BIOHAZARD labeling for shipped blood specimens

September 17, 2002

Mr. Jon Carter

U.S. Department of Transportation

Research and Special Programs Administration

[Recipient address omitted]

Dear Mr. Carter:

Thank you for your March 15 letter to the Occupational Safety and Health Administration (OSHA) regarding the bloodborne pathogens standard, 29 CFR 1910.1030. Specifically, you are looking for confirmation of when the OSHA "BIOHAZARD" label is required on the exterior of a package used to ship blood or other potentially infectious materials (OPIM). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenario not delineated within your original correspondence.

The OSHA bloodborne pathogen standard requires specimens of blood or OPIM to be placed in a container which prevents leakage during collection, handling, processing storage, transport, and/or shipping. This container must be labeled or color-coded according to paragraph 1910.1030(g)(1)(i). Further, according to paragraph 1910.1030(d)(2)(xiii) of the standard, if contamination of the outside of the primary container occurs, or if the specimen could puncture the primary container, the primary container must be placed in a secondary container which is puncture-resistant in addition to having the above characteristics.

Labeling is required on all containers used to store, transport, ship, or dispose of blood or other potentially infectious materials, except as noted in paragraphs 1910.1030(g)(1)(i)(F-I) of the standard. For example, if 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 "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. As you know, the BIOHAZARD label is fluorescent orange with lettering and symbols in a contrasting color.

The OSHA BIOHAZARD label is distinct from the black-and-white DOT hazard warning labels; it should not be readily confused or conflict with the DOT labels so its appearance on packages in transportation is not prohibited under 49 CFR 172.401(b). Also, its appearance on packages in transportation should not give the impression that a DOT-regulated hazardous material is in the package.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. 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]