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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
204600001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202 5661744, and the telephone number for the OPP
Docket is 703 3055805.
Due to the public health concerns related to COVID19, the EPA Docket Center EPA/DC and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC
services and docket access, visit https
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration Division 7505P, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 204600001; main telephone number: 703 3057090;
email address: RDFRNotices@epa.gov.
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. 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/
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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
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in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPAHQ
OPP20200450 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 October 12, 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
20200450, 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.
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 December 21, 2020 85 FR 82998 FRL1001693, EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition PP IN11384 by Spring Regulatory Sciences, on behalf of BASF
Corporation, 100 Park Avenue, Florham Park, New Jersey 07932. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of pyrrolo3,4-cpyrrole-1,4dione, 3,6-bis4-chlorophenyl-2,5dihydroCAS Reg. No. 84632655
when used as an inert ingredient dye, coloring agent in pesticide formulations applied preand post-harvest. That document referenced a summary of the
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petition prepared by BASF Corporation, the petitioner, which is available in the docket, http www.regulations.gov. One comment was received on the notice of filing. EPAs response to this comment is discussed in Unit V.B.
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 the 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 the FFDCA
defines safe to mean that EPA has determined 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 it 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 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 harm to human health. In order to
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