September 9, 1991

Ms. Carolyn S. Parker
Senior Contract Administrator
Office of Research Contracts
Research Triangle Institute
Post Office Box 12194
Research Triangle Park, North Carolina 27709-2194

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.

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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

Sincerely,

Patricia K. Clark, Director
Directorate of Compliance Programs

Enclosure

June 11, 1991

Department of Labor
Occupational Safety and Health Administration
Frances Perkins Building, Room H3469
200 Constitution Avenue, N.W.
Washington, D.C. 20210

ATTENTION: Ms. Patricia Clark, Health Standards Division

Dear Ms. Clark:

Research Triangle Institute (RTI) is a not for profit research institute located in Research Triangle Park, North Carolina. One of the Institute's technical operating units, the Chemistry and Life Sciences Group provides custom synthesis services to other researchers in the Government and industry. RTI prepares radiolabeled, stable isotope labeled and unlabeled compounds of various classes such as pharmaceuticals including contraceptives, controlled drug standards (DEA Schedules I - V), and compounds of environmental interest for use in research and testing. Our Standard Industrial Code Classification is No. 8731. As RTI is not incorporated as a chemical manufacturer or importer, but a research institute we understand that the requirements of 29 CPR1910.1200 are not applicable to these custom synthesis activities.

RTI has received a Request for Proposals from the National Institute on Drug Abuse entitled "Synthesis and Distribution of Drugs of Abuse" which incorporates FAR 52.223-3, "Hazardous Material Identification and Material Safety Data". Briefly, the research support required includes the custom synthesis, storage and distribution of labeled and unlabeled drugs of abuse, related compounds and drug metabolites in research quantities to researchers designated by NIDA. Most of the compounds are designated as DEA Schedule I. We understand that such activities (preparation and delivery of research quantities of materials) may be exempt from the requirements for MSDS preparation. In addition, RTI assumes that the requirement for submission of Material Safety Data Sheets would not be required of non-manufacturers. However, written interpretation regarding this matter is requested. If you have questions or require additional information, please contact the undersigned at (919)541-6184. Thank you for your consideration and prompt response.

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Sincerely,

Carolyn S. Parker
Senior Contract Administrator
Office of Research Contracts