

[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Rules and Regulations]               
[Page 74688-74696]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de05-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0276; FRL-7746-5]

 
Bifenazate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of bifenazate in or on tart cherries and soybeans. 
This action is in response to EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on tart cherries and 
soybeans. This regulation establishes maximum permissible levels for 
residues of bifenazate in these food commodities. The tolerance will 
expire and is revoked on December 31, 2009.

DATES: This regulation is effective December 16, 2005. Objections and 
requests for hearings must be received on or before February 14, 2006.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0276. All documents in the 
docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced federal-wide electronic docket management and 
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is 
not publicly available, i.e., CBI or other information whose disclosure 
is restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., 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.

FOR FURTHER INFORMATION CONTACT:  Marcel Howard, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6784; e-mail address:howard.marcel@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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

[[Page 74689]]

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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.


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 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 
tart cherries at 5.0 parts per million (ppm); soybean seed at 1.5 ppm; 
soybean hulls at 20 ppm; soybean meal at 3.5 ppm; and soybean refined 
oil at 20 ppm. These tolerances will expire and are revoked on December 
31, 2009. EPA will publish a document in the Federal Register to remove 
the revoked tolerances 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.

III. Emergency Exemption for Bifenazate on Tart Cherries and Soybeans 
and FFDCA Tolerances

    The state of Utah petitioned EPA to allow use of bifenazate on tart 
cherries to control phytophagous spider mites. EPA has determined that 
Utah tart cherry growers are likely to suffer significant economic 
losses due to pest infestation without use of bifenazate. Data 
submitted indicate that effective control has not been achieved using 
current registered products. In addition, the primary pesticide used 
for mite control in the past, propargite, has been relabeled for post-
harvest use only. Bifenazate is necessary to prevent crop losses in the 
current year and to ensure tree vitality in the next year.
    In a separate action, the state of Delaware petitioned EPA to allow 
use of bifenazate on soybeans to control two spotted spider mites. 
According to the applicant, there are two registered products, 
dimethoate and chlorpyrifos, which have some miticidal activity and are 
recommended for spider mite control in Delaware soybeans. EPA has 
determined that, in the event of hot, dry weather, mite populations 
could cause significant economic losses to soybean growers in Delaware, 
even in light of these alternatives.
    EPA determined that bifenazate can be used with a reasonable 
certainty of no harm to humans or to the environment. Thus, EPA has 
authorized under FIFRA section 18 the use of bifenazate on tart 
cherries for control of phytophagous spider mites in Utah, and on 
soybeans for control of two spotted spider mites in Delaware. After 
having reviewed the submission, EPA concurs that emergency conditions 
exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bifenazate in or on tart 
cherries and soybeans. 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 these tolerances will expire and are revoked on 
December 31, 2009, 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 tart cherries and soybeans 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 these tolerances at the time of that application. EPA 
will take action to revoke these tolerances earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether bifenazate 
meets EPA's registration requirements for use on tart cherries and 
soybeans or whether a permanent tolerance for these uses would be 
appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of bifenazate by a State 
for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any State other than Utah and 
Delaware to use this pesticide on these crops 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

[[Page 74690]]

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 tart cherries at 
5.0 ppm; soybean seed at 1.5 ppm; soybean hulls at 20 ppm; soybean meal 
at 3.5 ppm; and soybean refined oil at 20 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 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 
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 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). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA safety factor 
(SF).
    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. 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 106 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
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population        An acute dietary endpoint was not selected based on the absence of an
 including infants, children, and                    endpoint of concern attributed to a single dose
 females 13-50 years old)
--------------------------------------
Chronic Dietary (All populations)      NOAEL = 1.0 mg/kg/day    FQPA SF = 1X             1-Year Dog Feeding
                                       UF = 100...............  cPAD = chronic RfD/FQPA   Study
                                       Chronic RfD = 0.01 mg/    SF = 0.01 mg/kg/day.    LOAEL = 8.9/10.4 mg/kg/
                                        kg/day.                                           day
                                                                                         [M/F] based on changes
                                                                                          in hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney
--------------------------------------
Incidental Oral, Short-Term (1 to 30   Oral study               LOC for MOE < = 100       Rat Developmental Study
 days)                                 NOAEL = 10 mg/kg/day...   (Residential)           maternal LOAEL = 100 mg/
(Residential)........................                                                     kg/day based on
                                                                                          clinical signs,
                                                                                          decreased body weight
                                                                                          and food consumption
                                                                                          during the dosing
                                                                                          period
--------------------------------------
Incidental Oral, Intermediate-Term     Oral study               LOC for MOE < = 100       90-Day Subchronic Dog
 (30 days to 6 months)                 NOAEL = 0.9 mg/kg/day..   (Residential)            Study
(Residential)........................                                                    LOAEL = 10.4/10.7 mg/kg/
                                                                                          day
                                                                                         [M/F] based on changes
                                                                                          in hematologic
                                                                                          parameters
--------------------------------------
Short-, Intermediate-, and Long-Term   Dermal study             LOC for MOE < = 100       21-Day Dermal Toxicity
 Dermal (1 to 30 days, 30 days to 6    NOAEL = 80 mg/kg/day...   (Residential)            Study in Rats
 months, and 6 months to lifetime)                                                       LOAEL = 400 mg/kg/day
(Residential)........................                                                     based on decreased
                                                                                          body weight and food
                                                                                          consumption,
                                                                                          hematologic effects,
                                                                                          increased spleen
                                                                                          weight, and
                                                                                          extramedullary
                                                                                          hemapoiesis in the
                                                                                          spleen
--------------------------------------

[[Page 74691]]


Short-Term Inhalation (1 to 30 days)   Oral study               LOC for MOE < = 100       Rat Developmental Study
(Residential)........................  NOAEL = 10 mg/kg/         (Residential)           LOAEL = 100 mg/kg/day
                                        day(inhalation                                    based on decreased
                                        absorption rate =                                 body weight andfood
                                        100%).                                            consumption
--------------------------------------
Intermediate-Term Inhalation (30 days  Oral study               LOC for MOE < = 100       90 Day Dog Feeding
 to 6 months)                          NOAEL = 0.9 mg/kg/day     (Residential)            Study
(Residential)........................   (inhalationabsorption                            LOAEL = 10.4/10.7 mg/kg/
                                        rate = 100%).                                     day
                                                                                         [M/F] based on changes
                                                                                          in hematologic
                                                                                          parameters
--------------------------------------
Long-Term Inhalation (6 months         Oral study               LOC for MOE < = 100       1-Year Dog Feeding
 tolifetime)                           NOAEL = 1.0 mg/kg/day     (Residential)            Study
(Residential)........................   (inhalation absorption                           LOAEL = 8.9/10.4 mg/kg/
                                        rate = 100%).                                     day
                                                                                         [M/F] based on changes
                                                                                          in hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney
--------------------------------------
Cancer (oral, dermal, inhalation)         Bifenazate is classified as ``not likely'' to be a human carcinogen
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns of FQPA.

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, 
in or on a variety of raw agricultural commodities. Tolerances on 
primary crops range from 0.1 ppm to 35 ppm on pome fruit, fruiting 
vegetable, cucurbit vegetable, tree nut, nectarine, peach, plum, grape, 
strawberry, cotton, hops, okra, peppermint, and spearmint. Tolerances 
have also been established in milk, ruminant meat, and ruminant meat 
byproducts at 0.02 ppm. Bifenazate is a selective miticide which 
controls the motile stage of mites either by direct contact or through 
contact with foliar residues. Risk assessments were conducted by EPA to 
assess dietary exposures from bifenazate in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. As indicated in Table 1 above, toxicological data for 
bifenazate do not identify any dose to the chemical which triggers a 
toxic effect based on an acute dose. As there were no toxic effects 
attributable to a single dose, an endpoint of concern was not 
identified to quantitate acute-dietary risk to the general population, 
to infants, to children or to the subpopulation females 13-50 years 
old. Therefore, there is no acute reference dose (aRfD) or acute 
population-adjusted dose (aPAD) for the general population or females 
13-50 years old. An acute aggregate risk assessment was not performed 
because no acute risk is expected.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption 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 chronic dietary exposure analysis was based on tolerance level 
residues excluding tomato and soybean (average field trial residues was 
assumed for these crops) and average percent crop treated information. 
DEEM\TM\ (Version 7.76) default processing factors were used for some 
commodities. The analyses also included the chronic surface water point 
estimate generated using the Tier 1 model First Index Reservoir 
Screening Tool (FIRST) which assumed that 87% of the basin is cropped 
and 100% of the cropped area treated at the maximum rate (surface water 
chronic point estimate was greater than the ground water point 
estimate).
    iii. Cancer. Bifenazate has been classified as ``not likely'' to be 
a human carcinogen.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such Data Call-Ins for information relating to anticipated 
residues as is required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such Data Call-Ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by

[[Page 74692]]

section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used average PCT information for several commodities.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which bifenazate may 
be applied in a particular area.
    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 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/EXAMS (a Tier 2 model). The FIRST model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to bifenazate they are further 
discussed in the aggregate risk sections below.
    Based on the FIRST and SCI-GROW models the EECs of bifenazate for 
chronic exposures are estimated to be 6.4 parts per billion (ppb) for 
surface water and < 0.001 ppb for ground water.
    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: Ornamentals and non-bearing fruit trees. 
The risk assessment was conducted using the following exposure 
assumptions: Only short-term dermal and short-term inhalation exposure 
are expected for homeowner applicators. Post-application exposure is 
anticipated to be negligible and was not assessed.
    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.''
    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/.


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.

[[Page 74693]]

    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.
    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 the additional 10X 
safety factor for childrens' health can be reduced to 1X.

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. 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 + chronic non-dietary, non-occupational 
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 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 ground water 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. If 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. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bifenazate from food will utilize 36% of the cPAD for the U.S. 
population, 72% of the cPAD for all infants (<  1 year old) and 84% of 
the cPAD for children 1-2 years old. Based on the use pattern, chronic 
residential exposure to residues of bifenazate is not expected. In 
addition, despite the potential for chronic dietary exposure to 
bifenazate in drinking water, after calculating DWLOCs and comparing 
them to conservative model EECs of bifenazate in surface water and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 2 of this unit:

              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           36          6.4       < 0.001          230
------------------------------------------------
All infants (< 1 year old)                               0.01           72          6.4       < 0.001           26
------------------------------------------------
Children (1-2 years old)                                0.01           84          6.4       < 0.001           21
------------------------------------------------
Children (3-5 years old)                                0.01           78          6.4       < 0.001           25
------------------------------------------------
Children (6-12 years old)                               0.01           52          6.4       < 0.001           47
------------------------------------------------
Youth (13-19 years old)                                 0.01           33          6.4       < 0.001          200
------------------------------------------------
Adults (20-49 years old)                                0.01           31          6.4       < 0.001          250
------------------------------------------------
Adults (50 + years old)                                 0.01           30          6.4       < 0.001          270
------------------------------------------------
Females (13-49)                                         0.01           35          6.4       < 0.001          260
----------------------------------------------------------------------------------------------------------------

    2. 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 use(s) 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 1,672 for U.S. population, 1,741 
for youth 13-19 years old, 1,820 for adults 20-49 years old, 1,849 for 
adults 50+ years old, and 1,684 for females 13-49 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 of this unit:

[[Page 74694]]



                    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                                        1,672          100          6.4       < 0.001        3,200
-----------------------------------------------
Youth (13-19 years old)                                1,741          100          6.4       < 0.001        3,000
-----------------------------------------------
Adults (20-49 years old)                               1,820          100          6.4       < 0.001        3,300
-----------------------------------------------
Adults (50 + years old)                                1,849          100          6.4       < 0.001        3,500
-----------------------------------------------
Females (13-49 years old)                              1,684          100          6.4       < 0.001        2,700
----------------------------------------------------------------------------------------------------------------

    3. 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). Though residential exposure could occur with the use of 
bifenazate, only short-term exposures are expected for homeowner 
applicators. Therefore, the aggregate risk is the sum of the risk from 
food and water, which were previously addressed.
    4. Aggregate cancer risk for U.S. population. Bifenazate is 
classified as ``not likely'' to be a human carcinogen. Thus, a 
quantification of human cancer risk has not been performed.
    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.

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: residuemethods@epa.gov.

B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits for 
residues of bifenazate in or on the proposed crops. Therefore, 
harmonization is not an issue.

VI. Conclusion

    Therefore, 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 or on 
tart cherries at 5.0 ppm; soybean seed at 1.5 ppm; soybean hulls at 20 
ppm; soybean meal at 3.5 ppm; and soybean refined oil at 20 ppm.

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 EPA-HQ-OPP-2005-0276 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 February 
14, 2006.
    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 issue(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 (1900L), 
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 Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A.1., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in ADDRESSES. Mail 
your copies, identified by the docket ID number EPA-HQ-OPP-2005-0276, 
to: Public Information and Records Integrity Branch, Information 
Technology and Resource Management 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 ADDRESSES. You may also 
send an

[[Page 74695]]

electronic copy of your request via e-mail to: opp-docket@epa.gov. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or 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 issue(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 time-limited tolerances 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 
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.

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 and pests, Reporting and 
recordkeeping requirements.

    Dated: December 1, 2005.
Donald R. Stubbs,
Acting 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), 346a and 371.


0
2. Section 180.572 is amended by alphabetically adding commodities in 
the table in paragraph (b) to read as follows:


Sec.  180.572  Bifenazate; tolerance for residues.


* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Cherry, tart..................................          5.0     12/31/09
                                * * * * *
Soybean, hulls................................           20     12/31/09
Soybean, meal.................................          3.5     12/31/09

[[Page 74696]]


Soybean, refined oil..........................           20     12/31/09
Soybean, seed.................................          1.5     12/31/09
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-24137 Filed 12-15-05; 8:45 am]

BILLING CODE 6560-50-S
