[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]
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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.
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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 http://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 http://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: http://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
http://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, http://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 http://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
* * * * * * *
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[[Page 13200]]
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[FR Doc. 2021-04720 Filed 3-5-21; 8:45 am]
BILLING CODE 6560-50-P