Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25805 Specific Regulatory Levels: Chemicals Causing Reproductive Toxicity Sulfur Dioxide
NOTICE IS HEREBY GIVEN that the Office of Environmental Health Hazard Assessment (OEHHA) proposes to establish a Proposition 65 Maximum Allowable Dose Level (MADL) for sulfur dioxide (SO2) of 220 micrograms per day by amending Section 25805(b) of Title 27 of the California Code of Regulations.
PUBLIC PROCEEDINGS
Any written comments concerning this proposed action, regardless of the form or method of transmission, must be received by OEHHA by 5:00 p.m. on August 20, 2012, the designated close of the written comment period. All comments received will be posted on the OEHHA website at the close of the public comment period.
The public is encouraged to submit written information via e-mail, rather than in paper form. Send e-mail comments to P65Public.Comments@oehha.ca.gov. Please include “SULFUR DIOXIDE MADL” in the subject line. Hard-copy comments may be mailed, faxed, or delivered in person to the appropriate address below.
Mailing Address: Sam Delson
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-8803
Street Address: 1001 I Street
Sacramento, California 95814
A public hearing on this proposed regulatory amendment will be scheduled on request. To request a hearing send an e-mail to Sam Delson at sam.delson@oehha.ca.gov or to the address listed above by no later than August 6, 2012, which is 15 days before the close of the comment period. OEHHA will mail a notice of the hearing to the requester and interested parties on the Proposition 65 mailing list for regulatory public hearings. The notice will also be posted on the OEHHA web site at least ten days before the public hearing date. The notice will provide the date, time, and location of the hearing.
If a hearing is scheduled and you have special accommodation or language needs, please contact Susan Luong at (916) 327-3015 or sam.delson@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
Please direct inquiries concerning the proposed regulatory action described in this notice to Susan Luong, in writing at the address given above, via e-mail to sam.delson@oehha.ca.gov or by telephone at (916) 327-3015. Monet Vela is a back-up contact person for inquiries concerning processing of this action and is available at monet.vela@oehha.ca.gov or (916) 323-2517.
INFORMATIVE DIGEST/POLICY STATEMENT OVERVIEW
Proposition 65 prohibits a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical that has been listed as known to the State to cause cancer or reproductive toxicity, without first giving clear and reasonable warning to such individual. The Act also prohibits a business from knowingly discharging a listed chemical into water or onto or into land where such chemical passes or probably will pass into any source of drinking water. Warnings are not required and the discharge prohibition does not apply when exposures are insignificant. The MADL safe harbors provide guidance for determining when this is the case.
Details on the basis for the proposed MADL for sulfur dioxide (SO2) are provided in the Initial Statement of Reasons for this regulatory amendment, which is available on request from Sam Delson and is posted on the OEHHA web site at www.oehha.ca.gov.
This proposed regulation sets forth a MADL for adoption into Section 25805 that was derived using scientific methods outlined in Section 25803.
The proposed regulation would adopt the following MADL for sulfur dioxide (SO2), by amending Section 25805 as follows (addition in underline):
|
(b) Chemical Name |
Level (Micrograms/day) |
|---|---|
|
Sulfur dioxide |
220 |
OEHHA reviewed relevant studies on the developmental toxicity of sulfur dioxide, which were identified through comprehensive searches of the scientific literature. For purposes of Proposition 65, the study by Murray et al., in mice is the most sensitive study deemed to be of sufficient quality as defined in Section 25803(a)(7) for exposure to sulfur dioxide. OEHHA relied on the values from this study as the basis for calculating the MADL for sulfur dioxide proposed for adoption into Section 25805(b).
RESULTS OF ECONOMIC IMPACT ANALYSIS (Gov. Code section 11346.3(b))
By providing a MADL, this regulatory proposal spares businesses the expense of calculating their own MADL and may also enable them to reduce or avoid litigation costs. In addition, the MADL does not require, but may encourage, businesses to lower the amount of the listed chemical in their product to a level that does not cause a significant exposure, thereby providing a public health benefit to Californians.
Impact on the Creation, Elimination, or Expansion of Jobs/Businesses in California
This regulatory proposal will not affect the creation or elimination of jobs within the State of California. Proposition 65 requires businesses with ten or more employees to provide warnings when they expose people to chemicals that are known to cause cancer or reproductive harm. The law also prohibits the discharge of listed chemicals into sources of drinking water. Sulfur dioxide is listed under Proposition 65; therefore businesses that expose the public or employees to sulfur dioxide through their operations or products must provide a warning.
Because the proposed MADL provides compliance assistance to businesses subject to the Act, but does not impose any mandatory requirements on those 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.
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 businesses, state or local agencies and does not address compliance with any other law or regulation.
Benefits of the Proposed Regulation: Some businesses may not be able to afford the expenses of establishing a MADL and therefore may face litigation for a failure to warn or for a prohibited discharge of the listed chemical. Adopting this regulation will save these businesses those expenses and may reduce litigation costs. In addition, by providing a MADL, this regulatory proposal may encourage businesses to lower the amount of the listed chemical in their products to a level that does not require a warning. This in turn may reduce exposures to sulfur dioxide and reduce resident, worker and environmental exposures to chemicals that cause reproductive toxicity.
PEER REVIEW
This notice and the Initial Statement of Reasons will be provided to the Developmental and Reproductive Toxicant Identification Committee for scientific peer review and comment.
AUTHORITY
Health and Safety Code Section 25249.12.
REFERENCE
Health and Safety Code Sections 25249.5, 25249.6, 25249.9, 25249.10 and 25249.11.
IMPACT ON LOCAL AGENCIES OR SCHOOL DISTRICTS
Because Proposition 65 expressly 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 expressly does not apply to any State agency, OEHHA has determined that no savings or increased costs to any State agency will result from the proposed regulatory action.
EFFECT ON FEDERAL FUNDING TO THE STATE
Because Proposition 65 expressly does not apply to any federal agency, OEHHA has 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 determined that the proposed regulatory action will have no effect on housing costs because it provides compliance assistance to businesses subject to the Act, but does not impose any mandatory requirements on those businesses.
SIGNIFICANT STATEWIDE ADVERSE ECONOMIC IMPACT DIRECTLY AFFECTING BUSINESS, INCLUDING ABILITY TO COMPETE
Because the proposed regulatory level provides compliance assistance to businesses subject to the Act, but does not impose any mandatory requirements on those businesses, 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.
COST IMPACTS ON REPRESENTATIVE PRIVATE PERSONS OR BUSINESSES
The proposed MADL was developed to provide compliance assistance for these businesses in determining whether a warning is required or a discharge is prohibited. The MADL provides a level of exposure at or below which a warning is not required and a discharge is not prohibited. Use of the MADL is not mandatory. The implementing regulations allow a business to calculate its own level and provide guidance in order to assist businesses in doing so. However, conducting such a process can be expensive and time consuming, and the resulting levels may not be defensible in an enforcement action.
EFFECT ON SMALL BUSINESSES
OEHHA has determined that the proposed MADL will not impose any mandatory requirements on small business. Rather, the proposed MADL will provide compliance assistance for small businesses subject to the Act because it will help them determine whether or not an exposure for which they are responsible is subject to the warning requirement or discharge prohibition of the Act.
CONSIDERATION OF ALTERNATIVES
Government Code section 11346(a)(13) requires that OEHHA must determine that no reasonable alternative considered by the OEHHA or that has otherwise been identified and brought to the attention of the OEHHA would be more effective in carrying out the purpose for which the action is proposed, 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 than the proposal described in this Notice.
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 regulation, which contains the text of the regulation and the information upon which the regulation is based. A copy of the Initial Statement of Reasons, the text of the regulation and documents used by OEHHA to develop the proposed regulation are available upon request from OEHHA at the address, e-mail address and telephone number indicated above. These documents are also posted on OEHHA’s Web site.
AVAILABILITY OF CHANGED OR MODIFIED TEXT
The full text of any 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 changed regulations and the full text will be mailed to individuals who testified or submitted written comments at the public hearing, if held, or whose comments were received by OEHHA during the public comment period, and anyone who requests notification from OEHHA of the availability of such changes. Copies of the notice and the changed regulation will also be available on the OEHHA Web site.
FINAL STATEMENT OF REASONS
A copy of the Final Statement of Reasons for this regulatory action may be obtained, when it becomes available, from OEHHA at the address, e-mail address and telephone number indicated above, and on the OEHHA website.
OFFICE OF ENVIRONMENTAL
HEALTH HAZARD ASSESSMENT
Allan Hirsch
Chief Deputy Director
Link to Public Comments
- Sulfur Dioxide
The comment period closed on August 20, 2012.