Consideration of metribuzin [draft HID] for potential listing.
Consideration of the possible removal of Cyclohexanol [draft HID] and 2, 4-DP [draft HID] from the list.
Discussion of NRDC's November 26, 2001 request to relist the National Toxicology Program (NTP) as an "authoritative body" for Prop 65 listings of reproductive toxins

" . . .the seed number for the third round pilot random selection was determined by summing the first three numbers (27, 28, 10) drawn from the California Super Lotto Plus on Saturday, October 27, 2001 to yield 65. Beginning with the 65th number (59) and ending with the 164th number (278) on "Table 2 Random Numbers", each of the 100 chemicals had a unique random numerical value assigned to it. These 100 assigned random numbers, and corresponding chemicals, were reordered according to increasing value. The first 50 numerical values constitute the candidate chemicals in the third round random selection (see attached Table A: Third Round Randomly Selected Candidates for Carcinogenicity Evaluation). A list of the 50 randomly selected chemicals (see Table A), a list of the 100 eligible candidates (see attached Table 1), and the table of random numbers (see attached Table 2) are also available on the OEHHA Web site at the following address: http://www.oehha.ca.gov/. The remaining 50 chemicals will be part of the pool from which future selections will occur. "

Safe Harbor Number Development

Denton noted that the agency's intent was to "bring greater clarity and certainty to regulated businesses, the Attorney General, environmental groups, and private citizens that make determinations of compliance with Proposition 65."  She reiterated OEHHA's intent to develop between 20-35 safe harbor numbers each year.

Clarifying Regulations

Again stating her intent to "clarify ambiguous and vague provisions of the Proposition 65 regulations," Denton said she had met with representatives of various affected communitites to gather input as to which areas of the regulations could benefit from clarification.  She cautioned that the proposed changes would be piecemeal: "Instead of proceeding with a single voluminous regulatory package, I envision this will be an ongoing process," which will begin " with minor changes or a less complex nature and progess to more significant regulatory amendments." 

Petition to Amend Warning Regulations

Denton explained that the recent petition by the Advanced Medical Technology Association had been denied because it was "overly broad in its requests and did not provide an adequate basis for creating unique warning requirements for all medical device products."  She noted the recent proposed limited regulation (discussed below).

Resignations

Dr. Denton discussed the recent resignations of Dr. Andrew G. Hendrickx (chair of the DART Committee) and Dr. John R. Froines (a member of the CIC Committee).  Both reportedly resigned to focus on other duties.

Listing Activities

Dr. Denton reported the following statistics:

• since July 1999, 53 chemicals have been added to the list
  • 25 by authoritative bodies mechanism
  • 23 by the formally required to be labeled mechanism
  • 5 by the state's qualified experts mechanism
  • 22 were listed as carcinogens
  • 31 were listed as reproductive toxins
• of all listed chemicals
  • 58 have been listed due to inclusion in the Labor Code
  • 216 have been listed under the authoritative bodies mechanism
  • 186 have been listed under the  formally required to be labeled mechanism
  • 277 have been listed under the state's qualified experts mechanism

Delisting Activities

Denton noted that a total of 5 chemicals had been removed from the Prop 65 list since October 1999.  Four were removed by the CIC Committee, and the fifth, saccharin, was removed based on it's reclassification by IARC and NTP.

The amendment to Section 12705(d) would adopt the following "no significant risk" levels for chemicals listed as known to cause cancer:

The amendment to Section 12805 would adopt the following regulatory levels for chemicals known to the state to cause reproductive toxicity:

OEHHA Proposes More Delistings

A June 22 notice stated that OEHHA had determined that cyclohexanol and 2,4-DP, which had been listed in 1998 and 1999 as reproductive toxins under the "authoritative bodies" mechanism did not meet the listing criteria, finding that there is "no substantial evidence" that the regulatory criteria have been satisfied.  The notice indicates that hazard identification documents will be developed, and the DART Committee will consider whether the chemicals should remain listed.  Written comments made be filed until August 6.

The notice also stated that the listing criteria were not met for the developmental toxicity listing for 2,4-Butyric Acid.  That chemical will remain on the list, as the male reproductive toxicity listing is not affected.  The list was revised, however, to reflect the change.

Prop 65 List Updated

A June 15 notice stated that N-methylpyrrolidone was listed as a reproductive toxin, under the "authoritative bodies" mechanism.  The original document supporting this listing was published in June 1999.

Download the June 22, 2001 list (including the delisting above) in PDF format

• sorted alphabetically 
• sorted by CAS number
• sorted by date of listing

View the June 15, 2001 Proposition 65 List in html

Download the June 15, 2001 list as a MS Excel spreadsheet

April 30, 2001

Prop 65 List Updated

An April 20 notice indicated that nimopidine was joining the list as a reproductive toxin, under the "formally required to be labeled" mechanism.  

Download the April 20, 2001 list in PDF format

• sorted alphabetically
• sorted by CAS number
• sorted by date of listing

View the April 20, 2001 Proposition 65 List. [html]

Download the April 20, 2001 list as a MS Excel spreadsheet

Saccharin Delisted. . . Only to Be Reconsidered

On the same day, OEHHA issued a notice indicating that it  was asking the CIC to consider re-listing saccharin.  The notice stated:

"Since 1987, there has been considerable scientific information raising concerns regarding whether sodium saccharin poses a human cancer risk. In April 1994, OEHHA and the U.S. Environmental Protection Agency jointly sponsored the scientific workshop Assessing the Cancer Risk of Saccharin and Sodium Saccharin, which comprehensively reviewed the information available at that time relevant to cancer risk assessment for these chemicals. In 1999, IARC re-evaluated saccharin and its salts, and based on its conclusion that sodium saccharin produces urothelial bladder tumors in rats by a mechanism not relevant to humans because of critical interspecies differences in urine composition, re-classified saccharin and its salts as 'not classifiable as to their carcinogenicity to humans (Group 3).' In 2000, NTP released its Ninth Report on Carcinogens in which it removed saccharin from the list of substances "reasonably anticipated to be a human carcinogen."

"In light of the considerable new and relevant information on the carcinogenicity of sodium saccharin available since its consideration for listing by the State's qualified experts in 1987, OEHHA is asking the Carcinogen Identification Committee, i.e., the State's qualified experts for carcinogenicity determinations, to review the listing of sodium saccharin to determine whether the chemical should remain on the Proposition 65 list of substances known to cause cancer."  

The comment period on this notice expires June 5, 2001.

OEHHA Releases Final Criteria for Identifying Carcinogens

A March 5, 2001 notice provides the "Availability of the Final Guidance Criteria for Identifying Chemicals for Listing as "Known to the State to Cause Cancer."  The document is available in pdf as well.

As stated in the document, "These criteria are intended to give the CIC maximal flexibility in evaluating all pertinent scientific information in determining whether a chemical is known to the State to cause cancer," and establishes that a " 'weight-of evidence' approach shall be used to evaluate the body of information available for any given chemical."  The standard to be followed by the CIC is:

"[I]f the weight of scientific evidence clearly shows that a certain chemical causes invasive cancer in humans, or that it causes invasive cancer in animals (unless the mechanism of action has been shown not to be relevant to humans), the committee will normally identify that chemical for listing."

More Potential Listing

A March 30, 2001 notice of intent to list identifies methyleugenol as a potential carcinogen under the "authoritative bodies" provision.  You can download the supporting document for this potential listing.

March 2, 2001

Attorney General Proposes Final Regulations

In January 2001, California Attorney General Bill Lockyer responded to comments on initial proposed regulations regarding notification of Prop 65 litigation and settlements and private enforcers, and made minor changes in the proposed final regulations.  For more details, please go to our private enforcement page.

OEHHA Releases Documents from Safe Harbor Workshop

On February 23, 2001, a notice was issued by OEHHA making available documents from the November 15, 2000 public workshop on the development of safe harbor exposure numbers for Prop 65 listed chemicals.  Included in the documents released [all in pdf] were:

• Process for Developing Safe Harbor Numbers.  This document contains all of the risk assessment regulations.
• Proposition 65 Status Report on No Significant Risk Levels for Carcinogens and Maximum Allowable Daily Levels for Chemicals Causing Reproductive Toxicity.  This document sets out the levels provided in the 1994 report, and provides priority levels for the remaining chemicals.
• Public Input on the Process for Developing Safe Harbor Numbers: Issues Raised at the November 2000 Workshop and in Written Submissions. 

These documents reiterate OEHHA's commitment to developing 20-35 safe harbor levels per year.

OEHHA Lists 13 more Chemicals.

A February 23 notice indicated that 13 chemicals that were the subject of a December 22, 2000, notice of intent to list would be added to the Prop 65 list, effective February 27, 2001.  Ethoprop, indium phosphide, lynestrenol, norethynodrel, and propachlor were listed pursuant to the "authoritative bodies" mechanism.  Amantadine hydrochloride, diazoxide, dichlorphenamide, diltiazem hydrochloride, filgrastim, and trientine hydrochloride were listed under the "formally required to be labeled or identified" mechanism.  

Download the February 23, 2001 Proposition 65 List:

in PDF format:

• sorted alphabetically 
• sorted by CAS number
• sorted by date of listing

View the February 23, 2001 Proposition 65 List [html].

Download the list as a MS Excel spreadsheet

Two More Chemicals Proposed,One Rejected

OEHHA has issued two notices of intent to list chemicals.  A February 9, 2001 notice indicated that the agency intended to list bromate under the "authoritative bodies" mechanism.  The supporting document is available for download [html/pdf].  In a February 23, 2001 notice, the agency indicated that it intended to list nimodipene under the "formally required to be labeled or identified" mechanism.  The supporting document is available for download [html/pdf].

Meanwhile, OEHHA's January 26, 2001 notice stated that it had determined that diazinon would not be listed under the "authoritative bodies" mechanism.  The supporting document is available in pdf only.

Medical Device Regulation Rejected

On February 9, 2001 OEHHA issued a notice denying in almost all respects the petition of Advanced Medical Technology Association (formerly the Health Industry Manufacturers Association) for a warning regulation applicable to prescription medical devices.  Download the letter to AMTA's counsel, Gene Livingston [html/pdf].  The agency denied much of the requested relief because:

"While we are sympathetic to the challenges faced by medical device manufacturers in complying with warning regulations, we believe the petition is overly broad and does not provide an adequate basis for creating special and unique warning rules for a large number of medical device products. . . .  The variety of chemicals and exposure scenarios among these 4,000 categories of medical devices may mirror the variety found in all products that are subject to Proposition 65 warning requirements. After carefully studying the petition and the oral and written comments, we are not convinced that all of these medical device products require special regulations that treat them differently than other products falling within the jurisdiction of Proposition 65."

The agency did believe that a warning regulation was appropriate for a limited set of circumstances:

"We believe there is merit to the development of a regulation that addresses the administering of Proposition 65 warnings to an unconscious patient, a patient undergoing an urgent medical procedure, and a person who is legally incapable of giving consent. We do not believe current regulations properly recognize the unique circumstances involving the use of medical devices on these types of patients. OEHHA will begin drafting regulations this year in this area pursuant to the requirements of the Administrative Procedure Act."

Hazard Identification Documents Released

On February 22, 2001 OEHHA issued a notice stating that final hazard identification documents were now available for hexachlorobutadiene [html/pdf], 4-methylquinoline [html/pdf], and MX(3-chloro-4-(dichloromethyl)-5-hydroxy-2(5H)-furanone) [html/pdf].  

• 2001 Regulatory Update
• 2000 Regulatory Update
• 1999 Regulatory Update
• 1998 Regulatory Update
• 1997 Regulatory Update
• 1996 Regulatory Update