Document ID: EPA-HQ-OPP-2020-0244-0009
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Hypochlorous Acid
Posted Date: 2022-09-14T04:00Z

[Federal Register Volume 87, Number 177 (Wednesday, September 14, 2022)]
[Rules and Regulations]
[Pages 56280-56283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19799]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0244; FRL-10167-01-OCSPP]

Hypochlorous Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is exempting 
residues of the antimicrobial pesticide ingredient hypochlorous acid 
from the requirement of a tolerance when used on or applied to food-
contact surfaces in public eating places. The EPA is finalizing this 
rule on its own initiative under the Federal Food, Drug, and Cosmetic 
Act (FFDCA) to address residues identified as part of the EPA's 
registration review program under the Federal Insecticide,

[[Page 56281]]

Fungicide, and Rodenticide Act (FIFRA).

DATES: This regulation is effective September 14, 2022. Objections and 
requests for hearings must be received on or before November 14, 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 docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2020-0244, is 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 and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
7510M, Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
202-566-0737; 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 a 
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 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 numbers EPA-HQ-OPP-2020-0244 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 
November 14, 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-2020-0244, 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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Rule-For Exemption

What action is the Agency taking?

    In the Federal Register of May 17, 2022 (87 FR 29843) (FRL-9460-
01), EPA proposed to exempt residues of the antimicrobial pesticide 
ingredient hypochlorous acid from the requirement of a tolerance when 
used on or applied to food-contact surfaces in public eating places. 
This exemption covers residues of hypochlorous acid that may be found 
in food as a result of the use of these antimicrobials on food-contact 
surfaces in public eating places. These exemptions were proposed on 
EPA's own initiative under section 408(e) of the FFDCA, 21 U.S.C. 
346a(e). No comments were received on EPA's proposal. Therefore, EPA is 
finalizing the exemption from the requirement of a tolerance for 
residues of the antimicrobial pesticide ingredient hypochlorous acid 
when used on or applied to food-contact surfaces in public eating 
places.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of 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 408(c)(2)(A)(ii) 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 408(c)(2)(B) requires EPA to take into 
account, among other things, the considerations set forth in section 
408(b)(2)(C) and (D). Specifically, 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 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. . . .''
    Consistent with FFDCA section 408(b)(2)(D), 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 support the establishment 
of exemptions from the requirement of a tolerance for residues of 
hypochlorous acid.
    As noted in the ``Hypochlorous Acid Interim Decision'', there are 
tolerance exemptions under 40 CFR 180.940(b) and (c), which state that 
solutions containing hypochlorous acid may be applied to dairy-
processing equipment, and food-processing equipment and utensils, with 
the limitation that the end-use concentration of hypochlorous acid does 
not exceed 200 parts per

[[Page 56282]]

million (ppm) determined as total available chlorine. Because the 
current tolerance exemptions do not cover the antimicrobial products 
registered for use in public eating areas, the EPA is now establishing 
a tolerance exemption under section 40 CFR 180.940(a), which would 
cover all food-contact uses of hypochlorous acid pesticide products in 
public eating areas not to exceed 200 ppm determined as total available 
chlorine.
    EPA's safety determination for establishing a hypochlorous acid 
tolerance exemption under section 40 CFR 180.940(a) is based on 
chemical similarity to sodium, calcium, and potassium hypochlorites. 
Hypochlorous acid risk conclusions, including those related to dietary 
and aggregate exposure, can be bridged to the risk conclusions from the 
reevaluation of the sodium, calcium, and potassium hypochlorites (see 
docket EPA-HQ-OPP-2012-0004 at https://www.regulations.gov). Because 
EPA did not identify any dietary or aggregate risks of concern for the 
sodium, calcium, and potassium hypochlorites, due to the lack of 
toxicity of these substances, there are no dietary or aggregate risks 
of concern for hypochlorous acid due to a lack of toxicity for 
hypochlorous acid. For further information, the ``Hypochlorous Acid 
Interim Decision'' can be found at https://www.regulations.gov in 
docket identification number EPA-HQ-OPP-2020-0244.
    Based on the lack of any aggregate risks of concern, EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or specifically to infants and children, from 
aggregate exposure to hypochlorous acid residues. Thus, EPA has 
determined that the exemption from the requirement of a tolerance for 
residues of hypochlorous acid is safe.

IV. Analytical Enforcement Methodology

    An analytical method for residue is not required for enforcement 
purposes since the EPA is not establishing a numerical tolerance for 
residues of hypochlorous acid in or on any food commodities. EPA is 
establishing limitations on the amount of hypochlorous 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. These limitations 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 that 
allows for the end-use concentration of hypochlorous acid in the ready 
to use product to exceed the 200 ppm limit determined as total 
available chlorine.

V. Conclusion

    Therefore, EPA is establishing an exemption under 40 CFR 180.940(a) 
from the requirement of a tolerance for residues of hypochlorous acid 
when used in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils not to exceed 200 ppm determined as 
total available chlorine. Because the existing entries for hypochlorous 
acid in paragraphs (b) and (c) are duplicative of the new exemption in 
paragraph (a) of section 40 CFR 180.940, EPA is removing the tolerance 
exemptions for hypochlorous acid in paragraphs (b) and (c), as 
unnecessary.

VI. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(e). 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 due to its lack of significance, 
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). This action does 
not contain any information collection subject to OMB approval under 
the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.,) or 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.). Nor does it require any special considerations as required by 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994); or OMB review or any 
other Agency action under Executive Order 13045, entitled ``Protection 
of Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require EPA 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).

VII. Congressional Review Act

    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the EPA previously assessed whether establishment of tolerances, 
exemptions from tolerances, raising of tolerance levels, expansion of 
exemptions, or revocations might significantly impact a substantial 
number of small entities and concluded that, as a general matter, these 
actions do not impose a significant economic impact on a substantial 
number of small entities. These analyses for tolerance establishments 
and modifications, and for tolerance revocations were published in the 
Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 
FR 66020), respectively, and were provided to the Chief Counsel for 
Advocacy of the Small Business Administration. Taking into account this 
analysis, and available information concerning the pesticide listed in 
this rule, the EPA hereby certifies that this action will not have a 
significant negative economic impact on a substantial number of small 
entities. Furthermore, for the pesticide named in this rule, the EPA 
knows of no extraordinary circumstances that exist as to the present 
rule that would change EPA's previous analysis. No comments were 
submitted concerning EPA's similar determination in the rule.
    In addition, the EPA has determined that this action will not have 
a substantial direct effect on States, on the relationship between the 
National Government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the executive order to include regulations 
that have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government.'' 
This action directly regulates growers, food processors, food handlers, 
and food retailers, not States or Tribes. This

[[Page 56283]]

action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the EPA has 
determined that this action does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000). Executive Order 13175 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian Tribes, on the relationship between the Federal 
Government and the Indian Tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian Tribes.'' 
This action will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this action.

List of Subjects in 40 CFR Part 180

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

    Dated: September 7, 2022.
Anita Pease,
Director, Antimicrobials Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
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. Amend Sec.  180.940, by:
0
a. Adding in alphabetical order the pesticide chemical ``Hypochlorous 
Acid'' in table 1 to paragraph (a).
0
b. Removing the entry ``Hypochlorous Acid'' from the table in paragraph 
(b).
0
c. Removing the entry ``Hypochlorous Acid'' from the table in paragraph 
(c).
    The addition reads as follows:

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

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
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       Pesticide chemical         CAS Reg. No.            Limits
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                              * * * * * * *
Hypochlorous Acid..............       7790-92-3  When ready for use, the
                                                  end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine.
 
                              * * * * * * *
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[FR Doc. 2022-19799 Filed 9-13-22; 8:45 am]
BILLING CODE 6560-50-P