Regulatory Research Agencies


Last updated: December 6, 2007

The Occupational Safety and Health Administration (OSHA) is a division of the US Department of Labor mandated to “assure the safety and health of America’s workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace safety and health.”


Regulatory Authority

The Occupational Safety and Health Act of 1970 requires employers to “furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees” and to “comply with occupational safety and health standards promulgated under this Act.”

OSHA Regulatory Standards codified under Title 29 of the Code of Federal Regulations (29 CFR § 1910.1200) require “that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees.” Health hazards identified as being of particular concern to OSHA include “chemicals that are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes.”

Significantly, OSHA regulations (§ 1910.1200(g)(3)) provide that: “If no relevant information is found for any given category on the material safety data sheet, the chemical manufacturer, importer or employer preparing the material safety data sheet shall mark it to indicate that no applicable information was found.” Thus, the general requirement that chemical hazards be “evaluated” does not obligate manufacturers to conduct new testing of any kind to address the toxicological endpoints listed above (i.e., “the available results of toxicological testing in animal populations shall be used to predict the health effects that may be experienced by exposed workers”).

Hazardous properties are classified according to the United Nations’ Globally Harmonized System (GHS) and are reported in the form of Material Safety Data Sheets (MSDS), International Chemical Safety Cards (ICSC), or other similar documents that list:

  • Chemical and common name(s) of all ingredients determined to be health hazards
  • Physical and chemical characteristics (e.g., vapor pressure, flash point)
  • Physical hazards of the chemical (e.g., flammability, reactivity, explosive potential)
  • Health hazards, including signs and symptoms of exposure, and any medical conditions recognized as being aggravated by exposure
  • Primary route(s) of entry
  • OSHA permissible exposure limit, American Council on Government Industrial Hygienists Threshold Limit Value, and any other recommended exposure limit
  • Whether the chemical is listed in the National Toxicology Program’s Report on Carcinogens or International Agency for Research on Cancer monographs

Alternatives Policies & Actions

OSHA regulations state: “Chemical manufacturers, importers, and employers evaluating chemicals are not required to follow any specific methods for determining hazards, but they must be able to demonstrate that they have adequately ascertained the hazards of the chemicals produced or imported in accordance with the criteria set forth” in regulations. However, the regulations go on to note that “[i]n vitro studies alone generally do not form the basis for a definitive finding of hazard under the HCS since they have a positive or negative result rather than a statistically significant finding.”

OSHA’s current involvement in 3Rs activities appears to be limited to its membership in the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).