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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations
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 40 CFR part 180
through the Government Publishing Offices e-CFR site at http
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.

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C. How can I file an objection or hearing request?
Under FFDCA section 408g, 21
U.S.C. 346ag, 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
OPP20190607 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 9, 2021. 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
20190607, by one of the following methods:
Federal eRulemaking Portal: http
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.

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Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http
www.epa.gov/dockets.
II. Petition for Exemption In the Federal Register of February 11, 2020 85 FR 7708 FRL1000502, EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition PP IN11359 by Milliken Chemical, 920 Milliken Rd., M209
Spartanburg, SC 29303. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of Polyoxy-1,2-ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt CAS Reg. No. N/A
when used as an inert ingredient colorant in pesticide formulations applied to seed treatment slurries for raw agricultural commodities not to exceed 20% wt/wt. That document referenced a summary of the petition prepared by Milliken Chemical, the petitioner, which is available in the docket, http www.regulations.gov.
There were no comments received in response to the notice of filing.
III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients except when they have a pesticidal efficacy of their own:
Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose;
wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term inert is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
IV. Aggregate Risk Assessment and Determination of Safety Section 408c2Ai of FFDCA
allows EPA to establish an exemption
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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 tolerance 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 in residential settings but does not include occupational exposure. Section 408b2C and c2B of FFDCA
requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or exemption 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. . . .
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order 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 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 408c2A, and the factors specified in FFDCA section 408c2B, 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 Polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1ethanediylbisw-hydroxy-, monosodium salt including exposure resulting from the exemption established by this action. EPAs assessment of exposures and risks associated with Polyoxy-1,2ethanediyl, a, a-4-3sulfophenylazophenyliminodi-2,1-

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