Federal Register Vol. 82, No.231,

I. Background II. Section-by-Section Analysis III. Procedural Analysis A. Review Under the Administrative Procedure Act B. Review Under Executive Order 12866 and 13563 C. Review Under Executive Order 12988 D. Review Under the Regulatory Flexibility Act E. Review Under the Paperwork Reduction Act F. Review Under the National Environmental Policy Act G. Review Under Executive Order 13132 H. Review Under the Unfunded Mandates Reform Act of 1995 I. Review Under the Treasury and General Government Appropriations Act, 1999 J. Review Under Executive Order 13211 K. Review Under the Treasury and General Government Appropriations Act, 2001 L. Approval by the Office of the Secretary of Energy M. Congressional Notification I. Background

The Department of Energy is publishing this final rule in order to ensure it contains the most current national standards for determining access to classified matter and special nuclear material and to ensure listed authorities are still valid.

Appendix A to 10 CFR part 710 contained the Adjudicative Guidelines for Determining Eligibility for Access to Classified Information (Adjudicative Guidelines), originally issued in 1997. These were included because they were the standard to which all such access eligibility determinations within the Department of Energy were rendered. On December 10, 2016, the Director of National Intelligence, in his role as Security Executive Agent, signed Security Executive Agent Directive (SEAD) 4, National Security Adjudicative Guidelines, which became effective June 8, 2017. The standards enumerated in SEAD 4 supersede the former standards. This final rule now includes SEAD 4 as appendix A. Also, Executive Order (E.O.) 10450, Security Requirements for Government Employees, issued April 27, 1953, has historically been cited as one of the authorities within the rule. E.O. 10450 was revoked pursuant to E.O. 13764 of January 17, 2017. This rule deletes references to E.O. 10450.

Laws, regulations and directives which may apply to part 710 include, but are not limited to: The Atomic Energy Act of 1954; Executive Order 13764 (81 FR 8115, January 23, 2017) Executive Order 13467 (73 FR 38103), June 30, 2008; Executive Order 12968 (60 FR 40245, August 2, 1995, as amended); Executive Order 13526 (75 FR 707, January 5, 2010); Executive Order 10865 (25 FR 1583, February 24, 1960, as amended); Presidential Policy Directive 19 (October 10, 2012).

DOE amends 10 CFR part 710 as follows:

1. In the contents section, appendix A has been revised to reflect it now contains Security Executive Agency Directive 4—National Security Adjudicative Guidelines.

2. In the contents section, under “Authority”, reference to E.O. 10450 has been deleted.

3. Section 710.1 “Purpose” deletes references to E.O. 10450 and the former Adjudicative Guidelines and replaces them with current citations.

4. Section 710.2 “Scope” removes reference to the Adjudicative Guidelines.

5. Section 710.3 “Reference” replaces “Adjudicative Guidelines” with “National Security Adjudicative Guidelines.”

6. Section 710.7 “Application of the Adjudicative Guidelines”, is retitled “Application of the National Security Adjudicative Guidelines.”

7. Section 710.7(b) replaces “Adjudicative Guidelines” with “National Security Adjudicative Guidelines.”

8. Appendix A is retitled “SEAD 4, National Security Adjudicative Guidelines” and its content is changed to delete the former Adjudicative Guidelines and replace with the current SEAD 4 standards.

The Administrative Procedure Act (APA) requires that a notice of proposed rulemaking be published in the Federal Register unless certain exceptions apply. 5 U.S.C. 553(b). These exceptions include rules of agency procedure or practice, as well as rules for which the agency finds good cause to waive notice and comment as unnecessary, impracticable or contrary to the public interest. Id. This rule amends DOE regulations that set forth the policies and procedures for resolving questions concerning eligibility for DOE access authorization. Specifically, the revisions update Appendix A, and related text, with the most current national standards for determining eligibility for access to classified matter and special nuclear material, and delete references to Executive Order 10450, which was revoked pursuant to Executive Order 13764. The rule provides the means by which DOE determines eligibility for access to its own data—classified matter and special nuclear material. As such, the rule is one of agency procedure or practice exempt from the notice and comment requirements of the APA. In addition, the Department has no discretion in adopting the guidelines, which by their terms are “applicable to any executive branch agency authorized or designated to conduct adjudications of covered individuals to determine eligibility for initial or continued access to classified national security information or eligibility to hold a sensitive position.” (See SEAD 4, Section C. Applicability.) The new SEAD 4 standards also do not differ substantively from the Adjudicative Guidelines. SEAD 4 continues to set forth 13 criteria (Guidelines A to M) that may raise a security concern, but was revised to add or remove conditions that could raise and/or mitigate security concerns. Variations between the two versions are not expected to result in differing access eligibility determinations depending upon which standard was employed. For these reasons, DOE also finds that notice and comment on the adoption of SEAD 4 is also unnecessary, impracticable and contrary to the public interest. The 30-day delay in effective date specified in 5 U.S.C. 553(d) is waived for these same reasons.

This final rule has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993). Accordingly, this rule is not subject to review under the Executive Order by the Office of Information and Regulatory Affairs within the Office of Management and Budget.

DOE has also reviewed the regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281 (Jan. 21, 2011)). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.

DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. DOE believes that this rule is consistent with these principles, including the requirement that, to the extent permitted by law, agencies adopt a regulation only upon a reasoned determination that its benefits justify its costs and, in choosing among alternative regulatory approaches, those approaches maximize net benefits.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction.

With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this regulation meets the relevant standards of Executive Order 12988.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” (67 FR 53461, August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process (68 FR 7990). DOE has made its procedures and policies available on the Office of the General Counsel's Web site at http://www.gc.doe.gov.

This rule amends procedures that apply to the determination of eligibility of individuals for access to classified information and access to special nuclear material. The rule applies to individuals, and would not apply to “small entities,” as that term is defined in the Regulatory Flexibility Act. In addition, as stated above, the Department has no discretion in adopting the guidelines; it is the guidelines themselves that impose any impact on affected individuals. As a result, the rule does not have a significant economic impact on a substantial number of small entities.

Accordingly, DOE certifies that the rule will not have a significant economic impact on a substantial number of small entities, and, therefore, no regulatory flexibility analysis is required. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).

This rule does not impose a collection of information requirement subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

DOE has concluded that promulgation of this rule falls into a class of actions which would not individually or cumulatively have significant impact on the human environment, as determined by DOE's regulations (10 CFR part 1021, subpart D) implementing the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.). Specifically, this rule is categorically excluded from NEPA review because the amendments to the previous rule are strictly procedural (categorical exclusion A6). Therefore, this rule does not require an environmental impact statement or environmental assessment pursuant to NEPA.

Executive Order 13132, 64 FR 43255 (August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this rule and has determined that it does not preempt State law and does 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. No further action is required by Executive Order 13132.

The Unfunded Mandates Reform Act of 1995 (Public Law 104-4) generally requires a Federal agency to perform a detailed assessment of costs and benefits of any rule imposing a Federal Mandate with costs to State, local or tribal governments, or to the private sector, of $100 million or more. This rulemaking does not impose a Federal mandate on State, local or tribal governments or on the private sector.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277), requires Federal agencies to issue a Family Policymaking Assessment for any rule or policy that may affect family well being. This rule, has no impact on family well-being. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution and use. This rule is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under implementing guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

The Secretary of Energy has approved issuance of this rule.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set out in the preamble, DOE amends part 710 of title 10 of the Code of Federal Regulations as set forth below.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Section 106 of the Consumer Product Safety Improvement Act of 2008. Section 106(a) of the CPSIA mandated that beginning on February 10, 2009, ASTM F 963-07ε1, Standard Consumer Safety Specifications for Toy Safety,  1 shall be considered a mandatory consumer product safety standard issued by the CPSC. Public Law 110-314. Since ASTM F963 was first mandated in 2009, there have been three revisions, ASTM F963-08, ASTM F963-11, and ASTM F963-16. Currently, the provisions of ASTM F 963-16 are considered consumer product safety standards issued by the Commission under section 9 of the CPSA. Under section 106(g) of the CPSIA, if ASTM proposes revisions to ASTM F963, ASTM must notify the Commission. The revised standard shall be considered to be a consumer product safety standard issued by the CPSC under section 9 of the CPSA (15 U.S.C. 2058), effective 180 days after the date on which ASTM notifies the Commission of the revision, unless, within 90 days after receiving that notice, the Commission notifies ASTM that it has determined that the proposed revision does not improve the safety of toys.

Codification of Safety Standard Mandating ASTM F963 for Toys. As stated above, the CPSIA mandated provisions of ASTM F963 as a consumer product safety standard. Because this action took place by statute, the standard did not appear in the Code of Federal Regulations. On February 2, 2017, the Commission published a direct final rule notifying the public that the Commission had allowed ASTM F963-16 to become the new CPSC standard and also incorporated that standard by reference at 16 CFR part 1250. 82 FR 8989. Thus, when revisions of F963 become the new CPSC standard, the Commission will amend 16 CFR part 1250 to revise the reference to the ASTM standard. As explained below, the Commission is amending 16 CFR part 1250 to incorporate by reference ASTM F963-17, except for one provision.2

Notification of Revisions. On September 1, 2017, ASTM notified the CPSC of ASTM's approval and publication of revisions to ASTM F963-17 in a revised standard approved on May 1, 2017, ASTM F963-17, Standard Consumer Safety Specification for Toy Safety. On November 27, 2017, the Commission voted 3 to allow the provisions of ASTM F963-17 to become the CPSC mandatory toy standard, with one exception. As discussed below, the Commission has reviewed the differences between ASTM F963-16 and ASTM F963-17 (the revised toy standard).

ASTM F963-17 contains various grammatical corrections, editorial corrections, and substantive changes to provisions concerning projectiles and sound-producing toys. The 2017 revision was published less than 1 year after ASTM F963-16 to correct some of the drafting errors found in ASTM F963-16. In particular, ASTM notified CPSC staff of negative consequences of a 2016 drafting error. In response, CPSC used enforcement discretion in March 2017, regarding testing and certification requirements in one section of ASTM F963-16 that concerned low-energy projectiles with stored energy.

The changes from ASTM F963-16 to ASTM F963-17 are summarized below:

• Scope: Minor editorial changes only.

• Referenced documents: Nine new references were added that were mostly related to microbiological guidelines.

• Terminology: One definition was removed, one definition was clarified, and one definition was changed editorially.

• Safety Requirements: One substantive clarification was made to section 4.21.2, Projectiles Toys with Stored Energy; one non-substantive clarification was made to section 4.21.3, Projectiles Toys without Stored Energy; and one clarification was made to section 4.21.3, Projectiles Toys without Stored Energy. One of the three clarifications (section 4.21.2) had been balloted and approved by the ASTM F15 Committee for Consumer Products for inclusion in the 2016 version, but the wording in section 4.21.2.3 was inadvertently omitted in the test method associated with kinetic energy (KE) of stored energy projectiles in the ASTM F963-16 revision.

• Labeling Requirements: Minor editorial changes only.

• Instructional Literature: Minor editorial changes only.

• Test Methods: An additional sentence was added to the sound-producing toys test method in Section 8.20.1.5 (5). This sentence functionally exempts pull/push toys from the A-weighted maximum sound pressure level (LAFmax) requirement. As explained below, the Commission is not including this language in the mandatory standard.

• Annex: The rationale was added addressing the new language in 4.21.2.3 for projectiles with stored energy.

The majority of the editorial revisions changed the word “must” to “shall,” which brings the revised standard in line with ASTM's current preferred language. In addition, new reference documents, references to tables/figures, and other editorial corrections were completed to fix known grammatical errors and incorrect references in the ASTM F963-16 version.

Two changes were substantive in nature. The first change, relating to requirements for projectile toys (Section 4.21), was a clarification that will neither increase, nor decrease, safety. The Commission had anticipated this change. However, the second change, relating to sound-producing toys, is substantive and reduces safety. This item was not balloted and was not reviewed by CPSC staff before ASTM published ASTM F963-17. ASTM added a sentence to the sound-producing toys test method in Section 8.20.1.5 (5) of ASTM F963-17 that functionally exempts push/pull toys from the A-weighted maximum sound pressure level (LAFmax) requirement. The LAFmax is a measurement of continuous sound. Without the LAFmax requirement, push/pull toys will only be subject to the LCpeak requirement, a requirement that is based on noise limits for impulse sounds (e.g., gun shots), not the continuous sounds, such as regular popping or clacking, which would be expected from push/pull toys. The Commission's interpretation that the LAFmax requirement applied to push/pull toys in ASTM F963-16 is based on the text of the standard.

The additional text added in ASTM F963-17 is a substantial change that reduces safety, because the additional text in Section 8.20.1.5 (5) provides an exemption for push/pull toys to the LAFmax requirement, which did not exist in ASTM F963-16. If such toys are exempt from the LAFmax requirement, they would be allowed on the market, even though their continuous sound level is greater than the standard permits for other floor toys. The Commission finds that the addition of text in Section 8.20.1.5(5) related to sound-producing toy requirements will decrease safety by allowing toys that produce sound levels that exceed noise exposure limits by the National Institute of Occupational and Health (NIOSH).4 Staff concludes that the LAFmax exemption has a negative impact on safety. Additionally, the exemption will reduce harmonization with EN-71. See Tab A of the staff briefing package https://www.cpsc.gov/s3fs-public/Proposed%20Revision%20of%20ASTM%20F963%20Mandatory%20Toy%20Standard%20-%20November%2015%202017.pdf?Rqy8BAU21cW2qoESRe_DSqkDknOpDtBq for a more detailed discussion regarding the exemption's effect on safety.

Because addition of the text in Section 8.20.1.5(5) of ASTM F 963-17 would not improve the safety of toys, the Commission determined that this provision should not be allowed to become part of CPSC's mandatory toy standard. The other changes are either editorial non-substantive changes that will not affect safety, or they are substantive changes that will improve safety. Thus, the Commission accepts all changes in ASTM F963-17, with the exception of the addition of text in Section 8.20.1.5 (5) because it reduces safety.

Although ASTM F963-17 is mandatory by operation of statute, the Commission has incorporated by reference ASTM F963 in the Code of Federal Regulations (CFR) to indicate that ASTM F963 is a CPSC mandatory standard.

The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to the final rule, ways that the materials the agency incorporates by reference are reasonably available to interested persons and how interested parties can obtain the materials. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b).

In accordance with the OFR's requirements, section B of this preamble summarizes the ASTM F963-17 standard that the Commission incorporates by reference into 16 CFR part 1250. The standard is reasonably available to interested parties, and interested parties may purchase a copy of the standard from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 USA; phone: 610-832-9585; http://www.astm.org/. A copy of the standard can also be inspected at CPSC's Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923.

Section 14(a) of the CPSA imposes the requirement that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program or, for children's products, on tests on a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. As noted in the preceding discussion, standards issued under section 106(f)(1)(B) are “consumer product safety standards.” Thus, they are subject to the testing and certification requirements of section 14 of the CPSA.

Because toys are children's products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by the Commission. These products also must comply with all other applicable CPSC requirements, such as the lead content requirements of section 101 of the CPSIA, the phthalates prohibitions of section 106 of the CPSIA, and the tracking label requirement in section 14(a)(5) of the CPSA.

In accordance with section 14(a)(3)(B)(vi) of the CPSA, the Commission has previously published three NORs for accreditation of third party conformity assessment bodies for testing toys (76 FR 46598 (Aug. 3, 2011), 78 FR 15836 (March 12, 2013), and 82 FR 8989 (February 2, 2017)). The last NOR provided the criteria and process for our acceptance of accreditation of third party conformity assessment bodies for testing toys to ASTM F963-16. The NOR for ASTM F963-16 is listed in the Commission's rule, “Requirements Pertaining to Third Party Conformity Assessment Bodies.” 16 CFR part 1112.

The previous NOR for the toy safety standard included 37 sections from ASTM F963-16 that required third party testing.

Certain provisions of ASTM F963-17 do not require third party testing as was the case in the previous NORs issued for ASTM F963. The ASTM F963-17 provisions that do not require third party testing are in the following areas:

• Any provision of ASTM F963 that section 106 of the CPSIA excepted from being a mandatory consumer product safety standards issued by the Commission. The CPSIA also excepted from ASTM F963, any provision that restates or incorporates an existing mandatory standard or ban promulgated by the Commission or by statute. In addition, the CPSIA excepted provisions from ASTM F963 that restate or incorporate a regulation promulgated by the Food and Drug Administration or any statute administered by the U.S. Food and Drug Administration. Section 4, Public Law 112-28, Aug 12, 2011.

• Those sections of ASTM F963-17 that pertain to the manufacturing process and, thus, cannot be evaluated meaningfully by a test of the finished product (e.g., the purified water provision at section 4.3.6.1).

• Those provisions of ASTM F963-17 with requirements for labeling, instructional literature, or producer's markings.

• Those provision in ASTM F963-17 that sets a limit for a DI (2-ethylhexyl) phthalate in pacifiers, rattles, and teethers. This section is excepted from third party testing because section 108 of the CPSIA sets limits for this and other phthalates that are more stringent than this requirement in ASTM F963-17.

This latest revision of the toy safety standard, ASTM F963-17, had a much shorter period between revisions than is typical. In the earlier revisions, the transition period for CPSC acceptance of laboratory accreditation and the certification effective dates allowed adequate time for laboratories to update their accreditations to the latest standard. The revisions in earlier versions of the standard typically included several substantive changes in test requirements and testing methods. This is not the case when comparing ASTM F963-17 to ASTM F963-16. In response to the directions in the ASTM F963-16 NOR, testing laboratories began working with their accreditation bodies to update their scope of accreditation to include references to ASTM F963-16.

Since issuance of the ASTM F963-16 NOR, the CPSC has accepted applications from more than 100 testing laboratories for sections in ASTM F963-16 and posted the information for each laboratory on the CPSC Web site. However, there are still more than 100 CPSC-accepted laboratories that are listed only for ASTM F963-11 and have not yet updated their accreditation scope to include ASTM F963-16. Many of these laboratories may be in the process of updating their accreditation scope to ASTM F963-16. Other laboratories may be waiting on Commission action regarding adoption of ASTM F963-17 and the NOR for ASTM F963-17.

To address the transition just described, the Commission is permitting acceptance of testing that supports ASTM F963-17 certification, and acceptance of laboratory accreditation that take into account testing laboratories that are already CPSC-accepted for testing to relevant sections in ASTM F963-16, ASTM F963-11, and ASTM F963-07ε 1 Section 4.27, as described below.

The CPSC's online laboratory application and Web site listing for testing laboratories that have been CPSC-accepted to sections in ASTM F963-16 will be modified to show CPSC-acceptance to “ASTM F963-16/ASTM F963-17.” For example, CPSC-accepted laboratories currently listed on the CPSC Web site for:

For laboratories that are accredited to ASTM F963-11 and that have not yet updated their scope to later versions, they may elect scope revisions to reflect ASTM F963-16 or ASTM F963-17, or both. When these laboratories apply to the CPSC, the CPSC will accept references to either the -16 or -17 version, and the lab will be listed on the CPSC Web site for “4.x (ASTM F963-16/ASTM F963-17).”

This will provide an equitable approach for all the third party laboratories that applied and were CPSC-accepted for sections in ASTM F963-16 and for testing laboratories that are currently working with their accreditation bodies to update the ASTM F963 references in their accreditation scope. In addition, this will allow laboratories that are CPSC-listed for “ASTM F963-16/ASTM F963-17” to conduct testing to support certification to the -16 and -17 versions ASTM F963.

The NOR for ASTM F963-16 that was issued on February 2, 2017 (82 FR 8989), provided a transition period for CPSC-accepted labs to support certification testing to ASTM F963-16. During the transition period, CPSC will accept ASTM F963-16 testing results by test laboratories that are CPSC-accepted to ASTM F963-11 sections, or ASTM F963-07ε 1 section 4.27 for toy chests, for a period not to exceed 2 years. The 2-year period ends on February 4, 2019. This allowance was to provide adequate time for testing laboratories to work with their accreditation bodies, make official updates to their accreditation scope to include ASTM F963-16 sections, and submit applications to the CPSC. The ASTM F963-17 NOR will continue the transition period provided in the ASTM F963-16 NOR. The CPSC will accept ASTM F963-17 testing results by laboratories that are CPSC-accepted to ASTM sections in F963-11 (or 4.27 of ASTM F963-07ε 1) until February 4, 2019.

The CPSC will open the application process for all sections of ASTM F963-17 when this direct final rule is published in the Federal Register as an amendment to 16 CFR part 1112. The CPSC is providing notice of these requirements through this direct final rule and through direct email to all current CPSC-accepted laboratories and their accreditation bodies. This process will avoid disruption to continuous third party testing to the toy safety standard and allow for a practicable transition from ASTM F963-11 to ASTM F963-16 to ASTM F963-17 for testing laboratories, the toy industry, and other interested parties.

The Commission is issuing this rule as a direct final rule. Although the Administrative Procedure Act (APA) generally requires notice and comment rulemaking, section 553 of the APA provides an exception when the agency, for good cause, finds that notice and public procedure are “impracticable, unnecessary, or contrary to the public interest.” The Commission concludes that notice and comment is unnecessary because ASTM F963 automatically becomes a consumer product safety standard by operation of law. The Commission has voted to allow ASTM F963-17 to become the mandatory CPSC standard. Even without the incorporation by reference, ASTM F963-17, except for Section 8.20.1.5 (5) and provisions the CPSIA excluded, will take effect as the new mandatory CPSC standard pursuant to section 106(g) of the CPSIA. This rule amends 16 CFR part 1250 to reflect the standard that CPSC has allowed under section 106(g) of the CPSIA. Because this document merely incorporates by reference a standard that takes effect by operation of statute, public comment could not affect the changes to the standard or the effect of the revised standard as a consumer product safety standard under section 106(g) of the CPSIA. The rule also updates the corresponding provisions of the NOR for ASTM F963 in part 1112 to reflect the revision to the standard. The amendment to part 1112 does not establish substantive requirements, but updates the criteria and process for CPSC's acceptance of accreditation of third party conformity assessment bodies for testing toys under the revised ASTM F963 standard. Therefore, the Commission concludes that public comment is not necessary.

The Commission believes that issuing a direct final rule in these circumstances is appropriate. In Recommendation 95-4, the Administrative Conference of the United States (ACUS) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). ACUS also recommended using direct final rulemaking when an agency uses the “unnecessary” prong of the good cause exemption to notice and comment rulemaking. Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule because we do not believe comment is necessary and do not expect any significant adverse comments to the direct final rule.

Unless we receive a significant adverse comment within 30 days, the rule will become effective on February 28, 2018. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why the rule revising the incorporation by reference would be inappropriate. We note that comments on the underlying substantive provisions of ASTM F963-17 are not considered significant adverse comments because those provisions are mandatory by operation of the statute, and therefore, the Commission cannot change them in response to comments. The Commission could only make changes to the way the incorporation by reference appears in the CFR.

Should the Commission receive significant adverse comment, the Commission would withdraw this direct final rule. Depending on the comments and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.

The Regulatory Flexibility Act (RFA) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA. 5 U.S.C. 603 and 604. As explained above, the Commission has determined that notice and comment is not necessary for this direct final rule. We also note the limited nature of this document. The incorporation by reference of ASTM F963-17 and the update to the notice of requirements in part 1112 will not result in any substantive changes to the standard. Thus, the rule does not create new substantive obligations for any entity, including any small entity. Rather, with this action, the CFR will reflect the mandatory CPSC standard that takes effect under the CPSIA and will update the corresponding NOR provisions in 16 CFR part 1112.

The toy standard contains information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). OMB has approved the collection of information for ASTM F963 under OMB Control No. 3041-0159.

The Commission's regulations provide a categorical exclusion for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a “consumer product safety standard under [the CPSA)]” is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury, unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances.

Section 106(f) of the CPSIA states that rules issued under that section “shall be considered consumer product safety standards issued by the Commission under section of the Consumer Product Safety Act” thus, implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 106 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when it becomes effective.

Under the procedure set forth in section 106(g) of the CPSIA, when ASTM revises ASTM F963, the revision becomes the CPSC standard within 180 days of notification to the Commission, unless the Commission determines that the revision does not improve the safety of the product. In accordance with this provision, this rule establishes an effective date that is 180 days after we received notification from ASTM of revisions to the standard. As discussed in section F of this preamble, this is a direct final rule. Unless we receive a significant adverse comment within 30 days, the rule will become effective on February 28, 2018. Additionally, the effective date for the NOR is February 28, 2018, the same date that the provisions of ASTM F963-17 become effective.

For the reasons discussed in the preamble, the Commission amends 16 CFR chapter II, as follows:

Throughout this document, “we,” “us” and “our” refer to the EPA.

On January 15, 2016 (81 FR 2136) the EPA proposed to partially approve and partially disapprove SMAQMD's SIP revision to address Reasonably Available Control Technology (RACT) requirements for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS) based in part on our conclusion that the submittal did not satisfy the CAA section 182 requirements for RACT pertaining to pharmaceutical manufacturing operations. On August 12, 2016 we finalized our partial approval and partial disapproval and stated that sanctions would be imposed under CAA section 179 and 40 CFR 52.31 unless the EPA approved SIP revisions correcting this deficiency within 18 months of the effective date of our final rulemaking action.

On April 28, 2106 the SMAQMD repealed Rule 455, Pharmaceutical Manufacturing, and amended Rule 464, Organic Chemical Manufacturing Operations, to address the VOC RACT deficiencies. On August 22, 2016 the California Air Resources Board submitted these rules to the EPA for SIP approval and the EPA proposed to approve them into the California SIP on July 19, 2017 (82 FR 33030). Table 1 below summarizes the submittal timeline.

We proposed to approve these revisions because we determined that they correct the identified RACT deficiencies for the pharmaceuticals manufacturing category and comply with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving Rule 464 and rescinding Rule 455. Please see the docket for a copy of the complete submitted documents. Final approval satisfies California's obligation, under CAA section 182 for the 1997 8-hour ozone NAAQS, to implement RACT in the SMAQMD for the following control techniques guidelines VOC categories:

a. “Control of Volatile Organic Compound Emissions from Reactor Processes and Distillation Operations Processes in the Synthetic Organic Chemical Manufacturing Industry,” EPA-450/4-91-031, August 1993.

b. “Control of Volatile Organic Compound Emissions from Manufacture of Synthesized Pharmaceutical Products,” EPA-450/2-78-029, December 1978.

Our August 12, 2016 partial disapproval of SMAQMD's RACT SIP demonstration for the 1997 NAAQS also stated that a SIP submittal in the form of a rule or permit provision was required to implement VOC RACT for the Kiefer Landfill, a major VOC source. We are taking a separate action elsewhere in today's Federal Register to fully approve into the SIP operating permits for landfill gas flaring at the Kiefer Landfill. Our final approval of both the Kiefer Landfill operating permits and Rule 464 will terminate both the sanctions clocks and the federal implementation plan clock associated with our August 12, 2016 partial disapproval of SMAQMD's RACT SIP.

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 SMAQMD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT 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, the 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• 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 (Public Law 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 2, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Section 307(b)(1) of the Clean Air Act indicates which Federal Courts of Appeal have venue for petitions for review of final actions by EPA. This action pertains to facilities in Minnesota and is not based on a determination of nationwide scope or effect. Thus, under section 307(b)(1), any petitions for review of EPA's action denying the U.S. Steel petition for reconsideration must be filed in the Court of Appeals for the Eighth Circuit on or before February 2, 2018.

Throughout this document, “we,” “us,” and “our” refer to the EPA.

The EPA is approving a source-specific SIP revision for Danskammer Unit 4 (the “Danskammer SIP Revision”) that was submitted by the New York State Department of Environmental Conservation (NYSDEC) on August 10, 2015, and supplemented on August 5, 2016. Specifically, the EPA is approving BART emission limits for sulfur dioxide (SO2), oxides of nitrogen (NOX), and particulate matter (PM) for Danskammer Unit 4 that are equivalent to the emission limits established by the EPA's FIP that was promulgated on August 28, 2012 (77 FR 51915, 51917).

In its submittal, NYSDEC included the following BART emission limits for Danskammer Unit 4: 0.12 pounds of NOX per million British thermal units (lb NOX/MMBtu) calculated on a 24-hour average during the ozone season and on a rolling 30-day average during the rest of the year; 0.09 lb SO2/MMBtu calculated on a 24-hour average; and 0.06 lb PM/MMBtu calculated on a 1-hour average. NYSDEC also included a condition that restricts Danskammer Unit 4 to combusting only natural gas. As a result of the EPA's approval, the EPA is withdrawing those portions of the FIP that address BART for Danskammer Unit 4. The reader is referred to EPA's Proposed Rule, 82 FR 21749 (May 10, 2017), for a detailed discussion of this SIP revision.

EarthJustice (EJ) submitted the following comments on behalf of the National Parks Conservation Association (NPCA) and Sierra Club.

Comment 1: EJ supports the inclusion in the New York SIP of limits that restrict combustion at Danskammer Unit 4 to natural gas. EJ agrees with the EPA's conclusion that such a restriction will have the effect of reducing visibility-impairing emissions compared to the prior Title V permit and the EPA FIP that allowed combustion of coal, oil, or natural gas in Unit 4. According to the 2012 BART determination study for Danskammer Unit 4 that formed the basis for NYSDEC's and the EPA's BART determinations, 100% firing of natural gas is associated with the highest percent reduction of SO2 of the controls examined at the time, and the third highest percent reduction of NOX. Elimination of coal combustion is consistent with BART and will certainly provide visibility benefits at Class I areas.

Response: The EPA acknowledges EJ's support of the natural gas requirement in the Danskammer SIP Revision.

Comment 2: The 2012 BART determination for Danskammer Unit 4 formed the basis for NYSDEC's and EPA's prior BART determinations. Since the unit had already been converted to co-fire or exclusively fire natural gas in 1987, the determination included the option of 100% firing of natural gas as a feasible BART technology. Thus, the use of natural gas is not fuel switching for this unit. The prior BART analysis lists an achievable emission rate of 0.08 lbs/MMBtu for NOX, and a control efficiency of 99.95% under the 100% natural gas combustion scenario. Since natural gas combustion technology is already installed and operating, the cost of the technology to achieve these emission levels is $0.

Response: The commenter's intended point is that because restricting Danskammer Unit 4 to combusting natural gas is not a form of fuel switching, the state must adopt BART emission limits that reflect the low emission rates associated with natural gas combustion. The EPA disagrees that restricting Danskammer Unit 4 to combusting natural gas is not a form of fuel switching. The Danskammer Unit 4 boiler was designed to combust coal, fuel oil, and natural gas, and until recent years, coal was the unit's primary fuel source. By prohibiting Danskammer Unit 4 from combusting coal or fuel oil going forward, the Danskammer SIP Revision effects a fuel switch from multi-fuel capability to the exclusive use of natural gas. In the BART Guidelines, the EPA stated that “it is not our intent to direct States to switch fuel forms, e.g., from coal to gas.” 70 FR 39104, 39164 (July 6, 2005). As such, NYSDEC's decision to require fuel switching at Danskammer Unit 4 as a condition in its SIP revision was entirely discretionary. The EPA acknowledges that, by combusting only natural gas, Danskammer Unit 4 can achieve the lower emission limits cited by the commenter without additional cost, but the EPA cannot disapprove the SIP for not including lower limits when the BART Guidelines do not require states to consider fuel switching as a BART option in the first instance. See 70 FR at 39164.

Comment 3: As noted by the EPA, the emission limits for SO2 and NOX adopted by NYSDEC for Danskammer Unit 4 are identical to those contained in EPA's 2012 FIP. However, the rulemaking record for the 2012 FIP clearly demonstrates that these emission limits were designed for a plant that maintained the option to use coal as a fuel. The EPA's Regional Haze Rule requires that the “determination of BART must be based on an analysis of the best system of continuous emission control technology available and associated emission reductions achievable.” 40 CFR 51.308(e)(1)(ii)(A). According to the EPA's own BART Guidelines, “[t]o complete the BART process, you must establish enforceable emission limits that reflect the BART requirements.” 70 FR 39172. The coal-based emission limits in the EPA's current proposal no longer reflect BART, as the plant is now restricted to burning natural gas. Thus they are not emission reductions “associated” with natural gas combustion under the BART Guidelines. The EPA must instead establish lower limits under BART reflecting the natural gas-only fuel restriction it proposes to incorporate into the SIP.

Response: The EPA disagrees that the natural gas requirement in the Danskammer SIP Revision is BART. As explained in the response to comment 2, the BART Guidelines do not require states to consider fuel switching as a BART control option. In its 2012 SIP submittal, NYSDEC included at its discretion a potential control option of 100% combustion of natural gas for Danskammer Unit 4 before rejecting it in favor of other control options. In the Danskammer SIP Revision, however, NYSDEC did not indicate that it was now determining 100% natural gas combustion to be BART. Rather, NYSDEC adopted the BART emission limits that the EPA established in its 2012 FIP, which were based on flue-gas desulfurization (FGD) for SO2, various options for reducing NOX, and Unit 4's existing electrostatic precipitator (ESP) for PM. The EPA included a detailed technical justification for its BART determinations in the record for that rulemaking, see 77 FR 24793, 24812-15 (April 25, 2012) (proposal); 77 FR 51918-23 (final), and the commenter has not made any effort to rebut that analysis with new information. Nothing in the Clean Air Act (CAA), the Regional Haze Rule, or the BART Guidelines requires the EPA to disapprove the Danskammer SIP Revision and establish lower emission limits reflecting 100% combustion of natural gas simply because NYSDEC included that condition in addition to its BART emission limits in its SIP revision. In any event, the EPA notes that requiring the lower emission limits favored by the commenter would not achieve an environmental benefit because the natural gas requirement in the Danskammer SIP Revision already has the practical effect of reducing Danskammer Unit 4's emissions to levels that are consistent with those lower emission limits.

Comment 4: The EPA claims in its proposal that NYSDEC's proposal is sufficient because it is “more stringent than the EPA's FIP.” 82 FR 21750. However, the BART determination cannot simply be more stringent than the EPA's FIP; it must stand alone as a BART determination, which includes requiring an emission limit consistent with the “best system of continuous emission control technology available,” in this case, at a minimum, the exclusive use of natural gas. 40 CFR 51.308(e)(1)(ii)(A). In the original BART determination, as the EPA noted in its 2012 proposal, “[a]lthough gas co-firing (and 100% gas firing) appears to be feasible and cost effective, it was ruled out as a control option due to high price volatility of natural gas and potential reliability concerns on the state's electric system.” 77 FR 24812. These concerns are no longer valid, if indeed they were in the first place. Thus, based on the original BART determination for the unit, limits associated with the 100% firing of natural gas should be those originally associated with that control, i.e., no higher than 0.08 lbs/MMBtu for NOX and 99.95 percent SO2 control efficiency consistent with the unit's existing limits. The existing NOX limit is on a 24-hour average during the ozone season and a 30-day average during the remainder of the year. This is unjustified and inappropriate for a visibility-specific limit given 100% gas firing and higher impacts from nitrates during the wintertime. Also, the exclusive use of natural gas would reduce PM emissions as well, and so a PM emission limit should be set that reflects 100% natural gas firing, rather than the proposed limit of 0.06 lbs/MMBtu on a 1-hour basis, which was determined based on tests performed when burning coal.

Response: The EPA disagrees with this comment for the same reasons described in the EPA's previous responses. The EPA acknowledges that the Agency stated at proposal that the Danskammer SIP revision was approvable “because it is more stringent than the EPA's FIP.” 82 FR 21750. More accurately, the SIP revision is approvable because it meets minimum CAA requirements by adopting the emission limits in the EPA's FIP, and then goes beyond those minimum CAA requirements by including the “more stringent” natural gas requirement. See CAA section 116 (“[N]othing in [the CAA] shall preclude or deny the right of any State . . . to adopt or enforce . . . any requirement respecting control or abatement of air pollution . . . .”).

Comment 5: As noted, NYSDEC has claimed to submit these changes for Danskammer Unit 4 as an “updated” BART determination. The EPA has proposed to approve it as such, simultaneously withdrawing the BART determination in its FIP. However, NYSDEC has not submitted a BART determination, only changes to Unit 4's Title V permit. Neither the state nor the EPA has offered an actual BART determination, which must include consideration of: The costs of compliance, the energy and non-air quality environmental impacts of compliance, any pollution control equipment in use at the source, the remaining useful life of the source, and the degree of improvement in visibility which may reasonably be anticipated to result from the use of such technology. 40 CFR 51.308(e)(1)(ii)(A). In this case, any updated BART determination should also include consideration of controls that can be used in addition to 100% firing of natural gas. Because the proposed rulemaking does not include a BART determination, the EPA cannot use it as a replacement for its challenged FIP. To fix this critical shortcoming, the EPA has several options. First, the EPA could include a BART determination with the final rule based on the information submitted with the 2012 New York haze SIP, setting limits based on 100% natural gas combustion and any further controls that it determines to be BART. Second, NYSDEC could immediately supplement its 2012 haze plan as to Danskammer Unit 4, and include a BART determination, again based on the prior BART analysis for 100% natural gas combustion and any additional BART controls. If NYSDEC pursues the second option and it cannot be achieved in a timely manner, EPA must issue a limited approval of the Title V permit restriction as to natural gas combustion and maintain the current FIP, disapproving the current submission as to any purported BART determination and requiring NYSDEC to formally resubmit an actual BART determination that includes at least 100% natural gas combustion at Unit 4.

Response: In the 2012 FIP, the EPA “encourage[d] New York at any time to submit a SIP revision to incorporate provisions that match the terms of our FIP, or relevant portion thereof,” explaining that if we approved the SIP revision, it would replace the FIP provisions. 77 FR 51917. NYSDEC responded by submitting the Danskammer SIP Revision, which incorporated provisions that match the terms of our FIP, as well as an additional requirement restricting Danskammer Unit 4 to combusting natural gas. Because NYSDEC was not required to update its BART determinations beyond incorporating the BART emission limits from the 2012 FIP, the EPA has no basis to disapprove the SIP revision and supplant it with another FIP.

Comment 6: The CAA requires that Danskammer procure, install, and operate BART as expeditiously as practicable. “As expeditiously as practicable” is defined as five years after the date of approval of a plan revision or promulgation of a FIP. The FIP here was promulgated on August 28, 2012. Therefore, the EPA must act promptly to respond to the issues identified in this letter and determine BART for gas-only combustion to enable Danskammer to meet this deadline.

Response: The 2012 FIP required Danskammer Unit 4 to comply with the BART emission limits by July 1, 2014. As a result of damage to the facility sustained during flooding in 2012, Danskammer Unit 4 was non-operational until the fall of 2014, when it began operating as a natural gas peaking unit. Danskammer Unit 4 has been complying with the BART emission limits in the FIP since it restarted in 2014. The Danskammer SIP Revision adopts the FIP's BART emission limits, and they will become federally enforceable on the effective date of this final action. Therefore, NYSDEC has satisfied CAA section 169A(g)(4)'s requirement that BART must be installed as expeditiously as practicable, but in no event later than five years after the date of approval of a plan revision (i.e., the Danskammer SIP Revision).

The EPA has evaluated the Danskammer SIP Revision and is determining that it meets the requirements of the CAA and the Regional Haze Rule. Therefore, the EPA is approving the BART emission limits and related administrative requirements (i.e., monitoring, recordkeeping and reporting requirements) for Danskammer Unit 4, which are identical to those contained in the EPA's 2012 FIP: 0.12 lb NOX/MMBtu, calculated on a 24-hour average during the ozone season and on a rolling 30-day average during the rest of the year; 0.09 lb SO2/MMBtu, calculated on a 24-hour average; and 0.06 lb PM/MMBtu, calculated on a 1-hour average. NYSDEC also included in its SIP revision a condition that restricts Danskammer Unit 4 to combusting only natural gas, which the EPA is approving into the SIP. Consequently, the EPA is withdrawing those portions of the 2012 FIP that address BART for Danskammer Unit 4.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of a single-source SIP revision, dated August 10, 2015, and supplemented on August 5, 2016, from NYSDEC for Danskammer Unit 4 (Facility DEC ID 3334600011), including Title V permit conditions (permit ID 3-3346-00011/00017) with Best Available Retrofit Technology (BART) emission limits for NOX, SO2, and PM. NYSDEC renewed Danskammer's Title V permit on February 24, 2015. The summary of emission limits and other enforceable requirements for this SIP revision are included in section I of this rulemaking. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 2 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by the Director of the Federal Register in the next update to the SIP compilation.1

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is exempt from review by the Office of Management and Budget (OMB) because it will result in the approval of a SIP submitted by the New York State Department of Environmental Conservation for Danskammer Generation Station Unit No. 4. Approval of SIPs falls within a category of Actions that is exempted from review by OMB. It was therefore not submitted to OMB for review.

This action is not an Executive Order 13771 regulatory action because this action falls within the category of Actions that OMB has exempted from review. This action specifically is an Approval of a State Implementation Plan (SIP).

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act (PRA).2 Because this final rule has identical recordkeeping and reporting requirements to the EPA's 2012 FIP, the PRA does not apply.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This rule does not impose any requirements or create impacts on small entities as no small entities are subject to the requirements of this rule.

This action does not contain any unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Because this final rule has identical BART emission limits and related administrative requirements (i.e., monitoring, recordkeeping and reporting requirements) to the EPA's 2012 FIP, this final rule is not subject to the requirements of sections 202 or 205 of UMRA. This final rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.

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. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997). 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 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards. Therefore, the EPA is not considering the use of any voluntary consensus standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). As explained previously, this action provides identical BART emission limits and related administrative requirements (i.e., monitoring, recordkeeping and reporting requirements) to the EPA's 2012 FIP.

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).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 2, 2018. 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 CAA section 307(b)(2).

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

Throughout this document, “we,” “us” and “our” refer to the EPA.

On January 15, 2016 (81 FR 2136) the EPA proposed to partially approve and partially disapprove SMAQMD's SIP revision to address Reasonably Available Control Technology (RACT) requirements for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS) based in part on our conclusion that the submittal did not satisfy the CAA section 182 requirements for major source VOC RACT from landfill gas flaring operations at the Kiefer Landfill. On August 12, 2016 we finalized our partial approval and partial disapproval and stated that sanctions would be imposed under CAA section 179 and 40 CFR 52.31 unless the EPA approved SIP revisions correcting this deficiency within 18 months of the effective date of our final rulemaking action.

On July 28, 2016 the SMAQMD adopted portions of two operating permits (Operating Permit 24360—issued March 24, 2016 and reissued April 14, 2016; and Operating Permit 24361—issued March 24, 2016 and reissued April 14, 2016) to address the VOC RACT deficiency. On January 24, 2017 the California Air Resources Board (CARB) submitted these operating permits to the EPA for SIP approval and the EPA proposed to approve them into the California SIP on July 19, 2017 (82 FR 33032). Specifically, we proposed to approve permit conditions 2, 8, 13, 14, 16, 17, 22, 23, 24, 25, 26, 27, 37, 39 and 40 (or portions thereof) and Attachment A from SMAQMD Operating Permit Nos. 24360 and 24361. We proposed to approve these portions of the operating permits into the SIP because we determined that they complied with the relevant CAA requirements. Our proposed action contains more information on these operating permits and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted portions of the operating permits into the California SIP. Specifically, we are approving permit conditions 2, 8, 13, 14, 16, 17, 22, 23, 24, 25, 26, 27, 37, 39 and 40 (or portions thereof) and Attachment A from SMAQMD Operating Permit Nos. 24360 and 24361, which together establish enforceable VOC limitations that satisfy RACT for the landfill gas flares at the Kiefer Landfill. Please see the docket for a copy of the complete submitted documents.

Final approval satisfies California's obligation, under CAA section 182 for the 1997 8-hour ozone NAAQS, to implement RACT for the landfill gas flares at the Kiefer Landfill. Our August 12, 2016 partial disapproval of SMAQMD's RACT SIP demonstration for the 1997 NAAQS also stated that amendments to SMAQMD's pharmaceuticals manufacturing rule were required to satisfy RACT. We are taking a separate action elsewhere in today's Federal Register to fully approve SMAQMD Rule 464, Organic Chemical Manufacturing Operations, into the SIP. Our final approval of both the operating permits for the flares at the Kiefer Landfill and approval of Rule 464 will terminate both the sanctions clock and the federal implementation plan clock associated with our August 12, 2016 partial disapproval of SMAQMD's RACT SIP.

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 SMAQMD operating permits described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT 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, the 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 2, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

On December 23, 2015, Idaho submitted a certification that the Idaho SIP meets the infrastructure requirements of Clean Air Act (CAA) sections 110(a)(1) and (2) for the 2012 PM2.5 NAAQS. On September 12, 2017, the EPA proposed to approve the submission as meeting certain infrastructure requirements (82 FR 42772). Please see our proposed rulemaking for further explanation and the basis for our finding. The public comment period for this proposal ended on October 12, 2017. We received comments in support of this action and the Idaho Department of Environmental Quality.

The EPA finds that the Idaho SIP meets the following CAA section 110(a)(2) infrastructure elements for the 2012 PM2.5 NAAQS: (A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). This action is being taken under section 110 of the CAA.

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, the 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);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and it 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. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 2, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

Throughout this document, the terms “we,” “us,” and “our” refer to EPA.

On September 14, 2017 (82 FR 43202), the EPA proposed a conditional approval of the following rule that was submitted for incorporation into the BAAQMD portion of the California SIP.

We proposed a conditional approval of Regulation 2, Rule 4 because we determined that, separate from the deficiencies listed in Section II.B of our proposed rulemaking action, the rule: ensures that issued ERCs will meet the criteria laid out in 40 CFR 51.165(a)(3)(ii)(C)(1)(i) at the time of ERC issuance; satisfies the requirements of 40 CFR 51.165(a)(3)(i); satisfies the applicable requirements found in EPA's Emissions Trading Policy Statement; and satisfies the requirements of 40 CFR 51.165(a)(3)(ii)(C)(1)(ii), which requires pre-base year shutdown credits to be explicitly added back in to the most recent applicable air quality plans. Moreover, we concluded that if the District submits the changes it committed to submit in its August 28, 2017 commitment letter, the identified deficiencies will be cured.

The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted. Therefore, as authorized in sections 110(k)(4) and 301(a) of the Act, the EPA is finalizing conditional approval of Regulation 2, Rule 4 into the BAAQMD portion of the California SIP. If the State meets its commitment to submit the required measures, the revisions to Rule 2-4 will remain a part of the SIP until EPA takes final action approving or disapproving the new SIP revisions. However, if the State fails to submit these revisions within the required timeframe, the conditional approval will automatically become a disapproval, and EPA will issue a finding of disapproval. EPA is not required to propose the finding of disapproval.

There are no sanctions or Federal Implementation Plan (FIP) implications should the conditional approval become a disapproval. Sanctions would not be imposed under CAA section 179(b) because the submittal of Rule 2-4 is discretionary (i.e., not required to be included in the SIP). See ETPS, 51 FR 43,813 at 43,825 (“[S]tates are by no means required to adopt banking procedures, but . . . banks may help states and communities realize important planning and environmental benefits.”). A FIP would not be imposed under CAA section 110(c)(1) because the disapproval does not reveal a deficiency in the SIP that such a FIP must correct. Specifically: (1) The deficiencies identified herein do not impact or undermine the requirement that offsets satisfy the requirements of 40 CFR 51.165, including the requirement that offsets must satisfy the offset integrity criteria enumerated in 40 CFR 51.165(a)(3)(ii)(C)(1)(i) at the time of use; and (2) Rule 2-4 is not a required CAA submittal because states and air districts have the discretion, but are not required, to adopt banking rules. This final action will incorporate the submitted rule into the SIP, including those provisions identified as deficient.

In addition, because we are finalizing our proposed action, we are removing existing Regulation 2, Rule 4 from the BAAQMD portion of the California SIP.

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 BAAQMD Regulation 2, Rule 4 (Permits, Emissions Banking), as described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, this document generally available electronically through www.regulations.gov and in hard copy at the U.S. Environmental Protection Agency, Region IX (Air-3), 75 Hawthorne Street, San Francisco, CA 94105-3901.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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 an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.

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. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, will result from this action.

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, because the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.

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 impose additional requirements beyond those imposed by state law.

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

Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.

The EPA lacks the discretionary authority to address environmental justice in this rulemaking.

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).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 2, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

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

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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 174 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(g), 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-2017-0113 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2017-0113, 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 June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F8541) by Bayer CropScience LP., 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petitioner requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of the plant-pesticide Bacillus thuringiensis Cry14Ab-1 in or on soybean. That document referenced a summary of the petition prepared by the petitioner Bayer CropScience LP, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the Notice of Filing.

EPA is establishing a temporary exemption that varies slightly from the request, as explained in Unit III.C.

Section 408(r) of FFDCA authorizes EPA to establish a temporary exemption from the requirement of a tolerance for residues covered by an experimental use permit issued under the Federal Insecticide, Fungicide, and Rodenticide Act. That section states that the provisions of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA section 408(r). Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Bacillus thuringiensis Cry14Ab-1 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. In summary, the available data does not indicate any adverse effects due to toxicity or allergenicity of the Cry14Ab-1 protein. A full explanation of the data upon which EPA relied and its risk assessments based on that data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for the Plant-Incorporated Protectant Pesticide Bacillus thuringiensis Cry14Ab-1.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

There is likely to be exposure to Cry14Ab-1 through consumption of soybean plants containing the pesticide, and there is potential for exposure in drinking water. There is unlikely to be residential or non-occupational exposure due to incorporation within the plant and the lack of availability at this time of the plant for residential uses.

Although FFDCA section 408(b)(2)(C) provides for an additional tenfold margin of safety for infants and children in the case of threshold effects, EPA has determined that there are no such effects due to the lack of toxicity and allergenicity for this PIP. As a result, an additional margin of safety for the protection of infants and children is unnecessary.

Based upon its evaluation, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Cry14Ab-1 protein in or on soybean. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the lack of toxicity and allergenicity for the Bacillus thuringiensis Cry14Ab-1 protein. Therefore, a temporary exemption is established for residues of this plant-incorporated protectant Bacillus thuringiensis Cry14Ab-1 protein in or on soybean.

An analytical method is not required for enforcement purposes because EPA is establishing a temporary exemption from the requirement of a tolerance without any numerical limitation for which enforcement is unnecessary.

EPA's final rule revises the request from “plant-pesticide” to “plant-incorporated protectant” to align with the Agency's language published in 40 CFR 174.3; adds the term “temporary” to reflect that this exemption is linked to the pending experimental use permit action, and is published in part 174 rather than part 180, since PIP tolerance exemptions are published in part 174.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. 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); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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 exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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 174 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(g), 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-2017-0115 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2017-0115, 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 June 8, 2017 (82 FR 26639 (FRL-9961-90) and 82 FR 26641 (FRL-9961-14)), EPA issued notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (IN-11022) by Bayer CropScience LP 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for plant-pesticide inert HPPD-4 in or on all food commodities. A summary of the petition prepared by the petitioner Bayer CropScience LP, is available in the docket via http://www.regulations.gov. There were no comments received in response to either notice.

Two modifications have been made to the original request for a tolerance exemption. EPA changed “plant-pesticide inert” to “plant-incorporated protectant inert” to align with the Agency's vocabulary, which is published in 40 CFR part 174.3. Also, because EPA publishes all tolerances or exemptions for plant-incorporated protectants in part 174, EPA's rule is being issued in part 174, rather than part 180 as requested.

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 food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on HPPD-4 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the October 2, 2017, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Assessment of the plant-incorporated protectant inert Pseudomonas fluorescens 4-hydroxyphenylpyruvate dioxygenase (HPPD-4).” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

The HPPD-4 protein is derived from the 4-hydroxyphenylpyruvate dioxygenase (HPPD) enzyme of the bacterium Pseudomonas fluorescens. Four amino acid changes were made to the original bacterial protein sequence in order to decrease the binding efficacy of the HPPD-inhibitor herbicide. The resulting modified protein (the HPPD-4 protein) is the PIP inert ingredient. As a PIP inert, the HPPD-4 protein functions as a selectable marker in a PIP.

Based upon available data, EPA concludes that the HPPD-4 protein derived from the Pseudomonas fluorescens HPPD enzyme does not show evidence of toxicity. Moreover, the source is not allergenic, nor is there any significant similarity between the HPPD-4 protein and known toxins and allergens. In addition, the HPPD-4 protein readily digests in gastric fluids and therefore cumulative, chronic, and acute effects are unlikely.

Given the lack of toxicity or allergenicity of the HPPD-4 protein, the Agency has not identified any toxicological endpoints for assessing risk. Consequently, the Agency's assessment of exposure is qualitative. In addition, due to the lack of any threshold effects, EPA has determined that the provision to retain a 10X safety factor for the protection of infants and children does not apply. Similarly, the lack of any toxic mode of action or toxic metabolites means that the provision requiring an assessment of cumulative effects does not apply.

Oral exposure may occur from ingestion of the raw crops containing HPPD-4, as well as their processed derivatives. Currently, HPPD-4 is only proposed to be used as a PIP inert ingredient in soybean, although it could be used in other crops in the future. The current proposed use results in the presence of HPPD-4 protein at low levels within the plant, although future uses could be higher. Based on the lack of adverse effects and the rapid digestibility of the protein, however, the Agency does not anticipate any risk from reasonably foreseeable levels of exposure. Residues in drinking water may theoretically be present because plant stubble may release modified HPPD-4 protein into ground water upon decay. However, the protein would not be expected to survive in the soil due to microbial degradation, adherence to soil components, and removal upon drinking water treatment procedures. In addition, oral toxicity testing showed no adverse effects. Moreover, because the PIP inert ingredient is currently only proposed to be used only in plants grown for commercial use, the Agency does not anticipate residential exposures. In the event that future uses are sold for residential use, the Agency does not expect there to be residential, non-occupational dermal or inhalation exposures, due to containment of the HPPD-4 protein within the plant.

Based on the lack of any evidence of adverse effects in the toxicological database, dietary exposure to the HPPD-4 protein is not anticipated to pose any harm to the U.S. population. EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the HPPD-4 protein derived from the Pseudomonas fluorescens HPPD enzyme. Therefore, an exemption from the requirement of a tolerance is established for residues of the plant-incorporated protectant inert ingredient Pseudomonas fluorescens HPPD-4 protein in or on all food commodities.

An analytical method is not required because the lack of adverse effects makes enforcement and monitoring of residues unnecessary to ensure food safety.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. 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 exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0495 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2016-0495, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8492) by IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of prometryn in or on the raw agricultural commodity lettuce at 0.5 parts per million (ppm); cottonseed subgroup 20C at 0.25 ppm; fennel, Florence at 0.5 ppm; leaf petiole vegetable subgroup 22B at 0.5 ppm; sesame, oil at 0.12 ppm; sesame, seed at 0.05 ppm; and Swiss chard at 0.5 ppm.

In the Federal Register of April 10, 2017 (82 FR 17175) (FRL-9959-61), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8492) by IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of prometryn in or on the raw agricultural commodity celtuce at 0.5 ppm. This notice of filing corrected the November 30, 2016 notice of filing which incorrectly listed the commodity as “lettuce” not “celtuce.”

The documents referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to either notice of filing.

Based upon review of the data supporting the petition, EPA has corrected the number of significant figures used, modified one of the commodity definitions, and determined that the sesame oil tolerance was not necessary. The reason for these changes are explained in Unit IV.C.

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

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

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

Following subchronic and chronic oral exposures to rabbits, mice, dogs and rats, the most consistent effects observed in the database were decreases in body weight and food consumption. Following chronic exposure, effects in the dog included degenerative hepatic changes, renal tubule degeneration, and bone marrow atrophy. In rats following chronic exposure, renal toxicity (mineralized concentrations) was observed. No adverse effects were seen in rabbits following dermal exposures up to the limit dose.

There was evidence of increased pre- and post-natal quantitative susceptibility for prometryn. While there was no evidence of susceptibility in the developmental toxicity studies in rabbits and rats, there was evidence of quantitative susceptibility in the two-generation reproduction study in rats, with offspring effects (decreased pup body weight) occurring at lower doses than those that resulted in parental effects (decreased absolute bodyweight and food consumption).

There was no evidence of neurotoxicity in the acute or subchronic neurotoxicity studies. In an immunotoxicity study in rats, there was a decreased humoral immune response using the sheep red blood cell assay, but only at a dose above the limit dose (1045 mg/kg/day).

Prometryn has been classified by EPA as “Group E:—Evidence of non-carcinogenicity for humans” based on the lack of oncogenic effects at any dose in both rats and mice. Prometryn was determined to be non-mutagenic and non-clastogenic in in vitro and in vivo genotoxicity assays.

Specific information on the studies received and the nature of the adverse effects caused by prometryn as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Prometryn—Preliminary Human Health Risk Assessment for Registration Review and the Risk Assessment for the Section 3 Registration Request for a New Use on Sesame and Crop-Group Conversions” on pages 46-49 in docket ID number EPA-HQ-OPP-2016-0495.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prometryn, EPA considered exposure under the petitioned-for tolerances as well as all existing prometryn tolerances in 40 CFR 180.222. EPA assessed dietary exposures from prometryn in food as follows:

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

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

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues.

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for prometryn. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prometryn in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prometryn. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide in Water Calculator (PWC) and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of prometryn for chronic exposures are estimated to be 127 parts per billion (ppb) for surface water and 433 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 433 ppb was used to assess the contribution to drinking water.

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

Prometryn is not registered for any specific use patterns that would result in residential exposure.

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

EPA has not found prometryn to share a common mechanism of toxicity with any other substances, and prometryn does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that prometryn 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There was evidence of increased pre- and post-natal quantitative susceptibility for prometryn. While there was no evidence of susceptibility in the developmental toxicity studies in rabbits and rats, there was evidence of quantitative susceptibility in the two-generation reproduction study in rats, with offspring effects (decreased pup body weight) occurring at lower doses than those that resulted in parental effects (decreased absolute bodyweight and food consumption).

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

i. The toxicity database for prometryn is complete.

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

iii. There was no evidence of increased quantitative or qualitative susceptibility in the developmental toxicity studies in rabbits or rats. However, there was evidence of increased quantitative susceptibility in the two-generation reproduction study. In the two-generation reproduction study, the offspring effects (decreased absolute pup bodyweight in the F1 generation) were observed at doses below parental toxicity (decreases in absolute bodyweight, bodyweight gain and food consumption in the F1 generation). Concern is low since the effects are characterized by clear NOAEL and LOAEL values and the selected endpoints are protective of the observed effects.

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

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, prometryn is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prometryn from food and water will utilize 60% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. There are no residential uses for prometryn.

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

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

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

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

Adequate enforcement methodology is available to enforce the established and proposed tolerances. Prometryn is completely recovered (>80% recovery) using the Food and Drug Administration's (FDA's) Multiresidue Section 302. In addition, both Ciba-Geigy Method AG-559 (gas chromatography (GC)/flame-photometric detector (FPD)/S) and Method AG-673 (GC/nitrogen-phosphorous detector (NPD) method) are considered adequate for enforcement purposes.

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

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

The Codex has not established any MRLs for prometryn.

EPA modified the tolerance levels to reflect the correct number of significant figures and to be consistent with Agency policy. Also, the commodity definition for Florence fennel was modified to read “Fennel, Florence, fresh leaves and stalk” to be consistent with Agency nomenclature. Lastly, the petitioner recommended a tolerance for residues of prometryn in/on sesame, oil at 0.12 ppm. Residues in oil at a 5x application rate were 0.1076 which when extrapolated to 1x would be 0.02 ppm. As this value is well below the proposed raw agricultural commodity (RAC) tolerance, an oil tolerance is not necessary.

Therefore, tolerances are established for residues of prometryn, including its metabolites and degradates, in or on celtuce at 0.50 ppm; cottonseed subgroup 20C at 0.25 ppm; fennel, Florence, fresh leaves and stalk at 0.50 ppm; leaf petiole vegetable subgroup 22B at 0.50 ppm; sesame, seed at 0.05 ppm; and Swiss chard at 0.50 ppm. Additionally, the existing tolerances for the leaf petioles subgroup 4B and cotton, undelinted seed are removed as unnecessary, since they are superseded by the new tolerances.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0384 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2016-0384, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8488) by IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid in or on asparagus at 0.06 parts per million (ppm); the bushberry subgroup 13-07B, except lowbush blueberry at 0.6 ppm; and the caneberry subgroup 13-07A at 0.06 ppm. That document referenced a summary of the petition prepared by Albaugh, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the levels at which the tolerances are being established. The reason for these changes is explained in Unit IV.C.

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

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

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

Subchronic toxicity of quinclorac includes decreased body weight gains, increased water intake, increased liver enzymes (SGOT, SGPT) and focal chronic interstitial nephritis (rats). Chronic toxic effects of quinclorac include body weight decrement, increase in kidney and liver weights, and hydropic degeneration of the kidneys (dogs). At high doses, chronic toxicity also includes increased incidences of pancreatic acinar cell hyperplasia and adenomas (rats). Neurotoxic effects were not observed in any of the acute, subchronic, and chronic studies with quinclorac.

There was no increased qualitative or quantitative fetal or offspring susceptibility in the prenatal developmental or postnatal reproduction studies. Developmental toxicity in the rabbit consisted of increased resorptions, post-implantation loss, decreased number of live fetuses, and reduced fetal body weight. These effects occurred at much higher doses than the maternal effects of decreased food consumption and increased water consumption and decreased body weight gain. In the rat, no developmental toxicity was observed at the highest dose tested (438 mg/kg/day). In the 2-generation reproduction study, parental toxicity and offspring toxicity occurred at the same dose. Parental toxicity consisted of reduced body weight in both sexes during premating and lactation periods. Offspring toxicity consisted of decreased pup weight, developmental delays and possible marginal effect on pup viability. No reproductive toxicity occurred at the highest dose tested (480 mg/kg/day).

There are no mutagenicity concerns. Quinclorac is not mutagenic in bacterial assays and does not cause unscheduled DNA damage in primary rat hepatocytes. There is also no evidence of a genotoxic response in whole animal test systems (in vivo mouse bone marrow micronucleus assay). Quinclorac was negative in a mammalian cell in vitro cytogenetic chromosomal aberration assay in Chinese hamster ovary cells (CHO). Quinclorac was classified by the Agency as a group D carcinogen—not classifiable as to human carcinogenicity. Quantification of cancer risk is not required because the chronic RfD will adequately account for all chronic effects, including carcinogenicity, that may result from exposure to quinclorac.

Specific information on the studies received and the nature of the adverse effects caused by quinclorac as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Quinclorac: Human Health Risk Assessment for New Proposed Use on Bushberry Subgroup 13-07B, Caneberry Subgroup 13-07A, and Asparagus” on pages 41-46 in docket ID number EPA-HQ-OPP-2016-0384.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for quinclorac used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 29, 2013 (78 FR 71523) (FRL-9902-15).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to quinclorac, EPA considered exposure under the petitioned-for tolerances as well as all existing quinclorac tolerances in 40 CFR 180.463. EPA assessed dietary exposures from quinclorac in food as follows:

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

For the general population including infants and children, no such effects were identified in the toxicological studies for quinclorac; therefore, a quantitative acute dietary exposure assessment for these population groups is unnecessary.

However, for females 13 to 49 years of age, such effects were identified for quinclorac. In estimating acute dietary exposure, EPA used food consumption information from the 2003-2008 United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 2003-2008 USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT.

iii. Cancer. Based on the current cancer classification of quinclorac, quantification of cancer risk is not required and the chronic RfD will adequately account for all chronic effects, including carcinogenicity, that may result from exposure to quinclorac.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for quinclorac. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for quinclorac in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of quinclorac. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier 1 Rice Model and the Pesticide Water Calculator-Ground Water exposure model, the estimated drinking water concentrations (EDWCs) of quinclorac for acute exposures are estimated to be 511 parts per billion (ppb) for surface water and 817 ppb for ground water and for chronic exposures are estimated to be 481 ppb for surface water and 543 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 817 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 543 ppb was used to assess the contribution to drinking water.

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

Quinclorac is currently registered for the following uses that could result in residential exposures: Turf grass and ornamentals. EPA assessed residential exposure using the following assumptions: Short-term residential handler inhalation exposure is expected from the existing uses. The quantitative exposure/risk assessment developed for residential handlers is based on the following scenarios: Loading/applying granules for belly grinder; loading/applying granules for push type rotary spreader; loading/applying granules for a spoon; loading/applying granules for a cup and shaker can; applying granules by hand; mixing/loading/applying liquid and dry flowable formulations via manually-pressurized handwand, a hose-end sprayer, a backpack, and a sprinkler can; and mixing/loading/applying ready-to-use formulation via a trigger sprayer, and a hose-end sprayer.

Post-application short-term dermal and incidental oral exposure is expected from quinclorac treated turf in residential settings (i.e., lawns). Dermal exposures were not quantified due to a lack of a dermal toxicological endpoint. Incidental oral exposure risk estimates were calculated for hand-to-mouth, object-to-mouth, and soil ingestion exposures for 1 to <2-year old children playing in the treated turf. Even though there is a granular product, an assessment for episodic granular ingestion was not done since there is no applicable endpoint (i.e., no acute dietary point of departure for children).

The worst-case residential exposure scenario used in the adult aggregate assessment reflects inhalation exposure from residential handlers mixing/loading/applying water-dispersible granule/dry flowable formulations with a manually-pressurized handwand and/or backpack equipment.

The worst-case residential exposure scenario used in the children 1<2 years old aggregate assessment reflects hand-to-mouth exposures from post-application exposure to treated turf.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 quinclorac to share a common mechanism of toxicity with any other substances, and quinclorac does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that quinclorac 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. The toxicology database for quinclorac consists of developmental toxicity studies in rats and rabbits and a 2-generation reproduction study in rats. There is no indication of increased qualitative or quantitative susceptibility of rats or rabbit fetuses to in utero and/or postnatal exposure in the developmental and reproductive toxicity data.

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

i. The toxicity database for quinclorac is complete.

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

iii. There is no evidence that quinclorac results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

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

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. For the general population including infants and children, no adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, quinclorac is not expected to pose an acute risk to these population groups. However, an adverse effect was identified for females 13 to 49 years of age, and therefore an acute aggregate risk assessment was performed for this population group.

Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to quinclorac will occupy 2.4% of the aPAD for females 13 to 49 years old, the only population group of concern.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to quinclorac from food and water will utilize 9.4% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of quinclorac 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).

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

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2,100 for adults and 1,500 for children 1<2 years old. Because EPA's level of concern for quinclorac is a MOE of 100 or below, these MOEs are not of concern.

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

Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified, however, quinclorac is not registered for any use patterns that would result in intermediate-term residential exposure; therefore, an intermediate-term aggregate risk assessment was not performed nor required. In addition, since the short- and intermediate-term PODs are the same, the estimates for short-term duration are protective of intermediate-term duration.

5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., EPA considers the chronic aggregate risk assessment to be protective of any aggregate cancer risk. As there is no chronic risk of concern, EPA does not expect any cancer risk to the U.S. population from aggregate exposure to quinclorac.

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 quinclorac residues.

Adequate analytical methods (gas chromatography/electron capture detector (GC/ECD)) are available for enforcing quinclorac tolerances on plant and livestock commodities. The methods have undergone successful agency method validation trials and have been submitted to the Food and Drug Administration (FDA) for publication in the Pesticide Analytical Manual (PAM) II as the tolerance enforcement methods. The Limit of Quantitation (LOQ) of both methods is 0.05 ppm for all matrices.

Other adequate LC/MS/MS based analytical methods, BASF Method D9708/02 (for quinclorac) and BASF Method D9806/02 (for quinclorac methyl ester), are available for data collection and tolerance enforcement of residues of quinclorac and its methyl ester metabolite in/on plant commodities. The validated LOQ for both methods is 0.05 ppm. Both methods monitor two ion transitions. The Agency concurred with BASF's proposal to designate BASF Method D9708/02 and BASF Method D9806/02 as the new tolerance enforcement methods for quinclorac and quinclorac methy ester, respectively. These LC/MS/MS enforcement analytical methods without the methylation step are preferable to the previous GC/ECD method.

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

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

The Codex has not established any MRLs for quinclorac on any of the crops covered by this document.

Using the amended residue data in the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures, the Agency is establishing the tolerance of 0.08 ppm for combined residues of quinclorac and its methyl ester metabolite, in/on the bushberry subgroup 13-07B, the caneberry subgroup 13-07A, and asparagus. The tolerance of 0.08 ppm in/on the caneberry subgroup 13-07A and asparagus is higher than the petitioned-for tolerance (0.06 ppm) because the quinclorac residue values from the submitted field trial data did not include the residue values of methyl ester metabolite. However, the tolerance in/on the bushberry subgroup 13-07B is much lower than the petitioned-for tolerance (0.6 ppm). In blueberry trials, the petitioner included the single lowbush blueberry trial (ME03) in the tolerance calculation for bushberry subgroup 13-07B. Trial ME03 gives a quinclorac residue value (HAFT: 0.374 ppm) that is approximately sixteen times greater than the residue value (HAFT: 0.024 ppm) in/on blueberries from the six highbush blueberry trials. The difference in residue value is largely attributed to application patterns. The single lowbush blueberry sample (ME03) was subjected to two applications—one broadcast to the ground, the other broadcast to the foliage, whereas samples of highbush blueberry (subgroup 13-07B) were conducted with banded soil application twice. After excluding ME03 the tolerance value of blueberry from the OECD calculator (0.08 ppm) is significantly lower than the proposed tolerance (0.6 ppm).

Lastly, the Agency is modifying the proposed commodity definition of “Bushberry Subgroup 13-07B, except lowbush blueberry” to “Bushberry Subgroup 13-07B” because the lowbush blueberry tolerance is covered by the established tolerance at 1.5 ppm in/on berry, low growing, except strawberry, subgroup 13-07H.

Therefore, tolerances are established for residues of quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on asparagus at 0.08 ppm; the bushberry, subgroup 13-07B at 0.08 ppm; and the caneberry subgroup 13-07A at 0.08 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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:

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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select “Test Guidelines for Pesticides and Toxic Substances.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0563 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2017-0563, by one of the following methods:

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

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

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

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

EPA previously published final rules in the Federal Register for each chemical and commodity listed, establishing time-limited tolerances under FFDCA section 408, 21 U.S.C. 346a.

EPA established the tolerances because FFDCA section 408(l)(6) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established on EPA's own initiative and without providing notice or time for public comment.

EPA received requests to extend the emergency use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical in the listed commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.

The data and other relevant material have been evaluated and discussed in the final rules originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of FFDCA section 408(l)(6). Therefore, the time-limited tolerances are extended until the date listed. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in effect at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Tolerances for the use of the following pesticide chemicals on specific commodities are being extended:

A. Clothianidin. EPA has authorized under FIFRA section 18 the use of clothianidin on citrus for control of the Asian citrus psyllid in Florida and Texas. This regulation extends a time-limited tolerance for residues of the insecticide clothianidin and its metabolites in or on Fruit, citrus, group 10-10 at 0.07 ppm for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2020. A time-limited tolerance was originally published in the Federal Register of February 25, 2015 (80 FR 10003) (FRL-9919-59).

B. Sulfoxaflor. EPA has authorized under FIFRA section 18 the use of sulfoxaflor on sorghum for control of the sugarcane aphid in several states. This regulation extends time-limited tolerances for residues of the insecticide sulfoxaflor and its metabolites in or on sorghum, forage at 0.4 ppm; sorghum, grain at 0.3 ppm; and sorghum, stover at 0.9 ppm for an additional 3-year period. The tolerances will expire and are revoked on December 31, 2020. Time-limited tolerances were originally published in the Federal Register of January 28, 2015 (80 FR 4512) (FRL-9920-45).

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

The Codex has established MRLs for clothianidin in/on citrus fruits at 0.07 ppm. These MRLs are the same as the tolerance established for clothianidin in/on fruit, citrus, group 10-10 in the United States. The Codex has not established any MRLs for sulfoxaflor in/on sorghum commodities.

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

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

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

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

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA has submitted 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:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0314 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 2, 2018. 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-2016-0314, 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 July 20, 2016 (81 FR 47150) (FRL-9948-45), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8472) by IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.345 be amended by increasing the existing tolerance for the combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites (2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate) both calculated as the parent compound, in or on beet, sugar, molasses from 0.5 to 2.5 parts per million (ppm); beet, sugar, refined sugar from 0.2 to 1.0 ppm; beet, sugar, roots from 0.3 to 1.5 ppm; and beet, sugar, tops from 4.0 to 30.0 ppm. That document referenced a summary of the petition prepared by Willowood USA, LLC, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to the comment is found in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing tolerances that differ from what the petitioner requested. The reasons for these changes are explained in Unit IV.D.

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

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

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

The liver is the main target organ in rats and dogs, and the major critical effects seen in oral studies are decreased body weight/body weight gain and hepatic toxicity in the rat, dog and/or rabbit. Mice are relatively insensitive to ethofumesate up to the limit dose following subchronic and chronic dietary exposure.

Ethofumesate did not demonstrate the potential to cause neurotoxicity in four species (rats, mice, dogs and rabbits).

Rats did not show evidence of developmental, maternal, or offspring toxicity or susceptibility in a three-generation reproduction study or any developmental or maternal toxicity in the developmental toxicity study. Although increased prenatal quantitative sensitivity (increased resorptions, increased post-implantation loss and incomplete ossification of the vertebral arches) was observed in the rabbit developmental toxicity study, the developmental toxicity no observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) are well characterized. In maternal rabbits, effects included decreased body weight, increased mortality, abortions and complete litter resorption at levels in excess of the limit dose.

Ethofumesate is classified as “Not Likely to be Carcinogenic to Humans”, based on bioassays in the rat and the mouse, combined with a lack of in vitro or in vivo mutagenicity supported by a battery of mutagenicity studies that showed no evidence of a mutagenic effect.

Specific information on the studies received and the nature of the adverse effects caused by ethofumesate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Ethofumesate. Human Health Risk Assessment for an Amended Use on Sugar Beets” dated October 4, 2017 at pages 33-36 in docket ID number EPA-HQ-OPP-2016-0314.

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/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ethofumesate, EPA considered exposure under the petitioned-for tolerances as well as all existing ethofumesate tolerances in 40 CFR 180.345. EPA assessed dietary exposures from ethofumesate in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Because no appropriate endpoint was identified for the general population including infants and children, a quantitative acute dietary exposure assessment was not conducted for these populations. Such effects were observed for the population subgroup females 13-49 years of age.

In estimating acute dietary exposure for females 13-49 years, EPA used food consumption information from the United States Department of Agriculture (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA used an unrefined determination based on tolerance-level residues, 100 percent crop treated (PCT) information for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors, where available.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used an unrefined determination based on 100 PCT, tolerance-level residues for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors, where available.

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

iv. Anticipated residue and percent crop treated (PCT) information. The Agency did not use anticipated residue data or percent crop treated estimates.

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

Based on the Tier I: First Index Reservoir Screening Tool (FIRST) and Tier II: Pesticide Root Zone Model Ground Water (PRZM GW)/PWC, the estimated drinking water concentrations (EDWCs) of ethofumesate (parent compound only) for acute exposures are estimated to be 416 parts per billion (ppb) for surface water and 750 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 123 ppb for surface water and 695 ppb for ground water.

Modeled estimates of drinking water concentrations of ethofumesate for parent compound only, were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 750 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 695 ppb was used to assess the contribution to drinking water.

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

Ethofumesate is currently registered for the following uses that could result in residential exposures: ornamental lawns and turf (including golf courses, parks, cemeteries, and homeowner/commercial lawns). EPA assessed residential exposure using the following assumptions: All ethofumesate products are intended for either agricultural use or require professional application for ornamental turf. Although registered products are labeled for use on home lawns, residential handler exposures are not anticipated because the label language requiring personal protective equipment (PPE) and prohibiting the use of handheld equipment indicate that the product is not intended for homeowner use. Therefore, the Agency has not conducted a residential handler assessment.

There is potential for ethofumesate residential post-application exposure for individuals exposed as a result of being in an environment that has been previously treated. Residential post-application dermal (adults and children) and incidental oral (children only) exposures are anticipated from the registered turf uses. EPA conducted screening level calculations on the scenarios most likely to result in highest possible exposure. These scenarios are:

• For children 1 to <2 years old: incidental ingestion (hand-to-mouth), incidental ingestion (turf-to-mouth), incidental ingestion (soil-to-mouth), and dermal exposure

• for adults and youths (11 to <16 years old: dermal exposure (golfing, lawn mowing, etc.).

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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ethofumesate and any other substances and ethofumesate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ethofumesate 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/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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.

2. Prenatal and postnatal sensitivity. There are no concerns or uncertainties for pre- and/or post-natal toxicity resulting from exposure to ethofumesate. There is no evidence that ethofumesate results in increased susceptibility in in utero exposure to ethofumesate in the prenatal developmental study in rats. Increased pre-natal quantitative susceptibility was observed in the rabbit developmental toxicity study. The Agency concluded, however, that there is no concern that the risk assessment will not adequately safeguard against potential pre- and post-natal toxicity because the developmental toxicity NOAELs/LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups.

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

i. The toxicity database for ethofumesate is sufficiently complete and adequate for characterizing potential pre- and/or post-natal risks to infants and children. Available studies supporting this decision include developmental toxicity studies in rats and rabbits, and a three-generation reproduction study in rats.

Based on all available hazard and exposure data for ethofumesate, the Agency determined that the subchronic inhalation, acute and subchronic neurotoxicity, and the immunotoxicity studies for ethofumesate were not necessary and waived those requirements. The existing ethofumesate database is extensive and adequately sufficient to permit a full assessment of risks associated with proposed new uses under consideration.

ii. There is no indication that ethofumesate is a neurotoxic chemical. Ethofumesate did not cause clear clinical or histopathological signs of neurotoxicity in four species tested (rats, rabbits, mice and dogs) as evaluated by the current studies within the database. In addition, there was no evidence of neurotoxicity observed in the toxicity databases of chemicals in the same class as ethofumesate. Therefore, EPA is not requiring a developmental neurotoxicity study nor incorporating an additional UFs to account for neurotoxicity.

iii. There is no evidence that ethofumesate results in increased susceptibility in in utero exposure to ethofumesate in the prenatal developmental study in rats. No rat developmental effects were seen at the highest dose tested (limit dose of 1000 mg/kg). There is, however, quantitative evidence for increased susceptibility following in utero exposure to ethofumesate in an adequate developmental toxicity study in the rabbit. At 300 mg/kg/day, no maternal toxicity was reported, but developmental toxicity was observed as increased resorptions, post-implantation loss and skeletal abnormalities (incomplete ossification of vertebral arches). However, the developmental toxicity NOAELs and LOAELs are well characterized and are used as endpoints for risk assessment for the appropriate population subgroups.

There was no quantitative or qualitative evidence of increased susceptibility in the three-generation reproduction study in rats with ethofumesate since maternal, reproductive and offspring toxicity were not observed at any dose tested up to 5000 ppm (397 and 463 mg/kg/day, males and females, respectively). Although a limit dose was not achieved and no maternal toxicity reported, a new study was not required because the highest dose tested was similar to the dose level that caused toxicity to rats in the chronic/carcinogenicity dietary study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary exposure analyses are unlikely to underestimate exposure. The acute and chronic dietary food and drinking water exposure assessments were performed based on 100 PCT information for all commodities, tolerance-level residues, and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors where available. The dietary exposure analyses also assumed that all drinking water will contain ethofumesate at the highest EDWC levels modeled by EPA. The Agency used similarly conservative assumptions to assess post-application exposure of adults and children. The residential exposure estimates are based on EPA's 2012 Residential Standard Operations Procedures (SOPs). These assessments will not underestimate the exposure and risks posed by ethofumesate.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to ethofumesate will occupy 14% of the aPAD at the 95th percentile for females 13-49 years old, the only population subgroup for which an acute dietary endpoint attributable to a single exposure was identified.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure from food and drinking water only as chronic exposure from residential uses of ethofumesate is not expected, EPA identified separate chronic dietary endpoints for the general population, including infants and children, as well as for the population subgroup of females 13-49 years of age. Based on the input parameters and assumptions, the chronic dietary risk estimate for the U.S. population was determined to be 1.2% of the cPAD with the population subgroup of females 13-49 years having the highest risk estimate at 5.2% of the cPAD. EPA concluded that ethofumesate risk estimates for all population subgroups were below the level of concern of <100% of the cPAD.

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

Ethofumesate is currently registered for uses that could result in short-term residential exposure. Residential exposure to ethofumesate is not anticipated from the amended uses that are the subject of this regulatory action; however, it is anticipated from currently registered residential uses of ethofumesate. Residential exposures are only expected to be short-term in duration; however, since the point of departure is the same for short and intermediate-term exposures, the short-term aggregate is protective of any longer-term exposures.

Aggregate risk estimates (MOEs) were derived using recommended exposure scenarios including: For adults, dermal post-application exposure from high contact activities on treated turf; for children, including ages 11 to <16 years and 6 to <11 years, dermal post-application exposure from golfing on treated turf; and for children (1 to <2 years), combined dermal plus hand-to-mouth post-application exposure from high contact activities on treated turf.

EPA short-term aggregate risk calculations of aggregate MOEs, combining average food and drinking water, plus residential exposures (total exposure), ranged from 120 for females 13-49 years; to 430 for children 1 to <2 years; to 770 for adults, 20-49 years and significantly higher for population subgroups, children 6 to 11 years and youth 11 to <16 years. These short-term aggregate risk estimates are not of concern to EPA (i.e., MOEs are ≥ 100).

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

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

Adequate enforcement methodology (Method I in PAM Vol. II is listed as an adequate tolerance enforcement method for plants) is available to enforce the tolerance expression.

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

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

There are no Codex MRLs established for the residues of ethofumesate in/on any sugar beet raw agricultural or processed commodity.

One commenter supported the tolerance action but expressed concerns about the need for additional data to assess the toxicity of ethofumesate to bioaccumulate and to contribute to obesity and diabetes. To the extent the commenter is concerned about impacts on aquatic life, earthworms, and other non-human organisms, this comment is outside the scope of review appropriate for a tolerance safety assessment under section 408 of the FFDCA. If the commenter is raising concerns about potential human harm, the Agency has considered all the available data and determined that the tolerances are safe; there is nothing in the toxicity database that would suggest toxicity concerns related to diabetes or obesity.

The octanol-water partition coefficient (log Kow) for ethofumesate is 2.8. Compounds with log Kow values less than three are unlikely to bioaccumulate substantially. Therefore, further assessment of the bioaccumulation of ethofumesate is not warranted at this time.

EPA is not increasing the existing tolerance for “Beet, sugar, tops” because it is unnecessary due to the fact that this commodity is no longer a significant livestock feed item or a recognized human food.

Although the petitioner requested an increase in the existing sugar, beet, refined sugar tolerance, EPA has determined that the tolerance is not needed because the limit established for the raw agricultural commodity (RAC) (beet, sugar, roots at 1.5 ppm) is sufficient to cover residues in this processed commodity (at 1.0 ppm).

In setting the sugar beet molasses tolerance, EPA used the empirical processing factor previously derived for determining the concentration of residues in this processed commodity, which results in a tolerance of 2.0 ppm rather 2.5 ppm as requested.

The tolerance expressions at 180.345 paragraphs (a) and (c) for ethofumesate are being revised to comply with current EPA policies and to accommodate updated tolerance enforcement methods that convert the NC 20645 (2-(2-hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic acid) metabolite to NC9607 (3,3-dimethyl-5-[(methylsulfonyl)oxy]-2(3H)-benzofuranone) prior to quantitation.

Therefore, tolerances are established for residues of the herbicide ethofumesate in or on beet, sugar, molasses at 2.0 ppm and beet, sugar, roots at 1.5 ppm. Also, the tolerance for beet, sugar, refined is deleted because residues in that processed commodity are covered by the tolerance for beet, sugar, roots.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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:

This is a summary of the Commission's Order on Reconsideration in PS Docket No. 15-91, No. 15-94, FCC 17-143, released on November 1, 2017. The document is available for download at https://apps.fcc.gov/edocs_public/attachmatch/FCC-17-143A1.pdf. The complete text of this document is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

1. This Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) supplements the Final Regulatory Flexibility Analysis (FRFA) of the September 2016 WEA Report and Order, 81 FR 75710 (WEA R&O) to reflect the actions taken in this Order on Reconsideration and conforms to the RFA.

2. In the WEA R&O, we took advantage of the significant technological changes and improvements experienced by the mobile wireless industry since the passage of the Warning, Alert and Response Network (WARN) Act, and deployment of WEA to improve the utility of WEA as a life-saving tool. As pertinent to the Order on Reconsideration we adopt today, in the WEA R&O we adopted rules focused on improving WEA message content by narrowing the rules for the geo-targeting of alerts, requiring Participating Commercial Mobile Service (CMS) Providers to support embedded references (i.e., URLs and phone numbers) included in WEA Alert Messages. In doing so, we set a deadline for compliance with the embedded reference requirement of one year (12 months).

3. In this Order on Reconsideration, we grant, to the extent described herein, CTIA's Petition for Reconsideration of the WEA R&O and CCA's Petition for Waiver, or in the Alternative, Extension of Time. In doing so, we deny CCA's request for a waiver or an extension of time for compliance with the WEA R&O's best approximates geo-targeting standard, as compliance with the best approximate geo-targeting is well within the capabilities of CCA's members; and we reconsider the deadline for compliance with the embedded reference requirement from one year (12 months) to 30 months for all Participating CMS Providers except for AT&T, Verizon, T-Mobile, Sprint and U.S. Cellular, because these CMS Providers have indicated their ability and intent to meet the November 1, 2017 deadline for embedded references adopted in the WEA R&O. The actions we take today allow us to continue to advance down the path outlined in the WEA R&O while supplying additional time for compliance to smaller entities (i.e., small and regional carriers) with respect to the embedded reference requirement adopted therein.

4. In light of reconsideration, waiver, and extension requests, the Commission considered the potential impact of the rules proposed in the IRFA on small entities and reduced the compliance burden in order to reduce the economic impact of the rules enacted herein on such entities.

5. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rule(s) as a result of those comments.

6. The Chief Counsel did not file any comments in response to the proposed rule(s) in this proceeding.

7. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

8. As noted above, a FRFA was incorporated into the WEA R&O. In that analysis, we described in detail the small entities that might be significantly affected by the rules adopted in the WEA R&O. Those entities may be found in a number of services including, e.g.: Wireless telecommunications carriers, broadband Personal Communications Service, narrowband Personal Communications Service, Wireless Communications Services, Advanced Wireless Services, lower and upper 700 MHz Band licenses, software publishers, and radio and television broadcasting and wireless communications equipment manufacturing. In this Order on Reconsideration, we hereby use the descriptions and estimates of the number of small entities from the previous FRFA in this proceeding.

9. The data, information and document collection required by the WEA R&O as described in the previous FRFA in this proceeding is hereby used. The actions taken in this Order do not amend or otherwise revise those requirements, except to supply additional time for compliance with one of the requirements, i.e., embedded references in WEA messages.

10. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) and exemption from coverage of the rule, or any part thereof, for small entities.

11. The analysis of the Commission's efforts to minimize the possible significant economic impact on small entities as described in the previous FRFA in this proceeding is hereby incorporated by reference. Additionally, in this Order, in response to concerns raised by small entities, i.e., small and regional carriers, the Commission is supplying additional time, until May 1, 2019, for all carriers (apart from the five) to comply with the embedded reference requirement.

12. The Commission will send a copy of this Order, including this Supplemental FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. In addition, the Commission will send a copy of this Order, including the Supplemental FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of this Order and Supplemental FRFA (or summaries thereof) will also be published in the Federal Register.

13. In this Order on Reconsideration, we reaffirm our existing schedule for geo-targeting alerts to best approximate the target area and reaffirm that the five largest mobile service providers must provide clickable embedded references by November 1, 2017, but we extend the timeline for smaller, regional wireless providers to come into compliance with that requirement. These actions ensure that smaller, regional wireless providers remain part of the Wireless Emergency Alerts (WEA) system while maximizing the deployment of more effective wireless emergency alerts to consumers.

14. In September 2016, the Commission adopted the WEA Report and Order, 81 FR 75710 (WEA R&O), which eliminated the prohibition on the use of embedded references in non-Presidential Alerts and required Participating CMS Providers to support embedded references within one year of the rules' publication in the Federal Register. Among other issues, CTIA timely petitioned the Commission to reconsider, or, in the alternative, clarify this requirement.

15. CTIA requests that the Commission defer mandating implementation of embedded references until after feasibility testing is completed (i.e., testing whether embedded references in WEA alerts would cause harmful network congestion) and the requirements for compliance are clarified (e.g., that the Commission is requiring embedded reference capability only for new devices).

16. CTIA makes three arguments: mandating compliance before comprehensive feasibility testing may lead to substantial network congestion; testing, prior to mandating compliance, is necessary to determine the feasibility of supporting embedded references; and the compliance deadline has no sound basis in the record.

17. On August 16, 2017, the CCA filed a Petition for Waiver, or in the Alternative, Extension of Time, requesting a waiver or extension of the compliance timeline for support for embedded references until May 1, 2019, consistent with CTIA's request. CCA further requested a waiver or extension of time for compliance with the WEA R&O's geo-targeting requirement until May 1, 2019.

18. CCA requests that we waive or delay the November 1, 2017 deadline for basic geo-targeting (known as best approximates geo-targeting). We decline the request and reaffirm the current schedule for the deployment of basic geo-targeting for wireless emergency alerts.

19. The basic geo-targeting standard is designed to be flexible and to take into consideration the specific capabilities of each Participating CMS Provider. In the WEA R&O, the Commission set forth the expectation that Participating CMS Providers will take reasonable efforts to leverage existing technology to its fullest extent and articulated potential techniques and benchmarks for basic geo-targeting. As the Commission noted when it adopted the initial rules for WEA, the system is technologically neutral, and Participating CMS providers are in the best position to select and incorporate the technologies that will enable them to most effectively and efficiently deliver mobile alerts.

20. Although CCA asserts that many of its members cannot comply with the standard because they are still transitioning from 2G and 3G to 4G technologies and because the standards applicable to best approximates” are still in development, we reject CCA's contention that its ability to meet the basic geo-targeting standard is affected in any way by a particular technology such as cell broadcasting. Rather, we anticipate that CCA's members, like other Participating CMS Providers, will continue to employ the techniques that they have been deploying as a matter of best practice. Accordingly, given the inherent flexibility in the best approximates geo-targeting standard, we find no basis for granting relief from this requirement.

21. CTIA and CCA request we revise the compliance timeframe for the embedded reference requirement. We decline to do so for the five largest Participating CMS Providers—Verizon, AT&T, Sprint, T-Mobile, and U.S. Cellular—who have indicated that they are able to and intend to support embedded references on smartphones capable of processing them by the November 1, 2017 deadline. We observe that the WEA R&O explicitly made clear that the embedded reference requirement can be enabled through software updates, and that Participating CMS Providers could implement the necessary changes to their software to make the embedded reference capability available to customers. Mobile devices that support neither embedded references nor the software updates that would provide such capability will not be considered WEA capable.

22. We nonetheless grant 18 months of relief to smaller, regional operators—specifically, all Participating CMS Providers other than the largest five—so that they will have additional time to deploy network upgrades and learn from the deployment experiences of the largest Participating CMS Providers on how best to ensure embedded references are smoothly integrated into the WEA system.

23. CCA argues that its members, which are smaller and regional providers, have fewer resources, and that 18 additional months is sufficient time to implement the embedded references requirement. We agree. As CCA notes, smaller and regional wireless providers within its membership do not participate in the Alliance for Telecommunications Industry Solutions' (ATIS) standards-setting process and may need additional time to review and implement these standards. Further, as CCA notes, the capabilities necessary for some providers to implement enhanced WEA requirements are still in flux. For example, carriers that are currently participating in the WEA program through an application-based solution need additional time to coordinate, test, and implement updates to current standards. This transition may necessitate additional time for compliance, coordination, and testing. As the Commission has otherwise found, 30 months from the rules' publication in the Federal Register, i.e., May 1, 2019, is sufficient time to comply with WEA requirements that necessitate the development of standards and software, testing, and deployment, and we find this time frame to be sufficient and necessary for Participating CMS Providers (apart from the five largest) to comply with the embedded references deadline, particularly given the difficulties that CCA has described in its Petition. We anticipate that this relief will dissuade CCA members from withdrawing from WEA participation because they cannot comply with the embedded references requirement by the November 1, 2017 deadline.

24. Finally, we are aware that there will be a short period of time between the original November 1, 2017 deadline for embedded references and the publication of this Order on Reconsideration in the Federal Register, notwithstanding that the record reflects good cause for such relief being immediately effective. Accordingly, to the extent necessary to support the decision in this Order on Reconsideration, we waive the November 1, 2017 deadline for all Participating CMS Providers, except for AT&T, Verizon, T-Mobile, Sprint and U.S. Cellular, until the publication of this Order in the Federal Register.

25. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

26. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. Therefore, it does not contain any new or modified information collection burdens for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

27. The Commission will send a copy of this Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act. See 5 U.S.C. 801(a)(1)(A).

28. As required by the Regulatory Flexibility Act of 1980, as amended, we have prepared a Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) addressing the actions taken in this Order.

29. People with Disabilities. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

30. Additional Information. For additional information on this proceeding, contact Gregory Cooke of the Public Safety and Homeland Security Bureau, Policy and Licensing Division, [email protected], (202) 418-2351.

31. Accordingly, it is ordered, pursuant to Sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), and 706 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(o), 301, 301(r), 303(v), 307, 309, 335, 403, 544(g), and 606, as well as by sections 602(a), (b), (c), (f), 603, 604 and 606 of the WARN Act, 47 U.S.C. 1202(a), (b), (c), (f), 1203, 1204 and 1206, that the CTIA Petition is granted to the extent specified herein and denied to the extent specified herein.

32. It is also ordered, pursuant to Sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), and 706 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(o), 301, 301(r), 303(v), 307, 309, 335, 403, 544(g), and 606, as well as by sections 602(a), (b), (c), (f), 603, 604 and 606 of the WARN Act, 47 U.S.C. 1202(a), (b), (c), (f), 1203, 1204 and 1206, that the CCA Petition is granted to the extent specified herein and denied to the extent specified herein.

33. It is ordered, pursuant to Sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), and 706 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(o), 301, 301(r), 303(v), 307, 309, 335, 403, 544(g), and 606, as well as by sections 602(a), (b), (c), (f), 603, 604 and 606 of the WARN Act, 47 U.S.C. 1202(a), (b), (c), (f), 1203, 1204 and 1206, that the Order on Reconsideration in PS Docket Nos. 15-91 and 15-94 is hereby adopted.

34. It is further ordered that, as set forth in this Order, that except for AT&T, Verizon, T-Mobile, Sprint and U.S. Cellular, for which the operative date for this requirement remains November 1, 2017, the operative date of the requirement imposed by 47 CFR 10.441, published at 81 FR 75710, is delayed until May 1, 2019, the date other rules and amendments adopted by the WEA R&O were made effective (30 months from the publication of the WEA R&O in the Federal Register, published at 81 FR 75710).

35. It is further ordered that the provisions of this Order on Reconsideration will become effective immediately upon publication in the Federal Register.

36. It is further ordered that, effective upon the adoption of this order, that the requirements imposed by 47 CFR 10.441, published at 81 FR 75710, are waived to the extent set forth in this Order.

The rules in this part are issued pursuant to the authority contained in the Warning, Alert, and Response Network Act, Title VI of the Security and Accountability for Every Port Act of 2006, Public Law 109-347, Titles I through III of the Communications Act of 1934, as amended, and Executive Order 13407 of June 26, 2006, Public Alert and Warning System, 71 FR 36975 (2006).

This document announces that, on September 20, 2016, OMB approved, for a period of three years, the information collection requirements relating to §§ 51.917(f)(4), 69.4(k), 69.132, 69.311, and 69.416 of the Commission's rules as a revision to OMB Control Number 3060-0298 (Part 61, Tariffs (Other than the Tariff Review Plan)). Also on September 20, 2016, OMB approved, for a period of three years, the information requirements relating to §§ 51.917(f)(4), 69.4(k), 69.132, 69.311, and 69.416 of the Commission's rules as a revision to 3060-0400 (Part 61, Tariff Review Plan (TRP)). The Commission publishes this document as an announcement of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0400, in your correspondence. The Commission will also accept your comments via email at [email protected].

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on September 20, 2016, for the information collection requirements contained in §§ 51.917(f)(4), 69.4(k), 69.132, 69.311, and 69.416 of the Commission's rules. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers are 3060-0298 and 3060-0400.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0298.

OMB Approval Date: September 20, 2016.

OMB Expiration Date: September 30, 2019.

Title: Part 61, Tariffs (Other than Tariff Review Plan) (TRP).

Form Number: N/A.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 2,840 respondents; 4,277 responses.

Estimated Time per Response: 30 hours-50 hours.

Frequency of Response: On occasion, annual, biennial, and one-time reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-155, 201-203, 208, 251-271, 403, 502, and 503 of the Communications Act of 1934, as amended.

Total Annual Burden: 156,080 hours.

Total Annual Cost: $1,307,670.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Respondents are not being asked to submit confidential information to the Commission. If the Commission requests respondents to submit information which respondents believe is confidential, respondents may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: On March 23, 2016 the Commission released the Rate of Return Order, FCC 16-33, which reformed universal service for rate-of-return local exchange carriers (LECs). These reforms require approximately 95 rate-of-return LECs to make one-time tariff filings and NECA to make two tariff filings with the necessary support materials outside the normal tariff filing period.

Part 61 of the Commission's rules, 47 CFR part 61, prescribes the framework for the initial establishment of and subsequent revisions to tariffs. The information collected through the carriers' tariffs and supporting documentation is used by the Commission and state commissions to determine whether the services are offered in a just and reasonable manner.

OMB Control Number: 3060-0400.

OMB Approval Date: September 20, 2016.

OMB Expiration Date: September 30, 2019.

Title: Part 61, Tariff Review Plan (TRP).

Form Number: N/A.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 2,840 respondents; 5,437 responses.

Estimated Time per Response: 0.5 hours-53 hours.

Frequency of Response: On occasion, annual, biennial, and one-time reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 201, 202, 203, and 251(b)(5) of the Communications Act of 1934, as amended.

Total Annual Burden: 66,000 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Respondents are not being asked to submit confidential information to the Commission. If the Commission requests respondents to submit information which respondents believe is confidential, respondents may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: On March 23, 2016 the Commission released the Rate of Return Order, FCC 16-33, which reformed universal service for rate-of-return local exchange carriers (LECs). These reforms require rate-of-return LECs to make tariff filings with the necessary support materials outside the normal tariff filing period.

Sections 201, 202, and 203 of the Communications Act of 1934, as amended, require common carriers to establish just and reasonable charges, practices, and regulations for their interstate telecommunications services. For services that are still covered under section 203, tariff schedules containing charges, rates, rules, and regulations must be filed with the Commission. Part 61 of the Commission's rules, 47 CFR part 61, prescribes the framework for the establishment of and subsequent revisions to tariffs. Certain LECs are required to submit a biennial or annual Tariff Review Plan (TRP) in partial fulfillment of cost support material required by part 61. The Commission developed the TRP to minimize reporting burdens on reporting incumbent local exchange carriers (ILECs). TRPs set forth the summary material ILECs file to support revisions to their interstate access service tariffs. For those services still requiring cost support, TRPs assist the Commission in determining whether ILEC access charges are just and reasonable as required under the Act.

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2017 Pacific cod total allowable catch (TAC) in the BSAI specified for trawl catcher is 47,246 metric tons (mt), for AFA trawl catcher/processors is 4,917 mt, and for jig vessels is 107 mt as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and reallocations (82 FR 47162, October 11, 2017, 82 FR 43503, September 18, 2017 and 82 FR 41899, September 5, 2017). The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that trawl catcher vessels will not be able to harvest 3,083 mt of the remaining 2017 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(9), The Regional Administrator has determined that AFA trawl catcher/processors will not be able to harvest 205 mt of the remaining 2017 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(7). The Regional Administrator has determined that jig vessels will not be able to harvest 94 mt of the remaining 2017 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(1).

Therefore, in accordance with § 679.20(a)(7)(iii), taking into account the capabilities of the sectors to harvest reallocated amounts of Pacific cod, and following the hierarchies set forth in § 679.20(a)(7)(iii)(A) and § 679.20(a)(7)(iii)(B), NMFS reallocates 2,732 mt of Pacific cod to hook-and-line catcher/processors and 650 mt to pot catcher/processors.

The harvest specifications for Pacific cod included in the final 2017 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017) and two inseason adjustments (82 FR 8905, February 1, 2017 and 82 FR 41899, September 5, 2017) are revised as follows: 44,163 mt for trawl catcher vessels, 4,712 for AFA trawl catcher/processors, 13 mt for jig vessels, 106,444 mt for hook-and-line catcher/processors, and 4,844 mt pot catcher/processors.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from trawl catcher vessels, AFA catcher/processors, and jig gear to hook-and-line catcher/processors and pot catcher/processors in the BSAI management area. Since most of these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 21, 2017.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.