Federal Register Vol. 82, No.198,

I. Summary of the Interim Final Rule

On August 4, 2016, the Bureau issued the Amendments to the 2013 Mortgage Rules Under the Real Estate Settlement Procedures Act (Regulation X) and the Truth in Lending Act (Regulation Z) (2016 Mortgage Servicing Final Rule) amending certain of the Bureau's mortgage servicing rules.1 The Bureau has learned, through its outreach in support of industry's implementation of the 2016 Mortgage Servicing Final Rule, that certain technical aspects of the rule relating to the timing for servicers to provide modified written early intervention notices to borrowers who have invoked their cease communication rights under the Fair Debt Collection Practices Act (FDCPA) may create unintended challenges in implementation. To alleviate any unintended challenges and facilitate timely provision of written early intervention notices to these borrowers, the Bureau is issuing this interim final rule to address the provision in Regulation X, which would otherwise become effective October 19, 2017.2

Among other things, the 2016 Mortgage Servicing Final Rule addresses Regulation X's provision regarding early intervention requirements when a borrower has invoked the cease communication right under the FDCPA.3 Under that provision (and with certain exceptions not applicable here), a servicer subject to the FDCPA with respect to that borrower's loan must provide a modified written early intervention notice to that borrower on a periodic basis but is prohibited from doing so more than once during any 180-day period.

Based on feedback received through its efforts to support industry implementation of the 2016 Mortgage Servicing Final Rule, the Bureau understands that there is concern among some servicers that this 180-day prohibition in § 1024.39(d)(3)(iii), read in conjunction with the early intervention provision's other timing requirements regarding written notices, requires servicers to provide the notice exactly on the 180th day after providing a prior notice. The Bureau did not intend this result and is concerned that the provision imposes too narrow a window for compliance and may provide insufficient guidance as to when and how servicers comply with the timing requirements under certain circumstances. Thus (and as explained in further detail below), the Bureau is issuing this interim final rule to amend § 1024.39(d)(3)(iii) to give servicers a 10-day window to provide the modified notice at the end of the 180-day period.

The Bureau believes that the interim final rule provides clearer and more flexible standards than the timing requirements adopted in the 2016 Mortgage Servicing Final Rule, offering greater certainty for implementation and compliance, without undermining important borrower protections relating to early intervention. The Bureau seeks public comment on this interim final rule.

In August 2016, the Bureau issued the 2016 Mortgage Servicing Final Rule, which amends certain of the Bureau's mortgage servicing rules in Regulations X and Z.4 Most of these rules become effective on October 19, 2017, except that the provisions relating to bankruptcy periodic statements and successors in interest become effective on April 19, 2018. The Bureau has worked to support implementation by providing an updated compliance guide, other implementation aids, a technical corrections final rule,5 policy guidance regarding early compliance,6 and informal guidance in response to regulatory inquiries. Information regarding the Bureau's implementation support initiative and available implementation resources can be found on the Bureau's regulatory implementation Web site at https://www.consumerfinance.gov/policy-compliance/guidance/implementation-guidance/mortserv/. Based on its ongoing outreach, the Bureau believes that industry has made substantial implementation progress regarding the 2016 Mortgage Servicing Final Rule. However, as discussed herein, the Bureau believes that a limited disclosure timing provision under Regulation X from the 2016 Mortgage Servicing Final Rule may pose unintended implementation challenges and is appropriate to address in an interim final rule before it goes into effect.

As a result of feedback and questions received from servicers, the Bureau has decided to issue an interim final rule amending Regulation X relating to the timing for servicers to provide modified written early intervention notices to borrowers who have invoked their cease communication rights under the FDCPA. The Bureau believes this interim final rule provides clearer and more flexible standards than the timing requirements adopted in the 2016 Mortgage Servicing Final Rule, offering greater certainty for implementation and compliance, while also not undermining borrower protections.

The Bureau is issuing this interim final rule pursuant to its authority under RESPA and the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),7 including the authorities discussed below. This interim final rule amends a provision previously adopted by the Bureau in the 2016 Mortgage Servicing Final Rule. In doing so, the Bureau relied on one or more of the authorities discussed below, as well as other authority. The Bureau is issuing this interim final rule in reliance on the same authority and for the same reasons relied on in adopting the relevant provisions of the 2016 Mortgage Servicing Final Rule, as discussed in detail in the Legal Authority and Section-by-Section Analysis parts of the 2016 Mortgage Servicing Final Rule.

Section 19(a) of RESPA, 12 U.S.C. 2617(a), authorizes the Bureau to prescribe such rules and regulations, to make such interpretations, and to grant such reasonable exemptions for classes of transactions, as may be necessary to achieve the purposes of RESPA, which include its consumer protection purposes. In addition, section 6(j)(3) of RESPA, 12 U.S.C. 2605(j)(3), authorizes the Bureau to establish any requirements necessary to carry out section 6 of RESPA, and section 6(k)(1)(E) of RESPA, 12 U.S.C. 2605(k)(1)(E), authorizes the Bureau to prescribe regulations that are appropriate to carry out RESPA's consumer protection purposes. The amendments or clarifications to Regulation X in the interim final rule are intended to achieve some or all these purposes.

Section 1022(b)(1) of the Dodd-Frank Act, 12 U.S.C. 5512(b)(1), authorizes the Bureau to prescribe rules “as may be necessary or appropriate to enable the Bureau to administer and carry out the purposes and objectives of the Federal consumer financial laws, and to prevent evasions thereof.” RESPA and title X of the Dodd-Frank Act are Federal consumer financial laws.

Section 1032(a) of the Dodd-Frank Act, 12 U.S.C. 5532(a), provides that the Bureau “may prescribe rules to ensure that the features of any consumer financial product or service, both initially and over the term of the product or service, are fully, accurately, and effectively disclosed to consumers in a manner that permits consumers to understand the costs, benefits, and risks associated with the product or service, in light of the facts and circumstances.” The authority granted to the Bureau in section 1032(a) of the Dodd-Frank Act is broad and empowers the Bureau to prescribe rules regarding the disclosure of the “features” of consumer financial products and services generally. Accordingly, the Bureau may prescribe rules containing disclosure requirements even if other Federal consumer financial laws do not specifically require disclosure of such features.

Section 1032(c) of the Dodd-Frank Act, 12 U.S.C. 5532(c), provides that, in prescribing rules pursuant to section 1032 of the Dodd-Frank Act, the Bureau “shall consider available evidence about consumer awareness, understanding of, and responses to disclosures or communications about the risks, costs, and benefits of consumer financial products or services.” Accordingly, in issuing the interim final rule to amend provisions authorized under section 1032(a) of the Dodd-Frank Act, the Bureau has considered available studies, reports, and other evidence about consumer awareness, understanding of, and responses to disclosures or communications about the risks, costs, and benefits of consumer financial products or services.

To the extent that notice and comment would otherwise be required, the Bureau finds that there is good cause to publish this interim final rule without notice and comment and for the rule to be effective less than 30 days after publication. See 5 U.S.C. 553(b)(3)(B), (d)(3). As explained elsewhere in this rule, the Bureau has heard concerns from servicers that the 180-day prohibition in current § 1024.39(d)(3)(iii) requires them to provide the modified early intervention notice to delinquent borrowers who have invoked their right to cease communication under the FDCPA exactly on the 180th day after providing a prior notice. The Bureau did not intend this result and is concerned that current § 1024.39(d)(3)(iii) imposes too narrow a window for compliance and could cause legal risk for servicers, particularly when the 180th day falls on a Saturday, Sunday, or public holiday. This interim final rule amends § 1024.39(d)(3)(iii) to give servicers a 10-day window to provide the modified notice at the end of the 180-day period. The Bureau believes that this amendment will offer greater certainty for implementation and compliance, while also not undermining borrower protections. The Bureau finds that it would be impracticable to provide notice and comment before finalizing this rule because § 1024.39(d)(3)(iii) would otherwise become effective on October 19, 2017, and could cause unintended challenges in the implementation of the notice requirement. For similar reasons, the Bureau finds that it is impracticable to provide a 30-day period between publication of this rule and its effective date. The Bureau is requesting comment on this rule. Based on any comments received (and mindful of the need to avoid market disruption), the Bureau will consider whether to revisit this rule.

In this interim final rule, the Bureau is amending § 1024.39(d)(3)(iii) to specify in more detail when a servicer must provide the modified written early intervention notice, as required by § 1024.39(b) and (d), at the end of the 180-day period after the servicer provided a prior written notice. In general, § 1024.39(d) provides a partial exemption from the early intervention requirements for servicers that are subject to the FDCPA with respect to borrowers who have invoked their cease communication rights pursuant to section 805(c) of the FDCPA.8 Section 1024.39(d)(3) requires servicers to provide a modified written early intervention notice to those borrowers under certain circumstances, but § 1024.39(d)(3)(iii) prohibits a servicer from providing the modified notice more than once during any 180-day period. As revised under this interim final rule, § 1024.39(d)(3)(iii) gives servicers a 10-day window to provide the required notices at the end of the 180-day period. In particular, revised § 1024.39(d)(3)(iii) retains the 180-day prohibition and also specifies: (1) If a borrower is 45 days or more delinquent at the end of any 180-day period after the servicer has provided the written notice, a servicer must provide the written notice again no later than 190 days after the provision of the prior written notice, and (2) if a borrower is less than 45 days delinquent at the end of any 180-day period after the servicer has provided the written notice, a servicer must provide the written notice again no later than 45 days after the payment due date for which the borrower remains delinquent or 190 days after the provision of the prior written notice, whichever is later.

Section 1024.39(b) generally requires that a servicer provide a written early intervention notice prior to the 45th day of delinquency, and again no later than 45 days after each payment due date so long as the borrower remains delinquent. Section 1024.39(b) further provides that a servicer is not required to provide a notice more than once in any 180-day period, but also that a servicer must provide the written notice no more than 180 days after the servicer has previously provided the notice if the borrower remains delinquent and is 45 days or more delinquent at the end of the 180-day period.

Among other things, § 1024.39(d) modifies the timing requirements for providing the written notice required by § 1024.39(b) when a borrower has invoked the cease communication right under the FDCPA. Under § 1024.39(d)(2), a servicer subject to the FDCPA with respect to that borrower's loan is exempt from the written notice requirements of § 1024.39(b), but only if no loss mitigation option is available, or while any borrower on that mortgage loan is a debtor in bankruptcy. If neither of those conditions is met, § 1024.39(d)(3) provides that the servicer must comply with the written notice requirements of § 1024.39(b), as modified by § 1024.39(d)(3)(i) through (iii).9 The relevant provision for purposes of this interim final rule is § 1024.39(d)(3)(iii), which prohibits a servicer from providing the written notice more than once during any 180-day period. In the preamble to the 2016 Mortgage Servicing Final Rule, the Bureau noted that this 180-day prohibition reduces the risk that the modified written early intervention notice will be used to undermine a borrower's cease communication right under FDCPA section 805(c).

Concurrently with the 2016 Mortgage Servicing Final Rule, the Bureau issued an interpretive rule constituting an advisory opinion under FDCPA section 813(e), 15 U.S.C. 1692k(e), that, in part, interprets the FDCPA cease communication provisions in relation to the written early intervention requirements in Regulation X.10 Specifically, the interpretive rule provides a safe harbor from liability under FDCPA section 805(c) where a servicer that is a debt collector with respect to a mortgage loan is required by § 1024.39(d)(3) to provide a modified written early intervention notice to a borrower who has invoked the cease communication right.

After issuing the 2016 Mortgage Servicing Final Rule and the interpretive rule, the Bureau received several inquiries about how § 1024.39(d)(3)(iii) modifies § 1024.39(b)'s timing requirements. Section 1024.39(b) does not require a notice more than once in a 180-day period but, except as otherwise provided in § 1024.39(d)(3)(iii), permits more frequent provision of the written notices. It also provides that, if a borrower is 45 days or more delinquent at the end of any 180-day period after the servicer has provided the written notice, a servicer must provide the written notice again no later than 180 days after the provision of the prior written notice. However, with regard to a loan for which a borrower has invoked the cease communication right as described above, § 1024.39(d)(3)(iii) prohibits a servicer from providing the notice more than once in any 180-day period.

The Bureau is concerned that, as adopted by the 2016 Mortgage Servicing Final Rule, § 1024.39(d)(3)(iii) imposes too narrow a window for compliance and could provide insufficient guidance as to when and how servicers comply with the timing requirements under certain circumstances. The 180-day prohibition in § 1024.39(d)(3)(iii), read in conjunction with § 1024.39(b), provides only one day for a servicer to provide a subsequent written notice.11 Therefore, where a borrower that has invoked the cease communication right is 45 days or more delinquent at the end of the 180-day period after the servicer provided a prior written notice, a servicer would have to provide the next notice on the 180th calendar day after the prior notice, whether or not this day falls on a Saturday, Sunday, or public holiday. The Bureau narrowly tailored the timing requirements in § 1024.39(d) to prevent a servicer subject to the FDCPA from sending frequent, repeated notices that may undermine a borrower's cease communication right under section 805(c) of the FDCPA. The Bureau did not, however, intend for servicers subject to § 1024.39(d)(3) to have a one-day window to provide a subsequent written early intervention notice to borrowers who have invoked their cease communication rights. Thus, the Bureau is amending § 1024.39(d)(3)(iii).

As amended § 1024.39(d)(3)(iii) retains the general 180-day prohibition but also specifies that, if a borrower is 45 days or more delinquent at the end of any 180-day period after the servicer has provided the written notice, a servicer must provide the written notice again no later than 190 days after the provision of the prior written notice. If a borrower is less than 45 days delinquent at the end of any 180-day period after the servicer has provided the written notice, a servicer must provide the written notice again no later than 45 days after the payment due date for which the borrower remains delinquent or 190 days after the provision of the prior written notice, whichever is later. In effect, the interim final rule provides servicers a 10-day window to provide any required notices at the end of the 180-day period. The Bureau believes that a 10-day window at the end of the 180-day period affords servicers sufficient time to provide the notice while also ensuring that servicers provide the subsequent notice in a timely way, maximizing a borrower's opportunities to pursue loss mitigation and avoid further delinquency.

The Bureau seeks comment on whether the interim final rule permits servicers to timely provide the notice at the end of the 180-day period. The Bureau also seeks comment on whether the interim final rule adequately protects consumers who have invoked their cease communication rights while affording them timely access to information about loss mitigation.

Section 1024.39(d), as amended by the 2016 Mortgage Servicing Final Rule, becomes effective October 19, 2017. Thus, this interim final rule, which further amends § 1024.39(d)(3)(iii), also becomes effective October 19, 2017.

In developing this interim final rule, the Bureau has considered the potential benefits, costs, and impacts as required by section 1022(b)(2) of the Dodd-Frank Act. Specifically, section 1022(b)(2) calls for the Bureau to consider the potential benefits and costs of a regulation to consumers and covered persons, including the potential reduction of consumer access to consumer financial products or services, the impact on depository institutions and credit unions with $10 billion or less in total assets as described in section 1026 of the Dodd-Frank Act, and the impact on consumers in rural areas. In addition, 12 U.S.C. 5512(b)(2)(B) directs the Bureau to consult, before and during the rulemaking, with appropriate prudential regulators or other Federal agencies, regarding consistency with the objectives those agencies administer. The Bureau consulted, or offered to consult with, the prudential regulators, the Securities and Exchange Commission, the Department of Housing and Urban Development (HUD), the HUD Office of Inspector General, the Federal Housing Finance Agency, the Federal Trade Commission, the Department of the Treasury, the Department of Agriculture, and the Department of Veterans Affairs, including regarding consistency with any prudential, market, or systemic objectives administered by these agencies.

The Bureau previously considered the benefits, costs, and impacts of the 2016 Mortgage Servicing Final Rule's major provisions.12 The baseline 13 for this discussion is the mortgage servicing market as it would exist “but for” this interim final rule; that is, the Bureau considers the benefits, costs, and impacts of this interim final rule on consumers and covered persons relative to the baseline established by the 2016 Mortgage Servicing Final Rule.

In considering the relevant potential benefits, costs, and impacts of this interim final rule, the Bureau has used feedback received to date and has applied its knowledge and expertise concerning consumer financial markets. The discussion below of these potential costs, benefits, and impacts is qualitative, reflecting both the specialized nature of the amendments and the fact that the 2016 Mortgage Servicing Final Rule, which establishes the baseline for the Bureau's analysis, is not yet in effect. The Bureau requests comment on this discussion generally as well as the submission of data or other information that could inform the Bureau's consideration of the potential benefits, costs, and impacts of the interim final rule.

The interim final rule's provisions generally would decrease burden incurred by industry participants by modifying the timing requirements for certain disclosures required under the 2016 Mortgage Servicing Final Rule. As is described in more detail below, the Bureau does not believe that these changes would have a significant enough impact on consumers or covered persons to affect consumer access to consumer financial products and services.

Timing of written early intervention notice for borrowers who have invoked their cease communication rights under the FDCPA. The interim final rule revises § 1024.39(d)(3)(iii) to specify when a servicer must provide the modified written early intervention notice, as required by § 1024.39(b) and (d), at the end of the 180-day period after the servicer provided a prior written notice. Section 1024.39(b) requires that a servicer must provide a written early intervention notice to certain borrowers no more than 180 days after the servicer previously provided the notice. Section 1024.39(d) generally provides that servicers that are subject to the FDCPA with respect to borrowers who have invoked their cease communication rights pursuant to section 805(c) of the FDCPA must provide a modified written early intervention notice to those borrowers under certain circumstances. As originally adopted § 1024.39(d)(3)(iii) would have provided that a servicer may not provide the modified notice more than once during any 180-day period. Currently, the 180-day prohibition in § 1024.39(d)(3)(iii), read in conjunction with § 1024.39(b), provides only one day for a servicer to provide a subsequent written notice.

Under the interim final rule, revised § 1024.39(d)(3)(iii) gives servicers a 10-day window to provide the required notices at the end of the 180-day period.14 This provision will benefit covered persons by modifying the timing requirements for the early intervention notice and providing more than a one-day window. This will benefit servicers by providing additional flexibility in the timing for providing these notices.

The interim final rule may have the effect of delaying the date on which some borrowers receive written early intervention information about loss mitigation options. However, this delay in no case exceeds 10 days, and will affect only a limited subset of delinquent borrowers: Those who have invoked their FDCPA cease communication rights and are 45 days or more delinquent at the end of the 180-day period following provision of a prior written early intervention notice. Given that servicers may not be subject to the FDCPA with respect to many of the loans they service and that many borrowers will not choose to invoke the FDCPA's cease communication rights, the Bureau expects that the number of affected borrowers is small.15 Given that the delay under the interim final rule is limited and would likely apply to only a small subset of borrowers, the Bureau does not anticipate that the overall effect on consumers will be significant.

Potential specific impacts of the interim final rule. The Bureau believes that a large fraction of depository institutions and credit unions with $10 billion or less in total assets that are engaged in servicing mortgage loans qualify as “small servicers” for purposes of the mortgage servicing rules because they service 5,000 or fewer loans, all of which they or an affiliate own or originated. Small servicers are not subject to Regulation X § 1024.39, and so are not affected by the amendments in this interim final rule.

With respect to servicers that are not small servicers as defined in § 1026.41(e)(4), the Bureau believes that the consideration of benefits and costs of covered persons presented above provides a largely accurate analysis of the impacts of the final rule on depository institutions and credit unions with $10 billion or less in total assets that are engaged in servicing mortgage loans.

The Bureau has no reason to believe that the additional timing flexibility offered to covered persons by this interim final rule would differentially impact consumers in rural areas. The Bureau requests comment regarding the impact of the amended provisions on consumers in rural areas and how those impacts may differ from those experienced by consumers generally.

Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.16

Under the Paperwork Reduction Act of 1995 (PRA),17 Federal agencies are generally required to seek Office of Management and Budget (OMB) approval for information collection requirements prior to implementation. The collections of information related to the 2016 Mortgage Servicing Final Rule have been reviewed and approved by OMB previously in accordance with the PRA and assigned OMB Control Numbers 3170-0016 (Regulation X) and 3170-0015 (Regulation Z). Under the PRA, the Bureau may not conduct or sponsor and, notwithstanding any other provision of law, a person is not required to respond to an information collection unless the information collection displays a valid control number assigned by OMB.

The Bureau has determined that the interim final rule will provide firms with additional flexibility and clarity with respect to what must be disclosed under the 2016 Mortgage Servicing Final Rule; therefore, it will have only minimal impact on the industry-wide aggregate PRA burden relative to the baseline. The Bureau welcomes comments on this determination or any other aspects of this interim final rule for purposes of the PRA. Comments should be submitted to the Bureau as instructed in the ADDRESSES part of this document and to the attention of the Paperwork Reduction Act Officer. All comments will become a matter of public record.

For the reasons set forth in the preamble, the Consumer Financial Protection Bureau amends 12 CFR part 1024 as follows:

Pursuant to its authority under the Small Business Act, SBA provides assistance to small businesses located in the communities affected by Presidentially-declared disasters. The Agency has announced an initiative called the Express Bridge Pilot, which is designed to supplement the Agency's disaster response capabilities. The Express Bridge Pilot will authorize the Agency's 7(a) Lenders with SBA Express lending authority to deliver expedited SBA-guaranteed financing on an emergency basis for disaster-related purposes to small businesses located in these communities while the businesses apply for and await long-term financing (including through SBA's direct disaster loan program, if eligible).

The Express Bridge Pilot will apply the policies and procedures in place for the Agency's SBA Express program, except as outlined in this document, and include the following:

(1) The maximum loan amount under the pilot is $25,000 and the loans will carry a 50 percent guaranty from the Agency.

(2) Express Bridge Pilot loans in a particular disaster area can only be made by SBA Express lenders that were participants in the SBA Express program as of the date of the applicable disaster.

(3) Eligible small businesses are those that were located, as of the date of the applicable disaster, in the counties that have been Presidentially-declared as disaster areas, plus any contiguous counties.

(4) SBA Express lenders may make loans under the Express Bridge Pilot only to eligible small businesses that had an existing banking relationship with the SBA Express lender as of the date of the applicable disaster. A relationship with any of the SBA Express lender's affiliates will not satisfy this requirement.

(5) SBA Express lenders must certify to SBA, for each Express Bridge Pilot loan, that the loan funds will be used to support the survival and/or reopening of the small business within the affected counties.

(6) The maximum maturity for an Express Bridge Pilot loan is seven years. The SBA Express lender may require a borrower to pay down or pay off the Express Bridge Pilot loan if the borrower is approved for long-term disaster financing (including an SBA direct disaster loan) that allows proceeds to be used for Express Bridge Pilot loan reimbursement.

(7) Express Bridge Pilot loans cannot be sold in SBA's secondary market. Express Bridge Pilot loans are intended to be interim loans, thus SBA has determined pursuant to 13 CFR 120.612(a)(3) that the sale of such loans in SBA's secondary market would not be conducive to the successful operation of the secondary market program.

(8) Loans under the Express Bridge Pilot in a particular disaster area can only be made up to six months after the date of the applicable Presidential disaster declaration.

(9) The Express Bridge Pilot will be available for use starting October 16, 2017, and will expire on September 30, 2020. Express Bridge Pilot loans must be approved on or before such date, as evidenced by the issuance of an SBA loan number.

To maximize the effectiveness of the Express Bridge Pilot, SBA is modifying an Agency regulation (13 CFR 120.150) that applies to loans made in the 7(a) Business Loan Program. (SBA uses the term “modify” as contemplated under 13 CFR 120.3.) This modification will also minimize the burdens on the businesses applying for loans through the Express Bridge Pilot and expand the opportunities for SBA Express lenders to participate in the pilot.

Under § 120.150 of SBA's regulations, a small business applicant must be creditworthy and loans must be so sound as to reasonably assure repayment. In making this determination, character, reputation, credit history of the applicant and guarantors, past earnings, projected cash flow, and future prospects, among other things, must be considered. Currently, SBA Express lenders are authorized to make the credit decision using credit analysis processes and procedures (which may include credit scoring) that are consistent with those used for their similarly-sized non-SBA guaranteed commercial loans.

In order to streamline the loan underwriting process for the Express Bridge Pilot, SBA is modifying the requirements of 13 CFR 120.150 to allow SBA Express lenders to underwrite Express Bridge Pilot loans by considering only the following:

(1) A minimum acceptable credit score of 130 for the applicant issued by E-Tran upon submission of the loan application for screening;

(2) a personal credit score for each guarantor; and

(3) Lender must obtain a signed IRS Form 4506-T and an IRS tax transcript. For businesses in operation prior to the disaster but not long enough to have been required to file a tax return, Lender must provide an alternative to verify existence of the business.

The screening credit score is a FICO® Small Business Scoring ServiceSM Score. SBA may adjust the minimum acceptable credit score up or down from time to time during the pilot, and will post any such adjusted score on its Web site at www.sba.gov/for-lenders.

The modification of this regulation will allow SBA Express lenders to expedite the processing of these small guaranteed loans in order to provide immediate cash to assist the small business with rebuilding and continuing or restarting its operations while awaiting long-term disaster financing. Because an Express Bridge Pilot loan applicant must have had an existing banking relationship with the SBA Express lender, SBA expects this will help mitigate the risk associated with the modification of 13 CFR 120.150. SBA Express lenders are cautioned that the provisions of 13 CFR 120.140 (“What ethical requirements apply to participants?”) continue to apply to the Express Bridge Pilot.

SBA's modification of 13 CFR 120.150 is authorized by 13 CFR 120.3 of its regulations, which provides that the SBA Administrator may suspend, modify or waive rules for a limited period of time to test new programs or ideas. This modification applies only to those loans made under the Express Bridge Pilot and will last only for the duration of the pilot, which expires September 30, 2020. As part of the Express Bridge Pilot, this modification applies only to those small businesses that were located, as of the date of the applicable disaster, in counties that have been Presidentially-declared as disaster areas, plus any contiguous counties. A listing of Presidentially-declared disaster declarations, including primary and contiguous counties can be located at www.sba.gov/disaster.

Not more than ten percent of the total number of 7(a) loans guaranteed by SBA in any fiscal year may be made under the Express Bridge Pilot. 15 U.S.C. 636(a)(25). While SBA does not expect the number of Express Bridge Pilot loans to reach that limit, SBA will provide public notice of the need to suspend lending under the pilot for the remainder of the fiscal year if SBA determines that the number of pilot loans is approaching the limit.

SBA will be using the following criteria to evaluate the Express Bridge Pilot to determine how well it is achieving its objectives and other aspects of performance: (1) The measurable objectives to be achieved through the Express Bridge Pilot, including the number of small business concerns served, the percentage of Express Bridge Pilot loans made that were paid off or paid down using lower fixed rate disaster loans versus those that are held to term, and the default rate on the Express Bridge Pilot loans compared to regular SBA Express loans of similar size in the 7(a) portfolio; and (2) the costs and standards of performance which, in order to be acceptable, must not impact the subsidy model for the 7(a) Loan Program. The following method for data collection will be used: All loans will be entered directly using E-Tran or SBA One, which track eligibility by the county in which the small business is located, and which will facilitate tracking of performance on these loans.

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Hemphill County Airport, Canadian, TX, and Wheeler Municipal Airport, Wheeler, TX, to support IFR operations at these airports.

On June 20, 2017, the FAA published in the Federal Register (82 FR 28033) Docket No. FAA-2017-0458, a notice of proposed rulemaking (NPRM) to amend Class E airspace extending upward from 700 feet above the surface at Hemphill County Airport, Canadian, TX, and Wheeler Municipal Airport, Wheeler, TX, to enhance the safety and management of IFR operations at these airports. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface to:

Within a 6.5-mile radius (reduced from a 6.8-mile radius) of Hemphill County Airport with an extension 1 mile either side of the 224° bearing from the airport from the 6.5-mile radius to 6.6 miles south of the airport, and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database; and

Within a 6.3-mile radius (reduced from a 6.4-mile radius) of Wheeler Municipal Airport and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

Airspace reconfiguration is necessary due to the decommissioning of the Sayre VORTAC as part of the VOR MON Program and to bring the airspace in compliance with FAA Order 7400.2L, Procedures for Handling Airspace Matters. Controlled airspace is necessary for the safety and management of IFR operations at these airports.

Except for an editorial change removing “JO” where an FAA Order is cited throughout the document, this rule is the same as proposed in the NPRM.

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, is non-controversial and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace extending upward from 700 feet above the surface at Onida Municipal Airport, Onida, SD, to support standard instrument approach procedures for IFR operations at the airport.

The FAA published in the Federal Register (82 FR 37369, August 10, 2017) Docket No. FAA-2016-9546 a notice of proposed rulemaking to establish Class E Airspace extending upward from 700 feet above the surface at Onida, Municipal Airport, Onida, SD. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Onida Municipal Airport, Onida, SD, to accommodate new special instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport.

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, is non-controversial and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Hebron Municipal Airport, Hebron, NE, to support standard instrument approach procedures for IFR operations at the airport.

The FAA published in the Federal Register (82 FR 18593, April 20, 2017) Docket No. FAA-2017-0175 a notice of proposed rulemaking (NPRM) to modify Class E airspace extending upward from 700 feet above the surface at Hebron Municipal Airport, Hebron, NE. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 respectively of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet or more above the surface within a 6.3-mile radius of Hebron Municipal Airport, Hebron, NE.

Airspace reconfiguration is necessary due to the decommissioning and cancellation of the Hebron NDB, and NDB approaches. This action enhances the safety and management of the standard instrument approach procedures for IFR operations at the airport.

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, is non-controversial and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA, to support instrument flight rules (IFR) operations at this airport.

On July 21, 2017, the FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (82 FR 33834, Docket No. FAA-2017-0536) to modify Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Schenck Field, Clarinda, IA, by removing the Clarinda NDB from the legal description; removing the extension south of the airport; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

Airspace reconfiguration is necessary due to the decommissioning of the Clarinda NDB and cancellation of the associated instrument approach procedures at this airport. Controlled airspace is necessary for safety and the management of IFR operations at the airport.

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, is non-controversial and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it vertically subdivides the restricted airspace at Fort Gordon, GA, into three sections to enable more efficient use of airspace.

The restricted airspace at Fort Gordon, GA consists of R-3004A, extending from the surface to 7,000 feet MSL; and R-3004B, extending from 7,001 feet MSL to 16,000 feet MSL. The time of designation for both areas is as activated by NOTAM 24 hours in advance.

A FAA review of the utilization of the airspace revealed that most activities being conducted only require restricted airspace below 3,500 feet MSL. However, when R-3004A was activated, restrictions were in effect up to 7,000 feet MSL.

While lateral boundaries of the restricted airspace remain the same as currently charted and the overall vertical limits of the restricted airspace are unchanged, in order to provide for more efficient use of airspace, the FAA and the using agency agreed to further subdivide the restricted airspace vertically. The FAA is realigning the designated altitudes for R-3004A and R-3004B and establishing R-3004C as a third subdivision. The new configuration enables activation of restricted airspace to the lower altitude required for the majority of the using agency's training needs while maintaining the ability to activate additional restricted airspace for missions that require higher altitudes.

The designated altitudes for R-3004A are amended to read “surface to but not including 3,500 feet MSL” (decreased from 7,000 feet MSL). The designated altitudes for R-3004B are amended to read “3,500 feet MSL to but not including 7,000 feet MSL,” instead of the current “7,001 feet MSL to 16,000 feet MSL.” This amendment also established a third subdivision, designated R-3004C, which extends from 7,000 feet MSL to 16,000 feet MSL. These changes accommodate the using agency's requirements while releasing unneeded restricted airspace for access by other users.

In addition, the aircraft activity limitations on use of the areas are amended to clarify the limitations in effect during the annual Masters Golf Tournament.

These changes enhance the efficient use of the National Airspace System by providing for activation of the minimum amount of restricted airspace needed for the specific mission being conducted resulting in the release of unneeded restricted airspace for access by other users.

This rule amends Title 14 Code of Federal Regulations (14 CFR) part 73 by further dividing the current restricted airspace at Fort Gordon, GA, into three subareas instead of two. The designated altitudes for R-3004A are amended from the current “surface to 7,000 feet MSL,” to “surface to but not including 3,500 feet MSL.” The designated altitudes for R-3004B are amended from the current “7,001 feet MSL to 16,000 feet MSL” to “3,500 feet MSL to but not including 7,000 feet MSL.” A new third subdivision, designated R-3004C, is established and extends from 7,000 feet MSL to 16,000 feet MSL.”

Additionally, the terms and conditions listed in the restricted area legal descriptions for aircraft activities in the restricted areas are revised, in part. Specifically, in order to clarify aircraft operations during the annual Masters Golf tournament, the text of item number 1 is changed from “1. Aircraft activities may not be conducted on weekends, National holidays, or the entire week of the Masters Golf Tournament” to: “1. Aircraft activities must not be conducted on weekends, national holidays, or from the Sunday prior to the Masters Golf Tournament through the Monday after (and subsequent weather days if required).” The terms and conditions in Items 2 and 3 remain unchanged.

The above modifications enhance the efficient use of airspace and reduce the burden on the public by lessening the amount of restricted airspace at Fort Gordon, GA, that is activated on a routine basis. These modifications do not change the current lateral boundaries, overall designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

The FAA has determined that this action 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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of vertically subdividing limits of existing restricted airspace within the current lateral and vertical limits qualifies for categorical exclusion under the National Environmental Policy Act and in accordance with FAA Order 1050.1F—Environmental Impacts: Policies and Procedures, Categorical Exclusions for Procedural Actions, paragraph 5-6.5d—Modification of the technical description of special use airspace (restricted areas) that does not alter the dimensions, altitudes, or times of designation of the airspace. Therefore, this airspace action is not expected to result in any significant environmental impacts. In accordance with FAAO 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73, as follows:

I. Background

Upon request, FDA has classified the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On May 27, 2014, T2 Biosystems, Inc., submitted a request for classification of the T2Candida Panel and T2Dx® Instrument. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on September 22, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3960. We have named the generic type of device nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens, and it is identified as a qualitative in vitro device intended for the amplification, detection, and identification of microbial-associated nucleic acid sequences from patients with suspected bloodstream infections. This device is intended to aid in the diagnosis of bloodstream infection when used in conjunction with clinical signs and symptoms and other laboratory findings.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

I. Background

Upon request, FDA has classified the automated image assessment system for microbial colonies on solid culture media as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On December 24, 2015, Clever Culture Systems AG submitted a request for De Novo classification of the APAS Compact. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on October 6, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.2190. We have named the generic type of device automated image assessment system for microbial colonies on solid culture media, and it is identified as a system that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenotypic and morphologic characteristics through analysis of two dimensional digital images as an aid in diagnosis of infectious disease.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table  1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, the collections of information in part 820 have been approved under OMB control number 0910-0073, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

I. Background

Upon request, FDA has classified the enzyme packed cartridge as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On January 2, 2015, Alcresta, Inc. submitted a request for De Novo classification of the RELIZORBTM. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on November 20, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.5985. We have named the generic type of device enzyme packed cartridge, and it is identified as an ex vivo prescription device that is used in enzymatic hydrolysis of macronutrients into their essential nutrient forms at the time of delivery. The device consists of an outer casing containing an inert polymer with a covalently bound enzyme through which nutritional formula is directed. The device fits in line with enteral feeding systems.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).

At the time of classification, enzyme packed cartridges are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

Under the Controlled Substances Act (CSA), each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of scheduled substances is published at 21 CFR part 1308.

Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed. . . .” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); 1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated on the Attorney General's own motion, as delegated to the Administrator of the DEA, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of the HHS and an evaluation of all relevant data by the DEA. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle AB-CHMINACA, AB-PINACA and THJ-2201.

On January 30, 2015, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place the three synthetic cannabinoids N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA), and[1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl) methanone (THJ-2201) into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 80 FR 5042. That final order was effective on the date of publication, and was based on findings by the Administrator of the DEA that the temporary scheduling of these three synthetic cannabinoids was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of these substances expire two years from the issuance date of the scheduling order, on or before January 29, 2017. However, the CSA also provides that during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, the temporary scheduling of that substance could be extended for up to one year. Accordingly, on January 27, 2017, the DEA extended the temporary scheduling of AB-CHMINACA, AB-PINACA and THJ-2201 by one year, or until January 29, 2018. 82 FR 8590. Also, on January 27, 2017, the DEA published a notice of proposed rulemaking (NPRM) to permanently control AB-CHMINACA, AB-PINACA and THJ-2201 in schedule I of the CSA. 82 FR 8593. Specifically, DEA proposed to add these three synthetic cannabinoids to 21 CFR 1308.11(d), hallucinogenic substances.

On November 14, 2016, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Place [1-(5-Fluoropentyl)-1H-Indazol-3-yl] (Naphthalen-1-yl) Methanone (THJ-2201), N-[(2S)-1-Amino-3-Methyl-1-Oxo-2-Butanyl]-1-Pentyl-1H-Indazole-3-Carboxamide (AB-PINACA), and N-[(2S)-1-Amino-3-Methyl-1-Oxo-2-Butanyl]-1-(Cyclohexylmethyl)-1H-Indazole-3-Carboxamide (AB-CHMINACA) and their Salts in Schedule I of the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), and also considering each substance's abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21 U.S.C. 812(b), the Assistant Secretary of the HHS recommended that AB-CHMINACA, AB-PINACA and THJ-2201 be controlled in schedule I of the CSA. In response, the DEA conducted its own eightfactor analysis of AB-CHMINACA, AB-PINACA and THJ-2201. The DEA and HHS analyses are available in their entirety in the public docket for this rule (Docket Number DEA-402/DEA-2017-0001) at http://www.regulations.gov under “Supporting Documents.”

After a review of the available data, including the scientific and medical evaluation and the scheduling recommendations from the HHS, the DEA published an NPRM entitled “Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-PINACA and THJ-2201 into Schedule I,” proposing to control AB-CHMINACA, AB-PINACA and THJ-2201, and their salts, isomers, and salts of isomers in schedule I of the CSA. 82 FR 8593, January 27, 2017. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with the DEA regulations on or before February 27, 2017. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before February 27, 2017.

The DEA received five comments on the proposed rule to control AB-CHMINACA, AB-PINACA and THJ-2201 in schedule I of the CSA.

Support for rulemaking: Five commenters gave support for the rulemaking stating in unison that these substances have no medical use and are a danger to the community.

DEA Response: The DEA appreciates the comments in support of this rulemaking.

After consideration of the relevant matter presented as a result of public comments, the scientific and medical evaluations and accompanying recommendation of the HHS, and after its own eight-factor evaluation, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of AB-CHMINACA, AB-PINACA and THJ-2201. As such, the DEA is permanently scheduling AB-CHMINACA, AB-PINACA and THJ-2201 as controlled substances under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analyses and recommendations of the Assistant Secretary for HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:

(1) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol (Δ9-THC) and JWH-018;

(2) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) have no currently accepted medical use in treatment in the United States; and

(3) There is a lack of accepted safety for use of N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) under medical supervision.

Based on these findings, the Administrator of the DEA concludes that N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) including their salts, isomers and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

AB-CHMINACA, AB-PINACA and THJ-2201 will continue 2 to be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle AB-CHMINACA, AB-PINACA or THJ-2201, must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Security. AB-CHMINACA, AB-PINACA or THJ-2201are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b) and in accordance with 21 CFR 1301.71 through 1301.93.

3. Labeling and Packaging. All labels and labeling for commercial containers of AB-CHMINACA, AB-PINACA or THJ-2201 must be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

4. Quota. Only registered manufacturers are permitted to manufacture AB-CHMINACA, AB-PINACA or THJ-2201 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Every DEA registrant who possesses any quantity of AB-CHMINACA, AB-PINACA and THJ-2201 on the effective date of this final rule, must take an inventory of all stocks of these substances on hand as of October 16, 2017, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11 (a) and (d). Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements.

After the initial inventory, every DEA registrant must take a new inventory of all controlled substances (including AB-CHMINACA, AB-PINACA and THJ-2201) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to AB-CHMINACA, AB-PINACA and/or THJ-2201 pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312.

7. Order Forms. Every DEA registrant who distributes AB-CHMINACA, AB-PINACA or THJ-2201 must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of AB-CHMINACA, AB-PINACA or THJ-2201 must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

9. Liability. Any activity involving AB-CHMINACA, AB-PINACA or THJ-2201 not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this final scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On January 30, 2015, the DEA published a final order to temporarily place these three substances into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The DEA estimates that all entities handling or planning to handle these substances have already established and implemented the systems and processes required to handle AB-CHMINACA, AB-PINACA or THJ-2201. There are currently 25 registrations authorized to handle AB-CHMINACA, AB-PINACA and/or THJ-2201 specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 25 registrations represent 18 entities, of which 8 are small entities. Therefore, the DEA estimates eight small entities are affected by this rule.

A review of the 25 registrations indicates that all entities that currently handle AB-CHMINACA, AB-PINACA or THJ-2201 also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle AB-CHMINACA, AB-PINACA or THJ-2201. Therefore, the DEA anticipates that this rule will impose minimal or no economic impact on any affected entities; and thus, will not have a significant economic impact on any of the eight affected small entities. Therefore, the DEA has concluded that this rule will not have a significant effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: “an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets.” However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended as follows:

The Port of Los Angeles has requested a temporary change to the operation of the Henry Ford Avenue railroad bridge, mile 4.8, over the Cerritos Channel, at Long Beach, CA. The drawbridge navigation span provides a vertical clearance of 6 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.147(b). Navigation on the waterway is commercial, search and rescue, law enforcement, and recreational.

The drawspan will be secured in the closed-to-navigation position from 8 a.m. through noon on October 20, 2017, to allow the bridge owner to install necessary electrical equipment inside the bridge machinery room and operator house. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies. Los Angeles Harbor can be used as an alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

Louisiana Department of Transportation and Development (LA-DOTD) has requested to change the operating schedule that governs the Black Bayou Pontoon Bridge on State Road 384 across the Gulf Intracoastal Waterway (GIWW) mile 237.5 West of Harvey Locks (WHL) at Grand Lake, Calcasieu Parish, Louisiana. Closures to navigation traffic are required to make extensive repairs to the bridge protective system, tower and mechanical systems. This bridge operates under 33 CFR 117.5.

This deviation allows the bridge to close to vessel traffic during specific dates and times from October 9, 2017 through December 20, 2017 as follows: October 9-10, 2017 from 7 a.m. to 7 p.m.; October 18-19, 2017 from 7 a.m. to 7 p.m.; October 23-26 from 8:30 a.m. to 7 p.m.; October 30-31, 2017 from 8:30 a.m. to 7 p.m.; November 7, 2017 from 7 a.m. to 7 p.m.; November 17-18, 2017 from 8 a.m. to 7 p.m.; November 20-22 from 8 a.m. to 7 p.m.; November 27, 2017 from 8 a.m. to 7 p.m.; November 28-30, 2017 from 8 a.m. to 7 p.m.; December 1-2, 2017 from 8 a.m. to 7 p.m.; December 4-7, 2017 from 8 a.m. to 7 p.m.; December 11-12, 2017 from 8 a.m. to 7 p.m.; December 13, 2017 from 7 a.m. to 7 p.m.; December 14-16, 2017 from 8 a.m. to 7 p.m.; December 18-19, 2017 from 8 a.m. to 7 p.m.

During the above periods of closures, vessels will not be able to pass through the bridge.

Navigation at the site primarily consists of tugs and tows. The bridge will be able to open to vessel traffic during emergencies. The Coast Guard will inform waterways users of the bridge closures through Local and Broadcast Notices to Mariners so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

Table of Contents I. Abbreviations II. Background III. Response to Comments I. Abbreviations CFR Code of Federal Regulations CG-543 U.S. Coast Guard Office of Commercial Vessel Compliance COTP Captain of the Port D17 U.S. Coast Guard District 17 in Alaska MSIB Marine Safety Information Bulletin NPC National Planning Criteria VRP Vessel Response Plan U.S. United States II. Background

The alternative planning criteria national guidelines provide the maritime industry with guidance on developing and submitting alternatives in accordance with the regulations. Tank and nontank vessels meeting the applicability requirements in 33 CFR 155.1015 and 155.5015 must submit vessel response plans (VRPs). If a vessel owner or operator believes the national planning criteria (NPC) provided in 33 CFR part 155 are inappropriate for the areas in which the vessel intends to operate, the vessel owner or operator can submit an alternative(s) pursuant to 33 CFR 155.1065(f) and 155.5067. In August 2009, the U.S. Coast Guard (Coast Guard) published CG-543 Policy Letter 09-02, “Industry Guidelines for Requesting Alternate Planning Criteria Approval, One Time Waivers and Interim Operating Authorization.” The purpose of CG-543 Policy Letter 09-02, was to provide guidance to the maritime industry in proposing an alternative for tank vessel response plans pursuant to 33 CFR 155.1065(f). In September 2013, the Coast Guard published a final rule for nontank vessel regulations in 33 CFR part 155, subpart J (78 FR 60100). This final rule made the NPC in 33 CFR part 155 applicable to thousands of additional vessels across the U.S., including geographic areas with limited commercially available response resources. In 2015, D17 published a draft Marine Safety Information Bulletin (MSIB) that provided guidance for proposed alternative submissions and expectations within Alaskan waters, with a focus on nontank vessel traffic. Given the multitude of comments concerning alternative planning criteria, especially from various sectors of the maritime industry on the draft D17 MSIB, the Coast Guard determined it would be best to update the alternative planning criteria national guidelines to provide a foundation inclusive of both tank and nontank vessel communities and that applied nationally. Between 2016 and 2017, the Coast Guard drafted an update to the alternative planning criteria national guidelines, and made this available for public comment.

On May 27, 2016, the Coast Guard published a notice announcing the availability of a draft update to the alternative planning criteria national guidelines in the Federal Register (81 FR 33685). On August 16, 2016, the Coast Guard published in the Federal Register a notice announcing a public meeting and an extension to the comment period until September 23, 2016 (81 FR 54584). The public meeting was held on September 21, 2016, in Anchorage, Alaska. On January 10, 2017, the Coast Guard published a notice announcing the reopening of the comment period until April 10, 2017 (82 FR 3016). In conjunction with the reopened comment period, additional public meetings were held to further the dialogue and awareness of the alternative planning criteria national guidelines with federal, state, tribal, and local communities, especially in remote areas of Alaska including Bethel, Dillingham, Kotzebue, Nome, Utqiagvik, Kodiak, and Dutch Harbor.

In summary, the Coast Guard received 49 electronic submissions during the two public comment periods. In addition, the Coast Guard heard statements from 12 speakers at the public meeting convened in Anchorage on September 21, 2016. From the electronically submitted comments and the statements, the Coast Guard received approximately 200 individual comments.

The Coast Guard appreciates the amount of time that federal, state, tribal, and local government entities, as well as private industry, committed throughout the two public comment periods to provide input. The value of all comments and feedback received in this process cannot be overstated. We carefully considered all of the input received when drafting the final revision to the alternative planning criteria national guidelines. A summary of all comments, and the Coast Guard's response to them, is available in our online docket at http://www.regulations.gov, and on https://homeport.uscg.mil under Environmental > Vessel Response Plan Program.

The Coast Guard received 25 comments recommending that the alternatives permitted under 33 CFR 155.1065 and 155.5067 be accepted as permanent equivalencies with the National Planning Criteria (NPC) found in 33 CFR part 155. The Coast Guard disagrees. The Coast Guard views the allowance for alternatives to the response standards required in 33 CFR part 155 as a bridging strategy to future NPC compliance. The Coast Guard does acknowledge, however, that some operating areas, especially remote areas, may require long-term alternatives.

Particular to the NPC as an end state, one commenter noted that there exists an assumption by the Coast Guard that meeting the NPC is the only acceptable option for planning and responding to marine casualties that pose a threat of pollution, and that this assumption is flawed. We do not agree that there is an assumption that meeting the NPC is the only acceptable option for planning and responding to marine casualties that pose a threat of pollution. Such an assumption is contrary to the purpose and intent of the regulations that allow alternative planning criteria.

The Coast Guard received 21 comments stating that the Coast Guard, in the draft alternative planning criteria national guidelines, is abandoning prevention measures. Another commenter stated that the updated guidelines suggest that tracking and monitoring capability could take the place of the need to plan for resource capability. The Coast Guard disagrees. Prevention measures are fully acceptable when included in an alternative, but do not equal the value of response and recovery-based strategies at the time of an incident. Language in the alternative planning criteria national guidelines that may have led to the impression that prevention measures, such as vessel tracking and monitoring, could take the place of resource capability was removed.

Specific to prevention measures, one commenter believes that a conflict exists between the alternative planning criteria national guidelines and the regulations. Specifically, the commenter points out that the guidelines include very specific requirements for a tracking and monitoring system. In consideration of this comment and to avoid the perception of creating new requirements, the Coast Guard has amended the draft national guidelines to no longer include tracking and monitoring systems as a specific prevention measure within an alternative. However, we consider tracking and monitoring systems as a helpful tool for both response and prevention strategies.

One commenter noted that vessel tracking and monitoring is not necessary for all alternatives. The Coast Guard agrees. The alternative planning criteria national guidelines do not mandate the use or inclusion of vessel tracking and monitoring in proposals for alternatives.

One commenter perceived that the Coast Guard was requiring the tracking of vessels to be employed in a proposed “response vessel of opportunity” network. The Coast Guard disagrees and notes that the mention of vessel of opportunity tracking was an example of a process that an alternative might consider/propose. Nevertheless, language in the alternative planning criteria national guidelines was removed that may have led to the impression that tracking of vessels was required in a proposed “response vessel of opportunity” network.

Seventeen comments suggested that the alternative planning criteria national guidelines represent regulatory overreach and an attempt to side-step the rulemaking process. The Coast Guard disagrees. The alternative planning criteria national guidelines do not create any substantive legal requirements on the regulated population. Under current Coast Guard regulation, owners and operators of both tank vessels (33 CFR 155.1065(f)) and nontank vessels (33 CFR 155.5067) may propose alternative frameworks when such vessel owner or operator believes that the national planning criteria are inappropriate for the areas in which the vessel intends to operate. The alternative planning criteria national guidelines afford a flexibility currently permitted by regulation. Therefore, they are not a rulemaking subject to notice and comment under the Administrative Procedure Act. We are providing these guidelines for the purpose of clarifying existing regulations.1

On a related note, several commenters suggested that the language in the draft alternative planning criteria national guidelines is overly prescriptive or confusing, and therefore creates binding requirements with the “force and effect” of law. Examples include the use of definitions that either do not exist within, or are inconsistent with, the regulations. In consideration of these comments, and as noted above, we revised the alternative planning criteria national guidelines to remove language that could be perceived as inconsistent with or not covered by the regulations. The Coast Guard also removed the four draft enclosures.

Thirty-eight comments were received on the economic analysis to be submitted with the alternative planning criteria request, as set out in 33 CFR 155.5067. Several of these comments highlighted the potential for increased commodity and capital investment costs. Some of these comments also communicated that the alternative planning criteria national guidelines may result in significant increases in costs (for example, transportation of freight and fuel delivery by barges, transportation, home heating fuel costs of end users including native villages and other small communities in Alaska, oil spill equipment build-out costs, and contract and membership costs associated with the joining of multiple local spill response organizations as a solution to comply with the updated national guidelines).

Foremost, the Coast Guard appreciates the comments received concerning the economic impact of alternative planning criteria and associated national guidelines. The Coast Guard takes these comments very seriously, and will carefully evaluate the economic impact assessments that plan holders or Alternative Planning Criteria Administrators submit as part of their proposed alternative(s) in accordance with 33 CFR part 155.

Four comments noted that the alternative planning criteria national guidelines seem to remove the local Sector from decision making on proposed alternatives. The Coast Guard disagrees. While CG-MER is the ultimate decision making authority on proposed alternative planning criteria, local COTPs have a responsibility to review all proposed alternatives within their area of responsibility and provide an endorsement. This responsibility is set forth in 33 CFR 155.5067(a) for nontank vessels and the same responsibility applies in practice to tank vessels pursuant to 33 CFR 155.1065(f).

The Coast Guard received 21 comments regarding the inclusion of local Area Committees as part of the process for reviewing proposed alternatives. Specifically, the concern is that the Coast Guard intends to route proposed alternatives via Area Committees for approval. In consideration of these comments, we have modified the language in the alternative planning criteria national guidelines that could have led to the misimpression that the Coast Guard intends to seek Area Committee approval. The Coast Guard changed this language to reflect that local Area Committees may be included in a COTP's evaluation of proposed alternatives. Area Committees, however, do not approve alternatives.

Additional comments questioned the legal authority under which Area Committees may be involved in the evaluation of alternatives. Area Committees were established as part of the National Planning and Response System created pursuant to Section 311 of the FWPCA (33 U.S.C. 1321(j)). Area Committees represent an essential element of oil spill and hazardous substance contingency planning. Further, there is nothing in the legislation that would limit or prevent the Coast Guard from consulting with Area Committees on proposed alternatives.

Two comments suggested that the COTP and local Area Committee should coordinate with the other federal and state entities including the Regional Response Team, National Strike Force Coordination Center, and the District Response Advisory Team, and the State of Alaska to ensure a comprehensive review of the gaps identified in alternative planning criteria submissions. The Coast Guard agrees, and notes the requirements for consultation with such entities in accordance with the National Oil and Hazardous Substance Pollution Contingency Plan (40 CFR part 300). The local Area Committee, under the direction of the Federal On-scene Coordinator (who is generally the COTP in the coastal zone), is responsible for directing the development of the Area Contingency Plan (ACP). In accordance with 40 CFR 300.210, ACPs are prepared by an Area Committee consisting of federal, state, and local agencies and in consultation with regional response teams and other appropriate entities. With respect to evaluating proposed alternatives, although consultation with Area Committees is not required by the VRP regulations, COTPs, in their discretion, may consult with Area Committees, which may include the review of gaps identified in proposed alternatives.

A related comment suggested that local Area Committees be informed by the Coast Guard when it receives a proposed alternative. As mentioned above, COTPs maintain the discretion to consult with the local Area Committee on proposed alternatives.

One commenter acknowledged the Coast Guard's stated intent to coordinate with Area Committees, District Response Advisory Teams, and Coast Guard Sectors in its review of proposed alternatives. However, the commenter suggested that it is not clear how these public involvement procedures will work in practice, especially when the Coast Guard has indicated that some alternatives may be approved in fewer than 90 days. While our regulations say that alternatives should be submitted to the Coast Guard 90 days before a vessel intends to operate under the proposed alternative, we recognize that not all proposed alternatives are the same. Some alternatives may warrant more analysis than others. In recognition of this, the alternative planning criteria national guidelines recommend submission of proposed alternatives at least 180 days before a vessel intends to operate under the proposed alternative.

Twenty-seven comments highlighted concern over the Coast Guard's intent to allow for alternatives that address a geographic area smaller than the entire extent of a COTP zone. Specifically, comments questioned the Coast Guard's authority to accept an alternative that only partially covers a COTP zone. Additionally, one comment forecasted a “compliance quagmire” if a patchwork of alternatives is allowed to exist within a COTP zone. The Coast Guard appreciates these concerns, but disagrees. The Coast Guard will continue to evaluate alternatives that adequately address areas where the NPC are inappropriate. The regulations specify that an alternative can be submitted for the geographic area(s) where the vessel intends to operate. See 33 CFR 155.1065(f) and 155.5067(a).

One commenter noted the belief that the alternative planning criteria national guidelines requirement to consider “any and all” environmental impacts of not meeting the NPC requirements is unreasonable, particularly for large and remote areas (e.g. Western Alaska). The Coast Guard agrees in part and disagrees in part. Previous alternative planning criteria policy guidance for tank vessels, as well as the existing regulations for nontank vessel response plans, require that proposed alternatives should, at a minimum, contain an environmental impact assessment (CG-543 Policy Letter 09-02 and 33 CFR 155.5067(b)). To keep within the scope of the regulatory requirements, the Coast Guard reworded the guidelines to emphasize that an environmental impact assessment should, at a minimum, be included in the submission of an alternative. Additionally, to ensure compliance with 33 CFR 155.1030 and 155.5030, proposed alternatives should highlight sensitive areas from the applicable Area Contingency Plan(s) in their environmental impact assessment.

One commenter proposed that Alaska be given its own planning standards given the physical, environmental, and geographic challenges unique to Alaska. We wish to point out that both the tank and nontank VRP regulations allow for the planning criteria to be tailored for a specific geographic location when the vessel owner or operator believes that the NPC are inappropriate for the areas they intend to operate.

Seven comments reflected concern regarding the submission of a “strategic plan” as part of the proposed alternative(s). Additionally, some commenters asked how the Coast Guard would use and evaluate such a plan. We recognize the misunderstanding: We did not intend to refer to the company's strategic business plan, but rather a strategic plan for eventually meeting the NPC. In consideration of these concerns, we have revised the guidelines by replacing the phrase “strategic plan” with “build-out plan” to avoid the misimpression that industry business planning processes should be submitted as part of a proposed alternative. The build-out plan is a means by which a plan holder can address how they will build up response capability to meet the NPC. The Coast Guard has consistently stated that the intent of alternative planning criteria is to gradually build-up response capability in remote areas. See, Final Rule on “Nontank Vessel Response Plans and Other Response Plan Requirements” (78 FR 60099). The build-out plan is not a formal, organizational, strategic plan, but rather a detailed description of the measureable steps towards compliance with the NPC. The Coast Guard will review build-out plans in its review of submitted alternatives. Additionally, the Coast Guard will review achievement of build-out plan goals in its review of alternatives submitted for renewal.

The Coast Guard received 10 comments regarding the enforcement of alternative planning criteria, including concerns over the Coast Guard's ability to ensure compliance, especially in remote areas. The Coast Guard recognizes that remote areas may be challenging to frequent and regular verification efforts; nevertheless, at the discretion of the COTP, the Coast Guard will exercise its authority to verify compliance with approved alternatives.

One commenter recommended the Coast Guard add clarity as to what level of response capability, and future expanded capability, the Coast Guard will be seeking prior to approving future alternatives. The Coast Guard will evaluate the adequacy of response capabilities listed in alternatives, including expanded response capability addressed in the build-out plan. The Coast Guard's evaluation includes verifying that response resources are adequate in the areas intended, and that the alternative will provide an equivalent oil spill removal capacity. Additionally, alternatives are subject to equipment inspections, personnel training verifications, and exercise evaluations, including validation of build-out plan milestone achievement.

Two commenters questioned the need for the alternative planning criteria national guidelines, noting that the CG-543 Policy Letter 09-02 and MSIB 03-14 for Western Alaska were clear, concise, and simple. The CG-543 Policy Letter 09-02 was a national policy that only covered tank vessels. MSIB 03-14 was issued by the COTP for Western Alaska and specific to the Western Alaska COTP zone. The Coast Guard saw a need for a national policy that covers both tank and nontank vessels on alternative planning criteria.

One commenter noted that the Coast Guard's approval of an alternative plays a critical role in the level of environmental protection provided in the region. The Coast Guard agrees and notes that an environmental impact assessment is one of the elements that an owner or operator of a tank or nontank vessel should, at a minimum, include for the Coast Guard's consideration in determining whether to accept an alternative(s).

One commenter suggested that the policy reflect the stated regulation; that an alternative can be submitted for consideration any time that the vessel owner or operator feels the NPC are inappropriate or unattainable for reasons beyond their control or, when a vessel owner or operator can demonstrate that the alternative will provide an equivalent or superior level of response and/or protection as the NPC. The Coast Guard agrees in part and disagrees in part. The Coast Guard agrees that the alternative planning criteria may be submitted when an owner or operator believes the NPC are inappropriate for the area in which the vessel intends to operate. The Coast Guard does not agree, nor do the regulations in 33 CFR part 155 contemplate, the use of an alternative(s) where the NPC can be met.

One commenter noted that the Aleutian Islands Risk Assessment (AIRA) and the response model contained therein are better suited to the Alaskan region than compliance with the regulations. The Coast Guard disagrees. The AIRA presents one possible response model as an alternative planning approach for one region of the country. The Coast Guard will not dictate the prevention, response and/or mitigation strategies that a vessel owner or operator can propose where the NPC are inappropriate.

Two commenters recommended that salvage and marine firefighting resources should not be included in an alternative(s). The Coast Guard disagrees. Nothing in the regulations precludes the consideration of salvage and marine firefighting in a proposed alternative. Accordingly, in areas where salvage and marine firefighting national planning criteria are inappropriate, a vessel owner or operator may propose an alternative.

One commenter requested to know if the Coast Guard intends on requiring salvage and marine firefighting equipment to be listed in the Coast Guard response resource inventory (RRI). The Coast Guard appreciates the commenter's suggestion. The RRI is a voluntary option for certain response resource providers. The Coast Guard recommends that the response resources listed in alternatives be entered into the RRI.

One commenter noted that the requirement to state each class of vessel and its associated worst case discharge volume and oil group is unnecessary. The Coast Guard agrees and modified the language in the alternative planning criteria national guidelines to reflect that an alternative may cover a single vessel or fleet of vessels and should state the vessel type(s) and oil volumes by type.

One commenter felt that vessel tracking, administration of vessel of opportunity programs, vessel of opportunity training programs, and the requirement to assure five vessels are available are cost prohibitive, inconceivable, and unattainable. A related comment recommended that the Coast Guard consider clarifying that the examples listed in the alternative national policy guidelines and enclosures are not requirements, but examples. The draft alternative planning criteria national guidelines did not require any of the above programs or strategies but rather presented them as examples of strategies. To avoid further confusion, however, the Coast Guard removed these examples from the alternative planning criteria national guidelines.

One commenter noted that an oil spill trajectory and fate analysis for the entire coastline of a vessel's route within a VRP geographic specific appendix is an unreasonable requirement, costly, and adds no value to a proposed alternative. We wish to make clear that while there is no specific requirement for trajectories or fate analyses, these are useful for the Coast Guard's evaluation of proposed alternatives and may appropriately be included in a plan holder's environmental impact assessment.

Two commenters noted a concern that documenting a vessel's track line information was overly burdensome and goes beyond what is required by the regulations. In consideration of these comments, we revised the alternative planning criteria national guidelines to remove language that could be perceived as inconsistent with the regulations. The revised language recommends that proposed alternatives include a general description of the intended vessel operations, such as track lines and/or intended vessel routes.

One commenter noted that the alternative planning criteria national guidelines should be written to ensure that exercises and verifications are conducted in conditions that reflect all intended seasonal operations. The Coast Guard notes that the alternative planning criteria national guidelines do not limit or otherwise prescribe the timing of exercises or verifications. The timing will ultimately be determined by the COTP as part of a risk-based decision process.

One commenter stated that continual improvement on alternatives, with a focus on response resources, should be considered when reviewing an alternative. The Coast Guard agrees and notes that the alternative planning criteria national guidelines include these considerations, especially as part of the build-out plan.

One commenter noted that the term “administrator” is not defined in the VRP regulations. The Coast Guard agrees and defines the term “Alternative Planning Criteria Administrator” in the alternative planning criteria national guidelines.

One commenter noted that the Coast Guard's timelines for accepting alternatives has not been in accordance with the regulatory timelines, and believes the Coast Guard should adhere to the review timeline in the regulations. The Coast Guard agrees that timely review is beneficial, and will work toward completing timely reviews of proposed alternatives. While the regulations in 33 CFR 155.1065(f) and § 155.5067(a) require submission of alternative planning criteria requests 90 days before the vessel intends to operate under a proposed alternative, the alternative planning criteria national guidelines recommend submission at least 180 days due to the myriad factors that must be evaluated, as well as the need for coordination and consultation in the review process.

One commenter noted that the Coast Guard excluded the provision for Alternative Planning Criteria Administrators to submit alternative proposals. The Coast Guard agrees and has added “Alternative Planning Criteria Administrators” to the submission process in the alternative planning criteria national guidelines.

One commenter noted that the alternative planning criteria national guidelines should address mechanisms to make revisions or improvements to an alternative after approval and/or an appeals process. The Coast Guard agrees. The alternative planning criteria national guidelines were updated to address revisions to submitted alternatives. Specifically, vessel owner or operators, or Alternative Planning Criteria Administrators, should submit any significant change that affects the information included in the accepted alternative(s) to the cognizant COTP. COTPs should endorse the proposed alternative and forward to Commandant Office of Marine Environmental Response Policy (CG-MER) through the cognizant CG District and Area staff offices.

One commenter stated that, while the Coast Guard has held meetings with local stakeholders and communities in Western Alaska, the Coast Guard has not reached out to the wider shipping community that will also be affected by the alternative planning criteria national guidelines. The commenter recommended that the Coast Guard establish an industry working group that includes the wider community in order to seek constructive input into these important issues, especially given the large number of international trading vessels that transit the Great Circle Route through Western Alaska.

The Coast Guard agrees that input from stakeholders in every region is important and that is one of the reasons we requested public comment on the draft alternative planning criteria national guidelines. The Coast Guard is interested in continuing the discussion on improving the alternative planning criteria national guidelines and welcomes the opportunity to discuss the subject at local area committee meetings, regional response team meetings, and other relevant forums.

Two commenters supported improved communications between the Coast Guard and appropriate State environmental offices particular to response capability and alternatives. One commenter specifically mentioned that appropriate State environmental offices should be part of the approval and inspection/verification processes of alternatives. As Area Committee members, State environmental offices should be engaging with the Coast Guard on oil spill response planning, including response capability and alternatives. However, the Coast Guard is not abdicating its responsibility to evaluate, nor its decision making authority on the appropriateness of, proposed alternatives.

One commenter suggested that the current procedure for accepting proposed alternatives has been inconsistent and has not been an inclusive process specific to State environmental offices “as required by regulation.” We believe it is important to clarify that our regulations do not impose such a requirement, but note that the alternative planning criteria national guidelines mention that COTPs may, in their discretion, consult with Area Committees, of which State environmental offices are members. Concerning consistency in the procedure for accepting proposed alternatives, one of the goals of these alternative planning criteria national guidelines is to facilitate COTP consistency in the review of proposed alternatives. However, as noted above, not all proposed alternatives are the same; consequently, some proposals will generate more review and analysis than others.

One commenter suggested that engagement with the local communities and stakeholders should continue beyond that which has already taken place as part of the implementation of the alternative planning criteria national guidelines. The Coast Guard agrees. The Coast Guard is appreciative of the input received in the development of the alternative planning criteria national guidelines, and looks forward to continuing this dialogue at local area committee meetings, regional response team meetings, and other forums.

Three commenters suggested that it is essential that the Coast Guard monitor and report periodically to the public on the status of oil spill response readiness for a COTP zone. One commenter specifically requested that the Coast Guard require Alternative Planning Criteria Administrators or planholders to provide public summaries of the progress made toward closing response gaps and an evaluation of the prevention and risk reduction measures specified in the alternative. The Coast Guard COTPs, in coordination with the local area committee, can determine appropriate information sharing procedures to address oil spill response readiness. Additionally, the Coast Guard RRI may be a useful tool, where resource providers may voluntarily list response resources to facilitate this awareness, including the resources listed in alternatives.

One commenter suggested that the Coast Guard make available for public comment submitted alternatives, including alternatives submitted for renewal, before making its final approval determination. The Coast Guard is appreciative of this suggestion. However, we believe that initiating a public comment process for submitted alternatives would significantly impede the timely review of alternatives.

One commenter expressed concern with the aggressive timeline associated with updating and re-submitting existing alternative planning criteria to align with the updated alternative planning criteria national guidelines. The Coast Guard agrees. Vessel owner or operators, or Alternative Planning Criteria Administrators, of currently existing alternative planning criteria may request an extension from the Coast Guard for up to six months beyond the date of expiration.

One commenter recommended that the Coast Guard post response contracts online and provide local communities with funding to assist with the outreach effort needed to gain local knowledge and expertise in the contract review of alternatives in VRPs. Posting response contracts online would create significant delays in the Coast Guard's review of submitted alternatives. This is because parties to the contract would have to redact business proprietary information, and the Coast Guard, as the entity that is posting the information, would have the responsibility of reviewing the redactions to ensure the content was acceptable for posting. We believe these additional steps would significantly impede the timely review of alternatives. Regarding the suggestion to provide funding to organizations to assist in outreach efforts, the Coast Guard does not have the legal authority to provide funding to organizations. However, engagement with local area committees, or regional response teams, offer a means to help build awareness of, and further strengthen, current strategies and response capabilities to address removal of a worst case discharge, or substantial threat of such a discharge.

Two commenters suggested that they believe competition created by accepted alternatives, and in general, competition within the oil spill prevention and response markets, is a good thing. This comment is outside the scope of the alternative planning criteria national guidelines as the purpose of the alternative planning criteria national guidelines is to provide guidance for the development and submission of alternatives with the goal of increasing response capacity.

One commenter offered that competition created in alternative planning criteria has led to response capability reductions. The Coast Guard has no authority to control market competition; therefore, this comment is outside the scope of the alternative planning criteria national guidelines.

Three commenters stated that additional resources not listed in a vessel response plan or alternative plan will not be made available to respond to an incident. These comments are outside the scope of the updated alternative planning criteria national guidelines.

One commenter suggested that VRP requirements, including alternatives, should include vessels on innocent passage. This comment is outside the scope of the updated alternative planning criteria national guidelines.

This notice is issued under the authority of 5 U.S.C. 552(a).

On June 13, 2017, the State of West Virginia through the West Virginia Department of Environmental Protection (WVDEP) submitted a formal revision to West Virginia's SIP pertaining to amendments of Legislative Rule, 45 CSR 8—Ambient Air Quality Standards. The SIP revision consists of revising the effective date of the incorporation by reference of 40 CFR parts 50 and 53.

West Virginia has submitted this SIP revision to update the State's incorporation by reference of 40 CFR part 50, which contains the Federal NAAQS, and 40 CFR part 53, which contains the ambient air monitoring reference methods and equivalent reference methods. Currently, the version of 45 CSR 8 in the West Virginia SIP incorporates by reference 40 CFR parts 50 and 53 as effective on June 1, 2013; this SIP revision will update the effective date to June 1, 2016.

In the June 13, 2017 SIP submittal, WVDEP submitted amendments to the legislative rule which include the following changes: To section 45-8-1 (General), the filing and effective dates are changed to reflect the update of the legislative rule; to section 45-8-3 (Adoption of Standards), the effective dates for the incorporation by reference of 40 CFR parts 50 and 53 are changed; to section 45-8-4 (Inconsistency Between Rules), the reference to the “West Virginia Department of Environmental Protection,” is changed to the “Division of Air Quality.” West Virginia has amended 45 CSR 8 to revise the filing and effective dates of the rule to May 15, 2017 and June 1, 2017 respectively. The effective date of the incorporation by reference of 40 CFR parts 50 and 53 changed from June 1, 2013 to June 1, 2017. EPA finds the revised version of 45 CSR 8 with new effective dates incorporating by reference 40 CFR parts 50 and 53, as well as the changes to the reference of the state air agency, are in accordance with requirements in section 110 of the CAA.

This update will effectively add the following to the West Virginia SIP: The 2015 ozone NAAQS, monitoring reference and equivalent methods pertaining to PM2.5, CO, and PM10, and it will revise the ozone monitoring season to March 1st through October 31st, the FRM, the FEM, and the PAMS network.

EPA is approving the amendments to Legislative Rule, 45 CSR 8—Ambient Air Quality Standards, into the West Virginia SIP pursuant to section 110 of the CAA. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 15, 2017 without further notice unless EPA receives adverse comment by November 15, 2017. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the update to West Virginia's Legislative Rule, 45 CSR 8, as effective on June 1, 2017. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region III 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 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 EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update of the SIP compilation.1

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

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

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 15, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action.

This action, to approve West Virginia's SIP revisions to update of the effective date by which the State regulations incorporate by reference the Federal NAAQS, additional monitoring methods, and additional equivalent monitoring methods, which effectively adds the 2015 ozone NAAQS and ambient air monitoring reference and equivalent methods pertaining to PM2.5, PM10, and CO, and changing the reference to the state air agency, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) of the CAA are to be submitted by states within three years after promulgation of a new or revised NAAQS to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require states to address basic SIP elements such as requirements for monitoring, basic program requirements, and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs. Section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.

Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (prong 1) and from interfering with maintenance of the NAAQS in another state (prong 2). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (prong 3) and from interfering with measures to protect visibility in another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to include provisions ensuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement.

On January 22, 2010, EPA established a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion, based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. See 75 FR 6474 (February 9, 2010). This NAAQS is designed to protect against exposure to the entire group of nitrogen oxides (NOX). NO2 is the component of greatest concern and is used as the indicator for the larger group of NOX. Emissions that lead to the formation of NO2 generally also lead to the formation of other NOX. Therefore, control measures that reduce NO2 can generally be expected to reduce population exposures to all gaseous NOX which may have the co-benefit of reducing the formation of ozone and fine particles both of which pose significant public health threats.

States were required to submit infrastructure SIP submissions for the 2010 1-hour NO2 NAAQS to EPA no later than January 22, 2013. For comprehensive information on the 2010 1-hour NO2 NAAQS, please refer to the Federal Register notice cited immediately above.

In a notice of proposed rulemaking published on August 10, 2017 (82 FR 37384), EPA proposed to approve Florida's February 3, 2017, SIP submission concluding that its SIP adequately addresses prong 1 and prong 2 requirements for the 2010 1-hour NO2 NAAQS. Florida provided the following reasons for its determination: (1) The SIP contains state regulations that directly or indirectly control NOX emissions; (2) all areas in the United States are designated as unclassifiable/attainment for the 2010 1-hour NO2 NAAQS; (3) maximum 1-hour NO2 concentrations in states near Florida (Alabama, Georgia, Louisiana, Mississippi, and South Carolina) are below the 2010 standard; (4) monitored design values for NO2 in the State are well below the 2010 1-hour NO2 NAAQS and are trending downward; and (5) total NOX emissions in the State are also trending downward. The other applicable infrastructure SIP requirements for Florida for the 2010 1-hour NO2 NAAQS have been addressed in a separate rulemaking or will be addressed separately. On March 18, 2015 (80 FR 14019), EPA approved the portions of Florida's infrastructure SIP regarding the prevention of significant deterioration (PSD) permitting requirements of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2010 1-hour NO2 NAAQS. On November 23, 2016 (81 FR 84479), EPA approved the portions of Florida's infrastructure SIP regarding sections 110(a)(2)(A), prong 4 of section 110(a)(2)(D)(i), section 110(a)(2)(D)(ii), sections 110(a)(2)(E)-(H), and sections 110(a)(2)(K)-(M). The portion of Florida's infrastructure SIP related to the ambient air quality monitoring and data system requirements of section 110(a)(2)(B) will be acted on in a separate action.

The details of Florida's submission and the rationale for EPA's action are explained in the August 10, 2017, notice of proposed rulemaking. Comments on the proposed rulemaking were due on or before September 11, 2017. EPA did not receive any comments, adverse or otherwise.

As described above, EPA is taking final action to approve Florida's February 3, 2017, SIP revision addressing prongs 1 and 2 of CAA section 110(a)(2)(D)(i) for the 2010 1-hour NO2 NAAQS. EPA is taking final action to approve this portion Florida's infrastructure SIP submission because Florida's SIP includes adequate provisions to prevent emissions sources within the State from significantly contributing to nonattainment or interfering with maintenance of this standard in any other state.

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

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

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 15, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

I. Background

On October 26, 2015 (80 FR 65292), EPA revised the primary and secondary national ambient air quality standards (NAAQS) for ozone to 0.070 parts per million (ppm). The primary and secondary ambient air quality standards are met at an ambient air quality monitoring site when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.070 ppm.

On July 25, 2016, the Commonwealth of Virginia through the Virginia Department of Environmental Quality (VADEQ) submitted a formal revision to its SIP. The SIP revision seeks to incorporate the 2015 ozone NAAQS promulgated by EPA into the Virginia SIP.

In the July 25, 2016 SIP submission, Virginia seeks to add regulation 9VAC5-30-57 “Ozone (8-hour 0.070 ppm)” to the Virginia SIP. Regulation 9VAC5-30-57 incorporates by reference the 2015 ozone NAAQS as promulgated by EPA and is consistent with the NAAQS set out in 40 CFR part 50. See 80 FR 65292 (October 26, 2015).

Virginia's submittal seeks to incorporate the revised 2015 ozone NAAQS, as promulgated by EPA, into the approved Virginia SIP. Therefore, EPA finds the SIP submittal approvable pursuant to section 110 of the CAA.

EPA is approving the July 25, 2016 Virginia SIP revision submittal which seeks to add regulation 9VAC5-30-57 “Ozone (8-hour 0.070 ppm)” to the Virginia SIP pursuant to section 110 of the CAA. Regulation 9VAC5-30-57 sets the level of the 8-hour ozone standard at 0.070 ppm, consistent with EPA's 2015 ozone NAAQS. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of this Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 15, 2017 without further notice unless EPA receives adverse comment by November 15, 2017. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Virginia 9VAC5-30-57 described in the amendment to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region III 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 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 EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update of the SIP compilation.1

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

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

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 15, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action.

This action adding regulation 9VAC5-30-57 “Ozone (8-hour 0.070 ppm)” to the Virginia SIP may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

On November 18, 2016, PADEP submitted a revision to the Pennsylvania SIP concerning the adoption of EPA's CTG for miscellaneous metal parts surface coating processes, miscellaneous plastic parts surface coating processes, and pleasure craft surface coatings. Specifically, PADEP has amended 25 Pennsylvania Code (Pa. Code) Chapter 129 (relating to standards for sources) to address RACT and further reduce volatile organic compounds (VOC) emissions in Pennsylvania. In accordance with sections 172(c)(1), 182(b)(2)(A) and 184(b)(1)(B) of the CAA, Pennsylvania's SIP revision submittal establishes VOC emission limitations and other requirements consistent with the recommendations of EPA's 2008 Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings (MMPP) (Publication No. EPA 453/R-08-003; September 2008) and Control Techniques Guidelines for Automobile and Light-Duty Truck Assembly Coatings for these sources in the Commonwealth of Pennsylvania (Publication No. EPA 453/R-08-006).

Ground level ozone is formed in the atmosphere by photochemical reactions between VOCs, nitrogen oxides (NOX), and carbon monoxide (CO) in the presence of sunlight. In order to reduce ozone concentrations in the ambient air, the CAA requires all nonattainment areas to apply controls on VOC and NOX emission sources to achieve emission reductions. Among effective control measures, RACT controls significantly reduce VOC and NOX emissions from major stationary sources. NOX and VOC are referred to as ozone precursors and are emitted by many types of pollution sources, including motor vehicles, power plants, industrial facilities, and area wide sources, such as consumer products and lawn and garden equipment. Scientific evidence indicates that adverse public health effects occur following exposure to ozone. These effects are more pronounced in children and adults with lung disease. Breathing air containing ozone can reduce lung function and inflame airways, which can increase respiratory symptoms and aggravate asthma or other lung diseases.

RACT is defined as the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility (44 FR 53761 at 53762, September 17, 1979). Section 182 of the CAA sets forth two separate RACT requirements for ozone nonattainment areas. The first requirement, contained in section 182(a)(2)(A) of the CAA, and referred to as RACT fix-up requires the correction of RACT rules for which EPA identified deficiencies before the CAA was amended in 1990. Pennsylvania previously corrected its deficiencies under the 1-hour ozone standard and has no further deficiencies to correct under this section of the CAA. The second requirement, set forth in section 182(b)(2) of the CAA, applies to moderate (or worse) ozone nonattainment area as well as to marginal and attainment areas in ozone transport regions (OTRs) established pursuant to section 184 of the CAA, and requires these areas to implement RACT controls on all major VOC and NOX emission sources and on all sources and source categories covered by a CTG issued by EPA.1 See CAA section 182(b)(2) and 184(b).

On August 15, 2017 (82 FR 38605), EPA published a direct final rule approving portions of several SIP revisions submitted by the State of Georgia, through the Georgia Department of Natural Resources' Environmental Protection Division (GA EPD), on December 15, 2011, July 25, 2014, and November 12, 2014. EPA took a direct final action to approve portions of the December 15, 2011, July 25, 2014, and November 12, 2014, submissions that made changes to the following GA EPD regulations: Rule 391-3-1-.02(7)—“Prevention of Significant Deterioration of Air Quality (PSD),” which applies to the construction and modification of any major stationary source in areas designated as attainment or unclassifiable as required by part C of title I of the CAA; and Rule 391-3-1-.03(8)—“Permit Requirements,” which applies generally to the permitting program, including permitting requirements that apply to the construction and modification of any major stationary sources in nonattainment areas as required by part D of title I of the CAA, referred to as nonattainment new source review.

In the direct final rule, EPA explained that the Agency was publishing the rule without prior proposal because the Agency viewed the submittal as a non-controversial SIP amendment and anticipated no adverse comments. Further, EPA explained that the Agency was publishing a separate document in the proposed rules section of the Federal Register to serve as the proposal to approve the SIP revisions should an adverse comment be filed. EPA also noted that the rule would be effective generally 30 days after the close of the public comment period, without further notice unless the Agency received adverse comment by the close of the public comment period. EPA explained that if the Agency received such comments, then EPA would publish a document withdrawing the final rule and informing the public that the rule would not take effect. EPA specified, however, that if a comment were received on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. It was also explained that all public comments received would then be addressed in a subsequent final rule based on the proposed rule, and that EPA would not institute a second comment period on this action.

EPA received one adverse comment from a single Commenter on the portion of the direct final rule that made changes to Rule 391-3-1-.02(7) only, as submitted in the November 12, 2014, SIP revision. As a result of the comment received, EPA is withdrawing the direct final rule. EPA will address the comment in a separate final action based on the proposed action also published on August 15, 2017 (82 FR 38646). EPA will not open a second comment period for this action.

On November 12, 2014, GA EPD submitted a SIP revision to EPA for approval that involves changes to Georgia's regulations to make them consistent with federal requirements for NSR permitting, among other changes. As described below, EPA is approving certain portions of this Georgia submission that makes changes to Rule 391-3-1-.02(7)—“Prevention of Significant Deterioration of Air Quality (PSD),” which applies to the construction and modification of any major stationary source in areas designated as attainment or unclassifiable as required by part C of title I of the CAA. Georgia's PSD regulations at Rule 391-3-1-.02(7) were last updated in the SIP on April 9, 2013. See 78 FR 21065. EPA is also approving Rule 391-3-1.03(8)—“Permit Requirements” at paragraph (g), which revises NNSR rules, and at paragraph (d) as explained in the August 15, 2017 (82 FR 38646) direct final rule.

Georgia's November 12, 2014 SIP revision makes changes to the PSD regulations to reflect changes to the federal PSD regulations at 40 CFR 52.21, including provisions promulgated in the following federal rule: “Implementation of the New Source Review (NSR) Program for Particulate Matter Less Than 2.5 Micrometers (PM2.5): 1 Amendment to the Definition of `Regulated NSR Pollutant' Concerning Condensable Particulate Matter,” Final Rule, 77 FR 65107 (October 25, 2012) (hereinafter referred to as the PM2.5 Condensables Correction Rule). Georgia's November 12, 2014 SIP revision also makes changes to Georgia's PSD program to incorporate plantwide applicability limits (PALs) for greenhouse gases (GHGs) as allowed in the federal rule entitled “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule Step 3 and GHG Plantwide Applicability Limits.” See 77 FR 41051 (July 12, 2012) (hereinafter referred to as the GHG Step 3 Rule).2

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-2016-0392 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 15, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0392, 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 December 20, 2016 (81 FR 92758) (FRL-9956-04), 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 5E8440) by Dow AgroSciences LLC, 9330 Zionsville Rd, Indianapolis, IN 46268. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide fenpicoxamid (XDE- 777) in or on banana at 0.1 parts per million (ppm), rye, grain and wheat, grain at 0.7 ppm; and residues of fenpicoxamid and its metabolite X12326349 expressed as fenpicoxamid equivalents in or on meat and fat from cattle, goats, and sheep at 0.01 ppm; and meat byproducts of cattle, goats, and sheep at 0.02 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences LLC, 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 is establishing tolerances as follows: 0.15 ppm for banana and 0.60 ppm for rye, grain and wheat, grain. In addition, EPA has concluded that no tolerances are needed for livestock commodities at this time. 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 fenpicoxamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fenpicoxamid 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. Fenpicoxamid has no significant acute toxicity via oral, dermal or inhalation route of exposure. Moreover, it is not a skin irritant and does not cause skin sensitization.

Liver effects were consistently observed in mice regardless of duration; however, the severity, magnitude, and diversity of the liver response progressed from adaptive in subchronic exposures to adverse in chronic exposures. Mice exposed to fenpicoxamid in the diet for 80 weeks experienced liver weight increase accompanied by microscopic changes including very slight to moderate centrilobular/midzonal hepatocellular hypertrophy with altered tinctorial properties (increased cytoplasmic eosinophilia), vacuolization consistent with fatty change, and very slight hepatocyte necrosis. These liver effects also coincided with an increased incidence of microscopic calculi within the gallbladder in both sexes. A treatment-related increase in liver tumors were seen in male mice and is the basis for the Agency's classification of the chemical as “Suggestive Evidence of Carcinogenic Potential”. The Agency determined that a non-linear approach adequately accounted for all chronic toxicity, including carcinogenicity, that could result from chronic exposure to fenpicoxamid and, therefore, quantification of carcinogenic potential was not required. This decision was based on the following considerations: (1) There was limited evidence of carcinogenicity in the fenpicoxamid toxicity database; (2) the concern for mutagenicity and genotoxicity is low; and (3) there was no evidence of carcinogenicity at doses at or below the chronic reference dose.

Rats were likewise only adversely affected by treatment following chronic exposures. Chronic dietary exposure elicited treatment-related changes in the kidneys (increased severity of chronic progressive glomerulonephropathy) that were considered detrimental to the rat's health. However, unlike mice, chronic exposure did not elicit an increase in neoplasms in any tissue. Rabbits and dogs tolerated oral exposure up to doses of 495 and 1,115 milligrams/kilogram/day (mg/kg/day), respectively, without any signs of deteriorating health. There was no evidence of fetal susceptibility in rats or rabbits, or offspring susceptibility in rats. None of the available studies produced evidence of treatment-induced immunotoxicity or neurotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by fenpicoxamid 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 “Fenpicoxamid (XDE-777): Human Health Risk Assessment to Establish Tolerances for Bananas, Wheat, and Rye Commodities Without U.S. Registration” at pages 10 through 20 in docket ID number EPA-HQ-OPP-2016-0392.

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

A summary of the toxicological endpoints for fenpicoxamid 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 fenpicoxamid, EPA assessed dietary exposures from fenpicoxamid 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 fenpicoxamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

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

iii. Cancer. As discussed in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to fenpicoxamid.

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

2. Dietary exposure from drinking water. Because there are no domestic uses of fenpicoxamid registered in the United States, there will not be residues of fenpicoxamid in drinking water. Therefore, a drinking water assessment is not required.

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

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

2. Prenatal and postnatal sensitivity. Developmental toxicity was not observed in the rat or rabbit developmental studies and, no reproductive or offspring effects were observed in the reproduction toxicity study. As a result, EPA concluded there is low concern for prenatal or postnatal sensitivity from fenpicoxamid exposure.

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

i. The toxicity database for fenpicoxamid is complete.

ii. There is no indication that fenpicoxamid 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 fenpicoxamid 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.

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, fenpicoxamid 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 fenpicoxamid from food for the highest exposed population subgroup, children 1-2 years of age, is 0.002737 mg/kg/day or <1.0% of the cPAD. The chronic dietary exposure estimate for the general population is 0.001022 mg/kg/day or <1.0% of the cPAD.

3. Short-term and intermediate-term risk. Because fenpicoxamid is not registered for any uses that may result in residential exposure, fenpicoxamid is not expected to cause any short-term or intermediate-term risk not already accounted for in the Agency's assessment of chronic risk.

4. Aggregate cancer risk for U.S. population. Based on the Agency's assessment of chronic risk, the Agency concludes that fenpicoxamid is not expected to pose a cancer risk.

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 fenpicoxamid residues.

Adequate enforcement methodology (high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS), Method No. 120615) is available to enforce the tolerance expression.

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

Codex has not established any MRLs for residues of fenpicoxamid.

EPA is establishing tolerances for wheat, grain and rye, grain (at 0.60 ppm) that differ from what the petition requested (0.7 ppm). The petitioner included only wheat grain residues for individual growing season/area combinations. Including all residues for wheat grain in the OECD MRL calculator in accordance with Agency policy results in a tolerance level of 0.60 ppm. Because the wheat grain data can be used to assess residues in rye grain, the Agency is establishing a tolerance at 0.60 ppm for rye grain as well. Finally, although the notice of filing and the petition summary indicate that the petitioner was seeking tolerances for wheat and rye, the section of the petition that listed actual requested tolerances more narrowly sought only “wheat, grain” and “rye, grain” tolerances because those are the forms in which the wheat and rye will be imported. Accordingly, EPA is establishing tolerances for the commodities “wheat, grain” and “rye, grain”.

EPA is establishing a different tolerance level for banana than what was requested based on available residue data and the OECD calculator, and in order to harmonize with Canada's MRL.

EPA is not establishing any of the petitioned-for tolerances for livestock commodities. Based on the results of the livestock feeding studies, the residues of concern for livestock commodities (fenpicoxamid and X12326349) would be below the limit of quantification (LOQ) of the enforcement analytical method. Therefore, the Agency concludes, as indicated in 40 CFR 180.6(a)(3), that there is no reasonable expectation of finite residues and no tolerances are needed for livestock commodities at this time.

Therefore, tolerances are established for residues of fenpicoxamid and its metabolites and degradates, in or on banana at 0.15 ppm, and rye and wheat grain at 0.60 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0142 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 15, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0142, by one of the following methods:

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

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

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

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

In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-86), 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 6E8448) by E.I. Dupont de Nemours and Company, 974 Centre Road, Wilmington, DE 19805. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide triflumezopyrim (2,4-dioxo-1-(5-pyrimidinylmethyl)-3-[3-(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in or on rice, grain at 0.20 parts per million (ppm). That document referenced a summary of the petition prepared by E.I. Dupont de Nemours and Company, 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 revised the tolerance for rice, grain to 0.40 ppm based on the OECD tolerance calculation procedure. Additionally, EPA is requiring a tolerance for rice, hull at 1.0 ppm. The reason 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 triflumezopyrim including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with triflumezopyrim 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. The most common adverse effect observed across the triflumezopyrim toxicological database was a decrease in absolute bodyweight in dogs and rats in both sexes following subchronic and chronic exposures. No additional non-cancer effects relevant for human health risk assessment were noted in the subchronic rat and dog oral toxicity studies. No effects were seen in the mice and rabbit studies, including the dermal toxicity study.

Chronic exposures in rats resulted in an increased incidence of bile duct hyperplasia in the presence of decreases in absolute bodyweight (~70 milligrams/kilogram/day (mg/kg/day)). Additional lesions were seen in the liver, testes, and uterus at a higher dose (~400 mg/kg/day). The rat combined chronic/carcinogenicity study showed an increase in uterine and liver tumors at a dose of ~400 mg/kg/day, which is considered excessive for evaluating carcinogenic potential. The remaining doses were not considered excessive and did not show treatment-related tumors in either sex. Liver tumors in male mice during the mouse carcinogenicity study were considered treatment-related. The proposed mode of action (constitutive androstane receptor (CAR)-mediated proliferation) for the liver tumors in male mice was adequately supported by mechanistic data that clearly identified the sequence of events, dose-response concordance and temporal relationship for this tumor type. Triflumezopyrim is classified as “not likely to be carcinogenic to humans at dose levels that do not cause a significant induction in CYP2B activity.” Based on the mechanistic studies provided, significant induction in CYP2B only occurred at 7,000 ppm (727 mg/kg/day in male mice); the chronic reference dose used for the Agency's safety assessment is based on a no observed adverse effect level of 17 mg/kg/day. As a result, the Agency concludes that the chronic reference dose will be protective of potential carcinogenicity, which can be assessed through a non-linear approach. There is no mutagenicity concern based on the results from the in vitro and in vivo genetic toxicity studies.

Evidence of increased quantitative susceptibility in the rat developmental toxicity study was observed in the form of incomplete ossification of the parietal skull in the fetuses of dams treated with a relatively high dose (200 mg/kg/day) in the absence of any maternal toxicity. There was no evidence of susceptibility in the rat reproduction toxicity or rabbit developmental toxicity study.

Possible signs of neurotoxicity were observed in the acute neurotoxicity (ACN) in rats as well as in the 28-day subchronic oral toxicity study in dogs. An overall decrease in motor activity was observed in the ACN study on the day of dosing. Animals also showed slight decreases in body temperature and number of rearing movements, as well as increases in the incidence of high posture, at a dose 4x higher than what elicited the decrease in motor activity. The 28-day subchronic oral toxicity study in dogs showed neurobehavioral signs such as slight impairment of forelimb and/or hindlimb strength and effects on pupil constriction. However, the neurobehavioral signs were not seen in studies of longer duration in dogs.

Although evidence of neurotoxicity was seen in the ACN study in rats and 28-day oral toxicity study in dogs, concern is low since: (1) Effects are well-characterized with clearly established NOAEL/LOAEL values; (2) no additional neurotoxic effects were seen in the toxicological database including the subchronic neurotoxicity study (SCN); (3) there were no corroborating neuropathological findings; (4) the neurobehavioral signs in the dog were not observed in studies of longer durations in dogs; and (5) the selected endpoints for risk assessment are protective of these effects.

Specific information on the studies received and the nature of the adverse effects caused by Triflumezopyrim 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 Triflumezopyrim: Human Health Risk Assessment to Establish Tolerances for Rice Without U.S. Registration at page 21 in docket ID number EPA-HQ-OPP-2016-0142.

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

A summary of the toxicological endpoints for Triflumezopyrim used for human risk assessment is shown in the Table below.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to triflumezopyrim, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from triflumezopyrim in food as follows:

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

Such effects were identified for triflumezopyrim. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA). As to residue levels in food, EPA used an unrefined dietary analysis and incorporated tolerance-level residues and assumed 100% of all rice was treated.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 National Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA). As to residue levels in food, EPA used an unrefined dietary analysis and incorporated tolerance-level residues and assumed 100% of all rice was treated.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that triflumezopyrim is not likely to cause cancer to humans at dose levels that do not cause a significant increase in CYP2B activity. Additionally, there is no chronic risk from exposure to triflumezopyrim and the chronic reference dose is protective of potential carcinogenicity. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

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

2. Dietary exposure from drinking water. Because there are no domestic registrations for triflumezopyrim in the United States, dietary exposure (acute and chronic) from imported commodities is the only source of exposure assessed. Residues from imported commodities are not expected to reach drinking water sources.

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

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

2. Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility in the rabbit developmental or the rat reproduction toxicity studies; however, there was evidence of increased quantitative susceptibility in the rat developmental study in rats where an increased incidence of incomplete ossification of the parietal skull was seen in the absence of maternal toxicity. Concern is low since: (1) The effect is well-characterized with clearly established NOAEL/LOAEL values; and (2) the selected endpoints for this chemical are protective of these effects.

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

i. The toxicity database for triflumezopyrim is complete.

ii. Although there is evidence of neurotoxicity in the ACN study in rats and 28-day oral toxicity study in dogs for triflumezopyrim, the concern is low since: (1) The effects are well-characterized with clearly established NOAEL/LOAEL values; (2) no additional neurotoxic effects were seen in the toxicological database including the SCN; (3) there were no corroborating neuropathological findings; (4) the neurobehavioral signs in the dog were not observed in studies of longer durations in dogs; and (5) the selected endpoints for this chemical are protective of these effects. As a result, there is no need to require a developmental neurotoxicity study or retain the 10X to account for potential neurotoxic effects.

iii. Although there was evidence of increased quantitative susceptibility in the rat developmental toxicity study where incomplete ossification of the parietal skull in the fetuses of dams treated with a relatively high dose (200 mg/kg/day) was observed in the absence of any maternal toxicity, concern is low since: (1) The effect is well-characterized with clearly established NOAEL/LOAEL values and (2) the selected endpoints for this chemical are protective of these effects. There was no evidence of increased susceptibility in the rabbit developmental or the rat reproduction toxicity studies.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on considering that 100% of all rice was treated and using tolerance-level residues. Since the metabolites were found at insignificant levels in the metabolism studies, triflumezopyrim is considered the only residue of concern. These assessments will not underestimate the exposure and risks posed by triflumezopyrim.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to triflumezopyrim will occupy <1% of the aPAD for all infants <1 year old, the population group receiving the greatest exposure.

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

3. Short-term and Intermediate-term risk. Triflumezopyrim is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Because there are no residential uses for triflumezopyrim, as a result, aggregate risk estimates for short- and intermediate-term exposure are equivalent to the chronic dietary risk estimates and are not of concern.

4. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has determined that triflumezopyrim is not likely to be carcinogenic to humans at doses that do not cause a significant induction in CYP2B activity. Because there is no chronic risk from exposure to triflumezopyrim and the chronic reference dose is protective of potential carcinogenicity, triflumezopyrim is not expected to pose a cancer risk.

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 triflumezopyrim residues.

Adequate enforcement methodology (DuPont Liquid chromatography Mass spectrometry/mass spectrometry (LC/MS/MS) methods 36348 and 45170) 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.

The Codex has not established a MRL for triflumezopyrim.

EPA is establishing a tolerance for rice, grain at 0.40 ppm, rather than at 0.20 ppm as requested, in addition to establishing a tolerance for rice, hulls of 1.0 ppm. The rice grain tolerance is based on the OECD tolerance calculation procedure with the inputted residues adjusted proportionally to reflect the maximum application rate. The raw agricultural commodity of “rice, grain” consists of the rice kernel, as well as the rice hull. The rice hull is considered a processed commodity for rice, and where residues concentrate in processed commodities, a higher tolerance to cover those residues is warranted. Because the available data indicates a higher level of residues on the rice hull, EPA is establishing a separate tolerance to cover those residues.

Therefore, tolerances are established for residues of triflumezopyrim, (2,4-dioco-1-(5-pyrimidinylmethyl)-3-[3-(trifluoromethyl)phenyl]-2H-pyrido[1,2-a]pyrimidinium inner salt), in or on rice, grain at 0.40 and rice, hulls at 1.0 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) 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 document announces that, on October 6, 2017, OMB approved this information collection under the emergency processing of the Paperwork Reduction Act (PRA), 5 CFR 1320.13, for a period of six months, the information collection requirements relating to the State opt-out rules contained in the Commission's Report and Order, FCC 17-75, published at 82 FR 46690, October 6, 2017. The OMB Control Number is 3060-1245. 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, 3060-1245, 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 October 6, 2017, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR 90.532. 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 Number is 3060-1245.

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: 3060-1245.

OMB Approval Date: October 6, 2017.

OMB Expiration Date: April 30, 2018.

Title: Procedures for Commission Review of State Opt-Out Request from the FirstNet Radio Access Network.

Form Number: N/A.

Respondents: State, local or tribal governments.

Number of Respondents and Responses: 55 respondents; 110 responses.

Estimated Time per Response: 0.25 hours per initial notification.

Frequency of Response: One-time reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for requiring licensees to submit this information enter into the written agreements is contained in the Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112 96, 126 Stat. 156 §§ 6001-6303, 6413 (codified at 47 U.S.C. 1401-1443, 1457).

Total Annual Burden: 26,414 hours.

Total Annual Cost: No cost.

Nature and Extent of Confidentiality: Alternative state plans are very likely to contain proprietary information as well as information whose disclosure could compromise network security. Parties may therefore seek confidential treatment of any filing under our Part 0 rules, including the use of a protective order process to allow other those granted party status to the restricted proceeding access to the information on a confidential basis.

Privacy Act: No impact(s).

Needs and Uses: The purpose of requiring this collection is to comply with Middle Class Tax Relief and Job Creation Act of 2012. The Middle Class Tax Relief and Job Creation Act of 2012 provides that “the Governor shall choose whether to participate in the deployment of the nationwide, interoperable broadband network as proposed by [FirstNet,] or conduct its own deployment of a radio access network in such State.” If a Governor chooses not to participate in the NPSBN, section 6302(e)(3)(A) of the Act requires the Governor to “notify [FirstNet], the NTIA, and the Commission of such decision.” The Act also states that an opt-out state “shall submit” to the Commission an “alternative plan” for “the construction, maintenance, operation, and improvements” of the RAN within the state. Section 3(C)(ii) of the Act mandates that “upon submission of this plan, the Commission shall approve or disapprove of the plan.”

We require that either the Governor or the Governor's his duly authorized designee may provide notification of the Governor's decision. The opt-out notification to the Commission must also include a certification that the state is providing simultaneous notice of its opt-out decision to both to NTIA and FirstNet. To facilitate the electronic filing of opt-out notifications, we will establish the email address [email protected] as the address for this purpose.

Each opt-out state will have 60 days from the completion of its Request For Proposal (240 days from the date of its opt-out notification to the Commission) to file an alternative state plan via the secure email address [email protected] or via certified mail to the Secretary's office.

On May 8, 2015, PHMSA, in coordination with FRA, published a Final Rule adopting requirements designed to reduce the consequences and, in some instances, reduce the probability of accidents involving trains transporting large quantities of flammable liquids. See 80 FR 26643. The Final Rule defined certain trains transporting large volumes of flammable liquids as high-hazard flammable trains (HHFT) 1 and others as high-hazard flammable unit trains (HHFUT).2 The Final Rule required HHFUTs transporting at least one flammable liquid classified as a packing group I material be operated with an ECP braking system by January 1, 2021, and all other HHFUTs be operated with an ECP braking system by May 1, 2023. See 49 CFR 174.310(a)(3).

In December 2015, Congress passed the FAST Act. Pub. L. 114-94, 129 Stat. 1686 (Dec. 4, 2015) (codified at 49 U.S.C. 20168). Section 7311 of the FAST Act (section 7311) established a process, including independent study and testing, for DOT to use in developing an updated RIA related to the Final Rule's ECP brake provision. The Secretary is also required to solicit public comment on the revised RIA, and issue a final updated RIA. Finally, Section 7311 requires the Secretary of Transportation to review the final updated RIA and determine if the final rule's ECP brake requirements are justified, based on whether the final updated RIA demonstrates that the benefits exceed the costs. The FAST Act requires this entire process to be completed no later than December 4, 2017.

Section 7311 required DOT to enter into an agreement with NAS to test ECP brakes and reevaluate the economic analysis supporting the ECP brake requirement of the Final Rule.3 Section 7311 required the testing to “objectively, accurately, and reliably measure[s] the performance of ECP brake systems relative to other braking technologies or systems, such as distributed power and 2-way end-of-train devices.” The FAST Act also provided for GAO review of the potential costs and benefits of ECP brakes. In response, GAO completed an evaluation of the business benefits, safety benefits, and costs that DOT estimated in the RIA for the final rule.4 Additionally, GAO recently completed a second evaluation comparing the forecasted values of certain data points that were used to support DOT's ECP brake analysis.5 Both audits are discussed in the updated RIA.

PHMSA is providing the public with an opportunity to comment on the updated RIA. To enable PHMSA to meet section 7311's deadline, all comments must be received in the docket referenced in the ADDRESSES section of this document by November 1, 2017. Comments received after that date will be considered to the extent practicable, provided the comments do not result in additional delay or expense. All documents and comments related to this matter, including the updated RIA, are available for review at http://www.regulations.gov in docket number PHMSA-2017-0102.

We recently approved Framework Adjustment 56, which set 2017 annual catch limits (ACLs) for groundfish stocks (82 FR 16133). The possibility of minor adjustments and corrections was noted in the Framework 56 proposed and final rules because final allocations are not always available at the time of the rulemaking for the upcoming fishing year.

Based on final 2016 catch information that recently became available, the fishing year 2016 common pool sub-ACL for Georges Bank (GB) cod was exceeded by 2.8 metric tons (mt). If the common pool sub-ACL for any stock is exceeded, we are required to reduce the common pool sub-ACL by the amount of the overage in the next fishing year. Therefore, this action reduces the fishing year 2017 GB cod common pool sub-ACL by 2.8 mt, which results in a revised 2017 GB cod common pool sub-ACL of 7.0 mt. The revised Trimester Total Allowable Catches (TACs) are provided in Table 1.

As of October 3, 2017, the common pool fishery is projected to have caught 123 percent of the adjusted Trimester 2 TAC (2.6 mt) for GB cod. Additionally, the common pool fishery has caught 83 percent of its adjusted 2017 sub-ACL, and has only 1.2 mt left for the remainder of the fishing year. Federal regulations at 50 CFR 648.82(n)(2)(ii) require the Regional Administrator to close a common pool Trimester TAC Area for a stock when 90 percent of the Trimester TAC is projected to be caught. The closure applies to all common pool vessels fishing with gear capable of catching that stock for the remainder of the trimester.

As a result, effective October 11, 2017, the GB Cod Trimester TAC Area is closed for the remainder of Trimester 2, through December 31, 2017, to all common pool vessels fishing on a Northeast multispecies trip with trawl gear, sink gillnet gear, and longline/hook gear, including handgear vessels. The GB Cod Trimester TAC Area consists of statistical areas 521, 522, 525, and 561. The area reopens at the beginning of Trimester 3, on January 1, 2018.

Data indicate that common pool vessels have caught a significant portion of the total catch from outside the statistical areas that will be affected by the closure described above. The Regional Administrator is authorized under 50 CFR 648.86(o)(1) to adjust possession and trip limits for common pool vessels to prevent exceeding the pertinent common pool quotas during the fishing year. Given this, and because the common pool has caught more than 80 percent of its annual quota, the possession of GB cod by all common pool vessels is prohibited effective October 11, 2017, through April 30, 2018. This action is intended to prevent the common pool from further exceeding its Trimester 2 TAC or from exceeding its annual quota.

If a vessel declared its trip through the Vessel Monitoring System (VMS) or the interactive voice response system, and crossed the VMS demarcation line prior to October 11, 2017, it may complete its trip within the Trimester TAC Area. A vessel that has set gillnet gear prior to October 11, 2017, may complete its trip by hauling such gear.

Any overage of the Trimester 1 or 2 TACs must be deducted from the Trimester 3 TAC. If the common pool fishery exceeds its total quota for a stock in the 2017 fishing year, the overage must be deducted from the common pool's quota for that stock for fishing year 2018. Any uncaught portion of the Trimester 1 and Trimester 2 TACs is carried over into the next trimester. However, any uncaught portion of the common pool's total annual quota may not be carried over into the following fishing year.

Weekly quota monitoring reports for the common pool fishery are on our Web site at: http://www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information and, if necessary, we will make additional adjustments to common pool management measures.

The NMFS Assistant Administrator has determined that this temporary rule is consistent with the Northeast Multispecies Fishery Management Plan, other provisions of the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law.

This action is exempt from the procedures of Executive Order 12866 because this action contains no implementing regulations.

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.

There are several reasons that notice and comment are impracticable, unnecessary, and contrary to the public interest. First, the proposed and final rules for Framework 56 explained the possibility of minor adjustments and corrections because final allocations are not always available at the time of the rulemaking for the upcoming fishing year. These adjustments are routine and formulaic, required by regulation, and anticipated by industry. No comments were received on the potential for these adjustments, which provide an accurate accounting of the common pool's allocation.

The regulations require the Regional Administrator to close a trimester TAC area to the common pool fishery when 90 percent of the Trimester TAC for a stock has been caught. Updated catch information only recently became available indicating that the common pool fishery is projected to have caught 123 percent of its Trimester 2 TAC for GB cod as of October 3, 2017. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, would prevent the immediate closure of the GB Cod Trimester TAC Area and prohibition of GB cod possession. Not closing the area immediately and prohibiting GB cod possession increases the likelihood that the common pool fishery will further exceed its trimester TAC, or exceed its annual quota, to the detriment of this stock, which could undermine management objectives of the Northeast Multispecies Fishery Management Plan. Additional overages would negatively affect the common pool fishery as a result of future overage paybacks or premature closures of the fishery.

Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.110. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102, and the initial 2017 allocations were published on December 22, 2016 (81 FR 93842).

The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan, as published in the Federal Register on December 17, 1993 (58 FR 65936), provided a mechanism for transferring summer flounder commercial quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the NMFS Greater Atlantic Regional Administrator, can transfer or combine summer flounder commercial quota under § 648.102(c)(2). The Regional Administrator is required to consider the criteria in § 648.102(c)(2)(i)(A) through (C) in the evaluation of requests for quota transfers or combinations.

North Carolina is transferring 3,000 lb (1,361 kg) of summer flounder commercial quota to New York. This transfer was requested to repay landings by a North Carolina-permitted vessel that landed in New York under a safe harbor agreement.

The revised summer flounder quotas for calendar year 2017 are now: North Carolina, 1,536,693 lb (697,032 kg); and New York, 435,764 lb (197,659 kg); based on the initial quotas published in the 2017 Summer Flounder, Scup, and Black Sea Bass Specifications and subsequent transfers.

This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.