A meeting of the Developmental and Reproductive Toxicant (DART) Identification Committee was held on August 11, 2005, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. Below are the presentations made by staff of the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) as well as the public. The segments of the agenda covered by this material include the “Consideration of Chemicals as Known to the State to Cause Reproductive Toxicity” and “Re-Analysis of Developmental Toxicity of Chloroform as Requested by DART Identification Committee.”

Meeting Summary:

1. The DART Identification Committee determined that perchlorate had not been clearly shown to cause reproductive toxicity, and therefore declined to add it to the Proposition 65 chemical list.
2. At the November 4, 2004 meeting the Committee determined that progesterone had not been clearly shown to cause developmental toxicity; however, the Committee deferred the listing decision for the female and male reproductive toxicity endpoints asking OEHHA to develop proposed limiting language for the listing to take into account the therapeutic usage of progesterone in female and male reproduction and bring progesterone back to the Committee for consideration. OEHHA considered the Committee’s request and determined that limiting language for the listing was not necessary in light of the existing clear and reasonable warning regulations which essentially exempt prescription drugs from the Proposition 65 warning requirements as long as there is approved federal labeling regarding the drug and the prescribing physician follows the informed consent requirements a separate warning under Proposition 65 would not be required. The Committee was asked to opine as to whether progesterone had been clearly shown to cause female or male reproductive toxicity. The Committee determined that progesterone had not been clearly shown to cause female or male reproductive toxicity, and therefore declined to add progesterone to the Proposition 65 chemical list for either endpoint (Note: Progesterone remains listed as known to cause cancer, effective January 1, 1988.)
3. Also at the November 2004 meeting, the Committee asked OEHHA to contact the original authors of the chloroform epidemiology study, to request the full suite of data from the study, to perform additional evaluation of the data and bring the results of the re-analyses back to the Committee for information purposes. OEHHA staff presented the re-analysis of the data performed by the original authors for the benefit of the Committee.

The complete meeting transcript of the meeting is available from the court reporter, Ms. Phyllis Mank at Phylanna@aol.com.

Meeting Agenda
Follow this link to download a copy of this notice, or use the links below to download the individual presentations

Consideration of Chemicals as Known to the State to Cause Reproductive Toxicity

• Perchlorate
  Poorni Iyer, Ph.D., OEHHA

Public Commenters:

• Michele B. Corash and F. Jay Murray, Ph.D.
  On behalf of Perchlorate Study Group
• John Robinson and Gene Livingston
  On behalf of the California Attractions and Parks Association
• John P. Gibbs, Ph.D.
  Kerr McGee
• Gina Solomon, M.D., MPH
  On behalf of the Natural Resource Defense Council
• Sharon Rubalcalva
  On behalf of the Motion Picture Association of America
• Jim Embree, Ph.D.
  On behalf of the Motion Picture Association of America
• Michael A. Payne, Ph.D.
  University of California, Davis, Department of Environmental Toxicology
• Progesterone
  Mari Golub, Ph.D., OEHHA

Re-analysis of Developmental Toxicity of Chloroform as Requested by DART Identification Committee

• Staff Presentation
  Jim Donald, Ph.D., OEHHA
  

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