Document ID: EPA-HQ-OPP-2008-0302-0001
Agency: epa
Document Type: Rule
Title: Fludioxonil; Pesticide Tolerance for Emergency Exemption
Posted Date: 2008-07-23T04:00Z

[Federal Register: July 23, 2008 (Volume 73, Number 142)]
[Rules and Regulations]               
[Page 42713-42718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy08-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0302; FRL-8369-5]

 
Fludioxonil; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fludioxonil in or on carambola (starfruit). This action is 
in response to EPA's granting of an emergency exemption under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on carambola. This regulation 
establishes a maximum permissible level for residues of fludioxonil in 
starfruit. The time-limited tolerance expires and is revoked on 
December 31, 2010.

DATES: This regulation is effective July 23, 2008. Objections and 
requests for hearings must be received on or before September 22, 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-2008-0302. 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 either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are 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: Andrea Conrath, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9356; e-mail address: conrath.andrea@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:
     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 provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of

[[Page 42714]]

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 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 the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2008-0302 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 on or 
before September 22, 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 your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0302, 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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a 
time-limited tolerance for residues of the fungicide fludioxonil, (4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or 
on carambola at 10 parts per million (ppm). This time-limited tolerance 
expires and is revoked on December 31, 2010. EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fludioxonil on Carambola and FFDCA 
Tolerances

    The disease, Dothiorella fruit rot is a recent phenomenon in 
Florida and was documented as a major problem for citrus growers during 
the 2006-07 season. The current practice of dipping carambola in 
chlorine solution to remove other fungal pathogens has been ineffective 
in controlling Dothiorella fruit rot, and there are no other 
appropriate practices or materials available. The industry is also 
particularly vulnerable since it is still recovering from the 2005 
hurricane season and the 2006-07 spring drought which delayed flowering 
and fruiting. A postharvest dip of fludioxonil has demonstrated 
effective management of Dothiorella fruit rot. Losses suffered were 
expected to be significant if fludioxonil were not available for post-
harvest treatment as requested. After having reviewed the submission, 
EPA determined that emergency conditions exist for this State, and that 
the criteria for an emergency exemption are met. EPA has authorized 
under FIFRA section 18 the use of fludioxonil on carambola for control 
of Dothiorella fruit rot in Florida.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of fludioxonil 
in or on carambola. In doing so, EPA considered the safety standard in 
section 408(b)(2) of FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section

[[Page 42715]]

408(l)(6) of FFDCA. Although this time-limited tolerance expires and is 
revoked on December 31, 2010, under section 408(l)(5) of FFDCA, 
residues of the pesticide not in excess of the amount specified in the 
tolerance remaining in or on carambola after that date will not be 
unlawful, provided the pesticide was applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by this time-limited tolerance at the time of that 
application. EPA will take action to revoke this time-limited tolerance 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
fludioxonil meets FIFRA's registration requirements for use on 
carambola or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
fludioxonil by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than Florida to use this pesticide on this crop under FIFRA 
section 18 absent the issuance of an emergency exemption applicable 
within that State. For additional information regarding the emergency 
exemption for fludioxonil, contact the Agency's Registration Division 
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of this emergency exemption request and 
the time-limited tolerance for residues of fludioxonil on carambola at 
10 ppm. EPA's assessment of exposures and risks associated with 
establishing the time-limited tolerance follows.

A. 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 fludioxonil used for 
human risk assessment can be found at http://www.regulations.gov in 
document Fludioxonil. ``Human Health Risk Assessment for a Section 18 
Emergency Tolerance on Starfruit'' at page 35 in docket ID number EPA-
HQ-OPP-2008-0302.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fludioxonil, EPA considered exposure under the time-limited 
tolerance established by this action 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. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, an 
acute dietary assessment assuming tolerance-level residues for all 
commodities with existing and proposed tolerances and default 100% crop 
treated (CT) information was conducted for the population subgroup 
females 13 to 49 years old. The estimated peak drinking water 
concentration of 132 parts per billion (ppb) was directly incorporated 
into the acute risk assessment. There were no appropriate toxicological 
effects attributable to a single exposure (dose) for the general 
population or any other population subgroups; therefore these 
population subgroups were not included in this assessment. For food and 
drinking water, the exposure to females 13 to 49 yrs old (the most 
sensitive population subgroup) was 0.14 milligrams/kilogram/day (mg/kg/
day), which utilized 14% of the aPAD at the 95th percentile of exposure 
distribution.
    ii. Chronic exposure. 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 tolerance-
level residues for most commodities and 100% CT. Anticipated residue 
values for apple, grapefruit, lemon, lime, orange, and pear were 
generated from field trials. Anticipated residues were also determined 
from processing studies for apple, grapefruit, lemon, lime and orange 
juices. The mean drinking water estimate of 49 ppb was directly 
incorporated into the chronic assessment. For the U.S. population the 
exposure for food and water utilized 47% of the cPAD. The chronic 
dietary

[[Page 42716]]

risk estimate for the highest reported exposed population subgroup, 
children 1 to 2 years old, is 86% of the cPAD.
    iii. Cancer. Fludioxonil is classified as a ``Group D'' chemical - 
not classifiable as to human carcinogenicity. Therefore a cancer 
dietary assessment was not performed.
    iv. Anticipated residue 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 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.
    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 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.
    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 exposure is estimated to be 132 ppb (peak concentration), and for 
chronic (non-cancer) exposures, 49 ppm (mean concentration), both 
levels for surface water concentrations. Ground water sources were not 
included in this assessment, as the EDWCs for this water source are 
minimal in comparison to surface water (0.11 ppb for both acute and 
chronic concentrations).
    Modeled estimates of drinking water concentrations were entered 
directly into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 132 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 49 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 residential turf use, 
restricted to commercial applicators only. Since there are no short-
term or intermediate-term dermal toxicity endpoints, only a toddler 
post-application assessment for incidental ingestion exposures to 
treated lawns was included (for all children/infant subgroups). The 
combined short-term oral exposure risk estimate, which includes hand-
to-mouth, object-to-mouth and soil ingestion pathways, was determined 
to be 0.013 mg/kg body weight (bw)/day, while the intermediate-term was 
determined to be 0.0074 mg/kg bw/day. The MOEs for combined non-dietary 
oral exposures were 770 for short-term exposures and 450 for 
intermediate-term exposures. These do not exceed the EPA's LOC for 
residential exposures (MOEs < 100).
    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 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.

C. 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 SF 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 of rats and rabbits or following pre-natal/post-natal exposure 
of rats. In rats, 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 rats. In rats, developmental 
effects occurred in the presence of maternal effects. In rabbits, no 
developmental toxicity was seen up to the highest dose tested which 
demonstrated maternal toxicity. In the 2-generation rat reproduction 
study, offspring toxicity was seen at the dose that produced parental 
toxicity. The maternal toxicity was manifested as increased clinical 
signs, decreased body weight, body weight gain and food consumption. 
Fetal toxicity was manifested as decreased weight gain in pups. Since 
maternal and fetal 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 that 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. Anticipated residue values for apple, grapefruit, lemon, 
lime, orange, and pear were generated from field trials. Anticipated 
residues were also determined from processing studies for

[[Page 42717]]

apple, grapefruit, lemon, lime and orange juices. Data supporting the 
citrus crop group tolerance were used to estimate residues for 
carambola. These data are reliable and will not underestimate the 
exposure and risk. 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.

D. 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. Since the acute aggregate risk assessment includes 
exposure from food and water only, and the acute dietary analysis that 
was performed included both, no further calculations are necessary. An 
acute dietary assessment was conducted for the population subgroup 
females 13 to 49 years old. There were no appropriate toxicological 
effects attributable to a single exposure (dose) for the general 
population or other population subgroups; therefore only the subgroup 
of females 13 to 49 years old was included in this assessment. Using 
the exposure assumptions discussed in this unit for acute exposure, the 
acute aggregate exposure from food and water to fludioxonil will occupy 
14% of the aPAD for Females 13 to 49 years old.
    2. Chronic risk. Based on the explanation in the unit regarding 
residential use patterns, chronic residential exposure to residues of 
fludioxonil is not expected. Consequently, the chronic aggregate risk 
assessment includes exposure from food and water only. Because the 
chronic dietary analysis that was performed included both food and 
water, no further calculations are necessary for an aggregate chronic 
risk assessment. 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 86% of the cPAD for 
children 1 to 2 years old the population group receiving the greatest 
exposure. For the U.S. population the exposure for food and water 
utilized 47% of the cPAD.
    3. Short-term and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Fludioxonil 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- and intermediate-term residential exposures 
to fludioxonil.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded that combined short- 
and intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs for the most highly exposed subgroup, Infants 
<1 year old, of 320 for short-term exposures and 130 for intermediate-
term exposures. These do not exceed the level of concern for 
residential exposures (MOEs < 100).
    4. Aggregate cancer risk for U.S. population. Fludioxonil is 
classified as a ``Group D'' chemical - not classifiable as to human 
carcinogenicity. Therefore a cancer aggregate assessment was not 
performed.
    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 fludioxonil residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    The methods used in previous field trial studies were similar to a 
method validated by the Analytical Chemistry Branch (ACB). Since 
adequate method validation and concurrent recoveries were attained in 
the field trial studies, EPA concludes that the ACB validated method is 
appropriate for enforcement.
    Adequate enforcement methodology (high performance liquid 
chromatography method AG-597B) 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 CODEX maximum residue levels for fludioxonil residues 
on carambola.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on starfruit at 10 ppm. This tolerance expires and 
is revoked on December 31, 2010.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA. 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 in accordance 
with a FIFRA section 18 exemption under sections 408(e) and 408(l)(6) 
of FFDCA, such as the tolerances in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments,

[[Page 42718]]

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).

VIII. 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: July 9, 2008.
Donald R. 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 180.516 is amended by revising the table in paragraph (b) to 
read as follows:

Sec.  180.516  Fludioxonil; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Starfruit.........................                 10           12/31/10
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-16876 Filed 7-22-08; 8:45 am]

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