Bifenthrin; Pesticide Tolerance

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

[Federal Register: July 12, 2000 (Volume 65, Number 134)]
[Rules and Regulations]
[Page 42863-42871]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy00-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301018; FRL-6595-1]
RIN 2070-AB78

Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
bifenthrin in or on caneberry subgroup, grape, head lettuce and
peppers, bell and non-bell. The Interregional Research Project (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective July 12, 2000. Objections and
requests for hearings, identified by docket control number OPP-301018
must be received by EPA on or before September 11, 2000.

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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301018 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 305-7610; and e-mail address:
jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be 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 potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

[[Page 42864]]

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'' 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-301018. 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, Crystal 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

In the Federal Register of December 22, 1999 (64 FR 71772) (FRL-
6396-2), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of pesticide petitions (PP) for tolerances by IR-
4, New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers
University, New Brunswick, NJ 08903. This notice included a summary of
the petitions prepared by FMC Corporation, the registrant. There were
no comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.442 be amended by
establishing tolerances for residues of the insecticide bifenthrin, (2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3-trifluoro-1-
propenyl)-2,2-dimethylcyclopropane carboxylate, in or on the following
commodities:
(1) PP 9E6016 proposed a tolerance for grape at 0.2 ppm.
(2) PP 9E6030 proposed a tolerance for peppers, bell and non-bell
at 0.5 ppm.
(3) PP 9E6031 proposed a tolerance for head lettuce at 2.0 ppm,
subsequently revised in this final rule to 3.0 ppm.
(4) PP 9E6034 proposed a tolerance for the caneberry at 1.0 ppm.
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....''
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).

III. Aggregate Risk Assessment and Determination of Safety

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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of bifenthrin on caneberry
subgroup at 1.0 ppm, grape at 0.2 ppm, head lettuce at 3.0 ppm, and
peppers, bell and non-bell at 0.5 ppm. EPA's assessment of exposures
and risks associated with establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by bifenthrin are
discussed in this unit as well as the no observed adverse effect level
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the
toxicity studies reviewed.

Table 1.--Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
Guideline No./Study Type Results
------------------------------------------------------------------------
870.3700a Prenatal developmental in Maternal NOAEL = 1 mg/kg/day
rodents. LOAEL = 2 mg/kg/day based on
tremors
Developmental NOAEL = 1 mg/
kg/day
LOAEL = 24 mg/kg/day based
on increased incidence of
hydroureter
------------------------------------------------------------------------
870.3700b Prenatal developmental in Maternal NOAEL = 2.67 mg/kg/
nonrodents. day
LOAEL = 4 mg/kg/day based on
head and forelimb twitching
No Developmental effects
observed
------------------------------------------------------------------------

[[Page 42865]]

870.3800 Reproduction and fertility Parental/Systemic NOAEL = 3
effects. mg/kg/day
LOAEL = 5 mg/kg/day
Reproductive NOAEL = 5 mg/kg/
day
LOAEL = no reproductive
effects observed at the
highest dose tested (5 mg/kg/
day)
Offspring NOAEL = 5 mg/kg/
day
LOAEL = no adverse effects
observed at the highest dose
tested (5 mg/kg/day)
------------------------------------------------------------------------
870.4100b Chronic toxicity dogs.......... NOAEL = 1.5 mg/kg/day
LOAEL = 3 mg/kg/day based on
increased incidence of
tremors in both sexes
------------------------------------------------------------------------
870.4200 Carcinogenicity rats............ NOAEL = 2.5 mg/kg/day
LOAEL = 5 mg/kg/day based on
increased incidence of
tremors in both sexes and
possible increases in organ-
to-body weight ratios in
males. There was no evidence
of carcinogenicity.
------------------------------------------------------------------------
870.4300 Carcinogenicity mice............ NOAEL = 2.5 mg/kg/day
LOAEL = 10 mg/kg/day based
on incidence of tremors in
both sexes. Carcinogenic
potential was evidenced by
statistically significant
increased trend for
hemangiopericytomas in the
urinary bladders of males, a
significant dose-related
trend for combined
hepatocellular adenomas and
carcinomas in males, and a
significantly higher
incidence of combined lung
adenomas and carcinomas in
females.
------------------------------------------------------------------------
Gene Mutation............................ A gene mutation in
Salmonella (Ames) was
negative.
------------------------------------------------------------------------
Cytogenetics............................. Chromosomal aberrations in
Chinese hamster ovary and
rat bone marrow cells were
negative.
------------------------------------------------------------------------
Other Effects............................ HGPRT locus mutation in mouse
lymphoma cells and
unscheduled DNA synthesis in
rat hepatocytes were
negative.
------------------------------------------------------------------------
870.7485 Metabolism and pharmacokinetics. Metabolism studies in rats
demonstrated that
distribution patterns and
excretion rates in multiple
oral dose studies are
similar to single-dose
studies. There was an
accumulation of unchanged
compound in fat upon chronic
administration with slow
elimination. Otherwise,
bifenthrin was rapidly
metabolized and excreted.
Unchanged bifenthrin is the
major residue component of
toxicological concern in
meat and milk.
------------------------------------------------------------------------
870.7600 Dermal penetration.............. Dermal absorption rate is 25%
------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at which
adverse effects of concern are identified (the LOAEL) is sometimes used
for risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for intra
species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD=NOAEL/UF). Where an additional safety 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 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.

Table 2.--Summary of Toxicological Dose and Endpoints for bifenthrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population NOAEL =1.0 mg/kg/day aPAD = acute RfD Rat developmental LOAEL
including infants and children. UF = 100.............. FQPA SF = = 2 mg/kg/day based on
Acute RfD = 0.01 mg/kg/ 0.01 mg/kg/day tremors in dams during
day. and post dosing
FQPA SF = 1X..........
--------------------------------------------------------------- FQPA SF =
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[[Page 42866]]

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\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.442) for the residues of bifenthrin, in or on a
variety of raw agricultural commodities including tolerances on plants
ranging from 0.05 ppm for corn grain (field, seed, and pop) to 10 ppm
on dried hops. Tolerances are also established on animal commodities
ranging from 0.05 ppm on eggs to 1.0 ppm in milk fat (reflecting 0.1
ppm in whole milk). Risk assessments were conducted by EPA to assess
dietary exposures from bifenthrin 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. The Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 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 acute
exposure assessments: In this acute analysis, probabilistic Monte Carlo
analysis (Tier 3) was used. For those foods identified by EPA as
single-serving commodities, the Monte Carlo simulation is based on
iterative sampling from individual residue values from field trial data
reflecting maximum application rates and minimum preharvest intervals.
For those foods considered to be blended or processed, mean field trial
residues were calculated. For those samples which contained residues at
or below the limit of detection (LOD), \1/2\ of the LOD was used. It
was assumed that 100% of the following crops were treated with
bifenthrin: artichoke, bananas, Brassica vegetable, caneberry, canola,
citrus, cucurbits, eggplants, garden peas, grape, head lettuce, lima
beans, peanuts, pears, peppers, potatoes, snap beans, and sweet corn.
Processing factors for grapes were calculated using concentration
factors (grape juice = 1.2X, raisins = 4.2X). Secondary residues for
meat and milk were not affected by adding the uses on peppers, lettuce,
grape, and caneberry since no animal feed items are associated with
these crops.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 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: Anticipated residue values which were determined
from field trial data conducted at maximum label conditions of maximum
application rates and minimum preharvest intervals. Mean anticipated
residue values were calculated. One hundred percent of crop treated was
assumed for all crops except hops (43%) and cottonseed-oil and
cottonseed-meal (4%). Secondary residues for meat and milk were not
affected by the new proposed uses.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To

[[Page 42867]]

provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which bifenthrin may
be applied in a particular area.
2.Dietary exposure from drinking water. The Agency lacks sufficient
monitoring exposure data to complete a comprehensive dietary exposure
analysis and risk assessment for bifenthrin 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 bifenthrin.
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
Screening Concentration in ground water (SCI-GROW) model, which
predicts pesticide concentrations in groundwater. In general, EPA will
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a 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 percent of the Reference dose or
percent of the population adjusted dose. 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 bifenthrin they are further discussed in the aggregate risk
sections below.
Based on the GENEEC and the SCI-GROW models the EECs of bifenthrin
in surface water and ground water for acute exposures are estimated to
be 0.10 parts per billion (ppb) for surface water and 0.006 ppb for
ground water. The EECs for chronic exposures are estimated to be 0.032
ppb for surface water and 0.006 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). Bifenthrin is
currently registered for use on the following residential non-dietary
sites: lawns to control flea infestation, pets and as a termiticide.
Registered termiticide use of bifenthrin constitutes a chronic exposure
scenario, however, the exposure is considered negligible, considering
the application technique of the termiticide use (buried underground)
and the fact that vapor pressure of bifenthrin is extremely low. The
Agency conducted a residential exposure assessment for the lawn care
uses of bifenthrin. This risk assessment is based on post-application
to treated lawns (turf use), a worst case scenario estimate of
residential exposure. An assessment of applicator exposure was not
included since the registered products are primarily limited to
commercial use and, therefore, applied by professional lawn care
operators. Inhalation, dermal and oral non-dietary routes of exposure
were evaluated by this short- and intermediate-term risk assessment.
For adults, the routes of exposure from these registered residential
uses include dermal and inhalation, and for infants and children, the
routes of exposure include dermal, inhalation, and oral (non-dietary).
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 bifenthrin 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,
bifenthrin 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 bifenthrin has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism

[[Page 42868]]

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).

D. 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. See summary of developmental
toxicity studies in Unit IIIA. Toxicological Profile.
iii. Reproductive toxicity study. See summary of reproduction
toxicity studies in Unit IIIA. Toxicological profile.
iv. Conclusion. There is a complete toxicity data base for
bifenthrin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The FQPA Safety
Factor for enhanced sensitivity of infants and children was reduced
from 10X to 1X.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD-(average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC. A DWLOC will vary
depending on the toxic endpoint, drinking water consumption, and body
weights. Default body weights and consumption values as used by the
U.S. EPA's 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 groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide 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 residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary (food only) exposure to
bifenthrin will occupy 60% of the aPAD for the U.S. population, 40% of
the aPAD for females 13 years and older, 75% of the aPAD for infants (1
year old) and 99.7% of the aPAD for children (1 to 6 years old). In
addition, there is potential for acute dietary exposure to bifenthrin
in drinking water. Despite this potential and after calculating DWLOCs
and comparing them to the EECs for surface and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the aPAD.

Table 3.--Aggregate Risk Assessment for Acute Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute
kg) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.01 60 0.10 0.006 140
----------------------------------------------------------------------------------------------------------------
Females 13 years and older..................... 0.01 40 0.10 0.006 180
----------------------------------------------------------------------------------------------------------------
children (1 to 6 years old).................... 0.01 99.7 0.10 0.006 0.3
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenthrin from food will utilize 3.0% of the cPAD for the U.S.
population, and 8.2% of the cPAD for children (1 to 6 years old), the
subpopulation at greatest risk. Bifenthrin is also registered for
residential use on outdoor lawn/gardens, inside households, pets and as
a termiticide. Based on the use pattern, chronic residential exposure
to residues of the bifenthrin is not expected. In addition, there is
potential for chronic dietary exposure to bifenthrin in drinking water.
After calculating the DWLOCs and comparing them to the EECs for surface
and ground water, EPA does not expect the aggregate exposure to exceed
100% of the cPAD.

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.015 3.0 0.032 0.032 530
----------------------------------------------------------------------------------------------------------------

[[Page 42869]]

Females (13 yrs. and above).................... 0.015 3.0 0.032 0.032 450
----------------------------------------------------------------------------------------------------------------
children (1 to 6 years old).................... 0.015 3.0 0.032 0.032 140
----------------------------------------------------------------------------------------------------------------

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). Bifenthrin is currently
registered for use that could result in short- and intermediate-term
residential exposure. Registered termiticide use of bifenthrin
constitutes a chronic exposure scenario; however, the exposure is
considered negligible. The Agency has determined that it is appropriate
to aggregate chronic food and water and short- and intermediate-term
non-dietary exposures for bifenthrin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food (water not included) and
residential exposures aggregated result in aggregate MOEs of 940 for
adults, 350 for children ages 1 to 6 years old, and 470 for infants
less than 1 year old based on chronic food and residential use, e.g.,
turf representing the worst case residential exposure scenario. 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 bifenthrin in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern.

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
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............................... 940 100 0.032 0.006 320
----------------------------------------------------------------------------------------------------------------
Children 1 to 6 yrs. old...................... 350 100 0.032 0.006 71
----------------------------------------------------------------------------------------------------------------

Applying the same exposure assumptions as above for short-term
exposure, and after calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern.

Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population............................. 940 100 0.032 0.006 480
----------------------------------------------------------------------------------------------------------------
Children 1 to 6 yrs. old.................... 350 100 0.032 0.006 107
----------------------------------------------------------------------------------------------------------------

4. Aggregate cancer risk for U.S. population. A quantitative
(Q1*) dietary cancer risk assessment was not performed.
Dietary risk concerns due to long-term consumption of bifenthrin are
adequately addressed by the DEEM chronic exposure analysis
using the chronic RfD. For the U.S. population, only 3.0% of the cPAD
(cRfD) is occupied by chronic food exposure. Based on a comparison of
the calculated DWLOCs and the estimated exposure to bifenthrin in
drinking water (0.032 g/L), the Agency does not expect the
chronic aggregate exposure to exceed 100% of the cPAD (cRfD) for
adults. Thus, EPA concludes with reasonable certainty that the
carcinogenic risk is within acceptable limits.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to bifenthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are available for determination of the
regulated bifenthrin residue in plants. The data gathering method for
pepper, lettuce, grapes, and caneberry is FMC method P-2132M, with a
limit of quantitation of 0.05 ppm (given as 0.055 in some cases). This
method is a variation of two other methods which have been submitted
for inclusion in PAM II (FMC's Methods P-1031 and RAN-0140. This method
has been adequately validated and is adequate for data collection. 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.

[[Page 42870]]

B. International Residue Limits

No Codex, Canadian, or Mexican maximum residue levels (MRL) have
been established for residues of bifenthrin in/on bell or non-bell
peppers, head lettuce, grape, or caneberries. International
harmonization is therefore not an issue for these tolerances.

V. Conclusion

Therefore, the tolerances are established for residues of
bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane carboxylate, in or on
caneberry crop subgroup 13A at 1.0 ppm, grape at 0.2 ppm, head lettuce
at 3.0 ppm and peppers at 0.5 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA 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-301018 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 September
11, 2000.
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 VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301018, 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 file format or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16,

[[Page 42871]]

1994); or require OMB review or any Agency action under Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).

VIII. 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: June 29, 2000.
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), (346a) and 371.

2. Section 180.442 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:

Sec. 180.442 Bifenthrin; tolerances for residues.

(a) General. * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Caneberry subgroup......................................... 1.0

* * * * *
Grape...................................................... 0.2

* * * * *
Lettuce, head.............................................. 3.0

* * * * *
Pepper, bell............................................... 0.5
Peppers, non-bell.......................................... 0.5

* * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 00-17618 Filed 7-11-00; 8:45 am]
BILLING CODE 6560-50-F

Bifenthrin; Pesticide Tolerance

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