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 the Federal Register on December 12, 2011 (76 FR 77157). That NPRM proposed to require replacing bleed valve parts and tubing with new parts and tubing on the left and right Rolls-Royce RB211 Trent 800 engines; and installing AEDB software in the airplane AIMS hardware.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (76 FR 77157, December 12, 2011) and the FAA's response to each comment.

American Airlines (American) and Boeing requested that the NPRM (76 FR 77157, December 12, 2011) allow the use of Boeing Special Attention Service Bulletin 777-31-0177, Revision 1, dated October 13, 2011, as a source of information to comply with the actions required by paragraph (h) of the NPRM.

We agree. Paragraph (h) of the NPRM (76 FR 77157, December 12, 2011) specified the use of Boeing Special Attention Service Bulletin 777-31-0177, dated September 23, 2010. We have revised paragraph (h) of the final rule to add Boeing Special Attention Service Bulletin 777-31-0177, Revision 1, dated October 13, 2011, as an additional source of service information for accomplishing the actions specified in that paragraph. Boeing Special Attention Service Bulletin 777-31-0177, Revision 1, dated October 13, 2011, specifies updates to the concurrent requirements paragraph.

American requested that the NPRM (76 FR 77157, December 12, 2011) allow the use of Rolls-Royce Service Bulletin RB.211-75-G466, dated November 21, 2011, as an additional source of information to accomplish the requirements of paragraph (g) of the NPRM.

We agree. We have changed the final rule to specify that the actions required by paragraph (g) of the AD may be done in accordance with the Accomplishment Instructions of Rolls-Royce Service Bulletin RB.211-75-G466, Revision 1, including Supplement, dated June 20, 2011; or Rolls-Royce Service Bulletin RB.211-75-G466, Revision 2, including Supplement, dated November 21, 2011.

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

• Αre consistent with the intent that was proposed in the NPRM (76 FR 77157, December 12, 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 77157, December 12, 2011).

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 55 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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:

The Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil, has issued Brazilian Airworthiness Directive 2012-05-01, dated June 5, 2012 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Goodyear Aviation has issued Service Bulletin 2012-32-001, dated April 19, 2012. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure of the main landing gear tires during takeoff or landing could cause damage to the airplane structure, flaps, engine, wheel well and may result in reduced controllability of the airplane. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2012-0881; Directorate Identifier 2012-CE-029-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD will affect about 3,400 tires potentially installed on products of U.S. registry. We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $2,000 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $7,667,000, or $2,255 per product.

According to the manufacturer, some of the costs of this AD may be covered on a one-to-one basis as noted in Goodyear Aviation Service Bulletin 2012-32-001, dated April 19, 2012, thereby reducing the cost impact on affected individuals. We do not control warranty or exchange coverage for affected operators. As a result, we have included all costs in our cost estimate.

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.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 52-02-02 (21 FR 9447, December 4, 1956). That AD applies to the specified products. The NPRM published in the Federal Register on April 14, 2011 (76 FR 20894, April 14, 2011). That NPRM proposed to add airplanes to the Applicability section; require inspections of the ailerons, aileron balance assembly, and aileron rigging for looseness or wear; repair or replacement of parts as necessary; and require a report of the inspection results.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (76 FR 20894, April 14, 2011) and the FAA's response to each comment.

William R. Bayne and Hartmut Beil stated that the service bulletin and/or the manufacturer's existing recommendations, such as lubricating control rod ends at 300 hour intervals, are adequate, and the existing AD 52-02-02 (21 FR 9447, December 4, 1956) is sufficient. They stated that the number of in-flight breakups do not identify a failure of the flight control system and do not justify the need for AD action. They also stated the inspection interval should be 300 hours instead of 100 hours to match the existing recommendations, and the proposed AD puts a financial burden on owners with little or no gain for safety.

We disagree with these comments. This AD will add airplanes to the Applicability section that were not included in AD 52-02-02 (21 FR 9447, December 4, 1956). Also, the flight control free play limits can vary or be out of tolerance for many more reasons than not doing the 300-hour lubrication requirement. Also, varying field reports indicated that the majority of flight control systems are not in tolerance. In addition, Ercoupe Service Memorandum No. 57, Revision A, dated September 1, 2008, recommends free play inspection every 100 hours.

Linda Abrams requested we change the calibration of the airspeed indicator (ASI) requirement, paragraph (g)(8) of the proposed AD (76 FR 20894, April 14, 2011), to allow for “unless already done” credit since that applies to the other inspection requirements, and it would impose a financial burden on owners and operators.

We agree. “Unless already done” credit will be applied for the ASI calibration requirement in paragraph (g)(8) of this AD as all other “unless already done” credit is being applied by reference to the Compliance section, paragraph (f) of this AD.

James E. Dyer of Univair requested the Mooney M-10 service and maintenance requirements be addressed by separate applicable service information since the Ercoupe Service Memorandum No. 57 and 35A, both Revisions A, both dated September 1, 2008, are not applicable to the Mooney M-10.

We agree. We revised the “Required Actions” section paragraph (g) of this AD by adding text that requires inspecting and taking corrective action on the Mooney M-10 flight control system per pages 5-1 through 5-4 of the Mooney M-10 Service and Maintenance Manual, Serial Numbers 690001 through 690011 and 700001 and on, Revision A, dated September 1, 2008. We also added Ercoupe Service Memorandum No. 35A, Revision A, dated September 1, 2008, to the applicable service information, and added an area to the reporting requirement pertaining to the use of Ercoupe Service Memorandum No. 35A, Revision A, dated September 1, 2008.

James E. Dyer commented that Ercoupe Service Memorandum No. 20, Revision A, dated September 1, 2008, is only referenced in the one-time reporting requirement of the “Required Actions” section, paragraph (g) of the proposed AD and not referenced as a procedural requirement for the inspection of ailerons with counter weights.

We agree. We have revised this AD by adding Ercoupe Service Memorandum No. 20, Revision A, dated September 1, 2008, as a reference in the “Required Actions” section, paragraph (g), of this AD pertaining to airplanes with the aileron balance assembly (ERCO part number (P/N) 415-16009).

James E. Dyer, Linda T. Abrams, and Jack Chmiel commented that the calibration test for the ASI should be completed by an authorized instrument repair facility because Advisory Circular AC 23-8B, Appendix 9 contains technical requirements that exceed the ability of most owner/operators, repair stations, or Airframe & Powerplant (A&P) mechanics on this class of airplane.

We partially agree. We have revised the “Required Actions” section, paragraph (g)(8) of this AD to require an FAA-authorized instrument repair facility to calibrate the ASI if the bench test method is used. However we will allow an exception for global positioning system (GPS) or other owner/operator FAA-approved methods of calibrating the ASI following the instructions in FAA Advisory Circular AC 23-8C, Appendix 9, dated November 16, 2011. These procedures will be repetitively required every 4 years and any time maintenance affects the system integrity.

Jack Chmiel, William R. Bayne, and an anonymous commenter stated they did not think the Inspection Report should be submitted after each inspection interval. They didn't feel the referenced report was clearly defined in the NPRM as a one-time report that is only required at the time of initial compliance with the AD.

We agree. We have revised this AD to clearly state the reporting requirement is a one-time action submitted after the initial inspection.

James E. Dyer commented that there has been a revision to a P/N listed in the “Costs of Compliance” section of this AD, and we should change the P/N.

We agree. We revised this AD to reflect the aileron hinge and rudder hinge P/N from 415-24003 to F24003 in the “Costs of Compliance” section.

Vince Hammons and Jack Chmiel commented that the aileron free play should be limited to 1/8 inch to 5/16 inch, which they believe would be easily attainable and would remove any confusion on allowable amount of free play.

We do not agree. Ercoupe Service Memorandums No. 56 and No. 57, both Revisions A, both dated September 1, 2008, state that 7/16 inch is allowable for ailerons with counter weights, and 5/16 inch is allowable for ailerons without counter weights per the original design. Anything less could be unattainable due to different wear patterns and usage between airplane units and the services times and duration of the type design for the fleet since inception.

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

• Are consistent with the intent that was proposed in the NPRM (76 FR 20894, April 14, 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 20894, April 14, 2011).

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 2,600 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements for the flight control system that would be required based on the results of the inspection. We have no way of determining the number of airplanes that may need this replacement:

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 have 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 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:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2004-09-32, Amendment 39-13622 (69 FR 25481, May 7, 2004). That AD applies to the specified products. The NPRM published in the Federal Register on December 29, 2011 (76 FR 81890). That NPRM proposed to continue to require initial and repetitive inspections of the fuselage skin and bear strap at the forward upper corner of the L1 entry door cutout for cracking, and repair if necessary. That NPRM also provided an optional terminating action for the repetitive inspections. That NPRM also proposed to require additional inspections for airplanes having repairs or preventative modifications installed and inspections for certain other airplanes. That NPRM also proposed to add airplanes to the applicability.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (76 FR 81890, December 29, 2011) and the FAA's response to each comment.

Allegiant Air requested that we revise paragraph (k) of the NPRM (76 FR 81890, December 29, 2011) to include a 90-day compliance time for airplanes in Group 2. The commenter stated that Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009, specifies a compliance time after the “original issue date” or “Revision 1 date of the service bulletin.” Allegiant Air stated that Group 2 airplanes may have accumulated more than 500 flight cycles since August 12, 2009 (the issue date of Boeing Special Attention Service Bulletin 757-53-0094, Revision 1), and therefore airplanes would be non-compliant with the AD as soon as the AD is published.

We partially agree with the commenter. We disagree with adding a 90-day compliance time because paragraph (p)(1) of the AD includes an exception to the compliance times that refers to the dates in Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009. However, we have clarified paragraph (k) of this AD by referring to paragraph (p)(1) of this AD as an exception to the compliance times. We have also revised the language in paragraph (p)(1) of this AD for clarity.

American Airlines (AAL) and United Airlines (United) requested that we extend the repetitive intervals. AAL requested that we change the repetitive intervals specified in paragraphs (h) and (k) of the NPRM (76 FR 81890, December 29, 2011) from 1,400 flight cycles to 2,200 flight cycles. AAL stated that they have inspected over 50 percent of its fleet prior to the effective date of the NPRM, and have had no findings. AAL believes that the repetitive interval could be extended without jeopardizing safety. United requested that we lengthen the interval of the repetitive inspections from 1,400 flight cycles to 3,000 flight cycles, to align with normally scheduled maintenance. United also noted that other areas of the airplane fuselage skin shown in the Boeing structural repair manual (SRM) have intervals as long as 3,000 flight cycles.

We disagree with changing the repetitive interval as requested. A damage tolerance analysis of the predicted crack growth rate is used to establish the repetitive intervals of 1,400 flight cycles. These repetitive intervals must include the variability of crack growth rate between airplanes and include a probability of detection of the cracks for the method used for the inspection. The door surround structure appears to have higher stress levels than the other portions of the fuselage skin inspected by the repairs in the Boeing SRM. This is the main cause for the fatigue cracking addressed by Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009. The other areas of fuselage skin in the Boeing SRM have not demonstrated this premature fatigue cracking requiring the higher repetitive inspection intervals. We have determined that the 1,400 flight cycle interval is necessary to address the identified unsafe condition. No change has been made to this AD in this regard; however, operators may request an alternative method of compliance (AMOC) according to the provision of paragraph (r) of this AD, if the request is submitted with substantiating data that proves the repetitive interval will provide an adequate level of safety.

AAL requested that we revise the 1,400 flight cycle intervals for the eddy current inspection to include an option for a 1,000 flight cycle detailed inspection combined with a 3,000 flight cycle eddy current inspection to permit the eddy current inspections to be accomplished during normally scheduled maintenance intervals.

We disagree. Since no analysis was provided to demonstrate that the proposal provides an acceptable level of safety, we disagree with adding the requested option. It is unlikely that an analysis would demonstrate that the requested 1,000 flight cycle detailed inspections are adequate compared to the probability of detection by the eddy current inspections at 1,400 flight cycles, since the eddy current inspection methods are used to find very small cracks not readily detected by the human eye. Further, the inspections of the bear strap structure cannot be accomplished visually since the bear strap is covered by the fuselage skin. According to the provisions of paragraph (r) of this AD, operators may request an AMOC to include an option to the repetitive inspection intervals, if the request is submitted with substantiating data that proves that the alternate method and intervals will provide an adequate level of safety. No change has been made to this AD in this regard.

United requested that we revise the compliance time to increase the time allowed after the effective date from 500 flight cycles to 1,400 flight cycles. United stated that it would be a better transition for implementation of the inspections as 1,400 flight cycles would permit normal scheduling for the airplanes.

We disagree with revising the compliance time. In developing an appropriate compliance time for this AD, we considered not only the safety implications, but the manufacturer's recommendations, the availability of required parts, and the practical aspect of accomplishing the inspections within an interval of time that corresponds to typical scheduled maintenance for affected operators. Under the provisions of paragraph (r) of this AD, however, we may consider requests for adjustments to the compliance time if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety.

Delta Airlines, Inc. (Delta) requested that we revise the NPRM (76 FR 81890, December 29, 2011) to give credit for the inspections done using Figure 1 of Boeing Special Attention Service Bulletin 757-53-0089, dated March 18, 2004. This service bulletin is the appropriate source of service information for accomplishing the actions required by AD 2004-09-32, Amendment 39-13622 (69 FR 25481, May 7, 2004). Delta stated that the new inspections would be required in less than 500 flight cycles after the effective date of the new AD for airplanes that were already on the 1,400 flight cycle repetitive inspection required by AD 2004-09-32.

We disagree with this request to revise this AD. The inspections specified in Figure 1 in both Boeing Special Attention Service Bulletin 757-53-0089, dated March 18, 2004; and Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009; are the same method, locations, and sections of the Boeing 757 Non-destructive Testing Manual. Since paragraph (f) of this AD already provides credit for previous accomplishment of the inspection, no change has been made to the AD in this regard.

UPS requested that we revise paragraph (c) of the NPRM (76 FR 81890, December 29, 2011) to add the text, “as specified in Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009.” UPS stated that the NPRM is applicable to all Model 757-200 airplanes.

We agree to clarify the applicability paragraph. All Model 757-200, -200CB, and -300 series airplanes are affected by this AD, as specified in paragraph (c) of this AD. Model 757-200PF airplanes are not listed in the applicability and are not affected by the identified unsafe condition. We have clarified paragraph (c) of this AD by adding a sentence that specifies that Model 757-200PF series airplanes are not affected by this AD.

Boeing requested that we clarify paragraph (g)(3) of the NPRM (76 FR 81890, December 29, 2011) by adding the text, “around each fastener of the subject door edge corner for cracking,” to be consistent with paragraphs (g)(1) and (g)(2) of the NPRM.

We disagree with the request. Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009, clearly defines the inspection. No change has been made to the AD in this regard.

AAL requested that we add a statement to clarify the steps required to access the inspection area. AAL stated that this note is included in many Boeing service bulletins, but was not included in Boeing Special Attention Service Bulletin 757-53-0094, dated January 16, 2008; or Boeing Special Attention Service Bulletin 757-53-0094, Revision 1, dated August 12, 2009.

We agree that clarification is needed. We have added paragraph (p)(6) to this AD to state that if it is necessary to remove more parts for access, you may remove those parts, but it is not necessary to remove all of the parts. We have also added a reference to paragraph (p)(6) in paragraph (k) of this AD.

Boeing requested that we clarify paragraph (n) of the NPRM (76 FR 81890, December 29, 2011) by revising the text from, “a repair doubler, tripler, or quadrupler is installed;” to “a repair doubler; a doubler and a tripler; or a doubler, tripler, and quadrupler.” Boeing stated that a tripler installation also has a doubler installed, and a quadrupler installation also has a doubler and a tripler installed. Each combination has unique inspection requirements.

We agree that the requested text would provide clarity to the operators. Paragraph (n) of this AD has been revised to include the text, “a repair doubler; a doubler and a tripler; or a doubler, tripler, and quadrupler.”

Delta requested that the exceptions to certain compliance times in paragraph (p)(2) of the NPRM (76 FR 81890, December 29, 2011), be revised to include a third option of 4,000 flight cycles since installation of the preventive modification or repair. Delta stated that, by adding a third criteria of 4,000 flight cycles after installation, the inspection would be required at the next repetitive interval.

We agree that an optional compliance time is needed. In the case of an airplane that has more than 37,500 total flight cycles and has had the modification or the required repair installed more than 24 months after the effective date of the AD, the inspections would be required immediately. We have added paragraph (p)(2)(iii) to this AD to add an optional compliance time of 4,000 flight cycles since installation of the preventive modification or repair.

AAL requested that the NPRM (76 FR 81890, December 29, 2011) be revised to allow substitution of certain fasteners and materials as specified in Chapter 51 of the Boeing 757 SRM and Boeing Drawing 65-88700.

We partially agree with the request. We disagree because Boeing Drawing 65-88700 is not an FAA-approved document. However, we agree that the Boeing 757 SRM, which is an FAA-approved document, is an appropriate source of information for fastener and material substitution. We have added paragraph (p)(4) to this AD to allow fasteners and material to be substituted, as specified in Chapter 51 of the Boeing 757 SRM to be used as an appropriate source of information for fastener and material substitution. We have also revised paragraphs (l) and (m) of this AD to refer to this exception.

AAL requested that we permit fastener grip length adjustment substitution and washer installation for fastener grip length, as specified in Chapter 51 of the Boeing 757 SRM.

We agree that Chapter 51 of the Boeing 757 SRM is an appropriate source for fastener grip length adjustment substitution. We have added paragraph (p)(5) to this AD to allow Chapter 51 of the Boeing 757 SRM to be used as an appropriate source of information for fastener grip length adjustment substitutions. We have also revised paragraphs (l) and (m) of this AD to refer to this exception.

AAL requested that we allow credit for inspections done previously using Boeing Special Attention Service Bulletin 757-53-0094, dated January 16, 2008.

We agree. We have added paragraph (q) to this AD to allow the inspections for airplanes in Group 1, Configurations 1 and 2; and Group 2, Configuration 1; as defined in Boeing Special Attention 757-53-0094, Revision 1, dated August 12, 2009, done prior to the effective date of this AD, if done using Boeing Special Attention Service Bulletin 757-53-0094, dated January 16, 2008. We have also updated subsequent paragraph identifiers accordingly.

We have revised certain headings throughout this AD. We have also revised paragraph (h) of this AD to specify that the repair in paragraph (i) of this AD also terminates the repetitive inspections.

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

• Are consistent with the intent that was proposed in the NPRM (76 FR 81890, December 29, 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 81890, December 29, 2011).

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 591 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs that would be required based on the results of the inspections. We have no way of determining the number of aircraft that might need these repairs:

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 have 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 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

On June 27, 2012, the FAA published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to modify Class D and E airspace at Bozeman, MT (77 FR 38227). 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 D and E airspace designations are published in paragraphs 5000, 6002, 6004, 6005 and 6006, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR part 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E surface airspace and Class E airspace designated as an extension to Class D, at Bozeman Yellowstone International Airport, Bozeman, MT, adjusting the radii to be in alignment with the Class D airspace area. This action also updates the airport name from Bozeman, Gallatin Field Airport, to Bozeman Yellowstone International Airport for existing Class D and E airspace areas. This action is necessary for the safety and management of IFR operations.

The FAA has determined 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 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 discusses 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 Bozeman Yellowstone International Airport, Bozeman, MT.

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

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

On July 31, 2012, the FAA published a final rule, technical amendment, in the Federal Register amending the Class E airspace area for Montgomery, AL, by recognizing the name change to Prattville-Grouby Field Airport (formerly Autauga Airport) (77 FR 45238). After publication, the FAA found that the geographic coordinates of Maxwell AFB and Wetumpka Municipal Airport need to be adjusted to be in concert with the FAAs aeronautical database. This action makes the administrative adjustment that does not affect the altitude, boundaries, or operating requirements of the airspace. Therefore, notice and public procedures under 5 U.S.C. 553(b) are unnecessary.

The Class E airspace designations are published in Paragraphs 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.

Accordingly, pursuant to the authority delegated to me, the geographic coordinates for Maxwell AFB and Wetumpka Municipal Airport, as listed in the airspace designation of the Class E airspace, Montgomery, AL, as published in the Federal Register of July 31, 2012, (77 FR 45238), FR Doc. 2012-18522, are corrected as follows:

On June 27, 2012, the FAA published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to modify controlled airspace at Lewistown, MT (77 FR 38226). 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 6002 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface, at Lewistown Municipal Airport, Lewistown, MT, to accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined 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 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 discusses 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 modifies controlled airspace at Lewistown Municipal Airport, Lewistown, MT.

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:

A. Background: Section 104(b) of the Consumer Product Safety Improvement Act

The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant and toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. The term “durable infant or toddler product” is defined in section 104(f)(1) of the CPSIA as a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. Play yards are one of the products specifically identified in section 104(f)(2)(F) as a durable infant or toddler product.

In the Federal Register of September 20, 2011 (76 FR 58167), we published a notice of proposed rulemaking (NPR) for play yards, incorporating by reference ASTM F406-11, “Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/Play Yards,” with three clarifications. ASTM F406 is the safety standard for both non-full-size cribs and play yards. In the proposed rule for play yards, we indicated which sections of the ASTM standard apply to play yards, and we excluded the provisions of ASTM F406 that apply to non-full-size cribs.

The ASTM subcommittee on play yards developed a newer edition of this standard, ASTM F406-12a, which includes the three clarifications we proposed in the NPR. ASTM F406-12a also contains two clarifications that were suggested in comments we received from the public in response to the NPR. Those two clarifications: (1) Added a preload to the mattress vertical displacement test; and (2) exempted from the top rail configuration requirement play yards with upward-folding top rails.

In this document, we are issuing a safety standard for play yards, which incorporates by reference ASTM F406-12a and provides a 6-month (from the date of publication) effective date for the mandatory play yard standard.

ASTM F406-12a defines a “play yard” as a “framed enclosure that includes a floor and has mesh or fabric sided panels primarily intended to provide a play or sleeping environment for children. It may fold for storage or travel.” Play yards are intended for children who are less than 35 inches tall, who cannot climb out of the product. Some play yards include accessory items that attach to the product, including mobiles, toy bars, canopies, bassinets, and changing tables.

The preamble to the NPR (76 FR 58168) summarized the data for incidents related to play yards reported to us from early November 2007 through early April 2011. The final rule is based on the data provided in the NPR, as well as updated data on incidents related to play yards reported to us from April 2011 through December 31, 2011.

From April 10, 2011, through December 31, 2011, we received information on 41 play yard-related incidents. Fifteen of the 41 incidents were fatal. Of the remaining 26 incidents, eight resulted in injuries to the child.

Eleven of the 15 fatal incidents are attributable to an unsafe sleep environment, such as the presence of soft bedding. For one fatality, very little information was supplied to us and, we were unable to determine the cause of the death. Three of the 15 fatalities were play yard related. One child died when the bassinet accessory being used as a sleep environment was assembled without key structural elements, which resulted in a dangerous tilt of the sleep surface. The child slid into the corner of the bassinet and suffocated. In another incident, a child was attempting to climb out of a play yard and, while holding onto a separate bassinet nearby, the canopy of the bassinet fell forward and caught him on the back of the neck, suffocating him. A third child suffocated when he got his head stuck in a torn opening between the floor and the mesh side of the play yard.

The recent incidents have hazard patterns similar to those reported in the NPR, and include:

• Eleven incidents, all resulting in fatalities, were the result of unsafe sleep environments and unsafe sleep practices.

• Ten incidents were caused by broken or detached component parts, such as loose wheels and loose hardware, which resulted in the instability or collapse of the product. There were three injuries reported in this category.

• Five incidents were related to the mesh or fabric sides of the play yard, such as stitching that unraveled, tears in the fabric, and mesh holes that were too large. There were two injuries and one fatality reported in this category.

• Four incidents were caused by hazardous accessories, such as broken or detached components from a mobile or a tent accessory. There was one injury reported in this category.

• Three incidents were related to the mattress pad or floor of the play yard, including reports that the fasteners designed to keep the floor board in place failed. There were no injuries reported in this category.

• Three incidents were due to the side rail of the play yard collapsing. There were no injuries in this category.

• Two incidents were the result of the child being able to climb out of the play yard. There was one injury and one fatality reported in this category.

• One incident, which resulted in a fatality, can be attributed to assembly issues in the bassinet accessory of a play yard. In this incident, the bassinet was missing key structural elements meant to support the accessory. The sleep surface of the bassinet tilted, and the child slid into the corner and suffocated.

• One incident was the result of a child nearly choking on a sticker that was a component of the play yard.

• For one reported fatality associated with a play yard, there was insufficient information to determine the cause.

The preamble to the NPR invited comments concerning all aspects of the proposed rule. We received comments from 23 individuals or organizations. Many of the comments contained more than one issue. Thus, we organized our responses by issue, rather than responding to each individual commenter. Each comment and response is numbered below to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance, or the order in which it was received. All of the comments can be viewed on: www.regulations.gov , by searching under the docket number for this rulemaking, CPSC-2011-0064.

(Comment 1)— One commenter does not support government regulation of this, or any, consumer product and asserts that the free market will “weed out those manufacturers of unsafe products.”

(Response 1)— The CPSIA requires that we promulgate mandatory regulations for durable infant or toddler products, including play yards. This final rule fulfills a statutory obligation given to us by Congress. Accordingly, issuance of a play yard mandatory standard is consistent with the statutory requirements of the CPSIA.

(Comment 2)— One commenter notes a possible loophole in the ASTM F406 definition of “play yard” because materials other than mesh or fabric could be used to form the walls. According to the commenter, this would allow a manufacturer to circumvent the mandatory play yard rule.

(Response 2)— Play yards with sides made of materials that are not flexible would be considered rigid-sided products. These products would be classified as full-size- or non-full-size cribs, subject to more severe requirements under 16 CFR part 1219 (full-size cribs) or 16 CFR part 1220 (non-full-size cribs). It would be less burdensome to produce a mesh- or fabric-sided product. Accordingly, we do not believe that a play yard manufacturer would attempt to evade the play yard standard requirements by making a rigid-sided product.

(Comment 3)— Three commenters note that the ASTM standard might not be the best basis for the mandatory play yard rule. Each commenter asserts that because we do not have data to indicate whether the fatalities and injuries were caused by play yards not in compliance with the current ASTM standard, we cannot be sure that incorporating by reference the ASTM standard will result in safer play yards.

(Response 3)— The CPSIA requires that we base our mandatory standard for play yards on a voluntary standard. We chose the ASTM standard because it is the most widely used play yard standard in the United States. The ASTM committees that produce the durable infant and toddler product standards represent a cross-section of stakeholders, including manufacturers, retailers, testing laboratories, independent consultants, representatives from consumer advocacy groups, representatives from Health Canada, as well as CPSC staff. The creation of an ASTM standard involves analyzing CPSC incident data in detail, assessing other standards (including international standards), and testing products. The ASTM standard upon which we are basing the mandatory regulation addresses the known hazards of play yards and it is the most stringent standard available. Therefore, we believe that it is an appropriate standard upon which to base the play yard mandatory rule.

(Comment 4) —One commenter indicates that “the extremely low incidence of injury puts into question the need for regulation at all, outside of the CPSIA mandate, as there probably is no heinous market failure.”

(Response 4) —The standard is based on careful analysis of incidents, injuries, and fatalities associated with play yards. Injury rates, when available, are an important part of that analysis. In this case, however, even if we agreed with the commenter that the injury rate is too low, that does not negate the requirement for the issuance of a play yard mandatory standard, which fulfills a statutory obligation given to us by Congress. However, we disagree with the commenter and believe that the incidents, injuries, and fatalities justify the issuance of a play yard mandatory standard.

(Comment 5)— One commenter says that the “record demonstrates that the Commission relies solely upon information provided by a 2005 survey by American Baby Group for all market data,” and that “affected parties may challenge the rule by claiming that the Commission's actions are based on old, inaccurate data.”

(Response 5)— The commenter is incorrect in assuming that the 2005 American Baby Group survey ( 2006 Baby Products Tracking Study ) was the sole source of market information we considered in the rulemaking process. The Baby Products Tracking Study was used to provide an estimate of the magnitude of the play yard market. The initial regulatory flexibility analysis recognized the limitations of this data, both for its age and potentially biased sampling methods.

However, we also used market research—conducted independently—to perform the regulatory flexibility analysis. This research provided information on the number of firms supplying play yards to the U.S. market, their type, their size, and their location. We also researched, independently, the number of products supplied by each firm, each firm's compliance with the voluntary standard, as well as details about accessories sold with each play yard. It is this information, along with input from our staff and play yard manufacturers, which led to the conclusions of the initial regulatory flexibility analysis.

(Comment 6)— One commenter expresses concerns about how effectively the CPSC complied with the requirements of the Regulatory Flexibility Act (RFA). The commenter asserts that the proposed rule will have a significant impact on all small firms.

(Response 6)— The economic impact of the mandatory play yard standard proposed in the NPR would not be significant for play yard suppliers who already are in compliance with the ASTM play yard standard. Many play yard manufacturers and importers have a history of making adjustments to their play yards to remain in compliance with the ASTM standard, and they likely would continue to comply in the absence of a mandatory standard. Firms with a history of voluntary compliance would have few, if any, costs associated with the proposed rule, regardless of their size.

The initial regulatory flexibility analysis recognized that the impact on firms that supply noncompliant play yards to the U.S. market potentially could be significant. However, because the CPSIA requires that we promulgate a mandatory standard that is substantially the same as, or more stringent than, the voluntary standard, the CPSC is limited in how it can minimize the economic impact on small firms that are not in compliance with the standard.

(Comment 7) —We received two comments regarding international play yard standards. One commenter expresses the concern that our play yard mandatory standard could impact trade agreements and emphasizes the importance of standards harmonization as a way to avoid this. Another commenter states that international harmonization should be a priority.

(Response 7) —When drafting the NPR for play yards, we reviewed, compared, and considered a variety of play yard standards, including the Canadian standard, the European standard, and the Australian/New Zealand standard. There are differences among all of the international standards. Thus, even if we adopt part, or all, of one of the standards listed here, we still would not have complete international harmonization. We are aware of the utility of having harmonized standards in a global marketplace, and we will continue to strive to achieve this harmonization, whenever possible.

(Comment 8) —One commenter states that the proposed test methods for play yards, which do not include any cyclic tests (tests that involve hundreds or thousands of testing cycles in order to evaluate a product's durability), are insufficient because play yards are set up and taken down more often than cribs.

(Response 8) —Cyclic testing is time-consuming and expensive. For play yards, we have found that using very heavy loads applied for one testing cycle (instead of cyclic testing that would require relatively lighter loads and testing cycles that are repeated hundreds or thousands of times) can simulate a lifetime of use. The tests found in the play yard standard were developed over time, and they have been found to be reliable indicators of when a play yard could present a hazard.

(Comment 9) —One commenter states that the CPSC should establish a mandatory set of production and manufacturing inspection standards for the industry.

(Response 9) —The CPSC's role is to monitor the results of the manufacturing process, not participate in the process itself. We monitor the manufacturing process in several ways. First, we are able to act preventatively by issuing mandatory standards and requiring children's products be third party tested by an accredited laboratory. Second, we have the ability to act if the manufacturing process fails and a product is sold that does not meet a mandatory standard or is defective and presents a substantial risk of injury to the public.

(Comment 10) —Several commenters weigh in on the appropriate effective date for the proposed rule. One commenter, representing numerous juvenile product manufacturers, supports the proposed 6-month effective date. One manufacturer says: “from an industrial point of view, 6 months of fulfilling a new legislation is very short” and, therefore, suggests a 12-month effective date. Two other commenters also feel that the effective date should be longer. One suggests that it is “doubtful that a six month grace period would provide sufficient protection for the small businesses that the RFA intends to protect,” while the other says that an effective date “6 months after publication of the final rule” is “seemingly arbitrary” and that other alternatives “may encourage more compliance.”

One commenter, representing several consumer advocacy groups, recommends: “an effective date of 90 days after publication in the Federal Register .” Their rationale is twofold. First, “the changes to the voluntary standard proposed by CPSC are minor,” the commenter opines. Second, the commenter adds: “it affects only product manufactured after that date, not sold by that date,” and “manufacturers and retailers have large inventories of children's products and will be able to sell noncompliant product for years after the effective date. The sooner new products meet the standard, the better for the infants and toddlers who will be using them.”

(Response 10)— We consider 6 months sufficient time for suppliers to come into compliance with the proposed rule. Although a longer effective date would allow small entities to spread their costs out over a longer period of time, 6 months is common in the industry. For example, 6 months is the amount of time the Juvenile Products Manufacturers Association allows for products in their certification program to shift to a new standard. On the other hand, a shorter effective date could put a substantial burden on firms, particularly those whose play yards currently do not meet the requirements of the voluntary ASTM standard.

We share concerns about noncompliant products being available for years beyond the effective date. However, the number and severity of play yard incidents does not seem to warrant a shorter effective date than that used for other durable infant products, particularly given that ongoing compliance activities would continue to be used to pull unsafe play yards from the market.

(Comment 11)— One commenter states that incidents arise from products that appear to be set up correctly but are actually misassembled. The commenter recommends that we add language to the mandatory play yard standard to address this hazard, by requiring products with consumer-assembled components be designed to prevent misassembly. If that is not possible, the commenter suggests that clear visual indicators be included to alert consumers that the accessory has not been assembled correctly.

(Response 11) —Many play yards are sold with accessories that attach to the product, such as bassinets, changing tables, and mobiles. Bassinet accessories are unique among play yard accessories because bassinet accessories are intended to be used as a sleeping environment, and infants are meant to be left unsupervised in them for extended periods of time. Serious injuries or fatalities can result if a play yard bassinet accessory has been assembled without key structural elements, such as rods, tubes, bars, and hooks, which keep the sleep surface flat and level. A tilt in the sleeping surface of the bassinet can result in an infant getting into a position where he or she is unable to breathe and is at risk of suffocation.

It is possible that the omission of key structural elements initially may not be visually evident to the consumer. If the misassembled accessory supports an infant without a catastrophic and obvious change to the sleep surface, then a consumer may continue to use the accessory and place a child in danger inadvertently.

We considered adding a provision to the play yard final rule to address the hazards associated with play yard bassinet accessories that can be assembled while missing key structural elements. However, we have chosen, instead, to publish an NPR in today's issue of the Federal Register , in which we propose a requirement and a test method to address bassinet accessory misassembly in play yards.

(Comment 12)— One commenter, a play yard manufacturer, states that play yards with side rails that fold upward should be excluded from the top rail configuration requirement. The commenter notes that most play yards form a dangerous V-shape if the side rail latch mechanisms are not locked properly. The commenter states that his firm's play yards are designed differently than the “typical” play yard, in that the top rail folds upward, which forms a non-dangerous upside down V-shape. If a child were to put their weight on the top rail by leaning on it, their weight would actually lock the top side rail further, rather than unlock it. The commenter requests that the play yard standard exempt play yards that fold upward from the top rail configuration requirement because they will not expose a child to a dangerous V-shape.

(Response 12) —We agree with the commenter. The top rail configuration requirements, found in section 7.10 of ASTM F406-12a, are intended to address entrapment hazards associated with side rails folding and creating a V-shape. If a child's neck is caught in the V-shape, the child could suffocate. The exemption for play yards with upward folding side rails has already been added to ASTM F406-12a. By incorporating by reference ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.

(Comment 13)— Five commenters raise concerns about the addition of soft bedding, such as blankets, pillows, and quilted covers, which can create an unsafe sleep environment for an infant. Some commenters suggest methods to educate the public about this issue, including: Publishing a safety guide, providing public outreach through traditional and social media, and offering information on the Web site: www.saferproducts.gov, in addition to: www.cpsc.gov .

(Response 13) —We agree that this is an extremely serious issue, and we are dedicated to public outreach and education campaigns that could prevent infant fatalities caused by unsafe sleep environments and practices. Safety guides, blogs, and videos addressing safe sleep are already available on the agency's Web site at: www.cpsc.gov . Additionally, we use traditional media channels, as well as popular social media outlets, such as Twitter, YouTube and Flickr, to disseminate information to the public about unsafe sleep environments and practices.

(Comment 14)— One commenter recommends that graphics or pictograms depicting the dangers of unsafe sleep environments be added to the existing warnings in the play yard standard in order to enhance their effectiveness.

(Response 14) —We believe that graphics depicted on warnings are useful and potentially can enhance the effectiveness of warnings. However, the development of an effective pictogram warning takes considerable testing to ensure that the graphic is not confusing or counterintuitive or does not lessen the effectiveness of current warnings. We continue to evaluate warnings on play yards and other children's products and will revise such warnings, as necessary.

(Comment 15)— One commenter is concerned about outside objects, such as window blind cords and computer cords, which can fall into the play yard and potentially strangle a child. The commenter feels that requiring a minimum clearance of 24 inches around a play yard would prevent children from reaching out and pulling window blind cords or other hazardous objects into the play yard.

(Response 15) —For children who are too young to climb out of the play yard, a minimum clearance of about 3 feet usually would suffice. However, once a child can climb out of the play yard, this minimum clearance has limited utility. For this reason, we feel that the existing required warning on play yards, advising parents to stop using the product once the child can climb out, is the most effective way to prevent these incidents. The ASTM standard also includes warnings that address the hazards of strings, cords, and window blind cords that may fall into the play yard.

(Comment 16) —One commenter is concerned about fatalities that have occurred when caregivers place improvised covers on the play yard in an attempt to keep children in the product. In some instances, children were killed when attempting to climb out of the play yard because they became trapped between the cover and the play yard side rail. The commenter feels that perhaps, there is a “market failure in providing adequate, and adequately priced, covers.” The commenter also suggests that play yard covers could be subject to mandatory regulations.

(Response 16) —Before a child can stand and reach a cover, the cover likely presents little risk. Once the child can reach it, the cover itself becomes a hazard. We are aware of two fatal incidents associated with covers and tents that can be affixed on top of play yards and cribs. In one incident, a child was able to tear the tent fabric and strangle in the loose strands. In the other incident, the child was able to deform the tent poles and become trapped beneath the mattress and the inverted poles. Because of these incidents, we recommend that consumers avoid using tents and covers on play yards and cribs. We believe that the following existing warning in section 9.4.2.6 of ASTM F406-12a is sufficient to address this hazard: “Child can become entrapped and die when improvised netting or covers are placed on top of product. Never add such items to confine child in product.”

(Comment 17)— One commenter feels that the CPSC has “unnecessarily disregarded the idea to make the play yard walls higher” as a way to prevent children from climbing out of the product.

(Response 17)— A designer of a play yard faces limited options for preventing children from climbing out of the product. The play yard is essentially a lidless box. Play yards that prevent climbing out would require either higher sides or lids to be effective. Both designs could introduce other problems that potentially are of more concern than the problem of climbing out of the play yard. For instance, making the sides higher increases the difficulty caregivers have placing their children, especially the youngest ones, into the play yard. This could increase the use of alternative sleeping arrangements, such as allowing children to sleep in adult beds, which can have serious hazards associated with them. Introducing a lid or some other kind of cover to a play yard creates more movable parts and the potential for mechanical failures that could lead to entrapment, entanglement, or strangulation.

We have been unable to identify a performance requirement for inclusion in the play yard standard that would effectively reduce incidents of children climbing out of play yards without simultaneously introducing other potential hazards. The current ASTM standard contains a warning advising parents to stop using the product once a child can climb out of the play yard. We feel that this is the most effective way to prevent injuries associated with children being able to climb out of play yards.

(Comment 18)— In the NPR, we reported that two toddlers were killed in separate incidents while standing up in a play yard. It is believed that they leaned forward against the side rail (perhaps to reach an object that the child had thrown outside the play yard), lost consciousness, or suffocated when the pressure from the side rail compressed their airway. One commenter asks that we continue to investigate these deaths and address this hazard.

(Response 18)— We are very concerned about these deaths. At this time, we are unable to explain how these children died; and thus, we are unable to comment on whether there are changes that could be made to play yard designs that would prevent fatalities like this from occurring. We have reached out to medical professionals and are continuing to collect information that might assist us in understanding the deaths and determining whether there is an engineering solution that could prevent them.

(Comment 19) —One commenter notes that the accessories that come with play yards can be dangerous. Specifically, the commenter feels that changing table attachments should come with restraints.

(Response 19) —There are strong arguments against changing table attachments having restraints, including the concern that the presence of restraints will give the consumer a false sense of security about the accessory. Restraints might lead to the caregiver walking away while the infant is left on the table. More troubling is the concern that parents mistakenly will use changing tables as a sleep environment, which is not the intended use of the product and can be very dangerous. Thus, we cannot recommend that changing tables have restraints.

(Comment 20)— One commenter requests that play yard accessories, such as changing tables and bassinets, be banned completely. Failing this, the commenter asks that these products be required to lock in place so that they cannot be manipulated by infants and toddlers. The commenter's 13-month-old daughter died when her head became trapped between a non-locking changing table attachment and side rail of a play yard.

(Response 20) —The current ASTM standard includes a requirement to address this hazard. It can be found in section 5.15 of ASTM F406-12a, titled, Entrapment in Accessories . The requirement was added in 2005. The standard requires that accessories not separate from a play yard when an infant-size head probe is pushed against the attachment from inside the play yard with 25 pounds of force. The pushing direction is varied to evaluate the security of the attachment to the play yard better. We feel that this test is adequate to address the hazard the commenter mentions, and we are not recommending any further action.

(Comment 21)— One commenter states that the cyclic testing required for rigid-sided products, contained in section 8.5 of ASTM F406-12a, should be required for mesh-sided products, such as play yards. The commenter states that a cyclic test would better assess the integrity of play yard accessory attachment points used to secure bassinets and changing tables to the side rails of play yards. The commenter recommends that the cyclic testing in section 8.5 of the ASTM standard be repeated with and without the attachments installed. The commenter states that it appears that many incidents reported to the CPSC occur when the accessory became unattached at one or more attachment points and that additional durability testing will ensure that the attachment points will hold through a lifetime of use.

(Response 21) —The purpose of the cyclic testing requirement, found in section 8.5, is to evaluate the attachment security of threaded fasteners, such as screws, used in rigid-sided products, specifically full- and non-full-size cribs. Of the accessories mentioned by the commenter, bassinet play yard accessories are of the greatest concern because they are intended to be used while an infant is sleeping unsupervised. The majority of play yard bassinet accessories are structureless, fabric shells that attach to the top rails of play yards. Because they have no structure of their own they will be substantially unaffected by this kind of cyclic testing. The attachment components in play yards typically consist of plastic clips, hook-and-loop (Velcro) straps, or snaps sewn into soft material around the inner perimeter of the play yard. These attachment means are substantially different than the threaded fasteners this test is intended to evaluate. Thus, we feel that cyclic testing would not adequately test the durability of attachment points in play yard accessories.

We identified five incidents where the attachment points of a play yard bassinet accessory failed. None of the incidents resulted in an injury to the child. Three incidents were caused by weak fabric or poor stitching. These hazards are addressed in the ASTM standard for play yards at sections 7.7 and 7.8, which address the durability of fabric and the strength of seams. The other two incidents were caused by separated hook-and-loop (Velcro) closures. On one, the closure failed to secure during the consumer's first use of the product and permitted the sleep surface to tilt slightly. The consumer noticed the problem immediately. We have evaluated the incident and determined that it can be attributed, most likely, to poor quality control in the manufacturing process. In the other incident, the hook-and-loop closure, used as a back-up means of attachment, wore out over time. The concern is that if the primary attachment were to fail, the worn hook-and-loop closure might permit the sleep surface to tilt. However, in this case, because the hook-and-loop closure was a secondary means of attachment, the product did not cause an injury or incident.

We share the commenter's concern about the robustness of bassinet and cradle attachments, but we do not agree that requiring cyclic testing for the attachment points will address those concerns. At this point, we cannot recommend a performance requirement and test method that would reduce the risk of injury associated with this hazard. Incoming data will be monitored to ensure that any emerging trends are identified.

(Comment 22) —One commenter feels that the consistency of the mattress vertical displacement test could be improved by adding a provision that accounts for slack in the mattress.

(Response 22) —The change the commenter suggests will improve testing consistency for vertical mattress displacement by ensuring that free movement of fabric is taken up before establishing the initial clamp position reference point. It has already been approved by ASTM members and was published in ASTM F406-12. It is also contained in F406-12a. By incorporating by reference ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.

(Comment 23) —One commenter states that small children have “wobbly legs and can fall down” and sustain an injury because the play yard is not secured firmly to the floor, or it might be placed on an unlevel floor. The commenter suggests securing play yards to the surface of hard floors with suction cups.

(Response 23) —Our incident data suggest that most children who are injured by falling in a play yard simply lose their balance. Thus, we disagree that children fall in play yards because the products are not secured firmly to the floor. However, even if that were the case, we disagree that suction cups will provide an improved attachment to hard surfaces. The length of time for which the suction effect can be maintained depends significantly on the porosity, flatness, and cleanliness of the floor surface. Furthermore, play yards typically are set up and taken down multiple times and are used on a multitude of indoor surfaces, including carpet, hardwood, and tile, as well as outdoor surfaces, such as grass or dirt. A consumer would not only have to inspect the suction cups for cleanliness and physical deformation before each use, but also remember to remove and install the suction cups, as needed, depending upon the floor surface. Therefore, we feel that requiring suction cups is not an adequate means of preventing injuries to children who fall in play yards.

(Comment 24) —One commenter notes that the ASTM standard does not require multilingual warnings, and they ask us to consider requiring them. The commenter argues that the use of multilingual warnings reasonably could be expected to reduce play yard injuries by educating caregivers who do not speak or read English.

(Response 24) —We are not opposed to the use of multilingual labels. Many manufacturers already use multilingual warnings, although currently, they are not required. We feel that play yard manufacturers are in the best position to determine who uses their product and decide when to create labels and instructional materials in other languages.

(Comment 25) —One commenter feels that the warning label on play yards requiring adult supervision while the child uses the product is unreasonable because you cannot reasonably expect a parent to supervise a child who is sleeping in a play yard.

(Response 25) —The warning label that this commenter refers to can be found in section 9.4.2.11 of ASTM F406-12a, and it advises caregivers: “(a)lways provide the supervision necessary for the continued safety of your child. When used for playing, never leave child unattended.” This warning is intended to address the use of play yards as a play environment, not as a sleep environment. We agree with the commenter that a caregiver is not expected to continuously supervise a child who is sleeping in a play yard. This warning is intended for caregivers who are using the product as a play environment.

(Comment 26) —One commenter recommends that products be marked clearly to enable a consumer to determine if the product was manufactured after the play yard mandatory standard became effective. This would enable consumers to discern easily which products comply with the mandatory rule, and which were manufactured before the standard became effective.

(Response 26) —A date code is already required to be on the product, under section 9.1.1.2 of ASTM F406-12a. In addition, future changes to the standard may come into effect. Because it is not practicable to delineate every change to the standard through a new mark on the product, we decline to take action.

For the play yard final rule, we are incorporating by reference ASTM F406-12a. The final rule excludes sections of ASTM F406-12a that apply to non-full-size cribs exclusively. In this section, we: (1) summarize the requirements of ASTM F406-12a; and (2) describe the final rule, listing the excluded provisions of ASTM F406-12a that only apply to non-full-size cribs.

In the NPR (76 FR 58169 through 58170), we described, in detail, the key provisions of ASTM F406-11 that apply to play yards. ASTM F406-12a differs from ASTM F406-11 in the following ways:

• It includes the three changes to the play yard standard we proposed in the NPR, specifically two clarifications to the testing method used to measure the strength of the play yard floor, and one change to the Top Rail to Corner Post Attachment Test that would allow testers to choose the shape and area of the clamping surface, within a specified range. We reviewed the language that ASTM adopted and, while not exactly the same as the wording we proposed in the NPR, we believe it provides better clarity than what we proposed. By incorporating by reference ASTM F406-12a, we support the inclusion of these clarifications in the play yard mandatory standard.

• On its own initiative, the ASTM committee clarified the Top Rail to Corner Post Attachment Test, as well as the accompanying explanatory graphics. By incorporating by reference ASTM F406-12a, we support the inclusion of these clarifications in the play yard mandatory standard.

• A preload was added to the Mattress Vertical Displacement Test in order to improve testing consistency by ensuring that free movement of fabric is taken up before establishing the initial clamp position reference point. We also received a comment to the NPR suggesting this change. By incorporating by reference ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.

• An exemption was included in the Top Rail Configuration requirement to exclude play yards with side rails that fold upward. The side rails of most play yards move downward vertically. If the side rail latch mechanisms are not locked properly, they can form a dangerous V-shape. If the child's neck is caught in the V-shape, the child could suffocate. Play yards with side rails that fold upward, however, do not create this risk. We also received a comment to the NPR suggesting this change. By incorporating by reference of ASTM F406-12a, we support the inclusion of this clarification in the play yard mandatory standard.

The final play yard rule incorporates by reference ASTM F406-12a, with several exclusions for provisions that apply to non-full-size cribs only. In the Federal Register of December 28, 2010 (75 FR 81766), we issued a final rule on safety standards for non-full-size cribs. Thus, the final rule excludes provisions of ASTM F406-12a that apply to non-full-size cribs, including the following:

• Section 5.17 of ASTM F406-12a, containing the requirements for mattresses in rigid-sided products;

• Section 5.19 of ASTM F406-12a, containing a provision to prevent misassembly in non-full-size cribs;

• Section 5.20 of ASTM F406-12a, containing record keeping requirements for non-full-size cribs;

• The entirety of section 6 of ASTM F406-12a, containing the performance requirements for rigid-sided products;

• Sections 8.1 through 8.10.5 of ASTM F406-12a, containing the test methods for rigid-sided products;

• A portion of section 9.4.2.10 of ASTM F406-12a, containing warning label requirements for nonrectangular cribs; and

• Section 10.1.1.1 of ASTM F406-12a, containing instructional literature requirements for non-full-size cribs.

The Administrative Procedure Act (APA) generally requires that the effective date of a rule be at least 30 days after publication of the final rule. 5 U.S.C. 553(d).

We are providing a 6-month effective date, as proposed in the NPR. This will give suppliers sufficient time to come into compliance with the mandatory standard.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-605, requires that final rules be reviewed for their potential economic impact on small entities, including small businesses. Section 604 of the RFA requires that we prepare a final regulatory flexibility analysis when promulgating final rules. The final regulatory flexibility analysis must describe the impact of the rule on small entities and identify any alternatives that may reduce the impact. Specifically, the final regulatory flexibility analysis must contain:

1. A succinct statement of the need for, and objectives of, the rule;

2. A summary of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;

3. A description of, and an estimate of, the number of small entities to which the rule will apply, or an explanation of why no such estimate is available;

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

5. A description of the steps that the agency has taken to minimize the significant economic impact on small entities, consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule, and why each one of the other significant alternatives to the rule considered by the agency that affect the impact on small entities was rejected.

There are 21 domestic firms known to be producing or selling play yards in the United States. Ten are domestic manufacturers, and 11 are domestic importers. Under the U.S. Small Business Administration (SBA) guidelines, a manufacturer of play yards is small if it has 500 or fewer employees, and an importer is considered small if it has 100 or fewer employees. Based on these guidelines, nine domestic manufacturers and 10 domestic importers known to supply play yards to the U.S. market are small businesses. The remaining domestic entities are one large manufacturer and one large importer. There are also three foreign firms supplying play yards to the U.S. market. There may be additional unknown small manufacturers and importers operating in the U.S. market.

The Juvenile Products Manufacturers Association (JPMA) runs a voluntary certification program for juvenile products. Certification under the JPMA program is based on the most recent ASTM voluntary play yard standard, typically with a 6-month delay. Six of the nine small manufacturers produce play yards that are certified as compliant with the ASTM voluntary play yard standard by the JPMA. Of the importers, three import play yards that have been certified as compliant with the ASTM voluntary standard. One additional importer claims compliance with the ASTM standard but is not JPMA certified.

The extent to which each firm will be impacted by the play yard mandatory standard depends upon whether the firm's play yards currently comply with the ASTM voluntary standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs. Many of these firms are active in the ASTM standard development process, and compliance with the voluntary standard is part of an established business practice. Thus, it is likely that most of the firms that already comply with the ASTM standard would continue to do so, even in the absence of a mandatory regulation.

Six of the small manufacturers produce play yards known to comply with the voluntary standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs. For the three manufacturing firms whose play yards may not be compliant with the voluntary standard, the costs could be more significant. Meeting the existing voluntary standard could require manufacturers to redesign their product. The impact on manufacturers who produce noncompliant play yards may be mitigated if the costs are treated as new product expenses and amortized over time.

This scenario also assumes that the three firms whose play yards are not JPMA certified do not meet the voluntary standard. In fact, we have identified many instances in which a juvenile product not certified by the JPMA complies with the ASTM voluntary standard. To the extent that these firms already may supply play yards that meet the ASTM voluntary standard, the costs incurred would be lower.

Four of the 10 small importers produce play yards known to comply with the voluntary standard. Three are certified by the JPMA, and one additional firm claims compliance with the ASTM standard. Small firms whose play yards already comply with the voluntary standard will not incur any new costs.

The costs to the six importers whose play yards may not be compliant with the voluntary standard could be more significant. Importers of play yards would need to find an alternate source if their existing supplier does not come into compliance with the standard. Purchasing compliant, higher quality play yards could increase the cost of the product.

This will not be an option for two of the noncompliant play yard importers because they specialize in the importation of play yards from a specific foreign company. Thus, finding an alternative supply source is probably not an option for them. These firms could respond to the rule by discontinuing the import of play yards. The impact of this decision could be mitigated by replacing play yards with a different infant or toddler product. Deciding to import an alternative infant or toddler product would be a reasonable and realistic way to offset any lost revenue.

As with manufacturers, to the extent that some of the firms believed to supply noncompliant play yards actually may supply play yards that meet the ASTM voluntary standard, the costs incurred would be lower.

An alternative that could minimize the economic impact on small business is providing an effective date longer than 6 months. However, the JPMA, which represents many play yard manufacturers, felt that a 6-month effective date was adequate to allow suppliers to come into compliance with the mandatory standard. We agree. Therefore, we have chosen a 6-month effective date for the play yard mandatory standard.

We received several comments from the public in response to the initial regulatory flexibility analysis, including comments regarding the use of market data, the impact on small businesses, and the appropriate effective date. A summary of those comments and our responses can be found in part D of this preamble, titled, “Response to Comments on the Proposed Rule.”

The impact of the final play yard rule on firms supplying non-ASTM-compliant play yards could be significant. However, the requirements of the final rule address known play yard hazard patterns and will help reduce injuries and deaths. We are providing a 6-month effective date as proposed in the NPR. This will give suppliers sufficient time to come into compliance with the mandatory standard and spread the costs over a longer period of time.

The Commission's regulations address whether we are required to prepare an environmental assessment or an environmental impact statement. Our rules generally have “little or no potential for affecting the human environment,” and therefore, are exempt from any requirement to prepare an environmental assessment or impact statement. 16 CFR 1021.5(c)(1). This rule falls within the categorical exemption.

This rule contains information collection requirements that are subject to public comment and review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The preamble to the proposed rule (76 FR 58173 through 58174) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. Briefly, sections 9 and 10 of ASTM F406-12a contain requirements for marking, labeling, and instructional literature. These requirements fall within the definition of “collection of information,” as defined in 44 U.S.C. 3502(3).

OMB has assigned control number 3041-0152 to this information collection. We did not receive any comments regarding the information collection burden of this proposal. However, the final rule makes modifications regarding the information collection burden because the number of estimated suppliers subject to the information collection burden is now estimated to be 24 firms rather than the nine firms initially estimated in the proposed rule.

Accordingly, the estimated burden of this collection of information is modified as follows:

There are 24 known firms supplying play yards to the U.S. market. All 24 firms are assumed to use labels already on both their products and their packaging, but they might need to make some modifications to their existing labels. The estimated time required to make these modifications is about 1 hour per model. Each entity supplies an average of three different models of play yards; therefore, the estimated burden associated with labels is 1 hour per model × 24 entities × 3 models per entity = 72 hours. We estimate the hourly compensation for the time required to create and update labels is $28.36 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” September 2011, Table 9, total compensation for all sales and office workers in goods-producing private industries: http://www.bls.gov/ncs/ ). Therefore, the estimated annual cost to industry associated with the labeling requirements is $2,041.92 ($28.36 per hour × 72 hours = $2,041.92). There are no operating, maintenance, or capital costs associated with the collection.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection requirements of this final rule to the OMB.

Section 26(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may establish or continue in effect a requirement dealing with the same risk of injury, unless the state's requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules,” thus, implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when the rule becomes effective.

Once in effect, the final rule on play yards will make it unlawful for anyone to manufacture, distribute, or import a play yard into the United States that is not in conformity with the standard. 15 U.S.C. 2068(1). Pursuant to section 14(a)(2) of the CPSA, play yards must be certified by the manufacturer to the final standard based on testing conducted by a CPSC-accepted third party conformity assessment body. The third party testing and certification requirement for play yards will not be in effect until we issue a final notice of requirements (NOR). The final NOR establishes requirements for how third party conformity assessment bodies can become accepted by us to test play yards to the final rule. A proposed NOR for play yards was published in the Federal Register on May 24, 2012, as part of an NPR titled, “Requirements Pertaining to Third Party Conformity Assessment Bodies.” 77 FR 31086. When the final rule is effective and the NOR is final, third party conformity assessment bodies can apply to us for acceptance of their accreditation to test play yards. Play yard manufacturers will be required to certify products to the final play yard rule based on third party testing once we have accepted the accreditation of such laboratories.

Therefore, the Commission amends Title 16 of the Code of Federal Regulations by adding part 1221 to read as follows:

In a notice published in the Federal Register of December 17, 2009 (74 FR 66979), FDA announced that a food additive petition (FAP 9A4779) had been filed by Lallemand, Inc., c/o Dennis T. Gordon, 117 N. Welcome Slough Rd., Puget Island, Cathlamet, WA 98612. The petition proposed to amend the food additive regulations in part 172— Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172), to provide for the safe use of vitamin D 2 bakers yeast as a dual purpose nutrient supplement and leavening agent or dough relaxer in yeast-containing baked products at levels not to exceed 400 IU of vitamin D 2 per 100 g in the finished food. The specific foods identified by the petition in which the additive will be used are yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods. After the notice was published, Lallemand amended the petition to exclude the proposed use of the additive as a dough relaxer.

Vitamin D, 1 including Vitamin D 2 , is affirmed as generally recognized as safe (GRAS) for use in food as a nutrient supplement in § 184.1950(c)(1) (21 CFR 184.1950(c)(1)) in accordance with § 184.1(b)(2) (21 CFR 184.1(b)(2)), with the following specific limitations:

Additionally, under §§ 184.1950(c)(2) and (c)(3), vitamin D is affirmed as GRAS for use in infant formulas and margarine, respectively. Under § 172.380, vitamin D 3 is approved for use as a nutrient supplement in calcium-fortified fruit juices and fruit juice drinks; meal replacement and other type bars, soy protein-based meal replacement beverages represented for special dietary use in reducing or maintaining body weight; and cheese and cheese products as defined therein. Under § 172.379, vitamin D 2 is approved for use as a nutrient supplement in soy beverages, soy beverage products, soy-based butter substitute spreads, and soy-based cheese substitutes and soy-based cheese substitute products.

Vitamin D 2 , also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The additive that is the subject of this petition is vitamin D 2 bakers yeast that is produced by exposing bakers yeast ( Saccharomyces cerevisiae ) to ultraviolet (UV) light, resulting in increased conversion of endogenous ergosterol to ergocalciferol. The vitamin D 2 in the UV light-treated bakers yeast is the same substance affirmed as GRAS in § 184.1950 and approved for use as a nutrient supplement in § 172.379.

Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism such as rickets in children or osteomalacia in adults. Excessive intake of vitamin D elevates blood plasma calcium levels by increased intestinal absorption and/or mobilization from the bone.

To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as GRAS with specific limitations as listed in § 184.1950. Under § 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950.

To support the safety of the proposed uses of vitamin D 2 bakers yeast, Lallemand performed analyses for the presence of any potential toxic precursor sterol components in UV light-treated bakers yeast. In addition, Lallemand submitted dietary intake estimates of vitamin D from the proposed uses of vitamin D 2 bakers yeast, currently-regulated uses of vitamin D, and from naturally-occurring sources of vitamin D. They compared these intake estimates to the Tolerable Upper Intake Level (UL) for vitamin D established by the Institute of Medicine (IOM) of the National Academies. Lallemand also submitted a number of publications pertaining to human clinical studies on vitamin D. Based on this information, which is discussed in section II of this document, Lallemand concluded that the proposed uses of vitamin D 2 bakers yeast in yeast-leavened baked products are safe.

To support the safety of UV light-treated bakers yeast, Lallemand performed analyses to demonstrate that UV light treatment of bakers yeast does not produce additional sterols of toxicological concern. Lallemand provided chromatograms of extracts of UV light-treated and non-UV light-treated bakers yeast, and identified the substances present in the yeast extracts. One of the substances identified, tachysterol, is a photoisomer resulting from UV light treatment of the vitamin D precursor, pre-vitamin D. Tachysterol is a biologically inactive pre-vitamin form of vitamin D. Lallemand concluded that the small amount of tachysterol present in vitamin D 2 bakers yeast was insignificant and did not pose a toxicological concern.

A second photoisomer, lumisterol, is also typically formed from UV light treatment of pre-vitamin D. Lallemand reported that they did not detect lumisterol in the UV light-treated samples. Because tachysterol is reported as the predominant photoisomer produced at the UV wavelength used to make vitamin D 2 bakers yeast, it is reasonable that lumisterol would not be present at a detectable amount.

Other substances identified from the chromatograms were pre-vitamin D 2 (nonactive form of vitamin D 2 ), vitamin D 2 , and ergosterol (naturally present in yeast). No other substances related to UV light treatment of bakers yeast were observed.

To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, FDA considers the projected human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to the Agency. FDA compares an individual's estimated daily intake (EDI) of the additive from all food sources to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all food sources of the additive. The Agency commonly uses the EDI for the 90th percentile consumer of a food additive as a measure of high chronic dietary intake.

Lallemand provided mean and 90th percentile vitamin D intake estimates for consumers of yeast-leavened baked products from: (1) The proposed food uses of vitamin D 2 bakers yeast; (2) current food uses of vitamin D (including regulated uses, naturally-occurring sources of vitamin D, and dietary supplements); and (3) combined current and proposed food uses. Lallemand provided intake estimates for the overall U.S. population (1 year of age and older) and nine population subgroups (including infants less than 12 months of age). The Agency has determined that the methodology used to calculate these estimates is appropriate.

Lallemand's estimate of intake of vitamin D from all food sources for the overall U.S. population (1 year of age and older), including consumers of the yeast-leavened baked products identified in the petition, was 1,670 IU per person per day (IU/p/d) for the 90th percentile consumer. For the population subgroup of infants less than 12 months of age, including consumers of the yeast-leavened baked products identified in the petition, the dietary intake of vitamin D from all food sources was estimated to be 969 IU/p/d for the 90th percentile consumer. FDA concurs with these intake estimates.

In 1997, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at the IOM conducted an extensive review of toxicology and metabolism studies on vitamin D published through 1996. The IOM published a detailed report that included a UL for vitamin D for infants, children, and adults. At that time, the IOM established a UL for vitamin D of 2,000 IU/per day (p/d) for children 1 to 18 years of age and adults. The UL for all infants was 1,000 IU/p/d.

More recently, the IOM conducted an extensive review of relevant published scientific literature on vitamin D to update current dietary reference intakes and ULs for vitamin D. Based on more recent information, the IOM revised the ULs for vitamin D and developed a report on their findings. 2 In their current assessment of vitamin D, the IOM determined a UL of 1,000 IU/p/d for infants 0 months to 6 months of age and a UL of 1,500 IU/p/d for infants 6 months to 12 months of age. For children 1 year to 3 years of age, the UL was determined to be 2,500 IU/p/d; for children 4 years to 8 years of age, the UL was determined to be 3,000 IU/p/d. For children 9 years to 18 years of age and adults, the UL was determined to be 4,000 IU/p/d.

The IOM considers the UL as the highest usual intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients and considers intake from all sources: food, water, nutrient supplements, and pharmacological agents. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and an uncertainty factor.

FDA reviewed and evaluated the information submitted by Lallemand regarding the safety of UV light-treated bakers yeast. FDA concludes that the use of UV light-treated bakers yeast does not pose a safety concern, since the UV light treatment has been shown not to produce any new components of toxicological concern that could be introduced into the diet (see section II.A of this document).

In addition, FDA reviewed and evaluated the information submitted by Lallemand regarding the safety of the dietary intake of vitamin D 2 that would result from the proposed uses of vitamin D 2 bakers yeast. Lallemand submitted scientific articles published subsequent to the 1997 IOM report and issuance of the March 16, 2009, final rule (74 FR 11019) for the use of vitamin D 2 in soy-based food products. Lallemand concluded that these recent publications continue to support vitamin D supplementation in humans. FDA concurs with Lallemand's conclusion.

FDA considered the ULs established by the IOM relative to the intake estimates provided by Lallemand as the primary basis for assessing the safety of petitioned uses of vitamin D. FDA also reviewed the scientific articles submitted by Lallemand. Finally, FDA reviewed studies on vitamin D that have published since the Agency's evaluation of four previous food additive petitions for fortifying a variety of foods with vitamin D. The most recent petition resulted in FDA's amendment of the food additive regulations in § 172.379 to allow for the safe use of vitamin D 2 as a nutrient supplement in soy-based food products (74 FR 11019, March 16, 2009). The three earlier food additive petitions also resulted in amendments of the food additive regulations to allow for the safe use of vitamin D 3 as a nutrient supplement in certain foods (70 FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June 22, 2005; and 68 FR 9000, February 27, 2003).

Depending on the age group, the IOM ULs for the U.S. population 1 year of age and older range from 2,500 IU/p/d to 4,000 IU/p/d. The estimated intake of vitamin D from all food sources, including the proposed uses, at the 90th percentile for the overall U.S. population (1 year of age and older) is estimated to be 1,670 IU/p/d, which is below the lowest IOM UL in the range of ULs for the overall U.S. population (1 year of age and older). For infants less than 12 months of age, the estimated intake of vitamin D from all food sources, including the proposed uses, at the 90th percentile is 969 IU/p/d, which is below both the IOM UL of 1,000 IU/p/d for infants 0 months to 6 months of age and the IOM UL of 1,500 IU/p/d for infants 6 months to 12 months of age. Because the 90th percentile EDI of vitamin D from all current and proposed food sources calculated for each population group is less than the corresponding IOM UL for that population group, the Agency concludes that dietary intake of vitamin D 2 bakers yeast from its proposed uses as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products will not pose a safety concern.

Based on all data relevant to vitamin D 2 bakers yeast reviewed by the Agency, FDA concludes that there is a reasonable certainty that no harm will result from the use of vitamin D 2 bakers yeast as a source of vitamin D 2 and as a leavening agent in yeast-leavened baked products within the limits proposed by Lallemand. Thus, vitamin D 2 bakers yeast is safe for the proposed uses, and the Agency concludes that the food additive regulations should be amended as set forth in this document.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 171.1(h), the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The Agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 9A4779 (74 FR 66979). No new information or comments have been received that would affect the Agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) either electronic or written objections. Each objection must be separately numbered, and each numbered objection must specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested must specifically so state. Failure to request a hearing for any particular objection constitutes a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested must include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection constitutes a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FDA's review of this petition was limited to section 409 of the FD&C Act (21 U.S.C. 348). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is amended as follows:

EPA is taking final action to determine that the Bristol Area (comprising the portion of Sullivan County bounded by a 1.25 kilometer radius surrounding the Universal Transverse Mercator (UTM) coordinates 4042923 meters E, 386267 meters N, Zone 17, which surrounds the Exide Technologies Facility) has attaining data for the 2008 lead NAAQS. This clean data determination is based upon quality assured, quality controlled and certified ambient air monitoring data that shows the Area has monitored attainment of the 2008 lead NAAQS based on the 2009-2011 data. While still preliminary, the available 2012 monitoring data also monitored attainment for the 2008 lead NAAQS.

Other specific requirements of the clean data determination and the rationale for EPA's action are explained in the Notice of Proposed Rulemaking (NPR) published on June 14, 2012 (77 FR 35652) and will not be restated here. The comment period closed on July 16, 2012. No comments, adverse or otherwise, were received in response to the NPR.

This final action suspends the requirements for this Area to submit an attainment demonstration, associated RACM, RFP plan, and contingency measures for failure to meet RFP and attainment deadlines so long as this Area continues to meet the 2008 lead NAAQS. Finalizing this action does not constitute a redesignation of the Bristol Area to attainment for the 2008 lead NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further, finalizing this action does not involve approving a maintenance plan for the Area as required under section 175A of the CAA, nor does it involve a determination that the Area has met all requirements for a redesignation.

EPA is taking final action to determine that the Bristol Area has attaining data for the 2008 lead NAAQS. This clean data determination is based upon quality assured, quality controlled, and certified ambient air monitoring data showing that this Area has monitored attainment of the 2008 lead NAAQS during the period 2009-2011. This final action suspends the requirements for this Area to submit an attainment demonstration, associated RACM, RFP plans, and contingency measures for failure to meet RFP and attainment deadlines so long as this Area continues to meet the 2008 lead NAAQS. EPA is taking this final action because it is in accordance with the CAA and EPA policy and guidance.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action makes the determination based on air quality data, and suspends certain federal requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ). Because this rule makes a determination based on air quality data and suspends certain federal requirements, it 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). This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it only proposes to make a determination based on air quality data and suspend certain federal requirements, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it proposes to determine that air quality in the affected area is meeting federal standards. The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply because it would be inconsistent with applicable law for EPA, when determining the attainment status of an area, to use voluntary consensus standards in place of promulgated air quality standards and monitoring procedures that otherwise satisfy the provisions of the CAA. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ). Under Executive Order 12898, EPA finds that this rule involves a proposed determination of attainment based on air quality data and will not have disproportionately high and adverse human health or environmental effects on any communities in the area, including minority and low-income.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 29, 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 the determination of attaining data for the 2008 lead standard for the Bristol 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:

On July 13, 2011, the Puerto Rico Environmental Quality Board (PREQB) submitted to EPA a request for approval of revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution (PRRCAP). In the context of the Clean Air Act (CAA or Act), the Commonwealth of Puerto Rico is regarded as a state. Generally the changes to the PRRCAP involve administrative changes which improve the clarity of the rules. They do not change the emission limitations nor add significant new requirements.

On March 22, 2012 (77 FR 16676), EPA published a direct final rule that approved the revisions to the Puerto Rico Regulations for the Control of Atmospheric Pollution that were submitted to EPA by PREQB on July 13, 2011. EPA also published a proposed rule on March 22, 2012 (77 FR 16795). In the direct final rule, EPA stated that if we received adverse comments by April 23, 2012, the rule would be withdrawn and not take effect. EPA received an adverse comment and withdrew the direct final rule on May 29, 2012 (77 FR 31499). Based upon the proposed action published on March 22, 2012 (77 FR 16795), EPA is addressing the comment received in this final action. EPA is not instituting a second comment period on this action.

Most of the revisions consist of clarification type changes such as public law or code cites or word changes. A summary of the various revisions is given below. EPA has determined that the revisions improve the effectiveness of the PRRCAP and will have no negative effect on maintaining the national ambient air quality standards.

PREQB revised two definitions in the revised Rule 102. They include the definition for “Volatile Organic Compounds (VOC)” and the definition for “Applicable Rule and Regulation.” PREQB revised the VOC definition to make it consistent with EPA's definition for VOC found in 40 CFR section 51.100(s). The revision to the “Applicable Rule and Regulation” definition includes a change to the citation of Puerto Rico's Environmental Public Policy Act. It was previously referenced in the definition as Law No. 9 of June 18, 1970. That Law was replaced by Law No. 416 of September 22, 2004.

PREQB also revised Appendix A to the PRRCAP. PREQB revised Appendix A to make it consistent with EPA's amended list of hazardous air pollutants in CAA section 112. Appendix A is referenced in the federally approved definition of Rule 102—“Hazardous Air Pollutant” of the PRRCAP.

PREQB revised Rules 111 and 115 in order to change the citation to Puerto Rico's Environmental Public Policy Act. It was previously referenced in Rules 111 and 115 as Law No. 9 of June 18, 1970. That Law was replaced by Law No. 416 of September 22, 2004.

PREQB revised Rule 116 in order to revise the citation of the applicable Puerto Rico code. Rule 116 previously referenced Article 329 of the Penal Code of Puerto Rico and this reference was replaced with Article 277 of the Civil Prosecution Code of Puerto Rico.

None of the revisions to Rules 102, 111, 115, 116 or Appendix A of the PRRCAP involve changing the stringency of these provisions. EPA has thoroughly reviewed all of the revisions contained in these rules and has determined they meet EPA guidance and requirements; therefore, EPA is approving these revised rules. However, with regard to the revisions to the definition of VOC in Rule 102 and Appendix A, which are intended to achieve consistency with the CAA Section 112 list of chemicals, it is important to note that the CAA Section 112 list could potentially be revised by EPA and, for federal enforcement purposes, EPA will rely on the federally issued CAA Section 112 list.

PREQB also submitted a revision to Rule 609(g), “Confidential information” of the PRRCAP on July 13, 2011. The revisions to Rule 609 include the citation for Puerto Rico's Environmental Public Policy Act. It was previously referenced as Law No. 9 of June 18, 1970. That Law has subsequently been replaced by Law No. 416 of September 22, 2004. Rule 609 was never approved into the federally enforceable SIP for Puerto Rico since the provisions of Rule 609 are relevant to the Title V of the Act requirements. The federally approved SIP reflects only Title I of the Act requirements and not Title V. Therefore, EPA is not approving the revisions to Rule 609 into the federally enforceable Puerto Rico SIP. However, EPA is approving the revision to Rule 609 as part of the federally approved Puerto Rico Title V operating permits program. Rule 609 and the Puerto Rico Title V program were previously approved by EPA on February 26, 1996 (61 FR 7073).

On March 22, 2012 (77 FR 16676), EPA proposed to approve the revisions to the PRRCAP, submitted to EPA by the Puerto Rico Environmental Quality Board on July 13, 2011.

In response to EPA's March 22, 2012 proposed rulemaking action, EPA received one comment from Aida T. Fuentes Rivera, MPH.

Comment: The commentor states that there are other volatile organic compounds that have the potential to volatilize and produce adverse health effects, but are neither subject to the PRRCAP Rule 102 definition for VOCs, nor included in the section 112(b) Hazardous Air Pollutant (HAP) list. The commentor suggests that Puerto Rico harmonize all of its rules to clarify the applicability of all sources of VOCs, not just those sources applicable to Rule 102, National Emission Standards from Hazardous Air Pollutants (NESHAPs) or New Source Performance Standards (NSPS) or other federal requirements.

Response: EPA is approving a revision to the PRRCAP to include, among other things, the federal definition of “VOC” into Rule 102. This definition is consistent with the existing federal definition of VOC found in 40 CFR section 51.100(s). EPA is acting on a request by the PREQB to include such definition into its SIP. Incorporation of the definition into the Puerto Rico SIP does not impose any new requirements, i.e., emission rates, reporting or recordkeeping. It is PREQB's prerogative should they subsequently decide to revise their SIP approved regulations, i.e., Rules 102 and 206 (Rule 419 and Appendix B are not part of the federally approved Puerto Rico SIP), to include a discussion of those rules' applicability to sources not otherwise affected by NESHAPs, NSPS or other federal requirements. However, that is not necessary for EPA approval of the definition of VOC into the SIP, nor is that part of PREQB's request for which EPA is taking this action. EPA suggests the comment would be more appropriately directed towards PREQB during the public hearing process associated with any subsequent and relevant revisions to the PRRCAP. Also, it is important to note that approved implementation plans or SIPs pursuant to section 110 of the CAA are required to include provisions necessary to implement, maintain and enforce the criteria pollutants or national ambient air quality standards and not directly HAPs or air toxics.

The revisions to Rules 102, 111, 115, 116 and Appendix A of the PRRCAP, effective February 18, 2011, are generally administrative changes, which improve the clarity of the rules. They do not change emission limitations nor add significant new requirements. EPA has thoroughly reviewed all of the revisions contained in these rules and has determined they meet EPA guidance and requirements. EPA is therefore approving revised PRRCAP Rules 102, 111, 115, 116 and Appendix A into the SIP. In addition, EPA is approving revised Rule 609 of the PRRCAP, effective February 18, 2011, as part of the federally approved Puerto Rico Title V operating permits program.

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

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

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 29, 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 may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations 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 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).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0564 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 October 29, 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-2011-0564, by one of the following methods:

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

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

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

In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-9), 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 1E7885) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.439 be amended by establishing tolerances for residues of the herbicide thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl) amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, in or on chicory, roots at 0.01 parts per million (ppm) and chicory, tops at 0.01 ppm. That notice referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 thifensulfuron methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thifensulfuron methyl 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.

Thifensulfuron methyl has mild to low acute toxicity when administered via the oral, inhalation and dermal routes of exposure. It has moderate to low toxicity with respect to eye and skin irritation and is not a dermal sensitizer. Most findings in the submitted studies related to decreases in body weights, body weight gains, or organ weights (a reflection of the lower body weights compared with control weights). There were increased liver weights in male dogs and increased thyroid/parathyroid weights in female dogs. There were no gross or histopathological changes reported in any of the studies.

In the rat developmental study, there were no maternal effects at the highest dose tested (HDT). The rabbit developmental study showed a decrease in maternal body weights at the HDT. There were no developmental effects at the HDT. In the 2-generation rat reproduction study there were no parental, reproductive or offspring effects. There was an increase in quantitative susceptibility in the rat developmental study, based on decreased mean fetal body weights, and an increase in the incidence of small renal papillae (only at the highest dose level).

Neurotoxicity was not observed in any of the submitted studies, including the recently submitted neurotoxicity studies which are currently under review. Based on the lack of neurotoxicity in the submitted studies, a developmental neurotoxicity study (DNT) is not required. A decrease in spleen weight was noted only in mid-dose males in the subchronic rat study, and was considered a potential sign of immunotoxicity. However, in the recently submitted immunotoxicity study in female rats, dosing with thifensulfuron methyl did not affect any immunotoxicity parameters up to the HDT of 529 milligrams//kilograms/day.

Thifensulfuron methyl is classified as “not likely to be carcinogenic to humans,” based on acceptable chronic/carcinogenicity studies in rats and mice at doses that are considered to be adequate, and not excessive for the determination of carcinogenic potential; there were no tumors observed in the studies, and the only adverse effects were decreased body weights and body weight gains. The available mutagenicity studies in vivo and in vitro show that thifensulfuron methyl is neither mutagenic nor clastogenic.

Specific information on the studies received and the nature of the adverse effects caused by thifensulfuron-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Thifensulfuron Methyl. Human Health Risk Assessment for the Proposed Use of the Herbicide on Chicory” on pages 30-33 in docket ID number EPA-HQ-OPP-2011-0564.

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

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thifensulfuron methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing thifensulfuron methyl tolerances in 40 CFR 180.439. EPA assessed dietary exposures from thifensulfuron methyl 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 thifensulfuron methyl. 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, EPA assumed 100 percent crop treated (PCT) and tolerance level residues 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 assumed 100 PCT and tolerance level residues for all commodities.

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for thifensulfuron methyl. Tolerance level residues and 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 thifensulfuron methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thifensulfuron methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

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 thifensulfuron methyl for acute exposures are estimated to be 4.429 parts per billion (ppb) for surface water and 0.0972 ppb for ground water. For chronic exposures for non-cancer assessments the EDWCs are estimated to be 1.5 ppb for surface water and 0.0972 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 4.429 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 1.5 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).

Thifensulfuron methyl 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 thifensulfuron methyl to share a common mechanism of toxicity with any other substances, and thifensulfuron methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thifensulfuron methyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (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. The prenatal and postnatal toxicology database for thifensulfuron methyl includes rat and rabbit prenatal developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was evidence of increased quantitative susceptibility in the rat developmental toxicity study. At the HDT, decreased mean fetal weights, and an increase in incidence of small renal papillae were observed in the absence of maternal toxicity. There was no indication of pre- or post-natal susceptibility in the rabbit developmental or rat reproduction studies.

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 thifensulfuron methyl is complete.

ii. There is no indication that thifensulfuron methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. Although there was evidence of increased quantitative susceptibility in the rat developmental study, the Agency's degree of concern for the increased susceptibility is low because it was only observed in the rat developmental toxicity study and not seen in the rabbit developmental or reproduction studies, and was observed at doses considerably higher than the doses chosen for risk assessment; in addition, there was a clear NOAEL for the fetal effects, and therefore EPA's risk assessment is protective of the potential susceptibility.

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 thifensulfuron methyl in drinking water. These assessments will not underestimate the exposure and risks posed by thifensulfuron methyl.

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 thifensulfuron methyl will occupy less than 1% of the aPAD for females 13-49 years old, the only population subgroup of concern.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to thifensulfuron methyl from food and water will utilize 1.4% of the cPAD for children 3-5 years old, the population group receiving the greatest exposure. There are no residential uses for thifensulfuron methyl.

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

A short- and intermediate-term adverse effect was identified; however, thifensulfuron methyl is not registered for any use patterns that would result in either short- and/or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- and/or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- and intermediate-term risk), no further assessment of short- and intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for thifensulfuron methyl.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, thifensulfuron methyl is not expected to pose a cancer risk to humans.

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

Adequate enforcement methodology (liquid chromatograpy/mass spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 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 a MRL for thifensulfuron methyl in or on chicory roots and/or tops.

Therefore, tolerances are established for residues of thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-ylamino]carbonyl]amino] sulfonyl]-2-thiophenecarboxylate, in or on chicory roots at 0.01 ppm and chicory tops at 0.01 ppm.)

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (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. 801 et 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 the Federal 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. General Information A. Does this action apply to me?

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0521 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 October 29, 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 (excluding 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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0521, by one of the following methods:

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

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

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

In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-1), 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 1E7878) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.361 be amended by establishing tolerances for residues of the herbicide pendimethalin, N -(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347), in or on lettuce, leaf at 3.0 parts per million (ppm); Brassica, leafy greens, subgroup 5B at 0.2 ppm; turnip greens at 0.2 ppm; melons subgroup 9A at 0.1 ppm; vegetable, soybean, succulent at 0.1 ppm; and small fruit vine climbing subgroup 13-07E, except grape at 0.1 ppm. That notice referenced a summary of the petition prepared by BASF, 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 modified the level for which the tolerance is being established for leaf lettuce. The reason for this change is 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 pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin 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.

Pendimethalin has low acute oral, dermal, and inhalation toxicity, and is not a dermal sensitizer. The thyroid is a target organ for pendimethalin. Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones, increased thyroid weight, and microscopic thyroid lesions. Due to these effects, the Agency required that a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. A developmental thyroid study was submitted and demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin. The available prenatal and postnatal developmental toxicity data provided no indication of qualitative or quantitative susceptibility to the young. The overall weight of evidence suggests that this chemical does not directly target the immune system. There is no evidence of neurotoxicity for pendimethalin exposure.

The points of departure (PODs) used for the chronic and short-term risk assessments were based on a 92-day thyroid function study in rats, a 56-day thyroid study in rats, and a 14-day intra thyroid metabolism study in rats. Due to several important quantitative dynamic differences between rats and humans with respect to thyroid function, the interspecies uncertainty factor ((UF); used to account for animal to human differences in toxicokinetics and toxicodynamics) was reduced to 3X for the chronic and short-term risk assessments. A 10X interspecies UF was used in the acute risk assessment because the POD was based on an acute neurotoxicity study, not a thyroid study. The use of an oral POD, assuming 100 percent inhalation absorption is considered protective for assessing short-term inhalation exposure since pendimethalin has a low vapor pressure (1.24 x 10 −8 Millimeter (mm) mercury (Hg) at 20°C) and is not likely to volatilize substantially. It also has a relatively low solubility in water (0.275 ppm at 25 °C). Further, the EPA has determined a subchronic inhalation study is not needed at this time.

Pendimethalin is considered a possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid folliculate cell adenomas in male and female rats. A threshold approach is being used to evaluate cancer risk because mode of action studies are available demonstrating that the thyroid tumors are due to a thyroid-pituitary imbalance (a threshold effect), and also because pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ cells.

Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov, on pp. 51-54 in the document titled “ Revised Pendimethalin: Human Health Risk Assessment for Proposed Use on Leaf lettuce; Leafy brassica greens; Melons; Edamame; Kiwi and other small fruit vines ” in docket ID number EPA-HQ-OPP-2011-0521.

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

A summary of the toxicological endpoints for pendimethalin 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 pendimethalin, EPA considered exposure under the petitioned-for tolerances as well as all existing pendimethalin tolerances in 40 CFR 180.361. EPA assessed dietary exposures from pendimethalin 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 pendimethalin. 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 assumed 100 percent crop treated (PCT) and tolerance-level residues for all current and proposed crops.

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 assumed 100 PCT and tolerance-level residues for all current and proposed crops.

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 pendimethalin. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for pendimethalin. Tolerance level residues and 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 pendimethalin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pendimethalin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models the estimated drinking water concentrations (EDWCs) of pendimethalin for acute exposures are estimated to be 80.5 parts per billion (ppb) for surface water and 0.036 ppb for ground water; and for chronic exposures are estimated to be 6.2 ppb for surface water and 0.036 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 80.5 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 6.2 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).

Pendimethalin is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: For handlers, it is assumed that most residential use will result in short-term (1 to 30 days) dermal and inhalation exposures. Residential handlers are assumed to be wearing short-sleeved shirts, short pants, shoes and socks during application of pendimethalin.

Residential post-application exposure is assumed to be short-term (1-30 days) in duration, resulting from the following: physical activities on turf: adults (dermal) and children 1-2 years old (dermal and incidental oral); mowing: adults (dermal) and children 11 < 16 years old (dermal); and golfing: adults (dermal), children 11 < 16 years old (dermal), and children 6 < 11 years old (dermal).

EPA did not combine exposure resulting from adult handler and post-application exposure resulting from treated lawns and/or golfing because of the conservative assumptions and inputs within each estimated exposure scenario. The Agency believes that combining exposures resulting from handler and post-application activities would result in an overestimate of adult exposure. EPA selected the most conservative adult residential scenario (adults 50+ years old; dermal post-application exposure) as the contributing source of residential exposure to be combined with the dietary exposure for the aggregate assessment.

The children's oral exposure is based on post-application hand-to-mouth exposures. To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth could result in a very conservative estimation of exposure, as it would overestimate the potential for oral exposure. However, there is potential for co-occurrence of the dermal and oral exposure based on the use pattern and combining them is appropriate because risk estimated from the dermal and oral routes of exposure are based on the same toxicological study. As a result, the children's aggregate assessment combines post-application dermal and oral exposure along with dietary exposure from food and water.

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

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

EPA has not found pendimethalin to share a common mechanism of toxicity with any other substances, and pendimethalin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pendimethalin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There was no indication of pre- and/or post-natal qualitative or quantitative increased susceptibility in the developmental studies in rats and rabbits or the 2-generation reproduction studies in rats. In addition, a developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

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 pendimethalin is complete.

ii. There is no indication that pendimethalin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that pendimethalin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In addition, a developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

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 pendimethalin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pendimethalin.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and 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 pendimethalin will occupy 2.0% of the aPAD for all infants less than 1 year 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 pendimethalin from food and water will utilize 1.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pendimethalin is not expected.

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).

Pendimethalin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pendimethalin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 125 for adults and 93 for children 1-2 years old, the two population subgroups receiving the greatest combined dietary and non-dietary exposure. Because EPA's level of concern for pendimethalin is a MOE of 30 or below, these MOEs are not of concern.

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).

An intermediate-term adverse effect was identified; however, pendimethalin is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pendimethalin.

5. Aggregate cancer risk for U.S. population. Pendimethalin is considered a “possible human carcinogen” based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. A non-quantitative approach (i.e., non-linear, RfD approach) was used since mode of action studies are available to demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ cells. The chronic dietary risk assessment is considered to be protective of any cancer effects.

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 pendimethalin residues.

PAM Volume II lists four Gas Chromatography/Electron Capture Detector (GC/ECD), methods for the determination of pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite in plant commodities. Methods I and III determine residues of the parent, whereas Methods II and IV determine residues of the 3,5-dinitrobenzyl alcohol metabolite.

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 pendimethalin on any of these new uses.

The proposed tolerance of 3.0 ppm on leaf lettuce is being increased to 4.0 ppm. This is because the Agency used the Organization of Economic Cooperation and Development (OECD) tolerance calculation procedures in determining appropriate tolerance levels, whereas the petitioner used the North American Free Trade Agreement (NAFTA) tolerance calculation procedures.

Therefore, tolerances are established for residues of pendimethalin, N -(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347), in or on lettuce, leaf at 4.0 ppm; Brassica, leafy greens, subgroup 5B at 0.20 ppm; turnip greens at 0.20 ppm; melon subgroup 9A at 0.10 ppm; vegetable, soybean (edamame) at 0.10 ppm; and fruit, small vine climbing subgroup 13-07E, except grape at 0.10 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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 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 under FOR FURTHER INFORMATION CONTACT .

In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 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-2010-0217 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 29, 2012.

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 that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2010-0217, by one of the following methods:

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

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

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

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

In the Federal Register of May 6, 2011 (76 FR 26291) (FRL-8870-3), 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 1F7832) by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596. The petition requested that 40 CFR 180.586 be amended by establishing tolerances for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on rice, grain at 0.01 ppm. That notice referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Valent U.S.A. Corporation requested tolerances for residues of clothianidin to support rice, grain uses.

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 the petitioned-for tolerances for residues of clothianidin in or on rice, grain at 0.01 ppm. EPA's assessment of exposures and risks associated with clothianidin 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.

EPA considered the toxicity of clothianidin as well as several metabolites and degradates in conducting this risk assessment. Metabolites/degradates of concern in plants include parent and TMG for leafy and root and tuber vegetables; parent-only for other crops; and parent, TZNG and MNG for rotational crops. For livestock commodities, the metabolites/degradates of concern include: Parent and TZU, TZG, TZNG and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate for poultry. Acute toxicity and genotoxicity data are available for several metabolites/degradates of clothianidin. Given that the points of departure used for risk assessment are well below the LD 50 levels observed in the acute toxicology studies and that clothianidin and its metabolites/degradates of toxicological concern are similar in structure, EPA is assuming that these compounds are toxicologically equivalent to clothianidin with respect to the endpoints being used for risk assessment.

Clothianidin and its metabolites and degradates have relatively low acute toxicity via oral, dermal and inhalation routes of exposure; however, acute oral administration of clothianidin in mouse and the TMG metabolite in rat showed evidence of increased relative toxicity. There is no evidence of dermal sensitization or eye irritation with the exception of the clothianidin-triazan intermediate, which is a dermal sensitizer. The available data indicate that there are no consistent target organs in mammals; however, some effects noted in the liver, hematopoietic system and kidney are similar to effects from other neonicotinoid insecticides.

In subchronic oral studies, the dog seemed to be more sensitive to clothianidin than the rat. In addition to decreases in body weight and body weight gains observed in both animals, dogs also displayed decreased white blood cells, albumin and total protein, as well as some anemia. Long-term dietary administration of clothianidin did not result in a wider spectrum of effects in the dog; in contrast, the chronic feeding studies in rats showed additional effects in the liver, ovaries and kidneys. In the mouse chronic oral study, increases in vocalization and decreases in body weight and body weight gain were noted.

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

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

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

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

Specific information on the studies received and the nature of the adverse effects caused by clothianidin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Clothianidin: Human Health Risk Assessment for Requested Foliar Uses on Rice, Seed Treatment on Leafy Vegetables, Increased Application Rate for Vegetables, and Expanded Uses on Fruiting Vegetables and Pome Fruit.” in docket ID number EPA-HQ-OPP-2010-0217.

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

A summary of the toxicological endpoints for Clothianidin used for human risk assessment is shown in Table 1 of this unit.

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

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

Such effects were identified for clothianidin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food from use of clothianidin, EPA used maximum field trial values, empirical processing factors and assumed 100 percent crop treated (PCT) for all commodities. Clothianidin is a major metabolite of thiamethoxam, and there are a number of crops for which uses of both clothianidin and thiamethoxam have been registered. The labels for the various end-use products containing these active ingredients prohibit the application of both active ingredients to the same crop during a growing cycle. Due to that restriction and the assumption of 100 PCT, a single value reflecting the greatest clothianidin residue from either active ingredient has been used for crops listed for use with both active ingredients (versus combined estimates from clothianidin and from thiamethoxam). Generally, this assessment uses the established or recommended clothianidin tolerance for crops having tolerances for both compounds (the exception being low-growing berry, subgroup 13-07G, which is based on observed clothianidin residues in thiamethoxam strawberry field trials). For foods with thiamethoxam tolerances but without clothianidin tolerances, maximum residues of clothianidin observed in thiamethoxam field trials have been used in these assessments. These include meats, meat by-products, artichoke, tropical fruits, coffee, hop, mint, rice, and strawberry. The metabolism of clothianidin is complex, with a few major (> 10% of the total radioactive residues) and numerous minor metabolites. Metabolites/degradates of concern in plants include clothianidin and TMG for leafy and root and tuber vegetables; parent-only for other crops; and parent, TZNG and MNG for rotational crops. For livestock commodities, the metabolites of concern include: parent and TZU, TZG, TZNG, and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate for poultry. For leafy vegetables the EPA required analysis for residues of TMG along with parent in field trial samples. Residues of TMG were shown to occur in leafy vegetables at levels approximately 10-fold below those of clothianidin. EPA has not included these metabolites in the tolerance expression for plant or animal commodities because the metabolites are only found in certain commodities, including the metabolites would create tolerance harmonization issues with Canada, and monitoring residues of clothianidin based on parent only would be representative of total clothianidin residues and thus adequate for enforcement. Because the metabolites are not included in the tolerance expressions, an adjustment factor of 1.1 has been incorporated into the assessment for leafy vegetables to account for the presence of the metabolite TMG, and an adjustment factor of 1.5 has been incorporated for livestock-derived commodities (milk) to account for the presence of metabolites TZU, TZG, TZNG, ATMG-pyruvate and ATG-acetate. The 1.1 adjustment factor is based on field trial data showing TMG does not exceed 10% of the parent compound residue level in leafy vegetables and the 1.5 factor was based on metabolism data.

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 assessed chronic dietary exposure using the same residue information and assumptions regarding metabolites/degradates as in the acute exposure analysis.

iii. Cancer. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, EPA has classified clothianidin as “not likely to be carcinogenic to humans.” Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information.

For food with thiamethoxam tolerances but without clothianidin tolerances, maximum residues of clothianidin observed in thiamethoxam field trials have been used in these assessments. For all commodities, 100 PCT was assumed.

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

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 clothianidin for surface water are estimated to be 72 parts per billion (ppb) for acute exposures and <72 ppb for chronic exposures.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The EDWC of 72 ppb was used to account for residues of clothianidin in both the acute and chronic dietary risk assessments.

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

Clothianidin is currently registered for use on turf. Residential handler exposure is not expected from the currently registered or proposed uses of clothianidin since these products are to be applied by commercial applicators. Adult short- and intermediate-term postapplication exposures were assessed for dermal exposures from commercial applications (via granular push-type spreaders), dermal post-application contact and golfer postapplication contact. For toddlers, short- and intermediate-term postapplication incidental oral (hand-to-mouth and soil ingestion) and dermal risks were assessed for exposure to treated turf.

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

Clothianidin is a member of the neonicotinoid class of pesticides and is a metabolite of another neonicotinoid, thiamethoxam. Structural similarities or common effects do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). Although clothianidin and thiamethoxam bind selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, and the other neonicotinoids are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a noncompetitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nAChRs, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. While the insecticidal action of the neonicotinoids is neurotoxic, the most sensitive regulatory endpoint for clothianidin is based on unrelated effects in mammals, including changes in body and thymus weights, delays in sexual maturation, and still births. Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids (such as testicular tubular atrophy with thiamethoxam, and mineralized particles in thyroid colloid with imidaclopid). Thus, there is currently no evidence to indicate that neonicotinoids share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the neonicotinoids. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism released by OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

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

2. Prenatal and postnatal sensitivity. There is no indication of increased quantitative or qualitative susceptibility, as compared to adults, of rat and rabbit fetuses following in utero exposure to clothianidin in developmental studies. However, increased quantitative susceptibility was observed in both the developmental neurotoxicity and rat multi-generation reproduction studies. In the developmental neurotoxicity study, offspring toxicity (decreased body weight gains, motor activity and acoustic startle response) was seen at a lower dose than that which caused maternal toxicity. In the two-generation rat reproduction study, offspring toxicity (decreased body weight gains, delayed sexual maturation in males, decreased absolute thymus weights in F1 pups of both sexes and an increase in stillbirths in both generations) was seen at a dose lower than that which caused parental toxicity.

3. Conclusion. In the final rule published in the Federal Register of February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that the FQPA SF for clothianidin should be retained at 10X because EPA had required the submission of a developmental immunotoxicity study to address the combination of evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin data base, and evidence showing that juvenile rats in the two-generation reproduction study appear to be more susceptible to these potential immunotoxic effects. In the absence of a developmental immunotoxicity study EPA concluded that there was sufficient uncertainty regarding immunotoxic effects in the young that the 10X FQPA factor should be retained as a database uncertainty factor. Since that determination, EPA has received and reviewed an acceptable/guideline developmental immunotoxicity study, which demonstrated no treatment-related effects. Taking the results of this study into account as well as the rest of the data on clothianidin, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF for clothianidin were reduced to 1X. That decision is based on the following findings:

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. For linear cancer risks, EPA calculates the probability of additional cancer cases 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 POD to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to clothianidin will occupy 24% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to clothianidin from food and water will utilize 21% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of clothianidin is not expected.

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

Clothianidin is currently registered for use on turf that could result in short- and intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to clothianidin. Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in aggregate MOEs of greater than 450 for all population subgroups. As the aggregate MOEs are greater than 100 (the LOC) for all population subgroups, including infants and children, short- and intermediate-term aggregate exposures to clothianidin are not of concern to EPA.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in mice and rats at doses that were judged to be adequate to assess the carcinogenic potential, clothianidin was classified as “not likely to be carcinogenic to humans,” and is not expected to pose a cancer risk to humans.

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

Adequate enforcement methodology is available to enforce the tolerance expression. This method involves extraction of residues with acetonitrile/water, cleanup using solid phase extraction (SPE) cartridges, and analysis of clothianidin by LC/MS/MS. 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 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 clothianidin in/on rice, grain.

The tolerance is considered appropriate as proposed; therefore, no revisions were needed.

Therefore, tolerances are established for residues of clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on rice, grain 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, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under 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. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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 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. 801 et 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 the Federal 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:

DoD published an interim rule in the Federal Register at 77 FR 19127 on March 30, 2012, to implement section 814(b) of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112-81). The interim rule adjusted the dollar limitation on the acquisition of right-hand drive passenger sedans from $30,000 per vehicle to $40,000 per vehicle, and included this dollar limitation on the list of statutory acquisition-related dollar thresholds subject to inflation adjustment in accordance with the requirements of 41 U.S.C. 1908. One respondent submitted a public comment in response to the interim rule.

The respondent concurred with the inflation threshold increase listed at DFARS 212.271. There were no comments suggesting changes to the interim rule. Therefore, DoD is finalizing the interim rule without change.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because it merely adjusts upward the current limitation for acquisition of right-hand drive passenger vehicles from $30,000 to $40,000 due to inflation.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

This final rule amends the DFARS as follows:

1. Clarifies the designation at 209.403(1) for the Department of Army debarring and suspending official.

2. Revises codes of offices designated to receive reports referenced at 215.403-1(c)(3)(B) and 230.201-5.

3. Directs contracting officers to additional DFARS procedures, guidance, and information by adding references at 210.002, 217.7404, 237.102-77, and 237.102-78.

4. Corrects a form title at 245.7001-6.

6. Corrects a typographical error in clause 252.219-7003, paragraph (f), and revises the clause date.

7. Makes a conforming change to clause 252.225-7017(a) to add Armenia to the definition of “Designated country”, which was inadvertently omitted from publication of the final rule under DFARS Case 2011-D046 (77 FR 30368). The final rule for DFARS Case 2011-D057 (77 FR 4631) had previously added Armenia as a World Trade Organization Government Procurement Agreement country and a designated county.

Therefore, 48 CFR parts 209, 210, 215, 217, 230, 237, 245, and 252 are amended as follows:

DoD published a proposed rule under DFARS Case 2009-D043 in the Federal Register at 75 FR 80426 on December 22, 2010. Subsequently, DoD published a second proposed rule, under DFARS Case 2012-D001, in the Federal Register at 76 FR 64885 on October 19, 2011, to revise and standardize reporting requirements for Government-furnished property to include items uniquely and non-uniquely identified, and to clarify policy for contractor access to Government supply sources. DoD held a public meeting to discuss the second proposed rule on November 17, 2011. One respondent submitted comments in response to the second proposed rule. Discussions from the public meeting held to discuss the second proposed rule, as well as the public comments, were considered in drafting this final rule.

DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:

The revisions modify and standardize contractor Government property reporting requirements, making revisions that are necessary given DoD's emphasis on property accountability. The final rule alters the requirements of the current clause, which requires Defense contractors to report (primarily) Government-furnished equipment items valued at $5,000 or more, to a new requirement to report all serialized Government-furnished property regardless of unit acquisition value. The revised reporting requirement includes electronic receipt requirements, which will be expanded to non-serialized items by 2014. This effort is consistent with Secretary of Defense memorandum dated October 13, 2011, which emphasizes both asset accountability and the need to accelerate key elements of DoD's audit readiness plans.

Comment: A respondent stated that the rule is “premature.” The respondent thought that the current DFARS and its associated contract clause at 252.211-7007, Reporting of Government-Furnished Property, should include a summary of end processes for various types of contracts, such as production, depot, or services, and should include references to business rules used in each type of arrangement. The respondent also proposed that the “military departments must own the end to end process and use the IUID registry as a tool to manage process, programs and items. The IUID Registry must be integrated into other DoD business management systems. A stand-alone contractor centric system will not provide sufficient benefits to sustain existence.” In support of its position, the respondent proposed to add to the DFARS text, at 211.274-4, a new paragraph (f) as follows:

The respondent further stated that including the proposed DFARS text in part 211, rather than DFARS part 245, makes the requirements part of a Government-furnished property reporting system rather than part of the contractor's Government property system.

Response: As suggested by the respondent in separate correspondence, this revision to current DFARS requirements may be long overdue. In a letter dated October 18, 2011, the respondent requested the Director, DPAP, to “remind DoD agencies of their obligation to use the IUID registry as the system of record for GFP in the custody of contractors.” DoD has been considering those changes and has considered public comments submitted in response to two proposed rules and a public meeting.

A phased implementation, as suggested by the respondent, would not be consistent with Secretary of Defense memorandum dated October 13, 2011, “Improving Financial Information and Achieving Audit Readiness,” which emphasizes both asset accountability and the need to accelerate key elements of DoD's audit readiness plans.

DoD agrees that, as reflected in the proposed rules and final rule, DFARS part 211 is the appropriate place for including DoD policy for reporting Government-furnished property required to be recorded in the IUID registry because item identification and valuation, addressed at DFARS subpart 211.2, are considered to be elements of the specifications, or requirements, for a contract.

Comment: The respondent strongly proposed to revise the overall policy for reporting of Government-furnished property, at DFARS 211.274-4(a), in order to retain the $5,000 reporting threshold and “remain consistent with internal or DoD guidance DODI 5000.64.”

Response: The final rule is consistent with the current DoD Instruction 5000.64, which requires accountability of all Government furnished property regardless of dollar value.

Comment: The second proposed rule, at DFARS 211.274-4(b), listed types of property that would not be reported, such as “property under any statutory leasing authority.” The respondent proposed, instead, to list at paragraph (b) items, “if significant or material in nature,” that “shall be considered for” reporting, e.g., DoD Capital Equipment; and Special Tooling, Special Test Equipment, and Equipment. The respondent stated that its approach would increase reporting visibility for DoD. In addition, the respondent claimed that “providing (special tooling) is in concert with the spirit of the `Duncan Hunter National Defense Acquisition Act of FY 2009 * * * Section 815.' ” The respondent suggested that the Act's purpose would be served by revising DFARS 252.211-7007(b) to add a table to identify the specific items to be reported to the IUID Registry.

Response: The disclaimer “if significant or material in nature” would create unnecessary ambiguity, possibly resulting in calls for “more consistency.” In addition, DoD has not identified a nexus to section 815 of the National Defense Authorization Act for Fiscal Year 2009; the referenced provision refers to the preservation and storage of unique tooling, not whether to furnish special tooling to a contractor under a Government contract. The respondent's suggestion to add a table to paragraph (b) to identify the specific items to be reported to the IUID Registry would largely duplicate the Government-furnished property listing required by FAR 45.201.

Comment: The respondent objected to the portion of the clause prescription proposed at DFARS 211.274-6 that, at (a)(1)(ii), addressed “cost-reimbursement contracts that may result in the delivery of contractor-acquired property (see requirements at PGI 245.402-71).” The respondent commented that PGI references should not be contained in regulations. “They (PGI language) are not controlled, nor vetted with the public as required by FAR Part 1.103(b),” in the respondent's estimation. The respondent stated that “PGI is unreliable for regulatory purposes. It provides the PGI writers a form of a blank check.”

Response: The language at DFARS 211.274-6 has become obsolete with publication of this final rule and, therefore, is removed. However, regarding references to the PGI in the DFARS regulation, the PGI is a companion resource to the DFARS containing both mandatory and non-mandatory internal procedures, guidance, and supplemental information for Government contracting personnel. While the PGI is non-regulatory, PGI changes are internally coordinated in the same fashion as DFARS proposals, i.e., at the DAR Council level and coordinated with other DoD stakeholders. All PGI changes are vetted to ensure accuracy and reliability of content.

Comment: The respondent quoted FAR 1.304(b)(1) to the effect that material should not be unnecessarily repeated, paraphrased, or restated if it is contained in the FAR or higher-level agency regulations.

Response: FAR 52.202-1, Definitions, states that, “(w)hen a solicitation provision or contract clause uses a word or term that is defined in the Federal Acquisition Regulation (FAR), the word or term has the same meaning as the definition in FAR 2.101 in effect at the time the solicitation was issued, unless * * * the solicitation, or amended solicitation, provides a different definition * * * (or) the part, subpart, or section of the FAR where the provision or clause is prescribed provides a different meaning * * *” Although the respondent did not specify which definitions were at issue, DoD has reviewed each definition and removed definitions that are not significant to the interpretation of the clause or needed for increased clarity.

Comment: The respondent interpreted the exception to IUID reporting for material released for work in process, at DFARS 252.211-7007(c), to require reporting of material at the transactional level. The respondent objected to the latter, stating that it “is not practical and would be extremely expensive for contractors and the Government.” The respondent stated that “(t)here is no harm to the Government in that furnished material is only for a given contract for a given amount—and is not expected to be available for other uses.”

Response: The DFARS rule requires transactional reporting only for the receipt of material. Changes of “state” for material released to the floor as work-in-process are not required to be reported.

Comment: The respondent raised several issues regarding the clause at DFARS 252.211-7007, entitled “Reporting of Government-Furnished Property.” Citing paragraph (d) of the clause, entitled “Data for reporting to the IUID Registry,” the respondent stated that the proposed rule would include items that had been reported previously to the IUID registry. According to the respondent, the rule should address items that were reported as non-UII items that have changed to serially managed items. The respondent requested that the intent of paragraph (d) be made clear.

The respondent also raised issues regarding paragraph (e) of the clause, entitled “Procedures for establishing Unique Item Identifiers,” stating that there is “great efficiency in continuing the usage of virtual Unique Item Identifiers as Special Tooling and Special Test Equipment Unique Item Identifiers with concatenated CAGE plus Property Tag.”

Also citing paragraph (e) of the clause, the respondent proposed the deletion of item (5), the “mark record” data element. The respondent stated that the enabling of the contractor's reporting system to “pull data” to populate the mark record requirements should be sufficient. The respondent proposed to delete all the sub-elements under “(5) Mark record” because this is already a reportable event and is defined in paragraph (f) of the clause. Further, the respondent proposed deletion because its position is that material reporting should not be required.

Response: DoD did not make the requested changes because they would not contribute to the desired outcome, i.e., consistent accountability for Government property in the possession of contractors. To the extent items were previously reported, reporting would consist largely of only changes in status or disposition. The language referring to “(5) mark record” was not deleted because it is integral to reporting.

Comment: The respondent objected to the proposed DFARS 252.211-7007(g) because it is predicated on the eventual demise of other, existing property management systems. The respondent specifically recommended that the Government retain, and leverage, all current Government systems.

Response: This final rule, and previous rules for Government-furnished property, leverage the use of DoD enterprise systems (standard systems used throughout the DoD enterprise and called out in regulation). These systems include Wide-Area WorkFlow, the DoD IUID Registry, Electronic Document Access, and the Defense Contract Management Agency managed electronic tools: Plant Clearance Automated Reutilization and Screening System, and property Lost, Theft, Damaged, and Destroyed reporting system. While this final rule does not propose to eliminate any specific DoD system at this time, it is a step toward the elimination of disparate means of GFP reporting. This final rule supports DoD's plans for audit readiness and asset accountability, which will result in some systems coming under greater scrutiny in the near future.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., and is summarized as follows:

This final rule revises and standardizes reporting requirements for Government-furnished property to include items uniquely and non-uniquely identified and clarify policy for contractor access to Government supply sources. The clause at 252.211-7007 is significantly revised to eliminate the reported material weakness for DoD with regard to accounting for its property in the hands of contractors.

A number of issues were raised by the single respondent submitting comments in response to the second proposed rule. These resulted in some minor changes to clarify the rule. No comments were submitted by the Chief Counsel for Advocacy of the Small Business Administration.

The Defense Contract Management Agency, which has the overall responsibility for managing Government-furnished property, estimates that approximately 4,400 contractors possess Government-furnished property and, of this total, approximately one-fourth, or 1,100 contractors, are small businesses. All contractors in possession of Government property will be equally affected by the revision in reporting rules.

This rule will remove the mandatory $5,000 unit acquisition cost dollar threshold for reporting. This will not significantly impact items valued at less than $5,000 in unit acquisition cost, as they were also previously required to be reported if they were serially managed, mission essential, sensitive, or controlled inventory. There is potential for eventual elimination of some other electronic reporting tools, such as DoD's Commercial Asset Visibility (CAV) system. There are presently over 900 separate applications of CAV, all of which can be eliminated given the new reporting constructs contained within this rule. This will result in greater efficiency and considerable cost savings to both Government and industry.

All DoD contractors with Government-furnished property will be equally affected. However, DoD's Item Unique Identification (IUID) Registry is already in use by contractors with Government-furnished property. Under this final rule, DoD contractors will continue to use the IUID Registry for property reporting, but they will report somewhat different classes of property than they had been, and DoD will phase out the use of other property management systems.

DoD is responsible for entering new items in the IUID Registry, and contractors will be responsible only for reporting a change in state of the item. In the associated information collection justification, DoD estimated that the data are entered by the equivalent of a GS-11, step 5, that there will be approximately 5 responses annually per contractor, and that each response will take approximately one hour.

These changes were necessitated by the requirement for DoD to establish and maintain proper accountability for its property. The approach selected is designed to provide a single, electronic property management system and eliminate the many overlapping and parallel accountability systems currently in use. The result should be less costly for the DoD and its contractors, including small entities, while providing enhanced accountability.

This rule affects the information collection requirements in Government property reporting provisions prescribed at DFARS part 211, currently approved under OMB Control Number 0704-0246 (which covers DFARS part 245, Government Property, DFARS section 211.274, Reporting of Government-Furnished Equipment in the DoD Item Unique Identification (IUID) Registry, the related clauses at DFARS 252.245-7000 through -7004 and 252.211-7007, and the related forms) in the amount of 53,560 hours, in accordance with the Paperwork Reduction Act (44 U.S.C. chapter 35). The impact of this rule, however, is negligible, because the requirements of the final rule are not expected to significantly increase the overall burden hours approved under clearance number 0704-0246.

Therefore, 48 CFR parts 211, 212, and 252 are amended as follows:

DoD published a proposed rule in the Federal Register at 77 FR 2682 on January 19, 2012. The comment period closed on March 19, 2012. This rule revises requirements for approving interim vouchers and replaces the direct submission process currently referenced at DFARS 242.803(b)(i)(C) with a risk-based sampling process. Interim vouchers that are selected using sampling methodologies will be reviewed and approved by the contract auditors for provisional payment and sent to the disbursing office after a pre-payment review. Interim vouchers not selected for a pre-payment review will be considered to be provisionally approved and will be sent directly to the disbursing office. All provisionally approved interim vouchers are subject to a later audit of actual costs incurred.

One respondent submitted a comment requesting a clarification to the proposed language at 242.803(b)(i)(A). The respondent suggested that the proposed language could be interpreted to indicate that a contract auditor is authorized to receive vouchers from contractors, but only may approve them when directed by the terms of the contract. The final rule language at 242.803(b)(i)(A) has been revised to state that the contract auditor is the authorized representative of the contracting officer for receiving vouchers from contractors electronically, unless otherwise directed by the terms of the contract.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because this rule merely updates DoD's voucher processing procedures and better accommodates the Wide Area WorkFlow used to process vouchers. However, a final regulatory flexibility analysis has been performed consistent with 5 U.S.C. 604. This rule revises requirements for approving interim vouchers. Interim vouchers that are selected using sampling methodologies will be reviewed and approved by the contract auditors for provisional payment, and sent to the disbursing office after a pre-payment review. Interim vouchers not selected for a pre-payment review will be considered to be provisionally approved and will be sent directly to the disbursing office. All provisionally approved interim vouchers are subject to a later audit of actual costs incurred. No significant issues were raised by the public comments in response to the initial regulatory flexibility analysis and no comments were filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the rule. The proposed rule imposes no reporting, recordkeeping, or other information collection requirements and no known significant alternatives to the rule were identified.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore 48 CFR part 242 is amended as follows:

The U.S. Atlantic tuna fisheries are managed under the 2006 Consolidated Highly Migratory Species Fishery Management Plan and regulations at 50 CFR part 635, pursuant to the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and the Atlantic Tunas Convention Act (ATCA). Under ATCA, the Secretary shall promulgate such regulations as may be necessary and appropriate to carry out ICCAT Recommendations.

In 2002 and 2003, ICCAT adopted binding measures for Parties to prohibit imports of Atlantic bigeye tuna and its products from Bolivia and Georgia. Specifically, Recommendations 02-17 and 03-18 prohibited the imports to address illegal, unreported, and unregulated catches of tuna (especially bigeye tuna) by large-scale Bolivian and Georgian longline vessels respectively, because they operated in a manner that diminished the effectiveness of ICCAT measures. Recommendation 02-17 expressed concern regarding the overfished status of bigeye tuna in the Atlantic Ocean and noted ICCAT had reviewed information that Bolivian vessels fishing for Atlantic bigeye tuna had continued to operate in a manner that diminished the effectiveness of ICCAT conservation and management measures. Similarly, Recommendation 03-18 expressed concern regarding the overfished status of bigeye tuna in the Atlantic Ocean and stated that Georgian vessels had continued to operate in a manner that diminished the effectiveness of ICCAT conservation and management measures. In 2004, NMFS published a final rule (69 FR 70396; December 6, 2004) that implemented these ICCAT recommendations. When the import prohibitions were implemented in the 2004 final rule, neither Bolivia nor Georgia had exported Atlantic bigeye tuna to the United States in the previous 10 years; therefore, NMFS determined that the import prohibitions would have no socioeconomic impact on fishery participants.

At its 2011 annual meeting, ICCAT examined recent actions of Bolivia and Georgia, and determined that the actions of their vessels no longer diminish the effectiveness of ICCAT's conservation and management measures. Some of the relevant considerations were as follows: (1) Bolivia and Georgia have been responsive to ICCAT requests for information on actions taken to control their vessels; (2) Since 2006, Bolivia has not registered any fishing vessels to carry out fishing-related activities in the Convention area, and information available to ICCAT has indicated that Bolivia has not fished for ICCAT species in recent years; and (3) Georgia has recently taken action to de-register those of its vessels fishing without authorization in the Convention area and has considered increased participation in the work of ICCAT.

Thus, ICCAT adopted Recommendation 11-19, which requires Parties to lift import prohibitions on Atlantic bigeye tuna from Bolivia and Georgia as soon as possible in accordance with domestic procedures. Therefore, on June 26, 2012, NMFS published a proposed rule to remove the Atlantic bigeye tuna import prohibitions from Bolivia and Georgia (77 FR 38030), and provided a 30-day public comment period, which ended July 26, 2012. Because there were no imports of Atlantic bigeye tuna from these countries prior to the implementation of the prohibitions, and because NMFS does not expect imports in the future, NMFS does not expect that lifting the prohibitions will result in socioeconomic impacts on U.S. traders.

Consistent with the regulations at 50 CFR § 635.40(c), for one year after the date of filing of the final rule lifting the import restrictions, every shipment that previously was subject to the import restrictions will continue to be denied entry unless the shipment is accompanied by a certification executed by an authorized official of the country of export and authenticated by a consular officer or consular agent of the United States certifying that no portion of the shipment is composed of fish taken prior to or during the import restriction.

The June 26, 2012, proposed rule also included administrative changes in support of the International Trade Permit program. Importers, exporters and re-exporters of Atlantic, Pacific, and Southern bluefin tuna, swordfish, frozen bigeye tuna, and shark fins must obtain an International Trade Permit consistent with regulations at 50 CFR 300, subpart M. Permit holders must include the species-specific harmonized tariff codes on the necessary trade documentation when trading these species. The Harmonized System is an international product nomenclature system developed by the World Customs Organization. It is updated every 5 years, and the most recent update occurred in 2012, with subsequent modifications to the Harmonized Tariff Schedule of the United States. Thus, the section of the regulations that include harmonized tariff codes for highly migratory species products located at 50 CFR 300.184 is being changed accordingly. These changes are not expected to have economic impacts and are necessary to maintain consistency with current trade regulations and to ensure that permit holders have the most recent information in order to simplify compliance with the regulations. The Harmonized Tariff Schedule (HTS) of the United States is published by the ITC. The chapter pertaining to fish, including Highly Migratory Species (HMS), is available at the following Web site: http://www.usitc.gov/publications/docs/tata/hts/bychapter/1202C03.pdf .

NMFS received two written comments on the proposed rule during the public comment period.

Comment 1: The commenter opposed the regulatory changes, and suggested that Bolivia and Georgia “keep their fish”.

Response: If importers determine it is feasible and economically beneficial to import bigeye tuna from Bolivia or Georgia, they are now legally free to do so consistent with a binding decision made at the relevant international regional fishery management organization (ICCAT). That said, NMFS does not anticipate any imports as a result of this change.

Comment 2: The commenter noted that the regulations containing excerpts of the Harmonized Tariff Schedule (for HMS) exclude fresh bigeye tuna and yellowfin tuna and suggested that NMFS investigate the issue due to concerns about illegal, unregulated, and unreported (IUU) fishing and trade in these species.

Response: The commenter stated that the regulations contain “excerpts of the Harmonized Tariff Schedule.” To clarify, the regulations will no longer “excerpt” the Harmonized Tariff Schedule. Instead, the revised regulations will simply list the fish and fish products that are subject to reporting requirements. The commenter notes that fresh bigeye tuna and yellowfin tuna are not among the species subject to the reporting requirements. NMFS includes on the list at § 300.184 those species that are subject to trade tracking and documentation requirements by one or more regional fishery management organizations (RFMO), including ICCAT. Yellowfin and fresh bigeye tuna currently are not the subject of such reporting requirements and thus are not on the list of species. NMFS will continue to consider this issue as part of international discussions on IUU fishing and in conjunction with future requests to the ITC, to help determine whether additional tracking measures and attendant additional HTS codes are needed in the future.

Pursuant to section 304 (b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is necessary for the conservation and management of the Atlantic highly migratory species fishery, and is consistent with the 2006 Consolidated HMS FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

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

The Chief Council for Regulation of the Department of Commerce certified to the Chief Council for Advocacy of the Small Business Administration at the proposed rule stage that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. None of the public comments submitted to NMFS addressed the certification, and no new information has become available that would change this determination. As a result, a final regulatory flexibility analysis is not required and none has been prepared.

For the reasons set out in the preamble, 50 CFR parts 300 and 635 are amended as follows:

The snapper-grouper fishery of the South Atlantic is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP includes black sea bass, and it was prepared by the South Atlantic Fishery Management Council (Council) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

Black sea bass are managed throughout their range. In the South Atlantic EEZ, black sea bass are managed under the FMP by the Council from 35°15.19′ N. lat., the latitude of Cape Hatteras Light, North Carolina, south to the boundary between the South Atlantic and Gulf of Mexico (Gulf) Councils, off of Key West, Florida. The boundary between the South Atlantic and Gulf Councils coincides with the line of demarcation between the Atlantic Ocean and the Gulf, which begins at the intersection of the outer boundary of the EEZ, as specified in the Magnuson-Stevens Act, and 83°00′ W. long., proceeds northward along that meridian to 24°35′ N. lat., (near the Dry Tortugas Islands), thence eastward along that parallel, through Rebecca Shoal and the Quicksand Shoal, to the Marquesas Keys, and then through the Florida Keys to the mainland at the eastern end of Florida Bay, the line so running that the narrow waters within the Dry Tortugas Islands, the Marquesas Keys and the Florida Keys, and between the Florida Keys and the mainland, are within the Gulf. From Cape Hatteras Light, North Carolina, through Maine, black sea bass are managed jointly by the Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission. Therefore, the closure provisions contained in this notice are applicable to those vessels harvesting or possessing black sea bass from Cape Hatteras Light, North Carolina, through to the boundary between the South Atlantic and Gulf Councils (off of Key West, Florida), as described above.

The 2006 reauthorization of the Magnuson-Stevens Act established new requirements that ACLs and AMs be implemented to end overfishing and prevent overfishing from occurring. AMs are management controls to prevent ACLs from being exceeded, and to correct or mitigate the ACL if an overage occurs.

On December 30, 2010, NMFS issued a final rule (75 FR 82280) to implement Amendment 17B to the FMP (Amendment 17B). The final rule for Amendment 17B established ACLs for eight snapper-grouper species in the FMP that are undergoing overfishing, including black sea bass, and AMs if these ACLs are reached or exceeded. The recreational ACL for black sea bass is 409,000 lb (185,519 kg), gutted weight.

On June 1, 2012, NMFS issued a final rule (77 FR 32408) to implement Amendment 18A to the FMP (Amendment 18A). In part, the final rule for Amendment 18A modified the recreational sector AMs for black sea bass. The AMs described at 50 CFR 622.49(b)(5)(ii) require NMFS to close the recreational sector for black sea bass when the recreational ACL is reached, or is projected to be reached by filing a notification to that effect with the Office of the Federal Register. Based on the best scientific information available, NMFS has determined that the black sea bass recreational ACL of 409,000 lb (185,519 kg), gutted weight; 482,620 lb (218,913 kg), round weight, has been reached. Accordingly, NMFS is implementing the necessary AM to close the black sea bass recreational sector in the South Atlantic EEZ at 12:01 a.m., local time, on September 4, 2012, for the remainder of the 2012-2013 fishing year, from 35°15.19′ N. lat., the latitude of Cape Hatteras Light, North Carolina, south to the boundary between the South Atlantic and Gulf Councils, as previously described in this temporary rule.

On, and after, the effective date of the closure, the recreational bag and possession limit of black sea bass in or from the South Atlantic EEZ is zero. This zero bag and possession limit also applies in the South Atlantic on board a vessel for which a valid Federal charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, without regard to where such species were harvested, i.e., in state or Federal waters. The black sea bass recreational sector will reopen on June 1, 2013, the start of the 2013-2014 recreational fishing season.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the South Atlantic black sea bass component of the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

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

These measures are exempt from the procedures of the Regulatory Flexibility Act because this temporary rule is issued without opportunity for prior notice and comment.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the AMs established by Amendment 18A and located at 50 CFR 622.49(b)(5)(ii) have already been subject to notice and comment and authorize the Assistant Administrator for Fisheries, NOAA, (AA) to file a notification with the Office of the Federal Register to close the recreational sector for black sea bass for the remainder of the fishing year, if recreational landings for black sea bass, reach or are projected to reach the recreational sector ACL. All that remains is to notify the public of the closure of the recreational sector for black sea bass for the remainder of the 2012-2013 fishing year.

Additionally, there is a need to immediately notify the public of the closure of the black sea bass recreational sector because South Atlantic black sea bass are undergoing overfishing and there is a 10-year rebuilding plan in place. Failure to close the recreational harvest of black sea bass in a timely fashion could result in negative biological effects and affect the rebuilding plan for black sea bass within the timeline specified by the Magnuson-Stevens Act. The current ACL is projected to have been met at this time and the delay in effectiveness of the actual closure date is solely to allow for sufficient notice to the recreational sector, including private and for-hire fishers.

To allow for adequate notice to the fishers while simultaneously protecting the black sea bass resource, this temporary rule provides notice to the public prior to the closure of recreational black sea bass to minimize disruption to the activities of the recreational sector. This notice will provide time to schedule and prepare for trips and to purchase the appropriate amount of supplies.

Therefore, the timing for this temporary rule is intended to maximize the biological benefits to the resource while attempting to minimize the negative economic harm to fishermen.

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).

Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102.

The initial total commercial quota for summer flounder for the 2012 fishing year is 13,136,001 lb (5,958,490 kg) (76 FR 82189, December 30, 2011). The percent allocated to vessels landing summer flounder in Massachusetts is 6.82046 percent, resulting in a commercial quota of 895,936 lb (406,396 kg). The 2012 allocation was reduced to 868,226 lb (393,827 kg) after deduction of research set-aside and adjustment for 2011 quota overages.

The Administrator, Northeast Region, NMFS (Regional Administrator), monitors the state commercial quotas and determines when a state's commercial quota has been harvested. NMFS is required to publish notification in the Federal Register advising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing summer flounder in that state. The Regional Administrator has determined based upon dealer reports and other available information that Massachusetts has harvested its quota for 2012.

Section 648.4(b) provides that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, August 28, 2012, landings of summer flounder in Massachusetts by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2012 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 0001 hours, August 28, 2012, federally permitted dealers are also notified that they may not purchase summer flounder from federally permitted vessels that land in Massachusetts for the remainder of the calendar year, or until additional quota becomes available through a transfer from another state.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.