tal health and safety staff and/or with the local air quality authorities in monitoring and achieving compliance with these new CAA standards. Laboratory managers should also participate, along with their institution's environmental regulatory specialists, with the regulatory agencies in the development of workable rules for the laboratory special source category.


Under Title III of SARA, the Superfund Amendments and Reauthorization Act, facilities that use hazardous chemicals in their operations must maintain the Material Safety Data Sheets (MSDSs) required under OSHA's Hazard Communication Standard, submit copies of the MSDSs, provide inventories of hazardous chemicals, and report accidental releases to emergency planning authorities. The basic rationale for these regulations is twofold; the community's "right to know" what hazardous materials are present in facilities in their community, and the need for emergency response authorities and local fire departments to know what substances are being used or stored in case they are required to respond to a fire, explosion, release, or other emergency. "Hazardous chemical," however, is defined to exclude any chemical "to the extent it is used in a research laboratory or hospital or other medical facility under the direct supervision of a technically qualified individual." It is important to note, however, that (1) nonlaboratory uses of hazardous chemicals are not excluded, and (2) state or local laws relating to community right-to-know or emergency notification and response may, regardless of SARA exemptions, require chemical inventories or release notification for research laboratories.

Two other aspects of SARA Title III deserve mention. They are the emergency planning notification requirement and the release notification requirement. The emergency planning notification regulation requires that any institution that has an EPA-listed "extremely hazardous substance" on site in greater than EPA-specified "threshold planning quantities" must notify the state emergency response authorities. The quantity limits are based on the total quantity of the hazardous chemical present at the facility rather than in an individual laboratory.

The release notification provisions require that an institution notify state and community authorities in the event of a release into the environment of a "hazardous substance" or an "extremely hazardous substance" in excess of EPA-established "reportable quantities."

Another important aspect of SARA is the requirement for training of those who respond to emergencies involving hazardous materials. Although the training requirements are contained in OSHA regulations, Congress has stipulated that they should apply to all employers in all states. Researchers should contact their institution's environmental health and safety and/or local emergency response agencies to ascertain locally applicable requirements for notification and training.


The Toxic Substances Control Act (TSCA) is intended to control new or existing chemicals that may present unreasonable risks to human health or the environment. In 1976, Congress enacted this statute to fill gaps in chemical control not covered by other laws and agencies, such as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA). TSCA is not intended to overlap other laws that already regulate specified chemical uses. TSCA authorizes EPA to administer and enforce the rules it develops under TSCA.

TSCA's numerous sections deal with various aspects of chemical control:

  • reporting and record-keeping requirements of chemical manufacturers and processors,

  • establishment of an inventory of existing chemicals in U.S. commerce (the TSCA Inventory), and

  • requirements for premanufacture notification (PMN) of new chemicals to EPA.

TSCA also gives EPA authority to

  • require chemical testing,

  • ban or otherwise control chemicals in commerce,

  • control polychlorinated biphenyls (PCBs),

  • enforce and set penalties for violations, and

  • provide protection for confidential business information submitted to EPA.

TSCA's provisions have a major impact on chemical manufacturers and their associated research and development (R&D) laboratories. Primary regulations that can affect R&D laboratories are the R&D exemption from the PMN and "significant adverse reactions" in TSCA 8(c).

9.G.1 Research and Development (R&D) Exemption from the Premanufacture Notification (PMN)

Before a company can manufacture or import a new chemical (a chemical not listed on the TSCA Inventory), it must file a PMN with EPA and allow the agency a

The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement