Document ID: EPA-HQ-OPP-2018-0763-0005
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Sodium Lauryl Sulfate
Posted Date: 2019-10-02T04:00Z

[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Rules and Regulations]
[Pages 52369-52372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21121]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0763; FRL-9999-81]

Sodium Lauryl Sulfate; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the fungicide and miticide sodium lauryl 
sulfate in or on all food commodities when used in accordance with 
label directions and good agricultural practices. Central Coast Garden 
Products submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of sodium lauryl sulfate under FFDCA.

[[Page 52370]]

DATES: This regulation is effective October 2, 2019. Objections and 
requests for hearings must be received on or before December 2, 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-2018-0763, 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: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
BPPDFRNotices@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 Publishing 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(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-2017-0763 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 
December 2, 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-2018-0763, 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. Background

    In the Federal Register of March 18, 2019 (84 FR 9737) (FRL-9989-
71), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 8F8688) by Central Coast Garden Products, 1354 Dayton St., 
Unit N, Salinas, CA 93901. The petition requested that 40 CFR part 180 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of Sodium Lauryl Sulfate (SLS) (CAS No. 151-21-
3) in or on all raw agricultural commodities. That document referenced 
a summary of the petition prepared by the petitioner, Central Coast 
Garden Products, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C) and (D), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or tolerance 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 . . . .'' Additionally, FFDCA section 408(b)(2)(D) 
requires that EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on sodium 
lauryl sulfate and considered its validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. EPA also considered available information concerning the 
variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children.
    Sodium lauryl sulfate (also called sodium dodecyl sulfate) is an 
amphiphilic anionic surfactant that is widely used in cleaning 
products,

[[Page 52371]]

cosmetics, personal care products, foods, pesticide products, 
lubricants and paints.
    As a pesticide, the chemical is exempt from the requirements of 
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as a minimum 
risk active ingredient under the specifications in 40 CFR 152.25(f). As 
an inert ingredient in pesticide products, SLS is approved for nonfood 
and food uses without limitation as a surfactant for pre- and post-
harvest uses (40 CFR 180.910) and as a surfactant applied to animals 
(40 CFR 180.930). For antimicrobial pesticide products, SLS is approved 
for use in food-contact sanitizing solutions with an end-use 
concentration limit of 350 ppm (40 CFR 180.940(a), (b), and (c)). 
Currently, there is one federally-registered product where SLS is an 
active ingredient, an antiviral tissue, which was registered in 2009.
    The Food and Drug Administration (FDA) has approved its use as a 
direct and indirect food additive (with limitations) under 21 CFR 
172.210, 172.822, 175.105, 175.300, 175.320, 176.170, 176.180, 176.210, 
177.1200, 177.1210, 177.1630, 177.2600, 177.2800, 178.1010 and 179.45. 
These uses include emulsifier, whipping aid, coating and wetting agent. 
The chemical is also considered to be a Generally Recognized as Safe 
(GRAS) substance (21 CFR 172.822 (with limitations); Flavor and Extract 
Manufacturers Association (FEMA) # 4437).
    Overall, SLS is considered to be of low toxicity. Based on the 
available information and the fact that humans have been exposed to SLS 
for decades in food and nonfood products, the chemical is considered to 
have a history of safe use. The target organ is the liver, but no 
adverse effects were seen at or below 430 milligram/kilogram/day (mg/
kg/day). There is no evidence of increased susceptibility in the 
developmental and reproductive toxicity studies. Moreover, no 
neurotoxicity, genotoxicity, or carcinogenicity have been observed in 
the available database, which includes the following studies: Acute 
toxicity, repeat dose (gavage and dietary) toxicity, developmental 
toxicity, reproductive toxicity, genotoxicity and carcinogenicity.
    With regard to potential dietary exposure to SLS, the Agency 
expects that upon approval of this exemption, SLS may be used in any 
number of pesticide products, as it is listed as an active ingredient 
that can be used in minimum risk pesticide products without regulation 
under FIFRA (except as directed in 40 CFR 152.25(f)). Moreover, as 
noted above, SLS has been found safe for use as an inert ingredient in 
pesticide products and has been approved by FDA for use as a food 
additive. The Agency anticipates contributions to dietary exposures 
(food and drinking water) to be negligible due to the physical and 
chemical properties of SLS, which degrades rapidly in the environment 
and is highly soluble in water. Furthermore, any minimal residues that 
might be consumed are expected to be readily metabolized.
    Due to the low toxicity of SLS, long history of safe use, and 
expected minimal dietary exposure, the Agency did not identify any 
points of departure for a quantitative assessment of SLS.
    As part of its risk assessment for SLS, the Agency has further 
considered the potential risks of residential exposures, aggregate 
exposures, and cumulative risk. Based on SLS's low toxicity, 
anticipated negligible dietary exposure and history of safe use in 
consumer products, no risks of concern have been identified relative to 
residential (non-occupational) pesticidal uses or any aggregate of 
exposures to products containing SLS. Similarly, no risks of concern 
were identified for cumulative exposures to SLS since no common 
mechanism of toxicity was identified for either SLS or its metabolites.
    Therefore, based on the lack of toxicity and expected low 
exposures, EPA has determined that there is a reasonable certainty that 
no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to SLS. The data upon which EPA 
relied to make its safety determination, as well as other relevant 
information, including the Agency's dietary risk assessment, is 
available in the docket for this action as described under ADDRESSES.
    Based on its safety determination, EPA is establishing an exemption 
from the requirement of a tolerance for residues of the fungicide and 
miticide sodium lauryl sulfate in or on all food commodities when used 
on accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due 
to lack of concern for exposures, which supports the establishment of 
an exemption for residues of sodium lauryl sulfate.

IV. 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 EPA. 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 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 
exemption in this action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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.).

[[Page 52372]]

    This action does not involve any technical standards that would 
require EPA's 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).

V. 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: September 17, 2019.
Richard Keigwin,
Director, 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. Add Sec.  180.1372 to subpart D to read as follows:

Sec.  180.1372  Sodium lauryl sulfate; exemption from the requirement 
of a tolerance.

    Residues of the fungicide and miticide sodium lauryl sulfate (CAS 
No. 151-21-3) in or on all food commodities are exempt from the 
requirement of a tolerance, when used in accordance with label 
directions and good agricultural practices.

[FR Doc. 2019-21121 Filed 10-1-19; 8:45 am]
 BILLING CODE 6560-50-P