March 7, 2007

Mr. Mark T. Dorobiala Facilities Manager Dartmouth-Hitchcock Clinic 21 East Hollis Street Nashua, NH 03060 Dear Mr. Dorobiala: Thank you for your October 19, 2006, letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). In your letter you requested clarification of OSHA's material safety data sheet (MSDS) requirement. Specifically, you inquired about a chemical manufacturer 's claimed exemption from developing and providing MSDSs to its downstream users. Your paraphrased scenario and question are presented below, followed by our response Scenario: Gentian Violet, which is a 1 percent anti-infective solution containing 9 percent alcohol, is used by your medical staff on patients. In your quest to update your MSDSs, you were unable to obtain the MSDS for this product from the manufacturer, Cumberland Swan. Cumberland Swan has informed you that this product is exempt from the Hazard Communication Standard (HCS) pursuant to 29 CFR 1910.1200(b)(5)(iii) and 29 CFR 1910.1200(b)(6)(viii) and 1910.1200(b)(6)(ix) because it is a cosmetic regulated by the Food and Drug Administration (FDA). However, after reviewing several letters of interpretation, including OSHA's 12/30/1992 interpretation to Ms. Marcia B.Richards, you believe that an MSDS is in fact required for this product.

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Question: Does Cumberland Swan need to provide an MSDS for their product, Gentian Violet?

Response: Yes, an MSDS is required for Gentian Violet, which is considered a hazardous chemical under the HCS. As an initial matter, cosmetics, such as Gentian Violet, labeled pursuant to the Federal Food, Drug and Cosmetic Act are exempt from the labeling provisions of the HCS, 29 CFR 1910.1200(b)(5)(iii). Cosmetics packaged for sale to consumers in a retail establishment and those intended for personal consumption by employees in the workplace are not covered by the HCS only if these conditions are met, 29 CFR 1910.1200(b)(6)(viii). However, cosmetics such as Gentian Violet are covered when they contain hazardous chemicals and used in an occupational setting such as a medical office where employees are exposed to the product repeatedly during work. At your facility, employees are exposed whenever they use the product on the patients and, therefore, must be made aware of the hazards and recommended protective measures through an MSDS even if it is considered a cosmetic.

In the event you make another request for an MSDS, Cumberland Swan should be made aware that: 1) your employees are not personally using this product; 2) it is being used in an occupational setting repeatedly throughout the workday; and 3) although ordinarily considered a "consumer product," the use of Gentian Violet in your workplace results in duration and frequency of exposures far greater than exposures experienced by normal consumers using it for its intended purpose. The exemption to the HCS stated in 1910.1200(b)(6)(viii) and 1910.1200(b)(6)(ix), therefore, does not appear to apply to this product as used in your workplace.

Sincerely,

Richard E. Fairfax, Director
Directorate of Enforcement Programs