Federal Register Vol. 82, No.54,

Airworthiness Directive (AD) 2016-25-25, Amendment 39-18751 (82 FR 7, January 3, 2017) (“AD 2016-25-25”), currently requires repetitive detailed inspections for cracks, corrosion, and other defects of the rear face of the wing rear spar, and repair if necessary, for all BAE Systems (Operations) Limited Model 4101 airplanes.

As published, the Product Identification line of the regulatory text contains an error. The Product Identification line incorrectly identifies Bombardier as the product manufacturer, but should have identified BAE Systems (Operations) Limited. All other references to the product manufacturer appear correctly as BAE Systems (Operations) Limited throughout the preamble and regulatory text of AD 2016-25-25.

No other part of the preamble or regulatory information has been changed; therefore, only the changed portion of the final rule is being published in the Federal Register.

The effective date of this AD remains February 7, 2017.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Fokker Services B.V. Model F28 Mark 0100 airplanes equipped with Rolls-Royce TAY 650-15 engines. The NPRM published in the Federal Register on November 1, 2016 (81 FR 75759) (“the NPRM”). The NPRM was prompted by reports of uncontained engine fan blade failures in Rolls-Royce TAY 650-15 engines. The fan blade failures occurred due to cracking of the fan blades, which was initiated under conditions of fan blade flutter during engine ground operation. The NPRM proposed to require installation of a caution placard in the flight compartment. We are issuing this AD to prevent certain engine thrust settings during ground operation, which can cause the fan blades to flutter and fail, resulting in damage to the airplane and possible injury to personnel.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive Airworthiness Directive 2013-0141, dated July 12, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for Fokker Services B.V. Model F28 Mark 0100 airplanes equipped with Rolls-Royce TAY 650-15 engines. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9302.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We reviewed Fokker Service Bulletin SBF100-11-027, dated April 18, 2013. This service information describes procedures for the installation of a caution placard. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

On November 3, 2016, the Department of Transportation published a final rule in the Federal Register (81 FR 76800), titled “Enhancing Airline Passenger Protections III” (RIN 2105-AE11). This rule, among other things, expands the pool of carriers that must report airline service and performance data from any carrier that accounts for at least 1% of domestic scheduled passenger revenue to any carrier that accounts for at least 0.5% of domestic scheduled passenger revenue. It also requires reporting carriers to separately report airline service and performance data for their domestic scheduled flights operated by their code-share partners. This means that, under the November 2016 final rule, for air transportation taking place on or after January 1, 2018, airlines that account for at least 0.5% of domestic scheduled passenger revenue must provide airline service and performance data for flights they operate and separately for flights held out with their designator code and operated by their code-share partners. The airline service and performance data that is required consists of on-time performance, mishandled baggage and oversales data.

On March 2, 2017, the Department issued a rule extending the compliance date of its final rule on reporting of data for mishandled baggage and wheelchairs in aircraft cargo compartments to January 1, 2019. That final rule addressed the methodology for collection of mishandled baggage information and required separate statistics for mishandled wheelchairs and scooters used by passengers with disabilities. The change to the matrix on how to report mishandled baggage and to provide separate reporting of mishandled wheelchairs and scooters was incorporated into the Department's Enhancing Airline Passenger Protections III final rule. As such, this document is extending the compliance date to January 1, 2019 for the provision concerning baggage handling statistics in the Department's final rule on enhancing airline passenger protections. The compliance date for the requirements pertaining to on-time performance and oversales remain unchanged.

As is the case today, until January 1, 2019, airlines that account for at least 1% of domestic scheduled passenger revenue will continue to provide mishandled baggage data only for flights they operate based on the number of Mishandled Baggage Reports and the number of domestic passenger enplanement. Airlines that account for at least 0.5% but less than 1% of the domestic scheduled passenger revenue are not required to provide mishandled baggage data until February 15, 2019 for air transportation taking place on or after January 1, 2019. Separate statistics for mishandled wheelchairs and scooters used by passengers with disabilities and transported in aircraft cargo compartment are not required until January 1, 2019.

Accordingly, the Department of Transportation amends 14 CFR part 234 as follows:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS PORTLAND (LPD 27) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2(i)(i), Rule 27(a)(i) and (b)(i), pertaining to the placement of all-round task lights in a vertical line; Annex I, paragraph 3(a), pertaining to the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 2(k) as described in Rule 30(a)(i), pertaining to the vertical separation between anchor lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

The New Jersey Transit, who owns and operates the NJ Transit Railroad Bridge across the Shark River, mile 0.9, at Avon, NJ, has requested a temporary deviation from the current operating regulation set out in 33 CFR 117.751, to facilitate replacement of the drive motor on the vertical span of the bridge.

Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 10 p.m., March 24, 2017, to 6 a.m., March 25, 2017. The drawbridge is a single span which has a vertical clearance in the closed-to-navigation position of 9 feet above mean high water.

The NJ Transit Railroad Bridge is used by recreational vessels, tug and barge traffic, fishing vessels, and small commercial vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge span will not be able to open in case of an emergency and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

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

On December 22, 2016 (81 FR 93872), the EPA proposed a limited FIP for the North Coast Unified AQMD in California, which would apply the EPA's PSD regulatory program under 40 CFR 52.21 specifically to sources in the District subject to PSD review for emissions of PM2.5 or PM2.5 precursors. CAA section 110(c)(1) requires the EPA Administrator to promulgate a FIP at any time within two years after the Administrator either finds that a state has failed to make a required SIP submission or disapproves a state's SIP in whole or in part, unless the state submits and the EPA approves a SIP that corrects the deficiency before the Administrator promulgates the FIP. In this case, as discussed in the EPA's proposal for this limited FIP action, the EPA is required to promulgate this FIP for sources subject to PSD review for emissions of PM2.5 or PM2.5 precursors in the North Coast Unified AQMD in order to address SIP deficiencies relating to the PSD requirements for such sources that EPA identified in earlier actions; California has not submitted revised rules that resolve these deficiencies and thus we have not approved a SIP submittal for the North Coast Unified AQMD to correct these deficiencies.

The requirement that the EPA promulgate this limited FIP for the North Coast Unified AQMD stems from several actions taken previously by the EPA in accordance with CAA requirements. In 2008, the EPA promulgated a rulemaking finalizing regulations to implement the New Source Review program for PM2.5 (PM2.5 NSR Rule).1 The PM2.5 NSR Rule required, among other things, that states develop SIPs addressing the PSD permitting requirements for the regulation of major stationary sources and major modifications of PM2.5 emissions, including such sources emitting precursors of PM2.5. In 2010, the EPA promulgated a rulemaking amending the PSD program regulations for PM2.5 to add provisions governing the maximum allowable increases in ambient pollutant concentrations (increments), with which new major stationary sources and major modifications of PM2.5 or PM2.5 precursor emissions must demonstrate compliance as a condition of obtaining a PSD permit (PM2.5 Increments Rule).2 The PM2.5 Increments Rule requires states to submit SIPs modifying their PSD permitting regulations to incorporate the PM2.5 increment provisions.

On January 15, 2013, the EPA issued a finding of failure to submit for the State of California in which it found that California had failed to make an infrastructure 3 SIP submittal providing certain required basic program elements of CAA section 110(a)(2) that are necessary to implement the 2008 Ozone National Ambient Air Quality Standard (NAAQS).4 Relevant here, the EPA found that California had not submitted a SIP to address the PSD permitting requirements of CAA section 110(a)(2)(C), (D)(i)(II), and (J) for areas including the North Coast Unified AQMD. That finding resulted in a deadline of February 14, 2015, for the EPA to promulgate a FIP pursuant to CAA section 110(c)(1) to address the outstanding SIP elements unless, prior to that time, the State submitted, and the EPA approved, a SIP that corrected the identified deficiencies.5

On April 1, 2016, the EPA published a final rule partially approving and partially disapproving several CAA infrastructure SIP revisions submitted by the State of California related to the implementation, maintenance and enforcement of the NAAQS for ozone, PM2.5, lead, nitrogen dioxide (NO2), and sulfur dioxide (SO2).6 We partially disapproved a portion of these infrastructure SIP submittals as they pertained to the North Coast Unified AQMD with respect to the PSD-related requirements of CAA sections 110(a)(2)(C), (D)(i)(II), and (J) for all of these NAAQS, in part because we found that the District's SIP-approved PSD program did not include requirements for the regulation of PM2.5 and PM2.5 precursors, condensable PM2.5, or PSD increments for PM2.5.7 This infrastructure SIP partial disapproval action also triggered a duty for the EPA to promulgate a FIP pursuant to CAA section 110(c)(1) to address the identified deficiencies related to the District's PSD program for PM2.5, unless, prior to that time, the State submitted, and the EPA approved, a SIP that corrected the identified deficiencies.8 The State has not submitted a SIP revision that would correct the North Coast Unified AQMD's SIP deficiencies relating to the PSD program for PM2.5 and therefore EPA has not approved such a SIP revision. Thus, for these PM2.5 PSD requirements, the EPA remains subject to the duty to promulgate a FIP for the District that was triggered by our January 15, 2013 finding of failure to submit and our April 1, 2016 partial disapproval action for the infrastructure SIP requirements for the NAAQS discussed above.

On September 2, 2014, the EPA published a final rule finding that the North Coast Unified AQMD had failed to make a complete submittal to address new requirements for PM2.5 increments in its PSD program as required by implementing regulations that the EPA promulgated on October 20, 2010.9 That finding resulted in a duty and a deadline of October 2, 2016 for the EPA to promulgate a FIP pursuant to CAA section 110(c)(1) to address these outstanding SIP elements unless, prior to that time, the State submitted, and the EPA approved, a SIP that corrected the identified deficiencies. As noted above, the EPA has not approved a SIP revision for California that would address the requirements for PM2.5 increments in the PSD program for the North Coast Unified AQMD, thus the EPA remains subject to the requirement that it promulgate a FIP to do so.

In sum, the EPA has not approved a PSD SIP revision for California that would address the District's PM2.5 PSD program SIP deficiencies identified in the January 15, 2013, September 2, 2014, and April 1, 2016 EPA actions discussed above. Accordingly, as authorized by CAA section 110(c)(1), the EPA proposed to promulgate a limited FIP for the North Coast Unified AQMD in order to address the identified deficiencies in the State's PSD program with respect to the regulation of major stationary sources and major modifications of sources subject to PSD review for emissions of PM2.5 or PM2.5 precursors.

The EPA's proposed FIP action provided a 30-day public comment period, which closed on January 23, 2017. The EPA also preliminarily scheduled a public hearing for January 13, 2017 to receive written and oral comments on our proposed action, which we stated would be held only if we received a written request for such a hearing by December 29, 2016. No one requested such a hearing during this period and therefore the hearing was canceled. During the public comment period, we received no comments on our proposed action.

Under CAA section 110(c)(1) and for the reasons discussed in our December 22, 2016 proposed rule and in the Proposed Action section of this notice, we are finalizing the limited PSD FIP for the North Coast Unified AQMD as proposed. CAA section 110(c)(1) requires the Administrator to promulgate a FIP at any time within two years after the Administrator either finds that a state has failed to make a required submission or disapproves a state's SIP in whole or in part, unless the state submits and the EPA approves a SIP that corrects the deficiency before the Administrator promulgates a FIP. As indicated earlier in this notice, the EPA has not approved a PSD SIP revision for California to regulate PM2.5 and PM2.5 precursors in the North Coast Unified AQMD that would address the District's PM2.5 PSD program deficiencies identified in the January 15, 2013, September 2, 2014, and April 1, 2016 EPA actions discussed above. Accordingly, as authorized by CAA section 110(c)(1), the EPA is promulgating a limited FIP for the North Coast Unified AQMD in order to address the identified deficiencies in the State's PSD program with respect to the regulation of major stationary sources and major modifications of sources subject to PSD review for emissions of PM2.5 or PM2.5 precursors.

This limited FIP consists of the EPA regulations found in 40 CFR 52.21, including the PSD applicability provisions, with a limitation to assure that, strictly for purposes of this rulemaking, the FIP applies only to the regulation of PM2.5 and PM2.5 precursors. Accordingly, for the purposes of ensuring compliance with the PSD permitting requirements with respect to PM2.5 and PM2.5 precursors for sources within the North Coast Unified AQMD, the EPA will serve as the PSD permitting authority.

The EPA has previously promulgated limited CAA PSD FIPs for the North Coast Unified AQMD to implement the federal PSD permitting program under 40 CFR 52.21 for certain other sources and pollutants, including the PSD program as it regulates oxides of nitrogen (NOX) as an ozone precursor, as discussed above; these limited FIPs remain in effect. See 40 CFR 52.270(b)(2). The EPA and the District have entered into partial delegation agreements pursuant to 40 CFR 52.21(u), dated January 8, 1993 and October 6, 2015, whereby the EPA has delegated authority to the District to conduct PSD review for certain sources subject to these limited PSD FIPs. The District may similarly seek a partial delegation of authority from the EPA, pursuant to 40 CFR 52.21(u), to conduct PSD review for the sources regulated under this limited PSD FIP. For all other major emitting facilities and pollutants not covered by the limited PSD FIPs applicable to the District as specified in 40 CFR 52.270(b)(2), the North Coast Unified AQMD will continue to serve as the PSD permitting authority under its SIP-approved PSD program.

This limited FIP is narrow in scope, in that it will only address the PM2.5 PSD deficiencies for the District that were identified in our 2016 infrastructure SIP partial disapproval action. We note that such deficiencies include the deficiencies for PSD requirements for PM2.5 increments that were also the focus of the EPA's September 2, 2014 finding of failure to submit action. Today's final limited FIP action will satisfy the remaining FIP requirements for the North Coast Unified AQMD that were triggered by our January 15, 2013 finding of failure to submit relating to ozone infrastructure SIP requirements; our September 2, 2014 finding of failure to submit related to the District's PSD requirements for PM2.5 increments; and our April 1, 2016 partial disapproval action for the infrastructure SIP requirements for the NAAQS for ozone, PM2.5, lead, NO2, and SO2. This limited FIP will be codified in 40 CFR 52.270(b)(2)(v).

This limited FIP will remain in place until California submits a SIP revision addressing the identified deficiencies relating to the District's PSD program for PM2.5 and we approve that SIP revision. The EPA is working with the North Coast Unified AQMD to develop District rules that would address these requirements.

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

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

This action does not impose any new information collection burden. The OMB has previously approved the information collection requirements contained in the existing regulations for PSD (e.g., 40 CFR 52.21) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0003. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are a single biomass generating facility, which is currently not operating. The Agency has determined that this single facility may experience an impact associated with the requirements of this action, but only in the event that the facility elects to significantly expand its operations. The EPA is not aware of any specific new sources that would be subject to regulation under this action in the future. We expect a negligible financial impact on any facilities subject to the requirements of this action because any such facility would be subject to substantially similar, and in some respects more stringent, regulatory requirements that are already in effect under state and federal law.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. While the EPA's action will lead to the application of federal PSD regulations for PM2.5 to sources within the North Coast Unified AQMD, general PSD requirements for major emitting facilities with emissions of other regulated NSR pollutants already apply within the District, and thus the incremental impact associated with application of the specific requirements of the PSD regulations for certain sources emitting PM2.5 or its precursors is expected to be relatively minor. In addition, there are few major emitting facilities currently located in the District that would be subject to the requirements of the FIP. The EPA is not aware of any specific new sources that would be subject to regulation under our narrow FIP in the future. Accordingly, the EPA has determined that this action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and that it will not significantly or uniquely affect small governments.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, 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 FIP is not applicable on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because, as a limited FIP establishing PSD regulatory requirements for the PM2.5 NAAQS for certain sources located in the North Coast Unified AQMD, it implements a previously promulgated federal standard.

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

This rulemaking does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment. With this action, the EPA is only implementing the PSD permitting requirements mandated by the CAA in order to ensure compliance with the PM2.5 NAAQS and PM2.5 increments, which were promulgated in separate, prior rulemaking actions.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 22, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section CAA 307(b)(2)).

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

I. Background

On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR 50.15, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm. Ambient air quality monitoring data for the 3-year period must meet a data completeness requirement. The ambient air quality monitoring data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90 percent, and no single year has less than 75 percent data completeness as determined in appendix I of part 50.

Upon promulgation of a new or revised NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS based on the three most recent years of ambient air quality data at the conclusion of the designation process. The Atlanta Area was designated nonattainment for the 2008 8-hour ozone NAAQS on April 30, 2012 (effective July 20, 2012) using 2009-2011 ambient air quality data. See 77 FR 30088 (May 21, 2012). At the time of designation, the Atlanta Area was classified as a marginal nonattainment area. On March 6, 2015, EPA issued a final rule entitled, “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule), which establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2008 8-hour ozone NAAQS.1 See 80 FR 12264. Areas that were designated as marginal ozone nonattainment areas were required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2015, based on 2012-2014 monitoring data. See 40 CFR 51.1103. The Atlanta Area did not attain the 2008 8-hour ozone NAAQS by July 20, 2015, and therefore on April 11, 2016, the EPA Administrator signed a final rule reclassifying the Atlanta Area from a marginal nonattainment area to a moderate nonattainment area for the 2008 8-hour ozone standard. See 81 FR 26697 (May 4, 2016). Moderate areas are required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2018, six years after the effective date of the initial nonattainment designations.2 See 40 CFR 51.1103.

Based on the initial nonattainment designation for the 2008 8-hour ozone standard, Georgia was required to develop a SIP revision addressing certain CAA requirements for the Atlanta Area. On February 6, 2015, Georgia submitted a SIP revision addressing the emissions inventory, emissions statements, and NNSR requirements related to the 2008 8-hour ozone NAAQS for the Atlanta Area.3 On August 11, 2015, EPA approved Georgia's SIP revision as meeting the requirements of sections 110, 182(a)(1), and 182(a)(3)(B) of the CAA by addressing the emissions inventory and emissions statements requirements for the 2008 8-hour ozone NAAQS for the Atlanta Area. See 80 FR 48036. EPA is now taking action on the NNSR portion of Georgia's February 6, 2015, SIP revision. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS is provided below.

The minimum SIP requirements for NNSR permitting programs for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.165. See 40 CFR 51.1114. These NNSR program requirements include those promulgated in the “Phase 2 Rule” implementing the 1997 8-hour ozone NAAQS (75 FR 71018 (November 29, 2005)) and the SIP Requirements Rule implementing the 2008 8-hour ozone NAAQS. Under the Phase 2 Rule, the SIP for each ozone nonattainment area must contain NNSR provisions that: Set major source thresholds for NOX and VOC pursuant to 40 CFR 51.165(a)(1)(iv)(A)(1)(i)-(iv) and (2); classify physical changes as a major source if the change would constitute a major source by itself pursuant to 40 CFR 51.165(a)(1)(iv)(A)(3); consider any significant net emissions increase of NOX as a significant net emissions increase for ozone pursuant to 40 CFR 51.165(a)(1)(v)(E); consider certain increases of VOC emissions in extreme ozone nonattainment areas as a significant net emissions increase and a major modification for ozone pursuant to 40 CFR 51.165(a)(1)(v)(F); set significant emissions rates for VOC and NOX as ozone precursors pursuant to 40 CFR 51.165(a)(1)(x)(A)-(C) and (E); contain provisions for emissions reductions credits pursuant to 40 CFR 51.165(a)(3)(ii)(C)(1)-(2); provide that the requirements applicable to VOC also apply to NOX pursuant to 40 CFR 51.165(a)(8); and set offset ratios for VOC and NOX pursuant to 40 CFR 51.165(a)(9)(i)-(iii) (renumbered as (a)(9)(ii)-(iv) under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS). Under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS, the SIP for each ozone nonattainment area designated nonattainment for the 2008 8-hour ozone NAAQS and designated nonattainment for the 1997 ozone NAAQS on April 6, 2015, must also contain NNSR provisions that include the anti-backsliding requirements at 40 CFR 51.1105. See 40 CFR 51.165(a)(12).

Georgia's longstanding SIP-approved NNSR program, established in Air Quality Control Rule 391-3-1-.03(8)—Permit Requirements, applies to the construction and modification of major stationary sources in nonattainment areas. In its February 6, 2015 SIP revision, Georgia certifies that the version of Air Quality Control Rule 391-3-1-.03(8) in the SIP exceeds the federal NNSR requirements for the Atlanta Area. EPA last approved revisions to the SIP-approved version of Georgia's NNSR rule in 2010 addressing, among other things, the NNSR requirements in the Phase 2 Rule that were relevant to the counties designated as nonattainment for the 1997 8-hour ozone NAAQS in and around the Atlanta metropolitan area (1997 Atlanta Area) and that were not already satisfied by the SIP-approved rule.4 See 75 FR 71020 (November 22, 2010). Georgia's rule revision did not include Phase 2 Rule requirements for 8-hour ozone nonattainment areas classified as serious or above because the 1997 Atlanta Area was classified as a moderate nonattainment area.

The version of Rule 391-3-1-.03(8) that is contained in the current SIP has not changed since the 2010 rulemaking.5 This version of the rule covers the entire Atlanta Area and remains adequate to meet all applicable NNSR requirements for the 2008 8-hour ozone NAAQS. The Phase 2 requirements for 8-hour ozone nonattainment areas classified as serious or above remain inapplicable because the Atlanta Area is classified as a moderate nonattainment area for the 2008 8-hour NAAQS and the anti-backsliding requirements added in the 2008 8-hour ozone implementation rule are inapplicable because the Atlanta Area was redesignated to attainment for the 1997 8-hour ozone NAAQS in 2013.

EPA is approving the portion of Georgia's February 6, 2015, SIP revision addressing the NNSR requirements for the 2008 8-hour ozone NAAQS for the Atlanta Area. EPA has concluded that the State's submission fulfills the 40 CFR 51.1114 revision requirement and meets the requirements of CAA section 110 and the minimum SIP requirements of 40 CFR 51.165.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the NNSR portion of the SIP revision should adverse comments be filed. This rule will be effective May 22, 2017 without further notice unless the Agency receives adverse comments by April 21, 2017.

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All adverse comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on May 22, 2017 and no further action will be taken on the proposed rule.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 22, 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 today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0337 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 May 22, 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-2016-0337, by one of the following methods.

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

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

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

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

In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10949) filed by Clariant Corporation, 4000 Monroe Road, Charlotte, NC 28205. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of fatty acids, montan-wax, ethoxylated (CAS No. 68476-04-0). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 2- fatty acids, montan-wax, ethoxylated conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

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

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

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

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

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

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

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6).

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

8. The polymer's number average MW of 1,800 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000,

Thus, fatty acids, montan-wax, ethoxylated meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to fatty acids, montan-wax, ethoxylated.

For the purposes of assessing potential exposure under this exemption, EPA considered that fatty acids, montan-wax, ethoxylated could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational, non-dietary exposure was possible. The number average MW of fatty acids, montan-wax, ethoxylated is 20,500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since fatty acids, montan-wax, ethoxylated conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of fatty acids, montan-wax, ethoxylated, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of fatty acids, montan-wax, ethoxylated.

There are no existing exemptions from a tolerance for fatty acids, montan-wax, ethoxylated.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 fatty acids, montan-wax, ethoxylated.

Accordingly, EPA finds that exempting residues of fatty acids, montan-wax, ethoxylated from the requirement of a tolerance will be safe.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0378 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 May 22, 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-2016-0378, 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 August 29, 2016 (81 FR 59165) (FRL-9950-22), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10851) by the Technology Sciences Group, 1150 18th Street NW., Suite 1000, Washington, DC 20036, on behalf of the Jeneil Biosurfactant Company, 400 N. Dekora Woods Blvd., Saukville, WI 53080. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of isoamyl acetate (CAS Reg. No.123-92-2) when used as an inert ingredient (buffering agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That document referenced a summary of the petition prepared by the Technology Sciences Group on behalf of the Jeneil Biosurfactant Company the petitioner, which is available in the docket, http://www.regulations.gov. One comment was received and posted to this docket. The comment did not pertain to isoamyl acetate but to a totally unrelated compound.

This regulation eliminates the need to establish a maximum permissible level for residues of isoamyl acetate when applied in accordance with the conditions under 40 CFR 180.910.

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

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

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

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

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

Isoamyl acetate exhibits low levels of acute toxicity with oral lethal dose (LD)50s for rats and rabbits being 16.6 grams/kilogram (g/kg) and 7.4 g/kg respectively. The dermal LD50 for rabbits is >5g/kg. It is not irritating to rabbit skin.

The National Toxicology Program reported dogs exposed to 5,000 parts per million (ppm) isoamyl acetate via inhalation for one hour showed drowsiness and nasal irritation. Cats exposed to 4,000 ppm isoamyl acetate for 20 minutes experienced eye and nose irritation.

The potential for eye irritation in rabbits was evaluated with a mixture of n-pentyl acetate and 2-methylbutyl acetate, two structural isomers of isoamyl acetate. Moderate conjunctival irritation, with no effects to the cornea or iris, resulted from ocular exposure and minor, transient conjunctival irritation was also observed. Conjunctival effects cleared up in 7 days.

There are no repeat-dose toxicity studies with isoamyl acetate. However, there are studies available regarding isoamyl alcohol. Isoamyl acetate readily metabolizes to isoamyl alcohol and toxicity data on isoamyl alcohol may be used as a surrogate for isoamyl acetate.

In a 4-week range-finding drinking water study, SPF-Wistar rats received isoamyl alcohol doses of 360 milligrams/kilogram/day (mg/kg/day) for two weeks and 1160 mg/kg/day for the next two weeks (20,000 and 16,000 ppm respectively). The higher concentration was unpalatable to the rats. Exposure to isoamyl alcohol did not affect body weight gain or food consumption and no effects were observed upon gross post-mortem examination. The NOAEL for this study is 1,160 mg/kg/day.

In a subsequent 90-day study, rats were given daily drinking water concentrations of 0, 1,000, 4,000 and 16,000 ppm isoamyl alcohol (males 0, 73, 295, 1,068 mg/kg/day and females 91, 385, 1,657 mg/kg/day, respectively). Treatment did not induce any effect on mortality, body weight, various clinical chemistry parameters, or organ weights or any abnormality at gross and microscopic examination. There were marginal increases in red blood cell counts in the male animals of the mid- and high-dose groups and slight decreases in mean corpuscular volume and mean corpuscular hemoglobin content in the male animals of the high-dose group. The highest dose levels tested were the no observed-adverse-effect levels (NOAEL) in the drinking water study in rats (1,068 and 1,657 mg/kg/day in males and females respectively.

In a 17-week oral gavage study, Ash/CSE rats were administered daily doses of 0, 150, 500 or 1,000 mg/kg/day isoamyl alcohol. Parameters and endpoints evaluated included clinical observations, body weight, food and water consumption, hematology, clinical chemistry, urinalysis, organ weights (brain, liver, heart, spleen, stomach, small intestine, caecum, adrenals, gonads, pituitary and thyroid) and macroscopic and microscopic evaluations. Two high-dose rats died from lung congestion which was attributed to gavage error. No deaths or abnormalities in behavior occurred during the study in any of the test groups. After 17 weeks treatment, there were slight decreases in body weight gain in the high-dose males. That was ascribed to 5-10% lower food consumption compared to controls. No other consistent test-related effects were seen in any of the test groups. The NOAEL under the conditions of this study was 1,000 mg/kg/day.

Isoamyl acetate was negative in bacteria cell and in vitro genotoxicity assays as well as one in vivo study. It did not induce reverse gene mutations in Salmonella typhimurium in the absence and presence of metabolic activation.

Prenatal toxicity to isoamyl alcohol was studied using Wistar rats and Himalayan rabbits exposed 6 hours/day on gestational days 6-15 and 7-19 respectively. Dose concentrations were 0, 500, 2,500 and 10,000 mg/m3 (0, 135, 675, 2,700 ppm). All rats and rabbits were sacrificed on days 20 and 29 respectively. In both species, maternal toxicity was manifested by slight retardation of body weight gain during the first days of the exposure period in animals of the high-dose group. The rabbits of this group had eye irritation (reddish, lid closure, or slight discharge) during exposure. There were no compound-related signs of embryo/fetotoxicity or teratogenicity in any of the treated rat groups. In rabbits, there was a statistically significant increase incidence of total fetal soft tissue variations mainly caused by a significant increase in the incidence of `separated origin of carotids'. However, the incidences of variations were within the range of biological variation and unexpectedly low in control animals. The NOAEL for maternal toxicity in both rats and rabbits was 2,500 mg/m3 (675 ppm; 1,013 mg/kg/day) and the NOAEL for developmental toxicity was 10,000 mg/m3 (2,700 ppm; 4,054 mg/kg/day).

An in vitro Hydra attenuata developmental toxicity assay was conducted with isoamyl acetate. It was equally toxic to adults and embryos indicating low concern for developmental toxicity.

The Joint FAO/WHO Expert Committee on Food Additives summarized a chronic study where male and female rats received 2% isoamyl alcohol in their drinking water. No adverse effects or tumors were observed up to 2,000 mg/kg/day in rats given isoamyl alcohol in their drinking water for 53-56 weeks.

A DEREK analysis conducted on the isoamyl acetate structure did not reveal any structural alerts for possible carcinogenicity with regard to systemic and organ toxicity or mutagenicity. Therefore, based on the results of the DEREK analysis, the lack of toxicity in the submitted studies, and the lack of mutagenicity, isoamyl acetate is not expected to be carcinogenic to humans.

Due to the lack of adverse effects in the available data, no toxicological endpoint of concern has been identified. Therefore, a quantitative assessment of human exposure and risk is not necessary and have not been conducted.

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

Under this exemption from the requirement of a tolerance, residues of isoamyl acetate may be found on foods from crops that were treated with pesticide formulations containing isoamyl acetate. However, a quantitative dietary exposure assessment was not conducted since an endpoint for risk assessment was not identified.

2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted, although exposures may be expected from use on food crops.

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

Isoamyl acetate may be used in pesticide products and non-pesticide products that may be used around the home. Based on the discussion in Unit IV.B., a quantitative residential exposure assessment for isoamyl acetate was not conducted.

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 isoamyl acetate to share a common mechanism of toxicity with any other substances, and isoamyl acetate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isoamyl acetate 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.

As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of isoamyl acetate, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.

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

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

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for isoamyl acetate (CAS Reg. No. 123-92-2) when used as an inert ingredient (buffering agent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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-2016-0299 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 May 22, 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-2016-0299, 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 August 29, 2016 (81 FR 59165) (FRL-9950-22), 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# 5E8432) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR part 180.560 be amended by establishing tolerances without U.S registrations for residues of the cloquintocet-mexyl for use as an inert ingredient (safener) in combination with the herbicide pyroxulam in or on the raw agricultural commodities teff, forage at 0.2 parts per million (ppm); teff, grain at 0.1 ppm; teff hay at 0.5 ppm; teff straw at 0.1ppm. That document referenced a summary of the petition prepared by Dow AgroSciences, LLC, the registrant, which is available in the docket EPA-HQ-OPP-2016-0299 at http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

Consistent with FFDCA section 408(b)(2)(D), 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 cloquintocet-mexyl in or on teff forage, grain, hay and straw, consistent with FFDCA section 408(b)(2).

In the Federal Register of August 2, 2016 (81 FR 50630) (FRL-9947-78), EPA established tolerances for residues of cloquintocet-mexyl and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) when used in pesticide formulations containing the active ingredient halauxifen-methyl, in or on barley grain, barley hay, barley straw, and wheat forage, wheat grain, wheat hay, and wheat straw. EPA is relying upon the risk assessments that supported the findings made in the August 2, 2016, Federal Register document in support of this action. The toxicity profile of cloquintocet-mexyl has not changed, and the previous risk assessments that supported the establishment of those tolerances remain valid.

The Agency evaluated the request to establish tolerances in or on teff forage, grain, hay, and straw. Teff is prepared like other whole grains, such as rice and barley, and may also be used to make flour in a manner similar to wheat and other cereal grains. In considering likely residue levels on teff, EPA concludes that because of the similarity in application rates for pesticides containing cloquintocet-mexyl between teff and wheat, the likely decline in residue levels as teff moves through commerce, and the similarities to the small grains in terms of morphology, taxonomy and cultural practices, residue levels of cloquintocet-mexyl on teff will be similar to residue levels on wheat. The lack of teff consumption data being reported in the available food consumption data indicates a very low overall consumption of teff in the United States. When teff is consumed in the U.S., it is typically consumed in place of wheat. Using these assumptions regarding likely residue levels and consumption, EPA concludes that aggregate exposure and risk estimates resulting from cloquintocet-mexyl residues in/on teff would not be substantially different than those presented in the most recent human health risk assessment and published in the August 2, 2016 final rule. As those risk estimates were not of concern to the Agency, 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 cloquintocet-mexyl residues.

For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the August 2, 2016, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0843. Further information about EPA's determination that an updated risk assessment was not necessary may be found in the document, “Cloquintocet-mexyl—Human Health Risk Assessment of Tolerances without a U.S. Registration for Use on Teff” in docket ID number EPA-HQ-OPP-2016-0299.

For specific information on the studies received and the nature of the adverse effects caused by cloquintocet-mexyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies, the reader is referred to the final rule published in the Federal Register of December 16, 2005 (70 FR 74679) (FRL-7753-4); Docket ID number EPA-HQ-OPP-2005-0234.

Adequate enforcement methodology, high performance liquid chromatography with ultraviolet detection (HPLC-UV); method REM 138.01for the cloquintocet-mexyl (parent) and the HPLC-UV Method RED 138.10 for its acid metabolite, are available to enforce the tolerance expression.

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

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

The Codex has not established a MRL for cloquintocet-mexyl.

Therefore, tolerances are established for combined residues of cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), expressed as cloquintocet-mexyl, for use as an inert ingredient (safener) in combination with the herbicide pyroxsulam in or on teff, forage at 0.2 ppm; teff, grain at 0.1 ppm; teff, hay at 0.5 ppm; and teff, straw at 0.1 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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-2014-0357 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 May 22, 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-2014-0357, by one of the following methods:

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

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

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

In the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 4F8258 and 4F8320) by E.I. du Pont de Nemours & Company, 1007 Market St., Wilmington, DE 19898 and Syngenta Crop Protection LLC, P.O. Box 18300, Greensboro, NC 27419, respectively. The petitions requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide cyantraniliprole, in or on artichokes, globe (import tolerance) at 0.1 parts per million (ppm); berries, low growing, except strawberries (crop subgroup 13-07H) (import tolerance) at 0.08 ppm; coffee, bean, green (import tolerance) at 0.05 ppm; grapes (import tolerance) at 1.5 ppm; olives (import tolerance) at 1.5 ppm; peanuts at 0.01 ppm; peanut hay at 3 ppm; pomegranates (import tolerance) at 0.01 ppm; rice, grain (import tolerance) at 0.03 ppm; soybeans, seed at 0.4 ppm; strawberries at 1.0 ppm; vegetables, foliage of legume (crop group 7) at 50 ppm; vegetables, leaves of root and tuber (crop group 2) at 40 ppm; vegetables, legume, dried shelled, except soybean (crop subgroup 6C) at 0.9 ppm; vegetables, legume, edible podded (crop subgroup 6A) at 2 ppm; vegetables, legume, succulent shelled (crop subgroup 6B) at 0.2 ppm; vegetables, root, except sugar beet (crop subgroup 1B) at 0.4 ppm; and tea, dried (import tolerance) at 30 ppm (PP 4F8258) and corn, field and pop, forage at 0.04 ppm; corn, field and pop, grain at 0.01 ppm; corn, field and pop, stover at 0.015 ppm; corn, sweet, forage at 0.02 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and corn, sweet, stover at 0.08 ppm (PP 4F8320). That document referenced a summary of the petitions prepared by E.I. du Pont de Nemours & Company and Syngenta Crop Protection LLC, the registrants, which is available in the dockets EPA-HQ-OPP-2014-0357 and EPA-HQ-OPP-2014-0890, respectively, at http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

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

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

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

In general, cyantraniliprole administration in mammals produces both adverse and adaptive changes in the liver, thyroid gland, and adrenal cortex. With repeated dosing, consistent findings of mild to moderate increases in liver weights across multiple species (rats, mice, and dogs) are observed. Dogs appear to be more sensitive than rats and mice; cyantraniliprole produces adverse liver effects (increases in alkaline phosphatase, decreases in cholesterol, and decreases in albumin) in dogs at lower dose levels than in rats. In addition, the liver effects in the dog show progressive severity with increased duration of exposure. The available data also show thyroid hormone homeostasis is altered in rats following exposure to cyantraniliprole after 90 days due to enhanced metabolism of the thyroid hormones by the liver. However, cyantraniliprole does not act directly on the thyroid; the thyroid effects observed are secondary to the effects on the liver.

Cyantraniliprole is classified as “Not Likely to be Carcinogenic to Humans” based on the absence of increased tumor incidence in carcinogenicity studies in rats and mice. In addition, there are no genotoxicity, mutagenicity, neurotoxicity, or immunotoxicity concerns. There are also no developmental or reproductive toxicity concerns and there is no evidence of an adverse effect attributable to a single dose.

Specific information on the studies received and the nature of the adverse effects caused by cyantraniliprole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Cyantraniliprole. Human Health Risk Assessment for the Proposed Uses on Root Vegetables (except Sugar Beet) (Crop Subgroup 1B), Leaves of Root and Tuber Vegetables (Crop Group 2), Legume Vegetables (Crop Group 6 except soybean), Leaves of Legume Vegetables (Crop Group 7 except soybean), Peanuts, Strawberries, Tobacco and Seed Treatment Uses on Corn (Field, Pop, Seed, Sweet). Tolerance Requests without U.S. Registration for Artichokes, Coffee Green Bean, Wine Grapes, Low Growing Berries (except Strawberries) (Crop Subgroup 13-07H), Olives, Pomegranate, and Tea Dried. Amended Tolerance Requests for Cucurbit Vegetables (Crop Group 9) due to New Use Pattern and Amended Uses for Tomatoes and Peppers” on page 40 in docket ID number EPA-HQ-OPP-2014-0357.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for cyantraniliprole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of February 5, 2014 (79 FR 6826) (FRL-9388-7).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyantraniliprole, EPA considered exposure under the petitioned-for tolerances as well as all existing cyantraniliprole tolerances in 40 CFR 180.672. EPA assessed dietary exposures from cyantraniliprole 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 cyantraniliprole; 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 2003-2008 United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, a refined chronic (food and drinking water) dietary assessment was conducted assuming average field trial residues for all proposed crops (except sugar beet root), percent crop treated (PCT) where available, and percent crop treated for new uses (PCTn) for some crops. In addition, the estimated percentage of imported grapes was incorporated into the assessment. For processed commodities, input values included combined average residues of parent and the metabolite (IN-J9Z38) with relevant processing factors. The chronic assessment incorporated empirical processing factors, if available, or Dietary Exposure Evaluation Model (DEEM) Version 7.81 default processing factors as appropriate. Empirical processing factors were used for potato flakes and chips, tomatoes (paste, puree, dried, and juice), orange juice, apple juice, cottonseed oil, citrus oil, and dried plums. The processing factors for these commodities were set at 1 because the residue input values included combined residues of the parent and the metabolite with relevant processing factors. Crop field trial data depicting residues in/on citrus fruit peels (lemon and orange) were available and included into the assessment.

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

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

The Agency estimated the PCT for existing uses as follows:

Citrus: Oranges 62%, grapefruit 87%, and lemons 46%; pome fruit: Apples 61% and pears 76%; stone fruits: Apricots 53%, cherries 48%, peaches 41%, and plums/prunes 59%; tree nuts: Almonds 72%, hazelnuts 65%, pecans 22%, pistachios 49%, and walnuts 53%; bushberries (subgroup 13-07B): Blueberries 45%; fruiting vegetables: Peppers 45% and tomatoes 54%; cucurbits: Cantaloupes 50%, cucumbers 23%, pumpkins 18%, squash 24%, and watermelons 29%; leafy vegetables: Celery 70%, lettuce 78%, and spinach 53%; Brassica (cole) leafy vegetables: Broccoli 81%, cabbage 50%, and cauliflower 83%; onion 58%; potato 50%; oilseeds: Canola 15% and sunflower 35%; and corn 56%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency estimated the PCT for new uses as follows:

Cotton 41%; peanuts 41%; carrots 23%; soybeans 21%; strawberries 59%; vegetable crop group 7: Dry beans/peas 6%, soybeans 21%, beans (snap, bush, etc.) 49%, and peas fresh/green/sweet) 38%; vegetable crop group 2: Sugar beets 40%; vegetable crop group 6A: Soybeans 21%, beans (snap, bush, etc., string) 49%; peas fresh/green/sweet) 38%; vegetable crop group 6C: Dried bean and peas 6%. For the imported grapes (wine grapes) a 50% import estimate was used in the chronic dietary risk assessment.

EPA estimates of the PCTn of cyantraniliprole represent the upper bound of use expected during the pesticide's initial five years of registration; that is, PCTn for cyantraniliprole is a threshold of use that EPA is reasonably certain will not be exceeded for each registered use site. The PCTn recommended for use in the chronic dietary assessment is calculated as the average PCT of the market leader or leaders (i.e., the currently registered pesticide(s) with the greatest PCT) on that site over the three most recent years of available data. Comparisons are only made among pesticides of the same pesticide type (e.g., the market leader for insecticides on the use site is selected for comparison with a new insecticide). The market leader included in the estimation may not be the same for each year since different pesticides may dominate at different times.

Typically, EPA uses USDA/NASS as the source of data because it is publicly available and directly reports values for PCT. When a specific use site is not reported by USDA/NASS, EPA uses market survey data and calculates the PCT given reported data on acres treated and acres grown. If no data are available, EPA may extrapolate PCTn from other crops, if the production area and pest spectrum are substantially similar.

A retrospective analysis to validate this approach shows few cases where the PCT for the overall market leaders were exceeded. Further review of these cases identified factors contributing to the exceptionally high use of a new pesticide. To evaluate whether the PCTn for cyantraniliprole could be exceeded, EPA considered whether there may be unusually high pest pressure, as indicated in emergency exemption requests for cyantraniliprole; how the pest spectrum of the new pesticide compares with the market leaders; and whether pest resistance issues with past market leaders provide cyantraniliprole with significant market potential. EPA also considered the potential for resistance to cyantraniliprole to develop as a limiting factor in its use. Given currently available information, EPA concludes that it is unlikely that actual PCT for cyantraniliprole will exceed the estimated PCT for new uses during the next five years.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which cyantraniliprole may be applied in a particular area.

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

Based on the First Index Reservoir Screening Tool (FIRST) and Pesticide in Water Calculator (PWC), the estimated drinking water concentrations (EDWCs) of cyantraniliprole for chronic exposures are estimated to be 24 ppb for surface water and 64 ppb for ground water, respectively.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. An acute dietary risk assessment was not conducted since no acute toxicological effects were found. For the chronic dietary risk assessment, the water concentration value of 64 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyantraniliprole is currently registered for the following uses that could result in residential exposures: Turfgrass (including residential, recreational, and golf course turf), ornamentals, and structural buildings (including indoor crack/crevice and outdoor broadcast). EPA assessed residential exposure using the following assumptions: Residential exposure may occur by the dermal, oral, and inhalation routes and is expected to be short-term in duration of exposures. However, since a dermal hazard has not been identified for cyantraniliprole, the only exposures of concern are handler inhalation (for adults), and post-application incidental oral (for children). For adults, the oral and inhalation routes of exposure were not aggregated since the endpoints of concern are not common. The turf and ornamental labels indicate that a maximum of two applications are allowed per season. Thus, intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Post-application incidental oral exposures for children may occur for short- and intermediate-term durations due to the persistence of cyantraniliprole. Although intermediate-term incidental oral post-application exposures are possible (i.e., from soil ingestion, due to the persistence of cyantraniliprole), the short-term incidental oral exposures are protective of the possible intermediate-term incidental oral exposures because the POD for both durations is the same. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

EPA has not found cyantraniliprole to share a common mechanism of toxicity with any other substances, and cyantraniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyantraniliprole does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (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 is no evidence of susceptibility in developmental toxicity studies in rats and rabbits. The developmental toxicity study in rats tested up to the limit dose (1,000 mg/kg/day). In the rabbit developmental toxicity study decreases in fetal body weight are seen at a dose higher than that resulting in maternal effects. In the reproductive toxicity study, increased incidence of thyroid follicular epithelium hypertrophy/hyperplasia occurs in F1 parental animals at a dose lower than that for the parental (P) generation. A clear NOAEL (1.4 mg/kg/day) is established for F1 parental animals, and the PODs selected for risk assessment from the dog studies (1 or 3 mg/kg/day) are protective of the effect (thyroid effect at 14 mg/kg/day) seen in the F1 parental animals. In addition, the submitted data support the conclusion that the effects on the thyroid are secondary to effects on the liver.

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

i. The toxicity database for cyantraniliprole is complete.

ii. There is no indication that cyantraniliprole 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 of susceptibility in developmental toxicity studies in rats and rabbits. In the reproductive toxicity study, increased incidence of thyroid follicular epithelium hypertrophy/hyperplasia occurs in F1 parental animals at a dose lower than that for the parental (P) generation. However, for the reasons summarized in Unit III.D.2. these effects are not of concern.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was a refined assessment which assumed average field trial residues for all crops (except sugar beet root), PCT where available, and PCTn data. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyantraniliprole in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyantraniliprole.

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, cyantraniliprole 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 cyantraniliprole from food and water will utilize 98% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of cyantraniliprole is not expected.

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

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

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 149 for children 1-2 years old. For adults, the oral and inhalation routes of exposure were not aggregated since the endpoints of concern are not common. Because EPA's level of concern for cyantraniliprole is a MOE of 100 or below, this MOE is not of concern.

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

Cyantraniliprole is currently registered for uses that could result in intermediate-term residential exposure, however, the short-term aggregate risk estimate described above is protective of potential intermediate-term exposures and risks in children.

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

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

Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS)) 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.

For the commodities discussed in this action, there are only Codex MRLs established for residues of cyantraniliprole on coffee beans (0.03 ppm), cucurbit fruiting vegetables (0.3 ppm), legume animal feeds (in the U.S. identified as Foliage of legume vegetables) (0.8 ppm), and root and tuber vegetables (0.05 ppm). There are also Codex MRLs for residues of cyantraniliprole in/on ruminants at (0.01-0.05 ppm), milk (0.02 ppm), and poultry commodities at (0.01 ppm).

The EPA has not harmonized the tolerances for these commodities with the existing Codex MRLs. The petitioner requested a tolerance on coffee without a U.S. registration be established at 0.05 ppm to be line with the existing MRL for coffee in Canada. The Codex MRLs established for residues of cyantraniliprole on cucurbit fruiting vegetables at 0.3 ppm, root and tuber vegetables at 0.05 ppm, and legume animal feeds at 0.8 ppm are lower than the U.S. tolerances of 0.7 ppm, 0.15 ppm and 40 ppm, respectively. The U.S. tolerances cannot be harmonized because following the label use directions could result in residues above the established Codex MRLs. The Codex MRLs for residues of cyantraniliprole in/on ruminants at (0.01-0.05 ppm), milk (0.02 ppm), and poultry commodities at (0.01 ppm) are lower than the U.S. tolerances. The U.S. and Codex livestock MRLs are not harmonized due to different animal diets and tolerances (MRLs) established for different animal feed commodities. The U.S. tolerances cannot be harmonized (lowered) because following the label use directions could result in residues above the Codex MRLs.

A comment was submitted on behalf of the Center for Biological Diversity and the Center for Food Safety and was primarily concerned about EPA's consideration of the impacts of cyantraniliprole on the environment, pollinators, and endangered species. This comment is not relevant to the Agency's evaluation of safety of the cyantraniliprole tolerances under section 408 of the FFDCA, which requires the Agency to evaluate the potential harms to human health, not effects on the environment.

EPA received two other comments to the Notices of Filing noting general concerns about the toxicity of this chemical and stating, in part, that “this product represents a clear and present danger” and “should not be approved to be sold.” The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. EPA has assessed the effects of this chemical on human health and determined that aggregate exposure to it will be safe.

The Agency is not establishing the proposed tolerances for corn, field and pop, forage; corn, field and pop stover; corn, sweet, forage; and corn, sweet stover because the proposed uses are seed treatment only, not a foliar use, so no residues will be present on these feed commodities. Therefore, these tolerances are not necessary.

The proposed tolerance for residues of cyantraniliprole in/on rice, grain of 0.03 ppm is being modified to 0.02 ppm based on the OECD statistical calculation applied to the field trial residue data.

The proposed wine grape tolerance is being modified from 1.5 ppm to 2.0 ppm and a tolerance is being established on olive oil at 2.0 ppm due to concentration demonstrated in the processing studies.

The proposed tolerance for residues in/on legume vegetables, subgroup 6C of 0.9 ppm is being modified to 1.0 ppm based on the OECD statistical calculation applied to the field trial residue data.

The proposed tolerance for residues in/on soybean seed including the foliage (forage and hay) is not being established since processing studies were not submitted for soybean processed commodities (hulls, meal, oil). Therefore, the proposed tolerance for residues of cyantraniliprole in/on vegetables, foliage of legume (crop group 7) is being revised to “Vegetable, foliage of legume, except soybean, group 7A.”

Numerous ruminant commodity tolerances are already established. These ruminant (cattle, goats, horses, and sheep) commodity tolerances are being increased to reflect the new dietary burdens from the tolerances established by this document.

Therefore, tolerances are established for residues of cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, including its metabolites and degradates, in or on Artichoke, globe at 0.10 ppm; Berry, low growing, except strawberry, subgroup 13-07H at 0.08 ppm; Coffee, green bean at 0.05 ppm; Corn, field, grain at 0.01 ppm; Corn, pop, grain at 0.01 ppm; Corn, sweet, kernel plus cob with husks removed at 0.01 ppm; Grape, wine at 2.0 ppm; Olive at 1.5 ppm; Olive, oil at 2.0 ppm; Peanut at 0.01 ppm; Pomegranate at 0.01 ppm; Rice, grain at 0.02 ppm; Strawberry at 1.0 ppm; Tea at 30 ppm; Vegetable, foliage of legume, except soybean, group 7A at 40 ppm; Vegetable, leaves of root and tuber, group 2 at 40 ppm; Vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0 ppm; Vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; Vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm; and Vegetable, root, except sugar beet, subgroup 1B at 0.40 ppm.

In addition, the following tolerances are modified as follows: Peanut, hay from 0.01 ppm to 3.0 ppm and Vegetable, cucurbit, group 9 from 0.40 ppm to 0.70 ppm.

Also, due to the tolerances being established the following tolerances are modified as follows: Cattle, fat from 0.01 ppm to 0.10 ppm; Cattle, meat from 0.01 ppm to 0.10 ppm; Cattle, meat byproducts from 0.01 ppm to 0.40 ppm; Goat, fat from 0.01 ppm to 0.10 ppm; Goat, meat from 0.01 ppm to 0.10 ppm; Goat, meat byproducts from 0.01 ppm to 0.40 ppm; Horse, fat from 0.01 ppm to 0.10 ppm; Horse, meat from 0.01 to 0.10 ppm; Horse, meat byproducts from 0.01 ppm to 0.40 ppm; Milk from 0.01 ppm to 0.20 ppm; Sheep, fat from 0.01 ppm to 0.10 ppm; Sheep, meat from 0.01 ppm to 0.10 ppm; and Sheep, meat byproducts from 0.01 to 0.40 ppm.

Lastly, due to the tolerances being established above, the indirect or inadvertent tolerances under 40 CFR 180.672 (d) for Peanut, hay; Vegetable, foliage of legume (group 7); Vegetable, leaves of root and tuber vegetables (group 2); and Vegetable, root (subgroup 1A) are removed as unnecessary, and new tolerances are established under 180.672 (d) for Beet, sugar, roots at 0.02 ppm; Soybean, forage at 0.70 ppm; and Soybean, hay at 0.70 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 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0566 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 May 22, 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-2016-0566, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6E8471) by Interregional Research Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.1206 be amended by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on almond and fig. That document referenced a summary of the petition prepared by the petitioner IR-4, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

EPA evaluated the available toxicity and exposure data on Aspergillus flavus AF36 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the February 2017, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus AF36.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

Based upon its evaluation, EPA concludes that Aspergillus flavus AF36 is not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when Aspergillus flavus AF36 is used on fig and almond in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Aspergillus flavus AF36.

Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus AF36. Therefore, the existing tolerance exemption for Aspergillus flavus AF36 is amended by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on almond and fig when used in accordance with label directions and good agricultural practices.

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

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

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing 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-2016-0617 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 May 22, 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-2016-0617, 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, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10984) filed by Spring Trading Company on behalf of Ethox Chemicals, LLC, 1801 Perimeter Road, Greenville, SC 29605. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)]; CAS Reg. No. 1939051-18-9. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

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

2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

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

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

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

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

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).

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

8. The polymer's number average MW of 5,000 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)].

For the purposes of assessing potential exposure under this exemption, EPA considered that octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] is 5,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

EPA has not found octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] to share a common mechanism of toxicity with any other substances, and octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)], EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)].

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)].

Accordingly, EPA finds that exempting residues of octadecanoic acid, 12-hydroxy-, homopolymer, ester with α, α',α”-1,2,3-propanetriyltris[ω-hydroxypoly(oxy-1,2-ethanediyl)] from the requirement of a tolerance will be safe.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0606 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 May 22, 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-2016-0606, 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 927580) (FRL-9956-04), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10970) filed by AgroFresh Inc., 400 Arcola Road, P.O. Box 7000 (RC3356), Collegeville, PA 19426. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of polyglycerol polyricinoleate (CAS Reg. No. 29894-35-7). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Polyglycerol polyricinoleate conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers:

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

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

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

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

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

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

g. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6).

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

h. The polymer's number average MW of 2,500 daltons is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

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

For the purposes of assessing potential exposure under this exemption, EPA considered that polyglycerol polyricinoleate could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of polyglycerol polyricinoleate is 2,500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since polyglycerol polyricinoleate conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of polyglycerol polyricinoleate, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

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

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 polyglycerol polyricinoleate.

Accordingly, EPA finds that exempting residues of polyglycerol polyricinole from the requirement of a tolerance will be safe.

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

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

In the addenda to FR Doc 2016-26668 (81 FR 80170 through 80562), the final rule entitled, “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements” there was a technical error in an element of the payment calculation for several services that is identified and corrected in this correcting document. These corrections are effective as if they had been included with the document published November 15, 2016. Accordingly, the corrections are applicable beginning January 1, 2017.

Due to a technical error in the allocation of indirect practice expense (PE) for CPT codes 97161 through 97168, the incorrect CY 2017 PE relative value units (RVUs) were included in Addendum B. The corrected CY 2017 PE RVUs for these codes are reflected in the corrected Addendum B available on the CMS Web site at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Social Security Act (the Act) requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and includes a statement of the finding and the reasons for it in the rule. In addition, section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and the agency includes in the rule a statement of the finding and the reasons for it.

In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements. This document merely corrects technical errors in the CY 2017 PFS final rule. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies that were proposed subject to notice and comment procedures and adopted in the CY 2017 PFS final rule. As a result, the corrections made through this correcting document are intended to resolve inadvertent errors so that the rule accurately reflects the policies adopted in the final rule.

Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the CY 2017 PFS final rule or delaying the effective date of the corrections would be contrary to the public interest because it is in the public interest to ensure that the rule accurately reflects our policies as of the date they take effect. Further, such procedures would be unnecessary because we are not making any substantive revisions to the final rule, but rather, we are simply correcting the Federal Register document to reflect the policies that we previously proposed, received public comment on, and subsequently finalized in the final rule. For these reasons, we believe there is good cause to waive the requirements for notice and comment and delay in effective date.

This document announces that, on February 27, 2017, OMB approved, for a period of three years, the information collection requirements contained in the Commission's Orders, FCC 16-33, published at 81 FR 24282, April 25, 2016, FCC 16-64, published at 81 FR 44414, July 7, 2016, and FCC 16-143, published at 81 FR 83706, November 22, 2016. The OMB Control Number is 3060-1228. The Commission publishes this notice as an announcement of the effective date of the rules associated with the Orders related to certain high-cost carriers' obligation to report broadband location information where they have deployed facilities meeting their public interest obligations, as well as associated certifications and quarterly reports, published at 81 FR 24282, April 25, 2016, 81 FR 44414, July 7, 2016 (Phase II Auction Order), and 81 FR 83706, November 22, 2016, as well as 47 CFR 54.316 and 54.320(d). 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, 3060-1228, in your correspondence. The Commission will also accept your comments via email please send them to [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 OMB approval on February 27, 2017, for the rules associated with t the Orders related to certain high-cost carriers' obligation to report broadband location information where they have deployed facilities meeting their public interest obligations, as well as associated certifications and quarterly reports, published at 81 FR 24282, April 25, 2016, 81 FR 44414, July 7, 2016, and 81 FR 83706, November 22, 2016, as well as 47 CFR 54.316 and 54.320(d). Under 5 CFR 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 3060-1228.

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: 3060-1228.

OMB Approval Date: February 27, 2017.

OMB Expiration Date: February 29, 2020.

Title: Connect America Fund—High Cost Portal Filing.

Form No.: N/A.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 1,526 unique respondents; 3,595 responses.

Estimated Time per Response: 8 hours-30 hours.

Frequency of Response: On occasion, quarterly reporting requirements, annual reporting requirements, one-time reporting requirement and recordkeeping requirement.

Obligation To Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 410, and 1302.

Total Annual Burden: 65,713 hours.

Total Annual Cost: No Cost.

Nature and Extent of Confidentiality: We note that USAC must preserve the confidentiality of certain data obtained from respondents; must not use the data except for purposes of administering the universal service programs or other purposes specified by the Commission; and must not disclose data in company-specific form unless directed to do so by the Commission. Respondents may request materials or information submitted to the Commission or the Administrator believed confidential to be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Needs and Uses: This information collection addresses the requirement that certain carriers with high cost reporting obligations must file information about their locations which meet their broadband deployment public interest obligations via an electronic portal (“portal”). The Rate-of-Return Order required that the Universal Service Administrative Company (USAC) establish the portal so that carriers could file their location data with the portal starting in 2017. The Rate-of-Return Order required all recipients of Phase II model-based support and rate-of-return carriers to submit geocoded location data and related certifications to the portal. Recipients of Phase II model-based support had been required to file such information in their annual reports due by July 1. The Phase II Auction Order requires auction winners to build-out networks capable of meeting their public interest obligations and report, to an online portal, locations to which auction winners had deployed such networks. The ACS Phase II Order requires Alaska Communications Systems (ACS), a recipient of Phase II frozen support, to comply with the reporting, certification and non-compliance measures similar to those previously adopted for ETCs electing Phase II model-based support. For the same reason, the Commission also adopted a cost certification requirement for certain locations. This collection also implements the Rate-of-Return Order by moving and revising the currently approved requirements under OMB Control Numbers 3060-1200 and 3060-0986 to enable recipients of Phase II model-based support and rural broadband experiment funding to file their location information and associated reports and certifications in the portal instead of on the FCC Form 481 or as is currently required.

The snapper-grouper fishery in the South Atlantic includes vermilion snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The South Atlantic Fishery Management Council prepared the FMP. The FMP is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial ACL (commercial quota) for vermilion snapper in the South Atlantic is divided into two 6-month time periods, January through June and July through December. For the January 1 through June 30, 2017, fishing season, the commercial quota is 388,703 lb (176,313 kg), gutted weight, 431,460 lb (195,707 kg), round weight (50 CFR 622.190(a)(4)(i)(D)).

Under 50 CFR 622.191(a)(6)(ii), NMFS is required to reduce the commercial trip limit for vermilion snapper from 1,000 lb (454 kg), gutted weight, 1,110 lb (503 kg), round weight, when 75 percent of the fishing season commercial quota is reached or projected to be reached, by filing a notification to that effect with the Office of the Federal Register, as established by Regulatory Amendment 18 to the FMP (78 FR 47574, August 6, 2013). The reduced commercial trip limit is 500 lb (227 kg), gutted weight, 555 lb (252 kg), round weight. Based on current information, NMFS has determined that 75 percent of the available commercial quota for the January 1 through June 30, 2017, fishing season for vermilion snapper will be reached by March 22, 2017. Accordingly, NMFS is reducing the commercial trip limit for vermilion snapper to 500 lb (227 kg), gutted weight, 555 lb (252 kg), round weight, in or from the South Atlantic EEZ at 12:01 a.m., local time, on March 22, 2017. This reduced commercial trip limit will remain in effect until the start of the next fishing season on July 1, 2017, or until the seasonal commercial quota is reached and the commercial sector closes, whichever occurs first.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic vermilion snapper and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.191(a)(6)(ii) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this commercial trip limit reduction constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary rule is unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule establishing and providing for a reduction in the commercial trip limit has already been subject to notice and comment, and all that remains is to notify the public of the commercial trip limit reduction. Providing prior notice and opportunity for public comment is contrary to the public interest because any delay in reducing the commercial trip limit could result in the commercial quota being exceeded. There is a need to immediately implement this action to protect the vermilion snapper resource, since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Providing prior notice and opportunity for public comment on this action would require time and increase the likelihood that the commercial sector could exceed its quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).