Document ID: EPA-HQ-OPP-2017-0103-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: 2,2-Dimethyl-1,3-dioxolane-4-methanol
Posted Date: 2021-04-07T04:00Z

[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Rules and Regulations]
[Pages 17914-17917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07028]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0103; FRL-10015-73]

2,2-Dimethyl-1,3-dioxolane-4-methanol; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of 2,2-dimethyl-1,3-dioxolane-4-methanol (CAS 
Reg. No. 100-79-8) when used as an inert ingredient in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest and in antimicrobial formulations applied to certain 
food-contact surfaces. SciReg. Inc., on behalf of Solvay USA, submitted 
a petition to EPA under section 346a of 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 2,2-dimethyl-1,3-
dioxolane-4-methanol, when used in accordance with these exemptions.

DATES: This regulation is effective April 7, 2021. Objections and 
requests for hearings must be received on or before June 7, 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-2017-0103, 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.
    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: 
RDFRNotices@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, 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-2017-0103 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 
June 7, 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-2017-0103, 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. Petition for Exemption

    In the Federal Register of June 8, 2017 (82 FR 26642) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11024) by 
SciReg. Inc., 12733, Director's

[[Page 17915]]

Loop, Woodbridge, VA 22192, on behalf of Solvay USA, 504 Carnegie 
Center, Princeton, NJ 08540. The petition requested that 40 CFR 180.910 
and 180.940 be amended by establishing an exemption from the 
requirement of a tolerance for residues of 2,2-dimethyl-1,3-dioxolane-
4-methanol (CAS Reg. No.100-79-8) when used as an inert ingredient 
(solvent/cosolvent) in pesticide formulations applied to growing crops 
or raw agricultural commodities after harvest and in antimicrobial 
pesticide formulations (food-contact surface sanitizing solutions). 
That document referenced a summary of the petition prepared by SciReg, 
Inc., on behalf of Solvay USA Inc., the petitioner, which is available 
in the docket, http://www.regulations.gov. One comment was received on 
the notice of filing. EPA's response to this comment is discussed in 
Unit V.C.

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 2,2-dimethyl-1,3-dioxolane-4-
methanol including exposure resulting from the exemption established by 
this action. EPA's assessment of exposures and risks associated with 
2,2-dimethyl-1,3-dioxolane-4-methanol 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 2,2-dimethyl-1,3-dioxolane-4-methanol 
as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 2,2-
Dimethyl-1,3-dioxolane-4-methanol exhibits low levels of acute toxicity 
via the oral, dermal, and inhalation routes of exposure. It is not 
irritating to the rabbit skin, the rabbit eye, and is not a dermal 
sensitizer. 2,2-Dimethyl-1,3-dioxolane-4-methanol is negative for 
genotoxic effects in a battery of genotoxicity assays. Based on a 
cancer expert prediction system (DEREK analysis), 2,2-dimethyl-1,3-
dioxolane-4-methanol is unlikely to pose a carcinogenic risk to humans. 
2,2-Dimethyl-1,3-dioxolane-4-methanol exhibits no adverse toxicological 
effects in a combined repeat dose oral toxicity study with the 
reproduction/developmental toxicity screening test in rats at doses 
equal to or exceeding the limit dose of 1,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    Due to the lack of hazard associated with 2,2-dimethyl-1,3-
dioxolane-4-methanol based on the available data, no points of 
departure were identified for assessing risk; therefore, a quantitative 
risk assessment was not conducted.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 2,2-dimethyl-1,3-dioxolane-4-methanol, EPA considered 
exposure under the proposed exemption from the requirement of a 
tolerance. EPA assessed dietary exposures from 2,2-dimethyl-1,3-
dioxolane-4-methanol in food as follows:
    Acute and chronic dietary assessments take into account exposure 
estimates from dietary consumption of food and drinking water. Because 
no adverse effects attributable to a single or repeat exposures to 2,2-
dimethyl-1,3-dioxolane-4-methanol were seen in the toxicity databases, 
quantitative dietary risk assessments are not appropriate. Due to the 
expected use of 2,2-dimethyl-1,3-dioxolane-4-methanol in pesticide 
formulations applied to growing crops and raw agricultural commodities 
post-harvest, and in antimicrobial products, it is reasonable to expect 
that there will be some exposure residues of 2,2-dimethyl-1,3-
dioxolane-4-methanol in or on food from its use in pesticide products.
    2. From 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).
    It is possible that 2,2-dimethyl-1,3-dioxolane-4-methanol may be 
used as an inert ingredient in pesticide products that may result in 
residential exposures,

[[Page 17916]]

although no residential uses are currently proposed. A residential 
exposure assessment was not conducted because no endpoint of concern 
following a single or repeat dose exposure was identified in the 
available studies.

D. Safety Factor for Infants and Children

    Because there are no threshold effects associated with 2,2-
dimethyl-1,3-dioxolane-4-methanol, 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 
2,2-dimethyl-1,3-dioxolane-4-methanol, 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

    Taking into consideration all available information on 2,2-
dimethyl-1,3-dioxolane-4-methanol, EPA has determined that there is a 
reasonable certainty that no harm to any population subgroup, including 
infants and children, will result from aggregate exposure to 2,2-
dimethyl-1,3-dioxolane-4-methanol under reasonable foreseeable 
circumstances. Therefore, the establishment of an exemption from 
tolerance under 40 CFR 180.910 and 180.940 for residues of 2,2-
dimethyl-1,3-dioxolane-4-methanol when used as an inert ingredient in 
pesticide formulations is safe under FFDCA.

V. Other Considerations

A. 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 limit.

B. Response to Comments

    One commenter opposed a tolerance for residues of pesticides in or 
on food, although the commenter did not present any information that 
the Agency could take into account when making a determination about 
the safety of this pesticide. Although the Agency recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops, the existing legal framework provided by section 408 of the 
FFDCA authorizes EPA to establish tolerances when it determines that 
the tolerance is safe. Upon consideration of the validity, 
completeness, and reliability of the available data as well as other 
factors the FFDCA requires EPA to consider, EPA has determined that 
these exemptions from the requirement of a tolerance are safe. The 
commenters have provided no information to indicate that 2,2-dimethyl-
1,3-dioxolane-4-methanol is not safe.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established under 40 CFR 180.910 and 180.940 for 2,2-dimethyl-1,3-
dioxolane-4-methanol (CAS Reg. No 100-79-8) when used as an inert 
ingredient as solvent/cosolvent in pesticide formulations applied to 
growing crops and raw agricultural commodities after harvest and 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 exemptions 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), nor is it considered 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 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: November 20, 2020.
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:

[[Page 17917]]

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.  180.910, amend table 1 by adding alphabetically the inert 
ingredient ``2,2-Dimethyl-1,3-dioxolane-4-methanol (CAS Reg. No.100-79-
8)'' to read as follows:

Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

                                               Table 1 to 180.910
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               Inert ingredients                      Limits                           Uses
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                                                  * * * * * * *
2,2-Dimethyl-1,3-dioxolane-4-methanol (CAS Reg.  ...............  Solvent/cosolvent.
 No.100-79-8).
 
                                                  * * * * * * *
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0
3. In Sec.  180.940, amend the table in paragraph (a) by adding 
alphabetically the inert ingredient ``2,2-Dimethyl-1,3-dioxolane-4-
methanol'' 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) * * *

                                                Table 180.940(a)
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               Pesticide chemical                  CAS Reg. No.                       Limits
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
2,2-Dimethyl-1,3-dioxolane-4-methanol..........         100-79-8
 
                                                  * * * * * * *
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* * * * *

    Editorial note: This document was received for publication by 
the Office of the Federal Register on April 1, 2021.

[FR Doc. 2021-07028 Filed 4-6-21; 8:45 am]
BILLING CODE 6560-50-P