[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 [www.gpo.gov]
[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 
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 Public 
Reading Room and the OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

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: 
[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

[[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:
     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 Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title40.

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.
     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 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 http://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(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 
https://www.regulations.gov 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 https://www.regulations.gov 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 https://www.epa.gov/pesticides/cumulative.

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 
https://www.regulations.gov 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).

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                        Table 1 to Paragraph (a)
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       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