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 April 25, 2012 (77 FR 24643). That NPRM proposed to require repetitive inspections of electrical heat terminals on the left and right windshields for damage, and corrective actions if necessary. That NPRM also proposed to allow replacing an affected windshield with a windshield equipped with different electrical connections, which would terminate the repetitive inspections for that windshield.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (77 FR 24643, April 25, 2012) and the FAA's response to each comment.

The Air Line Pilots Association, International stated that the proposed actions will enhance safety, and that it supports the intent and language of the NPRM (77 FR 24643, April 25, 2012).

UPS stated that it agrees with the intent of the NPRM (77 FR 24643, April 25, 2012).

FedEx and UPS recommended superseding AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), to add the additional inspection requirements described in Boeing Special Attention Service Bulletin 757-30-0019, Revision 3, dated December 16, 2011, instead of issuing a new AD that would require accomplishing the actions proposed in the NPRM (77 FR 24643, April 25, 2012). FedEx stated that issuing this new AD will impose an additional burden on the operators. UPS stated that the addition of new requirements for the J5 terminal in the NPRM conflicts with the requirements of AD 2010-15-01. UPS stated that issuing a superseding AD would ease tracking and avoid conflicting requirements.

United Airlines (United) stated that an additional inspection is not warranted and that more issues are likely to arise by disturbing the terminals. We infer that United is requesting that we withdraw the NPRM (77 FR 24643, April 25, 2012).

We do not agree with the commenters' requests. The additional inspection requirements of this AD apply only to Model 757 airplanes; and AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), applies to Model 757, 767, and 777 airplanes. Superseding AD 2010-15-01 would delay accomplishment of the actions required by this AD, which would be inappropriate in light of the unsafe condition identified on the J1 and J4 upper windshield electrical power terminal connections on Model 757 airplanes.

In regard to United's comment, the unsafe condition identified in the J1 and J4 upper windshield electrical power terminal connections significantly outweighs the potential for an operator to inadvertently create a new problem during the accomplishment of the actions required by this AD.

As for UPS's concern about conflicting J5 terminal requirements between AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), and this AD, we point out that accomplishing the actions required by this AD terminates the requirements of AD 2010-15-01 for Model 757 airplanes only. Paragraphs (h) and (l) of this AD provide further clarification regarding this issue.

We have not changed the AD in this regard.

The National Transportation Safety Board (NTSB) requested that the NPRM (77 FR 24643, April 25, 2012) also apply to Model 747, 767, and 777 airplanes, because a similar window design is used on these models, as stated in NTSB Safety Recommendation A-07-50, dated September 4, 2007. (See http://www.ntsb.gov/doclib/recletters/2007/A07_49_50.pdf. ).

In addition, the NTSB stated that AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), was applicable to certain Model 757, 767, and 777 airplanes—not just Model 757 airplanes. The NTSB noted that there is another AD action similar to AD 2010-15-01 for Model 747 airplanes.

We disagree to add Model 747, 767, and 777 airplanes to the applicability of this AD. AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), which is applicable to certain Model 757, 767, and 777 airplanes, addresses an unsafe condition on the lower windshield terminals. There were four reported Model 757 windshield upper terminal overheat/arcing events. We have not received any reports of upper terminal overheat/arcing events on Model 767 and 777 airplane windshields, and only one reported upper terminal overheat/arcing event on a Model 747 airplane windshield. Boeing increased the specified torque for installation of the windshield terminals for Model 747, 767, and 777 airplanes and communicated this information to operators. Due to the number of reported events on Model 757 airplanes and the lower specified torque for windshield installations on Model 757 airplanes, this AD is applicable to that model only. We have not changed the AD in this regard.

American Airlines (AAL) and the NTSB requested that we revise the NPRM (77 FR 24643, April 25, 2012) to provide instructions for more effective inspections in detecting and correcting all failure modes of the windshield electrical terminal connections.

AAL stated that it is concerned that the NPRM (77 FR 24643, April 25, 2012) does not offer a comprehensive solution to flight deck window heat smoke events, and that inspection of the J1, J4, and J5 electrical terminals for loose connections might not prevent electrical arcs at the windshield side of the terminal blocks. AAL stated that its analysis and service history have shown that damage of the solder joints inside the windshield terminal blocks are the primary root cause of the smoke and odor events in the flight deck window heat system. AAL stated that the NPRM should also address the electrical connections at the windshield side of the terminal block, specifically the use of unclenched, low temperature solder joints connecting the braid wire to the terminal block.

The NTSB stated that it agrees that windshield heat system terminal blocks J1 and J4 should be added to the NPRM (77 FR 24643, April 25, 2012), but that the FAA needs to revise the NPRM to ensure that the inspections are effective in detecting and correcting the potential problem involving loose electrical connections. The NTSB cited two serious incidents that it investigated during 2010, which involved in-flight fires and electrical odors that the actions required in AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010) (which requires inspection of terminal block J5) did not adequately address.

We partially agree. We agree with AAL that the required inspection would not detect arcing events in the solder joints inside the terminal blocks of the PPG Aerospace (PPG) windshields. However, we disagree with AAL's suggestion to revise this AD to address the solder joints connecting the braid wire to the terminal block inside the windshield; this is not feasible, as there are currently no non-destructive inspection methods developed to detect and correct damage inside the windshield terminal block. Electrical current through a loose electrical connector will generate heat which can compromise the adjacent solder joint. The requirements of paragraphs (g), (h), and (i) of this AD focus on proper connection of screw/lug connectors, which will protect against smoke/fire events at the connector and damage to the adjacent solder joint.

We disagree with the NTSB that the inspections required by this AD are not effective. We point out that the screw/lug-type connection is partially exposed to flight deck activities and can be bumped during cleaning of the windshield or by any clipboards/books or other articles placed on the glare shield. Therefore, while the inspections required by AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), and this new AD might not eliminate all occurrences of terminal overheat/arcing, they should reduce the likelihood of events as demonstrated since the issuance of AD 2010-15-01.

The most straightforward way to eliminate overheat/arcing events, and to terminate the detailed inspections required by this AD, is replacing the screw/lug-type windshields with windshields having pin/socket-type power connections. This option is specified in paragraph (k) of this AD. However, we also consider a properly installed screw/lug connector to provide an adequate conductive path to prevent overheating of the electrical connection. This is addressed in the requirements of paragraphs (g), (h), and (i) of this AD. In addition, if we were to add a requirement that operators must do that replacement, we would need to issue a supplemental NPRM, and therefore, would delay issuance of the final rule. To delay this final rule would be inappropriate, since we have determined that an unsafe condition exists and the actions required by this AD adequately address the identified unsafe condition. We have not changed the AD in this regard.

Boeing requested that GKN Aerospace (GKN) windshields having part numbers (P/Ns) 141T4800-15 and 141T4800-16 (with pin/socket terminals) be approved as optional parts for the terminating action specified in paragraph (k) of the NPRM (77 FR 24643, April 25, 2012).

We agree with the commenter's request, because we have approved alternative methods of compliance (AMOCs) for paragraphs (f), (g), (h), and (i) of AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), to allow installation of GKN windshields having P/Ns 141T4800-15 and 141T4800-16 for Model 757 airplanes only.

We have added new paragraphs (n)(3) and (n)(4) to this AD, which state that AMOCs approved previously in accordance with AD 2010-15-01 are approved as AMOCs for the actions specified in paragraphs (g), (h), (i), (j), and (k) of this AD.

In addition, AAL stated that installation of a GKN flight deck windshield having P/N 141T4800 should be included as a terminating action to the inspection requirements stated in the NPRM (77 FR 24643, April 25, 2012). AAL stated that the P/N 141T4800 window does not incorporate the solder joint, which causes an extreme arcing ignition source and possible glass damage.

We partially agree. We agree with AAL that damaged solder joints are a cause of electrical arcs, because the heat caused by a loose terminal exceeds the rated melting point of the solder, which could result in high voltage arcing that might damage the windshield glass. We disagree with AAL to include all GKN windshields having P/N 141T4800 as terminating action for this AD because some of these have screw/lug heat terminals and some have pin/socket heat terminals. A main cause of an overheated terminal, and resultant melting of the solder and subsequent arcing, is a loose, cross-threaded, or incorrectly installed screw. Since we have received reports of arcing/smoking on GKN windshields having P/N 141T4800 with screw/lug heat terminals, we have determined that these windshields do not provide an acceptable level of safety without accomplishing the repetitive inspections required by this AD and cannot be included as a terminating action for this AD. Windshields with pin/socket heat terminals are terminating action as specified in paragraphs (k) and (n)(4) of this AD. We have not changed the AD in this regard.

FedEx recommended retaining the 500-flight-hour or 150-day compliance time, whichever occurs first, as specified in Boeing Special Attention Service Bulletin 757-30-0019, Revision 3, dated December 16, 2011, for certain inspections, in lieu of the 500 flight hours proposed by the NPRM (77 FR 24643, April 25, 2012). FedEx stated that some airplanes have a low average utilization rate (3.3 or less flight hours per day) and it is possible to reach 150 days before 500 flight hours.

We do not agree to change the compliance time. We have determined that the 150-day compliance time is too restrictive, and a compliance time of 500 flight hours for the initial and certain other inspections addresses the identified unsafe condition soon enough to ensure an adequate level of safety. As we noted in the NPRM (77 FR 24643, April 25, 2012), this difference between Boeing Special Attention Service Bulletin 757-30-0019, Revision 3, dated December 16, 2011, and this AD was coordinated with Boeing. We have not changed the AD in this regard.

FedEx recommended having one repetitive inspection interval for both GKN and PPG windows. FedEx recommended a repetitive inspection interval of 6,000 flight hours or 24 months, whichever occurs first. FedEx stated that this will help operators manage the repetitive inspection interval without the need to require maintenance “to check on the manufacturer of the windows and/or part numbers.”

We disagree with having the same repetitive inspection interval for both GKN and PPG windows. Having this one inspection interval would reduce the repetitive inspection interval for the GKN-manufactured windshields from 12,000 flight hours or 48 months, to 6,000 flight hours or 24 months, whichever occurs later. The reason for the longer repetitive inspection interval for the GKN windshields is that the frequency of overheat/arcing events on the GKN windshields with screw/lug-type electrical connections is significantly lower and the effects are not as severe as those of the PPG windshields. FedEx may choose to inspect all its airplanes at the more restrictive interval, if desired, to simplify its maintenance program. We have not changed the AD in this regard.

FedEx and UPS requested we delete the requirements of paragraph (i) of the NPRM (77 FR 24643, April 25, 2012). In eliminating paragraph (i) from the NPRM, FedEx also suggested that we change the repetitive inspection intervals specified in paragraphs (g)(1) and (g)(2) of the NPRM to “every 500 flight hours” (reduced from 6,000 or 12,000 flight hours, as proposed) or 150 days (reduced from 24 or 48 months, as proposed), whichever comes first, to address the unsafe condition. FedEx and UPS stated that it is difficult for the operators to meet the requirements of paragraph (i) of the NPRM, especially if the windshield is removed due to pilot and/or maintenance write-ups and/or non-routine findings during operation.

We do not agree to remove paragraph (i) of the AD, or to change the repetitive inspection intervals of paragraphs (g)(1) and (g)(2) of the NPRM (77 FR 24643, April 25, 2012). However, we have revised paragraph (i) of this AD to limit the inspection to windshields that are replaced and connections that are re-assembled in accordance with the requirements of this AD. The current Boeing Model 757 airplane maintenance manual (AMM) provides instructions for tasks associated with the windshield heating system, including replacement of a windshield with another windshield with screw/lug electrical connectors and for testing of the window heater element loop resistance. These tasks specify the correct torque for assembly of the windshield electrical terminal connections. We find that re-inspecting windshields after replacement or disassembly as part of routine maintenance is not necessary since the AMM specifies the proper torque.

We have revised (and reformatted) paragraph (i) of this AD to clarify that the inspections are done on windshields replaced or connections re-assembled in accordance with the service information specified in this AD. Therefore, this AD only requires re-inspection of windshield terminal installations on airplanes on which corrective actions required by this AD must be done.

UPS questioned whether popping off the plastic cover on the Wallace-Black and Cory/Tri-Star lug connectors to gain access for visual inspection is a “re-assembly” when the cover is popped back on. UPS stated that if it is a re-assembly, then another re-inspection is required at 500 flight hours, which starts a repetitive inspection loop that cannot be terminated. UPS stated that the only conceivable reason for “re-assembling” any J1, J4, or J5 connection would be for a finding of an improper assembly (i.e., cross-threading, gapping, low screw torque, loose screw), and that these issues have been adequately addressed in AD 2010-15-01, Amendment 39-16367 (75 FR 39804, July 13, 2010), and in the previous inspections of the NPRM (77 FR 24643, April 25, 2012).

We agree to provide clarification. Removing and installing the cover, as described in Figure 1 and Figure 2 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-30-0019, Revision 3, dated December 15, 2011, is not considered “re-assembly” for the requirements specified in paragraph (i) of this AD. We have not changed the AD in this regard.

UPS requested that the Boeing AMM be revised to include the re-inspection requirements of paragraph (i) of the NPRM (77 FR 24643, April 25, 2012), or that a requirement similar to a critical design configuration control limitation/airworthiness limitation (CDCCL/AWL) be added to the appropriate AMM section. UPS stated that the re-inspection requirements in paragraph (i) of the NPRM include unscheduled maintenance activities, and UPS, like other operators, has no means to identify and impose a required re-inspection when the re-inspection is not in the instructions for continued airworthiness (ICAs), namely, the AMM. UPS stated that having the operator change its manual to include a “unique” requirement is not a viable solution.

We disagree with the request. However, as previously stated, we have removed the requirement to inspect windows replaced during normal maintenance. We find that the safety of the fleet of affected airplanes will be ensured by the revised requirements of paragraph (i) of this AD. In addition, if we were to add a requirement to include a CDCCL or AWL in the maintenance program instead of the inspection specified in paragraph (i) of this AD, we would need to issue a supplemental NPRM, and therefore, would delay issuance of the final rule. To delay this final rule would be inappropriate, since we have determined that an unsafe condition exists and the actions required by this AD, including the inspections specified in paragraph (i) of this AD, must be conducted to ensure continued safety. We have not changed the AD in this regard.

UPS requested approval to operate with missing plastic protective terminal covers on the lug-screw-style connectors. UPS stated that, with the increased amount of inspection activity required on these terminals, it is common for the plastic protective covers to be missing. UPS stated that Boeing Special Attention Service Bulletin 757-30-0019, Revision 3, dated December 15, 2011, specifies the inspection of these covers for signs of heat damage. UPS stated that there is no provision for a missing cover. UPS requested that provisions be made for dispatching an airplane with a simple temporary repair for those instances when a cover is missing; since failure to resolve this minor point will result in grounded airplanes for the sake of an inexpensive cover.

We partially agree. We disagree with granting approval to operate with missing plastic protective terminal covers on the lug-screw-style connectors in this AD. We agree that the availability of an alternative to seal the windshield terminal(s) would provide relief if the type design part is missing from the terminal and it is not readily available at the time it is needed. According to Boeing, the use of Dow Corning RTV-3145 sealant, also called DC-3145 potting compound, would be acceptable to use in place of the missing cover. The procedure to apply the DC-3145 sealant is specified in the Boeing Standard Wiring Practices Manual, Chapter 20-60-08. Operators can submit a request for an AMOC, including the specific details of when and how this substitution would be used, in accordance with the procedures specified in paragraph (n) of this AD. We have not changed the AD in this regard.

We have added new paragraph (c)(3) to this AD to state that installation of Supplemental Type Certificate (STC) ST01920SE ( http://rgl.faa.gov/Regulatory-and-Guidance-Library/rgstc.nsf/0/082838ee177dbf62862576a4005cdfc0/$FILE/ST01920SE.pdf ) does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01920SE is installed, a “change in product” AMOC approval request is not necessary to comply with the requirements of 14 CFR 39.17. For all other AMOC requests, the operator must request approval for an AMOC in accordance with the procedures specified in paragraph (n) of this AD.

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

• Are consistent with the intent that was proposed in the NPRM (77 FR 24643, April 25, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 24643, April 25, 2012).

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

We estimate that this AD affects 664 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 1, 2012 (77 FR 32439), and proposed to supersede AD 2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005). That NPRM proposed to correct an unsafe condition for the specified products. Transport Canada Civil Aviation (TCCA) Mandatory Continuing Airworthiness Information (MCAI) states:

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

Air Wisconsin requested that we remove paragraphs (g) and (h) from the NPRM (77 FR 32439, June 1, 2012) because paragraph (i) of the NPRM supersedes those paragraphs. Air Wisconsin stated several examples of how paragraphs (g) and (h) are superseded by paragraph (i) of the NPRM.

We disagree with the commenter's request to remove paragraphs (g) and (h) from this final rule. We find it necessary to restate those paragraphs in this final rule to ensure the existing inspections are done until the required maintenance program revision specified in paragraph (i) of this AD is accomplished. In addition, if an airplane is imported into the United States, it is necessary to accomplish the requirements of paragraph (g) of this AD before the airplane may be operated in this country.

However, we find that clarification of paragraph (i) of this AD is necessary. Once the maintenance program revision is accomplished, the restated requirements of paragraph (g) of this AD are terminated. Therefore, we have revised the last sentence of paragraph (i) of this AD to specify that doing the revision required by paragraph (i) of this AD terminates the requirements of paragraph (g) of this AD.

In addition, we have retained paragraph (h) in this final rule because it is necessary to allow Canadair Regional Jet Temporary Revision TR 2B-2109, dated October 13, 2005, to be removed from the maintenance requirements manual once a general revision is done. Further, we have determined that it is necessary to add a paragraph similar to paragraph (h) of this AD to allow removal of the temporary revision specified in paragraph (i) of this AD. Accordingly, we have revised this final rule to add new paragraph (k) to this AD to specify that information. Subsequent paragraphs have been reidentified.

Air Wisconsin requested that we correct the serial numbers in paragraph (c) or (g) of the NPRM (77 FR 32439, June 1, 2012) for consistency.

We disagree with the request. The serial numbers specified in paragraph (g) of this AD are only those that were part of the applicability of AD 2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005). Paragraph (c) of this AD lists all serial numbers that are affected by this new AD.

In regard to paragraph (i)(2) of the NPRM (77 FR 32439, June 1, 2012), Air Wisconsin requested we clarify that, if the last inspection performed met the requirements of AWL 53-61-153 specified in Bombardier TR 2B-2187, dated June 22, 2011, to Appendix B—Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM, the next inspection cycle as specified in that TR is acceptable provided that interval is not greater than that specified in Bombardier TR 2B-2187, dated June 22, 2011.

In addition, Comair requested that we provide credit for paragraph (i) of the NPRM (77 FR 32439, June 1, 2012) for operators that performed previous inspections using the special detailed inspection option specified in AWL 53-61-153 of the Canadair Regional Jet TR 2B-2109, dated October 13, 2005, to Appendix B, “Airworthiness Limitations,” of Part 2 of the Canadair Regional Jet MRM. Comair stated that it requested this credit so that operators would not be subject to the initial compliance time specified in paragraph (i)(1) or (i)(2) of the NPRM (77 FR 32439, June 1, 2012).

We agree to clarify the inspection compliance time. We agree that, if the last special detailed inspection (not the detailed visual inspection) performed met the requirements of AWL 53-61-153 specified in Bombardier TR 2B-2187, dated June 22, 2011; or Canadair Regional Jet TR 2B-2109, dated October 13, 2005; to Appendix B—Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM; the next inspection should be at the next compliance time specified in AWL 53-61-153 of Bombardier TR 2B-2187, dated June 22, 2011 (i.e., within 4,360 landings since the last inspection). We have changed paragraph (i) of this AD to state that for airplanes that have already complied with AWL 53-61-153 of Bombardier TR 2B-2187, dated June 22, 2011, or the special detailed inspection option specified in Canadair Regional Jet TR 2B-2109, dated October 13, 2005, the initial compliance time for AWL 53-61-153 is within 4,360 flight cycles after accomplishing the most recent special detailed inspection, or within 1,500 flight cycles after accomplishing the most recent detailed inspection as specified in AWL 53-61-153 of Canadair Regional Jet TR 2B-2109, dated October 13, 2005, whichever occurs later.

Air Wisconsin requested that a statement be added to paragraph (k) of the NPRM (77 FR 32439, June 1, 2012) approving use of existing AMOCs that were approved previously in accordance with AD 2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005).

We agree to allow existing AMOCs approved in accordance with AD 2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005), as AMOCs for the corresponding requirements of paragraphs (g) and (h) of this AD only. We have revised paragraph (l)(1) of this AD (referred to as paragraph (k)(1) of the NPRM (77 FR 32439, June 1, 2012)) accordingly.

Air Wisconsin requested that we remove the reference to Canadair Regional Jet TR 2B-2109, dated October 13, 2005, to Appendix B—Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM from paragraph (j) of the NPRM (77 FR 32439, June 1, 2012). Air Wisconsin noted that Canadair Regional Jet TR 2B-2109, dated October 13, 2005, conflicts with Bombardier TR 2B-2187, dated June 22, 2011, and stated that Bombardier TR 2B-2187, dated June 22, 2011, specifically removed the “visual inspection” option that was in Canadair Regional Jet TR 2B-2109, dated October 13, 2005.

We agree with the request for the reasons stated by the commenter. We have removed the reference to Canadair Regional Jet TR 2B-2109, dated October 13, 2005, to Appendix B—Airworthiness Limitations, of Part 2 of the Bombardier CL-600-2B19 MRM, from paragraph (j) of this AD. Paragraph (i) of this AD requires that the maintenance program be revised to incorporate Bombardier TR 2B-2187, dated June 22, 2011. Paragraph (i) of this AD also specifies that once the revision is done, the requirements of paragraph (g) of this AD are terminated (paragraph (g) of the AD incorporated Bombardier TR 2B-2109, dated October 13, 2005).

We reviewed the available data, including 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 changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 32439, June 1, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 32439, June 1, 2012).

We estimate that this AD will affect about 586 products of U.S. registry.

The actions that are required by AD 2005-23-01, Amendment 39-14359 (70 FR 69073, November 14, 2005), and retained in this AD take about 2 work-hours per product, at an average labor rate of $85 per work hour. Based on these figures, the estimated cost of the currently required actions is $170 per product.

We estimate that it will take about 1 work-hour per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $49,810, or $85 per product.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (77 FR 32439, June 1, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

On May 22, 2012, at 77 FR 30234, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 to include an AD that would apply to Model A109E helicopters, up to and including serial number (S/N) 11694, except 11633 and 11634; and Model A109S helicopters, up to and including S/N 22034, except 22026 and 22033; with lower semichannel assemblies, part number (P/N)109-0641-10-213 or 109-0642-01-171, installed. That NPRM proposed to require a one-time inspection of the lower semichannel assemblies to determine if metallic spacers are installed. If the metallic spacers are installed, the AD proposed to require an inspection for the correct installation of the metallic spacers and correct seating of the gaskets. If the metallic spacers are installed without rivets, the AD proposed to require modification of the lower semichannel assemblies and inspection of the main drive shaft for damage. The proposed requirements were intended to detect missing spacer rivets, which could allow the metallic spacers to rotate and lead to damage and failure of the main drive shaft, and subsequent loss of helicopter control.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Emergency AD No. 2007-0192-E, dated July 13, 2007 (EAD 2007-0192-E), to correct an unsafe condition for certain serial-numbered Agusta Model A109E, A109S, and A109LUH helicopters with lower semichannel assemblies, P/N 109-0641-10-213 or 109-0642-01-171, installed. EASA advises that some cases of interference between the metallic spacer, P/N 109-0642-01-195, and the main drive shaft, P/N 109-0415-06-103, have been detected on the Model A109LUH helicopter, a military version of the Model A109 helicopter that is not type certificated in the U.S., and that this interference has damaged the main drive shaft. EASA advises that this condition, if not corrected, could lead to failure of the main drive shaft “with significant effects on the safety of the helicopter.”

We gave the public the opportunity to participate in developing this AD, but we received no comments on the NPRM (77 FR 30234, May 22, 2012).

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

This AD differs from the EASA AD as follows:

• This AD is not applicable to A109LUH model helicopters because they are not type certificated for use in the United States;

• This AD does not require compliance “not later than September 30, 2007” because that date has passed;

• This AD uses the term “hours time-in-service” rather than “flight hours” when referring to compliance times; and

• This AD does not contain the steps necessary to install the main drive shaft.

Agusta has issued Mandatory Alert Bollettino Tecnico No. 109EP-79, dated July 12, 2007 (BT 109EP-79), which applies to certain S/Ns of the model A109E helicopter, and Mandatory Alert Bollettino Tecnico No. 109S-15, dated July 12, 2007 (BT 109S-15), which applies to certain S/Ns of the model A109S helicopter. Both BT 109EP-79 and BT 109S-15 specify performing an inspection on the left side and right side lower semichannel assemblies to determine if metallic spacers are installed. If the metallic spacers are installed, BT 109EP-79 and BT 109S-15 specify inspecting the metallic spacers for correct installation, inspecting the gaskets for correct seating, modifying the semichannel assemblies by installing missing rivets, and inspecting the main drive shaft for damage if the metallic spacers are installed without rivets.

We estimate that this AD will affect about 90 helicopters of U.S. registry. We also estimate an average labor rate of $85 per work hour. Based on these assessments, we calculate the following costs:

• Inspecting the lower semichannel assembly for metallic spacers will take about 15 minutes for a labor cost of $21 per helicopter. No parts will be needed, so the total cost for the 90-helicopter fleet will be $1,890.

• Inspecting for missing rivets will take about three work-hours for a total labor cost of $255 per helicopter. Parts will cost $10, increasing the per-helicopter cost to $265.

• Removing, inspecting for damage, and reinstalling the main drive shaft will take four work-hours for a labor cost of $340. No parts will be required.

• Replacing the main drive shaft. This task also will take four work-hours, so that labor costs will again total $340. Parts will cost $20,824 for a total per-helicopter cost of $21,164.

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 helicopters 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 to the extent that it justifies making a regulatory distinction; and

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on July 11, 2012 (77 FR 40832). That NPRM proposed to require installing new software, replacing the duct assembly with a new duct assembly, making wiring changes, and routing certain wire bundles.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (77 FR 40832, July 11, 2012), and the FAA's response to each comment.

Boeing requested that we refer to Boeing Alert Service Bulletin 747-21A2523, Revision 2, which has not been issued, instead of Boeing Alert Service Bulletin 747-21A2523, Revision 1, dated October 3, 2011, as the appropriate source of service information in the NPRM (77 FR 40832, July 11, 2012). Boeing stated that Boeing Alert Service Bulletin 747-21A2523, Revision 2, describes additional wire changes for Model 747-400 airplanes, and that one additional airplane is added to the effectivity of that service bulletin.

We disagree to refer to Boeing Alert Service Bulletin 747-21A2523, Revision 2, in this AD. That service bulletin has not been issued. Referring to a document that has not been issued violates the Federal Register regulations for materials incorporated by reference rules. See 1 CFR 51.1(f). We do not consider that delaying this action until after the release of a planned service bulletin is warranted. Additionally, increasing the AD applicability would require issuing a supplemental NPRM for public comment. We find that delaying this action would be inappropriate in light of the identified unsafe condition. Once Boeing Alert Service Bulletin 747-21A2523, Revision 2, is issued and we have reviewed that service bulletin, we might consider further AD rulemaking. We have not changed this final rule regarding this issue.

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

• Are consistent with the intent that was proposed in the NPRM (77 FR 40832, July 11, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 40832, July 11, 2012).

We estimate that this AD affects 33 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:

On December 21, 2011, the Federal Aviation Administration (FAA) issued a final rule that was published in the Federal Register as Flight Crew Member Duty and Rest Requirements on January 4, 2012. 77 FR 330. The regulations, which are limited to passenger operations conducted under 14 CFR part 121 (part 121), become effective on January 4, 2014. On December 21, 2011, the FAA also issued a Regulatory Impact Analysis (original RIA) dated November 18, 2011 (FAA-2009-1093-2477). The original RIA provides the basis for the FAA's decision to (1) promulgate the final rule establishing new flight, duty and rest requirements for flight crews in passenger operations; and (2) exclude flight crews in cargo-only operations from the new mandatory requirements. While cargo-only operations are not required to meet the new regulations, the rule permits these operators to opt in to the rule if they so choose.

On December 22, 2011 the Independent Pilots Association (IPA) filed a timely petition for review. During the course of reviewing the administrative record for the purpose of preparing the government's brief, the FAA discovered errors in the original RIA that supports the final rule. The errors were associated with the scope of costs related to the implementation of the regulations for cargo-only operations. These errors appeared to be of a sufficient amount that the FAA concluded it was prudent to review the portion of the cost-benefit analysis related to cargo-only operations and allow interested parties an opportunity to comment on the corrected analysis.

On May 17, 2012, the FAA asked the United States Court of Appeals for the District of Columbia Circuit to suspend the litigation of the final rule while the agency corrected the inadvertent errors it had discovered. The court granted the FAA's motion on June 8, 2012. While the passenger operations rule is not at issue in the court proceedings, the FAA, in an abundance of caution, decided to have that portion of the original RIA reevaluated as well. The FAA contracted with the John A. Volpe National Transportation Systems Center to review the original RIA for accuracy, correct any errors identified, and prepare a supplemental regulatory evaluation laying out the revised analysis. This Initial Supplemental RIA is the product of that review.

The FAA does not believe that it is statutorily foreclosed from issuing an RIA and considering the costs and benefits of the flight, duty, and rest rule. Section 212 of Public Law 111-216 contains a list of factors that Congress wanted the FAA to consider as part of this rulemaking. There is no indication in the statutory text of this section that this list was intended to be exhaustive. However, in its motion to the Court of Appeals, the FAA stated that it would provide petitioner with an opportunity to present its view that Public Law 111-216 prohibits the FAA from conducting a cost-benefit analysis. Accordingly, the FAA seeks comment on whether Public Law 111-216 permits the FAA to conduct a cost-benefit analysis.

Turning to the Initial Supplemental RIA, while this Initial Supplemental RIA largely mirrors the original RIA in both content and organizational structure, it does not re-evaluate the policy decisions behind the FAA's decision to issue a final rule implementing new flight, duty and rest requirements for part 121 carriers engaged in passenger operations. Rather, this Initial Supplemental RIA provides expanded discussion of the methodology and information sources used in the rulemaking analysis, corrects reporting and calculation errors identified in the original RIA, and presents sensitivity analysis on key assumptions used in the analysis. 1 A new Appendix B contains the results of those sensitivity analyses while Appendix C contains detailed data tables, which are summarized in the body of this Initial Supplemental RIA. The Initial Supplemental RIA results in data that provides greater justification for the exclusion of cargo operations from the final rule, and continues to provide justification for the final rule on passenger operations. As a result, the FAA has determined that no revisions to the final rule on either cargo or passenger operations is warranted.

In the original RIA, the portion of scheduling costs related to cargo-only operations of air carriers that conduct both passenger and cargo-only operations (mixed operations carriers) were inadvertently excluded from the reported costs of extending the final rule to cargo-only operations. This Initial Supplemental RIA fixes that omission and that revision has significantly increased the estimates of the stated costs of extending the final rule to cargo-only operations. Due to inclusion of impacts on cargo-only operations, a few air carriers were reclassified for ease of explication.

Table 1 and Table 2 summarize the differences between the original RIA and the Initial Supplemental RIA.

The FAA invites interested persons to review the Initial Supplemental RIA and submit written comments, data, or views. The most helpful comments reference a specific portion of the Initial Supplemental RIA, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, please send only one copy of written comments, or if filing comments electronically, please submit your comments only one time.

The FAA will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning the Initial Supplemental RIA. Before issuing the Final Supplemental RIA, the agency will consider all comments we receive on or before the closing date for comments. It will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change the Final Supplemental RIA in light of the comments we receive.

Do not file in the docket information that you consider to be proprietary or confidential business information. Send or deliver this information directly to the legal contact person identified in the FOR FURTHER INFORMATION CONTACT section of this document. You must mark the information that you consider proprietary or confidential. If you send the information on a disk or CD ROM, mark the outside of the disk or CD ROM and also identify electronically within the disk or CD ROM the specific information that is proprietary or confidential.

Under 14 CFR 11.35(b), when the FAA is aware of proprietary information filed with a comment, the agency does not place it in the docket. It is held in a separate file to which the public does not have access, and a note is placed in the docket that the agency has received it. If the agency receives a request to examine or copy this information, it treats it as any other request under the Freedom of Information Act (5 U.S.C. 552). The FAA processes such a request under the DOT procedures found in 49 CFR part 7.

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

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

2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or

3. Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.

Alternatively, a copy may be requested directly from the FAA by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the docket number or notice number of this rulemaking.

All documents the FAA considered in developing the underlying final rule, Flight Crew Member Duty and Rest Requirements and this Initial Supplemental RIA, including economic analyses and technical reports, are located in the docket for this rulemaking and may be viewed on the internet through the Federal eRulemaking Portal referenced in paragraph (1).

The Commission promulgated the Used Car Rule in 1984 and the Rule became effective in 1985. 1 The Used Car Rule is intended primarily to prevent oral misrepresentations and unfair omissions of material facts by used car dealers concerning warranty coverage. To accomplish that goal, the Rule provides a uniform method for disclosing warranty information on a window sticker called the “Buyers Guide” that dealers are required to display on used cars. The Rule requires used car dealers to disclose on the Buyers Guide whether they are offering a used car for sale with a dealer's warranty and, if so, the basic terms, including the duration of coverage, the percentage of total repair costs to be paid by the dealer, and the exact systems covered by the warranty. The Rule additionally provides that the Buyers Guide disclosures are to be incorporated by reference into the sales contract, and are to govern in the event of an inconsistency between the Buyers Guide and the sales contract.

Among other information, the Buyers Guide includes: (1) A suggestion that consumers ask the dealer if a pre-purchase inspection is permitted; (2) a warning against reliance on spoken promises that are not confirmed in writing; and (3) a list of fourteen major systems of a used motor vehicle and the major defects that may occur in these systems.

The Rule prescribes Spanish language versions of the Buyers Guide when dealers conduct sales in Spanish. 2 In 1995, as part of its periodic review, the Commission amended the Used Car Rule by, 3 among other things, adopting several minor grammatical changes to the Spanish language version of the Buyers Guide.

On July 21, 2008, the Commission announced in the Federal Register its regulatory review of the Rule as part of the FTC's systematic review of its rules and guides. 4 The Commission has decided to retain the Rule, to revise the Spanish translation of the Buyers Guide as proposed in that Federal Register document, and to make three nonsubstantive technical changes to the text of the Rule.

During the regulatory review, the Commission received one comment favoring the translation changes, 5 and none opposing them. The Commission received two comments recommending that the Rule require translations of the Buyers Guide into the language used to conduct the sale. 6 Two comments state that the Buyers Guide should not be translated into Spanish. 7

During the original 1984 rulemaking, the Commission chose to translate the Buyers Guide only into Spanish. At that time, the Commission considered whether to require a translation of the Buyers Guide into the language used to conduct a used car sale. 8 The Commission concluded that such a requirement could result in translations of the Buyers Guides of varying linguistic quality and accuracy unless the Commission published official translations of the Buyers Guide into the various languages used in the United States. 9 The Commission decided to limit the translation of the Buyers Guide to Spanish because, besides English, Spanish is the language most frequently used in the United States during used car transactions. 10 The Commission sees no reason to revisit its earlier decision and declines to propose requiring translations of the Buyers Guide into languages other than English and Spanish.

The Commission is also making three minor nonsubstantive changes to the Rule. First, the Commission is correcting a typographical error by changing “diffential” to “differential” in 16 CFR 455.2(b)(2)(ii). Second, the Commission is correcting the terminology used in 16 CFR 455.2(d) by changing the term “name” to “make.” Finally, the Commission is changing the example of an automobile make in 16 CFR 455.2(d) from “Vega” to “Corvette” because the Vega has not been manufactured since 1977.

Section 1029(d) of Title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act  11 authorizes the Commission to use Administrative Procedure Act  12 procedures to issue or amend rules with respect to motor vehicle dealers predominantly engaged in the sale and servicing, or leasing and servicing, of motor vehicles. Pursuant to this authority, the Commission is implementing several technical amendments to the Used Car Rule.

The Commission finds good cause to adopt these changes without further public comment. Under the APA, notice and comment are not required “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”  13

In this case, the Commission finds that additional public comment on the rule is unnecessary because the Commission has already provided an opportunity for public comment on these revisions to the Spanish translation of the Buyers Guide. Specifically, the Commission requested public comment on these revisions to the Spanish translation of the Buyers Guide as part of its regulatory review of the Buyers Guide. See 73 FR 42285. In response to the Commission's request for comment on these proposed changes, the Commission received one comment favoring the translation changes, 14 and no comments opposing the changes. Accordingly, the Commission has determined that the public has had sufficient opportunity to comment on the proposed changes. As a result, additional opportunity for public comment is unnecessary.

Moreover, additional public comment is unnecessary because the changes are merely nonsubstantive revisions to ensure the clarity and accuracy of the translation of the Buyers Guide. The Commission finds that these technical, nonsubstantive changes are minor, routine clarifications of the text of the Spanish translation that will not have a significant effect on industry or the public, and therefore additional public comment is unnecessary.

Accordingly, the Commission finds that there is good cause for adopting this final rule as effective on February 11, 2013.

The Regulatory Flexibility Act (“RFA”) requires an agency to provide a Final Regulatory Flexibility Act Analysis (“FRFA”) when promulgating a final rule that cannot be promulgated without publishing a proposed rulemaking. 15 An FRFA is not necessary if a general notice of proposed rulemaking is not required for promulgation or if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. 16

The Commission anticipates that the final Rule will not have a significant economic impact on a substantial number of small entities. The amended Rule, like the current Used Car Rule, does not contain reporting or recordkeeping requirements, but does require that dealers disclose certain information. The amended Rule requires only that dealers use a revised Spanish Buyers Guide when conducting sales in Spanish. The amended Rule does not impose additional recordkeeping requirements or change the information that dealers themselves must disclose on the Buyers Guide. Dealers will experience only an initial cost in obtaining revised Spanish Buyers Guides and will be permitted to use existing stocks of Spanish Buyers Guides. As such, the economic impact of the Rule will be minimal.

This document serves as notice to the Small Business Administration (“SBA”) of the agency's certification of no significant economic impact on a substantial number of small entities.

The final Rule revises the Spanish translation of the Buyers Guide that the Used Car Rule requires used car dealers to display. The final Rule does not require dealers to disclose additional information that they are not already required to provide under the current Rule. Thus, the final Rule does not give rise to changes in the FTC's previously submitted and approved “collection of information” requirements and related Paperwork Reduction Act burden analysis for public comment  17 and cleared by the Office of Management and Budget. 18

Section 22 of the FTC Act, 15 U.S.C. 57b, requires the Commission to issue a preliminary regulatory analysis when promulgating a final rule amending a rule if the Commission: (1) Estimates that the amendment will have an annual effect on the national economy of $100,000,000 or more; (2) estimates that the amendment will cause a substantial change in the cost or price of certain categories of goods or services; or (3) otherwise determines that the amendment will have a significant effect upon covered entities or consumers.

A final regulatory analysis is not necessary because the Commission has determined that these amendments to the Used Car Rule will not have such an annual effect on the national economy, on the cost or prices of goods or services sold by used car dealers, or on covered businesses or consumers. Commission staff estimates that each business affected by the final Rule will likely incur only minimal initial added compliance costs as dealers obtain revised Spanish Buyers Guides.

Accordingly, after review of the public comments, the Commission has determined to amend 16 CFR 455.5 by translating the term “dealer” into Spanish as “concesionario” in footnote 4 of the rule and in the accompanying illustration of the Spanish Buyers Guide. The Commission is also revising the translation of certain other terms in the Guide as follows: “regardless of” shall be translated as “independientemente de”; “Frame-cracks” shall be translated as “Grietas en el chasis”; “Cooling System” shall be translated as “Sistema de enfriamiento”; “Air conditioner” shall be translated as “Aire acondicionado”; “Defroster” shall be translated as “Desempañador”; and “Not enough pedal reserve” shall be translated as “Distancia insuficiente del pedal.”  19 Finally, the Commission is amending the Rule by making the three nonsubstantive textual revisions described in Section II.B. above.

Accordingly, for the reasons stated above, the Federal Trade Commission amends part 455 of title 16 of the Code of Federal Regulations as follows:

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have provided.

As this temporary interim rule will be in effect before the end of the comment period, the Coast Guard will evaluate and revise this rule as necessary to address significant public comments.

If you submit a comment, please include the docket number for this rulemaking (USCG-2011-1125), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number (USCG-2012-1125) in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

If you submit comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change this rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number “USCG-2012-1125” in the “SEARCH” box and click “Search.” Click and Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

The Coast Guard does not currently plan to hold public meetings. However, a public meeting may be requested by using one of the methods specified under ADDRESSES . Please explain why you believe such a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

This is the second temporary interim rule with request for comments issued by the Coast Guard to establish a regulated navigation area in connection with the S99 Alford Street Bridge rehabilitation over the main channel of the Mystic River between Boston and Chelsea, Massachusetts. The first rule was published in the Federal Register on January 9, 2012 (77 FR 1020). We received no public comments on the first rule.

The Coast Guard is issuing this second rule without prior Federal Register notice pursuant to authority under section 4(a) of the Administrative Procedure Act (APA), 5 U.S.C. 553(b). This provision authorizes an agency to issue a rule without prior notice when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard has good cause to find that publishing a notice of proposed rulemaking (NPRM) for this second rule, and taking public comment on that NPRM, would be both impracticable and contrary to the public interest. The repair work that necessitated the first rule has not been completed on schedule and therefore the hazardous conditions that gave rise to the need for RNA protective measures continue. Expiration of the first RNA on November 30, 2012 leaves no time for notice and comment procedures if both the repair work and RNA protective measures are to remain in place after that date. Temporarily stopping necessary repair work would impracticably delay the resumption of normal traffic patterns and raise construction costs, contrary to the public interest. To some extent, it is also unnecessary to follow normal notice and comment practice with respect to this RNA, because the affected public can clearly see that the bridge repair work and that work's associated hazards continue, and anyone who wishes to comment on the need for or the terms of the RNA may at any time submit comments to the Coast Guard, and the Coast Guard will respond to those comments.

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

Under the Ports and Waterways Safety Act, the Coast Guard has the authority to establish RNAs in defined water areas that are determined to have hazardous conditions and in which vessel traffic can be regulated in the interest of safety. See 33 U.S.C. 1231 and Department of Homeland Security Delegation No. 0170.1.

The purpose of this temporary interim rule and request for comments is to keep in place and extend the regulated navigation area that was the subject of the Coast Guard temporary interim rule and request for comments published in the Federal Register on January 9, 2012 in order to ensure the safe transit of vessels in the area and to protect all persons, vessels, and the marine environment during the rehabilitation project of the S99 Alford Street Bridge.

This rule reinstates a regulated navigation area that was promulgated to protect the public against hazardous conditions created by repair work on the S99 Alford Street Bridge across the Mystic River between Boston and Chelsea, Massachusetts. The original RNA took effect with actual notice on December 27, 2011, was the subject of a temporary interim rule and request for comments published in the Federal Register on January 9, 2012, and expires by its own terms at 11:59 p.m. on November 30, 2012. However, the repair work is continuing beyond that date and therefore the RNA must be reinstated to extend the RNA's protective measures for the duration of that work. This new temporary interim rule and request for comments makes no substantive changes in the RNA.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be minimal because the amount of traffic in this waterway is extremely limited. Furthermore, the Captain of the Port has the ability to suspend the provisions of this regulation when necessary.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended requires federal agencies to consider the potential impact of regulations on small entitles during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities some of which may be small entities: The owners or operators of marinas, businesses (such as waterside restaurants), and vessels who intend to transit in the Mystic River beneath the S99 Alford Street Bridge during the effective period.

This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: this action only serves to reinstate an RNA that is already in place and for which no public comments were received. Many parties that have the potential to be affected have been involved in the discussions and have made plans to work around the closure times. We will use appropriate means to inform the public before, during, and at the conclusion of any RNA enforcement period.

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

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the modification of an existing regulated navigation area. This rule is categorically excluded from further review under, paragraph 34(g) of figure 2-1 of the Commandant Instruction. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

The National Park Service (NPS) has managed winter use in Yellowstone National Park for several decades. A detailed history of the winter use issue, past planning efforts, and litigation is provided on the park's Web site, http://www.nps.gov/yell/parkmgmt/timeline.htm. The park has most recently operated under a temporary one-year rule (76 FR 77131). That rule extended for one winter season the daily entry limits and operational requirements for snowmobiles and snowcoaches adopted by the 2009 interim plan, which had been in effect for the prior two winter seasons, but the authorizations of snowmobile and snowcoach use expired by their own terms on March 15, 2012.

On July 5, 2011, the NPS published a proposed long-term rule to implement the preferred alternative identified in the Draft Winter Use Plan/Environmental Impact Statement (DEIS) (76 FR 39048). Under that alternative, the NPS proposed providing four different use-level combinations for snowmobiles and snowcoaches, which would vary according to a seasonal schedule. The NPS had intended to issue a record of decision and finalize a long-term rule for Yellowstone winter use by December 2011. However, some of the more than 59,000 public comments received on the DEIS raised reasonable questions as to long-term management strategies and environmental impacts, and the NPS decided to delay implementation of a long-term rule in order to prepare a Supplemental Environmental Impact Statement (SEIS) further analyzing the impacts of winter use under various long-term management options.

Accordingly, in its December 2011 Record of Decision (ROD) (76 FR 77249), the NPS announced its decision to select and implement Alternative 8 in the Final Environmental Impact Statement (FEIS). Alternative 8 extended for one additional winter season—the 2011-2012 season—the daily entry limits and operating requirements of the 2009 rule, which allowed up to 318 commercially guided, best available technology snowmobiles and 78 commercially guided snowcoaches in the park per day, as well as authorizing a variety of non-motorized uses. The DEIS and FEIS contained and analyzed an alternative—identified as Alternative 2—implementing those limits and operating requirements indefinitely into the future. On December 12, 2011, the NPS published a final rule to implement Alternative 8 (76 FR 77131). The NPS believed that the additional time afforded by a new one-season rule would allow it to complete the SEIS, decide on a long-term plan for managing winter use, and promulgate a new long-term rule before the beginning of the 2012-2013 winter season.

On June 29, 2012, the NPS released the Draft SEIS and published a Notice of Availability in the Federal Register (77 FR 38824). Public comment on the Draft SEIS closed on August 20, 2012. The response from the public and stakeholders was robust. A majority of the substantive comments addressed the proposal in the Draft SEIS's preferred alternative to manage snowmobiles and snowcoaches by a new concept known as “transportation events.” Numerous commenters requested additional time to consider this new management concept and to respond substantively to it. Accordingly, the NPS decided to reopen public comment on the Draft SEIS for an additional 30 days. Mindful of the short amount of time left before the opening of the 2012-2013 winter season on December 15, 2012, and desiring to take the time necessary to make a reasoned long-term decision on winter use, the NPS decided to amend the December 2011 ROD to authorize extending the most recent winter use management framework for an additional year. The NPS is promulgating this new rule to extend for one additional winter season the 2011-2012 daily entry limits and operating requirements. The NPS intends to complete the Draft SEIS, make a decision on a plan for long-term winter use, and issue a new long-term regulation for winter use before the 2013-2014 winter season.

The public comment period was open from September 4, 2012 to October 4, 2012. Comments were accepted through the mail, hand delivery, and through the Federal eRulemaking Portal: http://www.regulations.gov. The NPS received 33 comments. Most of the comments focused on the analysis in the Draft SEIS and addressed issues related to long-term management. The NPS will consider these comments regarding long-term issues as it works on the SEIS and new rule for the long-term winter use plan. A summary of comments and the NPS responses is provided below.

1. Comment: Several comments did not support extending the 2011-2012 daily entry limits and operating requirements for the 2012-2013 winter season, and instead favored implementation of Alternative 4 in the Draft SEIS.

NPS Response: As described above, the NPS decided to extend the 2011-2012 requirements for one additional season to ensure that the public would have additional time to consider the new management concept in the Draft SEIS and to allow the NPS to make a reasoned long-term decision on winter use at Yellowstone National Park.

2. Comment: One commenter stated that all regulation of snowmobile use in the park should be removed.

NPS Response: In the 2011 FEIS, the NPS considered but dismissed an alternative that would have removed limits on snowmobile use in the park, due to the fact that unmanaged use could result in impairment to park resources and values.

3. Comment: Several commenters stated that the rule should be revised to allow fewer snowmobiles and snowcoaches.

NPS Response: In the 2011 ROD, the NPS determined that use of snowmobiles and snowcoaches in the park at the levels allowed in this rule is appropriate. The data included in the 2011 FEIS demonstrates that allowing 318 snowmobiles and 78 snowcoaches in the park per day results in only minor to moderate impacts to park resources, while allowing the public to experience the park's unique winter resources.

4. Comment: Several commenters suggested that the NPS alter the way it tests emissions from snowmobiles and snowcoaches.

NPS Response: The NPS may consider altering the testing standards for snowmobiles and snowcoaches as part of the long-term rule. However, there is not enough time to alter the testing standards for this rule, which goes into effect on December 15, 2012, and applies to the 2012-2013 winter season only.

5. Comment: Several commenters suggested that the NPS ban the use of snowmobiles and snowcoaches in the park.

NPS Response: As part of the range of alternatives analyzed in the SEIS, the NPS is considering an alternative that would eliminate motorized oversnow vehicle use. This rule was promulgated to allow the status quo that has governed winter use for the past three seasons while the NPS makes a long-term decision about motorized winter use in the park.

6. Comment: Several commenters suggested that the NPS allow only snowcoaches in the park.

NPS Response: As part of the range of alternatives analyzed in the SEIS, the NPS is considering an alternative that would prohibit snowmobiles and allow only snowcoaches. This rule was promulgated to allow the status quo that has governed winter use for the past three seasons while the NPS makes a long-term decision about motorized winter use in the park.

7. Comment: Several commenters suggested that the NPS increase the number of snowmobiles allowed in the park.

NPS Response: As part of the range of alternatives analyzed in the SEIS, the NPS is considering an alternative that would increase the number of snowmobiles allowed in the park. This rule was promulgated to allow the status quo that has governed winter use for the past three seasons while the NPS makes a long-term decision about motorized winter use in the park.

8. Comment: One commenter stated that the NPS should restrict snowmobile use to areas where people and wildlife are not present.

NPS Response: Under this rule, snowmobile and snowcoach use is only allowed on designated routes, which are groomed over roads that are used in the summer and provide access from park entrances to the interior of the park. There are many additional areas and trails that are open to visitors in the park where snowmobile and snowcoach use is not allowed.

9. Comment: One commenter stated that the NPS should impose snowcoach weight limitations that would ban Bombardiers.

NPS Response: The NPS may consider imposing additional restrictions on snowcoaches as part of the long-term rule. This rule was promulgated to allow the status quo that has governed winter use for the past three seasons while the NPS makes a long-term decision about motorized winter use in the park.

10. Comment: One commenter stated that unguided snowmobile use should be allowed.

NPS Response: The NPS believes that requiring all snowmobile and snowcoach trips to be guided reduces law enforcement incidents and accidents, and offers the best opportunity for achieving goals of protecting park resources and allowing balanced use of the park. The guiding requirement has proven effective at keeping groups under the speed limits, staying on the groomed road surfaces, reducing conflicts with wildlife, and ensuring other appropriate behavior for visitors to safely and responsibly visit the park.

The NPS is revising § 7.13 paragraphs (l)(3)(ii) and (l)(4)(vi) and the introductory text of paragraphs (l)(7)(i) and (l)(8)(i) by replacing the terms “the winter season of 2011-2012” and “the winter of 2011-2012” with the terms “the winter season of 2012-2013” and “the winter of 2012-2013.” These are the only changes to the existing regulations.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

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

This rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ).

The NPS used two separate baselines for its regulatory flexibility analysis. If no new rule were passed, Baseline 1 would be defined by the no-action alternative in the EIS. Under this baseline, no motorized oversnow vehicles would be allowed in the park. In addition, the NPS defined a second baseline, Baseline 2. Baseline 2 represents the continuation of the same levels of use allowed under the 2009 interim regulation in place for the past three winter seasons. Under Baseline 2, there would be a zero net change between the past three years and the actions being implemented under this rule, because the rule extends the management framework in place the past three winter seasons for one additional year. A regulatory flexibility analysis is included in the report titled “Economic Analysis of Winter Use Regulations in Yellowstone National Park” (RTI International, 2011). The NPS has reviewed the economic analysis contained in that report and has concluded that it still is relevant and that its results would apply to the additional year.

This rule is not a major rule under 5 U.S.C. 804(2), the SBREFA. This rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, state, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This rule has no effect on methods of manufacturing or production and specifically affects the Greater Yellowstone Area, not national or U.S.-based enterprises.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. A statement containing the information required by the UMRA (2 U.S.C. 1531 et seq. ) is not required. The rule addresses public use of national park lands, and imposes no requirements on other agencies or governments.

Under the criteria in section 2 of Executive Order 12630, this rule does not have significant takings implications. Access to private property located adjacent to the park will be afforded the same access during winter as before this rule. No other property is affected. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. It addresses public use of national park lands, and imposes no requirements on other agencies or governments.

This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required. Numerous tribes in the area were consulted in the development of the previous winter use planning documents.

This rule does not contain any new collection of information that requires approval by the Office of Management and Budget (OMB) under the PRA of 1995 (44 U.S.C. 3501 et seq. ). OMB has approved the collection requirement associated with Commercial Services and has assigned OMB control number 1024-0125 (expires 03/31/2013). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This winter use plan and rule constitute a major Federal action with the potential to significantly affect the quality of the human environment. The NPS prepared the 2011 FEIS under the National Environmental Policy Act of 1969. The NPS has reexamined the analyses contained in the 2011 FEIS, as well as new data from the 2011-2012 winter season, and has amended the December 2011 ROD (76 FR 77249) to authorize extending the most recent winter use management framework for an additional year. The 2011 FEIS is available for review at http://parkplanning.nps.gov/yell by clicking on the link entitled “Winter Use Plan/EIS” and then clicking on the link entitled “Document List.”

This rule is not a significant energy action under the definition in Executive Order 13211, a statement of Energy Effects is not required.

The National Park Service recognizes that under 5 U.S.C. 553(d) new rules ordinarily go into effect thirty days after publication in the Federal Register . However, we have determined under 5 U.S.C. 553(d) and 318 DM 6.25 that good cause exists for this rule to become effective on December 15, 2012, for the following reasons:

(1) A 30-day public comment period was open from September 4, 2012, through October 4, 2012, on the proposed rule, during which the NPS stated its intent to implement this winter use plan during the 2012-2013 winter season as an additional transition year. The NPS has received voluminous public comment on previous rulemaking efforts regarding winter use of the park, including efforts in 2000, 2003, 2004, 2007, 2008, and 2011. Those rulemaking efforts addressed many of the same issues as are addressed in this rulemaking, which simply extends existing rules that have been in place for the previous three winter seasons.

(2) The rule implements the winter use plan for Yellowstone National Park and allows snowmobile and snowcoach use that otherwise would be prohibited.

(3) Since at least December 2011 the NPS has in good faith publicly stated that the 2012-2013 winter season for Yellowstone National Park would commence on the traditional date of December 15, and the public and businesses have made decisions based on the widespread public knowledge of this customary opening date.

(4) There would be no benefit to the public in delaying the effective date of this rule, given that there has already been substantial notice of the opening date and that the park will be open under conditions substantially similar to those in effect for the past three years.

(5) Many persons planning to visit the park have already made travel plans in anticipation of the park being open for snowmobile and snowcoach use, such as reserving time off from work, booking airfares and hotel accommodations, making reservations for snowmobile or snowcoach tours, and the like. The Christmas-New Year period is one of the most heavily visited times of the winter season. If the park does not open as scheduled on December 15, 2012, it would create unnecessary hardship for visitors who have already planned trips, and would likely result in economic losses for some visitors if reservations had to be cancelled. Significant revenue loss for businesses in and around the park would also occur. Many businesses in the gateway communities surrounding the park, and the people who rely upon them for their livelihoods, are highly dependent upon the park being open for the entire duration of the approximately 90-day season.

(6) Snowmobile and snowcoach operators have made business decisions and investments for the winter season premised on an opening date of December 15, 2012. Such actions include purchasing new snowmobiles and snowcoaches for their fleets, making offers of employment, preparing advertising and other materials, and purchasing snowmobile accessories such as suits, helmets, boots, mittens, etc. A late opening would shorten an already-brief winter season, thereby depriving these businesses and others that depend on the winter season (such as hotels, restaurants, service stations, and other hospitality-oriented businesses) of revenue that is important to their livelihoods.

In consideration of the forgoing, the NPS amends 36 CFR part 7 as set forth below:

On October 2, 2012 (77 FR 60094), EPA published a notice of proposed rulemaking (NPR) for the State of West Virginia for the Charleston Area. The NPR proposed approval of the PM 2.5 2002 base year emissions inventory portion of the West Virginia SIP revision for the Charleston Area. The formal SIP revision was submitted by the State of West Virginia on November 4, 2009.

The PM 2.5 2002 base year emissions inventory submitted by WVDEP on November 4, 2009 for the Charleston Area includes emissions estimates that cover the general source categories of point sources, non-road mobile sources, area sources, on-road mobile sources, and biogenic sources. The pollutants that comprise the inventory are nitrogen oxides (NO X ), volatile organic compounds (VOCs), PM 2.5 , coarse particles (PM 10 ), ammonia (NH 3 ) and sulfur dioxide (SO 2 ). WVDEP selected the year 2002 as the base year for the emissions inventory per 40 CFR 51.1008(b). A discussion of the emissions inventory development as well as the emissions inventory for the Charleston Area can be found in Appendices C and D of the November 4, 2009 SIP submittal.

EPA has reviewed the results, procedures and methodologies for the base year emissions inventory submitted by WVDEP. EPA's evaluation can be found in the Technical Support Document dated August 12, 2010, available online at www.regulations.gov, Docket No. EPA-R03-OAR-2012-0422. EPA found that the process used to develop this emissions inventory for the Charleston Area is adequate to meet the requirements of CAA section 172(c)(3), the implementing regulations, and EPA guidance for emission inventories.

Specific requirements of the base year inventory and the rationale for EPA's action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

EPA is approving the 2002 base year PM 2.5 emissions inventory for the Charleston Area as a revision to the West Virginia SIP.

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 11, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to the PM 2.5 2002 base year emissions inventory for the Charleston 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 October 2, 2012 (77 FR 60087), EPA published a notice of proposed rulemaking (NPR) for the State of West Virginia. The NPR proposed approval of the 2002 base year emissions inventory portion of the West Virginia SIP revision submitted by the State of West Virginia on September 9, 2008.

The 2002 base year emissions inventory submitted by WVDEP on September 9, 2008 for the Parkersburg Area includes emissions estimates that cover the general source categories of point sources, non-road mobile sources, area sources, on-road mobile sources, and biogenic sources. The pollutants that comprise the inventory are nitrogen oxides (NO X ), volatile organic compounds (VOCs), PM 2.5 , coarse particles (PM 10 ), ammonia (NH 3 ) and sulfur dioxide (SO 2 ). EPA has reviewed the results, procedures and methodologies for the base year emissions inventory submitted by WVDEP. The year 2002 was selected by WVDEP as the base year for the emissions inventory per 40 CFR 51.1008(b). A discussion of the emissions inventory development as well as the emissions inventory for the Parkersburg Area can be found in the September 9, 2008 SIP submittal. Specific requirements of the base year inventory and the rationale for EPA's action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

EPA is approving the 2002 base year PM 2.5 emissions inventory for the Parkersburg Area as a revision to the West Virginia SIP.

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 11, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action pertaining to the PM 2.5 2002 base year emissions inventory for the Parkersburg 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:

Definitions

For the purpose of this document, we are giving meaning to certain words or initials as follows:

i. The words or initials Act or CAA mean or refer to the Clean Air Act, unless the context indicates otherwise.

ii. The initials BART mean or refer to Best Available Retrofit Technology.

iii. The initials EGUs mean or refer to electric generating units.

iv. The initials GCVTC mean or refer to the Grand Canyon Visibility Transport Commission.

v. The initials NO X mean or refer to nitrogen oxides.

vi. The initials PM mean or refer to particulate matter.

vii. The initials SIP mean or refer to State Implementation Plan.

viii. The initials URP mean or refer to uniform rate of progress.

ix. The initials WAQSR mean or refer to Wyoming Air Quality Standards and Regulations.

The CAA requires each state to develop plans, referred to as SIPs, to meet various air quality requirements. A state must submit its SIPs and SIP revisions to us for approval. Once approved, a SIP is enforceable by the EPA and citizens under the CAA, also known as being federally enforceable. This action involves the requirement that states have SIPs that address regional haze.

In 1990, Congress added section 169B to the CAA to address regional haze issues, and we promulgated regulations addressing regional haze in 1999. 64 FR 35714 (July 1, 1999), codified at 40 CFR part 51, subpart P. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in our visibility protection regulations at 40 CFR 51.300-309. The requirement to submit a regional haze SIP applies to all 50 states, the District of Columbia and the Virgin Islands. States were required to submit a SIP addressing regional haze visibility impairment no later than December 17, 2007. 40 CFR 51.308(b) and 40 CFR 51.309(c).

Wyoming submitted SIPs addressing regional haze on January 12, 2011 and April 19, 2012 (these superseded and replaced prior SIP submittals dated December 24, 2003, May 7, 2004, and November 21, 2008).

In a lawsuit in the U.S. District Court for the District of Colorado, environmental groups sued us for our failure to take timely action with respect to the regional haze requirements of the CAA and our regulations for the State of Wyoming. As a result of this lawsuit, we entered into a consent decree. The consent decree requires that we sign a notice of final rulemaking addressing the regional haze requirements of 40 CFR 51.309 for Wyoming by November 14, 2012. 1 We are meeting that requirement with the signing of this notice of final rulemaking.

We signed our notice of proposed rulemaking on May 9, 2012, and it was published in the Federal Register on May 24, 2012 (77 FR 30953). In that notice, we provided a detailed description of the various regional haze requirements. We are not repeating that description here; instead, the reader should refer to our notice of proposed rulemaking for further detail.

In our proposal, we proposed to approve Wyoming SIP revisions submitted on January 12, 2011 and April 19, 2012 that address the regional haze rule (RHR) for the mandatory Class I areas under 40 CFR 51.309. EPA proposed that the January 12, 2011 and April 19, 2012 SIPs meet the requirements of 40 CFR 51.309, with the exception of 40 CFR 51.309(d)(4)(vii), and 40 CFR 51.309(g), as explained below.

As part of the January 12, 2011 and April 19, 2012 SIPs, the State submitted revisions to the Wyoming Air Quality Standards and Regulations (WAQSR). The State submitted WAQSR Chapter 14, Sections 2 and 3— Emission Trading Program Regulations . WAQSR Chapter 14, in conjunction with the SIP, implements the backstop trading program provisions in accordance with the applicable requirements of 40 CFR 51.308 and 40 CFR 51.309. We proposed to approve WAQSR Chapter 14, Section 2 and Section 3. The State also submitted WAQSR Chapter 10, Section 4— Smoke Management. WAQSR Chapter 10, Section 4, in conjunction with the SIP, implements the requirements for smoke management under 40 CFR 51.309(d)(6). We proposed to approve WAQSR Chapter 10, Section 4.

The State's submitted another SIP revision dated January 12, 2011 that addresses the requirements under 40 CFR 51.309(d)(4)(vii) and 40 CFR 51.309(g) pertaining to best available retrofit technology (BART) for particulate matter (PM) and nitrogen oxides (NO X ) and additional Class I areas, respectively. EPA proposed action on this SIP in a separate notice (77 FR 33022). In addition, the January 12, 2011 and April 19, 2012 submittals we proposed to act on supersede and replace regional haze SIPs submitted on December 24, 2003, May 27, 2004, and November 21, 2008.

We requested comments on all aspects of our proposed action and provided a sixty-day comment period, with the comment period closing on July 23, 2012. We received comments on our proposed rule that supported our proposed action and that were critical of our proposed action. In this action, we are responding to the comments we have received, taking final rulemaking action, and explaining the bases for our action.

In this action, EPA is approving Wyoming SIP revisions submitted on January 12, 2011 and April 19, 2012 that address the RHR requirements for the mandatory Class I areas under 40 CFR 51.309. EPA taking final action to find that the January 12, 2011 and April 19, 2012 SIPs meet the requirements of 40 CFR 51.309, with the exception of 40 CFR 51.309(d)(4)(vii), and 40 CFR 51.309(g).

As part of the January 12, 2011 submittal, the State submitted revisions to WAQSR. The State submitted WAQSR Chapter 14, Sections 2 and 3— Emission Trading Program Regulations . We are approving WAQSR Chapter 14, Section 2 and Section 3. The State also submitted WAQSR Chapter 10, Section 4— Smoke Management. We are approving WAQSR Chapter 10, Section 4. We are also approving Wyoming's April 19, 2012 SIP submittal that contains the pre-trigger emission inventory requirements, which are covered by WAQSR Chapter 14, Section 3— Emission Inventory.

We have fully considered all significant comments on our proposal and have concluded that no changes from our proposal are warranted. Our action is based on an evaluation of Wyoming's regional haze SIP submittal against the regional haze requirements at 40 CFR 51.300-51.309 and CAA sections 169A and 169B. All general SIP requirements contained in CAA section 110, other provisions of the CAA, and our regulations applicable to this action were also evaluated. The purpose of this action is to ensure compliance with these requirements. Our authority for action on Wyoming's SIP submittal is based on CAA section 110(k).

We are approving the State's regional haze SIP provisions because they meet the relevant regional haze requirements. The adverse comments we received concerning our proposed approval of the regional haze SIP pertained to our proposed approval of the SO 2 backstop trading program. However, the comments have not convinced us that the State did not meet the requirements of 40 CFR 51.309 that we proposed to approve.

EPA has proposed to approve the SO 2 backstop trading program components of the RH SIPs for all participating states and has done so through four separate proposals: For the Bernalillo County proposal see 77 FR 24768 (April 25, 2012); for the Utah proposal see 77 FR 28825 (May 15, 2012); for the Wyoming proposal see 77 FR 30953 (May 24, 2012); finally, for the New Mexico proposal see 77 FR 36043 (June 15, 2012). National conservation organizations paired with organizations local to each state have together submitted very similar, if not identical, comments on various aspects of EPA's proposed approval of these common program components. These comment letters may be found in the docket for each proposal and are dated as follows: May 25, 2012 for Bernalillo County; July 16, 2012 for Utah; July 23, 2012 for Wyoming; and July 16, 2012 for New Mexico. Each of the comment letters has attached a consultant's report dated May 25, 2012, and titled: “Evaluation of Whether the SO 2 Backstop Trading Program Proposed by the States of New Mexico, Utah and Wyoming and Albuquerque-Bernalillo County Will Result in Lower SO 2 Emissions than Source-Specific BART.” In this section, we address and respond to those comments we identified as being consistently submitted and specifically directed to the component of the published proposals dealing with the SO 2 backstop trading program. For our organizational purposes, any additional or unique comments found in the conservation organization letter that is applicable to this proposal (i.e., for the State of Wyoming) will be addressed in the next section where we also address all other comments received.

Comment: The commenter acknowledges that prior case law affirms EPA's regulatory basis for having “better than BART” alternative measures, but nevertheless asserts that it violates Congress' mandate for an alternative trading program to rely on emissions reductions from non-BART sources and excuse electric generating units (EGUs) from compliance with BART.

Response: The CAA requires BART “as may be necessary to make reasonable progress toward meeting the national goal” of remedying existing impairment and preventing future impairment at mandatory Class I areas. See CAA Section 169A(b)(2) (emphasis added). In 1999, EPA issued regulations allowing for alternatives to BART based on a reading of the CAA that focused on the overarching goal of the statute of achieving progress. EPA's regulations provided states with the option of implementing an emissions trading program or other alternative measure in lieu of BART so long as the alternative would result in greater reasonable progress than BART. We note that this interpretation of CAA Section 169A(B)(2) was determined to be reasonable by the D.C. Circuit in Center for Energy and Economic Development v. EPA, 398 F.3d 653, 659-660 (D.C. Cir. 2005) in a challenge to the backstop market trading program under Section 309, and again found to be reasonable by the D.C. Circuit in Utility Air Regulatory Group v. EPA, 471 F.3d 1333, 1340 (D.C. Cir. 2006) (“* * * [W]e have already held in CEED that EPA may leave states free to implement BART-alternatives so long as those alternatives also ensure reasonable progress.”). Our regulations for alternatives to BART, including the provisions for a backstop trading program under Section 309, are therefore consistent with the CAA and not in issue in this action approving a SIP submitted under those regulations. We have reviewed the submitted 309 trading program SIPs to determine whether each has the required backstop trading program (see 40 CFR 51.309(d)(4)(v)), and whether the features of the program satisfy the requirements for trading programs as alternatives to BART (see 40 CFR 51.308(e)(2)). Our regulations make clear that any market trading program as an alternative to BART contemplates market participation from a broader list of sources than merely those sources that are subject to BART. See 40 CFR 51.308(e)(2)(i)(B).

Comment: The submitted 309 trading program is defective because only three of nine transport states remain in the program. The Grand Canyon Visibility Transport Commission (GCVTC) Report clearly stated that the program must be “comprehensive.” The program fails to include the other western states that account for the majority of sulfate contribution in the Class I areas of participating states, and therefore, Class I areas on the Colorado Plateau will see little or no visibility benefit. Non-participation by other transport region states compounds the program's deficiencies.

Response: We disagree that the 309 trading program is defective because only three states remain in the program. EPA's regulations do not require a minimum number of Transport Region States to participate in the 309 trading program, and there is no reason to believe that the limited participation by the 9 Transport Region States will limit the effectiveness of the program in the three states that have submitted 309 SIPs. The commenter's argument is not supported by the regional haze regulations and is demonstrably inconsistent with the resource commitments of the Transport Region States that have worked for many years in the WRAP to develop and submit SIPs to satisfy 40 CFR 51.309. At the outset, our regulations affirm that “certain States * * * may choose” to comply with the 40 CFR 51.309 requirements and conversely that “[a]ny Transport Region State [may] elect not to submit an implementation plan” to meet the optional requirements. 40 CFR 51.309(a); see also 40 CFR 51.309(f). We have also previously observed how the WRAP, in the course of developing its technical analyses as the framework for a trading program, “understood that some States and Tribes may choose not to participate in the optional program provided by 40 CFR 51.309.” 68 FR 33,769 (June 5, 2003). Only five of nine Transport Region States initially opted to participate in the backstop trading program in 2003, and of those initial participants only Oregon and Arizona later elected not to submit 309 SIPs.

We disagree with the commenter's assertion that Class I areas on the Colorado Plateau will see little or no visibility benefit. Non-participating states must account for sulfate contributions to visibility impairment at Class I areas by addressing all requirements that apply under 40 CFR 51.308. To the extent Wyoming, New Mexico and Utah sources “do not account for the majority of sulfate contribution” at the 16 class I areas on Colorado Plateau, there is no legal requirement that they account for SO 2 emissions originating from sources outside these participating states. Aside from this, the modeling results detailed in the proposed rulemaking show projected visibility improvement for the 20 percent worst days in 2018 and no degradation in visibility conditions on the 20 percent best days at all 16 of the mandatory Class I areas under the submitted 309 plan.

Finally, we do not agree with the commenter's characterization of the GCVTC Report, which used the term “comprehensive” only in stating the following: “It is the intent of [the recommendation for an incentive-based trading program] that [it] include as many source categories and species of pollutants as is feasible and technically defensible. This preference for a `comprehensive' market is based upon the expectation that a comprehensive program would be more effective at improving visibility and would yield more cost-effective emission reduction strategies for the region as a whole.”  2

It is apparent that the GCVTC recommended comprehensive source coverage to optimize the market trading program. This does not necessitate or even necessarily correlate with geographic comprehensiveness as contemplated by the comment. We note that the submitted backstop trading program does in fact comprehensively include “many source categories,” as may also be expected for any intrastate trading program that any state could choose to develop and submit under 40 CFR 51.308(e)(2). As was stated in our proposal, section 51.309 does not require the participation of a certain number of states to validate its effectiveness.

Comment: The submitted 309 trading program is defective because the pollutant reductions from participating states have little visibility benefit in each other's Class I areas. The states that have submitted 309 SIPs are “largely non-contiguous” in terms of their physical borders and their air shed impacts. Sulfate emissions from each of the participating states have little effect on Class I areas in other participating states.

Response: We disagree. The 309 program was designed to address visibility impairment for the sixteen Class I areas on the Colorado Plateau. New Mexico, Wyoming and Utah are identified as Transport Region States because the GCVTC had determined they could impact the Colorado Plateau class I areas. The submitted trading program has been designed by these transport region states to satisfy their requirements under 40 CFR 51.309 to address visibility impairment at the sixteen Class I areas. The strategies in these plans are directed toward a designated clean-air corridor that is defined by the placement of the 16 Class I areas, not the placement of state borders. “Air sheds” that do not relate to haze at these Class I areas or that relate to other Class I areas are similarly not relevant to whether the requirements for an approvable 309 trading program are met. As applicable, any transport region state, with Class I areas not on the Colorado Plateau, implementing the provisions of section 309 must also separately demonstrate reasonable progress for any additional mandatory Class I areas other than the 16 Class I areas located within the state. See 40 CFR 51.309(g). More broadly, the state must submit a long-term strategy to address these additional Class I areas as well as those Class I areas located outside the state, which may be affected by emissions from the state. 40 CFR 51.309(g) and 51.308(d)(2). In developing long-term strategies, the Transport Region States may take full credit for visibility improvements that would be achieved through implementation of the strategies required by 51.309(d). A state's satisfaction of the requirements of 51.309(d), and specifically the requirement for a backstop trading program, is evaluated independently from whether a state has satisfied the requirements of 51.309(g). In neither case, however, does the approvability inquiry center on the location or contiguousness of state borders.

Comment: The emission benchmark used in the submitted 309 trading program is inaccurate. The “better-than-BART” demonstration needs to analyze BART for each source subject to BART in order to evaluate the alternative program. The submitted 309 trading program has no BART analysis. The “better-than-BART” demonstration does not comply with the regional haze regulations when it relies on the presumptive SO 2 emission rate of 0.15 lb/MMBtu for most coal-fired EGUs. The presumptive SO 2 limits are inappropriate because EPA has elsewhere asserted that “presumptive limits represented control capabilities at the time the BART Rule was promulgated, and that [EPA] expected that scrubber technology would continue to improve and control costs would continue to decline.” 77 FR 14614 (March 12, 2012).

Response: We disagree that the submitted 309 trading program requires an analysis that determines BART for each source subject to BART. Source specific BART determinations are not required to support the better-than-BART demonstration when the “alternative measure has been designed to meet a requirement other than BART.” See 40 CFR 51.308(e)(2)(i)(C). The requirements of Section 309 are meant to implement the recommendations of the Grand Canyon Visibility Transport Commission and are regulatory requirements “other than BART” that are part of a long-term strategy to achieve reasonable progress. As such, in its analysis, the State may assume emission reductions “for similar types of sources within a source category based on both source-specific and category-wide information, as appropriate.” See id. The 309 states used this approach in developing their emission benchmark, and we view it to be consistent with what we have previously stated regarding the establishment of a BART benchmark. Specifically, we have explained that states designing alternative programs to meet requirements other than BART “may use simplifying assumptions in establishing a BART benchmark based on an analysis of what BART is likely to be for similar types of sources within a source category.” 71 FR 60619 (Oct. 13, 2006).

We also previously stated that “we believe that the presumptions for EGUs in the BART guidelines should be used for comparisons to a trading program or other alternative measure, unless the State determines that such presumptions are not appropriate.” Id. Our reasoning for this has also long been clear. While EPA recognizes that a case-by-case BART analysis may result in emission limits more stringent than the presumptive limits, the presumptive limits are reasonable and appropriate for use in assessing regional emissions reductions for the better than BART demonstration. See 71 FR 60619 (“the presumptions represent a reasonable estimate of a stringent case BART because they would be applied across the board to a wide variety of units with varying impacts on visibility, at power plants of varying size and distance from Class I areas”). The submitted SIP revisions from the 309 states have accordingly and appropriately, followed our advice that the presumptions for EGUs in the BART guidelines, generally “should” be used for comparisons to the trading program unless the state determines otherwise.

EPA's expectation that scrubber technology would continue to improve and that control costs would continue to decline is a basis for not regarding presumptive limits as a default or safe harbor BART determination when the BART Guidelines otherwise call for a complete, case-by-case analysis. We believe it was reasonable for the developers of the submitted trading program to use the presumptive limits for EGUs in establishing the emission benchmark, particularly since the methodology used to establish the emission benchmark was established near in time to our promulgation of the presumptive limits as well as our guidance that they should be used. We do not think the assumptions used at the time the trading program was developed, including the use of presumptive limits, were unreasonable. Moreover, the commenter has not demonstrated how the use of presumptive limits as a simplifying assumption at that time, or even now, would be flawed merely because EPA expects that scrubber technology and costs will continue to improve.

Comment: The presumptive SO 2 emission rate overstates actual emissions from sources that were included in the BART benchmark calculation. In addition, states in the transport region have established or proposed significantly more stringent BART limits for SO 2. Using actual SO 2 emission data for EGUs, SO 2 emissions would be 130,601 tons per year (tpy), not the benchmark of 141,859 tpy submitted in the 309 trading program. Using a combination of actual emissions and unit-specific BART determinations, the SO 2 emissions would be lower still at 123,529 tpy. Finally, the same data EPA relied on to support its determination that reductions under the Cross State Air Pollution Rule are “better-than-BART” would translate to SO 2 emissions of 124,740 tpy. These analyses show the BART benchmark is higher than actual SO 2 emissions reductions achievable through BART. It follows that the submitted 309 trading program is flawed because it cannot be deemed to achieve “greater reasonable progress” than BART.

Response: The BART benchmark calculation does not overstate emissions because it was not intended to assess actual emissions at BART subject sources nor was it intended to assess the control capabilities of later installed controls. Instead, the presumptive SO 2 emission rate served as a necessary simplifying assumption. When the states worked to develop the 309 trading program, they could not be expected to anticipate the future elements of case-by-case BART determinations made by other states (or EPA, in the case of a BART determination through any federal implementation plan), nor could they be expected to anticipate the details of later-installed SO 2 controls or the future application of enforceable emission limits to those controls. The emissions projections by the WRAP incorporated the best available information at the time from the states, and utilized the appropriate methods and models to provide a prediction of emissions from all source categories in this planning period. In developing a profile of planning period emissions to support each state's reasonable progress goals, as well as the submitted trading program, it was recognized that the final control decisions by all of the states were not yet complete, as decisions as they may pertain to emissions from BART eligible sources. Therefore, we believe it is appropriate that the analysis and demonstration is based on data that was available to the states at the time they worked to construct the SO 2 trading program. The states did make appropriate adjustments based on information that was available to them at the time. Notably, the WRAP appropriately adjusted its use of the presumptive limits in the case of Huntington Units 1 and 2 in Utah, because those units were already subject to federally enforceable SO 2 emission rates that were lower than the presumptive rate. The use of actual emissions data after the 2006 baseline is not relevant to the demonstration that has been submitted.

Comment: SO 2 emissions under the 309 trading program would be equivalent to the SO 2 emissions if presumptive BART were applied to each BART-subject source. Because the reductions are equivalent, the submitted 309 trading program does not show, by “the clear weight of the evidence,” that the alternative measure will result in greater reasonable progress than would be achieved by requiring BART. In view of the reductions being equivalent, it is not proper for EPA to rely on “non-quantitative factors” in finding that the SO 2 emissions trading program achieves greater reasonable progress.

Response: We recognize that the 2018 SO 2 milestone equals the BART benchmark and that the benchmark generally utilized the presumptive limits for EGUs, as was deemed appropriate by the states who worked together to develop the trading program. If the SO 2 milestone is exceeded, the trading program will be activated. Under this framework, sources that would otherwise be subject to the trading program have incentives to make independent reductions to avoid activation of the trading program. We cannot discount that the 2003 309 SIP submittal may have already influenced sources to upgrade their plants before any case-by-case BART determination under Section 308 may have required it. In addition, the trading program was designed to encourage early reductions by providing extra allocations for sources that made reductions prior to the program trigger year. Permitting authorities that would otherwise permit increases in SO 2 emissions for new sources would be equally conscious of the potential impacts on the achievement of the milestone. We note that the most recent emission report for the year 2010 shows a 35% reduction in emissions from 2003. The 309 trading program is designed as a backstop such that sources would work to accomplish emission reductions through 2018 that would be superior to the milestone and the BART benchmark. If instead the backstop trading program is triggered, the sources subject to the program would be expected to make any reductions necessary to achieve the emission levels consistent with each source's allocation. We do not believe that the “clear weight of the evidence” determination referenced in 40 CFR 51.308(e)(2)(E)—in short, a determination that the alternative measure of the 309 trading program achieves greater reasonable progress than BART—should be understood to prohibit setting the SO 2 milestone to equal the BART benchmark. Our determination that the 2018 SO 2 milestone and other design features of the 309 SIP will achieve greater reasonable progress than would be achieved through BART is based on our understanding of how the SIP will promote and sustain emission reductions of SO 2 as measured against a milestone. Sources will be actively mindful of the participating states' emissions inventory and operating to avoid exceeding the milestone, not trying to maximize their emissions to be equivalent to the milestone, as this comment suggests. We note the 2018 milestone constitutes an emissions cap that persists after 2018 unless the trading program can be replaced via future SIP revisions submitted for EPA approval that will meet the BART and reasonable progress requirements of 51.308. See 40 CFR 51.309(d)(4)(vi)(A).

Comment: In proposing to find that the SO 2 trading program achieves greater reasonable progress than BART, EPA's reliance on the following features of the 309 trading program is flawed: Non-BART emission reductions, a cap on new growth, and a mass-based cap on emissions. The reliance on non-BART emission reductions is “a hollow promise” because there is no evidence that the trading program will be triggered for other particular emission sources, and if the program is never triggered there will be no emission reductions from smaller non-BART sources. The reliance on a cap on future source emissions is also faulty because there is no evidence the trading program will be triggered, and thus the cap may never be implemented. Existing programs that apply to new sources will already ensure that SO 2 emissions from new sources are reduced to the maximum extent. EPA's discussion of the advantages of a mass-based cap is unsupported and cannot be justified. EPA wrongly states that a mass-based cap based on actual emissions is more stringent than BART. There should not be a meaningful gap between actual and allowable emissions under a proper BART determination. A mass-based cap does not effectively limit emissions when operating at lower loads and, as an annual cap, does not have restrictive compliance averaging. EPA's argument implies that BART limits do not apply during startup, shutdown or malfunction events, which is not correct. The established mass-based cap would allow sources to operate their SO 2 controls less efficiently, because some BART-subject EGUs already operate with lower emissions than the presumptive SO 2 emission rate of 0.15 lb/MMBtu and because some EGUs were assumed to be operating at 85% capacity when their capacity factor (and consequently their SO 2 emissions in tpy) was lower.

Response: We disagree that it is flawed to assess the benefits found in the distinguishing features of the trading program. The backstop trading program is not specifically designed so that it will be activated. Instead, sources that are covered by the program are on notice that it will be triggered if the regulatory milestones are not achieved. Therefore, the backstop trading program would be expected to garner reductions to avoid its activation. It also remains true that if the trading program is activated, all sources subject to the program, including smaller non-BART sources would be required to secure emission reductions as may be necessary to meet their emission allocations under the program.

We also disagree that the features of the 2018 milestone as a cap on future source emissions and as a mass-based cap has no significance. As detailed in our proposal, the submitted SIP is consistent with the requirement that the 2018 milestone does indeed continue as an emission cap for SO 2 unless the milestones are replaced by a different program approved by EPA as meeting the BART and reasonable progress requirements under 40 CFR 51.308. Future visibility impairment is prevented by capping emissions growth from those sources not eligible under the BART requirements, BART sources, and from entirely new sources in the region. The benefits of a milestone are therefore functionally distinct from the control efficiency improvements that could be gained at a limited number of BART subject sources. While BART-subject sources may not be operating at 85% capacity today, we believe the WRAP's use of the capacity assumption in consideration of projected future energy demands in 2018 was reasonable for purposes of the submitted demonstration. While BART requires BART subject sources to operate SO 2 controls efficiently, this does not mean that an alternative to BART thereby allows, encourages, or causes sources to operate their controls less efficiently. On the contrary, we find that the SIP, consistent with the well-considered 309 program requirements, functions to the contrary. Sources will be operating their controls in consideration of the milestone and they also remain subject to any other existing or future requirements for operation of SO 2 controls.

We also disagree with the commenter's contention that existing programs are equivalent in effect to the emissions cap. EPA's new source review program is designed to permit, not cap, source growth, so long as the national ambient air quality standards and other requirements can be achieved. Moreover, we have not argued that BART does not apply at all times or that emission reductions under the cap are meant to function as emission limitations that are made to meet the definition of BART (40 CFR 51.301). The better-than-BART demonstration is not, as the comment would have it, based on issues of compliance averaging or how a BART limit operates in practice at an individual facility. Instead, it is based on whether the submitted SIP follows the regulatory requirements for the demonstration and evidences comparatively superior visibility improvements for the Class I areas it is designed to address.

Comment: The submitted 309 SIP will not achieve greater reasonable progress than would the requirement for BART on individual sources. The BART program “if adequately implemented” will promote greater reasonable progress, and EPA should require BART on all eligible air pollution sources in the state. EPA's proposed approval of the 309 trading program is “particularly problematic” where the BART sources cause or contribute to impairment at Class I areas which are not on the Uniform Rate of Progress (URP) glide-path towards achieving natural conditions. EPA should require revisions to provide for greater SO 2 reductions in the 309 program, or it should require BART reductions on all sources subject to BART for SO 2.

Response: We disagree with the issues discussed in this comment. As discussed in other responses to comments, we have found that the State's SIP submitted under the 309 program will achieve greater reasonable progress than source-by-source BART. As the regulations housed within section 309 make clear, states have an opportunity to submit regional haze SIPs that provide an alternative to source-by-source BART requirements. Therefore, the commenter's assertion that we should require BART on all eligible air pollution sources in the state is fundamentally misplaced. The commenter's use of the URP as a test that should apparently be applied to the adequacy of the 309 trading program as a BART alternative is also misplaced, as there is no requirement in the regional haze rule to do so.

Comment: The 309 trading program must be disapproved because it does not provide for “steady and continuing emissions reductions through 2018” as required by 40 CFR 51.309(d)(4)(ii). The program establishes its reductions through milestones that are set at three- year intervals. It would be arbitrary and capricious to conclude these reductions are “steady” or “continuous.”

Response: We disagree and find that the reductions required at each milestone demonstrate steady and continuing emissions reductions. The milestones do this by requiring regular decreases. These decreases occur in intervals ranging from one to three years and include administrative evaluation periods with the possibility of downward adjustments of the milestone, if warranted. The interval under which “steady and continuing emissions reductions through 2018” must occur is not defined in the regional haze rule. We find the milestone schedule and the remainder of the trading program submitted by Wyoming does in fact reasonably provide for “steady and continuing emissions reductions through 2018.”

Comment: The WRAP attempts to justify the SO 2 trading program because SO 2 emissions have decreased in the three transport region states relying on the alternative program by 33% between 1990-2000. The justification fails because the reductions were made prior to the regional haze rule. The reliance on reductions that predate the regional haze rule violates the requirement of 40 CFR 51.308(e)(2)(iv) that BART alternatives provide emission reductions that are “surplus” to those resulting from programs implemented to meet other CAA requirements.

Response: We did not focus on the WRAP's discussion of early emission reductions in our proposal. However, we do not understand commenter's claim or agree with this comment. The WRAP's statements regarding past air quality improvements are not contrary to the requirement that reductions under a trading program be surplus. Instead, the WRAP was noting that forward-planning sources had already pursued emission reductions that could be partially credited to the design of the 309 SIP. We note that the most recent emission report for the year 2010 shows a 35% reduction in emissions from 2003. Sources that make early reductions prior to the program trigger year may acquire extra allocations should the program be triggered. This is an additional characteristic feature of the backstop trading program that suggests benefits that would be realized even without triggering of the program itself. The surplus emission reduction requirement for the trading program is not an issue, because the existence of surplus reductions is studied against other reductions that are realized “as of baseline date of the SIP.” The 1990-2000 period plainly falls earlier than the baseline date of the SIP, so we disagree that the WRAP's discussion of that period was problematic or violates 40 CFR 51.308(e)(2)(iv), regarding surplus reductions.

Comment: EPA must correct discrepancies between the data presented in the 309 SIPs. 3 There are discrepancies in what has been presented as the results of WRAP photochemical modeling. The New Mexico regional haze SIP proposal shows, for example, that the 20% worst days at Grand Canyon National Park have visibility impairment of 11.1 deciviews, while the other proposals show 11.3 deciviews. The discrepancy appears to be due to the submittals being based on different modeling scenarios developed by the WRAP. EPA must explain and correct the discrepancies and “re-notice” a new proposed rule containing the correct information.

Response: We agree that there are discrepancies in the numbers in Table 1 of the proposed notices. The third column of the table below shows the modeling results presented in Table 1 of the Albuquerque, Wyoming, and Utah proposals. The modeling results in the New Mexico proposal Table 1 are shown in the fourth column in the table below. The discrepancies come from New Mexico using different preliminary reasonable progress cases developed by the WRAP. The Wyoming, Utah, and Albuquerque proposed notices incorrectly identify the Preliminary Reasonable Progress (PRP) case as the PRP18b emission inventory instead of correctly identifying the presented data as modeled visibility based on the “PRP18a” emission inventory. The PRP18a emission inventory is a predicted 2018 emission inventory with all known and expected controls as of March 2007. The preliminary reasonable progress case (“PRP18b”) used by New Mexico is the more updated version produced by the WRAP with all known and expected controls as of March 2009. Thus, we are correcting Table 1, column 5 in our proposed notices for Wyoming, Utah, and Albuquerque to include model results from the PRP18b emission inventory, consistent with the New Mexico proposed notice and the fourth column in the table below. We are also correcting the description of the Preliminary Reasonable Progress Case (referred to as the PRP18b emission inventory and modeled projections) to reflect that this emission inventory includes all controls “on the books” as of March 2009.

We are not re-noticing our proposed rulemaking as the discrepancies do not change our proposed conclusion that the SIP submitted by Wyoming contains reasonable projections of the visibility improvements expected at the 16 Class I areas at issue. The PRP18a modeling results show projected visibility improvement for the 20 percent worst days from the baseline period to 2018. The PRP18b modeling results show either the same or additional visibility improvement on the 20 percent worst days beyond the PRP18a modeling results. We also note there are two discrepancies in New Mexico's Table 1, column four compared to the other participating states' notices. The 2018 base case visibility projection in the New Mexico proposed notice for Black Canyon of the Gunnison National Park Wilderness and Weminuche Wilderness should be corrected to read 10.1 deciview rather than 10.0. Notwithstanding the discrepancies described above, we believe that Wyoming's SIP adequately projects the improvement in visibility for purposes of Section 309.

Comment: We received comments from PacifiCorp and New Mexico Environment Department supporting our proposed approval of Wyoming's 309 SIP.

Response: We acknowledge the commenters' support of our proposed rulemaking.

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 February 11, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by the EPA, you must identify docket ID number EPA-HQ-OPP-2011-0669 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 February 11, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any CBI) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by the EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0669, 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.

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 September 7, 2011 (76 FR 55329) (FRL-8886-7), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F7896) by Agraquest, Inc., 1540 Drew Ave., Davis, CA 95618. The petition requested that 40 CFR part 180.1209 be amended by including residues of Bacillus subtilis strain QST 713 variant soil. This notice referenced a summary of the petition prepared by the petitioner, Agraquest, Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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 * * *.” Additionally, FFDCA section 408(b)(2)(D) requires that 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.”

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with FFDCA section 408(b)(2)(D), the EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. The EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Bacillus subtilis is a rod-shaped, gram-positive, aerobic flagellar bacterium that is ubiquitous in nature and has been recovered from water, soil, air, and decomposing plant residues (Ref 1.). The bacterium produces an endospore that allows it to endure extreme conditions of heat and desiccation in the environment (Ref. 1). Bacillus subtilis is not considered toxic or pathogenic to humans, animals, or plants (Ref. 2). Several strains of Bacillus subtilis are used predominantly as fungicidal active ingredients in various pesticides registered with the EPA.

In 2000, the EPA first registered Bacillus subtilis strain QST 713 as a pesticide active ingredient. EPA described the nature and toxicological profile of Bacillus subtilis strain QST 713 in the Federal Register of July 5, 2000 (65 FR 41365) (FRL-6555-3) as the basis for establishing the tolerance exemption for Bacillus subtilis strain QST 713 in or on all food commodities at 40 CFR 180.1209. A battery of tests, as described in that Federal Register citation, determined that Bacillus subtilis strain QST 713 is not pathogenic and has no significant toxicity. The petitioner is now requesting that this tolerance be amended to include residues of Bacillus subtilis strain QST 713 variant soil. Bacillus subtilis strain QST 713 variant soil is a naturally occurring variant of Bacillus subtilis strain QST 713 and is present in products containing the active ingredient Bacillus subtilis strain QST 713, although at low levels (Ref. 3). The variant strain is distinguished from the parent strain by the presence of the swrA gene, which is an essential gene for Bacillus to move over solid substances, and by a phenotype associated with enhanced biofilm formation, growth promotion and disease protection (Ref. 3). Based on its review of the variant and studies submitted by the petitioner, EPA concludes that the variant and the parent strain are substantially similar for the purposes of assessing toxicity, pathogenicity and infectivity (Ref. 3).

The applicant, Agraquest, Inc., cited or submitted adequate mammalian toxicology data and information to support the exemption from the requirement of a tolerance for residues of Bacillus subtilis strain QST 713 variant soil in or on all raw agricultural commodities. These data are cited and described in the EPA's March 2012 Bacillus subtilis Final Registration Review Decision (Ref. 1). In addition, Agraquest submitted an acute injection toxicity/pathogenicity study (OCSPP Guideline 885.3200; MRID 48530909) that showed that Bacillus subtilis strain QST 713 variant soil TGAI was not toxic, infective, or pathogenic to rats when injected intravenously at a dose of 6.6 × 10 8 colony forming units.

The applicant reported that no hypersensitivity incidents occurred during research, development, or testing of Bacillus subtilis strain QST 713 variant soil. Acceptable Tier I mammalian toxicology data and information support registration of the proposed end-use product, Serenade Soil DPZ. In light of the results of the acute toxicity/pathogenicity data and the absence of hypersensitivity incidents, the EPA did not require testing at higher tiers (i.e., Tiers II and III).

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food exposure. Due to the ubiquitous nature of the Bacillus subtilis and the concentrations of Bacillus subtilis and other closely related Bacillus species that already exist in the environment, the EPA expects human exposure to Bacillus subtilis s train QST 713 variant soil resulting from the proposed pesticidal uses will be no greater than existing human exposure to background levels of Bacillus subtilis. The EPA in its registration review decision (Ref. 1) concluded “the risk posed to adults, infants, and children is likely to be minimal because of the low acute oral toxicity/pathogenicity potential of Bacillus subtilis s train QST 713.” Based on the EPA's evaluation of the Bacillus subtilis s train QST 713 data and the EPA's conclusion that Bacillus subtilis s train QST 713 and Bacillus subtilis s train QST 713 variant soil are substantially similar for the purposes of assessing toxicity, pathogenicity, and infectivity (Ref. 3), no adverse effects from dietary exposure to Bacillus subtilis strain QST 713 variant soil from its pesticidal uses are expected (see Unit III.).

2. Drinking water exposure. Because Bacillus subtilis is ubiquitous in the environment, exposure to the microbe through drinking water may already be occurring and likely will continue (Ref. 3). EPA expects exposures to Bacillus subtilis strain QST 713 variant soil to be not much greater than background levels because the proposed use patterns are soil directed and/or soil incorporated, thereby limiting contact with surface water by drift and runoff. Furthermore, ground water is not expected to have significant exposure to Bacillus subtilis strain QST 713 variant soil since, like other microorganisms, this microbial pesticide would likely be filtered out by the particulate nature of many soil types. If residues of Bacillus subtilis strain QST 713 variant soil were to be transferred to surface or ground waters that are intended for eventual human consumption (e.g., through spray drift or runoff) and directed to wastewater treatment systems or drinking water facilities, Bacillus subtilis strain QST 713 variant soil likely would not survive the conditions water is subjected to in such systems or facilities, including chlorination, pH adjustments, filtration, and/or occasional high temperatures. As discussed in the EPA's Bacillus subtilis Case 6012, Final Registration Review Decision (Ref. 1), intake of low levels of ubiquitous Bacillus subtilis in drinking water may occur, but exposure would represent a minimal risk due to the low toxicity of the strain. Similarly, exposure to other strains of Bacillus subtilis would not represent a greater risk. It is reasonable to conclude, based on the similarity in product composition and production, measured physical/chemical, and pathogenicity/infectivity toxicity data, that the risk from any potential exposure to Bacillus subtilis strain QST 713 variant soil resulting from the proposed pesticidal use would be minimal and equivalent to the risk from exposure to Bacillus subtilis strain QST 713.

The use sites proposed for products containing Bacillus subtilis strain QST 713 variant soil include both agricultural and residential garden sites, so the EPA expects there to be some non-occupational exposure as a result of the application of this pesticide. Given Bacillus subtilis strain QST 713 variant soil's natural occurrence in soil, the EPA determined that non-occupational exposure to the bacterium likely is already occurring (Ref. 3). Additional exposure to the microorganism, due to pesticidal applications, is likely to occur but is not expected to exceed EPA's level of concern, particularly in light of available data that demonstrate Bacillus subtilis strain QST 713 is not toxic (acute dermal toxicity and acute pulmonary toxicity/pathogenicity), non-irritating (primary dermal irritation), and not pathogenic (acute pulmonary toxicity/pathogenicity) and the EPA's conclusion that Bacillus subtilis s train QST 713 and Bacillus subtilis s train QST 713 variant soil are substantially similar for the purposes of assessing toxicity, pathogenicity, and infectivity (Ref. 3). Based on the toxicity information submitted to the EPA, aggregate exposure to Bacillus subtilis strain QST 713 variant soil would be below the levels in the safety testing conducted on Bacillus subtilis strain QST 713 and would not represent an undue risk due to the lack of residues of toxicological concern and the low toxicity of the active ingredient. The EPA concluded that non-dietary exposures to the general population, including infants and children, would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

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.”

Bacillus subtilis strain QST 713 variant soil does not operate via a toxic mode of action and thus does not share a common mechanism of toxicity with any other substances. Therefore, section 408(b)(2)(D)(v) does not apply.

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of exposure (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 that a different margin of exposure (safety) will be safe for infants and children. This additional margin of exposure (safety) is commonly referred to as the Food Quality Protection Act Safety Factor. 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.

Based on the information discussed in Unit III.B., EPA concludes that there are no threshold effects of concern to infants, children, or adults when Bacillus subtilis strain QST 713 variant soil is used as labeled in accordance with good agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) is necessary to protect infants and children and that not adding any additional margin of exposure (safety) will be safe for infants and children.

Moreover, based on the same data and EPA analysis as presented directly above, the Agency is able to conclude that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of Bacillus subtilis strain QST 713 variant soil when it is used as labeled and in accordance with good agricultural practices. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, there appears to be no potential for harm from this bacterium in its use as an antifungal agent via dietary exposure since the microorganism is non-toxic, non-pathogenic, and not infective. This conclusion is supported by the data on the substantially similar strain Bacillus subtilis strain QST 713, public literature and EPA's Bacillus subtilis Case 6012, Final Registration Review Decision (Ref. 1). EPA concludes that there is a reasonable certainty of no harm to infants and children from aggregate exposure to Bacillus subtilis strain QST 713 variant soil.

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

In making its tolerance decisions, the EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. The 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. The 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 Bacillus subtilis strain QST 713 variant soil.

The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Bacillus subtilis strain QST 713 variant soil. Therefore, the EPA is amending the tolerance exemption for Bacillus subtilis strain QST 713 to include residues of Bacillus subtilis strain QST 713 variant soil in or on all food commodities when used in accordance with good agricultural practices.

1. U.S. EPA. 2010. Bacillus subtilis Final Registration Review Decision. Case 6012. March 2010.

2. U.S. EPA. 1997. Bacillus subtilis Final Risk Assessment.

3. U.S. EPA. July 11, 2012. Memorandum from Dr. Ibrahim S. Barsoum and Dr. John L. Kough to Michael Glikes: Review of Product Chemistry and Acute Toxicity Studies for Section 3 Registration of a new TGAI, Bacillus subtilis strain QST variant soil, and a new EP, Serenade soil DPZ (EPA Reg. No. 69592-EI).

This final rule amends an exiting tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children From Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 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 exemption from 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. ), the 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. 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-2012-0326, 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 February 11, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0326, 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.

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 July 25, 2012 (77 FR 43562) (FRL-9353-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7952) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.608 be amended by modifying tolerances for residues of the insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on apple, wet pomace and grape, raisin from 2.0 and 4.0 parts per million (ppm) respectively, to 2.4 and 6.0 ppm respectively, and by deleting the tolerance for grape juice. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

In 2005, EPA assessed the use of spirodiclofen on citrus fruit, grape, pome fruit, stone fruit, and tree nut crops and reviewed the residue chemistry data submitted in support of these uses. Apple and grape processing studies were required as conditional to these registrations. These processing studies were subsequently submitted by Bayer CropScience, and reviewed by the Agency in a memo dated October 25, 2007, posted to docket EPA-HQ-OPP-2012-0326. In this memo, EPA concluded that the tolerances for wet apple pomace and raisin grape need to be revised as indicated above, and the tolerance for grape juice is no longer necessary.

In the most recent spirodiclofen tolerance rulemaking published in the Federal Register of May 5, 2010 (75 FR 24428) (FRL-8820-4), EPA assessed risk from aggregate exposure to spirodiclofen assuming that exposure occurred in wet apple pomace and raisins at the levels of the revised wet apple pomace and raisin grape tolerances. In that action, EPA determined that aggregate risk from exposure to spirodiclofen was safe. Based upon the 2010 spirodiclofen rulemaking and the other information discussed above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to spirodiclofen residues.

Adequate enforcement methodology, a liquid chromatography/mass spectrometry (LC/MS/MS) method, is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 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 spirodiclofen.

Therefore, the established tolerances for residues of spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on apple, wet pomace and grape, raisin are amended from 2.0 and 4.0 ppm to 2.4 and 6.0 ppm respectively, and the tolerance for grape juice is deleted.

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. 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-2007-0099 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 February 11, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2007-0099, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of May 23, 2012 (77 FR 30481) (FRL-9347-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F7981) by Bayer CropScience LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.), P.O. Box 12014, Research Triangle Park, NC 27709-2014. The petition requested that the established tolerances listed in 40 CFR 180.639 for residues of the insecticide flubendiamide, N 2 - [1, 1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo- N 1 -[2-methyl-4-[l, 2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in or on Apple, wet pomace be increased from 2.0 parts per million (ppm) to 5.0 ppm; and Fruit, pome, group 11 be increased from 0.70 ppm to 1.5 ppm. That document referenced a summary of the petition prepared by Bayer CropScience LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.), the registrant, which is available in the docket, http://www.regulations.gov. There were no substantive 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 flubendiamide including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flubendiamide 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.

Flubendiamide has a low acute toxicity via the oral and dermal routes of exposure. Though it is a slight irritant to the eye, flubendiamide is not a skin irritant and it is not a skin sensitizer under the conditions of the guinea pig maximization test.

In the mammalian toxicology database, the primary target organ of flubendiamide exposure is the liver, with secondary effects reported in the thyroid and kidney at equivalent or higher doses; no-observed-adverse-effect-levels (NOAELs) established to protect for liver toxicity are protective of effects seen in the thyroid and kidney. Adverse adrenal effects were also noted in the dog.

Buphthalmia (eye enlargement), opacity, and exophthalmus with hemorrhage appearing only in infancy, were observed in rat offspring in the reproductive and developmental neurotoxicity (DNT) studies. There was no clear dose-response relationship for this effect, but ocular toxicity was noted in three rat studies and accompanied by histopathological findings of synechia, hemorrhage, keratitis, iritis, and cataracts. Therefore, bupthalmos is considered an effect of treatment. No evidence of cancer was seen for flubendiamide in cancer bioassays in mice and rats. Flubendiamide was also negative in mutagenicity testing. Accordingly, flubendiamide was classified as “Not Likely To Be Carcinogenic to Humans.”

More detailed information on the studies received and the nature of the adverse effects caused by flubendiamide as well as the NOAEL and the lowest-observed-adverse effect-level (LOAEL) from the toxicity studies can be found in the document entitled, “Flubendiamide: Human Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree Fruit, Tree Nuts, Vine Crops and Vegetable Crops,” dated April 3, 2008, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view the referenced information on pages 65-70 of 105.

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 flubendiamide used for human risk assessment is shown in the following Table 1.

A summary of the toxicological endpoints for flubendiamide used for human risk assessment can be found in the document entitled, “Flubendiamide: Human Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree Fruit, Tree Nuts, Vine Crops and Vegetable crops,” dated April 3, 2008, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES . Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view the referenced information on pages 37-38 of 105.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flubendiamide, EPA considered exposure under the petitioned-for tolerances as well as all existing flubendiamide tolerances in 40 CFR 180.639. Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model, Version 3.16—Food Commodity Intake Database (DEEMFCID TM ) which uses food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The analyses were performed to support Section 3 requests for increases in the tolerances for pome fruit and wet apple pomace 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 flubendiamide. In estimating acute dietary exposure, EPA used DEEMFCID TM along with food consumption information from the USDA's 2003-2008 NHANES/WWEIA survey. As to residue levels in food, for the acute assessment, the modeled exposure estimates are based on tolerance level residues, assuming 100% of crops were treated. In addition, experimental processing (where available) factors were assumed for both registered and requested crop uses.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA survey. EPA assumed a subset of the currently registered crops contains residues at the average residue levels found in the crop field trials. For the newly proposed crops, livestock commodities, and the remaining currently registered crops, EPA assumed tolerance level residues. In addition, experimental processing factors were used where available. Finally, EPA assumed 100% of crops were treated.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that flubendiamide should be classified as “Not Likely To Be Carcinogenic to Humans.” As a result, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary for flubendiamide, and was not conducted.

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

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

Flubendiamide is persistent and potentially mobile in terrestrial and aquatic environments. These fate properties suggest that it has a potential to move into surface water and ground water. Potential residues in drinking water were included in the acute and chronic dietary analyses based on surface water results from the Tier II, Pesticide Root Zone Modeling/Exposure Analysis Modeling System(PRZM/EXAMS) Index Reservoir model as these values were higher than the groundwater estimates from the Screening Concentration in Ground Water (SCI-GROW) model. Estimated acute and chronic drinking water values were 24.57 parts per billion (ppb) and 11.46 ppb, respectively.

A summary of the dietary exposure from drinking water for flubendiamide used for human risk assessment can be found in the documents entitled, “Flubendiamide: Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure Assessment for the Increased Tolerance on Pome Fruit,” dated September 11, 2012, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES . Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view the referenced information on pages 2-4 of 29.

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). Flubendiamide 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 flubendiamide to share a common mechanism of toxicity with any other substances, and flubendiamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flubendiamide 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 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. While both the rat and rabbit developmental studies did not identify teratogenic effects and showed no evidence of increased prenatal susceptibility, adverse eye effects (eye enlargement) were noted in postnatal rat pups older than 14 days in multiple studies (the 2-generation reproduction and 1-generation supplemental studies). Additionally, the DNT study reported eye effects appearing in some offspring between lactation days 14 and 42, even though exposure stopped at lactation day 21, indicating a possible delay (a latent response) from the time of last exposure to onset of bupthalmos. These eye effects did not occur in adult rats. Since the iris and chamber angle are differentiating and specializing into definite structures during postnatal days 5 to 20, neonatal rats appear to have an increased susceptibility to flubendiamide exposure as compared to adults.

In addition to the reported eye effects in the DNT study, there was also a balanopreputial separation (separation of the prepuce (foreskin) from the glans penis (balanus)) delay. While this effect is generally considered adverse per se, it is not assumed to be a developmental effect from in utero exposure. Here, delayed balano-preputial separation is considered secondary to reduced postnatal pup body weight as a result of postnatal exposure. Furthermore, it was resolved within the appropriate age range of puberty and no effects on reproductive function were observed in the multigeneration study in rats. Delayed balanopreputial separation was seen only at doses causing maternal toxicity and is not more severe than the maternal effects of hepatotoxicity seen at the common pup/maternal LOAEL of the DNT study. Accordingly, the delayed balanopreputial separation seen in the DNT study does not cause concern for increased sensitivity to the young for flubendiamide.

Human microsomes have been shown to be capable of approximately 4 times higher hydroxylation rates of flubendiamide as compared to female mouse microsomes and may be able to efficiently metabolize and excrete flubendiamide, preventing accumulation of the parent compound. It remains unclear whether the ability to metabolize and clear the parent compound is the only requirement to avoid ocular toxicity. Due to the potential ocular toxicity, this perinatal ocular effect is considered in the human health risk assessment for flubendiamide.

3. Conclusion. EPA evaluated the quality of the toxicity and exposure data and, based on these data, has determined that the safety of infants and children would be adequately protected if the FQPA SF were reduced to lX. That decision is based on the following findings:

i. The toxicology database for flubendiamide is complete with the exception of a subchronic neurotoxicity study which is now a new data requirement under 40 CFR part 158; however, the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios, and for evaluation of the requirements under the FQPA. Flubendiamide is not a neurotoxic chemical based on neurotoxicity assessments conducted in the acute and developmental neurotoxicity studies and as part of the chronic rat study. Additionally, in several short-term studies in rats (subacute and subchronic feeding, plaque-forming cell assay, one-generation pilot, developmental toxicity) no neurobehavioral signs were observed at doses up to and exceeding the limit dose; therefore, an additional database uncertainty factor is not needed to account for potential neurotoxicity.

ii. Although susceptibility was identified in the toxicological database (eye effects), the selected regulatory PODs (which are based on clear NOAELs) are protective of these effects; therefore, the human health risk assessment is protective.

iii. There are no residual uncertainties identified in the exposure databases and the exposure assessment is protective. The acute dietary food exposure assessment utilizes tolerance-level residues, the chronic dietary food exposure assessment utilizes, in part, average residue levels found in the crop field trials/livestock commodities and, in part, tolerance-level residues. Both assessments assume that 100% of crops with requested or existing uses of flubendiamide are treated. The drinking water assessment generated estimated drinking water concentrations (EDWCs) using models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. The highest relevant EDWCs were used in the dietary (food and drinking water) exposure assessment. By using these screening-level exposure assessments in the acute and chronic dietary (food and drinking water) assessments, risk is not underestimated for flubendiamide.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (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.

For this action, there is potential exposure to flubendiamide from food and drinking water, but not from residential use sites (as there are no proposed or existing residential uses for flubendiamide). Since hazard was identified via the oral route over both the acute and chronic duration, the aggregate risk assessments considers exposures from food and drinking water consumed over the acute and chronic durations.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, EPA has concluded that acute dietary exposure from food and water to flubendiamide will utilize 3.1% of the aPAD for the general U.S. population and 5% of the aPAD for the most highly exposed population subgroup, children aged 1 to 2 years old.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic dietary exposure to flubendiamide from food and water will utilize 20% of the cPAD for the general U.S. population and 58% of the cPAD for the most highly exposed population subgroup, children aged 1 to 2 years old. There are no proposed or existing residential uses for flubendiamide. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flubendiamide is not expected.

3. Aggregate cancer risk for U.S. population. Based on the lack of evidence of cancer in cancer bioassays in mice and rat, flubendiamide is not expected to pose a cancer risk.

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

Adequate enforcement methodology (Liquid Chromatography with tandem Mass Spectrometry detection ((LC/MS/MS), Methods 00816/M002 and 00912) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort 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.

There are currently no established Codex, Canadian or Mexican MRLs for residues of flubendiamide in/on apple, wet pomace or fruit, pome, group 11 commodities.

The Agency's “Guidance for Setting Pesticide Tolerances Based on Field Trial Data,” was utilized for determining appropriate tolerance levels for many raw agricultural commodities (RACs) which showed quantifiable residues in or on samples that were treated according to the proposed use patterns. The following revisions to tolerance levels were made:

The recommended tolerance levels are the same values as in the petition. The Organization of Economic Coordination and Development (OECD) calculation procedure was utilized to derive the tolerance estimate for pome fruit based on all apple field trial data and all pear field trial data (D386262, S. Funk, 04/01/2011). The new apple pomace tolerance is derived from the highest average apple field trial result (1.21 ppm) and the processing factor for conversion of apples to apple pomace (3.6X) from a previously reviewed study. The proposed increases in tolerances for pome fruit and wet apple pomace have no effect on the dietary burdens of livestock. Therefore, the established tolerances for meat, milk, poultry, and eggs are adequate.

Therefore, the established tolerances for residues of flubendiamide, N 2 -[1,1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo- N 1 -[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamidein or on apple, wet pomace is being increased to 5.0 ppm. The established tolerance for fruit, pome, group 11 is being increased to 1.5 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).

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-2011-0541 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 February 11, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing 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-2011-0541, 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.

In the Federal Register of Wednesday, September 7, 2011 (76 FR 55329) (FRL-8886-7), 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 1E7881) by IR-4, Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540; and on Wednesday, May 2, 2012 (77 FR 25954) (FRL-9346-1) for PP 1F7902 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petitions requested that 40 CFR 180.566 be amended by establishing tolerances for residues of the insecticide fenpyroximate, ( E )-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1 H -pyrazol-4-yl) methyene]amino]oxy]methyl]benzoate and its Z-isomer, ( Z )-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1 H -pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate, in or on avocado at 0.2 parts per million (ppm); bean, snap at 0.4 ppm; canistel at 0.2 ppm; cucumber at 0.25 ppm; fruit, citrus, group 10-10 at 0.6 ppm; fruit, pome, group 11-10 at 0.4 ppm; mango at 0.2 ppm; papaya 0.2 ppm; sapodilla at 0.2 ppm; sapote, black at 0.2 ppm; sapote, mamey at 0.2 ppm; star apple at 0.2 ppm; tea, plucked leaves at 15 ppm; and vegetable, fruiting, group 8-10 at 0.2 ppm; corn, field, grain at 0.02 ppm; corn, field, forage/silage at 2.0 ppm; corn, field, stover at 7.0 ppm; corn, field, aspirated fractions at 2.0 ppm; corn, pop, grain at 0.02 ppm; corn, pop, forage/silage at 2.0 ppm; corn, pop, stover at 7.0 ppm; and corn, pop, aspirated fractions at 2.0 ppm. In addition, petition 1E7881 proposed to remove established tolerances in or on the raw agricultural commodities/groups: Fruit, citrus, group 10 at 0.60 ppm; fruit, pome, group 11 at 0.40 ppm; and vegetable, fruiting, group 8 at 0.20 ppm. The notices referenced a summary of the respective petition prepared by Nichino America, Inc., the registrant, available in the docket, http://www.regulations.gov. There were no comments received in response to these notices of filing. Based upon review of the data supporting the petitions, EPA is establishing tolerance levels for certain commodities other than the proposed level. The reasons for these changes are explained in Unit IV.C.

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

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

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

Fenpyroximate induced moderate acute oral and inhalation toxicity in rats. It exhibited low dermal acute toxicity and was neither a skin nor eye irritant. Fenpyroximate was a slight to moderate sensitizer by the maximization test method. Subchronic and chronic oral exposures to fenpyroximate resulted in overall systemic toxicity (no specific target organ/tissue identified). The most sensitive species tested was the dog. The effects reported in the dog included slight bradycardia, deficits in food consumption, body weight, body-weight gain, and an increased incidence of emesis and diarrhea. Emaciation and torpor (sluggish inactivity) were reported in female dogs at lower dose levels than males. The highest dose tested in the dog (50 milligrams/kilogram/day (mg/kg bw/day)) resulted in first- and second-degree heart block, increased urea concentration, decreased glucose, and altered plasma electrolyte levels among other signs of toxicity. In subchronic and chronic studies with rats, the primary effect was decreased body-weight gain in both sexes with hematological changes (e.g., higher counts of red blood cells) at higher doses.

In a rat prenatal developmental toxicity study, a fenpyroximate dose level that marginally affected maternal body weight and food consumption also resulted in an increased litter incidence of increased thoracic ribs, indicating increased prenatal (qualitative) susceptibility. In the rabbits, there no developmental effects reported at the levels tested. In the rat two-generation reproductive toxicity study, there was no indication of increased pre- or post-natal susceptibility; maternal toxicity (decreased body-weight) and offspring toxicity (decreased lactational weight gain in both generations) occurred at the same dose. Reproductive parameters were not affected.

Acute and subchronic neurotoxicity studies in the rat show no evidence that fenpyroximate specifically targets the nervous system. In the acute neurotoxicity study, neurotoxicity signs such as decreases in motor activity occurred in the presence of other effects including decreases in body weight and food consumption, and in the absence of neuropathology. Similar results were noted in a delayed acute neurotoxicity study in the hen where no effects (neurotoxic or otherwise) were reported. The results of the rat subchronic neurotoxicity study did not indicate any neurotoxicity-specific effects; deficits in body weight and food consumption were the main effects reported. Effects reported in a rat immunotoxicity study were limited to decreased body-weight gain, indicating the fenpyroximate does not directly target the immune system.There is no evidence of carcinogenic potential for fenpyroximate based on the results of carcinogenicity studies via the oral route in either the rats or mice resulting in the carcinogenicity classification of “not likely” to be carcinogenic to humans. Genotoxicity studies including mutagenicity did not demonstrate any genotoxic potential resulting from fenpyroximate exposure.

Specific information on the studies received and the nature of the adverse effects caused by fenpyroximate 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: “Fenpyroximate. Human-Health Risk Assessment for (1) Proposed Section 3 Uses on Cucumber, Snap Bean, Avocado, Black Sapote, Canistel, Mamey Sapote, Mango, Papaya, Sapodilla, Star Apple, Corn (Field, Pop, Silage, and Grown for Seed); (2) Updated Tolerances for Citrus Fruit- Group 10-10, Pome Fruit Group 11-10, and Fruiting Vegetable Group 8-10; (4) the Establishment of a Tolerance on Imported Tea; (3) Increase in Maximum Seasonal Application Rate on Mint; and (4) Proposed Label Amendment to Include Aerial Applications to Existing Uses on Citrus in Texas, Melons, Fruiting Vegetables, and Snap Beans,” dated April 16, 2012 at p. 32 in docket ID number EPA-HQ-OPP-2011-0541-0005.

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenpyroximate, EPA considered exposure under the petitioned-for tolerances as well as all existing fenpyroximate tolerances in 40 CFR 180.566. EPA assessed dietary exposures from fenpyroximate 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 fenpyroximate. 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), tolerance-level residues for all commodities, DEEM TM (ver. 7.81) default processing factors for all commodities except for apple, pear, and grape juice; raisin; orange, grapefruit, tangerine, lemon and lime juice; tomato paste and puree; and peppermint and spearmint oil. Chemical-specific data were used to calculate empirical processing factors for these 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, tolerance-level residues for all commodities, and DEEM TM (ver. 7.81) default processing factors for most commodities except for apple, pear, and grape juice; raisin; orange, grapefruit, tangerine, lemon and lime juice; tomato paste and puree; and peppermint and spearmint oil. Chemical-specific data were used to calculate empirical processing factors for these commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenpyroximate 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 percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for fenpyroximate. 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 fenpyroximate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenpyroximate. 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), a Provisional Cranberry Model and Screening Concentration in Ground Water (SCI-GROW) model, the Agency calculated conservative estimated drinking water concentrations (EDWCs) of fenpyroximate. Tier 1 EDWCs reflect exposure in drinking water to the residues of fenpyroximate and its isomer/degradate, its cis isomer M-1, and its carboxylic acid M-3, all of which are assumed to have similar toxicity.

For acute exposures, EDWCs are estimated to be 43 parts per billion (ppb) for surface water and 0.27 ppb for ground water.

For chronic exposures, EDWCs are estimated to be 8.6 ppb for surface water and 0.27 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 43 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 8.6 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fenpyroximate 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 fenpyroximate to share a common mechanism of toxicity with any other substances, and fenpyroximate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fenpyroximate 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 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 evidence of increased prenatal (qualitative) susceptibility in a rat prenatal developmental toxicity study. A dose level that marginally affected maternal body weight and food consumption also resulted in an increased litter incidence of increased thoracic ribs. However, concern for pre-natal and post-natal toxicity to fenpyroximate is low because (1) there was a clear NOAEL in the rat prenatal developmental toxicity study; (2) the NOAEL for this developmental study is being used as POD for the acute dietary risk assessment for the population of concern—females 13-49 years old; (3) in the rabbit, there were no developmental effects reported at the levels tested, and (4) in the rat two-generation reproductive toxicity study, there was no indication of increased pre- or post-natal susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for all exposure scenarios. That decision is based on the following findings:

i. The toxicity database for fenpyroximate is complete.

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

iii. There is evidence that fenpyroximate 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. Increased (qualitative) prenatal susceptibility was seen following oral exposures in the rat developmental toxicity study. However, for the reasons noted in Unit III.D.2., the concern is low.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment utilizes tolerance-level residues (established or recommended) and 100 PCT for all proposed/established commodities. By using these assumptions, the acute and chronic exposures/risks will not be underestimated. The dietary drinking water assessment utilizes water concentration values generated by models and associated modeling parameters, which are designed to provide conservative, health-protective, high-end estimates of water concentrations that will not likely be exceeded. There are no registered or proposed uses that will result in residential exposure. These assessments will not underestimate the exposure and risks posed by fenpyroximate.

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 fenpyroximate will occupy 3.6% of the aPAD for children 1 to 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 fenpyroximate from food and water will utilize 9.0% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. There are no residential uses for fenpyroximate.

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

Short- and intermediate-term adverse effects were identified; however, fenpyroximate is not registered for any use patterns that would result in short- and intermediate-term residential exposure. Short- and intermediate-term risks are assessed based on short- and intermediate term residential exposures plus chronic dietary exposure. Because there are no short- and 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 risks), no further assessments of short- and intermediate-term risks are necessary. EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risks for fenpyroximate.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fenpyroximate 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 fenpyroximate residues.

Adequate enforcement methodology (gas chromatography with nitrogen/phosphorus detection (GC/NPD), Method S19, has passed an Agency validation) and is available to enforce the tolerance expression.

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

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

Codex MRLs are established for residues of fenpyroximate per se in/on several crop commodities. Harmonization with the Codex MRLs is not possible because the U.S. tolerance expressions include both the parent fenpyroximate and additional metabolites/isomers. However, the Agency is lowering the pome fruit tolerance from 0.40 ppm to 0.30 ppm in order to harmonize with the Codex MRL level. Similarly, based on recently submitted residue data on citrus, EPA is lowering the existing citrus fruit tolerance from 0.60 ppm to 0.50 ppm in order to harmonize with the Codex MRL level.

EPA modified/revised certain IR-4 proposed tolerances based on results from the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures in order to determine appropriate tolerance levels from available U.S. residue data. The proposed tolerance at 0.20 ppm for avocado, black sapote, mamey sapote, canistel, mango, papaya, sapodilla, and star apple was lowered to 0.15 ppm. Similarly, proposed tolerances for cucumber and tea, dried were increased from 0.25 ppm to 0.40 ppm, and from 15 ppm to 20 ppm, respectively. The submitted residue data for corn grain were not entered into the tolerance spreadsheet for OECD calculations because all treated samples showed combined fenpyroximate residues below the level of quantitation (LOQ) of 0.02 ppm. However, based on available residue data, EPA established a tolerance for grain, aspirated fractions at 0.40 ppm to replace proposed tolerances for corn, field aspirated fractions at 2.0 ppm and corn, pop aspirated fractions at 2.0 ppm. In addition, EPA established a tolerance for corn, refined oil at 0.05 ppm. Also, tolerances for fruit, citrus crop group 10-10 and fruit, pome, group 11-10 were reduced to 0.50 ppm and 0.30 ppm, respectively, in order to harmonize with Codex MRL.

The Agency is deleting the existing tolerance for okra at 0.20 ppm since it is included in vegetable, fruiting group 8-10 established by this action. In addition, EPA corrected commodity definitions to comply with current EPA policy as follows: “corn, field, forage/silage” and “corn, pop, forage/silage” were corrected to “corn, field, forage” and “corn, pop, forage,” respectively, and “tea, plucked leaves” was corrected to “tea, dried.”

Finally, EPA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of fenpyroximate not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Therefore, tolerances are established for residues of the insecticide fenpyroximate, ( E )-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1 H -pyrazol-4-yl)methyene]amino]oxy]methyl]benzoate and its Z-isomer, ( Z )-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1 H -pyrazol-4-yl)methylene]amino]oxy]methyl]benzoate, including its metabolites and degradates in or on avocado at 0.15 ppm, bean, snap, succulent at 0.40 ppm, canistel at 0.15 ppm, corn, field, grain at 0.02 ppm, corn, field, forage at 2.0 ppm, corn, field, stover at 7.0 ppm, corn, pop, grain at 0.02 ppm, corn, pop, forage at 2.0 ppm, corn, pop, stover at 7.0 ppm, corn, field, refined oil at 0.05 ppm, grain, aspirated fractions at 0.40 ppm, cucumber at 0.4 ppm, fruit, citrus, group 10-10 at 0.50 ppm, fruit, pome, group 11-10 at 0.30 ppm, mango at 0.15 ppm, papaya 0.15 ppm, sapodilla at 0.15 ppm, sapote, black at 0.15 ppm, sapote, mamey at 0.15 ppm, star apple at 0.15 ppm, tea, dried at 20 ppm, and vegetable, fruiting, group 8-10 at 0.20 ppm.

Lastly, EPA is removing the entries for “fruit, citrus, group 10,” “fruit, pome, group 11,” “okra” and “vegetable, fruiting, group 8” from the table at 40 CFR 180.566(a)(1) since “new tolerances” established by this action will supersede the existing tolerances.

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:

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-2011-1012 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 February 11, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any (Confidential Business Information CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-1012, by one of the following methods:

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

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

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

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

In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7950) by IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.510 be amended by establishing tolerances for residues of the insecticide pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on vegetable, bulb, group 3-07 at 0.70 parts per million (ppm); vegetable, fruiting, group 8-10 at 0.20 ppm; fruit, citrus, group 10-10 at 0.30 ppm; fruit, pome, group 11-10 at 0.20 ppm; caneberry subgroup 13-07A at 1.0 ppm; bushberry subgroup 13-07B at 1.0 ppm; berry, low growing, except strawberry, subgroup 13-07H at 1.0 ppm; and herb subgroup 19A at 50 ppm. Also, due to the establishment of the tolerances for the new crop groups listed in this unit, the petition proposed the removal of the following commodities as unnecessary: Vegetable, bulb, group 3, except onion, bulb; onion, bulb; vegetable, fruiting, group 8; okra; fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry subgroup 13-B; cranberry; loganberry; juneberry; lingonberry; and salal. That document referenced a summary of the petition prepared by Valent USA Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the levels at which tolerances are being established for several commodities. The reason for these changes 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 pyriproxyfen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyriproxyfen 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.

Pyriproxyfen is of low acute toxicity by oral, dermal, inhalation, and ocular routes of exposure. Pyriproxyfen is not a skin irritant and was negative in the dermal sensitization study in guinea pigs. Based on repeated dose studies in mice, rats, and dogs the liver and kidney are the principal target organs, with slight anemia occurring in rodent species. The review of the acute and subchronic neurotoxicity studies indicates pyriproxyfen is not a neurotoxic chemical. There was no evidence of prenatal or postnatal sensitivity or increased susceptibility in developmental studies in rats and rabbits, and in reproduction studies in rats. In the 2-generation reproduction toxicity study, offspring toxicity (decreased body weight on pups during lactation days 14 to 21) occurred in the presence of decreased body weight in parental animals at the same dose level. An immunotoxicity study showed no adverse effects on the immune system. No significant systemic toxicity was observed in either the 21-day dermal toxicity study in rats. In a 28-day inhalation study, the Lowest-observed-adverse-effect-level (LOAEL) of 1 milligram/Liter (mg/L) based on salivation in females and sporadic decreased body weight gains in males was not considered biologically relevant. With respect to carcinogenicity pyriproxyfen has been classified as a “Group E” chemical—no evidence for carcinogenicity to humans based on the absence of carcinogenicity in mice and rats. Pyriproxyfen is negative for mutagenic activity in a battery of mutagenicity studies conducted with both the parent and/or metabolites.

Specific information on the studies received and the nature of the adverse effects caused by pyriproxyfen 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. 28-33 in the document titled “Pyriproxyfen. Human Health Risk Assessment for the Request to Add Uses on Herb Subgroup 19A, and the Expansions of Existing Crop Group Uses to Numerous Crop Subgroups” in docket ID number EPA-HQ-OPP-2011-1012.

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 pyriproxyfen 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 pyriproxyfen, EPA considered exposure under the petitioned-for tolerances as well as all existing pyriproxyfen tolerances in 40 CFR 180.510. EPA assessed dietary exposures from pyriproxyfen 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.

No such effects were identified in the toxicological studies for pyriproxyfen; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance level residues.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that pyriproxyfen 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pyriproxyfen. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pyriproxyfen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyriproxyfen. 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 Tier 1 Rice Model and the Generic Estimated Exposure Concentration (GENEEC) model the estimated drinking water concentrations (EDWCs) of pyriproxyfen for chronic exposure assessments are estimated to be 2.98 parts per billion (ppb) for surface water and 0.006 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 2.98 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).

Pyriproxyfen is currently registered for flea and tick control (home environment and pet treatments) as well as products for ant and roach control (indoor and outdoor applications). Formulations include carpet powders, foggers, aerosol sprays, liquids (shampoos, sprays, and pipettes for pet treatments), granules, bait (indoor and outdoor), and impregnated materials (pet collars). EPA assessed residential exposure using the following assumptions: Although there is the potential for short-term residential handler dermal and inhalation exposure as well as short or intermediate post-application exposure from the registered uses of pyriproxyfen, there are no short-term dermal or inhalation PODs and quantitative assessments were not conducted.

Based on the registered use patterns, the following post-application scenarios were assessed: Short- and intermediate-term hand-to-mouth exposures for 1 to <2 year olds from treated carpets and flooring and petting treated animals (shampoos, sprays, spot-on treatments and collars); long-term hand-to-mouth exposures for 1 to <2 year olds from treated carpets and flooring and petting treated animals; and long-term dermal exposures from treated carpets, flooring, and pets.

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 pyriproxyfen to share a common mechanism of toxicity with any other substances, and pyriproxyfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyriproxyfen 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 Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factors (SF) when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Based on the available data, there is no quantitative and qualitative evidence of increased susceptibility observed following in utero pyriproxyfen exposure to rats and rabbits or following prenatal/postnatal exposure in the 2-generation reproduction study.

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 pyriproxfen is complete.

ii. There is no indication that pyriproxyfen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that pyriproxyfen 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.

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

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, pyriproxyfen is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyriproxyfen from food and water will utilize 12% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. A long-term post-application residential assessment was performed for toddlers only since they are anticipated to have higher exposures than adults from treated home environments and pets due to their behavior patterns. The total chronic dietary and residential aggregate MOE is 220 for children 1-2 years old. As this MOE is greater than 100, the chronic aggregate risk does not exceed EPA's level of concern.

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). Pyriproxyfen 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 pyriproxyfen.

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 an aggregate MOE of 2,000 for children 1-2 years old, the population subgroup receiving the greatest exposure. Because EPA's level of concern (LOC) for pyriproxyfen is a MOE of 100 or below, this MOE is 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).

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

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 720 for children 1-2 years old, the population subgroup receiving the greatest exposure. Because EPA's LOC for pyriproxyfen is a MOE of 100 or below, this MOE is not of concern.

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

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 pyriproxyfen residues.

Adequate enforcement methodology (Gas Chromatography with Nitrogen Phosphorous Detection; GC/NPD) 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 established MRLs for pyriproxyfen in or on citrus fruit at 0.50 ppm. This MRL is the same as the tolerance being established for pyriproxyfen on the citrus group 10-10 in the United States. There are no Codex MRLs for the other commodities addressed by this final rule.

Based on calculations using the Organization for Economic Co-operation and Development (OECD) MRL calculator, the Agency is establishing the tolerance for the herb subgroup 19A at 100 ppm instead of the proposed level of 50 ppm. In addition, the tolerance for the citrus fruit group 10-10 is being revised to 0.5 ppm to harmonize with Codex and the tolerance for the fruiting vegetable group 8-10 is being revised to 0.8 ppm to harmonize with the Canadian MRL for bell peppers.

Lastly, EPA has revised the tolerance expression to clarify:

1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of pyriproxyfen not specifically mentioned.

2. That compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Therefore, tolerances are established for residues of pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy) ethoxypyridine, in or on vegetable, bulb, group 3-07 at 0.70 ppm; vegetable, fruiting, group 8-10 at 0.80 ppm; fruit, citrus, group 10-10 at 0.50 ppm; fruit, pome, group 11-10 at 0.20 ppm; caneberry subgroup 13-07A at 1.0 ppm; bushberry subgroup 13-07B at 1.0 ppm; berry, low growing, except strawberry, subgroup 13-07H at 1.0 ppm; and the herb subgroup 19A at 100 ppm. Also, due to the establishment of the tolerances for the new crop groups listed in this unit, the following are being removed as unnecessary: Vegetable, bulb, group 3, except onion, bulb; onion, bulb; vegetable, fruiting, group 8; okra; fruit, citrus; fruit, pome; caneberry subgroup 13-A; bushberry subgroup 13-B; cranberry; loganberry; juneberry; lingonberry; salal; and citrus hybrids.

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:

This is a summary of the Commission's Order, adopted on October 4, 2012 and released on October 5, 2012, FCC 12-122, correcting § 101.147 of the Commission's final rules adopted in the Wireless Backhaul 2nd R&O, FCC 12-87, published at 77 FR 54421 (September 5, 2012). The table under Frequency assignments, §§ 101.147(i)(9) and 101.147(o)(8) were incorrect and an entry to the table under Directional antennas in § 101.115(b)(2) is incorrect. This document makes the following corrections.

Accordingly, 47 CFR part 101 is corrected by making the following correcting amendments:

Background

In 2004, a large abundance of small scallops was discovered in the ETA, and later that year, the ETA was closed to scallop fishing to protect the small scallops and allow them to grow. Following closure of the ETA, scallop biomass increased steadily in the area. When the ETA opened in 2007, it contained over one-quarter of the total scallop biomass. The area was fished as a controlled access area for 4 years (2007-2010) and supported a total of 12 access area trips for each full-time vessel, yielding around 72 million lb (32,659 mt) of scallops while it was an access area. As designed under the scallop fishery's area rotation program, the heavy fishing effort decreased scallop biomass significantly. Framework Adjustment 22 to the Scallop FMP (Framework 22) (76 FR 43774; July 21, 2011), which used 2010 scallop resource survey results, changed the ETA from an access area to an open area because the scallop biomass no longer supported access area trip allocations to that area.

At the Council's Scallop Plan Development Team (PDT) meeting on August 19 and 20, 2012, staff from the NMFS Northeast Fisheries Science Center and researchers from the Virginia Institute of Marine Science (VIMS), Arnie's Fisheries, and the University of Massachusetts School for Marine Science and Technology (SMAST) presented results from their 2012 ETA scallop resource surveys. All four surveys, which represent the best available scientific information regarding the status of the scallop resource, indicated that the abundance of very small scallops (which represents future recruitment for the fishery) in the ETA is extremely high compared to recent years. In 2012, the mean number of scallops per tow with less than 75 mm (3 in) shell height in the ETA was 994, compared to 24 in 2011. Most of the scallop biomass in the Mid-Atlantic is in the ETA and the Delmarva Area (currently closed). However, most of this biomass is small scallops.

Vessels are currently allowed to fish open area days-at-sea in the ETA. To allow any additional trips into the area will result in the taking of these abundant small scallops, thereby preventing maximizing optimal catch in the future under the rotational management scheme. Targeting of scallops in the ETA at this time is likely to have negative impacts on recruitment in the short and medium term, and could reduce the long-term biomass and yield from the ETA and the overall Mid-Atlantic area. The success of the entire scallop access area rotational management program depends on timely openings and closing of access areas in order to protect scallop recruitment and optimize yield. This is particularly true in the Mid-Atlantic, where recruitment has been well below average for several years. Further, if vessels choose to fish in the ETA, scallop catch rates will likely be low, which increases fishing effort, bycatch, costs, and impacts on protected resources and habitat.

At its September 2012 meeting, the Council requested that we take emergency action under Section 305(c) of the Magnsuson-Stevens Act to close the ETA as soon as possible to avoid the negative impacts described above. The Council's request was supported by the Fisheries Survival Fund (a group that represents the majority of the full-time scallop vessels in the scallop fishery). The Council voted 15-1 in favor of the emergency request with the NMFS representative voting against, based on NMFS's policy to avoid unanimous votes for emergency recommendations, which would obligate the Secretary to implement the emergency request. This policy was explained to the Council.

Pursuant to the Council's request, NMFS publishes this emergency action to close the ETA for 180 days, the maximum allowed, without an extension, under Magnuson-Stevens Act. NMFS expects that the closure will continue for an additional 2 years through a combination of an extension of the emergency action, as allowed under the Magnuson-Stevens Act, if needed, measures being developed by the Council under Framework 24, and future actions. NMFS does not expect the closure to adversely impact the scallop fleet, because these vessels have flexibility to fish in other areas to make-up for lost fishing opportunities in the ETA.

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

The emergency results from recent, unforeseen events or recently discovered circumstance. The new information from the ETA 2012 scallop surveys presents a recently discovered circumstance and therefore warrants emergency action. Results of the most recent survey were presented at the August 20 and 21, 2012, Scallop PDT meeting. The new information suggests that there is a significantly larger amount of small scallops in ETA than projected through Framework 22, which changed the ETA from an access area into an open area. In 2012, the mean number of scallops per tow with less than 75 mm shell height in the ETA was 994, compared to 24 in 2011.

This situation presents serious conservation or management problems in the fishery. The success of the entire scallop area rotation program, and the need to attain optimal yield from this fishery, depends on timely openings and closing of access areas in order to protect scallop recruitment and optimize yield. This is particularly true in the Mid-Atlantic, where recruitment has been well below average for several years but has recently begun to rebound. If the smaller scallops are not protected as soon as possible, it would jeopardize the area rotation program and optimal production of scallops in the ETA in the future. Fishing effort in the ETA could compromise the overall success of the area rotation program and achieving optimum yield. Fishing activity in ETA could negatively impact scallop recruitment and reduce long-term biomass and yield from the area. Due to low catch rates of legal-size scallops in this area, there is much concern about discard and bycatch mortality of the abundant smaller scallops that could occur while vessels are targeting the larger scallops. Further, when catch rates fall, vessels must fish longer to harvest the same total catch, increasing area swept, or time that fishing gear is in the water. Increased area swept has greater impacts on bycatch, habitat, and protected resources, as well as increased costs for fishing vessels due to longer trips. The increase in fishing costs would also have negative impacts on the producer surplus and net economic benefits from the fishery.

The emergency can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process. The Council has the authority to develop a management action to close the ETA and it is doing so through Framework 24, but this process is too slow to address the immediate problem presented in the ETA. Framework 24 was adopted by the Council in November 2012, but will not be implemented until the spring of 2013 due to procedural and rule making requirements. However, protection of the small scallops in the ETA is needed as soon as possible to prevent vessels from depleting the abundance of small scallops by fishing inefficiently in the ETA. There is no other action that either the Council or NMFS can take through the normal rulemaking process that would enable us to implement the critical closure in time to prevent harmful fishing activity in the ETA. An emergency action enables us to redirect open area scallop fishing effort in order to avoid unnecessary adverse biological and economic impacts. Therefore, the urgency to protect these small scallops through a final rule outweighs the value of providing prior public comment, particularly given that the members of the public most affected by this action have requested it and public comment was provided at the September Council meeting.

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

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(b)(B) that it is contrary to the public interest and impracticable to provide for prior notice and opportunity for the public to comment. As more fully explained above, the reasons justifying promulgation of this rule on an emergency basis make solicitation of public comment contrary to the public interest.

By closing the ETA, this action avoids jeopardizing the success of the access area program in future years by protecting scallop recruitment in the ETA. The new information from the ETA 2012 scallop surveys suggests that there is a significantly larger amount of small scallops in ETA than projected through Framework 22, which changed the ETA from an access area into an open area. An analysis of VMS data showed that, in the 2 months following this PDT meeting, 36 trips were taken in the ETA, resulting in over 3,000 hr of fishing activity. There is no action that either the Council or NMFS can take through the normal rulemaking process that would enable NMFS to implement the critical closure in time to prevent harmful fishing activity in the ETA. This emergency action enables NMFS to redirect open area scallop fishing effort in order to avoid unnecessary adverse biological and economic impacts. Therefore, the urgency to protect these small scallops through a final rule outweighs the value of providing prior public comment, particularly given that the members of the public most affected by this action have requested it and public comment was provided at the September Council meeting. This action did not allow for prior public comment because the review process and determination could not have been completed any earlier, due to the inherent time constraints associated with the process. The new information from the ETA 2012 scallop surveys presents a recently discovered circumstance and therefore warrants emergency action. Results of the most recent survey were only presented at the August 20 and 21, 2012, Scallop PDT meeting. Although this action is being implementing without notice and comment, NMFS is seeking public comment on this rule for purposes of assessing the need to extend the rule if other measures to close the area are not implemented before the expiration of this rule.

For these same reasons stated above, pursuant to 5 U.S.C. 553(d)(3), the Assistant Administrator finds good cause to waive the full 30-day delay in effectiveness for this rule. This action is undertaken at the request of the Council. The Council, with the support of a group representing a large portion of the industry, urged that NMFS implement this action quickly in order to minimize any fishing effort in the ETA. Moreover, it would be contrary to the public interest if this rule does not become effective immediately because even an additional 30 days of fishing in the area could lead to increased mortality of small scallops in the ETA. This could have negative impacts on recruitment in the short and medium term, and could reduce the long term biomass and yield from the ETA and the overall Mid-Atlantic. For these reasons, there is good cause to waive the requirement for delayed effectiveness.

Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

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

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

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