April 13, 1993

Dr. Joseph Ferro
Assistant Medical Director
Bristol-Myers Squibb Company
One Squibb Drive
Post Office Box 191
New Brunswick, New Jersey 08903-0191

Dear Dr. Ferro:

This is in response to your letter of November 10, 1992, in which you requested an interpretation regarding the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." Specifically, you requested that Albumin Human USP be excluded from coverage under the standard.

You state that this product "is prepared via a cold ethanol fractionation process, heat treated to kill bloodborne pathogens, tested as per FDA approved procedures and is considered safe for intravenous use." You submitted a package of literature and data intended to support your contention that this product "poses no risk to employees who handle it in our manufacturing facility." You also included a supporting letter from the New Jersey Blood Services.

OSHA has reviewed the material you submitted and has decided that Albumin Human USP cannot be excluded from the standard's definition of blood (i.e., human blood, human blood components, and products made from human blood) on the basis that it is not an infectious material and, therefore, that employees who handle it are covered under the scope of the regulation.

During the public comment period that followed publication of OSHA's proposed standard, the agency received comments from at least two parties stating that some human blood products such as sterile human albumin do not present a risk and recommending that the definition of blood be amended to exclude products that have been treated to render bloodborne pathogens noninfectious. In issuing the final standard, OSHA was concerned with the lack of information in the public record dealing with such treatment and left stand the definition. An allowance was made for an exception to the labeling requirement for these products (see paragraph g(1)(i)(F) of the standard).

Sterility is a process that is determined by lot and/or batch validation. The sterility validation data is scrutinized under the appropriate statistical sampling methodology which ensures the acceptability of a lot being characterized as sterile. It is our understanding that all methods of validation, statistical validation methodologies, and data review fall under the regulatory mandate of the Food and Drug Administration (FDA) and its regional laboratories.

FDA compliance inspections may include validation of sterility for a representative sample of a specific product as well as a records review of overall sterilization procedures. This, however, does not ensure that a specific lot is sterile and/or pyrogen-free.

At the same time, OSHA has decided that failure to provide employees handling only this product with certain protections of the bloodborne pathogens standard (such as personal protective equipment) will be considered a technical "de minimis" violation bearing no penalties provided that an FDA certificate of analysis validating sterility and issued within the preceding two years is available for the product in question. Such certification was not included in your package and the letter from the New Jersey Blood Services would not suffice for this purpose.

Because training employees in the recognition of products to which universal precautions and other requirements of the standard apply is critical, failure to train even those employees handling only human albumin USP would not be considered a "de minimis" violation and would result in a "serious" citation.

Please bear in mind that if any employee who handles a sterile product also handles any blood products for which the FDA certificate of sterility is not available, the employer will be held responsible for providing all the protections of the standard to that employee.

We hope this information is responsive to your concerns and thank you for your interest in worker safety and health.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs