[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Rules and Regulations]
[Pages 2725-2728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00854]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0045; FRL-9331-01-OCSPP]
Ethaboxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
ethaboxam in or on Brassica, leafy greens, subgroup 4-16B and
Vegetable, Brassica, head and stem, group 5-16. The Interregional
Research Project Number 4 (IR-4) requested these tolerance actions
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
[[Page 2726]]
DATES: This regulation is effective January 19, 2022. Objections and
requests for hearings must be received on or before March 21, 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-2021-0045, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns relating to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide customer service via
email, phone, and webform. For the latest status information on EPA/DC
services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[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 relatedinformation?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How 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-2021-0045 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
March 21, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0045, 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. Summary of Petitioned-For Tolerance
In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-
44) EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0E8871) by IR-4, North Carolina State University, 1730 Varsity Drive,
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to
establish tolerances in 40 CFR 180.622 for residues of the fungicide
ethaboxam, (N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-
thiazolecarboxamide) in or on Brassica, leafy greens, subgroup 4-16B at
7 parts per million (ppm) and Vegetable, Brassica, head and stem, group
5-16 at 3 ppm. That document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. ''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for ethaboxam including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with ethaboxam follows.
In an effort to streamline its publications in the Federal
Register,
[[Page 2727]]
EPA is not reprinting sections that repeat what has been previously
published for tolerance rulemakings of the same pesticide chemical.
Where scientific information concerning a particular chemical remains
unchanged, the content of those sections would not vary between
tolerance rulemaking, and EPA considers referral back to those sections
as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for ethaboxam,
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to ethaboxam and established tolerances for residues of that
chemical. EPA is incorporating previously published sections from those
rulemakings that remain unchanged as described further in this
rulemaking.
Toxicological profile. For a discussion of the Toxicological
Profile of ethaboxam, see Unit III.A. of the ethaboxam tolerance
rulemaking published in the Federal Register of August 3, 2017 (82 FR
36086) (FRL-9961-69).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
ethaboxam used for human risk assessment, see Unit III.B. of the August
3, 2017 ethaboxam tolerance rulemaking.
Exposure assessment. Much of the exposure assessment remains
unchanged from the previous rulemaking, although the exposure
assessment has been updated to include the petitioned-for tolerances
based on the same previous assumptions of tolerance level residues and
100 percent crop treated (PCT). Additionally, the estimated drinking
water concentration is the same as that used in the previous assessment
(7.4 ppb) for the chronic assessment (the only dietary assessment
needed). There are no residential uses for ethaboxam, therefore no
short- or intermediate-term exposure is expected. For a description of
the previous approach to and assumptions for the exposure assessment,
please reference Unit III.C. of the August 3, 2017 rulemaking.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
August 3, 2017 rulemaking for a discussion of the Agency's rationale
for that determination.
Aggregate risks and Determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
An acute endpoint attributable to a single dose exposure was not
identified; therefore, an acute dietary risk assessment was not
conducted. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 39% of the cPAD for children 1 to
2 years old, the group with the highest estimated exposure. As the
chronic dietary endpoint and dose are protective of potential cancer
effects, ethaboxam is not expected to pose a dietary or aggregate
cancer risk of concern.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to ethaboxam residues. More detailed information on
this action can be found in the document entitled, ``Ethaboxam. Human
Health Risk Assessment for the Proposed New Uses on Brassica Head and
Stem Vegetable Crop Group 5-16 and Brassica Leafy Greens Crop Subgroup
4-16B'' by going to the docket established by this action, EPA-HQ-OPP-
2021-0045.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the August 3, 2017 rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
Codex does not have established MRLs for ethaboxam in commodities
that are members of subgroup 4-16B or group 5-16.
V. Conclusion
Therefore, tolerances are established for residues of ethaboxam in
or on Brassica, leafy greens, subgroup 4-16B at 7 ppm and Vegetable,
Brassica, head and stem, group 5-16 at 3 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances 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 to 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 tolerances 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
[[Page 2728]]
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).
VII. 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: December 29, 2021.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. Amend Sec. 180.622, by adding in alphabetical order to table 1 to
paragraph (a) the entries ``Brassica, leafy greens, subgroup 4-16B''
and ``Vegetable, Brassica, head and stem, group 5-16'' to read as
follows:
Sec. 180.622 Ethaboxam; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
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Parts per
Commodity million
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* * * * *
Brassica, leafy greens, subgroup 4-16B....................... 7
* * * * *
Vegetable, Brassica, head and stem, group 5-16............... 3
* * * * *
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[FR Doc. 2022-00854 Filed 1-18-22; 8:45 am]
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