Definitions and key terms

Under 1990.103, "Act" means the Occupational Safety and Health Act of 1970 (Pub. L. 91-596, 84 Stat. 1590 et seq., 29 U.S.C. 551 et seq.).

• This is the statutory law that establishes OSHA and the obligations referenced in this part. See 1990.103 for the exact wording.

Under 1990.103, "Administrator of EPA" means the Administrator of the United States Environmental Protection Agency, or a designee.

• In practice, this means the person in charge of the EPA or someone officially delegated to act for the Administrator. See 1990.103.

Under 1990.103, "Chairperson of CPSC" means the Chairman of the United States Consumer Product Safety Commission, or a designee.

• This definition covers the Commission head or anyone officially designated to act on their behalf. See 1990.103.

Under 1990.103, "Commissioner of FDA" means the Commissioner of the Food and Drug Administration, United States Department of Health and Human Services, or a designee.

• That is, the agency head or their authorized representative. See 1990.103.

Under 1990.103, "Director of NCI" means the Director of the National Cancer Institute, United States Department of Health and Human Services, or a designee.

• This covers the NCI Director or someone officially delegated to act for the Director. See 1990.103.

Under 1990.103, "Director of NIEHS" means the Director of the National Institute of Environmental Health Sciences, United States Department of Health and Human Services, or a designee.

• The term covers the NIEHS Director or an individual officially delegated to act on the Director's behalf. See 1990.103.

Under 1990.103, "Director of NIOSH" means the Director of the National Institute for Occupational Safety and Health, United States Department of Health and Human Services, or a designee.

• This means the NIOSH Director or someone the Director formally authorizes. See 1990.103.

Under 1990.103, "Mutagenesis" means the induction of heritable changes in the genetic material of either somatic or germinal cells.

• In plain language: mutagenesis refers to changes in DNA that can be passed on in body cells (somatic) or reproductive cells (germinal). See 1990.103.

Under 1990.103, "Positive results in short-term tests" means positive results in assays for two or more of the listed types of effects.

• The listed assay types are:

  • the induction of DNA damage and/or repair;
  • mutagenesis in bacteria, yeast, Neurospora or Drosophila melanogaster;
  • mutagenesis in mammalian somatic cells;
  • mutagenesis in mammalian germinal cells; or
  • neoplastic transformation of mammalian cells in culture.

• So, to meet this definition you need positive assays in at least two of the above categories. See 1990.103.

Yes. Under 1990.103, the definition explicitly includes mutagenesis assays in bacteria, yeast, Neurospora, or Drosophila melanogaster as one of the recognized test types.

• A substance showing positive results in two or more of the listed test types (including these) meets the part's definition of "positive results in short-term tests." See 1990.103.

Yes. Under 1990.103, "neoplastic transformation of mammalian cells in culture" is listed as one of the types of effects that count toward "positive results in short-term tests."

• It is one of five specific assay outcomes; two or more positive outcomes are required to meet the definition. See 1990.103.

Under 1990.103, a "Potential occupational carcinogen" is any substance or mixture that increases the rate of benign or malignant tumors, or that greatly shortens the time between exposure and tumor development in humans or in one or more experimental mammal species.

• This includes substances causing tumors after oral, breathing, skin, or other exposures that produce tumors at a site different from the administration site.
• It also covers substances that are metabolized by mammals into one or more potential occupational carcinogens. See 1990.103.

Yes. Under 1990.103, a "Potential occupational carcinogen" can be any substance, or a combination or mixture of substances, that meets the carcinogenic criteria described.

• That means employers must consider mixtures and not just single chemicals when assessing occupational cancer risk. See 1990.103.

Yes. Under 1990.103, the definition explicitly includes any substance which is metabolized into one or more potential occupational carcinogens by mammals.

• In other words, a parent chemical that becomes carcinogenic after metabolism is covered. See 1990.103.

Under 1990.103, the definition covers oral, respiratory, dermal, or any other exposure that results in the induction of tumors at a site other than the site of administration.

• That means ingestion, inhalation, skin contact, and other exposure routes that lead to tumor formation are included. See 1990.103.

Yes. Under 1990.103, "Mutagenesis" is defined as the induction of heritable changes in the genetic material of either somatic (body) or germinal (reproductive) cells.

• This confirms that mutagenic effects on both cell types are within the definition. See 1990.103.

Under 1990.103, "Secretary of HHS" means the Secretary of the United States Department of Health and Human Services, or a designee.

• This refers to the HHS head or an official delegated to act for that person. See 1990.103.

Yes. Under 1990.103, the term requires positive results in assays for two or more of the specified types of effect.

• That means a single positive assay is not enough; at least two different categories listed in the definition must show positive results. See 1990.103.