Krishna Engineering, (Vatva)

To: Whom it may concern

From: EOSA, The Ethylene Oxide Sterilization Association

Re: INFORMATION UPDATE ON ETHYLENE OXIDE (ETO)

Date: 10 January 2005

EOSA is an industry trade group of suppliers and users of ETO as a sterilant. This memo is intended to eliminate confusion regarding commercially-motivated “rumors” to the effect that EtO is being or will be banned. These rumors are simply untrue. The sterilant, ethylene oxide, is NOT being banned; it is here to stay.

ETO (or EO, if you please) is not, has not and will not be banned or phased out. No American federal, state nor other judicial, legislative or regulatory body is even entertaining such a prospect. The “issue” does not involve EtO. The only likely link to EtO is the scheduled phase-out of CFC and HCFCs which have been used as propellants in 12/88 EtO/CFC and/or 10/90 EtO/HCFC blends or mixtures used in some sterilization systems.

The current ETO facts are:

• The production of CFCs was banned in the U.S. as of January 1, 1996. Certain hydroflourocarbons (HCFCs) are scheduled to be restricted in the future in compliance with the Montreal Protocol. All of this is unrelated to ETO usage as a sterilant.
• ETO is the number one sterilant. The market for ETO used for sterilization is strong and continues to grow at 1.5 - 3% per year. Sources: ARC Specialty Products and Honeywell.
• In calendar year 2000, US hospitals used ETO to sterilize over 75% of their devices needing low temperature gas processing. Source: Honeywell.*/
• More than 1,200 hospitals currently use the ETO/HCFC mixture for sterilization purposes. Source: Honeywell.
• In the U.S. the medical sterilant industry (hospitals, medical device manufacturers and contract sterilizers) used 10 million pounds of ETO in 2000 to sterilize more than half of all single use items produced/used (the same ones that hospitals and consumers buy! – 52% of everything sterilized, in fact. Source: ARC Specialty Products.
• And, the other 8+ billion pounds of ETO produced and utilized in this country each year are used to make antifreeze, fibers, detergents, surfactants and numerous other consumer and industrial products. Source: Union Carbide/Dow**/ */
• ARC Specialty Products, a division of Balchem Corporation, is the number one supplier of 100% ETO to the medical device and contract sterilizer industries. Honeywell International, Inc. is the number one supplier of ETO blend. **/ Union Carbide, a division of Dow Chemical, one of the world’s largest manufacturers of ETO. Other domestic producers include: BASF, Dow itself and Sun.