[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8468-8472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02037]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0783; FRL-10004-05]


Chlorfenapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
chlorfenapyr in or on basil, fresh leaves; chive, fresh leaves; and 
cucumber and increases the established tolerance on vegetable, 
fruiting, group 8-10. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, 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-2018-0783, 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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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-2018-0783 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 14, 2020. 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-2018-0783, 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/

[[Page 8469]]

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 http://www.epa.gov/dockets/contacts.html.
    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 March 18, 2019 (84 FR 9737) (FRL-9989-
71), 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 
8E8717) by IR-4 Headquarters, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.513 be 
amended by establishing tolerances for residues of the insecticide 
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on Basil, fresh 
leaves at 80 parts per million (ppm); Chive, fresh leaves at 20 ppm; 
Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2.0 ppm. 
Upon establishment of the above tolerance, the petitioner requested 
removal of the existing tolerance on Vegetable, fruiting, group 8-10 at 
1.0 ppm. That document referenced a summary of the petition prepared by 
BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition and pursuant 
to its authority in section 408(d)(4)(A)(i), EPA is establishing the 
requested tolerances and one tolerance at a different level than 
requested. The reason for this change is explained in Unit IV.C.

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 chlorfenapyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with chlorfenapyr follows.

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.
    Chlorfenapyr has moderate acute toxicity via the oral route of 
exposure and low acute toxicity via the dermal and inhalation routes of 
exposure. It is a mild eye irritant, but it is not a dermal irritant or 
sensitizer. Chlorfenapyr targets the central nervous system (CNS), 
inducing neurohistological changes (spongiform myelinopathy of the 
brain and spinal cord and vacuolization of the brain, spinal cord, and 
optic nerve) from subchronic and chronic dietary administration in mice 
and rats. In addition to neuropathology, rats also exhibited 
neurobehavioral changes on the day of dosing in the acute neurotoxicity 
study. Decreased motor activity was observed in the acute neurotoxicity 
study as well as in offspring in the developmental neurotoxicity (DNT) 
study. Several rat studies also noted effects in the liver (increased 
organ weights and tumors) at similar doses or above those where CNS 
effects were seen. The liver was identified in metabolism studies as 
the single organ to have the highest recovery of administered dose.
    There was evidence of increased quantitative susceptibility to 
offspring in the database as a result of chlorfenapyr exposure. In the 
2-generation reproduction study, decreased pup weights were seen at a 
lower dose than parental toxicity (decreased body-weight). In the DNT 
study, offspring toxicity (decreased motor activity and increased pup 
deaths on postnatal days 1-4) was seen in the absence of maternal 
toxicity. Additional effects on the CNS (vacuolation of white matter in 
the brain and decreased hippocampus size) were also observed in 
offspring at a higher dose in this study. There was no evidence of 
increased susceptibility to offspring in the developmental toxicity 
studies. In both the rat and rabbit developmental toxicity studies, 
although no maternal or developmental effects were noted up to the 
highest doses tested (HDT), maternal observations are limited in these 
developmental studies. Consequently, the data from the DNT are 
considered more robust for assessing the effects of chlorfenapyr on the 
nervous system.
    Chlorfenapyr has a relatively high octanol-water partition 
coefficient and due to its lipophilic nature has been shown to 
accumulate in milk in a dietary cow study. Additionally, in the rat 
metabolism study, chlorfenapyr was found to accumulate in the fat 
tissue, such that females exhibited greater accumulation than males. 
This observation suggests chlorfenapyr is capable of accumulating in 
breast milk and leading to the early pup deaths seen in the 
reproduction toxicity and DNT studies through lactation.
    Furthermore, the lack of toxicity in the rat and rabbit 
developmental studies suggests that the early pup deaths in the 
reproduction toxicity and DNT studies is the result of postnatal 
exposure through lactation.
    EPA has concluded that a nonlinear approach using the chronic RfD 
for assessing cancer risk is appropriate for chlorfenapyr. For more 
information about this conclusion, see section 4.5.3 in the document 
entitled ``SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the 
Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small 
Tomatoes,'' in docket ID number EPA-HQ-OPP-2018-0783.
    Specific information on the studies received and the nature of the 
adverse effects caused by chlorfenapyr 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 at http://www.regulations.gov in the document entitled ``SUBJECT: Chlorfenapyr. 
Human Health Risk Assessment for the Proposed New Uses on Greenhouse-
Grown Basil, Chive, Cucumber, and Small Tomatoes,'' at pages 24-28 in

[[Page 8470]]

docket ID number EPA-HQ-OPP-2018-0783.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) 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 chlorfenapyr used for 
human risk assessment is discussed in Unit III of the final rule 
published in the Federal Register of January 26, 2018 (83 FR 3605) 
(FRL-9970-88).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to chlorfenapyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing chlorfenapyr tolerances in 40 
CFR 180.513. EPA assessed dietary exposures from chlorfenapyr 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 chlorfenapyr. In estimating acute dietary exposure, EPA used the 
Dietary Exposure Evaluation Model--Food Consumption Intake Database 
(DEEM-FCID), Version 3.16, which uses food consumption data from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-
2008. As to residue levels in food, EPA's acute unrefined analysis used 
tolerance-level residues and 100% crop-treated (PCT). DEEM processing 
factors were set to 1 for all commodities except tomato and peppers. 
EPA 2018 default processing factors were used in the acute dietary 
analyses for tomato and pepper processed raw agricultural commodities 
(RACs) to account for potential imports of foreign agricultural use of 
chlorfenapyr.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the DEEM-FCID, Version 3.16, which uses food 
consumption data from the U.S. Department of Agriculture's National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA's 
chronic analysis was unrefined and used tolerance-level residues and 
100 PCT. DEEM processing factors were set to 1 for all commodities 
except tomato and peppers. EPA 2018 default processing factors were 
used in the chronic dietary analyses for tomato and pepper processed 
RACs to account for potential imports of foreign agricultural use of 
chlorfenapyr.
    iii. Cancer. As indicated in Unit III.A., EPA has concluded that a 
nonlinear approach using the chronic RfD for assessing cancer risk is 
appropriate for chlorfenapyr; therefore, a separate quantitative cancer 
risk assessment is not required.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for chlorfenapyr. Tolerance level residues for 
proposed and established uses and 100 PCT were assumed for all food 
commodities.
    2. Dietary exposure from drinking water. Contamination of drinking 
water from chlorfenapyr is not expected to occur since none of the 
registered uses (which are all indoor uses) would result in residues in 
drinking water. Therefore, a dietary exposure assessment for 
chlorfenapyr in drinking water is unnecessary.
    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).
    Chlorfenapyr is currently registered for the following uses that 
could result in residential exposures: Crack/crevice/spot treatment on 
indoor and outdoor residential sites (including as a bed bug 
treatment). There are no residential uses associated with the 
petitioned-for new uses; therefore, an updated residential exposure 
assessment was not necessary for the proposed uses. The most 
conservative residential exposure scenarios were selected for use in 
the aggregate risk assessment. EPA combined post-application dermal and 
inhalation exposure from indoor applications (surfaces and mattresses) 
to control bed bugs to assess risks to adults and post-application 
dermal, inhalation, and hand-to-mouth exposures from indoor 
applications (surfaces and mattresses) to control bed bugs to assess 
risks to children 1 to <2 years old. The residential exposures are 
short- and intermediate-term for incidental oral, dermal and 
inhalation. No long-term exposures is expected.
    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.''
    EPA has not found chlorfenapyr to share a common mechanism of 
toxicity with any other substances, and chlorfenapyr does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
chlorfenapyr does not have 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

[[Page 8471]]

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. Although DNT studies show 
evidence of neurotoxicity/neuropathology and reproduction studies show 
susceptibility/sensitivity to offspring, the effects are well-
characterized with clearly established NOAEL/LOAEL values and selected 
endpoints are protective for the observed effects.
    3. Conclusion. EPA determined that the FQPA SF should be reduced to 
1X for all exposure scenarios. That decision is based on the following 
findings:
    i. The toxicity database for chlorfenapyr is complete.
    ii. Although the central nervous system is the primary target for 
chlorfenapyr and neurotoxic effects were observed across studies, 
concern is low since the selected PODs are protective of observed 
neurotoxic effects.
    iii. Although there is evidence of increased quantitative 
susceptibility in available DNT and reproduction studies, concern is 
low since the offspring effects are well-characterized with clearly 
established NOAEL/LOAEL values and the endpoints selected for risk 
assessment are protective of observed offspring effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary analysis assumed tolerance-level residues, EPA's 
2018 default processing factors (except for tomatoes and peppers), and 
100 PCT. The dietary analysis did not include exposure from drinking 
water as contamination of drinking water with chlorfenapyr as the 
result of all registered uses, including greenhouses or food/feed 
handling uses, is not expected to occur. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
chlorfenapyr.

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 chlorfenapyr will occupy 75% of the aPAD (at the 95th percentile of 
exposure) for children 3 to 5 years old, 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 
chlorfenapyr from food and water will utilize 19% of the cPAD for 
children 3 to 5 years old, the population group receiving the greatest 
exposure. There are no chronic drinking water or residential exposure 
scenarios, therefore, the chronic aggregate risk is equivalent to the 
chronic dietary risk which is below the Agency's LOC.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate risk assessments were conducted since there is potential for 
short- and intermediate-term post-application exposures from previously 
registered uses of chlorfenapyr in residential settings. Short-term 
residential exposure estimates were aggregated with the average dietary 
exposure to provide a worst-case estimate of short-term aggregate risk 
for adults and children 1 to 2 years old (considered protective for 
children of all ages). Short-term aggregate MOEs are protective of 
intermediate-term exposure durations since the same endpoints and PODs 
were selected for both durations. Resulting short-term aggregate MOEs 
for adults at 660 and 120 for children (1 to 2 years old) are not of 
concern.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III, the Agency has determined that quantification of risk using a non-
linear approach (i.e., using a cRfD) adequately accounts for all 
chronic toxicity, including carcinogenicity that could result from 
exposure to chlorfenapyr. Since there are no chronic risks of concern, 
the Agency concludes that aggregate exposure to chlorfenapyr will not 
pose a cancer risk.
    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 chlorfenapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The plant analytical enforcement method is designated as M2427, a 
gas chromatography/electron-capture detection (GC/ECD) method with a 
limit of quantitation (LOQ) of 0.05 ppm. The method has been subjected 
to a successful independent laboratory validation (ILV) as well as an 
acceptable radio validation using samples obtained from lettuce and 
tomato metabolism studies. EPA has concluded that method M2427 is 
adequate for data collection and tolerance enforcement purposes.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no Codex maximum residue limits (MRLs) for residues of 
chlorfenapyr in/on the proposed commodities.

C. Revisions to Petitioned-For Tolerances

    EPA revised the proposed tolerances for residues of chlorfenapyr on 
vegetable, fruiting, group 8-10 based on current OECD rounding classes. 
There is no need to remove the existing tolerance for vegetable, 
fruiting, group 8-10 at 1.0 ppm; rather EPA is simply amending the 
existing tolerance as requested.

[[Page 8472]]

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-
5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on Basil, fresh 
leaves at 80 ppm; Chive, fresh leaves at 20 ppm; and Cucumber at 0.5 
ppm; and Vegetable, fruiting, group 8-10 at 2 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 24, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.513, amend the table in paragraph (a)(1) as follows:
0
 a. Add alphabetically the entries for ``Basil, fresh leaves''; 
``Chive, fresh leaves''; and ``Cucumber''; and
0
 b. Revise the entry for ``Vegetable, fruiting, group 8-10''.
    The additions and revision read as follows:


Sec.  180.513  Chlorfenapyr; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, fresh leaves.........................................          80
Chive, fresh leaves.........................................          20
Cucumber....................................................         0.5
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................           2
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-02037 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P


