Sodium lauroyl sarcosinate; Exemption From the Requirement of a Tolerance, 25956-25960 [2021-10000]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Rules and Regulations]
[Pages 25956-25960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10000]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0451; FRL-10022-72]


Sodium lauroyl sarcosinate; 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 sodium lauroyl sarcosinate when used as 
an inert ingredient in antimicrobial pesticide formulations applied to 
food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils at an end-use 
concentration not to exceed 10,000 parts per million (ppm). Clorox 
Services Company representing Clorox Professional Products Company 
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 sodium lauroyl 
sarcosinate when used in accordance with this exemption.

DATES: This regulation is effective May 12, 2021. Objections and 
requests for hearings must be received on or before July 12, 2021, 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-2020-0451, 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

[[Page 25957]]

Public Reading Room is (202) 566-1744, and the telephone number for the 
OPP Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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: 
[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:
     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 Publishing Office's e-CFR site at 
https://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(g), 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-2020-0451 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 
July 12, 2021. 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-2020-0451, 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. Petition for Exemption

    In the Federal Register of September 30, 2020 (85 FR 61681) (FRL-
10014-74), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11391) by Clorox Services Company representing Clorox Professional 
Products Company, P.O. Box 493, Pleasanton, CA 94566-0803. The petition 
requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of sodium 
lauroyl sarcosinate (CAS Reg. No. 137-16-6) when used as an inert 
ingredient at an end-use concentration not to exceed 10,000 ppm in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. That document referenced a summary 
of the petition prepared by Clorox Services Company, the petitioner, 
which is available in the docket, https://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 the 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 the FFDCA 
defines ``safe'' to mean that EPA has determined 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(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing an exemption 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.''
    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 harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the

[[Page 25958]]

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 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 to sodium lauroyl sarcosinate, 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with sodium 
lauroyl sarcosinate 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 sodium lauroyl sarcosinate 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.
    Sodium lauroyl sarcosinate is metabolized to the fatty acid lauric 
acid and the amino acid sarcosine, both of which are found naturally in 
food. Sodium lauroyl sarcosinate has low acute oral toxicity, and 
results on a surrogate chemical showed low dermal toxicity. Two acute 
inhalation studies in rats showed varying LC50 values 
(lethal concentration for 50% of the animals), with one study reporting 
the LC50 to be between 0.05-0.5 mg/L and the other 
indicating a LC50 of 1 to 5 mg/L. These studies indicate 
that sodium lauroyl sarcosinate is potentially toxic if inhaled. 
However, inhalation exposure to sodium lauroyl sarcosinate is not 
likely because it is unlikely that sodium lauroyl sarcosinate will 
volatilize based on its physical/chemical properties (e.g. vapor 
pressure and Henry's Law Constant). Sodium lauroyl sarcosinate caused 
minimal eye irritation, did not cause skin irritation, and was not a 
skin sensitizer.
    Repeat dose oral toxicity testing in rats include a 90-day, 6-
month, and 2-year study. In addition, a developmental toxicity test was 
conducted. High repeated exposures to sodium lauroyl sarcosinate in the 
diet resulted in minor irritation to the stomach in studies up to 2 
years. This effect was not seen as an adverse effect of treatment and 
therefore, the NOAEL for the 6-month and 2-year studies were 1,000 mg/
kg/day, the highest dose tested. When the test substance was 
administered by gavage, the effects were more severe and include, in 
addition to increasing thickness in the stomach wall, a yellow 
discoloration of non-glandular gastric mucosa, more severe squamous 
cell hyperplasia, hyperkeratosis/parakeratosis, inflammation and edema 
of the non-glandular gastric mucosa. Systemic effects of sodium lauroyl 
sarcosinate have not been observed in animal studies.
    Sodium lauroyl sarcosine tested negative for genotoxic effects in 
various studies. Similarly, there was no evidence of carcinogenicity or 
neuropathological changes or effects reported in any of the studies. 
The agency does not believe sodium lauroyl sarcosine is carcinogenic or 
neurotoxic.

B. Toxicological Points of Departure/Levels of Concern

    The local effects seen in the stomach in the 90-day and 
developmental studies are the result of gavage dosing and are not 
relevant for end point selection for the purposes of assessing this 
chemical as an inert ingredient in pesticide formulations. Therefore, 
no toxicological significant endpoint of concern for sodium lauroyl 
sarcosinate has been identified in the database.

C. Exposure Assessment

    1. Dietary exposure from food, feed uses, and drinking water. In 
evaluating dietary exposure to sodium lauroyl sarcosinate, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance. Sodium lauroyl sarcosinate is currently exempt from the 
requirement of a tolerance under 40 CFR 180.1207 for use as an inert 
ingredient (surfactant) at levels not to exceed 10% in pesticide 
formulations containing glyphosate. Dietary exposure to sodium lauroyl 
sarcosinate may occur from eating foods treated with pesticide 
formulations containing this inert ingredient, from eating foods that 
come in contact with surfaces treated with pesticide formulations 
containing the inert ingredient, and drinking water containing runoff 
from soils containing the treated crops. In addition, sodium lauroyl 
sarcosinate is used as an additive in food packaging. However, no 
toxicological endpoint of concern was identified for sodium lauroyl 
sarcosinate and therefore, a quantitative assessment of dietary 
exposure is not necessary.
    2. 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).
    Residential exposure to sodium lauroyl sarcosinate may occur based 
on its use as an inert ingredient in pesticide formulations registered 
for residential uses. Additional non-dietary exposure may occur from 
use of sodium lauroyl sarcosinate in household products and cosmetics. 
However, no toxicological endpoint of concern was identified for sodium 
lauroyl sarcosinate and therefore a quantitative residential exposure 
assessment for sodium lauroyl sarcosinate was not conducted.
    3. 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 sodium lauroyl sarcosinate to share a common 
mechanism of toxicity with any other substances, and sodium lauroyl 
sarcosinate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this action, therefore, EPA has 
assumed that sodium lauroyl sarcosinate 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 the FFDCA requires EPA to retain an 
additional tenfold margin of safety in the case of threshold effects 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 Unit IV.B., there is no indication of threshold

[[Page 25959]]

effects being caused by sodium lauroyl sarcosinate. Therefore, this 
requirement does not apply to the present analysis. Moreover, due to 
the lack of any toxicological endpoints of concern, EPA conducted a 
qualitative assessment of magnesium sulfate, which does not use safety 
factors for assessing risk, and no additional safety factor is needed 
for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on sodium 
lauroyl sarcosinate, EPA has determined that there is a reasonable 
certainty that no harm to the general population or any population 
subgroup, including infants and children, will result from aggregate 
exposure to sodium lauroyl sarcosinate. Therefore, the establishment of 
an exemption from the requirement of a tolerance under 40 CFR 
180.940(a) for residues of sodium lauroyl sarcosinate when used as an 
inert ingredient in antimicrobial pesticide formulations applied to 
food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils at a maximum end-
use concentration of 10,000 ppm is safe under FFDCA section 408.

V. 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 sodium lauroyl sarcosinate (CAS 
Reg. No. 137-16-6) when used as an inert ingredient in antimicrobial 
pesticide formulations applied to food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils at an end-use concentration not to exceed 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). 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 exemption 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: May 4, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is 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, in paragraph (a), add alphabetically the inert 
ingredient ``Sodium lauroyl sarcosinate'' to table 180.940(a) to read 
as follows:


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

* * * * *
    (a) * * *

[[Page 25960]]



                            Table 180.940(a)
------------------------------------------------------------------------
       Pesticide chemical          CAS reg. No.           Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Sodium lauroyl sarcosinate.....        137-16-6   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 10,000 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-10000 Filed 5-11-21; 8:45 am]
BILLING CODE 6560-50-P