Document ID: EPA-HQ-OPP-2016-0333-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Chlorfenapyr
Posted Date: 2018-01-26T05:00Z

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3605-3610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01487]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0333; FRL-9970-88]

Chlorfenapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on tea, dried. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 26, 2018. Objections and 
requests for hearings must be received on or before March 27, 2018, 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-2016-0333, 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 L. Goodis, P.E., Director, 
Registration Division (750P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001;

[[Page 3606]]

main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing 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-2016-0333 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 
March 27, 2018. 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-2016-0333, 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 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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 
6E8473) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. 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-(trifluromethyl)-1H-
pyrrole-3-carbonitrile, in or on tea, dried at 70 parts per million 
(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. This tolerance was requested to cover 
residues of chlorfenapyr in or on tea resulting from uses of this 
pesticide on tea outside the United States. There is no current U.S. 
registration for use of chlorfenapyr on tea. In addition, there were no 
substantive comments received in response to the notice of filing.

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 doses similar to 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 
two-

[[Page 3607]]

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.
    Given the lack of toxicity in the rat and rabbit developmental 
studies, the early pup deaths in the reproduction toxicity and DNT 
studies are suspected to be the result of postnatal exposure through 
lactation. Chlorfenapyr has a relatively high octanol-water partition 
coefficient (log KOW = 4.83) and has been shown to 
accumulate in milk due to its lipophilic nature in a dietary cow study. 
In addition, in a rat metabolism study, chlorfenapyr was found to 
accumulate in the fat, such that females exhibited greater accumulation 
than males. This suggests chlorfenapyr is capable of accumulating in 
breast milk and likely causing the early pup deaths seen in the 
reproduction toxicity and DNT studies through lactation.
    Chlorfenapyr did not show any evidence of mutagenicity in in vitro 
or in vivo studies. Chlorfenapyr is classified as ``suggestive evidence 
of carcinogenicity, but not sufficient to assess human carcinogenic 
potential.''
    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 ``Chlorfenapyr: Revised 
Preliminary Human Health Risk Assessment for Registration Review,'' 
dated September 7, 2016, which can be found in docket ID number EPA-HQ-
OPP-2010-0467 as well in the document completed in support of this 
tolerance action entitled ``Chlorfenapyr. Human Health Risk Assessment 
for the Establishment of a Tolerance without a U.S. Registration for 
Residues in/on Imported Tea,'' dated March 1, 2017, which can be found 
in docket ID number EPA-HQ-OPP-2016-0333.

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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological 
endpoints for chlorfenapyr used for human risk assessment is shown in 
Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Chlorfenapyr for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RFD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (All populations)..  NOAEL = 5 mg/kg/day.  Acute RfD = 0.05 mg/ Developmental Neurotoxicity Study
                                   UFA = 10X...........   kg/day.              (Rat).
                                   UFH = 10X...........  aPAD = 0.05 mg/kg/   LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Chronic Dietary (All populations)  NOAEL = 5 mg/kg/day.  Chronic RfD = 0.05   Developmental Neurotoxicity Study
                                   UFA = 10X...........   mg/kg/day.           (Rat).
                                   UFH = 10X...........  cPAD = 0.05 mg/kg/   LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                                                              Chronic Neurotoxicity Study (Rat).
                                                                              NOAEL = 2.6 mg/kg/day.
                                                                              LOAEL = 13.6 mg/kg/day based on
                                                                               alterations of the myelin of the
                                                                               CNS and decreased water
                                                                               consumption in male rats,
                                                                               decreased food consumption in
                                                                               females, and decreased body-
                                                                               weight in both sexes.
                                  ------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30   NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 days) and Intermediate-Term (1-6  UFA = 10X...........   MOE = 100.           (Rat).
 months).                          UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------

[[Page 3608]]

 
Dermal Short-Term (1-30 days) and  NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 Intermediate-Term (1-6 months).   UFA = 10X...........   MOE = 100.           (Rat).
                                   UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Inhalation Short-Term (1-30 days)  NOAEL = 5 mg/kg/day.  Residential LOC for  Developmental Neurotoxicity Study
 and Intermediate-Term (1-6        UFA = 10X...........   MOE = 100.           (Rat).
 months).                          UFH = 10X...........                       LOAEL = 10 mg/kg/day based on
                                   FQPA SF = 1X........                        increased pup deaths (post-natal
                                                                               days 1-4) and decreased motor
                                                                               activity.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classified as ``suggestive evidence of carcinogenicity, but not sufficient to
                                    assess human carcinogenic potential.'' The Agency 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.
----------------------------------------------------------------------------------------------------------------
NOAEL = no-observed adverse-effect level. LOAEL = lowest-observed adverse-effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population-adjusted dose
  (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

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 (food only) 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 analysis was unrefined 
and used tolerance-level residues and 100% crop-treated (PCT). 
Tolerances for food/feed handling establishments are not included in 
the acute dietary assessment unless the food/feed handling 
establishment is the only use; however, this is not the case for 
chlorfenapyr. DEEM 7.81 default processing factors were used in the 
acute analysis for tomato commodities as there is a registered 
agricultural use on fruiting vegetables.
    ii. Chronic exposure. In conducting the chronic dietary (food only) 
risk assessment, EPA used the DEEM-FCID, Version 3.16, which uses food 
consumption data from the U.S. Department of Agriculture's NHANES/WWEIA 
from 2003-2008. As to residue levels in food, EPA's chronic dietary 
exposure analysis for the all population subgroups was unrefined and 
used tolerance-level residues and 100% PCT. As most tolerances for 
chlorfenapyr are for food or feed handling establishment uses and 
residues are expected to be incurred after processing, DEEM 7.81 
processing factors were set to 1 for all commodities except tomato 
commodities (as there is a registered agricultural use on fruiting 
vegetables). For tomato commodities, default processing factors were 
used in the analysis.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized 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 
unnecessary.
    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 and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The acute and chronic 
dietary analysis did not include exposure from drinking water as 
contamination of drinking water with chlorfenapyr as a result of all 
registered uses, including greenhouses, is not expected to occur. 
Furthermore, as there are no U.S. registrations for tea, a dietary 
exposure assessment from drinking water is not needed.
    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). 
Residential exposures are not expected to occur from use of 
chlorfenapyr on tea since chlorfenapyr will not be applied to tea in 
the United States. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be

[[Page 3609]]

found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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://www.epa.gov/pesticides/cumulative.

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. Although there is evidence 
of increased quantitative susceptibility, 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, including those observed in 
lactating pups.
    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 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, 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 acute and chronic analysis did not include exposure from 
drinking water as contamination of drinking water with chlorfenapyr as 
the result of all registered uses, including greenhouses, is not 
expected to occur. Furthermore, as there is no U.S. registration for 
tea, a dietary exposure assessment from drinking water is not needed. 
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. An acute aggregate risk assessment takes into 
account the acute exposure assumptions discussed in this unit for acute 
exposure, the resulting acute (food only) risk estimates were less than 
EPA's LOC (<100% of the aPAD) for the general U.S. population (15% of 
the aPAD) and all population subgroups. The most highly exposed 
population subgroup was children 1 to 2 years old with an estimated 
equivalent risk to 36% of the aPAD; therefore, the acute dietary 
exposure to chlorfenapyr is below the Agency's LOC.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that the resulting chronic 
risk estimate utilizes 4.6% of the cPAD for the general U.S. 
population. The most highly-exposed population subgroup was children 1 
to 2 years old which utilized 9.9% of the cPAD; therefore, the chronic 
dietary exposure to chlorfenapyr for all population subgroups is below 
the Agency's LOC. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
chlorfenapyr is not expected.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate risk assessments were performed since there is potential for 
post-application exposure from the previously registered uses of 
chlorfenapyr in residential settings. Since the short- and 
intermediate-term endpoints and PODs are the same, the short-term 
aggregate assessment is protective of intermediate-term exposure. The 
short-term aggregate MOE of 840 for adults is greater than the LOC 
(100), and is, therefore, not a concern. For children (1 to <2 years 
old), the most highly exposed population subgroup, the short-term 
aggregate MOE of 140 is greater than the LOC (100), and is, therefore, 
not a concern.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III. C.1.iii., EPA concluded that regulation based on the cRfD will be 
protective for both chronic and carcinogenic risks. As noted in this 
unit, there are no chronic risks of concern; therefore, 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 enforcement method is designated as M 2427, a gas 
chromatography/electron capture detection (GC/ECD) method with a limit 
of quantitation (LOQ) of 0.05 ppm. Method M 2427 has been subjected to 
a successful independent laboratory validation (ILV) as well as an 
acceptable radiovalidation using samples obtained from lettuce and 
tomato metabolism studies. This method is adequate for data collection 
and tolerance enforcement purposes.

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

[[Page 3610]]

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. The Codex has not established a MRL for chlorfenapyr in or 
on tea, dried.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing a tolerance for ``tea, dried'', as opposed to 
``tea'' as requested by the petitioner, for consistency with the 
Agency's food and feed commodity vocabulary. In addition, EPA is 
amending the introductory text of paragraph (a)(1) to be consistent 
with the Agency's policy for drafting the tolerance expression. These 
revisions reflect the language in FFDCA section 408(a)(3), which 
includes metabolites and degradates of a pesticide chemical under the 
same tolerance unless otherwise excluded, as well as providing greater 
clarity for measuring residues to determine compliance. These revisions 
do not substantively change the existing tolerances in paragraph 
(a)(3).

V. Conclusion

    Therefore, a tolerance is established without U.S. registrations 
for residues of chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-
(ethoxymethyl)-5-(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on 
tea, dried at 70 parts per million.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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 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: December 18, 2017.
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, revise paragraph (a)(1) to read as follows:

Sec.  180.513   Chlorfenapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
chlorfenapyr, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only chlorfenapyr, 4-
bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Tea, dried \1\..............................................          70
Vegetable, fruiting, group 8-10.............................         1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for Tea, dried as of January 26,
  2018.

* * * * *
[FR Doc. 2018-01487 Filed 1-25-18; 8:45 am]
 BILLING CODE 6560-50-P