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ethylene NYSDEC Letter - Registration of Pesticide Containing New Active Ingredient 1/03

New York State Department of Environmental Conservation
Division of Solid and Hazardous Materials
Bureau of Pesticides Management, 9th Floor
625 Broadway, Albany, New York 12233-7254
Phone: (518) 402-8788     FAX: (518) 402-9024

January 7, 2003


Mr. Todd Craun
Vice President
Airgas Specialty Gases, Inc.
259 N. Radnor-Chester Road
Suite 100
Radnor, Pennsylvania 19087-5283

Dear Mr. Craun:

Re: Registration of the Pesticide Product Ethylene, Compressed (EPA Reg. No. 69180-1) Containing the New Active Ingredient Ethylene

    The New York State Department of Environmental Conservation (Department) has evaluated the application and data package, received on July 26, 2002, in support of the above-referenced application. Ethylene, Compressed (USEPA Reg. No. 69180-1) contains the new active ingredient Ethylene. This application was declared complete by the Department on September 9, 2002.

    Ethylene Compressed is labeled as a plant growth regulator for use in ripening and degreening fruits and vegetables. Ethylene is designated by the United States Environmental Protection Agency (USEPA) as a biorational pesticide because it is naturally occurring. It is exempt from tolerance when used as a plant growth regulator on fruit and vegetable crops.

    The New York State Department of Health (DOH) stated that the USEPA did not require any new studies to be conducted for the federal registration of ethylene, and the USEPA Reregistration Eligibility Document (RED) included a summary of the toxicological studies obtained from the published literature that were used by the USEPA to develop a health hazard assessment for this compound. In addition, the USEPA waived all environmental fate data requirements and exempted ethylene from the requirement of a tolerance when used as a plant regulator on fruits and vegetables.

    Since ethylene is a gas, inhalation exposure is considered the principal exposure route of concern. A review of the toxicological literature found only a few available inhalation toxicity studies on ethylene. The lethal concentration for mice is reported to be 950,000 parts per million (ppm) in air. Ethylene was used for many years as an anesthetic in humans at concentrations up to 900,000 ppm without any reported significant toxicity. Ethylene has since been replaced by anesthetics that do not pose as great an explosion hazard (ethylene reaches explosive levels at a concentration of about 30,000 ppm in air). A chronic inhalation toxicity/oncogenicity study in rats found no exposure-related toxicity or oncogenicity at concentrations up to 3,000 ppm ethylene in air (the highest concentration tested). Ethylene did not produce mutagenic effects in the bone marrow of rats and mice exposed by inhalation for four weeks to concentrations up to 3,000 ppm in air (the highest concentration tested). Ethylene reportedly did not cause genotoxic effects in several other studies. In addition, the USEPA noted that there are no known health effects associated with chronic exposure to ethylene.

    The USEPA RED presented a brief discussion of occupational risks from ethylene. Data requirements for characterizing worker risks were waived, but the possibility of eye and skin frost burns from the liquefied or compressed gas were considered potential occupational hazards. To mitigate these concerns, the Ethylene, Compressed label requires the use of personal protective equipment (long-sleeved shirt, long pants, boots, goggles and chemical-resistant gloves) when handling cylinders of the compressed gas. Although workers entering the enclosed ripening room could potentially be exposed to ethylene and the risk of asphyxiation, the low target treatment concentration (1-150 ppm) and the product's label instructions to wear a NIOSH/MSHA-approved respirator in unventilated treatment areas should considerably reduce this risk. Overall, the USEPA believes that the occupational risk from ethylene is minimal because of low toxicity concerns, human experience data from ethylene's widespread use as an anesthetic and the minimal dermal exposure potential.

    There are no chemical-specific federal or State drinking water/groundwater standards for ethylene. Based on its chemical structure, ethylene falls under the 50 microgram per liter general New York State drinking water standard for "unspecified organic contaminants" (10 NYCRR Part 5, Public Water Systems).

    The Department accepts for general use registration in New York State Ethylene, Compressed (USEPA Reg. 69180-1) which contains the new active ingredient Ethylene, contingent upon Airgas Specialty Gases, Inc. complying with the following condition:

    Enclosed are your Certificate of Registration and New York State stamped "ACCEPTED" label. Please note that a proposal by Airgas Specialty Gases, Inc. or any other registrant, to register a product that contains ethylene, and whose labeled uses are likely to increase the potential for significant impact to humans, non-target organisms, or 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 listed in Appendix 1.B. of "New York State Pesticide Product Registration Procedures" (August 1996). Such information as well as forms can be accessed at our website as listed in our letterhead.

    If you have any questions, please contact Mr. Samuel Jackling, Chief of our Pesticide Product Registration Section, at (518) 402-8768.


Maureen P. Serafini
Director, Bureau of Pesticides Management
Division of Solid & Hazardous Materials

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