Rule2024-19456
Lactic Acid and L-Lactic 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
August 29, 2024
Effective
August 29, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation removes the duplicative exemption from the requirement of a tolerance for residues of lactic acid and l-lactic acid, herein referred to as l-lactic acid, when applied/used in dairy processing equipment and food processing equipment and utensils. In addition, the Agency is amending an existing exemption from the requirement of a tolerance for lactic acid to also include l-lactic acid. The Agency is also establishing exemptions from the requirement of a tolerance for residues of l-lactic acid when used as a fruit and vegetable wash in or on all raw agricultural commodities, and for indirect or inadvertent residues of l-lactic acid in or on all livestock commodities, when residues are present therein as a result of animal drinking water coming into contact with hard non-porous surfaces treated with l-lactic acid (i.e., troughs). These tolerance exemptions are established on the Agency's own initiative under the Federal, Food, Drug, and Cosmetic Act (FFDCA), in order to implement the tolerance actions EPA identified during its review of this chemical 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 89 Issue 168 (Thursday, August 29, 2024)</title>
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[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Rules and Regulations]
[Pages 70106-70109]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19456]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0455; FRL-12194-01-OCSPP]
Lactic Acid and L-Lactic Acid; Exemption From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation removes the duplicative exemption from the
requirement of a tolerance for residues of lactic acid and l-lactic
acid, herein referred to as l-lactic acid, when applied/used in dairy
processing equipment and food processing equipment and utensils. In
addition, the Agency is amending an existing exemption from the
requirement of a tolerance for lactic acid to also include l-lactic
acid. The Agency is also establishing exemptions from the requirement
of a tolerance for residues of l-lactic acid when used as a fruit and
vegetable wash in or on all raw agricultural commodities, and for
indirect or inadvertent residues of l-lactic acid in or on all
livestock commodities, when residues are present therein as a result of
animal drinking water coming into contact with hard non-porous surfaces
treated with l-lactic acid (i.e., troughs). These tolerance exemptions
are established on the Agency's own initiative under the Federal, Food,
Drug, and Cosmetic Act (FFDCA), in order to implement the tolerance
actions EPA identified during its review of this chemical as part of
the Agency's registration review program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
DATES: This regulation is effective August 29, 2024. Objections and
requests for hearings must be received on or before October 28, 2024,
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-2023-0455, 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 for the OPP Docket is (202) 566-1744. Please review
the visitor instructions and additional information about the docket
available at <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; main telephone
number: (202) 566-0736; email address: <a href="/cdn-cgi/l/email-protection#d8a8bdb9abbdf6b9b6b1acb998bda8b9f6bfb7ae"><span class="__cf_email__" data-cfemail="4131242032246f202f283520012431206f262e37">[email protected]</span></a> or
<a href="/cdn-cgi/l/email-protection#74353032263a1b001d171107341104155a131b02"><span class="__cf_email__" data-cfemail="28696c6e7a66475c414b4d5b684d5849064f475e">[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 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:
<bullet> Food manufacturing (NAICS code 311),
<bullet> Pesticide manufacturing (NAICS code 32532),
<bullet> Restaurant kitchen cleaning services (NAICS code 561720),
<bullet> Milk production, dairy cattle (NAICS code 112120),
<bullet> Food processing machinery and equipment wholesalers (NAICS
code 423830).
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, 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-2023-0455 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
October 28, 2024. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b). Notwithstanding
the procedural requirements of 40 CFR 178.25(b), the Office of the
Administrative Law Judges has issued an order urging parties to file
and serve
[[Page 70107]]
documents with the Tribunal by electronic means only. See Revised Order
Urging Electronic Filing and Service (dated June 22, 2023), <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
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-2023-0455, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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. Background
A. Proposed Rule
In the Federal Register of November 13, 2023 (88 FR 77544) (FRL-
11520-01-OCSPP), EPA proposed to remove a duplicative exemption from
the requirement of a tolerance for residues of L-lactic acid, referred
to as lactic acid in the proposed rule, when applied to dairy-
processing equipment and food-processing equipment and utensils.
Specifically, the action proposed removing the duplicative entry at 40
CFR 180.940(b). In addition, EPA proposed an amendment to 40 CFR
180.1090 to establish exemptions from the requirement of a tolerance
for residues of lactic acid when used as a fruit and vegetable wash in
or on all agricultural commodities, and for indirect or inadvertent
residues of lactic acid in or on all livestock commodities, when
residues are present therein as a result of animal drinking water
coming into contact with hard non-porous surfaces treated with lactic
acid (i.e., troughs).
As noted in the proposal, the L-lactic Acid Interim Registration
Review Decision (L-lactic Acid ID) identified the need for these
exemptions based on existing registered pesticide uses and concluded
that there were no risks of concern associated with these uses.
Consequently, EPA concluded that the exemptions from the requirement of
a tolerance for residues of l-lactic acid, when used as a fruit and
vegetable wash in or on all raw agricultural commodities, and for
indirect or inadvertent residues of lactic acid in or on all livestock
commodities, when residues are present therein as a result of animal
drinking water coming into contact with hard non-porous surfaces
treated with lactic acid (i.e., troughs) would be safe. Electronic
copies of the L-lactic Acid ID and other documents are available in EPA
docket number EPA-HQ-OPP-2020-0552 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
B. What is the Agency's authority for taking this action?
Under section 408(e) of the FFDCA, EPA can establish an exemption
from the requirement of a tolerance for residues of a pesticide
chemical after publishing a proposed rule and providing 60-day period
for public comment. 21 U.S.C. 346a(e). EPA published the proposed rule
on May 5, 2023, and provided 60 days for public comment (until July 5,
2023).
III. Final Rule
A. Comments
The proposed rule received one anonymous public comment requesting
the Agency consider adding another CAS number for l-lactic acid. The
comment can be accessed electronically via <a href="https://www.regulations.gov">https://www.regulations.gov</a>
using document ID EPA-HQ-OPP-2023-0455-0002. The proposed rule
identified CAS # 50-21-5, which represents lactic acid. The commenter
suggested adding CAS # 79-33-4, which represents lactic acid's
biologically important stereoisomer, l-lactic acid, for clarity. L-
lactic acid has two optical isomers. One is known as L-(+)-Lactic acid,
and the other, its mirror image, is D-(-)-Lactic acid. L-(+)-Lactic
acid is the isomer that imparts biocidal activity.
This comment does not change any Agency analysis of risk findings
for l-lactic acid. The Agency agrees with the commenter that CAS # 79-
33-4 should be included in this final rule for the exemption of the
requirement of a tolerance.
B. Determination of Safety
Section 408(c)(2)(A)(i) of 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 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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which 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. . .
.''
As noted in the proposed rule, EPA has reviewed the available
scientific data and other relevant information as part of registration
review and in support of this action. Based on that review, EPA's
proposed rule concluded that the exemptions would be safe.
EPA's assessment of the potential for risks from exposure to these
pesticide chemicals and conclusions about the safety of these
exemptions remains unchanged. Therefore, based on the lack of any
aggregate risks of concern, EPA concludes that these exemptions from
the requirement of a tolerance for residues of l-lactic acid, are safe,
i.e., there is a reasonable certainty that no harm will result from
aggregate exposures to l-lactic acid, when used in accordance with the
terms of the respective exemptions. In addition, EPA has determined
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residues, in accordance with FFDCA section 408(b)(2)(C).
IV. Conclusion
Therefore, exemptions from the requirement of a tolerance are
established for residues of l-lactic acid when used as a fruit and
vegetable wash in or on all raw agricultural commodities, and for
indirect or inadvertent residues of l-lactic acid in or
[[Page 70108]]
on all livestock commodities, when residues are present therein as a
result of animal drinking water coming into contact with hard non-
porous surfaces treated with lactic acid (i.e., troughs). In addition,
EPA is adding CAS # 79-33-4 to table 1 to 40 CFR 180.940(a) to capture
lactic acid's biologically important stereoisomer, l-lactic acid. EPA
is also removing the existing exemption in 40 CFR 180.940(b) for
residues of lactic acid, as it is unnecessary and redundant of existing
exemptions.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence">https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action is exempt from review by the Office of Management and
Budget (OMB) under Executive Orders 12866 (58 FR 51735, October 4,
1993), and 13563 (76 FR 3821, January 21, 2011) because it establishes
tolerance exemptions under FFDCA section 408.
B. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA, 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this rule is any significant adverse economic
impact on small entities and that the Agency is certifying that this
rule will not have a significant economic impact on a substantial
number of small entities because the rule has no net burden on small
entities subject to the rule. As discussed in the proposed rule, this
takes into account the EPA analysis for the establishment and
modification of tolerances. Furthermore, the Agency did not receive any
comments on these conclusions as presented in the proposed rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any State,
local, or Tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132, August 10, 1999 (64 FR 43255). It will not 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.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have Tribal implications as specified in
Executive Order 13175, November 9, 2000 (65 FR 67249), because it will
not have substantial direct effects on Tribal governments, 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.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of health and safety effects of the
planned regulation on children in Federal health and safety standards
and explain why the regulation is preferable to potential effective and
reasonably feasible alternatives. This action is also not subject to
Executive Order 13045 because it is not a significant regulatory action
under section 3(f)(1) of Executive Order 12866 (See Unit V.A.) and
because EPA does not believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children.
However, EPA's Policy on Children's Health applies to this action.
This rule finalizes tolerance actions under the FFDCA, which
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. . . .'' (FFDCA 408(b)(2)(C)). Consistent with FFDCA
section 408(b)(2)(D), and the factors specified therein, EPA has
reviewed the available scientific and other data and other relevant
information in support of these final tolerance actions. The Agency's
consideration is documented in the pesticide specific registration
review decision documents. See the discussion in Unit III. and access
the chemical specific registration review documents in each chemical
docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards under NTTAA
section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations. As discussed in more detail in the
pesticide specific risk assessments conducted as part of the
registration review for the pesticides identified in Unit II., EPA has
considered the safety risks for the pesticides subject to this
rulemaking and in the context of the tolerance actions set out in this
rulemaking. EPA believes that the human health and environmental
conditions that exist prior to this action do not result in
disproportionate and adverse effects on people of color, low-income
populations, and/or indigenous peoples. Furthermore, EPA believes that
this action is not likely to result in new disproportionate and adverse
effects on people of color, low-income populations, and/or indigenous
peoples.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not
[[Page 70109]]
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: August 22, 2024.
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. In table 1 to paragraph (a), removing the entry for ``Lactic Acid'',
and adding, in alphabetical order, the entry for ``Lactic acid
(including l-lactic acid)''; and
0
b. In the table in paragraph (b), removing the entry for ``Lactic
Acid''.
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) * * *
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Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Lactic acid (including l-lactic 50-21-5, 79-33-4............. When ready for use, the end-use concentration
acid). is not to exceed 10,000 ppm in antimicrobial
formulations applied to food-contact
surfaces in public eating places.
* * * * * * *
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* * * * *
0
3. Revise and republish Sec. 180.1090 to read as follows:
Sec. 180.1090 Lactic acid, including l-lactic acid; exemption from
the requirement of a tolerance.
(a) Lactic acid (2-hydroxypropanoic acid), including l-lactic acid
is exempted from the requirement of a tolerance when used as a plant
growth regulator or fruit and vegetable wash in or on all raw
agricultural commodities.
(b) An exemption from the requirement of a tolerance is established
for indirect or inadvertent residues of lactic acid (2-hydroxypropanoic
acid), including l-lactic acid, in or on all livestock commodities,
when residues are present therein as a result of animal drinking water
coming into contact with hard non-porous surfaces treated with lactic
acid (i.e., troughs).
[FR Doc. 2024-19456 Filed 8-28-24; 8:45 am]
BILLING CODE 6560-50-P
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