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Regulatory Context

A well-known hazard to human and environmental health, both the U.S. Occupational Safety and Health Administration (OSHA) and EPA regulate ethylene oxide.

  • The OSHA permissible exposure limit (PEL) for an eight-hour workshift for ethylene oxide is 1 ppm and the short-term exposure limit (STEL) it should not be exceeded during any 15-minute work period is 5 ppm.

The U.S. EPA regulates ethylene oxide under the authority of six environmental statutes. Under the:

  • Comprehensive Environmental Responsibility, Compensation and Liability Act (popularly known as Superfund), EtO is an "extremely hazardous substance."
  • Emergency Planning and Community Right-to-Know Act, TRI program, all large quantity users of ethylene oxide must submit data on environmental releases and off-site transfers.
  • Federal Insecticide, Fungicide, and Rodenticide Act, ethylene oxide is a "registered pesticide."
  • Resource Conservation and Recovery Act, ethylene oxide is a "hazardous constituent."

The U.S. Food and Drug Administration has regulatory jurisdiction over liquid chemical sterilants and/or high level disinfectants used to process reusable critical and semicritical medical devices.

At the international level, Sweden has phased-out most uses of nonylphenol ethoxylate. An ethylene oxide based surfactant used in detergents, nonylphenol ethoxylates degrade easily into products toxic to marine organisms. Acknowledging the marine toxicity of nonylphenol ethoxylate byproducts, U.S. manufacturers voluntarily ceased using nonylphenol ethoxylates in household detergents.

Endnotes:

The data in this section are from the following sources: EDF, 1999; New Jersey Department of Health and Senior Services, 1996; and Swedish National Chemicals Inspectorate, 1991 (see endnote #1 for full citations).