Document ID: EPA-HQ-OPP-2018-0157-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Lactic Acid
Posted Date: 2019-07-26T04:00Z

[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Rules and Regulations]
[Pages 35996-36000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15647]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0157; FRL-9994-63]

Lactic Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of lactic acid (CAS Reg. No. 50-21-5) when 
used as an inert ingredient (acidifier) on food-contact surfaces in 
public eating places, dairy processing equipment, food-processing 
equipment and utensils at 10,000 parts per million (ppm). Ecolab Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of lactic acid when 
used in accordance with the terms specified in the regulation.

[[Page 35997]]

DATES: This regulation is effective July 26, 2019. Objections and 
requests for hearings must be received on or before September 24, 2019, 
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-2018-0157, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2018-0157 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 
September 24, 2019. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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-2018-0157, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11113) by 
Ecolab Inc., 655 Lone Oak Drive, Eagan, MN 55121. The petition 
requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of lactic 
acid (CAS Reg. No. 50-21-5) when used as an inert ingredient 
(acidifier) in pesticide formulations applied to food-contact surfaces 
in public eating places, dairy processing equipment, food-processing 
equipment and utensils at 10,000 parts per million (ppm). That document 
referenced a summary of the petition prepared by Ecolab Inc., the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and 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 tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(c)(2)(B) requires EPA, in 
determining whether an exemption would be safe, to take into account 
the considerations set forth in subparagraphs (b)(2)(C) and (D). 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a

[[Page 35998]]

reasonable certainty that no harm will result to infants and children 
from aggregate exposure to the pesticide chemical residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    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 for lactic acid including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with lactic acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by lactic acid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    Lactic acid is practically non-toxic to mammals, apart from 
irritation stemming from its low pH. It is an endogenous compound 
produced in the mammalian system. L-lactic acid (lactate) is a product 
of fermentation in the muscles produced from pyruvate via lactate 
dehydrogenase. Lactate is also generated from glucose under aerobic 
conditions in some tissues and cell types. L-Lactic acid is normally 
found in the blood and interstitial fluid of humans at a level of 10 
mg/dL (EPA 2009). In addition, L-lactic acid occurs naturally in 
several foods, primarily found in fermented milk products such as sour 
milk, cheese, buttermilk and yogurt. It also occurs naturally in meats, 
fruits, tomato juice, beer, wine, molasses, blood and muscles of 
animals, and in the soil.
    The available acute toxicity studies indicate that lactic acid is 
not acutely toxic via the oral or inhalation route of exposure. Because 
the test substance (80% lactic acid) has a very low pH (<1), L-lactic 
acid is a severe dermal irritant in rabbits but not a skin sensitizer 
at high concentrations (e.g., 80%).
    Although some minor effects were observed in repeat dosing studies 
in rats (e.g., decrease in body weight gain or organ weight gain), no 
significant systemic toxicity was identified for lactic acid, even at 
dose levels greater than 1,000 mg/kg/day. In addition, there was no 
indication of developmental toxicity in a developmental toxicity study 
in mice. Furthermore, none of the available data indicate that lactic 
acid is neurotoxic, immunotoxic, or carcinogenic.
    Based on a review of 15 mutagenicity and clastogenicity studies on 
lactic acid and the ammonium, calcium, and sodium salts of lactic acid, 
EPA notes that the results were negative for all studies and there is 
no evidence that lactic acid is genotoxic.
    In an in vitro chromosomal aberration study, some pseudo-positive 
reactions were observed at low pH.

B. Toxicological Points of Departure/Levels of Concern

    Although the toxicity database for lactic acid is limited, the 
toxicity profile indicates no significant systemic toxicity even at 
high dose levels. Since no toxicity is observed, an endpoint of concern 
for risk assessment purposes was not identified.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to lactic acid, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from lactic acid in food as follows:
    Dietary exposure to lactic acid may occur following ingestion of 
foods containing residues of lactic acid from its use as an acidifier 
in pesticide formulations applied to food-contact surfaces as well as 
from other pesticidal uses that are already approved that may result in 
residues o treated crops. In addition, lactic acid occurs naturally in 
several foods and in the soil. However, a quantitative dietary exposure 
assessment was not conducted since a toxicological endpoint for risk 
assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted, although exposures may be expected 
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Lactic acid may be used in pesticide products and non-pesticide 
products that may be used in and around the home. Based on the lack of 
a hazard endpoint of concern above, a quantitative residential exposure 
assessment for lactic acid was not conducted.
    4. 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 http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    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

[[Page 35999]]

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 
general population, or to infants and children from aggregate exposure 
to lactic acid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for lactic acid (CAS Reg. No. 50-
21-5) when used as an inert ingredient (acidifier) in pesticide 
formulations applied to food-contact surfaces in public eating places, 
dairy processing equipment, food-processing equipment and utensils at 
10,000 ppm.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action 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) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not 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.).
    This action 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).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not 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: July 5, 2019.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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, add alphabetically the inert ingredient ``lactic 
acid'' to the table in paragraph (a) and remove the inert ingredient 
``lactic acid'' from the table in paragraph (c).
    The addition reads as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS Reg. No.           Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Lactic acid.....................         50-21-5  When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 10,000 ppm
                                                   in antimicrobial
                                                   formulations applied
                                                   to food-contact
                                                   surfaces in public
                                                   eating places.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 36000]]

* * * * *
[FR Doc. 2019-15647 Filed 7-25-19; 8:45 am]
BILLING CODE 6560-50-P