§ 69402.2. Evidence for Carcinogenicity Hazard Trait.

(a) Each of the following constitutes strong evidence of carcinogenicity for a given chemical substance:

(1) Identification as known to the state to cause cancer in Title 27, California Code of Regulations, section 27001.

(2) Meeting the U.S. Environmental Protection Agency's criteria for being identified as Carcinogenic to Humans or Likely to Be Carcinogenic to Humans or as a Group A, B1 or B2 carcinogen.

(3) Meeting the International Agency for Research on Cancer criteria for Group 1, 2A, or 2B classification.

(4) Meeting the criteria for classification as known to be or reasonably anticipated to be a human carcinogen by the U.S. National Toxicology Program.

(5) Meeting the criteria for being classified as a Category 1 Known or Presumed Carcinogen under the United Nation's Globally Harmonized System for Classification and Labeling of Chemicals.

(6) Identification as or other recognition that the chemical substance is a known or potential carcinogen in a report by the National Academy of Sciences' National Research Council or Institute of Medicine.

(7) Recognition as a known or potential carcinogen by an authoritative organization.

(b) Each of the following constitutes suggestive evidence of carcinogenicity for a given chemical substance:

(1) Identification by the U.S. Environmental Protection Agency as having Suggestive Evidence of Carcinogenic Potential, or as being in Group C.

(2) Meeting the International Agency for Research on Cancer criteria for limited evidence of carcinogenicity in animals.

(3) Recognition as a suspected carcinogen by an authoritative organization.

(4) Possessing strong evidence for the Genotoxicity Hazard Trait as defined in Article 3 subsection 69403.5 of this Chapter.

(5) Mechanistic evidence that is suggestive of carcinogenic potential, from cell-based, tissue-based or whole organism-based assays showing perturbations of known physiological, biochemical or other pathways involved in carcinogenesis, such as described by the International Agency for Research on Cancer in the current Preamble to its Monographs on the Evaluation of Carcinogenic Risks to Humans.

(6) Strong indications of carcinogenicity from structure activity relationships, including but not limited to those from Quantitative Structure Activity Relationship models.

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.