Document ID: EPA-HQ-OPP-2012-0941-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluopicolide
Posted Date: 2014-03-05T05:00Z

[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Rules and Regulations]
[Pages 12396-12401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04832]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0941; FRL-9906-19]

Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for indirect or 
inadvertent residues of fluopicolide in or on corn, field, forage; 
corn, field, grain; corn, field, stover. Valent U.S.A. Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective March 5, 2014. Objections and 
requests for hearings must be received on or before May 5, 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-2012-0941, 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), EPA West 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; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
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-2012-0941 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 5, 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

[[Page 12397]]

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2012-0941, 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.htm. 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), 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 
(2F8099) 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 indirect or inadvertent residues 
of the fungicide fluopicolide, 2,6-dichloro-N-[3-chloro-5-
(trifluoromethyl)-2-pyridylmethyl]-benzamide, and its metabolite, 2,6-
dichlorobenzamide, in or on corn, field, forage at 0.09 parts per 
million (ppm); corn, field, grain at 0.01 ppm; and corn, field, stover 
at 0.3 ppm. These tolerances are being requested for fluopicolide 
residues that are likely to be found in or on corn when corn is planted 
as a rotational crop into a field that has previously been treated with 
fluopicolide, not for residues that result from direct application of 
fluopicolide to corn. That document referenced a summary of the 
petition prepared by Valent U.S.A. Corporation, the registrant, which 
EPA failed to make available through http://www.regulations.gov. 
Subsequently, EPA posted the summary to the docket via http://www.regulations.gov and republished notice of the availability of 
Valent's summary of its petition in the docket on September 12, 2013 
(78 FR 56185) (FRL-9399-7). There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerances for corn, field, forage from 0.09 ppm 
to 0.08 ppm; and for corn, field, stover from 0.3 ppm to 0.20 ppm. 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 
children.
    The toxicological database indicates that fluopicolide has 
relatively low acute toxicity. Fluopicolide is not a dermal sensitizer, 
primary eye irritant, or primary skin irritant. The subchronic and 
chronic toxicity studies showed that the primary effects of 
fluopicolide 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 (700 
milligrams/kilogram/day (mg/kg/day)) in the presence of maternal 
toxicity. Similarly, offspring effects (decreased body weight and body 
weight gain) occurred only at levels causing significant toxicity in 
parents of the multi-generation reproductive toxicity study. 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. The rabbit 
developmental and rat chronic/cancer studies were therefore considered 
as potential studies for deriving risk assessment endpoints for all 
durations of exposure. Fluopicolide is classified as ``not likely to be 
carcinogenic to humans'', thus no quantification of cancer risks is 
required.
    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 selected for BAM. Since 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 ``Fluopicolide and its Metabolite, 2,6-Dichlorobenzamide 
(BAM). Amended Human Health Risk Assessment to Support New Section 3 
Uses on Brassica Leafy Greens Subgroup 5B, Potatoes, Sugar Beets, 
Carrots and to Allow Rotation to Wheat,'' dated November 21, 2007 
(``2007 BAM Risk Assessment'') in docket ID number EPA-HQ-OPP-2006-
0481).
    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. Human Health Risk 
Assessment of the new section 3 tolerance on Rotational Corn'' in 
docket ID number EPA-HQ-OPP-2012-0941.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies

[[Page 12398]]

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) 
(FRL-8859-9).

C. Exposure Assessment

    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 did not consider additional 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 2007 BAM Risk 
Assessment. These conclusions remain unchanged and a revised 
quantitative BAM risk assessment was not conducted to support the 
proposed tolerances. 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.
    Acute effects were identified for BAM, and a conservative acute 
dietary exposure assessment for BAM was conducted. Maximum residues of 
BAM from fluopicolide field trials on tuberous and corm vegetables, 
leafy vegetables (except brassica), fruiting vegetables, cucurbit 
vegetables, grapes (domestic and imported), (except potato), and from 
dichlobenil field trials on food commodities with established/pending 
tolerances (40 CFR 180.231) were included in the assessments. The 
assessments used 100 percent crop treated (PCT) except for apples, 
blueberries, cherries, cranberries, peaches, pears, and raspberries.
    ii. Chronic exposure. A chronic aggregate dietary (food and 
drinking water) exposure and risk assessment was conducted for 
fluopicolide using the Dietary Exposure Evaluation Model software with 
the 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 PCT and tolerance-level residues.
    A conservative chronic dietary exposure assessment for BAM was 
conducted as described in Unit III.C.1.i. for the acute assessment.
    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.
    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. In its previous BAM assessment, EPA assumed 
that BAM's potential for carcinogenicity is similar to the parent 
having the greatest carcinogenic potential, specifically, dichlobenil, 
which has been classified as ``Group C, possible human carcinogen'' and 
for which EPA used a reference dose (RfD) approach for quantification 
of human cancer risk. Accordingly, EPA has assessed BAM's cancer risk 
by using an RfD approach. For this assessment, EPA relied on BAM 
chronic exposure assessment as described in Unit III.C.1.ii.
    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.
    EPA used anticipated residues and PCT information for the acute and 
chronic dietary risk assessments for BAM. For further analysis and 
EPA's findings under section 408(b)(2)(E) of the FFDCA, see Unit 
III.C.1.iv. of the preamble to the fluopicolide final rule published in 
the Federal Register of April 20, 2011 (76 FR 22045, 22050) (FRL-8859-
9).
    2. Dietary exposure from drinking water. A new drinking water 
assessment was not necessary for the establishment of tolerances 
resulting from inadvertent residues of fluopicolide on rotational corn. 
Previously, 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 exposures (non-cancer) assessments are estimated to be 24.14 
ppb for surface water and 0.5 ppb for ground water. Acute and cancer 
dietary risks were not quantified, as previously discussed.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 24.14 ppb was used to 
assess the contribution to drinking water.
    Considering residues of BAM in drinking water from uses of 
dichlobenil and fluopicolide, the uses on dichlobenil will result in 
the highest residues in drinking water. Therefore, the results from 
dichlobenil (from the use of nutsedge at 10 lb dichlobenil active 
ingredient/Acre (ai)/(A)) were used in the 2007 BAM Risk Assessment, 
i.e., 56.2 ppb was used as the value of BAM residues in drinking water 
in the dietary assessment for both the acute and chronic assessment.

[[Page 12399]]

    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 short-
term residential exposures: Residential turf grass, recreational sites 
and ornamental plants. EPA assessed residential exposure using the 
following assumptions: Residential handlers may receive short-term 
dermal and inhalation exposure to fluopicolide when mixing, loading, 
and applying the 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 also experience exposure via incidental non-dietary 
ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil 
ingestion) 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.
    BAM is a metabolite/degradate which forms slowly; therefore, the 
scenarios were assessed in the previous assessment assuming that BAM is 
present at levels which reflect high end measurements observed in the 
longer-term metabolism studies in order to provide a protective 
assessment. The short-/intermediate-term dermal MOEs for adults and 
children are 10,000 and 6,000, respectively, and the combined 
incidental oral MOE for toddlers is 62,000. These MOEs are greater than 
the LOC of 100 for dermal exposure and 1,000 for incidental oral 
exposure, on the day of application, and therefore, are not of concern. 
See 2007 BAM Risk Assessment.
    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: http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. For fluopicolide, there is 
no evidence of quantitative susceptibility following in utero and/or 
postnatal 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. 
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 of 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. 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. As discussed in Unit III.D.2. in this document, 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 post-natal 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).
    For reasons explained in III.D. of the preamble to the fluopicolide 
final rule published in the Federal Register of April 20, 2011 (76 FR 
22045) (FRL-8859-9), 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 April 20, 2011 final rule and the 
2007 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 probability of acquiring cancer given the 
estimated aggregate exposure. Short-,

[[Page 12400]]

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.
    The acute dietary exposure estimates for BAM at the 99.9th 
percentile of the exposure distribution are 11% of the aPAD for the 
general U.S. population and 28% aPAD for all infants 1 year old, the 
most highly exposed group.
    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 12% of the cPAD for 
children 1-2 years of age, 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.
    The chronic dietary exposure estimates for BAM are 29% of the 
chronic cPAD for the general U.S. population and 93% cPAD for all 
infants (< 1 year old), the most highly exposed group, which is not of 
concern to the Agency.
    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 chronic 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 adult 
males and females and 183 for children 6-11 years of age. Because EPA's 
level of concern for fluopicolide is a MOE of 100 or below, these MOEs 
are not of concern.
    Short-term exposures for fluopicolide's metabolite BAM, may occur 
as a result of activities on treated turf. Incidental oral exposures 
related to turf activities have been combined with chronic dietary 
exposure estimates to assess short-term aggregate exposure for BAM. 
Since aggregate MOEs for BAM are greater than the LOC, they represent 
risk estimates that are below the Agency's level 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). Intermediate-term exposures are not likely because of the 
intermittent nature of applications by homeowners.
    5. Aggregate cancer risk for U.S. population. As noted in Unit 
III.A., EPA has determined that fluopicolide is ``not likely to be 
carcinogenic to humans.'' As discussed in Unit III.C., EPA assessed the 
BAM cancer risk using an RfD approach. Relying on the BAM chronic risk 
assessment, EPA determines that BAM does not pose a cancer risk. 
Therefore, fluopicolide is not expected to pose a cancer risk.
    6. 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/Tandum Mass 
Spectrometry (LC/MS/MS) method) 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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for fluopicolide on corn, field, 
forage; corn, field, grain or corn, field, stover.

C. Revisions to Petitioned-For Tolerances

    The established tolerance levels for field corn forage and field 
corn stover differ from the petition. The petitioner's calculations 
were based on the sum of fluopicolide and BAM. Since the tolerance 
expression includes monitoring of residues of fluopicolide only for 
rotational crops for both food and feed commodities, it is not 
appropriate to consider residues of BAM in tolerance calculations. 
Therefore, EPA is establishing tolerances based on field trial data for 
fluopicolide only and using the Organization of Economic Cooperation 
and Development (OECD) calculation procedure.

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide, 
2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-
benzamide, in or on corn, field, forage at 0.08 ppm; corn, field, grain 
at 0.01 ppm; and corn, field, stover at 0.20 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

[[Page 12401]]

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 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: February 26, 2014.
Lois Rossi,
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, in paragraph (d), add alphabetically the following 
commodities to the table to read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.....................................            0.08
Corn, field, grain......................................            0.01
Corn, field, stover.....................................            0.20
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2014-04832 Filed 3-4-14; 8:45 am]
BILLING CODE 6560-50-P