Revised Safe Use Regulations Become Effective

OEHHA's proposed revisions to the SUD regulation will became effective on June 21, 2003, according to a June 6 notice from the agency [html/pdf].

• Notice of Proposed Rulemaking (5/17/02) [pdf]
• Initial Statement of Reasons [pdf]
• Original Proposed Regulatory Text [pdf]
• Final Statement of Reasons [pdf]
• Updated Informative Digest [pdf]
• Revised text of Title 22, Section 12204 [pdf]

Nickel Compound Listing Revised

"Nickel and certain nickel compounds" were originally listed under Prop 65 in 1989 because they were identified by the National Toxicology Program ("NTP"), a Prop 65 "authoritative body," as "reasonably anticipated to be a human carcinogen." The NTP Tenth Report on Carcinogens identified (metallic) nickel, nickel acetate, nickel carbonate, nickel carbonyl, nickel hydroxide, nickelocene, nickel oxide, and nickel subsulfide. The Proposition 65 listing, however, only referred to "certain nickel compounds."

Some nickel compounds were already listed under Proposition 65 at the time of the 1989, including nickel carbonyl, nickel refinery dust from the pyrometallurgical processes and nickel subsulfide. In a June 6, 2003 notice [html/pdf], OEHHA is proposing to separately list the particular nickel compounds known to cause cancer, effective June 6, as follows (deletions in strike-out, additions in bold, no change in normal font):

Chemical	CAS No.	Effective Proposition 65 Listing Date
Nickel (Metallic)	7440020	October 1, 1989
Nickel and Certain Nickel Compounds	---	October 1, 1989
Nickel acetate	373024	October 1, 1989
Nickel carbonate	3333393	October 1, 1989
Nickel carbonyl	13463393	October 1, 1987
Nickel hydroxide	12054487; 12125563	October 1, 1989
Nickelocene	1271289	October 1, 1989
Nickel oxide	1313991	October 1, 1989
Nickel refinery dust from the pyrometallurgical processes	----	October 1, 1987
Nickel subsulfide	12035722	October 1, 1987

The same notice then proposes to list all nickel compounds, both NTP and IARC have found that all nickel compounds are human carcinogens, since the 1989 Proposition 65 listing of nickel and certain nickel compounds. Because the inclusion of all nickel compounds in the IARC and NTP reports triggerst the listing of those chemicals on Labor Code Section 6382(b)(1) and (d), and thus in Prop 65. OEHHA has requested comments by July 5 on the proposed revisions to the list.

OEHHA Considers Safe Use Determination

A March 28, 2003 notice [html/pdf] stated that OEHHA had received a request from the California Paint Council on behalf of the National Paint and Coatings Association (NPCA) for t a safe use determination for the use of interior latex paints used to cover or decorate the interior of buildings and the potential exposure to airborne particles of crystalline silica of respirable size that may result during the course of painting activities (e.g., painting and sanding). Pursuant to the notice, a public hearing was held on April 28, at which time no oral public comments were submitted. If granted, this would only be the third issued by OEHHA in the history of Prop 65.

Acrylamide Workshop Held

On May 12, 2003, OEHHA held a workshop to discuss the impact of recent research showing that appreciable levels of acrylamide result from the cooking of certain foods at high temperatures. According to the April 25, 2003 notice for the workshop [html/pdf], "the presence of acrylamide in food is a matter of public health significance due to the extremely broad range of foods in which acrylamide has been detected. Accordingly, it is appropriate for OEHHA to further assess the health issues related to acrylamide in food and provide its assessment to interested parties." According to the agenda, the purpose of the scoping workshop was "to discuss appropriate Proposition 65 regulatory options regarding acrylamide created by cooking foods." Speaker presentations can be downloaded.

DEHP Back in Regulatory Crosshairs

DEHP has been listed as a carcinogen since 1988, and was the subject of a court ruling in October 2002 that it did not cause cancer and thus did not require Prop 65 warnings. Now, OEHHA's April 11, 2003 notice [html/pdf] indicates that the agency intends to list the chemical as a reproductive toxin. A May 9 notice [html/pdf] has extended the public comment period until June 11.

DEHP was originally the subject of a December 4, 1998 notice requesting data on a number of chemicals that were being considered for listing under the authoritative bodies mechanism. The document supporting the potential listing is available for download [pdf].

Other Recent Listing Issues

Catechol

On May 16, 2003, OEHHA issued a notice [html/pdf] indicating that it intended to list catechol as known to the state to cause cancer. The chemical was the subject of a September 29, 2000 notice [html/pdf] regarding a number of chemicals under consideration through the authoritative bodies mechamism Download the supporting document [pdf].

Perchlorate

Following petitions considered by the DART Committee at its December 2002 meeting, OEHHA issued an April 15, 2003 notice [html/pdf] requesting comments on whether perchlorate is known to the state to cause reproductive toxicity. According to the notice, the agency "will review the available literature and data on perchlorate and develop a hazard identification document based on the evidence of its developmental or reproductive toxicity. The DART Identification Committee will consider the hazard identification document before rendering an opinion whether perchlorate has been clearly shown through scientifically valid testing according to generally accepted principles to cause reproductive or developmental toxicity."

You can download the following information made available by OEHHA in conjunction with the December meeting:

• Requests from NRDC and CBE for expedited listing of perchlorate as a reproductive toxin.
• OEHHA responses to NRDC and CBE.
• OEHHA Draft Public Health Goal for perchlorate
• EPA's External Draft Toxicological Review and Risk Characterization for perchlorate.

Following the CIC's decision to consider the potential listing all of the statin drugs together, in a February 21, 2003 notice [html/pdf], OEHHA has requested data on the carcinogenicity of atorvastatin calcium, cerivastatin sodium, fluvastatin sodium, lovastatin, pravastatin sodium, and simvastatin. An April 18 notice [html/pdf] extended the public comment period until June 23.

Strong Inorganic Acid Mists Containing Sulfuric Acid

A March 14, 2003 notice [html/pdf] stated that OEHHA was listing strong inorganic acid mists containing sulfuric acids as known to the state to cause cancer under the authoritative bodies mechanism.

Diethanolamine

In a March 7, 2003 notice [html/pdf], OEHHA stated that it was not proceeding with a listing of diethanolamine under the authoritative bodies mechanism. The chemical was the subject of a February 5, 1999 request for comments on its potential listing. According to the March notice, "[c]onsiderable scientific information has been released subsequent to the release of the National Toxicology Program report on diethanolamine (NTP, 1997a). This new information has been considered by OEHHA in light of 22 CCR Section 12306(f). Because it is not clear that the scientific criteria for listing under the authoritative bodies mechanism have been met, OEHHA has decided not to proceed with the administrative listing of diethanolamine under Proposition 65."

Carbon Black

In a February 21 notice [html/pdf], OEHHA announced that it was listing carbon black (airborne, unbound particles of respirable size) as a carcinogen based on the authoritative bodies mechanism. OEHHA oferred the following qualification for the listing

The listing only pertains to airborne, unbound carbon black particles of respirable size. As noted by IARC, the respirable fraction is "that fraction of an aerosol with an aerodynamic diameter suitable for penetration into the alveoli/gas exchange region of the lung (typically <10 µm)" (pp. 171-172, Volume 65, IARC Monographs on the Evaluation of Carcinogenic Risks to Human, 1996). OEHHA and the California Air Resources Board have also noted that, "In general, particles 10 µm or less in diameter are considered respirable by humans " (California Environmental Protection Agency, Air Resources Board, Staff Report: Public Hearing to Consider Amendments to the Ambient Air Quality Standards for Particulate Matter and Sulfates, prepared by staff of the Air Resources Board and OEHHA, 2002). Thus, for the purposes of Proposition 65, carbon black particles 10 µm or less shall be considered respirable. Exposure to carbon black, per se, does not occur when it remains bound within a product matrix,

Safe Harbor Levels

In a March 14, 2003 notice [html/pdf], OEHHA proposed to establish regulatory safe harbor levels having no observable effect for 2,4-D butyric acid (2,4-DB, 2,4-dichlorophenoxybutyric acid), m-dinitrobenzene, hydramethylnon and N-methylpyrrolidone and amend Title 22, California Code of Regulations, Section 12805, as follows:

Attorney General Finalizes Regulations

The controversial regulations proposed by the Attorney General designed to implement the provisions of SB 471 were finalized and became effective January 17, 2003. The regulations, summarized previously (February 25, 2002 and September 16, 2002 Regulatory Update) include mandatory requirements for the certificate of merit that is included in a Prop 65 60-day notice. They also provide "guidance" in the form of the Attorney General's opinions regarding some of the factors to be considered by the court in approving settlements, with regard to attorney's fees, warnings, and monetary payments.

The Attorney General took the unusual step of requesting that the regulations take effect immediately, instead of the normal 30-day waiting period after publication. As explained in the Immediate Effect Justification document:

The Department’s request is based on a prior experience concerning this statute. In 2001, the Legislature adopted SB 471 (Stats 2001, Ch. 578), which imposed the Certificate of Merit requirement (although not with the specificity set forth in the regulation), and which took effect on January 1, 2002. While the Attorney General had received about 2,000 notices of intent to sue under Proposition 65 per year for the last several years, during the month of December, 2001, just before SB 471 was to take effect, the Attorney General received approximately 4,300 notices of intent to sue. These notices were submitted in an apparent attempt to avoid application of the Certificate of Merit requirement. Many Certificates of Merit received by the Attorney General during 2002 do not meet the requirements for Certificates of Merit as set forth in the regulation. If the regulation is published with the normal thirty day delay prior to effectiveness, the Attorney General may receive a large number of notices during the thirty day period designed to avoid application of the new regulation.

Download the following regulatory documents:

• Final Regulatory Text
• Final Statement of Reasons
• Addendum to FSOR

OEHHA Modifies Proposed SUD Regulation

A final version of the proposed revision to the Prop 65 Safe Use Determination regulation was issued in a January 27, 2003 notice [html/pdf]. The minor revisions to the proposed regulation [pdf] would allow OEHHA to consider a SUD request that is the subject of litigation, if the request is accepted before a complaint was filed, and clarify the treatment of requests as "official information."

Revised Regulations Become Effective

A February 1, 2003 notice [html/pdf] stated that OEHHA's housekeeping revisions to the Prop 65 regulations had become effective. As previously reported, these revisions were largely cosmetic, with nonsubstantive grammatical and reference changes. Download the revised Prop 65 regulatory package (in pdf, showing changes in redline/strikeout).

Prop 65 List Updated

As a result of the decisions at the December meetings of the DART Identification Committee and the CIC, the Prop 65 chemical list was updated (and then revised, effective February 14, 2003.

Download the February 14, 2003 list in PDF format

• sorted alphabetically
• sorted by CAS number
• sorted by date of listing
• in the new format (ordered alphabetically by chemical, with the endpoint of concern (developmental, female or male) for listing each chemical clearly noted)

View the February 14, 2003 Proposition 65 List sorted alphabetically

Download the February 14, 2003 list

• as a MS Excel spreadsheet

OEHHA Requests Information on Phenol

A February 14 notice [html/pdf] stated that OEHHA was seeking information on the potential listing of phenol as a reproductive toxin. Phenol is being considered by the DART Identification Committee, after having received a "high" priority for consideration.