California Code of Regulations
Title 27 - Environmental Protection
Division 4 - Office of Environmental Health Hazard Assessment
Chapter 1 - Safe Drinking Water and Toxic Enforcement Act of 1986
Article 3 - Science Advisory Board: Carcinogen Identification Committee and Developmental and Reproductive Toxicant (Dart) Identification Committee
Section 25306 - Chemicals Formally Identified by Authoritative Bodies
Current through Register 2024 Notice Reg. No. 38, September 20, 2024
(a) Pursuant to section 25249.8(b) of the Act, a chemical is known to the state to cause cancer or reproductive toxicity if the lead agency determines that an authoritative body has formally identified the chemical as causing cancer or reproductive toxicity, as specified in this section.
(b) A "body considered to be authoritative" is an agency or formally organized program or group which utilizes one of the methods set forth in subsection (d), for the identification of chemicals, and which the Carcinogen Identification Committee has identified as having expertise in the identification of chemicals as causing cancer or the DART Identification Committee has identified as having expertise in the identification of chemicals as causing reproductive toxicity. For purposes of this section, "authoritative body" means either a "body considered to be authoritative" in the identification of chemicals as causing cancer by the Carcinogen Identification Committee or a "body considered to be authoritative" in the identification of chemicals as causing reproductive toxicity by the DART Identification Committee. The Carcinogen Identification Committee and the DART Identification Committee shall have the authority to revoke or rescind any determination that a body is authoritative on the grounds that the respective Committee no longer considers the body to have expertise in the identification of chemicals as causing cancer or reproductive toxicity, respectively, in which case chemicals listed pursuant to this section prior to the effective date of the revocation shall remain on the list. Nothing in this section shall be construed to limit or otherwise interfere with such authority.
(c) The lead agency shall determine which chemicals have been formally identified by an authoritative body as causing cancer or reproductive toxicity.
(d) For purposes of this section a chemical is "formally identified" by an authoritative body when the lead agency determines that:
(e) For purposes of this section, "as causing cancer" means that either of the following criteria has been satisfied:
(f) The lead agency shall find that a chemical does not satisfy the definition of "as causing cancer" if scientifically valid data which were not considered by the authoritative body clearly establish that the chemical does not satisfy the criteria of subsection (e), paragraph (1) or subsection (e), paragraph (2).
(g) For purposes of this section, "as causing reproductive toxicity" means that either of the following criteria have been satisfied:
(h) The lead agency shall find that a chemical does not satisfy the definition of "as causing reproductive toxicity" if scientifically valid data which were not considered by the authoritative body clearly establish that the chemical does not satisfy the criteria of subsection (g), paragraph (1) or subsection (g), paragraph (2).
(i) At least 60 days prior to adding a chemical determined to have been formally identified by an authoritative body as causing cancer or reproductive toxicity to the list of chemicals known to the state to cause cancer or reproductive toxicity, the lead agency shall cause to be published in the California Regulatory Notice Register a notice identifying the authoritative body and the chemical, and stating the lead agency's intention to cause the chemical to be added to the list. Copies of the notice shall be provided to the Carcinogen Identification Committee or the DART Identification Committee, as appropriate, to permit the appropriate Committee at least 30 days to review and comment on the proposed action. Within 30 days following the publication of the notice, interested parties, including any member of the appropriate Committee, shall submit to the lead agency their written objections to the addition of the chemical to the list of chemicals known to the state to cause cancer or reproductive toxicity, along with any supporting documentation. Objections shall be made on the basis that there is no substantial evidence that the criteria identified in subsection (e) or in subsection (g) have been satisfied. The lead agency shall review such objections. If the lead agency finds that there is no substantial evidence that the criteria identified in subsection (e) or in subsection (g) have been satisfied, the lead agency shall refer the chemical to the appropriate Committee to determine whether, in the Committee's opinion, the chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity.
(j) Subsequent to the addition of a chemical determined to have been formally identified by an authoritative body as causing cancer or reproductive toxicity to the list of chemicals known to the state to cause cancer or reproductive toxicity, the lead agency shall reconsider its determination that the chemical has been formally identified as causing cancer or reproductive toxicity if the lead agency finds:
Reconsideration may be initiated by the lead agency on its own motion, or on a request from an interested party, including any member of the appropriate Committee. The lead agency shall refer chemicals under reconsideration pursuant to this subsection to the appropriate Committee for a recommendation concerning whether the chemical should continue to be included on the list of chemicals known to the state to cause cancer or reproductive toxicity. Pending such reconsideration, the chemical shall remain on the list.
(k) The Carcinogen Identification Committee or the DART Identification Committee may condition any determination that a body is considered to be authoritative upon the subsequent application of the controls set forth in this section to the determination of which chemicals have been formally identified by the body as causing cancer or reproductive toxicity. In the event that this section or any portion thereof is found to be invalid by any court of competent jurisdiction, the Carcinogen Identification Committee or the DART Identification Committee may determine that such invalidation constitutes a failure of the condition. Upon finding such failure of condition, the determination that the body is authoritative shall be deemed to be revoked. Chemicals which the lead agency has determined have been formally identified by the body as causing cancer or reproductive toxicity pursuant to the controls set forth in this section and which have been placed upon the list of chemicals known to the state to cause cancer or reproductive toxicity prior to such revocation shall remain on the list.
(l) The following have been identified as authoritative bodies for purposes of this section for the identification of chemicals as causing reproductive toxicity:
(m) The following have been identified as authoritative bodies for the identification of chemicals as causing cancer:
1. New section filed 10-30-89 as an emergency; operative 10-30-89 (Register 89, No. 44). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-27-90.
2. Change without regulatory effect filed 10-31-89 pursuant to section 100, Title 1, California Code of Regulations (Register 89, No. 44).
3. Certificate of Compliance as to 10-30-89 order including amendment of subsections (c)-(l) transmitted to OAL 2-27-90 and filed 3-29-90 (Register 90, No. 16).
4. Amendment of subsection (l) submitted to OAL for printing only pursuant to Government Code section 11343.8 (Register 90, No. 28).
5. Editorial correction of printing error relettering subsection (d) (Register 90, No. 45).
6. Certificate of Compliance as to 10-24-94 order including amendment of section transmitted to OAL 2-22-95 and filed 4-5-95 (Register 95, No. 14).
7. Amendment of subsections (l)-(l)(1), repealer of subsection (l)(3), subsection renumbering, and new subsections (m)-(m)(5) filed 4-9-99; adopted and effective 7-27-98; changes not considered to be a regulation for the purposes of the Administrative Procedure Act pursuant to Health and Safety Code section 25249.8(e); printed pursuant to Government Code section 11343.8 (Register 99, No. 15).
8. Amendment of subsections (a), (b), (i) and (k) filed 1-7-2003; operative 2-6-2003 (Register 2003, No. 2).
9. Change without regulatory effect adopting new subsection (l)(3) and renumbering subsections filed 2-19-2003 pursuant to section 100, title 1, California Code of Regulations (Register 2003, No. 8).
10. Change without regulatory effect renumbering title 22, section 12306 to title 27, section 25306 filed 6-18-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 25).
Note: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.8 and 25249.12, Health and Safety Code.
