August 7, 1992

The Honorable Howard M. Metzenbaum
United States Senate
Washington, D.C. 20510

Dear Senator Metzenbaum:

This is in further response to your letter of May 18, addressed to Mr. Charles Adkins, Director of Health Standards Programs. In your letter, and in those of two of your constituents that you have enclosed, you have requested clarification of issues regarding the Occupational Safety and Health Administration (OSHA) regulation "Occupational Exposure to Bloodborne Pathogens," 29 CFR 1910.1030. The specific issues of concern are the requirements for offering the hepatitis B vaccine and for providing personal protective equipment to employees performing residential services for individuals with developmental disabilities, and OSHA's policy regarding the laundering of "gowns" in a dental office.

Concerning the application of the standard in establishments providing care for the developmentally disabled, the first issue in question is whether, due to hepatitis screening and vaccination of the residents, the employee vaccination requirement may be waived. OSHA concludes that the proposed practices of screening and vaccinating residents cannot alone provide a reliable level of protection for employees who have occupational exposure while providing care.

Your constituent's reference to a practice of screening residents upon admission and annually is unclear as to what method of screening is intended to be used. Any method of testing, however, reveals only the immune status or infection status of an individual on a given day. The frequency of such testing that would be required to monitor a population of residents which was not restricted from potentially infectious contacts cannot be determined and would not reasonably be expected to be feasible.

An individual who is tested upon admission may also, for example, be in the early stages of infection which may not be detectable. The Centers for Disease Control (CDC) of the U.S. Public Health Service reports that hepatitis B surface antigen (Hbsag) can be identified in serum only 30-60 days after exposure and that it persists for variable periods. Therefore, infected individuals who are within this "window period" could go undetected, and consequently pose a risk to employees providing their care.

The public record supporting the vaccination requirement of this regulation shows that developmentally disabled adults who are or have been institutionalized have an increased risk for hepatitis B infection and that, in 1990, the CDC recommended the hepatitis B vaccine for both the clients and the staff of institutions for the developmentally disabled. 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 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 80-95% efficacy in preventing infection or clinical hepatitis among susceptible persons, and the CDC states that the duration of protection and need for booster doses are not yet fully defined.

Further, the vaccination requires a series of at least three inoculations over a period of six months or longer and cannot be accomplished and confirmed immediately "upon admission" to a facility as your constituent's letter may suggest. (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.)

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 patients or residents such as described in your constituent's letter.

You should note, however, that it is the employer's responsibility to determine which job classifications involve occupational exposure, and that the employer is only required to offer and make the vaccine available to those employees having occupational exposure. Occupational exposure is defined as reasonably anticipated exposure to blood or other potentially infectious materials (OPIM) as the result of performing job duties.

In an ambulatory residential facility, only certain employees may have jobs which involve occupational exposure, although OSHA expects an employer to take into account all potential circumstances of exposure (such as biting and contact with skin lesions or other potentially infectious secretions) when determining which, if any, employees in a facility have occupational exposure. Employees who do not have occupational exposure are not covered by the scope of this standard.

With respect to the second issue raised in your constituent's letter about the appropriate use of personal protective equipment, the requirements of 29 CFR 1910.1030 are performance oriented. The standard requires the employer to evaluate the task and the potential contact with blood and OPIM. Based on this determination, the employer is to select the "appropriate" personal protective equipment in accordance with paragraph (d)(3)(i) of the standard.

In specific examples cited in your constituent's letter, procedures such as flossing and brushing teeth, and suctioning of body fluids would be reasonably anticipated to result in potential exposure to blood or other potentially infectious materials and would, therefore, require the use of some level of personal protective equipment. It is not OSHA's position or expectation, however, that protective equipment would be required for employees assisting patients in eating under normal circumstances.

The second letter you enclosed concerned OSHA's policy regarding laundering or disposal of "gowns" in a dental office. The writer is mistaken in stating that under the standard "... all gowns must be laundered either commercially or discarded...." The standard does require that employers ensure that these and other similar items of reusable personal protective equipment remain within their control. The standard thus prohibits home laundering, but it does not prohibit the employer from laundering them on site as long as the cleaning and laundering is performed by trained individuals utilizing universal precautions and acceptable laundering methods.

We hope this information is responsive to your concerns and the concerns of your constituents. Thank you for your interest in employee safety and health.

Sincerely,



Patricia K. Clark, Director
Directorate of Compliance Programs