Proposed Amendments to Title 27, California Code of Regulations, Sections 25801 and 25803 No Observable Effect Levels for Listed Chemicals
NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to amend Title 27, California Code of Regulations sections 25801 and 258031 .
PUBLIC PROCEEDINGS
OEHHA is requesting public comment concerning these proposed amendments to the regulation. A public hearing to present oral comments will be scheduled only upon request. Such request must be submitted in writing no later than 15 days before the close of the comment period on Friday, January 28, 2011. The written request must be received by OEHHA at the address listed below no later than Thursday, January 13, 2011. 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, location and subject matter to be heard. Notices will also be sent to those individuals requesting such notification.
If you have any special accommodation or language needs, please contact Monet Vela at (916) 323-2517 or mvela@oehha.ca.gov by Thursday, December 23, 2010. TTY/TDD/Speech-to-Speech users may dial 7-1-1 for the California Relay Service.
Any written statements or arguments, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on Friday, January 28, 2011, which is hereby designated as the close of the written comment period.
Written comments regarding this proposed action may be sent by mail or by e-mail addressed to:
Fran Kammerer
Office of Environmental Health Hazard Assessment
P. O. Box 4010
Sacramento, California 95812-4010
Telephone: 916-445-4693
E-mail: fkammerer@oehha.ca.gov
Comments sent by courier should be delivered to:
Fran Kammerer
Office of Environmental Health Hazard Assessment
1001 I Street, 23rd Floor
Sacramento, California, 95814
CONTACT
Inquiries concerning the substance and processing of 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 for inquiries concerning processing of this action and is available at (916) 323-2517.
INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW
The Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65 (hereinafter referred to as “Proposition 65” or “the Act”), was enacted as a voters’ initiative on November 4, 1986, and codified at Health and Safety Code section 25249.5 et seq. The Office of Environmental Health Hazard Assessment (OEHHA), within the California Environmental Protection Agency is the state entity responsible for the implementation of the Act. OEHHA has the authority to promulgate and amend regulations to further the purposes of the Act2. The Act requires businesses to provide a warning when they cause an exposure to a chemical listed as known to cause cancer or reproductive toxicity. The Act also prohibits the discharge of listed chemicals to sources of drinking water. Certain exceptions to these requirements are provided by the Act
Section 25801 et. seq. was originally adopted in 1989 to implement Health and Safety Code section 25249.10(c) of the Act. For chemicals known to cause reproductive toxicity, an exemption to the warning and discharge provisions is provided if there would be no observable effect given an exposure one thousand (1,000) times the level of exposure in question
Summary of Proposed Changes
Subsection 25801(c) the term “maximum dose level” would be changed to “maximum level of exposure” to provide consistency between section 25801(c) and 25803(b)(1).
Subsection 25803(a)(1) has been split into sections (a)(1) and (a)(2) for clarity. In the new subsection 25803(a)(2) the term “highest dose level” has been changed to “highest exposure level” for further consistency. Subsection 25803(a)(2) has also been amended to add the following language “(t)his may be the no observed effect level in a scientific study or, alternatively, may be calculated by means of a generally accepted scientific methodology such as the benchmark dose methodology. Where a study, for example epidemiological publication, reports a range of exposure levels associated with no observed effect the NOEL may be selected from within the range or calculated by benchmark dose or other accepted scientific methodology”. This added language recognizes procedures which may be more scientifically appropriate for certain data sets, such as the benchmark dose methodology.
The previously numbered subsection 25803(a)(2) would be renumbered to (a)(3) and amended to describe with more specificity the intent of the regulation.
The following language will be added to subsection 25803(b) “(i)n the absence of principles or assumptions scientifically more appropriate based upon the available data, the following default principles or assumptions shall apply in any such assessment” making this subsection consistent with subsection 25803(a). Also proposed for addition to subsection 25803(b) are default bodyweights for children and infants, where currently only default bodyweights for adults were provided.
AUTHORITY
Health and Safety Code section 25249.12.
REFERENCE
Health and Safety Code sections 25249.5, 25249.6, 25249.7, 25249.9, 25249.10, and 25249.11
IMPACT ON 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. Proposition 65 expressly does not apply to federal, state or local governmental agencies (Health and Safety Code section 25249.11(b)).
COSTS OR SAVINGS TO STATE AGENCIES
OEHHA has initially determined that no savings or increased costs to any State agency will result from the proposed regulatory action. Proposition 65 expressly does not apply to federal, state or local governmental agencies (Health and Safety Code section 25249.11(b)).
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.
SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE
OEHHA has made an initial determination that the adoption of 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 business.
IMPACT ON THE CREATION, ELIMINATION, OR EXPANSION OF JOBS/BUSINESSES
OEHHA has initially 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.
COST IMPACTS ON REPRESENTATIVE PRIVATE PERSONS OR BUSINESSES
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 new or additional requirements on small business. Proposition 65 is limited by its terms to businesses with 10 or more employees (Health and Safety Code sections 25249.5, 25249.6, and 25249.11(b)). The proposed amendments would provide an affirmative defense, under specified circumstances, to allegations that a person doing business may have violated the Act or related regulations.
CONSIDERATION OF ALTERNATIVES
In accordance with 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 the action is proposed or would be as effective and less burdensome to affected private persons than the proposed action.
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 amendments to these regulations, all the critical information upon which the regulation is based, and the text of the proposed amendments. A copy of the Initial Statement of Reasons and a copy of the text of the proposed amendments to these regulations 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 regulation which is changed or modified from the express terms of the 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 who request notification from OEHHA of availability of such change. Copies of the notice and the changed regulation will also be available at the OEHHA’s 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 the OEHHA’s Web site at www.oehha.ca.gov.
OFFICE OF ENVIRONMENTAL
HEALTH HAZARD ASSESSMENT
(Original signed by:)
Allan Hirsch
Chief Deputy Director
Dated: November 15, 2010
Related Notices
Footnotes and References
1All further references are to Title 27 of the California Code of Regulations, unless otherwise indicated.
2Health and Safety Code section 25249.12(a)