Biohazard labels on shipped human specimens

July 21, 1999

Michael Sweeney
Vice President, Business Development
World Courier, Inc.
[Recipient address omitted]

Dear Mr. Sweeney:

Thank you for your May 7 letter to the Occupational Health and Safety Administration (OSHA). We apologize for the delay in responding to your letter. You address a very important issue relating to biohazard labeling when shipping "non-infectious" human specimens by air, which is regulated by 29 CFR 1910.1030, the Bloodborne Pathogens Standard. We hope that this letter serves as an additional resource of information, reinforcing the information that our New York Area Office has provided to you. Your concerns are addressed below along with OSHA's interpretation.

You request clarification regarding the OSHA regulation and Department of Transportation (DOT) regulation, 49 CFR 172.401, for labeling as it pertains to the exterior of shipping boxes containing blood, plasma, serum, etc. To immediately target your concerns, yes, OSHA will accept the DOT "Infectious Substances" label in lieu of the OSHA label "Biohazard" on outer containers containing blood or other potentially infectious materials (OPIM). As to avoid the imposition of conflicting regulatory requirements, labeling in accordance with the OSHA standard, paragraph 1910.1030(g)(1)(i), is required for containers housing human specimens where DOT regulations do not apply. For those interior receptacles packaged within the exterior DOT labeled box, warning labels shall be affixed to containers of regulated waste or OPIM alerting those who may come in to contact with them of their contents and potentially infectious character. More simply, where DOT regulations do not apply for labeling of hazardous materials during shipping or transport, OSHA regulations do, ensuring safety to those in the workplace of the package's final destination.

Further, you refer to the human specimens requiring labeling, as "non-infectious human specimens, such as blood, plasma, serum, etc." Please be advised that human blood, human blood components, and products made from human blood are included in the bloodborne pathogens standard, and cannot be considered "non-infectious", whether used for diagnostic purposes or other purposes. Regardless of a specimen's declared purpose as a diagnostic tool and its relative safety, cases have been reported to the Centers for Disease Control and Prevention (CDC) where transmission of Hepatitis C has occurred from these types of specimens.

Thank you for your interest in the safety and health of your employees and others. We hope that you find this information useful. It may please you to review our website, http://www.osha.gov, where you will find OSHA's past letters of interpretation addressing very similar issues. If you have any further questions or concerns, 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]