OSHA's approach to risk assessment for setting a revised occupational exposure standard for 1,3-butadiene

In its 1980 benzene decision [Industrial Union Department, ALF-CIO v. American Petroleum Institute, 448 U.S. 607 (1980)], the Supreme Court ruled that "before he can promulgate any permanent health or safety standard, the Secretary [of Labor] is required to make a threshold finding that a place of employment is unsafe--in the sense that significant risks are present and can be lessened by a change in practices" (448 U.S. at 642). The Occupational Safety and Health Administration (OSHA) has interpreted this to mean that whenever possible, it must quantify the risk associated with occupational exposure to a toxic substance at the current permissible exposure limit (PEL). If OSHA determines that there is significant risk to workers' health at its current standard, then it must quantify the risk associated with a variety of alternative standards to determine at what level, if any, occupational exposure to a substance no longer poses a significant risk. For rulemaking on occupational exposure to 1,3-butadiene, there are two studies that are suitable for quantitative risk assessment. One is a mouse inhalation bioassay conducted by the National Toxicology Program (NTP), and the other is a rat inhalation bioassay conducted by Hazelton Laboratories Europe. Of the four risk assessments that have been submitted to OSHA, all four have used the mouse and/or rat data with a variety of models to quantify the risk associated with occupational exposure to 1,3-butadiene. In addition, OSHA has performed its own risk assessment using the female mouse and female rat data and the one-hit and multistage models.(ABSTRACT TRUNCATED AT 250 WORDS)