March 19, 2014 Meeting of the Developmental And Reproductive Toxicant Identification Committee

The Developmental and Reproductive Toxicant Identification Committee (DART IC) of OEHHA’s¹ 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 the DART IC will be held on Wednesday, March 19, 2014.  On January 10, 2014, OEHHA released the hazard identification materials for the six chemicals with listings that will be reconsidered at the March 19 meeting.  The meeting will be available via webcast.  The URL for the webcast (not active until the day and time of the meeting) is: http://calepa.ca.gov/Broadcast/.  On the day of the meeting, the link to the webcast will also be posted on the OEHHA web site.  If you have special accommodation or language needs, please contact the Proposition 65 Office at (916) 445-6900 or P65.Questions@oehha.ca.gov by March 12, 2014.  TTY/TDD/Speech-to-Speech users may dial 7‑1‑1 for the California Relay Service.

Agenda

1. WELCOME AND OPENING REMARKS
   Dr. George Alexeeff, Director, Office of Environmental Health Hazard Assessment (OEHHA)
2. RECONSIDERATION OF LISTING OF CHEMICALS LISTED VIA THE LABOR CODE AS KNOWN TO THE STATE TO CAUSE REPRODUCTIVE TOXICITY
   Introductory comments – Carol Monahan-Cummings, Chief Counsel, and Dr. James Donald, Chief of Reproductive Toxicology and Epidemiology Section, OEHHA

• n-Butyl glycidyl ether
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision 
• Diglycidyl ether
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision 
• Phenyl glycidyl ether
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision
• Methyl n-butyl ketone
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision
• Methyl isopropyl ketone
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision
• α-Methyl styrene
  • Staff presentation – Dr. Francisco Moran, OEHHA
  • Public comments*
  • Committee discussion and decision

3. Committee Discussion on Tabulation of Data from Epidemiological and Animal Data in Hazard Identification Documents
   • Introduction – Dr. Gold
   • Public comments*
   • Committee discussion
4. Update of Section 27000 List of Chemicals Which Have Not Been Adequately Tested as Required
   Carol Monahan-Cummings, Chief Counsel, OEHHA
5. STAFF UPDATES
   • Chemical listings (the Proposition 65 Office, Proposition 65 Implementation, OEHHA)
   • Proposition 65 litigation (Carol Monahan-Cummings, Chief Counsel, OEHHA)
6. SUMMARY OF COMMITTEE ACTIONS
   Dr. George Alexeeff, Director, OEHHA

* Generally public comments should be limited to 5 minutes, which may be changed if time allows and at the discretion of the chair.

SUMMARY OF THE COMMITTEE DECISIONS: 

Reconsideration of Listing of Chemicals Listed Via the Labor Code as Known to Cause Reproductive Toxicity

Following presentations by Office of Environmental Health Hazard Assessment (OEHHA) staff, public comments and committee discussions, the DARTIC made the following decisions:

1. The following chemicals will be removed from the Proposition 65 list as known to cause reproductive toxicity:

• n-butyl glycidyl ether
• diglycidyl ether
• phenyl glycidyl ether
• methyl isopropyl ketone
• α-methyl styrene

The DARTIC deferred its decision on methyl n-butyl ketone and asked OEHHA to investigate the availability of the original animal data from a developmental study of the chemical that was published by the National Institute for Environmental Health Sciences.  The DARTIC asked OEHHA to report back at its next meeting.  In the interim, methyl n-butyl ketone will remain on the Proposition 65 list.

Follow the links in the downloads section below to download the slide presentations made at the meeting by OEHHA staff:

• Introductory comments – Carol Monahan-Cummings, Chief Counsel, and
• Staff Presentations by Dr. James Donald, Chief of Reproductive Toxicology and Epidemiology Section and Dr. Francisco Moran, Staff Toxicologist

2. COMMITTEE DISCUSSION ON TABULATION OF EPIDEMIOLOGICAL AND ANIMAL DATA IN HAZARD IDENTIFICATION DOCUMENTS

The DARTIC discussed draft templates for tabulating data from epidemiology and animal studies in hazard identification documents, and the public comments received on the draft templates.

Several members stated that they liked the draft templates.  Members made suggestions for additional information that could be included in future tables in hazard identification documents:

• more detailed information on statistical analyses and statistical study power
• hyperlinks to reference materials within the electronic file of the hazard identification document (in both the tables and the text)

In addition, there was a suggestion to include graphical presentations of outcomes across studies as additional information to complement the tables.

Lastly, a member suggested that the National Toxicology Program (NTP) be asked to make a presentation to the DARTIC on the data tools the NTP is developing for use in evaluating studies of chemical toxicities.

3. UPDATE OF THE SECTION 27000 LIST OF CHEMICALS WHICH HAVE NOT BEEN ADEQUATELY TESTED AS REQUIRED

The DARTIC was asked to consider the addition of 16 chemicals to and the removal of six other chemicals from the Section 27000 list of Chemicals That Have Not Been Adequately Tested as Required.  The DARTIC voted unanimously to add the 16 chemicals as identified by the U.S. Environmental Protection Agency to the Section 27000 list.  The DARTIC also voted unanimously to remove the 6 chemicals as identified by the U.S. EPA and the Department of Pesticide Regulation from the Section 27000 list.

4. STAFF UPDATES

Staff updated the committee regarding chemical listing activities and Proposition 65 litigation and regulatory activities.

¹ 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, codified at Health and Safety Code, section 25249.5 et seq. (commonly known as Proposition 65).

Related Content

• Tabulating Epidemiological and Animal Data In Hazard Identification Documents for the Developmental and Reproductive Toxicant Identification Committee

  Start of public comment period on a draft table for presenting epidemiological data. The Developmental and Reproductive Toxicant Identification Committee reviewed a draft table and decided to discuss this further after the public had an opportunity to comment on this table as well as a similar table for tabulating data from studies in laboratory animals.

  Read more

• Availability of Hazard Identification Materials to Support Reconsideration of Listing: 6 Chemicals Listed Via The Labor Code as Known to the State of California to Cause Reproductive Toxicity

  Hazard identification document to support the reconsideration for n-Butyl glycidyl ether, Diglycidyl ether, Phenyl glycidyl ether, Methyl n-butyl ketone, Methyl isopropyl ketone, α-Methyl styrene for listing under Proposition 65 as known to cause reproductive toxicity.

  Read more