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CpGV - Registration of Carpovirusine 12/03

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials

Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024
Website: www.dec.state.ny.us

December 16, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Robin Todd
Technical Consultant
Sumitomo Corporation of America
c/o Insect Control and Research, Inc.
1330 Dillon Heights Avenue
Baltimore, Maryland 21228

Dear Mr. Todd:

Re: Registration of One New Pesticide Product, Carpovirusine (EPA Reg. No.49911-3), Which Contains the New Active Ingredient Codling Moth Granulosis Virus (CpGV).

    The New York State Department of Environmental Conservation (Department) has reviewed the application, received January 27, 2003, from Sumitomo Corporation of America, to register the above-mentioned product in New York State. The product contains the new active ingredient codling moth granulosis virus (CpGV). The application was deemed complete for purposes of review on June 23, 2003 and a registration decision was due by November 20, 2003. On November 19, 2003, a request for a waiver of the registration decision date was received from Sumitomo and an extension of 30 days was granted by the Department. The registration decision date for Carpovirusine was then extended to December 22, 2003 to allow time to resolve the wording in the Storage and Disposal Statement.

    Carpovirusine is a microbial end-use product containing the naturally-occurring active ingredient, Codling Moth (or Cydia pomenella) Granulosis Virus (CpGV). To use Carpovirusine, dilute one liter in 1,000 liters of water with agitation (one quart in 250-264 gallons of water). Apply diluted Carpovirusine with a conventional sprayer at the beginning of egg hatch of the first generation. Repeat application every ten to 12 days as long as oviposition is evident. According to the label, 1,000 liters (264 gallons) of diluted product can treat 2.5 acres. Carpovirusine is labeled for use as a treatment against the codling moth in apple, pear and walnut orchards.

    The Department has reviewed the information submitted to date in support of the application for registration of Carpovirusine (EPA Reg. No. 49911-3).

    The New York State Department of Health stated that data from acute toxicity studies in laboratory animals indicate that neither CpGV nor the Carpovirusine product are very toxic via the oral, dermal or inhalation routes. While CpGV was not irritating to the eyes (tested on rabbits), Carpovirusine was a moderate eye irritant. Carpovirusine also caused slight dermal irritation (tested on rabbits) and is considered a potential dermal sensitizer (tested on guinea pigs). Acute pathogenicity/infectivity studies on CpGV were not required by the United States Environmental Protection Agency (USEPA).

    The USEPA waived the requirement for subchronic, chronic, developmental, reproductive toxicity, genotoxicity and oncogenicity studies for federal registration of Carpovirusine because the active ingredient, CpGV, is a naturally-occurring organism that is ubiquitous in the environment and has demonstrated low mammalian acute toxicity and a lack of mammalian pathogenicity. The USEPA also exempted CpGV from the requirement of a tolerance for residues of this active ingredient in or on all raw agricultural commodities. A search of the toxicological literature did not find any additional significant information on CpGV.

    The limited toxicity data required to support the federal registration of Carpovirusine indicate that this product is not very toxic following acute exposures. In addition, the active ingredient, CpGV, is a ubiquitous, naturally-occurring virus whose pathogenicity is reportedly specific to the codling moth. The USEPA determined that, "...there is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population including infants and children.:." from anticipated dietary exposures to CpGV. While Carpovirusine can cause eye and dermal irritation, as well as dermal sensitization, potential exposures to workers should be largely mitigated by the personal protective equipment required by the label (protective eyewear, long-sleeved shirt and long pants, and shoes plus socks). The use of gloves would further reduce potential exposures to Carpovirusine and according to a letter from USEPA (see correspondence from J. Andersen to E. Quinn, July 6, 1998), waterproof gloves were identified as a requirement for handlers of Carpovirusine. The final label for Carpovirusine which was submitted with the application, did not contain this requirement. Given this apparent discrepancy, the Department requested that the registrant either add this requirement to the product label or provide an explanation for why this was waived by USEPA, prior to the registration of Carpovirusine in New York State.

    On November 10, 2003, the revised labels, with the addition of waterproof gloves added to the personal protection equipment, were received by the Department. However, at the same time, other changes were made on the Storage and Disposal Statement which were not acceptable. After discussing the label with Leonard Cole of the USEPA, the Storage and Disposal Statement was changed to convey the correct storage temperatures. At the same time, a statement was added alerting users that the product should be stored in a refrigerator/freezer inaccessible to children.

    As of December 10, 2003, additional corrected labels for Carpovirusine were submitted by Sumitomo.

    Our Division of Fish, Wildlife & Marine Resources' Bureau of Habitat stated that they had completed an assessment of Carpovirusine insecticide and had no objection to its registration.

    Our environmental fate review staff stated that the USEPA has exempted this product from food tolerances and, therefore, need for environmental fate and groundwater data (Tier 11, (40CFR Section 158.690(d)(2)(vii through xv)) were not triggered because Tier I studies are waived on products that are exempt from food tolerances. Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed. Therefore, the environmental fate review staff have no objection from a groundwater perspective to the registration of this product as labeled.

    The Department concludes that Carpovirusine should not have an adverse effect on the health of workers or the general public, the fish and wildlife resources, or the ground and surface water of New York State when used as labeled.

    Therefore, the Department hereby accepts for general use registration inNew York State Carpovirusine (EPA Reg. No. 49911-3) which contains the new active ingredient Cydia pomonella Granulosis Virus (CpGV).

    Enclosed is your Certificate of Registration and New York State stamped "ACCEPTED" label.

    If you have any questions, please contact Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768.

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 University, PMEP