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Deltamethrin
Cancellation of Registration for DeltaGard G Insecticide Granules 11/97

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

50 Wolf Road, Albany, New York 12233-7250
PHONE 518-457-6934 FAX 518-457-0629

November 11, 1997

TRANSMITTED VIA FACSIMILE AND
CERTIFIED MAIL RETURN RECEIPT REQUESTED


Ms. Michelle K. Phoenix
Registration Specialist
AgrEvo Environmental Health
95 Chestnut Ridge Road
P.O. Box 30 Montvale, NJ 07645

Dear Ms. Phoenix:

RE: Cancellation of Registration for DeltaGard G Insecticide Granules (EPA Reg. No. 432-824) in New York State

    This letter is to advise you that the New York State Department of Environmental Conservation (Department) is canceling the registration of the above-referenced pesticide product in New York State, effective 30 calendar days from the date of service of this notification. This registration is being canceled due to a misclassification of the application type, resulting in the product being registered by the Department in error. Consequently, the material required to be submitted, at the time of application, did not comply with the provisions of New York State Environmental Conservation Law (ECL) Article 33 and the implementing standards.

    DeltaGard G Insecticide Granules (EPA Reg. No. 432-824) is labeled for outdoor use on the home lawn and around other residential buildings. It contains the active ingredient deltamethrin. The active ingredient deltamethrin was previously evaluated by this Department in the products RUC 161 Insecticide (EPA Reg. No. 432-763) and DeltaTech (EPA Reg. No. 432-762). RUC 161 Insecticide is labeled to control insect pests in and around residential, industrial and institutional structures and their immediate surroundings and on various modes of transportation. DeltaTech is labeled for formulation into insecticides for these uses. As a result of our technical review, we concluded that the use pattern for RUC 161 as an outside perimeter treatment did not pose a significant threat to human health and environmental resources in New York State. Both products were registered in New York State on August 5, 1996 (reference letter from N. Nosenchuck to J. Stern dated August 5, 1996, enclosed).

    The application to register a new routine product, DeltaGard G Insecticide Granules, was received on October 24, 1996. However, the application was improperly identified as an initial registration type (I.B.1) and as a result, the product was inadvertently accepted for registration on October 30, 1996. DeltaGard G Insecticide Granules expands the perimeter treatment use of deltamethrin to use on home lawns and should have been identified as a major change in labeling. The application for DeltaGard G Insecticide Granules was not identified by AgrEvo as a major change in use pattern and no supporting data was submitted with the application. Section II(A)(2) of the "New York State Pesticide Product Registration Procedures" handbook (August 1996 - copy enclosed) states that applications must be clearly identified by the applicant as to the registration type. Because the application was misidentified, the evaluation required for an application constituting a major change in labeling was not conducted.

    Pursuant to our letter dated August S, 1996, the Department informed AgrEvo that any additional uses for deltamethrin, at or above the maximum application rate for RUC 161, would have to be reviewed and supported by additional data. Based upon our initial evaluation, the Department was concerned about potential toxicity to fish, invertebrates and mammals from use of deltamethrin in outdoor settings beyond the approved perimeter treatments. Data was suggested which could be submitted to address the Department's concerns if AgrEvo intended to apply for expanded outdoor uses for deltamethrin.

    AgrEvo agreed to the destruction of the data package submitted to support the registration of RUC 161. In a letter dated August 26, 1996 (copy enclosed), the Department confirmed that the data had been destroyed, per AgrEvo's concurrence, because there was, and is ently, no capacity to store inactive data packages.

    The Department did not evaluate the use of deltamethrin on home lawns under the previously-submitted application for RUC 161 as it was not a proposed use in that application. It is our procedure to evaluate only the use(s) proposed on the product label submitted with an application. Any changes or additions to the general use pattem which is currently registered for the active ingredient must be reviewed separately pursuant to a separate application identifying the change as a major change in use pattern for the active ingredient in New York State.

    The use of deltamethrin on home lawns must be evaluated by this Department for potential risks to human health and environmental resources in New York State. Deltamethrin is potentially toxic, on an acute and chronic basis, to fish and invertebrate in both fresh and saltwater, and may be toxic to small mammals. RUC 161 was determined not to pose significant risks to fish and wildlife resources in New York State because of the limited outdoor use pattern for the product. The limited use pattern for RUC 161 was a mitigating factor in our decision of whether to register the product. However, use on home lawns increases the potential for fish, invertebrate, and mammals to be exposed to the active ingredient.

    Under Section II(C)(1) of our Procedures handbook, a major change in use pattern is defined as a change that is likely to increase the exposure of any nontarget organism or that increases the potential for significant impact to humans, property, or the environment. DeltaGard meets that criteria. The procedures for reviewing applications constituting a "new active ingredient" or a "major change in labeling" were discussed at our New York State Pesticide Product Registration Workshop on December 12, 1995. AgrEvo was invited to attend the December 12, 1995 workshop, responded to the Department that a representative from AgrEvo would attend, but did not attend. Our Pesticide Product Registration Section will continue to operate under the procedures established in the "New York State Pesticide Registration Procedures" handbook (August 1996).

    As previously noted, the cancellation of the registration in New York State for DeltaGard G Insecticide Granules is effective 30 calendar days from the date of service of this notification.

    Please be advised that AgrEvo may, in accordance with ECL§33-0713(3) and within this 30-day period, respond by making the necessary corrections, filing a petition requesting that the matter be referred to an advisory committee, or file objections with the Department and request a public hearing.

    If no response is received within the time frame noted above, the cancellation will be final and AgrEvo must take the necessary actions to remove the product from the channels of trade in New York State.

    After the effective date of cancellation, DeltaGard G Insecticide Granules may not . be used, distributed, sold or offered for sale in New York State. Products found to be offered for sale will be quarantined and AgrEvo will be subject to penalties. Additionally, please provide the Department within this 30-day period a detailed plan of action to remove the product from the channels of trade in New York State.

    If you intend to reapply for registration of DeltaGard G Insecticide Granules in New York State, you must submit a new application along with the information previously requested in our August 5, 1996 letter. The application must meet the requirements outlined in the New York State Pesticide Product Registration Procedures handbook.

    If you have any questions, please contact Maureen Serafini, Supervisor of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,
Norman H. Nosenchuck, P.E.
Director
Division of Solid & Hazardous Materials

Enclosures TF/NHN:had