January 11, 1996

MEMORANDUM FOR: LINDA ANKU, REGIONAL ADMINISTRATOR
FROM: JOHN B. MILES, JR., DIRECTOR, Directorate of Compliance Programs
SUBJECT: Labeling of Latex

This memo is in response to your March 27 inquiry concerning reported latex allergy and failure of medical glove manufacturers to label "...latex gloves with warnings concerning the potential for sensitivity." It follows that you are seeking an interpretation and enforcement guidance regarding potential labelling issues under 29 CFR 1910.1200, the OSHA Hazard Communication standard. In reviewing your request and the information you provided, we have considered the issue from the standpoint of both the applicability of the Hazard Communication standard, and of the applicability of Section 4(b)(1) of the OSH Act which may preclude OSHA from regulation in this area in deference to authority exercised by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) in regulating latex medical gloves as "medical devices". We find that the FDA defines medical gloves, which would include the latex gloves in question, as "medical devices" and exercises regulatory authority over their manufacture, sale and distribution. Further, we find that the FDA specifically regulates glove quality (as "adulteration"; see FR 55 239 51254: December 12, 1990, enclosed) with respect to employee/health care worker safety; in this case, with respect to the effectiveness of gloves as barrier protection against HIV/HBV hazards. The FDA has subsequently published a medical alert (March 29, 1991, enclosed) which recognizes the hazard of latex allergy of health care workers. It is our understanding at this time, that the FDA has most recently stated that they are considering requiring latex labelling in the future.

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With respect to the applicability of the Hazard Communication standard, we find it may not be appropriate in this case for several reasons. In order to be applicable, the standard requires identification of a "hazardous chemical." The information available at this time is not sufficient to determine that the reported cases of latex allergy are caused by an identifiable chemical that can be classified as "hazardous" under the definitions of Appendix A of the Hazard Communication standard. The criteria of Appendix A regarding a chemical "sensitizer" may not be met as it is unclear whether the reported instances of latex allergy are induced by exposure and/or if, as the definition requires, "a substantial proportion of exposed... (employees)... develop an allergic reaction in normal tissue after repeated exposure to the chemical."

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Therefore, it is not appropriate for OSHA to allege violations requiring warning labelling of medical gloves concerning latex allergy. Alternative protection is provided by other existing requirements that employers include consideration of allergy in conjunction with the personal protective equipment (PPE) requirements of 29 CFR 1910.1030, the OSHA Bloodborne Pathogens standard. Bear in mind that under paragraph (d)(3)(iii) of the standard, an employer is required to provide "Hypoallergenic gloves, glove liners, ...or other similar alternatives to those employees who are allergic to the gloves normally provided." OSHA expects employers to accomplish the requirements of this provision through employee training and surveillance of PPE use. With the implementation of this alternative, the absence of the warning labelling at issue here is not reasonably expected to diminish employee protection.

Should you have further questions concerning this issue, please contact Lewis Ligon at (202)219-8036.

Enclosures

(For Federal Register, December 12, 1990, see printed copy.)