Adipic Acid; Exemption From the Requirement of a Tolerance, 11312-11315 [2022-04077]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Rules and Regulations]
[Pages 11312-11315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04077]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0635 and EPA-HQ-OPP-2021-0636; FRL-9551-01-OCSPP]


Adipic Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of adipic acid (CAS Reg. No. 124-04-9) when 
used as an inert ingredient (acidification or buffering agent, pH 
regulator) in pesticide formulations applied to growing crops. 
Verdesian Life Sciences U.S., LLC, and Fine Agrochemicals Ltd., 
submitted petitions to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) requesting the establishment of an exemption from the 
requirement of a tolerance for adipic acid. This regulation eliminates 
the need to establish a maximum permissible level for residues of 
adipic acid on food or feed commodities when used in accordance with 
this exemption.

DATES: This regulation is effective March 1, 2022. Objections and 
requests for hearings must be received on or before May 2, 2022 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The dockets for this action, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2021-0635 and EPA-HQ-OPP-2021-
0636 are available at https://www.regulations.gov or at the Office of 
Pesticide Programs Regulatory Public Docket (OPP Docket) in the 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC 20460-0001. 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) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, 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 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

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).

[[Page 11313]]

     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 Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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 EPA-HQ-OPP-2021-0635 and/or EPA-HQ-OPP-2021-0636 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 May 2, 2022. Addresses for mail and hand 
delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    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 EPA-HQ-OPP-2021-0635 and/or 
EPA-HQ-OPP-2021-0636, 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 
20460-0001.
     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. Petition for Exemption

    In the Federal Register of October 21, 2021 (86 FR 58241) (FRL-
8792-04-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of pesticide petitions PP IN-11546 
by Verdesian Life Sciences U.S., LLC, 1001 Winstead Drive, Suite 480, 
Cary, NC 27513 and PP IN-11616 by Fine Agrochemicals Ltd., Hill End 
House, Whittington, Worcester WR5 2RQ, UK. The petitions requested that 
40 CFR 180.920 be amended by establishing an exemption from the 
requirement of a tolerance for residues of adipic acid when used as an 
inert ingredient pre-harvest. That document referenced a summary of the 
petitions prepared by Verdesian Life Sciences U.S. and Fine 
Agrochemicals Ltd, the petitioners, which are available in their 
respective dockets, https://www.regulations.gov. There were no comments 
received in response to the notice of filings for either petition.

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 408(c)(2)(A)(i) 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 408(c)(2)(A)(ii) 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 408(b)(2)(C) 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 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 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 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), 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 to adipic acid, including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with adipic acid follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, and EPA considers referral back to those 
sections as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published a rule for the exemption from the 
requirement of a tolerance for residues of adipic acid

[[Page 11314]]

in which EPA concluded, based on the available information, that there 
is a reasonable certainty that no harm would result from aggregate 
exposure to adipic acid. EPA is incorporating previously published 
sections from that rulemaking as described further in this rulemaking, 
as they remain unchanged.
    Toxicological Profile. For a discussion of the Toxicological 
Profile of adipic acid, see Unit IV.A. of the December 3, 2020, 
rulemaking (85 FR 78002) (FRL-10015-57).
    Toxicological Points of Departure/Levels of Concern. No 
toxicological endpoint of concern for adipic acid has been identified 
in the database below the limit dose of 1000 mg/kg/day.
    Exposure Assessment. The Agency's approach to and assumptions for 
the exposure assessments for adipic acid are discussed in Unit IV.C. of 
the December 3, 2020, rulemaking. Additional exposures are possible 
from the expanded use of adipic acid; however, no toxicological 
endpoint of concern was identified for adipic acid below the limit dose 
and therefore, a quantitative assessment of exposure is not necessary.
    Safety Factor for Infants and Children. EPA continues to reach the 
same conclusion regarding the Food Quality Protection Act (FQPA) safety 
factor as discussed in Unit IV.D. of the December 3, 2020, rulemaking.
    Aggregate Risks and Determination of Safety. Based on the risk 
assessment and information described above, EPA concludes there is a 
reasonable certainty that no harm will result to the general 
population, or to infants and children, from aggregate exposure to 
adipic acid residues when used as an inert ingredient in pesticide 
formulations applied to growing crops. More detailed information about 
the Agency's analysis can be found at https://www.regulations.gov in 
the document titled ``IN-11317; Adipic Acid: Human Health Risk and 
Ecological Effects Assessment of a Food Use Pesticide Inert 
Ingredient'' in docket ID number EPA-HQ-OPP-2019-0569.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance, without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for residues of adipic acid (CAS Reg. 
No. 124-04-9) when used as an inert ingredient in pesticide 
formulations applied pre-harvest under 40 CFR 180.920.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 17, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, amend Table 1 to 180.920 by adding, in 
alphabetical order, the inert ingredient ``Adipic acid (CAS Reg. No. 
124-04-9)'' to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

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[[Page 11315]]



                           Table 1 to 180.920
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      Inert ingredients              Limits                 Uses
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                              * * * * * * *
Adipic acid (CAS Reg. No.     ....................  Acidification or
 124-04-9).                                          buffering agent; pH
                                                     regulator
 
                              * * * * * * *
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[FR Doc. 2022-04077 Filed 2-28-22; 8:45 am]
BILLING CODE 6560-50-P