Proposed Amendment of Section 25204 - Safe Use Determinations
NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to amend Title 27, California Code of Regulations, Section 252042 . These amendments would delete existing language in subsection (a) providing that Safe Use Determinations are advisory only and replace it with language providing that the Safe Use Determinations shall have presumptive effect, increase the filing fee for a Safe Use Determination request from $500.00 to $1000.00 in subsection (d)(1) to better cover the costs of initial review of the requests, and would create in subsection (g) a time limit of sixty (60) days for submission of additional material requested by OEHHA.
A public hearing will be held on November 7, 2008, at which time any person may present statements or arguments orally or in writing relevant to the action described in this notice. The public hearing will commence at 10:00 in the Coastal Hearing Room, California Environmental Protection Agency Building, 1001 I Street, 2nd Floor, Sacramento, California and will last until all business has been conducted, or until 12:00 noon.
If you have any special accommodation or language needs, please contact Monet Vela at (916) 323-2517 or firstname.lastname@example.org. 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 November 21, 2008, 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:
Office of Environmental Health Hazard Assessment
P. O. Box 4010
Sacramento, California 95812-4010
Comments sent by courier should be delivered to:
Office of Environmental Health Hazard Assessment
1001 I Street, 23rd Floor
Sacramento, California, 95814
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, 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 Act3. 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. The law and regulations provide exceptions to these requirements in certain circumstances. One way an affected business can determine whether a warning is required for a specific exposure, or whether a discharge of a chemical to a source of drinking water is prohibited, is by asking for a formal opinion from OEHHA.
Section 25204 of the California Code of Regulations, Title 274, is a Proposition 65 regulation that sets out the procedures and criteria for requesting that OEHHA issue a Safe Use Determination (SUD). OEHHA considers these determinations upon the request of persons subject to Proposition 65 who need to know how the warning and discharge prohibitions apply to their business activities. Currently, subsection (a) of section 25204 states that OEHHA’s SUDs are advisory only. OEHHA wants to encourage businesses to use the SUD process to resolve the often difficult legal and scientific issues that arise under the law and regulations, rather than wait to have these issues addressed by the courts on a case-by-case basis. Some interested parties have requested that OEHHAs SUDs carry more weight in court so that they are worth the time and expense involved in obtaining one. Therefore, OEHHA is proposing an amendment to Section 25204(a). This amendment will remove the existing language that makes OEHHA’s SUDs “advisory only” and instead give OEHHA’s determinations presumptive effect in an enforcement proceeding.
Subsection 25204(d)(1) currently establishes a nonrefundable processing fee of $500 to be paid when a SUD request is submitted to the agency. To more accurately reflect the actual minimum cost of the initial processing and review of a SUD request, OEHHA proposes to increase the processing fee to $1000.00.
Subsection 25204(g) of the Act states that the lead agency or any other state agency may ask for additional information or explanation from the SUD applicant at any time while a request for an accepted SUD is pending. In order to ensure that these requests are responded to in a timely manner, OEHHA proposes a change to the regulation that would add a requirement that any information requested be provided to the agency within 60 days, unless otherwise agreed by the agency.
Health and Safety Code section 25249.12.
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. No business is required to seek a Safe Use Determination from OEHHA. The process is completely voluntary. In fact, the proposed amendments are intended to provide an affirmative defense, under specified circumstances, to allegations that a person doing business may have violated the Act or related regulations.
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. No business is required to seek a Safe Use Determination from OEHHA. The process is completely voluntary.
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)). No business is required to seek a Safe Use Determination from OEHHA. The process is completely voluntary. The proposed regulation is intended to respond to requests from businesses subject to the Act that OEHHA’s SUDs carry more weight in court. 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 regulations, all the critical information upon which the regulation is based, and the text of the proposed regulations. A copy of the Initial Statement of Reasons and a copy of the text of the proposed 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.
FINAL STATEMENT OF REASONS
A copy of the Final Statement of Reasons may be obtained, when it becomes available, from OEHHA’s Monet Vela at the telephone number indicated above. The Final Statement of Reasons will also be available at the OEHHA’s Web site.
OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT
Chief Deputy Director
- Workshop - Proposition 65 Regulatory Update Project Safe Use Determination Regulation
Footnotes and References
1Formerly Title 22, Cal. Code of Regulations, section 12204
2All further references are to Title 27 of the California Code of Regulations (Formerly Title 22 of the Code), unless otherwise indicated.
3Health and Safety Code section 25249.12(a)
4Formerly Title 22, Cal. Code of Regs. section 12204