Document ID: EPA-HQ-OPP-2016-0257-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluopicolide
Posted Date: 2018-03-07T05:00Z

[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Rules and Regulations]
[Pages 9703-9712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04533]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0257; FRL-9973-44]

Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluopicolide in or on multiple commodities which are identified and 
discussed later in this document. In addition, this regulation removes 
several previously established tolerances that are superseded by this 
final rule. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective March 7, 2018. Objections and 
requests for hearings must be received on or before May 7, 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-2016-0257, is available at http://www.regulations.gov or at the Office of Pesticide Programs

[[Page 9704]]

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, Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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-2016-0257 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 7, 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-2016-0257, 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 Wednesday, June 22, 2016 (81 FR 40594) 
(FRL-9947-32), 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 6E8464) by IR-4 Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.627 be 
amended by establishing tolerances for residues of the fungicide, 
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], including its metabolites and degradates, 
in or on the commodities: Basil, dried leaves at 200 parts per million 
(ppm); basil, fresh leaves at 30 ppm; bean, succulent at 0.9 ppm; 
citrus, dried pulp at 0.048 ppm; citrus, oil at 1.94 ppm; hop, dried 
cones at 15 ppm; fruit, citrus, group 10-10 at 0.02 ppm; fruit, small, 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and 
vegetable, fruiting, crop group 8-10 at 1.60 ppm. That document 
referenced a summary of the petition prepared by Valent, the 
registrant, which is available in the docket, http://www.regulations.gov. Two similar anonymous public comments were 
received in response to the notice of filing. The Agency's response to 
the comments is included in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing certain tolerances that differ from what the petitioner 
requested. The reasons for these changes are explained in Unit IV.D.

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 fluopicolide including exposure 
resulting from the tolerances established by this action.
    Fluopicolide shares a metabolite, 2,6-dichlorobenzamide (BAM), with 
another active ingredient, dichlobenil. Residues of BAM are assessed 
independently of fluopicolide and dichlobenil because it has its own 
toxicity database and endpoints of concern. The BAM assessment 
considers residues resulting from both fluopicolide and dichlobenil 
uses. EPA's safety finding for

[[Page 9705]]

fluopicolide considers the aggregate exposures to fluopicolide alone as 
well as the aggregate exposure to BAM from both fluopicolide and 
dichlobenil uses.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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.
    Fluopicolide. Fluopicolide has low acute toxicity by the oral, 
dermal, and inhalation routes. Following subchronic and chronic 
exposures, increased liver weights and/or liver hypertrophy were 
observed in rats and mice. Additional liver lesions were seen in mice, 
including oval cell proliferation in a 90-day oral toxicity study and 
altered cell foci in the carcinogenicity study. Treatment-related 
effects in rats also included kidney and thyroid effects; however, 
these effects were not seen consistently across studies in the 
fluopicolide database. In the 28-day oral toxicity study in rats, there 
were indications of nephrotoxicity including pale kidneys and 
microscopic lesions (granulation, proteinaceous material, and 
hydronephrosis). Kidney effects were not observed in any other studies, 
except the reproduction toxicity study where slightly increased organ 
weights and kidney lesions were observed in parental animals. Thyroid 
toxicity was only observed in the combined chronic/carcinogenicity 
study in rats and consisted of increased thyroid weights, gross 
pathological observation of enlarged thyroids, and increased incidence 
of cystic follicular hyperplasia in males (slight to moderate 
severity).
    Evidence of increased quantitative susceptibility was seen in the 
rat developmental toxicity study. Developmental effects (delayed 
ossification and fetal growth) were only seen at a relatively high dose 
(700 mg/kg/day) in the absence of maternal effects. There was no 
evidence of susceptibility in the rabbit developmental toxicity and rat 
reproduction toxicity studies. In the rabbit developmental toxicity 
study, late abortions/premature deliveries were observed at 60 mg/kg/
day. Additional effects at this dose included late maternal deaths and 
decreased crown rump length in fetuses. In the rat reproduction 
toxicity study, offspring effects (decreased body weight) were seen in 
the presence of parental effects (kidney effects).
    There is no evidence of neurotoxicity, immunotoxicity, or 
mutagenicity in the fluopicolide toxicity database. Due to the absence 
of treatment-related tumors in two adequate rodent carcinogenicity 
studies, fluopicolide is classified as ``Not Likely to be Carcinogenic 
to Humans''.
    BAM. Acute toxicity studies on BAM demonstrated moderate acute 
toxicity via the oral route of exposure. In subchronic and chronic 
toxicity studies, the primary oral effects seen in the rat and dog were 
body weight changes. Adverse liver effects, including hepatocellular 
alterations and increased liver weights, were also observed. Toxicity 
to the olfactory sensory neurons has been observed following 
intraperitoneal exposure of mice to BAM, indicating potential 
neurotoxicity; however, no effects on the olfactory system were 
observed via the oral route. There is no evidence that BAM is either 
mutagenic or clastogenic nor is there evidence of endocrine mediated 
toxicity. A BAM combined chronic toxicity/carcinogenicity study in the 
rat is available; however, in the absence of a carcinogenicity study 
data for a second species, EPA has assumed that BAM's carcinogenic 
potential is similar to that of dichlobenil, the parent compound having 
the greatest carcinogenicity potential. Dichlobenil is classified as 
``Group C, possible human carcinogen.'' Therefore, EPA has concluded 
that quantification of cancer risk using a non-linear approach (i.e., 
RfD) will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to dichlobenil, and 
therefore, to BAM.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluopicolide and BAM, 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 document: Fluopicolide and 2,6-Dichlorobenzamide 
(BAM). Human Health Risk Assessment to Support Registration for 
Application of Fluopicolide on Basil, Succulent Bean, Hops, Small Vine 
Climbing Subgroup 13-07F, and Citrus Fruit Group 10-10 and Crop Group 
Conversion for Fruiting Vegetables 8-10, dated December 5, 2017 at 
pages 19-25 in docket ID number EPA-HQ-OPP-2016-0257.

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 fluopicolide and BAM 
used for human risk assessment is shown in Table 1 and Table 2, 
respectively, of this unit.

[[Page 9706]]

 Table 1--Summary of Toxicological Doses and Endpoints for Fluopicolide 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
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..      An endpoint attributable to a single dose was not identified from the
                                                                   available data.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  Maternal NOAEL = 20   cRfD = cPAD = 0.2    Developmental Toxicity Study in
                                    mg/kg/day.            mg/kg/day.           Rabbits.
                                   UFA = 10x...........                       LOAEL (maternal) = 60 mg/kg/day
                                   UFH = 10x...........                        based on death, abortions/
                                   FQPA SF = 1X........                        premature deliveries, and
                                                                               decreased food consumption.
                                                                              Co-critical: Chronic/Oncogenicity
                                                                               Study in Rats.
                                                                              NOAEL = 31.5 mg/kg/day.
                                                                              LOAEL = 109.4 mg/kg/day based on
                                                                               increased thyroid weight and
                                                                               increased incidence of thyroid
                                                                               lesions.
Incidental oral short- and         Maternal NOAEL = 20   LOC for MOE <100...  Developmental Toxicity Study in
 intermediate-term (1-30 days,      mg/kg/day.                                 Rabbits.
 and 1-6 months).                  UFA = 10x...........                       LOAEL (maternal) = 60 mg/kg/day
                                   UFH = 10x...........                        based on death, abortions/
                                   FQPA SF = 1X........                        premature deliveries, decreased
                                                                               food consumption and body-weight
                                                                               gain.
Dermal short- and intermediate-    Maternal NOAEL = 20   LOC for MOE <100...  Developmental Toxicity Study in
 term (1-30 days, and 1-6 months).  mg/kg/day.                                 Rabbits.
                                   UFA = 10x...........                       LOAEL (maternal) = 60 mg/kg/day
                                   UFH = 10x...........                        based on death, abortions/
                                   FQPA SF = 1X (when                          premature deliveries, decreased
                                    applicable).                               food consumption and body-weight
                                   DAF = 5%............                        gain.
                                                                              Co-critical: Chronic/Oncogenicity
                                                                               Study in Rats.
                                                                              NOAEL = 31.5 mg/kg/day.
                                                                              LOAEL = 109.4 mg/kg/day based on
                                                                               increased thyroid weight and
                                                                               increased incidence of thyroid
                                                                               lesions.
Inhalation short- and              Maternal NOAEL = 20   LOC for MOE <100...  Developmental Toxicity Study in
 intermediate-term (1-30 days,      mg/kg/day.                                 Rabbits.
 and 1-6 months).                  Inhalation assumed                         LOAEL (maternal) = 60 mg/kg/day
                                    equivalent to oral.                        based on death, abortions/
                                   UFA = 10x...........                        premature deliveries, decreased
                                   UFH = 10x...........                        food consumption.
                                   FQPA SF = 1X, when                         Co-critical: Chronic/Oncogenicity
                                    applicable.                                Study in Rats.
                                                                              NOAEL = 31.5 mg/kg/day.
                                                                              LOAEL = 109.4 mg/kg/day based on
                                                                               and increased thyroid weight and
                                                                               increased incidence of thyroid
                                                                               lesions.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
                                     absence of treatment-related tumors in two adequate rodent carcinogenicity
                                                                      studies.
----------------------------------------------------------------------------------------------------------------
Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

  Table 2--Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) 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
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  LOAEL = 100 mg/kg/    aRfD = aPAD = 0.1    Dose-range finding assay for in
                                    day.                  mg/kg/day.           vivo mouse erythrocyte
                                   UFA = 10x...........                        micronucleus assay.
                                   UFH = 10x...........                       LOAEL = 100 mg/kg/day based on
                                   FQPA SF/UFL= 10x....                        lethargy after a single oral
                                                                               dose.
Chronic dietary (All populations)  NOAEL = 4.5 mg/kg/    cRfD = cPAD = 0.045  Chronic toxicity (dog).
                                    day.                  mg/kg/day.          LOAEL = 12.5 mg/kg/day based on
                                   UFA = 10x...........                        decreased body weight and body
                                   UFH = 10x...........                        weight gain.
                                   FQPA SF = 1X........
Incidental oral short- and         NOAEL = 14 mg/kg/day  LOC for MOE <100...  90-day oral (rat).
 intermediate-term (1-30 days,     UFA = 10x...........                       LOAEL = 49 mg/kg/day based on
 and 1-6 months).                  UFH = 10x...........                        decreased body weight gain (M)
                                   FQPA SF = 1X........                        and reduced skeletal muscle tone
                                                                               (day 4 only in males; days 91 and
                                                                               92 only in females).

[[Page 9707]]

 
Dermal short- and intermediate-    NOAEL = 25 mg/kg/day  LOC for MOE <100...  5-day dermal using dichlobenil
 term (1-30 days and 1-6 months).  UFA = 10x...........                        (mouse; literature study).
                                   UFH = 10x...........                       LOAEL = 50 mg/kg/day based on
                                   FQPA SF = 1X (when                          olfactory epithelial damage.
                                    applicable).
Inhalation short- and              NOAEL = 12.1 mg/m\3\  LOC for MOE <100...  28-day inhalation using
 intermediate-term (1-30 days and  UFA = 3X............                        dichlobenil (rat).
 1-6 months).                      UFH = 10X...........                       LOAEL = 21 mg/m\3\ based on nasal
                                   FQPA SF = 1X (when                          degeneration.
                                    applicable).
----------------------------------------------------------------------------------------------------------------
Cancer...........................     Classification: unclassified; parent herbicide dichlobenil classified as
                                        ``Group C, possible human carcinogen'' with RfD approach utilized for
                                                            quantification of human risk
----------------------------------------------------------------------------------------------------------------
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, UFL = use of a
  LOAEL to extrapolate a NOAEL, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed adverse-effect
  level, RfD = reference dose (a = acute, c = chronic), PAD = population-adjusted dose, MOE = margin of
  exposure, LOC = level of concern, N/A = not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopicolide and its metabolite BAM, EPA considered 
exposure under the petitioned-for tolerances as well as all existing 
fluopicolide tolerances in 40 CFR 180.627 and the exposures from BAM 
from existing dichlobenil tolerances under 40 CFR 180.231. EPA assessed 
dietary exposures from fluopicolide and its metabolite BAM in food as 
follows:
    a. 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.
    i. Fluopicolide. A toxicity endpoint attributable to a single dose 
has not been identified in the toxicological studies for fluopicolide; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. BAM. Such effects were identified for BAM. In estimating acute 
dietary exposures to BAM, EPA used food consumption information from 
the United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
This dietary survey was conducted from 2003 to 2008. EPA conducted a 
partially refined acute dietary exposure assessment. As to residue 
levels in food, EPA assumed maximum BAM residue from either the 
fluopicolide or dichlobenil field trial data. The acute assessment 
assumed 100% crop treated for all commodities, except apples, 
blueberries, cherries, peaches, pears, and raspberries. These values 
reflect the dichlobenil percent crop treated estimates as fluopicolide 
is not registered for application to these crops. Default processing 
factors were used for commodities where empirical processing data were 
not available
    b. Chronic exposure--i. Fluopicolide. In estimating chronic dietary 
exposure, EPA used Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID, Version 3.16). The software 
uses 2003-2008 food consumption data from the U.S. Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). The chronic analysis assumed 
tolerance-level residues or maximum field trial residues, 100% crop 
treated, default processing factors, and modeled drinking water 
estimates.
    ii. BAM. In estimating chronic dietary exposures, EPA conducted a 
partially refined chronic dietary exposure assessment using DEEM-FCID 
(ver. 3.16) and USDA's NHANES/WWEIA (2003 through 2008). The chronic 
dietary assessment assumed the maximum BAM residue from either the 
fluopicolide or dichlobenil field trial data. The chronic assessment 
assumed 100% crop treated for all commodities except apple. These 
values reflect the dichlobenil percent crop treated estimates as 
fluopicolide is not registered for application to these crops. Default 
processing factors were used for commodities where empirical processing 
data were not available.
    c. Cancer. Fluopicolide has been classified as ``not likely to be 
carcinogenic to humans.'' Therefore, a cancer dietary exposure 
assessment was not conducted for the parent fluopicolide. Additionally, 
EPA has determined BAM's potential for carcinogenicity is similar to 
that of dichlobenil, which is classified as ``group C, possible human 
carcinogen.'' Quantification of cancer risk is based on the reference 
dose (RfD) approach which requires comparison of the chronic exposure 
to the RfD. Using this methodology will adequately account for all 
chronic toxic effects, including carcinogenicity, likely to result from 
exposure to BAM. Hence, a separate cancer exposure assessment to BAM 
was not conducted.
    d. 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, 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 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

[[Page 9708]]

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:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, 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.
    EPA did not use anticipated residue or PCT information in the 
dietary assessment for fluopicolide. Tolerance level residues or 
maximum field trial residues and 100 PCT were assumed for all food 
commodities.
    EPA used anticipated residues and PCT information for the acute and 
chronic dietary risk assessments for BAM. The BAM acute assessment 
assumed 100 PCT for all commodities except apples (2.5%), blueberries 
(2.5%), cherries (2.5%), peaches (2.5%), pears (5%) and raspberries 
(20%). The BAM chronic assessment assumed 100 PCT for all commodities 
except apples (1%). These values reflect the dichlobenil percent crop 
treated estimates as fluopicolide is not registered for application to 
these crops. Default processing factors were used for commodities where 
empirical processing data were not available.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
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 2.5%. The maximum PCT figure is the highest 
observed maximum value reported within the most recent 6 years of 
available public and private market survey data for the existing use 
and rounded up to the nearest multiple of 5%, except for situations in 
which the maximum PCT is less than 2.5%. In cases where the estimated 
value is less than 2.5% but greater than 1%, the average and maximum 
PCT used are 2.5%. If the estimated value is less than 1%, 1% is used 
as the average PCT and 2.5% is used 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 BAM may be found 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 fluopicolide in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluopicolide. 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.
    No monitoring data are available for fluopicolide or BAM. Drinking 
water residues of fluopicolide (parent) estimates were generated using 
maximum annual application rate of 0.375 lbs ai/acre, and the surface 
water concentration calculator (SWCC version 1.106) for surface water, 
and the pesticide root zone model for groundwater (PRZM-GW version 
1.07). The estimated drinking water concentrations (EDWCs) of 
fluopicolide for non-cancer chronic exposures are 12.90 ppb for surface 
water and 103 ppb for ground water.
    Estimates of BAM residues in drinking water were generated using 
the Provisional Cranberry Model (PCM) and Pesticide Water Concentration 
Calculator (PWC) for surface water, and the PRZM-GW model for 
groundwater. BAM drinking water concentrations can result from the 
application of dichlobenil and fluopicolide. The BAM estimates 
resulting from application of dichlobenil are higher than those 
resulting from application of fluopicolide. The acute and chronic 
analyses assumed a BAM drinking water concentration of 239 ppb and 206 
ppb, respectively, based on the PRZM-GW model from turf use (worst case 
scenario).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment for BAM, the water concentration value of 239 ppb was used 
to assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 206 ppb and 103 ppb were 
used to assess the contribution to drinking water for BAM and 
fluopicolide, respectively.
    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).
    Fluopicolide is currently registered for the following uses that 
could result in residential exposures: Residential turf grass and 
recreational sites; however, all registered fluopicolide product labels 
with residential use sites require that handlers wear specific clothing 
and/or use personal protective equipment (PPE). Therefore, the Agency 
has concluded that these products are not intended to be used by 
homeowners and did not conduct residential handler assessments. There 
is potential for post-application exposure for individuals entering 
areas that have been previously treated with fluopicolide. EPA assessed 
the following residential exposure scenarios for fluopicolide:
    Post-application exposure to children, youth, and adults from 
treated lawns, turf, gardens, trees, and golf courses.
    In the case of BAM, the Agency considered the potential for 
residential exposures to BAM from dichlobenil and fluopicolide uses. As 
noted above, fluopicolide is registered for use on residential 
turfgrass and recreational

[[Page 9709]]

sites, such as golf courses. These uses may also result in short-term 
dermal post-application exposure to BAM to youth and adults from 
treated gardens. Post-application exposures from treated turf is not 
expected since BAM was not detected in turf transferable residue 
studies with fluopicolide.
    As discussed above, residential handler assessments were not 
performed for fluopicolide; therefore, a residential handler assessment 
for BAM is also not required. Residential handler exposure to BAM 
resulting from the application of dichlobenil is not expected. While 
dichlobenil is currently registered for residential uses on ornamental 
plants, they are approved for professional applicator use only. Post-
application exposure of adults and children to dichlobenil and BAM 
exposure from the use of dichlobenil products on ornamental plants is 
expected to be negligible and, therefore, was not assessed.
    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 fluopicolide and any other 
substances. Fluopicolide shares a common metabolite, BAM, with 
dichlobenil. EPA's assessment of BAM from pesticide use of fluopicolide 
and dichlobenil has been updated for the current assessment and no 
risks of concern were identified. For the purposes of this tolerance 
action, therefore, EPA has not assumed that fluopicolide (parent) and 
its metabolite BAM 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 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. For fluopicolide, there is 
no evidence of increased susceptibility in the rabbit developmental or 
rat reproduction toxicity studies. There was evidence of increased 
quantitative susceptibility in the rat developmental toxicity study; 
however, the developmental effects were only seen at a relatively high 
dose (700 mg/kg/day), the effects are well-characterized with a clear 
NOAEL, and the selected endpoints are protective of the observed 
effects. For BAM, there was no evidence of increased susceptibility in 
the rabbit developmental study.
    3. Conclusion for fluopicolide. 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 fluopicolide is complete.
    ii. There is no indication that fluopicolide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence of increased susceptibility in the rabbit 
developmental or rat reproduction toxicity studies. Although there is 
evidence of increased quantitative susceptibility in the rat 
developmental toxicity study, the developmental effects were only seen 
at a relatively high dose, the effects are well characterized with a 
clear NOAEL, and the selected endpoints are protective of the observed 
effects. There are no residual uncertainties concerning prenatal and 
postnatal toxicity for fluopicolide.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to fluopicolide in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children. These assessments will not underestimate the exposure and 
risks posed by fluopicolide.
    4. Conclusion for BAM: EPA is retaining the FQPA SF of 10X for the 
acute dietary exposure scenario for the general population to account 
for the use of a LOAEL to extrapolate to a NOAEL. For all other 
exposure scenarios, the FQPA SF has been reduced to 1X. That decision 
is based on the following findings:
    i. Acute, subchronic, and chronic oral studies are available for 
BAM and utilized for endpoint selection. For the dermal and inhalation 
routes of exposures, the Agency is relying on dichlobenil toxicity 
data, where olfactory toxicity was observed. Based on a comparison of 
toxicity via the intraperitoneal route of exposure, higher doses of BAM 
are needed to induce levels of olfactory toxicity that are similar to 
those caused by dichlobenil; therefore, the endpoints based on 
dichlobenil are considered protective of potential BAM toxicity.
    ii. Although there is potential neurotoxicity in the olfactory 
system from BAM exposure, concern is low since the effects are well-
characterized and selected endpoints based on dichlobenil are 
protective of these effects.
    iii. There is no evidence of increased susceptibility in the 
developmental rabbit study.
    iv. The assessments of BAM are unlikely to underestimate exposure 
and risks. Acute and chronic dietary assessments assumed maximum BAM 
residues from field trial data as well as conservative (protective) 
assumptions of BAM exposure in drinking water. Similar conservative 
assumptions were used to assess post-application exposure of children 
to BAM.

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

[[Page 9710]]

PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected for 
fluopicolide. Therefore, fluopicolide is not expected to pose an acute 
risk.
    In the case of BAM, using the exposure assumptions discussed in 
this unit for acute exposure, the acute dietary exposure from food and 
water to BAM will occupy 81% of the aPAD for children 1 to <2 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 
fluopicolide from food and water will utilize 15% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. In the case of BAM, chronic exposure to BAM from food and 
water will utilize 26% of the cPAD for all infants (<1 year old), the 
population group receiving the greatest exposure. Based on the 
explanation in Unit III.C.3., regarding residential use patterns, 
chronic residential exposure to residues of fluopicolide or BAM is not 
expected.
    3. Short-term/intermediate-term risk. Short-term aggregate exposure 
takes into account short-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Fluopicolide is currently registered for uses that could result in 
short-term residential exposure and may result in post-application 
exposures of BAM. The Agency has determined that it is appropriate to 
aggregate chronic exposure through food and water with short-term 
residential exposures to fluopicolide and BAM. There are no 
intermediate-term exposures expected for fluopicolide or BAM; however, 
the short-term aggregate assessment is considered protective of 
intermediate-term since the same endpoints were selected to evaluate 
short- and intermediate-term exposures.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined fluopicolide short-term 
food, water, and residential exposures for children 1-2 years old and 
children 6-11 years old result in aggregate MOEs of 490 and 670, 
respectively. In addition, an aggregate assessment conducted for adults 
resulted in an MOE of 500. Because EPA's level of concern for 
fluopicolide is a MOE of 100 or below, these MOEs are not of concern. 
For BAM, dermal and inhalation exposures may not be combined with oral 
exposures due to different toxicological effects used as the basis of 
the selected endpoints. As a result, the aggregate risk estimates are 
equivalent to the dietary risk estimates and are not of concern.
    4. Aggregate cancer risk for U.S. population. Due to the absence of 
treatment-related tumors in two adequate rodent carcinogenicity 
studies, fluopicolide is classified as ``not likely to be carcinogenic 
to humans''; therefore, a quantitative cancer assessment is not 
required.
    EPA has assumed BAM's potential for carcinogenicity is similar to 
that of dichlobenil, which is classified as ``group C, possible human 
carcinogen.''
    Quantification of cancer risk is based on the RfD approach which 
requires comparison of the chronic exposure to the RfD. Therefore, the 
chronic risks discussed in Unit III.E.2. are considered protective of 
both non-cancer and cancer effects.
    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 fluopicolide residues, including its metabolite.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectroscopy (LC/MS/MS) enforcement method RM-43C-2) is available 
to enforce the tolerance expression. Enforcement methodology (LC/MS/MS 
Method, Methods 00782, 00782/M001, 00782/M002, and 00782/M003) is 
available to adequately enforce the tolerance expression for BAM.
    The methods 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: 
[email protected].

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.
    Codex has not established MRLs for basil, hop, bean, or citrus. The 
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
tolerance is harmonized with Codex grape MRL. Codex established a 
tolerance for ``Fruiting vegetables other than cucurbits'' at 1.0 ppm. 
Based on the field trial data and the Organization for Economic 
Cooperation and Development (OECD) calculator, using the labeled 
application scenario may result in residues greater than 1.0 ppm in/on 
fruiting vegetables. As a result, harmonization of the vegetable, 
fruiting, crop group 8-10 tolerance with the Codex MRL could result in 
food containing residues exceeding tolerances despite legal application 
of the pesticide, which would not be appropriate.

C. Response to Comments on Notice of Filing

    Two anonymous public comments were received on the notice of filing 
that center around opposing IR-4 and the uses of pesticides (toxic 
chemicals), such as fluopicolide, on food commodities including grape, 
citrus and basil, claiming these chemicals are harmful to human health.
    EPA's Response: Aside from assertions that chemicals are toxic and 
linked to adverse human health effects, the commenters provided no 
information supporting these assertions that EPA could use to evaluate 
the safety of fluopicolide or BAM. The existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. When new or amended tolerances 
are requested for residues of a pesticide in food or feed, the Agency 
evaluates all available data and assesses the potential for risk from 
aggregate exposure to the pesticide. As discussed in this rule, EPA 
examined all relevant data for fluopicolide and BAM and has concluded 
that there is a reasonable certainty that no harm will result from

[[Page 9711]]

aggregate human exposure to fluopicolide, including residues of its 
metabolite BAM. The commenters have presented no information to support 
reconsideration of that conclusion.

D. Revisions to Petitioned-For Tolerances

    The established tolerances differ from the petitioner's requests as 
follows:
    i. EPA is establishing a tolerance for ``basil fresh leaves'' at 40 
ppm, rather than 30 ppm, as a result of removing certain inadequate 
residue data from the tolerance calculation.
    ii. The petitioner requested a tolerance for residues of 
fluopicolide for the general category of ``bean, succulent'' at 0.9 
ppm. This term is defined in EPA's regulations as including a variety 
of beans in succulent form (see 40 CFR 180.1(g)). At this time, EPA is 
establishing tolerances for only those beans included in the succulent 
bean definition that are also supported by the submitted snap bean 
field trial data. Those specific succulent beans are the following: 
``bean, moth, succulent'', ``bean, yardlong, succulent'' (species of 
the Vigna genus), ``bean, runner, succulent'', ``bean, snap, 
succulent'', and ``bean, wax, succulent'' (species of the Phaseolus 
genus). Tolerances for the other beans contained within the definition 
of ``bean, succulent'' as contained in 180.1(g) are not being 
established at this time due to lack of adequate residue data. In 
addition, the Agency has adjusted the tolerance values for these beans 
(from 0.9 to 0.90) to be consistent with its current guidance on 
significant figures.
    iii. Because all reported residue data on crops supporting the 
``fruit, citrus, crop group 10-10'' were below the 0.01 ppm limit of 
quantitation, EPA is establishing a tolerance for this group at 0.01 
ppm.
    iv. The petitioner's requested tolerances for ``citrus, dried 
pulp'' at 0.048 ppm and ``citrus, oil'' at 1.94 ppm were based on the 
petitioned-for tolerance level for citrus group 10-10 at 0.02 ppm. 
Using the 0.01 ppm tolerance level for group 10-10 as indicated in the 
previous paragraph and applying appropriate processing factors yields 
tolerances of 0.03 for citrus, dried pulp and 1.0 for citrus, oil.

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide 
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], including its metabolites and degradates 
(determined by measuring the parent only), in or on Basil, fresh leaves 
at 40 ppm; Basil, dried leaves at 200 ppm; Bean, moth, succulent at 
0.90 ppm; Bean, snap, succulent at 0.90 ppm; Bean, runner, succulent at 
0.90 ppm; Bean, wax, succulent at 0.90 ppm; Bean, yardlong, succulent 
at 0.90 ppm; Citrus, dried pulp at 0.03 ppm; Citrus, oil at 1.0 ppm; 
Fruit, citrus, crop group 10-10 at 0.01 ppm; Fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; Hop, 
dried cones at 15 ppm; and Vegetable, fruiting, crop group 8-10 at 1.6 
ppm. Also, the tolerances for ``Grape'' and ``Vegetable, fruiting, 
group 8'' in the table in paragraph (a) and for ``Hop, dried, cones'' 
in the table in paragraph (b) are deleted as they are superseded by 
this action. Finally, in an additional housekeeping measure, the 
expired tolerances for ``Potato, processed potato waste'' at 1.0 ppm 
and ``Vegetable, tuberous and corm, subgroup 1C'' at 0.3 ppm are 
deleted since they have no effect anymore and have been replaced by 
lower tolerances for those commodities as discussed in the Federal 
Register of September 26, 2016 (81 FR 65924).

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); 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: February 20, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 9712]]

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.  180.627:
0
a. In the table to paragraph (a):
0
i. Add alphabetically the entries ``Basil, dried leaves''; ``Basil, 
fresh leaves''; ``Bean, moth, succulent''; ``Bean, runner, succulent''; 
``Bean, snap, succulent''; ``Bean, wax, succulent''; ``Bean, yardlong, 
succulent''; ``Citrus, dried pulp''; ``Citrus, oil''; ``Fruit, citrus, 
crop group 10-10''; and ``Fruit, small, vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F'';
0
ii. Remove the entry for ``Grape'';
0
iii. Add alphabetically the entry ``Hop, dried cones'';
0
iv. Remove the entry for ``Potato, processed potato waste \1\ '';
0
v. Add alphabetically the entry ``Vegetable, fruiting, crop group 8-
10''; and
0
vi. Remove the entries for ``Vegetable, fruiting, group 8'' and 
``Vegetable, tuberous and corm, subgroup 1C \1\ '' and footnote 1 of 
the table.
0
b. Revise paragraph (b).
    The additions and revision read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, dried, leaves........................................         200
Basil, fresh leaves.........................................          40
Bean, moth, succulent.......................................        0.90
Bean, runner, succulent.....................................        0.90
Bean, snap, succulent.......................................        0.90
Bean, wax, succulent........................................        0.90
Bean, yardlong, succulent...................................        0.90
------------------------------------------------------------------------
 
                                * * * * *
Citrus, dried pulp..........................................        0.03
Citrus, oil.................................................         1.0
Fruit, citrus, crop group 10-10.............................        0.01
Fruit, small, vine climbing, except fuzzy kiwifruit,                 2.0
 subgroup 13-07F............................................
 
                                * * * * *
Hop, dried cones............................................          15
 
                                * * * * *
Vegetable, fruiting, crop group 8-10........................         1.6
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2018-04533 Filed 3-6-18; 8:45 am]
 BILLING CODE 6560-50-P