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.

September 6, 2000

Dennis Sleister, President
Niche Medical
55 Access Road
Warwick, RI 02886

Dear Mr. Sleister:

Thank you for your May 25 letter to the Occupational Safety and Health Administration's (OSHA's) [Directorate of Enforcement Programs] regarding whether surgical smoke is covered under the Bloodborne Pathogens Standard, 29 CFR 1910.1030. Please be aware that this response may not be applicable to any question not delineated within your original correspondence. Your concern is outlined below, followed by our response.

"I feel that protective measures must be taken against surgical smoke either because it contains OPIM (other potentially infectious materials) or because it, like high speed instruments, produces aerosols that are assumed to be infectious... I would like to request a letter of interpretation (regarding) the application of the Bloodborne Pathogens Standard to surgical smoke."

According to the scope of the Bloodborne Pathogens Standard, "(it) applies to all occupational exposure to blood or other potentially infectious materials (OPIM)..." Blood is defined as "...human blood, blood components, and products made from blood." Subsequently, OPIM is defined by the standard as "...the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; any unfixed tissue or organ (other than intact skin) from a human (living or dead); and HIV-containing cell or tissue cultures, organ culture, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV." Surgical smoke would not qualify as blood or OPIM under the standard and its provisions would not apply.

The National Institute of Occupational Safety and Health (NIOSH) is currently researching the hazards associated with surgical smoke and the subsequent protection that may be needed. From a safety and health regulatory point of view, we will be better prepared to address the safety measures needed for employees exposed to surgical smoke upon the conclusion of their research. For updated research information from NIOSH, you may want to visit their website at http://www.cdc.gov/niosh. You may also want to contact the American National Standards Institute (ANSI), which recommends the use of smoke evacuators and high efficiency surgical masks, as noted by Mark S. Davis, M.D. in Advanced Precautions for Today's O.R. (1999).

Thank you for your interest in occupational safety and health. We hope you find this information helpful. Compliance guidance provided by OSHA represents OSHA's explanation, clarification, or application of the provisions of the OSH Act, OSHA standards or OSHA regulations, but it does not add to, alter, or replace those provisions, which alone are legally binding. You should also be aware that OSHA's compliance guidance is subject to periodic review and clarification, amplification, or correction and can also be affected by subsequent rulemaking or other changes in the law. One way for you to track future changes that might affect the information provided herein is by consulting 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].

Sincerely,


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

[Corrected 6/2/2005]