November 27, 1995

David J. Wilson, CIH
O'Brien & Gere Engineers, Inc.
5000 Brittonfield Parkway
Post Office Box 4873
Syracuse, New York, 13221

Dear Mr. Wilson:

This is in response to your letter of September 5, addressed to the Occupational Safety and Health Administration (OSHA). The letter requested clarification on several issues regarding OSHA's Hazard Communication Standard (HCS), 29 CFR 1910.1200. Specifically, your client repackages bulk supplies of toiletries, cosmetics, and non-prescription health care products and the manufacturers who supply the bulk materials have determined that they are not obligated for several reasons to supply Material Safety Data Sheets (MSDS's) to your client because they believe they are exempt from the requirements of the standard. The standard requires that chemical manufacturers or importers of chemicals perform a "Hazard Determination" on their chemical products to assess whether they are hazardous. The scope and depth of research of the hazard determination are given by 1910.1000(d), and Appendices A and B of the standard. If the product's chemicals are defined as hazardous given the parameters of the hazard determination, then the manufacturer or importer is required to prepare MSDS's according to 1910.1200(g) of the standard, and label according to 1910.1200(f), with identity and appropriate hazard warning, the containers of hazardous chemicals. In addition, for chemicals that are defined hazardous, the manufacturers or importer are required to provide the MSDS's and container labels to downstream users of chemical.

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Paragraph (b), Scope and Application, of the standard states that: "This section requires chemical manufacturers or importers to assess the hazards of chemicals which they produce..." The standard further defines produce to mean: "... to manufacture, process, blend, extract, generate, emit, or repackage." Manufacturers who provide bulk supplies for repackaging are clearly covered by the HCS and would be required to meet the MSDS requirements for hazardous chemicals.

There are a number of exemptions in paragraph 1910.1200(b)(6) of the HCS. Two exemptions that may appear to be relevant to your letter are subparagraphs (b)(6)(vii) and (b)(6)(ix); they are restated below:

"(vii) Any drug, as that term is defined in the Federal Food and Drug, and Cosmetic Act ... when it is in solid final from for direct administration to the patient (e.g., tablets or pills);"

"(ix) Any consumer product or hazardous substance, as those terms are defined in the Consumer Product Safety Act ... where the employer can show that it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended;"

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However, based on the information provided in your letter, repackaging of hazardous bulk supplies would not meet these exemptions. In the case of packaging pills, the HCS exemption only applies to direct patient administration of the pill or tablet. The suppliers of a box containing thousands of pills would not qualify for this exemption. For hazardous bulk material being packaged into health care products, the hazardous chemical exposures resulting from the packaging operation would be different, predictably of a significantly greater magnitude, and therefore, not comparable to that experienced by a normal consumer. Repackaging of hazardous bulk materials would not qualify for the consumer product exemption. The HCS provides workers exposed to chemicals with the right to know the chemicals' hazards and associated protective measures. As stated above the labels and MSDSs are developed by the chemical manufacturer or importer of the product, and provided to downstream employers. When employers have adequate information regarding chemical hazards, they are better able to establish appropriate protective programs to help prevent the occurrence of adverse effects to employees exposed to the chemical.

Your interest in occupational safety and health is appreciated. If we can be of further assistance please contact OSHA's Office of Health Compliance Assistance at (202) 219-8036.

Sincerely,

Ruth E. McCully, Director
Office of Health Compliance Assistance

September 6, 1995

Office of Health Compliance
Occupational Safety and Health Administration
U.S. Department of Labor
200 Constitution Avenue, NW
Washington, DC 20210

Re: Hazard Communication Standard (29 CFR 1910.1200)

Dear OSHA Official:

This letter is a request for an interpretation by the Occupational Safety and Health Administration regarding the Hazard Communication Standard (29 CFR 1910.1200) and the duties of manufacturers who provide bulk supplies of toiletries, cosmetics, and health care products to our client who packages these materials into personal use containers for distribution to hotels. Bulk supplies can consist of a box containing thousands of individual pills, 55-gallon drums of liquid, or other bulk storage containers of liquid or solid product.

Suppliers of bulk material have indicated the following reasons to our client why they are not required to provide an MSDS to companies that package their material. In addition, we have provided information identifying our concern with this interpretation by bulk material suppliers. Supplier statement: The material is a health care product for personal use that consists of direct administration, such as shampoo, hand lotion, bath gels, etc. Concern: Exposure to the material is not in the same manner as personal use, therefore an MSDS is required. Supplier statement: The material presents no known health hazard when handled according to the recommended directions. Concern: Recommended directions are for individual, personal use and do not apply to an exposure in a manufacturing environment; therefore, an MSDS is required. Supplier statement: The material is a drug in its final form for direct administration to the patient (pills). Concern: Pills are received in a box containing several thousand and worker exposure to pill dust that may be associated with processing and packaging would require an MSDS.

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Your assistance for an interpretation concerning an MSDS requirement associated with the above statements is appreciated.

Very truly yours,

O'BRIEN & GERE ENGINEERS, INC.
David J. Wilson, CIH
Senior Scientist