Hazard data sheets for research pharmaceuticals

September 9, 1991

Ms. Carolyn S. Parker
Senior Contract Administrator
Office of Research Contracts
Research Triangle Institute
[Recipient address omitted]

Dear Ms. Parker:

Thank you for your letter of June 11, to the Occupational Safety and Health Administration (OSHA) regarding the requirement to develop material safety data sheets (MSDSs) for pharmaceutical products and controlled substances prepared and utilized by Research Triangle Institute (RTI). Please except my apology for the delay of this response.

OSHA's Hazard Communication Standard (HCS), 29 CFR 1910.1200, was first published in the Federal Register on November 25, 1982. The standard at that time applied only to the manufacturing sector, Standard Industrial Classification (SIC) Codes 20-39. OSHA was ordered by the U.S. Court of Appeals for the Third Circuit to expand the scope of the standard to cover all employers, and on August 24, 1987, a final rule covering all employers in all SIC codes was published. Due to subsequent administrative and court challenges, OSHA was prevented from (among other provisions) applying the requirements of the rule to the coverage of drugs in the nonmanufacturing sector.

However, as a result of a February 21, 1990, Supreme Court decision (see Dole, Secretary of Labor, et. al., v. United Steelworkers of America, et. al., No. 88-1434), all provisions of the rule are now in effect for all industrial segments, including the coverage of drugs and pharmaceuticals in the nonmanufacturing sector. MSDSs are required to be prepared and transmitted with the initial shipment of all hazardous chemicals including drugs and pharmaceutical products except for drugs as defined by the Federal Food, Drug and Cosmetic Act which are in solid, final form for direct administration to the patient (i.e., tablets, pills, or capsules) or which are packaged for sale to consumers in a retail establishment.

OSHA's HCS defines "chemical manufacturer" as "an employer with a workplace where chemical(s) are produced for use or distribution." Research institutes which produce or synthesize chemicals must develop MSDSs for the hazardous chemicals that they distribute to other workplaces. If a chemical is produced for in-house study only, an MSDS need not be generated, as long as there is MSDS information for the component chemicals utilized in the synthesis which are readily available on site to exposed employees. The "preparation and delivery of research quantities of materials," as discussed in your letter, is therefore not exempt from the requirements of the HCS, and the work RTI does involving these activities is covered under the scope of the standard.

MSDSs need not be "submitted" to OSHA. As discussed above, they are to be developed and transmitted with the initial shipment of the chemical to downstream employers, and whenever the information required to be included on the data sheet changes. For your further information, radioactivity and biological hazards are not covered by the HCS. If, however, another type of hazard is present along with the material (e.g., a container with a radioactive material is packed in a hazardous solvent), the container would be subject to the requirements of the HCS for the hazards of the solvent.

We hope this discussion has been responsive to the concerns you raised in your letter. For your information, we are enclosing a copy of the August 24, 1987, final Hazard Communication rule which expanded the scope of the standard to all workplaces as discussed herein. Further, as you may know, the State of North Carolina operates its own occupational safety and health program under a plan approved and closely monitored by Federal OSHA. The Occupational Safety and Health Act of 1970 gave the States the right to assume responsibility for their own occupational safety and health programs, and North Carolina operates such a State Plan program.

As a condition of plan approval, States are required to adopt and enforce standards that are either identical to or "at least as effective" as the Federal standards. For more information regarding the requirements of North Carolina's standards, you may wish to contact:

Commissioner North Carolina
Department of Labor
4 West Edenton Street
Raleigh, North Carolina 27603
Telephone: (919) 733-7166

Please feel free to contact us again if we can be of further assistance.

Sincerely,
Patricia K. Clark, Director
Directorate of Compliance Programs

Enclosure

[The requester’s June 11 letter reproduced on the OSHA page is omitted here.]