Federal Register Vol. 81, No.45,

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Willapa Harbor Heliport, South Bend, WA.

On November 24, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface, at Willapa Harbor Heliport, South Bend, WA, (80 FR 73152). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Willapa Harbor Heliport, South Bend, WA. Establishment of a GPS approach and departure procedure has made this action necessary for the safety and management of IFR operations at the heliport. Class E airspace is established within a 1.8-mile radius of the Willapa Harbor Heliport, with a segment extending from the 1.8-mile radius to 5.5 miles northwest of the heliport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D and Class E airspace at McNary Field, Salem, OR.

On September 21, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class D airspace, Class E surface area airspace, Class E airspace extending upward from 700 feet above the surface at McNary Field, Salem, OR, (80 FR 56935). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. A total of 71 commenters responded to the NPRM. All comments received were considered before making a determination on this final rule.

Of the 71 responses received, 19 concerned the potential economic impact to Christmas tree farms in the area. The FAA concurs that approximately two thirds of the Christmas tree farming acreage could be adversely affected. To mitigate the concerns for the agricultural areas, the FAA is creating shelves in the Class D, where feasible, between 4 and 5 miles southeast and southwest of the airport.

Many commenters made reference to the current airspace configuration. As the comments do not pertain to this proposal, no changes were required nor made. Twenty-four commenters requested the airspace to be changed to a configuration that existed prior to Aug 20, 2015. The FAA does not agree; the airspace that existed prior to Aug 20, 2015 did not protect the Instrument Flight Rule arrivals and departures or account for rising terrain.

Many commenters referenced the lack of adherence to airspace design criteria and Safety Risk Management directives during the previous airspace development process. The FAA does not concur. A review of the design process and the results was completed for both the current and previous proposals. The FAA found that all criteria contained in FAA Order JO 7400.2, Procedures for Handling Airspace Matters; FAA Order JO 8000.369, Safety Management System and the Administrative Procedures Act (5 U.S.C. 501 et seq.) were followed.

Nineteen commenters referenced a lack of public input. The FAA conducted a review of the process and found that all public coordination was completed consistent with the process outlined in JO 7400.2.

Three commenters were concerned that users would not be aware of airspace changes. They recommended that future airspace changes occur congruently with VFR Sectional chart publication and that a Notice to Airman (NOTAM) be used to identify pending changes. The FAA does not concur with publishing airspace changes congruent with the charting cycles; this could unnecessarily delay airspace changes six months to a year. Changes that become effective outside of the chart publication cycles are reflected in the Airport/Facilities Directory (A/FD), in the Aeronautical Chart Bulletin section. Pilots are required to consult the AF/D, prior to flying in a specific area, for information related to airspace changes that are pending. This publication is reviewed to ensure the potential airspace changes are published and accurate. For this proposal the FAA agrees to coordinate congruent effective and charting dates. Additionally, the FAA has modified its policies to allow a facility to post a Pointer NOTAM indicating the location of additional information for expanding airspace, to advise the aviation community of an airspace increase or altitude change that occurs outside of a sectional chart cycle.

Several commenters stated that Salem air traffic control tower was not aware of the changes. The FAA does not agree with these comments, as the facility was directly involved in and concurred with, the previous and current proposals.

The description of the Class D airspace area has been modified from that proposed in the NPRM. In light of public input, the FAA reevaluated the Class D design for McNary Field and incorporated shelves to facilitate access, into and out of the impacted Christmas Tree Farms, by commercial operators.

Class D and Class E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface at McNary Field, Salem, OR. After further review, the FAA found some airspace unnecessary when implementing Standard Instrument Approach Procedures for Instrument Flight Rules (IFR) operations at the airport. Class D airspace is extended upward from the surface to and including 2,700 feet within a 4-mile radius of McNary Field Airport, extending to 5 miles from the east clockwise to the north, excluding segments below 1,500 feet beyond 4 miles east and southwest of the airport. Class E surface area airspace extends upward from the surface within a 4-mile radius of McNary Field Airport, extending to 5 miles from the east clockwise to the north of the airport. Class E airspace extending upward from 700 feet above the surface is modified to within a 6.2-mile radius south to the northwest of McNary Field, with segments extending to 6.7 miles to the northeast, and 8.2 miles to the southeast of the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

The Entity List (Supplement No. 4 to Part 744) identifies entities and other persons reasonably believed to be involved, or to pose a significant risk of being or becoming involved, in activities contrary to the national security or foreign policy interests of the United States. The EAR imposes additional licensing requirements on, and limits the availability of most license exceptions for, exports, reexports, and transfers (in-country) to those listed. The “license review policy” for each listed entity or other person is identified in the License Review Policy column on the Entity List and the impact on the availability of license exceptions is described in the Federal Register notice adding entities or other persons to the Entity List. BIS places entities and other persons on the Entity List pursuant to sections of part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy, and, where appropriate, the Treasury, determines all additions to, removals from, and other modifications to the Entity List. The ERC makes decisions to add an entry to the Entity List by majority vote and decisions to remove or modify an entry by unanimous vote.

This rule implements the decision of the ERC to add four entities—three in China and one in Iran—to the Entity List under the authority of § 744.11 (License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States) of the EAR.

The ERC reviewed § 744.11(b) (Criteria for revising the Entity List) in making the determination to list these four entities. Under that paragraph, entities and other persons for which there is reasonable cause to believe, based on specific and articulable facts, have been involved, are involved, or pose a significant risk of being or becoming involved in, activities that are contrary to the national security or foreign policy interests of the United States, and those acting on behalf of such persons, may be added to the Entity List. Paragraphs (b)(1) through (5) of § 744.11 set out an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.

Pursuant to § 744.11 of the EAR, the ERC determined that Zhongxing Telecommunications Equipment Corporation (“ZTE Corporation”), located at ZTE Plaza, Keji Road South, Hi-Tech Industrial Park, Nenshan District, Shenzhen, China, be added to the Entity List under the destination of China for actions contrary to the national security and foreign policy interests of the United States. Specifically, the ZTE Corporation document “Report Regarding Comprehensive Reorganization and Standardization of the Company Export Control Related Matters” (available at http://www.bis.doc.gov) indicates that ZTE Corporation has reexported controlled items to sanctioned countries contrary to United States law. The ZTE Corporation document “Proposal for Import and Export Control Risk Avoidance” (available at http://www.bis.doc.gov) describes how ZTE Corporation also planned and organized a scheme to establish, control, and use a series of “detached” (i.e., shell) companies to illicitly reexport controlled items to Iran in violation of U.S. export control laws.

Pursuant to § 744.11 of the EAR, the ERC determined that three entities located in China and one in Iran should be added to the Entity List for actions contrary to the national security or foreign policy interests of the United States. Specifically, the following three entities (in addition to ZTE Corporation) were identified in the scheme developed by ZTE Corporation to reexport controlled items to Iran contrary to United States law, as detailed in the ZTE Corporation document “Proposal for Import and Export Control Risk Avoidance,” referenced above and available on the BIS Web site:

Pursuant to § 744.11(b)(5) of the EAR, the ERC determined that the conduct of these four entities raises sufficient concern that the prior review of exports, reexports, and transfers (in-country) of items subject to the EAR involving these entities, and the possible imposition of license conditions or license denials on shipments to the entities, will enhance BIS's ability to prevent violations of the EAR.

For the four entities this rule adds to the Entity List on the basis of § 744.11, the ERC specified a license requirement for all items subject to the EAR and a license review policy of presumption of denial. The license requirements apply to any transaction in which items subject to the EAR are proposed for export, reexport, or transfer (in-country) to any of the four listed entities or any other transaction in which such entities act as purchaser, intermediate consignee, ultimate consignee, or end user of items subject to the EAR. In addition, no license exceptions are available for exports, reexports, or transfers (in-country) of items subject to the EAR to the entities being added to the Entity List in this rule.

This final rule adds the following four entities to the Entity List:

(1) Beijing 8-Star International Co., Unit 601, 6th Floor, Tower 1, Prosper Center, No. 5, Guanghua Road, Chaoyang District, Beijing, China;

(2) Zhongxing Telecommunications Equipment (ZTE) Corporation, ZTE Plaza, Keji Road South, Hi-Tech Industrial Park, Nanshan District, Shenzen, China; and

(3) ZTE Kangxun Telecommunications Ltd., 2/3 Floor, Suite A, Zte Communication Mansion Keji (S) Road, Hi-New Shenzhen, 518057 China.

(1) ZTE Parsian, No. 100, Africa Ave., Mirdamad Entersection, Tehran, Iran.

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export or reexport, on March 8, 2016, pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR).

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and carries a burden estimate of 43.8 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285.

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

4. For the four entities added to the Entity List in this final rule, the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment, and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (See 5 U.S.C. 553(a)(1)). BIS implements this rule to protect U.S. national security or foreign policy interests by preventing items from being exported, reexported, or transferred (in-country) to the entities being added to the Entity List. If this rule were delayed to allow for notice and comment and a delay in effective date, then entities being added to the Entity List by this action would continue to be able to receive items without a license and to conduct activities contrary to the national security or foreign policy interests of the United States. In addition, because these parties may receive notice of the U.S. Government's intention to place this entity on the Entity List if a proposed rule is published, doing so would create an incentive for these entities to either accelerate receiving items subject to the EAR to conduct activities that are contrary to the national security or foreign policy interests of the United States, or to take steps to set up additional aliases, change addresses, and other measures to try to limit the impact of the listing on the Entity List once a final rule was published. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

On February 18, 2016, the Commission issued an Annual Update to Fee Schedule for the Use of Government Lands for Hydropower Licensees in the above-captioned proceeding. Pursuant to Annual Charges for the Use of Government Lands, Order No. 774, 78 FR 5256 (January 25, 2013), FERC Stats. & Regs. ¶ 31,341 (2013) this document corrects the per-acre values for the State of Nevada, as reflected in the caption below.

Accordingly, 18 CFR part 11 is corrected by making the following correcting amendment:

The Metro-North Bridge, mile 1.0, across the Mianus River, has a vertical clearance in the closed position of 20 feet at mean high water and 27 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.209.

The waterway is transited by seasonal recreational traffic.

Connecticut DOT requested a temporary deviation from the normal operating schedule to perform superstructure repairs and timber ties replacement at the bridge.

Under this temporary deviation, the Metro-North Bridge will operate according to the schedule below:

a. From March 21, 2016 8 a.m. to March 25, 2016 4 a.m. the bridge will not open to marine traffic.

b. From March 25, 2016 4 a.m. to March 28, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

c. From March 28, 2016 8 a.m. to April 01, 2016 4 a.m. the bridge will not open to marine traffic.

d. From April 01, 2016 4 a.m. to April 04, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

e. From April 04, 2016 8 a.m. to April 08, 2016 4 a.m. the bridge will not open to marine traffic.

f. From April 08, 2016 4 a.m. to April 11, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

g. From April 11, 2016 8 a.m. to April 15, 2016 4 a.m. the bridge will not open to marine traffic.

h. From April 15, 2016 4 a.m. to April 18, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

a. From June 13, 2016 8 a.m. to June 17, 2016 4 a.m. the bridge will not open to marine traffic.

b. From June 17, 2016 4 a.m. to June 20, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

c. From June 20, 2016 8 a.m. to June 24, 2016 4 a.m. the bridge will not open to marine traffic.

d. From June 24, 2016 4 a.m. to June 27, 2016 8 a.m. the bridge will open fully on signal upon 24 hour advance notice.

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations 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.

Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (September 30, 1993), and Executive Order 13563, Improving Regulation and Regulation Review, 76 FR 23821 (January 18, 2011), direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). This rule is not “significant” under section 3(f) of Executive Order 12866 because it proposes to make only minor administrative revisions. The Office of Management and Budget (OMB) has reviewed this regulation.

This review requires an agency to prepare an initial regulatory flexibility analysis and publish it when the agency publishes the rule. This requirement does not apply if the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities (5 U.S.C. 603). NARA certifies, after review and analysis, that this rule will not have a significant adverse economic impact on small entities because it makes only minor administrative changes to the rule and the rule governs how people may access these records, which does not impact small entities.

This rule does not contain information collection activities that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

Review under Executive Order 13132 requires that agencies review regulations for Federalism effects on the institutional interest of states and local governments, and, if the effects are sufficiently substantial, prepare a Federal assessment to assist senior policy makers. This rule will not have any direct effects on State and local governments within the meaning of the Executive Order. Therefore, this regulation does not require a Federalism assessment.

For the reasons stated in the preamble, NARA revises 36 CFR part 1275 to read as follows:

The Agency included in the November 20, 2015 document a list of those who may be potentially affected by this action.

The dockets for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0194 are available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the dockets available at http://www.epa.gov/dockets.

The final rule in the Federal Register of November 20, 2015, amended 40 CFR 180.361 to remove the entry “Rice, straw” from the table in paragraph (a). In the final rule in the Federal Register of December 21, 2015 (80 FR 79267) (FRL-9937-18), paragraph (a) was redesignated as paragraph (a)(1) so we are amending 40 CFR 180.361 to remove the entry “Rice, straw” from the table in paragraph (a)(1).

FR Doc. 2015-28491 published in the Federal Register of November 20, 2015 (80 FR 72593) (FRL-9935-01) is corrected 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-2014-0922 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 9, 2016. 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-2014-0922, by one of the following methods:

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

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

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

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

In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), 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 4E8335) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of residues of the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 parts per million (ppm) and vegetable, tuberous and corm, subgroup 1C at 0.060 ppm. In addition, IR-4 requested to establish tolerances for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4- methylbenzamide, in or on the raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm. IR-4 also proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm. That document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 zoxamide including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with zoxamide 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 repeat dose oral and dermal toxicity studies in rats, there were no indications of systemic toxicity up to the highest dose tested (HDT); most of the highest doses were at or above the limit dose (1,000 milligrams/kilogram/day (mg/kg/day)). In the repeat dose oral toxicity studies in dogs, effects included increased liver and thyroid weights, liver histopathology (i.e., hepatocellular hypertrophy), and increased alkaline phosphatase.

In the rat and rabbit prenatal developmental toxicity studies, there were no indications of susceptibility, as there was neither maternal nor developmental toxicity up to the HDT. In the rat reproduction study, there were no indications of susceptibility, since parental effects (i.e., decreased maternal body weight) occurred in the absence of reproductive or offspring toxicity.

Zoxamide has been classified as “not likely to be carcinogenic in humans” based on the results of carcinogenicity studies in rats and mice. In the acute and subchronic neurotoxicity studies, there were no indications of neurotoxicity up to the HDT.

Specific information on the studies received and the nature of the adverse effects caused by zoxamide 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 “Zoxamide. Human Health Aggregate Risk Assessment for the Proposed New Uses on Ginseng, Tomato Subgroup 8-10A; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; and Tuberous and Corm Vegetable Subgroup 1C” on page 25 in docket ID number EPA-HQ-OPP-2014-0922.

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 zoxamide used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 18, 2014 (79 FR 41911) (FRL-9913-35).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to zoxamide, EPA considered exposure under the petitioned-for tolerances as well as all existing zoxamide tolerances in 40 CFR 180.567. EPA assessed dietary exposures from zoxamide 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 zoxamide; 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 United States Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) database. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all established and proposed commodities. The assessment also utilized default processing factors from the Dietary Exposure Evaluation Model—Food Commodity Intake Database (DEEM-FCID) version 7.81 except for raisin and potato granules/flakes, where the processing factor was set at 1.

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

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of zoxamide and its major metabolites for chronic exposures are estimated to be 22.84 parts per billion (ppb) for surface water and 65.8 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 65.8 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). Zoxamide is not registered for any specific use patterns that would result in residential exposure.

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

EPA has not found zoxamide to share a common mechanism of toxicity with any other substances, and zoxamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that zoxamide 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 Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no evidence for increased susceptibility following prenatal exposure in prenatal developmental toxicity studies in rats and rabbits. Additionally, there was no evidence for increased susceptibility following pre- or postnatal exposure in the reproduction and fertility effects study in rats.

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 1×. That decision is based on the following findings:

i. The toxicity database for zoxamide is complete.

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

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

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

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, zoxamide 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 zoxamide from food and water will utilize 6.3% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for zoxamide.

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

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

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

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

Adequate enforcement methodology (Gas chromatography with electron capture detection (GC/ECD) and GC with mass selective detection (GC/MSD)) is available to enforce the tolerance expression.

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

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

The tolerances being established for the tomato subgroup 8-10A and the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F are harmonized with established Codex MRLs on tomato and grape, respectively. The tolerance being established for the tuberous and corm vegetable subgroup 1C at 0.06 ppm is not harmonized with a Codex MRL on potato at 0.02 ppm. The underlying residue data and residue definition used to support the Subgroup 1C tolerance supports a tolerance recommendation that is higher than the established Codex MRL on potato at 0.02 ppm. There is not a Codex MRL for ginseng.

Therefore, tolerances are established for residues of zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 ppm and vegetable, tuberous and corm, subgroup 1C at 0.06 ppm. In addition, tolerances are established for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4-methylbenzamide, in or on raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm. Lastly, upon the establishment of the aforementioned tolerances, the established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm are removed as unnecessary.

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:

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-2015-0443 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 9, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0443, 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.

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 26, 2015 (80 FR 51759) (FRL-9931-74), 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 4F8284) by Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, North Carolina 27709. The petition requested that 40 CFR 180.661 be amended by establishing tolerances for residues of the fungicide fluopyram in or on the raw agricultural commodities artichoke, globe at 4.0 parts per million; aspirated grain fractions at 50.0 ppm; peanut hay at 40.0 ppm; hops at 60.0 ppm; root vegetables, except beet, sugar, root, crop subgroup 1B at 0.30 ppm; tuberous and corm vegetables, crop subgroup 1C at 0.10 ppm; potato wet peel at 0.30 ppm; vegetables, leaves of root and tuber, crop group 2 at 30.0 ppm; bulb vegetables, bulb onion (crop subgroup 3-07A) at 0.30 ppm; bulb vegetables, green onions (crop subgroup 3-07B) at 15.0 ppm; leafy greens (crop subgroup 4A), without spinach at 20.0 ppm; leafy greens (crop subgroup 4A) spinach at 40.0 ppm; leafy petioles subgroup, celery (crop subgroup 4B) at 20.0 ppm; brassica leafy vegetables: Head and stem (crop subgroup 5A) at 4.0 ppm; brassica leafy vegetables: Leafy greens (crop subgroup 5B) at 50.0 ppm; soybean forage at 9.0 ppm; soybean hay at 30.0 ppm; legume vegetables: Edible podded (crop subgroup 6A) at 4.0 ppm; legume vegetables: Succulent shelled peas and beans (crop subgroup 6B) at 0.20 ppm; legume vegetables: Dried shelled peas and beans (crop subgroup 6C) at 0.70 ppm; vegetable, foliage of legume vegetables, forage, hay and vines, forage (crop group 7) at 90.0 ppm; fruiting vegetables, tomato subgroup (crop subgroup 8-10A) at 1.00 ppm; fruiting vegetables, pepper/eggplant subgroup (crop subgroup 8-10B) at 3.00 ppm; cucurbit vegetables (crop group 9A), melon subgroup at 0.90 ppm; cucurbit vegetables (crop group 9B), cucumber/squash subgroup at 0.30 ppm; citrus fruits (crop group 10-10) at 0.90 ppm; citrus oil at 8.0 ppm; pome fruit (crop group 11-10) at 2.0 ppm; stone fruit (crop group 12-12A), cherry subgroup at 2.00 ppm; stone fruit (crop group 12-12B), peach subgroup at 1.00 ppm; stone fruit (crop group 12-12C), plum subgroup at 0.50 ppm; berries and small fruit: Caneberry (crop subgroup 13-07A) at 5.0 ppm; berries and small fruit: Bushberry (crop subgroup 13-07B) at 7.0 ppm; raisins at 4.0 ppm; berries and small fruit, small fruit vine climbing, except fuzzy kiwi (crop subgroup 13-07F) at 1.5 ppm; berries and small fruit: Low growing berry (crop subgroup 13-07G) at 2.0 ppm; sorghum, grain at 1.5 ppm; wheat milled by-products at 2.0 ppm; grass forage, fodder and hay: Forage (crop group 17) at 80.0 ppm; herb crop (crop subgroup 19A) at 70.0 ppm; dill seed at 70.00 ppm; herbs, dried at 400 ppm; oilseeds, rapeseed, canola (crop subgroup 20A) at 0.70 ppm; oilseeds, sunflower, seed (crop subgroup 20B) at 0.70 ppm; and oilseeds: Cottonseed (crop subgroup 20C) at 0.80 ppm and in or on the animal commodities chicken, meat byproducts at 0.40 ppm; chicken, fat at 0.15 ppm; chicken, meat at 0.10 ppm; goat, fat at 4.00 ppm; and goat, meat at 4.00 ppm. Bayer CropScience also requests to establish a tolerance in 40 CFR 180.661 for indirect or inadvertent residues of the fungicide fluopyram in or on the raw agricultural commodity sugarcane, cane at 0.08 ppm. The petition also requested to amend tolerances in 40 CFR 180.661 for residues of the fungicide fluopyram in or on the raw agricultural commodities peanut at 0.20 ppm; sugar beet, roots at 0.09 ppm; soybean, seed at 0.30 ppm; soybean forage at 9.0 ppm; soybean hay at 30.0 ppm; tree nuts (crop group 14) at 0.04 ppm; almond hulls at 10.00 ppm; grain, cereal, except rice and sorghum (crop group 15) at 0.90 ppm; cereal grain, except rice, forage, fodder and straw (crop group 16) at 20.0 ppm; and cotton gin by-product at 30.00 ppm and in or on the animal commodities cattle, meat byproducts at 40.00 ppm; cattle, fat at 4.00 ppm; cattle, meat at 4.00 ppm; milk, cattle at 2.00 ppm; eggs, chicken at 0.20 ppm; hog, meat byproducts at 0.40 ppm; hog, fat at 0.04 ppm; hog, meat at 0.04 ppm; horse, meat byproducts at 40.00 ppm; horse, fat at 4.00 ppm; horse, meat at 4.00 ppm; goat, meat byproducts at 40.00 ppm; sheep, meat byproducts at 40.00 ppm; sheep, fat at 4.00 ppm; and sheep, meat at 4.00 ppm. Bayer CropScience also requests to delete tolerances in 40 CFR 180.661 for residues of the fungicide fluopyram in or on the raw agricultural commodities apple at 0.30 ppm; bean, dry at 0.09 ppm; beet, sugar, roots at 0.04 ppm; apple wet pomace at 0.60 ppm; cherry at 0.60 ppm; grape, wine at 2.0 ppm; potato at 0.02 ppm; strawberry at 1.5 ppm; and watermelon at 1.0 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is issuing some tolerances that vary from the fluopyram tolerances as requested. The reasons for these changes are explained in Unit IV.C.

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

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

Decreased body weight and liver effects were the common and frequent findings in the fluopyram subchronic and chronic oral toxicity studies in rats, mice, and dogs, and they appeared to be the most sensitive effects. Liver effects were characterized by increased liver weight, hepatocellular hypertrophy, hepatocellular vacuolation, increased mitosis and hepatocellular necrosis. Thyroid effects were found at dose levels similar to those that produced liver effects in rats and mice; these effects consisted of follicular cell hypertrophy, increased thyroid weight, and hyperplasia at dose levels greater than or equal to 100 milligrams/kilogram/day (mg/kg/day). Changes in thyroid hormone levels were also seen in a subchronic toxicity study. In male mice, there was an increased incidence of thyroid adenomas.

Although increased liver tumors were observed in female rats in the carcinogenicity study, EPA has concluded that fluopyram is “Not Likely to be Carcinogenic to Humans” at doses that do not induce cellular proliferation in the liver or thyroid glands. This classification was based on convincing evidence that non-genotoxic modes of action for liver tumors in rats and thyroid tumors in mice have been established and that the carcinogenic effects have been demonstrated as a result of a mode of action dependent on activation of the CAR/PXR receptors. The Agency is using a point of departure for regulating fluopyram (NOAEL of 1.2 mg/kg/day) that is below the doses that cause cell proliferation in the liver (11 mg/kg/day) and subsequent liver tumor formation (89 mg/kg/day); therefore, the Agency concludes that exposure to fluopyram will not be carcinogenic. Moreover, fluopyram is not genotoxic or mutagenic.

Fluopyram is not a developmental toxicant, nor did it adversely affect reproductive parameters. No evidence of qualitative or quantitative susceptibility was observed in developmental studies in rats and rabbits or in a multigeneration study in rats.

In an acute neurotoxicity study, transient decreased motor activity was seen only on the day of treatment, but no other findings demonstrating neurotoxicity were observed. In addition, no neurotoxicity was observed in the subchronic neurotoxicity study in the presence of other systemic adverse effects. Fluopyram did not produce treatment-related effects on the immune system.

Fluopyram has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Fluopyram is not a skin or eye irritant or sensitizer under the conditions of the murine lymph node assay. Specific information on the studies received and the nature of the adverse effects caused by fluopyram 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 entitled: “Fluopyram: Human Health Risk Assessment for Proposed New Uses on Crop Subgroup 1B, Subgroup 1C, Crop Group 2, Subgroup 3-07A, Subgroup 3-07B, Subgroup 4A, Subgroup 4B, Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dried Beans, Soybean, Subgroup 8-10A, Subgroup 8-10B, Subgroup 9A, Subgroup 9B, Subgroup 10-10, Group 11-10, Subgroup 12-12A, Subgroup 12-12B, Subgroup 12-12C, Subgroup 13-07A, Subgroup 13-07B, Subgroup 13-07F, Subgroup 13-07G, Crop Group 15 (except corn and Rice), Crop Group 16, Subgroup 19A, Dill Seed, Subgroup 20A, Subgroup 20B, Subgroup 20C, Artichoke (Globe), Hops, and Sugarcane (Rotated). Amended Tolerance Requests for the Registered Uses due to Crop Group/Subgroup Expansion Requests. Proposed New Uses on Turf Grass, Ornamentals, and Christmas trees, and as a seed treatment to Peanuts” in docket ID number EPA-HQ-OPP-2015-0443.

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://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1.

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

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluopyram, EPA considered exposure under the petitioned-for tolerances as well as all existing fluopyram tolerances in 40 CFR 180.661. EPA assessed dietary exposures from fluopyram in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for fluopyram. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA included tolerance residue levels, the assumption of 100% crop treated, and processing factors (empirical and default).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA included average residue levels, % crop treated, and processing factors (empirical and default).

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fluopyram does not pose a cancer risk to humans at doses that do not induce cellular proliferation in the liver or thyroid glands. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (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.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the PCT for the chronic dietary exposure assessment for existing uses as follows:

Almonds 33%; apples 40%; blackberries 55%; blueberries 54%; broccoli 24%; cantaloupes 22%; celery 60%; corn field 9%; corn, sweet 15%; cucumbers 41%; dry beans/peas 7%; fresh tomatoes 64%; grape wine 79% (used for grape, wine and sherry); head lettuce 67%; leaf lettuce 62%; oranges 39%; peaches 56%; pears 43%; peanuts 67%; potatoes 64%; processed tomatoes 57%; pumpkins 45%; snap beans 44%; soybeans 17%; spinach 43%; squash 47%; strawberries 75%; sugar beets 48%; watermelons 54%; and wheat 17% (from spring wheat at 17% and winter wheat at 6%).

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 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 fluopyram 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 fluopyram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluopyram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and the surface water concentration calculator (SWCC), the estimated drinking water concentrations (EDWCs) of fluopyram for acute exposures are estimated to be 50.6 parts per billion (ppb) for surface water and 97.6 ppb for ground water. The chronic exposures for non-cancer assessments are estimated to be 17.3 ppb for surface water and 90.5 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 97.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 90.5 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).

Fluopyram is proposed for use that could result in residential exposures: golf course turf, residential lawns, fruit trees, nut trees, ornamentals and gardens. EPA assessed residential exposure using the following assumptions: short-term dermal, oral (derived from incidental oral hand to mouth post-application exposures to treated lawn in children), and inhalation exposures derived from treating lawns by hose-end sprayers (adults); residential post-application exposures: adults and children (1 to <2 years old) dermal exposure to treated turf during high contact lawn activities; children (1 to <2 years old) incidental oral exposure as a result of contacting treated turf; adults and youths (11 to <16 yr old) dermal exposure to treated turf during mowing and golfing activities; children (6 to <11 years old) dermal exposure to treated turf during golfing activities; and adults and children (6 to <11 years old) dermal exposure to treated gardens. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

2. Prenatal and postnatal sensitivity. The available developmental toxicity studies in rats and rabbits and the multi-generation reproduction in rats demonstrate no evidence of increased susceptibility in the developing or young animals which were exposed during pre- or post-natal periods.

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 fluopyram is complete.

ii. There is no indication that fluopyram is a neurotoxic chemical. Although transient decreases in motor and locomotor activities in the acute neurotoxicity study were seen on the day of treatment and limited use of hind-limbs and reduced motor activity was seen in the rat chronic/carcinogenicity study, there were no other associated neurobehavioral or histopathology changes found in other studies in the fluopyram toxicity database. The effects seen in the chronic/carcinogenicity study were in the presence of increased mortality and morbidity such as general pallor and emaciated appearance. Therefore, the reduced motor activity and limited use of hind-limbs seen in these two studies were judged to be the consequence of the systemic effects and not direct neurotoxicity. Additionally there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

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

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure assessment was performed using conservative exposure inputs, including tolerance-level residues for all crops, whereas the chronic dietary assessment included average field-trial residue levels for all crops. The acute dietary assessment assumed 100 PCT, whereas the chronic dietary assessment utilized average percent crop treated numbers for several crops. Both acute and chronic dietary assessments incorporated empirical or default processing factors. The dietary exposure assessment also assumed that all drinking water will contain fluopyram at the highest EDWC levels modeled by the Agency for ground or surface water. Therefore, it can be concluded that the dietary exposure analysis does not underestimate risk from acute and chronic dietary exposure to fluopyram. While there is the potential for handler and post-application residential exposure, the best data and approaches currently available were used in the fluopyram residential assessment. The Agency used the current conservative approaches for residential assessment, many of which include recent upgrades to the SOPs. The Agency believes that the calculated risks represent conservative estimates of exposure because maximum application rates are used to define residue levels upon which the calculations are based. Therefore, residential exposures are unlikely to be underestimated.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluopyram will occupy 35% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluopyram from food and water will utilize 81% 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 fluopyram 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). Fluopyram 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 fluopyram.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs from handler inhalation exposure (the most conservative risk estimate) of 1,500 for adults. For children 1-2 years old, post-application incidental oral exposures aggregated with food and drinking water resulted in an MOE of 1,500. Because EPA's level of concern for fluopyram is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate-term residential exposure is not expected given the intermittent nature of applications in residential settings.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A, because the Agency is regulating exposure to fluopyram at doses lower than those that may induce cellular proliferation in the liver or thyroid glands, fluopyram 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 fluopyram residues.

The German multiresidue method DFG Method S 19, a gas chromatography with mass selective detection (GC/MSD) method, is the method for the enforcement of tolerances for fluopyram residues in/on crop commodities and a high performance liquid chromatography method with tandem mass spectrometry detection (HPLC/MS/MS), Method 01079, has been accepted for the enforcement of tolerances for residues of fluopyram and its metabolite, AE C656948-benzamide, in livestock commodities. The validated limit of quantitation (LOQ) is 0.01 ppm and the calculated limit of detection (LOD) is 0.003 ppm for each analyte in each matrix. The method was adequately validated using cattle milk, fat, muscle, liver, and kidney, and hen whole egg fortified with fluopyram and AE C656948-benzamide, each at 0.01 and 0.10 ppm. The method was subjected to ILV using samples of beef muscle, beef liver, eggs, and milk fortified with fluopyram and AE C656948-benzamide, each at 0.01 and 0.10 ppm.

Adequate enforcement methodology DFG Method S 19 and Method 01079 are available to enforce the tolerance expression.

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

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

There are Codex maximum residue levels MRLs established on berries (blackberry and raspberry 3 ppm), broccoli and Brussels sprouts (0.3 ppm), dry beans (0.07 ppm), head cabbage (0.15 ppm), carrot (0.4 ppm), cauliflower (0.09 ppm), cherry (0.7 ppm), cucumber (0.5 ppm), dried grapes (currants, raisins and sultanas 5 ppm), grapes (2 ppm), leek (0.15 ppm), lettuce (head and leaf 15 ppm), onion bulb (0.07 ppm), peach subgroup (1 ppm), peanut (0.03 ppm), plums (0.5 ppm), pome fruits (0.5 ppm), potato (0.03 ppm), rapeseed (1 ppm), strawberry (0.4 ppm), sugar beet (0.04 ppm), tomato (0.4 ppm), and tree nuts (0.04 ppm).

The tolerance definitions are harmonized among the US, Canada, and Codex for all plant and livestock commodities. In addition, the U.S. tolerances for grape (within the fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F), peach (within the fruit, stone, peach subgroup 12-12B), and plum (within the fruit, stone, plum subgroup 12-12C) are harmonized with the Codex MRLs for grape, peach, and plum.

Harmonization with Codex MRLs for berries (blackberry and raspberry 3 ppm), broccoli and Brussels sprouts (0.3 ppm), dry beans (0.70 ppm), head cabbage (0.15 ppm), cauliflower (0.09 ppm), cherry (0.7 ppm), cucumber (0.5 ppm), leek (0.15 ppm), lettuce (head and leaf 15 ppm), onion bulb (0.07 ppm), peanut (0.03 ppm), pome fruits (0.5 ppm), potato (0.03 ppm), rapeseed (1 ppm), strawberry (0.4 ppm), sugar beet (0.04 ppm), tomato (0.4 ppm), and tree nuts (0.04 ppm) is not possible because the Codex MRLs are lower than the recommended U.S. tolerances. The U.S. tolerances cannot be harmonized because following the approved label directions could result in residues above the recommended tolerances. The U.S. tolerances for carrot and raisin are higher than the Codex MRLs. EPA is not harmonized with Codex in order to remain harmonized with Canada.

The U.S. and Codex livestock MRLs are not harmonized due to different livestock dietary burdens. Fluopyram is approved for use on more livestock feed stuffs in the United States and thus contributes to a greater portion of the assessment of the livestock dietary burden in the United States than in the assessment of livestock dietary burden supporting the Codex MRLs. Harmonization could lead to tolerance exceedances when the pesticide is used legally in the United States.

The petitioned-for tolerances differ from the tolerances that EPA is establishing for sugar beet roots, onion bulbs, leafy greens subgroup 4A, crop subgroup 6C, fruiting vegetables (8-10B), melon subgroup 9A, citrus, subgroup 13-07F, raisin, tree nuts, crop group 15, herb subgroup 19A, dill seed, and subgroup 20A.

For citrus, crop group 15, fruiting vegetables (8-10B), onion bulbs, rapeseed subgroup 20A, and tree nuts, the Organization for Economic Cooperation and Development (OECD) statistical calculation procedures applied to the field trial residue data provided a different value than the petitioned-for tolerances. Also, for crop group 15 and subgroup 20A, the values petitioner requested were based on a data set that excluded a field trial (on sorghum and canola, respectively) as an outlier based on statistical tests. However, the trials could not be excluded by the Agency since there were no abnormal field conditions.

While the petitioner requested a tolerance for crop group 15, except rice and sorghum, the Agency has determined that a crop group 15 tolerance, except corn and rice is appropriate. This is due to the wide variation in residue levels from the available data. The minimum residues on sweet corn at 0.01 ppm and the maximum residues on sorghum 3.2 ppm differ by more than 5x; therefore, the tolerance level (1.5 ppm) is not appropriate to establish a crop group tolerance with all the representative crops. Rather, based on the available data, EPA is establishing tolerances on grain, cereal, except rice and corn, group 15 at 4.0 ppm; and individual tolerance on corn, field, grain at 0.02 ppm; corn, pop, grain at 0.02 ppm; and corn, sweet, kernal plus cob with husks removed at 0.01 ppm.

Although the petitioner requested two separate tolerances for commodities of subgroup 4A, the available data support a tolerance of 40 ppm for residues of fluopyram in/on leafy greens subgroup 4A and at 20 ppm on leaf petioles subgroup 4B.

The petitioner requested two separate tolerances for herb subgroup 19A, fresh and herbs, dried. Because subgroup 19A covers both dried and fresh herbs, the Agency is establishing a tolerance on herb subgroup 19A at 40 ppm, based on available data.

The petitioner has requested to establish tolerances on vegetables, legume; dried beans and peas, except soybeans (subgroup 6C) at 0.70 ppm. Because only data on dried beans is available, there is not sufficient data to support establishing a subgroup tolerance. Therefore, based on the available residue data for dried beans, the Agency is establishing an individual tolerance of 0.70 ppm on dried beans only. EPA is establishing dry bean tolerance at 0.70 ppm to harmonize with Canada.

The petitioner had requested to establish tolerances on vegetables, cucurbit, cucumber/squash subgroup at 0.30 ppm and fruit, pome at 1.0 ppm. Based on available data that reflect the proposed use pattern, EPA is establishing a tolerance on squash/cucumber subgroup 9B at 0.60 ppm and fruit, pome, group 11-10 at 0.80 ppm.

For harmonization purposes with Canada, tolerances being established for sugar beet, melon subgroup 9A, tree nuts, and subgroup 13-07F are slightly increased above the tolerance levels requested for those commodities.

The requested grape, raisin tolerance of 4.0 ppm is being reduced to 3.0 ppm based on the highest average field trial (HAFT) (0.948 ppm) for grape and processing factor of 2.4.

Because use of fluopyram is limited to Region 3 (Florida), the Agency is establishing a tolerance with a regional registration for inadvertent or indirect residues of fluopyram on sugarcane, cane (0.08 ppm) when sugarcane is used as a rotational crop.

The requested tolerances for livestock commodities were based on some livestock feed stuffs that have been withdrawn from the list of crops to be treated with fluopyram. Based on a recalculation of the livestock dietary burden, the Agency is establishing tolerances for livestock commodities that are lower than requested.

In addition, the Agency has revised several commodity terms to reflect the current commodity definitions used by the Agency and revised several tolerance level values to be consistent with EPA's practice of extending tolerance values out to two significant figures.

Although the petition requested a tolerance for nut tree group 14, the Agency is establishing a tolerance for nut, tree 14-12 consistent with its stated policy of not establishing tolerances for pre-existing crop groups. See 77 FR 50617, 50619 (Aug. 22, 2012).

Finally, the requests for tolerances were withdrawn for the following commodities: Crop group 7 at 90.0 ppm; crop group 17 at 80.0 ppm; peanut hay at 40.0 ppm, soybean forage at 9.0 ppm; and soybean hay at 30.0 ppm. A separate tolerance for wheat, milled byproducts is not needed as it is covered by the crop group 15 tolerance.

Therefore, tolerances are established for residues of fluopyram in or on almond, hulls at 10 ppm; artichoke, globe at 4.0 ppm, bean, dry at 0.70 ppm; beet, sugar at 0.10 ppm; berry, low growing, except cranberry, subgroup 13-07G at 2.0 ppm; brassica, head and stem, subgroup 5A at 4.0 ppm; brassica, leafy greens, subgroup 5B at 50 ppm; bushberry subgroup 13-07B at 7.0 ppm; grain, aspirated grain fractions at 50 ppm; caneberry subgroup 13-07A at 5.0 ppm; cereal, forage, fodder and straw, group 16 at 20 ppm; cherry subgroup 12-12A at 2.0 ppm; citrus, oil at 8.0 ppm; corn, field, grain at 0.02 ppm; corn, pop, grain at 0.02 ppm; corn, sweet, kernel plus cob with husks removed 0.01 ppm; cotton, gin byproducts at 30 ppm; cottonseed subgroup 20C at 0.80 ppm; dill, seed at 70 ppm; rapeseed subgroup 20A at 5.0 ppm; fruit, citrus, group 10-10 at 1.0 ppm; fruit, pome, group 11-10 at 0.80 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; grape, raisin at 3.0 ppm; grain, cereal, group 15, except corn and rice at 4.0 ppm; grain, herb subgroup 19A at 40 ppm; hop, dried cones at 60 ppm; leaf petioles subgroup 4B at 20 ppm; leafy greens subgroup 4A at 40 ppm; melon subgroup 9A at 1.0 ppm; nut, tree, group 14-12 at 0.05 ppm; onion, bulb, subgroup 3-07A at 0.40 ppm; onion, green, subgroup 3-07B at 15 ppm; pea and bean, succulent shelled, subgroup 6B at 0.20 ppm; peach subgroup 12-12B at 1.0 ppm; peanut at 0.20 ppm; potato, wet peel at 0.30 ppm; pepper/eggplant subgroup 8-10B at 4.0 ppm; plum subgroup 12-12C at 0.50 ppm; soybean, seed at 0.30 ppm; squash/cucumber subgroup 9B at 0.60 ppm; sunflower subgroup 20B at 0.70 ppm; tomato subgroup 8-10A at 1.0 ppm; vegetable, leaves of root and tuber, group 2 at 30 ppm; vegetable, legume, edible podded, subgroup 6A at 4.0 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.30 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.10 ppm.

Tolerances are also established for residues of fluopyram and its metabolite 2-(trifluoromethyl)benzamide, expressed in parent equivalents for cattle, fat at 0.70 ppm; cattle, meat at 0.80 ppm; cattle, meat byproducts at 7.5 ppm; egg at 0.08 ppm; goat, fat at 0.70 ppm; goat, meat at 0.80 ppm; goat, meat byproducts at 7.5 ppm; hog, meat byproducts at 0.20 ppm; horse, fat at 0.70 ppm; horse, meat at 0.80 ppm; horse, meat byproducts at 7.5 ppm; milk at 0.40 ppm; poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, meat byproducts at 0.16 ppm; sheep, fat at 0.70 ppm; sheep, meat at 0.80 ppm; and sheep, meat byproducts at 7.5 ppm.

In addition, the Agency is removing tolerances for almond, hull; apple, wet pomace; bean, dry; beet, sugar, root; canola seed; cotton, gin byproducts; cotton, undelinted seed; cherry; grape, wine; grain, cereal, except rice, group 15; grain, cereal, forage, fodder, and straw, group 16; nut, tree, group 14; peanut; pistachio; potato; soybean forage; soybean hay; soybean, seed; strawberry; and watermelon because they are superseded by other tolerances being established in this action.

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:

In FR Doc. 2015-28005 (80 FR 70886 through 71386), the final rule entitled “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016” (hereinafter referred to as the CY 2016 PFS final rule with comment period), there were a number of technical and typographical errors that are identified and corrected in section IV., the Correction of Errors. The effective date for the rule was January 1, 2016, except for the definition of “ownership or investment interest” in § 411.362(a), which has an effective date of January 1, 2017. These corrections are applicable as of January 1, 2016. We note that Addenda B and C to the CY 2016 PFS final rule with comment period as corrected by this correcting amendment are available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

On page 70894, we inadvertently omitted a sentence from the first comment summary regarding applying the same overrides used for the MP RVU calculations to the PE calculations.

On page 70894, we inadvertently omitted a clause from the response summary regarding the overrides that also apply to the MP RVU calculation in the development of PE RVUs.

On page 70898, due to data errors made in the ratesetting process, many of the values contained in Table 4: Calculation of PE RVUs under Methodology for Selected Codes, are incorrect.

On page 70953, we inadvertently included language regarding the application of the equipment utilization assumption.

On page 70971,

a. Due to a typographical error, the work RVU for CPT code 76945 was listed incorrectly. As a result, the work RVU for CPT code 76948 was also inadvertently listed incorrectly.

b. Due to a typographical error, we inadvertently referred to CPT code 76948 rather than CPT code 76945.

On page 70992, due to a typographical error in Table 13—CY 2016 Actions on Codes with CY 2015 Interim Final RVUs, the CY 2016 work RVU for CPT code 76948 was incorrectly displayed.

On page 71317, we inadvertently included language in our comment discussion on the issue regarding compensation arrangements.

On page 71357,

a. Due to data errors, we incorrectly stated the estimated CY 2016 net reduction in expenditures.

b. Due to data errors, we incorrectly stated the reduction to the conversion factor.

c. Due to data errors, we incorrectly stated the CY 2016 PFS conversion factors. As a result, many of the values in Table 60—Calculation of the CY 2016 PFS Conversion Factor, are incorrect.

d. Due to data errors, we incorrectly stated the CY 2016 PFS anesthesia conversion factors. As a result, many of the values in Table 61—Calculation of the CY 2016 PFS Anesthesia Conversion Factor, are incorrect.

On pages 71358 through 71359, due to data errors, many of the values in Table 62—CY 2016 PFS Estimated Impact On Total Allowed Charges By Specialty, are incorrect.

On pages 71359 through 71360, due to data errors, many of the values in Table 63— Impact on CY 2016 Payment for Selected Procedures, are incorrect.

On page 71369,

a. Due to data errors, we incorrectly stated the CY 2016 national payment amount in the nonfacility setting for CPT code 99203.

b. Due to data errors, we incorrectly stated the CY 2016 proposed beneficiary coinsurance for CPT code 99203.

On page 71375 of the CY 2016 PFS final rule with comment period, we made a typographical error in § 411.357(d)(1)(iv). In this paragraph, we inadvertently included the word “for”.

On page 71377 of the CY 2016 PFS final rule with comment period, we made a typographical error in § 411.357(x)(1)(vi)(A). In this paragraph, we inadvertently omitted the word “directly”.

Due to the errors identified and summarized in section II.A and B of this document, we are correcting errors in the work, PE or MP RVUs (or combinations of these RVUs) in Addendum B: CY 2016 Relative Value Units (RVUs) And Related Information Used In Determining Final Medicare Payments and Addendum C: CY 2016 Interim Final Relative Value Units (RVUs). We note that corrections to the RVUs for codes with identified errors affect additional codes due to the budget neutrality and relativity of the PFS. These errors are corrected in the revised Addenda B and C available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

In addition to the errors identified in section II.A. of this document, the following errors occur in the addenda.

Due to a technical error in the development of PE RVUs, the PE RVUS displayed in Addenda B and C were incorrect. In constructing the algorithm used to adjust specialty-specific volume for individual codes as described on page 70895 of the CY 2016 PFS final rule, claims volumes for codes billed with payment modifiers with different adjustments for payment and time were erroneously adjusted based on the time-based adjustment factor, not the payment-based factor. As a result, payment-adjusted volume associated with those modifiers for which the time-based adjustment factor is different from the payment-based adjustment factor was inaccurate and has been corrected. The direct impact of the errors were limited to the practice expense for services frequently reported with payment modifiers with different adjustments for payment and time. However, the PE RVUs for many more codes may have been affected indirectly due to BN adjustments. The two specialties that report services paid under the anesthesia fee schedule were the only specialties significantly affected by the change. The PE RVUs that result from the correction of this error are reflected in the corrected Addendum B (and Addendum C, if applicable) available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to an error in the algorithm that we used to identify services that were subject to the phase-in of significant RVU reductions, CPT codes 67108, 67113, 67227 and 67228 were not included on the list of codes subject to the phase-in. These errors are corrected in the revised Codes Subject to Phase-in file available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/, and the resulting changes to the RVUs are reflected in the corrected Addenda B and C, available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to a data error, the useful life for the equipment item “FibroScan” (ER101) was incorrect in the direct PE input database. This error is corrected in the revised Direct PE Input Database available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/. As a result of this error being corrected, changes to PE RVUs are reflected in the corrected Addenda B and C, available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to a data error, the incorrect CY 2016 global periods were included in Addendum B (and Addendum C, if applicable) for the following CPT codes: 20240, 43210, 61650, 67227, 67228, 73060, and 73560. The corrected CY 2016 global periods for these codes are reflected in the corrected Addendum B (and Addendum C, if applicable) available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to an inadvertent error, the CY 2016 work RVUs for HCPCS codes G0296 and G0297 were incorrectly displayed in Addendum B. The correct CY 2016 work RVUS for these codes are reflected in the corrected Addendum B available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to a technical error, the clinical labor times associated with CPT codes 31654, 88333 and 99416 were inadvertently omitted from the direct PE input database. This error is corrected in the revised direct PE input database available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/. The PE RVUs that result from the correction of this error are reflected in the corrected Addendum B available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Due to a data input omission, the RVUs that reflect the appropriate payment rates for the treatment of intensive cardiac rehabilitation, as specified under section 1848(b)(5) of the Social Security Act (the Act), were not included in Addendum B. The appropriate RVUs for intensive cardiac rehabilitation are reflected in the corrected Addendum B available on the CMS Web site at http://www.cms.gov//PhysicianFeeSched/.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (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 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; similarly, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and comment, and delay in effective date requirements of the Act. 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 notice. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act 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 typographical and technical errors in the CY 2016 PFS final rule with comment period and the corresponding addenda posted on the CMS Web site. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies that were adopted subject to notice and comment procedures in the CY 2016 PFS final rule with comment period. As a result, the corrections made through this correcting document are intended to ensure that the CY 2016 PFS final rule with comment period accurately reflects the policies adopted in that 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 2016 PFS final rule with comment period 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 CY 2016 PFS final rule with comment period accurately reflects our final policies as soon as possible following the date they take effect. Further, such procedures would be unnecessary, because we are not altering the payment methodologies or policies, but rather, we are simply correcting the Federal Register document to reflect the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the CY 2016 PFS final rule with comment period accurately reflects these policies. For these reasons, we believe there is good cause to waive the requirements for notice and comment and delay in effective date.

In FR Doc. 2015-28005 of November 16, 2015 (80 FR 70886), make the following corrections:

1. On page 70894, first column,

a. First full paragraph, line 9, is corrected by adding the sentence “One commenter suggested that for CY 2016 we apply the same overrides used for the MP RVU calculations to the PE calculations.”.

b. Second full paragraph, lines 21 through 27, the sentence “Therefore, we are finalizing the policy as proposed for CY 2016 but will seek comment on the proposed CY 2017 PFS rates and whether or not the incorporation a new year of utilization data mitigates the need for service-level overrides.” is corrected to read “Therefore, we are finalizing the policy as proposed for CY 2016 and only apply the overrides that also apply to the MP RVU calculation in the development of PE RVUs but will seek comment on the proposed CY 2017 PFS rates and whether or not the incorporation of a new year of utilization data mitigates the need for service-level overrides.”.

2. On page 70898, Table 4-Calculation of PE RVUs under Methodology for Selected Codes, the table is corrected to read as follows:

3. On page 70953, second column, first partial paragraph, lines 3 through 6, the sentence “This approach is consistent with the application of the equipment utilization assumption for advanced diagnostic imaging” is deleted.

4. On page 70971,

a. First column, first full paragraph, line 15, the phrase “work RVU of 0.56” is corrected to read “work RVU of 0.67”.

b. First column, third full paragraph, line 12, the CPT code “76945” is corrected to read “76948”.

c. First column, fourth full paragraph, line 4 the CPT code “76945” is corrected to read “76948”.

d. First column, fourth full paragraph, line 16 the CPT code “76945” is corrected to read “76948”.

5. On page 70992, in Table 13—CY 2016 Actions on Codes with CY 2015 Interim Final RVUs, bottom half of the page, in columns 3 and 4, the work RVU “0.38” for CPT code 76948 is corrected to read “0.67”.

6. On page 71317,

a. Third column, second full paragraph, line 2, the phrase “on this issue (38, 50, 68, 73, 80)” is corrected to read “on this issue”.

b. Third column, second full paragraph, line 10, the phrase “Another commenter (38)” is corrected to read “Another commenter”.

7. On page 71357,

a. Third column, first partial paragraph, line 13, the figure “0.23” is corrected to read “0.22”.

b. Third column, first partial paragraph, line 24, the figure “-0.77” is corrected to read “−0.78.”

c. Third column, first full paragraph, line 9, the figure “$35.8279” is corrected to read “$35.8043”.

d. Third column, first full paragraph, line 17, the figure “$22.3309” is corrected to read “$21.9935”.

e. Table 60—Calculation of the CY 2016 PFS Conversion Factor, the table is corrected to read as follows:

f. Table 61—Calculation of the CY 2016 Anesthesia Conversion, the table is corrected to read as follows:

8. On pages 71358 through 71359, Table 62—CY 2016 PFS Estimated Impact On Total Allowed Charges By Specialty, the table is corrected to read as follows:

9. On pages 71359 through 71360, Table 63—Impact on CY 2016 Payment for Selected Procedures, the table is corrected to read as follows:

10. On page 71369,

a. Second column, fifth paragraph, line 20, the figure “$109.28” is corrected to read “108.85”.

b. Second column, fifth paragraph, line 23, the figure “$21.86” is corrected to read “21.77”.

Accordingly, 42 CFR chapter IV is corrected by making the following correcting amendments to part 411:

Regulations governing the summer flounder fishery are in 50 CFR 648.100 through 50 CFR 648.110. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.102.

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

North Carolina is transferring a total of 64,978 lb (29,473 kg) of summer flounder commercial quota to the following states: New Jersey, 13,200 lb (5,987 kg); Massachusetts, 9,805 lb (4,447 kg); Virginia, 30,573 lb (13,868 kg); and Rhode Island, 11,400 lb (5,171 kg). These transfers were requested by the State of North Carolina to repay landings by North Carolina permitted vessels that landed in these other states under safe harbor agreements.

The revised summer flounder quotas for calendar year 2016 are: North Carolina, 2,164,731 lb (981,905 kg); Virginia, 1,762,354 lb (799,390 kg); Rhode Island, 1,285,491 lb (583,089 kg); Massachusetts, 563,902 lb (255,782 kg); and New Jersey, 1,371,944 lb (622,303 kg), based on the quotas published in the 2016-2018 Summer Flounder, Scup and Black Sea Bass Specifications, (December 28, 2015, 80 FR 80689).

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