Blood product labeling exemption for diagnostic kits

April 19, 1993

Kay J. Williams, MS
INCSTAR Corporation
[Recipient address omitted]
Dear Ms. Williams:

This is in further response to your letter of July 6, 1992, in which you requested a clarification of the Occupational Safety and Health Administration (OSHA) regulation 29 CFR 1910.1030, "Occupational Exposure to Bloodborne Pathogens." We apologize for the delay in this response.

Specifically, you wrote requesting the INCSTAR products be exempted from additional labeling requirements, based on the labeling exemption defined in Section (g)(1)(i)(F) of the standard. Your products include in-vitro medical diagnostic kits and components, and you stated in your letter that "INCSTAR product labeling is consistent with Food and Drug Administration (FDA) labeling requirements for in-vitro diagnostic products."

Your labels appear to be reviewed by the Food and Drug Administration as part of that agency's review of clinical and diagnostic products prior to allowing your product to be marketed, and the FDA reviews labeling changes you make as required. Therefore, your labeling procedures appear to meet the conditions of the labeling exemption of paragraph (g)(1)(i)(F).

This section allows blood and blood products bearing an identifying label as specified by the FDA, which have been screened for HBV and HIV antibodies and released for transfusion or other clinical use, to be exempted from 1910.1030's labeling requirements. Please note that employees handling your product continue to be covered by all of the other protections of this standard.

We hope this information has been responsive to your concerns. Thank you for your interest in worker safety and health.

Sincerely,
Roger A. Clark, Director
Directorate of Compliance Programs