[Federal Register Volume 67, Number 22 (Friday, February 1, 2002)]
[Rules and Regulations]
[Pages 4913-4922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2612]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301206; FRL-6818-3]
RIN 2070-AB78
Bifenazate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for (i) combined
residues of bifenazate (hydrazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester) and D3598 (expressed as
bifenazate; diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl),
1-methylethylester) in or on raw agricultural commodities (apple, wet
pomace; cotton, undelinted seed; cotton gin byproducts (gin trash);
fruit, pome group; grape; grape, raisin; hop, dried cones; nectarine;
peach; plum; strawberry and in fat of cattle, goat, hog, horse and
sheep and (ii) combined residues of bifenazate, D3598 (expressed as
bifenazate), A1530 (1,1'-biphenyl, 4-ol) and A1530-sulfate (expressed
as A1530; 1,1'-biphenyl, 4-oxysulfonic acid) in meat and meat
byproducts of cattle, goat, horse, hog and sheep and milk. Uniroyal
Chemical Company requested this tolerance under the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act (FQPA)
of 1996.
DATES: This regulation is effective February 1, 2002. Objections and
requests for hearings, identified by docket control number OPP-301206,
must be received by EPA on or before April 2, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301206 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Suku Oonnithan, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 605-0368; 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 Office of Prevention,
Pesticides, and Toxic Substances (OPPTS) Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301206. 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 April 18, 2001; (66 FR 19935) (FRL-6777-
4), 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 FQPA
of 1996 (Public Law 104-170) announcing the filing of a pesticide
petition (PP 0F6108) for tolerance by Uniroyal Chemical Company, Benson
Road, Middlebury, CT 06749. This notice included a summary of the
petition prepared by Uniroyal Chemical Company, 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 a tolerance for residues of the insecticide bifenazate in
or on the raw agricultural commodities apple, wet pomace at 1.2 parts
per million (ppm); cotton seed at 0.5 ppm; cotton, gin byproducts (gin
trash) at 20 ppm; fruit, pome, group at 0.75 ppm; fruit, stone, group
(except cherries) at 1.5 ppm; grape at 0.75 ppm; hop at 15 ppm and
strawberry at 1.5 ppm. As cotton processed commodities fed to animals
may be transferred to milk and edible tissue of ruminants, tolerances
were also proposed for meat at 0.02 ppm and milk at 0.01 ppm.
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
[[Page 4914]]
determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii)
defines ``safe'' to mean that`` there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of bifenazate and D3598
(expressed as bifenazate) in or on apple, wet pomace at 1.2 ppm;
cattle, fat at 0.1 ppm; cotton, gin byproducts at 35 ppm; cotton,
undelinted seed at 0.75 ppm; fruit, pome, group at 0.75 ppm; goat, fat
at 0.1 ppm; grape at 0.75 ppm; grape, raisin at 1.2 ppm; hog, fat at
0.1 ppm; hop, dried cones at 15 ppm; horse, fat at 0.1 ppm; nectarine
at 1.7 ppm; peach at 1.7 ppm; plum at 0.3 ppm; sheep, fat at 0.1 ppm;
strawberry at 1.5 ppm and combined residues of bifenazate and D3598
(expressed as bifenazate), A1530 and A1530-sulfate (expressed as A1530)
in: cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm;
goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, meat at
0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, meat at 0.01 ppm;
horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep, meat at
0.01 ppm; sheep, meat byproducts at 0.01 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance 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 bifenazate 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
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Study Type (All
OPPTS Guideline No. Studies Results
Acceptable)
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 13.8 mg/kg/
toxicity rodents- day in males, 3.2
rat mg/kg/day in
females.
LOAEL = 27.7 mg/kg/
day in males, 16.3
mg/kg/day in
females based on
decreased body
weight gain in
both sexes,
decreased liver
weight in males,
increased spleen
weight in females,
and histopathology
in liver in both
sexes, and
histopathological
changes in the
spleen and adrenal
cortex in males.
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870.3150 90-Day oral NOAEL = 0.9 mg/kg/
toxicity day in males, 1.3
nonrodents-dog mg/kg/day in
females.
LOAEL = 10.4 mg/kg/
day in males, 10.7
mg/kg/day in
females based on
changes in
hematological
parameters in both
sexes, increased
bilirubin in the
urine in males,
increased absolute
and relative liver
weight in females
and liver
histopathologic
effects in both
sexes.
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870.3200 21-Day dermal NOAEL = 80 mg/kg/
toxicity-rat day in males and
females
LOAEL = 400 mg/kg/
day in males and
females based on
decreased body
weight in females,
decreased food
consumption in
both sexes,
increased urinary
ketones, increased
urinary protein,
increased urinary
specific gravity,
and decreased
urinary volume in
both sexes, and
increased
incidence of
extramedullary
hematopoiesis in
the spleen in both
sexes.
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870.3700 Prenatal Maternal NOAEL = 10
developmental in mg/kg/day.
rodents-rat
LOAEL = 100 mg/kg/
day based on
increased clinical
signs, and
decreased body
weight, body
weight gain, and
food consumption.
Developmental NOAEL
= 500 mg/kg/day
LOAEL = not
established
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870.3700 Prenatal Maternal NOAEL =
developmental in 200 mg/kg/day
nonrodents-rabbit
LOAEL = not
established; Doses
for the main study
were selected
based on a range-
finding study in
which groups of 5
rabbits each
received 0, 125,
250, 500, 750, or
1,000 mg/kg/day
during gestation
days 6-19 by
gavage.
[[Page 4915]]
Maternal toxicity
was seen as
increased deaths
and decreased body
weight at 750 mg/
kg/day and above.
A treatment-
related increase
in the number of
does aborting was
seen at 250 mg/kg/
day and above.
Developmental NOAEL
= 200 mg/kg/day.
LOAEL = not
established; Due
to only one or two
litters available
in each of the
treated groups in
the range finding
study, a clear
assessment of
developmental
toxicity was not
possible. Based on
these results,
doses of 10, 50,
and 200 mg/kg/day
were selected for
the main study.
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects- NOAEL = 1.6 mg/kg/
rat day in males, 1.8
mg/kg/day in
females.
LOAEL = 6.5 mg/kg/
day in males and
7.4 mg/kg/day in
females based on
decreased body
weight, body
weight gain, and
food consumption
in both sexes.
Reproductive NOAEL
= 16.4 mg/kg/day
in males, 18.3 mg/
kg/day in females.
LOAEL = not
established.
Offspring NOAEL =
16.4 mg/kg/day in
males, 18.3 mg/kg/
day in females.
LOAEL = not
established.
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = 1.01 mg/kg/
dogs day in males, 1.05
mg/kg/day in
females
LOAEL = 8.95 mg/kg/
day in males,
10.42 mg/kg/day in
females based on
changes in
hematological and
clinical chemistry
parameters in both
sexes and
histopathological
effects in bone
marrow, liver, and
kidney in both
sexes.
------------------------------------------------------------------------
870.4300 Chronic/ NOAEL = 3.9 mg/kg/
Carcinogenicity day in males, 4.8
rats mg/kg/day in
females.
LOAEL = 9.7 mg/kg/
day in males and
9.7 mg/kg/day in
females based on
decreased body
weight, body
weight gain, and
food consumption
in both sexes.
No evidence of
carcinogenicity
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870.4300 Carcinogenicity NOAEL = 1.5 mg/kg/
mice day in males, 19.7
mg/kg/day in
females.
LOAEL = 15.4 mg/kg/
day in males, 35.7
mg/kg/day in
females based on
decreased body
weight and body
weight gain in
females and
hematological
effects and
decreased kidney
weight in males.
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5265 Gene Mutation Non-mutagenic when
tested up to 5000
ug/plate, in
presence and
absence of
activation, in S.
typhimurium
strains TA98,
TA100, TA1535 and
TA1537 and E. coli
strain WP2uvra.
------------------------------------------------------------------------
870.5300 Gene Mutation Non-mutagenic at
the TK locus in
L5178Y mouse
lymphoma cells
tested up to
cytotoxic
concentrations or
limit of
solubility, in
presence and
absence of S-9
activation.
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870.5375 Chromosome Did not induce
aberration structural
chromosome
aberration in CHO-
K1 cell cultures
in the presence
and absence of
activation up to
cytotoxic
concentrations.
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870.5385 Chromosomal Non-mutagenic in
aberration ICR mouse bone
marrow
micronucleus
chromosomal
aberrations assay
up to cytotoxic
concentrations.
[[Page 4916]]
870.7485 Metabolism and Total recovery of
pharmacokinetics - the administered
rat dose was > 93% for
all treatment
groups. Fecal
excretion was the
major route of
elimination (66-
83% of the dose),
with eight primary
metabolites
detected. These
metabolites, as
well as those
identified in the
urine and bile,
were the result of
metabolic
reactions
including
hydrazine
oxidation to the
diazene (D3598),
demethylation,
ring
hydroxylation, and
molecular scission
with the loss of
hydrazinecarboxyli
c acid portion to
methoxybiphenyl
(D1989) with
subsequent
conjugation. The
Metabolism
Assessment Review
Committee (MARC)
determined that
D1989 is not
likely to be more
toxic than the
parent compound.
------------------------------------------------------------------------
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
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 variations.
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
variations) 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 bifenazate used for human risk assessment is shown in the
following Table 2:
Table 2--Summary of Toxicological Dose and Endpoints for bifenazate for Use in Human Risk Assessment\1\
----------------------------------------------------------------------------------------------------------------
FQPA SF\*\ and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary for general population None An acute dietary None
and females 13-50 years old endpoint was not
selected based on the
absence of an
appropriate endpoint
attributed to a single
dose
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 1.0 mg/kg/day; FQPA SF = 1X; cPAD = LOAEL = 8.9/10.4 mg/kg/
UF = 100; Chronic RfD cRfD/FQPA; SF = 0.01 day [M/F] based on
= 0.01 mg/kg/day mg/kg/day changes in
hematological and
clinical chemistry
parameters, and
histopathology in bone
marrow, liver, and
kidney in the One Year
Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short Term (1-30 Oral NOAEL = 10 mg/kg/ LOC = 100 LOAEL = 100 mg/kg/day
days) day based on clinical
signs, decreased body
weight and food
consumption during the
dosing period in the
Rat Developmental
Study
----------------------------------------------------------------------------------------------------------------
[[Page 4917]]
Incidental Oral, Intermediate Term Oral NOAEL = 0.9 mg/kg/ LOC = 100 LOAEL = 10.4/10.7 mg/kg/
(30 days - 6 months) day day [M/F] based on
changes in hematologic
parameters in the 90-
Day Subchronic Dog
Study
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate- and Long-Term Dermal NOAEL = 80 mg/kg/ LOC for MOE = 100 LOAEL = 400 mg/kg/day
Dermal (1-30 days, 30 days-6 months, day based on decreased
and 6 months to lifetime) body weight and food
(Occupational/Residential) consumption,
hematologic effects,
increased spleen
weight and
extramedullary
hemapoiesis in the
spleen in the 21-Day
Dermal Toxicity Study
in Rats
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1-30 days) Oral NOAEL= 10 mg/kg/ LOC for MOE = 100 LOAEL = 100 mg/kg/day
(Occupational/Residential) day (inhalation based on decreased
absorption rate = body weight and food
100%) consumption in the Rat
Developmental Study
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (30 days- Oral study NOAEL= 0.9 LOC for MOE = 100 LOAEL = 10.4/10.7 mg/kg/
6 months) (Occupational/Residential) mg/kg/day (inhalation day based on changes
absorption rate = in hematologic
100%) parameters in the 90-
Day Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (6 months- Oral study NOAEL= 1.0 LOC for MOE = 100 LOAEL = 8.9/10.4 mg/kg/
lifetime) (Occupational/Residential) mg/kg/day (inhalation day [M/F] based on
absorption rate = changes in
100%) hematological and
clinical chemistry
parameters, and
histopathology in bone
marrow, liver, and
kidney in the One Year
Dog Feeding Study
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Cancer classification Risk Assessment not No evidence of
not likely conducted carcinogenicity
----------------------------------------------------------------------------------------------------------------
\1\ FQPA SF = Food Quality Protection Act safety factor, LOAEL = lowest observed adverse effect level, LOC =
level of concern, MOE = margin of exposure, NOAEL = no observed adverse effect level, PAD = population
adjusted dose (a = acute, c = chronic), RfD = reference dose, UF = uncertainty factor.
\*\ 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. Tolerances have been
established 40 CFR 180.572 for the combined residues of bifenazate and
D3598 (expressed as bifenazate) in or on raw agricultural commodities
and animal fat and combined residues of bifenazate, D3598 (expressed as
bifenazate), A1530 and A1530-sulfate (expressed as A1530) in animal
tissues (excluding fat) and milk. Risk assessments were conducted by
EPA to assess dietary exposures from bifenazate in food as follows:
i. Acute exposure. The Agency did not identify an acute endpoint
for the general population, infants, children, and females 13 to 50
years old. Therefore, an acute dietary exposure analysis is not
necessary.
ii. Chronic exposure. A chronic dietary exposure analysis was
conducted using the Dietary Exposure Evaluation Model (DEEM
ver 7.73) which incorporates consumption data from the USDA 1989-92
Continuing Surveys of Food Intake by Individuals (CSFII). The dietary
exposure analysis assumed tolerance level residues and 100% crop
treated for all registered and proposed crops. Processing factors for
apple juice and grape juice were reduced to 0.23 and 0.17,
respectively. The DEEM default processing factor ratio
between juice and concentrate was maintained and default processing
factors were assumed for all other commodities.
There is a Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) sec 18 registration for application of bifenazate to greenhouse
grown tomatoes. The potential for fresh market tomatoes to enter the
processed market channel from this use is minimal for the following
reasons: (a) this sec 18 approval will treat only about 300 acres of
greenhouse grown tomatoes in Colorado, Texas and Virginia, (b) the
tomato variety grown is an indeterminant type unsuitable for processing
due to less solids and higher water content, (c) fresh market tomatoes
do not tolerate the bulk handling required for processing, (d) higher
price for fresh tomatoes would dictate the growers not to divert
greenhouse grown tomatoes to the processing market. Therefore, the
dietary contribution of bifenazate residues from treated tomatoes was
determined to be negligible and a zero residue in/on tomatoes was
assumed for this action.
The chronic dietary food exposure estimates to bifenazate were less
than The Agency 's level of concern (< 100% cPAD) for the general U.S.
population and all population subgroups. The most highly exposed
population was infants (< 1 year) at 52% of the cPAD.
iii. Cancer. The Agency classified bifenazate as ``not likely'' to
be a human carcinogen according to EPA Proposed Guidelines for
Carcinogen Risk Assessment (April 10, 1996). Therefore, a cancer
dietary exposure analysis is not necessary.
2. Dietary exposure from drinking water. The available
environmental fate data indicate that bifenazate may not persist in the
environment nor have the ability to leach into ground water resources.
Bifenazate dissipates quickly through metabolic processes under aerobic
soil conditions (with a half-life of 30 minutes), by aqueous photolysis
(half-life of 0.67 day), and by hydrolysis, especially in alkaline
water (half-life of 0.08 day). In neutral and acidic water systems,
bifenazate may persist for approximately one day or longer (half-lives
of 0.8 day at pH 7, and 5.4 days in pH 5). Although photodegradation of
bifenazate in soil may be possible, it could not be confirmed in the
laboratory
[[Page 4918]]
due to rapid biodegradation of bifenazate under aerobic soil
conditions. In the laboratory soil column studies, bifenazate showed
low to no mobility in the soils tested.
Two major degradates of bifenazate were identified in the aqueous
photolysis and aerobic soil metabolism studies D3598 (diazinecarboxylic
acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester) and D1989
(4-methoxybiphenyl). Similar to parent bifenazate, D3598 seemed to
metabolize quickly under aerobic soil conditions (half-life of 8.3
hours). D1989 on the other hand, is believed to be more persistent and
have some potential to leach into the ground water resources. D1989 has
an aerobic soil metabolism half-life of 60 days and was observed to
have slight mobility in laboratory leaching studies. D1989 was the only
degradate of bifenazate detected in terrestrial field dissipation
studies, but only the 0 - 6 inches soil depth.
Since parent bifenazate and its degradate D3598 are not persistent
in the environment and since there are no acute dietary endpoint data
for these compounds, the Agency has decided not to consider bifenazate
and D3598 as residues of concern in drinking water. Instead, D1989 was
assumed to have the possible potential to contaminate the drinking
water resources.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
bifenazate 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 bifenazate.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Ground Water (SCI-GROW) model is used to
predict pesticide concentrations in shallow groundwater. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to bifenazate they are further
discussed in the aggregate risk sections below.
Based on the FIRST or PRZM/EXAMS and SCI-GROW models the estimated
environmental concentrations (EECs) of D1989 for acute exposures are
estimated to be 18 parts per billion (ppb) for surface water and less
than 1 part per trillion (ppt) for ground water. The EECs for chronic
exposures are estimated to be 5 parts per billion (ppb) for surface
water and <1 ppt for ground water. These concentrations were based on
one application of bifenazate on hops at a maximum rate of 0.75 lb ai/
acre/year, and on the assumption that bifenazate totally metabolizes
and degrades to D1989.
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). The currently
registered Floramite (EPA Reg. No. 400-481) and the proposed
new product for food uses (Acramite; EPA File Symbol: 400
LNG) of bifenazate are not expected to result in residential exposures.
The Floramite label allows application of bifenazate to
landscape ornamentals at residential/recreational sites by commercial
applicators only. The Acramite label specifies agricultural
use only. Therefore, this action assumes that bifenazate products will
not be used by homeowners, so no homeowner exposure assessment is
included. With respect to post-application residential exposures, the
Agency contends that no significant post-application exposure is
anticipated from treated ornamentals, either by residents or
professional applicators; therefore, no residential post-application
assessment is warranted.
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 bifenazate 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,
bifenazate 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 bifenazate has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no qualitative or
quantitative toxicity evidence of increased susceptibility of rats and
rabbits during
[[Page 4919]]
in utero exposure or during post-natal exposure based on developmental
toxicity and reproductive toxicity studies performed with bifenazate.
3. Conclusion. There is a complete toxicity database for bifenazate
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Based on the lack of
increased susceptibility and the completeness of the toxicity and
exposure databases, EPA has concluded that an additional 10X safety
factor is not needed to protect infants and children.
E. Aggregate Risks and Determination of Safety
Because The Agency does not have ground and surface water
monitoring data to calculate a quantitative aggregate exposure, DWLOCs
were calculated. A DWLOC is a theoretical upper limit on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food, drinking water, and through residential uses. A
DWLOC will vary depending on the toxic endpoint, drinking water
consumption, body weights, and pesticide uses. Different populations
will have different DWLOCs. The Agency uses DWLOCs in the risk
assessment process to assess potential concern for exposure associated
with pesticides in drinking water. DWLOC values are not regulatory
standards for drinking water. The Agency compares DWLOC values for each
relevant population subgroup to the estimated concentration of
bifenazate in surface water and ground water from the Agency' screening
models. If the DWLOC values are greater than the estimated
concentration of bifenazate in surface water and ground water, The
Agency concludes with reasonable certainty that exposures to bifenazate
in drinking water do not pose a significant human health risk.
To calculate the chronic DWLOCs, the food estimates (from
DEEM) were subtracted from the appropriate PAD value to
obtain the maximum water exposure level. DWLOCs were then calculated
using the standard body weights and drinking water consumption figures:
70kg/2L (adult male and U.S. population), 60 kg/2L (adult female), and
10kg/1L (infants and children). Because there is no residential
exposure to bifenazate, only chronic aggregate exposures are necessary.
1. Acute risk. The Agency did not identify an acute endpoint for
the general U.S. population, infants, children, and females 13-50 years
old. Therefore, an acute risk is expected.
2. Chronic risk. The chronic dietary food exposure to bifenazate
was estimated at 0.005242 mg/kg/day (52% of cPAD) for infants (< 1 year
old) and 0.001557 mg/kg/day (16% of cPAD) for the general U.S.
population. The calculated DWLOCs ranged between 48 to 320 ppb for all
the population subgroups. The surface and ground water chronic EECs for
the bifenazate metabolite D1989 were estimated to be 5 ppb and < 1 part
per trillion (ppt), respectively. Since the chronic EECs are less than
the Agency's DWLOCs for all population subgroups including infants, the
chronic aggregate risk estimates are below the Agency's level of
concern. Table 3 summarizes the chronic aggregate exposure to
bifenazate.
Table 3--Chronic Aggregate Exposures to Bifenazate Residues.
----------------------------------------------------------------------------------------------------------------
Maximum
Chronic Chronic Ground Surface Chronic
Scenario/Population Subgroup cPAD, mg/kg/ Food Water Water Water DWLOC\3\,
day Exposure mg/ Exposure\1\ EEC\2\, ppt EEC\2\, ppb ppb
kg/day mg/kg/day
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.01 0.001557 0.008443 <1 5 300
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.01 0.005242 0.004758 <1 5 48
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.01 0.003941 0.006059 <1 5 61
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old) 0.01 0.002343 0.007657 <1 5 77
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.01 0.001088 0.008912 <1 5 270
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 0.01 0.000931 0.009069 <1 5 320
----------------------------------------------------------------------------------------------------------------
Males (20+ years old) 0.01 0.001050 0.00895 <1 5 310
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old) 0.01 0.001924 0.008076 <1 5 280
----------------------------------------------------------------------------------------------------------------
\1\ Maximum chronic water exposure (mg/kg/day) = cPAD (mg/kg/day) - chronic food exposure from DEEM
(mg/kg/day); no residential exposure
\2\ EECs resulting from one applications at 0.75 lbs ai/acre;
\3\ The chronic DWLOCs were calculated as follows: DWLOC (/L) = maximum water exposure (mg/kg/day) x
body weight (kg)/consumption (L/day) x 0.001 mg/g
3. Short-term risk. A short term risk assessment was not performed
because there are no significant exposures anticipated from registered
residential non-food uses of bifenazate.
4. Intermediate-term risk. An intermediate term risk assessment was
not performed because there are no significant post-application
exposures anticipated from registered residential non-food uses of
bifenazate.
5. Aggregate cancer risk for U.S. population. Bifenazate is not
carcinogenic.
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 bifenazate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The analytical methods used in the field trial, processing, and
ruminant feeding have been adequately validated and are appropriate for
data gathering purposes. The following paragraphs pertain to the
proposed plant and livestock enforcement methods.
1. Plant. The method proposed for enforcement of the plant
tolerances
[[Page 4920]]
associated with this petition has been adequately radiovalidated and
validated by an independent laboratory. The Agency's Analytical
Chemistry Laboratory (ACL) is currently doing a Petition Method
Validation (PMV). After reviewing the independent validation, EPA
believes that the PMV will at most show that relatively minor
modifications or revisions may need to be made. The registrant will be
required to make any modifications or revisions to the proposed
enforcement method resulting from the PMV.
2. Livestock. The method proposed for enforcement of the animal
product tolerances associated with this petition has been adequately
validated by an independent laboratory. The independent laboratory
validation study resulted in marginal recoveries for bifenazate (milk
and kidney), D3598 (liver), and A1530-sulfate (kidney). A
radiovalidation of the method was not undertaken by the registrant, as
the total radioactive bifenazate and its metabolite residues were very
low for analytical purposes. However, the analytical method used for
quantifying residues in animal tissues were satisfactorily validated on
freshly spiked matrices. The ACL is currently doing a PMV. After
reviewing the independent validation, EPA believes that the PMV will at
most show that relatively minor modifications or revisions may need to
be made. The registrant will be required to make any modifications or
revisions to the proposed enforcement method resulting from the PMV.
3. Multiresidue method (MRM). The registrant submitted data
concerning the recovery of bifenazate and D3598 using FDA multiresidue
method protocols A, C, D, E, and F (Pesticide Analytical Manual Vol.
I). Acceptable results were only attained using Protocol C. These data
were forwarded to FDA for inclusion in the Pesticide Analytical Manual
I. The tolerance expression for livestock commodities includes A1530
and A1530-sulfate. The registrant should submit information concerning
the behavior of these compounds through the FDA multiresidue protocols.
Adequate enforcement methodology (utilizing reversed phase high
pressure liquid chromatography (HPLC) and oxidative coulometric
electrochemical detection) is available to enforce the tolerance
expression. The method may be requested from: Francis Griffith,
Analytical Chemistry Branch, Environmental Science Center,
Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead,
MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
[email protected]. In addition, Mulitresidue Enforcement Method,
Protocol C, has been shown to be adequate for enforcing these
tolerances.
B. International Residue Limits
There is neither a CODEX proposal, nor Canadian or Mexican limits
for residues of bifenazate and D3598 in/on pome fruit, stone fruit,
strawberry, hops, cotton, or grape or for resides of bifenazate, D3598,
A1530 and A1530-sulfate in/on livestock commodities. Therefore,
harmonization is not an issue for this pesticide tolerance.
C. Conditions
The submitted residue chemistry and toxicological studies are
adequate for a conditional registration of bifenazate for food uses.
There is high confidence in the hazard end points used for human health
risk assessment. However, the following data are being required within
2 years time in order to confirm the results of the studies already
reviewed by the Agency and/or to complete the database requirements
prior to approval of an unconditional registration of bifenazate:
a. Confirmatory method and interference study for proposed plant
and livestock enforcement.
b. Radio validation of proposed livestock enforcement method.
c. FDA multi residue methods testing of A1530 and A1530-sulfate.
d. Storage stability data for hops, strawberry, apple juice, and
wet apple pomace.
e. Additional peach field trial data.
f. Additional plum field trial data.
g. Additional grape field trial data.
h. Additional cotton field trial data.
i. 28-day inhalation toxicity study. This study was requested by
the Agency for further characterization of inhalation risk assessments.
Due to the potential for inhalation exposure, there is concern for
toxicity by the inhalation route. The 28-day inhalation toxicity study
would give a dose and endpoint examined via the route of exposure of
concern (i.e., route specific study) and thus would avoid using an oral
study and route-to-route extrapolation. The protocol for the existing
90-day inhalation toxicity study (OPPTS 870.3465) should be followed
with the exposure (treatment) ending after 28 days, instead of 90 days.
The rationale for not requiring these data before registration of
food uses are provided below:
1. Deficiencies a, b and c. Adequate analytical methods are
available for enforcement purposes. These methods were independently
validated and a petition method validation is in progress at the
Agency's Analytical Chemistry Laboratory. In addition, a Mulitresidue
Enforcement Method, Protocol C, has been shown to be adequate for
enforcing these tolerances.
2. Deficiencies d through h. The storage interval of almost all
commodity samples collected from the field trial and processing have
been validated. The storage interval for hops, strawberry, apple juice,
and wet apple pomace were not validated as required and are necessary
to confirm the submitted residue chemistry data. The Agency concluded
that the interval from sampling until analysis was reasonable and will
not invalidate the submitted data due to lack of stability of
bifenazate residues of concern. For peach, plum, grape and cotton, the
requirements are additional field trials to fulfil the geographical
distribution and also to confirm the data already submitted and
reviewed by the Agency. The crops and number of trials required are
peach(2), plum(1), grape(1) and cotton(1).
3. Deficiency i. Bifenazate is not acutely toxic by oral, dermal or
inhalation routes (Toxicity category IV). Because of low inhalation
toxicity, the registrant did not do a subchronic inhalation toxicity
and its absence, the Agency used for endpoint selection the oral NOAELs
for short-, intermediate- and long-term inhalation exposure risk
assessment for this action. To fully characterize the toxicity
potential by inhalation route of exposure over long term use of
bifenazate, a 28-day inhalation study is required.
V. Conclusion
Therefore, the tolerances are established for combined residues of
bifenazate and D3598 (expressed as bifenazate) in or on apple, wet
pomace at 1.2 ppm; cattle fat at 0.1 ppm; cotton, undelinted seed at
0.75 ppm; cotton, gin byproducts at 35 ppm; fruit, pome, group at 0.75
ppm; goat fat at 0.1 pm; grape 0.75 ppm; grape, raisin at 1.2 ppm; hog
fat at 0.1 ppm; hop, dried cones at 15 ppm; horse fat at 0.1 ppm;
nectarine at 1.7 ppm; peach at 1.7 ppm; plum at 0.30 ppm; sheep fat at
0.1 ppm strawberry at 1.5 ppm and combined residues of bifenazate,
D3598 (expressed a bifenazate), A1530 and A1530-sulfate (expressed as
A1530) in cattle meat at 0.01 ppm; cattle meat byproducts at 0.01 ppm;
goat meat at 0.01 ppm; goat meat byproducts at 0.01 ppm; hog meat at
0.01 ppm; hog meat byproducts at 0.01 ppm; horse meat at 0.01 ppm;
horse meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep meat at 0.01
ppm; and sheep meat byproducts at 0.01 ppm.
Some of the tolerance values requested by the registrant in their
petition are different from that
[[Page 4921]]
determined by the Agency. The differences are due to the following
reasons: The registrant requested a group tolerance for stone fruits.
This is not appropriate at this time as no field trial data were
submitted on cherry and apricot and/or the maximum peach (1.45 ppm) and
plum (0.15 ppm) residue varied by a factor > 5x. In the case of
undelinted cotton seeds and cotton gin byproducts, the Agency concluded
that a higher tolerance of 0.75 ppm and 35 ppm are required as compared
with 0.5 ppm and 20 ppm, respectively, for the combined residues of
bifenazate and D3598 (expressed as bifenazate) due to the correction
factors applied to the percent recoveries of residues for concern in
the storage stability study. For meat of cattle, goat, hog, horse and
sheep the registrant requested a 0.02 ppm tolerance; however, the
Agency concluded that the bifenazate level used in the animal feeding
study (maximum theoretical dietary burden) supports only 0.01 ppm for
the combined residues of bifenazate, D3598 (expressed as bifenazate),
A1530 and A1530-sulfate (expressed as A1530).
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301206 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 April 2,
2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or 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-301206, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not
[[Page 4922]]
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
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 responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal government and Indian tribes, or on the distribution of power
and responsibilities between the Federal government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA 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 record
keeping requirements.
Dated: January 15, 2002.
James Jones,
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), 346(a) and 371.
2. Section 180.572 is amended by adding text to paragraph (a) to
read as follows:
Sec. 180.572 Bifenazate; tolerances for residues.
(a) General. (1) Tolerances are established for combined residues
of bifenazate (hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-
yl), 1-methylethyl ester) and D3598 expressed as bifenazate
(diazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethylester) in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple, wet pomace.......................................... 1.2
Cattle, fat................................................ 0.1
Cotton, gin byproducts..................................... 35
Cotton, undelinted seed.................................... 0.75
Fruit, pome, group......................................... 0.75
Goat, fat.................................................. 0.1
Grape...................................................... 0.75
Grape, raisin.............................................. 1.2
Hog, fat................................................... 0.1
Hop, dried cones........................................... 15
Horse, fat................................................. 0.1
Nectarine.................................................. 1.7
Peach...................................................... 1.7
Plum....................................................... 0.3
Sheep, fat................................................. 0.1
Strawberry................................................. 1.5
------------------------------------------------------------------------
(2) Tolerances are established for combined residues of bifenazate
(hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethyl ester) and D3598 expressed as bifenazate (diazinecarboxylic
acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethylester), A1530
(1,1'-biphenyl, 4-ol) and A1530-sulfate expressed as A1530 (1,1'-
biphenyl, 4-oxysulfonic acid) in the following animal commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, meat............................................... 0.01
Cattle, meat byproducts.................................... 0.01
Goat, meat................................................. 0.01
Goat, meat byproducts...................................... 0.01
Hog, meat.................................................. 0.01
Hog, meat byproducts....................................... 0.01
Horse, meat................................................ 0.01
Horse, meat byproducts..................................... 0.01
Milk....................................................... 0.01
Sheep, meat................................................ 0.01
Sheep, meat byproducts..................................... 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-2612 Filed 1-31-02; 8:45 am]
BILLING CODE 6560-50-S