New York State Department of Environmental Conservation

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1 New York State Department of Environmental Conservation Division of Solid & Hazardous Materials th Bureau of Pesticides Management, 11 Floor 625 Broadway, Albany, New York Phone: FAX: Website: Alexander B. Grannis Commissioner June 11, 2008 DELIVERY CONFIRMATION Mr. Jim Baxter State Regulatory Manager Dow AgroSciences, LLC 9330 Zionsville Road Indianapolis, Indiana Dear Mr. Baxter: Re: Registration of Gavel 75DF Agricultural Fungicide (EPA Reg. No ) for Use On Grapes. Contains the Active Ingredient Zoxamide. (Chemical code ) The New York State Department of Environmental Conservation (Department) has evaluated your application and data package submitted on 9/4/2007 and the additional information submitted on 11/29/07. The Department has completed a full technical review of the information and has registered the use of Gavel 75DF on grapes in New York State. This product contains the active ingredient zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl- 1-methyl-2-oxopropyl)-4-methylbenzamide) and is labeled for control of fungal diseases in grapes, potatoes, cucurbits and tomatoes. Gavel 75DF is currently registered for use on potatoes, cucurbits and tomatoes and additionally contains the currently registered active ingredient mancozeb. The additional proposed use of zoxamide on grapes was determined to represent a major change in labeled use pattern for this active ingredient in New York State. This active ingredient and product were previously reviewed by the Department and registered in New York State on September 12, However, per the September 12, 2003 registration letter, there was a concern for worker exposure to the active ingredient zoxamide as a dermal sensitizer and as a potential inhalation sensitizer. Dow Agrosciences, LLC had reported during the original review that a delayed contact hypersensitivity study in guinea pigs was completed and submitted to the United States Environmental Protection Agency (USEPA) in February The Gavel 75DF label requirements for PPE were appropriate to protect workers from over-exposure via dermal or inhalation routes. However, the addition of a major crop allowed the Department a second opportunity to review this issue. The Gavel 75DF label states that the product may be applied foliarly by ground or aerial application. The maximum single application rate of product on grapes is 2.0 to 2.5 lb./acre. The maximum annual rate East of the Rocky Mountains, is not more than 8 applications or more than 15 lb. (10 lb mancozeb and 1.25 lb zoxamide) per acre per season. The previous review of Gavel 75DF had a similar annual rate for tomatoes and cucurbits of 16 lb. (10.67 lb of mancozeb and 1.33 lb of zoxamide) and a lesser rate for potatoes. The USEPA approved the label amendment, which added application to grapes, on May 16, The Gavel MCL application submitted to New York State was declared complete for purposes of review per Department letter dated January 17, Pursuant to the review

2 Mr. James Baxter 2. time frame specified in ECL , a registration decision date of June 13, 2008 was established. The Department conducted the following technical review with regard to the registration of Gavel 75DF for use on grapes for impacts to human health in order to review any new data/information regarding dermal sensitization or inhalation sensitization. Review of impacts to nontarget organisms and environmental fate were deferred to the previous registration decision of 9/12/2003 as no new information was presented. The New York State Health Department (NYSDOH) review summary is provided below: Human Health Assessment: The NYSDOH reviewed the application and supporting data submitted by Dow AgroSciences, LLC to register the pesticide product Gavel 75DF Agricultural Fungicide (EPA Reg. No ) for use on grapes in New York State. This product contains the active ingredient zoxamide (3,5-dichloro-N- (3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4- methylbenzamide) and is labeled for control of fungal diseases in cucurbits, grapes, potatoes and tomatoes. Gavel 75DF is currently registered for use on cucurbits, potatoes and tomatoes. The additional proposed use of zoxamide on grapes has been determined to represent a major change in labeled use pattern for this active ingredient in New York State. Gavel 75DF also contains the active ingredient mancozeb which is currently registered for use on all four of the above-listed crops. We previously reviewed the toxicological properties of the active ingredient zoxamide and the formulated end product Gavel 75DF Agricultural Fungicide. Neither zoxamide nor the formulated product was very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals. Both the active ingredient and the formulated product were moderate eye irritants (tested on rabbits). Zoxamide was not a skin irritant, but the formulated product was slightly irritating (tested on rabbit skin). Both zoxamide and Gavel 75DF Agricultural Fungicide were strong dermal sensitizers (tested on guinea pigs). In our initial review letter we expressed concern for workers from the sensitizing potential of the active ingredient and formulated product. For this current review, we requested USEPA Data Evaluation Record (DER) reports or USEPA reviews of the delayed contact hypersensitivity studies in guinea pigs, and any information concerning occupational incidents of skin and pulmonary sensitization received by the registrant. In response, the registrant submitted two delayed contact hypersensitivity studies (the registrant submitted full studies rather than the DERs because they are currently under review by the USEPA). Our review of these studies confirms that Gavel 75DF is a dermal sensitizer. The registrant also stated that a review of their incident database indicates that no allergic skin reactions, asthma symptoms or rhinitis were reported for zoxamide-containing products. Zoxamide did not cause toxicity in rodents, even at the highest doses tested in subchronic and chronic feeding studies, but caused some liver and thyroid toxicity in dogs. Zoxamide did not cause developmental or reproductive toxicity or toxic effects in neurotoxicity studies. Furthermore, zoxamide did not cause oncogenic effects and was negative in a number of genotoxicity studies. The USEPA classified zoxamide as not likely to be a human carcinogen. The USEPA Office of Pesticide Programs established a reference dose of 0.48 milligrams per kilogram body weight per day (mg/kg/day) for zoxamide based on the no-observed-effect level (NOEL) of 48 mg/kg/day from the chronic dog feeding study and an uncertainty factor of 100. This same value was used as a chronic population adjusted dose (cpad) for evaluating dietary risks. This RfD value has not yet been adopted in USEPA s Integrated Risk Information System (IRIS).

3 Mr. James Baxter 3. The USEPA established tolerances for zoxamide at 3.0 parts per million (ppm) for grapes and 15.0 ppm for grape raisins. The USEPA estimated that chronic dietary exposure to these residues (including those from use of zoxamide on potatoes) would be 1.0% of the cpad of 0.48 mg/kg/day for children one to six years old, and less than 1.0% of the cpad for all other groups. This chronic exposure analysis is based on the assumption that 100% of crops are treated and contain tolerance level residues. Actual residues and resulting exposure levels are expected to be less than these estimates. The USEPA conducted an occupational risk assessment for inhalation exposures to zoxamide from use on grapes. The USEPA did not identify an appropriate toxicity endpoint for dermal exposure (no systemic effects were noted in the 28-day dermal study in rats), so this exposure pathway was not considered in the occupational risk assessment. For grapes, it was assumed that zoxamide was mixed, loaded and applied to 50 acres of crop per day by an airblast sprayer. For determining margins of exposure (MOEs), the USEPA compared short- and intermediate-term inhalation exposures to a NOEL of 48 mg/kg/day from the chronic dog feeding study. For mixer/loaders supporting grape applications, the MOE was 420,000 and for applicators, the MOE was 72,000. Generally, the USEPA considers MOEs of 100-fold or greater to provide adequate worker protection. Post-application exposures were not evaluated because dermal endpoints were not identified by the USEPA for this potential exposure pathway. There are no chemical specific federal or State drinking water/groundwater standards for zoxamide. Based on its chemical structure, zoxamide falls under the 50 microgram per liter New York State drinking water standard for unspecified organic contaminants (10 NYCRR Part 5, Public Water Systems). The available information on zoxamide and Gavel 75DF Agricultural Fungicide indicates that they are not very acutely toxic in laboratory animal studies, but were dermal sensitizers. Additionally, the active ingredient was not neurotoxic, oncogenic or genotoxic, and did not cause reproductive or developmental effects. Zoxamide did not cause effects in rodents, even at the highest doses tested in subchronic and chronic feeding studies, but caused some liver and thyroid toxicity in dogs. Risks to the general public from Gavel 75DF Agricultural Fungicide use are expected to be low as there are no labeled residential uses and estimated dietary exposure to zoxamide from treated food commodities is minimal. While zoxamide has the potential to cause dermal sensitization from worker exposure, this potential is mitigated by the label requirements for personal protective equipment (long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks, and a chemical-resistant apron when cleaning equipment, mixing or loading) and label statements warning of this concern. Overall, the risks to the general public and workers from the addition of grapes to the Gavel 75DF Agricultural Fungicide label are expected to be minimal. REGISTRATION SUMMARY: The Department has completed its review of your major change in labeling application to register Gavel 75DF (EPA Reg. No ) for application to grapes in New York State. Enclosed for your record is a copy of the stamped accepted supplemental label for use on grapes. The Department reminds Dow AgroSciences, LLC of the requirement to submit incident reports (FIFRA 6a(2)) for all pesticide products that the Company has registered in New York State and as related to zoxamide containing products, especially those that relate to occupational incidents of skin and pulmonary sensitization. Please note that a proposal by Dow AgroSciences, LLC or any other registrant, to register a product that contains zoxamide, and whose labeled uses are likely to increase the potential for significant impact to humans, nontarget organisms, or the environment, would constitute a major change in labeled (MCL) use pattern. Such an application must be accompanied by a new

4 Mr. James Baxter 4. application fee and meet the requirements listed in Appendix 1.B. of New York State Pesticide Product Registration Procedures (September 2005). Such information as well as forms can be accessed at our website as listed in our letterhead. Please also note that Gavel 75DF (EPA Reg. No ) continues to be classified as a Restricted Use Pesticide under rules and regulations 6 NYCRR Part (e) due to concerns regarding potential sensitization from exposure to zoxamide products. The Gavel 75DF Agricultural Use Requirements Box (Cucurbits and Tomatoes) states: Notify workers that the area has been treated with a pesticide that is a dermal sensitizer by warning them orally and by posting warning signs at entrances to the treated areas. The signs must be posted in place for 4 days after the end of the application and must state that the area has been treated with a dermal sensitizer. In addition, the following text must appear on the signs: If an allergic skin reaction (rash, redness, swelling, itchiness) or asthma symptoms or rhinitis occurs following the use of this product, report the incident to Dow AgroSciences at This label warning along with Dow AgroSciences contact information is necessary to mitigate Department concerns for use of the product by New York State agricultural workers. According to Department regulations specified in 6 NYCRR 326.3(a): It shall be unlawful for any person to distribute, sell, offer for sale, purchase for the purpose of resale, or possess for the purpose of resale, any restricted pesticide unless said person shall have applied for, and been issued a commercial permit. If you require information regarding a commercial permit, please contact the Pesticide Reporting and Certification Section, at (518) The Pesticide Reporting Law (PRL) requires all certified commercial pesticide applicators to report information annually to the Department regarding each pesticide application they make. Commercial pesticide retailers are required to report all sales of restricted pesticide products and sales of general use pesticide products to private applicators for use in agricultural crop production. If no sales are made within New York State, a report still must be filed with the Department indicating this is the case. Information relating to the PRL or annual report forms is available at the Department s website at or from the Pesticide Reporting and Certification Section, at (518) Please be aware that any unregistered product may not be sold, offered for sale, distributed, or used in New York State. Please contact our Pesticide Product Registration Section, at (518) , if you have any questions. Enclosures ecc: w/enc. - A. Grey/E. Horn - NYS Dept. of Health R. Mungari - NYS Dept. of Ag. & Markets W. Smith - Cornell University, PSUR Sincerely, Maureen P Serafini Maureen P. Serafini Director Bureau of Pesticides Management

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