Pydiflumetofen; Pesticide Tolerance, 55193-55196 [2020-17791]

Download as PDF Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Rules and Regulations flexibility to manage the program (85 FR 35404). The Postal Service received 63 comment letters from the public, associations, and members of Congress. All commenters were in favor of the revisions. Most noted that the revisions would permit resumption of sales of the Alzheimer’s semipostal stamp. Summary of Changes The regulations in effect before this final rule, promulgated April 20, 2016, limited sales of discretionary semipostal stamps to one at a time and a two-year sales period, and contemplated five semipostal stamp offerings over the 10year term of the Semipostal Stamp program. This proved impracticable. Further, the Postal Service encountered continued interest in the sale of a previously offered discretionary semipostal stamp for which the Postal Service possesses unsold inventory. The final rule eliminates the one at a time limitation and the two-year sales period limitation, and provides more flexibility to the Postal Service. The immediate effect of this final rule is to permit resumption of sales of the Alzheimer’s semipostal stamp. List of Subjects in 39 CFR Part 551 Administrative practice and procedure. For the reasons stated in the preamble, the Postal Service amends 39 CFR part 551 as follows: PART 551—SEMIPOSTAL STAMP PROGRAM 1. The authority citation for part 551 continues to read as follows: Authority: 39 U.S.C. 101, 201, 203, 401, 403, 404, 410, 414, 416. 2. Amend § 551.3, by revising paragraph (a) to read as follows: ■ § 551.3 Procedure for selection of causes and recipient executive agencies. jbell on DSKJLSW7X2PROD with RULES * * * * (a) The Office of Stamp Services will accept proposals from interested persons for future semipostal stamps beginning on May 20, 2016. The Office of Stamp Services will begin considering proposals on July 5, 2016. This section should not be read to reflect the intention of the Postal Service to issue any particular number of semipostal stamps during the 10-year period of this part. Proposals may be submitted and will be considered on a rolling basis until seven years after May 20, 2016. The Office of Stamp Services may publicize this request for proposals in the Federal Register or through other means, as it determines in its discretion. Proposals for semipostal stamps made VerDate Sep<11>2014 15:43 Sep 03, 2020 Jkt 250001 § 551.5 [Amended] 3. In § 551.5, remove and reserve paragraphs (b) and (c). ■ Joshua J. Hofer, Attorney, Federal Compliance. [FR Doc. 2020–18549 Filed 9–3–20; 8:45 am] BILLING CODE 7710–12–P closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2019–0273; FRL–10012–18] Pydiflumetofen; Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for the inadvertent residues of pydiflumetofen in or on animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, group 17, except straw; and grass, forage, fodder and hay, group 17, straw. Syngenta Crop Protection, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective September 4, 2020. Objections and requests for hearings must be received on or before November 3, 2020, 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–2019–0273, is available at https://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. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is DATES: ■ * prior to May 20, 2016 will not be given further consideration. Nothing in this section should be construed as barring the resubmission of previously submitted causes and recipient executive agencies. * * * * * 55193 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 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 Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/ text-idx?&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–2019–0273 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 November 3, 2020. Addresses for mail and hand delivery of objections and E:\FR\FM\04SER1.SGM 04SER1 55194 Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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– 2019–0273, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of June 7, 2019 (84 FR 26630) (FRL–9993–93), 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 9F8744) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.699 be amended by establishing tolerances for inadvertent residues of the fungicide, pydiflumetofen (3-(difluoromethyl)-Nmethoxy-1-methyl-N-[1-methyl-2-(2,4,6 trichlorophenyl)ethyl]-1H-pyrazole-4carboxamide) in or on rice, grain at 0.01 parts per million (ppm); non-grass animal feed (Crop Group 18), forage at 0.01 ppm; non-grass animal feed (Crop Group 18), hay at 0.03 ppm; grasses, forage at 0.15 ppm; grasses, hay at 0.50 ppm; grasses, straw at 0.04 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, https:// 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 VerDate Sep<11>2014 15:43 Sep 03, 2020 Jkt 250001 establishing tolerances that vary slightly from what the petitioner requested, by using altered commodity definitions to reflect the Agency’s preferred terminology and adjusted tolerance levels for several commodities. In addition, EPA is not establishing tolerances for residues of pydiflumetofen in or on rice, grain and non-grass animal feed (crop group 18), forage. The reasons for these changes are 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), 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 pydiflumetofen including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with pydiflumetofen follows. On August 12, 2019, EPA published in the Federal Register a final rule establishing a tolerance for residues of the fungicide pydiflumetofen in or on various commodities. See (84 FR 39761) (FRL–9997–09). EPA is incorporating by reference the aspects of that rulemaking that remain the same for this rulemaking: The toxicological profile and points of departure/levels of concern; the determination for reducing the children’s safety factor and conclusions about cumulative risk. The Agency conducted an updated risk assessment to evaluate exposure to residues of pydiflumetofen from the PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 reduced plant-back intervals on rice, grass grown for seed, non-grass animal feed crop group 18, and tobacco and concluded that the new use patterns would not impact previously assessed drinking water, dietary (food and drinking water), or residential, exposures to humans from the reduced plant-back intervals. Therefore, the Agency’s conclusions of aggregate risk remain unchanged from the August 12, 2019 rulemaking and are also incorporated into this rulemaking. Further information about EPA’s risk assessment and determination of safety supporting the tolerances for inadvertent residues established in the August 12, 2019 Federal Register action, as well as the new pydiflumetofen tolerance can be found at https://www.regulations.gov in the document entitled, ‘‘Pydiflumetofen. Human Health Risk Assessment for New Foliar Uses on Berries, Low Growing, Crop Subgroup 13–07G; Brassica Head and Stem Crop Group 5–16; Brassica Leafy Greens Subgroup 4–16B; Bulb Vegetable Crop Subgroup 3–07A; Green Onion Crop Subgroup 3–07B; Bushberry Crop Subgroup 13–07B; Citrus Fruit Crop Group 10–10; Cottonseed Subgroup 20C; Edible-podded Legume Vegetables Subgroup 6A; Succulent Shelled Pea and Bean Subgroup 6B; Pome Fruit Crop Group 11–10; Root Vegetable Crop Subgroup 1A; Sorghum; Stone Fruit Crop Subgroups 12–12A, 12–12B, and 12–12C; Sunflower Subgroup 20B; Tree Nut Crop Group 14–12; Leaves of Root and Tuber Vegetable Crop Group 2; and New Seed Treatment Uses on Rapeseed Crop Subgroup 20A and Soybean; and Registration of a New Seed Treatment End-Use Product,’’ dated July 22, 2019, in docket ID EPA–HQ–OPP–2018–0688. Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to pydiflumetofen residues. More detailed information on the subject action to establish tolerances in or on animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, group 17, except straw; and grass, forage, fodder and hay, group 17, straw can be found in the document entitled, ‘‘Pydiflumetofen. Human Health Risk Assessment for Amended Registrations to Allow 30-Day Minimum Plant-Back Interval (PBI) Restrictions for Rice, Grass Grown for Seed, Non-Grass Animal Feed Crop Group 18, and Tobacco and Petition for Inadvertent Tolerances in or on These Crops/ Commodities.’’ at https:// E:\FR\FM\04SER1.SGM 04SER1 Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Rules and Regulations www.regulations.gov, under docket ID number EPA–HQ–OPP–2019–0273. IV. Other Considerations A. Analytical Enforcement Methodology A multi-residue analytical method named Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) is adequate as the enforcement method for plant commodities. QuEChERS as described in Eurofins validation study S14–05402. 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 MRLs for pydiflumetofen in or on any of the commodities under consideration. jbell on DSKJLSW7X2PROD with RULES C. Revisions to Petitioned-For Tolerances The requested tolerance for ‘‘nongrass animal feed (Crop Group 18), hay’’ was modified to read ‘‘Animal feed, nongrass, group 18, hay’’ to be consistent with Agency naming practices. Requested tolerances for ‘‘grasses, forage,’’ ‘‘grasses, hay,’’ and ‘‘grasses, straw’’ were revised to read ‘‘Grass, forage, fodder and hay, group 17, except straw’’ and ‘‘Grass, forage, fodder and hay, group 17, straw’’ respectively, to be more consistent with the Agency’s preferred vocabulary and because EPA considers group 17 to be inclusive of a general request for tolerances on grasses. Tolerances for inadvertent residues of pydiflumetofen were requested for nongrass animal feed (Crop Group 18), VerDate Sep<11>2014 15:43 Sep 03, 2020 Jkt 250001 forage and rice, grain; however, the Agency is not setting tolerances because residues of pyflumetofen in field accumulation in rotational crop trials were found at <0.01 ppm in or on these commodities, and the Agency does not believe that tolerances are needed, in accordance with the Agency’s guidance (OPPTS Guideline 860.1900). The Agency is setting a tolerance in or on animal feed, nongrass, group 18, hay, of 0.04 ppm rather than at 0.03 ppm as requested based on clover hay data. The Agency is also setting a tolerance in or on grass, forage, fodder and hay, group 17, except straw of 0.7 ppm based on available data, which indicates that residues in or on grass forage and hay are within 5x, but residues on straw are much lower. V. Conclusion Therefore, tolerances are established for residues of pydiflumetofen in or on animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, group 17, except straw; and grass, forage, fodder and hay, group 17, straw. 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), nor is it considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 55195 the tolerance for inadvertent residues 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. E:\FR\FM\04SER1.SGM 04SER1 55196 Federal Register / Vol. 85, No. 173 / Friday, September 4, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES Dated: July 29, 2020. Catherine Aubee, Acting Director, Registration Division, Office of Pesticide Programs. the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of Therefore, for the reasons stated in the noncompliance with the floodplain management requirements of the preamble, EPA amends 40 CFR chapter program. If the Federal Emergency I as follows: Management Agency (FEMA) receives documentation that the community has PART 180—[AMENDED] adopted the required floodplain ■ 1. The authority citation for part 180 management measures prior to the continues to read as follows: effective suspension date given in this rule, the suspension will not occur and Authority: 21 U.S.C. 321(q), 346a and 371. a notice of this will be provided by ■ 2. In § 180.699, revise paragraph (d) to publication in the Federal Register on a read as follows: subsequent date. Also, information identifying the current participation § 180.699 Pydiflumetofen; tolerances for status of a community can be obtained residues. from FEMA’s Community Status Book * * * * * (CSB). The CSB is available at https:// (d) Indirect or inadvertent residues. www.fema.gov/national-floodTolerances are established for residues insurance-program-community-statusof pydiflumetofen, including its metabolites and degradates, in or on the book. commodities in table 2 to this paragraph DATES: The effective date of each community’s scheduled suspension is (d). Compliance with the tolerance the third date (‘‘Susp.’’) listed in the levels specified in table 2 to this third column of the following tables. paragraph (d) is to be determined by measuring only pydiflumetofen (3FOR FURTHER INFORMATION CONTACT: If (difluoromethyl)-N-methoxy-1-methylyou want to determine whether a N-[1-methyl-2-(2,4,6particular community was suspended trichlorophenyl)ethyl]-1H-pyrazole-4on the suspension date or for further carboxamide) in or on the commodity: information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance TABLE 2 TO PARAGRAPH (d) and Mitigation Administration, Federal Emergency Management Agency, 400 C Parts per Street SW, Washington, DC 20472, (202) Commodity million 674–1087. SUPPLEMENTARY INFORMATION: The NFIP Animal feed, nongrass, group 18, hay .................... 0.04 enables property owners to purchase Federal flood insurance that is not Grass, forage, fodder and otherwise generally available from hay, group 17, except straw .................................. 0.7 private insurers. In return, communities Grass, forage, fodder and agree to adopt and administer local hay, group 17, straw ......... 0.04 floodplain management measures aimed at protecting lives and new construction [FR Doc. 2020–17791 Filed 9–3–20; 8:45 am] from future flooding. Section 1315 of BILLING CODE 6560–50–P the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood DEPARTMENT OF HOMELAND insurance unless an appropriate public SECURITY body adopts adequate floodplain management measures with effective Federal Emergency Management enforcement measures. The Agency communities listed in this document no longer meet that statutory requirement 44 CFR Part 64 for compliance with program [Docket ID FEMA–2020–0005; Internal regulations, 44 CFR part 59. Agency Docket No. FEMA–8643] Accordingly, the communities will be suspended on the effective date in the Suspension of Community Eligibility third column. As of that date, flood insurance will no longer be available in AGENCY: Federal Emergency the community. We recognize that some Management Agency, Homeland of these communities may adopt and Security (DHS). submit the required documentation of ACTION: Final rule. legally enforceable floodplain SUMMARY: This rule identifies management measures after this rule is communities where the sale of flood published but prior to the actual insurance has been authorized under suspension date. These communities VerDate Sep<11>2014 15:43 Sep 03, 2020 Jkt 250001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply. 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. E:\FR\FM\04SER1.SGM 04SER1

Agencies

[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Rules and Regulations]
[Pages 55193-55196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17791]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0273; FRL-10012-18]


Pydiflumetofen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the inadvertent 
residues of pydiflumetofen in or on animal feed, nongrass, group 18, 
hay; grass, forage, fodder and hay, group 17, except straw; and grass, 
forage, fodder and hay, group 17, straw. Syngenta Crop Protection, LLC 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective September 4, 2020. Objections and 
requests for hearings must be received on or before November 3, 2020, 
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-2019-0273, is available at https://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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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: 
[email protected].

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 
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&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-2019-0273 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 
November 3, 2020. Addresses for mail and hand delivery of objections 
and

[[Page 55194]]

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-2019-0273, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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 
9F8744) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.699 be amended by 
establishing tolerances for inadvertent residues of the fungicide, 
pydiflumetofen (3-(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-
(2,4,6 trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on rice, 
grain at 0.01 parts per million (ppm); non-grass animal feed (Crop 
Group 18), forage at 0.01 ppm; non-grass animal feed (Crop Group 18), 
hay at 0.03 ppm; grasses, forage at 0.15 ppm; grasses, hay at 0.50 ppm; 
grasses, straw at 0.04 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, LLC, the registrant, 
which is available in the docket, https://www.regulations.gov. There 
were no comments received in response to the notice of filing. Based 
upon review of the data supporting the petition, EPA is establishing 
tolerances that vary slightly from what the petitioner requested, by 
using altered commodity definitions to reflect the Agency's preferred 
terminology and adjusted tolerance levels for several commodities. In 
addition, EPA is not establishing tolerances for residues of 
pydiflumetofen in or on rice, grain and non-grass animal feed (crop 
group 18), forage. The reasons for these changes are 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), 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 pydiflumetofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pydiflumetofen 
follows.
    On August 12, 2019, EPA published in the Federal Register a final 
rule establishing a tolerance for residues of the fungicide 
pydiflumetofen in or on various commodities. See (84 FR 39761) (FRL-
9997-09). EPA is incorporating by reference the aspects of that 
rulemaking that remain the same for this rulemaking: The toxicological 
profile and points of departure/levels of concern; the determination 
for reducing the children's safety factor and conclusions about 
cumulative risk. The Agency conducted an updated risk assessment to 
evaluate exposure to residues of pydiflumetofen from the reduced plant-
back intervals on rice, grass grown for seed, non-grass animal feed 
crop group 18, and tobacco and concluded that the new use patterns 
would not impact previously assessed drinking water, dietary (food and 
drinking water), or residential, exposures to humans from the reduced 
plant-back intervals. Therefore, the Agency's conclusions of aggregate 
risk remain unchanged from the August 12, 2019 rulemaking and are also 
incorporated into this rulemaking.
    Further information about EPA's risk assessment and determination 
of safety supporting the tolerances for inadvertent residues 
established in the August 12, 2019 Federal Register action, as well as 
the new pydiflumetofen tolerance can be found at https://www.regulations.gov in the document entitled, ``Pydiflumetofen. Human 
Health Risk Assessment for New Foliar Uses on Berries, Low Growing, 
Crop Subgroup 13-07G; Brassica Head and Stem Crop Group 5-16; Brassica 
Leafy Greens Subgroup 4-16B; Bulb Vegetable Crop Subgroup 3-07A; Green 
Onion Crop Subgroup 3-07B; Bushberry Crop Subgroup 13-07B; Citrus Fruit 
Crop Group 10-10; Cottonseed Subgroup 20C; Edible-podded Legume 
Vegetables Subgroup 6A; Succulent Shelled Pea and Bean Subgroup 6B; 
Pome Fruit Crop Group 11-10; Root Vegetable Crop Subgroup 1A; Sorghum; 
Stone Fruit Crop Subgroups 12-12A, 12-12B, and 12-12C; Sunflower 
Subgroup 20B; Tree Nut Crop Group 14-12; Leaves of Root and Tuber 
Vegetable Crop Group 2; and New Seed Treatment Uses on Rapeseed Crop 
Subgroup 20A and Soybean; and Registration of a New Seed Treatment End-
Use Product,'' dated July 22, 2019, in docket ID EPA-HQ-OPP-2018-0688.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to pydiflumetofen residues. More detailed 
information on the subject action to establish tolerances in or on 
animal feed, nongrass, group 18, hay; grass, forage, fodder and hay, 
group 17, except straw; and grass, forage, fodder and hay, group 17, 
straw can be found in the document entitled, ``Pydiflumetofen. Human 
Health Risk Assessment for Amended Registrations to Allow 30-Day 
Minimum Plant-Back Interval (PBI) Restrictions for Rice, Grass Grown 
for Seed, Non-Grass Animal Feed Crop Group 18, and Tobacco and Petition 
for Inadvertent Tolerances in or on These Crops/Commodities.'' at 
https://

[[Page 55195]]

www.regulations.gov, under docket ID number EPA-HQ-OPP-2019-0273.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A multi-residue analytical method named Quick, Easy, Cheap, 
Effective, Rugged, and Safe (QuEChERS) is adequate as the enforcement 
method for plant commodities. QuEChERS as described in Eurofins 
validation study S14-05402. 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].

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 MRLs for pydiflumetofen in or on any 
of the commodities under consideration.

C. Revisions to Petitioned-For Tolerances

    The requested tolerance for ``non-grass animal feed (Crop Group 
18), hay'' was modified to read ``Animal feed, nongrass, group 18, 
hay'' to be consistent with Agency naming practices. Requested 
tolerances for ``grasses, forage,'' ``grasses, hay,'' and ``grasses, 
straw'' were revised to read ``Grass, forage, fodder and hay, group 17, 
except straw'' and ``Grass, forage, fodder and hay, group 17, straw'' 
respectively, to be more consistent with the Agency's preferred 
vocabulary and because EPA considers group 17 to be inclusive of a 
general request for tolerances on grasses.
    Tolerances for inadvertent residues of pydiflumetofen were 
requested for non-grass animal feed (Crop Group 18), forage and rice, 
grain; however, the Agency is not setting tolerances because residues 
of pyflumetofen in field accumulation in rotational crop trials were 
found at <0.01 ppm in or on these commodities, and the Agency does not 
believe that tolerances are needed, in accordance with the Agency's 
guidance (OPPTS Guideline 860.1900).
    The Agency is setting a tolerance in or on animal feed, nongrass, 
group 18, hay, of 0.04 ppm rather than at 0.03 ppm as requested based 
on clover hay data. The Agency is also setting a tolerance in or on 
grass, forage, fodder and hay, group 17, except straw of 0.7 ppm based 
on available data, which indicates that residues in or on grass forage 
and hay are within 5x, but residues on straw are much lower.

V. Conclusion

    Therefore, tolerances are established for residues of 
pydiflumetofen in or on animal feed, nongrass, group 18, hay; grass, 
forage, fodder and hay, group 17, except straw; and grass, forage, 
fodder and hay, group 17, straw.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance for 
inadvertent residues 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.


[[Page 55196]]


    Dated: July 29, 2020.
Catherine Aubee,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.699, revise paragraph (d) to read as follows:


Sec.  180.699  Pydiflumetofen; tolerances for residues.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of pydiflumetofen, including its metabolites and 
degradates, in or on the commodities in table 2 to this paragraph (d). 
Compliance with the tolerance levels specified in table 2 to this 
paragraph (d) is to be determined by measuring only pydiflumetofen (3-
(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-(2,4,6-
trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on the 
commodity:

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, hay....................            0.04
Grass, forage, fodder and hay, group 17, except straw...             0.7
Grass, forage, fodder and hay, group 17, straw..........            0.04
------------------------------------------------------------------------

[FR Doc. 2020-17791 Filed 9-3-20; 8:45 am]
BILLING CODE 6560-50-P
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