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oxypurinol Registration as New Active Ingredient 8/01

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.state.ny.us/website/dshm
E-Mail: ppr@gw.dec.state.ny.us


August 17, 2001

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Kieran J. Halpin
Technical/Regulatory Coordinator
Cleary Chemical Corporation
178 Ridge Road, Suite A
Dayton, NJ 08810

Dear Mr. Halpin:

Re: Registration of the Roach Terminal (EPA Reg. No. 1001-73) Containing the New Active Ingredients Oxypurinol and Xanthine

    The New York State Department of Environmental Conservation (The Department) has completed review of your application and supplemental information supplied to date regarding registration of the referenced pesticide product in New York State. Roach Terminal (EPA Reg. No. 1001-73) contains the new active ingredients oxypurinol and xanthine.
    The end-use product, Roach Terminal (EPA Reg. No. 1001-73), is a bait formulation containing 1% oxypurinol and 1% xanthine as its active ingredients. Product is labeled as a cockroach population control agent for indoor use in residential, warehousing and commercial establishments, including food service, food manufacturing and processing facilities, hospitals, nursing homes, health care facilities, schools, daycare centers, basements, laboratories, computer and electronic equipment facilities, pet shops, zoos, aircraft, buses, boats, and trains.

    The subject application (rec'd 05/04/00) was initially submitted as a routine new product application. Following a determination of administrative incompleteness on June 23, 2000, Cleary Chemical Corporation submitted a data package (rec'd 08/02/00) in support of the new active ingredient application. This data package was deemed incomplete on September 25, 2000. Upon receipt (09/28/00) of supplemental information, the subject application and data package were deemed complete for purposes of technical review on September 28, 2000 following. Pursuant to the review time frame specified in ECL §33-0704.2, a registration decision date of February 25, 2001 was established. By mutual agreement, the registration decision date was subsequently waived to allow Cleary Chemical Corporation to respond to issues raised in the toxicological risk assessment and ultimately to pursue Child-Resistant Effectiveness testing of the bait station.

    The Department conducted a toxicological risk assessment for the technical grade active ingredients, oxypurinol and xanthine, and the Roach Terminal end-use product.

TOXICOLOGICAL RISK ASSESSMENT:
    The active ingredients oxypurinol and xanthine have not been shown to have pesticidal activity when each is used alone. However, when combined into one product, oxypurinol and xanthine are reported to block production of uric acid reserves needed for proper growth and reproduction in cockroaches, thus reducing their populations. For this reason, the United States Environmental Protection Agency (USEPA) treated the 1:1 oxypurinol/xanthine combination as a single active ingredient for the purposes of study requirements.

    The USEPA required very few studies to support the federal registration of the 1:1 oxypurinol/xanthine combination as an active ingredient. The USEPA apparently waived all but acute mammalian toxicity and genotoxicity studies, based on the fact that xanthine is a naturally occurring metabolite of purine and is found in all living tissues and oxypurinol is the major metabolite of the human drug allopurinol which has been used in the treatment of gout, hematological disorders and as a cancer chemotherapy agent. Xanthine is also chemically related to caffeine, theophylline and theobromine which are present in certain foods, beverages and medications.

    The active ingredient was not very acutely toxic by the oral, dermal or inhalation routes of exposure, nor was it a dermal sensitizer (equivalent studies for the formulated end product were not submitted but the inert ingredients would not be expected to increase product toxicity). Both the active ingredient and formulated end product caused some mild skin and eye irritation. The 1:1 oxypurinol/xanthine combination was negative in limited genotoxicity testing.

    The 1:1 oxypurinol/xanthine combination was not very acutely toxic nor very irritating to eyes or skin. Xanthine is a naturally occurring metabolite found in all living tissues and oxypurinol is the major metabolite of the human drug allopurinol. According to the USEPA in its Biopesticide Registration Eligibility Document on oxypurinol and xanthine, allopurinol is used at a therapeutic dose which is about 2 and 17-fold greater than the level of oxypurinol that a child and an adult would be exposed to, respectively, from ingesting one Roach Terminal bait station.

    Nevertheless, the review identified concerns regarding the degree of tamper-resistance for this products' bait station. An examination of a sample bait station showed that it was very easy to open. If this bait station was representative of the products' packaging, it would be quite possible for a child to open and ingest the bait from as many stations as were available. Furthermore, the appearance of the bait station (bright colored plastic), and the bait itself (the shape and color of a Hershey'sŪ Kiss candy) poses an attractive nuisance for children. These concerns were heightened by the bait station not appearing to meet standards for child resistance.

DISCUSSION:
    Initial and subsequent reviews of data and materials submitted by Cleary Chemical Corporation focused on the degree of tamper-resistance for the products' bait station. In order to mitigate this concern, Cleary Chemical Corporation contracted and executed a Child-Resistant Effectiveness study as per the current Code of Federal Regulations (CFR) Title 16, Part 1700. A review of the data presented by Perritt Laboratories, Inc. in the report titled "Evaluation of the Roach Baiter F=1 for Child-Resistant Effectiveness for Cleary Chemical; July 25, 2001" satisfies any remaining concerns. When packaged in the bait station which was evaluated for Child-Resistant Effectiveness, the use of Roach Terminal, as labeled, should not cause unreasonable adverse effects to humans or the environment.

    The Department hereby accepts the pesticide product Roach Terminal (EPA Reg. No. 1001-73) for registration in New York State. The only acceptable product is that which is packaged in the bait station which was evaluated for Child-Resistant Effectiveness as per 16 CFR part 1700. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped-"ACCEPTED" labeling.

    Please note that a proposal by Cleary Chemical Corporation or any other registrant to register a product containing oxypurinol or xanthine, whose labeled uses are likely to increase the potential for significant impact to humans, property or the environment, would constitute a major change in labeled (MCL) 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" (August 1996).

    Please contact me at (518) 402-8788 if you have any questions.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management

Enclosures

cc: w/enc. - N. Kim/D. Luttinger, NYS Dept. of Health
R. Zimmerman/R. Mungari, NYS Dept. of Ag. & Markets
G. Good/W. Smith, Cornell PMEP