December 27, 2002

Mr. Michael Cannavo
Vice President, Global Environment, Health, and Safety Matters
Aventis Behring, L.L.C.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA 19406

Dear Mr. Cannavo:

Thank you for your February 20 letter to the Occupational Safety and Health Administration's (OSHA's) [Directorate of Enforcement Programs]. You wrote in response to a letter of interpretation (Healey, September 10, 2001) that we issued regarding the inclusion of plasma derivatives within the scope of the bloodborne pathogens standard, 29 CFR 1910.1030. Over the last several months, we have had the opportunity to meet with you and your colleagues to discuss the implications of that letter for the safety and health of workers who handle, treat, collect, or administer plasma-derived products.

Your letter specifically requests an exemption from the standard for "market-ready, fully processed, plasma-derived products." You feel their inclusion under OSHA's standard "negatively impacts your business" and "increases the possibility that [Aventis] will have to defend unfounded litigation [from consumers] [clarification added]." We have considered your request, and after much thought and research, have decided against granting this exemption.

The standard, ". . .applies to all occupational exposure to blood or other potentially infectious materials [OPIM] as defined by paragraph (b) of this section. . ." (29 CFR 1910.1030(a)). "Blood" is defined as, ". . .human blood, human blood components, and products made from human blood." (29 CFR 1910.1030(b)). Thus, since plasma-derived products are products made from human blood they are "blood" within the meaning of the standard, and occupational exposure to plasma-derived products triggers the standard operation.

It would be inappropriate to revise the standard to grant an exemption from the standard for plasma-derived products or to classify violations involving occupational exposure to such products as de minimis. We note that according to the Food and Drug Administration's Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (January 2002), "for plasma-derived products other than albumin, you should revise the package insert warning section to include the following statement: Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent."

The material that you supplied with your request indicates that you strive to exceed the levels of testing and processing required by the FDA, and we applaud your efforts. However, as evidenced by the above recommendation, as of January 2002 it is the opinion of the FDA that a sufficient risk of bloodborne pathogens transmission exists to warrant precautionary labeling. In addition, new pathogens (e.g., West Nile virus) capable of bloodborne transmission for which there are no adequate testing guidelines, continue to arise. In view of the above, OSHA concludes that plasma derivatives pose a risk of bloodborne pathogens transmission.

Again, we do applaud Aventis Behring's continued efforts to ensure worker and product safety to the highest possible degree and 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