Fluoxastrobin. April 2003. Comment submitted in response to Bayer's petition to establish pesticide tolerances in and on raw agricultural commodities.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Fluoxastrobin. April 2003. Comment submitted in response to Bayer's petition to establish pesticide tolerances in and on raw agricultural commodities.

Comment submitted in response to Bayer's Pesticide petition to establish tolerances in and on raw agricultural products published in the Federal Register: April 23, 2003

To: opp-docket@epa.gov
From: Ellen Connett
Subject: OPP-2003-0129

April 25, 2003

Is this a first time use for Fluoxastrobin in the US?

Is Fluoxastrobin registered for use in the US? The following comment in this Notice implies that it is: "Non-dietary exposure. Residential (non-dietary) exposure is limited to post-application exposure of fluoxastrobin from professional applications to residential turf and golf courses." What does this comment refer to? Clarification of this statement is needed as this petition deals with tolerances for "raw agricultural commodities" and EPA's database provides no information of Fluoxastrobin as an approved active ingredient. If Fluoxastrobin is an approved active ingredient in the US, what are the names of the products used on residential turf and golf courses and how long have they been used? Also, are there any other approved uses of Fluoxastrobin as an active ingredient in the US?

A subchronic toxicity study cites a 14-week feeding study in dogs with a NOAEL of 3.0 mg/kg bwt/day. One of the effects noted was thyroid effects (decreased T3). There should have been a discussion or rationale given for this conflicting statement: ".. There is no evidence to suggest that fluoxastrobin has any primary endocrine disruptive potential."

A fuller discussion and description of the metabolites of Fluoxastrobin should have been presented. The Notice states: "The residue of concern is parent fluoxastrobin (sum of E and Z isomers)." According to the Compendium of Pesticide Common Names, Fluoxastrobin "was provisionally approved for the (EZ)-isomer [193740-76-0] in April 2002. The definition was changed to the (E)-isomer in January 2003 at the request of the sponsor." (Ref: http://www.alanwood.net/pesticides/fluoxastrobin.html ) Because of this change it is not clear from the information supplied in this Notice what isomer/metabolite are of concern.

I respectfully request that EPA OPP begin to incorporate the CAS Number(s) for every chemical, and its metabolite(s), in all future reports, especially those published in the Federal Register.

References were not given for the studies cited in this Notice; nor were they available in the Docket. Without this information, it is impossible to comment on the findings presented. Examples:

1. "Several genotoxicity tests were conducted"
2. Acute toxicity studies
3. An oral developmental toxicity study in rat
4. An oral developmental toxicity study in rabbits
5. A 2-generation study in rats
6. Subchronic toxicity feeding study with rats over 90 days
7. Subchronic feeding study in mice over 14 weeks
8. A 14-week feeding study in dogs
9. A 24-month chronic/oncogenicity feeding study in rats
10. Oncogenicity study in the mouse
11. 1-year feeding study with dogs
12. Metabolism and pharmacokinetic studies in the rats, lactating goats, and laying hens
13. Metabolite studies.

Why were references to these studies not made available in this Notice? And why were these studies not available in the Docket?

Ellen Connett
Director, Fluoride Action Network Pesticide Project
82 Judson Street
Canton NY 13617
Email: wastenot@northnet.org