October 21, 2010 Meeting of the Developmental and Reproductive Toxicant Identification Committee

Methyl isocyanate will be considered for possible listing under Proposition 65 by the DARTIC at its next meeting scheduled for Thursday, October 21, 2010. The meeting will be held in the Coastal Hearing Room at the Cal/EPA Headquarters building, 1001 I Street, Sacramento, California. Thursday’s meeting will begin at 10:00 a.m. and will last until all business is conducted or until 5:00 p.m.

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 Developmental and Reproductive Toxicant Identification Committee of OEHHA’s Science Advisory Board identifies chemicals for addition to the list of chemicals known to the State to cause reproductive toxicity (Health and Safety Code section 25249.8). The Committee serves as the “State’s Qualified Experts” for determining whether a chemical has been clearly shown, through scientifically valid testing according to generally accepted principles, to cause reproductive toxicity.

A public meeting of this committee will be held on Thursday, October 21, 2010 in the California Environmental Protection Agency Headquarters Building, Coastal Hearing Room, at 1001 I Street, Sacramento, California. The meeting will begin at 10:00 a.m. and continue until all business has been conducted, or 5:00 p.m. If you have special accommodation or language needs, please contact the Proposition 65 Office at (916) 445-6900 or sam.delson@oehha.ca.gov. TTY/TDD/Speech-to-Speech users may dial 7-1-1 for the California Relay Service.

The agenda for this meeting is as follows:

  1. WELCOME AND OPENING REMARKS
  2. CONSIDERATION OF A CHEMICAL AS KNOWN TO THE STATE TO CAUSE REPRODUCTIVE TOXICITY
    1. Methyl Isocyanate Hazard Identification
      • Staff presentation
      • Public comments
      • Committee discussion and decision
  3. DISCUSSION OF THE NEXT PRIORITIZATION DATA SCREEN

ITEMS IV. AND V. FOR COMMITTEE DISCUSSION ONLY:

  1. PROCEDURES FOR PRESENTATION OF PUBLIC COMMENTS, COMMITTEE DISCUSSIONS, AND COMMITTEE VOTES DURING MEETINGS
  2. PETITION TO RECONSIDER THE DESIGNATION OF NTP-CENTER FOR EVALUATION OF RISKS TO HUMAN REPRODUCTION AS AN AUTHORITATIVE BODY
  3. STAFF UPDATES
  4. SUMMARY OF COMMITTEE ACTIONS AND CLOSING REMARKS

Below is a synopsis of the meeting

SUMMARY OF THE LISTING DECISION FOR METHYL ISOCYANATE (MIC)

Following a staff presentation, comments from the public and committee discussion, the DARTIC determined that MIC has been clearly shown to cause developmental toxicity and female reproductive toxicity. The chemical was added to the Proposition 65 chemical list as known to cause reproductive toxicity (developmental and female reproductive toxicity endpoints) effective November 12, 2010.  The DARTIC did not find that MIC has been clearly shown to cause male reproductive toxicity.

Follow these links to the slide presentations made at the meeting by OEHHA staff:

SUMMARY OF THE NEXT PRIORITIZATION DATA SCREEN

Staff and the committee discussed the next data screen to apply in OEHHA’s prioritization of chemicals for possible DARTIC review. OEHHA suggested screening candidate chemicals first to identify chemicals that are known to occur in humans, then to screen that subset of candidate chemicals for those that have a substantial amount of relevant toxicological animal data. Such a screen would give OEHHA flexibility to use its resources more efficiently.  The DARTIC indicated agreement and also advised that the previously-used epidemiologic data screen should be repeated at some point in the future. 

  • Possible Future Screen for Prioritizing DART Candidates for Consideration
    James Donald, Ph.D., OEHHA

SUMMARY OF THE COMMITTEE MEETING PROCEDURES DISCUSSION

Following the staff presentation and committee discussion, the DARTIC advised that they preferred the following approaches:

  • For chemicals with complex data sets where it would facilitate committee review, staff presentations, committee discussion and public comment would be grouped by endpoint (e.g., male reproductive, female reproductive and developmental toxicity). The committee emphasized that redundancy should be avoided where possible, and that votes on all relevant endpoints would take place after all presentations, comments and committee discussion are completed.
  • Allocating time limits for each public commenter on a particular agenda item and announcing the time limits in advance of the meeting.  
  • Not allowing a public commenter to cede time to another commenter.
  • Maintaining the current voting method – voice or show of hands.
  • Reserving the option to ask commenters for voluntary financial disclosures or affiliations.

SUMMARY OF THE DISCUSSION OF THE PETITION TO RECONSIDER THE DESIGNATION OF NTP-CERHR AS AN AUTHORITATIVE BODY

Following the staff presentation and committee discussion, the DARTIC tabled the discussion of the American Chemistry Council’s petition for reconsideration of the National Toxicology Program as an authoritative body.  Instead, the DARTIC requested that an informational presentation be made by OEHHA staff at the next committee meeting to educate the committee about the four listing mechanisms available under Proposition 65.

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