FILE NAME:   company.wpt   (7/1/2005) (xml)

Template Number P25	

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

(1/1/2005)

EPA Registration Division contact: [George LaRocca, (703) 305-6100]	

TEMPLATE:

 

by establishing a national tolerance for residues of

[Cyfluthrin; Cyano
(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cy
clopropanecarboxylate] in or on the raw agricultural commodity [grass,
forage] at [15] parts per million (ppm) and [grass, hay] at [40] parts
per million (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 supports granting of the
petition.  Additional data may be needed before EPA rules on the
petition.

                                      



. [A total of 12 field trials were conducted, using three different
types of grass, to measure the magnitude of cyfluthrin
(cyano(4-fluoro-3-phenoxyphenyl)methyl
3-(2,2-dichloroethenyl)-2,2-dimethylcyclo-propanecarboxylate) residues
in/on pasture, rangeland, and seed grass following post-emergent 
application of  BAYTHROID 2 EC.  BAYTHROID 2 EC is an emulsifiable
concentrate formulation containing 2 lbs cyfluthrin per gallon of
formulated product. In all trials, BAYTHROID 2 EC was applied four times
as a foliar spray at a target rate of 0.044 lb ai/A/application (0.049
kg ai/ha/application) with a 5-day application interval between sprays
for a total of  0.176 lb ai/A.

In all of the field trials, duplicate composite samples of the seed
grass raw agricultural commodities (RACs) of forage and hay were
collected immediately following the final application (0-day pre-harvest
interval, PHI). Forage was harvested at a plant height of 6 in to boot
stage (BBCH 21 to 40). Hay was harvested at boot stage to early heading
(BBCH 40 to 51). Additionally, in two of the trials, duplicate samples
of both forage and hay were collected at PHIs of 7-, 14-, and 21-days to
determine the decline of cyfluthrin residue with time. A single
composite sample of each RAC was collected from the control  plot of
each trial.  The residue of cyfluthrin was quantitated in seed grass
RACs by extraction and analysis by capillary gas chromatography with
negative-ion chemical ionization mass spectrometry using a deuterated
internal standard. The limit of quantitation (LOQ) for cyfluthrin
residue was 0.05 ppm for both forage and hay.

[In a 28-day oral gavage study in rats, cyfluthrin demonstrated a NOAEL
of 20 mg/kg bw/day, based on clinical signs of neurotoxicity, decreased
body weight gain and changes in liver and adrenal weights at 80 and 40
mg/kg bw/day, respectively. In a 90-day feeding study in rats the
resulting NOAEL was 9.5 mg/kg bw/day, based on decreased body weight
gain, gait abnormalities, skin lesions and mortality seen at 37.5 mg/kg
bw/day.   A six-month toxicity feeding study in dogs established a NOAEL
of 5 mg/kg bw/day.  The LOAEL was 15 mg/kg bw/day based on clinical
signs of neurotoxicity and gastrointestinal disturbances.

5. Neurotoxicity. [An acute neurotoxicity study in rats was conducted
using beta-cyfluthrin.  The NOAEL for this study is 2 mg/kg, based on
clinical signs, changes in FOB parameters and decreases in motor
activity noted at 10 mg/kg.  In a subchronic neurotoxicity study with
beta-cyfluthrin the resulting NOAEL was 8 mg/kg, based on clinical
signs, changes in FOB parameters, and slightly decreased body weight
gain and food consumption.  In a Developmental neurotoxicity study with
beta-cyfluthrin the resulting maternal and offspring NOAEL was 11.0
mg/kg body weight/day based on decreased body weight and a change in
startle response in post-natal  day (PND) 22 male pups.  The database
for cyfluthrin is complete and there is no indication of pre- or
post-natal susceptibility.  There is no indication of delayed
neurotoxicity as a result of exposure to cyfluthrin.]

 

 

	

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