|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 http://www.osha.gov.|
December 30, 1996
Mr. William M. Honan
Horn, Goldberg, Gorny, Plackter
1300 Atlantic Avenue, Suite 500
Atlantic City, New Jersey 08401-7278
Dear Mr. Honan:
Thank you for your letter September 25, addressed to Mr. Joseph Woodward, Associate Solicitor of Labor for Occupational Safety and Health. Your letter requested information related to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) and has been referred to this office for response.
Your questions/comments followed by our written response are presented below:
In the Bloodborne Pathogen Standard (BBP), the definition of "Research Laboratory means a laboratory producing or using research-laboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities." "Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials." Based on the information in your letter, OSHA is not able to advise you. You and your client would need to make this determination based on the design and purpose of the facility and the amount of HIV-infected material handled.
- Analysis of, or experimentation with, properly fixed HIV-infected tissue, blood from properly fixed HIV-infected tissue, or DNA or RNA from properly fixed HIV-infected tissue brings a facility within the requirements of a "research facility" or "clinical or diagnostic laboratory" as those terms are defined in 29 CFR 1910.1030;
- DNA or RNA extracted from properly and previously fixed tissue, if it forms an aerosol, could, if inhaled, pose a recognized risk of HIV infection to anyone who might inhale it;
- Waste from experiments with (a) properly fixed tissue or (b) DNA or RNA extracted from properly fixed HIV-infected tissue was required to be autoclaved, prior to leaving the laboratory in which the experiments were done, according to any rules or regulations, including but not limited to OSHA's regulations entitled "Occupational Exposure to Bloodborne Pathogens" promulgated on December 6, 1991 and which became effective in July 1992 (29 CFR 1910.1030); and
- Incineration of wastes from experiments with (a) properly fixed HIV-infected tissue or (b) DNA or RNA extracted from properly fixed HIV-infected tissue, prior to final disposal, was a fully adequate method or means of rendering the waste innocuous.\
The BBP standard, paragraph 1910.1030(f), requires regulated waste from research laboratories or production facilities to be either incinerated or decontaminated by a method such as autoclaving known to effectively destroy bloodborne pathogens.
Enclosed as per your request is a copy of the compliance directive to the BBP standard, [CPL 2-2.69] that contains compliance information you may find relevant to your issue.
Ruth McCully, Director
[Office of Health Enforcement]