[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Rules and Regulations]
[Page 55494-55503]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-16]
[[Page 55494]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0297; FRL-7328-1]
Bifenazate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of bifenazate and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-
3-yl), 1-methylethyl ester (expressed as bifenazate) in or on almond,
hulls; nut, tree, group 14; okra; peppermint, tops; pistachio;
spearmint, tops; vegetable, cucurbit, group 9; and, vegetable,
fruiting, group 8; and increases the established tolerances for
combined residues of bifenazate; diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate);
1,1'-biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid (expressed
as 1,1'-biphenyl, 4-ol) in meat and meat byproducts of cattle, goat,
hog, horse, and sheep and milk. EPA is also deleting the bifenazate
time-limited tolerance for tomato, which is established in connection
with a section 18 emergency exemption. Tomato is included in the
tolerance established by this action for vegetable, fruiting group 8.
The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective September 26, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0297,
must be received on or before November 25, 2003.
ADDRESSES: Written objections and hearing requests- may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, and pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Industry (NAISC 111, 112, 311, 32532), e.g., Crop
production, Animal production, Food manufacturing, and 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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0297. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/http://.
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of January 15, 2003 (68 FR 2032) (FRL-7286-
4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petition (PP 2E6517) by IR-4, 681 US Highway 1 South, New
Brunswick, NJ 08902-3390. That notice included a summary of the
petition prepared by Crompton Manufacturing Company, Inc. (formerly
Uniroyal Chemical Company), Middlebury, CT 06749, the registrant.
The petition requested that 40 CFR 180.572 be amended by
establishing tolerances for combined residues of the miticide,
bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate),
in or on the following commodities: Nut, tree, group 14 at 0.20 ppm;
okra at 2.0 ppm; peppermint, tops at 25 ppm; pistachio at 0.20 ppm;
spearmint, tops at 25 ppm; vegetable, cucurbit, group 9 at 0.75 ppm;
and vegetable, fruiting, group 8 at 2.0 ppm. The petition was
subsequently amended by IR-4 to also propose tolerances for combined
residues of bifenazate and diazinecarboxylic acid in or on almond hulls
at 15 ppm; and to propose increases to the established bifenazate meat,
meat byproducts and milk tolerances; and to change the tolerance
expression for meat, meat byproducts and milk. IR-4 proposes tolerances
for combined residues of bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-
biphenyl]-3-yl) hydrazinecarboxylate); diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as
bifenazate); 1,1'-biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid
(expressed as 1,1'-biphenyl, 4-ol) in or on meat and meat byproducts of
[[Page 55495]]
cattle, goat, hog, horse, and sheep at 0.02 ppm and milk at 0.02 ppm.
There were no comments received on these petitions.
EPA has received objections to tolerances it established for
residues of bifenazate on a variety of food commodities in a final rule
published in the Federal Register of February 1, 2002 (67 FR 4913)
(FRL-6818-3). The objections were filed by the Natural Resources
Defense Council (NRDC) and raised several issues regarding aggregate
exposure estimates and the additional safety factor for the protection
of infants and children. NRDC's objections raise complex legal,
scientific, policy, and factual matters and EPA has initiated a public
comment period on them in the Federal Register of June 19, 2002 (67 FR
41628) (FRL-7167-7), which ended on October 16, 2002. Although that
proceeding remains ongoing, prior to acting on this current tolerance
action, EPA reviewed the bifenazate-specific objections raised by NRDC
and has addressed them at relevant points throughout this preamble.
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) of the FFDCA 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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for tolerances for combined residues of
bifenazate and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-
yl), 1-methylethyl ester (expressed as bifenazate) on almond, hulls at
15 ppm; nut, tree, group 14 at 0.20 ppm; okra at 2.0 ppm; peppermint,
tops at 25 ppm; pistachio at 0.20 ppm; spearmint, tops at 25 ppm;
vegetable, cucurbit, group 9 at 0.75 ppm; and vegetable, fruiting,
group 8 at 2.0 ppm, and combined residues of bifenazate;
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate); 1,1'-biphenyl, 4-ol; and
1,1'-biphenyl, 4-oxysulfonic acid (expressed as 1,1'-biphenyl, 4-ol) in
meat and meat byproducts of cattle, goat, hog, horse, and sheep at 0.02
ppm and milk at 0.02 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances follow.
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 Table 1 of this unit 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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Guideline No. Study Results
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870.3100 90-Day oral toxicity NOAEL = 13.8 mg/kg/day in males, 3.2 mg/kg/
rodents--rat 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 toxicity NOAEL = 0.9 mg/kg/day in males, 1.3 mg/kg/
nonrodents--dog 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 toxicity-- NOAEL = 80 mg/kg/day in males and females.
rat 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 developmental in Maternal NOAEL = 10 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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[[Page 55496]]
870.3700 Prenatal developmental in Maternal NOAEL = 200 mg/kg/day
nonrodents--rabbit LOAEL = not established; the dosing in this
study are considered adequate based on the
results of a range finding study in which
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
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870.3800 Reproduction and fertility Parental/Systemic
effects--rat NOAEL = 1.6 mg/kg/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
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870.4100 Chronic toxicity dogs NOAEL = 1.01 mg/kg/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.
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870.4300 Chronic/Carcino-genicity NOAEL = 3.9 mg/kg/day in males, 4.8 mg/kg/
rats 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 mice NOAEL = 1.5 mg/kg/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
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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.
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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 aberration Did not induce 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 aberration Non-mutagenic in ICR mouse bone marrow
micronucleus chromosomal aberrations assay
up to cytotoxic concentrations.
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870.7485 Metabolism and Total recovery of the administered dose was
pharmacokinetics--rat <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, demethylation, ring
hydroxylation, and molecular scission with
the loss of hydrazinecarboxylic acid
portion with subsequent conjugation.
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In its objection to a separate bifenazate tolerance action, NRDC,
asserts that developmental toxicity is a data gap for bifenzate. NRDC
appears to be referring to language in the Table 1, Unit III.A. of the
Federal Register final rule of February 1, 2002, that states that a
clear assessment of developmental toxicity was not possible in the
range finding study used to choose the dose levels for the
developmental toxicity study in rabbits. The Agency concludes there are
acceptable developmental toxicity studies conducted with bifenazate in
rats and in rabbits, and an acceptable 2-generation reproduction study
in rats, which are described in Table 1. of this unit.
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 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 factors
[[Page 55497]]
(SF) 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 SF.
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 bifenazate used for human risk assessment is shown is
shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Bifenazate for Use in Human Risk Assessment
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Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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Acute Dietary; general population and NA NA An acute dietary
females 13-50 years old endpoint was not
selected based on the
absence of an
appropriate endpoint
attributed to a single
dose.
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Chronic Dietary; all populations NOAEL= 1.0 mg/kg/day Special FQPA SF = 1X LOAEL = 8.9/10.4 mg/kg/
UF = 100............... cPAD = 0.01 mg/kg/day day [M/F] based on
cRfD = 0.01 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
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Incidental Oral, Short Term (1-30 oral NOAEL = 10 mg/kg/ LOC for MOE <= 100 Maternal LOAEL = 100 mg/
days) day (residential) kg/day based on
clinical signs,
decreased body weight
and food consumption
during the dosing
period in the Rat
Developmental Study
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Incidental Oral, Intermediate Term oral NOAEL = 0.9 mg/kg/ LOC for MOE <= 100 LOAEL = 10.4/10.7 mg/kg/
(30 days-6 months) day (residential) day [M/F] based on
changes in hematologic
parameters in the 90-
Day Subchronic Dog
Study
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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 (residential) based on decreased
and six months to lifetime) body weight and food
consumption,
hematologic effects,
increased spleen
weight and
extramedullary
hemapoiesis in the
spleen in the 21-Day
Dermal Toxicity Study
in Rats
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Short-Term Inhalation (1-30 days) oral NOAEL= 10 mg/kg/ LOC for MOE <= 100 LOAEL = 100 mg/kg/day
day inhalation (residential) based on decreased
absorption rate = 100% body weight and food
consumption in the Rat
Developmental Study
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Intermediate-Term Inhalation (30 days- oral NOAEL= 0.9 mg/kg/ LOC for MOE <= 100 LOAEL = 10.4/10.7 mg/kg/
6 months) day inhalation (residential) day based on changes
absorption rate = 100% in hematologic
parameters in the 90-
Day Dog Feeding Study
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Long-Term Inhalation six months- Oral study NOAEL= 1.0 LOC for MOE <= 100 LOAEL = 8.9/10.4 mg/kg/
lifetime) mg/kg/day (residential) day [M/F] based on
(inhalation absorption changes in
rate = 100%). hematological and
clinical chemistry
parameters, and
histopathology in bone
marrow, liver, and
kidney in the One Year
Dog Feeding Study
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Cancer (oral, dermal, inhalation) NA NA Bifenazate is
classified as not
likely to be a human
carcinogen
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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 (diazinecarboxylic acid, 2-(4-
methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester), in or on a variety
of food commodities.
Risk assessments were conducted by EPA to assess dietary exposures
from bifenazate in food as follows:
i. Acute exposure. An acute dietary reference dose (RfD) for the
females 13-50 years of age and the general population, including
infants and children, was not selected because an acute oral endpoint
attributed to a single-dose exposure could not be identified in any of
the studies in the toxicology data base, including
[[Page 55498]]
developmental and maternal toxicity in the developmental toxicity
studies.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\) which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 nationwide Continuing Surveys of Food Intake by Individuals
(CSFII) and accumulated exposure to the chemical for each commodity.
The following assumptions was made for the chronic exposure assessment:
The chronic dietary exposure analysis assumed tolerance level residues
and 100% crop treated for all registered and proposed crops excluding
tomato where average field trial residues were used. DEEM (ver 7.73)
default processing factors were assumed for all commodities excluding
apple juice, grape juice, wine/sherry, tomato paste, and tomato puree.
The processing factors for these commodities were reduced to 0.23,
0.17, 0.17, 5.0, and 5.0, respectively, based on data from processing
studies.
In its objections to the earlier bifenazate tolerance action, NRDC
claims that EPA relied upon unsupported and apparently arbitrary
processing factors to reduce estimates of dietary exposure to
bifenazate on apples and grapes. NRDC was incorrect to assert that the
processing factors for apples and grapes were unsupported and
arbitrary. The DEEM processing factors for apple juice and grape juice
used for this action and the earlier bifenazate tolerance action are
based on data from processing studies. In this action, the Agency used
DEEM (ver 7.73) default processing factors when processing studies were
not available. These default factors are worst case assumptions
regarding pesticide partitioning into component commodity fractions.
DEEM (ver 7.73) default processing factors assume that 100 percent of
the pesticide that was originally present in the commodity is present
in the processed fractions. This is a worst case theoretical
concentration factor since it assumes that processing does not result
in any reduction in pesticide content.
iii. Cancer. EPA has classified bifenazate as a not likely human
carcinogen. Therefore, a quantitative cancer dietary exposure and risk
assessment was not performed.
2. Dietary exposure from drinking water. 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 model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The 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. FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and 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 screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would 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 risks in Unit III.E.
Parent bifenazate degrades rapidly in aerobic soil conditions with
a half-life of approximately 30 minutes. The first degradate formed
(D3598 (diazinecarboxylic acid, 2-(4-methoxy-1,1'- biphenyl-3-yl)
(half-life of 7 hours)) was reported in a concentration of 95% of the
applied radioactivity. D3598 degrades to D1989 (4-methylethylester)
(reported at a maximum of 26% of the applied radioactivity), which is
moderately persistent with an EPA-calculated half-life of approximately
96 days. Photodegradation and other routes of dissipation of parent
bifenazate do not appear to be significant.
The Agency concluded that the residue of concern in drinking water
is D1989. Parent and D3598 were not included as a residue of concern in
drinking water due to the short half-lives of these compounds and the
lack of an acute dietary endpoint (toxicity of D3598 is assumed to be
equivalent to bifenazate). Since ground or surface water monitoring
data to calculate a quantitative aggregate exposure are not available,
EPA provided Tier I ground (SCI-GROW) and surface water (FIRST) EECs
for D1989. Both models were conducted using the strawberry application
scenario (one application at 0.75 lbs ai/acre; highest registered/
proposed application rate). The resulting ground and surface water
chronic EECs are < 0.001 ppb and 6.4 ppb, respectively.
In its objections to a separate bifenazate tolerance action, NRDC
asserts that EPA failed to complete an assessment of drinking water
exposure to bifenazate degradates. As stated in the Federal Register
final rule of February 1, 2002, and restated in this document, EPA
considered the environmental persistence of bifenazate and its two
major metabolites D3598 and D1989. Aqueous photolysis and soil
metabolism studies demonstrated that the parent bifenazate and the
D3598 degradate quickly metabolize under aerobic soil conditions.
Noting the lack of persistence of these two compounds and the absence
of any acute dietary endpoint, EPA focused its drinking water exposure
assessment for bifenazate on the degradate (D1989) that had a
possibility of being present in drinking water. Accordingly, NRDC is
incorrect to assert that potential exposure to bifenazate degredates in
drinking water was not assessed by EPA.
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). In its objections to
a separate bifenazate tolerance action, NRDC asserts that EPA failed to
assess and incorporate residential uses as a source of aggregate
exposure. In the current risk assessment, EPA calculated short-term
residential risks to homeowner applicators.
[[Page 55499]]
However, the Agency concluded that no significant post-application
exposure is aniticipated from landscape ornamentals; therefore, no
residential post-application assessment was conducted.
Bifenazate is currently registered for use on the following
residential non-dietary sites: Commercial application to ornamental
plants (including bedding plants, flowering plants, foliage plants,
bulb crops, perennials, trees and shrubs; not turf) and all fruit trees
which will not bear fruit for a minimum of 12 months. The registrant
has proposed an amendment to the Floramite (EPA Reg. No. 400-508) label
to permit application to home ornamental plants and fruit trees that
will not bear fruit within 12 months by residents/homeowners. The risk
assessment was conducted using the following residential exposure
assumptions: EPA anticipates only short-term dermal and short-term
inhalation exposure for the residential handler (applicator). The
proposed formulation is appropriate for application via pump up
sprayers, garden hose-end sprayers or similar homeowner pesticide
devices. A larger area per day may be treated with a hose-end sprayer
than with a pump up compressed air sprayer, which in turn results in
possibly greater contact with the active ingredient per day. Therefore,
exposure from a hose-end sprayer is assessed rather than that of a
compressed air sprayer. For the treatment of shrubs and ornamentals,
EPA assume 100 gallons of finish spray are applied per day. The unit
exposure value for a residential handler using open pour mixing/loading
for a garden hose-end sprayer is 11 mg/lb handled (dermal) and 0.013
mg/lb handled (inhalation). Exposures were calculated using the
Agency's draft Residential Standard Operating Procedures.
The highest label rate of application is 8 fl oz product/100 gal
water.
2.0 lb ai/gal / 128 fl oz/gal = 0.015625 lb ai/fl oz.
(8 fl oz/100 gal)(100 gal/day)(0.015625 lb ai/fl oz) = 0.125 lb ai/day
i. Dermal Exposure Assessment and MOE.
((11.0 mg ai/lb handled)(0.125 lb ai handled/day)) / 70 kg bw = 0.019
mg/kg/day
MOE = NOAEL / ADD = 80 mg/kg/day / 0.019 mg/kg bw/day = 4,200
ii. Inhalation Exposure Assessment and MOE.
((0.013 mg ai/lb handled)(0.125 lb ai handled/day)) / 70 kg bw =
0.0000232 mg/kg/day
MOE = NOAEL / ADD = 10 mg/kg/day / 0.0000232 mg/kg/day = 430,000
MOEs are combined for the dermal and inhalation routes of exposure
since the short term toxicological effects are the same (reduced body
weight gain and food consumption).
iii. Combined MOE.
combined MOE = 1/ ((1/MOEdermal) + (1/
MOEinhalation) = 4,200
An MOE of 100 is adequate to protect a residential handler under
the circumstances described. The estimated MOE is > 100 therefore this
use is not of concern.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to bifenazate
and any other substances and 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 policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov
\pesticides\cumulative\.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA 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 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 indication of
qualitative or quantitative increased susceptibility of rats and
rabbits during in utero exposure or post-natal exposure based on
developmental toxicity and reproductive toxicity studies performed with
bifenazate.
3. Conclusion. There is a complete toxicity data base for
bifenazate and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children should be reduced to 1X
for the following reasons:
Acceptable developmental toxicity studies in the rat and the rabbit
are available, as is an acceptable 2-generation reproduction study in
the rat and there is no indication of qualitative or quantitative
increased susceptibility of rats and rabbits to in utero or postnatal
exposure. A developmental neurotoxicity study is not required for
bifenazate. The dietary (food and water) and non-dietary (residential)
exposure assessments are not expected to underestimate the potential
exposures for infants and children from the use of bifenazate.
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: 2 liter (L)/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
[[Page 55500]]
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 exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. Bifenazate is not expected to pose an acute risk to
humans.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenazate from food will utilize 24% of the cPAD for the U.S.
population, 59% of the cPAD for all infants < 1 year old, 85% of the
cPAD for children 1-2 years old (the most highly exposed population
subgroup), and 17% of the cPAD for females 13-49 years old. Based on
the use pattern, chronic residential exposure to residues of bifenazate
is not expected. In addition, there is potential for chronic dietary
exposure to bifenazate 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 cPAD, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.01 24 6.4 <0.001 260
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old) 0.01 59 6.4 <0.001 40
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.01 85 6.4 <0.001 15
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.01 17 6.4 <0.001 250
----------------------------------------------------------------------------------------------------------------
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). In its objections to a
separate bifenazate tolerance action, NRDC claims that residential
short- and intermediate-term risk assessments are data gaps for
bifenazate. In the current risk assessment, EPA calculated short-term
residential risks to homeowner applicators. However, the Agency
concluded that no significant post-application exposure is aniticipated
from landscape ornamentals; therefore, no residential post-application
assessment was conducted. In addition, intermediate-term aggregate
exposure (30 days to 6 months) is not expected since homeowner exposure
is not expected to exceed 1 to 30 days.
Bifenazate is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for bifenazate.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 2,069 for the U.S. population;
2,418 for youth 13-19 years old; 2,429 for adults 20-49 years old;
2,467 for females 13-49 years old; and 2,377 for adults 50+ years old.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of bifenazate in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 2,100 100 6.4 <0.001 3,300
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old 2,400 100 6.4 <0.001 2,900
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old 2,400 100 6.4 <0.001 3,400
----------------------------------------------------------------------------------------------------------------
Females 13-49 year old 2,500 100 6.4 <0.001 2,900
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old 2,400 100 6.4 <0.001 3,400
----------------------------------------------------------------------------------------------------------------
[[Page 55501]]
4. Aggregate cancer risk for U.S. population. Bifenazate is
classified as not likely to be a human carcinogen. The Agency concludes
that bifenazate is not expected to pose a cancer risk to humans.
5. 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
1. Plant. The enforcement method for plant tolerances associated
with these petitions is method UCC-D2341, which uses high pressure
liquid chromatography with an oxidative coulometric electrochemical
detector.
2. Livestock. The enforcement method for animal products utilizes
high pressure liquid chomatography with oxidative coulometric
electrochemical detection.
3. Multiresidue method. Multiresidue Enforcement Method Protocol C
has been shown to be adequate for enforcing these tolerances.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
for residues of bifenazate in/on the proposed crops. Therefore,
harmonization is not an issue.
V. Conclusion
Therefore, tolerances are established for combined residues of
bifenazate, and diazinecarboxylic acid; 2-(4-methoxy-[1,1'-biphenyl]-3-
yl), 1-methylethyl ester (expressed as bifenazate) in or on almond,
hulls at 15 ppm; nut, tree, group 14 at 0.20 ppm; okra at 2.0 ppm;
peppermint, tops at 25 ppm; pistachio at 0.20 ppm; spearmint, tops at
25 ppm; vegetable, cucurbit, group 9 at 0.75 ppm; and vegetable,
fruiting, group 8 at 2.0 ppm, and combined residues of bifenazate;
diazinecarboxylic acid, (expressed as bifenazate); 1,1'-biphenyl, 4-ol;
and 1,1'-biphenyl, 4-oxysulfonic acid (expressed as 1,1'-biphenyl, 4-
ol)] in [meat and meat byproducts of cattle, goat, hog, horse, and
sheep at 0.02 ppm and milk at 0.02 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
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 ID number OPP-2003-0297 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
25, 2003.
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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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-
0001.
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 20460-0001.
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.1. Mail your
copies, identified by docket ID number OPP-2003-0297, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. 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 or
[[Page 55502]]
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. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain 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 section 408(d) of the FFDCA, such as the tolerances 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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act
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 15, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.572 is amended:
i. In paragraph (a)(1) by revising the introductory text and
alphabetically adding commodities to the table;
ii. By revising paragraph (a)(2); and
iii. In paragraph (b), by revising the introductory text and
removing the commodities ``Hop'' and ``Pear'' from the table.
The amendments read as follows:
Sec. 180.572 Bifenazate; tolerances for residues.
(a) General. (1) Tolerances are established for combined residues
of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate) in
or on the following food commodities:
[[Page 55503]]
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls............................. 15
* * * * *
Nut, tree, group 14....................... 0.20
Okra...................................... 2.0
* * * * *
Peppermint, tops......................... 25
Pistachio................................ 0.20
* * * * *
Spearmint, tops.......................... 25
* * * * *
Vegetable, cucurbit, group 9............. 0.75
Vegetable, fruiting, group 8............. 2.0
------------------------------------------------------------------------
(2) Tolerances are established for combined residues of bifenazate
(1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate);
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate); 1,1'-biphenyl, 4-ol; and
1,1'-biphenyl, 4-oxysulfonic acid (expressed as 1,1'-biphenyl, 4-ol) in
or on the following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, meat.............................. 0.02
Cattle, meat byproducts................... 0.02
Goat, meat................................ 0.02
Goat, meat byproducts..................... 0.02
Hog, meat................................. 0.02
Hog, meat byproducts...................... 0.02
Horse, meat............................... 0.02
Horse, meat byproducts.................... 0.02
Milk...................................... 0.02
Sheep, meat............................... 0.02
Sheep, meat byproducts.................... 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of bifenazate (1-methylethyl 2-(4-
methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic
acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester
(expressed as bifenazate) in connection with use of the pesticide under
section 18 emergency exemptions granted by EPA. The tolerances will
expire and are revoked on the dates specified in the following table.
* * * * *
[FR Doc. 03-24370 Filed 9-25-03; 8:45 am]
BILLING CODE 6560-50-S