Propanoic Acid, 3-hydroxy-(hydroxymethyl)-2-methyl-, Polymer With 2-amino-2-methyl-1-propanol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and Methyloxirane Polymer With Oxirane Ether With 4,4′-(1-methylethylidene)bis[phenol] (2:1), Polyethylene-Polypropylene Glycol 2-aminopropyl Me Ether-Blocked, Compds. With 2-amino-2-methyl-1-propanol; Tolerance Exemption, 12213-12217 [2023-03866]
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Rules and Regulations
amending title 22, chapter I, subchapter
M, which was published at 87 FR 16396
on March 23, 2022, is adopted as final
with the following changes:
1. The authority citation for part 120
continues to read as follows:
■
Authority: 22 U.S.C. 2651a, 2752, 2753,
2776, 2778, 2779, 2779a, 2785, 2794, 2797;
E.O. 13637, 78 FR 16129, 3 CFR, 2013 Comp.,
p. 223.
2. Amend § 120.13 by adding
paragraph (c) to read:
■
Registration.
*
*
*
*
*
(c) The registration requirements as
set forth in parts 122 and 129 of this
subchapter include limited exemptions.
§ 120.40
[Amended]
PART 121—THE UNITED STATES
MUNITIONS LIST
4. The authority citation for part 121
continues to read as follows:
■
Authority: 22 U.S.C. 2752, 2778, 2797; 22
U.S.C. 2651a; Sec. 1514, Pub. L. 105–261, 112
Stat. 2175; E.O. 13637, 78 FR 16129, 3 CFR,
2013 Comp., p. 223.
[Amended]
5. In § 121.1, Category XIII, paragraph
(l), remove the phrase ‘‘(see § 120.32) of
this subchapter)’’ and add in its place
‘‘(see § 120.32 of this subchapter)’’.
■
Bonnie Jenkins,
Under Secretary, Arms Controls and
International Security, Department of State.
[FR Doc. 2023–03828 Filed 2–24–23; 8:45 am]
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Propanoic Acid, 3-hydroxy(hydroxymethyl)-2-methyl-, Polymer
With 2-amino-2-methyl-1-propanol, αhydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
Methyloxirane Polymer With Oxirane
Ether With 4,4′-(1methylethylidene)bis[phenol] (2:1),
Polyethylene-Polypropylene Glycol 2aminopropyl Me Ether-Blocked,
Compds. With 2-amino-2-methyl-1propanol; Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of propanoic acid,
3-hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol (IN–
11729) when used as an inert ingredient
in a pesticide chemical formulation.
Nouryon Surface Chemistry LLC
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of propanoic acid, 3hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol on
food or feed commodities when used in
accordance with these exemptions.
DATES: This regulation is effective
February 27, 2023. Objections and
SUMMARY:
3. In § 120.40 paragraph (g), remove
the phrase ‘‘a technical data license’’
and add in its place ‘‘a license’’.
■
§ 121.1
40 CFR Part 180
[EPA–HQ–OPP–2022–0935; FRL–10656–01–
OCSPP]
PART 120—PURPOSE AND
DEFINITIONS
§ 120.13
ENVIRONMENTAL PROTECTION
AGENCY
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12213
requests for hearings must be received
on or before April 28, 2023, 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–2022–0935, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, Registration Division
(7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–2875; 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 Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. Can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
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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–2022–0935 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
28, 2023. 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/202005/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–
2022–0935, 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/where-sendcomments-epa-dockets.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of January 3,
2023 (88 FR 38) (FRL–9410–08–OCSPP),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11729) filed by Nouryon
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Chemicals LLC, c/o Keller and Heckman
LLP, 1001 G Street NW, Suite 500 West,
Washington DC, 20001. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol (CAS
Reg. No. 515152–49–5). That document
included a summary of the petition
prepared by the petitioner and solicited
comments on the petitioner’s request.
The Agency did not receive any
comments.
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 exemption 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
use 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 an
exemption from the requirement of 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 . . .’’ and specifies
factors EPA is to consider in
establishing an exemption.
III. Risk Assessment and Statutory
Findings
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be shown that the
risks from aggregate exposure to
pesticide chemical residues under
reasonably foreseeable circumstances
will pose no 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
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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(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. In the
case of certain chemical substances that
are defined as polymers, the Agency has
established a set of criteria to identify
categories of polymers expected to
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol
conforms to the definition of a polymer
given in 40 CFR 723.250(b) and meets
the following criteria that are used to
identify low-risk polymers.
1. The polymer is not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymer does contain as an
integral part of its composition at least
two of the atomic elements carbon,
hydrogen, nitrogen, oxygen, silicon, and
sulfur.
3. The polymer does not contain as an
integral part of its composition, except
as impurities, any element other than
those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed
nor can it be reasonably anticipated to
substantially degrade, decompose, or
depolymerize. An available
biodegradation study supports that
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
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with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol is
not readily biodegradable (MRID
52014302).
5. The polymer is manufactured or
imported from monomers and/or
reactants that are already included on
the TSCA Chemical Substance
Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 Daltons.
7. The polymer does not contain
certain perfluoroalkyl moieties
consisting of a CF3- or longer chain
length as listed in 40 CFR 723.250(d)(6).
Additionally, the polymer also meets
as required the following exemption
criteria: specified in 40 CFR 723.250(e):
The polymer’s number average MW of
6,800 Daltons is greater than 1,000 and
less than 10,000 Daltons. The polymer
contains less than 10% oligomeric
material below MW 500 and less than
25% oligomeric material below MW
1,000, and the polymer contains only
reactive functional groups listed in 40
CFR 723.250(e)(1)(ii)(A).
Thus, propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol
meets the criteria for a polymer to be
considered low risk under 40 CFR
723.250. Based on its conformance to
the criteria in this unit, no mammalian
toxicity is anticipated from dietary,
inhalation, or dermal exposure to
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-
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aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol (CAS
Reg. No. 515152–49–5).
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol
could be present in all raw and
processed agricultural commodities and
drinking water, and that nonoccupational non-dietary exposure was
possible. The number average MW of
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol is
6,800 Daltons. Generally, a polymer of
this size would be poorly absorbed
through the intact gastrointestinal tract
or through intact human skin. Since
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol
conform to the criteria that identify a
low-risk polymer, there are no concerns
for risks associated with any potential
exposure scenarios that are reasonably
foreseeable. The Agency has determined
that a tolerance is not necessary to
protect the public health.
V. 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
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12215
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 propanoic acid, 3hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol to
share a common mechanism of toxicity
with any other substances, and
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance exemption,
therefore, EPA has assumed that
propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol 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-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
VI. Additional Safety Factor for the
Protection of 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
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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. Due to the expected
low toxicity of propanoic acid, 3hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol, EPA
has not used a safety factor analysis to
assess the risk. For the same reasons no
additional safety factor is needed for
assessing risk to infants and children.
VII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of propanoic acid, 3-hydroxy(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, ahydro-w-hydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol.
VIII. Other Considerations
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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.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of propanoic acid,
3-hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1-
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propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
with 2-amino-2-methyl-1-propanol from
the requirement of a tolerance will be
safe.
X. 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
PO 00000
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Fmt 4700
Sfmt 4700
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).
XI. 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: February 17, 2023.
Daniel Rosenblatt,
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, amend table 1 to the
section by adding, in alphabetical order,
the polymer ‘‘Propanoic acid, 3hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1propanol, a-hydro-whydroxypoly[oxy(methyl-1,2ethanediyl)], 5-isocyanato-1(isocyanatomethyl)-1,3,3trimethylcyclohexane and
■
E:\FR\FM\27FER1.SGM
27FER1
12217
Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Rules and Regulations
methyloxirane polymer with oxirane
ether with 4,4′-(1methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2aminopropyl Me ether-blocked, compds.
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
with 2-amino-2-methyl-1-propanol,
minimum number average molecular
weight (in amu), 6,800’’ to read as
follows:
*
*
*
*
*
TABLE 1 TO § 180.960
Polymer
CAS No.
*
*
*
*
*
*
Propanoic
acid,
3-hydroxy-(hydroxymethyl)-2-methyl-,
polymer
with
2-amino-2-methyl-1-propanol,
a-hydro-whydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane
polymer with oxirane ether with 4,4′-(1-methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol 2-aminopropyl
Me ether-blocked, compds. with 2-amino-2-methyl-1-propanol, minimum number average molecular weight (in amu), 6,800 ....
*
*
*
*
*
[FR Doc. 2023–03866 Filed 2–24–23; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 6560–50–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0931, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0931; FRL–10650–01–
OCSPP]
2-Propenoic Acid, Methyl-, Polymer
With Butyl 2-Propenoate and Methyl 2Methyl-2-Propenoate Compd. With 2Amino-2-Methyl-1-Propanol; Tolerance
Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of 2-propenoic
acid, methyl-, polymer with butyl 2propenoate and methyl 2-methyl-2propenoate compd. with 2-amino-2methyl-1-propanol when used as an
inert ingredient in a pesticide chemical
formulation. Nouryon Chemicals LLC
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of 2-propenoic acid,
methyl-, polymer with butyl 2propenoate and methyl 2-methyl-2propenoate compd. with 2-amino-2methyl-1-propanol on food or feed
commodities when used in accordance
with these exemptions.
DATES: This regulation is effective
February 27, 2023. Objections and
requests for hearings must be received
on or before April 28, 2023 and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
18:59 Feb 24, 2023
Jkt 259001
FOR FURTHER INFORMATION CONTACT:
Daniel Rosenblatt, Registration Division
(7505T), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–2875; 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).
PO 00000
Frm 00085
Fmt 4700
Sfmt 4700
*
*
515152–49–5
*
• 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. 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–2022–0931 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
28, 2023. 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/202005/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
E:\FR\FM\27FER1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Rules and Regulations]
[Pages 12213-12217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03866]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0935; FRL-10656-01-OCSPP]
Propanoic Acid, 3-hydroxy-(hydroxymethyl)-2-methyl-, Polymer With
2-amino-2-methyl-1-propanol, [alpha]-hydro-[omega]-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and Methyloxirane Polymer
With Oxirane Ether With 4,4'-(1-methylethylidene)bis[phenol] (2:1),
Polyethylene-Polypropylene Glycol 2-aminopropyl Me Ether-Blocked,
Compds. With 2-amino-2-methyl-1-propanol; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol (IN-11729) when used as an inert ingredient in a pesticide
chemical formulation. Nouryon Surface Chemistry LLC submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of propanoic acid, 3-hydroxy-(hydroxymethyl)-2-methyl-,
polymer with 2-amino-2-methyl-1-propanol, [alpha]-hydro-[omega]-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane polymer
with oxirane ether with 4,4'-(1-methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-aminopropyl Me ether-blocked,
compds. with 2-amino-2-methyl-1-propanol on food or feed commodities
when used in accordance with these exemptions.
DATES: This regulation is effective February 27, 2023. Objections and
requests for hearings must be received on or before April 28, 2023, 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-2022-0935, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-2875; 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. Can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an
[[Page 12214]]
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-2022-0935 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 28, 2023. 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-2022-0935, 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/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of January 3, 2023 (88 FR 38) (FRL-9410-08-
OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11729)
filed by Nouryon Chemicals LLC, c/o Keller and Heckman LLP, 1001 G
Street NW, Suite 500 West, Washington DC, 20001. The petition requested
that 40 CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol (CAS Reg. No. 515152-49-5). That document included a summary
of the petition prepared by the petitioner and solicited comments on
the petitioner's request. The Agency did not receive any comments.
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 exemption 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 use 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 an exemption from the
requirement of 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 . . .'' and
specifies factors EPA is to consider in establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no 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(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol conforms to the definition of a polymer given in 40 CFR
723.250(b) and meets the following criteria that are used to identify
low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize. An
available biodegradation study supports that propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer
[[Page 12215]]
with 2-amino-2-methyl-1-propanol, [alpha]-hydro-[omega]-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane polymer
with oxirane ether with 4,4'-(1-methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-aminopropyl Me ether-blocked,
compds. with 2-amino-2-methyl-1-propanol is not readily biodegradable
(MRID 52014302).
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 Daltons.
7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
Additionally, the polymer also meets as required the following
exemption criteria: specified in 40 CFR 723.250(e):
The polymer's number average MW of 6,800 Daltons is greater than
1,000 and less than 10,000 Daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer contains only reactive functional
groups listed in 40 CFR 723.250(e)(1)(ii)(A).
Thus, propanoic acid, 3-hydroxy-(hydroxymethyl)-2-methyl-, polymer
with 2-amino-2-methyl-1-propanol, [alpha]-hydro-[omega]-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane polymer
with oxirane ether with 4,4'-(1-methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-aminopropyl Me ether-blocked,
compds. with 2-amino-2-methyl-1-propanol meets the criteria for a
polymer to be considered low risk under 40 CFR 723.250. Based on its
conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to propanoic
acid, 3-hydroxy-(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-
methyl-1-propanol, [alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-
ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and methyloxirane polymer with oxirane ether with
4,4'-(1-methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene
glycol 2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol (CAS Reg. No. 515152-49-5).
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol could be present in all raw and processed agricultural
commodities and drinking water, and that non-occupational non-dietary
exposure was possible. The number average MW of propanoic acid, 3-
hydroxy-(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-
propanol, [alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-
ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and methyloxirane polymer with oxirane ether with
4,4'-(1-methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene
glycol 2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol is 6,800 Daltons. Generally, a polymer of this size would be
poorly absorbed through the intact gastrointestinal tract or through
intact human skin. Since propanoic acid, 3-hydroxy-(hydroxymethyl)-2-
methyl-, polymer with 2-amino-2-methyl-1-propanol, [alpha]-hydro-
[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane polymer
with oxirane ether with 4,4'-(1-methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-aminopropyl Me ether-blocked,
compds. with 2-amino-2-methyl-1-propanol conform to the criteria that
identify a low-risk polymer, there are no concerns for risks associated
with any potential exposure scenarios that are reasonably foreseeable.
The Agency has determined that a tolerance is not necessary to protect
the public health.
V. 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 propanoic acid, 3-hydroxy-(hydroxymethyl)-2-
methyl-, polymer with 2-amino-2-methyl-1-propanol, [alpha]-hydro-
[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and methyloxirane polymer
with oxirane ether with 4,4'-(1-methylethylidene)bis[phenol] (2:1),
polyethylene-polypropylene glycol 2-aminopropyl Me ether-blocked,
compds. with 2-amino-2-methyl-1-propanol to share a common mechanism of
toxicity with any other substances, and propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance exemption,
therefore, EPA has assumed that propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol 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-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
VI. Additional Safety Factor for the Protection of 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
[[Page 12216]]
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. Due to the expected low toxicity of propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol, EPA has not used a safety factor analysis to assess the risk.
For the same reasons no additional safety factor is needed for
assessing risk to infants and children.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol.
VIII. 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.
IX. Conclusion
Accordingly, EPA finds that exempting residues of propanoic acid,
3-hydroxy-(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-
propanol, [alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-
ethanediyl)], 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and methyloxirane polymer with oxirane ether with
4,4'-(1-methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene
glycol 2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol from the requirement of a tolerance will be safe.
X. 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).
XI. 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: February 17, 2023.
Daniel Rosenblatt,
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. 180.960, amend table 1 to the section by adding, in
alphabetical order, the polymer ``Propanoic acid, 3-hydroxy-
(hydroxymethyl)-2-methyl-, polymer with 2-amino-2-methyl-1-propanol,
[alpha]-hydro-[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and
[[Page 12217]]
methyloxirane polymer with oxirane ether with 4,4'-(1-
methylethylidene)bis[phenol] (2:1), polyethylene-polypropylene glycol
2-aminopropyl Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol, minimum number average molecular weight (in amu), 6,800'' to
read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
Table 1 to Sec. 180.960
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Propanoic acid, 3-hydroxy-(hydroxymethyl)-2-methyl-, 515152-49-5
polymer with 2-amino-2-methyl-1-propanol, [alpha]-hydro-
[omega]-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 5-
isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and methyloxirane polymer with
oxirane ether with 4,4'-(1-methylethylidene)bis[phenol]
(2:1), polyethylene-polypropylene glycol 2-aminopropyl
Me ether-blocked, compds. with 2-amino-2-methyl-1-
propanol, minimum number average molecular weight (in
amu), 6,800............................................
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-03866 Filed 2-24-23; 8:45 am]
BILLING CODE 6560-50-P
