  SEQ CHAPTER \h \r 1 FILE NAME:   company.wpt   (5/11/2007) (xml)

	

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COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(5/11/2007)

EPA Registration Division contact: Shaja R. Brothers (703) 308-3194	

		

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Interregional Research Project Number 4

PP No.: 7E7227

	EPA has received a pesticide petition ([PP No.: 7E7227) from IR-4, 500
College Road, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180. by establishing a tolerance
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 the following raw agricultural commodities: 
bushberry subgroup 13-B and juneberry;  lingonberry; salal; aronia
berry; blueberry, lowbush; buffalo currant; chilean guava;  european
barberry; highbush cranberry; honeysuckle; jostaberry; native currant;
sea buckthorn at 2.0 ppm, and leafy petioles subgroup 4-B at 3.0 ppm.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry      

                                

	1. Plant metabolism. The metabolism of bifenthrin in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabelled bifenthrin in various crops all showing
similar results. The residue of concern is the parent compound only.

	2. Analytical method. There is a practical analytical method for
detecting and measuring levels of bifenthrin in or on food with a limit
of detection that allows monitoring of food with residues at or above
the levels set in these tolerances (Gas Chromatography with Electron
Capture Detection (GC/ECD).

	3. Magnitude of residues. Field residue trials meeting EPA study
requirements have been conducted at the maximum label rate for the crops
blueberries and celery.  Results from the studies demonstrate that the
highest bifenthrin residues found will not exceed the proposed
tolerances for bushberry subgroup 13B, juneberry, lingonberry, salal,
aronia berry, blueberry, lowbush, buffalo currant, chilean guava,
european barberry, highbush cranberry, honeysuckle, jostaberry, native
currant, sea buckthorn at 2.0 ppm,  and leafy petiole subgroup 4-B at
3.0 ppm when bifenthrin is applied following the proposed use
directions.

B. Toxicological Profile

	1. Acute toxicity.  For the purposes of assessing acute dietary risk,
FMC has used the results of the 2003 EPA completed risk assessment for
bifenthrin. This acute dietary endpoint  used to determine acute dietary
risks to the general population including infants and children is from
the acute neurotoxicity study in rats, LOAEF = 70.3 mg ai/kg, NOAEL =
32.8 mg ai/kg, UF = 1000, Acute RfD = 0.033 mg/kg/day

	2. Genotoxicty.  The mouse lymphoma mutagenesis assay gave a weak
positive result; however, the weight of the evidence from short-term
mutagenicity tests indicate that bifenthrin is not mutagenic.

	3. Reproductive and developmental toxicity.  i. Rat reproduction study.
 Parental toxicity occurred as decreased body weight at 5.0 mg/kg/day
with a no observed adverse effect level (LOAEL) of 3.0 mg/kg/day.  There
were no developmental (pup) or reproductive effects up to 5.0 mg/kg/day
(highest dose tested).

	ii. Postnatal Sensitivity.  Based on the absence of pup toxicity up to
dose levels, which produced toxicity in the parental animals, there was
no evidence of special postnatal sensitivity to infants and children in
the rat reproduction study.  In a developmental neurotoxicity study,
pups were not more sensitive than the dams.  The NOELs for maternal and
developmental neurotoxicity were both 50 ppm.

	4. Subchronic toxicity.  The results of the 21-day dermal toxicity
study in rats is used for short-term (1-30 days), intermediate-term (1-6
months) and long-term (> 6 months) dermal risk calculations.  The 21-day
dermal toxicity study NOEL for systemic toxicity is 47 mg ai/kg/day
based on observations of clinical signs (exaggerated hindlimb flexion
and staggered gait).

	5. Chronic toxicity. The reference dose (RfD) has been established at
0.004 mg/kg/day.  This RfD is based on a one-year oral study in dogs
with a LOAEF of 2.7 mg ai/kg/day and a NOAEL of 1.3  mg ai/kg/day, UF =
300 based on observations of increased incidence of tremors in both
sexes. 

	Bifenthrin is classified as a Group C chemical (possible human
carcinogen); No Q1* has been derived.

	6. Animal metabolism. The metabolism of bifenthrin in animals is
adequately understood.  Metabolism studies in rats with single doses
demonstrated that about 90% of the parent compound and its hydroxylated
metabolites are excreted.

	7. Metabolite toxicology. The Agency has previously determined that the
metabolites of bifenthrin are not of toxicological concern and need not
be included in the tolerance expression.

	8. Endocrine disruption.  No special studies investigating potential
estrogenic or other endocrine effects of bifenthrin have been conducted.
 However, no evidence of such effects was reported in the standard
battery of required toxicology studies, which have been completed and
found acceptable.  Based on these studies, there is no evidence to
suggest that bifenthrin has an adverse effect on the endocrine system.

C. Aggregate Exposure

	1. Dietary exposure. Tolerances have been established for the residues
of bifenthrin, in or on a variety of raw agricultural commodities. 
Tolerances, in support of registrations, currently exist for residues of
bifenthrin on the following crops: hops, strawberries, corn (grain,
forage and fodder), sweet corn, eggplant, cottonseed, artichokes,
peppers (bell and non-bell), lettuce (head), grapes, spinach, cabbage,
rapeseed, tomatoes, Food Handling Establishments, banana (import),
pears, okra, cilantro .  Also for the crop groups: vegetables, cucurbit,
group 9, fruit, citrus, group 10 and nuts, tree, group 14 and the
subgroups: vegetable, legume, edible podded, subgroup 6A, pea and bean,
succulent shelled, subgroup 6B, caneberry subgroup 13A, and brassica,
head and stem, subgroup 5A, herb subgroup 19A, leaf petioles subgroup
4B, vegetables tuberous and corm, subgroup 1C, pea and bean, dried
shelled, except soybeans, subgroup 6C.  Also, for the livestock
commodities of cattle, goats, hogs, horses, sheep, poultry, eggs, and
milk.  Pending tolerances for mayhaw, peanut, soybeans, root crops
subgroup 1B, and fruiting vegetables group 8 also exist.  For the
purposes of assessing the potential dietary exposure for these existing
and pending tolerances, EPA conducted an exposure estimate using Dietary
Exposure Evaluation Model – Food Commodity Intake Database TM
(DEEM-FCIDTM) Version 2.04, results from field trials and processing
studies, monitoring data, consumption data from the 1989-1992, USDA
Continuing Surveys of Food Intakes by Individuals (CSFII), and
information on the percentages of the crops treated (where available)
with bifenthrin were utilized.

		i. Food.  a. Acute Dietary Exposure 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.  For the purposes of assessing acute dietary risk, FMC
has used the results of the 2003 EPA completed risk assessment for
bifenthrin. This acute dietary endpoint  used to determine acute dietary
risks to the general population including infants and children is from
the acute neurotoxicity study in rats, LOAEF = 70.3 mg ai/kg, NOAEL =
32.8 mg ai/kg, UF = 1000, Acute RfD = 0.0328 mg/kg/day.   Available
information on anticipated residues, monitoring data and percent crop
treated (if no estimate was available the conservative estimate of 50%
crop treatment was used) were incorporated into a Tier III analysis;
using Monte Carlo modeling for commodities that may be consumed in a
single serving.  These assessments demonstrate that the MOEs at the
99.9th percentile are greater than the EPA standard of 100% aPAD for all
subpopulations.  The 99.9th percentile of exposure for the overall U.S.
Population is estimated to be 0.006225 mg/kg/day (18.9% aPAD).  The
99.9th percentile of exposure for children 3 to 5 years old (most highly
exposed population subgroup) is estimated to be 0.014898 mg/kg/day
(45.4% aPAD).  The 99.9th percentile of exposure to all infants less
than 1 year old is estimated to be 0.010252 mg/kg/day (31.25% aPAD). 
Based on the conservatism used in the analyses, actual dietary exposure
will be less than that presented here.  FMC concludes that based on
adequate % aPAD for all population subgroups there is reasonable
certainty that no harm will result from the proposed additional uses of
bifenthrin.

	b. Chronic Exposure.  The reference dose (RfD) has been established at
0.004 mg/kg/day.  This RfD is based on a one-year oral study in dogs
with a LOAEF of 2.7 mg ai/kg/day and a NOAEL of 1.3  mg ai/kg/day, UF =
300 based on observations of increased incidence of tremors in both
sexes.  The chronic exposures for the U.S. Population are estimated to
be 0.000132 mg/kg/day and utilize 3.3% of the cPAD.  The chronic
exposures for Non-nursing infants (most highly exposed population
subgroup) is estimated to be 0.000322 mg/kg/day and utilizes 8.1% of the
cPAD.  Chronic dietary exposure estimates for all infants (< 1 year old)
is estimated to be 0.000276 mg/kg/day and utilizes 6.9% of the cPAD. 
Therefore, FMC concludes with reasonable certainty that no harm will
result from the proposed additional uses of bifenthrin.

	ii. Drinking water. US EPA’s draft SOP for Incorporating Estimates of
Drinking Water Exposure into Aggregate Risk Assessments was used to
perform a drinking water analysis.  This SOP utilizes a variety of tools
to conduct drinking water assessment.  These tools include water models
such as FQPA Index Reservoir Screening Tool (FIRST), PRZM/EXAMS, SCIGROW
and monitoring data.  If monitoring data are not available then the
models are used to predict potential residues in surface water.  A
comparison of the calculated Drinking Water Level of Concern (DWLOC)
value to the Estimated Environmental Concentration (EEC) is made.  If
the DWLOC exceeds the EEC value then there is reasonable certainty that
no harm will result from the short- or intermediate-term aggregate
exposure.  In the case of bifenthrin, monitoring data do not exist, so
the FIRST model was used to estimate a surface water residue and SCIGROW
for the groundwater.  

	Based on the analyses the acute aggregate exposures to bifenthrin
residues, the   DWLOC for all seasons for the US population was 831 ppb
while the modeled EEC, was 0.1 and 0.006 ppb for surface water and
ground water respectively.  For children (1-6 year old), the DWLOCs was
147 ppb while the modeled EEC was the same as that for the whole US
population.  For the chronic aggregate exposures to bifenthrin residues,
the   DWLOC for all seasons for the US population was 128 ppb while the
modeled EEC, was 0.1 and 0.006 ppb for surface water and ground water
respectively.  For children (1-6 year old), the DWLOCs was 35 ppb while
the modeled EEC was the same as that for the whole US population. 
Since, the calculated DWLOC values for all population subgroups exceeded
the modeled EEC for surface water and ground water residues, there is
reasonable certainty that no harm will result from aggregate exposures
to bifenthrin residues.

	2. Non-dietary exposure. The aggregate residential exposure analyses
were based on conservative screening-level assumptions.  The residential
risk assessments resulted in acceptable MOEs and a clear indication of
reasonable certainty of no harm.  The short-term analyses, all of the
route- and product-specific MOEs were greater than 300 and the aggregate
MOEs were greater than 300 for all population subgroups.  Based on the
above information, FMC concludes that bifenthrin does not pose a risk
due to short- and intermediate-term aggregate exposure.

D. Cumulative Effects

	To our knowledge there are currently no available data or other
reliable information indicating that any toxic effects produced by
bifenthrin would be cumulative with those of other chemical compounds;
thus only the potential risks of bifenthrin have been considered in this
assessment of its aggregate exposure.

E. Safety Determination

	1. U.S. population. Using the conservative exposure assessment analyses
the estimated chronic exposure to the U.S. Population is 0.000132
mg/kg/day and utilizes 3.3% of the cPAD.  In addition, the chronic
exposure estimates for all population subgroups (including infants and
children) are well below the cPAD of 0.004 mg/kg/day.  The acute dietary
exposure analyses at the 99.9th percentile for the U.S. Population is
0.006225 and utilizes 18.9% of the aPAD.  In addition, the acute
exposure estimates for population subgroups of concern (infants and
children) indicate that the maximum %aPAD or %cPAD utilized is 31.25%
(aPAD) and 6.9% (cPAD) .  Based on this information FMC concludes that
there is reasonable certainty that no harm will result from acute and
chronic exposure to bifenthrin.

	2. Infants and children. i. General.  In assessing the potential for
additional sensitivity of infants and children to residues of
bifenthrin, FMC considered data from developmental toxicity studies in
the rat and rabbit, a developmental neurotoxicity study, and a
two-generation reproduction study in the rat.  The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development to one or both parents.  Reproduction studies provide
information relating to effects from exposure to the systemic toxicity. 
FFDCA Section 408 provides that the EPA may apply an additional margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and completeness of the
database. 

	 ii.  Developmental toxicity studies.  In the rabbit developmental
study, there were no developmental effects observed in the fetuses
exposed to bifenthrin.  The maternal NOAEL was 2.67 mg/kg/day based on
head and forelimb twitching at the LOAEL of 4 mg/kg/day.  In the rat
developmental study, the maternal NOEL was 7.4 mg/kg/day, based on
treatment-related clinical signs and reductions in body weights,
adjusted maternal body weights, and corresponding reductions in food
consumption noted among dams receiving the LOEL of 16.3 mg/kg/day.  The
developmental NOEL was greater than 16.3 mg/kg/day based on lack of any
adverse fetal effects at levels up to and including 16.3 mg/kg/day.

	  iii.  Developmental neurotoxicity study.  In a rat developmental
neurotoxicity study, pups were not more sensitive than the dams.  The
NOEL for maternal toxicity was 50 ppm, based on tremors at the LOEL of
100 ppm.  The NOEL for developmental neurotoxicity was also 50 ppm.

	 iv.  Reproductive toxicity study.  In the rat reproduction study,
parental toxicity occurred as decreased body weight at 5.0 mg/kg/day
with a NOAEL of 3.0 mg/kg/day.  There were no developmental (pup) or
reproductive effects up to 5.0 mg/kg/day (highest dose tested).  

	v. Conclusion.  Based on the absence of fetal effects and pup toxicity
in any of the referenced studies, FMC concludes that reliable data
support use of the standard 100-fold uncertainty factor, and that an
additional uncertainty factor is not needed to protect the safety of
infants and children.  As previously stated, aggregate exposure
assessments utilized no more than 45.5% of the aPAD or cPAD for either
the entire U.S. Population or any of the population subgroups including
infants and children.  Therefore, it may be concluded that there is
reasonable certainty that no harm will result to infants and children
from aggregate exposure to bifenthrin residues.

F. International Tolerances

	There are no Codex, Canadian, or Mexican residue limits for the residue
of bifenthrin in or on bushberry; juneberry; lingonberry; salal; aronia
berry; blueberry, lowbush;  buffalo currant; chilean guava; european
barberry; highbush cranberry; honeysuckle; jostaberry; native currant;
sea buckthorn; and leafy petiole subcrop 4-B.

