September 1, 1995

Diane M. Dwyer, M.D., Chief,
Center for Clinical Epidemiology
State of Maryland
Department of Health and Mental Hygiene
201 West Preston Street
Baltimore, Maryland 21201

Dear Dr. Dwyer:

This is in further response to your letter of April 10, 1995, requesting clarification of issues regarding the Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you requested an interpretation regarding the coverage of child care workers under the scope of the standard and a "waiver" of the compliance requirements of the standard regarding pre-exposure hepatitis B vaccination.

The bloodborne pathogens standard addresses the broad issue of occupational exposure to blood and other potentially infectious materials and is not meant solely for employees in health care settings. Since there is no population that is risk-free for human immunodeficiency virus and hepatitis B virus infectivity, any employee who has occupational exposure to blood or other potentially infectious materials (OPIM) is included within the scope of this standard.

With respect to your contention that child care workers were not specified by ACIP or identified by OSHA in the rulemaking process as an occupational group at increased risk for hepatitis B. the record of the proceedings upon which the final standard is based indicates that risk will be present in any work setting where human blood is encountered. The rulemaking process identified several occupational groups at "increased risk," as you have pointed out, and specifically identified workers providing for special needs of developmentally disabled children. The proceedings did not, however, deny the risk of exposure to hepatitis B to other child care workers working with developmentally normal children. Again, the standard does not quantify the risk of exposure; it applies where there is reasonably anticipated contact with blood or OPIM.

It is important to note that occupational exposure is defined as reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM that may result from the performance of an employee's duties. OSHA anticipates that this standard will impact upon your industry in a similar fashion as upon other non-health care industries, i.e., that employees who are designated as responsible for rendering first aid or medical assistance as part of their job duties are to be covered by this standard. This is because it is reasonable to anticipate that an employee designated to render first aid will have occupational exposure to blood or OPIM.

OSHA has issued a policy statement specifying that, while designated first aiders are covered under the scope of the standard, failure to offer the hepatitis B vaccine pre-exposure to persons who render first aid only as a collateral duty, and who have no other occupational exposure, will be considered a de minimis violation carrying no penalties, provided that a number of conditions are met. A copy of the text of the current OSHA policy describing the conditions under which this may apply is enclosed. Under this policy, offering of pre-exposure vaccination is not required if it is made available within 24 hours of possible exposure (i.e. the rendering of first aid when blood or OPIM is present). We believe that the parameters placed on this exception will be sufficient to provide protection to those employees who render first aid on an occasional basis. All other requirements of the standard continue to apply to designated first aid providers.

Concerning the issue of whether, due to hepatitis screening and vaccination of children in your care, the employee vaccination requirement may be waived, OSHA concludes that the proposed practices of screening and reliance upon vaccination of potential source cannot alone provide a reliable level of protection for employees who have occupational exposure while providing care. It is true, as you have noted, that the ACIP has recommended universal immunization of all U.S. infants against HBV. While making that recommendation and stating that protection against illness is virtually complete for persons who develop an adequate antibody response after vaccination, the CDC also reported that the vaccine does not produce an adequate antibody response in all recipients. Field trials of the vaccines licensed in the United States have, likewise, shown only 80 to 95 percent efficacy in preventing infection or clinical hepatitis among susceptible persons.

OSHA, therefore, having based the vaccination requirements of this regulation on the CDC recommendations and in consideration of the known occurrence of non-responders, does not permit an exemption to any requirement of the standard based on vaccination of potential sources such as described in your letter.

Should you have any further questions on this matter, please contact the Office of Health Compliance Assistance at 202 219-8036 extension 36. Thank you for your interest in occupational safety and health.

Sincerely,

Ruth McCully, Director
Office of Health Compliance Assistance