Date: Feb 01, 1999
In 1991, the Occupational Safety and Health Administration (OSHA) adopted a standard to prevent the infection of medical workers with various diseases as a result of exposure to their patients. Principally, the standard was intended to implement the recommendations of the Centers for Disease Control (CDC) and
thereby prevent the transmission of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV). The AIDS epidemic had been running full force for ten years. Reports of hospital workers becoming infected by HIV were becoming more frequent, although only 24 cases (including only one dentist) had been reported by the year the standard was adopted. The CDC guidelines had become generally accepted by the health care profession. On the assumption that one could not predict whether any particular patient was infected with either virus (or any one of a number of other infectious diseases) when treatment is initiated, and because of the public pressure to allow patients to avoid disclosure of their infection, CDC instituted so-called "universal precautions," steps health care workers were to take to avoid contact with potentially infectious body fluids.
OSHA's standard applied these requirements to ordinary procedures in dental
offices and to home health care workers, albeit to a somewhat lesser degree than in other situations with clearly greater possible exposure to blood and other fluids. Essentially, such workers were to use gloves, spectacles with side shields, and protective clothing as part of their daily routine, and employers were to provide, among other things, site-specific controls, such as readily available running water and maintaining clean and sanitary conditions. The American Dental Association (ADA) and the Home Health Services and Staffing Association challenged the application of the rule to their employees on the grounds, in part, that OSHA had not demonstrated a significant risk to their employees as a result of the potential exposure to blood and other body fluids in the course of treatment of their patients. The Seventh Circuit Court of Appeals ruled that OSHA had determined on a reasonable basis that the standard would materially reduce a significant risk to these employees, even though OSHA had not determined what the specific risk of infection was in the dental and home health care industries. Rather, said the Court, OSHA had
concluded that procedures which involved exposure to body fluids constituted a significant risk of exposure to the infectious agent, and directed its remedy at minimizing the potential effect of those procedures; exposure was equated with risk. Thus, the Court said, OSHA reasonably concluded that the procedures would reduce or eliminate the potential for transmission of the HIV and HBV in those two industries and that the cost was not unbearable. This met the applicable legal standard of materially reducing a significant risk without "imperiling the existence of, or threatening massive dislocation to, the health care industry."
OSHA did not estimate the risks of HIV and HBV transmission by industry or in any numerical fashion. It did its required cost and feasibility analysis on a limited, industry-by-industry basis. While the Court, known for its application of
economic analysis to legal questions, did fault OSHA for not considering some costs it
thought could be significant, the Court also criticized the industry for not also
evaluating the costs and putting the agency on notice of them. The Court upheld the application of the standard to the dental industry, and generally to the home health care industry, but vacated the standard as to the obligations it applied to the home health care industry regarding sites not controlled by the employer.
As might have been expected, the opinion by Judge Posner focused on the deficiencies of both OSHA's and the industry's economic analysis. He concluded, though, that on the record before it, OSHA had reached a reasonable conclusion. He gave OSHA the benefit of the doubt regarding the significant risk estimates, and credited OSHA's estimates of the avoided deaths due to infection by HBV, principally by the requirement for employers to make the HBV vaccine available to employees. Both the industry and OSHA apparently accepted without question or analysis the CDC's assessment that the risk of infection was significant in some circumstances and that the "universal precautions" required would materially reduce that risk. On the record before the Court, they could not say that OSHA's rule "flunked the test of materially reduction a significant risk to workplace health."
In a concurring opinion, Judge Coffey discussed the rule in a more traditional
analysis. He considered OSHA's significant risk determination and argued that OSHA's method was flawed. OSHA had concluded that the risk was significant by estimating the number of health care workers infected with HBV and relying on estimates of the risk of exposure for all employees in the health
care field. While OSHA need not "establish the existence of a significant risk to a scientific certainty," OSHA should have done more to assess the real risk in industry segments where the risks were clearly different. For example, OSHA combined
the risk of infection during surgical procedures with the risks for dental and home health care work, then concluded "that its self-generated, artificial risk level exist[ed]
in each respective health care area." Judge Coffey examined other aspects of OSHA's risk assessment, and concluded that the result was "nothing more than a scheme to achieve a desired result for the sake of administrative convenience."
Should OSHA examine the risks in different industries? Under the 11th Circuit's decision in the case of the Permissible Exposure Limits (PEL) decision, OSHA has to examine the risks and benefits on
an industry-by-industry basis for standards to control toxic substances. Arguably, a standard on bloodborne pathogens is a health standard no different from one on benzene or carbon monoxide. The 7th Circuit decision in this case
is inconsistent with the 11th Circuit decision to the degree that OSHA is
relieved of the obligation to disaggregate both risks and costs; such a conflict in the
circuits often prods the U.S. Supreme Court to take such cases to resolve the
disagreement. Employers can (and should) submit both risk and cost information on their specific industry during the rulemaking so that OSHA cannot simply ignore the differences between industries, and should comment
specifically on those differences. Then, when OSHA examines the record "taken as a
whole," it will not be able to conclude that clearly distinct risks and costs between
industries are essentially the same, and might lead to quite a different result in the
Court of Appeals.
This article appeared in Compliance Magazine (February 1999) and
it is reprinted with permission of Compliance Magazine. Copyright © 2001 by IHS
Publishing Group. All rights reserved.
For further information about this article, please contact David G. Sarvadi at 202-434-4249 or by e-mail at firstname.lastname@example.org.