2-Isobutyl-2-methyl-1,3-dioxolane-4-methanol; Exemption From the Requirement of a Tolerance
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Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of 2-isobutyl-2-methyl-1,3-dioxolane-4- methanol (CAS Reg. No. 5660-53-7) when used as an inert ingredient (solvent/cosolvent) on growing crops and raw agricultural commodities after harvest, and in antimicrobial formulations applied to food- contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. SciReg, Inc., on behalf of Solvay USA Inc., submitted a petition to EPA under 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-isobutyl-2-methyl-1,3-dioxolane-4-methanol, when used in accordance with the terms of those exemptions.
Full Text
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<title>Federal Register, Volume 87 Issue 25 (Monday, February 7, 2022)</title>
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[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Rules and Regulations]
[Pages 6779-6783]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02495]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0541; FRL-9418-01-OCSPP]
2-Isobutyl-2-methyl-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 an exemption from the requirement
of a tolerance for residues of 2-isobutyl-2-methyl-1,3-dioxolane-4-
methanol (CAS Reg. No. 5660-53-7) when used as an inert ingredient
(solvent/cosolvent) on growing crops and raw agricultural commodities
after harvest, and in antimicrobial formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment,
and food-processing equipment and utensils. SciReg, Inc., on behalf of
Solvay USA Inc., submitted a petition to EPA under 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-isobutyl-2-methyl-1,3-dioxolane-4-methanol, when used in
accordance with the terms of those exemptions.
DATES: This regulation is effective February 7, 2022. Objections and
requests for hearings must be received on or before April 8, 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-2017-0541, 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 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#d1839597839fbea5b8b2b4a291b4a1b0ffb6bea7"><span class="__cf_email__" data-cfemail="55071113071b3a213c363026153025347b323a23">[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 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).
[[Page 6780]]
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/title-40">https://www.ecfr.gov/current/title-40</a>.
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-2017-0541 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
April 8, 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-2017-0541, 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 December 15, 2017 (82 FR 59604) (FRL-
9970-50), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11066) by SciReg Inc., 12733 Director's Loop, Woodbridge, VA, 22192 on
behalf of Solvay USA Inc., 504 Carnegie Center, Princeton, NJ, 08540.
The petition requested that 40 CFR 180.910 and 180.940(a) be amended by
establishing an exemption from the requirement of a tolerance for
residues of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol (CAS Reg. No.
5660-53-7) when used as an inert ingredient (solvent/co-solvent) in
pesticide formulations applied to growing crops or raw agricultural
commodities after harvest under 40 CFR 180.910 and when used in
antimicrobial formulations (food-contact surface sanitizing solutions)
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils under
40 CFR 180.940(a). 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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There
were no relevant 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. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). 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 . .
. . '' Section 408(b)(2)(D) lists other factors for EPA consideration
making safety determinations, e.g., the validity, completeness, and
reliability of available data, nature of toxic effects, available
information concerning the cumulative effects of the pesticide chemical
and other substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances, among others.
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-isobutyl-2-
[[Page 6781]]
methyl-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-isobutyl-2-methyl-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-isobutyl-2-methyl-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
The toxicological database of 2-isobutyl-2-methyl-1,3-dioxolane-4-
methanol is supported by data regarding 2,2-dimethyl-1,3-dioxolane-4-
methanol. EPA has determined that it is appropriate to bridge 2,2-
dimethyl-1,3-dioxolane-4-methanol data due to similarities in the
manufacturing processes, functional groups/structure, composition, and
physical/chemical properties, and among the available human health
toxicity and ecological toxicity data of the two substances.
2-Isobutyl-2-methyl-1,3-dioxolane-4-methanol exhibits low levels of
acute toxicity via the oral, dermal, and inhalation routes of exposure.
In the rat, the oral LD<INF>50</INF> 7,000 mg/kg, the dermal
LD<INF>50</INF> > 2,000 mg/kg, and the inhalation LC<INF>50</INF> is >
5.11 mg/L. It is not irritating to the rabbit skin. It is irritating to
the rabbit eye. It is not a dermal sensitizer, it is negative for
mutagenicity and the DEREK analysis indicates it is unlikely to pose a
carcinogenic risk to humans. In a 6-week, repeat-dose toxicity study
with reproduction/developmental screening, the maternal, offspring and
reproduction NOAELs were 1,000 mg/kg/day.
There were no studies/data directly related to the possible
neurotoxicity of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol. However,
evidence of potential neurotoxicity was not observed in functional
observation battery (FOB) performed in the developmental study in the
rat. Therefore, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is not
expected to be neurotoxic.
There were no studies/data directly related the immunotoxic
potential of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol. There were
no indications of possible immunotoxicity from the data that are
available.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticides/factsheets/riskassess.html">https://www.epa.gov/pesticides/factsheets/riskassess.html</a>.
The hazard profile of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol
is adequately defined. Overall, 2-isobutyl-2-methyl-1,3-dioxolane-4-
methanol is of low acute, subchronic, and developmental toxicity. No
systemic toxicity is observed up to 1,000 mg/kg/day. Since signs of
toxicity were not observed, no endpoint of concern was identified.
Therefore, a qualitative risk assessment for 2-isobutyl-2-methyl-1,3-
dioxolane-4-methanol was conducted.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance. EPA assessed dietary exposures from 2-isobutyl-2-
methyl-1,3-dioxolane-4-methanol in food as follows:
Dietary exposure (food and drinking water) to 2-isobutyl-2-methyl-
1,3-dioxolane-4-methanol may occur following ingestion of foods with
residues from their use in accordance with this exemption. However, a
quantitative dietary exposure assessment was not conducted since a
toxicological endpoint for risk assessment was not identified.
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).
2-Isobutyl-2-methyl-1,3-dioxolane-4-methanol may be used in
pesticide products and non-pesticide products that may be used in and
around the home. Based on the discussion above regarding the low
toxicity of the 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol, a
quantitative residential exposure assessment was not conducted.
3. 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 data, 2-isobutyl-2-
methyl-1,3-dioxolane-4-methanol and its metabolites are not expected to
share a common mechanism of toxicity with other chemicals; therefore,
section 408(b)(2)(D)(v) does not apply.
D. Safety Factor for Infants and Children
In general. 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 2-isobutyl-
2-methyl-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
[[Page 6782]]
additional safety factor is needed for assessing risk to infants and
children. Based on an assessment of 2-isobutyl-2-methyl-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
Because no toxicological endpoints of concern were identified, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol residues.
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, exemptions from the requirement of a tolerance is
established for residues of 2-isobutyl-2-methyl-1,3-dioxolane-4-
methanol (CAS Reg. No. 5660-53-7) when used as an inert ingredient
(solvent/co-solvent) in pesticide formulations applied to growing crops
and raw agricultural commodities after harvest under 40 CFR 180.910 and
when used in antimicrobial 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).
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). 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 exemptions 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: January 20, 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. 180.910, amend Table 1 to 180.910 by adding, in
alphabetical order, an entry for ``2-Isobutyl-2-methyl-1,3-dioxolane-4-
methanol (CAS Reg. No. 5660-53-7)'' 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
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
2-Isobutyl-2-methyl-1,3- .............. Solvent/Co-solvent.
dioxolane-4-methanol (CAS
Reg. No. 5660-53-7).
* * * * * * *
------------------------------------------------------------------------
[[Page 6783]]
0
3. In Sec. 180.940, amend Table 1 to Paragraph (a) by adding, in
alphabetical order, an entry for ``2-Isobutyl-2-methyl-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 1 to Paragraph (a)
------------------------------------------------------------------------
Inert ingredients CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
2-Isobutyl-2-methyl-1,3- 5660-53-7 ..........................
dioxolane-4-methanol.
* * * * * * **
------------------------------------------------------------------------
* * * * *
[FR Doc. 2022-02495 Filed 2-4-22; 8:45 am]
BILLING CODE 6560-50-P
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</html>This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.