Ethaboxam; Pesticide Tolerances, 8710-8713 [2021-02574]
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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
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
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: January 5, 2021.
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.
■
2. Revise § 180.245 to read as follows:
§ 180.245 Streptomycin; tolerances for
residues.
(a) General. Tolerances are
established for residues of the fungicide
streptomycin, including its metabolites
and degradates, in or on the
commodities in Table 1 to this
paragraph (a). Compliance with the
tolerance levels specified in Table 1 to
this paragraph (a) is to be determined by
measuring only streptomycin (O-2Deoxy-2-(methylamino)-aLglucopyranosyl-(1-2)-O-5-deoxy-3Cformyl-a-L-lyxofuranosyl-(1-4)-N,N′bis(aminoiminomethyl)-D-streptamine)
in or on the commodity.
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
Bean, dry, seed ........................
Bean, succulent ........................
Celery .......................................
Fruit, citrus, group 10–10 .........
Fruit, citrus, group 10–10, dried
pulp .......................................
Fruit, pome, group 11 ...............
Pepper ......................................
Potato .......................................
Tomato ......................................
0.5
0.5
0.25
0.8
3
0.25
0.25
0.25
0.25
(b) Section 18 emergency exemptions.
Time-limited tolerances are established
for residues of streptomycin, in or on
the agricultural commodities, as
specified in Table 2 to this paragraph
(b), resulting from use of the pesticide
pursuant to FIFRA section 18
emergency exemptions. Compliance
with the tolerance levels listed in Table
2 to this paragraph (b) is to be
determined by measuring the levels of
streptomycin only, in or on the
commodities listed in this Table 2
paragraph (b). The tolerances expire on
the dates specified in Table 2 to this
paragraph (b).
TABLE 2 TO PARAGRAPH (b)
Parts per
million
Commodity
Fruit, citrus, group 10–10 ................................................................................................................................................
Fruit, citrus, group 10–10, dried pulp ..............................................................................................................................
(c)–(d) [Reserved]
ACTION:
[FR Doc. 2021–02511 Filed 2–8–21; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0230; FRL–10018–73]
Environmental Protection
Agency (EPA).
AGENCY:
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This regulation establishes
tolerances for residues of ethaboxam in
or on beet, sugar, roots. Valent U.S.A.
LLC., requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
February 9, 2021. Objections and
requests for hearings must be received
on or before April 12, 2021, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
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12/31/22
12/31/22
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0230, 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,
ADDRESSES:
SUMMARY:
BILLING CODE 6560–50–P
Ethaboxam; Pesticide Tolerances
Final rule.
2.0
6.0
Expiration
date
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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: 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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s
e-CFR site at https://www.ecfr.gov/cgibin/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0230 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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must be in writing, and must be
received by the Hearing Clerk on or
before April 12, 2021. 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–
2019–0230, 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/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. Summary of Petitioned-For
Tolerance
In the Federal Register of August 2,
2019 (84 FR 37818) (FRL–9996–78),
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 9F8747) by Valent
U.S.A. LLC, P.O. Box 8025, Walnut
Creek, CA 94596–8025. The petition
requested that 40 CFR part 180 be
amended by establishing a tolerance for
residues of the fungicide, ethaboxam,
(N-(cyano-2-thienylmethyl)-4-ethyl-2(ethylamino)-5-thiazolecarboxamide), in
or on beet, sugar, root at 0.01 parts per
million (ppm). That document
referenced a summary of the petition
prepared by Valent U.S.A. LLC, the
registrant, which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing. Based
upon review of the data supporting the
petition, EPA has modified the
commodity definitions, tolerance levels,
and tolerances being established. The
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8711
reasons for these changes are explained
in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 in
FFDCA section 408(b)(2)(D), 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
tolerance established by this action.
EPA’s assessment of exposures and risks
associated with ethaboxam follows.
On August 8, 2017, EPA published in
the Federal Register a final rule
establishing tolerances for residues of
ethaboxam in or on several commodities
based on the Agency’s conclusion that
aggregate exposure to ethaboxam is safe
for the general population, including
infants and children. See (82 FR 36086)
(FRL–9961–69). EPA is incorporating
the following portions of that document
by reference here, as they have not
changed in the Agency’s current
assessment of ethaboxam tolerances:
The toxicological profile and points of
departure; description of the
assumptions for assessing exposure
from residues in or on food, in drinking
water, and residential exposures; cancer
assessment and conclusion that a
nonlinear reference dose (Rfd) approach
is appropriate for assessing cancer risk;
conclusions about cumulative risk;
Agency’s determination regarding the
children’s safety factor; and tolerance
expression, which have not changed.
EPA’s risk assessment, titled
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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
‘‘Ethaboxam. Human Health Risk
Assessment for Non-food Seed
Treatment,’’ supports the tolerances
established in March 9, 2012, and can
be found at https://www.regulations.gov
at docket ID EPA–HQ–OPP–2011–0908–
0003. Although the Agency
incorporated the assumptions for
exposure assessment from the March 9,
2012, final rule and risk assessment, the
Agency conducted a revised risk
assessment to incorporate exposure to
residues of ethaboxam from use as a
seed treatment on sugar beets. The
updated risk assessment, titled
‘‘Ethaboxam. Human Health Risk
Assessment Supporting the Proposed
New Use on Sugar Beet Seeds,’’ is in
docket ID number EPA–HQ–OPP–2019–
0230.
EPA’s exposure assessments have
been updated to include the additional
exposure from use of ethaboxam on
sugar beet, relied on tolerance-level
residues, an assumption of 100 percent
crop treated (PCT), and 2018 default
processing factors for all processed
commodities, except for potato, grape,
and sugar beet proceeded commodities,
for which the processing studies
demonstrated no concentration. EPA’s
aggregate exposure assessment
incorporated this additional dietary
exposure, which includes exposure
through drinking water. However,
drinking water exposures are not
impacted by the new use on sugar beet,
and thus have not changed since the last
assessment. Additionally, although
sugar beet molasses and dried pulp are
considered significant livestock feed
items, the requested new use on sugar
beets will not result in the need to
establish ethaboxam tolerances in
livestock commodities.
An acute dietary risk assessment was
not conducted since effects attributable
to a single exposure were not identified.
Chronic dietary risks are below the
Agency’s level of concern: 36% of the
chronic population adjusted dose
(cPAD) for children 1 to 2 years old, the
group with the highest exposure. Due to
no existing registered or proposed
residential uses associated with
ethaboxam, there is not expected to be
any residential handler exposure or
post-application dermal exposures.
Residential post-application oral and
inhalation exposures are not expected.
Since there are no residential uses, the
aggregate exposure is equal to the
dietary exposure and thus is not 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
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infants and children from aggregate
exposure to ethaboxam residues. More
detailed information on the subject
action to establish tolerances in or on
beet, sugar, roots can be found in the
document entitled, ‘‘Ethaboxam. Human
Health Risk Assessment Supporting the
Proposed New Use on Sugar Beet
Seeds’’ by going to https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
described under ADDRESSES. Locate and
click on the hyperlink for docket ID
number EPA–HQ–OPP–2019–0230.
IV. Other Considerations
A. Analytical Enforcement Methodology
There are adequate residue analytical
methods for enforcing tolerances for
ethaboxam residues of concern in/on
the registered plant commodities. The
methods include high-performance
liquid chromatography with tandem
mass-spectrometric detection (LC–MS/
MS) for determining residues in/on
sugar beets.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex has not established MRLs
for ethaboxam in or on beet, sugar,
roots; however, Canada’s Pest
Management Regulatory Agency
(PMRA) is simultaneously evaluating
the proposed use for ethaboxam on
sugar beet seeds. EPA is establishing the
same tolerance level for beet, sugar,
roots as PMRA’s proposed MRL of 0.03
ppm. Therefore, there are no
harmonization issues.
C. Revisions to Petitioned-For
Tolerances
The requested tolerance in ‘‘beet,
sugar, root’’ was modified to read ‘‘beet,
sugar, roots’’ to be consistent with
Agency naming practices. The
petitioned-for tolerance level of 0.01
ppm in beet, sugar, roots has been
modified to 0.03 ppm based on the pertrial average residue corrected for all
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field trial dissipation. This is consistent
with the Organization for Economic
Cooperation and Development (OECD)
tolerance calculation procedure when
all residues are corrected for apparent
storage stability decline.
V. Conclusion
Therefore, tolerances are established
for residues of ethaboxam in or on beet,
sugar, roots at 0.03 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). 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
E:\FR\FM\09FER1.SGM
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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
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).
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: January 15, 2021.
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:
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■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.622, amend paragraph (a)
by designating the table and adding in
alphabetical order in newly designated
table 1 to paragraph (a) an entry for
‘‘Beet, sugar, roots’’ to read as follows:
■
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§ 180.622 Ethaboxam; tolerances for
residues.
*
*
*
*
*
8713
Illinois 60604, (312) 886–6162, email
Gromnicki.jean@epa.gov.
SUPPLEMENTARY INFORMATION:
A. What changes to Illinois’ hazardous
waste program is EPA authorizing with
this action?
Parts
per
Commodity
million
On August 7, 2019, Illinois submitted
a complete program revision application
seeking authorization of changes to its
*
*
*
*
*
Beet, sugar, roots .....................
0.03 hazardous waste program in accordance
with 40 CFR 271.21. EPA published a
Proposed Rule on July 30, 2020 and
*
*
*
*
*
requested public comment. EPA
received two comments which were
*
*
*
*
*
generally supportive of this state
[FR Doc. 2021–02574 Filed 2–8–21; 8:45 am]
authorization action. EPA now makes a
BILLING CODE 6560–50–P
final decision that Illinois’ hazardous
waste program revisions that are being
authorized are equivalent to, consistent
ENVIRONMENTAL PROTECTION
with, and no less stringent than the
AGENCY
Federal program, and therefore satisfy
40 CFR Part 271
all of the requirements necessary to
qualify for final authorization. For a list
[EPA–R05–RCRA–2020–0275; FRL–10017–
of State rules being authorized with this
08–Region 5]
Final Authorization, please see the
Proposed Rule published in the July 30,
Illinois: Final Authorization of State
2020, Federal Register at 85 FR 45834.
Hazardous Waste Management
Program Revisions
B. What is codification and is EPA
TABLE 1 TO PARAGRAPH (a)
Environmental Protection
Agency (EPA).
ACTION: Final authorization.
AGENCY:
The Environmental Protection
Agency (EPA) is granting Illinois final
authorization for changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). The Agency published a
Proposed Rule on July 30, 2020 and
provided for public comment. No
adverse comments were received on the
proposed revisions. No further
opportunity for comment will be
provided.
SUMMARY:
This final authorization is
effective February 9, 2021.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R05–RCRA–2020–0275. All
documents in the docket are listed on
the https://www.regulations.gov website.
Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
DATES:
Jean
Gromnicki, Illinois Regulatory
Specialist, U.S. EPA Region 5, LL–17J,
77 West Jackson Boulevard, Chicago,
FOR FURTHER INFORMATION CONTACT:
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codifying the Illinois’ hazardous waste
program as authorized in this rule?
Codification is the process of placing
citations and references to the State’s
statutes and regulations that comprise
the State’s authorized hazardous waste
program into the Code of Federal
Regulations. EPA does this by adding
those citations and references to the
authorized State rules in 40 CFR part
272. EPA is not codifying the
authorization of Illinois’ revisions at
this time. However, EPA reserves the
ability to amend 40 CFR part 272,
subpart O for the authorization of
Illinois’ program changes at a later date.
C. Statutory and Executive Order
Reviews
This final authorization revises
Illinois’ authorized hazardous waste
management program pursuant to
Section 3006 of RCRA and imposes no
requirements other than those currently
imposed by State law. For further
information on how this authorization
complies with applicable executive
orders and statutory provisions, please
see the Proposed Rule published in the
July 30, 2020, Federal Register at 85 FR
45834. The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
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]]>Agencies
[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8710-8713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02574]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0230; FRL-10018-73]
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 beet, sugar, roots. Valent U.S.A. LLC., requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective February 9, 2021. Objections and
requests for hearings must be received on or before April 12, 2021, 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-2019-0230, 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,
[[Page 8711]]
and the telephone number for the OPP Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0230 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 12, 2021. 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-2019-0230, 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/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. Summary of Petitioned-For Tolerance
In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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
9F8747) by Valent U.S.A. LLC, P.O. Box 8025, Walnut Creek, CA 94596-
8025. The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the fungicide, ethaboxam, (N-
(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-thiazolecarboxamide),
in or on beet, sugar, root at 0.01 parts per million (ppm). That
document referenced a summary of the petition prepared by Valent U.S.A.
LLC, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing. Based upon review of the data supporting the
petition, EPA has modified the commodity definitions, tolerance levels,
and tolerances being established. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 in FFDCA section 408(b)(2)(D), 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 tolerance established by this action. EPA's
assessment of exposures and risks associated with ethaboxam follows.
On August 8, 2017, EPA published in the Federal Register a final
rule establishing tolerances for residues of ethaboxam in or on several
commodities based on the Agency's conclusion that aggregate exposure to
ethaboxam is safe for the general population, including infants and
children. See (82 FR 36086) (FRL-9961-69). EPA is incorporating the
following portions of that document by reference here, as they have not
changed in the Agency's current assessment of ethaboxam tolerances: The
toxicological profile and points of departure; description of the
assumptions for assessing exposure from residues in or on food, in
drinking water, and residential exposures; cancer assessment and
conclusion that a nonlinear reference dose (Rfd) approach is
appropriate for assessing cancer risk; conclusions about cumulative
risk; Agency's determination regarding the children's safety factor;
and tolerance expression, which have not changed. EPA's risk
assessment, titled
[[Page 8712]]
``Ethaboxam. Human Health Risk Assessment for Non-food Seed
Treatment,'' supports the tolerances established in March 9, 2012, and
can be found at https://www.regulations.gov at docket ID EPA-HQ-OPP-
2011-0908-0003. Although the Agency incorporated the assumptions for
exposure assessment from the March 9, 2012, final rule and risk
assessment, the Agency conducted a revised risk assessment to
incorporate exposure to residues of ethaboxam from use as a seed
treatment on sugar beets. The updated risk assessment, titled
``Ethaboxam. Human Health Risk Assessment Supporting the Proposed New
Use on Sugar Beet Seeds,'' is in docket ID number EPA-HQ-OPP-2019-0230.
EPA's exposure assessments have been updated to include the
additional exposure from use of ethaboxam on sugar beet, relied on
tolerance-level residues, an assumption of 100 percent crop treated
(PCT), and 2018 default processing factors for all processed
commodities, except for potato, grape, and sugar beet proceeded
commodities, for which the processing studies demonstrated no
concentration. EPA's aggregate exposure assessment incorporated this
additional dietary exposure, which includes exposure through drinking
water. However, drinking water exposures are not impacted by the new
use on sugar beet, and thus have not changed since the last assessment.
Additionally, although sugar beet molasses and dried pulp are
considered significant livestock feed items, the requested new use on
sugar beets will not result in the need to establish ethaboxam
tolerances in livestock commodities.
An acute dietary risk assessment was not conducted since effects
attributable to a single exposure were not identified. Chronic dietary
risks are below the Agency's level of concern: 36% of the chronic
population adjusted dose (cPAD) for children 1 to 2 years old, the
group with the highest exposure. Due to no existing registered or
proposed residential uses associated with ethaboxam, there is not
expected to be any residential handler exposure or post-application
dermal exposures. Residential post-application oral and inhalation
exposures are not expected. Since there are no residential uses, the
aggregate exposure is equal to the dietary exposure and thus is not 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
the subject action to establish tolerances in or on beet, sugar, roots
can be found in the document entitled, ``Ethaboxam. Human Health Risk
Assessment Supporting the Proposed New Use on Sugar Beet Seeds'' by
going to https://www.regulations.gov. The referenced document is
available in the docket established by this action, which is described
under ADDRESSES. Locate and click on the hyperlink for docket ID number
EPA-HQ-OPP-2019-0230.
IV. Other Considerations
A. Analytical Enforcement Methodology
There are adequate residue analytical methods for enforcing
tolerances for ethaboxam residues of concern in/on the registered plant
commodities. The methods include high-performance liquid chromatography
with tandem mass-spectrometric detection (LC-MS/MS) for determining
residues in/on sugar beets.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The Codex has not established MRLs for ethaboxam in or on beet,
sugar, roots; however, Canada's Pest Management Regulatory Agency
(PMRA) is simultaneously evaluating the proposed use for ethaboxam on
sugar beet seeds. EPA is establishing the same tolerance level for
beet, sugar, roots as PMRA's proposed MRL of 0.03 ppm. Therefore, there
are no harmonization issues.
C. Revisions to Petitioned-For Tolerances
The requested tolerance in ``beet, sugar, root'' was modified to
read ``beet, sugar, roots'' to be consistent with Agency naming
practices. The petitioned-for tolerance level of 0.01 ppm in beet,
sugar, roots has been modified to 0.03 ppm based on the per-trial
average residue corrected for all field trial dissipation. This is
consistent with the Organization for Economic Cooperation and
Development (OECD) tolerance calculation procedure when all residues
are corrected for apparent storage stability decline.
V. Conclusion
Therefore, tolerances are established for residues of ethaboxam in
or on beet, sugar, roots at 0.03 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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
[[Page 8713]]
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).
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: January 15, 2021.
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. 180.622, amend paragraph (a) by designating the table and
adding in alphabetical order in newly designated table 1 to paragraph
(a) an entry for ``Beet, sugar, roots'' to read as follows:
Sec. 180.622 Ethaboxam; tolerances for residues.
* * * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Beet, sugar, roots......................................... 0.03
* * * * *
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* * * * *
[FR Doc. 2021-02574 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P
