[Federal Register Volume 69, Number 23 (Wednesday, February 4, 2004)]
[Rules and Regulations]
[Pages 5289-5297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2271]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0370; FRL-7335-6]


Bifenazate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance 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 potatoes. This action is in response to use of 
this chemical on potatoes under an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
This regulation establishes a maximum permissible level for residues of 
bifenazate in this food commodity. The tolerance will expire and is 
revoked on December 31, 2006.

DATES: This regulation is effective February 4, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0370, 
must be received on or before April 5, 2004.

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 VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; 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, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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-2003-0370. 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://

[[Page 5290]]

www.access.gpo.gov/nara/cfr/cfrhtml--00/Title--40/40cfr180--00.html, a 
beta site currently under development.
    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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for combined residues of the 
insecticide 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 potatoes at 0.05 parts per million (ppm). This tolerance will 
expire and is revoked on December 31, 2006. EPA will publish a document 
in the Federal Register to remove the revoked tolerance from the Code 
of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18-related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. * * 
*''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.
    EPA has received objections to a tolerance it established for 
bifenazate on a different food commodity. 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. Although these objections 
concern separate rulemaking proceedings under the FFDCA, EPA has 
considered whether it is appropriate to establish this emergency 
exemption tolerance for bifenazate while the objections are still 
pending.
    Factors taken into account by EPA included how close the Agency is 
to concluding the proceedings on the objections, the nature of the 
current action, whether NRDC's objections raised frivolous issues, and 
extent to which the issues raised by NRDC had already been considered 
by EPA. Although NRDC's objections are not frivolous, the other factors 
all support establishing this tolerance at this time. First, the 
objections proceeding is unlikely to conclude prior to when action is 
necessary on this petition. NRDC's objections raise complex legal, 
scientific, policy, and factual matters. EPA has published a notice 
describing the nature of the NRDC's objections in more detail. This 
notice offered an opportunity for the public to comment on this matter 
and published in the Federal Register of June 19, 2002 (67 FR 41628) 
(FRL-7167-7). EPA is now examining the extensive comments received. 
Second, the nature of the current action is extremely time-sensitive 
and addresses an emergency situation. Third, the issues raised by NRDC 
are not new matters but questions that have been the subject of 
considerable study by EPA and comment by stakeholders. Accordingly, EPA 
is proceeding with establishing the tolerance for bifenazate.

III. Emergency Exemption for Bifenazate on Potatoes and FFDCA 
Tolerances

    The states of Oregon and Washington requested the emergency use of 
bifenazate on potatoes to control an outbreak of spider mites. The use 
of bifenazate on potatoes in these states took place under a section 18 
crisis declaration. The states invoked the crisis authorities because 
of damage that spider mites cause to the crop.
    EPA assessed the potential risks presented by residues of 
bifenazate in or on potatoes. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of the FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of the FFDCA. Although this tolerance will expire and 
is revoked on December 31, 2006, under section 408(l)(5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on potatoes after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by this tolerance at the time of that application. EPA will take action 
to revoke this tolerance earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether bifenazate 
meets EPA's registration requirements for use on potatoes or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of bifenazate by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for

[[Page 5291]]

any States other than Oregon and Washington to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for bifenazate, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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).
    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 bifenazate and to make a determination on aggregate 
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of bifenazate in or on potatoes 
at 0.05 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the no observed 
adverse effect level (NOAEL)) from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological endpoint. However, the lowest dose at which adverse 
effects of concern are identified (the lowest observed adverse effect 
level (LOAEL)) is sometimes used for risk assessment if the 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 intraspecies 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). The FQPA requires, in certain 
circumstances, an additional safety factor for the protection of 
infants and children. Where this FQPA safety factor applies, EPA 
calculates an acute or chronic Population Adjusted Dose (aPAD or cPAD) 
by dividing the RfD by the FQPA safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. The non-dietary risk (other 
than cancer) is expressed as the margin of exposure (MOE), a ratio of 
the NOAEL to estimated exposures (margin of exposure (MOE) = NOAEL/
exposure). An MOE higher than the applicable LOC would indicate that 
the risk is not of concern.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for bifenazate used for human risk assessment is shown in the 
following Table 1:

      Table 1.--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 milligram/    FQPA SF = 1X             LOAEL = 8.9/10.4 mg/kg/
                                        kilogram/day (mg/kg/    cPAD = 0.01 mg/kg/day..   day M/F based on
                                        day) UF = 100                                     changes in
                                       cRfD = 0.01 mg/kg/day..                            hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney in the 1-Year
                                                                                          Dog Feeding Study
-----------------------------------------------------------------------------------------
Incidental oral, short-term (1-30      Oral NOAEL = 10 mg/kg/   LOC for MOE [le] 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 [le] 100     LOAEL = 10.4/10.7 mg/kg/
 (30 days to 6 months)                  day                     (residential)..........   day M/F based on
                                                                                          changes in hematologic
                                                                                          parameters in the 90-
                                                                                          Day Subchronic Dog
                                                                                          Study
-----------------------------------------------------------------------------------------

[[Page 5292]]

 
Short-, intermediate- and long-term    Dermal NOAEL = 80 mg/kg/ LOC for MOE [le] 100     LOAEL = 400 mg/kg/day
 dermal (1-30 days, 30 days to 6        day                     (residential)..........   based on decreased
 months, and 6 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 [le] 100     LOAEL = 100 mg/kg/day
                                        day                     (residential)..........   based on decreased
                                       inhalation absorption                              body weight and food
                                        rate = 100%.                                      consumption in the Rat
                                                                                          Developmental Study
-----------------------------------------------------------------------------------------
Intermediate-term inhalation (30 days  Oral NOAEL= 0.9 mg/kg/   LOC for MOE [le] 100     LOAEL = 10.4/10.7 mg/kg/
 to 6 months)                           day                     (residential)..........   day based on changes
                                       (inhalation absorption                             in hematologic
                                        rate = 100%).                                     parameters in the 90-
                                                                                          Day Dog Feeding Study
-----------------------------------------------------------------------------------------
Long-term inhalation 6 months to       Oral study NOAEL= 1.0    LOC for MOE [le] 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 1-Year
                                                                                          Dog Feeding Study
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Bifenazate is
                                                                                          classified as ``not
                                                                                          likely'' to be a human
                                                                                          carcinogen
----------------------------------------------------------------------------------------------------------------

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.572) for the combined residues of bifenazate, 
(hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethyl ester) and D3598 expressed as bifenazate (diazinecarboxylic 
acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester)], in or on 
apple, wet pomace; cattle, fat; cotton, gin byproducts; cotton, 
undelinted seed; fruit, pome, group 11; goat, fat; grape; grape, 
raisin; hog, fat; hog, dried cone; horse, fat; nectarine; peach; plum; 
sheep, fat, and strawberry, and bifenazate (hydrazinecarboxylic acid, 
2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethyl ester) and D3598 
expressed as bifenazate (diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethylester), A1530 (1,1'-biphenyl, 4-ol) and 
A1530-sulfate expressed as A1530 (1,1'-biphenyl, 4-oxysulfonic acid) in 
or on cattle, meat; cattle, meat byproducts; goat, meat; goat, meat 
byproducts; hog, meat; hog, meat byproducts; horse, meat; horse, meat 
byproducts; milk; sheep, meat; and sheep, meat byproducts.
    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 developmental and 
maternal toxicity in the developmental toxicity studies.
    ii. Chronic exposure. In conducting this acute dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM/FCIDTM) 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 were 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.
    iii. Cancer. EPA has classified bifenazate as ``not likely'' to be 
a human carcinogen. Therefore, a 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 First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The Screening Concentrations in Groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water, EPA will generally use 
FIRST (a Tier 1 model) before using PRZM/

[[Page 5293]]

EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS 
model that uses a specific high-end runoff scenario for pesticides. 
While both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, the PRZM/EXAMS model includes a percent crop area factor 
as an adjustment to account for the maximum percent crop coverage 
within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for estimating the highest 
pesticide drinking water concentrations that might ever be encountered.
    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, EPA 
determines the maximum permissible exposures (acute, short-term, 
intermediate-term and chronic) to the pesticide in drinking water, 
taking into account the expected exposure through food and residential 
uses. These maximum permissible level of exposure through drinking 
water are called drinking water levels of comparison (DWLOCs) and used 
as a point of comparison against the model estimates of a pesticide's 
concentration in water. So long as the estimated EECs from these 
screening models (which are designed to estimate theoretical upper 
limits on a pesticide's concentration in drinking water) do not exceed 
the applicable DWLOCs, EPA concludes that exposure to the pesticide in 
drinking water does not pose a risk of concern in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Because DWLOCs address total aggregate exposure to bifenazate they are 
further discussed in the aggregate risk sections below.
    Parent bifenazate degrades rapidly in aerobic soil conditions with 
a half-life of approximately 30 minutes. The first degradate formed 
(D3598; half-life of 7 hours) was reported in a concentration of 95% of 
the applied radioactivity . D3598 degrades to D1989 (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 EEC calculations with both models were based on the 
strawberry application scenario (one application at 0.75 lbs ai/acre;) 
because this is the highest registered/proposed application rate). The 
resulting ground and chronic surface water EECs are <0.001 ppb and 6.4 
ppb, respectively.
    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).
    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 proposed 
label is amended to permit application 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 from the requested residential use. The proposed 
formulation is appropriate for application via pump up sprayers, garden 
hose-end sprayers or similar ``homeowner'' pesticide devices. The 
Agency believes that persons using a hose-end sprayer are likely to 
treat a larger area per day than those using a ``pump up'' compressed 
air sprayer, which in turn results in possibly greater contact with the 
pesticide active ingredient per day for applicators using hose-end 
sprayers. In order to avoid underestimating residential risk, exposure 
from a hose-end sprayer is assessed rather than that of a compressed 
air sprayer. For the treatment of shrubs and ornamentals, EPA assumed 
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. Exposures were calculated using the Agency's draft Residential 
Standard Operating Procedures.
    4. Cumulative exposure to 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 Web site at http://www.epa.gov/pesticides/cumulative/.

C. 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. Developmental toxicity and 
reproductive toxicity studies performed with bifenazate yield no 
qualitative or quantitative toxicity evidence of increased 
susceptibility among rats and rabbits during in utero exposure or 
during postnatal exposure.

[[Page 5294]]

    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. Based on the 
lack of increased susceptibility and the completeness of the toxicity 
and exposure databases, EPA has concluded that an additional 10X safety 
factor is not needed to protect infants and children.

D. 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, instead, DWLOCs indicate the 
maximum pesticide concentration in drinking water that would be of no 
regulatory concern in light of total aggregate exposure to a pesticide 
in food and residential uses. A DWLOC represents 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 + chronic non-dietary, non-occupational 
exposure)).
    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 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, EPA concludes with reasonable certainty that 
exposures to bifenazate in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA 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. Before new 
uses are added in the future, EPA will reassess the potential impacts 
of bifenazate on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Because no acute oral toxicity endpoint attributed 
to a single-dose exposure was identified in any of the studies in the 
toxicology data base, including developmental and maternal toxicity in 
the developmental toxicity studies, an acute dietary risk assessment 
was not conducted.
    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 25% of the cPAD for the U.S. 
population, 60% of the cPAD for all infants < 1 year old, 86% 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 water and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the cPAD, as shown 
in Table 2:

               Table 2.--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           25          6.4       <0.001          260
---------------------------------------------------------------------------
All infants (<1 year old)                               0.01           60          6.4       <0.001           75
---------------------------------------------------------------------------
Children (1-2 years old)                                0.01           86          6.4       <0.001           14
---------------------------------------------------------------------------
Females (13-49 years old)                               0.01           17          6.4       <0.001          290
----------------------------------------------------------------------------------------------------------------

    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).
    Bifenazate is currently registered for uses 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 2,000 for the U.S. population, 
2,100 for youth 13-19 years old, 2,400 for adults 20-49 years old, 
2,200 for females 13-49 years old, and 2,300 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 water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface water and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 3:

[[Page 5295]]



                    Table 3.--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                                        2,000          100          6.4       <0.001        3,500
---------------------------------------------------------------------------
Youth (13-19 years old)                                2,100          100          6.4       <0.001        3,000
---------------------------------------------------------------------------
Adults (20-49 years old)                               2,400          100          6.4       <0.001        3,500
---------------------------------------------------------------------------
Females (13-49 year old)                               2,200          100          6.4       <0.001        3,000
---------------------------------------------------------------------------
Adults (50+ years old)                                 2,300          100          6.4       <0.001        3,500
----------------------------------------------------------------------------------------------------------------

    x4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Residential intermediate-term aggregate exposure (30 days to 6 
months) is not expected from use of this chemical. Thus, the 
intermediate-term risk for the public consista od food and water 
exposures which were previously addressed.
    5. Aggregate cancer risk for U.S. population. EPA has classified 
bifenazate as ``not likely'' to be a human carcinogen. Therefore, a 
cancer dietary exposure and risk assessment was not performed.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to bifenazate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. The method 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 crop. Therefore, 
harmonization is not an issue.

VI. Conclusion

    Therefore, a time-limited tolerance is 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 potatoes at 0.05 ppm. This time-limited tolerance will expire on 
December 31, 2006.

VII. 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 the 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-2003-0370 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before April 5, 
2004.
    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

[[Page 5296]]

[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 VII.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 the docket ID number OPP-2003-0370, 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 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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of 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.

IX. 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

[[Page 5297]]

and pests, Reporting and recordkeeping requirements.

    Dated: January 21, 2004.
Lois Rossi,
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 by alphabetically adding the following 
commodity to the table in paragraph (b) to read as follows:


Sec. 180.572  Bifenazate; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
Potato............................               0.05           12/31/06
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 04-2271 Filed 2-3-04; 8:45 am]
BILLING CODE 6560-50-S