Preliminary TSCA health studies on material safety data sheets

June 17, 1996

Michael C. Strong
Industrial Hygienist
Wacker Silicones Corp.
[Recipient address omitted]
Dear Mr. Strong:

Thank you for your letters of February 19, March 4, and March 18, to the Occupational Safety and Health Administration (OSHA) regarding the Hazard Communication Standard (HCS)(29 CFR 1910.1200) requirements for reporting health hazard information on a Material Safety Data Sheet (MSDS). Specifically, you asked whether preliminary health effects reports filed under the Environmental Protection Agency (EPA) Toxic Substance Control Act (TSCA) Section 8(e) notification of substantial risk requirements must be included on an MSDS, or whether the information may be omitted from the MSDS until final submission of the completed study.

According to paragraph 1910.1200(d)(2) of the HCS, chemical manufacturers evaluating chemicals must identify and consider the available scientific evidence concerning chemical hazards. For health hazards, evidence which is statistically significant and which is based on at least one positive study conducted in accordance with established scientific principles is considered to be sufficient to establish a hazardous effect if the results of the study meet the definitions of health hazards in the standard. The mandatory Appendix B of the HCS further states that the results of any studies which are designed and conducted according to established scientific principles, and which report statistically significant conclusions regarding the health effects of a chemical, are sufficient basis for a hazard determination and must be reported on the MSDS.

EPA's TSCA 8(e) reporting requirements are distinct from those of OSHA's HCS, and therefore, are independent requirements. However, as you noted in your letter of March 18, a TSCA 8(e) notice of substantial risk is required where available information "reasonably supports the conclusion that [the] substance or mixture presents a substantial risk of injury to health or the environment." Where these conclusions are supported by evidence that is statistically significant and based on at least one positive study, the effect must be reported on the MSDS.

In any case, it is the responsibility of the chemical manufacturer or importer to evaluate the available studies and determine whether the results of these studies must be reported on the MSDS.

We hope that this response provides the clarification you need. If you have further questions, please contact our office at (202) 219-8036.

Sincerely,
Ruth McCully, Director
Office of Health Compliance Assistance

[Requester letter reproduced on OSHA page; omitted here.]