Prioritizing Chemicals for Consideration as Carcinogens by the "SQE": Third Round Random Selection
Prioritizing Chemicals for Consideration as Carcinogens Under Proposition 65 by the "State's Qualified Experts": Third Round Random Selection
The Office of Environmental Health Hazard Assessment (OEHHA) is responsible for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65; Health and Safety Code Section 25249.5 et seq.) Under Proposition 65, a chemical may be identified as "known to the State to cause cancer" when the state's qualified experts find it to be clearly shown through scientifically valid testing according to generally accepted principles to cause cancer. The Carcinogen Identification Committee (CIC) of the OEHHA Science Advisory Board serves as the state's qualified experts for identifying chemicals as causing cancer under Proposition 65. The effort described in this notice is directed at prioritizing chemicals for carcinogenicity evaluation by the CIC.
OEHHA has developed a database of chemicals that have been nominated for carcinogenicity consideration under Proposition 65. The database contains entries on several hundred chemicals. Candidacy is based on information taken from the scientific literature, lists and databases, and on nominations from members of OEHHA's Science Advisory Board, other state agencies, the scientific community, and the general public. The toxicological information on nominees includes, for example, positive cancer data from animal and human studies, or data from other relevant studies. Chemicals are tracked and the database updated as new information becomes available.
OEHHA first randomly selected chemicals for prioritization for carcinogenicity evaluation in August 1997. A second round of random selection was conducted in March 1998. This notice announces a third round of random selection. The third round of random selection will be conducted on 100 chemicals (Table 1) that consist of the 39 chemicals remaining from the previous random selection and 61 additional chemicals selected from the database using a table of random numbers. [Note: Forty chemicals remained (were not selected) from the second round of random selection. One of the 40 chemicals, ortho-phenylphenol, was administratively added to the Proposition 65 list as a chemical known to cause cancer on August 4, 2000.] The additional 61 chemicals were selected from among those chemicals in the database that are produced, used, released or present in California, and for which there is some information suggesting the chemicals may be carcinogenic. The criterion that the chemicals must have a potential for exposure to Californians in order to be considered at this stage is new to this round of random selection. Members of the CIC requested the change to ensure that the chemicals brought to their consideration for listing are used or otherwise present in California.
Fifty chemicals will be selected in this third round of random selection. Each of the 50 selected chemicals will receive a screening toxicity evaluation, based on a brief review of available scientific literature. A draft priority ranking of "High" or "Not High" will be assigned to each of the 50 chemicals, based on the evidence of carcinogenicity. OEHHA will hold a public workshop and a 60-day public comment period to solicit oral as well as written comment on the draft priority rankings. Chemicals receiving a final priority ranking of "High" toxicity concern will be considered first by the CIC. To facilitate the CIC's consideration, hazard identification documents are prepared that summarize the scientific evidence on the carcinogenicity of the chemical.
For the random selection process, OEHHA developed a series of 500 randomly generated numbers using Microsoft Excel (shown in Table 2 below). OEHHA will insert the 100 alphabetically arranged chemicals shown in Table 1 into Table 2 to determine a numerical reordering of the 100 chemicals. This will result in a "shuffling" of the alphabetical list. The relative position where the alphabetical listing in Table 1 is inserted into the series of random numbers in Table 2 will be based on the sum of the first three Super Lotto Plus numbers drawn on Saturday, October 27, 2001. For purposes of illustration only, if the first three numbers drawn are 48, 3, and 27, the sum will be 78 and the first chemical in Table 1 will be assigned the numerical value of the 78th number (336) in Table 2. The second chemical in Table 1 will have the numerical value of the 79th number (277) in Table 2 and so on. These 100 assigned random numbers, and corresponding chemicals, will be reordered according to increasing value. The lowest 50 numerical values will constitute the 50 chemicals selected in this round of random selection. The results of the random selection will be posted on OEHHA's Web site on or before November 5, 2001. The remaining 50 chemicals will be part of the pool from which future selections will occur.
OEHHA is committed to an open and public process in the implementation of Proposition 65.
For inquiries on Proposition 65, please call or write to:
Cynthia Oshita
Office of Environmental Health Hazard Assessment
Street Address: 1001 I Street
Sacramento, California 95814
Mailing Address: P.O. Box 4010
Sacramento, California 95812-4010
FAX (916) 323-8803
Telephone (916) 445-6900
