  SEQ CHAPTER \h \r 1 FILE NAME:   Pytech.wpt   (9/08/06)

	

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Commodity Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

	

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(9/1/2002)

EPA Registration Division contact: [Marion Johnson (7505C),
703-305-6788]	

		

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Summary of Petitions

	EPA has received a request from [Pytech Chemicals GmbH], [9330
Zionsville Road, Indianapolis, IN 46268] 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 180.438, section 3 by adding
gamma-cyhalothrin to lambda-cyhalothrin. The residue definition under
section 3 should read as follows:

(3) A food additive tolerance of 0.01 part per million is established
for residue of the insecticide lambda-cyhalothrin
((S)-alpha-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoro
prop-1-enyl)-2,1-dimethylcyclopropanecarboxylate and
(R)-alpha-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluorop
rop-1-enyl)-2,2-dimethyl-cyclopropanecarboxylate), or the isolated
active isomer gamma-cyhalothrin
((S)--cyano-3-phenoxybenzyl(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoripro
penyl)-2,2-dimethyl cyclopropanecarboxylate).  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. Residue Chemistry                                       

. [Gamma-cyhalothrin relies on the metabolism data conducted on
lambda-cyhalothrin, which has been thoroughly tested and is adequately
understood.]

. [An adequate analytical method is available for enforcement purposes.]

. [Gamma-cyhalothrin, the isolated active isomer, will be applied at
half the application rates of lambda-cyhalothrin.  Comparison studies of
gamma-cyhalothrin versus lambda-cyhalothrin used on the representative
crops of tomatoes, sweet corn, broccoli and cottonseed prove that the
established tolerances for lambda-cyhalothrin will be sufficient to
cover the potential residues of gamma-cyhalothrin.]

B. Toxicological Profile

.  [The acute oral LD50 was >50 mg/kg bw in male rats and 55 mg/kg bw in
female rats, acute dermal LD50 was >1500 mg/kg bw in male rats and 1643
mg/kg bw in female rats and the 4 hr-LC50 for male rats was 40.2 mg/m3
and, for female rats, 28.2 mg/m3.]

.  [The following genotoxicity tests were all negative: 

Salmonella- E.coli Reverse Mutation Assay, Mouse Bone Marrow
Micronucleus Test, in vitro chromosomal aberration in rat lymphocytes
and mouse lymphoma forward mutation assay.]

.  [A developmental toxicity study in rats given gavage doses of 0, 0.1,
0.5, and 2 mg/kg/day with no developmental toxicity observed under the
conditions of the study. The developmental NOAEL is greater than 2
mg/kg/day, the highest dose tested. The maternal NOAEL and LOAEL are
established at 0.5 and 2 mg/kg/day, respectively, based on reduced body
weight, body weight gain and feed consumption.]

[A 90-day feeding study in rats fed doses of 

0, 2.5, 10, 50 and 100 ppm with a NOAEL of 50 ppm and a LOAEL of 100 ppm
based on mortality, decreased feed consumption, decreased body weights
and increases relative liver and kidney weight at 100 ppm.]

. [Gamma-cyhalothrin, and lambda-cyhalothrin are contained within the
chemical cyhalothrin.  Cyhalothrin consists of four isomers,
lambda-cyhalothrin consists of two of these isomers and
gamma-cyhalothrin is the single active isomer contained in both.  The
chronic studies were conducted on cyhalothrin.]

. [NA-Remove.]

. [The Agency has previously determined that 

the metabolites of lambda-cyhalothrin are not of toxicological concern 

and need not be included in the tolerance expression. Given this 

determination, it is concluded that there is no need to discuss 

metabolite toxicity.]

.  [No studies have been conducted to investigate the potential of
gamma-cyhalothrin to induce estrogenic or other endocrine effects. 
However, no evidence of such effects has been noted in the battery of
toxicity studies which have been conducted on
cyhalothrin/lambda-cyhalothrin, and there is no reason to suspect that
any such effects would be likely.]

C. Aggregate Exposure

The Agency has conducted an extensive assessment of the aggregate
exposure for lambda-cyhalothrin.  Results are reported in the Federal
Register: September 27, 2002 (Volume 67, Number 188, page 60902-60915). 
In the Federal Register: April 8, 2004 (Volume 69, No. 68, page 18480)
the Agency has also concluded that lambda-cyhalothrin’s risk
assessment is sufficient to cover gamma-cyhalothrin.

. [NA-Remove]

.  [NA-Remove]

. [NA-Remove]

. [NA-Remove]

D. Cumulative Effects

	[For purposes of this request, it has been assumed that cyhalothrin
(i.e. gamma-cyhalothrin and lambda-cyhalothrin) does not have a common
mechanism of toxicity with other substances. ]

E. Safety Determination

[The Agency has conducted an extensive assessment of the aggregate
exposure.  Results are reported in the Federal Register: September 27,
2002 (Volume 67, Number 188, page 60902-60915).]

. [NA-Remove]

. [NA-Remove]

F. International Tolerances

	[There are Codex maximum residue levels (MRL) established or pending 

for residues of cyhalothrin, as the sum of all isomers, in or on the 

following crops and commodities.

------------------------------------------------------------------------

                   Crop                              MRL (mg/kg)

------------------------------------------------------------------------

Apricots............................................  0.2

Cabbage, head.................................  0.2

Cherries............................................  0.2

Cotton seed......................................  0.02

Cotton seed, oil................................  0.02

Oil seed (including rapeseed oil)....  0.02

Peaches.............................................  0.2

Plums................................................ 0.1

Pome fruit........................................  0.1

Potatoes...........................................  0.02

Tree nuts (shelled and unshelled)..  0.05

------------------------------------------------------------------------

    Canadian MRLs of 0.1 ppm for pome fruit, stone fruit and canola are 

established in Canada for lambda-cyhalothrin based on the ``negligible''


residue clause of Canadian Food & Drug Act Regulations (B.15.002(1)).]

	DOW AGROSCIENCES CONFIDENTIAL - Do not share without permission

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