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Capsaicin NYS DEC Letter - Registration of Havahart® Critter Ridder® 11/04

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

Bureau of Pesticides Management, 11th Floor
625 Broadway, Albany, New York 12233-7254
Phone 518-402-8788 FAX 518-402-9024
Website: http://www.dec.state.ny.us/website/dshm
E-Mail: ppr@gw.dec.state.ny.us

November 4, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Christina M. Swick
Woodstream Corporation
c/o Lewis & Harrison, LLC
122 C Street, N.W., Suite 740
Washington, DC 20001

Dear Ms. Swick:

Re: Registration of New Active Ingredients Oil of Black Pepper and Piperine Contained in the Pesticide Product Havahart® Critter Ridder® (EPA Reg. No. 50932-10)

    The New York State Department of Environmental Conservation (Department) has completed a review of the application and data package (received April 20, 2004) submitted by Lewis & Harrison, LLC, acting as agent for Woodstream Corporation, in support of the referenced application.

    Havahart® Critter Ridder® (EPA Reg. No. 50932-10) contains 0.480% oil of black pepper, 0.185% piperine, and 0.032% capsaicin and related capsaicinoids. Product is a granular formulation labeled for indoor (nonliving areas only) and outdoor use to repel dogs, cats, ground hogs, squirrels, skunks and racoons from treated areas for up to 30 days.

    Oil of black pepper (Chemical Code 000669) and piperine (Chemical Code 043501) are new active ingredients in New York State. Capsaicin is a component of a number of currently-registered animal repellent products.

    The registration package was deemed complete for purposes of technical review on June 10, 2004. Pursuant to the review time frame specified in Environmental Conservation Law (ECL) §33-0704.2, a registration decision date of November 8, 2004 was established.

    Toxicological, ecotoxicity and environmental fate risk assessments were conducted for oil of black pepper, piperine and the Havahart® Critter Ridder® end-use product.

TOXICOLOGICAL RISK ASSESSMENT: The two new active ingredients, oil of black pepper and piperine occur naturally in the black pepper plant Piper nigrum L. and are considered by the United States Environmental Protection Agency (USEPA) to be biochemical pesticides. The USEPA required acute toxicity testing for the formulated product, but not for the active ingredients to support federal registration. On an acute basis, the Havahart® product was not very toxic to laboratory animals by the oral, dermal or inhalation routes of exposure. It also was neither very irritating to the skin or eyes (tested on rabbits) nor did it cause dermal sensitization (tested on guinea pigs).

    The USEPA, in addition to waiving acute toxicity studies on the active ingredients, oil of black pepper and piperine, also waived all subchronic, chronic, developmental/reproductive toxicity, genotoxicity, oncogenicity and immunotoxicity studies. The study waivers were based on: 1) the low concentration of the active ingredients in the formulated product; 2) the low acute toxicity of the formulated product; 3) human exposure is expected to be minimal due to the use pattern and application methods of the formulated product; and 4) oil of black pepper and piperine are considered "generally recognized as safe" by the United States Food and Drug Administration (USFDA) and are used as direct food additives. Oil of black pepper has been reported at concentrations in foods ranging from 0.1 parts per million (ppm) in ice cream to 40 ppm in meats, whereas piperine has been reported at concentrations from 0.4 to 6 ppm in candy and up to 640 ppm in baked goods.

    A search of the toxicological literature found very limited information on the toxicity of piperine and oil of black pepper. The little information that was found indicated That piperine appears not to be genotoxic, but that it caused reproductive effects (e.g., decreased mating and implantations) in mice and rats repeatedly given oral doses of 10 milligrams/kilogram body weight/day or more.

    There are no chemical specific federal or State drinking water/groundwater standards for piperine or oil of black pepper. Based on its chemical structure, piperine falls under the 50 microgram per liter (ug/L) New York State drinking water standard for "unspecified organiccontaminants" (10 NYCRR Part 5, Public Water Systems). Because oil of black pepper is composed of numerous compounds, the applicable New York State drinking water standard would be 100 ug/L for all "principal" and "unspecified organic contaminants" combined.

    The Havahart® Critter Ridder® product was not very acutely toxic. The active ingredients oil of black pepper and piperine both occur naturally in foods and are used as direct food additives, and are considered to be "generally recognized as safe" by the USFDA. Risks to users of the Havaharto product should be minimal given the granular formulation of the product and the label requirement that handlers wear gloves. Moreover, the product is labeled for use outdoors and for nonliving areas only indoors, so post-application exposures should also be minimal.

ECOTOXICITY RISK ASSESSMENT: Havahart Critter Bidder® is a ready-to-use granular formulation used to repel skunks, groundhogs, dogs, cats, squirrels, and raccoons. Product is labeled for use in indoor nonliving areas like attics, basements, cellars, barns, etc. Outdoors it may be used as a perimeter barrier to protect areas such as lawns, flowerbeds, and garden paths or as a spot treatment to protect individual trees or shrubs and items like garbage bags. Product should not be applied to shrubs or soft-bodied ornamentals and may not be used on food or feed crops. Applications may be repeated at 30-day intervals.

    The new active ingredients, oil of black pepper and piperine, are both obtained from the fruit of the black pepper plant Piper nigrum. Both are classified by the federal Food And Drug Administration as Generally Recognized as Safe (GRAS) compounds and are approved as direct additives in human food. Havahart® Critter Bidder® is practically nontoxic to birds and mammals on an acute basis. All subchronic and other longer term avian and mammalian testing was waived for federal registration as were all ecotoxicicty and environmental fate requirements. The active ingredients are all non-soluble in water and are volatile and will dissipate into the atmosphere over time.

    The low active ingredient content, nontoxic mode of action, and 30-day treatment intervals make adverse impacts to fish or wildlife resources unlikely from use of Havaharto Critter Bidder' as labeled.

ENVIRONMENTAL FATE RISK ASSESSMENT: Havahart® Critter Bidder® contains 0.48% oil of black pepper, 0.185% piperine, and 0.032% capsaicin for use in repelling skunks, groundhogs, dogs, cats, squirrels and raccoons outdoors, and in indoor nonliving areas. The product is a granular formulation and the maximum application rate is 1 pound per 40 square feet. The inerts do not appear to be solvent carriers.

    The need for environmental fate and groundwater data (Tier II, (40 CFR Section 158.690(d)(2)(vii through xv)) was not triggered because of the practically nontoxic results indicated in the Tier I studies. Since environmental fate data were waived, there is no impact to the groundwater to be assessed.

REGISTRATION ACTION: The Department hereby accepts Havahart® Critter Bidder' (EPA Reg. No. 50932-10) for registration in New York State. Enclosed for your files are the Certificate of Pesticide Registration and New York State stamped "ACCEPTED" label.

    Please note that a proposal by Woodstream Corporation, or any other applicant, to register a product containing oil of black pepper or piperine, whose labeled uses are likely to increase the potential for significant exposure to humans or impact to 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 specified in 6 NYCRR Part 326.17.

    Please contact Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768 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
W. Smith, Cornell University, PSUR