HHS/NTP Report on Carcinogens Program
HHS/NTP
NTP Defers Listing Proposals for Talc
Dr. Kenneth Olden, NTP Director, has informed stakeholders that both proposals to list Talc has been deferred pending further review. The review will determine whether clear definitions of the different kinds of talc can be developed and whether additional research is appropriate. He stated that the decision to defer did not address concerns over potential lung cancer hazard from talc containing asbestiform fibers, nor potential ovarian cancer hazard from cosmetic talc. Dr. Olden also invited further input on the issues.
Comment on Item
Strong Vote Against Listing Talc in 10th Report on Carcinogens Puts at Issue the Value of the External Peer Reviewers
The Program's external expert review panel voted 8-2 against an NTP proposal to list cosmetic talc which does not contain asbestiform fibers as "reasonably anticipated" to be a human carcinogen. Previously, two internal government review groups had voted in favor of listing. The divergent recommendations will now be sent to the NTP Executive Committee, and then to the NTP Director and the Secretary. CRE has submitted comments explaining how this unprecedented decisive contrary external peer review vote resulted from finding serious flaws in the earlier internal reviews, and was far more rational and supportable. The CRE comments question how the Executive Committee, the Director, and the Secretary could override such a strong external peer review vote and still maintain that those reviewers perform the valuable function envisioned when the RoC Subcommittee was created in 1996.
Read CRE letter to the National Toxicology Program
Comment on Item
National Cancer Institute, NTP Executive Committee Member, replies to CRE's inquiries on Talc
"We have a meeting next week," says Dr. David Longfellow, NCI Executive Committee and RG2 Panel Member. He recognizes the weight votes carry on talc. "The predecessor to this was glass wool," he adds (fiberglass). Dr. Longfellow says substances executing a wide impact on producers and consumers, such as talc and fiberglass, make for variegated voting. "There have been calls that are not clear, or straight down the line," he says. "Sometimes some of these things have been awkward and controversial enough that Dr. Olden gets outside, additional input." Dr. Longfellow explains the sought out sources consist of "people who have, historically, been players in the carcinogenis community." He states that sometimes this input is sought before the Executive Committee meets, sometime after. It's all based on "the body of information we have" and "industry comment."
Comment on Item
NTP Executive Committee to Vote on Talc in The Report on Carcinogens Program
CRE Website Reporter, Sydney Smith, conducts extensive interviews with National Toxicology Program (NTP) Executive Committee Panel. The purpose of the article is to educate the public on the process and procedures used by the Committee. A current split-vote on talc cosmetic powder lends controversy to the next committee meeting and depth to the CRE's reports.
Read the CRE Guest Column Article
Comment on item
Member of CRE Board of Advisors Initiated Litigation on NTP Report on Listing of Dioxin
A member of the CRE Board of Advisors has initiated litigation on the NTP report on the listing of Dioxin as a known human carcinogen. The details for this litigation are set forth in the Issues Section entitled "HHS/NTP Report on Carcinogens." By clicking to that issues section on the homepage and then examining Tozzi v. DHHS, the details of the action are documented in detail.
Read More
See CRE Litigation
Report on Carcinogens Reviewers Vote Against Listing Talc
The Program's external expert review panel, after hearing public comments, voted 8-2 against an NTP proposal to list cosmetic talc which does not contain asbestiform fibers as "reasonably anticipated" to be a human carcinogen. Previously, two internal government review groups had voted in favor of listing. The reviewers also deadlocked 5-5 on whether to list talc which contains asbestiform fibers as "reasonably anticipated". CRE comments addressed fundamental programmatic issues such as proper characterization of exposures, adherence to the listing criteria, and consideration of all relevant information. The next steps in the review process are consideration by the NTP Executive Committee, then decisions by the Director of NTP and the Secretary of HHS.
Click to view CRE comments
Click to view CRE white paper
Click to view final CRE comments.
Court Reviews RoC, Holds Plaintiff in Tozzi v. HHS Has Standing
Judge Emmet Sullivan ruled that a PVC manufacturer had standing to challenge a proposed upgraded listing for dioxin in the 9th Report on Carcinogens. The court's September 30, 2000 opinion also ignored government arguments that the RoC is not judicially reviewable. This aspect of the decision sets important precedent for review of risk assessments and similar so-called "informational" agency actions. The court sided with the agency on its interpretation of the RoC listing criteria, however, a decision plaintiffs are appealing.
Read Judge Sullivan's Opinion (get plug-in)
Read More About This and Other Tozzi Suits
Read More About This Suit, Including Briefs
Court May Stay 9th RoC "Known Carcinogen" Listing in Tozzi v. HHS
Judge Emmet Sullivan indicated at a hearing June 14 that he may stay the government's listing of dioxin as a "known" human carcinogen in the 9th Report on Carcinogens -- even if he found in favor of NTP on the merits of the case -- in order to give CRE Advisory Board Member Jim Tozzi and the other plaintiffs a chance to appeal the decision. The judge took the matter under advisement following the argument, noting he would give the case "high priority".
Read More About This Suit, Including Briefs
Read More About This and Other Tozzi Suits
Tozzi Plaintiffs Again Delay Final Issuance of Dioxin Listing
Oral argument previously scheduled for May 4 did not take place as planned in the case of Tozzi v. DHHS, but instead was rescheduled for June 14, 2000. The court ordered additional briefing on the proposed listing be filed under seal and also gave the government permission to publish the remainder of the 9th RoC without the upgraded listing for dioxin.
Read More About This Suit, Including Briefs
Read More About This and Other Tozzi Suits
NTP Postpones Its "Imminent" Release of 9th RoC Until May 15, 2000, Following Hearing in Tozzi v. HHS.
Justice Department attorneys filed notice April 3 that HHS is prepared to release the 9th RoC later this month. The agency is withholding release, however, because of a May 4 court hearing in a lawsuit by CRE Advisory Board Member Jim Tozzi and other plaintiffs. The final report, which Secretary Shalala has now approved, still lists dioxin as a "known human carcinogen", despite plaintiffs' claims that the agency failed to follow its own listing criteria on the proposed dioxin upgrade.
Read More About This Suit, Including Briefs
Read More About This and Other Tozzi Suits
Litigation over 9th RoC
CRE Advisory Board Member Jim Tozzi is seeking a federal court injunction against the proposed dioxin listing, claiming that HHS/NTP disregarded their own criteria on "known" human carcinogens.
Bitter Medicine: Pharmaceutical Listings in the Report on Carcinogens
Report claiming a neeed for a pharmaceutical category separate from NTP, which could provide a much fuller explanation of the risk and benefits of covered drug products, and would allow the public to make better informed decisions.
Background on Ninth Report on Carcinogens (NIEHS/NTP)
U.S. Department of Health and Human Services (NIEHS/NTP)
Letter to the Director of NIEHS
Letter from CRE to the Director of the National Institute of Environmental Health Sciences (NIEHS).
Attachment to Letter
The Need To Supplement Certain Listings In The Biennial Reports On Carcinogens In Order To Avoid Misleading The Public And Harming Public Health.
Regulatory and Legislative Impacts of the Ninth Report on Carcinogens
Providing an ongoing forum to identify and discuss various legislative and regulatory actions taken at the federal, State, and local level based upon the Ninth Report. CRE welcomes additional examples suitable for inclusion in this section.
Summary of NTP's October 1999 Public Meeting on the Report on Carcinogens Program
On October 21-22, 1999, the National Institute of Environmental Health Sciences and the National Toxicology Program sponsored a two-day public meeting at the Doubletree Hotel in Rockville, MD to discuss ways in which the Report on Carcinogens program could be improved.
