Regulations (Preambles to Final Rules) - Table of Contents Regulations (Preambles to Final Rules) - Table of Contents
• Record Type: Occupational Exposure to Bloodborne Pathogens
• Section: 2
• Title: Section 2 - II. Pertinent Legal Authority

II. Pertinent Legal Authority

The primary purpose of the Occupational Safety and Health Act (29 U.S.C. 651 et seq.) (the Act) is to assure, so far as possible, safe and healthful working conditions for every American worker over the period of his or her working lifetime. One means prescribed by the Congress to achieve this goal is the mandate given to, and concomitant authority vested in, the Secretary of Labor to set mandatory safety and health standards. The Congress specifically directed that:

The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of the standards, and experience gained under this and other health and safety laws. Whenever practical, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired. [Section 6(b)(5)].

Where appropriate, standards are required to include provisions for labels or other appropriate forms of warning to apprise employees of hazards, suitable protective equipment, exposure control procedures, monitoring and measuring of employee exposure, employee access to the results of monitoring, and training and education. Standards may also prescribe recordkeeping requirements where necessary or appropriate for enforcement of the Act or for the development of information regarding occupational accidents and illnesses [Section 8(c)].

In vacating OSHA's 1978 revision to its benzene standard, the Supreme Court required in Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 601, 64 L. Ed. 2d 1010, 100 S. Ct. 2844 (1980), that before the issuance of a new or revised standard pursuant to Section 6(b)(5) of the Act, OSHA must make two threshold findings: that a place of employment is unsafe in that significant risks are present; and that the risks can be reduced or eliminated by a change in practices (448 U.S. at 642).

The Court also stated "that the Act does limit the Secretary's power to requiring the elimination of significant risks" (448 U.S. at 644, n. 49). The Court indicated, however, that the significant risk determination is "not a mathematical straitjacket," and that "OSHA is not required to support its finding that a significant risk exists with anything approaching scientific certainty." The Court ruled that "a reviewing court [is] to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge [and that] the Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking error on the side of overprotection rather than underprotection" (448 U.S. at 655, 656). The Court also stated that "while the Agency must support its finding that a certain level of risk exists with substantial evidence, we recognize that its determination that a particular level of risk is 'significant' will be based largely on policy considerations." (448 U.S. at 655, 656, n. 62).

OSHA has used these guidelines provided by the Supreme Court in setting health standards for known carcinogens such as benzene and ethylene oxide as well as other substances such as cotton dust whose adverse health effects is not carcinogenic but is very serious. Exposure to cotton dust, for example, causes byssinosis.

After OSHA has determined that a significant risk exists and that such risk can be reduced or eliminated by the regulatory action, it must set the standard "which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employees will suffer material impairment of health" [Section 6(b)(5) of the Act]. The Supreme Court has interpreted this section to mean that OSHA must enact the most protective standard possible to eliminate a significant risk of material health impairment, subject to the constraints of technological and economic feasibility. American Textile Manufacture's Institute, Inc. v. Donovan, 452 U.S. 490 (1981). The Court held that "cost-benefit analysis is not required by the statute because feasibility analysis is." (452 U.S. at 509). The Court stated that the Agency could use cost-effectiveness analysis and choose the least costly of two equally effective standards. (452 U.S. 531, n. 32).

Authority for this action is also found in Section 8(c)(3) of the Act. In general, this section empowers the Secretary to require employers to make, keep, and preserve records regarding activities related to the Act. In particular, Section 8(c)(3) gives the Secretary authority to require employers to "maintain accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under Section 6."

The Secretary's authority to issue this standard is further supported by the general rulemaking authority granted in Section 8(g)(2) of the Act. This section empowers the Secretary "to prescribe such rules and regulations as [she] may deem necessary to carry out [her] responsibilities under the Act" -- in this case as part of a Section 6(b) standard. The Secretary's responsibilities under the Act are defined largely by its enumerated purposes, which include:

Encouraging employers and employees in their efforts to reduce the number of occupational safety and health hazards at their places of employment, and to stimulate employers and employees to institute new and to perfect existing programs for providing safe and healthful working conditions [29 U.S.C. 651(b)(1)];

Authorizing the Secretary of Labor to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce [29 U.S.C. 651 (b)(3)];

Building upon advances already made through employer and employee initiative for providing safe and healthful working conditions [29 U.S.C. 651(b)(4)];

Providing for appropriate reporting procedures with respect to occupational safety and health which procedures will help achieve the objectives of this Act and accurately describe the nature of the occupational safety and health program [29 U.S.C. 651(b)(12)];

Exploring ways to discover latent diseases, establishing causal connections between diseases and work in environmental conditions [29 U.S.C. 651 (b)(6)];

Encouraging joint labor-management efforts to reduce injuries and disease arising out of employment [29 U.S.C. 651(b)(13)]; and

Developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems [29 U.S.C. 651(b)(5)].

The Agency's judgement is that the bloodborne pathogens standard is reasonably related to these statutory goals, that the evidence satisfies the statutory requirements, and that the standard will reduce a significant risk of hepatitis B and other adverse health effects, including but not limited to AIDS and hepatitis C. Thus, the Secretary finds that this standard is necessary and appropriate to carry out her responsibilities under the Act.

[56 FR 64004, Dec. 6, 1991; FR 29206, July 1, 1992]

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