Document ID: EPA-HQ-OPP-2007-0339-0003
Agency: epa
Document Type: Rule
Title: Fluopicolide; Pesticide Tolerances
Posted Date: 2008-05-28T04:00Z

[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Rules and Regulations]               
[Page 30492-30498]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my08-12]                         

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0339; FRL-8363-7]

 
Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fluopicolide in or on vegetable, root, subgroup 1A, except sugar beet 
and carrot; vegetable, leaves of root and tuber, group 2; vegetable, 
bulb, group 3-07; and Brassica, head and stem, subgroup 5A. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In 
connection with a request for new uses of the active ingredient, 
fluopicolide, the Agency has also evaluated the toxicity and exposure 
databases for 2,6-dichlorobenzamide (BAM) which is a common metabolite/
degradate of dichlobenil and fluopicolide. Further characterization of 
fluopicolide and its metabolite BAM, will be discussed herein of this 
document.

DATES: This regulation is effective May 28, 2008. Objections and 
requests for hearings must be received on or before July 28, 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-2007-0339. 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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@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).
    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-2007-0339 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 as required by 40 CFR part 178 on or 
before July 28, 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-2007-0339, 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.

[[Page 30493]]

     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 27, 2007 (72 FR 35237) (FRL-8133-
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 
7E7172) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.627 be amended by 
establishing tolerances for residues of the fungicide fluopicolide, 
[2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], in or on vegetable, root and tuber, group 
1 at 0.2 parts per million (ppm); vegetable, leaves of root and tuber, 
group 2 at 12.0 ppm; vegetable, bulb, group 3 at 5.0 ppm; chive, fresh 
leaves at 5.0 ppm; chive, Chinese, fresh leaves at 5.0 ppm; daylily, 
bulb at 5.0 ppm; elegans hosta at 5.0 ppm; fritillaria, bulb at 5.0 
ppm; fritillaria, leaves at 5.0 ppm; garlic, serpent, bulb at 5.0 ppm; 
kurrat at 5.0 ppm; lady's leek at 5.0 ppm; leek, wild at 5.0 ppm; lily, 
bulb at 5.0 ppm; onion, Beltsville bunching at 5.0 ppm; onion, Chinese, 
bulb at 5.0 ppm; onion, fresh at 5.0 ppm; onion, macrostem at 5.0 ppm; 
onion, pearl at 5.0 ppm; onion, potato, bulb at 5.0 ppm; onion, tree, 
tops at 5.0 ppm; shallot, bulb at 5.0 ppm; shallot, fresh leaves at 5.0 
ppm; and brassica, head and stem, subgroup 5A at 5.0 ppm. The notice 
referenced a summary of the petition prepared by Valent Corporation, 
the registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petitions, EPA has 
revised certain proposed tolerance levels and corrected commodity 
definitions as follows:
    1. The Agency determined that adequate data are available to 
support establishing a tolerance for the bulb vegetable crop group 3-
07. IR-4 petitioned for a tolerance for bulb vegetable group 3 as well 
as individual tolerances on chive, fresh leaves; chive, Chinese, fresh 
leaves; daylily, bulb; elegans hosta; fritillaria, bulb; fritillaria, 
leaves; garlic, serpent, bulb; kurrat; lady's leek; leek, wild; lily, 
bulb; onion, Beltsville bunching onion; Chinese, bulb; onion, fresh; 
onion, macrostem; onion, pearl; onion, potato, bulb; onion, tree, tops; 
shallot, bulb; and shallot, fresh leaves (PP 7E7172). In the Federal 
Register of December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a 
final rule that revised the crop grouping regulations. As part of this 
action, EPA expanded and revised bulb vegetable group 3. Changes to 
crop group 3 (bulb vegetable) included adding new commodities, revising 
existing subgroups and creating new subgroups (including bulb vegetable 
crop group 3-07 consisting of the commodities requested in PP 7E7172 
and cultivars, varieties, and/or hybrids of these).
    EPA indicated in the December 7, 2007 final rule as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920) that, for existing 
petitions for which a notice of filing had been published, the Agency 
would attempt to conform these petitions to the rule. Therefore, 
consistent with this rule, EPA is establishing tolerances on bulb 
vegetable crop group 3-07. Bulb vegetable crop group 3-07 consists of a 
variety of commodities for which tolerances were requested in PP 
7E7172.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerances so that they agree with the recent crop grouping revisions 
because:
     i. Although the subgroup includes several new commodities, these 
commodities were proposed as individual tolerances and are closely 
related minor crops which contribute little to overall dietary or 
aggregate exposure and risk;
    ii. Fluopicolide exposure from these added commodities was 
considered when EPA conducted the dietary and aggregate risk 
assessments supporting this action and
    iii. The representative commodities for the revised subgroup has 
not changed.
    2. Based upon review of the data supporting PP 7E7172, EPA has also 
revised the tolerance levels for vegetable, root, subgroup 1A, except 
sugar beet and carrot to 0.15 ppm; vegetable, leaves of root and tuber, 
group 2 to 15.0 ppm; and vegetable, bulb, crop group 3-07 to 7.0 ppm. 
EPA revised these tolerance levels based on analyses of the residue 
field trial data using the Agency's Tolerance Spreadsheet in accordance 
with the Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data Standard Operating Procedure (SOP). EPA has also 
determined that it is not appropriate to establish tolerances on sugar 
beet and carrot at this time and revised the subgroup tolerance 
accordingly.

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 fluopicolide 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 fluopicolide 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 
fluopicolide 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 fluopicolide 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 the petitioned-for 
tolerances 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 vegetable, 
root, subgroup 1A, except sugar beet and carrot at 0.15 ppm; vegetable, 
leaves of root and tuber, group 2 at 15.0 ppm; vegetable, bulb, crop 
group 3-07 at 7.0 ppm; and brassica, head and stem, subgroup 5A at 5.0 
ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follow.

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

[[Page 30494]]

information on the studies received and the nature of the adverse 
effects caused by fluopicolide and its metabolite BAM as well as the 
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at 
http://www.regulations.gov in documents entitled Floupicolide: Human 
Health Risk Assessment for the Establishment of Tolerances for use on 
root vegetables (subgroup 1A), leaves of root and tuber vegetables 
(group 2), bulb vegetables (group 3), and head and stem brassica 
(subgroup 5A) on pages 29-35; and 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 on pages 54-62. Each of these risk assessments is 
contained within in docket ID number EPA-HQ-OPP-2007-0339.
    In general, the toxicology studies conducted on fluopicolide 
demonstrate few or no biologically significant toxic effects at 
relatively low-dose levels in animal studies and only mild or no toxic 
effects at high doses. The subchronic and chronic toxicity studies 
showed that the primary effects of fluopicolide are in the liver. 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. Fluopicolide is also 
not neurotoxic, carcinogenic, nor mutagenic. Fluopicolide is not a 
developmental or reproductive toxicant. There is no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero or post-
natal exposure to fluopicolide. No toxic effects were observed in 
studies in which fluopicolide was administered by the dermal routes of 
exposure.
    The rabbit developmental and rat chronic/carcinogenicity studies 
were considered co-critical for endpoint selection. The toxicological 
profile for fluopicolide suggests that increased durations of exposure 
(i.e., 90-day versus chronic) does not significantly increase the 
severity of observed effects. The rabbit developmental and rat chronic/
cancer studies were therefore considered for all exposure scenarios.
    BAM is a metabolite and/or environmental degradate of both the 
fungicide fluopicolide and the herbicide dichlobenil. Residues of BAM 
from uses of both fluopicolide and dichlobenil were considered when 
assessing BAM as a metabolite/degradate resulting from proposed uses of 
fluopicolide. BAM was assessed separately since there is no common 
toxicological effect for BAM and other fluopicolide residues of 
concern. The submitted acute and chronic studies on BAM were sufficient 
to evaluate human hazard potential. BAM demonstrated 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 but at 
doses of BAM that were higher than those of dichlobenil. 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 EPA 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 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 dichlobenil and therefore to BAM.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the 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) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.

    A summary of the toxicological endpoints for fluopicolide and its 
metabolite BAM used for human risk assessment can be found at http://
www.regulations.gov in documents entitled: Fluopicolide Human Health 
Risk Assessment for the Establishment of Tolerances for use on root 
vegetables (subgroup 1A), leaves of root and tuber vegetables (group 
2), bulb vegetables (group 3), and head and stem brassica (subgroup 5A) 
on pages 10-11; and BAM as a Metabolite/Degradate of Fluopicolide and 
Dichlobenil. Human Health Risk Assessment for proposed uses of 
Fluopicolide on root vegetables (subgroup 1A), leaves of root and tuber 
vegetables (group 2), bulb vegetables (group 3), and head and stem 
brassica (subgroup 5A) on pages 3-4. Each of these risk assessments is 
contained within in docket ID number EPA-HQ-OPP-2007-0339.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluopicolide and its metabolite BAM, EPA considered 
exposure under the petitioned-for tolerances as well as all existing 
fluopicolide and its metabolite BAM tolerances in 40 CFR 180.627 and 
the exposures from BAM from existing dichlobenil tolerances under 
180.231. EPA assessed dietary exposures from fluopicolide and 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.

[[Page 30495]]

    a. Fluopicolide. No effects were identified in the toxicological 
studies for fluopicolide; therefore, a quantitative acute dietary 
exposure assessment was not conducted.
    b. BAM. In estimating acute dietary exposure to BAM, EPA used food 
consumption information from the U.S. Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, maximum residues of 
BAM from fluopicolide and dichlobenil field trials on food commodities 
with established/pending tolerances were included in the assessment. 
The assessments used 100 percent crop treated (PCT) except for apples, 
blueberries, cherries, peaches, pears, and raspberries. No livestock 
tolerances are established or proposed for either fluopicolide or 
dichlobenil.
    ii. Chronic exposure.--a. Fluopicolide. In conducting the chronic 
dietary exposure assessment EPA used the food consumption data from the 
USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA 
assumed all foods for which there are tolerances or for which 
tolerances are being established contain tolerance-level residues and 
100 PCT.
    b. BAM. In conducting the chronic dietary exposure assessment EPA 
used the food consumption data from the USDA 1994-1996 and 1998 CSFII. 
As to residue levels in food, EPA assumed, maximum residues of BAM from 
fluopicolide and dichlobenil field trials on food commodities with 
established/pending tolerances were included in all foods for which 
there are tolerances. The assessments used 100 PCT except for apples, 
blueberries, cherries, cranberries, peaches, pears, and raspberries. No 
livestock tolerances are established or proposed for either 
fluopicolide or dichlobenil.
    iii. Cancer. Fluopicolide has been classified as ``not likely to be 
carcinogenic to humans.'' Therefore a cancer dietary exposure 
assessment was not conducted for the parent fluopicolide. Additionally, 
EPA has determined BAM's potential for carcinogenicity is similar to 
that of dichlobenil, which is classified as ``group C, possible human 
carcinogen.'' Quantification of cancer risk 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. Therefore, a separate cancer exposure assessment was 
not conducted.
    iv. Anticipated residue and PCT information. 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 pursuant to FFDCA section 
408(f)(1) require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such Data Call-Ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    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:
    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 
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by FFDCA section 
408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    For the BAM acute assessment, maximum PCT estimates were used for 
the following commodities: Apples (2.5%), blueberries (2.5%), cherries 
(2.5%), peaches (2.5%), pears (2.5%) and raspberries (2.5%).
    For the BAM chronic assessment, average PCT estimates were used for 
the following commodities: Apples (1%), blueberries (1%), cherries 
(1%), peaches (1%), pears (1%), raspberries (1%) and cranberries (45%).
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five percent except for those situations in which 
the average PCT is less than one. In those cases <1% is used as the 
average and <2.5% is used as the maximum. EPA uses a maximum PCT for 
acute dietary risk analysis. The maximum PCT figure is the single 
maximum value reported overall from available Federal, State, and 
private market survey data on the existing use, across all years, and 
rounded up to the nearest multiple of five percent. In most cases, EPA 
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent six years.
    The Agency believes that the three conditions listed in this unit 
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 
information on the regional consumption of food to which BAM may be 
applied in a particular area.
    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, and fate/transport 
characteristics of fluopicolide. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    No monitoring data were available for fluopicolide or BAM. Drinking 
water residues of fluopicolide (parent) were modeled for exposures 
resulting from uses on grapes, vegetables, and turf, which are the uses 
that are expected to yield the highest estimated environmental 
concentrations (EECs).

[[Page 30496]]

Drinking water residues for BAM were modeled for exposures resulting 
from the use currently registered on dichlobenil for control of 
nutsedge. This use is expected to yield the highest EECs for BAM.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW), the estimated drinking water concentrations (EDWCs) 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. Chronic 
exposures are estimated to be 8.34 ppb for surface water and 0.64 ppb 
for ground water. Based on the PRZM/EXAMS and SCI-GROW models, the 
EDWCs of BAM for acute exposures are estimated to be 20.9 ppb for 
surface water and 56.2 for ground water. Chronic exposures are 
estimated to be 8.61 ppb for surface water and 56.2 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment for BAM, the water concentration value of 56.2 ppb was used 
to assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 8.34 ppb and 56.2 were 
used to assess the contribution to drinking water for fluopicolide and 
BAM, respectively.
    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 
recreational sites.The labels do not prohibit homeowners from using 
these products; therefore, residential handlers may receive short-term 
dermal and inhalation exposure to fluopicolide when mixing, loading and 
applying the formulations. Dermal exposure is likely for adults and 
children entering treated lawns. Toddlers may also experience exposure 
via incidental non-dietary ingestion during postapplication activities 
on treated turf.
     EPA assessed residential exposure for fluopicolide using the 
following assumptions:
    i. Handler exposure scenarios resulting from residential lawn 
applicators were assessed for 1. mix/load and spot application of 
liquid formulation (low-pressure hand sprayer), and 2. mix/load and 
broadcast application of liquid formulation (garden hose-end sprayer).
    Post-application exposure scenarios resulting from lawn treatment 
were assessed for 1. adult and toddler postapplication dermal exposure, 
2. toddlers' incidental ingestion of pesticide residues on lawns from 
hand-to-mouth transfer, 3. toddlers' object-to-mouth transfer from 
mouthing of pesticide-treated turfgrass, and 4. toddlers' incidental 
ingestion of soil from pesticide-treated residential areas. There are 
short and intermediate term exposures for fluopicolide.
    BAM exposure estimates are based on fluopicolide use only since the 
use pattern for dichlobenil is not expected to result in scenarios with 
significant residential/non-occupational exposure. Exposure to BAM from 
fluopicolide uses on residential turfgrass and recreational sites, such 
as golf courses, has been evaluated. Residential handler exposure was 
not evaluated because the metabolite BAM is believed to form slowly in 
plants and soil after the product containing the parent (fluopicolide) 
has been applied.
     EPA assessed residential exposure for BAM using the following 
assumptions:
    ii. Post-application exposure scenarios resulting from lawn 
treatment were assessed for 1. adult and toddler postapplication dermal 
exposure, 2. toddlers' incidental ingestion of pesticide residues on 
lawns from hand-to-mouth transfer, 3. toddlers' object-to-mouth 
transfer from mouthing of pesticide-treated turfgrass, and 4. toddlers' 
incidental ingestion of soil from pesticide-treated residential areas. 
Short and intermediate term exposures for fluopicolide are expected.

    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 (parent) and 
its metabolite BAM, and any other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that fluopicolide 
(parent) and its metabolite BAM has a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses or pups to in utero 
or post-natal exposure to fluopicolide.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for fluopicolide is complete.
    ii. There is no indication that fluopicolide is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluopicolide results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    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. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to fluopicolide in drinking water. EPA used 
similarly conservative assumptions to assess postapplication exposure 
of children as well as incidental oral

[[Page 30497]]

exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by fluopicolide.
    BAM: 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

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure from food and water to BAM will occupy 28% of the aPAD 
for all infants <1 year old and females 13-49 years old, the population 
groups receiving the greatest exposure.
    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 11% of the cPAD for 
children 1-2 years old, and chronic exposure to BAM from food and water 
will utilize 93% of the cPAD for all infants <1 year old, the 
population group receiving the greatest exposure. Based on the 
explanation in Unit III.C.3., regarding residential use patterns, 
chronic residential exposure to residues of fluopicolide and its 
metabolite is not expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fluopicolide is currently registered for uses that could result in 
short and intermediate term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short-term and intermediate-term residential 
exposures to fluopicolide. Using the exposure assumptions described in 
this unit for short-term and intermediate-term exposures, EPA has 
concluded the combined short-term and intermediate-term food, water, 
and residential exposures aggregated for fluopicolide result in 
aggregate MOEs of 300 for children 1-2 years.
    As discussed in the unit for short-term and intermediate-term 
exposures, exposures to BAM may result based on use of fluopicolide 
only since the use pattens for dichlobenil are not expected to result 
in scenarios with significant residential/non-occupational exposure. 
Exposure to BAM from fluopicolide uses on residential turfgrass and 
recreational sites, such as golf courses, has been evaluated. The 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short and intermediate term 
residential exposures to BAM. Using the exposure assumptions described 
in this unit for short-term and intermediate-term exposures for BAM, 
EPA has concluded the combined short and intermediate term food, water, 
and residential exposures aggregated result in aggregate MOEs of 3200 
for all infants <1 year old and 5,400 for children 1-2 years old.
    4. Aggregate cancer risk for U.S. population. Fluopicolide has been 
classified as ``not likely to be carcinogenic to humans.'' As such, an 
estimate of cancer risk is not warranted for parent fluopicolide.
    EPA has determined BAM's potential for carcinogenicity is similar 
to that of dichlobenil, which is classified as ``group C, possible 
human carcinogen.'' Quantification of cancer risk is based on the RfD 
approach which requires comparison of the chronic exposure to the RfD. 
Therefore, the chronic risks discussed in Unit III.E.2. are considered 
protective of both non-cancer and cancer effects.
    5. 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 mass 
spectrometry ((LC/MS/MS) method, Method RM-43C-2) is available to 
enforce the tolerance expression for fluopicolide. Enforcement 
methodology (LC/MS/MS Method, Methods 00782, 00782/M001, 00782/M002, 
and 00782/M003) is available to adequately enforce the tolerance 
expression for BAM. The methods 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.

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 vegetable, root, subgroup 1A, 
except sugar beet and carrot at 0.15 ppm; vegetable, leaves of root and 
tuber, group 2 at 15.0 ppm; vegetable, bulb, crop group 3-07 at 7.0 
ppm; and brassica, head and stem, subgroup 5A at 5.0 ppm.

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

[[Page 30498]]

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, 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 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (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: May 14, 2008.
Donald Stubbs,
Acting Director, Registration Division, 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 alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                 Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A......                                                                   5.0
                                                    * * * * *
Vegetable, bulb, crop group 3-07..........                                                                   7.0
                                                    * * * * *
Vegetable, leaves of root and tuber, group                                                                  15.0
 2........................................
Vegetable, root, subgroup 1A, except sugar                                                                  0.15
 beet and carrot..........................
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. E8-11853 Filed 5-27-08; 8:45 am]

BILLING CODE 6560-50-S