Section 25801 - General (California Code of Regulations)

§ 25801. General

(a) The determination of whether a level of exposure to a chemical known to the state to cause reproductive toxicity has no observable effect for purposes of Section 25249.10(c) of the Act shall be based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of a chemical as known to the state to cause reproductive toxicity. Nothing in this article shall preclude a person from using evidence, standards, assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure has no observable effect at one thousand (1,000) times the level in question.

(b) A level of exposure to a listed chemical shall be deemed to have no observable effect, assuming exposure at one thousand times that level, provided that the level is determined:

(1) By means of an assessment that meets the standards described in Section 25803 to determine the maximum dose level having no observable effect, and dividing that level by one thousand (1,000) to arrive at the maximum allowable dose level; or

(2) By application of a specific regulatory level for the chemical in question as provided in Section 25805.

(c) For purposes of this article, "NOEL" shall mean that no observable effect level, which is the maximum level of exposure at which a chemical has no observable reproductive effect.

(d) The chemicals specifically contained in this article do not include all chemicals listed as causing reproductive toxicity for which there is a level of exposure which has no observable effect assuming exposure at one thousand times the level in question. The fact that a chemical does not specifically appear in this article does not mean that it has an observable effect at any level.

(e) This article establishes exposure levels solely for purposes of Section 25249.10(c) of the Act. Nothing in this article shall be construed to establish exposure levels for other regulatory purposes.

(f) Whenever the lead agency proposes to formally adopt a regulation pursuant to Sections 25801 through 25821, such as a maximum allowable dose level, the lead agency shall provide each member of the Developmental and Reproductive Toxicant Identification Committee notice of the proposed action, the proposed change to the regulation, and a copy of the initial statement of reasons supporting the proposal for their review and comment. The Committee shall be given at least 45 days to comment. Any such comment by members of the Developmental and Reproductive Toxicant Identification Committee shall become a part of the formal rulemaking record. Nothing in this section shall be construed to require the members of the Developmental and Reproductive Toxicant Identification Committee to submit any comments. This procedure complies with the peer review requirements of section 57004 of the California Health and Safety Code.

(1. New section filed 2-24-88 as an emergency; operative 2-27-88 (Register 88, No. 11). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-27-88. 2. New section refiled 6-27-88 as an emergency; operative 6-27-88 (Register 88, No. 27). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 10-25-88. 3. New section refiled 10-17-88 as an emergency; operative 10-25-88 (Register 88, No. 44). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-22-89. 4. New section refiled 2-21-89 as an emergency; operative 2-22-89 (Register 89, No. 10). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-22-89. 5. Certificate of Compliance including amendment transmitted to OAL 6-9-89 and filed 7-10-89 (Register 89, No. 30). 6. Amendment filed 1-7-2003; operative 2-6-2003 (Register 2003, No. 2). 7. Change without regulatory effect renumbering title 22, division 2, subdivision 1, chapter 3, article 8 (sections 12801-12821) to title 27, division 4, chapter 1, article 8 (sections 25801-25821) and renumbering title 22, section 12801 to title 27, section 25801, including amendment of subsections (b)(1)-(2), filed 6-18-2008 pursuant to section 100, title 1, California Code of Regulations (Register 2008, No. 25). 8. Amendment of subsection (c) filed 3-17-2011; operative 4-16-2011 (Register 2011, No. 11). 9. New subsection (f) and amendment of Note filed 7-12-2012; operative 8-11-2012 (Register 2012, No. 28).)

Note: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.5, 25249.6, 25249.9, 25249.10, 25249.11 and 57004, Health and Safety Code.

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