[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58364-58375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24947]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301052; FRL-6745-9]
RIN 2070-AB78


Flucarbazone-sodium; Time-Limited Pesticide Tolerances

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes time-limited tolerances for 
combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-
methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 
1-carboxamide, sodium salt) and its N-desmethyl metabolite in or on 
wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01 
ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined 
residues of flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses and sheep at 1.5 ppm. Bayer Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

[[Page 58365]]

The tolerances will expire and be revoked on November 1, 2005.

DATES:  This regulation is effective September 29, 2000.Objections and 
requests for hearings, identified by docket control number OPP-301052, 
must be received by EPA on or before November 28, 2000.

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-301052 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703)-305-6224; 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 Potentially
             Categories                 NAICS       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/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301052. 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, 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

    In the Federal Register of October 8, 1999 (64 FR 195) (FRL-6384-
2), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (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) for tolerance by Bayer 
Corporation, 8400 Hawthorne Road, Kansas City, Missouri 64120-0013. 
This notice included a summary of the petition prepared by Bayer 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the herbicide 
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[[2(trifluoromethoxy)phenyl]sulfonyl]-1H-1,2,4-triazole 1-carboxamide, 
sodium salt) and its N-desmethyl metabolite in or on wheat, forage at 
0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; wheat, 
straw at 0.05 ppm, milk at 0.005 ppm; meat of cattle, goats, hogs, 
horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses 
and sheep at 0.60 ppm. As a result of its review of scientific data 
submitted in support of this petition, the Agency has determined that 
additional sulfonamide metabolites should be included in the tolerance 
expression for both wheat and the associated animal commodities. The 
submitted analytical method and residue data for livestock are 
sufficient to establish tolerances for livestock commodities that 
include the additional sulfonamide metabolites. The animal tolerances 
requested by Bayer Corporation for flucarbazone-sodium and its N-
desmethyl metabolite are adequate to cover the additional metabolites, 
with the exception of the tolerance for liver, which EPA has determined 
must be raised from 0.60 ppm to 1.5 ppm. However, before EPA can 
establish tolerances for wheat forage, grain, hay and straw that 
include the sulfonamide metabolites, the registrant must submit a 
revised method and additional residue data that measure not only the 
parent and N-desmethyl metabolite, but also the sulfonamide metabolites 
of concern. Therefore, EPA is establishing time-limited tolerances for 
combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-
methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 
1-carboxamide, sodium salt) and its N-desmethyl metabolite in or on 
wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 
ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses and sheep at 1.5 ppm. The tolerances are 
being established as time-limited to allow time to develop additional 
analytical methodology and residue data for wheat to support revised 
tolerances that include the

[[Page 58366]]

sulfonamide metabolites. These tolerances will expire and be revoked on 
November 1, 2005. Although EPA does not have sufficient data to 
establish wheat tolerances that include the sulfonamide metabolites, 
sufficient data are available for the Agency to estimate human exposure 
and risk from these metabolites as described in the ``Exposure 
Assessment'' section below.
    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 
aggrege 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 tolerances for combined residues of flucarbazone-sodium, 
4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] 
sulfonyl]-1H-1,2,4-triazole 1-carboxamide, sodium salt) and its N-
desmethyl metabolite in or on wheat, forage at 0.30 ppm; wheat, grain 
at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and 
combined residues of flucarbazone-sodium and its metabolites converted 
to 2-(trifluoromethoxy)benzene sulfonamide and calculated as 
flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat 
byproducts (excluding liver) of cattle, goats, hogs, horses and sheep 
at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 1.5 
ppm. EPA's assessment of exposures and risks associated with 
establishing these 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 flucarbazone-sodium 
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                         28-Day oral         NOAEL = 27 mg/kg/
                                  toxicity in         day in males and
                                  rodents (rats)      25 mg/kg/day in
                                                      females.
                                                     LOAEL = 266 mg/kg/
                                                      day in males and
                                                      251 mg/kg/day in
                                                      females based on
                                                      immunological
                                                      changes in both
                                                      sexes
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 73.5 mg/kg/
                                  toxicity in         day in males and
                                  rodents (rats)      102 mg/kg/day in
                                                      females
                                                     LOAEL = 287 mg/kg/
                                                      day in males and
                                                      358 mg/kg/day in
                                                      females based on
                                                      immunological
                                                      findings in both
                                                      sexes
------------------------------------------------------------------------
870.3100                         28-Day oral         NOAEL = > 4,554 mg/
                                  toxicity in         kg/day in males
                                  rodents (mice)      and 6,429 mg/kg/
                                                      day in females
                                                     LOAEL > 4,554 mg/kg/
                                                      day in males and
                                                      6,429 mg/kg/day in
                                                      females. There
                                                      were no signs of
                                                      toxicity
                                                      attributable to
                                                      treatment at any
                                                      dose level
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = > 2,083 mg/
                                  toxicity in         kg/day in males
                                  rodents (mice)      and 3,051 mg/kg/
                                                      day in females
                                                     LOAEL > 2,083 mg/kg/
                                                      day in males and
                                                      3,051 mg/kg/day in
                                                      females. There
                                                      were no signs of
                                                      toxicity
                                                      attributable to
                                                      treatment at any
                                                      dose level.
------------------------------------------------------------------------
870.3150                         28-Day oral         NOAEL = 164 mg/kg/
                                  toxicity in         day in males and
                                  nonrodents (dogs)   171 mg/kg/day in
                                                      females
                                                     LOAEL = 1,614 mg/kg/
                                                      day in males and
                                                      1,319 mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight gain,
                                                      decreased food
                                                      consumption,
                                                      decreased T4
                                                      levels and
                                                      increased
                                                      thyroxine-binding
                                                      capacity,
                                                      induction of
                                                      microsomal
                                                      enzymes, increased
                                                      liver weight and
                                                      liver
                                                      histopathology in
                                                      both sexes
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = 33.8 mg/kg/
                                  toxicity in         day in males and
                                  nonrodents (dogs)   35.2 mg/kg/day in
                                                      females with the
                                                      occurrence of
                                                      slight, adaptive
                                                      induction of
                                                      hepatic microsomal
                                                      enzymes
                                                     LOAEL = 162 mg/kg/
                                                      day in males and
                                                      170 mg/kg/day in
                                                      females based on
                                                      decreased T4
                                                      levels, increased
                                                      thyroxine-binding
                                                      capacity,
                                                      induction of
                                                      microsomal
                                                      enzymes, gross
                                                      pathology and
                                                      histopathology in
                                                      the stomach, and
                                                      histopathology in
                                                      the liver in both
                                                      sexes
------------------------------------------------------------------------
870.3200                         21/28-Day dermal    NOAEL 1,000 mg/kg/
                                  toxicity in         day for both
                                  rabbits             sexes.

[[Page 58367]]

 
                                                     LOAEL > 1,000 mg/kg/
                                                      day. There were no
                                                      signs of toxicity
                                                      attributable to
                                                      treatment at any
                                                      dose level.
------------------------------------------------------------------------
870.3250                         90-Day dermal       Not applicable (NA)
                                  toxicity in rats
------------------------------------------------------------------------
870.3465                         90-Day inhalation   NA
                                  toxicity in rats
------------------------------------------------------------------------
870.3700a                        Prenatal            Maternal NOAEL = >
                                  developmental       1,000 mg/kg/day
                                  toxicity in rats
                                                     LOAEL > 1,000 mg/kg/
                                                      day
                                                     Developmental NOAEL
                                                      = > 1,000 mg/kg/
                                                      day
                                                     LOAEL > 1,000 mg/kg/
                                                      day
------------------------------------------------------------------------
870.3700b                        Prenatal            Maternal NOAEL =
                                  developmental       100 mg/kg/day
                                  toxicity in
                                  rabbits
                                                     LOAEL = 300 mg/kg/
                                                      day based on
                                                      decreased food
                                                      consumption and
                                                      increased clinical
                                                      signs
                                                     Developmental NOAEL
                                                      = 300 mg/kg/day
                                                     LOAEL = 500 mg/kg/
                                                      day based on
                                                      decreased fetal
                                                      weight and
                                                      increased
                                                      incidence of
                                                      delayed fetal
                                                      ossification
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects   NOAEL = 287 mg/kg/
                                  in rats             day for males and
                                                      340 mg/kg/day for
                                                      females with a
                                                      slight, increased
                                                      incidence of
                                                      moderate cecal
                                                      enlargement
                                                      occurring as an
                                                      adaptive response
                                                      to treatment
                                                     LOAEL = 800 mg/kg/
                                                      day for males
                                                      based on decreased
                                                      liver weight and
                                                      991 mg/kg/day for
                                                      females based on
                                                      decreased uterine
                                                      weight and
                                                      increased
                                                      incidence of
                                                      severe cecal
                                                      enlargement
                                                     Reproductive/
                                                      Offspring NOAEL =
                                                      287 mg/kg/day for
                                                      males and 340 mg/
                                                      kg/day for females
                                                     LOAEL = 800 mg/kg/
                                                      day for males and
                                                      991 mg/kg/day for
                                                      females based on
                                                      reduced pup
                                                      weights, decreased
                                                      liver weight in
                                                      male pups, marbled
                                                      liver, air filled
                                                      stomach
------------------------------------------------------------------------
870.4100b                        Chronic toxicity    NOAEL = 35.9 mg/kg/
                                  in dogs             day in males and
                                                      37.1 mg/kg/day in
                                                      females.
                                                     LOAEL = 183 mg/kg/
                                                      day in males and
                                                      187 mg/kg/day in
                                                      females based upon
                                                      body weight gain
                                                      depression and
                                                      increased N-
                                                      demethylase levels
                                                      in both sexes,
                                                      decreased T4
                                                      levels and
                                                      marginally
                                                      increased liver
                                                      weight in females.
------------------------------------------------------------------------
870.4300                         2-Year Chronic      NOAEL = 125 mg/kg/
                                  toxicity/           day in males and
                                  carcinogenicity     females
                                  in rats
                                                     LOAEL = 1,000 mg/kg/
                                                      day in males and
                                                      females based on
                                                      decreased body
                                                      weight and
                                                      increased food
                                                      consumption in
                                                      females, thickened
                                                      mucosa of the
                                                      glandular stomach
                                                      in both sexes,
                                                      inflammatory
                                                      infiltrates
                                                      (males),
                                                      vacuolation of the
                                                      squamous
                                                      epithelium in the
                                                      fore-stomach
                                                      (females) and
                                                      immunological
                                                      effects in males
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4200b                        2-Year              NOAEL = 275 mg/kg/
                                  Carcinogenicity     day in males and
                                  in mice             459 mg/kg/day in
                                                      females
                                                     LOAEL = 2,066 mg/kg/
                                                      day in males and
                                                      3,212 mg/kg/day in
                                                      females based on
                                                      decreased body
                                                      weight in both
                                                      sexes and
                                                      increased food
                                                      consumption in
                                                      males.
                                                     No evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5100                         Gene Mutation;      There was no
                                  reverse gene        evidence of
                                  mutation assay in   induced mutant
                                  bacteria            colonies over
                                                      background.
------------------------------------------------------------------------
870.5100                         Gene Mutation;      There was no
                                  reverse gene        evidence of
                                  mutation assay in   induced mutant
                                  bacteria with MKH   colonies over
                                  10868, an animal,   background
                                  plant, and soil
                                  metabolite
------------------------------------------------------------------------
870.5300                         Gene mutation       No increase in
                                  assay in V79        mutant frequency
                                  cultured            above that of
                                  mammalian cells     negative controls
                                                      up to the limit
                                                      dose.
------------------------------------------------------------------------
870.5375                         Cytogenetics; in    No increases in
                                  vitro mammalian     aberrant
                                  cytogenetics        metaphases were
                                  assay               observed up to the
                                                      limit dose.
------------------------------------------------------------------------
870.5395                         bone marrow         There was no
                                  micronucleus        significant
                                  assay               increase in the
                                                      frequency of
                                                      micronucleated
                                                      polychromatic
                                                      erythrocytes in
                                                      bone marrow at
                                                      2,000 mg/kg.
------------------------------------------------------------------------

[[Page 58368]]

 
870.5550                         Other               There was no
                                  Genotoxicity;       evidence of
                                  Unscheduled DNA     unscheduled DNA
                                  synthesis in        synthesis up to
                                  primary rat         cytotoxic levels.
                                  hepatocytes
------------------------------------------------------------------------
870.6200a                        Acute               NOAEL = 500 mg/kg/
                                  neurotoxicity       day for males and
                                  screening battery   females
                                  in rats
                                                     LOAEL = 2,000 mg/kg/
                                                      day based on
                                                      increased
                                                      incidence of
                                                      perianal staining
                                                      in males,
                                                      decreased motor
                                                      activity and
                                                      locomotor activity
                                                      in both sexes and
                                                      increase in the
                                                      incidence of
                                                      animals exhibiting
                                                      low levels of
                                                      activity in open
                                                      field in both
                                                      sexes.
------------------------------------------------------------------------
870.6200b                        Subchronic          NOAEL = 147 mg/kg/
                                  neurotoxicity       day in males and
                                  screening battery   1,736 mg/kg/day in
                                  in rats             females
                                                     LOAEL = 1,482 mg/kg/
                                                      day based on
                                                      decreased body
                                                      weight, decreased
                                                      body weight gain,
                                                      and decreased food
                                                      consumption in
                                                      males. LOAEL >
                                                      1,736 mg/kg/day in
                                                      females.
------------------------------------------------------------------------
870.6300                         Developmental       NA
                                  neurotoxicity in
                                  rats
------------------------------------------------------------------------
870.7800                         Antibody Plaque-    NOAEL = > 1,000 mg/
                                  forming cell        kg/day
                                  assay in male
                                  rats
                                                     LOAEL > 1,000 mg/kg/
                                                      day
------------------------------------------------------------------------
870.7800                         Antibody Plaque-    NOAEL = > 1,000 mg/
                                  forming cell        kg/day
                                  assay in female
                                  rats
                                                     LOAEL > 1,000 mg/kg/
                                                      day
------------------------------------------------------------------------
870.7800                         Splenic T-cells, B- NOAEL = > 1,000 mg/
                                  cells, and NK-      kg/day
                                  cell assay in
                                  male rats
                                                     LOAEL > 1,000 mg/kg/
                                                      day
------------------------------------------------------------------------
870.7800                         Splenic T-cells, B- NOAEL = > 1,000 mg/
                                  cells, and NK-      kg/day
                                  cell assay in
                                  female rats
                                                     LOAEL > 1,000 mg/kg/
                                                      day
------------------------------------------------------------------------
870.7800                         Plaque-Forming      NOAEL = 2,205 mg/kg/
                                  cell assay in       day in males and
                                  rats                2,556 mg/kg/day in
                                                      females
                                                     LOAEL > 2,205 mg/kg/
                                                      day in males and
                                                      2,556 mg/kg/day in
                                                      females
------------------------------------------------------------------------
870.7485                         Metabolism in rats  There were no sex-
                                                      related
                                                      differences in the
                                                      absorption,
                                                      distribution,
                                                      metabolism or
                                                      excretion. Based
                                                      on urinary
                                                      excretion,
                                                      absorption was 15-
                                                      30% and maximum
                                                      plasma
                                                      concentrations
                                                      were achieved
                                                      within 30 minutes.
                                                      At sacrifice,
                                                      tissues and
                                                      carcass contained
                                                      less than 1% of
                                                      radioactivity. The
                                                      highest residue in
                                                      the tissues was in
                                                      the liver. Greater
                                                      than 90% of the
                                                      administered dose
                                                      was eliminated
                                                      within 24 hours.
                                                      The major
                                                      component in urine
                                                      and feces was
                                                      unchanged parent
                                                      which represented
                                                      90-95% of the
                                                      administered dose.
------------------------------------------------------------------------
870.7485                         Metabolism in rats  Major component in
                                                      urine and feces
                                                      was unchanged
                                                      parent which
                                                      represented 94% of
                                                      the administered
                                                      dose. Less than 1%
                                                      of the
                                                      administered dose
                                                      was recovered in
                                                      the carcass,
                                                      tissues, expired
                                                      air, or cage wash.
                                                      Highest residue
                                                      was in the liver.
------------------------------------------------------------------------
870.7485                         Metabolism in       Metabolized via two
                                  rats: M: 5.13 mg/   pathways. One
                                  kg of phenyl- UL-   pathway involved
                                  C14 MKH 6562        the oxidative
                                  sulfonamide         decarboxylation of
                                  lactate (plant      sulfonamide
                                  metabolite of MKH   lactate to form
                                  6562)               sulfonamide
                                                      acetate. The other
                                                      pathway involved
                                                      the hydrolysis of
                                                      sulfonamide
                                                      lactate and
                                                      sulfonamide
                                                      acetate to give
                                                      sulfonamide.
------------------------------------------------------------------------
870.7485                         Metabolism in       Approximately 70%
                                  rats: M: 5 mg/kg    absorption and
                                  of phenyl-C14 MKH   elimination with
                                  6562 sulfonamide    98% recovery in
                                  alanine (a plant    urine and feces.
                                  metabolite of MKH   Several
                                  6562)               metabolites in
                                                      addition to parent
                                                      (17%). Less than
                                                      1% of the
                                                      administered dose
                                                      was recovered in
                                                      the carcass,
                                                      tissues, expired
                                                      air, or cage wash.
                                                      Highest residue
                                                      was in the liver.
------------------------------------------------------------------------
870.7600                         Dermal penetration  NA
------------------------------------------------------------------------

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). 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

[[Page 58369]]

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.
    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 flucarbazone-sodium used for human risk assessment is 
shown in the following Table 2:

 Table 2.--Summary of Toxicological Dose and Endpoints for Flucarbazone-sodium] 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 13-50 years of   NOAEL = 300 mg/kg/day;   FQPA SF = 1X; aPAD =     Developmental Toxicity
 age                                    UF = 100; Acute RfD =    acute RfD        Study - rabbit;
                                        3.0 mg/kg/day            FQPA SF = 3.0 mg/kg/     Developmental LOAEL =
                                                                 day                      500 mg/kg/day based on
                                                                                          decreased fetal body
                                                                                          weight and delayed
                                                                                          ossification.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 35.9 mg/kg/day;  FQPA SF = 1X; cPAD =     One year dog feeding
                                        UF = 100; Chronic RfD    chronic RfD      study LOAEL = 183 mg/
                                        = 0.36 mg/kg/day;        FQPA SF = 0.36 mg/kg/    kg/day based on
                                                                 day                      decreased body weight
                                                                                          gain, decreased
                                                                                          thyroxine, increased N-
                                                                                          demethylase, and
                                                                                          increased liver weight
 
----------------------------------------------------------------------------------------------------------------
*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. No tolerances have 
previously been established for flucarbazone-sodium. Risk assessments 
were conducted by EPA to assess dietary exposures from flucarbazone-
sodium 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. An appropriate endpoint attributable to a single 
exposure was not identified for the general population, including 
infants and children. The decreased motor and locomotor activity 
observed at 2,000 mg/kg on the day of dosing only in the acute 
neurotoxicity study in rats was reversible within 18 minutes. The NOAEL 
of 500 mg/kg for these findings was not considered appropriate for 
selection as an acute dietary endpoint for the general population. An 
acute dietary risk assessment was performed for flucarbazone-sodium for 
the population subgroup, females 13 to 50 years old, based on the 
results of the rabbit developmental toxicity study. The Dietary 
Exposure Evaluation Model (DEEM) 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 acute exposure assessment: 
For all commodities, 100% crop treated was assumed. In order to account 
for the metabolites of concern in wheat and livestock commodities, the 
anticipated residue levels (parent and metabolites of concern) to be 
used in the dietary exposure assessment were determined. Using the 
ratio of the sulfonamide metabolites to the sum of the parent and N-
desmethyl metabolite observed in the wheat metabolism study and the 
Highest Average Field Trial (HAFT) value from the crop field trial 
studies, the anticipated total residues (parent and metabolites of 
concern) expected to be in wheat were determined. A processed wheat 
food/feed study was not submitted in support of this petition. 
Therefore, in order to represent the worse case scenario, the wheat 
maximum theoretical concentration factor of 8x (Table 1, Residue 
Chemistry Test Guidelines OPPTS 860.1520) was used for all wheat 
commodities. Default concentration factors were used for all other 
commodities in DEEM.
     ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide CSFII and accumulated 
exposure to the chemical for each commodity. The following assumptions 
were made for the chronic exposure assessments: For all commodities, 
100% crop treated was assumed. In order to account for the metabolites 
of concern in wheat and livestock commodities, the anticipated residue 
levels (parent and metabolites of concern) to be used in the dietary 
exposure assessment were determined. Using the ratio of the sulfonamide 
metabolites to the sum of the parent and N-desmethyl metabolite 
observed in the wheat metabolism study, and the Highest Average Field 
Trial (HAFT)

[[Page 58370]]

value from the crop field trial study, the anticipated total residues 
(parent and metabolites of concern) expected to be in wheat were 
determined. A processed wheat food/feed study was not submitted in 
support of this petition. Therefore, in order to represent the worse 
case scenario, the wheat maximum theoretical concentration factor of 8x 
(Table 1, Residue Chemistry Test Guidelines OPPTS 860.1520) was used 
for all wheat commodities. Default concentration factors were used for 
all other commodities in DEEM.
     iii. Cancer. The Agency concluded that flucarbazone-sodium was 
negative for carcinogenic potential in mice and rats and classified 
flucarbazone-sodium as ``not likely'' to be a human carcinogen 
according to EPA Draft Guidelines for Carcinogen Risk Assessment. 
Therefore, a cancer dietary exposure analysis was not performed.
     Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance. EPA used anticipated residues in this case to estimate 
exposure to the sulfonamide metabolites of flucarbazone-sodium in wheat 
that are not included in the time-limited tolerance expression. As a 
condition of registration, EPA will require Bayer Corporation to submit 
revised analytical methodology and wheat residue data that measure all 
residues of concern, including the sulfonamide metabolites. These data 
must be submitted within 3 years of registration, well within the 5 
year time frame specified in the regulations, and should allow the 
Agency to set tolerances for wheat that include these metabolites and 
eliminate the need for sulfonamide anticipated residue calculations in 
future risk assessments for flucarbazone-sodium.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flucarbazone-sodium 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 flucarbazone-sodium.
    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 
the Screening Concentration in Ground Water model (SCI-GROW), which 
predicts pesticide concentrations in groundwater. 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 includes 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 flucarbazone-sodium they are 
further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of flucarbazone-
sodium (parent only) in surface water and ground water for acute 
exposures are estimated to be 1.42 parts per billion (ppb) for surface 
water and 0.2 ppb for ground water. The EECs for chronic exposures are 
estimated to be 1.25 ppb for surface water and 0.2 ppb for ground 
water.
     Based on the GENEEC model, total flucarbazone-sodium EECs (parent 
plus metabolites) in surface water are not likely to exceed 1.45 ppb 
for acute exposures and 1.44 ppb for chronic (60-day) exposures. Agency 
interim policy recommends that the 60-day GENEEC value to be divided by 
an adjustment factor of 3 to obtain a value for chronic risk assessment 
calculations. Therefore, a surface water value of 0.48 ppb was used for 
chronic risk assessment.
     Because the degradates of flucarbazone-sodium are so resistant to 
aerobic metabolism in soil, they lie outside the range of environmental 
characteristics from which SCI-GROW was developed. It was therefore not 
appropriate in this case to use the model to estimate total 
flucarbazone-sodium EECs in ground water. Instead, the concentration of 
total flucarbazone residues in soil porewater of the top 1-foot of soil 
immediately postapplication was estimated to be approximately 50 ppb. 
This number would be an upper limit on the amount of chemical that 
could be found in the soil porewater and was used by the Agency as an 
estimate of expected residues of flucarbazone-sodium and its 
metabolites in ground water for risk assessment purposes.
    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).
     Flucarbazone-sodium is not registered for use on any sites that 
would result in residential exposure.
    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 flucarbazone-sodium 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, 
flucarbazone-

[[Page 58371]]

sodium 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 flucarbazone-sodium 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. 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. Prenatal and postnatal sensitivity. No increased quantitative 
or qualitative susceptibility was seen following prenatal and/or 
postnatal exposures. There were no developmental findings in rats up to 
the limit dose of 1,000 mg/kg/day. In the rabbit developmental toxicity 
study, the effects seen in fetuses (decreased fetal body weight and 
delayed ossification) are at dose levels equal to or greater than doses 
where maternal toxicity (increased clinical signs and decreased food 
consumption) were observed. In a 2-generation reproductive toxicity 
study in rats, the effects seen in offspring were at dose levels equal 
to or greater than doses where parental toxicity were seen.
    iii. Conclusion. There is a complete toxicity data base for 
flucarbazone-sodium and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. EPA 
determined that the 10X safety factor to protect infants and children 
should be removed. The FQPA factor is removed because there is no 
indication of quantitative or qualitative increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure; a developmental 
neurotoxicity study is not required; the dietary (food and drinking 
water) exposure assessments will not underestimate the potential 
exposures for infants and children; and there are no registered 
residential uses at the current time.

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 from food to 
flucarbazone-sodium will occupy < 1% of the aPAD for females 13 to 50 
years old. Since an appropriate endpoint attributable to a single 
exposure was not identified for the general population, including 
infants and children, an acute exposure assessment was not performed 
for these population subgroups. In addition, there is potential for 
acute dietary exposure to flucarbazone-sodium in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD for the population of concern (females 13 to 50 years old), 
as shown in the following Table 3:

                  Table 3.--Aggregate Risk Assessment for Acute Exposure to Flucarbazone-sodium
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/       %aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females, 13 to 50 years old                                3           <1         1.45           50       90,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flucarbazone-sodium from food will utilize 1% of the cPAD for the U.S. 
population, <1% of the cPAD for all infants less than 1 year old and 2% 
of the cPAD for children 1 to 6 years old, the population subgroup with 
the highest estimated exposure to flucarbazone-sodium. There are no 
residential uses for flucarbazone-sodium that result in chronic 
residential exposure to flucarbazone-sodium. In addition, there is 
potential for chronic dietary exposure to flucarbazone-sodium in 
drinking water. After calculating the DWLOCs and comparing

[[Page 58372]]

them to the EECs for surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 4:

          Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Flucarbazone-sodium
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.36            1         0.48           50       12,000
Infants less than 1 year old                            0.36           <1         0.48           50        3,600
Children 1 to 6 years old                               0.36            2         0.48           50        3,500
----------------------------------------------------------------------------------------------------------------

    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).
    Flucarbazone-sodium 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).
     Flucarbazone-sodium 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. The Agency concluded 
that flucarbazone-sodium was negative for carcinogenic potential in 
mice and rats and classified flucarbazone-sodium as ``not likely'' to 
be a human carcinogen according to EPA Draft Guidelines for Carcinogen 
Risk Assessment. Therefore, a cancer dietary exposure analysis was not 
performed.
    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 flucarbazone-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed residue analytical methods for 
tolerance enforcement in wheat and livestock commodities. The 
analytical enforcement method for wheat employs accelerated solvent 
extraction, clean-up using solid phase extraction columns followed by 
detection and quantitation by liquid chromatography/tandem mass 
spectroscopy (LC/MS/MS). The analytical method for livestock 
commodities is a common moiety method which measures residues of 
flucarbazone-sodium (MKH6562) in animal tissues and milk by extracting 
and hydrolysing MKH 6562 and MKH 6562-related residues to MKH 6562 
sulfonamide. Detection is achieved using negative ion electrospray mass 
spectrometry using deuterated MKH 6562 sulfonamide as an internal 
standard. Both methods have undergone successful validations by 
independent laboratories. They are currently being validated by the 
Analytical Chemistry Branch laboratories, BEAD (7503C), Office of 
Pesticide Programs. Upon successful completion of the EPA validation 
and the granting of this registration these methods will be forwarded 
to FDA for publication in a future revision of the Pesticide Analytical 
Manual, Vol-II (PAM-II). Prior to publication in PAM-II and upon 
request, the methods will be available from the Analytical Chemistry 
Branch (ACB), BEAD (7503C), Environmental Science Center, 701 Mapes 
Road, Ft George G. Meade, MD 20755-5350; contact Francis D. Griffith, 
Jr, telephone (410) 305-2905, e-mail [email protected]. The 
analytical standards for these methods are also available from the EPA 
National Pesticide Standard Repository at the same location.

B. International Residue Limits

    A default Maximum Residue Limit (MRL) of 0.01 ppm has been 
established in Canada for residues of flucarbazone-sodium and its N-
desmethyl metabolite on wheat grain. This value is consistent with the 
tolerance being established in the United States on wheat grain. There 
are no Codex MRLs for this compound on wheat. Therefore, no 
compatibility issues exist with Codex in regard to the U.S. tolerances 
discussed in this review.

C. Conditions

    The registration of flucarbazone-sodium will be time-limited and 
conditioned upon submission of a revised method and additional residue 
data for wheat commodities that measure all of the metabolites of 
concern. In addition, the registrant must submit a 28-day rat 
inhalation study and additional storage stability data.

V. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-
N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-
carboxamide, sodium salt) and its N-desmethyl metabolite in or on 
wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 
ppm; and wheat, straw at 0.05 ppm; and combined residues of 
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding 
liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver 
of cattle, goats, hogs, horses and sheep at 1.5 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.

[[Page 58373]]

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-301052 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 
28, 2000.
    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 
tompkins.jim@epa.gov, 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 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-301052, 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: opp-docket@epa.gov. 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 file format 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 
etermines 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). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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 
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

[[Page 58374]]

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).

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 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: September 21, 2000.

Susan B. Hazen,

Acting Director, 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), (346a) and 371.


    2. Section 180.562 is added to read as follows:


Sec. 180.562  Flucarbazone-sodium; tolerances for residues.

    (a) General. (1) Time-limited tolerances are established for 
combined residues of the herbicide flucarbazone-sodium, 4,5-dihydro-3-
methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-
1,2,4-triazole 1-carboxamide, sodium salt) and its N-desmethyl 
metabolite in or on the following food commodities:

 
------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation  Date
------------------------------------------------------------------------
Wheat, forage.....................               0.30           11/01/05
Wheat, grain......................               0.01           11/01/05
Wheat, hay........................               0.10           11/01/05
Wheat, straw......................               0.05           11/01/05
------------------------------------------------------------------------

    (2) Time-limited tolerances are established for combined residues 
of the herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-
oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-
carboxamide, sodium salt) and its metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on the following food commodities:

 
------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
Cattle, liver.....................               1.50           11/01/05
Cattle, mbyp except liver.........               0.01           11/01/05
Cattle, meat......................               0.01           11/01/05
Goats, liver......................               1.50           11/01/05
Goats, mbyp except liver..........               0.01           11/01/05
Goats, meat.......................               0.01           11/01/05
Hogs, liver.......................               1.50           11/01/05
Hogs, mbyp except liver...........               0.01           11/01/05
Hogs, meat........................               0.01           11/01/05
Horses, liver.....................               1.50           11/01/05
Horses, mbyp except liver.........               0.01           11/01/05
Horses, meat......................               0.01           11/01/05
Milk..............................              0.005           11/01/05
Sheep, liver......................               1.50           11/01/05
Sheep, mbyp except liver..........               0.01           11/01/05
Sheep, meat.......................               0.01           11/01/05
------------------------------------------------------------------------


[[Page 58375]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

FR Doc. 00-24947 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S