US Dept of Labor

Occupational Safety & Health AdministrationWe Can Help

Standard Interpretations - Table of Contents
• Standard Number: 1910.1030

April 19, 1993

Kay J. Williams, MS
INCSTAR Corporation
1990 Industrial Blvd.
PO Box 285
Stillwater, MN 55082-0285

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.


Roger A. Clark, Director
Directorate of Compliance Programs

Standard Interpretations - Table of Contents

Thank You for Visiting Our Website

You are exiting the Department of Labor's Web server.

The Department of Labor does not endorse, takes no responsibility for, and exercises no control over the linked organization or its views, or contents, nor does it vouch for the accuracy or accessibility of the information contained on the destination server. The Department of Labor also cannot authorize the use of copyrighted materials contained in linked Web sites. Users must request such authorization from the sponsor of the linked Web site. Thank you for visiting our site. Please click the button below to continue.