Document ID: EPA-HQ-OPP-2007-0471-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-01T04:00Z

SEQ CHAPTER \h \r 1 FILE NAME:   company.wpt   (8/14/2006) (xml)

	

ATTENTION: 

	All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

	All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff. 
Instructional text and prompts in green font should also be removed.

	

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(8/14/2006)

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

		

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
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TEMPLATE:

  by establishing tolerances 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:
pistachio at 0.05 parts per million (ppm); mayhaw at 1.4 ppm;
vegetables, fruiting, group 8 at 0.5 ppm; peanut at 0.05 ppm; soybean at
0.2ppm; vegetable, root, except sugar beet and garden beet, subgroup 1B
at 0.07 ppm; beet, garden, roots at 0.45 ppm; beet, garden, tops at 15
ppm; and radish, tops at 4.5 ppm. EPA has determined that the petitions
contain 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 petitions.  Additional data may be needed before
EPA rules on these petitions.

  

                                    

.  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).

. 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. 

.  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 0.003398 mg/kg/day (10.4% aPAD).  The
99.9th percentile of exposure for children 1 to 6 years old (most highly
exposed population subgroup) is estimated to be 0.005422 mg/kg/day
(16.5% aPAD).  The 99.9th percentile of exposure to all infants less
than 1 year old is estimated to be 0.001604 mg/kg/day (4.9% 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.

. 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.  

. 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). 

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