[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Rules and Regulations]
[Pages 42765-42772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20392]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301153; FRL-6793-3]
RIN 2070-AB


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 hop and pear. This action is 
in response to EPA's granting of emergency exemptions under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on hops and pears. This regulation establishes a 
maximum permissible level for residues of bifenazate in these food 
commodities. The tolerances will expire and are revoked on June 30, 
2003.

DATES: This regulation is effective August 15, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301153, 
must be received by EPA on or before October 15, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301153 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6463; and 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 categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations

[[Page 42766]]

and Proposed Rules,'' and then look up the entry for this document 
under the ``Federal Register--Environmental Documents.'' You can also 
go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301153. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    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, (hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl-, 1-methylethyl ester) and diazenecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl-, 1-methylethyl ester, in or on hop at 15 
parts per million (ppm) and pear at 0.50 ppm. These tolerances will 
expire and are revoked on June 30, 2003. 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 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) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Bifenazate on Hops and Pears and FFDCA 
Tolerances

A. Hops

    The two-spotted spider mite is a serious problem in Northwest hop 
yards due to the prolific nature of this pest and its ability to 
develop multiple generations in one season. This mite has a history of 
developing rapid resistance to insecticides used on hops, which have 
been documented through field studies and failures observed in 
commercial plantings. There are currently no effective late-season 
miticides registered for use on hops.
    Abamectin has good activity against mites in the early season when 
foliage is young and uptake is optimum. It has provided over 90% of 
mite control for the past 11 years, but due to a lack of alternative 
modes of action, its efficacy and residual effect have declined 
significantly.
    The Applicant proposes to replace abamectin with bifenazate for 
early season mite control. Only one application of bifenazate will be 
allowed, compared to the current two applications allowed for 
abamectin. Although bifenazate is moderately harmful to some predator 
species, approximately 50% survival is anticipated. With the addition 
of one application of hexythiazox, these two treatments should be 
adequate to control early season mites (prior to bloom).

B. Pears

    Spider mites are a ubiquitous and perennial pest of pears in 
Washington and Oregon. They have a history of rapidly developing 
resistance to acaricides, and have evolved resistance to every 
pesticide directed at their control. For the past 10-12 years, growers 
have relied heavily on abamectin to control spider mites in pears. 
Prior to the use of abamectin, the primary control for mites was 
organotins (especially cyhexatin) for control. Resistance to abamectin 
in the Northwest mite populations has been documented. This resistance 
to the only consistently effective mite control creates the potential 
for severe losses to pear production in the Northwest. In recent years, 
pear growers have continued to use abamectin, and been faced with 
limited success. They have been forced to augment abamectin with other 
acaricides, such as fenbutatin-oxide and hexythiazox. However, 
resistance was documented during the 2000 growing season to the few 
viable alternatives to abamectin. Entering the 2001 growing season, 
there are no viable acaricides for which resistance does not occur in 
pears in Washington. Resistance to many of these products has also been 
observed in Oregon.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bifenazate in or on hops 
and pears. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) 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 these tolerances without notice and opportunity for public 
comment as provided in section 408(l)(6). Although these tolerances 
will expire and are revoked on June 30, 2003, under FFDCA section 
408(l)(5), residues of the

[[Page 42767]]

pesticide not in excess of the amounts specified in the tolerance 
remaining in or on hops and pears 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 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 hops or pears 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 Idaho and Washington to use this 
pesticide on these crops under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing 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 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), 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), for time-limited tolerances for 
combined residues of bifenazate in or on hop at 15 ppm and pear at 0.50 
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.
    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 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
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   None                     None                     None
 age and general population including
 infants and children
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 1.01 mg/kg/day   FQPA SF = 10             One-year oral toxicity
                                       UF = 100...............  cPAD = chronic.........   study in dogs
                                       Chronic RfD = 0.01 mg/   RfD FQPA SF = 0.001 mg/  LOAEL = 8.95 mg/kg/day
                                        kg/day.                  kg/day.                  based on changes in
                                                                                          hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in the
                                                                                          bone marrow, liver,
                                                                                          and kidneys of both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------

[[Page 42768]]

 
Short-term incidental oral Exposure    NOAEL = 10 mg/kg/day     LOC for MOE = 1,000      Developmental toxicity
 (residential)                                                   (residential)            study in rats
                                                                                         LOAEL= 100 mg/kg/day
                                                                                          based on clinical
                                                                                          signs and decreased
                                                                                          body weight gain and
                                                                                          food consumption.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) and    Dermal study NOAEL= 80   LOC for MOE = 1,000      21-Day dermal toxicity
 intermediate-term Dermal (1 week to    mg/kg/day                (residential)            study in rats
 several months) (residential)                                                           LOAEL = 400 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight and food
                                                                                          consumption in females
                                                                                          and an increased
                                                                                          incidence of
                                                                                          extramedullary
                                                                                          hematopoiesis in the
                                                                                          spleen in both sexes.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    None                     None                     None
 lifetime) (Residential)
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    inhalation (or oral)     LOC for MOE = 1,000      Developmental toxicity
 (Residential)                          study NOAEL= 10 mg/kg/   (residential)            study in rats
                                        day (inhalation                                  LOAEL = 100 mg/kg/day
                                        absorption rate =                                 based on decreased
                                        100%)                                             bodyweight and food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week   Inhalation (or oral)     LOC for MOE = 1,000      90-day feeding study in
 to several months) (residential)       study NOAEL= 1.0 mg/kg/  (residential)            dogs LOAEL = 10.4 mg/
                                        day (inhalation                                   kg/day based on
                                        absorption rate =                                 changes in
                                        100%)                                             hematological
                                                                                          parameters and
                                                                                          histopathological
                                                                                          effects in the liver.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months   None                     None
 to lifetime) (residential)None
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Bifenazate has been      None                     Carcinogenicity studies
                                        classified as ``not                               in mice and rats in
                                        likely'' to be a human                            which there were an
                                        carcinogen.                                       absence of treatment-
                                                                                          related tumors.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

    1. Dietary exposure from food and feed uses. Bifenazate is 
currently only registered for use on ornamental plants and trees. An 
emergency exemption was granted earlier in 2001 for use of bifenazate 
on greenhouse grown tomatoes and a time-limited tolerance for residues 
on tomatoes was established. There are no other tolerances established 
for the combined residues of bifenazate. 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. An acute dietary endpoint for females 13-50 years old 
or the general U.S. population was not selected due to the absence of 
an effect of concern occurring as a result of a 1 day or single 
exposure.
    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 1989-1992 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 
assessments: tolerance level residues, 100% crop treated, and DEEM\TM\ 
default processing factors for all proposed commodities.
    iii. Cancer. Bifenazate has been classified as ``not likely'' to be 
a human carcinogen based on carcinogenicity studies in mice and rats in 
which there were an absence of treatment-related tumors.
    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 Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a

[[Page 42769]]

tier 2 model) for a screening-level assessment for surface water. The 
GENEEC model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. GENEEC incorporates a farm 
pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. 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 GENEEC and SCI-GROW models, the estimated 
environmental concentrations (EECs) of bifenazate for chronic exposures 
are estimated to be 0.02 part per billion (ppb) for surface water and 
0.02 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: ornamental plants and trees. The risk 
assessment was conducted using the following exposure assumptions: 
There is a potential for residential exposures, including homeowner 
applicator exposure and post-application exposures, for the currently 
registered uses of bifenazate. However, since broad spectrum 
insecticides are generally used in the residential setting, application 
of bifenazate (a selective insecticide) by a homeowner is expected to 
be limited. Nevertheless, a homeowner applicator is anticipated to have 
short-term dermal and inhalation exposures. Exposure estimates were 
based on the applicator wearing short pants and short sleeves.
    The registered use of bifenazate on ornamentals is also expected to 
result in residential post-application exposure. The exposure estimate 
for homeowners and children was based on the default assumptions for 
treatment to garden plants from the Agency's Standard Operating 
Procedures (SOPs) for Residential Exposure Assessment (December 18, 
1997). Only short-term dermal exposures are anticipated.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether bifenazate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
bifenazate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that bifenazate has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Developmental toxicity studies. In a developmental toxicity 
study in rats the maternal toxicity NOAEL was 10 milligrams/kilograms/
day (mg/kg/day) based on clinical signs and decreased body weight gains 
and food consumption at the LOAEL of 100 mg/kg/day. The developmental 
NOAEL was greater than 500 mg/kg/day (HDT) and the developmental LOAEL 
was not established. Therefore, there were no developmental effects 
observed in the presence of maternal toxicity in this study.
    In a developmental toxicity study in rabbits there were no toxic 
effects up to the highest dose tested of 200 mg/kg/day in either the 
maternal animals or the fetuses. Although no toxicity was observed in 
this study, sufficient evidence of adequate dose selection was based on 
a range-finding study which was performed at doses of 0, 125, 250, 500, 
750, or 1,000 mg/kg/day. Abortions were seen at 250 mg/kg/day and above 
and deaths and decreased body weight were seen at 750 mg/kg/day and 
1,000 mg/kg/day. Based on these results, doses of 10, 50, and 200 mg/
kg/day were selected for the main study.
    iii. Reproductive toxicity study. In a 2-generation reproductive 
toxicity study in rats, the parental toxicity NOAEL was 20 ppm 
(equivalent to 1.6/1.8 mg/kg/day (males/females)) based on decreased 
body weight and cumulative weight gain in males and females at the 
LOAEL of 80 ppm (equivalent to 6.5/7.4 mg/kg/day (males/females)). The 
NOAEL for offspring toxicity and reproductive toxicity was 200 ppm 
(equivalent to 16.4/18.3 mg/kg/day (males/females)) which was the 
highest dose tested. A LOAEL for offspring toxicity and reproductive 
toxicity was not established.
    iv. Prenatal and postnatal sensitivity. Based on the results of the 
developmental and reproduction studies, there is no indication of 
increased sensitivity in rats or rabbits to in utero and/or postnatal 
exposure to bifenazate.
    v. Conclusion. There were no developmental or reproductive effects 
observed in the presence of maternal toxicity. However, bifenazate has 
not been evaluated by the Agency's FQPA Safety Factor Committee. 
Therefore, for the purposes of this emergency exemption, the FQPA 
safety factor of 10X, to protect infants and children has

[[Page 42770]]

been retained for all dietary and residential risk assessments.

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: 2L/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. Acute risk. An acute dietary endpoint for females 13-50 years 
old or the general US population was not selected due to the absence of 
an effect of concern in studies conducted for bifenazate occurring as a 
result of a 1 day or single exposure. Therefore, no acute dietary risk 
assessments were conducted for bifenazate.
    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 34% of the cPAD for the U.S. 
population, 65% of the cPAD for infants and 48% of the cPAD for 
children (7-12 years), the most highly exposed children's subgroup. 
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 estimated 
environmental concentrations of bifenazate in surface and ground water, 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD, 
as shown in the following 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                                        0.001           34         0.02         0.02           23
----------------------------------------------------------------------------------------------------------------
All infants (less than 1 year)                         0.001           65         0.02         0.02            4
----------------------------------------------------------------------------------------------------------------
Children (7-12 years)                                  0.001           48         0.02         0.02            5
----------------------------------------------------------------------------------------------------------------

    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 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 1,300 to 1,400 for short-term 
dermal, inhalation and incidental oral exposures. 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 and ground water, EPA does not 
expect short-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 3:

                    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                                        1,300        1,000         0.02         0.02           80
----------------------------------------------------------------------------------------------------------------
All infants (less than 1 year)                         1,400        1,000         0.02         0.02           27
----------------------------------------------------------------------------------------------------------------
Children (7-12 years)                                  1,400        1,000         0.02         0.02           29
----------------------------------------------------------------------------------------------------------------


[[Page 42771]]

    4. 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, currently, only short-term dermal and short-term inhalation 
residential exposures are expected. Therefore, an aggregate risk 
assessment for intermediate-term exposures was not conducted.
    5. Aggregate cancer risk for U.S. population. Bifenazate has been 
classified as ``not likely'' to be a human carcinogen based on 
carcinogenicity studies in mice and rats in which there were an absence 
of treatment-related tumors. Therefore, an aggregate risk assessment to 
estimate cancer risk was not conducted.
    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 (multiresidue method) is available 
to enforce the tolerance expression. The method may be requested from: 
Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits, 
for residues of bifenazate and its metabolite in or on hop and pears. 
Therefore, harmonization is not an issue for this use.

C. Conditions

    Hops--a maximum of 1 ground application at a rate of 0.37-0.75 lbs 
active ingredient per acre may be made per season. A 14-day pre-harvest 
interval (PHI) is required.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
bifenazate, (hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-
yl-, 1-methylethyl ester) and diazenecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl-, 1-methylethyl ester, in or on hop at 15 ppm and 
pear at 0.50 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301153 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 October 
15, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3.Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit 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.2. Mail your 
copies, identified by the docket control number OPP-301153, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your

[[Page 42772]]

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. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances under FFDCA 
section 408. 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). 
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 other 
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 FFDCA 
section 408, 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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 19, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

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


Sec. 180.572  Bifenazate; tolerance for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Hop                                                      15      6/30/03
Pear                                                   0.50      6/30/03
                    *      *      *       *        *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-20392 Filed 8-14-01; 8:45 am]
BILLING CODE 6560-50-S