Rule2022-14067
Sodium Dioctyl Sulfosuccinate (CAS Reg. No. 577-11-7); Tolerance Exemption
Primary source
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Published
July 1, 2022
Effective
July 1, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of sodium dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) 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 under 40 CFR 180.940(a). Spring Regulatory Sciences, on behalf of Evonik Corporation, 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 dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 126 (Friday, July 1, 2022)</title>
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[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Rules and Regulations]
[Pages 39345-39348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14067]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0682; FRL-9932-01-OCSPP]
Sodium Dioctyl Sulfosuccinate (CAS Reg. No. 577-11-7); Tolerance
Exemption
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 sodium dioctyl sulfosuccinate (CAS Reg.
No. 577-11-7) 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 under 40 CFR 180.940(a). Spring Regulatory
Sciences, on behalf of Evonik Corporation, 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 dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) when
used in accordance with this exemption.
DATES: This regulation is effective July 1, 2022. Objections and
requests for hearings must be received on or before August 30, 2022 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-2021-0682, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 and the OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#9bc9dfddc9d5f4eff2f8fee8dbfeebfab5fcf4ed"><span class="__cf_email__" data-cfemail="51031517031f3e2538323422113421307f363e27">[email protected]</span></a>.
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
[[Page 39346]]
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title40">https://www.ecfr.gov/current/title40</a>.
C. 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-2021-0682 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
August 30, 2022. 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-2021-0682, by one of
the following methods.
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-04-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11566) by Spring Regulatory Sciences (6620 Cypresswood Dr, Suite 250,
Spring, TX 77379), on behalf of Evonik Corporation, (P.O. Box 34628,
Richmond, VA 23234). 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 dioctyl sulfosuccinate (CAS Reg. No.
577-11-7) for use as an inert ingredient in antimicrobial pesticide
formulations. That document referenced a summary of the petition
prepared by the petitioner, which is available in the docket, and
solicited comments on the petitioner's request at <a href="http://regulations.gov">http://regulations.gov</a>. 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(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 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 shown 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 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(b)(2)(D), 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 and considered its validity, completeness and reliability and
the relationship of this information 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. EPA has sufficient data to assess the hazards of
and to make a determination on aggregate exposure to sodium dioctyl
sulfosuccinate including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with sodium dioctyl sulfosuccinate follows.
[[Page 39347]]
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. Sodium dioctyl sulfosuccinate is also known as dioctyl sodium
sulfosuccinate or DSS. Specific information on the studies received and
the nature of the adverse effects caused by sodium dioctyl
sulfosuccinate, 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 the November 5, 2012 document titled
``Dioctyl Sodium Sulfosuccinate: Preliminary Human Health Risk
Assessment in Support of Registration Review,'' which is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPP-2010-1006,
and in the June 10th, 2022 document titled ``IN-11566; Petition to an
amend Tolerance Exemption for Sodium dioctyl sulfosuccinate (CAS No.
577-11-7), adding it to the approved list of food use inert ingredients
under 40 CFR 180.940(a) in Pesticide Formulations.'' which is available
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the docket for this action.
Sodium dioctyl sulfosuccinate has low acute oral, dermal and
inhalation toxicity. It is neither a skin sensitizer nor a skin or eye
irritant. Toxicity to offspring occurred in the reproduction and
developmental studies only at the limit dose and in the presence of
parental toxicity. The subchronic toxicity, chronic toxicity, and
mutagenicity studies did not demonstrate any significant toxicity of
sodium dioctyl sulfosuccinate.
In a 90-day oral toxicity study in Sprague-Dawley rats with sodium
dioctyl sulfosuccinate, no adverse effects were observed up to the
highest dose tested and the NOAEL is 1000 mg/kg/day.
B. Toxicological Points of Departure/Levels of Concern
The toxicological points of departure/levels of concern of sodium
dioctyl sulfosuccinate remain unchanged from the Toxicological Profile
in Preliminary Human Health Risk Assessment in Support of Registration
Review. D405928, November 5, 2012. No toxicological endpoints of
concern were identified for sodium dioctyl sulfosuccinate because there
was no offspring susceptibility and the only effects observed occurred
at the limit dose.
C. Exposure Assessment
Dietary and residential (non-occupational and non-dietary)
exposures are expected from the proposed and existing uses of sodium
dioctyl sulfosuccinate. However, no quantitative dietary or residential
exposure assessments were conducted because no toxicological endpoints
of concern were identified.
D. 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 determined that sodium dioctyl sulfosuccinate share a
common mechanism of toxicity with any other substances, and sodium
dioctyl sulfosuccinate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has assumed that sodium dioctyl sulfosuccinate 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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
E. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold 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 unless EPA concludes that
a different margin of safety will be safe for infants and children.
Based on an assessment of sodium dioctyl sulfosuccinate, EPA has
concluded that there are no toxicological endpoints of concern for the
U.S. population, including infants and children, and a qualitative
assessment is being conducted for sodium dioctyl sulfosuccinate. The
qualitative assessment does not use safety factors for assessing risk,
and no additional safety factor is needed for assessing risk to infants
and children.
F. Determination of Safety
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to sodium dioctyl sulfosuccinate residues. More
detailed information about the Agency's analysis can be found at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> in the November 5, 2012 document titled
``Dioctyl Sodium Sulfosuccinate: Preliminary Human Health Risk
Assessment in Support of Registration Review'' in docket ID number EPA-
HQ-OPP-2010-1006, and in the June 10th, 2022 document titled ``IN-
11566; Petition to an amend Tolerance Exemption for Sodium dioctyl
sulfosuccinate (CAS No. 577-11-7), adding it to the approved list of
food use inert ingredients under 40 CFR 180.940(a) in Pesticide
Formulations.'' in the docket for this action.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
sodium dioctyl sulfosuccinate in or on any food commodities.
VI. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for sodium dioctyl sulfosuccinate
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.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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).
[[Page 39348]]
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: June 22, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.940, amend Table 1 to Paragraph (a) by adding, in
alphabetical order, an entry for ``Sodium dioctyl sulfosuccinate'' to
read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
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* * * * * * *
Sodium dioctyl sulfosuccinate.. 577-11-7 None.
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[FR Doc. 2022-14067 Filed 6-30-22; 8:45 am]
BILLING CODE 6560-50-P
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