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Sodium Carbonate Peroxyhydrate
NYS DEC Letter: Registration of One New Pesticide Product, GreenClean Granular Algaecide (EPA Reg. No. 70299-4), which Represents a Major Change in Labeling for the Active Ingredient Sodium Carbonate Peroxyhydrate 9/04

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 9, 2004

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, GreenClean Granular Algaecide (EPA Reg. No. 70299-4), which Represents a Major Change in Labeling for the Active Ingredient Sodium Carbonate Peroxyhydrate

    The New York State Department of Environmental Conservation (Department) has reviewed your application, received October 20, 2003, and additional information, received November 17, 2003 and March 8, 2004, to register one new product GreenClean Granular Algaecide (EPA Reg. No. 70299-4) in New York State. The product represents a major change in labeling for the active ingredient sodium carbonate peroxyhydrate (chemical code 128860).

    The active ingredient is currently registered in New York State, as the product Terracyte, to control algae, bacteria, fungi and moss on ornamental plants and turf. GreenClean Granular Algaecide (EPA Reg. No. 70299-4) is labeled for application to numerous agricultural, horticultural and commercial sites including farms, greenhouses, amusement parks, sports facilities, boats and hotels, as well as to any water sites except treated, finished drinking water reservoirs or drinking water receptacles.

    The application was deemed complete for purposes of review on April 12, 2004 and a registration decision is due by September 9, 2004.

    The Department has reviewed the information supplied to date in support of registration of the new product GreenClean Granular Algaecide (EPA Reg. No. 70299-4).

    The New York State Department of Health (DOH) stated that the available information on sodium carbonate peroxyhydrate indicates that this chemical was not very acutely toxic in laboratory animal studies, but can cause severe eye damage from direct contact. Because the active ingredient in GreenClean Granular Algaecide is classified by the United States Environmental Protection Agency (USEPA) as a biochemical pesticide and this product is labeled for non-food uses, only acute toxicity studies were required for federal registration. 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. Hydrogen peroxide itself is also unstable in the environment and rapidly breaks down to water and oxygen. A current search of the toxicological literature did not find any significant new information on the toxicity of sodium carbonate peroxyhydrate.

    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 either of these chemicals.

    Because sodium carbonate peroxyhydrate can cause severe eye damage, the GreenClean Granular Algaecide label requires the use of protective eyewear (goggles or face shield). The label also requires the use of other personal protective equipment including chemical resistant gloves and foot wear, and coveralls over long-sleeved shirt and long pants, which should reduce the potential for direct contact by workers/handlers of this product. Given the rapid breakdown of the active ingredient and hydrogen peroxide, post-application exposure of the general public to these chemicals is also expected to be minimal. This includes those individuals who swim in water treated with the GreenClean product at the maximum label rate. Based on this application rate, the maximum potential concentration of hydrogen peroxide (the breakdown product of sodium carbonate peroxyhydrate in water) in GreenClean treated water is approximately 8.5 parts per million (ppm). According to the USEPA, studies from the open literature indicate that hydrogen peroxide concentrations as high as 0.5 percent (5,000 ppm) have no negative impact on human skin, eyes or respiratory system. The concentration of hydrogen peroxide in over-the-counter antiseptic solutions is 3 percent (30,000 ppm).

    Given the label requirements for personal protective equipment, and the fact that the product is labeled for direct application to water and would be classified as restricted use, the DOH does not object to the registration of GreenClean Granular Algaecide in New York State.

    The Department's Division of Fish, Wildlife & Marine Resources' Bureau of Habitat (BOH) 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. However, all eco-toxicology study requirements were waived and no avian toxicity information was located from sources other than the submitted data package.

    Substantial aquatic organism toxicity data for both sodium carbonate and hydrogen peroxide has been generated much of which, 67 and 123 records respectively, is available through the USEPA's ECOTOX online database. Sodium carbonate has very low toxicity to all organisms for which results are reported. Hydrogen peroxide was at most moderately toxic in the reported studies.

    Given the above, the BOH does not object to the registration of GreenClean Granular Algaecide in New York State.

    The Department's groundwater staff stated that the Environmental Assessment Branch of the USEPA does not perform an environmental exposure assessment on biopesticides unless the Toxicology Branch has concerns with the information presented by the registrant. In this case, no concerns were noted; therefore, no environmental fate data were required. Since environmental fate data were not necessary, there is no impact to the groundwater to be assessed.

    The Department concludes that GreenClean Granular Algaecide 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 GreenClean Granular Algaecide (EPA Reg. No. 70299-4).

    The pesticide product is classified as "restricted use" in New York State according to rules and regulations 6NYCRR 326.2(h). 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 Sate, 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.

    The Certificate of Pesticide Registration and a copy of the New York State stamped "ACCEPTED" labeling for GreenClean Granular Algaecide are enclosed for your records.

    BioSafe Systems and their agent, Technology Sciences Group, Inc., 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 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
W. Smith - Cornell University, PMEP