December 24, 1992

Dr. Clifford W. Lober
American Academy of Dermatology
930 N. Meacham Road
Post Office Box 4014
Schaumburg, Illinois 60168-4014

Dear Dr. Lober:

This is in further response to your inquiry of October 9, concerning the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200.

You requested guidance on whether "patch test kits" are exempt from the labeling requirements of HCS. If the patch test kit and its contents are subject to the labeling requirements of the Federal Food, Drug and Cosmetic Act and are labeled in accordance with the Food and Drug Administration, the kit would be exempt from the labeling requirements of HCS. This exemption, found in 29 CFR 1910.1200(b)(5)(ii), only applies to labels; employers must still comply with all other provisions of the standard.

You also list several instances that you feel would be exempt from all of the requirements of HCS, which we will address in the order that you presented them:

1) manufacturer supplied general office supply products, e.g., copier toner;

Chemicals such as copier toner in a business office, that are only used by employees incidentally in non-routine and isolated instances, are not covered by the standard. HCS would apply if copier toner was used by an employee whose job involves routine work with the toner. For example, employees who work in a copy room of an office or in a business establishment that professionally duplicates documents, must be trained and informed of hazards in accordance with HCS.

2) manufacturer supplied consumer supply products, e.g., daily use of Windex to clean surfaces;

Consumer products are only covered by HCS if the employees who use them experience exposures that are of greater duration and frequency than those of normal consumers, or if the product is not used in a manner that is consistent with normal consumer use.

A bottle of Windex could fall under the scope of chemicals that are covered by the company's HCS program if employees use the cleaner more frequently than normal consumer use, or if it is not used in the same manner that a normal consumer would use Windex. For example, cleaning staff who use the product repeatedly on a daily basis would need information on the hazards of Windex because they use the product more frequently than a normal consumer would.

3) FDA approved drugs and emergency medical kits; and

MSDSs must be readily accessible to all workers who may be exposed to hazardous chemicals during normal conditions of use or during foreseeable emergencies at their workplaces, including FDA approved drugs. Such drugs are not subject to the labeling requirements of HCS when they are labeled in accordance with FDA guidelines, as per 29 CFR 1910.1200(b)(5). Unless otherwise exempted, they are subject to all other requirements of the standard.

Drugs that are in solid and final form for direct administration to the patient (i.e. tablets, pills or capsules) are completely exempt from the requirements of HCS, as per 29 CFR 1910.1200(b)(6). Vaccines, whose hazards are biological rather than chemical, are also exempt from the standard.

Medical kits are exempt from the HCS requirements because they are intended for employee consumption, as per 29 CFR 1910.1200(b)(6)(vi).

4) pharmaceutical sample medications.

Please see our answer to the question above. Sample medications are comparable to other FDA approved medications, and would be covered in the same manner.

We hope this information is helpful. If you have any further questions please contact the Office of Health Compliance Assistance at (202) 219-8036.

Sincerely,



Roger A. Clark, Director
Directorate of Compliance Programs