Federal Register Vol. 80, No.196,

Entities affected by this action are those that apply for and/or receive Federal financial assistance (grants, cooperative agreements or fellowships) from EPA including but not limited to: State and local governments, Indian tribes, intertribal consortia, institutions of higher education, hospitals, and other non-profit organizations, and individuals.

This final rule implements for the Environmental Protection Agency the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards published by the Office of Management and Budget (OMB) on December 26, 2013 in 2 CFR part 200 (Uniform Guidance—available at 78 FR 78589) and amended in the joint interim final rule published on December 19, 2014 (Interim Final Rule—available at 79 FR 75867). The Uniform Guidance followed on a notice of proposed guidance issued February 1, 2013 (available at 78 FR 7282), and an advanced notice of proposed guidance issued February 28, 2012 (available at 77 FR 11778).

The final guidance incorporated feedback received from the public in response to those earlier issuances. Additional supporting resources are available from the Council on Financial Assistance Reform at www.cfo.gov/COFAR.

The Uniform Guidance delivered on two presidential directives; Executive Order 13520 on Reducing Improper Payments (74 FR 62201; November 15, 2009), and February 28, 2011 Presidential Memorandum on Administrative Flexibility, Lower Costs, and Better Results for State, Local, and Tribal Governments, (Daily Comp. Pres. Docs.; http://www.thefederalregister.org/fdsys/pkg/DCPD-201100123/pdf/DCPD-201100123.pdf). It reflected more than two years of work by the Council on Financial Assistance Reform to improve the efficiency and effectiveness of Federal financial assistance. For a detailed discussion of the reform and its impacts, please see the Federal Register notice for the issuance of the final guidance (78 FR 78589).

EPA's final rule incorporates minor changes to address a typographical error identifying the standard for quality management systems for environmental information and technology programs and to add 5 U.S.C. 301 to the authority citations in the regulation text.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2030-0020. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements under the APA or any other statute because this rule pertains to grants, which the APA expressly exempts from notice and comment rulemaking requirements. 5 U.S.C. 553(a)(2).

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. UMRA does not apply to this action because it requires compliance with accounting and auditing procedures for grants, other money or property provided by the federal government.

This action does not have federalism implications. It 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.

This action does not have tribal implications as specified in Executive Order 13175. This action affects all applicants and recipients of EPA financial federal assistance and therefore no one entity type will be impacted disproportionally. Thus, Executive Order 13175 does not apply to this action. Although Executive Order 13175 does not apply to this action, EPA has made a conscious effort to engage tribal entities on changes to federal financial assistance requirements. EPA published materials summarizing these changes which can be found at http://www.epa.gov/ogd/grants/regulations.htm. EPA intends to host informational sessions tailored to tribal entities.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This action does not involve technical standards.

The EPA believes that it is not feasible to determine whether the human health or environmental risk addressed by this action will have potential disproportionately high and adverse effects on minority, low-income or indigenous populations.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Accordingly, the interim rule amending 2 CFR part 1500 and 40 CFR parts 30, 31, 33, 35, 40, 45, 46, and 47 which was published in the Federal Register at 79 FR 75867 on December 19, 2014, is adopted as final with the following changes:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Gulfstream Aerospace Corporation Model GVI airplanes. The NPRM published in the Federal Register on March 31, 2015 (80 FR 17005). The NPRM was prompted by reports of corrosion on in-service air non-return valves. Failure of the HP Stage 5 air non-return valve in the open position could result in engine instability and uncommanded in-flight shutdown. The NPRM proposed to require a revision to the Emergency Procedures section of the AFM and a revision to the maintenance or inspection program, as applicable, to incorporate airworthiness limitations for the HP Stage 5 air non-return valves. We are issuing this AD to ensure the flightcrew is provided with procedures to mitigate the risks associated with failure of the HP Stage 5 air non-return valve.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 17005, March 31, 2015) 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 this 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 (80 FR 17005, March 31, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the (NPRM 80 FR 17005, March 31, 2015).

We consider this AD interim action. The manufacturer is currently developing a modification that will positively address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.

We reviewed Section 04-08-20, Normal Airstart—Automatic; Section 04-08-30, Manual Airstart—Starter Assist; and Section 04-08-40, Manual Airstart—Windmilling; of Chapter 04, Emergency Procedures, of the Gulfstream GVI (G650) AFM, Document Number GAC-AC-G650-OPS-0001, Revision 5, dated August 12, 2013. This service information describes revised procedures for in-flight engine restart and operating procedures.

In addition, we reviewed Section 05-10-10, Airworthiness Limitations, of Chapter 05, Time Limits/Maintenance Checks, of the Gulfstream GVI (G650) Maintenance Manual (MM), Revision 4, dated September 30, 2013. This service information adds an airworthiness limitation for the HP Stage 5 air non-return valve.

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 of this AD.

We estimate that this AD affects 52 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Honeywell International Inc. TPE331-5, -5A, -5AB, -5B, -10, -10R, -10U, -10UF, -10UG, -10UGR, and -10UR model turboprop engines. The NPRM published in the Federal Register on May 12, 2014 (79 FR 26906). The NPRM was prompted by numerous reports of engine propeller shaft coupling failures, leading to engine overspeed and unexpected propeller pitch changes. This condition causes high aerodynamic and asymmetric drag that has resulted in uncommanded airplane yaw and roll. The NPRM proposed to require removing certain P/N engine propeller shaft couplings from service within certain compliance times to address the flight safety risk. The NPRM also proposed to insert a copy of certain airplane operating procedures into the applicable flight manuals. These procedures describe an emergency procedure for pilot reaction to an engine overspeed event after an engine propeller shaft coupling failure. We are issuing this AD to prevent loss of airplane control, leading to an accident.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM (79 FR 26906, May 12, 2014) and the FAA's response to the comment.

Honeywell International questioned whether compliance time should be stated in flight hours as opposed to flight cycles as used in the NPRM (79 FR 26906, May 12, 2014). Major periodic inspections are based on hours and not cycles.

We disagree. The FAA practice of stating compliance time is based on the component's mode of failure. In this case the failure mode was fatigue; therefore, a compliance time in flight cycles is appropriate. We did not change this AD.

Since we issued the NPRM (79 FR 26906, May 12, 2014), we discovered that paragraph (e)(4) of the Compliance section required clarification. We clarified that paragraph in this AD by deleting the requirement to insert a copy of Honeywell International Inc. Operating Information Letter (OIL) and requiring that Figure 1 to Paragraph (e)—Airplane Operating Procedures be inserted. Reference to the OIL was added as related information. The replacement procedure provides simplified, more concise text, for increased clarity.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with clarification.

We estimate that this AD will affect 485 engines installed on airplanes of U.S. registry. We also estimate that it will take about one hour per engine to perform the actions required by this AD, if done at the next scheduled turbine hot section inspection (HSI), and 40 hours per engine if done during an unscheduled access of the engine propeller shaft coupling. We also estimate that 400 engines will have the replacement actions done at a scheduled time of next turbine HSI, and 85 engines will have the replacement actions done at an unscheduled access of the engine propeller shaft coupling. The average labor rate is $85 per hour. Required parts will cost about $12,000 per engine. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $6,143,000.

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

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

Discussion

We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2003-13-01, Amendment 39-13201 (68 FR 37402, June 24, 2003). AD 2003-13-01 applied to certain The Boeing Company Model 767 airplanes. The SNPRM published in the Federal Register on September 29, 2014 (79 FR 58294). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on February 9, 2012 (77 FR 6685). The NPRM proposed to continue to require an inspection to detect cracks and fractures of the outboard hinge fitting assemblies on the trailing edge of the inboard main flap, and follow-on and corrective actions if necessary. For certain airplanes, the NPRM proposed to continue to require inspecting to determine if a tool runout option has been performed in the area. The NPRM also proposed to reduce a certain compliance time and add airplanes to the applicability. The NPRM provided optional terminating action for certain inspections. The NPRM was prompted by reports of hinge assembly fractures found before certain required compliance times in AD 2003-13-01. The SNPRM revised the NPRM by reducing repetitive inspection intervals for certain airplanes and limiting the inspection area. We are issuing this AD to prevent the inboard aft flap from separating from the wing and potentially striking the airplane, which could result in damage to the surrounding structure and potential personal injury.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the SNPRM (79 FR 58294, September 29, 2014) and the FAA's response to each comment.

Boeing concurred with the contents of the SNPRM (79 FR 58294, September 29, 2014).

American Airlines and UPS requested that we revise the SNPRM (79 FR 58294, September 29, 2014) by removing paragraph (q), because its provisions are redundant with the requirements of paragraph (k) of the SNPRM.

We agree with the requests, for the reason provided by the commenters. We have removed the referenced paragraph and redesignated subsequent paragraphs accordingly.

American Airlines requested that we revise the SNPRM (79 FR 58294, September 29, 2014) to identify the part numbers for fittings that are acceptable for terminating action, but to not require specific removal and reinstallation procedures. The commenter added that the design change of the fitting—not the installation method—corrects the unsafe condition.

We partially agree with the request. Although we did not identify the part numbers, we revised paragraph (o) in this AD to specify only the specific step that provides the replacement instructions and identifies the part number of the new fittings. Other removal and reinstallation actions related to the fitting replacement may be done using accepted methods in accordance with the operator's maintenance or inspection program.

We disagree with American Airlines' assertion that only the fitting design “corrects the unsafe condition.” ADs contain requirements that are related to addressing the unsafe condition, as determined by the FAA and the design approval holder that developed the service information. Therefore, many provisions of ADs address aspects of accomplishing the required maintenance that are necessary to prevent operators from inadvertently aggravating the unsafe condition or introducing new unsafe conditions. As in this case, the replacement instructions provided in the referenced service information are reasonably related to addressing the unsafe condition.

As always, operators preferring to use a method other than that specified in the referenced service information may request approval for an alternative method of compliance and, if approved, may use it instead of the procedures specified in the service information.

We further clarified this action throughout this AD by revising the description of the replacement part by specifying “the inboard main flap outboard hinge fittings.”

Aviation Partners Boeing, United Airlines, Delta Air Lines, and UPS requested that the SNPRM (79 FR 58294, September 29, 2014) specify that accomplishment of supplemental type certificate (STC) ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/59027f43b9a7486e86257b1d006591ee/$FILE/ST01920SE.pdf) does not affect the actions in the SNPRM.

We concur with the request. We have redesignated the introductory text of paragraph (c) of the SNPRM (79 FR 58294, September 29, 2014) as paragraph (c)(1), and subparagraphs (c)(1) and (c)(2) as (c)(1)(i) and (c)(1)(ii), and added new paragraph (c)(2) to this AD to state that installation of STC ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/59027f43b9a7486e86257b1d006591ee/$FILE/ST01920SE.pdf) does not affect the ability to accomplish the actions required by this final rule. Therefore, for airplanes on which STC ST01920SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

We have removed Boeing Alert Service Bulletin 767-57A0079, Revision 1, dated May 6, 2010, which is referred to for credit for certain actions, from paragraph (g)(2) of the proposed AD. Instead, we have revised paragraph (p)(1) of this AD to specifically provide credit for actions required by paragraph (g)(2) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 767-57A0079, Revision 1, dated May 6, 2010. We have redesignated subsequent paragraphs (including the addition of new paragraph (p)(3)) accordingly. This change does not affect the intent of paragraph (g)(2) of this AD.

We have revised the wording in paragraph (l) of this AD; this change has not changed the intent of that paragraph.

We have added a reference to paragraph (j) of this AD in paragraph (q)(4) of this AD to account for any AMOCs that might have been approved for the optional action specified in paragraph (j) of this AD.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this 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 (79 FR 58294, September 29, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM (79 FR 58294, September 29, 2014).

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

We reviewed Boeing Alert Service Bulletin 767-57A0079, Revision 2, dated March 23, 2012; and Boeing Alert Service Bulletin 767-57A0076, Revision 3, dated April 4, 2012. The service information describes procedures for repetitive eddy current inspections for cracks or fractures of the outboard hinge fitting assemblies on the trailing edge of the inboard main flap. The service information also describes procedures for replacing the fittings, which would eliminate the need for the repetitive inspections. 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 of this final rule.

We estimate that this AD affects 440 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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 by adding an AD that would apply to all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 188 series airplanes. The NPRM published in the Federal Register on June 5, 2015 (80 FR 32069). The NPRM was prompted by an evaluation by the DAH indicating the left and right lower surface panels of the wings are subject to WFD. The NPRM proposed to require repetitive inspections for cracking at these panels, and repair if necessary. The NPRM also proposed to require a one-time bolt-hole eddy current inspection of all open holes for cracking, repair if necessary, and modification. We are issuing this AD to prevent fatigue cracking of the left and right lower surface panels of the wings, which could result in reduced structural integrity of the airplane.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 32069, June 5, 2015) 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 this 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 (80 FR 32069, June 5, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM 80 FR 32069, June 5, 2015).

We reviewed Lockheed Martin Electra Service Bulletin 88/SB-707C, Revision C, dated April 30, 2014. The service information describes procedures for repetitive inspections for cracking of the left and right lower surface panels of the wings on the inboard and outboard sides of the buttock line (BL) 65 splice joint, and repair. This service information also describes procedures for a one-time bolt-hole eddy current inspection of all open holes for cracking, repair, and modification of the BL 65 wing root joint. 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 of this AD.

We estimate that this AD affects 4 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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:

Background

The authority for parts 730 and 744 of the EAR rests, in part, on Executive Order 13224 of September 23, 2001—National Emergency With Respect to Persons Who Commit, Threaten To Commit, Or Support Terrorism, 66 FR 49079, 3 CFR, 2001 Comp., p. 786 and on annual notices continuing the emergency declared in that executive order. This rule revises the authority paragraphs for the affected parts to cite the most recent such notice, which the President signed on September 18, 2015.

This rule is purely non-substantive, and makes no changes other than to revise CFR authority paragraphs for the purpose of making the authority citations current. It does not change the text of any section of the EAR, nor does it alter any right, obligation or prohibition that applies to any person under the EAR.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). This rule does not impose any regulatory burden on the public and is consistent with the goals of Executive Order 13563. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule does not involve any collection of information.

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

4. The Department finds that there is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because they are unnecessary. This rule only updates legal authority citations. It clarifies information and is non-discretionary. This rule does not alter any right, obligation or prohibition that applies to any person under the EAR. Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness otherwise required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because neither the Administrative Procedure Act nor any other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, no Regulatory Flexibility Analysis is required and none has been prepared.

Accordingly, parts 730 and 744 of the EAR (15 CFR parts 730-774) are amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. The phrase “the Commonwealth” refers to the Commonwealth of Massachusetts.

Organization of this document. The following outline is provided to aid in locating information in this preamble.

On June 1, 2010, and July 10, 2014, the Commonwealth of Massachusetts submitted formal revisions to its State Implementation Plan (SIP). The Commonwealth held public hearings on February 28, 2007, March 2, 2007, and November 25, 2008 for the items within the June 1, 2010 submittal, and on November 17, 2011 for the July 10, 2014 submittal. The June 1, 2010 SIP revision request contains air pollution control requirements that will reduce volatile organic compound (VOC) emissions from architectural and industrial maintenance (AIM) coatings and from consumer products, and also contains a minor regulatory revision pertaining to the definition of VOC. We approved other portions of the Commonwealth's June 1, 2010 submittal pertaining to solvent metal degreasing, motor vehicle fuel dispensing, and several definitions on September 9, 2013. See 78 FR 54960. The Commonwealth's July 10, 2014 submittal contains a regulation limiting VOC emissions from adhesives and sealants, and several minor revisions to existing regulations.

The Commonwealth's June 1, 2010 submittal includes an amended version of Chapter 310 of the Code of Massachusetts Regulations (CMR), section 7.25, Best Available Controls for Consumer and Commercial Products. This regulation includes emission limits for AIM coatings. EPA approved Massachusetts' initial regulation for these sectors on December 19, 1995 (60 FR 65240), with a minor update approved on April 11, 2000 (65 FR 19323).

The amended regulation achieves further emission reductions of VOCs from these sectors. This was accomplished by lowering many of the existing VOC emission limits, and by expanding the universe of products covered by these regulations. Massachusetts adopted these requirements to assist with efforts to attain EPA's 1997 8-hour ozone standard. In 2004, EPA designated Massachusetts as nonattainment for this standard, and established two moderate ozone nonattainment areas which together encompass the entire state. See 69 FR 23858.

Subsequent to Massachusetts' initial adoption of these rules, EPA promulgated within 40 CFR part 59 emission standards for consumer products which became effective December 10, 1998, and for AIM coatings, which became effective on September 13, 1999. EPA has determined that the Commonwealth's rules are no less stringent than EPA requirements found at 40 CFR part 59.

Massachusetts based the current revisions on control measures in place in California and on model rules adopted by the Ozone Transport Commission (OTC) in 2001 for AIM coatings, and in 2006 for consumer products. The Commonwealth updated these existing requirements in two phases. The first phase occurred in 2007 and involved the majority of the changes to the regulation, consisting of the tightening of emission limits and addition of product categories described further in section III of this document. The second phased occurred in 2008 and was undertaken to add alternative compliance plan (ACP) provisions to the regulation.

Definitions relied upon within the Commonwealth's air pollution control regulations are codified within 310 CMR 7.00. On January 18, 2007 (72 FR 2193), EPA amended its definition of VOC that is contained within 40 CFR 51.100(s) by adding the chemical compound HFE-7300 to the list of compounds that are not considered VOCs due to their negligible photochemical reactivity. Therefore, the Commonwealth also added this compound to its list of compounds which are exempt from the definition of VOC pursuant to 310 CMR 7.00.

On July 10, 2014, Massachusetts submitted a newly adopted VOC control regulation, 310 CMR 7.18(30), Adhesives and Sealants, to EPA as a revision to its SIP. The regulation establishes VOC content limits for industrial adhesives and sealants and associated cleaning and surface preparation operations. The Commonwealth's submittal also makes minor revisions to other sections of 310 CMR 7.18 to make these sections consistent with the new adhesives and sealants regulation.

Massachusetts amended its existing VOC control regulation that ensures reasonably available control technology (RACT) is applied to certain industrial sources to clarify the relationship between RACT and Best Available Control Technology (BACT) and Lowest Achievable Emission Rates (LAER), and further amended it to clarify the requirements for emission control plan (ECP) submittals. In addition, Massachusetts' submittal initially included revisions to 310 CMR 7.18(1)(b). This provision, which deals with halogenated organic compounds (HOC), is not, however, part of the SIP. Therefore, Massachusetts subsequently withdrew the revised 310 CMR 7.18(1)(b) from the SIP submittal in a letter dated July 15, 2015.

The Commonwealth's NOX RACT regulation was amended similarly to the above mentioned amendment made to the VOC RACT requirements with regard to the relationship between RACT, BACT, and LAER, and also to ECPs. Additionally, the July 10, 2014 submittal included a rewording of 310 CMR 7.19(1)(c)(9) to clarify the intent of the paragraph.

The July 10, 2014 submittal included an edit to the paragraph located at 310 CMR 7.00 Appendix B(4)(b)(7) pertaining to bubbles approved prior to May 25, 1988. A bubble is a mechanism that allows the emission limits for two or more units to be analyzed collectively for regulatory purposes.

Massachusetts updated 310 CMR 7.25, Best Available Controls for Consumer Products, based on model rules adopted by the OTC in 2001 for AIM coatings, and in 2006 for consumer products. These OTC rules were, in turn, based on requirements adopted and implemented by the California Air Resources Board (CARB).

The technical support document (TSD) prepared for this action, which is available in the docket, contains tables that provide a comparison of the Commonwealth's newly adopted VOC content limits versus the existing EPA requirements. In conducting this comparison, we noted that a minor difference exists in how recycled coatings are treated within the Commonwealth's AIM coating rule and the federal rule. The Commonwealth's rule establishes a VOC content limit of 250 grams per liter (g/l) for recycled coatings. The federal AIM rule uses a formula based on the percent of the coating that is from recycled materials, and then determines an adjusted VOC content that is compared to the normative standard for that product category. Therefore, it is conceivable that the Commonwealth's regulation could provide a less stringent standard than the federal AIM rule would provide for a product containing recycled materials. If this situation occurs, we note that the limits within the federal AIM rule would need to be met. In all other cases, the Commonwealth's VOC content limits are either more stringent than, or equivalent to, those within the federal AIM rule.

Additionally, there are a number of product categories in the federal AIM rule that are not similarly named within the Commonwealth's rule. Table 2 within the TSD prepared for this action identifies these product categories, and links them to the product category with the Massachusetts AIM rule that applies to them. In all cases, the Commonwealth's VOC content limits are either more stringent than, or equivalent to, those within the federal AIM rule.

Massachusetts' revised requirements for AIM coatings contains a “sell through” provision which enabled coating manufacturers to sell coatings manufactured before the effective date of these requirements to be sold for up to three years from the rule's January 1, 2009 compliance date. The rule also includes labeling and recordkeeping requirements that are consistent with EPA's requirements. Coating manufacturers must maintain coating production records for a minimum of 5 years, and make these records available upon request.

Additional updates to the Commonwealth's previously SIP-approved requirements for AIM coatings include the following items:

1. The requirement at 7.25(4) regarding a prohibition against specifying non-compliant AIM products for work to be done within Massachusetts was moved to 7.25(11) because it pertains to AIM coatings, and does not apply to consumer and commercial products.

2. A provision explaining that possible future emission standards promulgated by EPA would override existing Massachusetts standards was removed. We note, however, that any future EPA standards that are more stringent than the comparable Massachusetts standard would indeed need to be complied with.

3. Requirements for products registered pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) were moved from 7.25(6) to 7.25(11) and (12).

4. The existing innovative products exemption was moved from 7.25(7) to 7.25(12);

5. The requirement at 7.25(8) that compliance certifications be submitted to the Massachusetts Department of Environmental Protection (MassDEP) was removed, but the obligation for sources to prepare and maintain this information on site, and submit it to MassDEP upon request, was retained.

The updates Massachusetts has made to its existing AIM coatings regulation strengthen the rule and are consistent with the Clean Air Act, and we are therefore approving them as revisions to the Commonwealth's SIP.

The Commonwealth's updated consumer product requirements became effective January 1, 2009, by which time other OTC states, and California, had adopted similar limits. This enables manufacturers to achieve compliance by using product reformulations that are similar to the available compliant products in other jurisdictions. Table 3 within the TSD prepared for this action compares the VOC content limits within Massachusetts' updated regulation and the federal requirements. The VOC content limits within Table 3 indicate that in all instances the Commonwealth's limits are equal to, or more stringent than, the comparable EPA limit.

The consumer products provisions of 310 CMR 7.25 contain a number of flexibility provisions, including the three year sell through provision mentioned earlier with regard to the AIM coating requirements. The rule also allows an entity to apply for a variance that would postpone compliance upon a successful showing of an economic hardship due to the tightened limits within the rule. A manufacturer may apply directly to the MassDEP for such an exemption, or alternatively, may request that an exemption awarded by CARB be used for compliance in Massachusetts. In the latter case, the CARB issued exemption must be shown to be based on data that is valid in the Commonwealth. In order for a variance to be granted, a source must meet a number of requirements including a demonstration that compliance would result in extraordinary economic hardship, and submittal of a compliance report indicating that the source will meet the rule's requirements as expeditiously as possible. Additionally, the rule requires that any such request for a variance be subject to a public hearing, and must also be approved by EPA before becoming effective.

The Commonwealth initially chose to not allow alternative compliance plans (ACPs) within its regulation, but changed course and adopted provisions allowing for them within amendments made on March 6, 2009, in part due to comments from industry requesting this flexibility. The provision allows manufacturers to average VOC emissions among products to meet overall VOC emission limits, and is used by other OTC states and by CARB within their consumer products rules. After consulting with other states on their experience offering this flexibility, the Commonwealth determined that it was appropriate to allow this with its consumer products regulation. EPA commented that any such ACP would need to be approved into the Massachusetts SIP, and within its response to comments, the Commonwealth committed to submit any such ACP it receives to EPA for approval into the Massachusetts SIP.

Our review of these amendments to Massachusetts' consumer products regulation finds that they act to strengthen them, meet federal requirements, and will help to further reduce VOC emissions, and we are therefore approving them into the Commonwealth's SIP.

The Commonwealth modified its existing definition of VOC contained within 310 CMR 7.00 by adding the compound HFE-7300 to the list of exempt compounds. This was done to be consistent with a similar action taken by EPA on January 18, 2007. See 72 FR 2193. EPA added HFE-7300 to the list of compounds that are exempt from the definition of VOC due to its negligible photochemical reactivity. This change is consistent with EPA's definition of VOC at 40 CFR 51.100(s), and we are approving it into the Massachusetts SIP.

The Commonwealth's adhesives and sealants regulation imposes VOC content limits, or other controls, on a number of products, and is based on similar control measures that many California air districts, and other states in the Northeast, have adopted. In particular, Massachusetts based its regulation on a 2006 OTC model rule, which in turn was based on earlier requirements adopted in California, and on EPA's 2008 document, “Control Techniques Guidelines for Miscellaneous Adhesives.” EPA develops Control Technique Guidelines (CTGs) to assist states with determining the appropriate level of control for sources subject to RACT. Due to its inclusion within the Ozone Transport Region, the Commonwealth is required to ensure that RACT is applied to industrial sources in the Massachusetts pursuant to section 184(b)(1)(B) of the CAA. In 2006, 2007, and 2008, EPA published final CTGs for a number of VOC emitting activities, and Massachusetts' adoption of this regulation satisfies the Commonwealth's obligation to adopt regulations for this particular CTG.

Although Massachusetts' existing Consumer Products regulation at 310 CMR 7.25(12) regulates “household” adhesives and sealants, it exempts such products sold in containers and volumes more than 16 fluid ounces or weighing more than 1 pound. Many of these exempted items would be covered by the Commonwealth's adhesives and sealants rule. The compliance date within the Commonwealth's adhesives and sealants rule is January 1, 2015 with regard to a manufacturer of products sold in Massachusetts. Additionally, the compliance date is September 1, 2015, for any person who sells, supplies, or offers for sale any covered product in Massachusetts, and May 1, 2016 for any person who uses, applies, or solicits the use of covered products in Massachusetts.

Table 4 of the TSD prepared for this action provides the VOC content limits contained within the rule for the covered product categories, which are adhesives, sealants, adhesive primers, and sealant primers, and Table 5 of the TSD contains the VOC content limits for adhesives applied to particular substrates. The Massachusetts rule contains VOC content limits that are equal to, or more stringent than, the comparable limits within EPA's CTG. EPA's CTG contains VOC content limits for “motor vehicle adhesives” and “motor vehicle weather-strip adhesives,” two product categories not directly addressed in the Commonwealth's rule. In its response to comments document prepared for the adhesives and sealants rulemaking, Massachusetts notes this difference and indicates that adhesives that fall under these two categories will be regulated under the applicable category limits for adhesives applied to particular substrates. These limits have a maximum VOC content of 250 grams/liter and are at least as stringent as the limits for motor vehicle adhesives and motor vehicle weather-strip adhesives within EPA's CTG.

The Commonwealth's adhesives and sealants rule also contains testing, labeling, and recordkeeping requirements for entities subject to the rule. We are approving the Commonwealth's adhesives and sealants regulation as meeting the requirements of RACT as outlined within EPA's 2008 CTG for this category of VOC emitting products.

Massachusetts amended its existing VOC RACT regulation to clarify the relationship between RACT, BACT, and LAER. Specifically, the Commonwealth clarified that an emission unit subject to a BACT or LAER plan approval is not subject to RACT unless and until such time as a RACT standard becomes more stringent than the existing BACT or LAER standard to which the unit is subject. Regarding emission control plans (ECPs), Massachusetts made changes to 310 CMR 7.18(20)(a) and (b) to clarify which sources need such plans, and which sources are exempt.

ii. Changes to 310 CMR 7.19, NOX RACT

The Commonwealth's NOx RACT regulation was amended similarly to the above mentioned amendment made to the VOC RACT requirements with regard to the relationship between RACT, BACT, and LAER. The revised language appears within the paragraph located at section 310 CMR 7.19(1)(c)(9).

The July 10, 2014 submittal included an edit to 310 CMR 7.00 Appendix B, which EPA previously approved into the Commonwealth's SIP on August 8, 1996. See 61 FR 41335. The amendment concerns paragraph (4)(b)(7) of Appendix B pertaining to bubbles approved prior to May 25, 1988. A bubble is a mechanism that allows the emission limits for two or more units to be analyzed collectively for regulatory purposes. The revision applies to facilities that were issued bubbles prior to May 25, 1988, that seek to modify the requirements of the bubble solely to incorporate a more stringent RACT requirement. The revised language clarifies the original intent of the regulation that such facilities are not subject to the requirements of 310 CMR 7.00: Appendix B(4).

We have reviewed the Commonwealth's SIP submittals made on July 10, 2014, and find that they are consistent with the requirements of the Clean Air Act. We are, therefore, approving them as revisions to the Commonwealth's SIP.

We are approving revisions to the Massachusetts SIP submitted on June 1, 2010, consisting of updates to an existing regulation limiting VOC emissions from AIM coatings and consumer products, and also a revised definition of VOC. We are also approving SIP revisions submitted on July 10, 2014, consisting of a new regulation that limits VOC emissions from adhesives and sealants, several minor updates to the Commonwealth's existing VOC and NOX RACT regulations, and a minor change to Appendix B, Emissions Banking, Trading, and Averaging.

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comments be filed. This rule will be effective December 8, 2015 without further notice unless the Agency receives relevant adverse comments by November 9, 2015.

If the EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 8, 2015 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Massachusetts' regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive 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 Clean Air Act; and

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 8, 2015. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. Section 110(a) of the CAA generally requires states to make a SIP submission to meet applicable requirements in order to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. For additional information on the infrastructure SIP requirements, see the proposed rulemaking published on July 30, 2015 (80 FR 45469).

On July 30, 2015, EPA proposed to approve portions of Kentucky's July 17, 2012, 2008 Lead NAAQS infrastructure SIP submission with the exception of provisions pertaining to PSD permitting in sections 110(a)(2)(C), prong 3 of D(i) and (J). EPA did not receive any comments, adverse or otherwise, on the July 30, 2015, proposed rule. EPA took final action to approve the PSD permitting requirements in sections 110(a)(2)(C), prong 3 of D(i) and (J) on March 18, 2015 (80 FR 14019).

With the exception of provisions pertaining to PSD permitting requirements, EPA is taking final action to approve Kentucky's July 17, 2012, infrastructure submission because it addresses the required infrastructure elements of the CAA 110(a)(1) and (2) to ensure that the 2008 Lead NAAQS is implemented, enforced, and maintained in Kentucky.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act 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, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive 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 Clean Air Act; and

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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 December 8, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. Section 110(a) of the CAA generally requires states to make a SIP submission to meet applicable requirements in order to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. For additional information on the infrastructure SIP requirements, see the proposed rulemaking published on July 20, 2015. See 80 FR 42777.

On July 20, 2015, EPA proposed to approve portions of Georgia's May 14, 2012, 2008 8-hour ozone NAAQS infrastructure SIP submission with the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), (D)(i)(II) prong 3 and (J); and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4). See 80 FR 42777. EPA did not receive any comments, adverse or otherwise, on the July 20, 2015, proposed rule. On March 18, 2015, EPA took final action to approve the PSD permitting requirements listed above (80 FR 14019), and is not taking any action on the interstate transport requirements listed above. EPA is taking final action to approve the portions of Georgia's infrastructure SIP submission proposed on July 20, 2015, as demonstrating that the State meets the applicable requirements of sections 110(a)(1) and (2) of the CAA for the 2008 8-hour ozone NAAQS.

With the exception of the PSD permitting provisions in sections 110(a)(2)(C), (D)(i)(II) prong 3 and (J); and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4), EPA is taking final action to approve Georgia's May 14, 2012, infrastructure SIP submission because it addresses the section 110(a)(1) and (2) requirements of the CAA to ensure that the 2008 8-hour ozone NAAQS is implemented, enforced, and maintained in Georgia.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act 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, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive 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 EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 8, 2015. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. Section 110(a) of the CAA generally requires states to make a SIP submission to meet applicable requirements in order to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. For additional information on the infrastructure SIP requirements, see the proposed rulemaking published on July 20, 2015 (80 FR 42765).

On July 20, 2015, EPA proposed to approve in part, and disapprove in part, Alabama's November 4, 2011, 2008 Lead NAAQS infrastructure SIP submission. EPA did not receive any comments, adverse or otherwise, on the July 20, 2015, proposed rule. EPA is not taking any action today pertaining to the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2008 Lead NAAQS. EPA took final action on these elements in a separate action on March 18, 2015 (80 FR 14019). With respect to Alabama's infrastructure SIP submissions related to section 110(a)(2)(E)(ii) respecting the section 128 state board requirements, EPA is taking final action to disapprove this element of Alabama's submissions.

With the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of (D)(i) and (J), and the state board requirements of section 110(a)(2)(E)(ii), EPA is taking final action to approve that ADEM's infrastructure SIP submission, submitted November 4, 2011, for the 2008 Lead NAAQS meets the above described infrastructure SIP requirements. EPA is taking final action to disapprove Alabama's infrastructure submission for section 110(a)(2)(E)(ii) because the State's implementation plan does not contain provisions to comply with section 128 of the Act.

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive 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 Clean Air Act; and

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 8, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

Organization of this document. The following outline is provided to aid in locating information in this preamble.

On July 24, 2014, supplemented with a technical support document (TSD) on August 20, 2015, the State of Maine submitted two formal revisions to its State Implementation Plan (SIP). The SIP revisions consist of Maine's 06-096 Code of Maine Regulations (CMR) Chapter 149, “General Permit Regulation for Nonmetallic Mineral Processing Plants” 1 (Chapter 149) and Maine's 06-096 CMR Chapter 164, “General Permit Regulation for Concrete Batch Plants” 2 (Chapter 164), accompanied by a TSD. Maine originally adopted Chapter 149 “General Permit Regulation for Nonmetallic Mineral Processing Plants” on July 17, 2008 and adopted amendments on April 4, 2014, with an effective date of April 27, 2014. Maine adopted Chapter 164 “General Permit Regulation for Concrete Batch Plants” on April 4, 2014, with an effective date of April 27, 2014.

Maine's Chapter 115 includes the State's new source review (NSR) requirements for new major and minor sources and modifications of air emissions. Among other requirements, Chapter 115 includes requirements for such sources to apply Best Available Control Technology (BACT). Maine's July 24, 2014 SIP submittal provides an option for minor new nonmetallic mineral processing plants and concrete batch plants to satisfy the state's minor NSR permitting requirements under Chapter 115 in lieu of obtaining an individual permit. The two general permit regulations include monitoring, record keeping and reporting requirements, as is required for an individual minor NSR permit under Chapter 115, and includes pollution control requirements and emission limitations that satisfy Chapter 115's BACT requirements for nonmetallic mineral processing plants and concrete batch plants. See section II of this notice for details about the requirements in Maine's general permit regulations and see section III for a summary of EPA's evaluation of the State's general permit regulations. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of either or both of Maine's regulations as part of this action and if that provision or provisions may be severed from the remainder of the State's regulations and this action, EPA may adopt as final those provisions of this action that are not the subject of an adverse comment.

Chapter 149, “General Permit Regulation for Nonmetallic Mineral Processing Plants” regulates stationary and portable nonmetallic mineral processing plants which are not major sources. Owners and operators may obtain specific regulatory coverage under Chapter 149 in lieu of an individual air emissions license. Sources do so by obtaining a Crusher Identification Number (CIN) for each individual rock crusher and submitting a Notification of Intent to Comply (NOITC), attesting to their formal agreement to abide by all applicable conditions of Chapter 149. Power plant engines, located at the plant in question, including generator sets and diesel drives, do not require a CIN, but are subject to the provisions of the general permit regulation when associated with the rock crushing activities. In addition, power plant engines located at the plant also have size limits and must be portable, non-stationary engines in order for the plant to be eligible for coverage under the general permit regulation. Maine's general permit regulation also limits facility-wide fuel use to no more than 65,000 gallons of fuel oil, or the combined equivalent of natural gas and propane, in a calendar year. This fuel use limit was chosen to ensure that emissions of all criteria pollutants remain under the reporting thresholds for Maine's Emissions Statements rule. The Emissions Statement reporting thresholds are well below Chapter 115 thresholds which require facilities to perform an air quality impact analysis. Finally, if the construction, modification, or operation of the nonmetallic mineral processing plant would not comply with all of the conditions of the general permit regulation, the owner must apply for an individual air emission license under Chapter 115 prior to beginning the actual construction, modification or operation of the source.

Chapter 149 requires operators to establish and maintain best management practices for suppression of fugitive particulate matter during any construction, reconstruction, or operation which may result in fugitive dust, and to maintain and operate all air pollution systems in a manner consistent with good air pollution control practices for minimizing emissions. Chapter 149 requires spray nozzles or other control equipment for particulate control on the rock crusher. Plants using a control method other than water sprays or carry over from up-stream water sprays are excluded from applicability of Chapter 149 and must obtain an individual air emission license under Chapter 115. Chapter 149 requires monthly inspections of water sprays and a log detailing the maintenance and corrective actions on particulate matter control equipment. For eligible power plant engines associated with the rock crushing activities, Chapter 149 sets facility-wide fuel usage limits, fuel sulfur content limits, particulate matter emission limits if the engine is greater than 3.0 MMBtu/hr, and prohibitions against using any engine as a dispatched load generator. See sections 5(B) and 5(C) of Chapter 149.

Chapter 164 “General Permit Regulation for Concrete Batch Plants” regulates concrete batch plants which are not major sources. Owners and operators may obtain specific regulatory coverage under Chapter 164 in lieu of obtaining an individual air emissions license. Sources do so by obtaining a General Permit Number (GPN) for each unit and submitting a Notification of Intent to Comply (NOITC), attesting to their formal agreement to abide by all applicable conditions of Chapter 164. Generator sets, small boilers and hot water heaters, located at the concrete batch plant, do not require a GPN but are subject to the provisions of the general permit regulation when associated with the operations of the plant. Engines, boilers, and hot water heaters eligible for coverage under the general permit regulation must meet specified size limits. In addition, engines must be portable, non-stationary engines in order for the plant to be eligible for coverage under the general permit regulation. Maine's general permit regulation also limits facility-wide fuel use to no more than 65,000 gallons of fuel oil, or the combined equivalent of natural gas and propane, in a calendar year. This fuel use limit was chosen to ensure that emissions of all criteria pollutants remain under the reporting thresholds for Maine's Emissions Statements rule. The Emissions Statement reporting thresholds are well below Chapter 115 thresholds which require facilities to perform an air quality impact analysis. Finally, if the construction, modification, or operation of a concrete batch plant would not comply with all of the conditions of the general permit regulation, the owner must apply for an individual air emission license under Chapter 115 prior to beginning the actual construction, modification or operation of the source.

Chapter 164 requires operators to establish and maintain best management practices for suppression of fugitive particulate matter during any construction, reconstruction, or operation which may result in fugitive dust, and to maintain and operate all air pollution systems in a manner consistent with good air pollution control practices for minimizing emissions. Operators are required to maintain particulate control on the concrete batch plant, and associated material handling systems, bag house filtration systems and cement silos. Chapter 164 requires monthly inspections of control equipment and a log detailing the maintenance and corrective actions on particulate matter control equipment, as well as testing, monitoring and recordkeeping requirements. In addition, for engines, boilers and hot water heaters, Chapter 164 sets sulfur content in fuel limits, facility fuel usage limits, and particulate matter limits if the engines, boilers, and hot water heaters are greater than 3.0 MMBtu/hr. See section 5(B) in Chapter 164.

Maine's July 24, 2014 SIP submittals establish and require general permit regulations meant to satisfy the Chapter 115 minor NSR requirements for nonmetallic mineral processing plants and concrete batch plants. The general permit regulations include control requirements and emission limits that satisfy the state's minor NSR BACT requirement. The regulations also include monitoring, recordkeeping and reporting requirements as required by the state's Chapter 115 minor NSR permitting requirements. The regulations provide an option for minor new and modified nonmetallic mineral processing plants and concrete batch plants to comply with the requirements of the general permit regulation in lieu of applying for and receiving a minor NSR permit under Chapter 115.

Section 110(a)(2)(C) of the Act requires, in part, that state SIPs include permit programs that regulate the construction and modification of stationary sources adequate to ensure the national ambient air quality standards (NAAQS) are achieved. A minor stationary source is a source whose potential to emit is lower than the major source applicability threshold for particular pollutants defined by the applicable major NSR program. Because Maine's SIP submittals are only meant to satisfy the requirements of minor NSR, we evaluated Maine's Chapter 149 and Chapter 164 general permit regulations under EPA's implementing regulations for minor NSR SIP revisions found at 40 CFR 51.160 through 51.164. EPA requires that a minor NSR program include legally enforceable procedures, public availability of information, identification of the responsible agency, administrative procedures, and stack height procedures (see 40 CFR 51.160-51.164). The following describes how Maine's SIP submittals meet these requirements.

The regulation at 40 CFR 51.160(a) requires that each plan must set forth legally enforceable procedures that enable the State or local agency to determine whether the construction or modification of a facility, building, structure or installation or combination of these will result in: (1) A violation of applicable portions of the control strategy; or (2) interference with attainment or maintenance of a national standard in the state in which the proposed source or modification is located or in a neighboring state. The regulation at 40 CFR 50.160(b) provides that such procedures must include means by which the State or local agency responsible for final decision-making on the application for approval to construct or modify will prevent such construction or modification if: (1) It will result in a violation of applicable portions of the control strategy; or (2) it will interfere with the attainment or maintenance of a national standard.

Maine's Chapter 115 Major and Minor Source Air Emission License Regulations require all applicants for new construction and modifications to existing sources to provide an assessment of the ambient air quality impact of the source, including the NAAQS, if the new source or modification exceeds certain thresholds. The source or modification must demonstrate that the maximum emission rates of all regulated and hazardous air pollutants will not violate any applicable requirements or interfere with attainment or maintenance of a NAAQS in Maine or a neighboring state.

To comply with this requirement, Maine's general permit regulations are not applicable to larger sources that exceed the regulations' emission threshold levels or other program requirements. These larger sources must obtain an individual air emissions license under Chapter 115. In addition, both general permit regulations give Maine the authority to prohibit a source from using the general permit rules if Maine has reasonable cause to believe that emissions from the proposed, modified, or relocated source will violate the control strategy or interfere with attainment or maintenance of a national standard in Maine or in a neighboring state. See section 1(F)(9) of Chapters 149 and 164.

Maine also conducted a technical analysis to determine the impact of the smaller nonmetallic mineral processing plants and concrete batch plants that would be eligible for coverage under the general permit regulations. Maine analyzed its 2011 emissions inventory data to assess the relative contribution of nonmetallic mineral processing plants and concrete batch plants to the statewide particulate matter (PM) inventory. Annual emissions from these source categories were significantly lower than total emissions of PM in the State. There is a total of 334 nonmetallic mineral processing plants licensed in Maine, of which 238 plants hold an individual license under Chapter 115. The remaining 96 facilities have been licensed under the Chapter 149 general permit rule and Maine estimates the emissions from these plants combined to be only 8.64 tons per year. There is a total of 73 licensed concrete batch plants in Maine, of which 59 hold an individual license under Chapter 115. The remaining 14 facilities are licensed under the Chapter 164 general permit rule and their combined emissions are estimated at 5.6 tons per year. Statewide PM emissions in 2011 totaled 69,370.64 tons per year.

Thus, Maine's TSD demonstrates that PM emissions from all nonmetallic mineral processing plants account for a maximum of 0.0433% of the statewide PM emissions inventory, with plants obtaining coverage under Maine's general permit regulations accounting for only 0.01% of the total PM emissions statewide. PM emissions from all concrete batch plants account for a maximum of 0.0421% of total statewide PM emissions, with plants obtaining coverage under Maine's general permit regulations accounting for only 0.008% of total PM emissions statewide. Therefore, Maine's TSD demonstrates to EPA's satisfaction that the air quality impacts from the nonmetallic mineral processing plants and concrete batch plants eligible for coverage under Maine's general permit regulations to be extremely small.

Maine does not expect there will be a significant change in the number of sources that are using the general permit programs, since many owners and operators of eligible units have other permitted equipment (e.g., an asphalt batch plant) that must be permitted through the standard licensing process under Chapter 115. Maine also does not expect significant growth in either of these source sectors. Sources applying for a license under these general permit rules will be required to meet all applicable control requirements, as described above in section II. Prior to the adoption of Chapters 149 and 164, Maine did not have specific regulations or control requirements for rock crushers and concrete batch plants per se. Instead, control requirements for new and modified sources were established utilizing a case-by-case best available control technology (BACT) determination through the Maine's Chapter 115 Major and Minor Source Air Emission License Regulations. With the adoption of the general permit rules, these control technology requirements are now explicitly codified for these specific sources in Maine's regulations. Although Maine does not anticipate control technology improvements for these minor sources, Maine retains the authority to amend these rules in the event federal standards or requirements change.

The regulation at 40 CFR 51.160(c) specifies that the plan's procedures must provide for the submission, by the owner or operator of the building, facility, structure, or installation to be constructed or modified, of such information on: (1) The nature and amounts of emissions to be emitted by it or emitted by associated mobile sources; (2) the location, design, construction, and operation of such facility, building, structure, or installation as may be necessary to permit the State or local agency to make the determination whether the propose construction would result in any unacceptable air quality impacts. See 40 CFR 51.160(a) and (b). Maine's Chapter 149 and 164 rules both establish application information required to be submitted for a general permit, including, but not limited to the following: (1) Identifying information, including contact information for the owner; (2) The age, type, and maximum processing rate; (3) A unique identifier, such as a serial number, etc. associated with the source; (4) Any other information that may be necessary to implement and enforce any requirements applicable to the source pursuant to federal or state air emission control regulations; and (5) If required by the Department, proposed monitoring, testing, record keeping and reporting protocols and results of previously performed performance tests. See section 3(B) of Chapter 149 and 164. Moreover, Maine's application forms for coverage under the general permit regulations require an applicant to submit other information, such as the location of the facility, which would assist the State in determining whether the proposed construction would result in any unacceptable air quality impacts. EPA's approval of Maine's general permit regulations is appropriate in light of this and the other information required of applicants, and EPA believes that Maine must continue to require such information in its applications in order to meet the requirements of the CAA and its implementing regulations.

The regulation at 40 CFR 51.160(d) specifies that the plan's procedures must provide that approval of any construction or modification must not affect the responsibility of the owner or operator to comply with applicable portions of the State's pollution control strategy. Maine's general permit rules explicitly state that the regulations do not release a person from the obligation to comply with any other applicable state or federal requirements. See section 1(E) of Chapter 149 and section 1(D) of Chapter 164.

The regulation at 40 CFR 51.160(e) provides that the plan's procedures must identify types and sizes of facilities, buildings, structures, or installations which will be subject to review under this section. The plan must discuss the basis for determining which facilities will be subject to review. Maine's Chapters 149 and 164 both contain applicability provisions that identify the types and size of facilities, buildings, structures, or installations that are covered under the respective rules. See section 1 of Chapters 149 and 164.

The regulation at 40 CFR 51.160(f) provides that the plan's procedures must discuss the air quality data and the dispersion or other air quality modeling used to meet the requirements of subpart I, Review of New Sources and Modifications. See the earlier discussion about Maine's technical analysis of the air quality impacts from the sources subject to these general permit rules in its TSD. In addition, Maine's Chapter 115 Major and Minor Source Air Emission License Regulations require every applicant to provide an affirmative demonstration that its emissions, in conjunction with all other sources, will not violate applicable ambient air quality standards, except that sources in nonattainment areas, or sources which significantly impact a nonattainment area, shall be required to demonstrate that the source's emissions are consistent with reasonable further progress provisions of the SIP. An applicant may use ambient air monitoring, modeling, or other assessment techniques as approved by Maine. NSR modeling required pursuant to Chapter 115 must be consistent with EPA regulations and guidelines or other requirements under the CAA. See sections 7(C) and (D) of Chapter 115. In the event Maine determines that it has reasonable cause to believe that emissions from the proposed, modified, or relocated source will violate the control strategy or interfere with attainment or maintenance of a national standard in Maine or in a neighboring state, Maine has the ability to require an operator to apply for and obtain an individual air emission license under Chapter 115 (and perform an ambient air quality analysis) before beginning the actual construction, modification, or operation of the source. See section 1(F)(9) of Chapter 149 and section 1(E)(9) of Chapter 164. If modeling is deemed necessary, Chapter 115 requires modeling to be based on the relevant air quality models, databases, and other requirements specified in the current Guideline on Air Quality Models found in Appendix W to 40 CFR part 51. See section 7(A) of Chapter 115.

The regulation at 40 CFR 51.161 requires that the legally enforceable procedures in 40 CFR 51.160 must also require the State or local agency to provide opportunity for public comment on information submitted by owners and operators. The public information must include the agency's analysis of the effect of construction or modification on ambient air quality, including the agency's proposed approval or disapproval. Chapter 149 and Chapter 164 rules were posted to a 30-day public comment period with opportunity to request a public hearing in accordance with state and federal administrative requirements. Public notice of the comment period was published on the Secretary of State's rulemaking Web site and in newspapers statewide on January 15, 2014.

The regulation at 40 CFR 51.162 specifies that each plan must identify the State or local agency which will be responsible for meeting the requirements of this subpart in each area of the State. Where such responsibility rests with an agency other than an air pollution control agency, such agency will consult with the appropriate State or local air pollution control agency in carrying out the provisions of this subpart. The Maine Department of Environmental Protection is the only CAA permitting authority in the State of Maine and Maine is not proposing to delegate this authority.

The regulation at 40 CFR 51.163 provides that the plan must include the administrative procedures which will be followed in making the determination specified in paragraph (a) of 40 CFR 51.160. Maine's Chapter 149 and Chapter 164 rules both contain the administrative procedures and application requirements pursuant to which the State will act upon an application for a general permit. The rules specify the terms and conditions for the general permit application, including the application form and any other additional information required by Maine. See section 3 of Chapters 149 and 164.

The regulation at 40 CFR 51.164 sets requirements for good engineering stack practice height. Maine's Chapter 115 Major and Minor Source Air Emission License Regulations provide that Maine may require an air quality impact analysis for a minor source that has the potential to emit certain pollutants exceeding the thresholds. See section 7(B)(3)of Chapter 115. Air quality impact analysis and air quality monitoring requirements will be determined by Maine on a case-by-case basis considering a number of factors, including good engineering stack height. See Section 7(C) of Chapter 115. As previously noted, both Chapter 149 and Chapter 164 provide authority for Maine to require an operator to obtain an individual Chapter 115 air emission license, if appropriate.

Our evaluation of Maine's July 24, 2014 SIP submittals and supporting TSD demonstrates that the SIP submittals meet compliance requirements for SIP minor NSR programs under section 110(a)(2)(C) of the Clean Air Act.

EPA is approving the revisions to the Maine SIP submitted on July 24, 2014 and August 20, 2015. Specifically, EPA is approving the incorporation of the Maine 06-096 CMR Chapter 149 “General Permit Regulation for Nonmetallic Mineral Processing Plants” (except the “director discretion” provisions in sections 5(A)(8), 5(A)(9)(a), and 5(A)(9)(b), and the opacity provisions in sections 5(A)(15), 5(C)(7), and 5(E), which were formally withdrawn from consideration as part of the SIP), and the Maine 06-096 CMR Chapter 164 “General Permit Regulation for Concrete Batch Plants” (except the “director discretion” provisions in sections 5(C)(2), 5(C)(3)(a), and 5(C)(3)(b), and the opacity provisions in sections 5(A)(10), 5(B)(3), 5(B)(4), 5(E), 5(F)(5) and 5(G)(4), which were formally withdrawn from consideration as part of the SIP).

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comments be filed. This rule will be effective December 8, 2015 without further notice unless the Agency receives relevant adverse comments by November 9, 2015.

If the EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 8, 2015 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Maine 06-096 CMR Chapter 149 “General Permit Regulation for Nonmetallic Mineral Processing Plants” (except the “director discretion” provisions in sections 5(A)(8), 5(A)(9)(a), and 5(A)(9)(b), and the opacity provisions in sections 5(A)(15), 5(C)(7), and 5(E), which were formally withdrawn from consideration as part of the SIP) and the Maine 06-096 CMR Chapter 164 “General Permit Regulation for Concrete Batch Plants” (except the “director discretion” provisions in sections 5(C)(2), 5(C)(3)(a), and 5(C)(3)(b), and the opacity provisions in sections 5(A)(10), 5(B)(3), 5(B)(4), 5(E), 5(F)(5) and 5(G)(4), which were formally withdrawn from consideration as part of the SIP) described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive 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 Clean Air Act; and

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 8, 2015. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2))

Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2012-0043 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 December 8, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0043, by one of the following methods:

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

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

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

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

In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 1E7938) by The Acta Group, L.L.C. (2200 Pennsylvania Avenue NW., Suite 100W, Washington, DC 20037) on behalf of Honeywell International, Inc., 101 Columbia Road, Morristown, NJ 07962. The petition requested that 40 CFR 180.910, 180.930 and 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an inert ingredient (propellant) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial pesticide formulations for food-contact surface sanitizing solutions, respectively. That document referenced a summary of the petition prepared by The Acta Group, L.L.C. on behalf of Honeywell International, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for trans-1,3,3,3-tetrafluoroprop-1-ene including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with trans-1,3,3,3-tetrafluoroprop-1-ene follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by trans-1,3,3,3-tetrafluoroprop-1-ene as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Acute inhalation toxicity is low for trans-1,3,3,3-tetrafluoroprop-1-ene. Acute inhalation LD50s are >101,850 parts per million (ppm); approximately 713 milligram/kilogram (mg/kg) in rats and mice. Trans-1,3,3,3-tetrafluoroprop-1-ene is not a dermal irritant in rabbits or a sensitizer in humans.

Two subchronic toxicity studies via the inhalation route of exposure are available for trans-1,3,3,3-tetrafluoroprop-1-ene in rodents. Toxicity is not observed in rats or mice at doses as high as 5,000 ppm (approximately equivalent to 7,800 milligram/kilogram/day (mg/kg/day) human equivalent dose) following 13 weeks and 90 days of exposure, respectively. The 90-day inhalation toxicity study in mice also evaluated the carcinogenic potential of trans-1,3,3,3-tetrafluoroprop-1-ene by conducting a toxicogenomic assessment. Trans-1,3,3,3-tetrafluoroprop-1-ene is classified as non-carcinogenic by the toxicogenomic assessment at 10,000 ppm (approximately equivalent to 15,600 mg/kg/day human equivalent dose), the highest dose tested (HDT).

Developmental toxicity studies via the inhalation route are available in rats and rabbits. Neither maternal nor developmental toxicity is observed in either study up to 15,000 ppm (approximately equivalent to 23,400 mg/kg/day human equivalent dose), the HDT.

Two Ames Tests via gas exposure are available for review with trans-1,3,3,3-tetrafluoroprop-1-ene. The mouse micronucleus assay was performed via inhalation exposure. These tests are negative.

A chronic study with trans-1,3,3,3-tetrafluoroprop-1-ene is not available for review. Although a chronic toxicity study is not available, there is no concern for the lack of it because toxicity is not seen following up to 13 weeks of exposure to trans-1,3,3,3-tetrafluoroprop-1-ene at excessive doses (7,800 and 15,600 mg/kg/day). Also, toxicity is not seen in the developmental study at an excessive dose of 23,400 mg/kg/day. Therefore, the likelihood that chronic exposure to doses below the limit dose will result in toxic effects is highly unlikely.

Neurotoxicity studies are not available for review. However, evidence of neurotoxicity is not observed in the submitted inhalation studies.

Immunotoxicity studies are not available for review. However, very slight mononuclear cell infiltrates in the heart are observed in only females (3/5) at the LOAEL of ≥5,000 ppm (approximately 7,800 mg/kg/day human equivalent dose lowest dose tested) following 10 days of exposure via inhalation in Sprague Dawley rats. This effect is not dose dependent with regard to either incidence or severity. Similar effects along with increased monocyte count are observed in the heart at 15,000 ppm (approximately 23,400 mg/kg/day human equivalent dose; HDT) in a 13-week study via inhalation in Sprague Dawley rats. The NOAEL is 5,000 ppm (equivalent to 7,800 mg/kg/day human equivalent dose). This study included more rats, is conducted in the same species of rats that underwent the same route of exposure and was of longer duration (13 weeks vs 10 days). Mononuclear cell infiltrates in the heart are not observed at 5,000 ppm (equivalent to 7,800 mg/kg/day human equivalent dose) in either the male or female rat as was observed in the 10-day study. Therefore, since the incidence and severity of these effects are not dose-dependent in the 10-day study, the 13-week study is considered more reflective of toxicity resulting from exposure to trans-1,3,3,3-tetrafluoroprop-1-ene. However, the Agency is not concerned about these effects since they occur well above the limit dose and exposure above that is highly unlikely and unrealistic.

Two studies are available for trans-1,3,3,3-tetrafluoroprop-1-ene on male rats and mice metabolism and pharmacokinetics. In rats and mice, trans-1,3,3,3-tetrafluoroprop-1-ene via the inhalation route of exposure is rapidly absorbed, metabolized and excreted. The urine is the major route of excretion. In rats, the major metabolite is S-(3,3,3-trifluoro-trans-propenyl)-mercaptolactic acid. In mice, the major metabolite is a presumed amino acid conjugate of 3, 3, 3-trifluoropropionic acid. Other identified metabolites are S-(3, 3, 3-trifluoro-transpropenyl)-L-cysteine, N-acetyl-S-(3,3,3-trifluoro-trans-propenyl)-L-cysteine and 3,3,3-trifluoropropionic acid.

Specific information on the studies received on trans-1,3,3,3-tetrafluoroprop-1-ene as well as the no-observed-adverse-effect level (NOAEL) and the lowest- observed- adverse-effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, “Trans-1,3,3,3-tetrafluoroprop-1-ene; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2012-0043.

The available toxicity studies indicate that trans-1,3,3,3-tetrafluoroprop-1-ene has very low overall toxicity. The lowest NOAEL in the database was 5,000 ppm (approximately 7,800 mg/kg/day human equivalent dose) observed in a 13 week toxicity study in rats via the inhalation route of exposure. Since signs of toxicity were not observed at well above the limit dose an endpoint of concern for risk assessment purposes was not identified.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to trans-1,3,3,3-tetrafluoroprop-1-ene, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from trans-1,3,3,3-tetrafluoroprop-1-ene in food as follows:

The general population may be exposed via the diet to trans-1,3,3,3-tetrafluoroprop-1-ene as a result of eating foods containing residues of trans-1,3,3,3-tetrafluoroprop-1-ene. However, since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment (food and drinking water), a dietary exposure risk assessment was not conducted.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Trans-1,3,3,3-tetrafluoroprop-1-ene may be used as an inert ingredient in pesticide products that could result in short- and intermediate-term residential exposure. However, based on the lack of toxicity, a quantitative exposure assessment from residential exposures was not performed.

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

EPA has not found trans-1,3,3,3-tetrafluoroprop-1-ene to share a common mechanism of toxicity with any other substances, and trans-1,3,3,3-tetrafluoroprop-1-ene does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that trans-1,3,3,3-tetrafluoroprop-1-ene does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on the lack of effects in subchronic and developmental toxicity studies, and an assessment of trans-1,3,3,3-tetrafluoroprop-1-ene, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.

Because no toxicological endpoints of concern were identified, EPA concludes that aggregate exposure to residues of trans-1,3,3,3-tetrafluoroprop-1-ene will not pose a risk to the U.S. population, including infants and children, and that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to trans-1,3,3,3-tetrafluoroprop-1-ene residues.

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

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910, 180.930 and 180.940(a) for trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an inert ingredient (propellant) in pesticide formulations applied to formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial pesticide formulations for food-contact surface sanitizing solutions, respectively.

This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this 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 exemptions 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:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2015-0482 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 December 8, 2015. 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-2015-0482, by one of the following methods.

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

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

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

In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10821) filed by Spring Trading Company (203 Dogwood Trail Magnolia, Texas 77354) on behalf of Lamberti USA, Incorporated, 161 Washington Street Eight Tower Bridge, Suite 1000 Conshohocken, PA 19428. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of cellulose carboxymethyl ether, potassium salt; CAS Reg. No. 54848-04-3. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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 use 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 an exemption from the requirement of 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. . .” and specifies factors EPA is to consider in establishing an exemption.

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

Consistent with FFDCA section 408(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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). cellulose carboxymethyl ether, potassium salt conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 9587 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, cellulose carboxymethyl ether, potassium salt meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to cellulose carboxymethyl ether, potassium salt.

For the purposes of assessing potential exposure under this exemption, EPA considered that cellulose carboxymethyl ether, potassium salt could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of cellulose carboxymethyl ether, potassium salt is 9587 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since cellulose carboxymethyl ether, potassium salt conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

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

Section 408(b)(2)(C) of FFDCA 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 concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of cellulose carboxymethyl ether, potassium salt, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of cellulose carboxymethyl ether, potassium salt.

There are no existing exemptions from a tolerance for cellulose carboxymethyl ether, potassium salt polymers.

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.

Accordingly, EPA finds that exempting residues of cellulose carboxymethyl ether, potassium salt from the requirement of a tolerance will be safe.

This action establishes a tolerance exemption 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This 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:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2014-0630 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 December 8, 2015. 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-2014-0630, by one of the following methods:

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

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

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

In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (IN-10713) by ISK BioSciences, 7470 Auburn Rd., Suite A, Concorde, OH 44077. The petition requested that 40 CFR 180.920 be amended by modifying an exemption from the requirement of a tolerance for residues of dimethyl sulfoxide (CAS Reg. No. 67-68-5) when used as an inert ingredient (diluent) at levels not to exceed 62% in pesticide formulations containing cyclaniliprole. That document referenced a summary of the petition prepared by ISK BioSciences, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the request for a tolerance exemption due to the concern regarding the chemical properties of dimethyl sulfoxide that may result in increased active ingredient residues. Therefore, the tolerance exemption under 40 CFR 180.920 was modified. This limitation is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document Dimethyl sulfoxide; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations in docket ID number EPA-HQ-OPP-2014-0630.

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

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

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

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

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by dimethyl sulfoxide as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Dimethyl sulfoxide has low acute toxicity via the oral and dermal in rats and mice and inhalation route in rats. The acute oral lethal dose (LD)50 ≥ 7,920 milligrams/kilograms (mg/kg) in rats and mice. The acute dermal LD50 ≥ 40,000 mg/kg in rats and mice. The acute inhalation lethal concentration (LC)50 ≥ 1,600 milligram/meter3 (mg/m3) (~277 mg/kg) in rats. It is a dermal, eye and gastric irritant in rats and rabbits. It is a sensitizer in guinea pigs.

Overall systemic toxicity with regard to oral and dermal exposure to dimethyl sulfoxide is low. The target organ of toxicity is the eye. Changes in the eyes, such as refractile changes in the lens and lens composition are seen in various animals at doses above the limit dose (1,000 mg/kg/day).

Systemic toxicity is not observed following exposure to dimethyl sulfoxide at dose levels up to 1,000 mg/kg/day (the limit dose) in subchronic, chronic or reproduction/developmental toxicity studies via oral, dermal or inhalation exposures in rats, dogs and rabbits. Dimethyl sulfoxide is not expected to be carcinogenic based on the lack of mutagenicity and the lack of tumor formation in cancer initiation/promotion studies. It is not neurotoxic nor immunotoxic.

Toxicity of dimethyl sulfoxide via the inhalation route of exposure is limited to portal of entry effects at 2.783 mg/1 (equivalent to 722 mg/kg/day).

In the rat and monkey, dimethyl sulfoxide administered via the oral and/or dermal route is rapidly absorbed, metabolized and excreted. Excretion is primarily via urine, feces was a minor route in the rat only. The major metabolite was dimethyl sulfone. Dimethyl sulfide, another metabolite, is eliminated through the breath. There is no bioaccumulation.

Specific information on the studies received and the nature of the adverse effects caused by Dimethyl sulfoxide as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document “Dimethyl sulfoxide; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2014-0630.

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

The available toxicity studies indicate that dimethyl sulfoxide has low toxicity. These data demonstrated adverse effects only at doses ≥1100 mg/kg/day (above the limit dose). Therefore, since no endpoint of concern was identified for dimethyl sulfoxide, a qualitative risk assessment is appropriate.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dimethyl sulfoxide, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from dimethyl sulfoxide in food as follows:

Dietary exposure can occur from eating foods containing residues of dimethyl sulfoxide. Because no hazard endpoint of concern was identified for the acute and chronic dietary assessment (food and feed uses, a quantitative dietary exposure risk assessment was not conducted.

2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Dimethyl sulfoxide may be used in consumer products that may be used around the home. However, based on the lack of toxicity, a quantitative exposure assessment from “residential exposures” was not performed.

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

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

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

At this time, there is no concern for potential sensitivity to infants and children resulting from exposures to dimethyl sulfoxide. There is no reported quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure to dimethyl sulfoxide in developmental toxicity studies in rats and rabbits. No quantitative or qualitative evidence of increased susceptibility has been reported following the pre/postnatal exposure to rats and rabbits in 2-generation reproduction toxicity studies in rats and rabbits. Given the lack of adverse toxicological effects at limit dose levels, a safety factor analysis has not been used to assess the risk. For these reasons the additional tenfold safety factor is unnecessary.

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that based on the low toxicity of dimethyl sulfoxide and since no chronic endpoint was identified, chronic risk 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). Because no short-term adverse effect was identified, dimethyl sulfoxide is not expected to pose a short-term 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). Because no intermediate-term adverse effect was identified, dimethyl sulfoxide is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of increased tumor formation in initiation/promotion toxicity studies and the lack of mutagenicity, dimethyl sulfoxide 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 dimethyl sulfoxide residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for dimethyl sulfoxide (CAS Reg. No. 67-68-5) when used as an inert ingredient solvent, cosolvent in pesticide formulations used before crop emerges from soil or prior to formation of edible parts of food plants; for pesticide formulations used after crop emerges but before harvest, provided that the potential for increased residues of the formulation's active ingredient(s) in or on food commodities has been assessed.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This 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:

1. The Omnibus Order denied one petition for rulemaking and dismisses another petition for rulemaking as both requests were subsumed in the declaratory ruling portion of that document. The Omnibus Order also addressed a number of requests for clarification or other relief.

2. Petitions for Rulemaking. The Professional Association for Customer Engagement (PACE) filed a Petition for Expedited Declaratory Ruling and/or Expedited Rulemaking, and ACA International filed a Petition for Rulemaking. PACE's petition was addressed on its merits as a Petition for Declaratory Ruling and its Petition for Expedited Rulemaking was therefore dismissed. In the Omnibus Order the Commission provided clarification regarding the issues raised by ACA and therefore its petition was denied.

3. Requests for Clarification or Other Action. The Omnibus Order also addressed separate requests for clarification or other action regarding the TCPA or the Commission's rules and orders implementing the TCPA. The full text of the Omnibus Order is available at https://www.fcc.gov/document/tcpa-omnibus-declaratory-ruling-and-order.

4. The Commission strengthened the core protections of the TCPA by confirming that:

○ Callers cannot avoid obtaining consumer consent for a robocall simply because they are not “currently” or “presently” dialing random or sequential phone numbers;

○ Simply being on an acquaintance's phone contact list does not amount to consent to receive robocalls from third-party applications downloaded by the acquaintance;

○ Callers are liable for robocalls to reassigned wireless numbers when the current subscriber to or customary user of the number has not consented, subject to a limited, one-call exception for cases in which the caller does not have actual or constructive knowledge of the reassignment;

○ Internet-to-phone text messages require consumer consent; and

○ Text messages are “calls” subject to the TCPA, as previously determined by the Commission.

○ The Commission also empowered consumers to stop unwanted calls by confirming that:

○ Consumers may revoke consent at any time and through any reasonable means; and

○ Nothing in the Communications Act or the Commission's implementing rules prohibits carriers or Voice over Internet Protocol providers from implementing consumer-initiated call-blocking technology that can help consumers stop unwanted robocalls.

5. Finally, the Commission recognized the legitimate interests of callers by:

○ Clarifying that application providers that play a minimal role in sending text messages are not per se liable for unwanted robocalls;

○ Clarifying that when collect-call services provide consumers with valuable call set-up information, those providers are not liable for making unwanted robocalls;

○ Clarifying that “on demand” text messages sent in response to a consumer request are not subject to TCPA liability;

○ Waiving the Commission's 2012 “prior express written consent” rule for certain parties for a limited period of time to allow them to obtain updated consent;

○ Exempting certain free, pro-consumer financial- and healthcare-related messages from the consumer-consent requirement, subject to strict conditions and limitations to protect consumer privacy; and

○ Providing and reiterating guidance regarding the TCPA and the Commission's rules, empowering callers to mitigate litigation through compliance and dispose of litigation quickly where they have complied.