[Federal Register Volume 66, Number 177 (Wednesday, September 12, 2001)]
[Rules and Regulations]
[Pages 47403-47410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22524]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301161; FRL-6797-5]
RIN 2070-AB78


Fludioxonil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fludioxonil (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-
pyrrole-3-carbonitrile) in or on pomegranates. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on pomegranates. This regulation establishes a 
maximum permissible level for residues of fludioxonil in this food 
commodity. The tolerance will expire and is revoked on June 30, 2003.

DATES: This regulation is effective September 12, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301161, 
must be received by EPA on or before November 13, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301161 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9367; and e-mail address: 
[email protected].

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 categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2.In person. The Agency has established an official record for this 
action under docket control number OPP-301161. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB 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 the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for residues of the fungicide 
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on pomegranates at 5.0 parts per million (ppm). 
This tolerance will expire and is revoked on June 30, 2003. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the 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 tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the 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 the 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) 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) 
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

[[Page 47404]]

certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (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.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fludioxonil on Pomegranates and FFDCA 
Tolerances

    Losses due to Botrytis have increased dramatically over the course 
of the last 2 years for pomegranate growers and packers. In the 1999 
and 2000 packing seasons, growers and packers experienced approximately 
a 20% loss of fruit after packing for the fresh market due to Botrytis 
mold and had never experienced such frequency of decay before. 
Previously, they had been able to hold pomegranates for 2 to 3 months, 
but now have difficulties storing much beyond 2 to 3 weeks. EPA has 
authorized under FIFRA section 18 the use of fludioxonil on 
pomegranates for control of gray mold (Botrytis cinerea) in California. 
After having reviewed the submission, EPA concurs that emergency 
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fludioxonil in or on 
pomegranates. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) 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). Although this tolerance will 
expire and is revoked on June 30, 2003, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on pomegranates after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by this tolerance at the time of that application. EPA will take action 
to revoke this 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 tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether fludioxonil 
meets EPA's registration requirements for use on pomegranates or 
whether a permanent tolerance for this use would be appropriate. Under 
these circumstances, EPA does not believe that this tolerance 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 any State other than California to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. 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

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with 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 
fludioxonil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of fludioxonil in or on pomegranates at 5.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect 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. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for fludioxonil used for human risk assessment is shown in 
the following Table 1:

[[Page 47405]]



     Table 1.--Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and LOC for    Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 100 mg/kg/day    FQPA SF = 1X             Developmental toxicity
 age)                                  UF = 100...............  aPAD = acute RfD          study - rat
                                       Acute RfD = 1.0 mg/kg/     FQPA SF.        Developmental LOAEL =
                                        day.                    = 1.0 mg/kg/day........   1,000 mg/kg/day based
                                                                                          on increased incidence
                                                                                          of fetuses and litters
                                                                                          with dilated renal
                                                                                          pelvis and dilated
                                                                                          ureter
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 3.3 mg/kg/day    FQPA SF = 1X             1 Year chronic toxicity
                                       UF = 100...............  cPAD = chronic RfD        study - dog LOAEL =
                                       Chronic RfD = 0.03 mg/     FQPA SF.        35.5 mg/kg/day based
                                        kg/day.                 = 0.03 mg/kg/day.......   on decreased weight
                                                                                          gain in female dogs
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1-7 days)           none                     No systemic toxicity     Endpoint was not
 (occupational/residential)                                      was seen at the limit    selected
                                                                 dose (1,000 mg/kg/day)
                                                                 in the 28-day dermal
                                                                 toxicity study in
                                                                 rats. This risk
                                                                 assessment is not
                                                                 required.
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several    Oral study NOAEL= 64 mg/ LOC for MOE = 100        13 Week Oral Feeding
 months) dermal (occupational/          kg/day (dermal           (Occupational)           Study - rat Systemic
 residential)                           penetration = 40%)      LOC for MOE = 100         LOAEL = 428 mg/kg/day
                                                                 (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          both sexes, chronic
                                                                                          nephropathy in males,
                                                                                          and centrilobular
                                                                                          hepatocyte hypertrophy
                                                                                          in females
----------------------------------------------------------------------------------------------------------------
Long-term (several months-lifetime)    Oral study NOAEL = 3.3   LOC for MOE = 100        1 Year chronic toxicity
 dermal (occupational/residential)      mg/kg/day (dermal        (Occupational)           study - dog LOAEL =
                                        penetration = 40%)      LOC for MOE = 100         35.5 mg/kg/day based
                                                                 (Residential).           on decreased weight
                                                                                          gain in female dogs
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 Days) inhalation       NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 (occupational/residential)             (inhalation absorption   (Occupational)           Study - rat Systemic
                                        rate = 100%)            LOC for MOE = 100         LOAEL = 428 mg/kg/day
                                                                 (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          both sexes, chronic
                                                                                          nephropathy in males,
                                                                                          and centrilobular
                                                                                          hepatocyte hypertrophy
                                                                                          in females
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week - several    NOAEL = 64 mg/kg/day     LOC for MOE = 100        13 Week Oral Feeding
 months) inhalation (occupational/      (inhalation absorption   (Occupational)           Study - rat Systemic
 residential)                           rate = 100%)            LOC for MOE = 100         LOAEL = 428 mg/kg/day
                                                                 (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          both sexes, chronic
                                                                                          nephropathy in males,
                                                                                          and centrilobular
                                                                                          hepatocyte hypertrophy
                                                                                          in females
----------------------------------------------------------------------------------------------------------------
Long-term (several months-lifetime)    NOAEL = 3.3 mg/kg/day    LOC for MOE = 100        1 Year chronic toxicity
 inhalation (occupational/              (inhalation absorption   (Occupational)           study - dog LOAEL =
 residential)-                          rate = 100%)            LOC for MOE = 100         35.5 mg/kg/day based
                                                                 (Residential).           on decreased weight
                                                                                          gain in female dogs
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Group D''- not         Not applicable           Acceptable oral rat and
                                        classifiable as to                                mouse carcinogenicity
                                        human carcinogenicity                             studies; evidence of
                                        via relevant routes of                            carcinogenic and
                                        exposure                                          mutagenic potential.
----------------------------------------------------------------------------------------------------------------

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.516) for the residues of fludioxonil, in or on 
a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from fludioxonil in food 
as follows:
    i. Acute exposure. Acute dietary 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. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food

[[Page 47406]]

consumption as reported by respondents in the USDA 1989-1992 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: For the acute 
DEEM\TM\ analysis (version 7.72), published and proposed tolerances 
level residues were used. Default processing factors and 100% crop 
treated (CT) were assumed for all commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: For the 
chronic DEEM\TM\ analysis (version 7.73), published and proposed 
tolerances level residues were used. Default processing factors and 
100% CT were assumed for all commodities.
    iii. Cancer. Fludioxonil has been put in ``Group D''- not 
classifiable as to human carcinogenicity via relevant routes of 
exposure and therefore this risk assessment is not required.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fludioxonil in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fludioxonil.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to fludioxonil they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models, the EECs of fludioxonil 
for acute exposures are estimated to be 46 parts per billion (ppb) for 
surface water and 0.35 ppb for ground water. The EECs for chronic 
exposures are estimated to be 11 ppb for surface water and 0.35 ppb for 
ground 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 not currently registered for residential (outdoor, 
non-food) uses, however, the registrant is seeking registration for the 
use of fludioxonil by commercial applicators on residential lawns. 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.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine 
whether fludioxonil has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
fludioxonil does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that fludioxonil has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold 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 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Developmental toxicity studies. In the rat developmental study, 
the maternal (systemic) NOAEL was 100 mg/kg/day, based on reduction in 
mean body weight gain in dams during gestation period at the LOAEL of 
1,000 mg/kg/day. The developmental (fetal) NOAEL was 100 mg/kg/day, 
based on increased fetal and litter incidence of dilated renal pelvis 
and dilated ureter at the LOAEL of 1,000 mg/kg/day. In the rabbit 
developmental toxicity study, the maternal (systemic) NOAEL was 10 mg/
kg/day, based on decreased body weight gains and food efficiency at the 
LOAEL of 100 mg/kg/day. The developmental (pup) NOAEL was 300 mg/kg/
day, the highest dose tested.
    iii. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the parental (systemic) NOAEL was 22.13 mg/kg/
day (males)

[[Page 47407]]

and 24.24 mg/kg/day (females), based on clinical signs and decreased 
body weight, body weight gain and food consumption at the LOAEL of 
221.6 mg/kg/day (males) and 249.7 mg/kg/day (females). The 
reproductive/developmental (pup) NOAEL was 22.13 mg/kg/day (males) and 
24.24 mg/kg/day (females), based on reduced pup weights at the LOAEL of 
221.6 mg/kg/day (males) and 249.7 mg/kg/day (females).
    iv. Prenatal and postnatal sensitivity. The toxicological data base 
for evaluating prenatal and postnatal toxicity for fludioxonil is 
complete with respect to current data requirements. There are no 
prenatal or postnatal toxicity concerns for infants and children, based 
on the results of the rat and rabbit developmental toxicity studies and 
the 2-generation rat reproductive toxicity study.
    v. Conclusion. EPA concludes that reliable data support the removal 
of the additional uncertainty factor; the standard hundred-fold 
uncertainty factor is adequate to protect the safety of infants and 
children.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to fludioxonil in drinking water (when considered along with 
other sources of exposure for which OPP has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because OPP considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, OPP will reassess the potential impacts of 
fludioxonil on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Because the acute endpoint applies to one population 
subgroup, females (13-50 years old), the acute risk assessment was 
conducted only for this group. An acute dose and endpoint were not 
selected for the U.S. population (including infants and children) 
because there were no effects of concern observed in oral toxicology 
studies, including maternal toxicity in the developmental toxicity 
studies in rats and rabbits, that are attributable to a single exposure 
(dose).
    Using the exposure assumptions discussed in this unit for acute 
exposure, the acute dietary exposure from food to fludioxonil will 
occupy 0.7% of the aPAD for females (13-50 years old). In addition, 
despite the potential for acute dietary exposure to fludioxonil in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model estimated environmental concentrations of 
fludioxonil in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 2:

                      Table 2.--Aggregate Risk Assessment for Acute Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                1.0          0.7           46         0.35       30,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fludioxonil from food will utilize 5.5% of the cPAD for the U.S. 
population, 22% of the cPAD for all infants <1 year old) and 14% of the 
cPAD for children 1 to 6 years old. Based on the use pattern, chronic 
residential exposure to residues of fludioxonil is not expected. In 
addition, despite the potential for chronic dietary exposure to 
fludioxonil in drinking water, after calculating DWLOCs and comparing 
them to conservative model of EECs fludioxonil in surface and ground 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
cPAD, as shown in the following Table 3:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.03          5.5           11         0.35          990
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                               0.03           22           11         0.35          230
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years old)                             0.03           14           11         0.35          260
----------------------------------------------------------------------------------------------------------------

[[Page 47408]]

 
Children (7 to 12 years old)                            0.03          8.2           11         0.35          280
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                               0.03          3.8           11         0.35          870
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                 0.03          3.2           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                   0.03          3.5           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                 0.03          5.1           11         0.35        1,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Fludioxonil is not currently registered for residential (outdoor, 
non-food) uses, however, the registrant is seeking registration for the 
use of fludioxonil by commercial applicators on residential lawns. 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.
    For the U.S. population and all infants (<1 year old) population 
subgroups, the total food and residential short-term aggregate MOEs are 
1,900 and 995, respectively. As these values are greater than 100, the 
short-term food and residential aggregate risks for the U.S. population 
and all infants (<1 year old) population subgroups are below the 
Agency's level of concern. Because the all infants (<1 year old) 
population subgroup has the highest exposure to fludioxonil residues 
from dietary sources, including all infants (<1 year old) is adequately 
protective of the children 1-6 and 7-12 years old population subgroups.
    In addition, short-term DWLOCs were calculated and compared to the 
EECs for chronic exposure of fludioxonil in ground water and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect short-term aggregate 
exposure to exceed the Agency's level of concern, as shown in the 
following Table 4:

                   Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Fludioxonil
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        1,900          100           11         0.35       21,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                995          100           11         0.35        5,800
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Though residential exposure could occur with the use of 
fludioxonil, no residential exposure scenarios for fludioxonil are 
expected to have intermediate-term durations. Therefore, an 
intermediate-term aggregate risk assessment is not required.
    5. Aggregate cancer risk for U.S. population. Fludioxonil has been 
put in ``Group D''- not classifiable as to human carcinogenicity via 
relevant routes of exposure and therefore this risk assessment is not 
required.
    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, and to infants and children from aggregate 
exposure to fludioxonil residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example - gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for fludioxonil on pomegranates.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
fludioxonil, (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-
carbonitrile), in or on pomegranates at 5.0 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

[[Page 47409]]

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301161 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 November 
13, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301161, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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). 
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., or 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). 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); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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). Since tolerances and exemptions that are 
established on the basis of a FIFRA section 18 exemption under FFDCA 
section 408, such as the [tolerance/exemption] 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. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of

[[Page 47410]]

power and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.''
    Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001).

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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 14, 2001.
Peter Caulkins, Acting
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.516 is amended by alphabetically adding the 
following commodity to the table in paragraph (b) to read as follows:


Sec. 180.516  Fludioxonil; tolerances for residues.

* * * * *
    (b)     *    *    *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                      *      *      *      *      *
Pomegranate                                       5.0            6/30/03
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-22524 Filed 9-11-01; 8:45 am]
BILLING CODE 6560-50-S