2016.

Amendment 18A contains several management measures intended to slow the rate of harvest of black sea bass and help ensure black sea bass landings remain below the ACL to allow the biomass to increase. The management measures also address the derby-style fishery (the race to fish) that has developed in the commercial sector. Commercial management measures contained in Amendment 18A include: A black sea bass pot endorsement program; a limit on the number of black sea bass pot tags issued to each endorsement holder each permit year; a requirement to return black sea bass pots to shore at the end of each fishing trip; a 1,000-lb (454-kg), gutted weight, commercial trip limit for black sea bass; and an increase in the minimum commercial size limit for black sea bass.

At its March 2012 meeting, the Council requested that, if Amendment 18A is approved, NMFS promulgate emergency regulations to delay the start date of the commercial black sea bass fishing season until after Amendment 18A is implemented, but no later than July 1, 2012. The Secretary partially approved Amendment 18A on May 2, 2012, and implementation of Amendment 18A will occur after June 1, 2012.

Delaying the start of the commercial sector until the actions in Amendment 18A become effective would reduce the rate of harvest and help to ensure the commercial black sea bass sector closes in a timely manner. Delaying the start of the 2012-2013 fishing season to allow Amendment 18A to become effective will also reduce the risk of potential safety-at-sea issues presented when fishermen under pressure to harvest a profitable portion of the quota fish in foul weather or other unsafe conditions. Therefore, delaying the start of the fishing season to allow for the implementation of the measures in Amendment 18A will ease derby fishing conditions and relieve some of the pressure on fishermen to make unsafe trips, preserve a significant economic opportunity that otherwise might be foregone, and prevent further overfishing of black sea bass from occurring that would result from the delay in implementation of Amendment 18A.

NMFS' Policy Guidelines for the Use of Emergency Rules (62 FR 44421, August 21, 1997) list three criteria for determining whether an emergency exists. This emergency rule is promulgated under these criteria. Specifically, to promulgate anemergency rule, NMFS' policy guidelines require that an emergency:

(1) Result from recent, unforeseen events or recently discovered circumstances; and

(2) Present serious conservation or management problems in the fishery; and

(3) Can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process.

The unforeseen circumstance is that NMFS did not foresee the 2011 stock assessment report would indicate overfishing was occurring in 2009 and 2010, and that the magnitude of landings during the 2011-2012 fishing year would be so high. To compound these circumstances, the Council submitted Amendment 18A for Secretarial Review on January 5, 2012, which provides little time for the Amendment 18A rulemaking to be implemented prior to the June 1 start of the commercial fishing season. The notice of availability for Amendment 18A published on January 31, 2012 (77 FR 4754), with a 60-day comment period ending April 2, 2012. The proposed rule for Amendment 18A did not publish until March 23, 2012 (77 FR 16991), with a 30-day comment period ending April 23, 2012, due to confusion over one action in the amendment (transferability of black sea bass endorsements). This action was ultimately not included in the proposed rule and was disapproved by the Secretary. The Council is developing a separate amendment to address this disapproved action.

If the start of the commercial fishing season is not delayed to allow time for the implementation of provisions in Amendment 18A, the snapper-grouper fishery will be faced with serious conservation and management problems. Under current management practices, the commercial black sea bass sector experiences derby-style harvesting, also termed “the race for fish.” Derby fishing has led to the ACL being reached and exceeded in a short amount of time, contributing to the overfishing of black sea bass. Derby fishing also produces safety-at-sea issues due to the short periods of increased effort where vessels compete to maximize harvest prior to the ACL being reached. Amendment 18A will implement an endorsement program for black sea bass pot fishermen, which will reduce the race to fish, because fewer permit holders will be fishing for the same quota and the number of pots used to harvest black sea bass will be restricted. Also, the 1,000-lb (454-kg), gutted weight, commercial trip limit will restrict the amount of fish harvested per trip. Therefore, the management measures contained in Amendment 18A, intended to end derby-style fishing, will reduce the risk of black sea bass overfishing and eliminate the associated safety-at-sea issues, consistent with National Standards 1 and 10 of the Magnuson-Stevens Act (16 U.S.C. 1851(a)(1) and (10)).

During the past three fishing seasons, derby fishing resulted in commercial sector closures on December 20, 2009; October 7, 2010; and July 15, 2011. These short derby commercial fishing seasons caused negative social and economic impacts as too many black sea bass entered the market at one time. Market glut can drive the price of the fish down and compromise the quality of the fish. If the commercial sector opens on June 1, 2012, without the provisions in Amendment 18A, NMFS expects that the 2012-2013 fishing season will be shorter than the 45-day 2011-2012 fishing season. Delaying the start of the commercial fishing season to allow for the implementation of the Amendment 18A endorsement program will allow the commercial fishing season to remain open longer, because there will be fewer fishermen harvesting black sea bass with pots, the number of pots that can be fished will be reduced, and the catch per trip will be restricted to 1,000 lb (454 kg), gutted weight. A longer fishing season will also allow for better monitoring of landings data and a better estimate of the date for an inseason commercial closure.

Additionally, delaying the start of the commercial fishing season is necessary to ensure the black sea bass rebuilding plan remains on track. A short commercial fishing season caused by derby conditions can increase the risk of exceeding the ACL and overfishing could occur. National Standard 1 of the Magnuson-Stevens Act states that “Conservation and Management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield (OY) from each fishery for the United States fishing industry” (16 U.S.C. 1851(a)(1)). Black sea bass landings must stay below the ACL to allow biomass to increase to target levels within the rebuilding timeframe.

Finally, the immediate benefit of implementing this emergency action outweighs the value of advance notice and public comment. The final rule for Amendment 18A, currently under review, would implement management measures for black sea bass that would reduce the rate of harvest and help to ensure the commercial black sea bass sector closes in a timely manner. Not implementing this temporary rule would likely lead to negative biological and economic impacts for the snapper-grouper fishery due to the delay in implementing the management measures contained in Amendment 18A. As stated above, if the commercial sector were to open before the effort-limiting provisions contained in Amendment 18A are implemented, the commercial ACL would likely be reached very quickly and the commercial sector could close even earlier than last year. Too many black sea bass flooding the market simultaneously creates market gluts which can affect overall profitability for snapper-grouper fishermen and create unstable market conditions for dealers. Management measures contained in Amendment 18A should help lengthen the commercial fishing season for black sea bass, stabilize the market, and preserve a significant economic opportunity for snapper-grouper fishermen.

Industry representatives have expressed support for this temporary rule for emergency action. Many black sea bass commercial fishermen also fish for vermilion snapper, which opens on July 1, 2012. Opening black sea bass and vermilion snapper on the same day would allow fishery participants to maximize fishery opportunities for both species concurrently.

This temporary rule delays the start date of the 2012-2013 commercial fishing season for black sea bass from June 1, 2012 to July 1, 2012. Opening the commercial fishing season July 1 instead of June 1 could allow the commercial fishing season to stay open until sometime between August and October, instead of sometime between July and September. The recreational fishing season is not changed and will start on June 1, 2012.

This action is issued pursuant to section 305(c) of the Magnuson-Stevens Act, 16 U.S.C. 1855(c). The Assistant Administrator for Fisheries, NOAA (AA), has determined that this temporary rule is necessary to reduce the rate of South Atlantic black sea bass harvest and help ensure black sea bass landings remain below the ACL and is consistent with the Magnuson-Stevens Act and other applicable laws.

This temporary rule has been determined to be not significant for purposes of Executive Order 12866.

The AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because they are impracticable and contrary to the public interest. This temporary rule delays the start date of the 2012-2013 commercial fishing season for black sea bass from June 1, 2012 to July 1, 2012, to allow NMFS to finalize and implement the final rule for Amendment 18A. Amendment 18A contains several management measures intended to slow the black sea bass harvest rate and help ensure black sea bass landings remain below the ACL to allow the biomass to increase. The management measures also address the derby-style fishery (i.e., the race to fish) that has developed in the commercial sector.

If the start date to the snapper-grouper fishery is not delayed, then the fishery will likely experience negative biological and economic impacts. As stated above, if the commercial sector opens before the effort-limiting provisions contained in Amendment 18A are implemented, the commercial ACL will likely be reached very quickly, and the commercial sector could close even earlier than last year. Too many black sea bass flooding the market simultaneously gluts markets, which can affect the overall profitability for snapper-grouper fishermen and create unstable market conditions for dealers. NMFS expects management measures contained in Amendment 18A will help lengthen the commercial fishing season for black sea bass, which should help to stabilize the market and preserve a significant economic opportunity for snapper-grouper fishermen. Moreover, if the start date is not delayed, the derby fishing conditions would continue to exist until NMFS is able to implement the provisions of Amendment 18A. As mentioned above, this style of fishing may lead to safety-at-sea issues due to the short periods of increased effort where vessels compete to maximize harvest prior to the ACL being reached.

Therefore, NMFS needs to implement this temporary rule as soon as possible to provide notice to commercial black sea bass pot fishermen that the commercial fishing season will be delayed until July 1, 2012, and to allow them time to revise their business strategies.

For similar reasons, the AA also finds good cause to waive the 30-day delay in effectiveness of the action under 5 U.S.C. 553(d)(3). Delaying this rules effectiveness will allow the black sea bass commercial sector to open on July 1, 2012, rather than on June 1, 2012. The earlier start to the black sea bass commercial season could result in a race to fish, which in turn could result in safety-at-sea issues, as well as glut the market for black sea bass by flooding it with product and depressing prices. Finally, delaying this rule's effectiveness may increase the risk that black sea bass will continue to be harvested at a fast pace and could result in black sea bass exceeding its ACL. Accordingly, delaying the rule's effectiveness is contrary to the public interest, and the 30-day delay in effectiveness is hereby waived.

Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq.are inapplicable.

For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

The reef fish fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP). The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act. The Magnuson-Stevens Act provides the legal authority for the promulgation of interim regulations under section 305(c) (16 U.S.C. 1855(c)).

The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the optimum yield (OY) from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, and protecting marine ecosystems. To further this goal, the Magnuson-Stevens Act requires fishery managers to end overfishing of stocks and to minimize bycatch and bycatch mortality to the extent practicable.

The last Southeast Data, Assessment, and Review (SEDAR) benchmark stock assessment for gray triggerfish was completed in 2006 (SEDAR 9). SEDAR 9 indicated that the gray triggerfish stock was both overfished and possibly undergoing overfishing. Subsequently, Amendment 30A to the FMP established a gray triggerfish rebuilding plan beginning in the 2008 fishing year (73 FR 38139, July 3, 2008). In 2011, a SEDAR update stock assessment for gray triggerfish determined that the gray triggerfish stock was still overfished and was additionally undergoing overfishing. The 2011 update assessment indicated the 2008 gray triggerfish rebuilding plan had not made adequate progress toward ending overfishing and rebuilding the stock as described in the rebuilding plan in Amendment 30A to the FMP. NMFS informed the Council of this determination in a letter dated March 13, 2012. NMFS also requested that the Council work to end overfishing of gray triggerfish immediately and to revise the gray triggerfish stock rebuilding plan.

The Council has begun developing more permanent measures to end overfishing and rebuild the gray triggerfish stock in Amendment 37 to the FMP. However, these measures will not likely be implemented until the end of the 2012 fishing year or at the beginning of the 2013 fishing year. Therefore, on April 19, 2012, the Council requested that NMFS implement a temporary rule to reduce overfishing of gray triggerfish on an interim basis.

The Council's Scientific and Statistical Committee (SSC) reviewed the gray triggerfish 2011 SEDAR update assessment. The SSC recommended that the gray triggerfish 2012 and 2013 fishing years acceptable biological catches (ABC) be set at 305,300 lb (138,346 kg), whole weight. Based on this recommendation, the commercial and recreational ACLs and ACTs for the gray triggerfish need to be updated.

According to the National Standard 1 guidelines (74 FR 3178, January 16, 2009), ACLs are defined as the highest level of landings for either a stock or fishing sector that is acceptable to maintain an adequate stock size and to prevent overfishing. ACTs are targets that provide a buffer, less than the ACL, to account for management uncertainty. ACLs and ACTs may both be implemented as triggers for AMs. AMs are management measures implemented to ensure ACLS are not exceeded or mitigate if ACLs are exceeded. AMs may be implemented to reduce overfishing or prevent overfishing from occurring.

In Amendment 30A to the FMP, the Council established a 21 percent commercial and 79 percent recreational allocation of the gray triggerfish ABC. These allocations are used to set the commercial and recreational sector-specific ACLs. The ABC recommended by the SSC is 305,300 lb (138,482 kg), whole weight. Based on the allocations established in Amendment 30A to the FMP, this rule sets, on a temporary basis, a reduced commercial ACL of 64,100 lb (29,075 kg), whole weight, and a reduced recreational ACL of 241,200 lb (109,406 kg), whole weight.

NMFS applied the ACL/ACT control rule to the sector ACLs to set the sector-specific ACTs. This control rule was developed and utilized in the final rule implementing the Generic Annual Catch Limit Amendment (76 FR 82044, December 29, 2011) so that the Council and NMFS could take into account management uncertainty when assigning ACLs and ACTs. The control rule specified a buffer between the commercial ACL and commercial ACT of 5 percent, and between the recreational ACL and recreational ACT of 10 percent. Therefore, this rule sets, on a temporary basis, the commercial ACT (commercial quota) at 60,900 lb (27,624 kg), whole weight, and the recreational ACT at 217,100 lb (98,475 kg), whole weight. Currently, there is a commercial gray triggerfish quota in place, which functions as the commercial ACT.

To reduce the risk of overfishing, Amendment 30A to the FMP established gray triggerfish AMs. For the commercial sector, there are currently both in-season and post-season AMs. The in-season AM closes the commercial sector after the commercial quota (commercial ACT) is reached or projected to be reached. Additionally, if the commercial ACL is exceeded despite the quota closure, the post-season AM would reduce the following year'scommercial quota (commercial ACT) by the amount of the prior-year's commercial ACL overage.

For the recreational sector, there is currently no in-season AM, but a post-season AM is in effect. For the recreational sector, if the recreational ACL is exceeded, NMFS will reduce the length of the following year's fishing season by the amount necessary to ensure that recreational landings do not exceed the recreational ACT during the following year.

In 2008, recreational landings exceeded both the recreational ACT and ACL. In 2009, the recreational ACT was exceeded. However, in 2010, recreational landings did not exceed the ACT or ACL. Reduced 2010 recreational landings may be attributable to fishery closures that were implemented that year as a result of the Deepwater Horizon MC252 oil spill. Based on recent trends in recreational landings and anticipated future recreational effort, the Council and NMFS have determined that there is a reasonable probability that the recreational sector will exceed its ACL in future years. The implementation of an in-season AM would reduce this risk. This temporary rule establishes an in-season AM for the recreational sector to prohibit the recreational harvest of gray triggerfish (a recreational sector closure) after the recreational ACT is reached or projected to be reached. This in-season AM would provide an additional level of protection to ensure that the recreational ACL is not exceeded and that the risk of overfishing will be reduced.

NMFS has determined that this temporary final rule is necessary to reduce overfishing of gray triggerfish in the Gulf. This rule will be effective for not more than 180 days after publication, as authorized by section 305(c) of the Magnuson-Stevens Act. This temporary final rule could be extended for an additional 186 days, provided that the public has had an opportunity to comment on the rule. NMFS and the Council will continue to develop more permanent measures to reduce overfishing of gray triggerfish through Amendment 37 to the FMP.

This action is issued pursuant to section 305(c) of the Magnuson-Stevens Act, 16 U.S.C. 1855(c). The Assistant Administrator for Fisheries, NOAA (AA), has determined that this final temporary rule is necessary to reduce overfishing and to achieve OY for the gray triggerfish component of the reef fish fishery in the Gulf EEZ and is consistent with the Magnuson-Stevens Act and other applicable laws.

This final temporary rule has been determined to be not significant for purposes of Executive Order 12866.

The AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. Providing prior notice and the opportunity for public comment would be contrary to the public interest because delaying the implementation of this rule is likely to allow overfishing of gray triggerfish to continue. Gray triggerfish are currently undergoing overfishing and are overfished, so any delay would undermine the intent of the rule. If this rule is not implemented immediately, NMFS will likely be required to implement more severe reductions in gray triggerfish catch limits, which could have higher socioeconomic impacts on Gulf reef fish fishermen. NMFS was not able to implement this rulemaking any sooner because the scientific review of the most recent gray triggerfish stock assessment, upon which this rule is based on, was only recently completed. Any delay in the implementation of these revised catch limits would allow harvest to continue at a level that is not consistent with National Standard 1 of the Magnuson-Stevens Act. Comments submitted on this final temporary rule through the Federal e-Rulemaking Portal:http://www.regulations.govand received by NMFS no later than June 13, 2012, will be considered during any possible subsequent rulemaking relative to this final temporary rule, such as an extension of this rule.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq.are inapplicable.

For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

The management unit of the Atlantic sea scallop fishery ranges from the shorelines of Maine through North Carolina to the outer boundary of the Exclusive Economic Zone. The Atlantic Sea Scallop Fishery Management Plan (Scallop FMP) was first established in 1982 and now includes a number of amendments and framework adjustments that have revised and refined the fishery's management. One of the foundations of the Scallop FMP's success is the rotational area management program. Area-based management was developed in 1998 in the scallop fishery and expanded through 2004. The rotational area management program was formally established in 2004 in the Scallop FMP. Under rotational management, areas that contain large concentrations of small scallops are closed before the scallops are harvested or disturbed, then the areas re-open when scallops are larger, producing more yield-per-recruit. These areas are known as scallop “access areas.”

There are currently five scallop access areas: Closed Area I (CAI), Closed Area II, Nantucket Lightship, Delmarva, and Hudson Canyon. When an area is re-opened, scallop vessels are allocated a certain number of trips into the area, based on their permit type. The limited access fleet, the larger “trip boat” fleet, consists of full-time (FT), part-time, and occasional vessels. Each vessel is allocated a certain number of trips, with FT vessels receiving area-specific trips and the other two types of limited access vessels receiving a fewer number of trips that are not specific to a certain access area. The smaller “day boat” fleet, known as the limited access general category individual fishing quota (IFQ) fleet, receive a fleet-wide allocation into most access areas. Once the fleet-wide trip allocation in a given access area is harvested, the area closes to IFQ vessels and the vessels can continue to fish their IFQ in other access areas or locations within the scallop management unit.

In order to manage the access areas' schedules, and to identify new potential access areas, the Council develops biennial framework adjustments, which also set the overall scallop allocations and expected fishing effort for upcoming fishing years (FYs). The specifications contained in these framework adjustments use the most recent scallop survey information available at the time of development to project scallop biomass levels in various access areas for future years (e.g., estimates from 2010 surveys are used to determine the specifications for FYs 2011 and 2012). As a result, projections of scallop biomass for the second year of a framework are often outdated for some areas: Updated surveys may show more or less harvestable scallop biomass in a given area than originally anticipated.

The scallop FY begins on March 1 of each year and the FY 2012 scallop specifications are the second-year specifications developed by the Council through Framework Adjustment 22 to the Scallop FMP (Framework 22) (76 FR 43774, July 21, 2011). Framework 22 set the access area schedules for FYs 2011 and 2012 based on 2010 survey results.In an attempt to account for unexpected changes in biomass levels, as well as optimize yield, Framework 22 included a new way to allocate access area trip for FT vessels: Although all FT vessels received a total of 4 access area trips in FY 2011 and in FY 2012, not all trips were allocated to the same access areas. Instead, Framework 22 included “split trip” allocations for FT vessels, where half the fleet is allocated a trip in one access area and half the fleet is allocated a trip in another access area. This split trip allocation scheme was successful in FY 2011. However, as explained in greater detail below, results from recent 2011 surveys show that the “split trip” access area allocations based on these older surveys should be adjusted for FY 2012 for the Delmarva and CAI access areas.

At the Council's Scallop Plan Development Team (PDT) meeting on January 5, 2012, staff from the Northeast Fisheries Science Center, the Virginia Institute of Marine Science (VIMS), and the University of Massachusetts School for Marine and Atmospheric Science presented results from their 2011 Delmarva scallop resource surveys. All three surveys, which represent the best available scientific information regarding the status of the scallop resource, indicated that the scallop biomass in Delmarva is substantially lower than expected for FY 2012.

The Delmarva estimates ranged from 5.1 M lb (2,313 mt) to 13.0 M lb (5,897 mt), depending on the type of survey used (i.e., dredge or video) and when the survey was conducted. For example, the VIMS dredge survey that estimated biomass of 5.1 M lb (2,313 mt) was the last survey of the area; it was conducted in October 2011, when nearly all vessels had fully fished their Delmarva trips, and also when scallop meat weights are at their lowest. For comparison, based on the 2010 survey estimates, Framework 22 allocated the FT vessel fleet 5.6 M lb (2,540 mt) and 2.8 M lb (1,270 mt) of scallops from this area in FYs 2011 and 2012, respectively. In 2011, all 313 FT vessels with permits in the Atlantic sea scallop fishery were each allocated one trip (18,000 lb/trip; 8,165 kg/trip) into Delmarva; in FY 2012, only 156 FT vessels were allocated one trip each into Delmarva. The recent survey information is supported by what was observed during FY 2011 fishing activity in Delmarva, where catch rates were much lower in the area than anticipated, and much lower than catch rates in other areas. Catch rates in Delmarva declined from about 2,000 lb (907 kg) per day in the start of FY 2011 to less than 1,000 lb (454 kg) per day later in the FY. The new survey results indicate that the scallop biomass in Delmarva is not high enough to support the FY 2012 allocations set through Framework 22.

In addition to identifying lower-than-expected scallop biomass in Delmarva, the 2011 results also indicated that this access area is one of the few areas in the Mid-Atlantic where there is relatively strong recruitment, meaning an abundance of small scallops (1.57 to 2.95 in (40 to 75 mm)) that have reached maturity (i.e., are able to reproduce). These small scallops will benefit from additional protection through closure of the area—a closure will allow them to grow larger (to the 3.5-in (89-mm) minimum size for harvest) and produce more scallops before they are harvested. Recruitment helps define the health of the resource in terms of reproduction and growth, and helps predict future abundance levels of harvestable scallops. Recruitment levels also help shape the area rotation program for future years.

The 2011 surveys estimated scallop biomass in CAI between 28-40 M lb (12,700-18,144 mt), depending on the survey results used and what time of year the surveys took place. These levels are higher than Framework 22's 2011 projections based on the 2010 survey results, which estimated CAI biomass to be closer to 26 M lb (11,793 mt) in 2011, and indicate that more fishing effort could be allocated to CAI in FY 2012. In FY 2011, the scallop fishery harvested about 8.8 M lb (3,992 mt) of scallops from this area and Framework 22 allocated 157 FT vessels one trip each (18,000 lb/trip; 8,165 kg/trip) into CAI for FY 2012.

Based on the most recent information on the status of the scallop resource described above, NMFS takes this emergency action to close Delmarva for the remainder of FY 2012, and reallocates any unused FT trips from Delmarva to CAI in FY 2012. By closing Delmarva, this action will prevent localized overfishing of the scallop resource, protect scallop recruitment, and improve future scallop yield in the Mid Atlantic. By reallocating FT vessel trips into a more productive scallop access area, this action ensures equity across the scallop fleet for FY 2012 and supports overall scallop harvest levels that are consistent with Framework 22.

Continued fishing in Delmarva during FY 2012 would result in longer fishing trips that damage scallop resources and increase the risk of overharvesting the available resource.

Based on FY 2011 catch rates, if Delmarva did not close in FY 2012, catch rates could continue to be around 1,000 lb (454 kg) per day, compared to about 2,200 lb (998 kg) per day or higher in CAI, which would result in longer fishing trips that damage scallop resources and increase the risk of overharvesting the available resource. Although some vessels received Delmarva allocations at the start of FY 2012, which began March 1, 2012, very few limited access vessels have fished their FY 2012 trips in the area to date due to the poor conditions. However, if Delmarva remained open for the remainder of FY 2012, FT vessels with Delmarva “split trip” allocations would eventually take their trips or risk losing a full access area trip. As previously mentioned, unlike other scallop vessels that have non-specific allocations that can be fished in Delmarva or elsewhere, FT limited access vessels must fish their trips in specific areas, or trade their trips with other FT vessels to fish in other areas. If this area remained open with these low catch rates, the 156 FT vessels with Delmarva allocations would not likely be able to trade their Delmarva trips for other more productive areas. Without any other alternatives, these vessel operators would have continued to fish in Delmarva until they reached the 18,000-lb (8,165 kg) limit, which would have required much longer trips to catch their full possession limit. This would have increased the amount of time and area that the scallop fishing gear is in contact with the sea floor (i.e., increased area swept), which in turn would have resulted in negative impacts on the scallop resource due to increased fishing pressure.

In addition, if Delmarva remained open in FY 2012, vessel operators would have taken longer fishing trips due to lower scallop biomass levels, which would negatively impact scallop recruitment in the short and medium term, and could reduce the long-term biomass and yield from Delmarva and the Mid-Atlantic overall. Vessel operators would have continued to fish in Delmarva until they reached the 18,000-lb (8,165 kg) limit, which will which negatively impact scallop recruitment due to the potential harvest and disturbance of the small-sized and less mature scallops. The success of the entire scallop access area rotational management program depends on timely openings and closing of accessareas in order to protect scallop recruitment and optimize yield. This is particularly true in the Mid-Atlantic, where recruitment has been well below average for several years. By closing Delmarva for the remainder of FY 2012, this action avoids the potential for localized overfishing of the area and promotes future yield from the area by protecting the small scallops located in the area.

Reallocating unused FY 2012 Delmarva trips to CAI would ensure equity across the scallop fleet, while not compromising the scallop resource.

The reallocation to CAI of unused FT vessel trips from Delmarva is not expected to result in excessive fishing in CAI for FY 2012, based on the most recent survey results. By reallocating to CAI any unused FT vessel trips (up to 156) currently assigned to Delmarva, this action increases the total number of CAI trips from 157 to up to 313. The increase in CAI trips results in an FY 2012 CAI allocation of 5.6 M lb (2,540 mt) of scallops, an area with an estimated scallop biomass of between 28-40 M lb (12,700-18,144 mt). This increase doubles the amount of fishing effort that was initially allocated to CAI at the start of FY 2012, but the recent surveys show that the scallop biomass in this area can support this level of fishing.

The FT Delmarva trips that will be converted to CAI once this action is effective include any undeclared FY 2012 trips and all FY 2012 Delmarva compensation trips. If a vessel began an FY 2012 Delmarva scallop trip, ended the trip prior to landing its full possession limit, and has received a subsequent FY 2012 Delmarva compensation trip in order to harvest the remainder of the possession limit, that compensation trip will also be converted to CAI upon the effective date of this action. Any vessel that has gained a Delmarva trip through a trip exchange will also have that trip converted to a CAI trip. In addition, this action reallocates the unused Delmarva FY 2012 observer set-aside (up to 36,000 lb; 16.3 mt) to CAI to account for the increase in FT trips.

NMFS's policy guidelines for the use of emergency rules (62 FR 44421; August 21, 1997) specify the following three criteria that define what an emergency situation is, and justification for final rulemaking: (1) The emergency results from recent, unforeseen events or recently discovered circumstances; (2) the emergency presents serious conservation or management problems in the fishery; and (3) the emergency can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process. NMFS's policy guidelines further provide that emergency action is justified for certain situations where emergency action would prevent significant direct economic loss, or to preserve a significant economic opportunity that otherwise might be foregone. NMFS has determined that the issue of closing Delmarva meets the three criteria for emergency action for the reasons outlined below.

The emergency results from recent, unforeseen events or recently discovered circumstance. Although the last survey in Delmarva was completed in October 2011, the results of the three 2011 Delmarva scallop resource surveys were not available until the January 5, 2012, Scallop PDT meeting. There is now evidence that there is significantly less biomass in Delmarva than projected through Framework 22. In addition, the surveys show that small scallops, or recruitment, are present within Delmarva and that there is not substantial recruitment elsewhere in the Mid-Atlantic.

The emergency also presents serious conservation and management problems in the fishery. Allowing fishing effort in Delmarva in FY 2012 with the current low biomass levels could result in negative impacts on recruitment and could reduce the long-term biomass and economic yield from this area. Since there has been well below average recruitment in the Mid-Atlantic for several years, protecting scallop recruitment in this area is essential for the future success of area rotation to maximize yield and economic benefits to the scallop fishery.

Additionally, catch rates are much lower for Delmarva than Framework 22 originally projected, and lower than other access areas that are currently open to vessels for FY 2012. When catch rates fall, vessels must fish longer to get the same total catch, increasing area swept, or time that fishing gear is in the water. Increased area swept has greater impacts on bycatch, habitat, and protected resources, as well as increased costs for fishing vessels due to longer trips.

The increase in fishing costs would also have negative impacts on the producer surplus and net economic benefits from the fishery. Assuming catch rates in FY 2012 are similar on average to catch rates in FY 2011, CAI trips would cost about $16,500 per FT vessel, about half as much as trip costs estimated for that vessel to take a Delmarva trip. Total fleet net revenue for those 156 vessels, assuming no used trips, which would each be reallocated a CAI trip instead of a Delmarva trip is estimated to be $25.5 million, $2.6 million more than if Delmarva had remained open and those vessels were required to fish their trips in that area.

These potentially serious conservation and management consequences of high fishing effort in Delmarva in FY 2012 justify the emergency closure of this area.

NMFS also finds that this emergency can be addressed through emergency regulations for which the immediate benefits to both the scallop resource and those who depend on it outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process. Although the Council has the authority to develop a management action to modify the scallop access area trip allocations, an emergency action can be developed and implemented by NMFS more swiftly than a Council action that is subject to procedural and other requirements not applicable to the Secretary. If the normal regulatory process is used to revise the trip allocations (e.g., considering “pay back” measures for vessels with unused FY 2012 Delmarva trips during the development of Framework 24, which would set the specifications for FYs 2013-2014) it would take substantially longer for the revised trip allocations to be implemented, could result in unintended impacts to future FY annual catch limits (ACLs), and could result in triggering economically harmful management actions that otherwise may have been avoided. By implementing these measures through emergency action, it is possible to maintain overall catch allocations for scallops for the remainder of FY 2012 and avoid unnecessary adverse biological and economic impacts.

This emergency action closes Delmarva in FY 2012 for 150 days (after a 30-day delay in effectiveness), and NMFS anticipates extending this action for an additional 186 days, which would carry these measures into May 2013. This emergency action is expected to be replaced by Framework Adjustment 24 to the Scallop FMP (Framework 24), which sets the specifications for FYs 2013 and 2014. The Council is currently developing Framework 24 management measures but it is likely Delmarva would continue to be closed for FY 2013. NMFS expects that Framework 24measures will be implemented in May 2013, if approved, which would coincide with the expiration of this emergency action.

The Assistant Administrator for Fisheries, NOAA, has determined that this rule is necessary to respond to an emergency situation and is consistent with the national standards and other provisions of the Magnuson-Stevens Act and other applicable laws. The rule may be extended for a period of not more than 186 days as described under section 305(c)(3)(B) of the Magnuson-Stevens Act.

The Assistant Administrator for Fisheries, NOAA, finds good cause under section 553(b)(B) of the Administrative Procedure Act (APA) that it is contrary to the public interest and impracticable to provide for prior notice and opportunity for the public to comment. As more fully explained above, the reasons justifying promulgation of this rule on an emergency basis make solicitation of public comment contrary to the public interest.

This action provides benefits to both the scallop resource and the scallop fishery by not jeopardizing the success of the access area program in future years, not compromising future scallop biomass levels and subsequent scallop harvest, and ensuring that some members of the limited access scallop fleet will not be inequitably subjected to fewer economic benefits than others. Specifically, by closing the Delmarva for the remainder of FY 2012, this action avoids jeopardizing the success of the access area program in future years by protecting scallop recruitment in the Mid-Atlantic and avoiding localized overfishing. In addition, by reallocating unused FT Delmarva trips (up to 156 trips) into CAI in FY 2012, this action avoids potential inequity in FY 2012 allocations and ensures that the limited access scallop fleet would not risk exceeding its sub-ACL in FY 2013, if vessels allocated Delmarva trips were compensated in FY 2013, rather than FY 2012. This also avoids the potential for the limited access fleet to be subjected to potential days-at-sea deductions in FY 2014 to account for any overage of their FY 2013 ACL. In addition, this action minimizes the likelihood of sea turtle interactions in the Mid-Atlantic, which are known to begin in June, due to longer Delmarva fishing trips. This action did not allow for prior public comment because the review process and determination could not have been completed before Delmarva opened on March 1, 2012, due to the inherent time constraints associated with the Council's rulemaking process to adjust FY 2012 allocations already specified through Framework 22. The results of the three 2011 Delmarva scallop resource surveys were not available until the January 5, 2012, Scallop PDT meeting, and thus there was not enough time for NMFS to complete a rulemaking through the Council's process under the Magnuson-Stevens Act before the Delmarva area opened to fishing on March 1, 2012. This action is undertaken at the request of the Council and is supported by the Fisheries Survival Fund, an organization that represents a large portion of the scallop industry, and that is an active participant in the development of scallop fishery management measures. The Council urged that NMFS implement this action quickly in order to minimize any fishing effort in the Delmarva, and ensure the industry is aware of any allocation adjustments before CAI opens on June 15, 2012. Had this action been further delayed past the start of FY 2012 to account for public comment, it is possible that FT vessels, uncertain whether or not they would receive CAI trips instead of their Delmarva trips, would have fished in the Delmarva when the meat weights would be highest (i.e., during the first few months of the fishing year), which would have negative implications on the recruitment in the area.

In the interest of receiving public input on this action, the EA analyzing this action will be made available to the public and this temporary final rule solicits public comment.

This rule has been determined to be not significant for purposes of Executive Order 12866.

This rule is exempt from the procedures of the Regulatory Flexibility Act to prepare a regulatory flexibility analysis because the rule is issued without opportunity for prior public comment.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: