Federal Register Vol. 82, No.176,

Discussion

On June 19, 2017, we issued AD 2017-13-12, Amendment 39-18942 (82 FR 30949, July 5, 2017) (“AD 2017-13-12”), which applied to all Airbus Model A318 series airplanes and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2017-13-12 was prompted by an evaluation by the design approval holder (DAH), which indicates that the main landing gear (MLG) does not comply with certification specifications, which could result in a locking failure of the MLG side stay. AD 2017-13-12 required modification or replacement of certain MLG side stay assemblies. We issued AD 2017-13-12 prevent possible collapse of the MLG during takeoff and landing.

Since we issued AD 2017-13-12, we have received reports indicating that affected parties misinterpreted the applicability of the affected part numbers due to the formatting of figure 1 to paragraphs (g), (h), and (i) in the published version of AD 2017-13-12, which could result in a negative effect on compliance. Therefore, we have determined that clarification of the formatting of the published figure is necessary.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2016-0018R1, dated September 14, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The EASA AD is referenced in AD 2017-13-12. EASA has not revised its AD since the issuance of AD 2017-13-12.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0809.

We have reviewed the following service information.

• Airbus Service Bulletin A320-32-1429, Revision 01, dated February 29, 2016.

• Messier-Bugatti-Dowty Service Bulletin 200-32-315, dated April 24, 2015.

• Messier-Bugatti-Dowty Service Bulletin 201-32-63, dated April 24, 2015.

The service information describes procedures for modifying the MLG side stay assembly. The Messier-Bugatti-Dowty documents are distinct since they apply to different airplane models. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

We are superseding AD 2017-13-12 to clarify the formatting of a figure in the regulatory text of the published AD. No other changes have been made to AD 2017-13-12. Therefore, we determined that notice and opportunity for prior public comment are unnecessary.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-0809; Product Identifier 2017-NM-094-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

We estimate that this AD affects 959 airplanes of U.S. registry. This AD adds no new economic burden to AD 2017-13-12. We estimate the following costs to comply with this AD:

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

The C.E.C. Inc., acting on behalf of Louisiana Department of Transportation and Development, has requested a temporary deviation from the operating schedule of the Harvey Canal Fourth Street Bascule Bridge across GIWW, mile 0.24 WHL (Harvey Canal), at Harvey, Louisiana. This deviation was requested to replace electrical and hydraulic lines including trunnion shafts along with span and tail locks initial installation to the drawbridge. This bridge is governed by 33 CFR 117.5.

This deviation allows the bascule bridge to remain in the closed-to-navigation position for 77 consecutive days from 6:30 a.m. on September 6, 2017 through 7 p.m. on Tuesday, November 21, 2017.

This bridge has a vertical clearance of 7 feet above mean high water in the closed-to-navigation position.

Navigation at the site of the bridge consists mainly of tugs with barges and some recreational pleasure craft. For the duration of the rehabilitation the bridge will not be able to open for emergencies and GIWW Algiers Alternate Route can be used as an alternate route to avoid unnecessary delays. The Coast Guard will inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by September 9, 2017 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to public interest in ensuring the safety of spectators and vessels during the event because immediate action is necessary to prevent possible loss of life and property. Broadcast Notices to Mariners (BNM) and information sharing with the waterway users will update mariners of the restrictions, requirements and enforcement times during this temporary situation.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the recurring fireworks displays from 3:30 p.m. on September 9, 2017 through 11 p.m. on November 25, 2017 will be a safety concern for all navigable waters of the Tennessee River extending from Mile Marker (MM) 646.8 to MM 647.0. The purpose of this rule is to ensure safety of life on the navigable waters in the temporary safety zone before, during, and after the University of Tennessee Football Season Fireworks Displays.

This rule establishes a temporary safety zone during each University of Tennessee football home game during the 2017 season that will have a fireworks display. The temporary safety zone will cover all navigable waters of the Tennessee River extending from MM 646.8 to MM 647.0. Transit into and through this area is prohibited from 30 minutes before kickoff until the end of each game. The first game will be on September 9, 2017 at 4 p.m. The safety zone will be enforced from 3:30 p.m. through the end of the game at approximately 8 p.m. The second game will be on September 23, 2017 at 4 p.m. The remaining home game dates are September 30, October 14, November 4, 18, and 25. Game times will be announced approximately two weeks prior and a Local Notice to Mariners will be issued to advise waterway users of the schedule as it is determined. The duration of the temporary safety zone is intended to ensure the safety of life, vessels, and these navigable waters before, during, and after the scheduled fireworks display. No vessel or person will be permitted to enter the temporary safety zone without obtaining permission from the COTP or a designated representative. Entry requests will be considered and reviewed on a case-by-case basis. The COTP may be contacted by telephone at 1-800-253-7475 or can be reached by VHF-FM channel 16. Public notifications will be made to the local maritime community prior to the event through the Local Notice to Mariners and Broadcast Notice to Mariners.

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the temporary safety zone. The temporary safety zone will be in effect for approximately 4 and-a-half hours and only on Saturdays during the University of Tennessee football season. The temporary safety zone covers an area of the waterway stretching less than one mile. The Coast Guard expects minimum adverse impact to mariners from the temporary safety zone activation as the game times will have been advertised to the public. Also, mariners may request authorization from the COTP or a designated representative to transit the temporary safety zone.

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

While some owners or operators of vessels intending to transit the special local regulation may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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 have determined that it is consistent with the fundamental Federalism principles and preemption requirements described in Executive Order 13132.

Also, 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. If you believe this rule has implications for Federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

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 (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 special local regulated area that would prohibit entry to unauthorized vessels. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this project 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 impracticable because it would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event. We are issuing this rule under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register for the same reason noted above.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with this project will be a safety concern to anyone within a 2000-foot area of the LD4 Ground Wire. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the project is being conducted.

This rule establishes a safety zone from 7 a.m. on September 12, 2017 through 7 p.m. on September 13, 2017. A safety zone is established to include all U.S. navigable waters of the St. Clair river, St. Clair, MI, between the following two lines from bank-to-the U.S./Canadian border: The first line is drawn directly across the channel from position 42°46.139′ N., 082°28.233′ W. (NAD 83); the second line, to the south, is drawn directly across the channel from position 42°45.799′ N., 082°28.251′ W. (NAD 83). This regulated area will be enforced during a one hour period of time between 7 a.m. through 7 p.m. on September 12, 2017. In the event of inclement weather the regulated area will be enforced during a one hour period of time between 7 a.m. through 7 p.m. on September 13, 2017. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Recreational vessel traffic will be able to safely transit around this safety zone with the exception of a one hour time frame between 7 a.m. to 7 p.m. during which the optic ground wire will cross the river on September 12 or 13, 2017. Commercial traffic shall not be impeded. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

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

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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 have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

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(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 36 hours that will prohibit entry within 2000-feet of the project site. It is categorically excluded under section 2.B.2, figure 2-1, paragraph 34(g) of the Instruction. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble.

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

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

The Coast Guard will enforce the Safety Zone for the Pittsburgh Steelers fireworks on the Allegheny River, Monongahela River and Ohio River, listed in 33 CFR 165.801 Table 1, Sector Ohio Valley, No. 57 on November 16, 2017, November 26, 2017, and December 10, 2017. Entry into the safety zone is prohibited unless authorized by the COTP or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552 (a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Local Notice to Mariners and updates via Marine Information Broadcasts.

Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

On June 2, 2010 (75 FR 35520), the EPA established a health-based 1-hour primary SO2 NAAQS at 75 ppb. Upon promulgation of a new or revised NAAQS, section 107(d) of the Clean Air Act (CAA) requires the EPA to designate any area that does not meet (or that contributes to ambient air quality in a nearby area that does not meet) the NAAQS as nonattainment. On August 5, 2013, the EPA designated a portion of Jefferson County, Missouri, as nonattainment for the 2010 1-hour primary SO2 NAAQS, effective October 4, 2013.1 The designation was based on 2008-2010 monitoring data in Herculaneum, Missouri, which monitored violations of the standard (see section III of this document for additional monitoring information). The effective date of the nonattainment designation was October 4, 2013. This action established an attainment date five years after the effective date for the areas designated as nonattainment for the 2010 SO2 NAAQS (i.e., by October 4, 2018).

On February 2, 2016, the state submitted a request asking the EPA to determine that the nonattainment area attained the 2010 1-hour primary SO2 NAAQS per the EPA's Clean Data Policy.2 3 On June 23, 2017, the EPA published a notice of proposed rulemaking (NPR) which proposed to approve the State's requests. See 82 FR 28605. Specifically, the EPA proposed to take the following actions: (1) Determine that the Jefferson County SO2 nonattainment area is attaining the 2010 1-hour SO2 NAAQS; (2) determine that the Jefferson County SO2 nonattainment area has clean monitoring data; (3) suspend the requirements for the state to submit an attainment demonstration, a reasonable further progress plan, contingency measures, and other planning SIPs revisions related to attainment of the 2010 1-hour primary SO2 NAAQS until such time, if any, that the EPA subsequently determines, after notice-and-comment rulemaking in the Federal Register, that the area has violated the 2010 1-hour primary SO2 NAAQS.

The details of Missouri's submittal and the rationale for EPA's proposed action are explained in the NPR and will not be restated here.

The public comment period on EPA's proposed rule opened June 23, 2017, the date of its publication in the Federal Register, and closed on July 24, 2017. During this period, the EPA received one set of public comments on the NPR, which supported the proposed redesignation and provided additional technical information. The EPA acknowledges these supportive comments, and the additional technical information, however, as the comments were essentially in favor of the agency's proposed action, the EPA is not responding to the individual comments.

The EPA is finalizing its determination that the Jefferson County 2010 1-hour primary SO2 nonattainment area (hereby referred to as “the nonattainment area”), in Missouri, has attained the 2010 1-hour primary SO2 NAAQS.4 This action is based on complete, quality assured, and certified ambient air monitoring data from the 2013-2015 monitoring period, with additional certified monitoring data from 2016, associated dispersion modeling for the 2013-2015 emission years, as well as supplemental 2016 emissions inventory information—which show that the nonattainment area has attained the 2010 1-hour primary SO2 NAAQS. 5 6

The EPA has made the monitoring data, the modeling data, the supplemental emissions inventory information and additional information submitted by the state to support this action available in the docket to this rulemaking through www.regulations.gov and/or at the EPA Region 7 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

Under the CAA, a determination that a nonattainment area is attaining a NAAQS is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those imposed by state law. A determination of attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been stated above. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, these actions merely approve state law as meeting federal requirements and do not impose additional requirements beyond those imposed by state law. This action results in the suspension of certain Federal requirements and would not impose any additional requirements. For these reasons, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

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

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

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

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

In addition, this action does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 11, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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-2015-0308 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 November 13, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0308, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

In the Federal Register of Friday, July 17, 2015 (80 FR 42462) (FRL-9929-13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F8355) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide EPTC, S-ethyl dipropylthiocarbamate, in or on grass grown for seed, forage at 0.6 parts per million (ppm) and grass grown for seed, hay at 0.5 ppm. That document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

On an acute exposure basis, EPTC is highly toxic via inhalation and is moderately toxic via the oral and dermal routes of exposure. It is slightly irritating to eyes and minimally-irritating to skin. It is a weak skin sensitizer.

EPTC is an S-alkylthiocarbamate, which consistently produced cardiomyopathy and neuronal cell necrosis in studies of varying length of treatment and in different species. Cardiotoxicity was observed in subchronic and long-term studies, and in general, the severity and incidence of the lesion increased with increasing doses of EPTC. In 90-day feeding and inhalation studies and in two chronic feeding/oncogenicity studies, histopathological evaluation revealed myocardial degeneration. Myocardial degeneration in adult rats was also observed in two separate two-generation reproduction studies. In two chronic dog studies, degenerative changes in the cardiac muscle were observed when EPTC was administered in a capsule, but not when administered (at comparable doses) in the diet. In both dog studies, electrocardiograms were taken, but only one high-dose male in the capsule study had changes which were described as “potentially” treatment-related.

EPTC, as well as other thiocarbamates (molinate, cycloate, pebulate, vernolate and butylate), have toxic effects on the central and peripheral nervous systems. With EPTC, there was an increased incidence and severity of neuronal necrosis/degeneration in both the central and peripheral nervous systems of rats and dogs. In the rat neurotoxicity studies, dose-related increases in the incidence of neuronal necrosis were observed in the brains after acute and subchronic exposure to EPTC. In the rat developmental neurotoxicity study, a marginal decrease in absolute (not relative) pup brain weight (4-6%) was observed in only one sex (male pups) and at only one time point (PND63). Furthermore, this marginal effect had no dose-response, was not seen after perfusion, and had no corresponding necrosis. Therefore, this effect was considered marginal at best and not robust. In both of the combined chronic toxicity/carcinogenicity studies in the rat and in the chronic (capsule) study in the dog, treatment-related neuromuscular lesions were observed. In all of these studies, hindquarter weakness with corresponding histopathology findings of atrophy and degeneration of the skeletal muscle were observed. In the dog study, the lesions were described as Wallerian-type degeneration in the spinal cords and various peripheral nerves.

EPTC is a reversible acetylcholinesterase (AChE) inhibitor. Toxicology studies with EPTC did not show any consistent pattern of AChE-inhibition between different species, length of treatment, or the type of AChE enzyme measured. In some studies, brain AChE activity was inhibited without any effect on either plasma or erythrocyte AChE activities. In other studies, erythrocyte AChE was inhibited with no inhibition of either plasma or brain AChE. AChE-inhibition was observed at comparable or higher doses than where cardiac/neuronal effects were observed.

There is no evidence of increased susceptibility following in utero exposure to EPTC in either the rat or rabbit developmental toxicity study or following in utero and/or postnatal exposure in the 2-generation reproduction study in rats. EPTC is classified as “Not Likely to be Carcinogenic to Humans.” This is based on the lack of carcinogenic potential noted in the available studies. There are no concerns for mutagenicity or clastogenicity. There is also no concern for immunotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by EPTC as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies scan be found at https://www.regulations.gov in document EPTC: Human Health Risk Assessment for the Proposed Section 3 Registration for Use on Grasses Grown for Seed Production in docket ID number EPA-HQ-OPP-2015-0308.

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

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to EPTC, EPA considered exposure under the petitioned-for tolerances as well as all existing EPTC tolerances in 40 CFR 180.117. EPA assessed dietary exposures from EPTC 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 EPTC. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA incorporated tolerance-level residues (adjusted for metabolites at 15X, to estimate the concentration of residues of toxicological concern), 100 percent crop treated (PCT) for all commodities, and default processing factors for all processed commodities except for potato granules (1.4X) and for sugar beets (4X).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the same food consumption data and food residue level information as described above for acute dietary exposure.

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

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for EPTC. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water.

The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for EPTC in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of EPTC. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier II Surface Water Concentration Calculator (SWCC) and Pesticide Root Zone Model Ground Water (PRZM-GW) model, the highest estimated drinking water concentration (EDWC) of EPTC for acute exposure is estimated to be 378 parts per billion (ppb) from ground water. For chronic exposure, the highest EDWC is estimated to be 335 ppb from ground water. These EDWCs were directly entered into the dietary exposure models for both acute and chronic dietary risk assessments to assess the contribution from 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). EPTC 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.” Although thiocarbamates share some chemical and toxicological characteristics, the toxicological database does not support a testable hypothesis for a common mechanism of action. Therefore, for the purposes of this tolerance action EPA has assumed that EPTC does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. As discussed in Unit III.A., there was no qualitative or quantitative evidence of increased susceptibility to developing fetuses following in utero exposure to EPTC in the rabbit and rat developmental toxicity studies, or to offspring in the rat two-generation reproduction toxicity study. Although there was evidence of increased qualitative and quantitative susceptibility of offspring observed in the rat developmental neurotoxicity study. The effect on a marginal decreased absolute brain weight was observed only in male pups at one time-point on postnatal day 63. This effect was considered marginal and not robust since it had no dose-response, was not seen after perfusion, and had no corresponding necrosis. Therefore, there is low concern for susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for assessing chronic dietary exposure but retained at 10X for assessing acute dietary exposure to account for extrapolating a NOAEL from a LOAEL. That decision is based on the following findings:

i. The toxicity database for EPTC is complete and adequate to assess potential risk to infants and children.

ii. There is indication that EPTC has toxic effects on the central and peripheral nervous systems. Neuronal necrosis and degeneration were observed in both the central and peripheral nervous systems of rats and dogs after acute and subchronic exposure. Treatment-related neuromuscular lesions were also observed in chronic rat and dog studies. In all of these studies hindquarter weakness was noted, and at necropsy evaluation atrophy and degeneration of the skeletal muscle was observed. In the dog study, the lesions were described as Wallerian-type degeneration in the spinal cords and various peripheral nerves. AChE inhibition was also seen in a number of toxicology studies; however, no consistent pattern was witnessed across studies with respect to AChE inhibition between different species, length of treatment, or the type of AChE enzyme measured. All studies provide clear NOAELs and LOAELs, except the acute neurotoxicity study, and because the Agency is relying on that study for selection of the acute dietary exposure endpoint, EPA is retaining the 10X FQPA safety factor to account from the extrapolation from the LOAEL to the NOAEL.

iii. There is no evidence that EPTC results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study. Evidence of increased susceptibility to offspring was observed in the developmental neurotoxicity study; however, this effect was considered marginal and not robust. Therefore, there is low concern for the susceptibility.

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

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 EPTC will occupy 46% of the aPAD for children between 1-2 years old, the population subgroup 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 EPTC from food and water will utilize 65% of the cPAD for children between 1-2 years old, the population subgroup receiving the greatest exposure. There are no residential uses for EPTC.

3. Short- and intermediate-term risks. Short- and intermediate-term aggregate exposures takes into account short-term (1 to 30 days) and intermediate-term (1 to 6 months) residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Short- and intermediate-term adverse effects were identified; however, EPTC is not registered for any use patterns that would result in residential exposure. Because there is no residential exposure and chronic dietary exposure has already been assessed under the appropriately protective PADs (which is at least as protective as the PODs used to assess short- and intermediate-term risks), no further assessment of short- and intermediate-term risks are necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risks for EPTC.

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

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

An adequate gas chromatography with micro coulometric (GLC/MC) detection method (RR-50) listed under Method A in the Pesticide Analytical Manual (PAM Volume II, Section 180.117; is available for enforcing tolerances of EPTC per se in plant commodities. For the determination of hydroxylated metabolites (free or conjugated) of EPTC in or on plant commodities, an adequate gas chromatography with nitrogen-phosphorus detection (GC/NPD) enforcement method (Method RR-96-089B) is also available.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for EPTC.

The Agency is establishing tolerances for the forage and hay forms of “grass” rather than “grass grown for seed” as requested to conform with its food and feed commodity vocabulary. Also, the Agency is establishing the tolerance levels to conform with its policy of significant figures.

Therefore, tolerances are established for residues of EPTC, S-ethyl dipropylthiocarbamate, including its metabolites and degradates, in or on grass, forage at 0.60 ppm and grass, hay at 0.50.

This action 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 action has been exempted from review under Executive Order 12866, this action 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 action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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

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

Therefore, 40 CFR chapter I is amended as follows: