Fluopicolide; Pesticide Tolerances, 22045-22054 [2011-9435]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Rules and Regulations]
[Pages 22045-22054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9435]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0481; FRL-8859-9]


Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
fungicide, fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-
2-pyridinyl]methyl]benzamide], including its metabolites and 
degradates. Compliance with the tolerance levels specified is to be 
determined by measuring only fluopicolide in or on the commodity. The 
fluopicolide metabolite, 2,6-dichlorobenzamide (BAM), is regulated with 
its own set of tolerances. This regulation establishes tolerances for 
residues of fluopicolide and its metabolites in or on multiple 
commodities which are identified and discussed later in this document. 
Valent U.S.A. Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 20, 2011. Objections and 
requests for hearings must be received on or before June 20, 2011, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0481. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 305-6129; e-mail 
address: whitehurst.janet@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

[[Page 22046]]

    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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 https://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go https://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-2006-0481 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 
June 20, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2006-0481, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
9F7617 and 9F7568 by Valent U.S.A, 1600 Riviera Ave., Walnut Creek, CA 
94596-8025). The petitions requested that 40 CFR 180.627 be amended by 
establishing tolerances for residues of the fungicide, fluopicolide, 
and its metabolites, in or on Brassica, leafy greens, subgroup 5B at 20 
parts per million (ppm) (9F7617). Additionally, Valent U.S.A. has 
proposed establishing tolerances for residues of the fluopicolide 
metabolite, BAM on cattle, goat, horse and sheep meat at 0.02 ppm; 
cattle, goat, horse and sheep fat at 0.05 ppm; cattle, goat, horse and 
sheep meat byproducts at 0.05 ppm; and milk at 0.01 ppm (9F7568). These 
notices referenced a summary of the petitions prepared by Valent 
U.S.A., the registrant, which is available in the docket, https://www.regulations.gov.
    Valent U.S.A. previously submitted petition 5F7016 to the Agency 
for consideration of uses on tuberous and corm vegetables and tolerance 
for indirect or inadvertent tolerances resulting from rotation to 
wheat. The Interregional Research Project No 4 (IR-4) submitted 
petition 7E7172 which included uses on root and tuber vegetables. In 
the Federal Register of May 28, 2008 (73 FR 30492) (FRL-8363-7), and 
the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-4), EPA 
issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of these petitions. The Agency 
reviewed the submitted petitions and concluded that due to data 
deficiencies, commodities that had associated animal feed items were 
not, at that time, supported by adequate data. Therefore, while the 
Agency approved the majority of new uses requested in the petition 
5F7016, the Agency did act on the request for uses on potato, sugar 
beets and carrots, and on the request to allow rotation to wheat.
    Valent U.S.A. subsequently submitted additional data to address 
deficiencies cited in the Agency reviews for the petition 5F7016, 
including supporting data for the animal metabolism study, a BAM 
feeding study, confirmatory analytical method and documentation that a 
BAM reference standard is available; and requests that 40 CFR 180.627 
be amended by establishing tolerances for residues of the fungicide 
fluopicolide in or on vegetable, tuberous and corm subgroup 1C at 0.02 
ppm; potato, processed potato waste at 0.05 ppm; vegetable root, 
subgroup 1A at 0.15 ppm. The petitioner also requested the 
establishment of tolerances for indirect or inadvertent residues of 
fluopicolide in or on wheat, forage at 0.20 ppm; wheat, grain at 0.02 
ppm; wheat, hay at 0.50 ppm; wheat, milled byproducts at 0.07 ppm; 
wheat, straw at 0.50 ppm; wheat, aspirated grain fractions at 0.07 ppm. 
Concurrently with establishing the crop subgroup 1A tolerance, the 
petitioner proposed to delete the current tolerance on the ``vegetable 
root, subgroup 1A, except sugar beet and carrot'' since the new 1A 
unrestricted tolerance will cover the existing commodity tolerances as 
well as tolerances needed for the new uses on sugar beets and carrots. 
Additionally, concurrently with establishing the crop supgroup 1C 
``vegetable, tuberous and corm subgroup,'' the petitioner proposed to 
delete the current tolerance on ``vegetable, tuberous and corm (except 
potato) subgroup 1D tolerance, since the new 1C subgroup tolerance will 
cover the existing commodity tolerances listed under 1C as well as the 
tolerance needed for the new use on potatoes.
    There were no comments received in response to these notices of 
filings.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerances proposed for vegetable, brassica (cole) leafy 
subgroup 5B. The appropriate tolerance for vegetable brassica (cole) 
leafy subgroup 5B is 18 ppm. The reason for this change is explained in 
Unit IV.D. EPA has not established the requested BAM tolerances because 
the relevant data showed that no new tolerances for BAM are required 
for animal commodities. 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.''

[[Page 22047]]

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 and 
separately for the fluopicolide metabolite, BAM, including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluopicolide and 
separately, the fluopicolide metabolite BAM follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data for fluopicolide 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 technical grade 
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 (body weight, kidney) occurred 
only at levels causing 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 for all exposure scenarios.
    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 https://www.regulations.gov in document Fluopicolide and its Metabolite, 2,6-
Dichlorobenzamide (BAM). 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 in the docket ID number 
EPA-HQ-OPP-2006-0481.
    BAM (AE C653711) is a common metabolite and/or environmental 
degradate of fluopicolide as well as the herbicide dichlobenil. Because 
the toxicological endpoints for BAM and fluopicolide are different, a 
separate human health risk assessment is required which addresses risks 
from exposure to BAM residues. 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.
    EPA has evaluated the available toxicity data for BAM 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 BAM toxicity database indicates that BAM has moderate acute 
toxicity via the oral route of exposure. In subchronic and chronic 
toxicity studies, the primary oral effects seen in the rat and dog were 
body weight changes. Adverse liver effects were also observed. There is 
no evidence that BAM is either mutagenic or clastogenic nor is there 
evidence of endocrine mediated toxicity. BAM is considered to be 
neurotoxic. In the absence of carcinogenicity study data for a second 
species, the Agency has assumed that BAM's carcinogenic potential is 
similar to that of dichlobenil, the parent compound having the greatest 
carcinogenicity potential. Dichlobenil is classified as ``Group C, 
possible human carcinogen.'' Quantification of cancer risk for BAM is 
based on the reference dose (RfD) approach which requires comparison of 
the chronic exposure to the RfD. Using this methodology will adequately 
account for all chronic toxic effects, including carcinogenicity, 
likely to result from exposure to BAM. Specific information regarding 
the metabolite of fluopicolide can be found in the document entitled 
2,6-Dichlorobenzamide (BAM) as a Metabolite/Degradate of Fluopicolide 
and Dichlobenil. Human Health Risk Assessment for Proposed Uses of 
Fluopicolide on Tuberous and Corm Vegetables, Leafy Vegetables (except 
brassica), Fruiting Vegetables, Cucurbit Vegetables, Grapes, Turf, and 
Ornamentals, and for Indirect or Inadvertent Residues on the Rotational 
Crop Wheat (PC Codes: 027402 BAM and 027412 (fluopicolide), Petition 
No: 5F7016 at regulations.gov). Both referenced documents are available 
in the docket established for this action, which is described under 
ADDRESSES, and is identified as docket ID number EPA-HQ-OPP-2006-0481. 
A quantitative reassessment of the BAM risk for the new uses associated 
with the petitions 9F7617 and 9F7568 was not conducted because the new 
uses do not add significantly to the BAM dietary exposure; therefore, 
the conclusions from the most recently conducted BAM human health risk 
assessment remain unchanged.

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

[[Page 22048]]

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The selected toxicological endpoints used for fluopicolide are 
presented below.

        Table 1--Summary of Toxicological Doses and Endpoints for Fluopicolide for Use in Dietary and Occupational Human Health Risk Assessments
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          RfD, PAD, level of
         Exposure/scenario             Point of departure        Uncertainty/ FQPA         concern for risk          Study and toxicological effects
                                                                   safety factors             assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Dietary (all populations)                     An endpoint attributable to a single dose was not identified from the available data.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Dietary (all populations)   Maternal NOAEL = 20 mg/   UFA = 10x                Chronic RfD =            Developmental Toxicity Study in Rabbits
                                     kg/day.                  UFH = 10x                0.2 mg/kg/day             LOAEL (maternal) = 60 mg/kg/day based
                                                              FQPA SF = 1X             cPAD = 0.2 mg/kg/day.     on death, abortions/premature
                                                                                                                 deliveries, decreased food consumption
                                                                                                                 and body weight gain.
                                    ........................  .......................  .......................  Co-critical: Chronic/Oncogenicity Study
                                                                                                                 in Rats
                                                                                                                NOAEL = 31.5 mg/kg/day.
                                                                                                                LOAEL = 109.4 mg/kg/day based on
                                                                                                                 decreased body weight gain and
                                                                                                                 increased thyroid weight and increased
                                                                                                                 incidence of thyroid lesions.
Incidental Oral Intermediate-Term   Maternal NOAEL = 20 mg/   UFA = 10x                MOE = 100                Developmental Toxicity Study in Rabbits
(1-6 months)                         kg/day.                  UFH = 10x                 (occupational).         LOAEL (maternal) = 60 mg/kg/day based on
                                                              FQPA SF = 1X             MOE = 100                 death, abortions/premature deliveries,
                                                                                        (residential).           decreased food consumption and body
                                                                                                                 weight gain
Dermal Short-, Intermediate- and    Maternal NOAEL = 20 mg/   UFA = 10x                MOE = 100                Developmental Toxicity Study in Rabbits
 Long-Term (1-30 days, 1-6 months,   kg/day.                  UFH = 10x                 (occupational).         LOAEL (maternal) = 60 mg/kg/day based on
 and > 6 months)                                              FQPA SF = 1X             MOE = 100                 death, abortions/premature deliveries,
                                                              37% dermal absorption.    (residential).           decreased food consumption and body
                                                                                                                 weight gain.
                                    ........................  .......................  .......................  Co-critical: Chronic/Oncogenicity Study
                                                                                                                 in Rats
                                                                                                                NOAEL = 31.5 mg/kg/day.
                                                                                                                LOAEL = 109.4 mg/kg/day based on
                                                                                                                 decreased body weight gain and
                                                                                                                 increased thyroid weight and increased
                                                                                                                 incidence of thyroid lesions.
Inhalation Short-, Intermediate-    Maternal NOAEL = 20 mg/   UFA = 10x                MOE = 100                Developmental Toxicity Study in Rabbits
 and Long-term (1-30 days, 1-6       kg/day.                  UFH = 10x                 (occupational).         LOAEL (maternal) = 60 mg/kg/day based on
 months, and > 6 months)                                      FQPA SF = 1X             MOE = 100                 death, abortions/premature deliveries,
                                                              (inhalation and oral      (residential).           decreased food consumption and body
                                                               toxicity are assumed                              weight gain.
                                                               to be equivalent).
                                    ........................  .......................  .......................  Co-critical: Chronic/Oncogenicity Study
                                                                                                                 in Rats
                                                                                                                NOAEL = 31.5 mg/kg/day.
                                                                                                                LOAEL = 109.4 mg/kg/day based on
                                                                                                                 decreased body weight gain and
                                                                                                                 increased thyroid weight and increased
                                                                                                                 incidence of thyroid lesions.
                                   ---------------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                               Classification: ``Not Likely to be Carcinogenic to Humans.''
--------------------------------------------------------------------------------------------------------------------------------------------------------
FQPA SF = FQPA Safety Factor.
LOC = level of concern.
LOAEL = lowest observed adverse effect level.
MOE = margin of exposure.
N/A = not applicable.
NOAEL = no observed adverse effect level.
PAD = population adjusted dose (a = acute, c = chronic).
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of
  extrapolation to determine risk associated with lower environmentally relevant human exposures.
RfD = reference dose.
UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).


[[Page 22049]]

    A summary of the toxicological endpoints for BAM used for human 
risk assessment can be found at regulations.gov in the document 
entitled 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 in docket ID number EPA-HQ-OPP-2006-0481.
    The selected toxicological endpoints used for BAM are presented 
below.

    Table 2--Summary of Toxicological Doses and Endpoints for 2,6-Dichlorobenzamide (BAM) for Use in Dietary,
                           Residential, and Occupational Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                                                   RfD, PAD, level of
  Exposure scenario    Point of departure     Uncertainty/ FQPA     concern for risk     Study and toxicological
                                               safety factors          assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary         LOAEL = 100 mg/kg/    UFA = 10X             aRfD = aPAD = 0.1 mg/ Dose-range finding assay
 (General              day.                 UFH = 10X              kg/day.               for in vivo mouse
 population,                                FQPA SF\4\ \5\ = 10X                         erythrocyte
 including infants                           (includes UFL and                           micronucleus assay.
 and children)                               UFDB).                                     LOAEL = 100 mg/kg/day
                                                                                         based on lethargy after
                                                                                         a single oral dose.
Acute Dietary         NOAEL = 30 mg/kg/     UFA = 10X             aRfD = aPAD = 0.03    Developmental toxicity
 (Females 13-49        day.                 UFH = 10X              mg/kg/day.            (rabbit)
 years of age)                              FQPA SF \4\ = 10X                           Offspring LOAEL = 90 mg/
                                            (includes UFDB).                             kg/day based on
                                                                                         increased incidences of
                                                                                         late abortion and
                                                                                         skeletal (bipartite
                                                                                         interparietal bone) and
                                                                                         visceral (postcaval
                                                                                         lung lobe agenesis)
                                                                                         anomalies
Chronic Dietary (All  NOAEL = 4.5           UFA = 10X             cRfD = cPAD = 0.0045  Chronic toxicity (dog)
 populations)         mg/kg/day.            UFH = 10X              mg/kg/day.           LOAEL = 12.5 mg/kg/day
                                            FQPA SF \4\ = 10X                            based on decreased body
                                            (includes UFDB).                             weight and body weight
                                                                                         gain.
Incidental Oral       NOAEL = 14            UFA = 10X             Residential LOC for   90-day oral (rat)
Short- and            mg/kg/day.            UFH = 10X              MOE = 1000.          LOAEL = 49 mg/kg/day
 Intermediate-Term                          FQPA SF\4\ = 10X                             based on decreased body
 (1-30 days and 1-6                         (includes UFDB).                             weight gain (M) and
 months)                                                                                 reduced skeletal muscle
                                                                                         tone (day 4 only in
                                                                                         males; days 91 and 92
                                                                                         only in females).
Dermal                NOAEL = 25            UFA = 10X             Residential and       5-day dermal using
Short-, Intermediate- mg/kg/day.            UFH = 10X              Occupational LOC      dichlobenil \6\ (mouse;
 , and Long-Term (1-                        FQPA SF = 1X           for MOE = 100.        literature study \1\).
 30 days, 1-6                                (residential uses                          LOAEL = 50 mg/kg/day
 months, and > 6                             only).                                      based on olfactory
 months)                                                                                 epithelial damage.
Inhalation            NOAEL = 3.1           UFA = 10X             Residential and       28-day inhalation using
Short-, Intermediate- mg/kg/day \2\         UFH = 10X              Occupational LOC      dichlobenil \6\ (rat)
 , and Long-Term (1-                        FQPA SF = 1X           for MOE = 100.       LOAEL = 5.5 mg/kg/day
 30 days, 1-6                                (residential uses                           \3\ based on nasal
 months, and > 6                             only).                                      degeneration.
 months)
                     -------------------------------------------------------------------------------------------
Cancer                 Classification: Formally unclassified; parent herbicide dichlobenil classified as ``Group
                         C, possible human carcinogen'' with RfD approach utilized for quantification of human
                                                                 risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = FQPA Safety Factor.
LOAEL = lowest observed adverse effect level.
LOC = level of concern.
NOAEL = no observed adverse effect level.
MOE = margin of exposure.
N/A = Not Applicable.
PAD = population adjusted dose.
RfD = reference dose (a = acute, c = chronic).
UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).
UFDB = to account for the absence of key data.
UFH = potential variation in sensitivity among members of the human population (intraspecies).
UFL = use of a LOAEL to extrapolate a NOAEL.
\1\ Deamer NJ, O'Callaghan JP, Genter MB. (1994). Olfactory toxicity resulting from dermal application of 2,6-
  dichlorobenzonitrile (dichlobenil) in the C57Bl mouse. Neurotoxicology 15(2):287-93.
\2\ Calculated as follows: (NOAEL) x (m\3\/1000 L) x (10.26 L/hr) x 6 hr/day x (1/0.236 kg), where NOAEL = 12 mg/
  m\3\ from 28-day inhalation toxicity study (Sprague Dawley rat).
\3\ Calculated as follows: (LOAEL) x (m\3\/1000 L) x (10.26 L/hr) x 6 hr/day x (1/0.236 kg), where LOAEL = 21 mg/
  m\3\ from 28-day inhalation toxicity study (Sprague Dawley rat).
\4\ The FQPA SF has been retained in the form of a UFDB for the lack of neurotoxicity data, including olfactory
  toxicity data.
\5\ The FQPA SF has been retained in the form of a UFL and UFDB for the use of a LOAEL to extrapolate a NOAEL
  and for the lack of olfactory toxicity data.
\6\ In the absence of route-specific data, endpoints for all dermal and inhalation exposure scenarios were
  identical to those for dichlobenil (parent), since olfactory toxicity has been observed following i.p.
  administration of BAM in mice [Brittebo EB, Eriksson C, Feil V, Bakke J, Brandt I. (1991). Toxicity of 2,6-
  dichlorothiobenzamide (chlorthiamid) and 2,6-dichlorobenzamide in the olfactory nasal mucosa of mice. Fundam
  Appl Toxicol 17(1):92-102].


[[Page 22050]]

    A summary of the toxicological endpoints for BAM used for human 
risk assessment can be found at regulations.gov in the document 
entitled 2,6-Dichlorobenzamide BAM as a Metabolite/Degradate of 
Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed 
Uses of Fluopicolide on Tuberous and Corm Vegetables, Leafy Vegetables 
(except brassica), Fruiting Vegetables, Cucurbit Vegetables, Grapes, 
Turf, and Ornamentals, and for Indirect or Inadvertent Residues on the 
Rotational Crop Wheat (PC Codes: 027402 BAM and 027412 Fluopicolide, 
Petition No: 5F7016 (71 FR 34345) (FRL-8071-4) in docket ID number EPA-
HQ-OPP-2006-0481).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopicolide and its metabolites, EPA considered exposure 
under the petitioned-for tolerances as well as all existing 
fluopicolide tolerances in 40 CFR 180.40. EPA assessed dietary 
exposures from fluopicolide and separately, its metabolite, 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 
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.
    A conservative acute dietary exposure assessment for the metabolite 
of fluopicolide, 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. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the U.S. Department 
of Agriculture 1994-1996 and 1998 Continuing Survey of Food Intake by 
Individuals. As to residue levels in food, two chronic assessments were 
conducted: One assessment for parent fluopicolide (including residues 
of concern other than the metabolite BAM) and one assessment for BAM. 
As to residue levels in food, EPA assumed for the parent fluopicolide 
assessment that all foods for which there are tolerances were treated 
and contain tolerance-level residues. A conservative chronic dietary 
exposure assessment for the metabolite of fluopicolide, BAM, was 
conducted as described in Unit III.C.1.i. for the acute assessment.
    iii. Cancer. Fluopicolide is not likely to be carcinogenic to 
humans; therefore, a cancer risk assessment was not conducted for the 
parent fluopicolide. 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. As noted, 
fluopicolide has been classified as not likely to be carcinogenic to 
humans; dichlobenil is classified as ``Group C, possible human 
carcinogen'' with the reference dose (RfD) approach utilized for 
quantification of human risk. Accordingly, EPA has assessed BAM's 
cancer risk by comparing BAM exposure to the dichlobenil RfD. 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 or maximum field trial 
residues and 100% CT were assumed for all food commodities.
    EPA used anticipated residues and PCT information for the acute and 
chronic dietary risk assessments for BAM. 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 (DCIs) 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.

The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which may be applied in a particular area.
    The assessments assumed 100 PCT for fluopicolide and dichlobenil, 
except for the following dichlobenil-treated crops:
    a. For the acute assessment: Apples (2.5%), blueberries (2.5%), 
cherries (2.5%), peaches (2.5%), pears (2.5%), and raspberries (5%).
    b. For the chronic assessment: Apples (1%), blueberries (1%), 
cherries (1%), cranberries (45%), peaches (1%), pears (1%), and 
raspberries (5%).
    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

[[Page 22051]]

fluopicolide. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at https://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 
acute exposures are estimated to be 25.50 parts per billion (ppb) for 
surface water and 0.5 ppb for ground water.
    The EECs for chronic exposures (non-cancer) assessments are 
estimated to be 24.14 ppb for surface water and 0.5 ppb for ground 
water.
    The EECs for chronic exposures (cancer) assessments are estimated 
to be 22.36 ppb for surface water. The EECs for acute and chronic 
assessments are estimated to be 0.5 ppb in ground water.
    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 
access 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)) are used in this 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.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fluopicolide is 
currently registered for the following uses that could result in 
residential exposures: Residential turf grass and 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. 
Toddlers 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 https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fluopicolide or the fluopicolide metabolite, BAM 
to share a common mechanism of toxicity with any other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
fluopicolide and BAM do not have a common mechanism of toxicity with 
other substances. Residues of BAM resulting from both the use of 
fluopicolide as well as from dichlobenil were evaluated to support the 
requested new uses. 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 https://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 posnatal 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. 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.
    For BAM, there is no evidence of quantitative susceptibility 
following in utero and/or postnatal expsoure 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 no residual uncertainties 
concerning prenatal and postnatal toxicity for BAM.
    3. Conclusion. As to fluopicolide, EPA has determined that reliable 
data show that it would be safe for infants and children to reduce the 
FQPA SF to 1X. That decision is based on the following findings:
    i. The toxicity database for fluopicolide is largely complete, 
lacking only an immunotoxicity study. EPA has evaluated the available 
toxicity data for fluopicolide and determined that an additional 
database uncertainty factor is not needed to account for potential 
immunotoxicity. The most sensitive endpoint in the database was 
decreased food consumption, decreased body weight gain, abortions/
premature deliveries, and death. No definitive cross-species target 
organ was identified for fluopicolide; however, liver toxicity, kidney 
toxicity, and thyroid toxicity were observed in the database. No 
treatment-related changes indicative of potential immunotoxicity were 
seen in hematology parameters, organ weights (thymus, spleen), gross 
necropsy (enlarged lymph nodes), or histopathology (spleen, thymus, 
lymph nodes) when tested up to the limit dose in mice and rats. 
Therefore, EPA does not believe that conducting a special harmonized 
test guideline series 870.7800 immunotoxicity study will result in a 
NOAEL less than 20 mg/kg/day, which is presently used as the

[[Page 22052]]

point of departure for chronic risk assessment.
    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. The degree of concern for prenatal and/or postnatal toxicity 
is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. Conservative ground water and 
surface water modeling estimates were used. Similarly conservative 
residential SOPs were used to assess post-application exposure to 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
fluopicolide.
    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, including olfactory toxicity 
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 toxicity 
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:
    a. 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 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 https://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.
    b. There is no evidence that BAM results in increased 
susceptibility of in utero rabbits in the prenatal developmental 
toxicity study.
    c. 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 water and surface water modeling used to 
assess exposure to BAM in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by BAM.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate 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 13% 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 proposed for registration for use(s) that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for fluopicolide. Using the exposure assumptions described in 
this unit for short-term exposures, EPA has concluded that food, water, 
and residential exposures result in aggregate MOEs greater than the LOC 
of 100 for all population groups, and the aggregate short-term risk 
estimates for fluopicolide are below the Agency's level 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

[[Page 22053]]

to be a background exposure level). Fluopicolide is proposed for 
registration for use(s) that could result in intermediate-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and intermediate-term 
exposures for fluopicolide. The intermediate-term aggregate risk for 
fluopicolide and BAM is the same as calculated above for the short-term 
aggregate risk.
    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. 
The chronic risk assessment for BAM is protective of any potential 
cancer risk. Fluopicolide has been classified as ``not likely to be 
carcinogenic to humans.''
    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 and its metabolite, BAM 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; e-mail 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 U.N. 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.
    A Codex tolerance for fluopicolide has been established at 0.2 ppm 
for the straw and fodder (dry) of cereal grains. However, this level is 
lower than residues values seen in wheat straw in U.S. field trials. 
Since the Codex MRL would not cover residues of fluopicolide in wheat 
straw resulting from the allowed use pattern in the U.S., the Agency 
has used the NAFTA MRL calculator to determine an appropriate tolerance 
level. There are no other Codex, Canadian, or Mexican MRLs which have 
been established for the other uses which are the subject of this 
action.

C. Revisions to Petitioned-for Tolerances

    The proposed tolerance for vegetable, brassica (cole) leafy 
subgroup 5B should be changed from 20 ppb to 18 ppb. This tolerance was 
determined considering residue/processing data and, as applicable, 
recent agency guidance (``NAFTA Guidance Document for Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data,'' Regulatory 
Proposal PRO2005-04, U.S. EPA and Health Canada, Pest Management 
Regulatory Agency, 2005.
    The Agency has considered the submitted BAM animal feeding study, 
has calculated maximum reasonably balanced diets for livestock 
commodities based on existing and new uses of fluopicolide and 
concludes that BAM tolerances are not required to support the requested 
new uses.

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide, 
in or on vegetable, tuberous and corm subgroup 1C at 0.02 ppm; potato, 
processed potato waste at 0.05 ppm; vegetable root, subgroup 1A at 0.15 
ppm; vegetable, brassica leafy greens subgroup 5B at 18 ppm; wheat, 
forage at 0.20 ppm; wheat, grain at 0.02 ppm; wheat, hay at 0.50 ppm; 
wheat, milled byproducts at 0.07 ppm; wheat, straw at 0.50 ppm; wheat, 
aspirated grain fractions at 0.07 ppm. Since the established tolerances 
for subgroup ``1A, except sugar beets and carrots,'' and crop subgroup 
1D (vegetable, tuberous and corm, except potato) are subsumed by the 
new unrestricted crop subgroup 1A tolerance and the subgroup 1C 
(vegetable, tuberous and corm) tolerance, the Agency will delete these 
tolerances concurrently with establishing the tolerances above.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 d