Dimethyl Sulfoxide; Exemption From the Requirement of a Tolerance, 61531-61534 [2022-22129]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Rules and Regulations]
[Pages 61531-61534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22129]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0774; FRL-10239-01-OCSPP]


Dimethyl Sulfoxide; 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 dimethyl sulfoxide (CAS Reg. No. 67-68-
5) when used as an inert ingredient (solvent, co-solvent), in pesticide 
formulations for pre-harvest applications, including post-emergence 
use. Exponent, Inc., on behalf of Gaylord Chemical Company submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an amendment to an existing tolerance exemption. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of dimethyl sulfoxide for pre-harvest applications.

DATES: This regulation is effective October 12, 2022. Objections and 
requests for hearings must be received on or before December 12, 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-2021-0774, 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 OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit 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 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/title-40.

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-2021-0774 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 12, 2022. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b), although the 
Office of the Administrative Law Judges, which houses the Hearing 
Clerk, encourages parties to file objections and hearing requests 
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    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-

[[Page 61532]]

2021-0774, 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 February 25, 2022 (87 FR 10760) (FRL-
9410-01), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11603) by Exponent, Inc., 1150 Connecticut Ave., Suite 1100, 
Washington, DC 20036, on behalf of Gaylord Chemical Company, LLC, 106 
Galeria Boulevard, Slidell, LA 70458. The petition requested that 40 
CFR 180.920 be amended by modifying an exemption from the requirement 
of a tolerance for residues of dimethyl sulfoxide (CAS Reg. No. 67-68-
5) by allowing its use as an inert ingredient (solvent, co-solvent) in 
pesticide formulations applied for pre-harvest applications, including 
post-emergence use. That document referenced a summary of the petition 
prepared by Exponent, Inc. on behalf of Gaylord Chemical 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 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(b)(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 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 dimethyl sulfoxide including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with dimethyl sulfoxide 
follows.

A. Toxicological Profile

    The toxicological profile of dimethyl sulfoxide remains unchanged 
from the Toxicological Profile in Unit IV.A. of the October 9, 2015, 
rulemaking (80 FR 61125) (FRL-9934-17). Refer to that section for a 
discussion of the toxicological profile of dimethyl sulfoxide.

B. Toxicological Points of Departure/Levels of Concern

    The toxicological points of departure/levels of concern of dimethyl 
sulfoxide remains unchanged from the Toxicological Points of Departure/
Levels of Concern discussion in Unit IV.B. of the October 9, 2015, 
rulemaking (80 FR 61125) (FRL-9934-17). No endpoints of concern were 
identified. Refer to that section for a discussion of the toxicological 
points of departure/levels of concern of dimethyl sulfoxide.

C. Exposure Assessment

    The exposure assessment for dimethyl sulfoxide remains unchanged 
from the discussion in Unit IV.C. of the October 9, 2015, rulemaking 
and supporting human health risk assessment (September 11, 2015). Refer 
to that section for a discussion of the exposure assessment for 
dimethyl sulfoxide.
    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.''
    Based on the lack of toxicity in the available database, EPA has 
not found dimethyl sulfoxide to share a common mechanism of toxicity 
with any other substances, and dimethyl sulfoxide does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance exemption, therefore, EPA has assumed that 
dimethyl sulfoxide 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/pesticide-science-and-

[[Page 61533]]

assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) 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 on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(FQPA) Safety Factor (SF). In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional safety 
factor when reliable data available to EPA support the choice of a 
different factor.
    Because there are no threshold effects associated with dimethyl 
sulfoxide, EPA conducted a qualitative assessment. As part of that 
assessment, the Agency did not use safety factors for assessing risk, 
and no additional safety factor is needed for assessing risk to infants 
and children. Based on an assessment of dimethyl sulfoxide 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

    The aggregate exposure assessment for dimethyl sulfoxide remains 
unchanged from the discussion in Unit IV.E. of the October 9, 2015, 
rulemaking and supporting human health risk assessment. Refer to that 
section for a detailed discussion of the aggregate assessment for 
dimethyl sulfoxide (these documents can be found at https://www.regulations.gov under docket ID numbers EPA-HQ-OPP-2014-0630 and 
EPA-HQ-OPP-2021-00774). In summary, qualitative dietary, residential 
and aggregate assessments were performed due to the lack of toxicity 
endpoints of concern. There was no dietary, residential or aggregate 
risks of concern for the U.S. population and all subpopulations. Based 
on this human health risk assessment, an exemption from the requirement 
of a tolerance was established for residues of dimethyl sulfoxide under 
40 CFR 180.920 for use before crop emerges from soil or prior to 
formation of edible parts of food plants; for pesticide formulations 
used after crop emerges but before harvest. This limitation was based 
on concerns regarding the chemical properties of dimethyl sulfoxide 
that could result in increased active ingredient residues. However, the 
petitioner submitted a comparative field trial residue study showing 
that dimethyl sulfoxide as an inert ingredient in pesticide 
formulations does not increase active ingredient residues. EPA has 
concluded that the use of dimethyl sulfoxide as an inert ingredient in 
pesticide formulations does not increase active ingredient residues; 
nor is it expected to result in active ingredient residue levels that 
exceed established tolerances. Therefore, since there is no concern for 
increased active ingredient residues on treated crops due to dimethyl 
sulfoxide and there are no endpoints of concern for dimethyl sulfoxide, 
the qualitative dietary, non-dietary risk, and aggregate assessments 
performed in 2015 are appropriate and remain unchanged. As a result, 
the Agency has determined that a tolerance is not necessary to protect 
public health.
    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 dimethyl sulfoxide.

V. Other Considerations

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 180.920 for dimethyl sulfoxide (CAS Reg. No. 
67-68-5) when used as an inert ingredient (solvent, co-solvent) in 
pesticide formulations pre-harvest applications, including post-
emergence use.

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). 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 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

[[Page 61534]]

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: October 5, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR part 180 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.  180.920, amend table 1 by:
0
a. Removing the entry for ``Dimethyl sulfoxide''; and
0
b. Revising the entry ``Dimethyl sulfoxide (CAS Reg. No. 67-68-5)''.
    The revision reads as follows:


Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

                           Table 1 to 180.920
------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Dimethyl sulfoxide (CAS Reg. No.    ..............  Solvent/co-solvent.
 67-68-5).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-22129 Filed 10-11-22; 8:45 am]
BILLING CODE 6560-50-P