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kaolin clay (Surround) Active Ingredient Registration 8/00

New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management, Room 498
Pesticide Product Registration Section

50 Wolf Road, Albany, New York 12233-7254
Phone: (518) 457-0300FAX: (518) 485-8836
Website: www.dec.state.ny.us/website/dshm/pesticid/pesticid.htm


August 22, 2000

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Dennis G. Sekutowski
Commercial Development Manager
Engelhard Corporation
P.O. Box 770
101 Wood Avenue
Iselin, NJ 08830-0770

Dear Mr. Sekutowski:

Re: Registration of the New Active Ingredient - Kaolin Contained in the Pesticide Product - Surround WP Crop Protectant (EPA Reg. No. 70060-14)

    The New York State Department of Environmental Conservation has completed its review of the application and supporting data received from Engelhard Corporation, on April 12, 2000, for the above mentioned pesticide product. Surround WP contains 95% of the active ingredient kaolin, which has never before been registered for use in New York State. Surround WP is labeled for use on a wide variety of crops including pome, stone and citrus fruits, berries, grapes, and row crop vegetables. Surround WP, according to the United States Environmental Protection Agency (USEPA) stamped "Accepted" label, forms a mineral-based particle film intended for protection of agricultural crops. When Surround WP is applied to plants, a dry white film results. This film will help reduce the damage to plants and crops caused by certain insects, mites, fungi, bacteria, and environmental stress such as solar effects. Surround WP may be used as the primary component in a pest management system that utilizes supplementary compatible pesticides.

    On June 12, 2000 the application was determined complete for purposes of review. Pursuant to the time frames specified in ECL§33-0704.2, a registration decision date of November 9, 2000 was established. The Department conducted toxicological, ecological effects and environmental fate risk assessments for kaolin (because Surround contains 95% kaolin the toxicological tests were accepted for the active ingredient and not required for the Surround formulation), for use as labeled.

TOXICOLOGICAL RISK ASSESSMENT:

    Kaolin is used for many different purposes including use as an indirect food additive for paper/paperboard, adhesives, toothpaste, polymeric coatings, rubber articles, cellophane, health products and toiletries, toothpastes, and antiperspirants. Kaolin can also be used directly in foods as an anticaking agent (up to 2.5%). Kaolin has GRAS (Generally Recognized as Safe) status under 21 CFR 186.1256. Kaolin is also used as an inert ingredient in many pesticide formulations.

    The USEPA required very few studies to support the federal registration of kaolin or products formulated with kaolin as an active ingredient. Based upon the history of wide kaolin use and the absence of any reported negative toxicological effects, the USEPA waived all but the acute mammalian toxicity studies. Since the formulated product is comprised of greater than 95% kaolin, the toxicological data on the active ingredient was used to support federal registration of the product. The active ingredient was not very acutely toxic by the oral, dermal or inhalation routes of exposure, but caused mild eye irritation. The USEPA also waived the residue chemistry studies and the requirement for a tolerance when kaolin is used for control of pests in plant crops. A search of the toxicological literature found no additional data on the toxicity of kaolin.

    Kaolin was not very acutely toxic nor very irritating to eyes or skin. Kaolin is used in numerous foods and food contact items as well as in cosmetics and toiletries, apparently without causing reported adverse effects. While inhalation of significant amounts of kaolin dust could act as a nuisance particulate and be somewhat irritating to workers, the Surround WP label requires that applicators and other handlers wear a dust/mist-filtering respirator (along with long-sleeved shirt, long pants, socks, and shoes.) The label also recommends that harvesters wear nuisance dust masks. Given the above, use of Surround WP Crop Protectant should not cause adverse health effects in New York State.

ECOLOGICAL RISK ASSESSMENT:

    The USEPA Biopesticides and Pollution Prevention Division (BPPD) granted Surround WP an unconditional registration on October 7, 1999. Mammalian acute toxicity test results reported in the BPPD Registration Eligibility Document (RED) confirm that kaolin is virtually non-toxic. All chronic mammalian testing was waived based on the acute test results. In the Ecological Exposure and Risk section the author states "test results indicate that the compound is practically nontoxic to birds and freshwater fish, and, at most, slightly toxic to aquatic invertebrates." The risk of avian or aquatic organisms toxicity occurring is minimal to nonexistent. Results from contact and feeding studies demonstrate that kaolin is nontoxic to honeybees. Therefore, when used as labeled Surround WP Crop Protectant is not likely to result in adverse effects to fish or wildlife resources.

ENVIRONMENTAL FATE RISK ASSESSMENT:

    Results from Tier 1 studies for kaolin submitted to the USEPA did not trigger the need for environmental fate and groundwater data to be generated. When used as labeled, Surround WP Crop Protectant should not adversely impact ground or surface water in New York State.

CONCLUSION:

    Surround WP Crop Protectant, when used as directed, should not cause any unreasonable risk to humans or the environment. Therefore, the Department accepts for registration Surround WP Crop Protectant (EPA Reg. No. 70060-14), for use as labeled, in New York State. Enclosed are the Certificate of Pesticide Registration and a New York State stamped 'Accepted' label for your records.

    If you have any questions, please contact Frank Hegener, Chief of our Pesticide Product Registration Section, at (518) 457-7446.

Sincerely,

Maureen P. Serafini
Director
Bureau of Pesticides Management
Enclosure

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

bcc: w/enc.- F. Hegener
S. Sanford
SPCS I, Reg. 1
PCS II's -Regions 2-7 & 9
D. Rollins, Reg. 8
B. Seeley
Product File
Chemical File
Active File

bcc: w/o enc.- M. Serafini
T. Lynch
J. Leach
T. Martin
L. Whitbeck
Daybook

BS:scy
(betty\surround.mps)