New York State Department of Environmental Conservation Division of Solid & Hazardous Materials Bureau of Pesticides Management Pesticide Product Registration Section 625 Broadway, Albany, New York 12233-7257 Phone: 518-402-8768 FAX: 518-402-9024 Website: http://www.dec.ny.gov/chemical/298.html E-Mail: ppr@gw.dec.state.ny.us Alexander B. Grannis Commissioner April 15, 2008 CERTIFIED MAIL (Co. No. 71965) RETURN RECEIPT REQUESTED Mr. Jim Messina Sci Protek, Inc. c/o Exponent 1730 Rhode Island Ave NW Washington, DC 20036 Dear Mr. Messina: Re: Registration of the New Active Ingredient Plant Extract (Chemical Code 169007) Contained in Nematec (EPA Reg. No. 59174-2-71965) The New York State Department of Environmental Conservation (Department) has completed review of your application and data package received on July 6, 2007 and supplemental information supplied to date regarding registration of the above-referenced pesticide product. The subject application and data package were deemed complete for purposes of technical review on December 12, 2007. Pursuant to the review time frame specified in Environmental Conservation Law (ECL) 33-0704.2, a registration decision date of May 9, 2008 was established. The active ingredient in Nematec, plant extract, is derived from Southern red oak (quercus falcata), fragrant sumac (rhus aromatica), mangrove (rhizophoria mangle), and prickly pear cactus (opuntia lindheimer). Nematec is labeled for the suppression of nematodes (thereby inhibiting secondary fungal infections) and is for use on golf course and other recreational turf, ornamental plants, and all food crops. Nematec contains a water-miscible liquid formulation. Application of Nematec is performed via ground (boom, fan jet, hand, backpack) and chemigation (drip and overhead) techniques. The maximum application on non-food sites is 0.05 pounds of active ingredient per acre per application and 0.28 pounds of active ingredient per acre per year. The maximum application on food crops is 0.029 pounds of active ingredient per acre per application and 0.052 pounds of active ingredient per acre per year. The active ingredient plant extract was classified as a biochemical pesticide by the Biopesticides & Pollution Prevention Division of the United States Environmental Protection Agency (U.S. EPA). As such, the basic registrant was exempted from the the requirement of
establishing tolerances for all crops treated with plant extract. In addition, the Environmental Assessment Branch of the U.S. EPA does not require environmental fate data on biochemical pesticides. Therefore, neither an environmental fate nor an ecological effects technical review were performed by the Department for the subject product. However, a human health technical review was conducted to evaluate the use of plant extract in New York State. HUMAN HEALTH EFFECTS: New York State Department of Health staff reviewed the information submitted in support of the new active ingredient application for Nematec. The following is the Department of Health staff s technical review: The U.S. EPA required limited toxicity testing on the active ingredient and formulated end product for federal registration. In acute exposure tests, plant extract was not very toxic via the oral and dermal routes, but was a moderate skin irritant (tested on rabbits). The Nematec product was not very acutely toxic via inhalation exposure, and was not a skin or eye irritant. The U.S. EPA waived the requirement for other acute toxicity studies as well as all subchronic, chronic, developmental, and oncogenicity studies for federal registration of Nematec. One genotoxicity study (the Ames test) was conducted on the formulated product, which yielded negative results. The U.S. EPA also did not require the registrant to submit any environmental fate or residue data, and exempted the requirement of a tolerance of residues of plant extract due to the lack of toxicity to mammals. Our search of the toxicological literature found no additional data on the toxicity of plant extract. The available data indicate that Nematec should not be very toxic or irritating following acute exposures. Little other toxicity data, including data from long-term studies, were available for review. Also, plant extract is derived from several plant species, and the exact chemical identity of this material and its mode of action are not known. However, given this product s diluted formulation (0.56 percent plant extract) and apparent low acute toxicity, identifiable risks to workers or the general public from Nematec are not expected. The personal protective equipment required by the label (long-sleeved shirt and long pants, waterproof gloves, shoes plus socks) should further mitigate worker risks from the use of the Nematec product. In view of the above, we do not object to the registration of Nematec in New York State. REGISTRATION SUMMARY Plant extract is an active ingredient derived from several plant species, namely the Southern red oak, fragrant sumac, mangrove, and prickly pear cactus. As such, it was classified as a biochemical pesticide by the U.S. EPA. In addition, a significant portion of the studies generally required by the U.S. EPA for registration of a new active ingredient were waived. As a result of the lack of available studies, neither an environmental fate nor an ecological effects technical review were performed by the Department. A human health review of the submitted information indicated no significant impact to human health is expected upon labeled use of Nematec. Therefore, the Department has registered Nematec (EPA Reg. No. 59174-2- 71965) for use in New York State. Enclosed for your record is a copy of the stamped Accepted For Registration label and the New York State Certificate of Pesticide Registration for Nematec. Please note that a proposal by Sci Protek, Inc. or any other registrant to register a product that contains plant extract, and whose labeled uses are likely to increase the potential for significant impact on humans, non-target organisms, or the environment, would constitute a major change in labeled use pattern. Such an application must be accompanied by a new 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 be aware that any unregistered product may not be sold, offered for sale, distributed, or used in New York State. If you have any questions regarding this matter, please contact our Pesticide Product Registration Section, at (518)-402-8768. Sincerely, Maureen P Serafini Maureen P. Serafini Director Bureau of Pesticides Management Enclosures ecc: w/enc. - R. Mungari, NYSA&M A. Gray/E. Horn, NYSDOH W. Smith, Cornell, PSUR