[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 [www.gpo.gov]
[FR Doc No: 2022-10563]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
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 https://www.epa.gov/dockets.

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 
regulations.govor 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 https://www.epa.gov/dockets/commenting-epa-dockets.

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 https://www.regulations.gov 
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 
(https://www.epa.gov/pesticide-registration/antimicrobial-pesticide-use-site-index), 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 https://www.regulations.gov). 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 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 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)
------------------------------------------------------------------------
      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. 2022-10563 Filed 5-16-22; 8:45 am]
BILLING CODE 6560-50-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>