Notice of Availability of the Regulatory Flexibility Act Review of the Occupational Health Standard for Ethylene Oxide

The Occupational Safety and Health Administration (OSHA) has conducted a review of its Ethylene Oxide (EtO) Standard pursuant to section 610 of the Regulatory Flexibility Act and section 5 of Executive Order 12866 on Regulatory Planning and Review. EtO is used as a chemical intermediate to produce antifreeze and as a sterilant. In 1984, OSHA promulgated a standard to lower exposure to EtO from 50 parts per million (ppm) to 1 ppm based on evidence EtO exposure was associated with cancer in animals. The regulatory review has concluded that new studies indicate that EtO is associated with cancer in humans, that employee exposures have been substantially reduced thereby lowering risk to employees, that the standard has not had a negative impact on small businesses, that EtO production has increased, and that EtO sterilizers have been developed that meet the standard and cost less than older non-compliant sterilizers. Public commenters agree that the standard should remain in effect. Based on this review, OSHA concludes the EtO standard should remain in effect, but will issue new guidance materials in response to some commenters requests for clarification.