[Federal Register Volume 67, Number 64 (Wednesday, April 3, 2002)]
[Rules and Regulations]
[Pages 15727-15735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8060]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301223; FRL-6828-4]
RIN 2070-AB78


Furilazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of the 
inert ingredient (herbicide safener) 3-dichloroacetyl-5-(2-furanyl)-2, 
2-dimethyloxazolidine, which is also known as furilazole (CAS Reg. No. 
121776-33-8)] in or on corn commodities. Monsanto Company requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 3, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301223, 
must be received by EPA on or before June 3, 2002.

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 VI.. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301223 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: 703 305-6304; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be 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            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

[[Page 15728]]

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/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic 
version of 40 CFR part 180 is available at: http://www.access.gpo.gov/cfr/cfrhtml_00/Title_40/40cfr180_00.html, beta site currently under 
development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301223. 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 thedocuments 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, 
Crystal 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

    Time-limited tolerances for 3-dichloroacetyl-5-(2-furanyl)-2, 2-
dimethyloxazolidine, also known as furilazole, in or on corn 
commodities have been established as requested by Monsanto Company 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
    In the Federal Register of October 20, 1999 (64 FR 56502)(FRL-6386- 
9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a as amended by the Food Quality Protection Act of 1996 (FQPA) 
(Public Law 104-170) announcing the filing of a pesticide petition (PP 
1E4031) for tolerance by Monsanto, Suite 1100, 700 14\th\ Street NW. , 
Washington DC 20005. This notice included a summary of the petition 
prepared by Monsanto, the petitioner. There were no comments received 
in response to the notice of filing.
    The petition requested that 40 CFR 180.471 be amended to establish 
again tolerances for residues of the inert ingredient (herbicide 
safener) 3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine, in or 
on corn commodities at 0.01 part per million (ppm). Time-limited 
tolerances, expiring February 25, 2002, were established in the Federal 
Register of February 23, 2000, (65 FR 8859) (FRL-6490-3). Permanent 
tolerances were not established due to an incomplete data base. The 
following data gaps were identified: Animal metabolism studies, 
radiovalidation and specificity studies for the analytical enforcement 
method for plants, field trial data, chronic toxicity study in the dog, 
developmental toxicity study in the rabbit, general metabolism study, 
and in vitro cytogenetic assay. These data gaps have now been either 
fulfilled or addressed in another manner, such as a data waiver.
    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 certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of furilazole on corn 
commodities at 0.01 ppm. EPA's assessment of exposures and risks 
associated with establishing the furilazole tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by furilazole are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 7 mg/kg/day
                                 toxicity rodents  LOAEL = 34/38 mg/kg/
                                                    day (male/female)
                                                    based on increased
                                                    absolute liver
                                                    weight in males,
                                                    increased liver-to-
                                                    body weight ratio in
                                                    males and females,
                                                    and increased gamma
                                                    glutamyltransferase
                                                    in females.
------------------------------------------------------------------------
870.3150                        90-Day oral        NOAEL = 5 mg/kg/day
                                 toxicity in       LOAEL = 15 mg/kg/day
                                 nonrodents         based on decreased
                                                    body weight gain and
                                                    bile duct
                                                    inflammation in one-
                                                    fourth of females.
------------------------------------------------------------------------

[[Page 15729]]

 
870.3200                        21-Day dermal      Systemic NOAEL = 25
                                 toxicity           mg/kg/day
                                                   Systemic LOAEL = 250
                                                    mg/kg/day based on
                                                    increased liver
                                                    weights.
------------------------------------------------------------------------
870.3700a                       Prenatal           Maternal NOAEL = 10
                                 developmental in   mg/kg/day
                                 rodents           LOAEL = 75 mg/kg/day
                                                    based on increased
                                                    liver weight.
                                                   Developmental NOAEL =
                                                    10 mg/kg/day
                                                   LOAEL = 75 mg/kg/day
                                                    based on increased
                                                    number of
                                                    resorptions.
------------------------------------------------------------------------
870.3700b                       Prenatal           Maternal NOAEL = 10
                                 developmental in   mg/kg/day
                                 nonrodents        LOAEL = 50 mg/kg/day
                                                    based on clinical
                                                    signs of toxicity
                                                    and reductions in
                                                    body weight, body
                                                    weight changes, and
                                                    food consumption.
                                                   Developmental NOAEL =
                                                    greater than or
                                                    equal to 50 mg/kg/
                                                    day
                                                   LOAEL = is not
                                                    identified, but
                                                    would be greater
                                                    than 50 mg/kg/day
------------------------------------------------------------------------
870.3800                        Reproduction and   Parental/Systemic
                                 fertility          NOAEL = 8.97/10.67
                                 effects            mg/kg/day male/
                                                    female
                                                   LOAEL = 92.39/106.42
                                                    mg/kg/day male/
                                                    female based on
                                                    lower body weight
                                                    gains and
                                                    microscopic lesions
                                                    of the liver,
                                                    kidneys (females) .
                                                   Reproductive NOAEL =
                                                    equal to or greater
                                                    than 92.39/106.42 mg/
                                                    kg/day male/female
                                                   LOAEL = is not
                                                    identified, but
                                                    would be greater
                                                    than 92.39/106.42 mg/
                                                    kg/day male/female
                                                   Offspring NOAEL =
                                                    8.97/10.67 mg/kg/day
                                                    male/female
                                                   LOAEL = 92.39/106.42
                                                    mg/kg/day based on
                                                    decreased body
                                                    weight gains in both
                                                    generations and
                                                    microscopic lesions
                                                    of the liver and
                                                    kidneys of F1 males
                                                    and females.
------------------------------------------------------------------------
870.4200                        Combined Chronic/  Chronic NOAEL = 0.26
                                 Carcinogenicity    mg/kg/day (males)
                                 rats              LOAEL = 5.05 mg/kg/
                                                    day (males) based on
                                                    increased absolute
                                                    and relative liver
                                                    and kidney weights
                                                    in males and
                                                    females, and kidney
                                                    nephropathy,
                                                    increased gamma
                                                    glutamyl
                                                    transferase,
                                                    decreased body
                                                    weight gain,and
                                                    moderate increase in
                                                    non-neoplastic liver
                                                    lesions in females.
                                                   Carcinogenic
                                                    (hepatocellular
                                                    carcinoma/adenoma)
                                                    in both sexes.
------------------------------------------------------------------------
870.4300                        Carcinogenicity    Chronic NOAEL = 5.9
                                 mice               mg/kg/day (males)
                                                   LOAEL = 60.2 mg/kg/
                                                    day (males) based on
                                                    increased incidence
                                                    of mortality and
                                                    elevated alanine
                                                    aminotransferase in
                                                    males and increased
                                                    liver weights,
                                                    increased incidence
                                                    of panlobular
                                                    hepatocellular
                                                    hypetrophy and
                                                    chronic lung
                                                    inflammation in
                                                    females.
                                                    Carcinogenic
                                                    (hepatocellular
                                                    carcinoma/adenoma
                                                    and bronchio-
                                                    alveolar carcinoma/
                                                    adenoma) in both
                                                    sexes
------------------------------------------------------------------------
870.5100 and 5300               Gene Mutation      There was a weak
                                                    positive response
                                                    for inducing reverse
                                                    gene mutations at
                                                    high precipitating
                                                    doses in Salmonella
                                                    typhimurium, but the
                                                    response was
                                                    negative in cultured
                                                    mammalian cells.
------------------------------------------------------------------------
870.5375                        Cytogenetics       Induced dose-related
                                                    chromosomal
                                                    aberrations over
                                                    background
------------------------------------------------------------------------
870.5385                        Cytogenetics       Did not induce
                                                    chromosomal
                                                    aberration in bone
                                                    marrow cells
------------------------------------------------------------------------
870.5395                        Cytogenetics       Did not yield
                                                    convincing evidence
                                                    that the compound
                                                    was clastogenic or
                                                    aneugenic in this in
                                                    vivo system;
                                                    however, the maximum
                                                    tolerated dose was
                                                    not achieved.
------------------------------------------------------------------------
870.5550                        Other Effects      Negative for the
                                                    induction of
                                                    unscheduled DNA
                                                    synthesis in rat
                                                    primary hepatocytes.
------------------------------------------------------------------------
870.7485                        Metabolism and     The compound
                                 pharmacokinetics   undergoes rapid
                                                    absorption and
                                                    nearly complete
                                                    excretion within 48
                                                    hours. The total
                                                    recovery of
                                                    administered
                                                    radioactivity was
                                                    87.7 - 95.1% for all
                                                    treatment groups.
                                                    Primary route of
                                                    excretion was via
                                                    the feces which
                                                    accounted for 58 -
                                                    77% of the
                                                    administered dose;
                                                    excretinggreater
                                                    than or equal to 94%
                                                    within 48 hours.
                                                    Urinary excretion
                                                    was minor and
                                                    accounted for 13 -
                                                    24% of the
                                                    administered dose
                                                    and most of it (
                                                    greater than or
                                                    equal to 84%) was
                                                    excreted within 24
                                                    hours.
------------------------------------------------------------------------
870.7600                        Dermal             A dermal absorption
                                 penetration        study is not
                                                    available. A dermal
                                                    absorption factor of
                                                    30 % was
                                                    extrapolated from
                                                    the developmental
                                                    toxicity study and
                                                    the 21-day dermal
                                                    toxicity study, both
                                                    in the rat.
------------------------------------------------------------------------

     

[[Page 15730]]

B. 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 level of concern 
(LOC). 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 intra species 
differences. An additional uncertainty factor of 3X was used to account 
for the lack of a chronic dog study.
    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 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 furilazole used for human risk assessment is shown in the 
following Table 2:

      Table 2.--Summary of Toxicological Dose and Endpoints for Furilazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50years of    NOAEL = 10 mg/kg/day     FQPA SF = 1              Developmental Toxicity
 age                                   UF = 100...............  aPAD = acute RfD/FQPA     Study in the rat
                                       Acute RfD = 0.1 mg/kg/    SF =.                   LOAEL = 75 mg/kg/day
                                        day.                    0.1 mg/kg/day..........   based on increased
                                                                                          number of resorptions.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 0.26 mg/kg/day   FQPA SF = 1              Combined Chronic/
                                       UF = 300...............  cPAD = chronic RfD/FQPA   Carcinogenicity Study
                                       Chronic RfD = 0.0009 mg/  SF =.                    in the rat
                                        kg/day.                 0.0009 mg/kg/day.......  LOAEL = 5.05 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          liver and kidney
                                                                                          weights in males
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1 to 7     oral study NOAEL = 10    LOC for MOE = 100        DevelopmentalToxicity
 days) (Residential)                    mg/kg/day                (Residential)            Study in the rat
                                                                                         LOAEL = 75 mg/kg/day
                                                                                          based on increased
                                                                                          liver weights,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains and food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1   oral study NOAEL = 7 mg/ LOC for MOE = 100         90-Day rat
 week toseveral months) (Residential)   kg/day                   (Residential)           LOAEL = 34 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          liver weights and
                                                                                          alterations in
                                                                                          clinical chemistry
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        dermal study NOAEL = 25  LOC for MOE = 100        21-Day Dermal in the
 (Residential)                          mg/kg/day                (Residential)            rat
                                       (dermal absorption rate                           LOAEL = 250 mg/kg/day
                                        = N/A%).                                          based on increased
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    dermal study NOAEL = 25  LOC for MOE = 100        21-Day Dermal in the
 several months) (Residential)          mg/kg/day                (Residential)            rat
                                       (dermal absorption rate                           LOAEL = 250 mg/kg/day
                                        = N/A%).                                          based on increased
                                                                                          liver weights.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    oral study NOAEL = 0.26  LOC for MOE = 100        Combined Chronic/
 lifetime) (Residential)                mg/kg/day                (Residential)            Carcinogenicity Study
                                       (dermal absorption rate                            in the rat
                                        = 30 %.                                          LOAEL = 5.05 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          liver and kidney
                                                                                          weights in males
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    oral study NOAEL =       LOC for MOE = 100        Developmental Toxicity
 (Residential)                         10 mg/kg/day              (Residential)            Study in the rat
                                        (inhalation absorption                           LOAEL = 75 mg/kg/day
                                        rate = 100%).                                     based on increased
                                                                                          liver weights,
                                                                                          decreased body
                                                                                          weights, body weight
                                                                                          gains and food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------

[[Page 15731]]

 
Intermediate-Term Inhalation (1 week   oral study NOAEL = 7 mg/ LOC for MOE = 100         90-Day rat
 to several months) (Residential)       kg/day                   (Residential)           LOAEL = 34 mg/kg/day
                                       (inhalation absorption                             based on increased
                                        rate = 100%).                                     absolute and relative
                                                                                          liver weights and
                                                                                          alterations in
                                                                                          clinical chemistry
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   oral study NOAEL =       LOC for MOE = 100        Combined Chronic/
 to lifetime) (Residential)            0.26 mg/kg/day            (Residential)            Carcinogenicity Study
                                        (inhalation absorption                            in the rat
                                        rate = 100%).                                    LOAEL = 5.05 mg/kg/day
                                                                                          based on increased
                                                                                          absolute and relative
                                                                                          liver and kidney
                                                                                          weights in males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      oral study               LOC = the range of 1 x   Classified as likely to
                                       Q1* = 0.0274 (mg/kg/      10\-6\                   be carcinogenic to
                                        day)\-1\.                                         humans by all routes
                                       (dermal absorption rate                            of exposure based on
                                        = 30 %.                                           hepatocellular
                                       inhalation absorption                              ademonas and
                                        rate = 100%).                                     carcinomas in rats and
                                                                                          mice, branchio-
                                                                                          alveolar adenomas and
                                                                                          carcinomas in female
                                                                                          mice, testicular
                                                                                          interstitial cell
                                                                                          tumors in male rats
                                                                                          and stomach tumors in
                                                                                          female mice.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Time-limited 
tolerances (expiring February 25, 2002) have been established (40 CFR 
180.471) for the residues of furilazole, in or on corn commodities. 
Risk assessments were conducted by EPA to assess dietary exposures from 
furilazole 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 one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported 
byrespondents in the USDA 1989-1992 nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. The Agency made the following assumptions 
for the acute exposure assessment: that 100% of the entire corn crop 
received an application of furilazole, i.e. 100% crop treated (PCT), 
and that all corn commodities contained residues of furilazole at the 
tolerance level.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (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 same assumptions were made for the chronic 
exposureassessments: That 100% of the entire corn crop received an 
application of furilazole, i.e. 100% crop treated (PCT), and that all 
corn commodities contained residues of furilazole at the tolerance 
level.
    iii. Cancer. In conducting this carcinogenic dietary risk 
assessment the Dietary Exposure Evaluation Model (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 same assumptions were made for the cancer exposure 
assessments: That 100% of the entire corn crop received an application 
of furilazole, i.e. 100% crop treated (PCT), and that all corn 
commodities contained residues of furilazole at the tolerance level.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for furilazole 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 furilazole.
    The Agency used the Pesticide Root Zone/Exposure Analysis Modeling 
System(PRZM/EXAMS), to produce estimates of pesticide concentrations in 
an index reservoir for an Ohio corn crop. 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. The SCI-
GROW model is used to predict pesticide concentrations in shallow 
groundwater.
    Neither 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 isto 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 furilazole they are further 
discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS model the estimated environmental 
concentrations (EECs) of furilazole for acute exposures are estimated 
to be 1.2 parts per billion (ppb), for chronic (non-

[[Page 15732]]

cancer) exposures are estimated to be 0.8 ppb, and for cancer exposures 
are estimated to be 0.22 ppb for surface water. Based on the SCI-GROW 
model the estimated environmental concentrations (EECs) of furilazole 
for acute, chronic and cancer exposures are estimated to be 0.02 ppb 
for ground water.
    3. From non-dietary exposure. The term ``residentialexposure'' 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). Furilazole is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism 
oftoxicity. 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 furilazole 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, 
furilazole 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 furilazole 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).

D. Safety Factor for Infants and Children

    1. 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.
    2. Prenatal and postnatal sensitivity. No qualitative or 
quantitative evidence of increased susceptibility in the rat or rabbit 
fetuses following in utero exposure in the developmental toxicity 
studies nor to the offspring following pre/post natal exposure in the 
two generation reproduction study.
    3. Conclusion. With the exception of the chronic dog study, there 
is a complete toxicity data base for furilazole and exposure data are 
complete or are estimated based on data that reasonably accounts for 
potential exposures. Taking into account the lack of increased 
susceptibility and the completeness of the data on toxicity and 
exposure, EPA determined that the 10X safety factor to protect infants 
and children should be removed.

E. 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 + residential 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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide 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 residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure (at the 95th 
percentile) from food to furilazole is less than one percent of the 
aPAD for females 13 to 50 years. In addition, there is potential for 
acute dietary exposure to furilazole in drinking water. The acute DWLOC 
is 3000 ppb. Since, the DWLOC is greater than the EEC for surface or 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
furilazole from food will utilize 1.4 % of the cPAD for the U.S. 
population, and 3.4 % of the cPAD for all infants less than 1 year old. 
Percent PADs for all other population subgroups are less than 3.4%. 
After calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expectthe aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 3:

[[Page 15733]]



                                  Table 3.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Furilazole
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day          % cPAD  (Food)              (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      0.0009                  1.4                     0.8                    0.02                   31
All infants (less than 1 year old)   0.0009                  3.4                     0.8                    0.02                   8.7
Children 1-6 years old               0.0009                  3.3                     0.8                    0.02                   8.7
Children 7-12 years old              0.0009                  2.5                     0.8                    0.02                   8.7
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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). Furilazole is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Furilazole is 
not registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions discussed in this unit for cancer exposure, the cancer 
dietary exposure from food to furilazole is 3.5 x 10-\7\. In 
addition, there is potential for cancer dietary exposure to furilazole 
in drinking water. The cancer DWLOC is 1.3 ppb. Since, the DWLOC is 
greater than the EEC for surface or groundwater, EPA does not expect 
the aggregate exposure to exceed the range of 1 x 10-\6\.
    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 furilazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromotography 
using electron capture detection) 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 limits for residues of 
furilazole in corn raw agricultural commodities.

V. Conclusion

    Therefore, tolerances are established for residues of furilazole, 
3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine, which is also 
known as furilazole (CAS Reg. No. 121776-33-8), in or on corn 
commodities at 0.01 ppm.

VI. 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.

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-301223 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 June 3, 
2002.
    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 bymailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental

[[Page 15734]]

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 VI.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 docket control number OPP-301223, 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 6.1/8.0or 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this 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). This final rule does 
not contain anyinformation 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 
petition under FFDCA section 408(d), 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. 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 13132requires 
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 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.

VIII. 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 willsubmit 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.



[[Page 15735]]


    Dated: March 19, 2002.
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 180.471 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.471  Furilazole; tolerances for residues.

    (a) General. Tolerances are established for residues of furilazole; 
3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine (CAS Reg. No. 
121776-33-8) when used as an inert ingredient (safener) in pesticide 
formulations in or on the following raw agricultural commodities when 
applied at an annual application rate of 0.1 pound of safener per acre:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage............................                     0.01
Corn, field, grain.............................                     0.01
Corn, field, stover............................                     0.01
Corn, pop, grain...............................                     0.01
Corn, pop, stover..............................                     0.01
------------------------------------------------------------------------

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[FR Doc. 02-8060 Filed 4-2-02; 8:45 am]
BILLING CODE 6560-50-S