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.

November 5, 1999

Ms. Diane O. Fleming, Ph.D.
15611 Plumwood Court
Bowie, MD 20716-1434

Dear Ms. Fleming;

This is in response to your letter of August 3, 1999, requesting an interpretation of the Bloodborne Pathogens standard, 29 CFR 1910.1030. In particular, you want to know whether therequirements in paragraph 1910.1030(e) must be followed in a facility who manufactures and tests diagnostic equipment. In your letter you have stated that the facility in question uses clinical specimensfrom patients with known disease to test a machine which is designed to read viral levels in blood plasma and that these viral levels are not in concentrations greater than would be tested in a clinical laboratory. You further point out that it would be infeasible to enclose this machinery in a biological safety cabinet.

Paragraph 1910.1030(e) applies to two types of facilities that we have designated "research laboratories" and "production facilities." For the purpose of the bloodborne standard, "research laboratories" means a laboratory producing or using research-laboratory scale amounts. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in the production facilities. Most activities involve high concentrations of virus and under this paragraph must be conducted in a biological safety cabinet or equivalent containment. However, the bloodborne standard does not require research laboratories such as laboratories using unconcentrated blood or blood components as the source of HIV or HBV to follow the requirements in paragraph (e) if this is the only source of virus used in the laboratory. However, they must follow the other provisions of the standard and avoid the production of aerosols.

"Clinical/Diagnostic Laboratories" for the purpose of this standard are not limited to hospital labs, free-standing clinical or diagnostic labs, labs in dentists' or physicians' offices, blood and plasma center labs, dental labs, and laboratories preparing reagents from human blood or blood components. Laboratories that conduct research using blood or blood components but do not produce or use concentrated amounts of HIV or HBV, would also fall into this category. The description of the facility you have supplied in your letter appears to fall into this category, in which case biological safety cabinets would not be required.

Please note that the Maryland Division of Labor and Industry is operating its own occupational and health program under a plan approved and closely monitored by Federal OSHA. Compliance enforcement of the Bloodborne Pathogens standard in Maryland may differ from that of Federal OSHA as States standards may be different from but at least as strict as Federal OSHA's.

The State enforces these standards for the private sector and city, county, and state employees. If you wish to pursue this matter further with the state of Maryland, you may contact:

[Maryland Department of Labor, Licensing and Regulation
1100 North Eutaw Street, Room 611
Baltimore, MD 21202
Phone: (410) 767-2189
FAX: (410) 767-2003
Website: http://www.dllr.state.md.us/labor/mosh.html ]

Thank you for your interest in occupational safety and health. We hope you find this information helpful. Please be aware that OSHA's enforcement guidance is subject to periodicreview and clarification, amplification, or correction. Such guidance could also be affected by subsequent rulemaking. In the future, should you wish to verify that the guidance provided herein remains current, you may consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the [Office of Health Enforcement at (202) 693-2190].


Richard E. Fairfax, Director
[Directorate of Enforcement Programs]

[Corrected 6/2/2005]