[Federal Register Volume 79, Number 151 (Wednesday, August 6, 2014)]
[Rules and Regulations]
[Pages 45688-45693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18458]



40 CFR Part 180

[EPA-HQ-OPP-2014-0225; FRL-9914-37]

Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation amends tolerances for residues of fluopicolide 
in or on potato, processed potato waste; and vegetable, tuberous and 
corm, subgroup 1C. Valent U.S.A. Corporation requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 6, 2014. Objections and 
requests for hearings must be received on or before October 6, 2014, 
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-2014-0225, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency

[[Page 45689]]

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: Lois Rossi, 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].


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-2014-0225 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 
October 6, 2014. 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-2014-0225, 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 
     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 May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3F8191) 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-
pyridinyl]methyl]benzamide, in or on potato, processed waste at 0.3 
parts per million (ppm); and vegetable, tuberous and corm, subgroup 1C 
at 0.3 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. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance in or on potato, processed waste from 
0.3 ppm to 1.0 ppm, and has revised the commodity terminology. 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. EPA's 
assessment of exposures and risks associated with fluopicolide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
    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

[[Page 45690]]

BAM. However, since increased tolerances on the commodities affected by 
this action do not add significantly to the BAM dietary exposure, the 
conclusions from the most recently conducted BAM human health risk 
assessment remain unchanged.
    The subchronic and chronic toxicity studies for fluopicolide showed 
that the primary effects following exposure are in the liver. Kidney 
and thyroid toxicity were observed in rats only. Fluopicolide is not 
neurotoxic, carcinogenic, nor mutagenic. Developmental toxicity in the 
rabbit occurred only at doses that caused severe maternal toxicity, 
including death. In the rat, developmental effects were seen only at 
high dose levels, in the presence of maternal toxicity. Similarly, 
offspring effects (decreased body weight and body weight gain) in the 
multi-generation reproductive toxicity study occurred only at levels 
causing significant toxicity in parents. There is no evidence of 
increased quantitative susceptibility of rat or rabbit fetuses to in 
utero or postnatal exposure to fluopicolide. No toxic effects were 
observed in studies in which fluopicolide was administered by the 
dermal routes of exposure. The toxicological profile for fluopicolide 
suggests that increased durations of exposure do not significantly 
increase the severity of observed effects. Toxic effects observed in 
the rabbit developmental and rat chronic/cancer studies were selected 
as risk assessment endpoints for all durations of exposure. 
Fluopicolide is classified as not likely to be carcinogenic to humans 
and no quantification of cancer risks is required.
    The toxicity profile for BAM has not changed since the last 
assessment EPA conducted for BAM; an analysis of the toxicology profile 
of BAM 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-
    Specific information on the studies received and the nature of the 
adverse effects caused by fluopicolide 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 its Metabolite, 
2,6-Dichlorobenzamide (BAEM). Human Health Risk Assessment to Support a 
Petition for an Increased Tolerance on Tuberous and Corm Subgroup 1C 
Vegetables,'' pp. 31-35 in docket ID number EPA-HQ-OPP-2014-0225.

B. Toxicological Points of Departure/Levels of Concern

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

C. Exposure Assessment

    The fluopicolide exposure assessment considers exposure from 
fluopicolide only. EPA did not reassess exposures from BAM since the 
proposed change in use pattern does not add significantly to the BAM 
dietary exposure, and residues of BAM due to fluopicolide applications 
are significantly lower than those from dichlobenil applications. EPA 
is relying on conclusions from the 2008 BAM Human Health Risk 
Assessment, which remain unchanged. A discussion of how BAM exposures 
were assessed can be found in Unit III.C. of the final rule published 
in the Federal Register of August 27, 2008 (73 FR 50563) (FRL-8377-7).
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopicolide, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluopicolide tolerances in 40 
CFR 180.627. EPA assessed dietary exposures from fluopicolide in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for fluopicolide; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software 
uses 2003-2008 food consumption data from the U.S. Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA assumed 100 percent crop treated (PCT) and tolerance-level 
residues. iii. Cancer. Based on the data summarized in Unit III.A., EPA 
has concluded that fluopicolide does not pose a cancer risk to humans. 
Therefore, a quantitative dietary exposure assessment for the purpose 
of assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for fluopicolide. Tolerance level residues and/or 100 PCT were assumed 
for all food commodities.
    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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the surface water concentrations estimated using the 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS); and Screening Concentrations in Ground Water (SCI-GROW) models, 
the estimated environmental concentrations (EECs) of fluopicolide for 
chronic exposure (non-cancer) assessments are estimated to be 24.14

[[Page 45691]]

ppb for surface water and 0.5 ppb for ground water. Acute and cancer 
dietary risks were not quantified, as previously discussed.
    3. From non-dietary exposure. i. 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).
    ii. Fluopicolide is currently registered for the use on residential 
turf grass, recreational sites, and ornamental plants that could result 
in short-term residential exposures. EPA assessed residential exposure 
using the following assumptions:
    a. Residential handler short-term dermal and inhalation exposures 
to fluopicolide when mixing, loading, and applying the formulations.
    b. Residential post-application exposures via the dermal route for 
adults and children entering treated lawns or treated gardens and 
during mowing and golfing activities. and
    c. Incidental non-dietary ingestion (i.e., hand-to-mouth, object-
to-mouth, and soil ingestion) by children during post-application 
activities on treated turf.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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. Although fluopicolide shares a common metabolite, BAM, with 
dichlobenil, quantification of risks for residues of BAM resulting from 
fluopicolide was not done as part of this assessment because they 
contribute an insignificant amount to the total BAM exposure. 
Furthermore, aggregate risks to 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's Web site at: 

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 
    2. Prenatal and postnatal sensitivity. There is no evidence of 
quantitative susceptibility following in utero and/or postnatal 
fluopicolide exposure in the rabbit and rat developmental toxicity 
studies or in the 2-generation rat reproduction study. Qualitative 
susceptibility was observed in the rat developmental toxicity study. In 
this study, fetal effects (reduced growth and skeletal defects) and 
late-term abortions were observed at doses at which only decreased body 
weight gain were observed in maternal animals. There is low concern for 
this qualitative susceptibility because the fetal effects and late-term 
abortions have been well characterized and only occurred at a dose 
level near the limit dose. Protection for the maternal effects also 
protects for any effects that may occur during development. There are 
no residual uncertainties concerning prenatal and postnatal toxicity 
for fluopicolide.
    3. Conclusion regarding 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 that fluopicolide results in increased 
susceptibility in in utero rabbits in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study. 
Although there was some evidence of qualitative susceptibility in the 
rat developmental toxicity study, as discussed in Unit III.D.2., the 
degree of concern for the prenatal and/or postnatal toxicity is low; 
thus, there is no need for the 10X FQPA safety factor to account for 
potential prenatal or postnatal toxicity.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessments were performed 
based on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to fluopicolide in drinking water. Although EPA has 
required additional data on transferable residues from treated turf for 
fluopicolide, EPA is confident that it has not underestimated turf 
exposure due to the conservativeness of the default turf transfer value 
and conservative assumptions in the short-term turf assessment 
procedures (e.g., assuming residues do not degrade over the thirty-day 
assessment period and assuming high-end activities on turf for every 
day of the assessment period). Therefore, EPA is confident that it has 
not underestimated postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by fluopicolide.
    4. Conclusion regarding BAM. For reasons explained in the Unit 
III.D.3.ii. of the preamble to the final rule published in the Federal 
Register of August 27, 2008, EPA reduced the FQPA safety factor for BAM 
to 1X for inhalation and dermal exposure scenarios and retained the 10X 
FQPA safety factor for all other BAM exposure scenarios. EPA is relying 
on the findings in the preamble of the August 27, 2008 final rule and 
the 2008 BAM Risk Assessment for the BAM FQPA safety factor 
determinations for this action.

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

[[Page 45692]]

probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account 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. Therefore, 
fluopicolide is not expected to pose an acute risk.
    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 13% of the cPAD for 
children 1-2 years 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 is not expected.
    3. Short-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 the Agency has determined that it is 
appropriate to aggregate average exposure through food and water with 
short-term residential exposures to fluopicolide.
    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 110 for adults 
and 180 for children aged 6 to less than 11 years old. Because EPA's 
level of concern for fluopicolide is a MOE of 100 or below, these MOEs 
are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be 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. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus average 
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 
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluopicolide is not expected to pose a cancer risk to humans.
    6. BAM. As noted in Unit III.C., EPA does not expect the increased 
tolerances in this action to increase BAM exposure above what was 
assessed in the June 19, 2008 BAM risk assessment. None of the results 
of this BAM risk assessment indicated a risk from aggregate BAM 
exposures, including for acute and chronic risks. Similarly, since 
short- and intermediate-term aggregate MOEs for BAM are greater than 
the LOC, they represent risk estimates that are below the Agency's 
level of concern. Finally, EPA has determined that BAM does not pose an 
aggregate cancer risk for the U.S. population. EPA has relied upon the 
conclusions from the June 19, 2008 BAM Risk Assessment in order to make 
these determinations.
    7. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, liquid chromatography/tandem mass 
spectrometry (LC/MS/MS), is available to enforce the tolerance 
    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 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 made a 
request to reconsider ``loosening tolerances'' for several pesticide 
petitions, including for fluopicolide. The commenter additionally noted 
that, ``It is an issue of environmental justice that our youngest 
citizens--our children--are disproportionately exposed to health 
risks.'' The commenter points to an American Academy of Pediatrics 
Policy statement regarding pesticide exposure in children, a Centers 
for Disease Control and Prevention report on human exposure to 
environmental chemicals, and a President's Cancer Panel regarding 
reducing environmental cancer risks in supporting the request to 
reconsider the tolerance amendments proposed for fluopicolide.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that certain pesticide chemicals should not be 
permitted in our food, or that pesticide tolerances should be 
``significantly tightened'' as the commenter notes. However, the 
existing legal framework provided by section 408 of the FFDCA states 
that tolerances may be set when EPA determines that aggregate exposure 
to that pesticide is safe, i.e., that there is a reasonable certainty 
that no harm will result from aggregate exposure to the pesticide 
chemical residue. When making this determination, EPA considers the 
toxicity, including any potential carcinogenicity, of the pesticide and 
all anticipated dietary exposures and all other exposures for which 
there is reliable information. EPA also gives special consideration to 
the potential susceptibility and exposures of infants and children to 
the pesticide chemical residue when making this determination. For 
fluopicolide, the Agency has considered all the available data, 
including all available data concerning the potential for 
carcinogenicity of fluopicolide and its metabolites, and concluded 
after conducting a risk assessment, that there is a reasonable 
certainty that no harm

[[Page 45693]]

will result from aggregate human exposure to fluopicolide and that, 
accordingly, the amended fluopicolide tolerances on potato, processed 
potato waste and vegetable, tuberous and corm, subgroup 1C, are safe.

D. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has determined that 
the proposed tolerance in or on potato, processed waste at 0.3 ppm 
should be established at 1.0 ppm. That determination was based on the 
following: Processing data previously provided for the use of 
fluopicolide on potato indicate that residues of fluopicolide 
concentrate in wet peels. Residues of fluopicolide found in or on 
potatoes are estimated to be in the range of 0.2 ppm to 0.25 ppm 
following directed soil application. Using the highest estimated value 
of residues found in or on potato and the theoretical concentration 
factor of 4.0X for potato processed waste (in accordance with EPA's 
Residue Chemistry Test Guidelines), EPA has determined that a tolerance 
of 1.0 ppm is appropriate for residues on potato, processed waste. 
Additionally, EPA has revised the commodity terminology to potato, 
processed potato waste in order to reflect the preferred designation.

 V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide, 
pyridinyl]methyl]benzamide, in or on potato, processed potato waste at 
1.0 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.3 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: July 29, 2014.
Lois Rossi,
 Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.627, revise the following entries in the table in 
paragraph (a) to read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

                                                              Parts per
                         Commodity                             million
                                * * * * *
Potato, processed potato waste.............................          1.0
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................          0.3

* * * * *
[FR Doc. 2014-18458 Filed 8-5-14; 8:45 am]