IN-11693: Oxirane, 2-Methyl-, Polymer With Oxirane, di-(9Z)-9-Octadecenoate; Tolerance Exemption, 47634-47637 [2022-16645]
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Rules and Regulations
II. The EPA’s Evaluation and Action
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We are making an interim final
determination to defer CAA section 179
sanctions associated with our
disapproval action on January 7, 2021,
of MCAQD’s RACT demonstration for
major sources of NOX with respect to
the requirements of part D of title I of
the CAA. This determination is based
on our previous proposed approval of
Rule 322 and this concurrent proposal
to fully approve Rules 323 and 324,
which resolves the remaining
deficiencies that triggered sanctions
under section 179 of the CAA.
Because the EPA has preliminarily
determined that MCAQD’s submittal of
Rules 322, 323 and 324 address the
conditional approval issues and
deficiencies under part D of title I of the
CAA identified in our 2020 and 2021
actions and is fully approvable, relief
from sanctions should be provided as
quickly as possible. Therefore, the EPA
is invoking the good cause exception
under the Administrative Procedure Act
(APA) in not providing an opportunity
for comment before this action takes
effect (5 U.S.C. 553(b)(3)). However, by
this action, the EPA is providing the
public with a chance to comment on the
EPA’s determination after the effective
date, and the EPA will consider any
comments received in determining
whether to reverse such action.
The EPA believes that notice-andcomment rulemaking before the
effective date of this action is
impracticable and contrary to the public
interest. The EPA has reviewed the
State’s submittal and, through its
proposed action, is indicating that it is
more likely than not that the State has
submitted a revision to the SIP that
corrects deficiencies under part D of the
Act that were the basis for the action
that started the sanctions clocks.
Therefore, it is not in the public interest
to impose sanctions. The EPA believes
that it is necessary to use the interim
final rulemaking process to defer
sanctions while the EPA completes its
rulemaking process on the approvability
of the State’s submittal. Moreover, with
respect to the effective date of this
action, the EPA is invoking the good
cause exception to the 30-day notice
requirement of the APA because the
purpose of this notice is to relieve a
restriction (5 U.S.C. 553(d)(1)).
III. Statutory and Executive Order
Reviews
This action defers sanctions and
imposes no additional requirements. For
that reason, this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
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of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide the EPA with the
discretionary authority to address
disproportionate human health or
environmental effects with practical,
appropriate, and legally permissible
methods under Executive Order 12898
(59 FR 7629, February 16, 1994).
• Is not approved to apply on any
Indian reservation land or in any other
area where the EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
• Is subject to the Congressional
Review Act (CRA), 5 U.S.C. 801 et seq.,
and the EPA will submit a rule report
to each House of the Congress and to the
Comptroller General of the United
States. The CRA allows the issuing
agency to make a rule effective sooner
than otherwise provided by the CRA if
the agency makes a good cause finding
that notice and comment rulemaking
procedures are impracticable,
unnecessary or contrary to the public
interest (5 U.S.C. 808(2)). The EPA has
made a good cause finding for this rule
as discussed in section II of this
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preamble, including the basis for that
finding.
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by October 3, 2022. Filing a
petition for reconsideration by the EPA
Administrator of this final rule does not
affect the finality of this rule for the
purpose of judicial review nor does it
extend the time within which petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements (see CAA
section 307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Nitrogen
oxides, Ozone, Particulate matter,
Reporting and recordkeeping
requirements.
Authority: 42 U.S.C. 7401 et seq.
Dated: July 27, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.
[FR Doc. 2022–16493 Filed 8–3–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2022–0325; FRL–9983–01–
OCSPP]
IN–11693: Oxirane, 2-Methyl-, Polymer
With Oxirane, di-(9Z)-9-Octadecenoate;
Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of oxirane, 2methyl-, polymer with oxirane, di-(9Z)9-octadecenoate (CAS Reg. No. 67167–
17–3) average number molecular weight
(in amu), 2500 when used as an inert
ingredient in a pesticide chemical
formulation. Ethox 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 oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9octadecenoate on food or feed
commodities.
SUMMARY:
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Rules and Regulations
This regulation is effective
August 4, 2022. Objections and requests
for hearings must be received on or
before October 3, 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).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2022–0325, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and OPP Docket
is (202) 566–1744. Please review the
visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 566–1030; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. 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–2022–0325 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
October 3, 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2022–0325, by one of
the following methods.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
on-line instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of May 20,
2022 (87 FR 30855) (FRL–9410–13),
EPA issued a notice pursuant to section
408 of FFDCA, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11693) filed by Ethox
Chemicals, LLC (1801 Perimeter Road,
Greenville, SC 29605). The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
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residues of oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate
(CAS Reg. No. 67167–17–3). That notice
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
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Rules and Regulations
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). Oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate
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. Although hydrolysis is
expected in the environment to yield
oleic acid and ethylene oxide/propylene
oxide (E.O./PO) copolymer, the E.O./PO
copolymer portion is not anticipated to
further biodegrade.
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.
Additionally, the polymer also meets as
required the following exemption
criteria specified in 40 CFR 723.250(e).
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 number average molecular weight
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
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and the polymer does not contain any
reactive functional groups as specified
in 40 CFR 723.250.
Thus, oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate
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
oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that
oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate could
be present in all raw and processed
agricultural commodities and drinking
water, and that non-occupational nondietary exposure was possible. The
number average MW of oxirane, 2methyl-, polymer with oxirane, di-(9Z)9-octadecenoate is 2,500 daltons.
Generally, a polymer of this size would
be poorly absorbed through the intact
gastrointestinal tract or through intact
human skin. Since oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9octadecenoate conforms 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 oxirane, 2-methyl, polymer with oxirane, di-(9Z)-9octadecenoate to share a common
mechanism of toxicity with any other
substances, and oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9octadecenoate does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9octadecenoate 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
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cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
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 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 data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. Due to the expected low
toxicity of oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate,
EPA has not used a safety factor analysis
to assess the risk. For the same reasons
the additional tenfold safety factor is
unnecessary.
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 oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate.
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 oxirane, 2methyl-, polymer with oxirane, di-(9Z)9-octadecenoate 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
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Rules and Regulations
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 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).
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: July 27, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
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
2. In § 180.960, add in alphabetical
order the polymer ‘‘Oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9octadecenoate’’ to table 1 to read as
follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.960
Polymer
CAS No.
*
*
*
*
*
*
Oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate, minimum number average molecular weight (in amu), 2500
*
*
*
BILLING CODE P
SURFACE TRANSPORTATION BOARD
49 CFR Part 1249
URCS Data Reporting
Surface Transportation Board.
Final rule.
AGENCY:
The Surface Transportation
Board adopts a final rule to codify a
longstanding voluntary practice
whereby Class I carriers, through the
Association of American Railroads
(AAR), have annually reported tare
weight and loss and damage data for use
in the Board’s Uniform Railroad Costing
System (URCS). Under the final rule,
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SUMMARY:
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This rule is effective on August
13, 2022.
DATES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. EP 769]
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*
Class I carriers may choose to provide
tare weight and loss and damage data
through AAR or to file the data with the
Board individually.
[FR Doc. 2022–16645 Filed 8–3–22; 8:45 am]
ACTION:
*
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Pedro Ramirez at (202) 245–0333.
Assistance for the hearing impaired is
available through the Federal Relay
Service at (800) 877–8339.
The Board
is authorized, under 49 U.S.C. 11161, to
maintain cost accounting rules for rail
carriers. In 1989, the Board’s
predecessor, the Interstate Commerce
Commission, adopted URCS as its
general purpose costing system.
Adoption of the Unif. R.R. Costing Sys.
as a Gen. Purpose Costing Sys. for All
Regul. Costing Purposes, 5 I.C.C.2d 894
(1989). The Board uses URCS for a
SUPPLEMENTARY INFORMATION:
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*
*
67167–17–3
*
variety of regulatory functions. URCS is
used in rate reasonableness proceedings
as part of the initial market dominance
determination, and at later stages is
used in parts of the Board’s
determination as to whether the
challenged rate is reasonable and, when
warranted, the maximum rate
prescription. URCS is also used, among
other things, to develop variable costs
for making cost determinations in
abandonment proceedings, provide the
railroad industry and shippers with a
standardized costing model, cost the
Board’s Carload Waybill Sample to
develop industry cost information, and
provide interested parties with basic
cost information regarding railroad
industry operations.
As a longstanding practice, AAR has
collected tare weight and loss and
damage data for use in URCS from Class
I carriers and voluntarily provided the
E:\FR\FM\04AUR1.SGM
04AUR1
]]>Agencies
[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Rules and Regulations]
[Pages 47634-47637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16645]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0325; FRL-9983-01-OCSPP]
IN-11693: Oxirane, 2-Methyl-, Polymer With Oxirane, di-(9Z)-9-
Octadecenoate; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate (CAS Reg. No. 67167-17-3) average
number molecular weight (in amu), 2500 when used as an inert ingredient
in a pesticide chemical formulation. Ethox 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 oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate on food or feed commodities.
[[Page 47635]]
DATES: This regulation is effective August 4, 2022. Objections and
requests for hearings must be received on or before October 3, 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-2022-0325, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 566-1030; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. 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-2022-0325 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
October 3, 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2022-0325, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of May 20, 2022 (87 FR 30855) (FRL-9410-
13), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11693)
filed by Ethox Chemicals, LLC (1801 Perimeter Road, Greenville, SC
29605). The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate (CAS Reg. No. 67167-17-3). That notice 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
[[Page 47636]]
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). Oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate 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.
Although hydrolysis is expected in the environment to yield oleic acid
and ethylene oxide/propylene oxide (E.O./PO) copolymer, the E.O./PO
copolymer portion is not anticipated to further biodegrade.
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.
Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
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 number average molecular weight 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 does not contain any reactive functional groups
as specified in 40 CFR 723.250.
Thus, oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate 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 oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate 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 oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate is
2,500 daltons. Generally, a polymer of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9-
octadecenoate conforms 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 oxirane, 2-methyl-, polymer with oxirane, di-
(9Z)-9-octadecenoate to share a common mechanism of toxicity with any
other substances, and oxirane, 2-methyl-, polymer with oxirane, di-
(9Z)-9-octadecenoate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that oxirane, 2-methyl-, polymer
with oxirane, di-(9Z)-9-octadecenoate 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/pesticides/cumulative.
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 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 data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of oxirane, 2-methyl-,
polymer with oxirane, di-(9Z)-9-octadecenoate, EPA has not used a
safety factor analysis to assess the risk. For the same reasons the
additional tenfold safety factor is unnecessary.
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 oxirane, 2-methyl-, polymer with
oxirane, di-(9Z)-9-octadecenoate.
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 oxirane, 2-
methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate 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
[[Page 47637]]
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 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: July 27, 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. 180.960, add in alphabetical order the polymer ``Oxirane,
2-methyl-, polymer with oxirane, di-(9Z)-9-octadecenoate'' to table 1
to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
Table 1 to 180.960
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * * * *
Oxirane, 2-methyl-, polymer with oxirane, di-(9Z)-9- 67167-17-3
octadecenoate, minimum number average molecular weight
(in amu), 2500.........................................
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2022-16645 Filed 8-3-22; 8:45 am]
BILLING CODE P
