Flonicamid; Pesticide Tolerances, 31983-31986 [2020-10565]

Download as PDF Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Rules and Regulations DATES: This final rule is effective May 28, 2020. requirements, Travel and transportation expenses, Veterans. FOR FURTHER INFORMATION CONTACT: Jeffrey M. Martin, Assistant Director, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. Patricia M. Hayes, Ph.D. Chief Consultant, Women’s Health Services, Patient Care Services, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW, Washington, DC 20420. (202) 461–0373. (This is not a toll-free number.) In a document published in the Federal Register on December 13, 2019, VA adopted as final, with changes, an interim final rule providing for reimbursement of qualifying adoption expenses incurred by certain veterans (84 FR 68046). The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See also 5 CFR 1320.8(b)(3)(vi). As required by 44 U.S.C. 3507(d), VA submitted the information collection associated with § 17.390 to OMB for its review. OMB approved the new information collection requirements associated with the interim final rule under a 6-month emergency clearance and assigned OMB control number 2900–0860, although the control number did not appear in § 17.390 as revised by the final rule because the OMB control number 2900– 0860 expired on March 31, 2019. VA applied to OMB for a renewal of this information collection under a separate document and OMB approved the renewal of this information collection requirement associated with the final rule on March 10, 2020. This document revises § 17.390 by adding the approved OMB control number. SUPPLEMENTARY INFORMATION: jbell on DSKJLSW7X2PROD with RULES List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs— veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping VerDate Sep<11>2014 16:03 May 27, 2020 Jkt 250001 For the reasons set forth in the preamble, VA amends 38 CFR part 17 as follows: PART 17—MEDICAL 1. The authority citation for part 17 continues to read in part as follows: ■ Authority: 38 U.S.C. 501, and as noted in specific sections. * * * * * 2. Amend § 17.390 by revising the parenthetical sentence at the end of the section to read as follows: ■ § 17.390 Reimbursement for qualifying adoption expenses incurred by certain veterans. * * * * * (The Office of Management and Budget has approved the information collection requirement in this section under control number 2900–0860) [FR Doc. 2020–10012 Filed 5–27–20; 8:45 am] BILLING CODE 8320–01–P 40 CFR Part 180 [EPA–HQ–OPP–2019–0250; FRL–10009–26] Flonicamid; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation revises the tolerance for residues of flonicamid in or on Leafy greens subgroup 4–16A, except spinach. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 28, 2020. Objections and requests for hearings must be received on or before July 27, 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). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2019–0250, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency ADDRESSES: Frm 00047 Fmt 4700 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 note that due to the public health emergency, the EPA Docket Center (EPA/DC) and Reading Room was closed to public visitors on March 31, 2020. Our EPA/DC staff will continue to provide customer service via email, phone, and webform. For further information on EPA/DC services, docket contact information and the current status of the EPA/DC and Reading Room, please visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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 PO 00000 31983 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 E:\FR\FM\28MYR1.SGM 28MYR1 31984 Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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–2019–0250 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 July 27, 2020. 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– 2019–0250, 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 August 2, 2019 (84 FR 37818) (FRL–9996–78), 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 9E8743) by IR–4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.613 be amended by increasing the existing tolerance for residues of the insecticide flonicamid, including its metabolites and degradates, to be determined by measuring only the sum of flonicamid, VerDate Sep<11>2014 16:03 May 27, 2020 Jkt 250001 N-(cyanomethyl)-4-(trifluoromethyl)-3pyridinecarboxamide, and its metabolites, TFNA (4trifluoromethylnicotinic acid), TFNAAM (4-trifluoromethylnicotinamide), and TFNG, N-(4trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on Leafy greens subgroup 4–16A, except spinach, from 4.0 parts per million (ppm) to 8.0 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, for IR–4 which is available in the docket, https://www.regulations.gov. One comment was received on the notice of filing. EPA’s response to this comment is discussed in Unit IV.C. EPA is establishing the tolerance at 8 ppm rather than 8.0 ppm to be consistent with the Organization for Economic Cooperation and Development (OECD) Rounding Class Practice. 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 flonicamid including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with flonicamid follows. On April 8, 2019, EPA published in the Federal Register a final rule establishing tolerances for residues of PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 flonicamid on sunflower subgroup 20B based on the Agency’s conclusion that aggregate exposure to flonicamid is safe for the general population, including infants and children. See 84 FR 13805 (FRL–9990–52). That document contains a short discussion of the toxicological profile, assumptions for exposure assessment, cumulative risk, and Agency’s determination regarding the children’s safety factor, which have not changed. In addition, the April 8, 2019 final rule referred to a summary of the toxicological profile and the toxicological endpoints and the points of departure for flonicamid used for human risk assessment in Unit III.B. of the final rule published in the Federal Register of July 23, 2018 (83 FR 34775) (FRL–9977–82). Those discussions are also incorporated here, as they have not changed since those documents were published. EPA’s exposure assessments have been updated to include the additional exposure from use of flonicamid in greenhouses on commodities in the Leafy greens subgroup 4–16A, except spinach. EPA relied on tolerance-level residues and an assumption of 100 percent crop treated for all commodities. EPA’s aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure in drinking water, although the drinking water exposures are not impacted by this new greenhouse use and thus have not changed since the last assessment. Flonicamid is not registered for any specific use patterns that would result in residential exposure. Further information about EPA’s risk assessment and determination of safety supporting the tolerances established in the April 8, 2019 Federal Register action, as well as the new flonicamid tolerance can be found at https://www.regulations.gov in ‘‘Flonicamid. Human Health Risk Assessment for the Establishment of Permanent Tolerances in or on Sunflower Subgroup 20B,’’ dated December 6, 2018 in docket ID number EPA–HQ–OPP–2018–0273 and the document titled, ‘‘Flonicamid. Human Health Risk Assessment for a Petition to Increase the Tolerance for Leafy Greens, Except Spinach (Subgroup 4–16A) to Support Use on Greenhouse-Grown Commodities,’’ dated April 28, 2020 in docket ID number EPA–HQ–OPP–2019– 0250. No adverse effects resulting from a single oral exposure was identified and no acute dietary endpoint was selected; therefore, an acute dietary assessment was not conducted. Chronic dietary risks are below the Agency’s level of concern: 62% of the chronic populationadjusted dose (cPAD) for children 1 to E:\FR\FM\28MYR1.SGM 28MYR1 Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Rules and Regulations 2 years old, the group with the highest exposure. Flonicamid is not registered for any use patterns that would result in short- or intermediate-term residential exposures. EPA has concluded that the cPAD is protective of possible cancer effects from flonicamid. Because aggregate exposure to flonicamid is below the cPAD, EPA concludes that there is not an aggregate cancer risk from exposures to flonicamid. Therefore, based on these 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 flonicamid residues. More detailed information on the subject action to revise the tolerance in or on the Leafy greens subgroup 4–16A, except spinach, can be found in the document entitled, ‘‘Flonicamid. Human Health Risk Assessment for a Petition to Increase the Tolerance for Leafy Greens, Except Spinach (Subgroup 4–16A) to Support Use on Greenhouse-Grown Commodities’’ by going to https://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and click on the hyperlink for docket ID number EPA–HQ–OPP–2019– 0250. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. FMC Method No. P–3561M, a liquid chromatography-tandem mass spectrometry (LC/MS/MS) method, is an acceptable enforcement method for flonicamid and its metabolites in plant commodities. 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. jbell on DSKJLSW7X2PROD with RULES 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 VerDate Sep<11>2014 16:03 May 27, 2020 Jkt 250001 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 established MRLs for flonicamid in or on leaf lettuce at 8.0 ppm and head lettuce at 1.5 ppm. No other Codex MRLs are established for the crops within this subgroup. While the tolerance expression for U.S. flonicamid tolerances is different than the expression for the Codex flonicamid MRLs, the level of the new U.S. tolerance for Leafy greens subgroup 4– 16A, except spinach, is harmonized with the Codex MRL for leaf lettuce. Because the U.S. tolerance is for a crop subgroup, it not possible to harmonize with the Codex MRL for head lettuce, which is another commodity in the Leafy greens subgroup 4–16A. C. Response to Comments One commenter opposed approval of this tolerance claiming it could have detrimental effects on beneficial insects. Whether a pesticide has detrimental effects on beneficial insects, however, is a question outside the scope of analysis under the FFDCA because it is not relevant to whether tolerances are safe. 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. This comment provides no information relevant the Agency’s safety determination. Concerns about environmental impacts of a pesticide are more appropriately raised in actions related to pesticides being registered under the Federal Insecticide, Fungicide and Rodenticide Act. V. Conclusion Therefore, the existing tolerance for residues of flonicamid, including its metabolites and degradates, in or on Leafy greens subgroup 4–16A, except spinach, is modified to be 8 ppm, rather than 4.0 ppm. VI. Statutory and Executive Order Reviews This action modifies 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 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 31985 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 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 E:\FR\FM\28MYR1.SGM 28MYR1 31986 Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Rules and Regulations consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). ENVIRONMENTAL PROTECTION AGENCY VII. Congressional Review Act [EPA–HQ–OPPT–2018–0321; FRL–10008– 14] 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). RIN 2070–AK57 List of Subjects in 40 CFR Part 180 40 CFR Parts 704 and 712 Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA) Section 8(a) Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is finalizing amendments to the definition of small manufacturer, including a new definition for small government, in accordance with the Toxic Substances Control Act (TSCA). Changes to the small manufacturer definition impact certain reporting and Dated: May 6, 2020. recordkeeping requirements established Michael Goodis, under TSCA. EPA is also finalizing other minor changes. Director, Registration Division, Office of Pesticide Programs. DATES: This final rule is effective June 29, 2020. Therefore, 40 CFR chapter I is ADDRESSES: The docket for this action, amended as follows: identified by docket identification (ID) number EPA–HQ–OPPT–2018–0321, is PART 180—[AMENDED] available at https://www.regulations.gov or at the Office of Pollution Prevention ■ 1. The authority citation for part 180 and Toxics Docket (OPPT Docket), continues to read as follows: Environmental Protection Agency Authority: 21 U.S.C. 321(q), 346a and 371. Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 ■ 2. In § 180.613, revise the entry ‘‘Leafy Constitution Ave. NW, Washington, DC. greens subgroup 4–16A, except The Public Reading Room is open from spinach’’ in the table in paragraph (a)(1) 8:30 a.m. to 4:30 p.m., Monday through to read as follows: Friday, excluding legal holidays. The telephone number for the Public § 180.613 Flonicamid; tolerances for Reading Room is (202) 566–1744, and residues. the telephone number for the OPPT (a) * * * Docket is (202) 566–0280. Please review the visitor instructions and additional (1) * * * information about the docket available at https://www.epa.gov/dockets. Parts per Commodity Please note that due to the public million health emergency the EPA Docket Center (EPA/DC) and Reading Room * * * * * was closed to public visitors on March Leafy greens subgroup 4–16A, 31, 2020. Our EPA/DC staff will except spinach ........................ 8 continue to provide customer service via email, phone, and webform. For * * * * * further information on EPA/DC services, docket contact information and the * * * * * current status of the EPA/DC and [FR Doc. 2020–10565 Filed 5–27–20; 8:45 am] Reading Room, please visit https:// BILLING CODE 6560–50–P www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Tyler Lloyd, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, SUMMARY: jbell on DSKJLSW7X2PROD with RULES Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. VerDate Sep<11>2014 16:03 May 27, 2020 Jkt 250001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 Washington, DC 20460–0001; telephone number: (202) 564–4016; email address: lloyd.tyler@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? You may be potentially affected by this action if you manufacture (defined by statute at 15 U.S.C. 2602(9) to include import) chemical substances, including byproduct chemical substances, and are subject to either of the following: (1) Reporting under the TSCA Chemical Data Reporting (CDR) requirements at 40 CFR part 711 or (2) TSCA reporting and recordkeeping requirements at 40 CFR part 704 or other TSCA reporting requirements which reference the small manufacturer standards at 40 CFR 704.3. Any use of the term ‘‘manufacture’’ in this document will encompass ‘‘import’’ and the term ‘‘manufacturer’’ will encompass ‘‘importer’’ unless otherwise stated. The potentially regulated community consists of entities that produce domestically or import into the United States chemical substances listed on the TSCA Inventory. The Agency’s previous experience with TSCA section 8(a) data collections has shown that most respondents affected by this collection activity are from the following North American Industrial Classification System (NAICS) code categories: • Chemical manufacturing or processing (NAICS code 325); and • Petroleum and coal products manufacturing (NAICS code 324). The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicable provisions at 40 CFR 711.8. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT. B. What is the Agency’s authority for taking this action? TSCA section 8(a)(1) authorizes EPA to promulgate rules under which manufacturers and processors of chemical substances must maintain such records and submit such reports as EPA may reasonably require (15 U.S.C. E:\FR\FM\28MYR1.SGM 28MYR1

Agencies

[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Rules and Regulations]
[Pages 31983-31986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10565]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0250; FRL-10009-26]


Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises the tolerance for residues of 
flonicamid in or on Leafy greens subgroup 4-16A, except spinach. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 28, 2020. Objections and 
requests for hearings must be received on or before July 27, 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-2019-0250, 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.
    Please note that due to the public health emergency, the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March 
31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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

[[Page 31984]]

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-2019-0250 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 July 27, 2020. 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-2019-0250, 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 August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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 
9E8743) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.613 be amended by increasing the existing 
tolerance for residues of the insecticide flonicamid, including its 
metabolites and degradates, to be determined by measuring only the sum 
of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on Leafy greens subgroup 4-16A, except 
spinach, from 4.0 parts per million (ppm) to 8.0 ppm. That document 
referenced a summary of the petition prepared by ISK Biosciences 
Corporation, the registrant, for IR-4 which is available in the docket, 
https://www.regulations.gov. One comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit IV.C.
    EPA is establishing the tolerance at 8 ppm rather than 8.0 ppm to 
be consistent with the Organization for Economic Cooperation and 
Development (OECD) Rounding Class Practice.

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 flonicamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flonicamid follows.
    On April 8, 2019, EPA published in the Federal Register a final 
rule establishing tolerances for residues of flonicamid on sunflower 
subgroup 20B based on the Agency's conclusion that aggregate exposure 
to flonicamid is safe for the general population, including infants and 
children. See 84 FR 13805 (FRL-9990-52). That document contains a short 
discussion of the toxicological profile, assumptions for exposure 
assessment, cumulative risk, and Agency's determination regarding the 
children's safety factor, which have not changed. In addition, the 
April 8, 2019 final rule referred to a summary of the toxicological 
profile and the toxicological endpoints and the points of departure for 
flonicamid used for human risk assessment in Unit III.B. of the final 
rule published in the Federal Register of July 23, 2018 (83 FR 34775) 
(FRL-9977-82). Those discussions are also incorporated here, as they 
have not changed since those documents were published.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of flonicamid in greenhouses on 
commodities in the Leafy greens subgroup 4-16A, except spinach. EPA 
relied on tolerance-level residues and an assumption of 100 percent 
crop treated for all commodities. EPA's aggregate exposure assessment 
incorporated this additional dietary exposure, as well as exposure in 
drinking water, although the drinking water exposures are not impacted 
by this new greenhouse use and thus have not changed since the last 
assessment. Flonicamid is not registered for any specific use patterns 
that would result in residential exposure. Further information about 
EPA's risk assessment and determination of safety supporting the 
tolerances established in the April 8, 2019 Federal Register action, as 
well as the new flonicamid tolerance can be found at https://www.regulations.gov in ``Flonicamid. Human Health Risk Assessment for 
the Establishment of Permanent Tolerances in or on Sunflower Subgroup 
20B,'' dated December 6, 2018 in docket ID number EPA-HQ-OPP-2018-0273 
and the document titled, ``Flonicamid. Human Health Risk Assessment for 
a Petition to Increase the Tolerance for Leafy Greens, Except Spinach 
(Subgroup 4-16A) to Support Use on Greenhouse-Grown Commodities,'' 
dated April 28, 2020 in docket ID number EPA-HQ-OPP-2019-0250.
    No adverse effects resulting from a single oral exposure was 
identified and no acute dietary endpoint was selected; therefore, an 
acute dietary assessment was not conducted. Chronic dietary risks are 
below the Agency's level of concern: 62% of the chronic population-
adjusted dose (cPAD) for children 1 to

[[Page 31985]]

2 years old, the group with the highest exposure. Flonicamid is not 
registered for any use patterns that would result in short- or 
intermediate-term residential exposures. EPA has concluded that the 
cPAD is protective of possible cancer effects from flonicamid. Because 
aggregate exposure to flonicamid is below the cPAD, EPA concludes that 
there is not an aggregate cancer risk from exposures to flonicamid.
    Therefore, based on these 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 flonicamid residues. More detailed 
information on the subject action to revise the tolerance in or on the 
Leafy greens subgroup 4-16A, except spinach, can be found in the 
document entitled, ``Flonicamid. Human Health Risk Assessment for a 
Petition to Increase the Tolerance for Leafy Greens, Except Spinach 
(Subgroup 4-16A) to Support Use on Greenhouse-Grown Commodities'' by 
going to https://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES. Locate and click on the hyperlink for docket ID number 
EPA-HQ-OPP-2019-0250.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. FMC Method No. P-3561M, a liquid chromatography-
tandem mass spectrometry (LC/MS/MS) method, is an acceptable 
enforcement method for flonicamid and its metabolites in plant 
commodities.
    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 established MRLs for flonicamid in or on leaf lettuce 
at 8.0 ppm and head lettuce at 1.5 ppm. No other Codex MRLs are 
established for the crops within this subgroup. While the tolerance 
expression for U.S. flonicamid tolerances is different than the 
expression for the Codex flonicamid MRLs, the level of the new U.S. 
tolerance for Leafy greens subgroup 4-16A, except spinach, is 
harmonized with the Codex MRL for leaf lettuce. Because the U.S. 
tolerance is for a crop subgroup, it not possible to harmonize with the 
Codex MRL for head lettuce, which is another commodity in the Leafy 
greens subgroup 4-16A.

C. Response to Comments

    One commenter opposed approval of this tolerance claiming it could 
have detrimental effects on beneficial insects. Whether a pesticide has 
detrimental effects on beneficial insects, however, is a question 
outside the scope of analysis under the FFDCA because it is not 
relevant to whether tolerances are safe. 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. 
This comment provides no information relevant the Agency's safety 
determination. Concerns about environmental impacts of a pesticide are 
more appropriately raised in actions related to pesticides being 
registered under the Federal Insecticide, Fungicide and Rodenticide 
Act.

V. Conclusion

    Therefore, the existing tolerance for residues of flonicamid, 
including its metabolites and degradates, in or on Leafy greens 
subgroup 4-16A, except spinach, is modified to be 8 ppm, rather than 
4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action modifies 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 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

[[Page 31986]]

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: May 6, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.613, revise the entry ``Leafy greens subgroup 4-16A, 
except spinach'' in the table in paragraph (a)(1) to read as follows:


Sec.  180.613  Flonicamid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Leafy greens subgroup 4-16A, except spinach.................           8
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-10565 Filed 5-27-20; 8:45 am]
BILLING CODE 6560-50-P
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