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Sodium Carbonate Peroxyhydrate
NYS DEC Letter - Registration of One New Pesticide Product, TerraCyte (EPA Reg. No. 70299-3), which Contains the New Active Ingredient Sodium Carbonate Peroxyhydrate 9/03

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

September 26, 2003

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Ms. Oleta A. Melnicoe
Agent for BioSafe Systems
c/o Technology Sciences Group, Inc.
Sacramento: State Affairs Division
712 Fifth Street, Suite A
Davis, California 95616

Dear Ms. Melnicoe:

Re: Registration of One New Pesticide Product, TerraCyte (EPA Reg. No. 70299-3), Which Contains the New Active Ingredient Sodium Carbonate Peroxyhydrate

    The New York State Department of Environmental Conservation (Department) has reviewed your application, received March 4, 2003, to register one new pesticide product, TerraCyte (EPA Reg. No. 70299-3), in New York State. The product contains the new active ingredient sodium carbonate peroxyhydrate (chemical code 128860).

    The application was deemed complete for purposes of review on May 1, 2003 and a registration decision is due by September 26, 2003.

    TerraCyte (EPA Reg. No. 70299-3) is a granular algaecide/fungicide labeled to treat, control and prevent algae, bacteria, fungi and moss on ornamental plants and turf. Organisms controlled include algae, moss, liver worts, slime molds and their spores.

    TerraCyte is labeled for use on well-established golf course fairways, greens and tees at a rate of 8 pounds per 1000 square feet (118.5 lbs. a.i. per acre) with subsequent applications of 2 to 4 pounds per 1000 square feet (29.62 to 59.25 lbs. a.i. per acre). The label states to repeat applications as needed and that TerraCyte can be applied on consecutive days.

    TerraCyte is labeled for use in greenhouses, storage areas and nursery yards on walkways, under benches, on gravel and dirt floors, weed control mats and hard surfaces at a rate of 4 pounds per 1000 square feet (59.25 lbs. a.i. per acre). Subsequent preventative treatments can be made every 5 to 7 days at a rate of 2 to 4 pounds of TerraCyte per 1000 feet (29.62 to 59.25 lbs. a.i. per acre).

    The Department has reviewed the information supplied to date in support of registration of the new product TerraCyte (EPA Reg. No. 70299-3).

HEALTH EFFECTS:

    The New York State Department of Health (DOH) stated that because TerraCyte is classified by the United States Environmental Protection Agency (USEPA) as a biochemical pesticide for non-food uses, only acute toxicity studies were required for federal registration of this product. These studies were only conducted on the active ingredient, not the formulated product. Sodium carbonate peroxyhydrate was not very toxic in acute oral or dermal toxicity studies in laboratory animals. The active ingredient was a slight dermal irritant (tested on rabbits), but was not a dermal sensitizer (tested on guinea pigs). However, sodium carbonate peroxyhydrate caused severe irreversible eye damage (tested on rabbits).

    Sodium carbonate peroxyhydrate is very unstable in the presence of water and rapidly breaks down into hydrogen peroxide and sodium carbonate, with hydrogen peroxide being the pesticidally-active component. The toxicity of hydrogen peroxide was previously reviewed for registration in another pesticide product and it is noted that this chemical can cause severe eye and skin irritation at high concentrations. However, the formulated product is applied as a dry granular material and conversion of sodium carbonate peroxyhydrate to hydrogen peroxide is only expected to occur upon contacting moisture at the sites of treatment. Hydrogen peroxide itself is also unstable in the environment and rapidly breaks down to water and oxygen.

    There are no chemical specific federal or State drinking water/groundwater standards for sodium carbonate peroxyhydrate or hydrogen peroxide. Because they are not organic compounds, the general New York State drinking water standards for principal and unspecified organic contaminants do not apply to sodium carbonate peroxyhydrate or hydrogen peroxide. The available information on sodium carbonate peroxyhydrate indicates that it was not very acutely toxic in laboratory animal studies, but can cause severe eye damage. The Terr aCyte label, however, requires the use of personal protective equipment, including protective eyewear (goggles or face shield), long pants, long-sleeved shirt and chemical-resistant footwear and gloves, which should reduce the potential for direct contact of workers with the active ingredient. Given the rapid breakdown of the active ingredient, post-application exposure of the general public is also expected to be minimal.

ECOLOGICAL EFFECTS:

    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) reviewed the information submitted in support of registration of TerraCyte and stated that sodium carbonate peroxyhydrate is slightly toxic to mammals on an acute basis. Because of its corrosive nature hydrogen peroxide is considered toxic to birds.

    No adverse effects to fish or wildlife resources are anticipated from labeled use of TerraCyte. The requirement to "water in" the product immediately following application will minimize or eliminate bird or mammal exposures. Although TerraCyte application rates are high and there is the potential for hydrogen peroxide aquatic toxicity to occur, the rapid active ingredient dissipation makes it unlikely. The TerraCyte label includes warnings that, if heeded, will be sufficiently protective of non-target organisms.

ENVIRONMENTAL FATE AND GROUNDWATER IMPACTS:

    The Department's groundwater staff that in the presence of water, the compound breaks down into hydrogen peroxide and sodium carbonate. The hydrogen peroxide oxidizes and thus kills the target pests. After contact, the hydrogen peroxide breaks down harmlessly into water and oxygen.

    The Environmental Assessment Branch of the USEPA does not perform an environmental exposure assessment on biopesticides unless the Toxicology Branch has a problem with the information presented by the registrant. Therefore, environmental fate data was not required.

    The Department concludes that TerraCyte 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 restricted use registration the new product TerraCyte (EPA Reg. No. 70299-3).

    The pesticide product is classified as "restricted use" in New York State according to rules and regulations 6NYCRR 326.23(e). Please note the "YES" under the "restriction" column on the enclosed Certificate of Pesticide Registration and the "classified for restricted use in New York State" stamp on the enclosed product label.

    As such this product is restricted in its purchase, distribution, sale, use, and possession in New York State. Furthermore, this product may only be purchased and used by a certified applicator in New York State.

According to New York State Department of Environmental Conservation Regulations 6NYCRR 326.3(a): "It shall be unlawful for any person to distribute, sell, offer for sale, purchase for the purpose of resale, or possess for the purpose of resale, any restricted pesticide unless said person shall have applied for, and been issued a commercial permit."

    Should you require information to obtain a commercial permit, please contact the Pesticide Certification Section at (518) 402-8748.

    The Pesticide Reporting Law (PRL) in the Environmental Conservation Law Article 33 Title 12 requires all certified commercial pesticide applicators to report information annually to the Department regarding each pesticide application they make. Commercial pesticide retailers are required to report all sales of restricted pesticide products and sales of general use pesticide products to private applicators for use in agricultural crop protection. If no sales are made within New York State, a report still must be filed with the Department indicating this is the case.

    If you need information relating to the Pesticide Reporting Law, or annual report forms, please visit the Department's website or contact the Pesticide Reporting Section at (518) 402-8765.     Enclosed are your New York State stamped "ACCEPTED" label and a copy of the Certificate of Registration.

    BioSafe Systems and Technology Sciences Group, Inc., agent for BioSafe Systems, are reminded that if New York State registration is requested for this product or for any other product which contains sodium carbonate peroxyhydrate with an increased application rate and/or expanded use sites, the product will be considered a Major Change in Labeling and the Department will require an extensive review.

    If you have any questions, please contact Mr. 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