[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Rules and Regulations]
[Pages 65917-65924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23184]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0791; FRL-9951-60]


Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends tolerances for residues of fluopicolide 
in or on potato, processed potato waste and vegetable, tuberous and 
corm, subgroup 1C and establishes a tolerance for residues of 
fluopicolide in or on potato, granules/flakes. Valent U.S.A. 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA). This regulation also assigns an expiration 
date to existing tolerances for potato, processed potato waste at 1.0 
ppm and vegetable, tuberous and corm, subgroup 1C at 0.3 ppm. Lastly, 
this regulation establishes a time-limited tolerance on hop, dried 
cones. The time-limited tolerance is in response to EPA's granting of 
an emergency exemption under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). The time-limited tolerance will expire and 
revoked on December 31, 2019.

DATES: This regulation is effective September 26, 2016. Objections and 
requests for hearings must be received on or before November 25, 2016, 
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-2015-0791, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2015-0791 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 
November 25, 2016. 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-2015-0791, 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 Agency's Action

A. Petitioned-For Tolerances

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86) 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 
5F8414) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, 
Walnut Creek, CA 94596. 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-
pyridylmethyl]-benzamide, in or on potato, chips at 0.1 parts per 
million (ppm) and potato, granules/flakes at 0.15 ppm. That document 
referenced a summary of the petition prepared by Valent U.S.A. 
Corporation, the registrant, which is

[[Page 65918]]

available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV.C.
    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-02) 
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 5F8414) 
by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut 
Creek, CA 94596. The petition requested that 40 CFR 180.627 be amended 
by amending tolerances for residues of the fungicide fluopicolide, 2,6-
dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-benzamide, in 
or on potato, processed potato waste at 0.25 ppm and vegetable, 
tuberous and corm, subgroup 1C at 0.10 ppm. That document referenced a 
summary of the petition prepared by Valent U.S.A. Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerance levels for potato, processed potato waste and 
vegetable, tuberous and corm, subgroup 1C that differ from the petition 
requests and is not establishing a tolerance for residues on potato, 
chips. The reasons for these changes are explained in Unit IV.D.

B. Tolerance for Use of Pesticide Under Emergency Exemption

    In response to a crisis exemption request filed under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on 
behalf of the Michigan Department of Agriculture and Rural Development 
for the emergency use of fluopicolide to control downy mildew on hops 
grown in Michigan, EPA is establishing, pursuant to FFDCA section 
408(l)(6), a time-limited tolerance for the use of fluopicolide on hop, 
dried cones at 30 ppm with an expiration date of December 31, 2019.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of fluopicolide 
on hops. In doing so, EPA considered the safety standard in section 
408(b)(2) of FFDCA, and the Agency decided that the necessary tolerance 
under section 408(l)(6) of FFDCA would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of FFDCA. Although 
this time-limited tolerance expires and is revoked on December 31, 
2019, under section 408(l)(5) of FFDCA, residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
hops after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by the time-limited tolerance at 
the time of that application. EPA will take action to revoke this time-
limited tolerance earlier if any experience with, scientific data on, 
or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions whether 
fluopicolide meets FIFRA's registration requirements for use in or on 
hops or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance serves as a basis for registration of 
fluopicolide by a State for Special Local Needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than Michigan to use this pesticide on hops under FIFRA 
sction 18 absent the issuance of an emergency exemption applicable 
within that State. For additional information regarding the emergency 
exemption for fluopicolide, contact the Agency's Registration Division 
at the address provided under FOR FURTHER INFORMATION CONTACT.

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 considered 
to be of regulatory concern, and separate toxicity data and endpoints 
for risk assessment have been identified for BAM. Therefore, EPA has 
considered the aggregate, or combined risks, from food, water, and non-
occupational exposure resulting from fluopicolide alone and BAM from 
all sources for this action. The BAM risk assessment considers residues 
resulting from both fluopicolide and dichlobenil uses. However, BAM 
residues generated from fluopicolide uses are expected to be 
significantly lower than BAM residues from dichlobenil uses.

A. Fluopicolide

    In the Federal Register of August 6, 2014 (79 FR 45688) (FRL-9914-
37), EPA amended tolerances to raise the residue levels of fluopicolide 
in or on potato, processed potato waste to 1.0 ppm and vegetable, 
tuberous and corm, subgroup 1C to 0.3 ppm. In March of 2016, the EPA 
updated the dietary assessment for fluopicolide to account for the use 
of fluopicolide on hops under an emergency exemption. The March 2016 
assessment considered the higher tolerance levels for potato, processed 
potato waste (1.0 ppm) and vegetable, tuberous and corm, subgroup 1C 
(0.3 ppm). Since this current action involves lowering the tolerances 
for potato, processed potato waste to 0.2 ppm and vegetable, tuberous 
and corm, subgroup 1C to 0.09 ppm, the EPA is relying upon the risk 
assessments and the findings made for fluopicolide in the August 6, 
2014 Federal Register document, as well as an updated dietary risk 
assessment conducted for hops to support the lowering of the tolerances 
for potato, processed potato waste and vegetable, tuberous and corm, 
subgroup 1C.
    The toxicity profile and the points of departure for evaluating 
human health for fluopicolide have not changed since the August 6, 2014 
rule. EPA conducted a dietary risk assessment to support the Section 18 
registration for use of

[[Page 65919]]

fluopicolide on hops grown in Michigan in March 2016. The March 2016 
assessment assumed the same exposure assumptions for assessing food 
exposure as discussed in Unit III.C. of the 2014 rule, where the 
analysis assumed 100 percent crop treated (PCT) and tolerance-level 
residues for all proposed/registered crops except for field corn/wheat 
grain (rotational crop tolerances) and tuberous and corm vegetables. 
For these crops, the residues of concern for risk assessment include 
metabolites that are not included in the tolerance expression, and the 
analysis assumed the highest combined residues from the field trials. 
However, the drinking water estimates used in 2016 are higher than 
those used in 2014 (24.14 ppb) based on the use of the Pesticide Root 
Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), where 
residues in ground water are now estimated to be 103 ppb. The March 
2016 assessment resulted in slightly higher chronic dietary exposure 
estimates than the August 2014 dietary risk assessment (an increase 
from 13% to 14% chronic population-adjusted dose (cPAD)). Since the 
2016 dietary risk assessment does not take into account the tolerance 
reductions for potato, processed potato waste (from 1.0 ppm to 0.2 ppm) 
and vegetable, tuberous and corm, subgroup 1C (from 0.3 ppm to 0.09 
ppm) and estimates a higher drinking water concentration (24.14 ppb to 
103 ppb), EPA expects the actual chronic dietary exposure estimates to 
be lower than 14%. The Agency has not made any new findings concerning 
cumulative exposure, nor has it identified any residual uncertainties 
to warrant changes to the Agency's August 6, 2014 FQPA safety factor 
determination. EPA concludes that reliable data continue to show that 
the safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X based on the same findings found in the 
August 6, 2014 rule and supporting documents. Therefore, relying upon 
the findings made in the August 6, 2014, Federal Register document and 
the 2016 dietary risk assessment, 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.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
August 6, 2014, Federal Register document and its supporting documents, 
available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2014-0225, as well as document titled ``Fluopicolide. Section 18 
Registration for Application of Fluopicolide to Hops Grown in Michigan. 
Dietary Risk Assessment.'' dated March 24, 2016, in docket ID number 
EPA-HQ-OPP-2015-0791.
    However, since the August 6, 2014 action relied on a 2008 action 
for BAM, the EPA has updated the BAM assessment to revisit the percent 
crop treated (PCT) and account for updated food consumption data. EPA's 
assessment of exposures and risks associated with BAM follows.

B. BAM

1. Toxicological Profile
    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The toxicity profile for BAM has not changed since the 2008 
assessment EPA conducted for BAM. Specific information on the studies 
received and the nature of the adverse effects caused by 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 in 
``2,6-Dichlorobenzamide (BAM). 2,6-Dichlorobenzamide (BAM) as a 
Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk 
Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries 
(Subgroup 13-07A), and Bushberries (Subgroup 13-07B).'' dated June 19, 
2008, in docket ID number EPA-HQ-OPP-2007-0604.
2. 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 BAM used for human 
risk assessment is discussed in Unit III.B. of the final rule published 
in the Federal Register of April 20, 2011 (76 FR 22045) (FRL-8859-9).
3. Exposure Assessment
    a. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to BAM, EPA considered exposure of BAM from petitioned-for 
tolerances discussed in this document, as well as all existing uses for 
both fluopicolide and dichlobenil. EPA assessed dietary exposures from 
BAM 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 
from a 1-day or single exposure.
    Such effects were identified for BAM. In estimating acute dietary 
exposure, 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 for the metabolite 
BAM. As to residue levels in food, EPA assumed maximum BAM residue from 
either the fluopicolide or dichlobenil field trial data. Further, 100 
PCT for all commodities was assumed except apples, blueberries, 
cherries, peaches, pears, and raspberries where EPA relied on PCT 
estimates based on use of dichlobenil on these commodities; 
fluopicolide is not registered for use on these commodities. DEEM 
default processing-factors were used for commodities where empirical 
processing data were not available.

[[Page 65920]]

    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the USDA NHANES/
WWEIA 2003 to 2008 dietary survey. As to residue levels in food, EPA 
assumed maximum BAM residue from either fluopicolide or dichlobenil 
field trials and, further, the chronic assessment used 100 PCT for all 
commodities except apples. DEEM default processing-factors were used 
for commodities where empirical processing data were not available.
    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. EPA has concluded that a nonlinear RfD 
approach is appropriate for assessing cancer risk to BAM.
    The carcinogenic potential of BAM has been evaluated in only one 
species, the rat. That study showed an increased incidence of 
hepatocellular adenomas in high-dose females that was marginally 
statistically significant. To be conservative, EPA has assumed that 
BAM's potential for carcinogenicity is similar to the parent having the 
greatest carcinogenic potential. Fluopicolide has been classified as 
not likely to be carcinogenic to humans; EPA classified dichlobenil as 
a Group C, possible human carcinogen, but determined that the chronic 
dietary risk assessment based on the cPAD would be protective of any 
potential cancer effects. EPA has assumed that BAM's carcinogenic 
potential is similar to that of dichlobenil, the parent compound having 
the greatest carcinogenicity potential. As with dichlobenil, the 
chronic dietary risk assessment based on the cPAD is expected to 
protect for any potential cancer effects. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.B.3.a.ii.
    For additional information, refer to the summary of the 
toxicological endpoints for BAM used for human risk assessment is 
discussed in Unit III.B. of the final rule published in the Federal 
Register of April 20, 2011 (76 FR 22045) (FRL-8859-9).
    iv. Anticipated residue and percent crop treated (PCT) information. 
For the BAM dietary assessment, EPA used available anticipated residue 
levels and PCT information on apples, blueberries, cherries, peaches, 
pears, and raspberries where EPA relied on PCT estimates based on use 
of dichlobenil; fluopicolide is not registered for use on these 
commodities. 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 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.
    In the acute dietary assessment for BAM, the Agency estimated the 
PCT from the existing dichlobenil uses as follows: Apple, 2.5%; 
blueberry, 2.5%; raspberry, 20%; cherry, 2.5%; peach, 2.5%; pear, 5%. 
In the chronic dietary assessment for BAM, the Agency estimated the PCT 
from the existing dichlobenil uses as follows: Apple, 1%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 to 7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.B.3.a.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 fluopicolide or dichlobenil may be applied in a 
particular area.
    b. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for BAM in drinking water. The Agency used estimates of BAM 
resulting from the application of dichlobenil, as they were higher than 
those resulting from the application of fluopicolide. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of BAM. 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.

[[Page 65921]]

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
BAM resulting from application of dichlobenil for acute exposures are 
estimated to be 25.5 parts per billion (ppb) for surface water and 67.4 
ppb for ground water. The EDWCs of BAM resulting from application of 
dichlobenil for chronic exposures for non-cancer assessments are 
estimated to be 10.5 ppb for surface water and 67.4 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessment, the water concentration of value 67.4 ppb was used to 
assess the contribution to drinking water.
    c. 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, 
recreational sites, and ornamental plants and trees. EPA assessed 
residential exposure to BAM from fluopicolide uses using the following 
assumptions: Residential handlers may receive short-term dermal and 
inhalation exposure to BAM when mixing, loading, and applying the 
fluopicolide formulations. Residential post-application exposure via 
the dermal route is likely for adults and children entering treated 
lawns or treated gardens and during mowing and golfing activities. 
Children may experience exposure via incidental non-dietary ingestion 
(i.e., hand-to-mouth, object-to-mouth, and soil ingestion) during post-
application activities on treated turf.
    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.
    d. 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. Quantification of risks for residues of BAM resulting from 
fluopicolide and dichlobenil was completed as part of this assessment; 
aggregate risks from BAM are not of concern. For the purposes of this 
tolerance action, EPA has not assumed that fluopicolide has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides
4. Safety Factor for Infants and Children
    a. 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.
    b. Prenatal and postnatal sensitivity. For BAM, there is no 
evidence of quantitative susceptibility following in utero and/or 
postnatal exposure in the rabbit developmental toxicity study or in the 
3-generation rat reproduction study. Qualitative susceptibility was not 
observed in the 3-generation reproduction study. Qualitative 
susceptibility was observed in the rabbit developmental toxicity study. 
Fetal effects (skeletal and visceral anomalies) and late-term abortions 
were observed. There is low concern for this qualitative 
susceptibility, because the fetal effects and late-term abortions have 
been well characterized and occurred at dose levels where significant 
maternal toxicity (severe body-weight gain decrements and decreased 
food consumption) was observed. Protection of the maternal effects also 
protects for any effects that may occur during development. There are 
not residual uncertainties concerning prenatal and postnatal toxicity 
for BAM.
    c. Conclusion. EPA has retained the 10X FQPA SF for BAM for those 
exposure scenarios that do not rely on dichlobenil toxicity data. These 
scenarios are acute dietary for the general population (including 
infants and children) and females 13-49 years of age, chronic dietary, 
and incidental oral non-dietary. Although EPA has developmental, 
reproduction, and subchronic and chronic toxicity studies for the 
metabolite BAM, and a structure activity analysis indicates EPA has 
identified its principal toxicological effects and level of toxicity, 
EPA is retaining the FQPA 10X SF due to remaining questions regarding 
the systemic neurotoxic potential of BAM (olfactory neurotoxicity) via 
the oral route of exposure and the use of a LOAEL in assessing acute 
dietary risk for the general population. For the dermal and inhalation 
routes of exposures, for which the Agency is relying on dichlobenil 
toxicity data, EPA has reduced the FQPA SF for BAM to 1X, based on a 
comparison of toxicity via the intraperitoneal route of exposure 
showing that higher doses of BAM are needed to induce levels of 
olfactory toxicity that are similar to those caused by dichlobenil. 
Olfactory toxicity, the most sensitive endpoint, was the endpoint 
chosen for these exposure scenarios. Other factors EPA considered in 
the FQPA SF decisions for BAM include the following:
    i. To compensate for deficiencies in the toxicology database for 
BAM, EPA performed a comparative analysis of the toxicity of BAM and 
the parent compounds, dichlobenil and fluopicolide, using the available 
animal data and DEREK analysis (Deductive Estimation of Risk from 
Existing Knowledge). DEREK is a toxicology application that uses 
structure-activity relationships to predict a broad range of 
toxicological properties based on a comprehensive analysis of a 
compound's molecular structure. Based on the available animal data and 
DEREK analyses, BAM does not appear to cause

[[Page 65922]]

different organ-specific toxicities compared to fluopicolide and 
dichlobenil. The kidney and liver toxicities are common to all three 
compounds. With respect to relative toxicity, conclusions from the 
evaluation of the animal studies appear to confirm that both 
fluopicolide and dichlobenil appear to be more or equally toxic 
compared to BAM. A full discussion of EPA's comparative toxicity 
analysis of BAM, dichlobenil and fluopicolide can be found at http://www.regulations.gov in the document Comparative Toxicity Using Derek 
Analysis for Dichlobenil, Fluopicolide and BAM in docket ID number EPA-
HQ-OPP-2007-0604. Based on the results of the available animal data and 
the DEREK analysis, EPA concludes that the safety factors discussed in 
the previous paragraph are adequate.
    ii. For BAM, there is no evidence of quantitative susceptibility 
following in utero and/or postnatal exposure in the rabbit 
developmental toxicity study or in the 3-generation rat reproduction 
study. Qualitative susceptibility was not observed in the 3-generation 
reproduction study however, qualitative susceptibility was observed in 
the rabbit developmental toxicity study. Yet the concern for this 
qualitative susceptibility is low because the fetal effects and late-
term abortions have been well characterized and occurred at dose levels 
where significant maternal toxicity (severe body-weight gain decrements 
and decreased food consumption) was observed. Protection of the 
maternal effects also protects for any effects that may occur during 
development.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were refined using 
reliable PCT information and anticipated residue values calculated from 
residue field trial results. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to BAM in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by BAM.
5. 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.
    a. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
BAM will occupy 26% of the aPAD for females 13 to 49 years old, the 
population group receiving the greatest exposure.
    b. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
BAM from food and water will utilize 95% of the cPAD for all Infants 
(<1 year old), the population group receiving the greatest exposure. 
Based on the explanation in Unit III.B.3.c., regarding residential use 
patterns, chronic residential exposure to residues of BAM is not 
expected.
    c. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered a background exposure level). Fluopicolide, is 
currently registered for uses that could result in short-term 
residential exposure to BAM, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to BAM associated with the application 
of fluopicolide. As noted in Unit III.B.3.c above, EPA does not expect 
there to be residential exposures to BAM from use of dichlobenil. Using 
the exposure assumptions described in this unit for short-term 
exposures, EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate MOEs of 3200 for All Infants 
(<1 year old) and 5,400 for children 1 to 2 years old. Because EPA's 
level of concern for BAM is a MOE of 1,000 or below, these MOEs are not 
of concern.
    d. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered a background exposure level). An 
intermediate-term adverse effect was identified; however, fluopicolide 
is not registered for any use patterns that would result in 
intermediate-term residential exposure. Further, fluopicolide and 
dichlobenil are not registered for any use patterns that would result 
in intermediate-term residential exposure to BAM. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for fluopicolide and its metabolite, BAM.
    e. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk. See Unit III.B.5.b, Chronic 
risk, above.
    f. 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 residues of fluopicolide and its metabolite, BAM.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/tandem mass 
spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[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

[[Page 65923]]

EPA explain the reasons for departing from the Codex level. The Codex 
has not established an MRL for fluopicolide on the subject commodities.

C. Response to Comments

    EPA received one comment to the Notice of Filing that stated, in 
part, that the citizenry of this country do not want to eat any food 
items that have been polluted by these toxic chemicals and to deny this 
exemption. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops. However, 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. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA revised the tolerance levels based on analysis of the residue 
field trial data using the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures. Based on 
evaluation of the residue data and use of the OECD calculation 
procedures, the Agency modified the tolerance for the vegetable, 
tuberous and corm, subgroup 1C from the requested level of 0.10 ppm to 
0.09 ppm. The Agency also modified the tolerance for potato, processed 
potato waste from the requested tolerance level of 0.25 ppm to 0.2 ppm 
(0.075 ppm maximum residue x 2.4 processing factor for wet peel). The 
EPA did not establish the requested tolerance for potato, chips because 
the tolerance for vegetable, tuberous and corm, subgroup 1C (0.09 ppm) 
will cover residues in or on potato chips (0.068 ppm estimated 
residue).

E. International Trade Considerations

    In this rulemaking, EPA is reducing the tolerances for vegetable, 
tuberous and corm, subgroup 1C from 0.3 ppm to 0.09 ppm and potato, 
processed potato waste from 1.0 ppm to 0.2 ppm. The petitioner 
requested these reductions in order to harmonize tolerances with field 
trial data after the tolerances were increased in 2014 to support an 
early season soil application to potato, which has since then been 
restricted. The reduction is appropriate based on available data and 
residue levels resulting from registered use patterns.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures Agreement, EPA notified the WTO of the 
request to revise these tolerances on July 19, 2016 as WTO notification 
G/SPS/N/USA/2861. In this action, EPA is allowing the existing higher 
tolerances to remain in effect for 6 months following the publication 
of this rule in order to allow a reasonable interval for producers in 
the exporting countries to adapt to the requirements of these modified 
tolerances. On March 27, 2017, those existing higher tolerances will 
expire, and the new reduced tolerances for vegetable, tuberous and 
corm, subgroup 1C and potato, processed potato waste will remain to 
cover residues of fluopicolide on those commodities. Before that date, 
residues of fluopicolide on those commodities would be permitted up to 
the higher tolerance levels; after that date, residues of fluopicolide 
on vegetable, tuberous and corm, subgroup 1C and potato, processed 
potato waste will need to comply with the new lower tolerance levels. 
This reduction in tolerance is not discriminatory; the same food safety 
standard contained in the FFDCA applies equally to domestically 
produced and imported foods.

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide, 
2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-
benzamide, in or on vegetable, tuberous and corm, subgroup 1C at 0.09 
ppm, potato, processed waste at 0.2 ppm, and potato, granules/flakes at 
0.15 ppm. The Agency is adding an expiration date of March 27, 2017 to 
the existing tolerances for vegetable, tuberous and corm, subgroup 1C 
at 0.3 ppm and potato, processed potato waste at 1.0 ppm. Residues of 
fluopicolide will be covered by these higher tolerances until the 
expiration date, after which time, they will need to comply with the 
lower tolerances being established today. Lastly, this regulation 
establishes a time-limited tolerance for residues of fluopicolide in or 
on hop, dried cone at 30 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning, and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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).

[[Page 65924]]

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: September 13, 2016.
Daniel J. Rosenblatt,
Acting 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.  180.627:
0
a. In the table in paragraph (a), add alphabetically entries for 
``Potato, granules/flakes'' and ``Potato, processed potato waste,'' 
revise the existing entry for ``Potato, processed potato waste,'' and 
add an entry for ``Vegetable, tuberous and corm, subgroup 1C''; and
0
b. Revise paragraph (b).
    The additions and revisions read as follows:


Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Potato, granules/flakes.....................................        0.15
Potato, processed potato waste..............................         0.2
Potato, processed potato waste.\1\..........................         1.0
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................        0.09
Vegetable, tuberous and corm, subgroup 1C \1\...............         0.3
------------------------------------------------------------------------
\1\ This tolerance expires on March 27, 2017.

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
fluopicolide, including its metabolites and degradates, in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to FIFRA section 18 emergency exemptions. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide] in or on the commodity. The tolerances 
expire on the date specified in the table.

------------------------------------------------------------------------
                                 Parts per
          Commodity               million           Expiration date
------------------------------------------------------------------------
Hop, dried cones............              30  December 31, 2019.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-23184 Filed 9-23-16; 8:45 am]
 BILLING CODE 6560-50-P