Notice of Modification of Text of Proposed Regulation - Title 22, California Code of Regulations, Sections 69401 Through 69406 - Green Chemistry Toxics Information Clearinghouse Identification of Hazard Traits, Endpoints and Other Relevant Data
Green Chemistry Toxics Information Clearinghouse Identification of Hazard Traits, Endpoints and Other Relevant Data for Inclusion in the Toxics Information Clearinghouse
The Office of Environmental Health Hazard Assessment (OEHHA) is providing notice of changes made to the proposed regulation: Title 22, California Code of Regulations, sections 69401 through 69406. A Notice of Proposed Rulemaking was originally issued for this proposed regulation on December 17, 2010 and published in the California Regulatory Notice Register (Register 2010, No 51-Z). The proposed regulation is related to the specification of hazard traits by OEHHA as required by Senate Bill (SB) 509 (Simitian, Chapter 560, Statutes of 2008). A public hearing on this regulatory proposal was held on January 31, 2011. Written comments from the public were received during a 45-day comment period which closed on February 15, 2011. Pursuant to Health and Safety Code (HSC) section 57004, the University of California coordinated an external scientific peer review of the proposed regulation. Comments from the three peer reviewers were received in June 2011.
OEHHA has reviewed the comments it received and is now proposing modifications to the proposed regulation. The comments received are posted on the OEHHA website or may be requested from Monet Vela at the OEHHA Legal Office at (916) 323-2517.
A copy of the text of the amended proposed regulation is attached. The proposed additions and deletions are shown in strike-out and underline. The page numbers for the table of contents and document page numbers have been changed to reflect the document shifts caused by the text modifications. Due to formatting difficulties, these number changes have not been shown in strike-out and underline. The changes to the proposed text, which were made in response to public comments and comments by the peer reviewers, are as follows:
- Amended definitions of “environmental endpoints” and “hazard traits” for clarity.
- Added the words “contributing to” to the definitions of the hazard traits eutrophication (subsection 69404.2(a)) and loss of genetic diversity (subsection 69404.4(a)) because chemicals contribute to, but are not solely responsible for, the adverse effects covered in the definitions of these hazard traits.
- Added Neurodevelopmental Toxicity as a separate hazard trait from neurotoxicity. There are separate and distinct toxicity tests specifically for neurodevelopmental toxicity, and this hazard trait specifically impacts infants and children who are sensitive subpopulations that the Department of Toxic Substances Control must consider under Health and Safety Code section 25252 in using hazard-trait information to identify chemicals of concern in consumer products.
- Added Article 7, Additional Relevant Data, to capture information that may be included in the Clearinghouse that is useful for chemical evaluations that are conducted under Health and Safety code section 25252. Physicochemical properties are typically used in evaluating the movement of chemicals through the environment and into wildlife and humans. Exposure-response information could include cancer potency factors, Reference Doses, Reference Exposure Levels, or No-Observed-Adverse-Effect Levels, for example. This type of information is used to evaluate the risks posed by chemical hazards.
- Amended the sections on other relevant data for each of the toxicological hazard traits to be consistent with one another in terms of structural and mechanistic information.
- Amended subsection 69403.17(a)(2), Evidence for Toxicological Hazard Traits and subsection 69404.10(a)(2), Evidence for Environmental Hazard Traits, to provide for more general consideration of the totality of a database on a specific chemical undergoing evaluation in the Green Chemistry program.
- Amended subsection 69405.2 for Bioaccumulation hazard trait to add additional types of evidence.
- Added language to subsection 69406.3(b) on the Flammability hazard trait to add additional U.S. based criteria.
- Made various minor wording changes to ensure clarity and consistency.
OEHHA will accept written comments on these amendments to the proposed regulation between July 29, 2011, and September 12, 2011. All written comments must be submitted to OEHHA by mail, fax, courier, e-mail, or hand-delivery by no later than 5:00 p.m. on September 12, 2011. Comments should be addressed to:
Office of Environmental Health Hazard Assessment
P. O. Box 4010
1001 I Street
Sacramento, California 95812-4010
Fax No.: 916-324-1786
Inquiries concerning the action described in this notice may be directed to Fran Kammerer, in writing at the address given above, or by telephone at (916) 445-4693. Monet Vela is a back-up contact person and is available at (916) 323-2517.
Comments on Proposed Modified Regulation [09/22/11]