Proposed Amendment of Sections 25305, 25701, 25705, and 25801 Science Advisory Board: No Significant Risk Levels, No Observable Effect Levels

Mar 23, 2012

NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to amend Title 27, Cal. Code of Regulations, sections 25305, 25701, 25705, and 25801¹, to clarify that the Science Advisory Board Committees provide peer review for the proposed No Significant Risk Levels for carcinogens and proposed Maximum Allowable Dose Levels for reproductive toxicants that are developed by OEHHA.

PUBLIC PROCEEDINGS
OEHHA is requesting public comment concerning these proposed amendments to the regulations. A public hearing to present oral comments will be scheduled only upon request. Such a request must be submitted in writing by no later than April 20, 2012 which is 15 days before the close of the comment period on May 7, 2012. A notice for the public hearing, if one is requested, will be posted on the OEHHA web site at least ten days in advance of the hearing date. The notice will provide the date, time and location of the hearing. Notices will also be sent to those individuals requesting such notification.
Any public comments, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on May 7, 2012, which is hereby designated as the close of the written comment period. If you submit your comments electronically, please include: “Science Advisory Board” in the subject line. Written comments regarding this proposed action may be sent by fax, mail or e-mail addressed to:

            Monet Vela
            Office of Environmental Health Hazard Assessment
            P. O. Box 4010
            Sacramento, California 95812-4010
            Telephone: 916-323-2517
            Fax: 916-323-2517
            E-mail: P65Public.Comments@oehha.ca.gov

Comments sent by courier should be delivered to:

            Monet Vela
            Office of Environmental Health Hazard Assessment
            1001 I Street, 23rd Floor
            Sacramento, California, 95814

If a hearing is scheduled and you have special accommodation or language needs, please contact Monet Vela at (916) 323-2517 or monet.vela@oehha.ca.gov at least one week in advance of the hearing. TTY/TDD/Speech-to-Speech users may dial 7-1-1 for the California Relay Service.

CONTACT

Inquiries concerning the Proposition 65 proposed regulation amendments described in this notice may be directed to Monet Vela at (916) 323-2517 or by e-mail at monet.Vela@oehha.ca.gov or by mail to OEHHA, P.O. Box 4010 Sacramento, California 95812-4010. Fran Kammerer is a back-up contact person for inquiries concerning processing of this action and is available at (916) 445-4693 or fran.kammerer@oehha.ca.gov.

INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW

BACKGROUND

Proposition 65 was enacted as a voters’ initiative on November 4, 1986, and is codified at Health and Safety Code section 25249.5 et seq. OEHHA, within the California Environmental Protection Agency, is the state entity responsible for the implementation of Proposition 65. OEHHA has the authority to adopt and amend regulations to further the purposes of Proposition 65². Proposition 65 requires businesses to provide a warning when they knowingly cause an exposure to a chemical listed as known to cause cancer or reproductive toxicity. Proposition 65 also prohibits persons in the course of doing business from knowingly discharging or releasing a chemical known to the state to cause cancer or reproductive toxicity into water or onto or into land where it passes or probably will pass into a source of drinking water.

EXEMPTIONS

Proposition 65 creates limited exceptions to these warning and discharge requirements. One exception provides that no warning is required for exposure to a chemical known to the state to cause cancer where the person responsible for the exposure can show that it poses no significant risk at that level of exposure. The exception also applies to an exposure to a chemical known to the state to cause reproductive toxicity. For chemicals that are listed as causing reproductive toxicity, the “no observable effect level” is determined by identifying the level of exposure that has been shown to not cause any reproductive effect to humans or laboratory animals. This “no observable effect level” is then divided by 1,000 in order to establish the level of exposure above which a warning must be provided. Businesses subject to Proposition 65 are not required to provide a warning if the exposures to chemicals listed for causing reproductive toxicity do not exceed 1/1000th of the “no observable effect level” ³.

PEER REVIEW

The proposed amendments clarify that the Carcinogen Identification Committee and the Developmental and Reproductive Toxicant Identification Committee of the Science Advisory Board provide the peer reviews of the scientific basis for regulations required under Health and Safety Code section 57004, for the No Significant Risk Levels for carcinogens and Maximum Allowable Dose Levels for the reproductive toxicants that are adopted by OEHHA.

SPECIFIC BENEFITS OF THE AMENDMED REGULATIONS

These regulatory amendments will provide clarity concerning OEHHA’s current practice for requesting scientific peer review for Proposition 65 regulatory proposals that comply with the requirements of Health and Safety Code section 57004. Safe harbor levels provide needed compliance assistance for businesses subject to the Act and provide relevant information to consumers who may choose to avoid or limit their exposure to listed chemicals. Ensuring the scientific basis for the safe harbor regulatory levels is critical in order to ensure the scientific integrity of the process.

NO INCONSISTENCY OR INCOMPATIBILITY WITH EXISTING REGULATIONS

OEHHA has determined that the proposed regulation is neither inconsistent nor incompatible with existing state regulations because it does not impose any mandatory requirements on those businesses, state or local agencies and does not address compliance with any other law or regulation.

Impact on the Creation, Elimination, or Expansion of Jobs/Businesses in California

The proposed amendments clarify an existing process for obtaining scientific peer reviews for proposed safe harbor regulatory levels. Because the proposed regulatory levels do not impose any mandatory requirements on businesses, OEHHA has determined that the proposed regulatory action will not have any impact on the creation or elimination of jobs, the creation of new businesses or the elimination of existing businesses, or the expansion of businesses currently doing business within the State of California.

RESULTS OF ECONOMIC IMPACT ANALYSIS (Gov. Code section 11346.3(b))

The proposed regulatory levels will facilitate the compliance of businesses with Proposition 65, which will provide the public with information about exposures to chemicals present in products, in order to allow consumers to make better-informed choices. It may also encourage businesses to reduce exposures or remove listed Proposition 65 chemicals from their products in order to avoid providing a warning. Both outcomes would protect not only the health and welfare of California residents, but also the State’s environment through reduced exposures to harmful chemicals. By adopting safe harbor regulatory levels, businesses will be able to more easily determine the point at which a warning for an exposure must be provided.

AUTHORITY

Health and Safety Code section 25249.12.

REFERENCE

Health and Safety Code sections 25249.5, 25249.6, 25249.10(c), 25249.11, and 25249.12

IMPACT ON LOCAL AGENCIES OR SCHOOL DISTRICTS

Because Proposition 65 by its terms⁴ does not apply to local agencies or school districts, OEHHA has determined the proposed regulatory action would not impose a mandate on local agencies or school districts; nor does it require reimbursement by the State pursuant to Part 7 (commencing with Section 17500) of Division 4 of the Government Code. OEHHA has also determined that no nondiscretionary costs or savings to local agencies or school districts will result from the proposed regulatory action.

COSTS OR SAVINGS TO STATE AGENCIES

Because Proposition 65 by its terms⁵ does not apply to any State agency and this regulation is simply a clarification of existing procedures, OEHHA has initially determined that no significant savings or increased costs to any State agency will result from the proposed regulatory action.

EFFECT ON FEDERAL FUNDING TO THE STATE

OEHHA has initially determined that no costs or savings in federal funding to the State will result from the proposed regulatory action.

EFFECT ON HOUSING COSTS

OEHHA has initially determined that the proposed regulatory action will have no effect on housing costs because it does not impose any mandatory requirements on any business.

SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE

OEHHA has made an initial determination that the adoption of the proposed amendments to the regulation will not have a significant statewide adverse economic impact directly affecting businesses, including the ability of California businesses to compete with businesses in other states. The proposed regulation does not impose any new requirements upon private persons or businesses.

COST IMPACTS ON REPRESENTATIVE PRIVATE PERSONS OR BUSINESSES

Because the proposed regulatory amendments do not impose any mandatory requirements on businesses, the OEHHA is not aware of any cost impacts that a representative private person or business would necessarily incur in reasonable compliance with the proposed action.

EFFECT ON SMALL BUSINESSES

OEHHA has determined that the proposed regulatory action will not impose any mandatory requirements on small businesses. Proposition 65 expressly exempts businesses with less than 10 employees⁶.

CONSIDERATION OF ALTERNATIVES

Pursuant to Government Code section 11346.5(a)(13), OEHHA must determine that no reasonable alternative considered by OEHHA, or that has otherwise been identified and brought to the attention of OEHHA, would be more effective in carrying out the purpose for which Proposition 65 is proposed, or would be as effective and less burdensome to affected private persons than the proposed action, or would be more cost-effective to affected private persons and equally effective in implementing the statutory policy or other provision of law.

AVAILABILITY OF STATEMENT OF REASONS AND TEXT OF PROPOSED REGULATIONS

OEHHA has prepared and has available for public review an Initial Statement of Reasons for the proposed regulatory amendments, all the information upon which the amendments are based, and the text of the proposed amendments to the regulation. A copy of the Initial Statement of Reasons and a copy of the text of the proposed regulation are available upon request from Monet Vela at the telephone number indicated above. These documents are also posted on OEHHA’s Web site at www.oehha.ca.gov.

AVAILABILITY OF CHANGED OR MODIFIED TEXT

The full text of any proposed regulation which is changed or modified from the express terms of this proposed action will be made available at least 15 days prior to the date on which OEHHA adopts the resulting regulation. Notice of the comment period on the changed proposed regulations and the full text will be mailed to individuals who testified or submitted oral or written comments at the public hearing, whose comments were received by OEHHA during the public comment period, and anyone who requests notification from OEHHA of the availability of such change. Copies of the notice and the changed regulation will also be available on the OEHHA Web site at www.oehha.ca.gov.

FINAL STATEMENT OF REASONS

A copy of the Final Statement of Reasons may be obtained, when it becomes available, from Monet Vela at the telephone number indicated above. The Final Statement of Reasons will also be available at OEHHA’s web site on www.oehha.ca.gov.

OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT

Allan Hirsch
Chief Deputy Director