Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Chemicals in or on Various Commodities (July 2024)

Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities (July 2024)

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 4E9104. EPA-HQ-OPP-2024-0200. 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 180.700, upon the approval of the requested tolerance, by revising the established tolerance for residues of the insecticide afidopyropen, including its metabolites and degradates, in or on leafy greens subgroup 4-16A at 2.0 parts per million (ppm) to a tolerance in or on leafy greens subgroup 4-16A, except lettuce, leaf at 2 ppm. Contact: RD.

2. PP 4F9135. EPA-HQ-OPP-2024-0322. Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85366, requests to amend the existing regional tolerance established in 40 CFR 180.448 for the ovicide/miticide hexythiazox in or on fruit, citrus group 10-10 (CA, AZ, TX only) at 0.6 ppm to include a national tolerance for citrus, fruit, subgroup 10-10B (lemon/lime). The residue analytical methodology, Morse Laboratories, LLC, Analytical Method# Meth-220, Original, titled "Determination of Hexythiazox In/On Various Matrices," dated May 6, 2013, with method modifications dated May 16, 2013, was reviewed by the Agency in the study, Magnitude of the Residue of Hexythiazox in or on Citrus Raw Agricultural Commodities Following One Application of Onager® 1E Miticide. The same method was used in the new residue data generated to amend the crop subgroup 10-10B lemon/lime tolerance, nationally. Contact: RD.

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

1. PP IN-11880. EPA-HQ-OPP-2024-0344. A&L Biological, Inc., 2136 Jetstream Rd., London, ON Canada, N5V 3P5 requests to establish an exemption from the requirement of a tolerance for residues of purified bovine serum albumin (CAS Reg. No. 9048-46-8), when used as an inert ingredient in or on the raw agricultural commodity greenhouse cucumber applied pre-bloom as a stabilizer in microbial pesticides at a concentration of ≤1.0% w/w under 40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.

2. PP IN-11882. EPA-HQ-OPP-2024-0354. Croda Inc., 300-A Columbus Circle, Edison, NJ 08837-3907, c/o Exponent, Inc. Chemical Regulation and Food Safety, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036, requests to establish an exemption from the requirement of a tolerance for residues of glycerol ester of rosin (CAS Reg. No. 8050-31-5), when used as an inert ingredient in pesticide formulations used pre- and post- harvest 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.

3. PP IN-11918. EPA-HQ-OPP-2024-0356. SpayVac-for-Wildlife, Inc., 1202 Ann Street, Madison, WI 53713, requests to establish an exemption from the requirement of a tolerance for residues of cholesterol (CAS Reg. No. 97281-47-5) in equine and cervid contraceptive formulations, when used as an inert ingredient under 40 CFR 180.930. 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 3F9084. EPA-HQ-OPP-2024-0340. MBFi LLC, 11125 North Ambassador Drive, Suite 120, Kansas City, MO 64153, requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the fungicide and nematicide Trichoderma asperellum DSM33649 in or on all food or feed commodities. The petitioner believes no analytical method is needed because this petition requests an exemption from the requirement of a tolerance without numerical limitations. Contact: BPPD.

2. PP 4F9112. EPA-HQ-OPP-2024-0329. EcoPhage LTD., 3 Pinchas Sapir St., Ness Ziona, Israel 7403626 (c/o Spring Regulatory Sciences 6620 Cypresswood Dr., Suite 250, Spring, TX 77379), requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the bactericides Bacteriophage active against Xanthomonas campestris pv. vesicatoria _EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato _EcoPhage in or on all food or feed commodities. The petitioner believes no analytical method is needed because this petition requests an exemption from the requirement of a tolerance without numerical limitations. Contact: BPPD.

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

1. PP 4E9104. EPA-HQ-OPP-2024-0200. 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 establish tolerances in 40 CFR 180.700 for residues of the insecticide afidopyropen, including its metabolites and degradates, in or on lettuce, leaf at 7 ppm. Compliance with the tolerance levels specified is to be determined by measuring only afidopyropen. An acceptable analytical method is available for enforcement purposes. Contact: RD.

2. PP 4E9110. EPA-HQ-OPP-2024-0262. Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419, requests to establish a tolerance in 40 CFR part 180 for residues of the insecticide, lambda-cyhalothrin, in or on pineapple and raspberry at 0.05 ppm. The ICI Method 81, ICI Method 86, ICI Method 96, and liquid chromotography with MS/MS detection analytical methods are used to measure and evaluate chemical residues of lambda-cyhalothrin. Contact: RD.

3. PP 4F9117. EPA-HQ-OPP-2024-0363. UPL NA Inc. P.O. Box 12219 Research Triangle Park, NC 27709-2219 requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide acifluorfen in or on sugar beet roots and sugar beet tops at 0.06 ppm. The LC/MS/MS method is used to measure and evaluate the chemical acifluorfen. Contact: RD.