September 8, 2005

Ms. Kathleen M. Caldwell, MT (ASCP)
Sr. Project Manager
Medpace Laboratories
4620 Wesley Avenue
Cincinnati, OH 45212

Dear Ms. Caldwell:

Thank you for your May 17, 2005, letter to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded to OSHA's Directorate of Enforcement Programs (DEP). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any question(s) or scenarios not delineated within your original correspondence. For clarification, your specific question is paraphrased below, followed by OSHA's response. We apologize for the delay in addressing your concerns.

Question: Are human samples (e.g., whole blood, plasma, serum, urine and tissue), which are shipped to a research laboratory, exempted from the biohazard labeling requirement under 29 CFR 1910.1030(g)(1)(i)(G) if the outer container is labeled with the IATA UN3373 Diagnostic Specimens marking?

Reply: Labeling is required on all containers used to store, transport, ship, or dispose of blood or other potentially infectious materials (OPIM), except as noted in paragraphs 1910.1030(g)(1)(i)(F-I) of the standard. Regarding the specific exemption provided by 29 CFR 1910.1030(g)(1)(i)(G), OSHA has provided clarification in a previously written letter of interpretation with regard to interplay between OSHA labeling requirements and those of the Department of Transportation (DOT). OSHA has stated:

[I]f individual containers of blood or OPIM are placed in a larger container during storage, transport, shipment or disposal and that larger container is either labeled with the OSHA "Biohazard" label or color-coded, the individual containers are exempt from the labeling requirement.

OSHA will accept the Department of Transportation's (DOT's) "INFECTIOUS SUBSTANCE" label in lieu of the [OSHA] "BIOHAZARD" label on packages where the DOT requires its label on shipped containers, but will require the BIOHAZARD label where OSHA regulates a material but DOT does not. If the DOT-required label is the only label used on the outside of the transport container, the OSHA-mandated label must be applied to any internal containers containing blood or OPIM. The BIOHAZARD label is fluorescent orange with lettering and symbols in a contrasting color. (Letter to Mr. Jon Carter, September 17, 2002)

You should consult with the United States Department of Transportation to determine what it requires for the outside labeling of packages containing these human samples. An identifying label that is acknowledged by the DOT as being sufficient may be used in lieu of the OSHA "BIOHAZARD" label on the shipping container; however, any internal containers containing blood or OPIM would still be required to be labeled with the OSHA-mandated label or color coding. It should be noted that not all diagnostic specimens are included in OSHA's definitions of blood or OPIM (e.g., urine and feces are not considered OPIM unless they contain visible blood) and, therefore, OSHA's labeling requirements are not applicable to all diagnostic specimens.

Thank you for your interest in occupational safety and health. We hope this provides the clarification you were seeking. 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. 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