Discussion

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007). The SNPRM published in theFederal Registeron February 2, 2012 (77 FR 5195). The SNPRM applied to all Boeing Model 747-100B SUD, 747-300, 747-400, and 747-400D series airplanes; and Model 747-200B series airplanes having a stretched upper deck. The original NPRM (74 FR 33377, July 13, 2009) proposed to supersede an existing AD that currently requires repetitively inspecting for cracking or discrepancies of the fasteners in the tension ties, shear webs, and frames at body stations 1120 through 1220; and related investigative and corrective actions if necessary. The original NPRM proposed to require modifying the frame-to-tension-tie joints at body stations (STA) 1120 through 1220 (including related investigative actions and corrective actions if necessary), which would provide a terminating action for the repetitive inspections. The original NPRM also proposed to require new repetitive inspections after the modification, corrective actions if necessary, and additional modification requirements at a specified time after the first modification. The original NPRM also proposed to remove certain airplanes from the applicability. The SNPRM proposed to add repetitive open hole high frequency eddy current (HFEC) inspections for cracking in the forward and aft tension tie channels, and repair if necessary. For certain airplanes, the SNPRM also proposed to require a one-time angle inspection to determine if the angle is installed correctly, and re-installation if necessary; and a one-time open-hole HFEC inspection at the fastener locations where the tension tie previously attached to the frame prior to certain modifications, and repair ifnecessary. The SNPRM also, for the Stage 2 inspections, proposed to reduce the initial compliance times for those inspections.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the SNPRM (77 FR 5195, February 2, 2012) and the FAA's response to each comment.

Boeing asked that we include AD 2007-16-19, Amendment 39-15158 (72 FR 45151, August 13, 2007), in the SNPRM (77 FR 5195, February 2, 2012) as related rulemaking. Boeing stated that AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007), is identified as being superseded by the actions proposed in the SNRPM, as specified in paragraph (b) of the SNPRM (titled “Affected ADs”). Boeing noted that AD 2007-16-19 is also affected by those actions. Boeing added that AD 2007-16-19 has inspection requirements at the affected tension tie locations, and doing the modification in paragraph (m) of the SNPRM also ends the inspections required by AD 2007-16-19 for the modified locations. Boeing asked that we change paragraph (b) of the SNPRM to specify that the AD may modify the compliance requirements in AD 2007-16-19.

Boeing also asked that we change paragraph (m) of the SNPRM (77 FR 5195, February 2, 2012) because the modification identified in Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011, eliminates the need for the inspection requirements in paragraphs (g), (j), (p), and (q) of AD 2007-16-19, Amendment 39-15158 (72 FR 45151, August 13, 2007). Boeing stated that the corresponding requirements, for body stations 1120 through 1220 only, terminate the inspections required by AD 2007-16-19, and all requirements for body stations 880 through 1100 still apply.

We acknowledge the commenter's requests and agree that AD 2007-16-19, Amendment 39-15158 (72 FR 45151, August 13, 2007), is affected by certain actions in the SNPRM (77 FR 5195, February 2, 2012). However, when Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011, was issued it contained an alternative method of compliance (AMOC) approval for certain actions in AD 2007-16-19 for the tension tie locations that were modified using Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011. AD 2007-16-19 also mandated inspections for tension ties between body stations 880 and 1100, which are not included in Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011. We do not agree to include AD 2007-16-19 in the affected ADs section identified in paragraph (b) of this AD because paragraph (b) of this AD identifies ADs that are superseded, and we are not superseding that AD. In addition, we have not changed paragraph (m) of the SNPRM—(paragraph (p) of this AD) because the inspections of tension ties between body stations 880 and 1100 required by AD 2007-16-19 are not related to this AD. We have made no change to the AD in this regard.

Boeing asked that we change paragraph (n) of the SNPRM (77 FR 5195, February 2, 2012) to add a provision for airplanes that were modified per Boeing Drawing 144U0061, including any deviations during the modification and post-modification inspections that were previously approved as an AMOC to AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007). The provision should specify that those actions are acceptable for compliance with the corresponding actions in the SNPRM.

We acknowledge and agree with the commenter's request. We have added a new paragraph (r)(5) to this AD to allow AMOCs approved previously in accordance with AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007), as a terminating action, to be approved as AMOCs for the requirements of paragraph (p) of this AD.

Boeing also asked that we change paragraph (s)(3) of the SNPRM (77 FR 5195, February 2, 2012) to provide direction for obtaining an AMOC for any deviations that occur when doing the modification specified in Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011.

We acknowledge the commenter's request; however, the reference to the Boeing Commercial Airplanes Organization Designation Authorization (ODA) specified in paragraph (s)(3) of this AD is our standard language. After the AD is published, we may empower certain authorized representatives of the Boeing ODA to approve AMOCs to deviations during the modification. We have made no change to the AD in this regard.

Boeing asked that we change paragraph (s)(4) of the SNPRM (77 FR 5195, February 2, 2012) to also refer to paragraph (j) of the AD, in addition to the paragraphs identified as corresponding requirements for AMOCs previously approved in accordance with AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007). Boeing stated that paragraph (j) also contains inspection requirements, and previously accomplished repairs can be considered AMOCs for this paragraph.

We agree with the commenter's request for the reason provided. We have added a reference to paragraph (j) of the AD to the AMOC language specified in paragraph (r)(4) of this AD.

Boeing asked that we change paragraph (b) of the SNPRM (77 FR 5195, February 2, 2012) to include credit for related SSID inspections. Boeing stated that AD 2007-23-18, Amendment 39-15266 (72 FR 65655, November 23, 2007), included language specifying that inspections done per Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010, meet the requirements of the SSID inspections in structurally significant item (SSI) F-19A.

We agree that the subject SSID inspections are related to this AD. When Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010; and Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011; were issued, they contained AMOCs to those SSID inspections. Therefore, those inspections do meet the requirements of the SSID inspections in structurally significant item (SSI) F-19A, except as defined in those AMOCs. However, we do not agree to revise paragraph (b) of this AD as that paragraph only identifies ADs that are superseded. We have made no change to the AD in this regard.

Boeing asked that we change the reporting requirement in paragraph (l) of the SNPRM (77 FR 5195, February 2, 2012). Boeing stated that the supplemental structural inspections (SSIs) in the SSID are replaced by Stage 1, Stage 2, and post-modification inspections in the SSID. Boeing added that reporting findings from these three inspections is necessary to maintain the fleet monitoring aspects of the SSI program. Boeing asked that paragraph (l) of the SNPRM be changed to add all three inspections to the reportingrequirements in lieu of just the Stage 1 inspection currently identified.

We acknowledge the commenter's request and agree that reporting is necessary for maintaining the fleet monitoring aspect of the SSI program. However, maintaining the fleet monitoring of the SSI program is not what the requirements in this AD were meant to do. We have evaluated the need for continued reporting, as required by paragraph (l) of this AD, and have determined that it is no longer necessary. Therefore, we have removed paragraph (l) from this AD and reidentified subsequent paragraphs accordingly.

British Airways asked that we change the compliance time in paragraphs (p) and (q) of the SNPRM (77 FR 5195, February 2, 2012) to match the compliance time for the Stage 2 inspections. British Airways stated that this would reduce further disruption to the operator's heavy maintenance program.

UPS asked that the compliance time specified in paragraph (m)(1) of the SNPRM (77 FR 5195, February 2, 2012) be changed for the Boeing Special Freighter (BSF) and the Boeing Converted Freighter (BCF). UPS stated that since the modifications to the BSF and BCF configurations were done after original production, the compliance times in that paragraph are not appropriate for the replaced structure. UPS added that the remaining locations (stations 1140, 1180, and 1220) are not adjacent to each other. UPS believes that the risk of widespread fatigue damage has been greatly reduced at those locations. UPS stated that for airplanes that have been modified to the BSF or BCF configuration, the compliance time threshold should take into account the replaced structure.

We do not agree with the commenters' requests. In developing an appropriate compliance time for this action, we considered the urgency associated with the subject unsafe condition and the practical aspect of accomplishing the required actions within a period of time that corresponds to the normal scheduled maintenance for most affected operators. Further, we considered and agree with the compliance time recommended by the manufacturer in Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010. In addition, UPS provided no technical justification for changing the compliance time for the BSF and BCF airplanes. However, under the provisions of paragraph (r) of this AD, we will consider requests for approval of changing the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. We have not changed the AD in this regard.

British Airways also asked that the modification threshold be increased from 17,000 total flight cycles to 20,000 total flight cycles. British Airways stated that an increased threshold would align with the Model 747-400 design service goal and the SSID inspection threshold of 20,000 total flight cycles.

We do not agree with the commenter's request. This request was already addressed in the comments section of the SNPRM (77 FR 5195, February 2, 2012) under “Request to Extend the Modification Compliance Time.” As stated in the SNPRM:

We have made no change to the AD in this regard.

UPS asked that the inspections required by paragraphs (o) and (q) of the SNPRM (77 FR 5195, February 2, 2012) be terminated after the modification required by paragraph (m) of the SNPRM is accomplished. UPS stated that the structure replaced by the modification, which is the structure that would have been inspected, has been removed.

We agree with the commenter's request; if the structure has been removed the inspection is not possible. Therefore, we have changed paragraph (m) of the SNPRM (77 FR 5195, February 2, 2012) (paragraph (p) of this AD) to include a reference to paragraphs (o) and (q) of the SNPRM—(paragraphs (l) and (n) of this AD) in the terminating action language for the inspections. We have also included terminating action language in those paragraphs.

British Airways asked that it be allowed to continue the Stage 1 and Stage 2 inspections with an option of doing the modification as terminating action for the inspections. British Airways added that the Stage 2 inspections provide an adequate level of safety, as the discrepant structure is repaired to a similar compliance standard as the original structure. British Airways noted that the substantial number of work-hours necessary to do the modification would be a significant financial burden.

This request was already addressed in the comments section of the SNPRM (77 FR 5195, February 2, 2012) under “Request for an Optional Modification.” As stated in the SNPRM, we do not agree with the request to make the required modification optional. The crack finding data and analysis performed support the inspection and modification actions in the SNPRM. Therefore, we have not changed the AD in this regard.

UPS asked that paragraphs (g) and (j) of the SNPRM (77 FR 5195, February 2, 2012) be changed to specify that it is structurally acceptable to use substitute fasteners per Chapter 51, Sections 51-40-03 and 51-40-05, of the Model 747-400SF Structural Repair Manual (SRM). UPS stated that Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010, includes a General Note which specifies that it is acceptable to use the Model 747-400 SRM for repairs on airplanes modified to BCF configuration, until such time as the SRM is updated with tension tie and frame repairs. UPS noted that Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010, does not have any appropriate references for Model 747-400SF airplanes regarding fastener substitution, open-hole sizes, and installation.

We do not agree with the request. Boeing Alert Service Bulletin 747-53A2507, Revision 1, dated January 14, 2010, identifies procedures for fastener substitution in paragraph 3.A., Notes 4, 5, and 9 of the Accomplishment Instructions. Therefore, we have made no change to the AD in this regard.

Boeing asked that we provide clarification in paragraph (g) of the SNPRM (77 FR 5195, February 2, 2012) that the reference to paragraph (l) of this AD as the terminating action paragraph should instead be paragraph (m) of this AD. Boeing added that paragraph (m) mandates the modification in Boeing Service Bulletin 747-53A2559, Revision 1, dated August 4, 2011, which terminates the repetitive inspections required by paragraph (g) of the SNPRM.

We agree with the commenter. Paragraph (g) of the SNPRM (77 FR 5195, February 2, 2012) specifies that doing the modification required by paragraph (l) of the AD terminates the repetitive inspections; however, that is in error. The modification is specified in paragraph (m) of the SNPRM—(paragraph (p) of this AD). We have changed the paragraph reference in paragraph (g) of this AD accordingly.

Boeing and UPS asked that we correct the error in paragraph (i)(1) of the SNPRM (77 FR 5195, February 2, 2012) which refers to doing the next inspection in accordance with paragraph (j) of this AD, but should instead refer to paragraph (h) of this AD.

We partially agree with the commenters. Paragraph (i)(1) of the SNPRM (77 FR 5195, February 2, 2012) specifies doing the next inspection after the initial Stage 1 inspection done in accordance with paragraph (j) of this AD; however, that is in error because the initial Stage 1 inspection is in paragraph (g) of this AD (paragraph (h) only contains the compliance times for the initial inspection). We have changed the reference in paragraph (i)(1) of this AD accordingly.

Boeing and UPS asked that we correct the error in paragraph (j) of the SNPRM (77 FR 5195, February 2, 2012), which refers to paragraph (j) of this AD as the exception paragraph; however, the correct reference is paragraph (k) of this AD.

We agree with the commenters. Paragraph (k) of this AD contains the exception to corrective action instructions. We have corrected the reference in paragraph (j) of this AD accordingly.

Boeing and UPS asked that we correct the error in paragraph (k) of the SNPRM (77 FR 5195, February 2, 2012), which refers to discrepancies found during any inspection required by paragraph (g), (h), or (i) of the AD. Boeing asked that the reference to paragraph (j) of this AD be added to paragraph (k) of this AD. UPS asked that the reference to paragraphs (j), (o), (p), and (q) of this AD be added to the paragraphs referenced in paragraph (k) of this AD.

We partially agree with the commenters. We agree that paragraph (j) of this AD should be included in the corrective action paragraphs referred to in paragraph (k) of this AD because it is included in the existing requirements. We have changed paragraph (k) of this AD accordingly. However, paragraphs (o), (p), and (q) of the SNPRM (77 FR 5195, February 2, 2012)—(paragraphs (l), (m), and (n) of this AD) are part of the new requirements, and the corrective actions are contained within those paragraphs.

UPS stated that the actions specified in paragraph (m) of the SNPRM (77 FR 5195, February 2, 2012) also require an additional modification, which is currently undefined in Boeing Service Bulletin 747 53A2559, Revision 1, dated August 4, 2011. UPS understands that, at this time, Boeing does not believe this additional modification will cause an undue burden. UPS noted that Boeing should include such a requirement in that service information, given the age of the affected fleet and available resources, as opposed to adjusting the limit of validity of the 747 fleet. UPS added that based on its fleet age and current utilization, it does not believe it will be affected; however, UPS is concerned with the precedent of mandating undefined requirements.

We infer that UPS wants clarification of the subject undefined requirement. Boeing has elected not to design the additional modification since Boeing foresees few, if any, operators that would require this modification. For this reason, Boeing Service Bulletin 747 53A2559, Revision 1, dated August 4, 2011, specifies that operators contact Boeing for instructions. We have addressed this issue by requiring AMOC approval when operators are instructed to contact Boeing for instructions. We have made no change to the AD in this regard.

UPS asked that the Costs of Compliance section in the SNPRM (77 FR 5195, February 2, 2012) be changed. UPS stated that the costs specified do not accurately reflect the actual costs. UPS added that, based on its review of the modification instructions and the experiences of other operators that have performed similar modifications, the actual modification work, not including incidental costs, may take at least 1,000 work-hours to accomplish. UPS stated that this is a substantial increase, and the cost section should be updated in the analysis of this rulemaking.

We do not agree with the commenter's request. This request was already addressed in the comments section of the SNPRM (77 FR 5195, February 2, 2012) under “Request to Change Cost Information.” As stated in the SNPRM:

We have not changed the AD in this regard.

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 SNPRM (77 FR 5195, February 2, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM (77 FR 5195, February 2, 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 67 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron March 15, 2012 (77 FR 15291). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

UPS requested that we extend the proposed compliance time. The NPRM (77 FR 15291, March 15, 2012) proposed a compliance time of “within 30 months or 4,500 flight hours after the effective date of this AD,” for modifying the wiring in zone 675 of the right-hand wing. UPS stated that extending the compliance time to “within 40 months or 4,500 flight hours after the effective date of this AD,” would allow it to accomplish the required actions at its heavy maintenance facility during C-check visits. UPS stated that the line maintenance environment is not conducive to this type of work due to the required ground time, labor, and other resources, which are available at its major maintenance facility. UPS stated that its current maintenance program is based on a 30-month C-check interval. UPS also stated that in order to accommodate this modification at C-check in its major maintenance facility, it will need an additional 10 months to allow for planning and preparations, including developing engineering orders, prototyping, obtaining necessary management and finance approvals, parts acquisition, and parts lead-time.

We do not agree to extend the compliance time specified in this final rule. In developing an appropriate compliance time for this action, we considered the urgency associated with the subject unsafe condition, the manufacturer's recommendations, the availability of required parts, and the practical aspect of accomplishing the required modification within a period of time that corresponds to the normal scheduled maintenance for most affected operators. Under the provisions of paragraph (h)(1) of the final rule, we will consider requests for approval of an extension of the compliance time if sufficient data are submitted to substantiate that the new compliance time would provide an acceptable level of safety. We have not changed the AD in this regard.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed.

We estimate that this AD will affect 132 products of U.S. registry. We also estimate that it will take about 7 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,720 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $305,580, or $2,315 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 athttp://www.regulations.gov;or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (77 FR 15291, March 15, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSES 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron June 5, 2012 (77 FR 33127). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 33127, June 5, 2012) or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM (77 FR 33127, June 5, 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 33127, June 5, 2012).

We estimate that this AD will affect 10 products of U.S. registry. We also estimate that it will take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $233 per product.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $7,430, or $743 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 this AD:

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

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

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

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron May 1, 2012 (77 FR 25642). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 25642, May 1, 2012) or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM (77 FR 25642, May 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 25642, May 1, 2012).

We estimate that this AD will affect about 171 products of U.S. registry. We also estimate that it will take about 28 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $6,504 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,519,164, or $8,884 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 athttp://www.regulations.gov;or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (77 FR 25642, May 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 theADDRESSESsection. Comments will be available in the AD docket shortly after receipt.

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

On May 1, 2012, we published a notice of proposed rulemaking (NPRM)entitled “Special Local Regulations for Marine Events; Patuxent River, Solomons, MD” in theFederal Register(77 FR 25649). We received no comments on the proposed rule. No public meeting was requested, and none was held.

On September 15 and 16, 2012, the Chesapeake Bay Power Boat Association will sponsor power boat races on the Patuxent River near Solomons, MD. The event consists of offshore power boats racing in a counter-clockwise direction on an irregularly-shaped course located between the Governor Thomas Johnson Memorial (SR-4) Bridge and the U.S. Naval Air Station Patuxent River, MD. The start and finish lines will be located near the Solomons Pier. A large spectator fleet is expected during the event. Due to the need for vessel control during the event, the Coast Guard will temporarily restrict vessel traffic in the event area to provide for the safety of participants, spectators and other transiting vessels.

The Coast Guard received no comments in response to the NPRM. No public meeting was requested and none was held.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this regulation will prevent traffic from transiting a portion of the Patuxent River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners and marine information broadcasts, so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety determined to be 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 entities during rulemaking. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Patuxent River during the event.

Although this regulation prevents traffic from transiting a portion of the Patuxent River at Solomons, MD during the event, this rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (seeADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 theFOR FURTHER INFORMATION CONTACT, above.

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

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR Part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. This rule is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated underADDRESSES.

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

The Oregon Department of Transportation has requested that the Lewis and Clark Drawbridge, mile 1.0, remain closed to vessel traffic to facilitate the milling and repaving of the roadway surface on the lift span. The bridge provides a vertical clearance of 25 feet above mean high water when in the closed position. Vessels that do not require a bridge opening to safely pass beneath the bridge may continue to do so during this closure period. Under normal operations this bridge opens on signal with advance notification as required by 33 CFR 117.899(c). This deviation allows the Lewis and Clark Drawbridge across the Lewis and Clark River in Astoria, OR to remain in the closed position and need not open for maritime traffic from 7 a.m. August 29, 2012 through 5 p.m. on August 30, 2012. The bridge shall operate in accordance to 33 CFR 117.899(c) at all other times. Waterway usage on the Lewis and Clark River is primarily recreational boaters. Mariners will be notified and kept informed of the bridge's operational status via the Coast Guard Notice to Mariners publication and Broadcast Notice to Mariners as appropriate. The draw span will be required to open, if needed, for vessels engaged in emergency response operations during this closure period.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Table of Acronyms DHSDepartment of Homeland Security FRFederal Register NPRMNotice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this year's event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with an air show and associated pyrotechnics, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. For the same reasonsdiscussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

Between 8:00 a.m. until 4:00 p.m. each day on Friday, Saturday, and Sunday of the second weekend of August 2012, an air show will be held over Lake Michigan in Milwaukee, WI. The Captain of the Port, Sector Lake Michigan, has determined that an air show with associated acrobatic maneuvers proximate to a gathering of watercraft and personnel pose a significant risk to public safety and property. Such hazards include aircraft malfunctions and subsequent crash and falling or burning debris. This temporary rule makes a temporary deviation to the Milwaukee Air and Water Show safety zone, which is established at 33 CFR 165.929(43).

Changes have been made to the boundaries and times previously codified for this event; these changes were necessary to provide the public with the most up to date information as received from the sponsoring organization. With the aforementioned hazards in mind, the Captain of the Port, Sector Lake Michigan, has determined that this temporary deviation of the size of this safety zone is necessary to ensure the safety of spectators and vessels during the air show. This zone will be enforced from 8:00 a.m. until 4:00 p.m. on Friday, Saturday, and Sunday of the second weekend of August 2012. The safety zone will encompass all waters and adjacent shoreline of Lake Michigan and Bradford Beach located within a 4000-yard by 1000-yard rectangle. The rectangle will be bounded by the points beginning at 43°02′42″ N, 087°52′14″ W; then northeast to 43°04′25″ N, 087°50′53″ W; then northwest to 43°04′40″ N, 087°51′29″ W; then southwest to 43°02′57″ N, 087°52′50″ W; then southeast returning to the point of origin (NAD 83). Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Lake Michigan, Milwaukee, WI on Friday, Saturday, and Sunday of the second weekend of August, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for only eight hours on these days. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the activation of the zone, we would issue local Broadcast Notice to Mariners.

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 theFOR FURTHER INFORMATION CONTACTsection above.

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

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

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

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in theFOR FURTHER INFORMATION CONTACTsection 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 oftheir discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated underADDRESSES. 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 Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The emergency sinking of the dredge vessel Arthur J. precluded the Coast Guard from having sufficient time to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect people vessels and the environment from the hazards associated with a vessel salvage operation, which are discussed further below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. For the same reasons discussed in the preceding paragraph, waiting for 30 day notice period run would be impracticable and contrary to the public interest.

As suggested above, salvage operations will continue in lower Lake Huron, MI. The Coast Guard expects these salvage operations to continue until approximately 11:00 a.m. on August 25, 2012. The Captain of the Port Detroit has determined that this continuing vessel salvage operation poses a significant risk to public safety and property. Such hazards include accidental vessel collisions, potential fuel spills, and potential diving operations.

In relation to the salvage operation associated with this Temporary Final Rule (TFR), the Coast Guard has already published and enforced two TFRs. Each of those TFRs established a safety zone centered on the same coordinate as the safety zone created herein. Although the center point of each of these three safety zones is identical, the radius of the first safety zone was only 100 yards, while the radius of this safety zone and the second safety zone is 500 yards. The first safety zone was effective and enforced from July 19, 2012 until July 21, 2012. The second safety zone was effective and enforced from July 21, 2012 until July 28, 2012. To date, the Coast Guard knows of no negative impacts on the public as a result of the enforcement of these two prior safety zones.

With the aforementioned hazards in mind, the Captain of the Port Detroit has determined that a temporary safety zone is necessary to ensure the safety of people and vessels during the continued Arthur J. dredge vessel salvage operations. As discussed above, two safety zones in response to this sunken vessel were previously established, running consecutively from July 19 to the morning of July 28, 2012. However, the Captain of the Port, Sector Detroit has determined that the safety zone needs to be established for a longer period of time in order to better mitigate the risks to public safety and property from this continued operation.

This safety zone will be effective and enforced from 11:00 a.m. on July 28, 2012 until 11:00 a.m. on August 25, 2012. This zone will encompass all waters of lower lake Huron, in the vicinity of Lake Port, MI within a 500 yards radius of position 43°06′06″ N, 082°27′03″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Detroit or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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

This rule will affect the following entities, some of which might be smallentities: The owners or operators of vessels intending to transit or anchor in a portion of lower Lake Huron from 11:00 a.m. on July 28, 2012 until 11:00 a.m. on August 25, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for a relatively short time, and if salvage operations are completed before August 25, 2012, the enforcement of the safety zone will be terminated early. Traffic will be allowed to pass around the zone with the coordination of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.

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 theFOR FURTHER INFORMATION CONTACTsection above.

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

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone, and therefore, it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated underADDRESSES. 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:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0109 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0109, 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 athttp://www.epa.gov/dockets/contacts.htm.Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof April 4, 2012 (77 FR 20337) (FRL-9340-4), 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 1F7857) by Syngenta Seeds, Inc., Field Crops NAFTA, P.O. Box 12257, 3054 E. Cornwallis Road, Research Triangle Park, NC 27709-2257. The petition requested that 40 CFR 174.532 be amended by establishing a permanent exemption from the requirement of a tolerance for residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop. This notice referenced a summary of the petition prepared by the petitioner Syngenta Seeds, Inc., Field Crops NAFTA, 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 EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the 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.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, 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), 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. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Based on amino acid sequence homology and crystal structures, known Cry proteins have a similar three-dimensional structure comprised of three domains, Domain I, II, and III (Refs. 1, 2, 3, and 4). The toxin portions of Cry proteins are characterized by having five conserved blocks (CB) across their amino acid sequence. These are numbered CB1 to CB5 from the N-terminus to the C-terminus (Ref. 5). The sequences preceding and following these conserved blocks are highly variable and are designated as variable regions V1 to V6. Because Cry proteins share structural similarities, chimeric cry genes can be engineered via the exchange of domains that are homologous between different cry genes.

eCry3.1Ab is an engineered chimera protein, composed of portions of modified Cry3A (mCry3A) protein, a protein derived from the native Cry3A protein fromBtsubsp.tenebrionis,and of the Cry1Ab protein fromBt thuringiensissubsp.kurstakiHD-1. The ecry3.1Ab gene (Entrez Accession Number GU327680 NCBI, 2011) (Walterset al.2010) consists of a fusion between the N-terminus (Domain I, Domain II, and a portion of Domain III) of a mcry3A gene and the C-terminus (a portion of Domain III and Variable Region 6) of a cry1Ab gene (Ref. 5). The eCry3.1Ab protein is 654 amino acid residues in size and is approximately 74.8 kilodaltons.

Syngenta has submitted acute oral toxicity data demonstrating the lack of mammalian toxicity at high levels of exposure to the pure eCry3.1Ab protein. These data demonstrate the safety of the product at a level well above maximum possible exposure levels that are reasonably anticipated in the crop. Basing this conclusion on acute oral toxicity data without requiring further toxicity testing and residue data is similar to the Agency position regarding toxicity testing and the requirement of residue data for the microbialBacillus thuringiensisproducts from which this plant-incorporated protectant was derived (see 40 CFR 158.2130(d)(1)(i) and 158.2140(d)(7)). For microbial products, further toxicity testing and residue data are triggered by significant adverse acute effects in studies, such as the mouse oral toxicity study, to verify and quantify the observed adverse effects and clarify the source of these effects (Tiers II & III).

An acute oral toxicity study in mice (MRID No. 477539-01) indicated that eCry3.1Ab is non-toxic. Two groups of 10 male and 10 female mice were orally dosed (via gavage) with 2,000 milligrams/kilograms bodyweight (eCry3.1Ab protein mg/kg bwt) of the eCry3.1AB-0208 test substance, a biochemically and functionally equivalent microbially-produced eCry3.1Ab protein. All treated animals gained weight and had no test material-related clinical signs and no test material-related findings at necropsy. Since there were no significant differences between the test and control groups related to the oral administration of the eCry3.1AB-0208 test material, the eCry3.1Ab protein does not appear to cause any significant adverse effects at an exposure level of up to 2000 mg/kg bwt, which supports the finding that the eCry3.1Ab protein would be non-toxic to mammals.

When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Ref. 6). Therefore, since no acute effects were shown to be caused by eCry3.1Ab, even at relatively high dose levels, the eCry3.1Ab protein is not considered toxic. Further, amino acid sequence comparisons showed no similarities between the eCry3.1Ab protein and known toxic proteins in protein databases that would raise a safety concern.

Since eCry3.1Ab is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist fordetermining the allergenic potential of novel proteins. Therefore, EPA uses a “weight-of-the evidence” approach where the following factors are considered: source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, includingin vitrodigestibility in simulated gastric fluid (SGF), and glycosylation (as recommended by CAC, 2003) (Ref. 7). Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by acid and proteases; may be glycosylated; and may be present at high concentrations in the food.

1.Source of the trait. Bacillus thuringiensisis not considered to be a source of allergenic proteins.

2.Amino acid sequence.A comparison of the amino acid sequence of eCry3.1Ab with known allergens showed no significant overall sequence similarity or identity at the level of eight contiguous amino acid residues. This is the appropriate level of sensitivity to detect possible IgE epitopes without high false positive rates.

3.Prevalence in food.Expression level analysis of eCry.1Ab protein demonstrates that it is present at relatively low levels. The expression has been shown to be in the parts per million range. Thus, dietary exposure is expected to be correspondingly low.

4.Digestibility.The eCry3.1Ab protein was rapidly digested in less than 30 seconds in simulated mammalian gastric fluid containing pepsin (pH 1.2) after incubation at 37 °C.

5.Glycosylation.The eCry3.1Ab protein expressed in corn was shown not to be glycosylated.

6.Conclusion.Considering all of the available information, EPA has concluded that the potential for eCry3.1Ab to be a food allergen is minimal.

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).

The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. First, with respect to other related substances, the eCry3.1Ab protein is a chimericBacillus thuringiensisprotein, composed of portions of Cry1Ab and mCry3A proteins, both of which are registered PIPs that were previously assessed as having a lack of mammalian toxicity at high levels of exposure. Exemptions from the requirement of a tolerance already have been established for Cry1Ab in food and mCry3A in maize, see 40 CFR 174.505 and 40 CFR 174.511, respectively. Second, and specific to the eCry3.1Ab protein, EPA has considered dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the plant-incorporated protectant chemical residue and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the plant-incorporated protectant is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid similarity assessment included similarity to known aeroallergens. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure toBtpesticides (Ref. 8). Exposure via residential or lawn use to infants and children is also not expected because the use sites for the eCry3.1Ab protein are all agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking water.

However, oral toxicity testing done at a dose of 2 gm/kg showed no adverse effects. Furthermore, the expected dietary exposure from corn is several orders of magnitude lower than the amounts of eCry3.1Ab protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the eCry3.1Ab protein.

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.”

Since eCry3.1Ab is not considered toxic, EPA has not found eCry3.1Ab to share a common mechanism of toxicity with any other substances, and eCry3.1Ab does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that eCry3.1Ab does not have a common mechanism of toxicity with other substances. Following from this, therefore, EPA concludes that there are no cumulative effects associated with eCry3.1Ab that need be considered. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

The data submitted and cited regarding potential health effects for the eCry3.1Ab protein include the characterization of the expressed eCry3.1Ab protein in corn, as well as the acute oral toxicity, heat stability, andin vitrodigestibility of the proteins. The results of these studies were used to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were also considered.

As discussed more fully in Unit III. B. above, the acute oral toxicity data submitted supports the prediction that the eCry3.1Ab protein would be nontoxic to humans. Moreover, eCry3.1Ab showed no sequence similarity to any known toxin. Because of this lack of demonstrated mammalian toxicity, no protein residue chemistry data for eCry3.1Ab were required for a human health effects assessment. Even so, preliminary expression level analysis showed eCry3.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low.

Since eCry3.1Ab is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Data considered as part of the allergenicity assessment include that the eCry3.1Ab protein came fromBacillus thuringiensiswhich is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that eCry3.1Ab protein will not be an allergen.

Considered together, the lack of mammalian toxicity at high levels of exposure to the eCry3.1Ab protein and the minimal potential for that protein to be a food allergen demonstrate the safety of the product at levels wellabove possible maximum exposure levels anticipated in the crop.

Finally, and specifically in regards to infants and children, FFDCA section 408(b)(2)(C) provides that 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 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 data base, unless EPA determines that a different margin of safety will be safe for infants and children.

Based on its review and consideration of all the available information, as discussed in more detail above, the Agency 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 the eCry3.1Ab protein and the genetic material necessary for its production in corn. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has also concluded, again for the reasons discussed in more detail above, that there are no threshold effects of concern and, as a result, that an additional margin of safety for infants and children is unnecessary in this instance.

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. Nonetheless, Syngenta has submitted validation method studies on two qualitative lateral flow strip kits for the analytical detection of eCry3.1Ab protein in corn grain, leaf and seed corn matrices. Results showed the test kits are able to detect eCry3.1Ab protein residues in corn with sufficient accuracy, precision, and sensitivity.

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 establishing a difference tolerance.

The Codex has not established a MRL forBacillus thuringiensiseCry3.1Ab protein in corn.

For all the reasons summarized above, 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 the plant incorporated protectant (PIP)Bacillus thuringiensiseCry3.1Ab protein in corn and the genetic material necessary for its production. Therefore, the current temporary exemption for residues ofBacillus thuringiensiseCry3.1Ab protein in corn, in or on the food or feed commodities of corn; corn, field; corn, sweet; and corn, pop, when used as a plant-incorporated protectant is amended in order to remove its expiration date and make it a permanent exemption.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established byCongress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

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-2011-0139 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0139, 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 athttp://www.epa.gov/dockets/contacts.htm.

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

In theFederal Registerof September 7, 2011 (76 FR 55329) (FRL-8886-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP) 0F7747 by Pace Chemicals Ltd., 8321 Willard Street, Burnaby, British Columbia, V3N 2X3. The petition requested that 40 CFR part 180 subpart D be amended by establishing an exemption from the requirement of a tolerance for residues of Didecyl dimethyl ammonium chloride on broccoli grown from treated seeds when applied by immersion. This notice referenced a summary of the petition prepared by the petitioner Pace Chemicals Ltd which is available in the docket,http://www.regulations.gov.A comment was received on the notice of filing. EPA's response to these comments is discussed in Unit VII.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the 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 section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, 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 section 408(b)(2)(D) of FFDCA, 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. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by Didecyl dimethyl ammonium chloride, part of the Aliphatic Alkyl Quaternary group of compounds, are discussed in this unit.

The Aliphatic Alkyl Quaternaries are corrosive and highly irritating to the eye and skin, with moderate acute toxicity by oral, dermal, and inhalation routes of exposure. These chemicals are classified as “not likely” to be human carcinogens based on negative carcinogenicity in rat and mouse feeding studies using doses above the limit dose. There is no evidence of these chemicals being associated with increased susceptibility of infants and children based on two developmental toxicity studies and a 2-generation reproductive toxicity study. Lastly, they are negative for mutagenicity and neurotoxicity. Specific information on the studies received and the nature of the toxic effects from the toxicity studies can be found athttp://www.regulations.gov.Docket ID Number EPA-HQ-OPP-2006-0338 Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision (RED) for Didecyl Dimethyl Ammonium Chloride (DDAC).

Toxic Endpoints—For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (NOAEL) from the toxicology study identified as appropriate for the risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in variations in sensitivity among members of the human population as well as other unknowns. A detailed discussion of EPA's conclusions regarding the toxic endpoints for the Aliphatic Alkyl Quaternaries can be found at 73 FR 37852 (July 2, 2008).

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

1.Food.Studies have not been submitted measuring residues of Didecyl dimethyl ammonium chloride (DDAC) in broccoli resulting from treatment of broccoli seed. Instead, EPA estimated the DDAC residue concentration that could theoretically result in broccoli heads from the proposed seed treatment use. The number of broccoli seed/pound (lb) is about 144,000 (Oregon State University, Commercial Vegetable Production Guides. Broccoli.Brassica oleracea(Italica Group). Last revised August 6, 2004). The proposed treatment rate is 1,200 milligram (mg) DDAC/100 g seed.Seed are to be soaked for 10 minutes and then dried.

The highest seeding rate for broccoli is 1.5 pound per acre (lb/A) (680 g/acre). The lower end of yield in a major broccoli-producing state is 13,000 lb/A in AZ (USDA/NASS; 2003-08). If 680 g seed are treated with 1,200 mg DDAC/100 g, a total of 8.2 g DDAC would be applied to the seed. If all the DDAC is retained by the seed and the 680 g of seed/acre are planted, the equivalent application rate would be 0.0181 lb DDAC/acre. If all the DDAC were absorbed and translocated to the 13,000 lb of harvested broccoli, the maximum theoretical residue level in broccoli would be 1.4 parts per million (ppm).

The intent of the proposed DDAC seed treatment, however, is to control pathogens on the surface of the broccoli seed which is the major way a number of serious diseases of crucifers are spread and not to control pathogens in soil. Therefore, draining and triple rinsing are conducted to reduce DDAC residues on the seed and there is no intended adsorption (binding) of the DDAC to the seed because the registrant is not claiming residual protection of seed from pathogens in the soil. However, while not intended, it is likely that traces of DDAC would have adsorbed to the seed coat during the 10-minute soaking time.

Taking the draining and rinsing of seed into account, EPA has made a conservative estimate of how much of the theoretical estimate of 1.4 ppm of DDAC on broccoli could actually be present. After seed are soaked in the DDAC solution for 10 min, the solution is drained. EPA estimates that at least 90% of the solution volume will drain off, leaving 10%. This would reduce the theoretical value of 1.4 ppm DDAC in harvested broccoli to 0.14 ppm. This is considered to be reasonable because the treatment solution volume is typically 2 liter (L) for each 100 g of seed and most of the DDAC will be eliminated by draining because of DDAC's solubility in water. Virtually no absorption of solution into the seeds is expected within the 10-minute soaking time. Also, if more than traces of solution were absorbed by seed, this would be detrimental to the seed treatment process because metabolic processes would be activated which would reduce seed viability and increase rotting. Another 90% of the DDAC from the drained seed is expected to be removed by the three water rinses which would reduce the calculated value of 0.14 ppm to 0.014 ppm. This is reasonable because most of the DDAC is in solution in the film of water between the drained seed and, due to its water solubility; the three rinses are expected to remove any free DDAC remaining.

Although there is no known plant uptake and metabolism studies available for Aliphatic Alkyl Quaternaries similar to DDAC, there are data indicating that DDAC is stable to hydrolysis and will bind tightly to soil. Thus, EPA expects traces of DDAC to be adsorbed (bound) to both the seed coat and the soil surrounding each seed. Considering its immobility, there is little likelihood that DDAC would be absorbed through the seed coat, translocated through the seed and developing shoot, and ultimately concentrated in the harvested broccoli head. This issue was addressed in an earlier EPA decision (K. Leifer, P. Wagner, OPP, RD, 8/1/06http://www.epa.gov/opprd001/inerts/dialkyl.pdf) reassessing the safety of three tolerance exemptions for DDAC when used as an inert ingredient (preservative) in pesticide formulations applied: To growing crops (40 CFR 180.920), postharvest to crops (40 CFR 180.910), or to livestock (40 CFR 180.930). In that decision, EPA concluded that soil application of DDAC to growing crops under 40 CFR 180.920 would not result in systemic uptake by plants because the DDAC would be bound to soil and, therefore, unavailable for plant uptake. Due to the strong binding of DDAC to the seed coat, cellulose, lignin, organic matter, and clay particles, EPA believes that the calculated concentration of 0.014 ppm DDAC in harvested broccoli heads/side shoots is a great overestimate. Given that the calculated concentration for DDAC in broccoli is both very small (0.014 ppm) and considered to be a large overestimate, dietary exposures to DDAC from use in treatment of broccoli seed are expected to be negligible.

2.Drinking water exposure.Contamination of drinking water with Didecyl dimethyl ammonium chloride residues is expected to be negligible as the treatment rate is very low (8.2 g/acre or 0.0181 lb/acre) and the use is expected to be minor. Crucifer seed production is carried out in only a few small areas of the country. In addition, based on data indicating that DDAC is stable to hydrolysis and binds tightly to soil, these residues are expected to be immobilized by components of the soil and sediments. DDAC is classified as a surfactant possessing a charged moiety (N+) and components that are nonpolar/lipophilic (the two 10-carbon alkyl groups). These components provide DDAC with properties allowing it to adsorb both to clay particles (via cation exchange) and organic matter (via hydrophobic attraction of the two alkyl groups). It adsorbs rapidly to soil and sediments but is not readily desorbed. It also binds to cellulose and lignin (organic matter) thus permitting its use as a wood preservative.

The only other Aliphatic Alkyl Quaternaries outdoor uses in addition to growing crops are as algaecides in decorative/swimming pools, antisapstain wood preservative treatment, once-through cooling tower treatment, and oil field uses. The pond and oil field uses are considered to be contained. The other uses are not expected to significantly contaminate drinking water sources. Therefore, the Aliphatic Alkyl Quaternaries contributions to drinking water exposure are considered to be negligible and are not quantified.

It should be noted that the Agency estimated water concentrations resulting from the antisapstain and cooling tower uses to which aquatic animals may be exposed. These levels were not considered appropriate for use in the drinking water assessment due to the very conservative nature of the models used, that the model estimates runoff/point source concentrations and not water body concentrations, and the fact that the models do not account for dilution.

Specific information on the dietary and drinking water exposure assessments for Aliphatic Alkyl Quaternaries can be found athttp://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Dietary Risk Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) & Didecyl Dimethyl Ammonium Chloride (DDAC).

No residential exposure to DDAC residues is expected from this proposed seed treatment use.

In general, residential exposure assessment considers all potential non-occupational pesticide exposure, other than exposure due to residues in food or in drinking water. Exposures may occur during and after application as a hard surfaces disinfectant (e.g., walls, floors, tables, fixtures), to textiles (e.g., clothing, diapers) to swimming pools and to carpets. Each route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate NOAEL.

Residential exposure may occur during the application of Aliphatic Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping, trigger pump sprays), carpets, swimming pools, wood as a preservative, textiles (e.g.,diaper treated during washing and clothes treated with fabric spray), and humidifiers. The residential handler scenarios were assessed to determine dermal and inhalation exposures. Surrogate dermal and inhalation unit exposure values were estimated using Pesticide Handler Exposure Database (PHED) data and the Chemical Manufacturers Association Antimicrobial Exposure Assessment Study (USEPA, 1999), and the SWIMODEL 3.0 was utilized to conduct exposure assessments of pesticides found in swimming pools and spas (Versar, 2003). Note that for this assessment, EPA assumed that residential users complete all elements of an application (mix/load/apply) without the use of personal protective equipment.

The duration for most residential exposures is believed to be best represented by the short-term duration (1 to 30 days). The short-term duration was chosen for this assessment because the residential handler and postapplication scenarios are assumed to be performed on an episodic, not daily basis.

Based on toxicological criteria and the potential for exposure, the Agency has conducted dermal and inhalation exposure assessments for Aliphatic Alkyl Quaternaries residential use. Specific information on the residential exposure assessment for Aliphatic Alkyl Quaternaries can be found athttp://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338 Didecyl Dimethyl Ammonium Chloride (DDAC) Occupational and Residential Exposure Assessment.

1.In general.Section 408 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 data base 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 when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA SF value based on the use of traditional uncertainty/safety factors and/or special FQPA SFs, as appropriate.

2.Prenatal and postnatal sensitivity.There is no evidence that Aliphatic Alkyl Quaternaries result in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

3.Conclusion.EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA SF to 1X except for assessments addressing inhalation exposure. For inhalation exposure assessments the 10X FQPA SF is retained. Those decisions are based on the following findings:

i. The toxicity database for Aliphatic Alkyl Quaternaries is complete except for a 90-day inhalation toxicity study in the rat which was requested in the Aliphatic Alkyl Quaternary Reregistration Eligibility Document. Due to the absence of the 90-day inhalation toxicity study, a FQPA SF of 10x has been applied to the oral endpoint to calculate inhalation risks in order to be protective of any uncertainties associated with route-to-route extrapolation.

ii. There is no indication that Aliphatic Alkyl Quaternaries are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. There is no evidence that Aliphatic Alkyl Quaternaries result in increased susceptibility inin uterorats or rabbits in the prenatal developmental toxicity studies or in young rats in the two-generation reproductive toxicity study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment was performed based on 10% transfer rate and tolerance-level residues. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by Aliphatic Alkyl Quaternaries.

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.”

The Aliphatic Alkyl Quaternaries are a group (Group I cluster from PR Notice 88-2) of structurally similar quaternary ammonium compounds that are characterized by having a positively charged nitrogen covalently bonded to two alkyl group substituent's (at least one C8or longer) and two methyl substituent's. In finished form, these quaternary ammonium compounds are salts with the positively charged nitrogen (cation) balanced by a negatively charged ion (anion). The anion for the quaternary ammonium compounds in this cluster is chloride or bromide. Dimethyl Didecyl ammonium chloride, or DDAC, was chosen as the representative chemical for the Group I Cluster in PR notice 88-2. On that basis, the toxicology database for DDAC is accepted as representative of the hazard for this class of quaternary ammonium compounds.

EPA's risk assessment for the Group I Cluster is based on an assessment of the exposure to all aliphatic alkyl quaternary compounds. Although grouped in 1988 based on structural similarity, a formal determination of common mechanism has not been conducted. The individual exposure scenarios in the DDAC assessments (as well as the aggregate assessment in the RED) were developed by assuming that a DDAC compound was used on 100 percent of the food contact surfaces authorized on the label that could result in human exposure. Thus, the risk assessment for DDAC accounts for exposures to all of the Aliphatic Alkyl Quaternary compounds. The Agency has not identified any other substances as sharing a common mechanism of toxicity with Didecyl dimethyl ammonium chloride.

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

Conservative estimates indicate that there is no reasonable expectation that anything greater than negligible residues of DDAC will be present in broccoli as a result of the proposed seed treatment use. EPA has previously.http://www.regulations.gov,Docket ID Number EPA-HQ-OPP-2006-0572 determined that risks from aggregate exposure are safe, 72 FR 51180 (September 6, 2007); 73 FR 37852 (July 2, 2008) this proposedseed treatment use adds essentially zero additional exposure so the prior aggregate risk conclusion remains applicable. The only change in this assessment is the retention of the FQPA 10X safety factor for inhalation risks which makes the level of concern MOEs of 1000 or below. The MOEs for residential handler inhalation risks were all ≥3400 and thus are not of concern. Adult and child inhalation risks were found to be of concern in the Reregistration Eligibility Document as a result of breathing mist from treated humidifier water; this was the only child's inhalation scenario. To eliminate this risk, Didecyl dimethyl ammonium chloride has been restricted to use in evaporative humidifiers. Evaporative humidifiers, unlike other types of humidifiers, do not generate and expel treated droplets or mist. The Didecyl dimethyl ammonium chloride will volatilize in, at most, negligible amounts from treated water in evaporative humidifiers. Aliphatic Alkyl Quaternaries are salts that are very soluble in water and have a negligible vapor pressure; as a result, they have a very low Henry's Law Constant which means they have a negligible tendency to volatilize from an aqueous solution such as that in treated humidifier water.

Accordingly, in reliance on the previous safety finding, and the determinations made in that rulemaking document and this document, EPA finds that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to Didecyl dimethyl ammonium chloride residues. Further, EPA concludes that the proposed use will not pose a risk under reasonable foreseeable circumstances. Therefore, EPA finds that exempting DDAC from the requirement of a tolerance when used as a broccoli seed treatment will be safe.

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

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

The Codex has not established a MRL for Didecyl dimethyl ammonium chloride in broccoli.

The Agency received one comment in response to the notice of filing for this petition. The commenter stated that they did not approve of the toxic chemical “dimethyl (mercury) ammnia chloride” being approved by the Agency.

In response to this comment, the Agency notes that mercury is not a component or degradate of Didecyl dimethyl ammonium chloride. EPA comprehensively evaluated the safety of DDAC in thehttp://www.regulations.gov,Docket ID Number EPA-HQ-OPP-2006-0572. The commenter has provided no basis for EPA to vary from its prior evaluation of the risk posed by DDAC.

Therefore, an exemption from the requirements of a tolerance is established for residues of Didecyl dimethyl ammonium chloride in or on broccoli grown from treated seeds when applied by immersion.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in 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. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0875 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0875, 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 athttp://www.epa.gov/dockets/contacts.htm.Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof December 15, 2010 (75 FR 78240) (FRL-8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7771) by Cheminova A/S, c/o Cheminova, Inc. 1600 Wilson Blvd., Arlington, VA 22209. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide flutriafol, including its metabolites and degradates, in or on corn, field, forage at 4.0 ppm; corn, field, stover at 6.0 ppm; corn, field, grain at 0.01 ppm; corn, field, flour at 0.03 ppm; corn, field, oil at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, pop, stover at 6.0 ppm; corn, pop, grain at 0.01 ppm; grape at 1.1 ppm; grape, raisin at 2.5 ppm; peanut at 0.08 ppm; peanut, hay at 18 ppm; fruit, pome (Crop Group 11) at 0.60 ppm; fruit, stone (Crop Group 12) at 0.80 ppm; beet, sugar, root at 1.5 ppm; beet, sugar, tops at 2.5 ppm; beet, sugar, refined at 0.70 ppm; beet, sugar, molasses at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; wheat, forage at 25 ppm; wheat, hay at 9.0 ppm; wheat, straw at 6.0 ppm; wheat, grain at 0.15 ppm; wheat, grain, bran at 0.20 ppm; wheat, grain, germ at 0.20 ppm; barley, hay at 9.0 ppm; barley, straw at 6.0 ppm; barley, grain at 0.15 ppm; barley, grain, bran at 0.20 ppm; buckwheat, grain at 0.15 ppm; oats, forage at 25 ppm; oats, hay at 9.0 ppm; oats, straw at 6.0 ppm; oats, grain at 0.15 ppm; oats, grain, bran at 0.20 ppm; rye, forage at 25 ppm; rye, straw at 6.0 ppm; rye, grain at 0.15 ppm; cattle, liver at 0.12 ppm; goat, liver at 0.12 ppm; horse, liver at 0.12 ppm; sheep, liver at 0.12 ppm; and milk at 0.02 ppm. The proposed tolerance for fruit, pome which is based on new field trial data for pears and previously submitted data for apples, will replace the current tolerance for apples at 0.20 ppm. That notice referenced a summary of the petition prepared by Cheminova A/S, c/o Cheminova, Inc, 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, tolerances for corn, field, forage; corn, field, stover; corn, field, refined oil; and corn, pop, stover were lowered. Tolerances for corn, field, flour and corn, field, meal were not required. Established tolerances for apple; cattle, liver; goat, liver; hog, liver; horse, liver; and sheep, liver and established rotational crop tolerances for corn, field, forage; corn, field, stover; corn, field, grain; corn, field, refined oil; corn, pop; and corn, pop, stover are removed. The proposed tolerances for wheat, forage; wheat, hay; wheat, straw; wheat, grain; wheat, grain, bran; wheat, grain, germ; barley, hay; barley, straw; barley, grain; barley, grain, bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat, grain; oat, grain, bran; rye, forage; rye, straw; and rye, grain were withdrawn by the petitioner. Tolerances were previously established on November 9, 2011 for banana, grape, raisin; pome and stone fruit, sugar beets and for the rotational corn crops—sweet, field, and popcorn, and cotton. 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 flutriafol including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutriafol 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. Flutriafol has high oral acute toxicity in the mouse. It has low acute toxicity via the oral, dermal and inhalation routes in rats. Flutriafol is minimally irritating to the eyes and is not a dermal irritant. Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs.

Short-term, subchronic, and chronic toxicity studies in rats, mice, and dogs identified the liver as the primary target organ of flutriafol. Hepatotoxicity was first evident in the subchronic studies (rats and dogs) in the form of increases in liver enzyme release (alkaline phosphatase), liver weights, and histopathology findings ranging from hepatocyte vacuolization to centrilobular hypertrophy and slight increases in hemosiderin-laden Kupffer cells. It is noteworthy that with chronic exposures, there are no indications of progression of liver toxicity in any of the species tested. After over 1 year of exposure, hepatotoxicity in rats, dogs, and mice took the form of minimal to severe fatty changes; bile duct proliferation/cholangiolarfibrosis; hemosiderin accumulation in Kupffer cells; centrilobular hypertrophy, and increases in alkaline phosphatase release. Slight indications of effects in the hematopoietic system are sporadically seen in the database. These effects were manifested in the form of slight anemia (rats and dogs) and increased platelet, white blood cell, neutrophil, and lymphocyte counts (mice). These effects, however, were minimal in severity.

Flutriafol is considered to be “Not likely to be Carcinogenic to Humans” based on the results of the carcinogenicity studies in rats and mice. The results of the rat chronic toxicity/carcinogenicity study and the mouse carcinogenicity study are negative for carcinogenicity. All genotoxicity studies on flutriafol showed no evidence of clastogenicity or mutagenicity.

Specific information on the studies received and the nature of the adverse effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document “Flutriafol: Human Health Risk Assessment for Proposed Uses on Corn, Grapes, Peanuts, Pome Fruit (Crop Group 11), Stone Fruit (Crop Group 12), Sugar Beets, Wheat, Barley, Triticale, Buckwheat, Oats, Rye, Teosinte, and Imported Bananas,” at p. 40 in docket ID number EPA-HQ-OPP-2010-0875.

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

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

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to flutriafol, EPA considered exposure under the petitioned-for tolerances as well as all existing flutriafol tolerances in 40 CFR 180.629. EPA assessed dietary exposures from flutriafol 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 flutriafol. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 NationwideContinuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA made the following assumptions for the acute exposure assessment: tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment, 100 percent crop treated (PCT), and Dietary Exposure Evaluation Model (DEEMTM) version 7.81 default processing factors were used.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA made the following assumptions for the chronic exposure assessment: tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment, 100 PCT, and DEEMTMversion 7.81 default processing factors were used.

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

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

Based on the Food Quality Protection Act (FQPA) Food Index Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model/Ground Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of flutriafol for acute exposures are estimated to be 48.8 parts per billion (ppb) for surface water and 310 ppb for ground water.

For chronic exposures for non-cancer assessments the EDWC's are estimated to be 5.70 ppb for surface water and 202 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 310 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). Flutriafol 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.”

Flutriafol is a member of the conazole (triazole) class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

Triazole-derived pesticides can form the metabolite 1,2,4-triazole (T) and several conjugated triazole metabolites. To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, EPA conducted an initial human-health risk assessment for exposure to T and the conjugated triazole metabolites resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment was a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA SF for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment can be found in the propiconazole reregistration docket athttp://www.regulations.gov,Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an updated assessment may be found in docket ID EPA-HQ-OPP-2011-0120 in the document entitled “Common Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk Assessment to Address the Amended metconazole Section 3 Registration to Add uses on Tuberous and Corm Vegetables (Group 1C) and Bushberry Subgroup 13-07B.” The Agency has determined that the proposed application to field and popcorn will not result in residues of 1,2,4-triazole (T), triazolylalanine (TA), and triazolylacetic acid (TAA) greater than the estimates incorporated in the most recent assessment. Therefore, a revised triazole metabolite assessment is not needed.

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.The potential impact ofin uteroand perinatal flutriafol exposure was investigated in three developmental toxicity studies (two in rats, one in rabbits) and two multigenerational reproduction toxicity studies in rats. In the first of two rat developmental toxicity studies, a quantitative susceptibility was observed (delayed ossification or non-ossification of the skeleton in the fetuses) at a lower dose than maternal effects. In the second rat developmental study, a qualitative susceptibility was noted. Although developmental toxicity occurred at the same dose level that elicited maternal toxicity, the developmental effects (external, visceral, and skeletal malformations; embryo lethality; skeletal variations; a generalized delay in fetal development; and fewer live fetuses) were more severe than the decreased food consumption and body-weight gains observed in the dams. For rabbits, intrauterine deaths occurred at a dose level that also caused adverse effects in maternal animals. In the 2-generation reproduction studies, a qualitative susceptibility was also seen. Effects in the offspring—decreased litter size and percentage of live births (increased pup mortality) and liver toxicity—can be attributed to the systemic toxicity of the parental animals (decreased body weight and food consumption and liver toxicity).

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

i. The toxicity database for flutriafol is complete.

ii. There is no concern for neurotoxicity with flutriafol. Signs of neurotoxicity were reported in the acute and subchronic neurotoxicity studies at the highest dose only; however, these effects were primarily seen in animals that were agonal (at the point of death) and thus, are not indicative of neurotoxicity. In addition, there was no evidence of neurotoxicity in any additional short-term studies in rats, mice, and dogs, or in the long-term toxicity studies in rats, mice, and dogs. A developmental neurotoxicity study (DNT) is not required given these results.

iii. There are no residual uncertainties for pre- and/or post-natal toxicity. Though there is evidence for increased susceptibility in the prenatal studies in rats and rabbits and the 2-generation reproduction study in rats, there are no concerns for the offspring toxicity observed in the developmental and reproductive toxicity studies for the following reasons:

a. Clear NOAELs and LOAELs were established in the fetuses/offspring;

b. The dose-response for these effects are well defined and characterized;

c. Developmental endpoints are used for assessing acute dietary risks to the most sensitive population (females 13-49) as well as all other short- and intermediate-term exposure scenarios; and

d. The chronic reference dose is greater than 300-fold lower than the dose at which the offspring effects were observed in the 2-generation reproduction studies.

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 (or higher) residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to flutriafol in drinking water. These assessments will not underestimate the exposure and risks posed by flutriafol.

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 flutriafol will occupy 24% of the aPAD for females 13-49 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 flutriafol from food and water will utilize 42% of the cPAD for all infants less than 1 year old the population group receiving the greatest exposure. There are no residential uses for flutriafol. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flutriafol is not expected.

3.Short-term risk.Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flutriafol is not registered for any use patterns that would result in short-term residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to flutriafol through food and water and will not be greater than the chronic aggregate risk.

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). Flutriafol is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to flutriafol through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

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

Adequate enforcement methodology (Gas Chromatography/Nitrogen/Phosphorus detector (GS/NPD) method for proposed tolerances and method ICIA AM00306 for ruminant liver) are 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 AgricultureOrganization/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 MRLs for flutriafol; therefore, harmonization is not an issue.

Based on the analysis of the residue trial data and Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures, tolerances for corn, field, forage; corn, pop, stover; and corn, field, stover were lowered. Established rotational crop tolerances for corn, field forage; corn, field, stover; corn, field, grain; corn, field, refined oil; corn, pop; and corn, pop, stover are removed as they are superseded by tolerances for direct application to the growing crop. The established tolerance for apple is removed and superseded by the previously established higher tolerance for fruit, pome, group 11-09. The established tolerances for cattle; liver; goat, liver; hog, liver; horse, liver; and sheep, liver are replaced by tolerances for meat byproducts of cattle, goat, hog, horse, and sheep. Based on the results from the field corn processing study, tolerances for corn, field, flour and corn, field, meal are not needed. Tolerances for wheat, forage; wheat, hay; wheat, straw; wheat, grain; wheat, bran; wheat, germ; barley, hay; barley, straw; barley, grain; barley, grain, bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat, grain; oat, grain, bran; rye, forage; rye, straw; rye, grain were withdrawn by the petitioner. Tolerances were previously established on November 9, 2011 for banana; grape; grape, raisin; pome and stone fruit; sugar beets and for the rotational crops, field and popcorn, and cotton.

Therefore, tolerances are established for residues of flutriafol, [((±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites and degradates, in or on corn, field, forage at 0.75 ppm; corn, field, stover at 1.5 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; corn, pop at 0.01 ppm; corn, pop, stover at 1.5 ppm; cattle, meat byproducts at 0.07 ppm; goat, meat byproducts at 0.07 ppm; hog, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.07 ppm and sheep, meat byproducts at 0.07 ppm. This final rule deletes established tolerances for apple; cattle; liver; goat, liver; hog, liver; horse, liver; and sheep, liver. This final rule also deletes established rotational crop tolerances for corn, field, forage; corn, field, stover; corn, field, grain; corn, field, refined oil; corn, pop; and corn, pop, stover.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

I. Authorization of Revisions to South Dakota's Hazardous Waste Program

On April 1, 2010, South Dakota submitted a final complete program revision application seeking authorization of their changes in accordance with 40 CFR 271.21. We now make a Final decision that South Dakota's hazardous waste program revisions satisfy all of the requirements necessary to qualify for Final authorization. For a list of rules that become effective with this Final Rule please see the Proposed Rule published in the December 27, 2010Federal Registerat 75 FR 81187.

Response to Comments:The EPA proposed to authorize South Dakota's State Hazardous waste management Program revisions published in the December 27, 2010Federal Registerat 75 FR 81187. The EPA received only one comment from the state of South Dakota objecting to the EPA's definition of Indian country, where the state is not authorized to administer its program. Specifically, the state disagreed that all “trust land” in South Dakota is Indian country. With this Final Rule the EPA is clarifying that Indian country lands within the exterior boundary of the Yankton Reservation are excluded from the state's authorized program. Further explanation of this interpretation of Indian country can be found at 67 FR 45684 through 45686 (July 10, 2002).

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of theNational Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.).

The Congressional Review Act, 5 U.S.C. 801et seq.,as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document 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 in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective August 8, 2012.

Atlantic HMS are managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA), 16 U.S.C. 1801et seq.,and the Atlantic Tunas Convention Act (ATCA), 16 U.S.C. 971et seq.Under the MSA, NMFS must ensure consistency with the National Standards and manage fisheries to maintain optimum yield, rebuild overfished fisheries, and prevent overfishing. Under the ATCA, the Secretary of Commerce is required to promulgate regulations, as may be necessary and appropriate, to implement the recommendations adopted by the International Commission for the Conservation of Atlantic Tunas (ICCAT). The authority to issue regulations under MSA and ATCA has been delegated from the Secretary to the Assistant Administrator for Fisheries, NOAA (AA). The implementing regulations for Atlantic HMS are at 50 CFR part 635.

On June 28, 2011 (76 FR 37750), NMFS published a proposed rule in theFederal Registerto require that Federal Atlantic swordfish, shark, and tunas dealers report receipts of Atlantic sharks, swordfish, and BAYS tunas to NMFS through an electronic reporting system. The proposed rule also included flexible reporting regimes, which would allow NMFS to collect more frequent dealer reports when key Atlantic shark fisheries are open or as quotas become filled in the Atlantic swordfish and BAYS tunas fisheries, and addressed two additional topics: the definition of an Atlantic HMS dealer and the timely submission of Atlantic HMS dealer reports. The proposed rule contained additional details regarding the impacts of the alternatives considered and a brief summary of the recent management history. Those details are not repeated here.

This final rule implements the requirement of electronic HMS dealer reporting, and is necessary to ensure timely and accurate reporting, which is critical for quota monitoring and management of these species. As described below, based in part on public comment, in this final rule, NMFS is changing several aspects of the proposed rule.

In the proposed rule, NMFS considered and analyzed fouralternatives. In the preferred alternative in the proposed rule, NMFS proposed to increase the frequency of both positive and negative dealer reporting for Atlantic sharks, swordfish, and BAYS tunas to better facilitate timely quota monitoring. Specifically, NMFS proposed to change the reporting frequency depending on the available quota, length of fishing season, and species/species complexes when certain triggers were met by the different fisheries, as described in the proposed rule. In addition, the rule also proposed that all first receivers of Atlantic sharks, swordfish, and BAYS tunas harvested by federally-permitted U.S. vessels, including entities that only shipped HMS product, must obtain a corresponding Federal Atlantic swordfish, shark, and/or tunas dealer permit and report such receipts to NMFS through the electronic reporting system so that NMFS can receive more species- and vessel-specific information. Finally, NMFS proposed that dealers must submit reports by the required deadline in order to be able to receive Atlantic swordfish, sharks, or BAYS tunas. Any delinquent reports would need to be submitted by the dealer and received by NMFS before a Federal Atlantic HMS dealer could purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas from a fishing vessel.

In this final rule, NMFS implements a requirement that dealers submit reports on a weekly basis in order to be able to purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas from a fishing vessel. NMFS recognizes that daily reporting requirements for sharks, as proposed under alternative A3 in the proposed rule, would not allow dealers sufficient time to gather accurate price information for sharks and could have resulted in a large reporting burden on dealers. At the same time, NMFS acknowledges that unlike some shark fisheries, Atlantic swordfish and BAYS tunas fisheries are currently not quota limited and may not require more frequent reporting than the current biweekly reporting. However, NMFS notes that other Federal dealer permits currently require weekly reporting, including all Northeast Regional Office (NERO)-issued dealer permits. Many HMS dealers also possess NERO-issued permits and, therefore, are already reporting on a weekly basis. Additionally, many fisheries managed by SERO are moving to weekly dealer reporting and many HMS dealers also possess permits for these fisheries. Therefore, NMFS believes that weekly reporting balances the need for more timely landings data and maintains consistency in reporting requirements for different dealer permits. In addition, NMFS is integrating the HMS electronic reporting requirements into existing electronic reporting programs mainly to ease the overall burden on dealers.

Thus, to better facilitate timely quota monitoring, NMFS will implement weekly reporting requirements for both positive and negative dealer reporting of Atlantic sharks, swordfish, and BAYS tunas. Positive reports of all species on a Federal dealer report through the NMFS-approved electronic reporting systems will fulfill reporting requirements for BAYS tunas, swordfish, and sharks purchased within the required reporting timeframe as required under § 635.5(b)(ii). A negative report by the required deadline indicates no receipt or purchase of any species required to be reported. NMFS may consider changing the reporting frequency in a future rulemaking as needed for management of Atlantic BAYS tunas, sharks, and swordfish fisheries.

In addition, during the comment period, NMFS heard that requiring first receivers to obtain dealer permits for receiving Atlantic swordfish and BAYS tunas would result in major disruptions to HMS dealers, and their business practices, especially in the Northeast. NMFS also heard that transporters of HMS product do not have the knowledge, training, or necessary equipment, such as scales for weighing product, to act as dealers. NMFS heard that Atlantic swordfish and BAYS tunas dealers have fewer species to identify compared to Atlantic shark dealers and price differences between Atlantic swordfish and BAYS tunas are greater so that species-specific reporting is more easily achieved for those fisheries. NMFS also heard that although the current definition of first receiver for Atlantic sharks potentially includes entities taking possession other than by purchasing trading or bartering, that has not been the practice in the industry. Furthermore, because many first receivers receive sharks, BAYS tunas, and swordfish, NMFS believe it is important to have one consistent definition of first receiver across all species. This one definition would simplify the regulations and maintain consistency with respect to who is considered a first receiver across species. Thus, NMFS will change the definition of first receiver with regard to which entity is required to have a dealer permit for receiving Atlantic tunas, sharks, and swordfish to make it more consistent with current industry practice and to simplify the regulations. That is, a person who takes possession for commercial purposes, any BAYS tunas, swordfish, or shark or parts of those species by purchasing, trading, or bartering once it is offloaded from the vessel owner or operator of a fishing vessel will be required to obtain the corresponding federal HMS dealer permit.

NMFS proposed a range of alternatives for the implementation date of the electronic dealer reporting requirements and associated regulations, ranging from implementation beginning within 30 days of the final rule to a delayed implementation of three months. NMFS received unanimous support for delaying the implementation of the final regulations to allow dealers additional time to adjust their business practices, receive training for the new reporting system, and obtain capital for computer equipment and internet service. As such, this final rule will delay implementation of the new electronic dealer requirements until 2013, when the reporting system will be available and training workshops will have occurred. The purpose of the training workshops and webinars is to introduce and train dealers in using the new system in order to help ease the transition from the paper format to the new electronic reporting system. NMFS intends to hold several training workshops in appropriate locations along the east coast and Gulf of Mexico. During final implementation, NMFS will provide all permitted dealers with instructions on how to access the system, information on the web browser requirements, and instructions on how to obtain login and password information. This information will also be provided for individuals applying for a new dealer permit.

During the comment period, NMFS also received some comments from dealers who were concerned about what would happen if they lost power, such as during a hurricane, or if the system went down. Specifically, these dealers did not want to be penalized for not reporting on time in such a situation. NMFS has designed the regulations to provide some Agency discretion, in responding to reporting delays caused by natural disasters or other non-preventable events. The system itself has backups and is not expected, in the course of normal business operations, to be down for long periods of time.

During the proposed rule stage, NMFS received nine written comments from non-governmental organizations,fishermen, dealers, and other interested parties. NMFS also heard numerous comments from constituents in attendance at eight public hearings and while conducting outreach during phone calls. A summary of the major comments received for each proposed measure (electronic dealer reporting, frequency of reporting, timely dealer reporting and IRFA Alternatives) on the proposed rule during the public comment period is shown below with NMFS' responses. NMFS also received comments on exempted fishing/display permits, weak hooks, re-opening of closed areas, the size of existing quotas, and the stock status of sharks. However, these comments were not considered in the summary below as they were outside the scope of this rulemaking. All written comments submitted during the comment period can be found athttp://www.regulations.gov/by searching for RIN 0648-BA75.

Comment 1:NMFS should set up a workshop to sit down with Agency and industry representatives to design the electronic reporting system so that NMFS can receive feedback on the practical aspects of how a dealer's business works.

Response:NMFS agrees. NMFS began designing and building an electronic reporting system when NMFS began working on the proposed rule. The system is based on similar systems such as the Standard Atlantic Fisheries Information System (SAFIS) and the Southeast electronic Trip Ticket reporting system. During this time, NMFS asked some HMS dealers to test the system and provide feedback. This feedback resulted in many changes and improvements to the system. NMFS also had early versions of the system available at the April 2011, September 2011, and March 2012 HMS Advisory Panel meetings for review and comment. In addition, as originally proposed, the Agency will delay implementation of the electronic dealer reporting system until 2013 in order to provide sufficient time for dealers to adjust to implementation of the new system and the additional requirements. During this time, NMFS will conduct outreach with industry representatives and dealers as well as provide additional outreach materials (e.g., System User Guide and Compliance Guides) to improve understanding and use of the new system. These outreach materials will be free and available through the new system and HMS Web site (http://www.nmfs.noaa.gov/sfa/hms/index.htm).

Comment 2:NMFS received several comments regarding the change to electronic reporting, including: support for the change to electronic reporting; questions about why NMFS is considering electronic reporting; support for NMFS requiring paper or electronic reporting, but not a mixture of both; and concern that more timely and efficient data collection is needed for management as the lack of real-time data is costing jobs. The Atlantic States Marine Fisheries Commission (ASMFC) also commented that electronic reporting does not require specialized equipment and dealers should be able to comply.

Response:The current regulations and infrastructure of the Atlantic HMS quota-monitoring systems result in a delay of several weeks to almost a month before NMFS receives dealer data. Once NMFS receives dealer data in a paper format, the data need to be transferred into the data systems and quality checked before it is available for use. This delay in the availability of dealer data effects the management and monitoring of small Atlantic HMS quotas and short fishing seasons, particularly for many of the shark fisheries. As such, NMFS is requiring all Federal Atlantic HMS dealers (except for dealers reporting Atlantic bluefin tuna) to report receipt of Atlantic sharks, swordfish, and BAYS tunas to NMFS through one centralized electronic reporting system. The new electronic reporting system will be integrated within existing SAFIS and Trip Tickets electronic reporting programs, thus reducing the number of places that dealers need to report. Under this new system, dealers will submit HMS data electronically instead of in a paper format and include additional information that is necessary for management of HMS (e.g., vessel and logbook information). The electronic submission of data will eliminate the delay associated with mailing in reports to NMFS and transferring reported data into electronic systems. In this manner, HMS landings data will be submitted on a more real-time basis, allowing for timely and efficient collection and use of data for management of Atlantic HMS. Once the system is fully operating, NMFS could consider altering the 80-percent trigger limit for closing the shark fishery to allow fishermen to more fully utilize the available quota.

Comment 3:NMFS received comments in opposition to mandatory electronic dealer reporting as some dealers do not currently own a computer and reporting on paper is easier than getting the electronic system up and running, which is often time-consuming.

Response:While NMFS recognizes that, in the short-term, the implementation of an HMS electronic dealer reporting system will change business practices for dealers and, for some, may result in some additional costs associated with purchasing a computer and internet service. In the short-term, electronic reporting can lead to more efficient fisheries and business practices that could be more economical in the long term (e.g., fishing seasons being open longer, easier negative reporting, etc.). As explained in the response to Comment 2, the existing regulations and infrastructure regarding dealer reporting have created issues for effective management and monitoring of small Atlantic HMS quotas and short fishing seasons. For instance, currently there is a delay of 10 to 25 days in the receipt of landings data received through dealer reports in a paper format. To reduce this delay, the Agency is requiring all federally-permitted HMS dealers to report receipt of swordfish, sharks, and BAYS tunas on a weekly basis to NMFS through the new HMS electronic reporting system. However, as previously mentioned in Comment 1, the Agency will delay the implementation of the new HMS electronic reporting system for all federally-permitted HMS dealers until 2013 to allow dealers more time to adjust their business practices, train in the new reporting system, and obtain necessary equipment (e.g., computer and internet service). NMFS is also holding training workshops to assist dealers in learning to use the new system. Anyone who would like to request a training workshop may contact Delisse Ortiz or Karyl Brewster Geisz at 301-427-8503.

Comment 4:NMFS received a comment questioning whether or not the electronic dealer reporting system would require a high-speed internet connection. Some dealers also stated that NMFS will need to help dealers in getting the electronic reporting system set up on their computers as well as conduct outreach to inform dealers how to use the new system.

Response:NMFS' new HMS electronic reporting system requires the most basic internet connection to support the new system. The electronic reporting system will be available through SAFIS, which requires data entry through a Web site. The system will also be available through Trip Tickets, which is a program that is downloaded to the dealer's computer. In the Trip Tickets system, dealers can enter data as time allows, and thenconnect to the internet and send the data to NMFS, thereby eliminating the need for a constant internet connection during data entry, as is needed for data entry into SAFIS. As mentioned in Comment 1, in order to give sufficient time for dealers to adjust to implementation of the new system and the additional requirements, NMFS will also delay implementation of the new HMS electronic reporting system for all federally-permitted HMS dealers until 2013. In addition, NMFS will conduct workshops to help dealers learn how to use the new system and easily transition from the current paper format to the new HMS electronic reporting system.

Comment 5:NMFS needs to streamline and simplify the reporting requirements, especially between state and Federal reporting requirements, and ensure that the new electronic dealer reporting requirements prevent duplicative reporting. It is good that NMFS is incorporating the electronic reporting program into existing systems, such as SAFIS and Trip Tickets; the SAFIS program is a promising model for this single reporting entity to meet Federal and state requirements. NMFS needs to make reporting as easy as possible as the reporting requirements are complex and confusing.

Response:NMFS is working with state agencies to streamline data collection to the extent possible to try to avoid duplicative reporting. Such coordination will also make the reporting process as simple and straightforward as possible. In addition, by incorporating electronic HMS dealer reporting requirements within SAFIS and Trip Tickets, NMFS is ensuring that in most cases dealers will only have to report to one system instead of multiple systems to meet their Federal and state reporting requirements. However, as mentioned below in Comment 40, some states require separate reporting as established by state law. NMFS also recognizes that the terms of the Federal permits may result in additional mandatory Federal reporting requirements beyond those required by states. NMFS will continue to coordinate with states to reduce duplicative reporting, to the extent possible.

Comment 6:NMFS received a comment questioning how NMFS monitors shark landings from the state of Louisiana as shark fishing from this state is a large problem.

Response:NMFS recognizes that Louisiana state fishermen, and state fishermen from other states, are major participants in the shark fisheries. The regulations implemented under this rulemaking will not change how shark landings are counted for quota monitoring. Currently, NMFS receives landings from all states and compares those landings with the landings reported by Federal dealers. Under the electronic system, this comparison could be easier depending on the extent that state and Federal requirements match, but the general concept for monitoring shark landings from all state and Federal fishermen will not change.

Comment 7:Dealers and first receivers should not have to report information where vessels fish as NMFS already receives vessel monitoring system (VMS) reports and daily logbooks from the fishing vessels. NMFS should use logbooks for quota monitoring as they have more detailed information than dealer reports.

Response:Logbooks, VMS, and dealer reports provide the Agency with different types of information, which are all necessary for management. The logbooks, which are required by most HMS commercial fishermen, provide information on fishing effort as well as amount of catch and location of fishing. Logbooks are submitted after each trip but, because of the amount of data and number of vessels involved, the data is not available for use on a real-time basis. VMS provides real-time information to inform enforcement on how and where a particular vessel is fishing as well as where it is fishing, but is not required on all HMS commercial vessels. Dealer reports provide information on landings as well as price information, which is not available in the logbook data or through VMS. In addition, under the new HMS electronic reporting system, NMFS will require dealers to provide information on where fish were caught to ensure proper quota management, for example by distinguishing between Atlantic and Gulf of Mexico non-sandbar LCS. In the past, the geographical information used in management of such quotas has been based on the physical location of the dealer, not where the sharks were actually caught. Therefore, the Agency requires different entities to submit different types of reports to NMFS in order to collect the necessary information for management (i.e., information on fishing effort, location of fishing, catch and landings information, and price information).

Comment 8:NMFS needs to make sure there is a way dealers can print a copy of their report as dealers need to keep a copy of submitted reports for their files. Dealers need a way to verify they submitted their reports electronically.

Response:NMFS agrees. The new HMS electronic reporting system will allow all Federal HMS dealers to print out a copy of each dealer report that is electronically submitted and received by NMFS. In addition, the new HMS electronic reporting system will provide dealers with a confirmation number once the reports have been submitted and received by NMFS, allowing dealers to verify submission of their dealer reports to NMFS.

Comment 9:NMFS should allow dealers to report bluefin tuna through the new electronic dealer reporting system under daily reporting requirements and get rid of the paper and fax reporting system currently in place. This change would allow electronic reporting for all HMS.

Response:Due to the complexity of the current Atlantic bluefin tuna reporting system, Federal HMS dealers reporting Atlantic bluefin tuna will continue to follow the current reporting requirements for this species at this time. However, in the future, NMFS could consider including Atlantic bluefin tuna in the HMS electronic dealer reporting system.

Comment 10:NMFS needs to develop a backup plan, such as reporting via fax or paper, for when the internet is down so that dealers are not forced to be out of compliance. This may be especially important for dealers in the Caribbean if there is a storm and the internet and power are down for a long period of time.

Response:The Agency recognizes that there may be interruptions in electrical power or internet service that are out of the control of Federal HMS dealers, but will impact dealers' abilities to submit reports to NMFS through the new HMS electronic reporting system. Further, given the changes to the reporting timeframe from the proposed to the final rule (i.e., from daily to weekly reporting), NMFS does not expect late reporting due to system disruptions to be as much of an issue. NMFS encourages dealers to contact the system administrator for the HMS electronic dealer reporting system when they experience any type of interruption for an extended period of time, and expects dealers to resume reporting as soon as possible once the disruption ends.

Comment 11:Many fishermen and dealers do not encounter sharks and tunas in Puerto Rico, therefore the proposed changes would not affect them. However, many of the dealers speak Spanish and are not familiar with computers, so they would need a second person to help them submit reports.

Response:Due to limits on Agency funding at this time, the new electronic dealer reports will be available only in English. The Agency may consider aSpanish or Vietnamese version in the future. We have, however, translated notices and outreach documents into Spanish and will translate these notices and documents in Vietnamese as well. We have and will continue to conduct workshops in Spanish. In addition, the new electronic reporting system will be tailored to include the landing ports and vessels specific to all regions, including the Caribbean. This tailoring should allow non-English speaking dealers from any region to more easily utilize the new system once they are familiar with it. For those non-English speaking dealers who need additional assistance, NMFS will establish a dedicated phone number (301-427-8590) and email address (HMS.DealerReports@noaa.gov) to provide assistance in completing reports. Finally, as previously mentioned in Comment 1, the Agency is delaying the implementation of the new HMS electronic reporting system until 2013 to allow dealers more time to adjust their business practices, obtain the necessary equipment (e.g., computer and internet service), and to allow NMFS to conduct workshops in areas like the Caribbean, which have not experienced electronic reporting to date.

Comment 12:NMFS received several comments stating that dealers operating small businesses would have difficulty reporting electronically on a more frequent basis because they lack the staff to support the current biweekly reporting requirements; the reporting requirements are complex and confusing; and the increased reporting frequency will result in a larger reporting burden. Small businesses would benefit from less frequent reporting, and more frequent reporting may result in dealers being late in their submission, which could potentially keep their permits from being renewed. The proposed electronic dealer reporting requirements are burdensome, and dealers are becoming frustrated with the increasing number of regulations, which ultimately take time away from ensuring product quality. NMFS also received specific comments regarding the reporting frequency for tunas and swordfish, including: dealers should report as soon as they receive product; dealers should submit weekly reports; dealers feel electronic reporting of BAYS tunas and swordfish on a 21-day to monthly timeframe would suffice; dealers support the status quo or biweekly reporting for BAYS tunas and swordfish; and dealers support biweekly reporting with reporting frequency reflecting the average landing rate when 80 percent of the quota is filled. NMFS also received comments that dealers were opposed to daily or weekly reporting for pelagic non-porbeagle sharks, BAYS tunas, or swordfish as these fisheries are not in any danger of experiencing overharvests. Daily reporting for swordfish would be a burden.

Response:Based on public comment, NMFS will change the reporting frequency that was originally proposed for Atlantic swordfish, BAYS tunas, and shark dealers in the proposed rule published on June 28, 2011 (76 FR 37750) to simplify reporting requirements as well as balance the need for timely landings data while avoiding excessive reporting burdens on dealers. NMFS recognizes that daily reporting requirements for sharks as proposed in the proposed rule would not allow dealers sufficient time to gather accurate price information for sharks and could have resulted in a large reporting burden on dealers. At the same time, NMFS acknowledges that unlike some shark fisheries, Atlantic swordfish and BAYS tunas fisheries are currently not quota limited and may not require more frequent reporting than the currently biweekly reporting. However, NMFS notes that some other Federal dealer permits, such as all NERO-issued dealer permits, require weekly reporting. Many HMS dealers also possess these NERO-issued permits and, therefore, are already reporting on a weekly basis. Additionally, many fisheries managed by the SERO are moving to weekly reporting and many HMS dealers also possess permits for these fisheries. NMFS believes that weekly reporting balances the need for more timely landings data and maintains consistency in reporting requirements for different dealer permits. In addition, NMFS is integrating the HMS electronic reporting requirements into existing electronic reporting programs, easing the overall burden on dealers.

Comment 13:NMFS received several comments regarding negative reports, including: dealers do not understand why they have to submit negative reports to NMFS; submitting negative reports should be as simple as replying to an email that reminds the dealer of a reporting deadline; NMFS should not require negative reports to be submitted on a daily basis; negative reports should be done on a biweekly or a monthly basis; submitting negative reports more than once a month is unnecessary busy work; and the submission of negative reports should not be required. NMFS also heard that there should be a way dealers can indicate a block of time when they will not be receiving product, as some fisheries are seasonal in nature.

Response:Negative reports submitted by HMS dealers are an essential part of quota monitoring. By submitting negative reports, dealers inform NMFS that they did not receive HMS product during that reporting time period. These reports allow NMFS to distinguish between dealers who have not received product during a reporting period and dealers who have simply not reported to NMFS during a given reporting period. By being able to identify dealers who have not reported versus those who have not received product, and by knowing the landings data historically reported by particular dealers, NMFS can better determine the potential status of different quotas as well as which dealers may have failed to report. Without negative reports, NMFS runs a greater risk keeping fisheries open when, in fact, they should be closed to prevent overharvest of the quota.

Negative reports must occur with the same frequency as positive reports in order to inform NMFS about which dealers did not receive product during a specific reporting period versus which dealers have not reported. Receiving negative reports on a less frequent reporting basis than positive reports will not allow NMFS to determine which dealers have received product during a given reporting period as described above.

Finally, the electronic reporting system will allow dealers to indicate time periods when they will not be accepting product for up to 90 days. This should lessen the negative reporting burden on dealers.

Comment 14:NMFS received a comment stating that because most fish are sold on consignment, with dealers often having to wait 21 days for actual price information, the proposed weekly reporting frequency would result in dealers having to submit and modify every report, creating an unnecessary burden on dealers. Therefore, NMFS should consider a reporting frequency of at least 21 days, so that dealers do not have to enter data in multiple times for a single transaction.

Response:Currently, the reporting frequency for all HMS dealers is biweekly. As outlined in the response to Comment 12, based on public comment, NMFS will require weekly reporting for Atlantic swordfish, sharks, and BAYS tunas dealers.

Dealers will be able to update price information on a past submitted report for up to 30 days from the submission of that report in order to provide NMFS with the most accurate price information available. This balances theneed for timely landings data with the need for additional time to provide NMFS with accurate price information.

Comment 15:Changing the reporting frequency for swordfish from weekly to daily when the quota reaches 80 percent makes it seem like there is a problem with the swordfish quota when the United States will most likely not fill its swordfish quota.

Response:As outlined in the response to Comment 12, in this final rule, NMFS has reconsidered the proposed reporting frequencies for Atlantic HMS dealers to simplify reporting requirements and balance the need for timely landings data while avoiding an excessive reporting burden on dealers. NMFS will require weekly reporting for Atlantic swordfish, sharks, and BAYS tunas dealers. NMFS may consider changing the reporting frequency in a future rulemaking as needed for management of Atlantic BAYS tunas, sharks, and swordfish fisheries. Allowing flexibility in the required reporting frequency for HMS dealers will allow NMFS to require more frequent dealer reporting if the swordfish fishery were to begin achieving its allocated quota in the future. It is not meant to indicate there are any problems with the swordfish fishery, rather, it will allow for more timely reporting and quota monitoring if the fishery were to ever become quota limited in the future.

Comment 16:NMFS received several comments regarding the reporting frequency for sharks, including: support for the proposed daily submission of shark dealer reports as sharks are hard to identify and are quota limited; NMFS should require weekly reporting when the shark season is open for non-sandbar LCS, non-blacknose SCS, blacknose sharks, increase the reporting frequency to daily when the quota reaches 50 percent, and then decrease the reporting frequency when the seasons for these fisheries close; NMFS should consider biweekly reporting for sharks when non-sandbar LCS, non-blacknose SCS, and blacknose shark fisheries are closed. NMFS also heard that daily reporting of sharks is not practical; closing the fishing season early is a better alternative to daily reporting; and NMFS should consider keeping the current biweekly reporting for sharks or consider monthly reporting; and NMFS should only consider daily reporting once the shark quota reaches 80-percent.

Response:As outlined in the response to Comment 12, based on public comment, NMFS has reconsidered the proposed reporting frequency for Atlantic shark dealers and will require Atlantic shark dealers to report on a weekly basis. This will simplify reporting requirements, as well as balance the need for timely shark landings with more time for dealers to report shark product unless NMFS determines more frequent reporting is required in the future. NMFS feels monthly reporting of shark landings will not provide timely enough data for monitoring small quotas, and will increase the probability of overharvests. In addition, NMFS considered changing the shark dealer reporting frequency as the shark quotas filled (i.e.,increasing the reporting frequency to daily when the quota reaches 50 percent, and then decreasing the reporting frequency when the seasons for these fisheries close), but felt such a reporting regime may be difficult for dealers to keep track of and may hamper compliance with the reporting requirements. Thus, NMFS is trying to simplify the reporting requirements while balancing the need for more frequent data without over burdening dealers or adding additional complexity to the reporting requirements for dealers.

Comment 17:NMFS should require weekly electronic reporting of BAYS tunas, swordfish and sharks so that all HMS species have the same reporting frequency; it is overly burdensome for dealers to keep track of different reporting frequencies for different species, especially if those frequencies change over time.

Response:NMFS agrees. The Agency appreciates that it may be difficult for dealers to keep track of different reporting requirements for different HMS. Therefore, to minimize the reporting burden on dealers, NMFS changed the proposed flexible reporting requirements in the proposed rule and is requiring Atlantic HMS swordfish, sharks, and BAYS tunas dealers to report on a weekly basis. NMFS believes that weekly reporting balances the need for more timely landings data and maintains consistency in reporting requirements for different dealer permits. In addition, NMFS is integrating the HMS electronic reporting requirements into existing electronic reporting programs, easing the overall burden on dealers. The system will accept reports more frequently if dealers need to report HMS on a more frequent basis.

Comment 18:The daily or weekly reporting frequency would be difficult given the time it takes for some dealers to receive product that is being transported from a fishing vessel or the time it takes to process product when a dealer is busy. In addition, some fish are sold to different dealers before the vessel is even offloaded, therefore, dealers would not be able to report on a daily or weekly basis as the fishing trips are longer than required reporting frequency.

Response:The timeframe associated with dealer reporting requirements applies once a dealer first receives HMS product (i.e., it does not apply while the fishing vessel is still at sea before the product is offloaded). As outlined in the response to Comment 12, NMFS will maintain weekly reporting for Atlantic swordfish, sharks, and BAYS tunas dealers as it satisfies the need for more timely landings data while maintaining consistency in reporting requirements for different dealer permits.

Comment 19:Dealers in the U.S. Virgin Islands may be able to comply with electronic dealer reporting; however, due to frequent power and internet outages, reporting more frequently (i.e., daily or weekly) would be an issue. Additionally, most fishermen sell their HMS catch directly to the public. If these individuals obtained dealer permits in the future, as most of them currently do not have HMS dealer permits, they most likely would not have access to computers for electronic reporting. Therefore, NMFS should obtain landings information from the territorial trip tickets and not through separate dealer reports.

Response:All entities that purchase HMS from federally-permitted HMS vessels are currently required to obtain HMS dealers permits. Federally-permitted HMS dealers located in the Caribbean region are also currently required to submit paper reports to NMFS on a biweekly basis. Based on this final rule, federally-permitted HMS dealers will be required to report electronically via the HMS electronic dealer reporting system. As explained in the response to Comment 10, the Agency recognizes that there may be interruptions in electrical power or internet service that are out of the control of Federal HMS dealers, but will impact how dealers submit reports to NMFS through the new HMS electronic reporting system. Further, given the changes to the reporting timeframe from the proposed to the final rule (i.e., from daily to weekly reporting), NMFS does not expect late reporting due to system disruptions to be as much of an issue. NMFS encourages dealers to contact the system administrator for the HMS electronic dealer reporting system when they experience any type of interruption for an extended period of time, and expects dealers to resume reporting as soon as possible once the disruption ends. Finally, NMFS is currently working on a rulemaking that may consider collecting landings informationassociated with any new HMS fishing permits through territorial trip tickets.

Comment 20:If there are problems with dealers accurately reporting different shark species, then NMFS should find a direct solution for species-specific reporting of sharks and not unnecessarily burden non-shark HMS dealers. NMFS has not provided any discussion of widespread problems with Atlantic HMS reporting and the industry is not aware of misidentification problems in HMS swordfish or tunas dealer reports. First receivers may need to be the dealer for sharks, but species identification is not a problem that the industry recognizes for BAYS tunas or swordfish. First receivers of BAYS tunas and swordfish should not have to get a dealer permit.

Response:NMFS realizes that swordfish and tuna fisheries operate differently than shark fisheries, in part due to the difference in prices associated with swordfish and BAYS tunas, and in part due to difficulties in identifying sharks. Thus, because species identification and species-specific reporting tend to be issues related to HMS shark dealers, NMFS will keep the status quo with regard to which entity is required to have a dealer permit for Atlantic tunas and swordfish. That is, a person who takes possession for commercial purposes, of any BAYS tunas, swordfish, or shark or any parts of those species by purchasing, trading, or bartering for it from the fishing vessel or owner of a fishing vessel, once it is offloaded, will be required to obtain the corresponding Federal HMS dealer permit.

Comment 21:Since non-U.S. citizens cannot obtain U.S. permits, the proposed first receiver requirement would not work for product that is offloaded in Canada or other foreign countries by first receivers who are not U.S. citizens, and NMFS has no jurisdiction to require reporting by docks, shipping companies, and transporters that are not U.S. companies.

Response:Due, in part, to the complexity of dealer transactions, including fish being brought in from foreign ports, and the importance of having one consistent definition of first receiver across all species, NMFS is changing the definition of first receiver with regard to which entity is required to have a dealer permit for Atlantic tunas, swordfish, and sharks to make it more consistent with current industry practice and to simplify regulations. As such, a person who takes possession, for commercial purposes, of any BAYS tunas, swordfish, or shark or any parts of those species by purchasing, trading, or bartering for it from the fishing vessel or owner of a fishing vessel, once it is offloaded, will be required to obtain the corresponding Federal HMS dealer permit.

Comment 22:Requiring the first receiver to obtain a dealer permit will result in duplicative reporting, especially in the Northeast, as the person who receives the product will be required to have a dealer permit and report to NMFS, and then the dealer who ultimately purchases that product from the fishing vessel will also be required to report his entire purchase through SAFIS. Identifying duplicate reports will be difficult as most HMS product is offloaded at a dock and goes to multiple fish houses/dealers.

Response:As explained above, NMFS will change the definition with regard to which entity is required to have a dealer permit in order to make it more consistent with current industry practice and to simply the regulations. This should reduce the possibility for duplicative reporting and should not interrupt business practices as it will not change the universe of permitted dealers. In addition, dealers will be able to report HMS through existing SAFIS and Trip Tickets electronic systems, which will keep dealers from having to report in multiple systems.

Comment 23:In the Gulf of Mexico, many dealers are the first receivers, and fish are offloaded at a fish house that weighs, packs, pays the vessel, and reports the landings to NMFS. In addition, dealers usually own their own trucks, so the truck drivers would be covered by the dealers' permits. Pack houses who receive fish also have the dealer permits and report to NMFS. NMFS needs to simplify it so that the person who has product come across the dock needs to report it to NMFS. However, NMFS also heard that a first receiver should be able to purchase product from a fishing vessel without necessarily owning the dock facility where the product is landed as long as they possess the proper permits, and the first receiver should not need a dealer permit unless they purchase product from the fishing vessel.

Response:In the proposed rule, NMFS proposed to have first receivers, such as pack houses, be required to obtain HMS dealer permits and report to NMFS. However, based on public comment that indicated this would create a major disruption in business practices, given that current regulations appear to work for dealers in both the Gulf of Mexico and Atlantic regions, and the importance of having one consistent definition of first receiver across all species, NMFS is changing the definition of first receiver with regard to which entity is required to have a dealer permit for Atlantic tunas, swordfish, and sharks to make it more consistent with current industry practice and to simplify the regulations. As such, a person who takes possession, for commercial purposes of any BAYS tunas, swordfish, or shark or any parts of those species by purchasing, trading, or bartering for it from the fishing vessel or owner of a fishing vessel, once it is offloaded, will be required to obtain the corresponding Federal HMS dealer permit.

Comment 24:NMFS received several comments regarding first receivers of HMS product having to obtain a dealer permit, including: NMFS should keep the current definition of dealer for swordfish and BAYS tunas (i.e., the entity that purchases the product from the vessel should be considered the dealer); the facilities where fish are unloaded and packed in vats for shipment do not know final weights or prices; when fish are packed by a dock for shipment, packing/saltwater ice is not removed from fish in order to keep fish cold, and tails are not cut to preserve freshness of the fish; dealers remove ice, cut tails, weigh the fish, determine prices, and then repack the fish in ice, which is a labor intensive and costly process; the dealers' weights are more accurate than the shipping weights and recording accurate weight information is important not only for economic reasons and domestic quota management, but also for reporting to ICCAT; and if a dealer pays a dockage fee to have fish cross a remote dock, the catch and vessel information is forwarded to the dealer via fax or the transporter so that the current dealers have vessel-specific information that can be reported to NMFS. NMFS also heard that entities purchasing product from fishing vessels are not going to share price information with transporters; therefore, NMFS will lose price information by requiring first receivers, such as transporters, to obtain dealer permits and report to NMFS.

Response:Based on public comment, NMFS understands that many entities responsible for packing and shipping fish do not have vessel or price information that is required on dealer reports. NMFS proposed that first receivers, including transporters, of non-BFT HMS product obtain an HMS dealer permit to ensure species-specific and vessel-specific information is received from dealers and reported to NMFS for quota monitoring. NMFS has learned that many of these facilities andtransporters that first receive Atlantic BAYS tunas and swordfish products do not have final fish weights or price information and lack the resources and incentive to function as proper HMS dealers. In addition, since requiring transporters to obtain an HMS dealer permit may disrupt business practices, result in vessels not being able to land in safe harbors/docks, or result in vessels being unable to unload at reliable dealers, NMFS will not require transporters to obtain HMS dealer permits at this time. If the current universe of dealers has access to the information required by NMFS for reporting, including vessel-specific information, NMFS agrees that requiring first receivers of Atlantic BAYS tunas and swordfish product to have dealer permits and report to NMFS would not be an efficient process. In addition, having accurate price information is critical for management and the analysis of economic impacts. Thus, NMFS will maintain the status quo with regard to which entity is required to have a dealer permit for Atlantic BAYS tunas and swordfish.

Comment 25:NMFS heard that in certain areas, such as in the Gulf of Mexico region, the trucks used to transport fish typically belong to the dealer who is purchasing the product; and individuals who transport fish should be an extension of the dealers' place of business to ensure that product is properly stored and handled.

Response:Requiring transportation companies to be owned by dealers is outside the scope of this rulemaking. The Food and Drug Administration (FDA) published regulations (December 18, 1995; 60 FR 65197) mandating the application of the Hazardous Analysis of Critical Control Point (HACCP) principles to ensure the safe and sanitary processing of seafood products. Dealers are responsible for ensuring product they purchase and sell is in compliance with FDA HACCP regulations.

Comment 26:NMFS received a comment asking if a dealer located in a region closed for a particular shark fishery could accept shark product from an area that is open for that fishery if the dealer does not have a facility in that open area.

Response:This final rule does not change the regulations at 50 CFR § 635.28(b)(4). Under those regulations, except for under certain conditions, sharks dealers located in a region closed to a specific species or complex are not able to accept that species or complex from an area that is open unless the dealer has a facility in the open area and can receive sharks at that facility.

Comment 27:NMFS should consider requiring fishermen to offload HMS product to designated ports/fish houses as is currently required in the reef fish Individual Fishing Quota (IFQ) Program in the Gulf of Mexico.

Response:NMFS may consider this requirement in future rulemakings, especially for any HMS fisheries that might be considering catch share programs in the future, such as the shark fishery.

Comment 28:Dealers in the U.S.V.I. and Puerto Rico are usually the first receivers.

Response:Given the current definition of an HMS “dealer” under § 635.4, this should not change any business practices of dealers in the U.S. Caribbean as this action will change the current definitions of a dealer to make it more consistent with current industry practice.

Comment 29:NMFS received several comments regarding the proposed regulations to encourage timely reporting, including: support for the proposed changes where dealers would not be able to accept HMS product unless they had submitted their reports on time; NMFS should not punish all dealers because of a small universe of dealers that are not reporting on time; and NMFS should have enforcement actions against dealers who are not reporting on time instead of implementing new regulations.

Response:There have been several issues of late reporting by Federal Atlantic HMS dealers, particularly for a number of the Atlantic shark dealers. Efforts by the Agency to follow up on dealer reports (i.e., phone calls; certified correspondence regarding late reporting; visits from local port agents and/or agents with the NOAA Office of Law Enforcement) drain scarce staff resources. In addition, late reporting negatively effects NMFS' ability to monitor the quota in a timely manner. NMFS feels the actions taken in this final rule, in regard to late reporting, strengthens the Agency's ability to take enforcement action when appropriate while not imposing any additional requirements on dealers. As such, in order to ensure timely reporting by all Atlantic HMS dealers, the Agency will require that a Federal Atlantic HMS dealer will only be authorized to purchase Atlantic swordfish, sharks, and BAYS tunas if the dealers have submitted all required reports to NMFS by the required reporting deadline. Any delinquent reports will need to be submitted and received by NMFS before a dealer could purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas from a fishing vessel. Failure to report Atlantic sharks, swordfish, and BAYS tunas to NMFS within the required reporting frequency will result in dealers being ineligible to purchase Atlantic sharks, swordfish, and BAYS tunas. Although submission of delinquent reports will allow a dealer to legally purchase commercially- harvested Atlantic swordfish, sharks, and BAYS tunas from a fishing vessel, late reporting will still be a violation of the regulations and could result in enforcement action.

Comment 30:Larger dealers may accept product even if a report has not been submitted on time due to different people submitting reports and accepting product. The scenario would not be intentional, but it could happen. NMFS should not deny a business the ability to accept fish strictly on the basis of late paperwork, and such a measure should be seen as a last resort. NMFS needs to be reasonable concerning penalties for inadvertent paperwork omissions. We have seen times when NMFS computers go down, sometimes over an entire weekend. NMFS should not apply penalties if they cannot receive information from dealers; therefore, NMFS should drop the idea of penalties for late reporting unless it becomes a persistent problem. NMFS should allow dealers to purchase product even if they are late in reporting, as it is important to revitalize HMS fisheries.

Response:As previously mentioned in the response to Comment 29, late reports from Federal HMS dealers effect timely quota monitoring and require staff resources to resolve. Under the new HMS electronic reporting system, all delinquent reports will need to be submitted and received by NMFS before a dealer could purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas. A Federal Atlantic HMS dealer who is receiving, and/or purchasing HMS product without having submitted all required report to NMFS will be in violation and subject to enforcement action for failing to submit reports on time as well as accepting non-BFT HMS product during the time the dealer reports were delinquent. This may require additional coordination between persons who receive fish and person who report to NMFS to ensure all the necessary reports have been submitted to NMFS before new non-BFT HMS product is accepted. In the event of a reporting disruption due to a loss of power or internet service, as with any instance of regulatory non-compliance, the Agency would exercise its enforcement discretion in determining whether ornot to take enforcement action considering all the circumstances, for example, whether the outage or loss was verified, and whether the dealer submitted the report as soon as possible once the outage ended. Further, given the changes to the reporting timeframe from the proposed to the final rule (i.e., from daily to weekly reporting), NMFS does not expect late reporting due to system disruptions to be as much of an issue. NMFS encourages dealers to contact the system administrator for the HMS electronic dealer reporting system when they experience any type of interruption for an extended period of time.

Comment 31:NMFS should have a way to remind dealers of when their reports are due to NMFS. NMFS should provide adequate warning and opportunity to provide reports before having their livelihoods damaged just for the convenience of NMFS.

Response:The Agency expects federal HMS dealers to comply with all applicable regulations without prompting from the Agency. It is the dealer's responsibility to keep track of reporting deadlines. In the final rule, NMFS will require a weekly reporting deadline for Atlantic swordfish, sharks, and BAYS tunas dealers. NMFS expects that the consistent reporting frequency for all HMS dealer permits should make it easier to remember when HMS reports are due to NMFS. Additionally, the new HMS electronic reporting system will track the timing and submission of Federal Atlantic HMS dealer reports and automatically notify dealers and NMFS (the HMS Management Division and NOAA Office of Law Enforcement) via email if reports are delinquent. The new HMS electronic reporting system will also notify dealers of the current reporting deadlines.

Comment 32:NMFS needs to provide incentives to dealers so they comply with all of the dealer requirements (e.g., valid dealer permit, reporting deadline).

Response:The Agency limits the sale of HMS product harvested from federally permitted vessels to federally-permitted HMS dealers. This should provide some incentive for federally-permitted HMS dealers to comply with all applicable regulations. Federal HMS dealers are required to submit dealer data in a timely manner to NMFS. Such timely submission is critical for accurate quota monitoring and management of HMS. Failure to comply with timely submission will affect the dealer's ability to accept new HMS product and will also make them subject to enforcement action. In addition, failure to submit timely dealer reports can lead to overharvests of allocated quotas, which can decrease quotas and shorten fishing seasons in subsequent fishing years, which can negatively affect both fishermen and dealers.

Comment 33:NMFS received a comment supporting the delayed implementation date of February 1, 2012. NMFS should give sufficient time for dealers to prepare for the new system's implementation and learn how to use it.

Response:NMFS agrees with this comment and will delay implementation of proposed electronic weekly reporting requirements for all federally-permitted HMS dealers for Atlantic swordfish, BAYS tunas, and shark dealers until January 2013.

Comment 34:NMFS has grossly under estimated the time it will take dealers to submit dealer reports and the cost associated with hiring additional personnel to be in compliance with the additional paperwork.

Response:Based on public comments, NMFS has reconsidered the proposed reporting frequencies for Atlantic HMS dealers to simplify reporting requirements and satisfy the need for timely landings data while avoiding an excessive reporting burden on dealers. NMFS recognizes that daily reporting requirements for sharks as proposed under alternative A3 in the proposed rule would not allow dealers sufficient time to gather accurate price information for sharks and could have resulted in a large reporting burden on dealers. At the same time, NMFS acknowledges that unlike some shark fisheries, Atlantic swordfish and BAYS tunas fisheries are currently not quota limited and may not require more frequent reporting than the current biweekly reporting. However, NMFS notes that other Federal dealer permits, such as all NERO-issued dealer permits, require weekly reporting. Many HMS dealers also possess these NERO-issued permits and, therefore, are already reporting on a weekly basis. Additionally, many fisheries managed by the SERO are moving to weekly reporting and many HMS dealers also possess permits for these fisheries. Therefore, NMFS believes that weekly reporting balances the need for more timely landings data and maintains consistency in reporting requirements for different dealer permits. In addition, NMFS is integrating the HMS electronic reporting requirements into existing electronic reporting programs in large part to ease the overall burden on dealers.

Comment 35:NMFS's average cost of internet service is incorrect and flawed. My monthly high-speed internet service is higher, around $110 a month.

Response:Based on public comment, NMFS has revised the cost of internet service from $50 per month used in the analyses for the proposed rule to $110 per month. This $110 estimate was the average cost for internet service presented in the IRFA, based on public comment, more accurately reflects the cost of having monthly internet service. Therefore, assuming dealers will need the most basic internet connection to support NMFS' electronic reporting system at a cost of $110 per month for internet services, the average annual cost to dealers will be $1,320 for internet services ($110 * 12 months = $1,320/year).

Comment 36:NMFS should have a dedicated email for submitting comments instead of having comments submitted through the regulations.gov Web site. The Councils provide an email address for submission of comments.

Response:Current NMFS guidance requires all public comments on rulemakings to be submitted throughhttp://www.regulations.gov.Regulations.gov is continually updating its Web page based on public feedback. Additionally, users can establish news feeds for any Federal agency that regularly publishes proposed and final rules.

Comment 37:The ASMFC and others commented that NMFS currently closes the Atlantic shark fisheries when landings in each fishery reach 80 percent of quota to avoid overages. NMFS should consider increasing this threshold with the implementation of electronic dealer reporting as the Agency will be receiving more timely data.

Response:NMFS will consider increasing the 80-percent threshold used to close the shark fisheries in the future based on timely receipt of state data and timely reporting by dealers.

Comment 38:Currently, the Gulf reef fish fishery requires fishing vessels to get a confirmation number for their catch before a vessel can offload. This ensures that the Agency can account for all landings under the IFQ system for Gulf reef fish. NMFS should consider a similar system for HMS so that product can be tracked and reported to NMFS.

Response:NMFS did not analyze the impact of requiring a confirmation code upon landing of HMS product in this rulemaking. However, NMFS may consider this requirement in a future rulemaking, as appropriate.

Comment 39:NMFS should require all state dealers to get Federal dealer permits in the Gulf of Mexico. It would make the collection of data more coordinated between state and Federal agencies.

Response:NMFS agrees that the coordination of data collection between state and Federal agencies would make data collection more efficient and timely. To that end, NMFS is appreciative of the efforts of ASMFC in implementing such a requirement in the Atlantic states under its jurisdiction. However, NMFS cannot require all states to implement such regulations. Rather, NMFS is working with state agencies in the Gulf of Mexico and Caribbean to streamline data collection, to the extent possible.

Comment 40:NMFS should ensure that dealers and brokers are not subjected to duplicative reporting and out of state dealer licensing requirement that presently occurs in South Carolina.

Response:As mentioned in the response to Comment 41, NMFS tries to streamline data collection, to the extent possible. However, NMFS does not have jurisdiction over what states can request for reporting under state law. While NMFS continues to coordinate with states to reduce duplicative reporting to the extent possible, because NMFS mandates reporting of HMS for federally-permitted dealers in all states from Maine through Texas and the Caribbean, there will be cases where NMFS requests data that is duplicative of some state requirements. NMFS feels that implementation of this electronic dealer system, because of the efforts to coordinate with states, ACCSP, SAFIS, and other electronic reporting systems, should remove some, but not all, of these duplicative requirements.

Comment 41:NMFS should consider electronic logbooks for commercial fishing, and NMFS should specify the collections methods being considered for recreational data.

Response:NMFS is currently working on electronic logbooks in some fisheries. For instance, in the Northeast region, fishermen can submit electronic vessel trip reports (VTRs). HMS fisheries may consider electronic logbooks in the future, and the Agency is continually working towards more timely data collection from both fishermen and dealers. In terms of recreational fishing data, NMFS collects recreational catch and effort information through the Marine Recreational Information Program (MRIP). MRIP is a new way NMFS is counting and reporting marine recreational catch and effort and replaces the Marine Recreational Fisheries Statistics Survey, or MRFSS, which had been in place since the 1970s. More information on MRIP can be found athttp://www.countmyfish.noaa.gov/index.html.

In addition to minor corrections throughout, NMFS has made several changes to the proposed rule. These changes are outlined below.

1. In § 635.2, the definitions of “first receiver” was removed and “first receive” was clarified and revised to mean “to take possession for commercial purpose of any fish or any part thereof by purchasing, trading or bartering for it from the fish vessel owner or operator or operator once it is offloaded from the vessel, where the owner or operator has been issued, or should have been issued, a valid permit under this part. First receive does not mean to take possession solely for transport.” In addition, the definition of “reporting week” was added to mean “the period of time beginning at 0001 local time on Sunday and ending at 2400 hours local time the following Saturday.”

2. Modifications made to § 635.4(g) under the proposed rule were removed in the final rule. Specifically, § 635.4(g)(1)(i), which stipulated different permitting requirements for Atlantic tunas dealers that received Atlantic bluefin, was removed. In addition, § 635.4(g)(1)(ii), which would have required first receivers of Atlantic BAYS tunas to obtain a dealer permits, was removed. Changes to sections § 635.4(g)(1)-(3), which stipulated different dealer permit requirements for BAYS tunas, sharks, and swordfish in the current regulations, respectively, were modified based on public comment. In addition, changes were made to maintain consistency with the “dealer” definition under § 600.10 and changes to the “first receive” definition under § 635.2 in this final rule.

3. In § 635.5(b)(1)(i)-(iii), NMFS made various modifications and clarifications based, in part, on public comment. Specifically, as described above, the reporting frequencies that apply to Atlantic swordfish, BAYS tunas, and shark dealers were modified based on public comment to satisfy the need for timely landings data while avoiding an excessive reporting burden on dealers. In addition, it was clarified that dealers must report through a NMFS-approved electronic reporting system no later than midnight, local time, of the first Tuesday following the end of the reporting week unless the dealer is otherwise notified by NMFS, and can make modifications to their dealer reports not more than 30 days from when the report is submitted and received by NMFS.

4. NMFS made various changes throughout § 635.31(a) and (c). Most were minor changes to the language in order to be consistent with the language in other sections of the final rule. Regarding § 635.31(a)(1)(i), NMFS determined that the proposed change was not needed and decided to keep the existing regulatory text. Regarding § 635.31(c)(6), this regulatory text was not proposed in the proposed rule as it has been implemented in a recent final rule (August 29, 2011, 76 FR 53652), which was implemented after the publication of the proposed rule of this action (June 28, 2011, 76 FR 37550). In this final rule, NMFS replaces the word “purchase” with “first receive” to be consistent with the other changes made in this final rule. Regarding § 635.31(d)(1), the proposed rule stipulated that fishermen could only offload Atlantic swordfish to dealers as all entities that first received Atlantic swordfish (i.e., not just entities which bought fish from fishermen) would have needed a dealer permit under the proposed rule. As a result of public comments, NMFS is not making that a requirement in this final rule. As such, NMFS is maintaining the existing language in § 635.31(d)(1).

5. In § 635.71, NMFS simplified paragraph (a)(3). NMFS also decided that due, in part, to the changes made as a result of public comments, the changes proposed in paragraphs (a)(4), (a)(55), and (e)(1) were not needed at this time. Therefore, NMFS kept the existing language for paragraphs (a)(4) and (e)(1) and moved the proposed paragraph (a)(56) to paragraph (a)(55).

The NMFS Assistant Administrator has determined that this final action is consistent with the Magnuson-Stevens Act, 2006 Consolidated Atlantic HMS Fishery Management Plan (FMP) and its amendments, ATCA, and other applicable law.

This final rule modifies a collection-of-information requirement associated with dealer reporting for Atlantic HMS dealers subject to the Paperwork Reduction Act (PRA) which has been approved by the Office of Management and Budget (OMB) under control number 0648-0040. The modifications were approved by OMB on July 31, 2012. The public reporting burden is associated with Atlantic HMS dealers having to report receipt of Atlantic swordfish, sharks, and BAYS tunas to NMFS electronically (15 minutes per positive report and 5 minutes pernegative report). NMFS will establish a weekly reporting frequency and may increase the reporting frequency via another regulatory action in the future for all HMS species if more frequent reporting is necessary to monitor the available quota. NMFS does not expect to do so in the near future for BAYS tunas, sharks, or swordfish.

Public reporting burden for Atlantic swordfish, sharks, and BAYS tunas will be one hour per month (15 minutes per report each week 7×4 weeks/month) or 12 hours per year. Based on the number of Atlantic swordfish, sharks, and tunas dealer permits (that deal with BAYS tunas) in 2011 (or 916 total permits), this will result in an estimated total annual burden of 10,992 hours.

Negative reports will require less of a reporting burden as negative reports are estimated to only take 5 minutes to complete and send to NMFS. Finally, all 916 permit holders affected by this final rule are considered respondents.

Send comments on this or any other aspects of the collection-of-information to NMFS (seeADDRESSES) and by email toOIRA_Submission@omb.eop.govor fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection-of-information subject to the requirements of the PRA, unless that collection-of-information displays a currently valid OMB control number.

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

Ecological impacts, outside of those that have been previously analyzed for Atlantic shark dealer reporting requirements in Amendment 2 to the 2006 Consolidated HMS FMP and categorically excluded for Atlantic swordfish and BAYS tunas, are not expected as a result of this final rule. This action will not directly affect fishing effort, quotas, fishing gear, authorized species, interactions with threatened or endangered species, or other relevant parameters. This final rule is exempt from the requirement to prepare an Environmental Assessment in accordance with NAO 216-6 because it will not have significant, additional impacts on the human environment, or any environmental consequences that have not been previously analyzed or are categorically excluded in accordance with Sections 5.05b and Section 6.03.c.3(i) of NOAA's Administrative Order (NAO) 216-6. However, social and economic impacts are expected as a result of this final action.

A FRFA was prepared, as required by 5 U.S.C. Section 604 of the Regulatory Flexibility Act (RFA). The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS responses to those comments, and a summary of the analyses completed to support the action. A summary of the analysis follows. A copy of this analysis is available from NMFS (seeADDRESSES).

Section 604(a)(1) of the Regulatory Flexibility Act requires that the Agency describe the need for, and objectives of, the final rule. The purpose of this final rule is, consistent with the Magnuson-Stevens Act and the 2006 Consolidated HMS FMP and its amendments, to aid NMFS in monitoring and enforcing fisheries regulations, including those implemented at 50 CFR part 635. Specifically, this final action will change the current regulations and infrastructure of the Atlantic HMS quota-monitoring system by requiring all federally-permitted Atlantic HMS dealers to report receipt of Atlantic swordfish, sharks, and BAYS tunas to NMFS through an electronic dealer reporting system on a weekly basis and, delinquent reports to be submitted by dealers and received by NMFS before a dealer could purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas. These actions are necessary to ensure timely and accurate reporting, which is critical for quota monitoring and management of these species.

Section 604(a)(2) requires a summary of the significant issues raised by the public comments in response to the Initial Regulatory Flexibility Analysis (IRFA) and a statement of any changes made in the proposed rule as a result of such comments. The Agency received comments concerning the Initial Regulatory Flexibility Analysis stating that the Agency's estimate of monthly internet service of $50 per month was not appropriate (see comment 35 above). As a result, the estimate of monthly internet costs associated with this final action has increased to $110 per month, based on public comment. Estimates of the economic impacts of compliance with the final regulations have been updated in the FRFA and final rule.

Comments were also received on the delayed implementation date discussed in the IRFA and proposed rule (see comment 33 above). The Agency proposed a delayed implementation date of 3 months, and the public was in support of such a delay. Therefore, NMFS plans to delay the implementation of the final action for this rule to provide dealers with approximately four to five months to learn about the electronic dealer reporting system before its use is required.

Finally, comments also indicated that it would take dealers additional time to submit more frequent dealer reports and that there would be additional costs associated with hiring personnel to be in compliance with the proposed reporting frequencies (see comments 12, 16, and 34 above). Based on public comments, NMFS has reconsidered the proposed reporting frequencies for Atlantic HMS dealers to simplify reporting requirements and satisfy the need for timely landings data while avoiding an excessive reporting burden on dealers. NMFS recognizes that daily reporting requirements for sharks as preferred in the proposed rule would not allow dealers sufficient time to gather accurate price information for sharks and could have resulted in a large reporting burden on dealers. At the same time, NMFS acknowledges that unlike some shark fisheries, Atlantic swordfish and BAYS tunas fisheries are currently not quota limited and may not require more frequent reporting than the current biweekly reporting. However, NMFS notes that other Federal dealer permits currently require weekly reporting, including all Northeast Regional Office (NERO)-issued dealer permits. Many HMS dealers also possess NERO-issued permits and, therefore, are already reporting on a weekly basis. Additionally, many fisheries managed by SERO are moving to weekly dealer reporting and many HMS dealers also possess permits for these fisheries. Therefore, NMFS believes that weekly reporting balances the need for more timely landings data and maintains consistency in reporting requirements for different dealer permits. In addition, NMFS is integrating the HMS electronic reporting requirements into existing electronic reporting programs, in part to ease the overall burden on dealers. Thus, NMFS feels the final action satisfies the need for timely reporting and avoids being overly burdensome on dealers with regard to reporting.

Under Section 604(a)(3), Federal agencies must provide an estimate of the number of small entities to which the rule would apply. The Small Business Administration (SBA) standards for a “small” versus “large” business entity are entities that have average annual receipts less than $4.0 million for fish-harvesting; average annual receipts less than $6.5 million for charter/party boats; 100 or fewer employees for wholesale dealers; or 500 or fewer employees for seafood processors. Under these standards, NMFS considers all HMS permit holders subject to this rulemaking to be small entities. Thisaction would apply to all 916 Federal Atlantic HMS dealer permit holders (in 2011), of which 183 had Atlantic shark, 350 had Atlantic swordfish, and 383 had Atlantic tunas (bigeye, albacore, yellowfin, and skipjack) dealer permits.

Under Section 604(a)(4), Federal agencies must provide a description of the projected reporting, recordkeeping, and other compliance requirements of the rule. The final action requires Federal Atlantic HMS dealers to report receipt of Atlantic sharks, swordfish, and BAYS tunas to NMFS through an electronic reporting system on a weekly basis. Under the final rule, the HMS dealer permit will continue to require the same application and fees (i.e., $50 to $75) that are currently in place. The information collected through the electronic dealer system will include additional data fields, including vessel and location of catch information; however, many new fields will be auto-populated or selected from data fields in a drop down menu in the electronic system. In addition, failure to report Atlantic sharks, swordfish, and BAYS tunas to NMFS within the required reporting frequency will result in dealers being ineligible to first receive Atlantic sharks, swordfish, and BAYS tunas. This final rule will not conflict, duplicate, or overlap with other relevant Federal rules. Fishermen, dealers, and managers in these fisheries must comply with a number of international agreements, domestic laws, and other FMPs. These include, but are not limited to, the MSA, the ATCA, the Marine Mammal Protection Act, the Endangered Species Act, the National Environmental Policy Act, and the Paperwork Reduction Act. NMFS does not believe that the new regulations proposed to be implemented will duplicate, overlap, or conflict with any relevant regulations, Federal or otherwise.

Under section 604(a)(5), agencies are required to describe any alternatives to the rule which accomplish the stated objectives and which minimize any significant economic impacts. These impacts are discussed below. Additionally, the RFA (5 U.S.C. 603(c)(1)-(4)) lists four general categories of “significant” alternatives that will assist an agency in the development of significant alternatives. These categories of alternatives are:

1. Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;

2. Clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;

3. Use of performance rather than design standards; and

4. Exemptions from coverage of the rule for small entities.

In order to meet the objectives of this final rule, consistent with the MSA, NMFS cannot exempt small entities or change the reporting requirements only for small entities because all of the participants in Atlantic HMS fisheries are considered small entities. All federally-permitted HMS dealers will submit weekly reports of all HMS received. Similarly, the application process for the dealer permit will be the same as the process that is required under the current regulations. The majority of the information required to report in the new reporting system will be the same as what is currently required. However, the final rule will require federally-permitted dealers to report information to NMFS weekly about Atlantic sharks, swordfish, and BAYS tunas received, in an electronic format rather than on paper.

NMFS considered and analyzed four alternatives to ensure more timely, efficient, and accurate dealer reporting and subsequent quota monitoring of Atlantic HMS. NMFS considered the following alternatives: Alternative A1—Status quo; Alternative A2—Establish new flexible reporting requirements for all federally-permitted HMS dealers effective 30 days after publication of the final rule; Alternative A3—Establish new flexible reporting requirements for all federally-permitted HMS dealers and delay implementation; and Alternative A4—Establish new weekly reporting requirements for all federally-permitted HMS dealers and delay implementation.

Alternative A1, the no action alternative, would maintain existing reporting requirements for federally-permitted HMS dealers. There is no monetary cost associated with the required reporting as NMFS provides pre-paid envelopes for dealers to mail in their reports to the SEFSC. However, HMS dealers must renew their open-access dealer permit each year, and the total cost associated with obtaining a dealer permit, on an annual basis, is between $50 to $75 per dealer, depending on their participation in each of the HMS fisheries. With 916 dealers in the HMS fishery (as specified in section 2.3), the total annual cost for maintaining the dealer permits under the current paper format is from $45,800 (916 dealers * $50 for dealer permits) to $68,700 (916 dealers * $75 for dealer permits).

Alternative A2, A3, and A4 would require all federally-permitted Atlantic HMS dealers to report receipt of Atlantic sharks, swordfish, and BAYS tunas to NMFS through an electronic dealer reporting system. As such, all of these alternatives would have similar direct economic impacts to dealers in terms of purchasing a computer and/or internet service (if they have not already done so) to comply with the final electronic reporting measures under alternative A2, A3, and A4. According to the Small Business Administration, Office of Advocacy (2010) approximately 94 percent of businesses own computers. Therefore, NMFS estimates that 861 dealers (916 * 0.94) already have a computer. Of businesses with computers, 95 percent or 817 dealers (861 dealers * 0.95) have Internet service. Using these estimates, approximately between 44 (861 − 817 = 44 dealers with computers, but without Internet) to 55 (916 − 861 = 55 without computer and Internet) dealers would have to purchase computer and/or Internet services under this alternative. The total amount of costs associated with dealers reporting through the new dealer electronic system is estimated to be $58,080 (44 dealers * $1,320 for Internet service) for those dealers with a computer, but without Internet service and $106,425 (55 dealers * $1,935 for computer and Internet service) for those dealers without a computer and Internet service. Therefore, the additional aggregate cost for electronic reporting under any of the alternatives is approximately $164,505 ($58,080 + $106,425) in the first year. The cumulative cost for electronic reporting and permitting would be approximately $210,305 ($164,505 + $45,800) to $233,205 ($164,505 + $68,700) in the first year, depending on the number of dealer permits obtained by each dealer.

Alternative A2 and A3 would have increased social and economic impacts based on reporting frequency and the requirement that all first receivers of Atlantic swordfish, sharks, and BAYS tunas, including transporters, obtain dealer permits. The increase in the reporting frequency could result in dealers having to hire additional personnel to comply with the increase number of dealer reports. The annual burden of reporting through the new system would depend on the species under alternative A2 and A3. For Atlantic swordfish and BAYS tunas, this would be an extra 0.5 hours per month (15 minutes per report each week × 4 weeks; dealers are currently required to report to NMFS twice a month) or 12 hours per year. Based on the number of Atlantic swordfish and tunas dealer permits (that deal with BAYS tunas) in 2011 (or 733 total permits), this wouldresult in an estimated total annual burden of 8,796 hours. If these fisheries reached 80 percent of any codified quotas, then the reporting burden would increase from weekly to daily reporting for positive or negative reports for any of the associated fisheries, however, NMFS does not anticipate that this would occur at this time.

Atlantic sharks dealers would have to report more often while the non-sandbar LCS, blacknose sharks, and non-blacknose SCS fishing seasons were open. Atlantic shark dealers would spend approximately 7.5 hours/month reporting to NMFS (15 minutes per report each day × 30 days; currently dealers spend 0.5 hours reporting each month) while the non-sandbar LCS, blacknose sharks, and non-blacknose SCS fishing seasons were open, and approximately 1 hour per month (15 minutes per report each week × 4 weeks/month) when the fishing seasons for these fisheries were closed. In 2010, the non-sandbar LCS, blacknose, or non-blacknose SCS fisheries were open for 33 weeks. In 2011, however, the blacknose and non-blacknose SCS were open all year round or for 52 weeks. A similar range of season lengths in subsequent years would result in 57.75 to 91.00 hours of reporting by the federal shark dealer to NMFS while these fisheries were open. However, the non-sandbar LCS, blacknose, or non-blacknose SCS fisheries were closed for 20 weeks during 2010, which would result in 5 hours of reporting by the federal shark dealer to NMFS under similar fishing seasons. Based on the number of Atlantic shark dealer permits in 2011 (or 183 total permits), this would result in an estimated total annual burden of 11,483 hours.

In addition, during the comment period on the proposed rule, NMFS heard that requiring all first receivers of Atlantic swordfish, sharks, and BAYS tunas, including transporters, to obtain dealer permits would result in changes to dealer business practices. While the absolute number of entities that would be affected by this alternative was not quantified, the information provided through public comment indicated that there would be negative social and economic impacts by requiring all first receivers, including transporters, of Atlantic swordfish, sharks, and BAYS tunas product to obtain dealers permits.

Alternative A4, the final action, will simplify dealer reporting on dealers compared to the proposed alternative (i.e.,alternative A3), and will change the current definition of who is considered an Atlantic HMS dealer in order to simplify the regulations and maintain consistency with respect to who is considered a first receiver across species. In addition, alternative A4 will only allow Atlantic HMS dealer to purchase commercially-harvested Atlantic swordfish, sharks, and BAYS tunas if the dealer has submitted timely reports to NMFS.

Under the final action, the cost associated with alternative A4 would be the additional reporting burden on dealers by requiring weekly reporting frequency for Atlantic swordfish, sharks, and BAYS tunas dealers. The amount of time it would take dealers to report through the electronic system is estimated to be the same amount of time HMS dealers currently take to report in a paper format (i.e., 15 minutes per report); however, dealers would be reporting twice as frequently as they do under the current regulations (i.e., they will be required to report weekly instead of twice a month). Thus, for Atlantic swordfish, sharks, and BAYS tunas, dealers would spend one hour per month (15 minutes per report each week × 4 weeks/month) or 12 hours per year reporting to NMFS. Based on the number of Atlantic swordfish, shark, and tuna dealer permits (that deal with BAYS tunas) in 2011 (or 916 total permits), this would result in an estimated total annual burden of 10,992 hours. Negative reports would require less of a reporting burden as negative reports are estimated to only take 5 minutes to complete and submit to NMFS. NMFS assumes that this reduction in the proposed reporting frequency should balance the need for timely data in quota limited fisheries while minimizing reporting burdens on HMS dealers.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide (the guide) was prepared. Copies of the final rule are available from the HMS Management Division, and the guide (i.e., permit holder letter) will be sent to all HMS dealers. The guide and this final rule will be available upon request.

For reasons set out in the preamble, 50 CFR part 635 is amended as follows:

During the Pacific Fishery Management Council's (Council) annual public meetings, the NMFS Southwest Fisheries Science Center presents the estimated biomass for Pacific sardine to the Council's CPS Management Team (Team), the Council's CPS Advisory Subpanel (Subpanel), the Council's Scientific and Statistical Committee (SSC) and the Council. After the biomass and the status of the fisheries are reviewed and discussed, the SSC and other advisory bodies then provide the calculated overfishing limit (OFL), available biological catch (ABC), ACL and ACT (and/or HG) recommendations. Following review by the Council and after considering public comment, the Council adopts a biomass estimate and makes its catch level recommendations to NMFS.

After review of the Council's recommendations from the November 2011 Council meeting, NMFS implements in this rule the 2012 ACL, HG and other annual catch reference points, including an OFL and an ABC that takes into consideration uncertainty surrounding the current estimate of biomass for Pacific sardine in the U.S. EEZ off the Pacific coast. The CPS FMP and its implementing regulations require NMFS to set these annual catch levels for the Pacific sardine fishery based on the annual specification framework in the FMP. This framework includes a harvest control rule that determines the maximum HG, the primary management target for the fishery, for the current fishing season. This level is reduced from the Maximum Sustainable Yield/OFL level for economic and ecological considerations. The HG is based, in large part, on the current estimate of stock biomass for the northern subpopulation of Pacific sardine. The harvest control rule in the CPS FMP is HG = [(Biomass−Cutoff) * Fraction * Distribution] with the parameters described as follows:

1.Biomass.The estimated stock biomass of Pacific sardine age one and above for the 2012 management season is 988,385 mt.

2.Cutoff.This is the biomass level below which no commercial fishery is allowed. The FMP established this level at 150,000 mt.

3.Distribution.The portion of the northern subpopulation of the Pacific sardine biomass estimated in the EEZ off the Pacific coast is 87 percent. This parameter is used to prorate the biomass used to calculate the target harvest level to account for the transboundary nature of the resource.

4.Fraction.The harvest fraction is the percentage of the biomass above 150,000 mt that may be harvested.

At the November 2011 Council meeting, the Council adopted the 2012 assessment of the Pacific sardine resource and a Pacific sardine biomass estimate of 988,385 mt. Based on recommendations from its SSC and other advisory bodies, the Council recommended, and NMFS is implementing, an overfishing limit of 154,781 mt, an acceptable biological catch (ABC) of 141,289 mt, an annual catch limit of 141,289 mt (equal to the ABC) and a maximum harvest guideline (HG) (HGs under the CPS FMP areoperationally similar to annual catch targets (ACT)) of 109,409 metric tons (mt) for the 2012 Pacific sardine fishing year. These catch specifications are based on the most recent stock assessment and the control rules established in the CPS FMP.

The Council also recommended, and NMFS is implementing, establishment of an the initial overall commercial fishing HG of 97,409 mt Pacific sardine and allocation of that HG across the three allocation periods. This number has been reduced from the maximum HG by 12,000 mt: (i) For potential harvest by the Quinault Indian Nation of up to 9,000 mt; and (ii) 3,000 mt, which is initially reserved for potential use under an exempted fishing permit(s) (EFPs). Additionally, incidental catch set asides are in place for each allocation period. The purpose of the incidental set-aside allotments and allowance of an incidental catch-only fishery is to allow for the restricted incidental landings of Pacific sardine in other fisheries, particularly other CPS fisheries, when a seasonal directed fishery is closed to reduce bycatch and allow for continued prosecution of other important CPS fisheries.

For the 2012 Pacific sardine fishing season, the incidental set asides and adjusted directed harvest levels for each period are shown in the following table in metric tons:

Although the 2012 HG is well below that of the ACL, additional inseason accountability measures are in place to ensure the fishery stays within the HG. If during any of the seasonal allocation periods the applicable adjusted directed harvest allocation is projected to be taken, fishing will be closed to directed harvest and only incidental harvest will be allowed. For the remainder of the period, any incidental Pacific sardine landings will be counted against that period's incidental set-aside. The incidental fishery will also be constrained to a 30 percent by weight incidental catch rate when Pacific sardine are landed with other CPS so as to minimize the targeting of Pacific sardine. In the event that an incidental set-aside is projected to be attained, the incidental fishery will be closed for the remainder of the period. If the set-aside is either not fully attained or is exceeded in a given seasonal period, the directed harvest allocation in the following seasonal period will automatically be adjusted upward or downward accordingly to account for the discrepancy. Additionally, if during any seasonal period the directed harvest allocation is either not fully attained or is exceeded, then the following period's directed harvest total will be adjusted to account for the discrepancy, as well.

If the total HG or these apportionment levels for Pacific sardine are reached or are expected to be reached, the Pacific sardine fishery will be closed until it re-opens either per the allocation scheme or at the beginning of the next fishing season. The NMFS Southwest Regional Administrator will publish a notice in theFederal Registerannouncing the date of any such closure.

At the April 2012 Council meeting the Council approved and subsequently made a recommendation to NMFS to approve an EFP for all of the 3,000 mt EFP set-aside. NMFS will likely make a decision on whether to issue an EFP for Pacific sardine sometime prior to the start of the second seasonal period (July 1, 2012). Any of the 3,000 mt that is not issued to an EFP will be rolled into the third allocation period's directed fishery. Any set-aside attributed to an EFP designed to be conducted during the closed fishing time in the second allocation period (prior to September 15), but not utilized, will roll into the third allocation period's directed fishery. In response to a request by the Quinault Indian Nation for the exclusive right to harvest Pacific sardine in 2012 in their Usual and Accustomed Fishing Area off the coast of Washington State, pursuant to their rights to fish under the 1856 Treaty of Olympia (Treaty with the Quinault), the Council recommended and NMFS approved an allocation of 9,000 mt of sardine to the Quinault in 2012. NMFS will consult with Quinault Department of Fisheries staff and Quinault Fisheries Policy representatives on or near September 1, 2012 to review Quinault catch to-date, Oregon and Washington catch to-date and any other relevant information in an attempt to project tribal catch for the remainder of the season. The purpose of this consultation will be to determine whether any unused portion of the 2012 Quinault Pacific sardine set-aside of 9,000 mt can be moved into the non-tribal third period allocation that begins September 15.

Detailed information on the fishery and the stock assessment are found in the report “Assessment of the Pacific Sardine Resource in 2011 for U.S. Management in 2012” (seeADDRESSES).

On April 3, 2012 NMFS published a proposed rule for this action and solicited public comments (77 FR 19991). NMFS received two comments from one commenter regarding the Pacific sardine annual specifications.

Comment 1:The commenter requested that the proposed action be disapproved because the harvest guideline (HG) control rule does not reflect the best available science for setting catch levels and results in a catch level that is too risky, fails to prevent overfishing, and does not account for the role of sardine as forage. As such, the commenter recommends a different approach to setting the catch level referring extensively to a report by the Lenfest Forage Fish Task Force. This report recommends that the fishing mortality rate for forage species be set at one-half the species' natural mortality rate, a rate said to have been traditionally used in some forage fisheries as a proxy for fishing at MSY (FMSY). The commenter references the Lenfest Report and a July 2011 article in the journalScienceto suggest the harvest guideline should be set at1/2of FMSY, but does not offer a specific suggestion for determining FMSY; the commenter then cites an FMSYrate of 0.12 pulled from modeling conducted for Amendment 8 to the CPS FMP and an FMSYrate of 0.18 developed through modeling as part of the 2011 sardine stock assessment. The comment also states that the best available information is not being used for the FRACTION parameter of the HG control rule and that the DISTRIBUTION parameter does not reflect current catch levels.

Response:To the extent this comment is directed to the setting of 2012 Pacific sardine ACL, HG, and associated annual reference points based on the HGcontrol rule and ABC control rule of the FMP, the 2012 specifications are based on the best available science. As explained above underSUPPLEMENTARY INFORMATION,this year's biomass estimate used to establish the 2012 specifications went through extensive review and along with the resulting OFL and ABC, was endorsed by the Council's SSC and NMFS as the best available science. Disapproving this action, as requested by the commenter, would allow the fishery to take place without any HG or quota. The HG and seasonal allocations being put in place by this action are important for preventing overfishing and managing the fishery at a level that will achieve optimum yield while allowing all sectors of the Pacific sardine fishery fair and equitable opportunities to harvest the resource. To the extent that the comment is directed at the HG control rule established in Amendment 8 to the CPS FMP, this rulemaking is not intended to revise the parameters of the existing HG control rule, and so the comment is beyond the scope of this rulemaking.

Although reconsideration of the existing HG control rule is beyond the scope of this rulemaking, NMFS will respond to some aspects of the comment that relate to the HG control rule itself, such as the FRACTION and DISTRIBUTION parameters. The CPS FMP and its implementing regulations require NMFS to set annual catch levels for the Pacific sardine fishery based on the annual specification framework in the FMP. This framework includes a harvest control rule established by Amendment 8 to the FMP, and continued in Amendment 13, that determines the maximum HG, the primary management target for the fishery, for the current fishing season (HGs are operationally similar to annual catch targets) based on the current year's estimated biomass.

NMFS agrees that Pacific sardine is an important prey component of the California Current ecosystem and as such the current harvest control rule formula used to determine the harvest guideline takes into account Pacific sardine's ecological role as forage. The current harvest control established in Amendment 8, developed after 15 public meetings, was chosen from a wide range of FMP harvest policies based on analysis of a variety of measures of performance. Of these performance measures, or OY considerations, six were chosen as priority considerations for determining which harvest policy to choose; three related specifically to sardine's role as forage in the California Current ecosystem, and three stemmed from an interest in maintaining a predictable and constant flow of catch and revenues over the long term. The current harvest policy was chosen because it is the most precautionary as related to conserving sardine as forage, while still providing long-term consistent fishing yields for the fishing industry, ultimately resulting in OY over the long term.

Thus, the HG control rule includes a variety of OY considerations as well as explicit precautions intended to prevent the stock from becoming overfished, prevent overfishing and continuously reduce harvest levels as biomass decreases (low harvest fraction and a 150,000 mt threshold below which fishing is prohibited). These considerations and precautions are based on the environmentally driven dynamic nature of the Pacific sardine stock as well as its importance in the ecosystem as forage for other species. The outcome of this control rule are catch levels more conservative than MSY-based management strategies (OFL/ABC), because the focus for CPS management is oriented primarily towards biomass versus catch, leaving adequate forage in the ocean and maintaining long-term, consistent catch levels for the fishing industry.

Due to past shifts in sardine productivity being linked with warm or cold ocean regimes, the CPS FMP uses a correlation between Scripps Pier sea surface temperature and sardine productivity to determine the FRACTION parameter of the HG rule. Recent work has shown that the strength of the direct correlation between Scripps Pier sea surface temperature and sardine productivity is likely not as strong or defined as previously thought. However, this work did not infer that there was no relationship between sardine productivity and the physical environment (including ocean temperature). It is well established that environmental forcing plays a strong role in Pacific sardine recruitment, with temperature likely being an important factor. However, NOAA recognizes that based on this recent work showing that the explicit relationship underlying the harvest FRACTION parameter may not be as strong as previously thought, it should be reassessed. To that end, the Council is planning a future workshop to determine what key fishery management parameters, such as FMSYor components of the HG control rule, in particular the temperature-based harvest FRACTION, should be reviewed and/or revised. Until the review process is completed, however, NOAA still considers the current control rule as the best available science for setting harvest levels for Pacific sardine. Additionally, on its own, a FRACTION at 15 percent would be considered conservative based on the below discussion of fishing mortality rates, but when used in concert with the other formula parameters it is particularly cautious. Fifteen percent is also less than the FMSYof 18 percent used in the OFL and ABC calculations, therefore adding further protection to the stock.

With regard to the DISTRIBUTION parameter of the sardine HG control rule, which is also used in the MSY type control rules (OFL and ABC), it is a measure of the average “distribution” of biomass for the northern subpopulation of Pacific sardine, not “catch.” The Distribution parameter is not intended to reflect the proportion of coastwide catch that Canada and Mexico actually catch, or are entitled to catch. The HG control rule was not developed with the assumptions that the entire biomass is readily available to the fleet, that there are no other fishing restrictions, or that U.S. fishing restrictions match those of other countries. Obviously, these assumptions are not correct. For example the U.S. fishery was only open for 83 days in 2011, while Mexico and Canada were not bound by this restriction. Additionally, the majority of the sardine biomass typically is outside the fishing area of the U.S. fleet, as sardines occur up to 300 nautical miles offshore and fisherman typically fish within 5 miles from shore. Therefore, the DISTRIBUTION factor is not incorrect on the basis that it does not reflect current catch levels between the three countries that harvest the northern subpopulation of Pacific sardine, because it was never intended to reflect catch levels. Additionally, due to mixing of the southern and northern subpopulations of Pacific sardine off of northern Baja Mexico, a significant amount of the Mexican catch referenced by the commenter is actually from the southern subpopulation of Pacific sardine not the northern subpopulation; only the northern subpopulation is monitored and managed under the CPS FMP.

Additionally, the commenter states that the information used to develop the current percentage used for the Distribution parameter (87%) came from data collected during low biomass years and that it is a greater percentage then was used by the State of California (59%) to set the state quota in 1998. Although it is correct that the State of California used a distribution factor of 59% in setting California quotas in 1998, this proportion was based on a regional biomass estimate that included sardine only off the area between Baja California and San Francisco. This 59%figure was probably a reasonable estimate of the fraction of sardine biomass in the region surveyed (the southern distribution of the stock), however the currently used 87% is based on the entire distribution of the stock which extends from the U.S./Canada border to U.S./Mexico border). Additionally, because the data used to calculate the currently used 87% came from low biomass years, this actually results in an underestimate for years with medium to high biomass.

With respect to the commenter's suggestion that catch levels should not be set based on the existing HG control rule but rather be set in accordance with recommendations in the Lenfest Report, it is illustrative to play out what this might mean. The Lenfest Report recommends that harvest be set at1/2the natural mortality rate for forage species; since the estimated natural mortality rate for Pacific sardine is 0.4 of biomass, therefore, based on the Lenfest recommendation, the harvest rate for Pacific sardine should be 0.2 of biomass. Under the MSY control rule in the CPS FMP, the FMSYfor the sardine in 2012 is 0.18 (i.e. the OFL), which is a fishing rate below 0.2, and the result of this year's HG control rule is well below this rate at 0.11. Therefore, even if this rulemaking included reconsideration of the HG control rule itself, following the1/2-natural-mortality recommendation would be less precautionary than the fishing level for 2012 under the HG control rule of the CPS FMP. To further highlight the current conservative nature of the management in place for Pacific sardine, due to the existing HG control rule and other management measures such as the 200,000 mt maximum catch level in place, annual fishing mortality rates can never exceed .12. Second, NMFS also notes that there is a very large difference (approximately 45,000 mt and 32,000 mt respectively) between the higher OFL and ABC/ACL levels and the lower HG catch level (which is the maximum directed fishing level) for the 2012 fishing year. The lower HG is the result of OY considerations and the management strategy in the CPS FMP that limits Pacific sardine to catch levels more conservative than needed to simply avoid overfishing as described under National Standard 1 or a risk of exceeding the ACL due to management uncertainty.

The commenter's recommendation to use a static management approach apparently does not include precautionary parameters that account for natural variability of the Pacific sardine stock as does the HG formula of the FMP. Furthermore, the commenter offered no clear standard for this approach; instead, commenter referenced an FMSYof 0.12 that appeared in a table in the environmental impact statement for Amendment 8 to the CPS FMP; commenter also references the estimated FMSYof 0.18 from a modeling exercise in Appendix 4 of the 2011 sardine stock assessment prepared by the NMFS Southwest Fisheries Science Center; the intent this estimate was for use in the calculation of OFL and intent of preventing overfishing. Neither modeling exercise was intended to result in an estimate of actual FMSYin the context of the recommendations presented by the commenter.

NFMS recognizes that management of trans-boundary stocks, such as Pacific sardine, is one of the more difficult issues in managing CPS. The current approach in the CPS FMP sets sardine harvest levels for U.S. fisheries by prorating the biomass used to calculate the target harvest level according to the portion of the stock estimated to be in U.S. waters on average over time. The primary advantage of prorating the total target harvest level is that U.S. fisheries can be managed unilaterally in a responsible manner that is consistent with the MSA. Mexican and Canadian landings are not considered explicitly when harvest levels for U.S. waters are determined. However, the allowable harvest level in U.S. waters depends on current biomass estimates, so U.S. harvest will be reduced if the stock is depleted by fishing in either Mexico or Canada. Additionally, fishery data from both Mexico and Canada is used in the U.S. stock assessment to ensure the best available information is used to assess the stock. In practice, this approach is similar to managing the U.S. and other portions of a stock separately since harvest for the U.S. fishery in a given year depends ultimately on the biomass in U.S. waters.

Prorating total harvest by the portion in U.S. waters may not protect CPS stocks against high combined U.S., Mexican and Canadian harvest, but harvest in U.S. waters will automatically decrease if biomass decreases. In any given year, combined harvest rates may be higher than desirable, and biomass and fishery yields may be reduced due to too much fishing. However, the total exploitation rate on the stock has averaged approximately only 13% over the last 10 years and is currently about 14.5%. The U.S. exploitation rate has averaged 7.6% since 2000 and is currently about 6.6%.

Comment 2:The same commenter also stated that an Environment Impact Statement (EIS) should have been prepared instead of an Environmental Assessment (EA), the range of alternatives analyzed in the EA was not adequate, and alternative methods for determining the annual specifications should have been analyzed. Specifically, the commenter suggested that the EA should have analyzed the setting of catch limits based one half of FMSY, in addition to alternatives based on the existing HG and ABC control rules. In connection with their NEPA comment, the commenter does not indicate what FMSYwould be. Based on discussion in another part of the comment letter, the commenter apparently supports using an FMSYof 0.12 used in an (unselected) alternative for the environmental analysis for Amendment 8 to the CPS FMP or perhaps an FMSYof 0.18 that was used as part of the 2011 sardine stock assessment.

Response:Regarding the comments about the National Environmental Policy Act (NEPA) analysis for this action, the EA completed for this action demonstrates that the implementation of these annual catch levels for the Pacific sardine fishery based on the HG and ABC control rules in the FMP will not significantly adversely impact the quality of the human environment. Therefore an EIS is not necessary to comply with NEPA for this action.

With regard to the scope and range of alternatives, the six alternatives analyzed in the EA was a reasonable number and covered an appropriate scope based on the limited nature of this action, which is the application of a set formula in the FMP's HG and ABC control rules to determine harvest levels of Pacific sardine for one year and the allocation of that level between allocation periods, with a set-aside for an exempted fishing permit and an Indian nation. The six alternatives analyzed (including the proposed action) were objectively evaluated in recognition of the purpose and need of this action and the framework process in place based on the HG and ABC control rules for setting catch levels for Pacific sardine. The CPS FMP describes a specific framework process for annually setting required catch levels and reference points. Within this framework are specific control rules used for determining the annual OFL, ABC, ACL, and HG/ACT. Although there is some flexibility built into this process in terms of determinations of scientific and management uncertainty, there is little discretion in the control rules for the OFL (level for determining overfishing) and the HG (level at which directed fishing is stopped), with the annual biomass estimate being theprimary determinant in both these levels. Therefore, the alternatives in the EA covered a range of higher and lower ABC and ACL levels in the context of the OFL and HG levels.

With regard to the suggestion by the commenter to analyze as an alternative in this EA one-half FMSY(a static percentage applied to the biomass estimate) as the basis from which to set the annual specifications, this would not have been a pertinent alternative for an EA on the 2012 annual specifications. The annual specifications implement the FMP, which uses a harvest guideline control rule with a specific, ecosystem-sensitive formula. To analyze such an alternative would have been outside the scope of the rulemaking. The purpose of this EA was to analyze alternative approaches to implementing the existing FMP, not alternatives for changing the FMP.

Furthermore, even if this were an EA considering amendments to the existing FMP, as stated above, fishery management approaches for small pelagic species based on equilibrium or steady-state concepts, such as those suggested by the commenter (i.e., MSY or BMSY), which ignore natural variability in abundance, are not the most appropriate or reasonable and therefore the current approach—which accounts for natural variability—is used. Although the commenter cites an FMSYof 0.12 from an alternative not chosen in the environmental impact statement for Amendment 8 to the CPS FMP as well as an FMSYof 0.18 from modeling conducted as part of the 2011 sardine stock assessment, neither value was intended even in those documents to be used as part of an actual static MSY harvest strategy because biomass and productivity of most CPS change in response to environmental variability on annual and decadal time scales. These numbers were postulated as modeling exercises, or for the sake of considering a range of alternatives or other specific purposes. The harvest strategy in the FMP accounts for environmental variability and requires annual estimates of biomass rather than using a static harvest strategy.

The commenter is welcome to recommend that the Council and NMFS amend the FMP to manage Pacific sardine using a steady-state formula that would not account for natural fluctuations or conditions, but the EA for the 2012 annual specifications was not the appropriate place to conduct the analysis of that alternative.

The Administrator, Southwest Region, NMFS, determined that this action is necessary for the conservation and management of the Pacific sardine fishery and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

NMFS finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for the establishment of the harvest specifications for the 2012 Pacific sardine fishing season. For the reasons set forth below, the immediate implementation of this measure is necessary for the conservation and management of the Pacific sardine resource. This rule establishes seasonal harvest allocations and the ability to restrict fishing when these allocations are approached or reached. These allocations are important mechanisms in preventing overfishing and managing the fishery at optimum yield while allowing fair and equitable opportunity to the resource by all sectors of the Pacific sardine fishery. A delay in effectiveness is likely to prevent the ability to close the fishery when necessary and cause the fishery to exceed the second seasonal allocation. The directed and incidental harvest allocations are designed to allow fair and equitable opportunity to the resource by all sectors of the Pacific sardine fishery and to allow access to other profitable CPS fisheries, such as squid and Pacific mackerel. Because the directed harvest allocation for the second allocation period is approximately 30,000 mt greater than the level in 2011, NMFS did not expect that it would be necessary to close the directed fishery prior to the start of the third allocation period. However, based on current landings information, which are significantly higher than anticipated, NMFS expects the directed fishery will need to be closed during the current allocation period, which began on July 1. Delaying the effective date of this rule is contrary to the public interest because additional reduction of Pacific sardine beyond the incidental take limit set out in this action would decrease the future harvest limits, thereby reducing future potential catch of the stock along with the profits associated with those harvests. Therefore, NMFS finds that there is good cause to waive the 30-day delay in effectiveness in this circumstance. To help keep the regulated community informed of this final rule NMFS will also announce this action through other means available, including fax, email, and mail to fishermen, processors, and state fishery management agencies. Additionally, NMFS will advise the CPS Advisory Subpanel, which is comprised of representatives from all sectors and regions of the sardine industry, including processors, fishermen, user groups, conservation groups, and fishermen association representatives, of current landings as they become available and for the public at-large also post them on NMFS' Southwest Regional Office Web site,http://swr.nmfs.noaa.gov/.

This final rule is exempt from Office of Management and Budget review under Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here.

No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

Electronic Access

This final rule is accessible via the Internet at the Office of the Federal Register's Web site athttp://www.gpo.gov/fdsys/search/home.action.Background information and documents are available at the Pacific Fishery Management Council's Web site athttp://www.pcouncil.org/.

The Pacific Coast Groundfish FMP and its implementing regulations at title 50 in the Code of Federal Regulations (CFR), part 660, subparts C through G, regulate fishing for over 90 species of groundfish off the coasts of Washington, Oregon, and California. Groundfish specifications and management measures are developed by the Pacific Fishery Management Council (Council), and are implemented by NMFS.

On November 3, 2010, NMFS published a proposed rule to implement the 2011-2012 harvest specifications and management measures for most species of the Pacific Coast groundfish fishery (75 FR 67810). The final rule to implement the 2011-12 harvest specifications and management measures for most species of the Pacific Coast Groundfish Fishery was published on May 11, 2011 (76 FR 27508). This final rule was subsequently amended by several inseason actions (76 FR 39313, 76 FR 67092, 76 FR 79122, 77 FR 12503, 77 FR 22679, 77 FR 24634). On September 27, 2011, NMFS published a proposed rule to implement final 2012 specifications for overfished species and assessed flatfish species pursuant to Secretarial Amendment 1 to the Groundfish FMP (76 FR 59634). That final rule was effective January 1, 2012. These specifications and management measures are codified in the CFR (50 CFR part 660, subparts C through G).

Changes to current groundfish management measures implemented by this action were recommended by the Council, in consultation with Pacific Coast Treaty Indian Tribes and the States of Washington, Oregon, and California, at its June 20-June 25, 2012 meeting. The Council recommended adjusting the biennial groundfish management measures for the remainder of the biennial period to respond to updated fishery information and additional inseason management needs. The adjustment to fishery management measures are not expected to result in greater impacts to overfished species than originally projected through the end of 2012. Estimated mortality of overfished and target species are the result of management measures designed to achieve, to the extent possible, but not exceed, annual catch limits (ACLs) of target species while fostering the rebuilding of overfished stocks by remaining within their rebuilding ACLs.

To ensure that harvest opportunities for this stock do not exceed the LE fixed gear sablefish DTL allocation north of 36° N. lat., the Council considered decreases to trip limits for sablefish in this fishery and the potential impacts on overall catch levels. Model-based landings projections of the LE fixed gear sablefish DTL fishery north of 36° N. lat. were made for the remainder of 2012 by the Council's Groundfish Management Team (GMT). These projections were made based on the most recent information available under the current 2012 trip limit scenario, and predicted a harvest overage of 41 percent, or 108 metric tons in excess of this fishery's harvest guideline under the status quo trip limits. Projections for the other three fixed gear sablefish fisheries were tracking within their targets for 2012. An overage by the northern LE fixed gear sablefish DTL fishery could result in an overage of the northern sablefish ACL.

Therefore, the Council recommended and NMFS is implementing trip limit changes for the LE fixed gear sablefish DTL fishery north of 36° N. lat. that decrease LE fixed gear sablefish DTL fishery limits from “1,000 lb (454 kg) per week, not to exceed 4,000 lb (1,814 kg) per 2 months” to “800 lb (363 kg) per week, not to exceed 1,600 lb (726 kg) per 2 months” beginning in period 5, September 1, 2012 through the end of the year. This decrease in trip limits is not anticipated to increase projected impacts to overfished species and is anticipated to help maintain mortality levels within the northern sablefish ACL.

The Council received an industry request to increase the LE fixed gear shelf rockfish trip limits south of 34°27′ N. lat. The shelf rockfish complex south of 40°10′ N. lat. has not been fully harvested in recent years, averaging between 29.7 percent and 51.1 percent of its ACL in years 2006-2010. West Coast Groundfish Observer Program data indicate very few encounters with overfished species and California state fish ticket data indicate that very few vessels actually attained full trip limits between 2008 and 2010.

Based on these data, the Groundfish Management Team estimated that landings would increase by approximately 0.2 metric tons, to a total of 2.2 metric tons. This modest increase in trip limits for shelf rockfish is not expected to result in an overharvest of any species' contribution to the complex as a result of this request.

Therefore, the Council recommended and NMFS is implementing increased trip limits for shelf rockfish in the LE fixed gear fishery south of 34°27′ N. lat., from “3,000 pounds (1361 kg) per 2 months” to “4,000 pounds (1814 kg) per 2 months” beginning in period 5, September 1, 2012 through the end of the year.

There are increased encounters with bocaccio south of 34°27′ N. lat. resulting from a very strong year class entering the fishery. In order to reduce unnecessary discarding as a result of increased encounters with the new year-class entrants, industry submitted a request to the Council to raise the bimonthly limit of bocaccio south of 34°27′ N. lat. The estimated take of bocaccio would increase to 0.7 metric tons from the annual average of 0.4 metric tons, which is well within the non-trawl bocaccio allocation south of 40°10′ N. lat.

Therefore, the Council recommended and NMFS is implementing trip limit changes for bocaccio in the LE fixed gear fishery south of 34°27′ N. lat. from “300 pounds (136 kg) per two months” to “500 pounds (227 kg) per two months” beginning in period 5, September 1, 2012 through the end of the year.

This final rule makes routine inseason adjustments to groundfish fishery management measures based on the best available information and is consistent with the Pacific Coast Groundfish FMP and its implementing regulations.

This action is taken under the authority of 50 CFR 660.60(c) and is exempt from review under Executive Order 12866.

These inseason changes in sablefish, shelf rockfish, and bocaccio limits are based on the most recent data available. The aggregate data upon which these actions are based are available for public inspection at the Office of the Administrator, Northwest Region, NMFS, (seeADDRESSES) during business hours.

For the following reasons, NMFS finds good cause to waive prior public notice and comment on the revisions to groundfish management measures under 5 U.S.C. 553(b) because notice and comment would be impracticable and contrary to the public interest. Also, for the same reasons, NMFS finds good cause to partially waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(3), so that this final rule may become effective September 1, 2012.

At the June Council meeting, the Council recommended that these changes, which are based on the most recent information available, be implemented by September 1, 2012. There was not sufficient time after that meeting to draft this document and undergo proposed and final rulemaking before these actions need to be in effect. For the actions to be implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent NMFS from managing fisheries using the best available science to approach, without exceeding, the ACLs for federally managed species in accordance with the FMP and applicable laws. The adjustments to management measures in this document affect commercial fisheries from southern California to Washington State. These adjustments to management measures must be implemented in a timely manner, by September 1, 2012, to: Allow LE fixed gear fishermen an opportunity to harvest their limits in 2012 for sablefish without exceeding the ACL North of 36° N. lat., to allow harvest of shelf rockfish without exceeding the ACL south of 34°27′ N. lat., and to allow incidental catch of bocaccio without exceeding the ACL south of 34°27′ N. lat. in response to significant recent recruitment events. These changes in the LE fixed gear fishery continue to allow fishermen opportunities to harvest available healthy stocks while staying within the ACLs for these species. If this rule is not implemented immediately, the public could have incorrect information regarding allowed LE fixed gear trip limits which would cause confusion and be inconsistent with the intent of the Council. It would be contrary to the public interest to delay implementation of these changes until after public notice and comment, because making this regulatory change by September 1, 2012, allows harvest as intended by the Council in fisheries that are important to coastal communities in a manner that prevents ACLs of overfished and target species from being exceeded.

No aspect of this action is controversial and no change in operating practices in the fishery is required from those intended in this inseason adjustment.

Delaying these changes would also keep management measures in place that are not based on the best available information. Such delay would impair achievement of the Pacific Coast Groundfish FMP objectives of providing for year-round harvest opportunities, extending fishing opportunities as long as practicable during the fishing year, or staying within ACLs or allocations for sablefish, shelf rockfish, and bocaccio in the LE fixed gear fishery.

Accordingly, for the reasons stated above, NMFS finds good cause to waive prior notice and comment and to partially waive the delay in effectiveness.

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows: