Bifenazate; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 15, 2001 (Volume 66, Number 158)]
[Rules and Regulations]
[Page 42765-42772]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au01-17]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301153; FRL-6793-3]
RIN 2070-AB

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:
Madden.Barbara@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 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 (MOE_cancer = 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:
furlow.calvin@epa.gov.

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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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: 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

[[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

Bifenazate; Pesticide Tolerances for Emergency Exemptions

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