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withdrawal of approval of these applications.

Dated: December 4, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine.
[FR Doc. 2015–31040 Filed 12–8–15; 8:45 am]

**BILLING CODE 4164–01–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2014–0822; FRL–9939–52]**

**Azoxystrobin; Pesticide Tolerances**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  This regulation establishes tolerances for residues of azoxystrobin in or on quinoa grain, ti leaves, ti roots, and modifies the existing tolerances for the stone fruit group 12 and tree nut group 14 to read ‘‘stone fruit group 12– 12’’ and ‘‘tree nut group 14–12, except pistachio’’ respectively. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

**DATES :**  This regulation is effective December 9, 2015. Objections and requests for hearings must be received on or before February 8, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the

**SUPPLEMENTARY INFORMATION**).

**ADDRESSES :**  The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0822, is 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 docket available
at http://www.epa.gov/dockets.

**FOR FURTHER INFORMATION CONTACT :**  Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov.

**SUPPLEMENTARY INFORMATION :** 
I. General Information A. Does this action apply to me?

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information?

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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab

_02.tpl. C. How can I file an objection or hearing request?

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–2014–0822 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 8, 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– 2014–0822, 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. II. Summary of Petitioned-For Tolerance

In the Federal Register of March 4, 2015 (80 FR 11611) (FRL–9922–68), 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 4E8319) 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 azoxystrobin (methyl (E)-2- { 2-[6-(2-cyanophenoxy) pyrimidin-4- yloxy]phenyl } -3-methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-{ 2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl } -3-methoxyacrylate) in or on the raw agricultural commodities ti palm, leaves at 50 parts per million (ppm); ti palm, roots at 0.5 ppm; fruit, stone, group 12–12 at 2.0 ppm; and nut, tree, group 14–12 at 0.02 ppm. Upon the approval of the aforementioned tolerances, the petitioner requested to remove the established tolerances for azoxystrobin in or on the raw agricultural commodities fruit, stone, group 12 at 1.5 ppm; and nut, tree, group 14 at 0.02 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. EPA received two comments in response to the March 4, 2015 Notice of Filing that simply said ‘‘Good.’’

In the Federal Register of October 21, 2015 (80 FR 63731) (FRL–9935–29), EPA amended the initial notice of filing for pesticide petition (PP 4E8319), including the commodity quinoa grain at 3.0 ppm in addition to the commodities originally requested and listed above. Comments were received


### 76389 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations

to the notice of filing. EPA’s response to these comments is discussed in Unit IV.C.

EPA has modified the tolerance for the tree nut group 14–12 to exclude pistachio. The reason for this change is explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with FFDCA section 408(b)(2), for tolerances for residues of azoxystrobin in or on quinoa grain, ti palm leaves, ti palm roots, the stone fruit group 12–12, and the tree nut group 14–12. As discussed below, EPA is relying upon the findings in the preamble to the rule published in the Federal Register May 1, 2015 (80 FR 24824) (FRL–9926–24) establishing tolerances for azoxystrobin and supporting risk assessments to establish and modify these tolerances.

On May 1, 2015, EPA published a final rule establishing tolerances for residues of azoxystrobin in or on coffee, green bean; pear, Asian; and tea, dried based on the Agency’s conclusion that aggregate exposure to azoxystrobin is safe for the general population, including infants and children. In addition to the tolerances listed above, EPA also considered the following uses in the risk assessments that supported the May 1, 2015 final rule: Ti palm leaves, ti palm roots, the stone fruit group 12–12, and the tree nut group 14– 12 and also separately evaluated the request to establish a tolerance in or on quinoa grain.

Since the publication of the May 1, 2015 final rule, the toxicity profile of azoxystrobin has not changed, and the risk assessments that supported the establishment of those azoxystrobin tolerances published in the May 1, 2015 Federal Register remain valid. Those risk assessments also support the establishment of the tolerances that are the subject of this action. The Agency also evaluated the request to establish a tolerance in or on quinoa grain at 3.0 ppm and concluded that the aggregate exposure and risks would not increase as a result of the proposed use on quinoa and are the same as those estimated in the May 1 final rule. Therefore, EPA is relying on those risk assessments in order to establish the new tolerances. For a detailed discussion of the aggregate risk assessments and determination of safety for the proposed tolerances, please refer to the May 1, 2015 Federal Register document and its supporting documents, available at http:// www.regulations.gov. EPA relies upon those supporting risk assessments and the findings made in the Federal Register document in support of this rule.

Based on the risk assessments and information described above, 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 azoxystrobin residues. Further information about EPA’s risk assessment and determination of safety supporting the tolerances established in the May 1,
2015 Federal Register action, as well as the new azoxystrobin tolerances can be found at http://www.regulations.gov in the documents entitled: ‘‘Azoxystrobin. Human Health Aggregate Risk Assessment for Permanent Tolerances on Imported Asian Pear, Imported Tea, and Imported Coffee; Establishment of Permanent Tolerances on Ti Palm and for Crop Group Conversions for Stone Fruits Group 12–12 and Tree Nut Group 14–12 Crop Groups’’ and ‘‘Azoxystrobin. Addendum to Human Health Aggregate Risk Assessment D423691 and D418374, Dated 4/7/2015, to Support a New Use on Quinoa.’’ The documents may be found in docket ID number EPA–HQ–OPP–2014–0822.

IV. Other Considerations A. Analytical Enforcement Methodology

Adequate enforcement methodology (gas chromatography with a nitrogenphosphorus detector (GC/NPD) method, RAM 243/04) is available to enforce the tolerance expression for residues of azoxystrobin and its Zisomer in crop commodities. This method (designated RAM 243, dated 5/ 15/98) has been submitted to FDA for inclusion in the Pesticide Analytical Manual (PAM), Volume II.

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: residuemethods@
epa.gov.
B. International Residue Limits

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

The Codex has not established a MRL for quinoa grain or ti palm leaves or
roots.

The Codex has established an MRL for stone fruit at 2 milligram/kilogram (mg/ kg), which is harmonized with the U.S. tolerance of 2 ppm.

The Codex has established an MRL of 0.01 mg/kg for tree nuts. The US crop group tolerance is based on a residue definition of azoxystrobin plus the Zisomer (R230310). Residues were < 0.01 ppm for each component in the almond and pecan trials. Therefore, the tolerance estimate is 0.02 ppm, the sum of the components. The Codex residue definition is parent only, which support the 0.01 mg/kg MRL. The US tolerance cannot be harmonized with Codex at this time.
C. Response to Comments

Four comments were received in response to the October 21, 2015 notice of filing. The first comment asserted that no residues should be allowed and that the pesticide should not be approved for sale or use. The second stated that pesticides are ‘‘causing normally


### 76390 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations

healthy people to have serious life treating (sic) health issues and is making many Americans overweight’’ and the commenter did not want their food to have pesticide residues. The third commenter stated that they were very allergic to any chemical and demanded that all chemical treatments must be rejected and stopped. The Agency understands the commenters’ concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The comments appear to be directed at the underlying statute and not EPA’s implementation of it; the citizens have made no contention that EPA has acted in violation of the statutory framework.

The fourth comment was from the Center for Biological Diversity and concerned endangered species; specifically stating that EPA cannot approve this new use prior to completion of consultations with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (‘‘the Services’’). This comment is not relevant to the Agency’s evaluation of safety of the azoxystrobin tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.

D. Revisions to Petitioned-For Tolerances

The petitioned-for tolerance for ‘‘Nut, tree, group 14–12’’ is being modified to read ‘‘Nut, tree, group 14–12, except pistachio’’ because an existing tolerance for pistachio exists at a higher level (0.50 ppm). In addition, although the petition requested tolerances for ti palm leaves and roots, EPA is establishing tolerances for ‘‘ti, leaves’’ and ‘‘ti, roots’’ to be consistent with its food and feed commodity vocabulary.

V. Conclusion

Therefore, tolerances are established for residues of azoxystrobin (methyl (E)-

2-{ 2-[6-(2-cyanophenoxy)pyrimidin-4- yloxy]phenyl } -3-methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-{ 2-[6-(2-cyanophenoxy)pyrimidin4-yloxy]phenyl } -3-methoxyacrylate) in or on the raw agricultural commodities quinoa, grain at 3.0 ppm; ti, leaves at 50 ppm; and ti, roots at 0.5 ppm. Additionally, the existing tolerance for ‘‘fruit, stone, group 12’’ is modified to read ‘‘fruit, stone, group 12–12’’ and to increase the tolerance level from 1.5 ppm to 2.0 ppm. Finally, the existing tolerance for ‘‘nut, tree, group 14’’ is modified to read ‘‘nut, tree, group 14– 12, except pistachio.’’ VI. Statutory and Executive Order Reviews

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

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

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

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

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). List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: December 2, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

**PART 180—[AMENDED]**

■ 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

■ 2. In § 180.507:

■ a. Add alphabetically the commodities to the table in paragraph (a)(1).

■ b. Revise the commodities ‘‘fruit, stone, group 12’’ and ‘‘nut, tree, group 14’’ in paragraph (a)(1).

The additions and revisions read as follows:

**§ 180.507 Azoxystrobin; tolerances for residues.** 

(a)(1) * * *

Commodity Parts per million

* * * * * Fruit, stone, group 12–12 ..... 2.0

* * * * *Nut, tree, group 14–12, except pistachio .................... 0.02


### 76391 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations

Commodity Parts per million

* * * * * Quinoa, grain ........................ 3.0

* * * * * Ti, leaves .............................. 50.0 Ti, roots ................................. 0.5

* * * * *

* * * * * [FR Doc. 2015–31053 Filed 12–8–15; 8:45 am]

**BILLING CODE 6560–50–P**

**DEPARTMENT OF HOMELAND SECURITY** 

**Federal Emergency Management Agency** 

**44 CFR Part 64**

**[Docket ID FEMA–2015–0001; Internal Agency Docket No. FEMA–8413]** 

**Suspension of Community Eligibility**

**AGENCY :**  Federal Emergency Management Agency, DHS.

**ACTION :**  Final rule.

**SUMMARY :**  This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA’s Community Status Book (CSB). The CSB is available at http:// www.fema.gov/fema/csb.shtm.

**DATES :**  The effective date of each community’s scheduled suspension is the third date (‘‘Susp.’’) listed in the third column of the following tables.

**FOR FURTHER INFORMATION CONTACT :**  If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646–4149.

**SUPPLEMENTARY INFORMATION :**  The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register

.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA’s initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. List of Subjects in 44 CFR Part 64

Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:

**PART 64—[AMENDED]**

■ 1. The authority citation for part 64 continues to read as follows:

Authority: 42 U.S.C. 4001 et seq. ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376.