L-Lactic Acid; Proposed Tolerance Actions, 77544-77548 [2023-24925]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 88, Number 217 (Monday, November 13, 2023)]
[Proposed Rules]
[Pages 77544-77548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24925]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0455; FRL-11520-01-OCSPP]
RIN 2070-ZA16


L-Lactic Acid; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to remove a duplicative exemption from the 
requirement of a tolerance for residues of L-lactic acid, herein 
referred to as lactic acid, when applied to dairy-processing equipment 
and food-processing equipment and utensils. In addition, the Agency is 
proposing 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 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). This rulemaking is proposed 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: Comments must be received on or before January 12, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(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 Confidential Business 
Information (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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is 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; telephone number: 
202-566-0736; email address: [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:

 Animal production (NAICS code 112)
 Food manufacturing (NAICS code 311)
 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.gov or email. Clearly mark the part or all of the 
information that you claim to be 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/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing the following tolerance actions related to lactic 
acid:
     To remove the duplicative exemption from the requirement 
of a tolerance under 40 CFR 180.940(b) for residues of lactic acid when 
applied to dairy-processing equipment and food-processing equipment and 
utensils, as these use sites are covered by the exemption under 40 CFR 
180.940(a) (i.e., food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils).
     To establish exemptions from the requirement of a 
tolerance under 40 CFR 180.1090 for residues of 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). EPA is 
proposing these exemptions to cover residues of lactic acid that may be 
found in food as a result of these uses.
    EPA is proposing these tolerance actions to implement the changes

[[Page 77545]]

identified as necessary during the registration review process to cover 
these pesticide chemical residues when used in antimicrobial 
formulations consistent with current label use directions. Registration 
review documents, such as the draft risk assessment, typically identify 
certain tolerance actions, including modifications to reflect current 
use patterns, meet safety findings, and change commodity names and 
groupings, that may be necessary or appropriate to cover pesticide 
chemical residues or reflect current EPA policy.
    For the pesticide chemical at issue in this rulemaking, EPA issued 
the L-lactic Acid Combined Preliminary Work Plan and Proposed Interim 
Registration Review Decision (Lactic Acid PWP/PID) in April 2021, and 
the L-lactic Acid Interim Registration Review Decision (Lactic Acid ID) 
in September 2021, as part of the second round of registration review 
for lactic acid. Electronic copies of the Lactic Acid PWP/PID, Lactic 
Acid ID, and other documents are available in docket ID number EPA-HQ-
OPP-2020-0552 at https://www.regulations.gov. These documents contain a 
summary of the Agency's assessment of the potential risk associated 
with current product uses, and the Lactic Acid ID identified the need 
for the tolerance actions described above.

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. 346a, 
authorizes the establishment, modification, and revocation of 
tolerances and exemptions from the requirement of a tolerance for 
residues of pesticide chemicals in or on raw agricultural commodities 
and processed foods. Residues of pesticides in or on food that are not 
covered by a tolerance or exemption are deemed unsafe under FFDCA 
section 408(a), 21 U.S.C. 346a(a), and any food containing unsafe 
residues is considered 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). For a food-use pesticide to be sold and distributed, 
the pesticide must not only have appropriate tolerances under the 
FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136 et seq. 
Residues of food-use pesticides not registered in the United States 
must also be covered by a U.S. tolerance or exemption in order for 
commodities treated with those pesticides to be imported into the 
United States.
    Section 408(c)(1)(B) of the FFDCA authorizes EPA to establish, 
modify, or revoke an exemption from the requirement of a tolerance on 
its own initiative, 21 U.S.C. 346(c)(e)(1)(B)). Before issuing a final 
regulation, EPA is required to issue a proposed rulemaking and provide 
a comment period. Id. 346(a)(e)(2).
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance only if EPA determines 
that the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the 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.'' 21 U.S.C. 
346a(c)(2)(A)(ii). This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(c)(2)(B) of the FFDCA requires EPA, when making a safety 
determination concerning an exemption, to take into account, among 
other relevant considerations, those listed in section 408(b)(2)(C) and 
(D) of the FFDCA. Section 408(b)(2)(C) of the 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. . . .'' Section 408(b)(2)(D) identifies various factors, 
including available information on aggregate and cumulative exposure, 
for EPA consideration in making a safety determination.

C. When do these actions become effective?

    EPA is proposing that these tolerance actions become effective on 
the date of publication of the final rule in the Federal Register.

III. Proposed Rule

    EPA is proposing this rule to implement the tolerance actions 
identified in the September 2021, Lactic Acid ID. As noted in the 
Lactic Acid ID, there is an exemption from the requirement of a 
tolerance under 40 CFR 180.940(b) for residues of lactic acid when 
applied to dairy-processing equipment and food-processing equipment and 
utensils, with the limitation that the end-use concentration of lactic 
acid does not exceed 138 parts per million (ppm). During registration 
review, EPA determined that this exemption is duplicative of another 
exemption under 40 CFR 180.940(a) for residues of lactic acid when 
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils, with 
the limitation that the end-use concentration of lactic acid does not 
exceed 10,000 ppm. EPA, on its own initiative, is therefore proposing 
to remove the duplicative exemption for lactic acid under 40 CFR 
180.940(b).
    As noted in the Lactic Acid ID, products containing lactic acid are 
registered for antimicrobial use as disinfectants, indirect food 
contact surface sanitizers, fungicides, and virucides. These products 
can be used for hard non-porous surfaces and in laundry machines; 
agricultural premises and equipment; food handling storage 
establishments, premises, and equipment; commercial, institutional, and 
industrial premises and equipment; fruit and vegetable treatment; human 
drinking water systems; and storage tanks. During registration review, 
EPA determined that residues of lactic acid may be present in or on raw 
agricultural commodities as result of its use as a fruit and vegetable 
wash. EPA also determined that lactic acid residues may be present in 
livestock commodities as a result of animal drinking water coming into 
contact with hard non-porous surfaces treated with lactic acid (i.e., 
troughs). The Agency currently does not have data to demonstrate that 
there is no reasonable expectation of residues in livestock 
commodities. Moreover, lactic acid is ubiquitous in the environment and 
occurs naturally in certain foods, such as meat and dairy products, 
making it difficult to distinguish lactic acid residues resulting from 
animal drinking water versus other sources. EPA, on its own initiative, 
therefore proposes to establish exemptions from the requirement of a 
tolerance to cover residues of lactic acid in or on all raw 
agricultural commodities that may result from its use as a fruit and 
vegetable wash, and to cover indirect or inadvertent residues of lactic 
acid in or on all livestock commodities that may result from animal 
drinking water coming into contact with hard non-porous surfaces 
treated with lactic acid (i.e., troughs).
    In order to establish tolerances or exemptions from the requirement 
of a tolerance, EPA is required to determine that each tolerance or 
exemption meets the safety standard of the FFDCA. In the Lactic Acid ID 
and other supporting

[[Page 77546]]

documents referenced in this proposed rule, EPA considered the 
potential risks from exposure to lactic acid from registered uses and 
concluded that those uses did not present risks of concern.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), 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 lactic 
acid proposed by this action.
    The Agency relied on the most current science policies and risk 
assessment information in support of the registration review of lactic 
acid from the initial round of registration review. In addition, the 
Agency considered whether any new data requirements promulgated since 
the initial round of registration review warranted the requirement of 
additional data for this round of registration review. Based on 
available data considered in the initial round of registration review, 
the lack of toxicity, and low exposure levels expected from registered 
uses, the Agency determined there was no need for new data or a new 
human health risk assessment. EPA's assessment of exposures and risks 
associated with lactic acid follows.

A. Toxicological Profile

    EPA evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA also considered available 
information concerning the variability of the sensitivities of major 
identifiable subgroups of consumers, including infants and children. 
The toxicity profile of lactic acid indicates no significant systemic 
toxicity even at high dose levels. Specific information on the studies 
received and the nature of the adverse effects caused by lactic acid 
from the toxicity studies can be found in the June 2009 document L-
Lactic Acid Final Registration Review Decision, which is available in 
docket ID number EPA-HQ-OPP-2008-0383 at https://www.regulations.gov.

B. Toxicological Points of Departure/Levels of Concern

    Based on the low toxicity of lactic acid, the Agency determined 
that a quantitative human health risk assessment was not necessary, and 
no human health toxicity endpoints for lactic acid were selected.

C. Exposure Assessment

    Dietary exposure (food and drinking water). Dietary exposures may 
occur from use of lactic acid as an active ingredient on food contact 
surfaces, treatment of fruits and vegetables, possibly in livestock 
commodities, and from exposure in human drinking water systems. Dietary 
exposure may also occur from the use of lactic acid as an inert 
ingredient in pesticide formulations applied to growing crops and to 
plants after harvest or in antimicrobial formulations applied to food-
contact surfaces. In addition, the U.S. Food and Drug Administration 
(FDA) has approved the use of lactic acid as a food additive at levels 
up to 138 ppm in sanitizing solutions, which is another source of 
dietary exposure. While an exemption from the requirement of a 
tolerance has been established for lactic acid when used as a plant 
growth regulator, there are no products currently registered by EPA for 
the plant growth regulator outdoor use pattern. Dietary exposure is not 
expected from use of lactic acid in mosquito control end-use products, 
as they are used in traps. Lactic acid occurs naturally in fruit, the 
soil, and the bloodstreams of animals, and is added to many foods such 
as beer and fermented milk products. It is generally recognized as safe 
by FDA. Because of the low toxicity associated with lactic acid, EPA 
concluded that dietary exposure through food and drinking water will 
not pose a risk of concern. Therefore, EPA determined that dietary and 
drinking water exposures and risks do not need to be quantitatively 
assessed for lactic acid.
    Non-dietary (residential) exposure. Based on the registered uses of 
lactic acid as an indirect food-contact sanitizer, disinfectant, and in 
indoor/outdoor traps for mosquitoes, there is potential for residential 
dermal, inhalation and incidental oral exposure. Exposures and risk as 
a result of the registered uses of lactic acid are expected to be 
minimal on the basis of the current label restrictions and 
precautionary statements, the low concentration of active ingredient in 
registered end-use products, and the limited evidence of any adverse 
effects. Thus, EPA determined that a quantitative residential exposure 
risk assessment is not needed for the registered uses of lactic acid.
    Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found lactic 
acid to share a common mechanism of toxicity with any other substances, 
and lactic acid does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance action, 
therefore, EPA has assumed that lactic acid does not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(FQPA) safety factor. In applying this provision, EPA either retains 
the default value of 10X, or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of lactic acid. That qualitative assessment does not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. Based on an 
assessment of lactic acid, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of lactic acid will not 
pose a risk to the U.S. population, including infants and children, and 
that there is a reasonable certainty that no harm will result to the

[[Page 77547]]

general population, or to infants and children, from aggregate exposure 
to lactic acid residues.
Analytical Enforcement Methodology
    An analytical method is not required for enforcement purposes since 
the Agency is proposing to establish exemptions from the requirement of 
a tolerance without any numerical limitation.

V. Conclusion

    Therefore, EPA is proposing to remove the duplicative exemption for 
residues of lactic acid when used in antimicrobial pesticide 
formulations applied to dairy-processing equipment and food-processing 
equipment and utensils, and 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 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).

VI. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to establish exemptions 
from the requirement of a tolerance under FFDCA section 408, and to 
remove an exemption that is not necessary. The Office of Management and 
Budget (OMB) has exempted these types of action 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 collections 
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) (FRL-5753-1), 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 pesticide 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: November 3, 2023.
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. In Sec.  180.940, amend paragraph (b) by removing the entry for 
``Lactic acid'' from the table.

[[Page 77548]]

0
3. Revise Sec.  180.1090 to read as follows:


Sec.  180.1090   Lactic acid; exemption from the requirement of a 
tolerance.

    (a) Lactic acid (2-hydroxypropanoic 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) 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. 2023-24925 Filed 11-9-23; 8:45 am]
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