Number range CHAPTER**FILE NAME:** **Pytech.wpt (9/08/06)**

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

**COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE**

**(9/1/2002)**

**EPA Registration Division contact: \[[Marion Johnson (7505C),
703-305-6788]{.mark}\]**

***INSTRUCTIONS:*** Please utilize this outline in preparing tolerance
petition documents. In cases where the outline element does not apply
please insert "NA-Remove" and maintain the outline. The comment notes
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company name*\]," with the information specific to your action.

**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-trifluoroprop-1-enyl)-2,1-dimethylcyclopropanecarboxylate
and
(R)-alpha-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-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-trifluoripropenyl)-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*

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

2\. *Analytical method*. **\[An adequate analytical method is available
for enforcement purposes.\]**

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

*B. Toxicological Profile*

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

2\. *Genotoxicty*. **\[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.\]**

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

4\. *Subchronic toxicity*. **\[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.\]**

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

6\. *Animal metabolism*. **\[NA-Remove.\]**

7\. *Metabolite toxicology*. **\[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.\]**

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

*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.**

1\. *Dietary exposure*. **\[NA-Remove\]**

i\. *Food*. **\[NA-Remove\]**

ii\. *Drinking water*. **\[NA-Remove\]**

2\. *Non-dietary exposure*. **\[NA-Remove\]**

*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*

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

1\. *U.S. population*. **\[NA-Remove\]**

2\. *Infants and children*. **\[NA-Remove\]**

*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)).\]**