[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Rules and Regulations]
[Pages 55494-55503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24370]



[[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: 
[email protected].

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/. A frequently updated 
electronic version of 40 CFR part 180 is available at 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
----------------------------------------------------------------------------------------------------------------
             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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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 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.
----------------------------------------------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF and
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Bifenazate is
                                                                                          classified as not
                                                                                          likely to be a human
                                                                                          carcinogen
----------------------------------------------------------------------------------------------------------------

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: 
[email protected].

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 [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-
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: [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

[[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