Biohazard labels on medical-device shipping packages

September 06, 2019

Mr. Troy Twesme

Sr. Manager, Facilities & EHS

Philips, IGTD

Colorado Springs, Colorado 80921

Dear Mr. Twesme:

Thank you for your letter to the Occupational Safety and Health Administration’s (OSHA) Directorate of Enforcement Programs. You requested a clarification on the labeling requirements of the OSHA Bloodborne Pathogens (BBP) standard, 29 CFR 1910.1030. Specifically, you asked about labeling of packages used to ship medical devices that may be contaminated with 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 questions not delineated within your original correspondence. Your specific question is paraphrased below, followed by OSHA’s response.

Question: Are OSHA biohazard labels required on tertiary shipping packages containing potentially infectious medical devices when Department of Transportation (DOT) labels are not?

Response: The BBP standard at paragraph 1910.1030(d)(2)(xiv) requires that equipment which may become contaminated with blood or other potentially infectious material (OPIM) shall be decontaminated before servicing or shipping unless decontamination is infeasible. If so, a readily observable label in accordance with (g)(1)(i)(H) shall be attached to the equipment and also state which portions of the equipment remain contaminated. 29 CFR 1910.1030(d)(2)(xiv)(A).

As stated in the preamble to the Bloodborne Pathogens Standard,

“Labels required for contaminated equipment…that is to be serviced or repaired shall contain the additional information stating which parts of the equipment are contaminated. This will assure that employees who repair, service or otherwise handle this equipment will be warned to take appropriate protective measures.”1

In regards to DOT labeling requirements, as stated in OSHA Directive, CPL 02-02-069, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, the labeling requirements do not preempt either the U.S. Postal Service labeling requirements or the DOT Hazardous Materials Regulations. However, DOT labeling is not required on all containers for which 29 CFR 1910.1030 requires the biohazard label. Where there is an overlap between the OSHA-mandated label and the DOT-required label, the DOT label will be considered acceptable on the outside of the container, provided that the OSHA label appears on any internal containers which may be present.2 Where DOT labels are not required, and where there is potential for exposure to blood or OPIM from the contents, the labeling requirements of the BPP standard must be followed on tertiary shipping packages.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA’s requirements are set by statute, standards, and regulations. Our letters of interpretation do not create new or additional requirements but rather explain these requirements and how they apply to particular circumstances. This letter constitutes OSHA’s interpretation of the requirements discussed. From time to time, letters are affected when the Agency updates a standard, a legal decision impacts a standard, or changes in technology affect the interpretation. To assure that you are using the correct information and guidance, please consult OSHA’s website at http://www.osha.gov. If you have further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,

Patrick J. Kapust, Acting Director

Directorate of Enforcement Programs

1 Federal Register. Volume 56. No. 235, December 6, 1991, pages 64162-61463

2 https://www.osha.gov/enforcement/directives/cpl-02-02-069-0, XIII.G.1.