EPA and FIFRA
While most matters regarding occupational exposure to toxic compounds—in the United States—fall under the purview of the Occupational Safety & Health Administration (OSHA), in some cases, other federal agencies are also involved.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 United States Code §§ 136-136y (2008), the EPA has re-registered ethylene oxide as a pesticide. Within FIFRA, the term “pesticide” means any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. Micro-organisms controlled by ethylene oxide sterilants are classified as pests.
The re-registration of ethylene oxide (EtO)
On 31 March 2008, EPA issued a document entitled “Reregistration Eligibility Decision for Ethylene Oxide.”
Quoting from the Abstract of that document…
The Agency has determined that the benefits of EtO use outweigh the occupational risks associated with its use provided that the risk mitigation measures outlined in this document are adopted and label amendments are made to reflect these measures. The Agency has therefore determined that products containing the active ingredient EtO are eligible for reregistration provided that the risk mitigation measures outlined in this document are adopted and label amendments are made to reflect these measures.
As this applies to the health care applications of EtO, in accordance with the Reregistration Eligibility Decision (RED)…
- In hospitals and health care facilities, sterilization/fumigation with EtO must be performed only in vacuum or gas tight chambers designed for use with EtO.
After February 28, 2010, a single chamber process is required for EtO treatment (sterilization and aeration are to occur in the same chamber) in hospitals and health care facilities.
- In contract sterilization facilities, including facilities treating medical equipment and supplies, musical instruments, library/museum artifacts, cosmetics, and spices the following requirements must be followed:
Sterilization/fumigation with EtO must be performed only in vacuum or gas tight chambers designed for use with EtO.
- Employee safety and awareness training is required for all employees (including office staff) in contract sterilization facilities. This requirement ensures that all facility employees are aware of the risks associated with ambient levels of EtO from sterilization processes.
The EPA has posted a fact sheet on the new single chamber regulations.
The new regulations appear on product labeling
For chemicals regulated under FIFRA, restrictions and instructions for use are to appear on the labeling of the product. When extensive information must be presented to the end user, additional documentation is often included on supplementary packaging materials.
Here is a facsimile of the tag provided by Honeywell Health Care.
Sterilant and sterilizer manufacturers are charged with promulgating this information to their customers. You can also contact Interscan for further clarification.
Our comments
It is quite significant that the EPA—hardly a cheerleader for the chemical industry—would determine, and indeed memorialize in its findings, that “the benefits of EtO use outweigh the occupational risks associated with its use.” This finding, along with the phasing out of the Steris System 1, should encourage and revitalize the use of ethylene oxide.
That said, we anticipate even closer scrutiny of this sterilant, and look forward to working with the health care community under these new guidelines.