Proposed Rule2022-10563
Hypochlorous Acid; Exemption From the Requirement of a Pesticide 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
May 17, 2022
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing 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 rulemaking is proposed on the Agency's own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address residues identified as part of the Agency'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 95 (Tuesday, May 17, 2022)</title>
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[Federal Register Volume 87, Number 95 (Tuesday, May 17, 2022)]
[Proposed Rules]
[Pages 29843-29846]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10563]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0064; FRL-9460-01-OCSPP]
RIN 2070-ZA16
Hypochlorous Acid; Exemption From the Requirement of a Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing 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 rulemaking is proposed on the Agency's own
initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) to
address residues identified as part of the Agency's registration review
program under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA).
DATES: Comments must be received on or before July 18, 2022.
ADDRESSES: Submit your comments, identified by docket identification
(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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
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
(7508P), 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#2656434755430847484f52476643564708414950"><span class="__cf_email__" data-cfemail="4636232735236827282f32270623362768212930">[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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a>or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What action is the Agency taking?
EPA is proposing to establish an exemption from the requirement of
a tolerance for residues of the antimicrobial pesticide hypochlorous
acid on food-contact surfaces in public eating places. EPA is proposing
this exemption to cover residues of hypochlorous acid that may be found
in food as a result of the use of these antimicrobials on food-contact
surfaces.
As noted in the December 2020 Hypochlorous Acid Interim
Registration Review Decision (available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
in docket ID number EPA-HQ-OPP-2020-0244), hypochlorous acid is
registered for use as a disinfectant on food-contact surfaces in public
eating places. As a
[[Page 29844]]
result of that use, residues of hypochlorous acid may be found in food
that comes into contact with treated surfaces.
According to the Agency's 2016 Antimicrobial Use Site Index
(<a href="https://www.epa.gov/pesticide-registration/antimicrobial-pesticide-use-site-index">https://www.epa.gov/pesticide-registration/antimicrobial-pesticide-use-site-index</a>), EPA categorizes that use as an ``indirect food use.''
40 CFR 158W requires a tolerance or exemption for direct and indirect
food uses. Historically, EPA did not require a tolerance or tolerance
exemption for the registered uses of hypochlorous acid because the
labels required a potable water rinse after application. EPA's
scientific assumption had been that if an antimicrobial pesticide use
required a potable water rinse on the label, residues of the pesticide
would be rinsed away. With no residues available to transfer to foods
coming into contact with the treated food surface, the use was
considered nonfood; and therefore, no tolerance or tolerance exemption
was needed. The presumption that there would be no available residues
for transfer to food is no longer supportable because available data
now suggest that a potable water rinse may not be 100% efficient in
removing residues; therefore, the Agency no longer considers a use to
be ``nonfood'' just because the label requires a potable water rinse.
Absent information supporting a conclusion that no residues would be
available for transfer to food from the use, a tolerance or tolerance
exemption is required. At this time, the Agency has not received any
information supporting a conclusion that residues of hypochlorous acid
would not be available for transfer to food after application to food
surfaces.
B. What is the Agency's authority for taking this action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C.
346(a), authorizes the establishment of tolerances, exemptions from
tolerance requirements, modifications in tolerances, and revocation of
tolerances for residues of pesticide chemicals in or on raw
agricultural commodities and processed foods. Without a tolerance or
exemption, food containing pesticide residues are considered unsafe and
therefore ``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce, 21 U.S.C.
331(a).
Section 408(e)(1)(B) of the FFDCA authorizes EPA to issue an
exemption from the requirement of a tolerance on its own initiative. 21
U.S.C. 346a(e)(1)(B). It is under section 408(e) of the FFDCA that EPA
is proposing to establish the exemption in this rulemaking. The
standard for establishing an exemption is found in section 408(c)(2)(A)
of the FFDCA and is discussed below. 21 U.S.C. 346a(c)(2)(A).
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
tolerances 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 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 Agency 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 the Agency 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 the exemption from the requirement of a tolerance for residues of
hypochlorous acid is safe, i.e., there is a reasonable certainty that
no harm will result from aggregate exposures to hypochlorous acid.
IV. Analytical Enforcement Methodology
An analytical method for residue is not required for enforcement
purposes since the Agency 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, 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, food-processing equipment and utensils that
allows for the end-use concentration of the ready to use product to
exceed the 200 ppm limit for residues of total available chlorine.
[[Page 29845]]
V. Conclusion
Therefore, EPA is proposing to establish 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 in paragraph (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
In this document, EPA is proposing to establish exemptions 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule 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 proposed rule 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 proposed
rule 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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency 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
pesticides listed in this proposed rule, the Agency hereby certifies
that this proposed rule will not have a significant negative economic
impact on a substantial number of small entities. Furthermore, for the
pesticides named in this proposed rule, the Agency knows of no
extraordinary circumstances that exist as to the present proposed rule
that would change EPA's previous analysis. Any comments about the
Agency's determination should be submitted to the EPA along with
comments on the proposed rule and will be addressed prior to issuing a
final rule.
In addition, the Agency has determined that this proposed rule 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 proposed rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This
proposed rule 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
Agency has determined that this proposed rule 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 proposed rule 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 proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 9, 2022.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended 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'' to the table 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) * * *
[[Page 29846]]
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. 2022-10563 Filed 5-16-22; 8:45 am]
BILLING CODE 6560-50-P
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