Document ID: EPA-HQ-OPP-2006-0481-0008
Agency: epa
Document Type: Rule
Title: Fluopicolide; Pesticide Tolerance
Posted Date: 2008-01-30T05:00Z

[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Rules and Regulations]               
[Page 5450-5455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja08-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0481; FRL-8341-6]

 
Fluopicolide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, as an indicator of combined residues of 
fluopicolide and its metabolite, 2,6-dichlorobenzamide (BAM), in or on 
grape at 2.0 parts per million (ppm); grape, raisin at 6.0 ppm; 
vegetable, cucurbit, group 9 at 0.50 ppm; vegetable, fruiting, group 8 
at 1.6 ppm; vegetable, leafy, except brassica, group 4 at 25 ppm; and 
vegetable, tuberous and corm, subgroup, except potato, 1D at 0.02 ppm. 
Valent U.S.A. Corporation requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 30, 2008. Objections and 
requests for hearings must be received on or before March 31, 2008, 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. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 http://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, Registration 
Division (7505P), 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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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 requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk

[[Page 5451]]

as required by 40 CFR part 178 on or before March 31, 2008.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0481, by one of the following methods:
     Federal eRulemaking Portal: http://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'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. Petition for Tolerance

    In the Federal Register of June 14, 2006 (71 FR 34345) (FRL-8071-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F7016) by Valent U.S.A. Company, 1600 Riviera Ave., Walnut Creek, CA 
94596-8025. The petition requested that 40 CFR 180.627 be amended by 
establishing a tolerance for residues of the fungicide fluopicolide, 
2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, in or on grape at 2.0 ppm; raisin at 6.0 
ppm; vegetable, leafy (except brassica) (group 4) at 20.0 ppm; 
vegetable, fruiting (group 8) at 0.8 ppm; vegetable, cucurbit (group 9) 
at 0.4 ppm; potato at 0.02 ppm; sweet potato, roots at 0.02 ppm; wheat, 
forage at 0.2 ppm; wheat, grain at 0.02 ppm; and wheat, hay and straw 
at 0.5 ppm. That notice referenced a summary of the petition prepared 
by Valent U.S.A. Company, the registrant, which is available to the 
public in the docket, http://www.regulations.gov. Comments were 

received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerances proposed for vegetable, leafy, except brassica, 
group 4; vegetable, fruiting, group 8; and vegetable, curcurbit, group 
9. The appropriate tolerances for vegetable, leafy, except brassica, 
group 4; vegetable, fruiting, group 8; and vegetable, curcurbit, group 
9 are 25, 1.6, and 0.50 ppm, respectively. These tolerances were 
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 (http://www.pmra-arla.gc.ca/english/pdf/pro/pro2005-04-e.pdf
).

    For the reasons stated in Unit V., EPA is not establishing at this 
time the following petitioned-for tolerances: Potato; wheat, forage; 
wheat, grain; and wheat, hay and straw.
    The existing tolerances for imported grape at 2.0 ppm, and grape, 
raisin at 6.0 ppm now apply to all imported and U.S. domestic grapes. 
Additionally, the residue definition in paragraph (a) of the tolerance 
expression is being changed from only fluopicolide, to: Tolerances are 
established for residues of fluopicolide, 2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of 
combined residues of fluopicolide and its metabolite, 2,6-
dichlorobenzamide (BAM).

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. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    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 the petitioned-for tolerance 
for residues of fluopicolide, 2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of 
combined residues of fluopicolide and its metablite, BAM, on grape at 
2.0 ppm; grape, raisin at 6.0 ppm; vegetable, cucurbit, group 9 at 0.50 
ppm; vegetable, fruiting, group 8 at 1.6 ppm; vegetable, leafy, except 
brassica, group 4 at 25 ppm; and vegetable, tuberous and corm, 
subgroup, except potato 1D at 0.02 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerance 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. 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 in the 
document entitled Fluopicolide: Human Health Risk Assessment for 
Proposed Uses 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 at regulations.gov. BAM (AE C653711) is a common metabolite 
and/or environmental degradate of fluopicolide as well as the herbicide 
dichlobenil. Because the toxicological endpoints of BAM and 
fluopicolide are different, a separate human health risk assessment was 
conducted for BAM residues. The BAM risk assessment considered 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 dichlobenill uses. Specific 
information regarding the metabolite of

[[Page 5452]]

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.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which NOAEL in the toxicology study identified 
as appropriate for use in risk assessment. However, if a NOAEL cannot 
be determined, the lowest dose at which adverse effects of concern are 
identified the LOAEL is sometimes used for risk assessment. Uncertainty 
(UFs)/safety factors are used in conjunction with the LOC to take into 
account uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. Safety is 
assessed for acute and chronic risks by comparing aggregate exposure to 
the pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the LOC by all applicable UFs. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the margin of exposure (MOE) called for by the 
product of all applicable UFs is not exceeded.
    A summary of the toxicological endpoints for fluopicolide used for 
human risk assessment can be found at regulations.gov in the document 
entitled Fluopicolide: Human Health Risk Assessment for Proposed Uses 
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 Code: 027412, Petition No: 5F7016 (71 FR 34345) (FRL-
8071-4) in docket ID number EPA-HQ-OPP-2006-0481). 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, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluopicolide tolerances in (40 
CFR 180.627). EPA assessed dietary exposures from fluopicolide in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
fluopicolide; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    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 
assessments EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 Continuing Surveys of Food 
Intakes by Individuals (CSFII). 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 
parent fluopicolide. The carcinogenic potential of BAM has been 
evaluated in only one species, the rat. That study showed 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, BAM's cancer risk is based 
on the chronic risk assessment and no separate cancer risk or exposure 
assessment has been conducted.
    iv. Anticipated residue and PCT information. Anticipated residues 
and PCT information were used for the acute and chronic dietary risk 
assessments for BAM. Maximum residues of BAM from fluopicolide field 
trials on tuberous and corm vegetables (except potato) leafy vegetables 
(except brassica), fruiting vegetables, cucurbit vegetables, grapes 
(domestic and imported), and from dichlobenil field trials on food 
commodities with established/pending tolerances (40 CFR 180.231) were 
included in the assessments. The assessments assumed 100% CT 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 lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for fluopicolide in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on

[[Page 5453]]

the environmental fate 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
fluopicolide for acute exposures are estimated to be 26.81 parts per 
billion (ppb) for surface water and 0.64 ppb for ground water. The EECs 
for chronic (non cancer) exposures are estimated to be 8.34 ppb for 
surface water and 0.64 ppb for ground water. The EECs for chronic 
(cancer) exposures are estimated to be 6.14 ppb for surface water and 
0.64 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 8.34 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 
assessments.
    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 proposed for registration on the following 
residential non-dietary sites: Residential turfgrass 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 postapplication 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 postapplication activities on treated turf.
    While it is necessary to evaluate residential exposure from all 
sources of fluopicolide's metabolite BAM, the use pattern for 
dichlobenil is not expected to result in scenarios with significant 
residential/non-occupational exposure. Therefore, BAM exposure 
estimates are based on fluopicolide use only.
     Residential handler exposure was evaluated for parent fluopicolide 
only because the metabolite BAM is believed to form slowly in plants 
and soil after the product containing the parent (fluopicolide) has 
been applied.
    Residential postapplication 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 (turf grass), and soil ingestion) during 
postapplication activities on treated turf.
     Residential short-term/intermediate-term postapplication MOEs were 
estimated for ``Day 0'' exposure (i.e., the day of application).
    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. For the purposes of this tolerance action, therefore, EPA 
has not assumed that fluopicolide has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
http://www.epa.gov/pesticides/cumulative.

    Fluopicolide and dichlobenil can form the common metabolite, BAM. 
To support existing tolerances and to establish new tolerances for 
fluopicolide, EPA conducted a human health risk assessment for exposure 
to BAM resulting from the use of all current and pending uses of 
fluopicolide and the herbicide dichlobenil. The risk assessment is 
conservative in terms of potential dietary and non-dietary exposures. 
In addition, the Agency retained the additional tenfold (10X) FQPA 
safety factor (SF) for the protection of infants and children. The 
assessment includes evaluations of risks for various subgroups, 
including those composed of infants and children. The Agency's complete 
risk assessment can be found at regulations.gov, docket ID number EPA-
HQ-OPP-2006-0481.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional 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 SF. In applying this provision, EPA 
either retains the default value of 10X when reliable data do not 
support the choice of a different factor, or, if reliable data are 
available, EPA uses a different additional FQPA SF value based on the 
use of traditional UFs and/or special FQPA SFs, as appropriate.
    2. Prenatal and postnatal sensitivity. Since there was evidence of 
increased susceptibility of offspring following exposure to 
fluopicolide in rat developmental study, a Degree of Concern Analysis 
was performed to:
    i. Determine the level of concern for the effects observed when 
considered in the context of all available toxicity data.
    ii. Identify any residual uncertainties after establishing toxicity 
endpoints and traditional UFs to be used in the risk assessment for 
this chemical.
EPA concluded that there is low concern for the qualitative 
susceptibility because: The offspring toxicity was well characterized 
and was accompanied by maternal toxicity; there was a clear NOAEL/LOAEL 
for offspring toxicity; and because the dose/endpoint selected for 
long-term risk assessments is considerably lower and would address the 
concerns for offspring toxicity seen in this study. Therefore, there 
are no residual uncertainties for prenatal and/or postnatal toxicity.
    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 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.

[[Page 5454]]

    iii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats, the risk 
assessment team did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment of fluopicolide. The degree of concern for prenatal 
and/or postnatal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure 
data bases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. Conservative ground water and 
surface water modeling estimates were used. Similarly conservative 
Residential Standard Operating Procedues (SOPs) were used to assess 
postapplication exposure to children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by fluopicolide.
    EPA is retaining 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, females 13-49 years of age, chronic dietary, and 
incidental oral non-dietary. This is due to the incompleteness of the 
data base with regard to the systemic neurotoxic potential of BAM, 
including olfactory toxicity via the oral route of exposure.
    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. The reasons for this are that, based on 
a comparison of toxicity via the intraperitoneal route of exposure, 
higher doses of BAM are needed to induce levels of olfactory toxicity 
that are similar to those caused by dichlobenil (Brandt et al. 1990; 
Brittebo et al. 1991; Eriksson and Brittebo 1995). Olfactory toxicity 
was the endpoint chosen for these exposure scenarios.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. EPA does not expect that fluopicolide will pose an 
acute risk because an endpoint attributable to a single dose was not 
identified from the available data for fluopicolide.
    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. The chronic dietary exposure estimates for 
fluopicolide are 6% cPAD for the general U.S. population and 9% cPAD 
for children 1-2 years old, the most highly exposed subgroup. Based on 
the use pattern, 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 (<  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 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 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 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. Long-term aggregate risk. In examining long-term aggregate risk, 
the Agency has assumed that the only pathway of exposure relevant to 
that time frame is dietary exposure (i.e., any non-dietary exposures 
are short-term and/or intermediate-term in duration). Therefore, the 
long-term aggregate risk is composed of exposures to fluopicolide 
residues in food and drinking water and is equivalent to the chronic 
dietary risk. The chronic risk estimates are below the Agency's level 
of concern for all population subgroups.
    6. Aggregate cancer risk for U.S. population. Fluopicolide has been 
classified as ``not likely to be carcinogenic to humans'' and, is thus 
not expected to pose a cancer risk. As explained in Unit III. the 
chronic risk assessment for BAM is protective of any potential cancer 
risk.
    7. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fluopicolide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, the Liquid Chromatography/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

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) or 
tolerances have been established for fluopicolide.

C. Response to Comments

    One comment was received from B. Sachau. Ms. Sachau's comments 
regarding general exposure to pesticides contained no scientific data 
or evidence to rebut the Agency's conclusion that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
fluopicolide, including all anticipated dietary exposures and other 
exposures for which there is reliable

[[Page 5455]]

information. This comment as well as her comments regarding animal 
testing have been responded to by the Agency on several occasions. For 
examples, see the Federal Register issues of January 7, 2005 (70 FR 
1349) (FRL-7691-4) and October 29, 2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide, 
2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, as an indicator of combined residues of 
fluopicolide and its metabolite, BAM, on grape at 2.0 ppm; grape, 
raisin at 6.0 ppm; vegetable, cucurbit, group 9 at 0.50 ppm; vegetable, 
fruiting, group 8 at 1.6 ppm; vegetable, leafy, except brassica, group 
4 at 25 ppm; and vegetable, tuberous and corm, except potato, subgroup 
1D at 0.02 ppm. Additional livestock feeding studies and livestock 
tolerance enforcement methods are needed to support tolerances for: 
Potatoes and wheat. Tolerances for these commodities are not 
established at this time.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 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 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 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 6, 2000) do not apply to this rule. In addition, This 
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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: January 17, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

0
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. Section 180.627 is amended by revising paragraph (a) to read as 
follows:

180.627  Fluopicolide; tolerances for residues.

    (a) General. Tolerances are established for residues of 
fluopicolide, 2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide, as an indicator of combined residues of 
fluopicolide and its metabolite, 2,6-dichlorobenzamide (BAM).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape......................................................          2.0
Grape, raisin..............................................          6.0
Vegetable, cucurbit, group 9...............................         0.50
Vegetable, fruiting, group 8...............................         1.60
Vegetable, leafy, except brassica, group 4.................           25
Vegetable, tuberous and corm (except potato), subgroup 1D..         0.02
------------------------------------------------------------------------

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[FR Doc. E8-1525 Filed 1-29-08; 8:45 am]

BILLING CODE 6560-50-S