OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

August 12, 1992

Ms. Elsie Toseki, RN
Miners Hospital of Northern Cambria
Crawford Avenue and First Street
Spangler, PA 15775

Dear Ms. Toseki:

This is in response to your letter of May 13, requesting review of the hepatitis B consent form and policy statement developed for your facility.

The Occupational Safety and Health Administration (OSHA) does not review or endorse documents or policies as you have requested. The final determination of compliance must take into account all factors pertaining to the appropriateness and implementation of such policies at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of employee training.

We can, however, clarify for you that paragraph (f) of the OSHA regulation, 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens," addresses requirements regarding hepatitis B vaccination programs. Appendix A of the standard contains mandatory language that must be used for hepatitis B vaccine declination statements.

Further, we note that the reference in your document to Heptavax-B may be inappropriate as it is a plasma-derived vaccine which is no longer being produced in the United States. The Centers for Disease Control (CDC) of the U.S. Public Health Service reports that the use of plasma-derived vaccines is now limited to hemodialysis patients, other immocompromised hosts, and persons with known allergy to yeast. (Reference: Centers for Disease Control. Protection Against Viral Hepatitis: Recommendations of the Immunization Practices Advisory Committee (ACIP). Morbidity and Mortality Weekly Report, 1990; 39 [Suppl. S-2]:1-26.) You are, of course, required to provide information on the specific vaccine offered.

For further information regarding this regulation, you may contact your regional bloodborne coordinator at the following location:

         Mr. Jim Johnston DOL-OSHA,
         Region III Gateway Building,
         Suite 2100 
         3535 Market Street
         Philadelphia, PA 19104
         Telephone:  215-596-1201

We hope this information is responsive to your concerns.  Thank you for your
interest in worker safety and health.


Patricia K. Clark, Director
Directorate of Compliance Programs