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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180
through the Office of the Federal Registers e-CFR site at https
www.ecfr.gov/current/title-40.

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C. Can I file an objection or hearing request?
Under FFDCA section 408g, 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 EPAHQ
OPP20210639 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 February 4, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40
CFR 178.25b.
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 EPAHQOPP
20210639, 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 204600001.
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. Background and Statutory Findings In the Federal Register of October 21, 2021 86 FR 58239 FRL879201

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OCSPP, EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition PP IN11612 filed by Spring Regulatory Sciences, 6620
Cypresswood Dr., Suite 250, Spring, TX
77379, on behalf of Colorants Solutions USA LLC., 4000 Monroe Road, Charlotte, NC 28205. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether CAS Reg. No.
1812871296. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioners request.
The Agency did not receive any substantive public comments.
Section 408c2Ai of FFDCA
allows EPA to establish an exemption from the requirement for a tolerance the legal limit for a pesticide chemical residue in or on a food only if EPA
determines that the exemption is safe.
Section 408c2Aii 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 use in residential settings but does not include occupational exposure. Section 408b2C of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of 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 . . . and specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. To determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in
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residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408b2D, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40
CFR 723.250b and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR
723.250d. 2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me ether CAS Reg.
No.1812871296 conforms to the definition of a polymer given in 40 CFR
723.250b and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250d2ii.
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize: An adequate biodegradation study MRID 51632702
was submitted for 2,5-furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylenepolypropylene glycol 2-aminopropyl Me ether showing lack of biodegradation 0% >28 days.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

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