2023-14192. Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities (May 2023)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of filing of petition and request for comment.

SUMMARY:

This document announces the Agency's receipt of an initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

DATES:

Comments must be received on or before August 4, 2023.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2023–0069, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Anne Overstreet, Biopesticides and Pollution Prevention Division (BPPD) (7511M), main telephone number: 202–566–2425, email address: [e-mail]; or Charles Smith, Registration Division (RD) (7505T), main telephone number: (202) 566–2427, email address: [e-mail]. The mailing address for each contact person is Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. As part of the mailing address, include the contact person's name, division, and mail code. The division to contact is listed at the end of each application summary.

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. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/​dockets/​comments.html.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. What action is the Agency taking?

EPA is announcing receipt of a pesticide petition filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the request before responding to the petitioner. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petition described in this document contains data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the pesticide petition. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on this pesticide petition.

Pursuant to 40 CFR 180.7(f), a summary of the petition that is the subject of this document, prepared by the petitioner, is included in a docket EPA has created for this rulemaking. The docket for this petition is available at https://www.regulations.gov.

As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

A. Notice of Filing—Amended Tolerances for Non-Inerts

1. PP 3E9059. EPA–HQ–OPP–2021–0624. Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 63167, requests to amend the tolerance in 40 CFR 180.3 for residues of the insecticide, tetraniliprole, 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-1H-pyrazole-5-carboxamide, in or on tea at 80 parts per million (ppm). The high-performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) is used to measure and evaluate the chemical tetraniliprole. Contact: RD.

2. PP 2E9028. EPA–HQ–OPP–2022–0890. Interregional Research Project Number 4 (IR–4), IR–4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606, requests to amend 40 CFR 180.417 by removing the established time-limited tolerance for residues of the herbicide, triclopyr, 2-[(3,5,6-trichloro-2- pyridinyl)oxy]acetic acid, including its metabolites and degradates, in or on sugarcane, cane at 40 ppm. Contact: RD.

3. PP 2E9045. EPA–HQ–OPP–2023–0080. IR–4, IR–4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606, requests to amend 40 CFR 180.649 by removing the established tolerances for residues of the herbicide, saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N′-isopropylsulfamide and N-[4-chloro-2-fluoro-5 ({(isopropylamino)sulfonyl]amino}carbonyl)phenylurea, calculated as the stoichiometric equivalent of saflufenacil in or on the following raw agricultural plant commodities: Barley, grain at 1 ppm; chia, seed at 0.6 ppm; crop subgroup 20A; rapeseed subgroup at 0.45 ppm; fruit, pome, group 10 at 0.03 ppm; fruit, pome, group 11 at 0.03 ppm; fruit, stone, group 12 at 0.03 ppm; grain, cereal, group 15 (except barley and wheat grain) at 0.03 ppm; nut, tree, group 14 at 0.03 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.3 ppm; pea and bean, succulent shelled, subgroup 6B at 0.03 ppm; pistachio at 0.03 ppm; vegetable, foliage of legume, group 7 (except pea, hay) at 0.1 ppm; vegetable, legume, edible podded, subgroup 6A at 0.03 ppm; and wheat, grain at 0.6 ppm. IR–4 originally requested to remove the established tolerance for rapeseed 20A at 0.45 ppm but withdrew that request. Contact: RD.

4. PP 3E9059. EPA–HQ–OPP–2021–0624. Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 63167, requests to amend the tolerance in 40 CFR 180.3 for residues of the insecticide, tetraniliprole, 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-1H-pyrazole-5-carboxamide, in or on tea at 80 ppm. The HPLC/MS/MS is used to measure and evaluate the chemical tetraniliprole. Contact: RD.

B. Notice of Filing—New Tolerance Exemptions for Inerts (Except PIPS)

PP IN–11745. EPA–HQ–OPP–2023–0296. AgroFresh, 3 Spring House Innovation Park, Suite 100, Lower Gwynedd, PA 19002, requests to establish an exemption from the requirement of a tolerance for residues of sodium nitrate (CAS Reg. No. 7631–99–4) when used as an inert ingredient in pesticide formulations applied under 40 CFR 180.910. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD

C. Notice of Filing—New Tolerance Exemptions for Non-Inerts (Except PIPS)

1. PP 2F9027. EPA–HQ–OPP–2023–0255. BioWorks, Inc., 100 Rawson Road, Suite 205, Victor, NY 14564, requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the insecticide and miticide Beauveria bassiana strain BW149 in or on all food and feed commodities. The petitioner believes no analytical method is needed because the natural occurrence of the organism indicates that exposure is expected regardless of treatment, the magnitude of residues is expected to be at the same level as non-treated commodities. Contact: BPPD.

2. PP 3F9053. EPA–HQ–OPP–2023–0221. Agrotecnologías Naturales S.L. Ctra.T–214, s/n Km 4,125 43762 Riera de Gaià La Tarragona, Spain (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192), requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the fungicide Trichoderma atroviride AT10 in or on all food commodities. The petitioner believes no analytical method is needed because an exemption from the requirement of a tolerance is being proposed. Contact: BPPD.

D. Notice of Filing—New Tolerances for Non-Inerts

1. PP 1E8910. EPA–HQ–OPP–2022–0139. Corteva Agriscience, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide methoxyfenozide in or on coffee at 0.15 ppm and sugarcane at 0.03 ppm, and in the processed commodity sugarcane molasses at 0.1 ppm. The Liquid Chromatography with Tandem Mass Spectrometry Detection (Method GRM 02.25) is used to measure and evaluate the methoxyfenozide residues. Contact: RD.

2. PP 2E9045. EPA–HQ–OPP–2023–0080. IR–4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606, requests to establish tolerances in 40 CFR 180.649 for residues of the herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N′-isopropylsulfamide and N-[4-chloro-2-fluoro-5 ({(isopropylamino)sulfonyl]amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil in or on the following raw agricultural plant commodities: Barley subgroup 15–22B at 1 ppm; edible-podded bean subgroup 6–22A at 0.03 ppm; edible-podded pea subgroup 6–22B at 0.03 ppm; field corn subgroup 15–22C at 0.03 ppm; forage and hay of legumes vegetable group 7–22 (except pea, hay) at 0.1 ppm; forage, hay, stover, and straw of cereal grains group 16–22 (except barley and wheat and chia straw) at 0.1 ppm; fruit, citrus group 10–10 at 0.03 ppm; fruit, pome group 11–10 at 0.03 ppm; fruit, stone group 12–12 at 0.03 ppm; grain sorghum and millet subgroup 15–22E at 0.03 ppm; mint, dried leaves at 0.04 ppm; and mint, fresh leaves at 0.04 ppm; nut, tree, group 14–12 at 0.03 ppm; pulses, dried shelled bean, except soybean, subgroup 6–22E at 0.3 ppm; pulses, dried shelled pea subgroup 6–22F at 0.3 ppm; rice subgroup 15–22F at 0.03 ppm; succulent shelled bean subgroup 6–22C at 0.03 ppm; succulent shelled pea subgroup 6–22D at 0.03 ppm; sweet corn subgroup 15–22D at 0.03 ppm; and wheat subgroup 15–22A at 0.7 ppm. The submission originally petitioned for a tolerance for rapeseed subgroup 20A at 0.6 ppm but was withdrawn by IR–4. A High-Performance Liquid Chromatograph-Mass Spectrometer (HPLC/MS/MS) was used to measure and evaluate the residues of saflufenacil. Contact: RD.

3. PP 2F9020. EPA–HQ–OPP–2023–0062. FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide. Fluindapyr in or on soybean, forage at 15 ppm; soybean, hay at 30 ppm; soybean, hulls at 0.6 ppm; soybean, seed at 0.2 ppm. The HPLC/MS/MS method is used to measure and evaluate the chemical fluindapyr. Contac t: RD.

E. Notice of Filing—New Tolerances for Non-Inerts

1. PP 1E8910. EPA–HQ–OPP–2022–0139. Corteva Agriscience, LLC, 9330 Zionsville Rd., Indianapolis, IN 46268, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide methoxyfenozide in or on coffee at 0.15 ppm and sugarcane at 0.03 ppm, and in the processed commodity sugarcane molasses at 0.1 ppm. The Liquid Chromatography with Tandem Mass Spectrometry Detection (Method GRM 02.25) is used to measure and evaluate the methoxyfenozide residues. Contact: RD.

2. PP 2E9028. EPA–HQ–OPP–2022–0890. IR–4, IR–4 Project Headquarters, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606 to establish a tolerance in 40 CFR 180.417 for residues of the herbicide triclopyr, 2-[(3,5,6-trichloro-2-pyridinyl)oxy]acetic acid, including its metabolites and degradates, in or on sugarcane, cane at 0.04 ppm resulting from the application of the butoxyethyl ester of triclopyr, triethylamine salt of triclopyr, or choline salt of triclopyr. Gas chromatography and HPLC/MS/MS methods are available for the enforcement of tolerances for triclopyr residues of concern. Contact: RD.

3. PP 2F9005. EPA–HQ–OPP–2022–0980. Bayer CropScience, 800 N Lindbergh Blvd. St. Louis, MO 63167, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide fluoxapiprolin (2-[3,5-bis(difluoromethyl)-1H-pyrazol-1-yl]-1-[4-[4-[5-[2-chloro-6-[(methylsulfonyl)oxy]phenyl]-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]ethenone) in or on: Tuberous and corm vegetables subgroup 1C at 0.01 ppm; onion, bulb subgroup 3–07A at 0.03 ppm; onion, green subgroup 3–07B at 2.0 ppm; lettuce, head, at 0.8 ppm; leafy vegetable group 4–16, except head lettuce at 5.0 ppm; brassica head and stem vegetable group 5–16 at 0.8 ppm; fruiting vegetable group 8–10 at 0.06 ppm; cucurbit vegetable group 9 at 0.06 ppm; small fruit vine climbing subgroup 13–07F, except fuzzy kiwifruit at 0.2 ppm; grape, raisin at 0.4 ppm; leafy petiole vegetable subgroup 22B at 1.5 ppm; and in or on low growing berry subgroup 13–07G at 0.01 ppm in rotational crop. The HPLC/MS/MS detector is used to measure and evaluate the chemical fluoxapiprolin. Contact: RD.

4. PP 2F9019. EPA–HQ–OPP–2022–0868. BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709, requests to establish tolerances in 40 CFR 180.649(a)(1) for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on corn, field, forage at 0.3 ppm, corn, field, milled byproducts at 0.125 ppm, and corn, field, stover at 5.0 ppm. Adequate enforcement methodology liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) methods for plant and livestock commodities are available to enforce the tolerance expression. Contact: RD.

5. PP 2F9019. EPA–HQ–OPP–2022–0868. BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709, requests to amend the existing commodity definition in 40 CFR 180.649(a)(1) for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on “grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw)” to “grain, cereal, forage, hay, stover, and straw group 16–22 (except field corn forage, field corn stover, barley straw, wheat straw, and chia straw)” unchanged at 0.1 ppm. Adequate enforcement methodology (LC/MS/MS) methods for plant and livestock commodities are available to enforce the tolerance expression. Contact: RD.

6. PP 3F9049. EPA–HQ–OPP–2022–0899. Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419, requests to establish a tolerance for residues of the insecticide spiropidion and its metabolite SYN547305 in or on apple, dry pomace at 3 ppm; cattle, meat at 0.02 ppm; citrus fruit, crop group 10–10 at 2.0 ppm; cotton, gin byproducts at 10 ppm; cottonseed, crop subgroup 20C at 0.6 ppm; cucumber at 2.0 ppm; fruit, pome, crop group 11–10 at 0.4 ppm; goat, meat at 0.02 ppm; horse, meat at 0.02 ppm; orange, fruit, citrus oil at 60 ppm; sheep, meat at 0.02 ppm; small fruit vine climbing, (except fuzzy kiwifruit), crop subgroup 13–07F at 2 ppm; soybean at 3.0 ppm; vegetables, tuberous and corm, crop group 1C at 1.5 ppm; vegetables, brassica, head and stem, crop group 5–16 at 15 ppm; vegetables, cucurbit, crop group 9, except cucumber at 0.9 ppm; vegetables, fruiting, crop group 8–10 at 1.5 ppm; vegetables, leafy, crop subgroup 4–16 at 15 ppm; and vegetables, tuberous and corm, crop group 1C at 1.5 ppm. Syngenta Crop Protection, LLC submitted a “quick, easy, cheap, effective, rugged, and safe” (QuEChERS) multi-residue method that has been validated and independently validated for post-registration monitoring of SYN546330 and SYN547305 for compliance with maximum residue levels (MRLs) and import tolerances in plant commodities at an LOQ of 0.01 mg/kg. QuEChERS multi-residue method has also been validated and independently validated for SYN548430 and SYN547435. Radiovalidation of the residue methods used for data generation in pre-registration studies (primary crop and rotational crop) have been conducted within the metabolism studies. For the QuEChERS multi-residue method, a separate radiovalidation study was conducted with samples taken from the primary crop metabolism studies. Contact: RD.

7. PP 3F9050. EPA–HQ–OPP–2023–0280. ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, has requested to establish a tolerance for the combined residues of the insecticide flonicamid and its metabolites, TFNA, TFNA–AM, and TFNG, in or on the raw agricultural commodities: Berry, low growing, subgroup 13–07G, except strawberry, at 1.5 ppm; and strawberry at 2.0 ppm. Analytical methodology has been developed to determine the residues of flonicamid and its three major plant metabolites, TFNA, TFNG, and TFNA–AM in various crops. The residue analytical method for the majority of crops includes an initial extraction with acetonitrile (ACN)/deionized (DI) water, followed by a liquid-liquid partition with ethyl acetate. The residue method for wheat straw is similar, except that a C18 solid phase extraction (SPE) is added prior to the liquid-liquid partition. The final sample solution is quantitated using a liquid chromatograph (LC) equipped with a reverse phase column and a triple quadruple mass spectrometer (MS/MS). Contact: RD.

Authority:21 U.S.C. 346a.

Dated: June 27, 2023.

Delores Barber,

Director, Information Technology and Resources Management Division, Office of Program Support.