Quizalofop ethyl; Pesticide Tolerances, 13196-13200 [2021-04720]
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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
[FR Doc. 2021–04413 Filed 3–5–21; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 6560–50–P
I. General Information
A. Does this action apply to me?
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0665; FRL–10020–34]
Quizalofop ethyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of quizalofop
ethyl in or on multiple commodities
which are identified and discussed later
in this document. The Interregional
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 8, 2021. Objections and requests
for hearings must be received on or
before May 7, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0665, 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
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, 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: RDFRNotices@
epa.gov.
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ADDRESSES:
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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 eCFR 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–2019–0665 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before May
7, 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–
2019–0665, by one of the following
methods:
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• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional
instructions on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of May 8, 2020
(85 FR 27346) (FRL–10008–38), 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 9E8803) by IR–4, Rutgers,
the State University of New Jersey, 500
College Road East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.441 be
amended by establishing tolerances for
residues of the herbicide quizalofop
ethyl convertible to 2-methoxy-6chloroquinoxaline, expressed as
quizalofop ethyl, in or on carinata at 1.5
parts per million (ppm); cottonseed
subgroup 20C at 0.1 ppm; fruit, pome,
group 11–10 at 0.1 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit,
subgroup 13 07F at 0.1 ppm; fruit, stone,
group 12–12 at 0.1 ppm; pennycress,
meal at 2 ppm; pennycress, seed at 1.5
ppm; and sunflower subgroup 20B at 3
ppm. Additionally, the petition
requested, upon approval of the above
tolerances, to remove the existing
tolerances in 40 CFR 180.441(a) in or on
cotton, undelinted seed at 0.1 ppm and
sunflower, seed at 1.9 ppm. That
document referenced a summary of the
petition prepared by AMVAC Chemical
Corporation, the registrant, which is
available in the docket, https://
www.regulations.gov. Two comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA corrected
several tolerance definitions and is not
establishing a tolerance on pennycress,
meal, as proposed by the petitioner. The
reasons for these changes are explained
in Unit IV.D.
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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 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 quizalofop ethyl
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with quizalofop ethyl
follows.
In an effort to streamline its
publications in the Federal Register,
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 rulemakings and
republishing the same sections is
unnecessary. 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 a
number of tolerance rulemakings for
quizalofop ethyl, in which EPA
concluded, based on the available
information, that there is a reasonable
certainty that no harm would result
from aggregate exposure to quizalofop
ethyl and established tolerances for
residues of that chemical. EPA is
incorporating previously published
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sections from those rulemakings as
described further in this rulemaking, as
they remain unchanged.
Toxicological Profile. For a discussion
of the Toxicological Profile of
quizalofop ethyl, see Unit III.A. of the
February 23, 2018 rulemaking (83 FR
8006) (FRL–9972–30).
Toxicological Points of Departure/
Levels of Concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern used for the safety
assessment, see Unit III.B. of the
December 1, 2016 rulemaking (81 FR
86581) (FRL–9950–89).
Exposure Assessment. Much of the
exposure assessment remains the same,
although updates have occurred to
accommodate exposures from the
petitioned-for tolerances. These updates
are discussed in this section; for a
description of the rest of the EPA
approach to and assumptions for the
exposure assessment, see Unit III.C. of
the February 23, 2018 rulemaking.
EPA’s dietary exposure assessments
have been updated to include the
additional exposure from the new uses
of quizalofop ethyl on brassica carinata;
fruit, pome, group 11–10; fruit, small,
vine climbing, except fuzzy kiwifruit,
subgroup 13–07F; fruit, stone, group 12–
12; and pennycress and the crop
subgroup expansions for cottonseed
subgroup 20C and sunflower subgroup
20B. The assessment used the same
assumptions as the February 23, 2018
final rule concerning tolerance level
residues and default processing factors
for all processed commodities except
sunflower oil, where an empirical factor
was used.
Updated average percent crop treated
values were used for the following crops
that are currently registered for
quizalofop-ethyl: Beans, green: 2.5%;
canola: 5%; cotton: 1%; dry beans/peas:
15%; peas, green: 2.5%; soybeans: 2.5%;
sugar beets: 1%; and sunflowers: 5%;
and 100% crop treated for other
registered and new uses of quizalofop
ethyl.
Anticipated residue and PCT
information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use
data on the actual percent of food
treated for assessing chronic dietary risk
only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, and the exposure
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estimate does not understate exposure
for the population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6 to 7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a maximum
PCT for acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that Conditions
a, b, and c discussed above have been
met. With respect to Condition a, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. The
Agency is reasonably certain that the
percentage of the food treated is not
likely to be an underestimation. As to
Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which quizalofop-ethyl may be applied
in a particular area.
Drinking water, non-occupational,
and cumulative exposures. Drinking
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water exposures and residential (nonoccupational) exposures are not
impacted by the new uses, and thus
have not changed since the last
assessment. EPA’s conclusions
concerning cumulative risk remain
unchanged from the February 23, 2018
rulemaking.
Safety Factor for Infants and
Children. EPA continues to conclude
that there is reliable data to support the
reduction of the Food Quality Protection
Act (FQPA) safety factor. See Unit III.D.
of the February 23, 2018 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 dietary exposure
estimates to the acute population
adjusted dose (aPAD) and the chronic
population adjusted dose (cPAD). Short-,
intermediate-, and chronic-term 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 dietary exposure assessment
was not conducted as toxicological
effects attributable to a single dose were
not identified. Chronic dietary risks are
below the Agency’s level of concern of
100% of the cPAD: They are 92% of the
cPAD for all infants less than 1-year old,
the population subgroup with the
highest exposure estimate. Quizalofopethyl is classified as a Category D
chemical, i.e. ‘‘Not Classifiable as to
Human Carcinogenicity;’’ therefore,
quantification of chronic risks using a
non-linear approach will adequately
account for all chronic toxicity,
including any potential carcinogenicity
that would result from exposure. There
are no registered or new uses of
quizalofop ethyl that would result in
residential exposure, therefore the
aggregate risk estimates are equivalent
to the chronic dietary (food and water)
risk estimates and are 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 quizalofop ethyl residues.
More detailed information about the
Agency’s analysis can be found at
https://www.regulations.gov in the
documents titled ‘‘Quizalofop-P-ethyl.
Human-Health Risk Assessment in
Support of the Proposed New Uses on
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Carinata, Pennycress, Pome Fruit
(Group 11–10), Stone Fruit (Group 12–
12), and Small Vine-climbing Fruit,
Except Fuzzy Kiwifruit (Subgroup 13–
07F); and Use Expansions for Sunflower
and Cottonseed (Subgroups 20B and
20C)’’ in docket ID number EPA–HQ–
OPP–2019–0665.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the February 23, 2018
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).
The Codex has not established MRLs
for quizalofop ethyl.
C. Response to Comments
Although two comments were
submitted to the docket in response to
the May 8, 2020 Notice of Filing, only
one specifically related to this tolerance
action. The commenter requested that
EPA deny IR–4’s request for tolerances
for quizalofop ethyl on cotton sunflower
seeds out of a concern for the general
health impacts of pesticides.
Although the Agency recognizes that
some individuals believe that pesticides
should be banned on agricultural crops,
the existing legal framework provided
by section 408 of the FFDCA authorizes
EPA to establish tolerances when it
determines that the tolerance is safe.
Upon consideration of the validity,
completeness, and reliability of the
available data as well as other factors
the FFDCA requires EPA to consider,
EPA has determined that the quizalofop
ethyl tolerances are safe. The
commenter has provided no information
indicating that a safety determination
cannot be supported.
D. Revisions to Petitioned-For
Tolerances
The commodity definition for carinata
has been revised to brassica carinata,
seed; and brassica carinata, meal. The
tolerance for brassica carinata, seed will
be established at 1.5 ppm; and the
tolerance for brassica carinata, meal will
be established at 2 ppm. EPA is not
establishing a tolerance for pennycress,
meal as requested by the petitioner
because the glucosinolates in
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pennycress meal restrict its use to a
livestock feedstuff, not a human food.
EPA’s current practice is to set
tolerances for livestock feedstuffs only if
they are significant, which is not the
case for pennycress meal.
V. Conclusion
Therefore, tolerances are established
for residues of quizalofop ethyl
convertible to 2-methoxy-6chloroquinoxaline, expressed as
quizalofop ethyl, in or on brassica
carinata, meal at 2 ppm; brassica
carinata, seed at 1.5 ppm; cottonseed
subgroup 20C at 0.1 ppm; fruit, pome,
group 11–10 at 0.1 ppm; fruit, small,
vine climbing, except fuzzy kiwifruit,
subgroup 13–07F at 0.1 ppm; fruit,
stone, group 12–12 at 0.1 ppm;
pennycress, seed at 1.5 ppm; and
sunflower subgroup 20B at 3 ppm. Upon
establishment of the above tolerances,
the established tolerances for cotton,
undelinted seed at 0.1 ppm; and
sunflower, seed at 1.9 ppm will be
removed as they are superseded by the
new tolerances on subgroups 20C and
20B, respectively.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to petitions 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
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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: March 2, 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. In § 180.441, amend the table in
paragraph (a)(1) as follows:
■ i. Add a table heading.
■ ii. Add alphabetically the entries
‘‘Brassica carinata, meal’’; and ‘‘Brassica
carinata, seed’’.
■ iii. Remove the entry for ‘‘Cotton,
undelinted seed’’.
■ iv. Add alphabetically the entries
‘‘Cottonseed subgroup 20C’’; ‘‘Fruit,
pome, group 11–10’’; ‘‘Fruit, small, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F’’; ‘‘Fruit, stone, group
12–12’’; and ‘‘Pennycress, seed’’.
■ v. Remove the entry for ‘‘Sunflower,
seed’’.
■ vi. Add alphabetically the entry
‘‘Sunflower subgroup 20B’’.
The additions read as follows:
■
§ 180.441 Quizalofop ethyl; tolerances for
residues.
(a) * * *
(1) * * *
TABLE 1 TO PARAGRAPH (a)(1)
Parts per
million
Commodity
*
*
*
*
*
*
Brassica carinata, meal .......................................................................................................................................................................
Brassica carinata, seed .......................................................................................................................................................................
*
*
*
*
*
*
*
Cottonseed subgroup 20C ...................................................................................................................................................................
*
*
*
*
*
*
*
Fruit, pome, group 11–10 ....................................................................................................................................................................
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F ..................................................................................................
Fruit, stone, group 12–12 ....................................................................................................................................................................
*
*
*
*
*
*
*
Pennycress, seed ................................................................................................................................................................................
*
*
*
*
*
*
*
Sunflower subgroup 20B .....................................................................................................................................................................
*
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proposed rule to remove Bradshaw’s
lomatium from the List of Endangered
and Threatened Plants (i.e., to ‘‘delist’’
the species). Please refer to that
proposed rule for a detailed description
of the Federal actions concerning this
species that occurred prior to November
26, 2019.
[FR Doc. 2021–04720 Filed 3–5–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R1–ES–2019–0013;
FF09E22000 FXES11130900000 212]
RIN 1018–BD59
Endangered and Threatened Wildlife
and Plants; Removing Bradshaw’s
Lomatium (Lomatium bradshawii)
From the Federal List of Endangered
and Threatened Plants
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), remove
Bradshaw’s lomatium (Lomatium
bradshawii, also known as Bradshaw’s
desert parsley), a plant found in western
Oregon and southwestern Washington,
from the Federal List of Endangered and
Threatened Plants. Our review of the
best available scientific and commercial
data indicates that the threats to
Bradshaw’s lomatium have been
eliminated or reduced to the point that
the species no longer meets the
definition of an endangered or
threatened species under the
Endangered Species Act of 1973, as
amended (Act).
DATES: This rule is effective April 7,
2021.
SUMMARY:
This final rule is available
on the internet at https://
www.regulations.gov under Docket No.
FWS–R1–ES–2019–0013. Comments
and materials we received, as well as
supporting documentation we used in
preparing this rule, are available for
public inspection at https://
www.regulations.gov under FWS–R1–
ES–2019–0013.
ADDRESSES:
Paul
Henson, State Supervisor, U.S. Fish and
Wildlife Service, Oregon Fish and
Wildlife Office, 2600 SE 98th Avenue,
Suite 100, Portland, OR 97266;
telephone 503–231–6179. If you use a
telecommunications device for the deaf
(TDD), please call the Federal Relay
Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with RULES
FOR FURTHER INFORMATION CONTACT:
Previous Federal Actions
On November 26, 2019, we published
in the Federal Register (84 FR 65067) a
VerDate Sep<11>2014
16:10 Mar 05, 2021
Jkt 253001
Summary of Changes From the
Proposed Rule
In response to public comments and
in the process of developing this final
rule, we have made the following
changes from our November 26, 2019,
proposed rule (84 FR 65067):
• We added language in the final
post-delisting monitoring plan to
indicate that additional Bradshaw’s
lomatium populations may be visited
upon occasion, as time and resources
allow, to provide for a ‘‘spot check’’ on
the status of additional populations that
are outside of the 18 priority sites
identified for regular visits during the
post-delisting monitoring period. These
abbreviated field visits may collect
information through assessment of
population abundance, photo points,
and/or evaluation of management
practices and habitat condition.
• We incorporated into the preamble
to this final rule mention of the recently
developed MOU among the U.S. Army
Core of Engineers, the Bureau of Land
Management, the Natural Resource
Conservation Service and the Service, to
provide for the long-term conservation
of Bradshaw’s lomatium, regardless of
listing status.
• We made minor editorial changes in
the preamble of this final rule, including
revising our description of how we
develop and implement recovery plans,
adding additional discussion about
which recovery criteria were met,
inserting an updated description of our
regulatory and analytical frameworks,
updating our description of how we
determine species status throughout all
or a portion of the species’ range, and
making minor textual updates to our
assessment of Bradshaw’s lomatium’s
status throughout a portion of its range.
I. Final Delisting Determination
Background
Status Assessment for Bradshaw’s
Lomatium
A thorough review of the taxonomy,
life history, and ecology of Bradshaw’s
lomatium is presented in the document
‘‘Species Status Assessment Report for
Bradshaw’s lomatium (Lomatium
bradshawii (Rose ex. Math.) Mathias &
Constance) Version 1.0’’ (SSA report)
(Service 2018), which is available at
https://www.regulations.gov in Docket
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
No. FWS–R1–ES–2019–0013, under
Supporting Documents. The SSA report
documents the results of our
comprehensive biological status review
for Bradshaw’s lomatium, and has
undergone peer review. The SSA report
does not represent any decision by the
Service regarding the status of
Bradshaw’s lomatium under the Act (16
U.S.C. 1531 et seq.). It does, however,
provide the scientific basis that
informed our most recent 5-year status
review, which resulted in a
recommendation that the species should
be removed from the List. The SSA
report also served as one of the bases for
this final rule and our regulatory
decision, which involves the further
application of standards within the Act
and its implementing regulations and
policies.
In this final rule, we present only a
summary of the key results and
conclusions from the SSA report; the
full report is available at https://
www.regulations.gov, as referenced
above.
Summary of the Biology of the Species
Bradshaw’s lomatium is a perennial
herb in the carrot or parsley family
(Apiaceae) that is endemic to wet prairie
habitats in western Oregon’s Willamette
Valley and adjacent southwestern
Washington. These seasonally wet
habitats may be flooded in the spring, or
have soils saturated at or near the
surface due to factors such as heavy
precipitation in winter and spring,
flooding, and poor drainage. A high
light environment is important for
Bradshaw’s lomatium to complete its
life cycle and reproduce, as reduced
sunlight is associated with lower flower
and seed production (Alverson 1993,
unpublished data). This species is often
associated with tufted hairgrass
(Deschampsia cespitosa), and frequently
occurs on and around the small mounds
created by senescent tufted hairgrass
plants. In wetter areas, Bradshaw’s
lomatium occurs on the edges of tufted
hairgrass or sedges in patches of bare or
open soil. In drier areas, it is found in
low areas, such as small depressions,
trails, or seasonal channels, with open,
exposed soils. Self-fertilization is rare in
Bradshaw’s lomatium (Kaye and
Kirkland 1994, p. 8), indicating that
pollinator-mediated outcrossing is
required for reproduction. Over 30
species of solitary bees, flies, wasps, and
beetles have been observed visiting the
flowers (Kaye 1992, p. 3; Kaye and
Kirkland 1994, p. 9; Jackson 1996, pp.
72–76). Bradshaw’s lomatium does not
reproduce asexually and depends
exclusively on seeds for reproduction
(Kaye 1992, p. 2), but does not maintain
E:\FR\FM\08MRR1.SGM
08MRR1
Agencies
[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Rules and Regulations]
[Pages 13196-13200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04720]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0665; FRL-10020-34]
Quizalofop ethyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
quizalofop ethyl in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective March 8, 2021. Objections and
requests for hearings must be received on or before May 7, 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-2019-0665, 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 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, 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 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-2019-0665 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
May 7, 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-2019-0665, 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 May 8, 2020 (85 FR 27346) (FRL-10008-
38), 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
9E8803) by IR-4, Rutgers, the State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.441 be amended by establishing tolerances for
residues of the herbicide quizalofop ethyl convertible to 2-methoxy-6-
chloroquinoxaline, expressed as quizalofop ethyl, in or on carinata at
1.5 parts per million (ppm); cottonseed subgroup 20C at 0.1 ppm; fruit,
pome, group 11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13 07F at 0.1 ppm; fruit, stone, group 12-12 at 0.1
ppm; pennycress, meal at 2 ppm; pennycress, seed at 1.5 ppm; and
sunflower subgroup 20B at 3 ppm. Additionally, the petition requested,
upon approval of the above tolerances, to remove the existing
tolerances in 40 CFR 180.441(a) in or on cotton, undelinted seed at 0.1
ppm and sunflower, seed at 1.9 ppm. That document referenced a summary
of the petition prepared by AMVAC Chemical Corporation, the registrant,
which is available in the docket, https://www.regulations.gov. Two
comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA
corrected several tolerance definitions and is not establishing a
tolerance on pennycress, meal, as proposed by the petitioner. The
reasons for these changes are explained in Unit IV.D.
[[Page 13197]]
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 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 quizalofop ethyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with quizalofop
ethyl follows.
In an effort to streamline its publications in the Federal
Register, 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 rulemakings and republishing the same sections is
unnecessary. 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 a number of tolerance rulemakings for
quizalofop ethyl, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to quizalofop ethyl and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological Profile. For a discussion of the Toxicological
Profile of quizalofop ethyl, see Unit III.A. of the February 23, 2018
rulemaking (83 FR 8006) (FRL-9972-30).
Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment, see Unit III.B. of the December 1, 2016 rulemaking
(81 FR 86581) (FRL-9950-89).
Exposure Assessment. Much of the exposure assessment remains the
same, although updates have occurred to accommodate exposures from the
petitioned-for tolerances. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, see Unit III.C. of the February 23, 2018
rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of quizalofop ethyl on brassica
carinata; fruit, pome, group 11-10; fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F; fruit, stone, group 12-12; and
pennycress and the crop subgroup expansions for cottonseed subgroup 20C
and sunflower subgroup 20B. The assessment used the same assumptions as
the February 23, 2018 final rule concerning tolerance level residues
and default processing factors for all processed commodities except
sunflower oil, where an empirical factor was used.
Updated average percent crop treated values were used for the
following crops that are currently registered for quizalofop-ethyl:
Beans, green: 2.5%; canola: 5%; cotton: 1%; dry beans/peas: 15%; peas,
green: 2.5%; soybeans: 2.5%; sugar beets: 1%; and sunflowers: 5%; and
100% crop treated for other registered and new uses of quizalofop
ethyl.
Anticipated residue and PCT information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 to 7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
quizalofop-ethyl may be applied in a particular area.
Drinking water, non-occupational, and cumulative exposures.
Drinking
[[Page 13198]]
water exposures and residential (non-occupational) exposures are not
impacted by the new uses, and thus have not changed since the last
assessment. EPA's conclusions concerning cumulative risk remain
unchanged from the February 23, 2018 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude
that there is reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
February 23, 2018 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
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic-term 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 dietary exposure assessment was not conducted as
toxicological effects attributable to a single dose were not
identified. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD: They are 92% of the cPAD for all infants
less than 1-year old, the population subgroup with the highest exposure
estimate. Quizalofop-ethyl is classified as a Category D chemical, i.e.
``Not Classifiable as to Human Carcinogenicity;'' therefore,
quantification of chronic risks using a non-linear approach will
adequately account for all chronic toxicity, including any potential
carcinogenicity that would result from exposure. There are no
registered or new uses of quizalofop ethyl that would result in
residential exposure, therefore the aggregate risk estimates are
equivalent to the chronic dietary (food and water) risk estimates and
are 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 quizalofop ethyl residues. More detailed
information about the Agency's analysis can be found at https://www.regulations.gov in the documents titled ``Quizalofop-P-ethyl.
Human-Health Risk Assessment in Support of the Proposed New Uses on
Carinata, Pennycress, Pome Fruit (Group 11-10), Stone Fruit (Group 12-
12), and Small Vine-climbing Fruit, Except Fuzzy Kiwifruit (Subgroup
13-07F); and Use Expansions for Sunflower and Cottonseed (Subgroups 20B
and 20C)'' in docket ID number EPA-HQ-OPP-2019-0665.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 23, 2018 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).
The Codex has not established MRLs for quizalofop ethyl.
C. Response to Comments
Although two comments were submitted to the docket in response to
the May 8, 2020 Notice of Filing, only one specifically related to this
tolerance action. The commenter requested that EPA deny IR-4's request
for tolerances for quizalofop ethyl on cotton sunflower seeds out of a
concern for the general health impacts of pesticides.
Although the Agency recognizes that some individuals believe that
pesticides should be banned on agricultural crops, the existing legal
framework provided by section 408 of the FFDCA authorizes EPA to
establish tolerances when it determines that the tolerance is safe.
Upon consideration of the validity, completeness, and reliability of
the available data as well as other factors the FFDCA requires EPA to
consider, EPA has determined that the quizalofop ethyl tolerances are
safe. The commenter has provided no information indicating that a
safety determination cannot be supported.
D. Revisions to Petitioned-For Tolerances
The commodity definition for carinata has been revised to brassica
carinata, seed; and brassica carinata, meal. The tolerance for brassica
carinata, seed will be established at 1.5 ppm; and the tolerance for
brassica carinata, meal will be established at 2 ppm. EPA is not
establishing a tolerance for pennycress, meal as requested by the
petitioner because the glucosinolates in pennycress meal restrict its
use to a livestock feedstuff, not a human food. EPA's current practice
is to set tolerances for livestock feedstuffs only if they are
significant, which is not the case for pennycress meal.
V. Conclusion
Therefore, tolerances are established for residues of quizalofop
ethyl convertible to 2-methoxy-6-chloroquinoxaline, expressed as
quizalofop ethyl, in or on brassica carinata, meal at 2 ppm; brassica
carinata, seed at 1.5 ppm; cottonseed subgroup 20C at 0.1 ppm; fruit,
pome, group 11-10 at 0.1 ppm; fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13-07F at 0.1 ppm; fruit, stone, group 12-12 at 0.1
ppm; pennycress, seed at 1.5 ppm; and sunflower subgroup 20B at 3 ppm.
Upon establishment of the above tolerances, the established tolerances
for cotton, undelinted seed at 0.1 ppm; and sunflower, seed at 1.9 ppm
will be removed as they are superseded by the new tolerances on
subgroups 20C and 20B, respectively.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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
[[Page 13199]]
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: March 2, 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. 180.441, amend the table in paragraph (a)(1) as follows:
0
i. Add a table heading.
0
ii. Add alphabetically the entries ``Brassica carinata, meal''; and
``Brassica carinata, seed''.
0
iii. Remove the entry for ``Cotton, undelinted seed''.
0
iv. Add alphabetically the entries ``Cottonseed subgroup 20C'';
``Fruit, pome, group 11-10''; ``Fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F''; ``Fruit, stone, group 12-12''; and
``Pennycress, seed''.
0
v. Remove the entry for ``Sunflower, seed''.
0
vi. Add alphabetically the entry ``Sunflower subgroup 20B''.
The additions read as follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Brassica carinata, meal................................. 2
Brassica carinata, seed................................. 1.5
* * * * * * *
Cottonseed subgroup 20C................................. 0.1
* * * * * * *
Fruit, pome, group 11-10................................ 0.1
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.1
subgroup 13-07F........................................
Fruit, stone, group 12-12............................... 0.1
* * * * * * *
Pennycress, seed........................................ 1.5
* * * * * * *
Sunflower subgroup 20B.................................. 3
* * * * * * *
------------------------------------------------------------------------
[[Page 13200]]
* * * * *
[FR Doc. 2021-04720 Filed 3-5-21; 8:45 am]
BILLING CODE 6560-50-P