Section 25306 - Chemicals Formally Identified by Authoritative Bodies (California Code of Regulations)

§ 25306. Chemicals Formally Identified by Authoritative Bodies

(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:

(1) the chemical has been included on a list of chemicals causing cancer or reproductive toxicity issued by the authoritative body; or is the subject of a report which is published by the authoritative body and which concludes that the chemical causes cancer or reproductive toxicity; or has otherwise been identified as causing cancer or reproductive toxicity by the authoritative body in a document that indicates that such identification is a final action; and

(2) the list, report, or document specifically and accurately identifies the chemical, and has been:

(A) Reviewed by an advisory committee in a public meeting, if a public meeting is required, or

(B) Made subject to public review and comment prior to its issuance, or

(C) Published by the authoritative body in a publication, such as, but not limited to, the federal register for an authoritative body which is a federal agency, or

(D) Signed, where required, by the chief administrative officer of the authoritative body or a designee, or

(E) Adopted as a final rule by the authoritative body, or

(F) Otherwise set forth in an official document utilized by the authoritative body for regulatory purposes.

(e) For purposes of this section, "as causing cancer" means that either of the following criteria has been satisfied:

(1) Sufficient evidence of carcinogenicity exists from studies in humans. For purposes of this paragraph, "sufficient evidence" means studies in humans indicate that there is a causal relationship between the chemical and cancer.

(2) Sufficient evidence of carcinogenicity exists from studies in experimental animals. For purposes of this paragraph, "sufficient evidence" means studies in experimental animals indicate that there is an increased incidence of malignant tumors or combined malignant and benign tumors in multiple species or strains, in multiple experiments (e.g., with different routes of administration or using different dose levels), or, to an unusual degree, in a single experiment with regard to high incidence, site or type of tumor, or age at onset.

(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:

(1) Studies in humans indicate that there is a causal relationship between the chemical and reproductive toxicity, or

(2) Studies in experimental animals indicate that there are sufficient data, taking into account the adequacy of the experimental design and other parameters such as, but not limited to, route of administration, frequency and duration of exposure, numbers of test animals, choice of species, choice of dosage levels, and consideration of maternal toxicity, indicating that an association between adverse reproductive effects in humans and the toxic agent in question is biologically plausible.

(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:

(1) there is no substantial evidence that the criteria identified in subsection (e) or subsection (g) have been satisfied, or

(2) the chemical is no longer identified as causing cancer or reproductive toxicity by the authoritative body.

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:

(1) International Agency for Research on Cancer solely as to transplacental carcinogenicity

(2) National Institute for Occupational Safety and Health

(3) National Toxicology Program solely as to final reports of the National Toxicology Program's Center for Evaluation of Risks to Human Reproduction

(4) U. S. Environmental Protection Agency

(5) U. S. Food and Drug Administration

(m) The following have been identified as authoritative bodies for the identification of chemicals as causing cancer:

(1) International Agency for Research on Cancer

(2) National Institute for Occupational Safety and Health

(3) National Toxicology Program

(4) U. S. Environmental Protection Agency

(5) U. S. Food and Drug Administration

(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.

Disclaimer: This content is regularly reviewed to ensure the information is current and accurate. However, Section 25306 Chemicals Formally Identified by Authoritative Bodies may have been updated since our last review. For the latest version of all legislation, please check the official resources.

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