Notice of Modifications to the Risk Assessment Document for Sodium Dimethyldithiocarbamate and OAL rulemaking files 04-1110-06s, 05-0318-04sr and 05-0608-02sr
Notice of Modifications to the Risk Assessment Document for Sodium Dimethyldithiocarbamate Which Serves as the Basis for the Proposed Regulations Title 22, California Code of Regulations, Section 12805
OAL rulemaking files 04-1110-06s, 05-0318-04sr and 05-0608-02sr
As required by Government Code Sections 11346.8(c) and 11347.1, and Title 1, Cal. Code of Regs., section 44, the Office of Environmental Health Hazard Assessment (OEHHA) is providing notice of changes made to the technical support document which serves as the basis for the proposed regulation, Title 22, California Code of Regulations, Section 12805, which was the subject of a regulatory hearing on August 23, 2004. OEHHA is including in the administrative record copies of documents cited in the risk assessment document attached to this notice. OEHHA received one written comment on the proposed adoption of a “safe harbor” level for sodium dimethyldithiocarbamate and these changes are in response to that comment. The changes are not substantive in that they do not alter the maximum allowable dose level (MADL) value proposed for sodium dimethyldithiocarbamate: however, they are additions to the administrative record for this rulemaking and, therefore, OEHHA is providing this notice.
The technical support document “Proposition 65 Maximum Allowable Dose Level (MADL) for Reproductive Toxicity for Sodium Dimethyldithiocarbamate for Oral Exposures,” included with this notice as Attachment 1, has been slightly modified based upon the one comment received. A sentence on page 2 describing studies of zinc dimethyldithiocarbamate (ziram) has been deleted and a sentence on page 3 describing studies of potassium dimethyldithiocarbamate (PDDC) has been revised. These changes more accurately reflect the consideration given to information on related dimethyldiothiocarbamate salts in developing the MADL. Two references pertaining to ziram were deleted. Wording has been added on page 3 in Attachment 1 to specify that the no observable effect level (NOEL) is based on the skeletal variant endpoint, which OEHHA finds to be related to sodium dimethyldithiocarbamate exposure, and not the resorption endpoint, which may not be treatment related. The date of the document was updated to June 2005. All changes are noted in underline/strikeout in Attachment 1.
If you have any comments regarding the noted changes to the risk assessment document for sodium dimethyldithiocarbamate, OEHHA will accept written comments between June 21, 2005 and July 6, 2005. All written comments must be submitted to OEHHA by mail, fax, courier or hand-delivery, no later than 5:00 p.m. on July 6, 2005, and addressed to:
Office of Environmental Health Hazard Assessment
Mailing Address: P. O. Box 4010
Sacramento, California 95812-4010
Street Address: 1001 I Street, 19th Floor
Sacramento, California 95814
Fax No.: (916) 323-8803
Telephone: (916) 445-6900
Comments may also be transmitted via email addressed to: P65Public.Comments@oehha.ca.gov. It is requested but not required that written statements or arguments be submitted in triplicate. A copy of the revised document is attached. Amendments to the text of the original document which was introduced during the 45-day comment period which closed on August 23, 2004 are shown in the following manner: deletions from the original text of the document are shown in strikeout and underline, and additions to the text of the original document are shown in double underline. Inquiries concerning the action described in this notice may be directed in writing at the address given above, or by telephone at (916) 445-6900.
- Sodium dimethyldithiocarbamate