September 10, 2001

Mr. Christopher Healey
Executive Director, North America
Plasma Protein Therapeutics Association (PPTA) North America
1350 I Street NW
Suite 550
Washington, DC 20005

Dear Mr. Healey:

This letter is in response to the Plasma Protein Therapeutics Association's (PPTA's) February 15, 2000 and August 27, 2001 correspondence. The February 15, 2000 letter from PPTA's then-Director of Regulatory Affairs, Mr. Jason Bablak, to the Occupational Safety and Health Administration's (OSHA's) [Office of Health Enforcement] pertained to the coverage of plasma derivatives under the Bloodborne Pathogens Standard ("the standard" or "BPS"), 29 CFR §1910.1030. His letter followed an informal meeting he had with Mr. Craig Moulton of this office.

Within the last year and a half, we sent two interim letters to Mr. Bablak explaining the extensive research that would be necessary to formulate our response. Again, we apologize for the delay and hope that this letter serves as an answer to PPTA's request. We appreciated his including the background and supplemental information along with his request for an exemption under the standard.

We have carefully reviewed PPTA's package. PPTA's request is outlined below, followed by OSHA's response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any situations not delineated within the original correspondence.

Plasma Protein Therapeutics Association (PPTA) is a trade association representing the major commercial processors of plasma derivatives. PPTA requests that, "OSHA limit its interpretations that include plasma derivatives in the BPS definition of ‘blood,' and provide an exemption from the standard for FDA-approved, US-licensed plasma derivatives that have undergone viral inactivation and/or removal processes."

Your request deals only with plasma derivatives after they have been fully processed, such as when they are used in a health care facility. As you know, the Bloodborne Pathogens Standard is intended to protect workers in diverse settings from occupational exposure to blood and other potentially infectious materials (OPIM). The standard's definition of blood includes, "human blood, human blood components, and products made from human blood" [29 CFR §1910.1030(b)]. Clearly, because plasma derivatives are derived from human blood, they would be considered to be "products made from human blood"; plasma derivatives are covered by the standard.

Although it is true that OSHA exempts certain human cell lines from the BPS, human cell lines do not come under the definition of "blood." They are covered under subparagraph (b) of the definition of "Other Potentially Infectious Materials," which applies to cell or tissue cultures only if they actually contain a pathogen.

Your letter raises the question of whether occupational exposure to fully processed plasma derivatives in the absence of the precautions prescribed in the standard should be regarded as a de minimis violation, which would not require abatement or trigger a penalty. (According to 29 U.S.C. §658(a), the Secretary of Labor may issue de minimis notices "...with respect to de minimis violations which have no direct or immediate relationship to safety or health.") Please be aware that for the reasons listed below we do not consider violations of the standard based on exposure to fully processed plasma derivatives to be de minimis; we expect full compliance with the standard for these products.

Although the FDA requires blood testing for hepatitis B, HIV, and syphilis (21 CFR §§610.40, 610.45, 640.5), and has also proposed to require testing for hepatitis C and human T-lymphotropic virus [64 FR 45340 August 19, 1999], the FDA has no actual or proposed regulations on testing for parva-virus B19 and other pathogens, such as those causing arboviral infections, Creutzfeldt-Jakob disease, and viral hemorrhagic fever. Also, new viruses, for which there are no testing procedures, may arise. It should be remembered that HIV was once a new virus; AIDS appeared in blood transfusion recipients and others before the HIV virus was isolated in 1983 and 1984 [Preamble to OSHA Bloodborne Pathogen Standard, 56 FR 64013 (December 6, 1991)].

It can not be stated with certainty that FDA testing protocols for viral inactivation of plasma derivatives will protect workers from all occupational exposure to bloodborne pathogens. While most "finished product" plasma derivatives may be free from the pathogens listed above, even the FDA recognizes that "...despite multiple precautions, there are occasions when problems are identified which may increase the potential risk that the plasma derivative may transmit a communicable disease." [(Plasma Derivatives and Other Blood-Derived Products) 64 FR 45384 (June 15, 1999) (Requirements for Trucking and Notification)].

The FDA also states in its "Blood Action Plan" that many of its requirements for the U.S. blood supply are obsolete and in need of revision. Also, studies indicate that, though small, there is a risk of transmission of the pathogen causing Creutzfeldt-Jakob disease (CJD) or other currently unrecognized human viruses from blood products that may be corrected by improving viral and bacterial inactivation procedures (Mary E. Chamberland et al., Blood Safety, Emerging Infectious Diseases, Vol 4, 1998).

We would also like to point out that not applying the standard to plasma derivatives will have no appreciable effect on the BPS compliance responsibilities of the health care industry. Health care workers, such as nurses, who would handle plasma derivatives, already have occupational exposure to human blood and other potentially infectious materials; their employers must comply with the BPS for these exposures.

We do applaud PPTA's comprehensive efforts to introduce additional measures beyond what is required by the FDA to further ensure the safety of plasma derivatives. These efforts will clearly result in increased safety to workers and consumers alike. But, because of the potential risks indicated by recent studies, papers, federal action plans, and feedback from other public health agencies, as well as by the FDA-approved package inserts, and because manufacturing processes, procedures, and quality control vary greatly across the industry, OSHA must continue to enforce the Bloodborne Pathogens Standard with respect to plasma derivatives. If, in the future, further research, scientific/clinical evidence, and/or increased pathogen inactivation procedures indicate an absolute degree of safety, we will reassess our position.

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 or would still like to schedule a meeting to discuss this issue, please feel free to call the [Directorate of Enforcement Programs] at (202) 693-2100.

Sincerely,



Richard E. Fairfax, Director
[Directorate of Enforcement Programs]



cc: OSHA Regional Administrators
John Finlasin, PhD, Center for Biologic Evaluation and Research (CBER), Food and Drug Administration (FDA)