Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PROP. 65 SUBSTANCE REVIEW BY INDEPENDENT SCIENTISTS IS RECOMMENDED

This article was originally published in The Tan Sheet

Executive Summary

PROP. 65 SUBSTANCE REVIEW BY INDEPENDENT SCIENTISTS IS RECOMMENDED by the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA). A memorandum issued recently by OEHHA Director Carol Henry proposes that the current Prop. 65 Scientific Advisory Panel, consisting entirely of state-employed scientists, be dissolved and that its functions be assumed by an OEHHA Science Advisory Board composed of external scientists. OEHHA is in the process of considering written and oral comments on the proposal. Under the OEHHA proposal, the board would advise OEHHA on "the variety of scientific issues that our programs face." Henry commented that OEHHA expects the "number of chemicals to be addressed by the proposed [Scientific Advisory Board] to be small, since the majority of listing activities can be accomplished via administrative listing mechanisms." Explaining the rationale for an independent Science Advisory Board, Henry noted that "objections have been raised by certain environmentalists, academicians and industry representatives regarding the current Proposition 65 Scientific Advisory Panel." She explained that "these objections include a lack of independent scientific peer review of state staff work, the appearance of conflict of interest in panel members reviewing their own state work, and the perception that panel members who report to political appointees may be unable to make independent scientific decisions." Henry added that "attracting and retaining scientists of high caliber to serve as members" of the panel "had been difficult" because of their limited role in the Prop. 65 review process. Also under the OEHHA proposal, two standing committees, each composed of six to eight members of the OEHHA Scientific Advisory Board, would be formed to deal exclusively with Prop. 65 listing issues. One committee would handle identification of reproductive/developmental toxicants and dose-response evaluation and the other would be responsible for identification of carcinogens and potency evaluation. OEHHA noted that hazard identification would be given greater priority than dose-response review. Public meetings of the two committees would be held about twice a year, the proposal says, but could be held more frequently if necessary. The proposal also recommends that existing Prop. 65 regulations be amended to designate the OEHHA director as the "state's qualified expert" with ultimate decision-making authority over the listing of ingredients. Under the plan, the role of the proposed Prop. 65 committees would be limited to providing "external peer review for the documentation in support of the listing or non-listing of a candidate chemical," the proposal states. Currently, the Prop. 65 Scientific Advisory Panel has the authority to list substances as hazardous. In joint comments submitted to OEHHA on Aug. 6, the Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry and Fragrance Association and the Grocery Manufacturers Association said that "OEHHA's proposal to replace the [Prop. 65 Scientific Advisory Panel] with a new body of outside experts is laudable." However, NDMA, CTFA and GMA asserted that "the proposed contours of the new [Scientific Advisory Board's] responsibilities would diminish rather than enhance the role of those experts," adding that "instead, the [Scientific Advisory Board] should be designated as the state's qualified experts and should be charged with the responsibility to review all scientific issues that arise with respect to a candidate substance." The groups maintained that the Scientific Advisory Board should be involved with risk- assessment, which is not addressed in the memo. The trade associations argued that designation of the OEHHA director as the "state's qualified expert" is "unlawful." The associations said that "the separation of functions required by current Prop. 65 regulations serves to ensure that listing decisions are made on the basis of . . . independent scientific judgment." The proposal to "give outside scientists essentially no effective control over listing decisions -- decisions that are both recommended and finalized by OEHHA -- entirely fails to address the concern over the 'appearance of [a] conflict of interest,'" the comments state. Moreover, the associations pointed out that the current Prop. 65 statute "plainly calls for 'experts' to make [listing] recommendations." The "use of the plural in the statute indicates that the expert function was intended to be performed by a body of scientists and not a single state official," they noted.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS081838

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel