§ 69401.2. Definitions.

(a) “Adverse effect” for toxicological hazard traits and endpoints means a biochemical change, functional impairment, or pathologic lesion that negatively affects the performance of the whole organism, or reduces an organism's ability to respond to an additional environmental challenge. “Adverse effect” for environmental hazard traits and endpoints means a change that negatively affects an ecosystem, community, assemblage, population, species, or individual level of biological organization.

(b) “Authoritative organization” means a state, national, international or non-governmental entity whose scientific findings on the safety, risks or hazards of chemical agents are relied upon by state, national or international governments and their supporting public health or environmental entities in regulating or otherwise protecting human health or the environment from threats posed by those chemical agents. Authoritative organizations include the following:

(1) OEHHA, DTSC and other State of California Boards, Departments, Offices or Agencies

(2) The National Academy of Sciences, including the National Research Council and the Institute of Medicine

(3) Departments or Agencies of the United States government, including but not limited to: the Consumer Product Safety Commission, Environmental Protection Agency, National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, National Institute for Occupational Safety and Health, the Occupational Safety and Health Administration, and the Department of Transportation

(4) Environmental and public health regulatory agencies of other states

(5) Canadian government agencies including Environment Canada and Health Canada

(6) Governmental bodies within the European Union, including the European Chemicals Agency and national governments

(7) Any agency or program within the United Nations including the World Health Organization and its International Agency for Research on Cancer.

(c) A “chemical substance” is a chemical, chemical compound, chemical mixture, elemental material, particulate matter, fiber, or radioactive agent, its metabolites or degradation by-products.

(d) An “environmental endpoint” for a specific hazard trait is a measured or otherwise observed adverse environmental effect in ecological systems, or in components of ecological systems, or in non-human organisms within ecological systems that indicates the presence of the hazard trait.

(e) “Hazard traits” are properties of chemicals that fall into broad categories of toxicological, environmental, exposure potential and physical hazards that may contribute to adverse effects in exposed humans, domesticated animals, wildlife, or in ecological communities, populations or ecosystems.

(f) “Mechanistic similarity” means that a chemical substance acts on a biological system in a manner similar to other chemicals that induce toxicological or environmental effects associated with a specific hazard trait.

(g) “Other relevant data” for a specific toxicological or environmental hazard trait means non-endpoint data, including chemical, physical, biochemical, biological or other data, that may indicate a chemical substance may have the hazard trait.

(h) A “toxicological endpoint” for a specific hazard trait is a measured or otherwise observed adverse effect in a biological system that indicates the presence of the hazard trait.

(i) “Well-conducted scientific studies” means studies published in the open literature or conducted by or submitted to a local, state, national or international government agency, using methods and analyses which are scientifically valid according to generally accepted principles.

(j) “Wildlife” means undomesticated animals including but not limited to aquatic and terrestrial vertebrate and invertebrate organisms.

HISTORY

1. New section filed 12-20-2011; operative 1-29-2012 (Register 2011, No. 51).

Note

Note: Authority cited: Sections 25256.1 and 59012, Health and Safety Code. Reference: Sections 25256.1 and 59012, Health and Safety Code.