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Flucarbazone-sodium (Bayer). September 29, 2000, Time-Limited Pesticide Tolerances. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2000/September/Day-29/p24947.htm
[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Rules and Regulations]
[Page 58364-58375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-9]
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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: miller.joanne@epa.gov.
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 griffith.francis@epa.gov. 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
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[[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