Document ID: EPA-HQ-OPP-2007-0940-0003
Agency: epa
Document Type: Rule
Title: Fludioxonil; Pesticide Tolerances
Posted Date: 2008-09-10T04:00Z

[Federal Register: September 10, 2008 (Volume 73, Number 176)]
[Rules and Regulations]               
[Page 52597-52603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se08-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0940; FRL-8379-9]

 
 Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fludioxonil in or on avocado; canistel; citrus, oil; mango; papaya; 
sapodilla; sapote, black; sapote, mamey; star apple; tomatillo; tomato; 
vegetable, cucurbit, crop group 9; vegetable, leaves of root and tuber, 
crop group 2; vegetable, root, except sugar beet, subgroup 1B; and 
vegetable, tuberous and corm, except potato, subgroup 1D. The 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) on 
behalf of the registrant, Syngenta Crop Protection, Greensboro, NC 
27409.

DATES: This regulation is effective September 10, 2008. Objections and 
requests for hearings must be received on or before November 10, 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-2007-0940. 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation

[[Page 52598]]

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-2007-0940 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 November 10, 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-2007-0940, 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 October 24, 2007 (72 FR 60369) (FRL-
8150-8), 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 
7E7234) by the Interregional Research Project Number 4 (IR-4), IR-4 
Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.516 be amended by 
establishing tolerances for residues of the fungicide fludioxonil, 4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on 
tomato at 0.4 parts per million (ppm); tomatillo at 0.4 ppm; tomato, 
paste at 1.0 ppm; avocado at 0.45 ppm; black sapote at 0.45 ppm; 
canistel at 0.45 ppm; mamey sapote at 0.45 ppm; mango at 0.45 ppm; 
papaya at 0.45 ppm; sapodilla at 0.45 ppm; star apple at 0.45 ppm; 
herb, subgroup 19A, fresh at 13 ppm; herb, subgroup19A, dried at 55 
ppm; leaves of root and tuber vegetables at 40 ppm; root vegetables, 
except sugar beet, subgroup at 0.5 ppm; lemon at 0.25 ppm; lime at 0.25 
ppm; cucurbits at 0.6 ppm; and tuberous and corm vegetables, except 
potato subgroup at 4.0 ppm. Additionally, IR-4 proposed that upon 
establishment of the above new tolerances, 40 CFR 180.516 be amended by 
removing the established tolerances for fludioxonil in or on the food 
commodities; herb, subgroup 19A, fresh at 10 ppm; herb, subgroup 19A, 
dried at 65 ppm; carrot at 0.75 ppm; and turnip, greens at 10 ppm. That 
notice referenced a summary of the petition prepared by Syngenta Crop 
Protection, Greensboro, NC 27409, 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 petition, EPA made 
changes or modifications to some of the proposed tolerances and/or 
commodity listings as detailed in this document--Unit IV.C. Revisions 
to Petitioned-For Tolerances.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Consistent with 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 fludioxonil in or on tomato at 0.4 ppm; 
tomatillo at 0.4 ppm; tomato, paste at 1.0 ppm; avocado at 0.45 ppm; 
black sapote at 0.45 ppm; canistel at 0.45 ppm; mamey sapote at 0.45 
ppm; mango at 0.45 ppm; papaya at 0.45 ppm; sapodilla at 0.45 ppm; star 
apple at 0.45 ppm; herb, subgroup 19A, fresh at 13 ppm; herb, 
subgroup19A, dried at 55 ppm; leaves of root and tuber vegetables at 40 
ppm; root vegetables, except sugar beet subgroup at 0.5 ppm; lemon at 
0.25 ppm; lime at 0.25 ppm; cucurbits at 0.6 ppm; and tuberous and corm 
vegetables, except potato subgroup at 4.0 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Fludioxonil is of low acute toxicity and is not a dermal 
sensitizer. For subchronic and chronic toxicity, the primary effects in 
the mouse and rat were similar and included decreased body weight and 
food consumption associated with clinical pathological and 
histopathological effects in the liver and kidney. In the subchronic 
dog study, diarrhea was the most sensitive indicator of toxicity. In 
contrast, decreased weight gain in females was the most sensitive 
indicator of toxicity in the chronic toxicity study in dogs. Liver 
toxicity was observed in both dog studies at higher doses. The 
available data did not indicate a need for acute or subchronic 
neurotoxicity studies. Fludioxonil was not teratogenic in rabbits. In a 
rat developmental toxicity study, it caused an increase in fetal 
incidence and litter incidence of dilated renal pelvis at the limit 
dose (1,000 mg/kg/day). There was no quantitative or qualitative 
evidence of increased susceptibility following in utero exposure to 
rats and rabbits or following pre-/post-natal exposure to rats.
    EPA determined that fludioxonil was not classifiable as to human 
carcinogenicity but nonetheless poses a negligible cancer risk. This 
conclusion was based on the fact that cancer studies with fludioxonil 
only showed marginal evidence of cancer in one sex of the species. 
There was no evidence of carcinogenicity in mice when tested up to the 
limited dose 7,000 ppm. There

[[Page 52599]]

was no evidence of carcinogenicity in male rats, but there was a 
statistically significant increase, both trend and pairwise, of 
combined hepatocellular tumors in female rats. The pairwise increase 
for combined tumors was significant at p=0.03, which is not a strong 
indication of a positive effect. Further, statistical significance was 
only found when liver adenomas were combined with liver carcinomas. 
Finally, the increase in these tumors was within, but at the high end, 
of the historical controls. Fludioxonil was not mutagenic in the tests 
for gene mutations. However, based on the induction of polyploidy in 
the in vitro Chinese hamster ovary cell cytogenetic assay and the 
suggestive evidence of micronuclei induction in rat hepatocytes in 
vivo, additional mutagenicity testing was performed in three studies 
specifically designed to address the concerns regarding aneuploidy. The 
results of these assays were negative for aneuploidy activity.
    Specific information on the studies received and the nature of the 
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Fludioxonil. Human Health Risk 
Assessment for Section 3 Tolerances on Avocado......and Brassica 
Vegetables, dated July 10, 2008 at page 20 in docket ID number EPA-HQ-
OPP-2007-0940-003.

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-, intermediate-
, 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 fludioxonil used for 
human risk assessment can be found at http://www.regulations.gov in 
document Fludioxonil. Human Health Risk Assessment for Section 3 
Tolerances on Avocado......and Brassica Vegetables, dated July 10, at 
page 20 in docket ID number EPA-HQ-OPP-2007-0940-0003.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fludioxonil, EPA considered exposure under the petitioned-
for tolerances as well as all existing fludioxonil tolerances in 40 CFR 
180.516. EPA assessed dietary exposures from fludioxonil 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.
    In estimating acute dietary exposure, EPA used the Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCIDTM, Version 2.03), which incorporates food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intakes by Individuals (CSFII). As to residue levels in food, 
acute dietary exposure analysis is based on tolerance-level residues. 
EPA assumed that 100% of the crops with fludioxonil tolerances are 
treated. The only population subgroup that is relevant for this acute 
assessment is females of child-bearing age (i.e., females 13 to 49 
years old).
    ii. Chronic exposure. In conducting the chronic dietary (food + 
water) exposure assessment EPA used the food consumption data from the 
USDA 1994-1996 and 1998 Nationwide CSFII. As to residue levels in food, 
the chronic dietary exposure analyses assumed tolerance-level residues 
for most commodities with existing and proposed tolerances. Anticipated 
residues (AR) values were determined for apple, grapefruit, lemon, 
lime, pear, orange and orange juices using average residues from field 
trials and processing factors from processing studies. Processing 
factors were set to 1X for all relevant processed commodities. DEEM-
FCID default processing factors were used for all other processed 
commodities. The population subgroup of highest exposure is children 
1to 2 years old. The Agency assumed 100% of crops with fludioxonil 
tolerances are treated.
    iii. Cancer. As explained above, EPA determined that fludioxonil 
was not classifiable as to human carcinogenicity. Therefore, no 
assessment of exposure for the purpose of estimating cancer risk is 
necessary.
    iv. Anticipated residue. 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 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.
    Anticipated residue data were used in the chronic (non-cancer) 
dietary risk analyses but not in the acute dietary risk analysis. For 
certain proposed tolerance crops, the anticipated residues values were 
determined from the field trial studies. Additionally, results of 
processed commodities studies show that fludioxinil residues do not 
concentrate to the extent that the existing crop tolerance would be 
exceeded.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fludioxonil in drinking water. These

[[Page 52600]]

simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of fludioxonil. 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.
    The maximum application rates for the new uses are less than the 
application rate for turfgrass. Therefore, the values for turfgrass 
(worst case) were used in the human health risk assessment. Tier 1 
drinking water assessment for fludioxonil on turfgrass is based on the 
label application rate for turfgrass, which is used in this current 
assessment, and is three applications of 0.67 lb active ingredient/Acre 
(ai/A) applied using 14-day intervals, for a total application rate of 
2 lb ai/A/year.
    Based on the First Index Reservoir Screening Tool (FIRST and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of fludioxonil for 
acute and chronic (non-cancer) exposures. EDWCs were modeled based on 
the use site with the highest application rate; i.e., spray/foliar 
applications to turfgrass of 2.0 lbs ai/A/yr. For acute exposure, EDWCs 
are estimated to be 81.3 parts per billion (ppb) for surface water and 
0.20 ppb for ground water. The EDWCs for chronic exposures for non-
cancer assessments are estimated to be 37.4 ppb for surface water and 
0.20 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 81.3 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 37.4 ppb was used to 
assess the contribution to drinking water.
    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).
    Fludioxonil is currently registered for the following uses that 
could result in residential exposures: turfgrass and ornamentals. EPA 
assessed residential exposure using the following assumptions: The 
current petition for fludioxonil results in no residential/non-
occupational exposures. Since the product registered for residential 
uses, Medallion[reg] (EPA Reg. No. 100-769), is restricted 
for residential uses to commercial applicators-only, and since the 
Agency did not identify short- or intermediate-term dermal endpoints, 
only a toddler post-application assessment for incidental ingestion 
exposures to treated lawns was included.
    The combined short-term oral exposure risk estimate, which includes 
hand-to-mouth, object-to-mouth and soil ingestion pathways, was 
previously determined to be 0.013 milligrams/kilogram of bodyweight/day 
(mg/kg bw/day), while the intermediate-term was determined to be 0.0074 
mg/kg bw/day. It should be noted that each of the incidental oral 
assessments (i.e., hand-to-mouth, object-to-mouth and soil ingestion) 
are considered conservative. Therefore, combining all the assessments 
is expected to provide a highly conservative assessment of children's 
incidental oral exposure.
    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 fludioxonil to share a common mechanism of 
toxicity with any other substances, and fludioxonil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fludioxonil does not have 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.

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 was no quantitative or 
qualitative evidence of increased susceptibility following in utero 
exposure to rats and rabbits or following prenatal/postnatal exposure 
to rats. In the rat developmental study, there was an increase in the 
number of fetuses and litters with dilated renal pelvis and dilated 
ureter. This finding was considered to be related to maternal toxicity 
rather than an indication of increased susceptibility. Therefore, it is 
concluded that there is no evidence of increased susceptibility in the 
developmental toxicity study in the rat. In the rabbit developmental 
study, no developmental toxicity was seen up to the highest dose 
tested. Materal toxicity was demonstrated at that dose. In the 2-
generation rat reproduction study, offspring toxicity was seen at the 
dose that produced parental toxicity. The parental toxicity was 
manifested as increased clinical signs, decreased body weight, body 
weight gain and food consumption. Offspring toxicity was manifested as 
decreased weight gain in pups. Since parental and offspring toxicity 
were comparable, it was concluded that there is no increased 
susceptibility in the 2-generation reproduction study.
    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 fludioxonil is complete.
    ii. There is no indication that fludioxonil 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 fludioxonil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues or residues from crop field 
trials. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to fludioxonil in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by fludioxonil.

[[Page 52601]]

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-, intermediate-, 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 for the 
general population including infants and children. Therefore, 
fludioxonil is not expected to pose an acute risk.
    Using the exposure assumptions discussed in this unit for acute 
exposure for females 13 to 49 years old, the acute dietary exposure 
from food and water to fludioxonil will occupy 14% of the aPAD for 
(females 13 to 49 years old) the population group 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 
fludioxonil from food and water will utilize 89% of the cPAD for 
(children 1 to 2 years old) the population group receiving the greatest 
exposure.
    Based on the discussions above regarding residential use patterns, 
chronic residential exposure to residues of fludioxonil is not 
expected. The chronic aggregate risk does not exceed the Agency's level 
of concern.
    3. Short-term risk. In aggregating short-term risk, EPA considers 
background chronic dietary exposure (food + water) and short-term, 
residential non-dietary oral and dermal exposures. Fludioxonil is 
restricted to commercial handlers. Therefore, the only non-occupational 
exposure expected to result from the residential uses of fludioxonil is 
post-application exposure. For adults, post-application exposures may 
result from dermal contact with treated turf. For toddlers, dermal and 
non-dietary oral post-application exposures may result from dermal 
contact with treated turf as well as hand-to-mouth transfer of residues 
from turfgrass. However, the Agency did not identify short-term dermal 
endpoints for fludioxonil. Therefore, the short-term aggregate risk for 
fludioxonil considers food, water, and residential non-dietary oral 
exposures (for toddlers).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 250 
for children (1 to 2 years old) and 280 for children (3 to 5 years old) 
for short-term scenario. These values are well above the Agency's level 
of concern of an aggregate MOE level of below 100.
    4. Intermediate-term risk. In aggregating intermediate-term risk, 
the Agency considers background chronic dietary exposure (food + water) 
and intermediate-term, residential non-dietary oral and dermal 
exposures. Based on the residential use pattern, there is a 
possibility, although unlikely, that a toddler may experience 
intermediate-term exposures to fludioxonil residues on treated lawns. 
As with the short-term aggregate assessment, only non-dietary exposures 
are included. Therefore, the intermediate-term aggregate risk for 
fludioxonil considers food, water, and residential non-dietary oral 
exposures (for toddlers).
    All intermediate-term aggregate risk estimates result in MOEs 
greater than 100, with the exception that the MOE for children 1 to 2 
years old is 98, just below 100. Due to the conservative nature of the 
dietary exposure assessment (assumes 100% of crops with tolerances are 
treated and most crops have residues at the tolerance-level and the 
fact that dietary exposure is 78 percent of the aggregate exposure), 
EPA does not have any concern for the purposes of this action. 
Intermediate-term aggregate exposure to fludioxonil, as a result of all 
registered and proposed uses, is below EPA's level of concern.
    5. Aggregate cancer risk for U.S. population. Fludioxonil poses a 
negligible cancer risk. Cancer studies with fludioxonil only showed 
marginal evidence of cancer in one sex of one species. There was no 
evidence of carcinogenicity in mice when tested up to the limited dose 
7,000 ppm. There was no evidence of carcinogenicity in male rats, but 
there was a statistically significant increase, both trend and 
pairwise, of combined hepatocellular tumors in female rats. The 
pairwise increase for combined tumors was significant at p=0.03, which 
is not a strong indication of a positive effect. Further, statistical 
significance was only found when liver adenomas were combined with 
liver carcinomas. Finally, the increase in these tumors was within, but 
at the high end, of the historical controls.
    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 fludioxonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, High Performance Liquid 
Chromatography 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

    There are no Canadian or Mexican Maximum Residue Limits (MRLs) for 
residues of fludioxonil. There are Codex limits on tomato (higher than 
the U.S. limit; 0.5 ppm vs 0.40 ppm, proposed), herbs (equal to or 
lower than the U.S. limit), cucurbits (lower than the U.S. limit), and 
carrot (lower than the U.S. limit). Except for tomato, the Codex MRLs 
are not a restriction on items for which there is a significant import 
trade. Since having the U.S. tolerance lower than the Codex MRL would 
cause a barrier to tomato imports, the tomato and tomatillo tolerances 
were raised from 0.40 ppm to 0.50 ppm.

C. Revisions to Petitioned-For Tolerances

    The Agency modified/amended certain tolerances as proposed by the 
registrant and/or indicated by available supporting data, as follows:
    i. Proposed new tolerances for herb subgroup 19A, fresh at 13 ppm 
and herb subgroup 19A, dried at 55 ppm were rejected by EPA and 
existing tolerances at 10 ppm and 60 ppm, respectively, were retained. 
The petitioner requested that the existing data for fresh and dry basil 
and chive be combined with the submitted parsley data and used in 
support of the requested tolerances on the herb subgroup 19A, fresh and 
dried at 13 ppm and 55 ppm, respectively. There are adequate residue 
field trials to support a tolerance on parsley, fresh and dried. The 
analytical results show

[[Page 52602]]

that fludioxonil residues were 3.87 ppm in fresh parsley and 22.29 ppm 
in dried parsley. It is EPA policy to analyze each crop in a group 
separately and establish the group tolerance using the highest of the 
individual analyses. Since there are existing tolerances for herb 
subgroup 19A, fresh and dried at 10 ppm and 65 ppm, respectively, and 
the data from the parsley residue field trials do not exceed those 
established tolerances using the same treatment pattern, no change in 
the group tolerance is required.
    ii. Proposed tolerances for lime at 0.25 ppm; and lemon at 0.25 ppm 
were determined to be unnecessary due to the existing tolerance on 
fruit, citrus, group 10 at 10 ppm and the citrus, oil tolerance at 500 
ppm established by this regulation.
    iii. Proposed tolerances for tomato at 0.40 and tomatillo at 0.40 
were both raised to 0.50 ppm to address international harmonization 
issues. Proposed tolerances for tomato paste at 1.0 ppm is not needed. 
Results of processed commodities studies show that fludioxonil residues 
do not appreciably concentrate, and
    iv. Certain commodity definitions in the petition were corrected or 
revised to comply with EPA's Pesticide Tolerance Crop Grouping Program 
outlined in the Federal Register of December 7, 2007, 72 FR 69150

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide 
fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile, in or on avocado at 0.45 ppm, canistel at 0.45 ppm, 
citrus, oil at 500 ppm, mango at 0.45 ppm, papaya at 0.45 ppm, 
sapodilla at 0.45 ppm, sapote, black at 0.45 ppm, sapote, mamey at 0.45 
ppm, star apple at 0.45 ppm, tomatillo at 0.50 ppm, tomato at 0.50 ppm, 
vegetable, cucurbit, crop group 9 at 0.45 ppm, vegetable, leaves of 
root and tuber, crop group 2 at 30 ppm, vegetable, root, except sugar 
beet, subgroup 1B at 0.75 ppm, and vegetable, tuberous and corm, except 
potato, subgroup 1D at 3.5 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 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: August 25, 2008.
Lois Rossi,
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. In Sec.  180.516 the table to paragraph (a) is amended by removing 
the entries for ``carrot;'' ``grapefruit oil'' and ``leaves and roots 
of tuber vegetables,'' and by alphabetically adding the following 
commodities, except for ``vegetable, cucurbit, group 9,'' which is 
revised. The added and revised entries read as follows:

Sec.  180.516   Fludioxonil; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Avocado......................................................       0.45
                                * * * * *
Canistel.....................................................       0.45
                                * * * * *
Citrus, oil..................................................        500
                                * * * * *
Mango........................................................       0.45
                                * * * * *
Papaya.......................................................       0.45
                                * * * * *
Sapodilla....................................................       0.45
Sapote, black................................................       0.45
Sapote, mamey................................................       0.45
                                * * * * *
Star apple...................................................       0.45
                                * * * * *
Tomatillo....................................................       0.50
Tomato.......................................................       0.50
                                * * * * *
Vegetable, cucurbit, crop group 9............................       0.45

[[Page 52603]]

                                * * * * *
Vegetable, leaves of root and tuber, crop group 2............         30
Vegetable, root, except sugar beet, subgroup 1B..............       0.75
                                * * * * *
Vegetable, tuberous and corn, except potato, subgroup 1D.....        3.5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-20547 Filed 9-9-08; 8:45 am]

BILLING CODE 6560-50-S