Status of EPA's Air Quality Standards for Carbon Monoxide

In response to a congressional request, GAO provided information on: (1) the Environmental Protection Agency's (EPA) development of the carbon monoxide standard and the research supporting the present standard; and (2) Food and Drug Administration (FDA) and Veterans Administration (VA) reviews and investigations of research conducted by a VA physician and how these agencies communicated the results of their investigations to EPA.

In 1971, carbon monoxide standards were established on the basis of a study which suggested that low-level carbon monoxide exposure would affect the central nervous system. Subsequently, questions were raised about the study's reliability. While EPA recognized the limitations of the study, it took no action to change the standards because new studies, including one by a VA physician, showed that the standards were needed to protect persons with certain heart conditions. In 1983, EPA postponed the issuance of revised standards based on these studies because questions arose concerning the validity of the VA study. In 1979, FDA began an investigation of the questioned study and found that the physician had used incorrect patient selection, conflicting data, and possible falsification of records. As a result of this investigation, the physician's research activities were discontinued. However, GAO could find no indication that VA had notified EPA of the physician's research problems, and FDA did not notify EPA of its investigation until 1982, after EPA had begun using the results of the VA study as a basis for the revised standards. Although EPA believes that the questioned study and three others provide a sufficient scientific basis to support a regulatory decision, it is sponsoring research to duplicate the studies. EPA officials stated that, had they received earlier notification of the physician's research problems, they would have been able to review his research and would have begun earlier to reexamine the database supporting the standards.