Rule2022-06327
Butoxypolypropylene glycol, et al.; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 25, 2022
Effective
March 25, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of butoxypolypropylene glycol (BPG; [alpha]- butyl-[omega]-hydroxy-poly-oxy(methyl-1,2-ethanediyl) (CAS Reg. No. 9003-13-8)), oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1- yl ether (CAS Reg. No. 9041-33-2; polyether 1), poly(oxy-1,2- ethanediyl), [alpha]-acetyl-[omega]-(2-propen-1-yloxy)- (CAS Reg. No. 27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl), [alpha]-methyl- [omega]-(2-propen-1-yloxy)- (CAS Reg. No. 27252-80-8; polyether 3) when used as an inert ingredient in/on growing crops and raw agricultural commodities pre- and post-harvest and applied to animals. Spring Trading Company, on behalf of Evonik Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of BPG and polyethers 1, 2, and 3 when used in accordance with these exemptions.
Full Text
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<title>Federal Register, Volume 87 Issue 58 (Friday, March 25, 2022)</title>
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[Federal Register Volume 87, Number 58 (Friday, March 25, 2022)]
[Rules and Regulations]
[Pages 17013-17018]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-06327]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0156; FRL-9574-01-OCSPP]
Butoxypolypropylene glycol, et al.; 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 butoxypolypropylene glycol (BPG; [alpha]-
butyl-[omega]-hydroxy-poly-oxy(methyl-1,2-ethanediyl) (CAS Reg. No.
9003-13-8)), oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-
yl ether (CAS Reg. No. 9041-33-2; polyether 1), poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-[omega]-(2-propen-1-yloxy)- (CAS Reg. No.
27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl), [alpha]-methyl-
[omega]-(2-propen-1-yloxy)- (CAS Reg. No. 27252-80-8; polyether 3) when
used as an inert ingredient in/on growing crops and raw agricultural
commodities pre- and post-harvest and applied to animals. Spring
Trading Company, on behalf of Evonik Corporation, submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of exemptions from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of BPG and polyethers 1, 2, and 3 when
used in accordance with these exemptions.
DATES: This regulation is effective March 25, 2022. Objections and
requests for hearings must be received on or before May 24, 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-2018-0156, 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 open to visitors by
appointment only. For the latest status information on EPA/DC services
and 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#70223436223e1f0419131503301500115e171f06"><span class="__cf_email__" data-cfemail="5a081e1c0814352e33393f291a3f2a3b743d352c">[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).
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-2018-0156 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
May 24, 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-2018-0156, 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
[[Page 17014]]
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 May 18, 2018 (83 FR 23249) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11104) by
Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354), on
behalf of Evonik Corporation (P.O. Box 34628, Richmond, VA 23234). The
petition requested that 40 CFR 180.910 and 180.930 be amended by
establishing exemptions from the requirement of a tolerance for
residues of BPG and polyethers 1, 2, and 3 when used as an inert
ingredient in pesticide formulations applied in/on growing crops pre-
and post-harvest and applied to animals. That document referenced a
summary of the petition prepared by Spring Trading Company on behalf of
Evonik Corporation, 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(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 BPG and polyethers 1, 2 and 3
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with BPG and
polyethers 1, 2 and 3 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 BPG and polyethers 1, 2 and 3 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 this unit.
Toxicity information is available for BPG but not for polyethers 1,
2 or 3. Therefore, information from BPG and the related compound
polyoxyethylene polyoxypropylene monobutyl ether (PPME; CAS Reg. No.
9038-95-3) and several related alcohol ethoxylates are used to assess
the toxicity of the petitioned-for polymers. Based on the available
read-across information, BPG and polyethers 1, 2, and 3, are considered
to have low acute toxicity via the oral, dermal, and inhalation routes.
They are minor eye irritants, but not dermal irritants or skin
sensitizers.
In repeated-dose toxicity studies, the kidneys, liver,
hematological system and lungs were the major target organs. However,
the effects observed in these oral and dermal studies occurred at doses
at or above the limit dose and thus, are not considered relevant for
risk assessment purposes. Based on their expected volatility and
results from a repeated-dose inhalation study, inhalation is the route
of toxicological concern for BPG and polyethers 1, 2, and 3. There is
no evidence of susceptibility in the available developmental toxicity
study and no effects on reproductive organs were observed throughout
the database. Concern for carcinogenicity is low based on negative
results in mutagenicity and genotoxicity studies and lack of effects in
the available chronic studies.
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
[[Page 17015]]
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.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
An acute dietary endpoint was not selected because no effect
attributable to a single dose was identified in the database. No
chronic dietary endpoint was selected because the effects observed in
the oral studies occurred at doses above the limit dose, which are not
relevant for risk assessment purposes. No short- and intermediate-term
incidental oral endpoints were selected because the effects observed in
the oral studies occurred at doses above the limit dose, which are not
relevant for risk assessment purposes. No dermal endpoints were
selected. There were also no adverse systemic effects reported in the
90-day dermal toxicity study in rats, and there was no evidence of
increased susceptibility in the young.
The short-term and intermediate-term inhalation endpoints were
derived from the 2-week inhalation toxicity study in rats, with a NOAEL
of 100 mg/m\3\ and a LOAEL of 500 mg/m\3\, based on rapid respiration
in females, hematology, clinical chemistry and urinalysis findings and
microscopic findings in the lung in both sexes. This represents the
lowest NOAEL in the database in the most sensitive species. The
standard uncertainty factors (UFs) were applied to account for
interspecies (10x) and intraspecies (10x) variations. The default value
of 100% was used for the dermal and inhalation absorption factors.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Although dietary
exposure via food is anticipated, no acute or chronic dietary endpoints
of concern were identified; therefore, a quantitative dietary exposure
assessment was not conducted.
2. Dietary exposure from drinking water. Although dietary exposure
via drinking water is anticipated, no acute or chronic dietary
endpoints of concern were identified; therefore, a quantitative dietary
exposure assessment was not conducted.
3. 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).
BPG and polyethers 1, 2 and 3 may be used as an inert ingredient in
products that are registered for specific uses that may result in
residential exposure. A screening level residential exposure and risk
assessment was completed for products containing BPG and polyethers 1,
2 and 3 as inert ingredients. The Agency selected representative
scenarios, based on end-use product application methods and labeled
application rates. The Agency conducted an assessment to represent
worst-case residential exposure by assessing BPG and polyethers 1, 2
and 3 in pesticide formulations (outdoor scenarios) and BPG and
polyethers 1, 2 and 3 in disinfectant-type uses (indoor scenarios). The
Agency assessed the disinfectant-type products containing BPG and
polyethers 1, 2 and 3 using exposure scenarios used by OPP's
Antimicrobials Division to represent worst-case indoor residential
handler exposure to possible non-food use applications. Further details
of the residential exposure and risk analysis can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the memorandum entitled ``JITF Inert
Ingredients. Residential and Occupational Exposure Assessment
Algorithms and Assumptions Appendix for the Human Health Risk
Assessments to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations''
(D364751, 5/7/09, Lloyd/LaMay) in docket ID number EPA-HQ-OPP-2008-
0710.
4. 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 found BPG or polyether 1, 2 or 3 to share a common
mechanism of toxicity with any other substances, and BPG and polyether
1, 2 and 3 do not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that BPG and polyether 1, 2 and 3 do 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>.
D. Safety Factor for Infants and Children
1. 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.
2. Prenatal and postnatal sensitivity. Based on the evaluation of
available toxicity studies with BPG and related compounds, there is low
concern for pre- and postnatal susceptibility for infants and children
from exposure to BPG, and polyethers 1, 2, and 3.
3. Conclusion. The FQPA safety factor has been reduced to 1X
because: (1) The toxicity database is adequate to characterize
potential pre- and postnatal risk for infants and children; (2) no
effects on reproductive organs or reproductive parameters were observed
in the available studies; (3) no developmental effects were observed in
the available dermal developmental study in rats; (4) no evidence of
neurotoxicity was observed in the database; and (5) the exposure
assessment is unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short- and intermediate-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the appropriate PODs to ensure that an adequate
MOE exists.
1. Acute dietary risk. An acute aggregate risk assessment takes
into account acute exposure estimates from dietary consumption of food
and
[[Page 17016]]
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
BPG and polyethers 1, 2 and 3 are not expected to pose an acute dietary
risk.
2. Chronic dietary risk. A chronic aggregate risk assessment takes
into account chronic exposure estimates from dietary consumption of
food and drinking water. No adverse effect resulting from repeated oral
exposure was identified and no chronic dietary endpoint was selected.
Therefore, BPG and polyether 1, 2 and 3 are not expected to pose a
chronic dietary risk.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). BPG and
polyethers 1, 2 and 3 are currently used as an inert ingredient in
pesticide products that are registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to BPG and polyethers 1, 2 and 3.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs ranging from 22,000
to 280,000 for adults (handler only; no dietary exposure). Because
EPA's level of concern for BPG and polyethers 1, 2 and 3 is an MOE of
100 or below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). BPG and polyethers 1, 2 and 3 are currently used as an inert
ingredient in pesticide products that are registered for uses that
could result in intermediate-term residential exposure, and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with intermediate-term residential exposures to
BPG and polyethers 1, 2 and 3.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs ranging from 22,000 to 280,000 for adults (handler only;
no dietary exposure). Because EPA's level of concern for BPG and
polyethers 1, 2 and 3 is a MOE of 100 or below, these MOEs are not of
concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in the provided studies, BPG and polyethers
1, 2 and 3 are not expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, 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 BPG and polyethers 1, 2 and 3 residues.
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 limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for BPG and polyether 1, 2 and 3.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established under 40 CFR 180.910 and 180.930 for butoxypolypropylene
glycol (BPG; [alpha]-butyl-v-hydroxy-poly-oxy(methyl-1,2-ethanediyl)
(CAS Reg. No. 9003-13-8), oxirane, 2-methyl-, polymer with oxirane,
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2; polyether 1),
poly(oxy-1,2-ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS
Reg. No. 27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl),
[alpha]-methyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-80-8;
polyether 3) when used as an inert ingredient in pesticide formulations
applied in/on growing crops and raw agricultural commodities pre- and
post-harvest under and applied to animals.
VII. Statutory and Executive Order Reviews
This action establishes 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 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
[[Page 17017]]
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: March 21, 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, the inert ingredients ``Butoxypolypropylene glycol
(CAS Reg. No. 9003-13-8)''; ``Oxirane, 2-methyl-, polymer with oxirane,
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2)''; ``Poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-
87-5)''; and ``Poly(oxy-1,2-ethanediyl), [alpha]-methyl-v-(2-propen-1-
yloxy)- (CAS Reg. No. 27252-80-8)'' 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
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Butoxypolypropylene glycol (CAS Reg. No. .............. ..............
9003-13-8).............................
* * * * * * *
Oxirane, 2-methyl-, polymer with
oxirane, mono-2-propen-1-yl ether (CAS
Reg. No. 9041-33-2)....................
* * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-acetyl-
v-(2-propen-1-yloxy)- (CAS Reg. No.
27252-87-5)............................
* * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-methyl-
v-(2-propen-1-yloxy)- (CAS Reg. No.
27252-80-8)............................
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, amend Table 1 to 180.930 by adding, in
alphabetical order, the inert ingredients ``Butoxypolypropylene glycol
(CAS Reg. No. 9003-13-8)''; ``Oxirane, 2-methyl-, polymer with oxirane,
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2)''; ``Poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-
87-5)''; and ``Poly(oxy-1,2-ethanediyl), [alpha]-methyl-v-(2-propen-1-
yloxy)- (CAS Reg. No. 27252-80-8)'' to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
Table 1 to 180.930
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Butoxypolypropylene glycol (CAS Reg. No.
9003-13-8).............................
* * * * * * *
Oxirane, 2-methyl-, polymer with
oxirane, mono-2-propen-1-yl ether (CAS
Reg. No. 9041-33-2)....................
* * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-acetyl-
v-(2-propen-1-yloxy)- (CAS Reg. No.
27252-87-5)............................
Poly(oxy-1,2-ethanediyl), [alpha]-methyl-
v-(2-propen-1-yloxy)- (CAS Reg. No.
27252-80-8)............................
* * * * * * *
------------------------------------------------------------------------
[[Page 17018]]
[FR Doc. 2022-06327 Filed 3-24-22; 8:45 am]
BILLING CODE 6560-50-P
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