77544 Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Proposed Rules 

health and welfare. The EPA has 

determined that this action increases the 

level of environmental protection for all 

affected populations without having any 

disproportionately high and adverse 

human health or income or 

environmental effects on any 

population, including any minority, 

low-income, or Indigenous populations. 

To the extent that any minority, lowincome, or Indigenous subpopulation is 

disproportionately impacted by landfill 

gas emissions due to the proximity of 

their homes to sources of these 

emissions, that subpopulation also 

stands to see increased environmental 

and health benefit from the emission 

reductions called for by this action. 

In addition, this proposed approval of 

Alabama’s State plan for existing MSW 

landfills does not have Tribal 

implications as specified by Executive 

Order 13175 (65 FR 67249, November 9, 

2000), because the State plan is not 

approved to apply in Indian country 

located in the State, and the EPA notes 

that it will not impose substantial direct 

costs on Tribal governments or preempt 

Tribal law. 

List of Subjects in 40 CFR Part 62 

Administrative practice and 

procedure, Air pollution control, 

Environmental protection, Landfills, 

Incorporation by reference, 

Intergovernmental relations, Methane, 

Ozone, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: November 2, 2023. 

Jeaneanne Gettle, 

Acting Regional Administrator, Region 4. 

[FR Doc. 2023–24959 Filed 11–9–23; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 dairyprocessing equipment and foodprocessing 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-sendcomments-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: pease.anita@

epa.gov. 

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 foodprocessing 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 


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Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Proposed Rules 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, dairyprocessing equipment, and foodprocessing 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 nonporous 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 


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77546 Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Proposed Rules 

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 LLactic 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 


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Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Proposed Rules 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.940, amend paragraph (b) 

by removing the entry for ‘‘Lactic acid’’ 

from the table. 


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77548 Federal Register / Vol. 88, No. 217 / Monday, November 13, 2023 / Proposed Rules 

■ 3. Revise § 180.1090 to read as 

follows: 

§ 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] 

BILLING CODE 6560–50–P 


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