[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Rules and Regulations]
[Pages 78002-78005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26005]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0569; FRL-10015-57]


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 when used as an inert 
ingredient in antimicrobial pesticide formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils at an end-use concentration 
not to exceed 100 parts per million (ppm). Ecolab, Inc. submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) 
requesting 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 when 
used in accordance with this exemption.

DATES: This regulation is effective December 3, 2020. Objections and 
requests for hearings must be received on or before February 1, 2020, 
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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0569, is available at http://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).
     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 Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2019-0569 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 1, 2020. 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-2019-0569, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.

[[Page 78003]]

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 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 May 29, 2020 (85 FR 32338) (FRL-10009-
84), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11317) by 
Ecolab, Inc., 655 Lone Oak Drive, Eagan, MN 55121. The petition 
requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of adipic 
acid when used as an inert ingredient at an upper limit of 100 ppm in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. That document referenced a summary 
of the petition prepared by Ecolab, Inc., the petitioner, which is 
available in the docket, http://www.regulations.gov. One comment was 
received on the notice of filing. EPA's 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 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.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by adipic acid in these toxicity studies 
are discussed in this unit.
    Available acute toxicity studies on adipic acid include various 
oral, dermal, and inhalation studies which showed low toxicity. 
Multiple dermal and eye irritation studies, and a dermal sensitization 
study, indicated that adipic acid is not a dermal irritant and does not 
cause skin sensitization. Adipic acid is an eye irritant. In available 
repeat dose studies, which were up to two years in duration, no adverse 
effects of treatment were seen below the limit dose of 1,000 mg/kg/day. 
In addition, there was no evidence of carcinogenicity or 
neuropathological changes or effects reported in any of the studies. 
Adipic acid was not found to be genotoxic in various in vitro and in 
vivo studies.
    All studies showed low acute and repeat dose toxicity, and no 
reproductive/developmental toxicity was seen in any of the species 
tested. The primary systemic health effect associated with adipic acid 
is irritation of the intestinal mucosa and decreased body weight after 
exposures to concentrations >2,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern for adipic acid has been 
identified in the database.

C. Exposure Assessment

    1. Dietary exposure from food, feed uses, and drinking water. In 
evaluating dietary exposure to adipic acid, EPA considered exposure 
under the current and proposed use patterns. Dietary exposure to adipic 
acid may occur from eating foods containing adipic acid (found 
naturally or as a food additive) or eating food that comes in contact 
with surfaces treated with pesticide formulations containing this inert 
ingredient. In addition, exposure through drinking water is also 
possible. However, no toxicological endpoint of concern was identified 
for adipic acid below the limit dose and therefore a quantitative 
assessment of dietary exposure is not necessary.

[[Page 78004]]

    2. Non-dietary exposure. The term ``residential exposure'' is used 
in this document to refer to non-occupational, non-dietary exposure 
(e.g., textiles (clothing and diapers), carpets, swimming pools, and 
hard surface disinfection on walls, floors, and tables). Residential 
exposure to adipic acid may occur based on its use as an inert 
ingredient in pesticide formulations registered for residential uses. 
Additional non-dietary exposure may occur from the use of adipic acid 
in pharmaceutical products and cosmetics. However, no toxicological 
endpoint of concern was identified below the limit dose for adipic acid 
and therefore a quantitative residential exposure assessment for adipic 
acid was not conducted.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke an exemption, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found adipic acid to share a common mechanism of 
toxicity with any other substances, and adipic acid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has assumed that adipic acid 
does not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of the FFDCA requires EPA to apply an 
additional tenfold margin of safety in the case of threshold effects 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. As noted in Unit IV.B., there is no indication of threshold 
effects being caused by adipic acid. Therefore, this requirement does 
not apply to the present analysis. Moreover, due to the lack of any 
toxicological endpoints of concern, EPA conducted a qualitative 
assessment of adipic acid, which does not use safety factors for 
assessing risk.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on adipic acid, 
EPA has determined that there is a reasonable certainty that no harm to 
the general population or any population subgroup, including infants 
and children, will result from aggregate exposure to adipic acid 
residues. Therefore, the establishment of an exemption from the 
requirement of a tolerance under 40 CFR 180.940(a) for residues of 
adipic acid when used as an inert ingredient in antimicrobial pesticide 
formulations applied to food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils 
at a maximum end-use concentration of 100 ppm, is safe under FFDCA 
section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
adipic acid in or on any food commodities. EPA is establishing a 
limitation on the amount of adipic acid that may be used in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. This limitation will be enforced 
through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any antimicrobial pesticide formulation 
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils 
pesticide formulation that exceeds an end-use concentration of adipic 
acid of 100 ppm.

B. Response to Comments

    One comment was received in response to the notice of filing 
associated with this action; however, the comment was unrelated to 
adipic acid and is not relevant to this action.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for residues of adipic acid (CAS 
Reg. No. 124-04-9) when used as an inert ingredient in antimicrobial 
pesticide formulations applied to food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils at an end-use concentration not to exceed 100 
ppm.

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), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). 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

[[Page 78005]]

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: November 6, 2020.
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.  180.940 amend the table in paragraph (a) by adding 
alphabetically the entry ``Adipic acid'' to read as follows:


Sec.  180.940   Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

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    (a) * * *

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           Pesticide chemical                     CAS Reg. No.                           Limits
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                                                  * * * * * * *
Adipic acid.............................  124-04-9...................  When ready for use, the end-use
                                                                        concentration is not to exceed 100 ppm.
 
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[FR Doc. 2020-26005 Filed 12-2-20; 8:45 am]
BILLING CODE 6560-50-P