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Court Lifts Seal in Tozzi v. HHS Case

On the eve of appeal, the U.S. District Court for the District of Columbia has ordered public disclosure of two key documents in the case of Tozzi v. DHHS.Judge Emmet Sullivan had placed the documents under seal in May 2000 while he considered the case and while NTP’s final dioxin listing remained unpublished.In light of NTP’s subsequent publication of that listing on January 19, 2001, however, the court ruled that confidentiality was no longer warranted.

The first document is a type-set version of a new rationale the agency put forward in support of the proposal to upgrade dioxin to "known human carcinogen."The government revealed this rationale for the first time only minutes before oral argument on May 4, 2000.The parties had jointly requested that this document be kept under seal until the court ruled on plaintiffs’ claims.

The second unsealed document is an internal HHS memorandum and reveals that, sometime between February 11 and May 4, 2000, the Director of NTP recommended to Secretary Shalala that dioxin be listed in the "known" category based on the rationale NTP had publicly advanced during the agency’s dioxin review, beginning in 1997.That rationale indicated at least partial reliance on animal test data and was one of the principal grounds for the Tozzi plaintiffs’ 1999 lawsuit.(NTP’s criteria for known human carcinogen listings require "sufficient evidence from studies in humans.")The newly disclosed document reveals that the Secretary’s Office evidently tried to supply a different rationale that it thought could pass legal muster in the face of legal challenge.

The final dioxin listing, which carefully avoids reference to animal data, states that the "known human carcinogen" classification is "based on sufficient evidence of carcinogenicity from studies in humans, involving a combination of epidemiological and mechanistic information which indicate a causal relationship."That rationale was never submitted to the public for comment, however, nor was it reviewed by outside experts pursuant to NTP’s formal peer review process.The agency’s reliance on its new-found rationale is one of the issues plaintiffs are appealing to the D.C