[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 [www.gpo.gov]
[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 
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 for the OPP Docket is (202) 566-1744. Please review 
the visitor instructions and additional information about the docket 
available at 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; main telephone 
number: (202) 566-0736; email address: [email protected] or 
[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 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:
     Food manufacturing (NAICS code 311),
     Pesticide manufacturing (NAICS code 32532),
     Restaurant kitchen cleaning services (NAICS code 561720),
     Milk production, dairy cattle (NAICS code 112120),
     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 
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, 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), https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
    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:
     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/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

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 https://www.regulations.gov.

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 https://www.regulations.gov 
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 https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence.

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 https://www.regulations.gov.

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