Rule2022-19799
Hypochlorous Acid; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 14, 2022
Effective
September 14, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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, Fungicide, and Rodenticide Act (FIFRA).
Full Text
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<title>Federal Register, Volume 87 Issue 177 (Wednesday, September 14, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#5525303426307b343b3c2134153025347b323a23"><span class="__cf_email__" data-cfemail="0e7e6b6f7d6b206f60677a6f4e6b7e6f20696178">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>). 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
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.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-19799 Filed 9-13-22; 8:45 am]
BILLING CODE 6560-50-P
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