Document ID: EPA-HQ-OPP-2010-0982-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Fludioxonil
Posted Date: 2011-02-11T05:00Z

[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Rules and Regulations]
[Pages 7707-7712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2405]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0982; FRL-8859-6]

Fludioxonil; Pesticide Tolerances for Emergency Exemptions

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 pineapple. 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 pineapple. This regulation establishes a 
maximum permissible level for residues of fludioxonil in or on this 
commodity. The time-limited tolerance expires on December 31, 2013.

DATES: This regulation is effective February 11, 2011. Objections and 
requests for hearings must be received on or before April 12, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION section).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0982. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at 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: 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 entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2010-0982 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before April 12, 2011. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).

[[Page 7708]]

    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0982, 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 Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. 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 fludioxonil, (4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile), in or on pineapple at 
13 parts per million (ppm). This time-limited tolerance expires on 
December 31, 2013.
    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 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of section 408 of FFDCA and the 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 Pineapple and FFDCA 
Tolerances

    The applicant stated that unforeseen changes in available options 
for shipping Hawaiian pineapple to the mainland of the United States 
resulted in increased storage and transport time for the fruit. The 
overall increased shipment time is allowing surface molds to become 
established, which is leading to rejection, downgrading, or dumping of 
the unacceptable fruit. The Applicant stated that because of this 
unanticipated situation, an emergency situation exists, with 
significant economic losses suffered. Further, the Applicant asserts 
that without a suitable fungicide, such as fludioxonil, to address this 
issue, the future viability of the pineapple industry in Hawaii is 
threatened.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of fludioxonil on 
Hawaiian pineapple for control of surface molds.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of fludioxonil 
in or on pineapple. 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 408(l)(6) of FFDCA. Although 
this time-limited tolerance expires on December 31, 2013, 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 pineapple 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 
pineapple 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 by itself serve as the authority for 
persons in any State other than Hawaii to use this pesticide on the 
applicable crops 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

    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerance for residues of fludioxonil on pineapple at

[[Page 7709]]

13 ppm. EPA's assessment of exposures and risks associated with 
establishing the time-limited tolerance follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the level at which no adverse effects are observed (the 
NOAEL) and the lowest level at which adverse effects of concern are 
identified (the LOAEL). Uncertainty/safety factors are used in 
conjunction with the POD to calculate a safe exposure level--generally 
referred to as a population-adjusted dose (PAD) or a reference dose 
(RfD)--and a safe margin of exposure (MOE). For non-threshold risks, 
the Agency assumes that any amount of exposure will lead to some degree 
of risk. Thus, the Agency estimates risk in terms of the probability of 
an occurrence of the adverse effect expected in a lifetime. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see 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 Pineapple,'' dated August 4, 2010, p. 23-24 in 
Docket ID number EPA-HQ-OPP-2010-0982.

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. Adverse effects from acute exposure were 
identified for fludioxonil for the population subgroup females 13-49 
years old. The acute population adjusted dose (aPAD) is set at 1.0 
milligrams/kilograms/day (mg/kg/day) based upon acute effects of 
increased incidence of fetuses and litters with dilated renal pelvis 
and dilated ureter seen in the rat developmental study. In estimating 
acute dietary exposure, 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, EPA conducted an acute dietary assessment assuming 
established and proposed tolerance-level residues for all commodities 
and default 100 percent crop treated (PCT) information for the 
population subgroup females 13-49 years old. No anticipated residue or 
estimated PCT data were used. The estimated peak drinking water 
concentration of 108 parts per billion (ppb) was directly incorporated 
into the acute risk assessment. There were no significant toxicological 
effects attributable to a single exposure (dose) for the general 
population or any other population subgroups; therefore these 
populations' subgroups were not included in this assessment. For food 
and drinking water, the exposure to females 13-49 years old (the only 
population subgroup demonstrating acute effects) utilized 15% 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 conducted a chronic 
dietary assessment assuming established and proposed tolerance-level 
residues with the exception of the following: Anticipated residues 
(ARs) were generated for apple, grapefruit, lemon, lime, orange, pear, 
tomato, lettuce (head and leaf), fresh parsley, Brassica leafy 
vegetables (crop group 5), grape, cherry, peach, and plum based upon 
field trial data. Empirical processing factors were determined from 
processing studies for the juices of tomato, apple, grapefruit, lemon, 
lime, grape, and orange, and for raisins; default processing factors 
were used in all other instances. No PCT data were used (100% crop 
treated was assumed). The estimated chronic drinking water 
concentration of 53 ppb was directly incorporated into the assessment. 
Food and water consumption were compared to the chronic population 
adjusted dose (cPAD) of 0.03 mg/kg/day, which is based upon the chronic 
effect of decreased weight gain in females seen in the 1-year dog 
feeding study. For food and water consumption, the chronic exposure to 
fludioxonil utilized 26% of the cPAD for the general U.S. population 
and 88% of the cPAD for children 1-2 years old, the most highly exposed 
population subgroup.
    iii. Cancer. Based on the available data, EPA has determined that 
fludioxonil is a ``Group D'' chemical, not classifiable as to human 
carcinogenicity, and 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 highest dose of 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 
statistically significant, but only 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. 
Therefore, the Agency concluded that a dietary exposure assessment for 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use PCT 
information in the dietary assessment for fludioxonil. One hundred 
percent of the pineapple crop was assumed treated.
    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 section 408(f)(1) of FFDCA 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 section 408(b)(2)(E) of FFDCA and authorized under 
section 408(f)(1) of FFDCA. Data will be required to be submitted no 
later than 5 years from the date of issuance of these tolerances.

[[Page 7710]]

    Anticipated residue data were used in the chronic (non-cancer) 
dietary risk analyses but not in the acute dietary risk analysis. For 
certain tolerances, the anticipated residue values were determined from 
the field trial studies. Additionally, results of processed commodities 
studies show that fludioxonil residues do not concentrate to the extent 
that the existing crop tolerances 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 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 exposures are estimated to be 108 ppb for surface water and 0.4 
ppb for ground water. The EDWCs for chronic exposures for non-cancer 
assessments are estimated to be 53 ppb for surface water and 0.4 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure models. For acute dietary risk 
assessment, the water concentration value of 108 ppb was used to assess 
the contribution of fludioxonil from drinking water. For chronic 
dietary risk assessment, the water concentration of value 53 ppb was 
used to assess the contribution of fludioxonil from 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: Residential turf and ornamental 
use, restricted to commercial applicators only. EPA assessed 
residential exposure using the following assumptions: The use on 
pineapple discussed in this document does not result in any residential 
non-occupational exposures. Since there are no short- or intermediate-
term dermal toxicity endpoints for fludioxonil, only a toddler post-
application assessment for incidental ingestion exposures to treated 
lawns was conducted (for all child/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 bw/day, while the intermediate-term was determined to be 0.0074 
milligrams/kilograms of bodyweight/day (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.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found 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 Web site at http://www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA, as modified by the 
Food Quality Protection Act (FQPA), 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 prenatal/postnatal exposure 
of rats. In the developmental study in rats, there was an increase in 
the number of fetuses and litters with dilated renal pelvis and dilated 
ureter, as well as a reduction in maternal body weight gain, at the 
lowest observed adverse effect level. The developmental effect was 
considered to be related to maternal toxicity rather than an indication 
of increased susceptibility. Since the developmental effects occurred 
at the same exposure levels that caused maternal effects, no evidence 
of increased susceptibility in rats was demonstrated from the 
developmental study. In the 2-generation rat reproduction study, 
offspring toxicity was seen at the dose that produced parental 
(maternal) 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 developmental effects occurred at the same exposure levels 
that caused maternal effects, maternal and fetal toxicity were 
comparable, and it was concluded that there is no increased 
susceptibility indicated by results from the 2-generation reproduction 
study. In rabbits, no developmental toxicity was seen up to the highest 
dose tested which demonstrated maternal toxicity, and therefore it is 
concluded that there is no evidence of increased susceptibility 
demonstrated in rabbits.
    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. There are no residual uncertainties in the toxicity database. 
Existing data are sufficient for endpoint selection for exposure/risk 
assessment. The fludioxonil toxicity database is complete with the 
exception of an immunotoxicity study, and acute and subchronic 
neurotoxicity studies. The immunotoxicity and acute and subchronic 
neurotoxicity studies are now required by new data requirements for 
conventional pesticide registration (40 CFR part 158). The available 
data do not show potential for neurotoxicity or immunotoxicity. The 
overall weight-of-evidence suggests that fludioxonil does not directly 
target the immune system. Further, there is no evidence of

[[Page 7711]]

neurotoxicity or neuropathology in the fludioxonil database. Therefore, 
the Agency does not believe that the immunotoxicity and acute and 
chronic neurotoxicity studies will result in a lower POD than that 
currently in use for overall risk assessment. Thus, the Agency believes 
that a database uncertainty factor is not needed to account for lack of 
these studies.
    ii. There is no indication that fludioxonil is a neurotoxic 
chemical and therefore EPA finds no need for a developmental 
neurotoxicity study or additional uncertainty factors (UFs) to account 
for neurotoxicity.
    iii. There is no evidence that fludioxonil results in increased 
susceptibility of 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 PCT, tolerance-level residues, and anticipated residues as 
follows: Anticipated residue values for apple, grapefruit, lemon, lime, 
orange, pear, tomato, head lettuce, leaf lettuce, grape, cherry, peach, 
and plum were generated from field trials; anticipated residues were 
also determined from processing studies for raisins, and for the juice 
of apple, grape, grapefruit, lemon, lime, orange and tomato. 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 dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
aPAD and cPAD. For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-, intermediate-, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Based on the explanation in Unit IV.B.3, regarding 
residential use patterns, acute residential exposure to residues of 
fludioxonil is not expected. Therefore, since the acute aggregate risk 
assessment only includes exposure from food and water, no further 
calculations are necessary beyond the acute dietary analysis. There 
were no significant 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. An acute dietary assessment was therefore conducted 
for the population subgroup females 13-49 years old. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
aggregate exposure (food and water) to fludioxonil will occupy 15% of 
the aPAD for females 13-49 years old.
    2. Chronic risk. Based on the explanation in IV.B.3, unit regarding 
residential use patterns, chronic residential exposure to residues of 
fludioxonil is not expected. Therefore, since the chronic aggregate 
risk assessment only includes exposure from food and water, no further 
calculations are necessary beyond the chronic dietary analysis. Using 
the exposure assumptions described in this unit for chronic exposure, 
EPA has concluded that chronic aggregate exposure to fludioxonil (food 
and water) utilized 88% of the cPAD for children 1-2 years old, the 
population subgroup receiving the greatest exposure. For the U.S. 
population the chronic aggregate exposure (food and water) utilized 26% 
of the cPAD.
    3. Short- and intermediate-term risk. Short- 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 result in aggregate MOEs for the most highly exposed 
subgroup, children 1-2 years old, of 250 for short-term exposures and 
100 for intermediate-term exposures. Because EPA's level of concern for 
fludioxonil is a MOE of less than 100, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Fludioxonil is 
classified as a ``Group D'' chemical, as discussed previously, and not 
classifiable as to human carcinogenicity. However, EPA expects the 
cancer risk of fludioxonil to be negligible.
    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

    An adequate enforcement methodology (high-pressure 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by section 
408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA 
explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for fludioxonil on pineapple.

VI. Conclusion

    For the reasons described above, 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 pineapple at 13 
ppm. This tolerance expires on December 31, 2013.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance 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,

[[Page 7712]]

entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
Because this final rule has been exempted from review under Executive 
Order 12866, this final rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) 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) (Pub. L. 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: January 24, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 alphabetically adding ``pineapple'' to 
the table in paragraph (b) to read as follows:

Sec.  [emsp14]180.516  Fludioxonil; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    revocation
                                                million        date
------------------------------------------------------------------------
Pineapple...................................          13        12/31/13
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-2405 Filed 2-10-11; 8:45 am]
BILLING CODE 6560-50-P