Facts
- OSHA promulgated a bloodborne pathogens standard, 29 C.F.R. § 1910.1030, to reduce health-care worker exposure to HIV and Hepatitis B.
- The rule required engineering and work-practice controls, personal protective equipment, housekeeping and decontamination procedures, training and recordkeeping, and a no-cost offer of Hepatitis B vaccination to covered employees.
- OSHA found occupational exposure caused a small number of HIV infections among health-care workers annually and a far larger number of work-related Hepatitis B infections, with deaths attributed to those infections.
- OSHA estimated annual compliance costs to the health-care industry at approximately $813 million.
- The American Dental Association and a home health staffing trade association petitioned for review, arguing OSHA lacked adequate proof of significant risk and necessity, lacked substantial evidence for various requirements, and issued an unjustified rule with excessive costs.
- Petitioners also claimed higher costs would reduce patient access to care and indirectly cause deaths, but they did not substantiate those predictions with evidence developed in the rulemaking record.
Issues
- Whether OSHA adequately found a “significant risk” of material health impairment to justify the standard under the OSH Act.
- Whether the standard’s scope and key requirements (including the no-cost Hepatitis B vaccination offer) were supported by substantial evidence in the administrative record.
- Whether the OSH Act requires OSHA to conduct formal cost-benefit balancing or to reject a standard based on speculative downstream societal costs.
- Whether objections and factual claims not properly developed in the notice-and-comment record can support vacating the standard on judicial review.
Decision
- The court denied the petitions for review and upheld the bloodborne pathogens standard in all material respects.
- The court held OSHA reasonably determined that bloodborne pathogens posed a significant occupational risk, including where the probability of harm was lower but the consequences were grave.
- The court concluded the standard was supported by substantial evidence, including scientific literature and measures consistent with Centers for Disease Control recommendations.
- The court rejected petitioners’ access-to-care and indirect-death theories as speculative and not substantiated in the administrative record.
- A separate opinion concurred in part and dissented in part, but it did not alter the judgment sustaining the rule.
Legal Principles
- OSHA must identify a significant risk of material health impairment before issuing a health standard; severity of harm may support regulation even with relatively low probability of occurrence.
- Judicial review of OSHA standards is limited to whether the rule is supported by substantial evidence on the record as a whole, with deference to agency evaluation of scientific and medical evidence.
- The OSH Act does not require a formal cost-benefit analysis; OSHA must consider feasibility and may consider costs generally, but it need not prove the rule maximizes overall social welfare.
- Courts generally will not invalidate a rule based on factual assertions and economic predictions not adequately presented and supported during notice-and-comment rulemaking.
Conclusion
The Seventh Circuit sustained OSHA’s bloodborne pathogens standard, holding that OSHA reasonably found significant occupational risk and supported the rule with substantial evidence, while petitioners’ speculative and record-deficient cost and access-to-care objections could not justify vacatur.