[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: 
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 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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[FR Doc. 2021-04720 Filed 3-5-21; 8:45 am]
BILLING CODE 6560-50-P


