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IN-11918: Cholesterol (CAS Reg. No. 97281-47-5), Exemption from the Requirement of a Tolerance
Application for the Exemption from the Requirement of Tolerance for Bacillus thuringiensis Cry1Da_7, Bacillus thuringiensis Cry1B.3, and Paenibacillus spp. Vip3Cb1 proteins in or on cotton, and an exemption from the requirement of a tolerance for the Vip3Cb1 protein in or on maize.
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Published Document: 2026-01991 (91 FR 4466)
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AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice of filing of petitions and request for comment.
SUMMARY:
This document announces the Agency's receipt of and solicits public comment on initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities. The Agency is providing this notice in accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA uses the month and year in the title to identify when the Agency compiled the petitions identified in this notice of filing. Unit II. of this document identifies certain petitions received in 2024 and 2025 that are currently being evaluated by EPA, along with information about each petition, including who submitted the petition and the requested action.
DATES:
Comments must be received on or before March 4, 2026.
ADDRESSES:
Submit your comments, identified by docket identification (ID) number and the pesticide petition (PP) of interest identified in Unit II. of this document, online 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:
Each application summary in Unit II. specifies a contact division. The appropriate division contacts are identified as follows:
BPPD (Biopesticides and Pollution Prevention Division) (Mail Code 7511M); Shannon Borges; main telephone number: (202) 566-1400; email address:BPPDFRNotices@epa.gov.
RD (Registration Division) (Mail Code 7505T); Charles Smith; main telephone number: (202) 566-1030; email address:RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in general.
B. What is the Agency's authority for taking this action?
EPA regulations for residues of pesticide chemicals in or on various food commodities are established under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), requires EPA to publish a notice of receipt of these petitions in the
Federal Register
and provide an opportunity for public comment on the requests.
C. What action is the Agency taking?
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the receipt of pesticide petitions filed under FFDCA section 408 that request the establishment or modification of regulations for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioner. Pursuant to 40 CFR 180.7(f), a summary of the petition identified in this document, prepared by the petitioner, is included in a docket. EPA has determined that the pesticide petitions described in this document contain data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2), and 40 CFR 180.7(b); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting the pesticide petitions. 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 these pesticide petitions.
Based upon review of the data supporting these petitions and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA may establish a final tolerance or tolerance exemption that “may vary from that sought by the petitioner.” For example, EPA may determine that it is appropriate to vary the commodity name for consistency with EPA's Food and Feed Commodity Vocabulary, which is located here
https://www.epa.gov/pesticide-tolerances/food-and-feed-commodity-vocabulary,
or vary the tolerance level based on available data, harmonization interests,
( printed page 4467)
or the trailing zeros policy. In addition, when evaluating a petition's requests for a tolerance or exemption, EPA will consider how use of the pesticide on a crop for which a tolerance is requested may result in residues in or on commodities related to that requested commodity (
e.g.,
whether use on sugar beets for which a tolerance was requested on sugar beet root also requires a tolerance on sugar beet tops or whether use on a cereal grain for which a grain tolerance was requested also requires a tolerance on related animal feed commodities derived from that cereal grain). Public commenters should consider the possibility of such revisions in preparing comments on these petitions.
D. What should I consider as I prepare my comments for EPA?
1.
Submitting CBI.
Do not submit CBI to EPA through
https://www.regulations.gov
or email. If you wish to include CBI in your comment, please follow the applicable instructions at
https://www.epa.gov/dockets/commenting-epa-dockets#rules
and clearly mark the information that you claim to be CBI. In addition to one complete version of the comment that includes CBI, a copy of the comment without CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
This unit provides the following information about the petitions:
The Pesticide Petition (PP) Identification (IN) number;
EPA docket ID number for the petition;
Information about the petition (i.e.,
name of the petitioner, name of the pesticide chemical residue and the commodities for which a tolerance or exemption is sought);
The analytical method available to detect and measure the pesticide chemical residue or the petitioner's statement about why such a method is not needed; and
The division to contact for that petition.
Additional information on the petitions may be obtained through the petition summaries that were prepared by the petitioners pursuant to 21 U.S.C. 346a(d)(2)(A)(i)(I) and 40 CFR 180.7(b)(1), which are included in the docket for the petition as identified in this unit.
PP IN-11918.
(EPA-HQ-OPP-2024-0356). SpayVac-for-Wildlife, Inc, 1202 Ann Street, Madison, WI, USA 53713, requests to establish an exemption from the requirement of a tolerance for residues of cholesterol (CAS Reg. No. 57-88-5), when used as an inert ingredient in pesticide formulations applied to animals (
i.e.,
equine, cervid, bovine, porcine, pinniped, elephant, raccoon, feral dog, and feral cat) under 40 CFR 180.930. The company submitted a revised Notice of Filing to expand the use pattern to include additional taxa from the original notice published in the
Federal Register
on August 27, 2024. The revised notice also corrects the CAS Reg. No. for cholesterol; therefore, EPA is re-issuing this notice. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance.
Contact:
RD.
PP IN-12206.
(EPA-HQ-OPP-2025-3192). GFBiochemicals SAS c/o Lewis & Harrison, LLC, 2461 South Clark Street, Suite 710, Arlington, VA 22202, requests to establish an exemption from the requirement of a tolerance for residues of butyl levulinate (CAS Reg. No. 2052-15-5), when used as an inert ingredient at a concentration not to exceed 40% 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.
PP 4F9162.
(EPA-HQ-OPP-2025-1345). Bayer CropScience LLC, 800 N Lindbergh Blvd., St. Louis, MO 63167, requests to establish an exemption from the requirement of a tolerance in 40 CFR part 174 for residues of the plant-incorporated protectants (PIPs)
Bacillus thuringiensis
Cry1Da_7 and
Bacillus thuringiensis
Cry1B.3 proteins and the genetic material necessary for their production in or on food and feed commodities of cotton, and
Paenibacillus spp
Vip3Cb1 protein and the genetic material necessary for its production in or on food and feed commodities of cotton and maize. The petitioner believes no analytical method is needed because this petition is for a permanent exemption from the requirement of a tolerance without numerical limitation, thus an analytical detection method should not be required.
Contact:
BPPD.
PP 5F9189.
(EPA-HQ-OPP-2025-3953). GreenLight Biosciences, Inc., 200 Boston Ave., Suite 1000, Medford, MA 02155, requests to establish an exemption from the requirement of a tolerance in 40 CFR part 180 for residues of the biochemical pesticide Unecyna in or on all food and feed commodities. The petitioner believes no analytical method is needed because an exemption from the requirement of a tolerance is being sought.
Contact:
BPPD.
PP 5F9200.
(EPA-HQ-OPP-2025-3295). Drexel Chemical Company, P.O. Box 13327, Memphis, TN 38113, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide trifluralin on pennycress at 0.05 parts per million (ppm). The LC/MS/MS method is used to measure and evaluate the chemical trifluralin.
Contact:
RD.