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Availability of Hazard Identification Materials for Perchlorate and Announcement of the Developmental and Reproductive Toxicant Identification Committee Meeting

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 (DART) Identification Committee of OEHHA's Science Advisory Board advises and assists OEHHA in compiling the list of chemicals known to the State to cause reproductive toxicity as required by 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.

On April 11, 2003, OEHHA published an initial request for information relevant to the assessment of the evidence of developmental and reproductive toxicity for perchlorate, a chemical to be considered by the DART Identification Committee for possible addition to the Proposition 65 list. At the request of several interested parties, on June 6, 2003, OEHHA issued an extension to the April 11 public comment period until 60 days after receipt of the peer reviewers' comments on OEHHA's draft Public Health Goal document for perchlorate. The peer reviewers' comments were received in February 2004, and thus, on February 27, 2004, a notice was published announcing the close of the 60-day data call-in period on April 27, 2004 . All Comments were received which were reviewed and considered by OEHHA in preparing and assembling the hazard identification materials for perchlorate.

OEHHA has prepared the hazard identification materials for perchlorate and announces the availability of the document entitled: “Evidence on the Developmental and Reproductive Toxicity of Perchlorate.” Copies of the document are available from the Proposition 65 Implementation Office and may be requested by calling (916) 445-6900. The document is also available through the Internet at the following address: http://www.oehha.ca.gov/. This notice marks the beginning of a 60-day public comment period. Comments should be submitted in triplicate and directed to:

the Proposition 65 Office
Office of Environmental Health Hazard Assessment
Proposition 65 Implementation
P.O. Box 4010
1001 I Street, 19 th floor
Sacramento, California 95812-4010

FAX (916) 323-8803

Comments may also be delivered in person or by courier to the above address. It is requested, but not required, that written comments and supporting documentation be transmitted via email addressed to: P65Public.Comments@oehha.ca.gov. In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered, sent by FAX, or transmitted electronically) by 5:00 p.m. on Tuesday, July 19, 2005.

OEHHA will organize and index the comments received and forward the information to the DART Identification Committee members prior to the meeting at which the candidate chemical will be considered.

At the last DART Identification Committee on November 4, 2004 at which the Committee considered listing chloroform and progesterone, the Committee asked OEHHA to present additional information related to the listing decision of each chemical. Additional information requested by the Committee concerning the possible reconsideration of the decision not to list ing chloroform will be made available in a future public notice. The Committee will also continue consideration of the listing of progesterone at its next meeting .

The next meeting of the DART Identification Committee is scheduled for Thursday, August 11, 2005 . The meeting will be held at the California Environmental Protection Agency Headquarters Building, Sierra Hearing Room, at 1001 I Street, Sacramento, California. The meeting will begin at 10:00 a.m. and will last until all business is conducted or until 5:00 p.m. The agenda for the meeting will be provided in a future public notice published in advance of the August 11 meeting.

Links to documents referenced in "Evidence on the Developmental and Reproductive Toxicity of Perchlorate" can be found below.

Attachment I: Public Health Goals for Chemicals In Drinking Water: Perchlorate (2005) prepared by OEHHA.

Attachment II: Health Implications of Perchlorate Ingestion (2005). Committee to Assess the Health Implications of Perchlorate Ingestion. National Research Council of the National Academies. (Read onscreen or order hard copy)

Attachment III: Greer et. al. “Health effects assessment for environmental perchlorate contamination: The dose-response for inhibition of thyroidal radioiodine uptake in humans.”

Attachment IV: Baldridge et. al. abstract only. “In utero and lactational exposure of Long-Evans rats to ammonium perchlorate (AP) disrupts ovarian follicle maturation.” (Full copy available from OEHHA Proposition 65 Implementation Office.)

Attachment Va: Argus Laboratories entitled, A neurobehavioral developmental study of ammonium perchlorate administered orally in drinking water to rats [report amendment: July 27]. Protocol no. 1613-002. Argus Research Laboratories, Inc., Horsham, PA. (1998a).

Attachment Vb: Argus Research Laboratories entitled, Hormone, thyroid and neurohistological effects of oral (drinking water) exposure to ammonium perchlorate in pregnant and lactating rats and in fetuses and nursing pups exposed to ammonium perchlorate during gestation or via maternal milk. Protocol no. 1416-003. Argus Research Laboratories, Inc., Horsham, PA. (2001).

Attachment Vc:

  1. York, R. (1997) Genealogy of F1 generation rats (Argus protocol #1613-002), [w/TL to D Dodd 10/26/98]. Argus Research Laboratories, Inc; October 30.
  2. York, R. G. (1998a) Update on additional items for 1613-002 [letter to Darol E. Dodd]. Horsham, PA: Argus Research Laboratories, Inc.; September 25.
  3. York, R. G. (1998b) Protocol 1613-002 - A neurobehavioral developmental study of ammonium perchlorate administered orally in drinking water to rats. Sponsor's study number: 7757A210-1096-25F [letter to Annie Jarabek]. Horsham, PA: Argus Research Laboratories, Inc.; October 2.
  4. York, R. G. (1998d) Study 1613-002 - A neurobehavioral developmental study of ammonium perchlorate administered orally in drinking water to rats. Sponsor's study number: 7757A210-1096-25F [letter with attachments to Annie Jarabek]. Horsham, PA: Argus Research Laboratories, Inc.; November 5.
  5. Consultants in Veterinary Pathology. (2001) Abbreviated morphometry report with appended thumbnails of scanned sections. Protocol 1416-003. Hormone, thyroid and neurohistological effects of oral (drinking water) exposure to ammonium perchlorate in pregnant and lactating rats and in fetuses and nursing pups exposed to ammonium perchlorate during gestation or via maternal milk. Murrysville, PA. (Supplement to neuropathology report on F1 generation day 10 and day 22 postpartum rats).
  6. Garman, R. (2001b) The morphometry component of the perchlorate effects protocol [memorandum to Jean Harry]. Murrysville, PA: Consultants in Veterinary Pathology, Inc.; August 14.
  7. Garman, R. H. (2001c) Perchlorate study [letter to Annie Jarabek regarding two topographs]. Murrysville, PA: Consultants in Veterinary Pathology, Inc.

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