Comment Period - Chemicals Selected by OEHHA for Consideration for Listing by the Carcinogen Identification Committee and Request for Relevant Information

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).  The Carcinogen Identification Committee (CIC) of OEHHA’s Science Advisory Board serves as the State’s qualified experts for rendering an opinion whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.  The chemicals identified by the CIC are added to the Proposition 65 list, which must be updated annually. 

On May 29, 2009, the CIC considered the priority ranking of 38 chemicals of which they recommended that nine of the chemicals be placed in the High priority category.  OEHHA has initially selected five of the nine chemicals for the CIC’s review for possible listing under Proposition 65 and is initiating the development of hazard identification materials for these chemicals.  [The remaining four chemicals will be the subject of a future public notice or notices.]  The five chemicals are listed in Table 1 below. 

Table 1. Chemicals Selected for Preparation of Cancer Hazard Identification Materials and Review for Possible Listing by the Carcinogen Identification Committee

Chemical

CAS No.

3-Monochloropropane-1,2-diol

96-24-2

1,3-Dichloro-2-propanol

96-23-1

Fluoride and its salts

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Diisononyl phthalate (DINP)

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Perfluorooctanoic acid (PFOA) and its salts and transformation and degradation precursors

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These chemicals were selected using the procedure described in the document entitled: “Process for Prioritizing Chemicals for Consideration under Proposition 65 by the State’s Qualified Experts,” adopted in 2004, and available on the Internet at www.oehha.ca.gov. 

OEHHA identified 38 chemicals through application of an epidemiology data screen and an animal data screen, and a preliminary toxicological evaluation of the available overall evidence of carcinogenicity, as outlined in the 2004 prioritization process.  These 38 chemicals were presented and released for public comment on March 5, 2009, along with a separate listing of the relevant studies identified for each chemical.  These materials were provided to the Committee and also made available on OEHHA’s Web site.  The Committee met to consider the materials for all 38 chemicals at a public meeting on May 29, 2009.  At this meeting, the Committee advised OEHHA by majority vote that nine chemicals be given high priority consideration for preparation of hazard identification materials.  The five chemicals identified in Table 1 are a subset of the nine high priority candidates.  The hazard identification materials for the five chemicals will be presented at a future meeting for Committee review for possible listing of the chemical under Proposition 65.  OEHHA anticipates announcing a similar request for relevant information on the remaining four chemicals at a future date.

By this notice, OEHHA is providing the public an opportunity to provide information relevant to the assessment of the evidence of carcinogenicity for any of the chemicals listed in Table 1.  Relevant information includes but is not limited to:  cancer bioassays, cancer epidemiological studies, genotoxicity testing, and other pertinent data on pharmacokinetics, biomarkers, and effects on biochemical and physiological processes in humans for any of the five chemicals.  Interested parties or members of the public wishing to provide such information should send it to the address given below. 

The publication of this notice marks the start of a 60-day data call-in period.  This period will end on Tuesday, December 15, 2009.  The information received during this data call-in period will be reviewed and considered by OEHHA as it prepares the cancer hazard identification materials on these chemicals.  This request for information is the next step in the process described in the 2004 prioritization procedure. 

Notification of the availability of the hazard identification materials and of the time, date, location, and agenda of the meetings of the Carcinogen Identification Committee where these chemicals will be considered will be provided in subsequent notices published in the California Regulatory Notice Register and will also be posted on OEHHA’s website.  It is anticipated that the hazard identification materials will be made available for a 60-day comment period prior to the Committee meetings at which these chemicals will be considered.

Relevant information on these chemicals should be submitted to:

the Proposition 65 Office
Office of Environmental Health Hazard Assessment
Proposition 65 Implementation
P.O. Box 4010
1001 I Street, 19th Floor
Sacramento, California 95812-4010
FAX:  (916) 323-8803
Or via e-mail to sam.delson@oehha.ca.gov

Submittal of materials in electronic form is encouraged.  It is requested that all hard-copy materials be submitted in triplicate.

Submissions may also be delivered in person or by courier to the above address.  In order to be considered, the relevant information must be received at OEHHA (if delivered in person or sent by FAX) by 5:00 p.m. on Tuesday, December 15, 2009.

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