[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Rules and Regulations]
[Pages 31950-31954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12609]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0067; FRL-10024-51]


Tolfenpyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tolfenpyrad in or on artichoke, globe. The Interregional Project Number 
4 (IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective June 16, 2021. Objections and 
requests for hearings must be received on or before August 16, 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-2020-0067, 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: 
<a href="/cdn-cgi/l/email-protection#d2809694809cbda6bbb1b7a192b7a2b3fcb5bda4"><span class="__cf_email__" data-cfemail="06544240544869726f6563754663766728616970">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2020-0067 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 
August 16, 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-2020-0067, by one of 
the following methods:
    <bullet> 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.

[[Page 31951]]

    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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 
9E8807) by the Interregional Project Number 4 (IR-4), Rutgers, The 
State University of New Jersey, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.675 be 
amended by establishing a tolerance for residues of the insecticide 
tolfenpyrad, (4-choro-3-ethyl-1-methyl-N-[[4-(4-
methylphenoxy)phenyl]methyl]-1H-pyrazole-5-carboxamide), in or on 
artichoke, globe at 5 parts per million (ppm). That document referenced 
a summary of the petition prepared by IR-4, the petitioner, which is 
available in the docket for this action, Docket ID EPA-HQ-OPP-2020-
0067, at http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The toxicology database is considered complete. A variety of toxic 
effects were noted in the toxicology database for tolfenpyrad. However, 
the most consistent findings across species and studies were effects on 
bodyweight and bodyweight gain. Decreases in bodyweight and/or 
bodyweight gain were observed in adults of all species (rat, mice, 
rabbit, and dog) in the majority of the subchronic oral and dermal 
toxicity studies, and all chronic toxicity studies. Bodyweight 
decreases in rats were observed at much lower doses than in other 
species. Chronic exposure resulted in bodyweight and bodyweight gain 
decreases in mice and dogs at lower doses than the effects that were 
observed from acute and subchronic exposures. In addition, quantitative 
susceptibility was observed in the database; in the rat developmental 
study, decreased fetal weights and number of ossified metacarpals were 
observed in the absence of adverse maternal toxicity and in the one-
generation reproduction study, decreased pup weights were observed at a 
lower dose than the dose at which parental bodyweight decreases reached 
biological significance. Tolfenpyrad is classified as ``not likely to 
be carcinogenic to humans''.
    A complete discussion of the toxicological profile for tolfenpyrad 
as well as specific information on the studies received and the nature 
of the adverse effects caused by tolfenpyrad as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found in the 
document titled ``Tolfenpyrad--Human Health Risk Assessment of the New 
Use on Globe Artichoke'' (hereinafter ``Tolfenpyrad Human Health Risk 
Assessment'') in docket ID number EPA-HQ-OPP-2020-0067 at https://regulations.gov.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (PODs) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for tolfenpyrad used for 
human risk assessment can be found in the Tolfenpyrad Human Health Risk 
Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolfenpyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolfenpyrad tolerances in 40 CFR 
180.675. EPA assessed dietary exposures from tolfenpyrad in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for tolfenpyrad. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, the acute assessment assumed tolerance-level 
residues and 100% crop treated (PCT) for all commodities. Refinements 
include a factor to account for the reduction in residues when wrapper 
leaves are removed from head lettuce, radicchio, cabbage, Chinese Napa 
cabbage, and Brussels sprouts. Empirical processing factors were 
available for processed commodities of apple, orange, cottonseed, 
grape, plum, potato and tomato, and were translated to other crop 
processed commodities where appropriate. Where empirical processing 
factors were not available or were not translated, the Agency's 2018 
default processing factors were used. Several factors were used to 
account for metabolite residues in/on bulb onion subgroup 3-07A 
commodities and livestock commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA's 2003-
2008 NHANES/WWEIA. As to residue levels in food, EPA used average 
residues from field trials. The chronic assessment includes estimates 
of PCT for some crops and all the refinements

[[Page 31952]]

described above for the acute assessment.
    iii. Cancer. Based on the data cited in Unit III.A., EPA has 
concluded that tolfenpyrad does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information to establish the 
tolerance, EPA must require pursuant to FFDCA section 408(f)(1) that 
data be provided 5 years after the tolerance is established, modified, 
or left in effect, demonstrating that the residue levels in food are 
not above the levels anticipated. For the present action, EPA will 
issue such data call-ins as are required by FFDCA section 408(b)(2)(E) 
and authorized under FFDCA section 408(f)(1). Data will be required to 
be submitted no later than 5 years from the date of issuance of these 
tolerances.
    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:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> 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.
    The acute assessment assumes 100 PCT. The Agency incorporated 
estimates of average PCT in the chronic assessment for the following 
crops: Grapefruit (15%), grapes (2.5%), lettuce (10%), onion (2.5%), 
oranges (5%), peppers (less than 2.5%), potatoes (2.5%), tangerines 
(2.5%), and tomatoes (2.5%).
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute 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 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. 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 tolfenpyrad may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tolfenpyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tolfenpyrad. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Residues of tolfenpyrad in surface and ground water were modeled 
with the Pesticide in Water Calculator (PWC Version 1.52). Groundwater 
estimated drinking water concentrations were modeled with the Pesticide 
Root Zone Model Groundwater (PRZM GW) model within the Pesticide in 
Water Calculator (Version 1.52). For tolfenpyrad, the assessment uses 
the total residues approach, which is commonly used to assess chemicals 
that have residues of concern with similar toxicity to parent compound. 
The recommended estimated drinking water concentrations (EDWCs) for 
tolfenpyrad acute exposures are estimated to be 32.6 parts per billion 
(ppb) for surface water and 168 ppb for ground water. For chronic 
exposures for non-cancer assessments, EDWCs are estimated to be 14.1 
ppb for surface water and 125 ppb for ground water. For the acute 
dietary exposure assessment, EPA used an EDWC of 168 ppm. For the 
chronic dietary exposure assessment, EPA used a value of 125 ppb.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Tolfenpyrad is not registered for any specific use patterns that 
would result in residential exposure. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to tolfenpyrad and any other 
substances, and tolfenpyrad does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not

[[Page 31953]]

assumed that tolfenpyrad has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased quantitative or qualitative susceptibility in the guideline 
rabbit developmental studies, the rat two-generation reproduction 
study, or the developmental immunotoxicity (DIT) study. Quantitative 
susceptibility was observed in the developmental rat study and the 
range-finding one-generation reproduction study. In the developmental 
rat study, decreased fetal weights and number of ossified metacarpals 
were observed in the absence of adverse maternal toxicity (only a 9% 
decrease in bodyweight). In the one-generation reproduction study, 
decreased pup weights were observed at a dose lower than the dose at 
which parental bodyweight decreases reached biological significance. 
All of the reviewed studies (developmental toxicity studies in the rat 
and rabbit and the one- and two-generation reproductive toxicity 
studies in the rat) include decreased bodyweight in the maternal LOAEL 
statement, as well as mortality in both of the developmental rabbit 
studies and the two-generation rat reproduction study. Reproductive 
toxicity was seen in rats as increased total litter loss in the two-
generation study and decreased pup viability in the one- and two-
generation study. Decreased pup weight was observed in all six studies, 
and additional offspring effects include: An increase in skeletal 
variation in both developmental toxicity studies; blackish abdominal 
cavity, dark green intestinal contents, and decreased survival of 
offspring in the developmental immunotoxicity study; decreased pup 
viability in both reproduction studies, with the addition of a delay in 
developmental landmarks in the two-generation reproductive toxicity 
study. Since most of these effects occurred in the presence of 
comparable or more severe maternal toxicity, or were partially 
attributable to the maternal animal behavior, they were not considered 
evidence of qualitative susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for tolfenpyrad is complete and includes 
acceptable developmental and reproductive toxicity studies.
    ii. Based on the available toxicity database, there is no 
indication that tolfenpyrad is a neurotoxic chemical, and there is no 
need for a developmental neurotoxicity study or additional uncertainty 
factors to account for neurotoxicity.
    iii. While there was evidence of quantitative susceptibility in two 
studies, the Agency's degree of concern for the susceptibility is low 
because the offspring effects consistently occurred at or near doses 
which caused maternal toxicity (bodyweight decrease), and because 
endpoints and doses selected for risk assessment are protective of the 
observed susceptibility.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure assessment is partially refined but 
does not underestimate potential dietary exposure to tolfenpyrad. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to tolfenpyrad in drinking 
water. These assessments will not underestimate the exposure and risks 
posed by tolfenpyrad.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tolfenpyrad will occupy 69% of the aPAD for children 1 to 2 years of 
age, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tolfenpyrad from food and water will utilize 59% of the cPAD for all 
infants less than 1-year old, the population group receiving the 
greatest exposure. There are no residential uses for tolfenpyrad.
    3. Short-term and Intermediate-term risks. Short-term and 
intermediate-term aggregate exposures take into account short-term and 
intermediate-term residential exposures plus chronic exposures to food 
and water (considered to be a background exposure level).
    Short-term and intermediate-term adverse effects were identified; 
however, tolfenpyrad is not registered for any use patterns that would 
result in short-term or intermediate-term residential exposures. Short-
term and intermediate-term risks are assessed based on short-term and 
intermediate-term residential exposures plus chronic dietary exposure. 
Because there are no short-term or intermediate-term residential 
exposures and chronic dietary exposures have already been assessed 
under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term and intermediate-term 
risk), no further assessments of short-term and intermediate-term risks 
are necessary, and EPA relies on the chronic dietary risk assessment 
for evaluating short-term and intermediate-term risks for tolfenpyrad.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tolfenpyrad is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to tolfenpyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An acceptable high-performance liquid chromatography method with

[[Page 31954]]

tandem mass spectrometry detection (LC/MS/MS) is available for 
enforcement of tolfenpyrad residue tolerances in/on plant commodities 
(Morse Laboratories Analytical Method #Meth-183, Revision #2). For 
livestock, a method described in PTRL West Study No. 1841W is 
available. Residues are determined by LC/MS/MS analysis.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd. Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
<a href="/cdn-cgi/l/email-protection#e29087918b8697878f87968a8d8691a2879283cc858d94"><span class="__cf_email__" data-cfemail="433126302a2736262e26372b2c2730032633226d242c35">[email protected]</span></a>.

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 an MRL for tolfenpyrad in globe 
artichoke.

V. Conclusion

    Therefore, a tolerance is established for residues of tolfenpyrad, 
(4-choro-3-ethyl-1-methyl-N-[[4-(4-methylphenoxy)phenyl]methyl]-1H-
pyrazole-5-carboxamide), in or on artichoke, globe at 5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National 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: June 10, 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.  180.675, amend paragraph (a)(1) by designating the table 
and adding in alphabetical order in newly designated Table 1 to 
paragraph (a)(1) the entry ``Artichoke, globe'' to read as follows:


Sec.  180.675   Tolfenpyrad; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe........................................               5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-12609 Filed 6-15-21; 8:45 am]
BILLING CODE 6560-50-P


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