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Tozzi Litigation Over NTP's
9th Report on Carcinogens

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CRE Advisory Board Member Jim Tozzi is suing the government over its proposed "known human carcinogen" listing of dioxin in the forthcoming 9th Report on Carcinogens ("RoC"). Along with a number of other plaintiffs, Mr. Tozzi is seeking a federal court injunction against the Department of Health and Human Services, Secretary Donna Shalala, NTP Director Ken Olden, and NIEHS Director of Toxicology, Christopher Portier. The other plaintiffs include two restaurants, a major restaurant association, and a medical device manufacturer that uses polyvinyl chloride ("PVC") in its operations.

Mr. Tozzi's lawsuit claims that HHS and NTP disregarded their own criteria for "known human carcinogen" listings by improperly basing the dioxin listing on animal, mechanistic, and in vitro data. The agency's published criteria state that known carcinogen listings may be based only on "sufficient evidence from studies in humans". Dioxin was listed as a second tier or "reasonably anticipated" carcinogen in past editions of the RoC, and Mr. Tozzi alleges that the government's proposed upgrade is arbitrary and capricious.

U.S. District Court Judge Emmet Sullivan on September 30, 2000 ruled that (i) the RoC listing was reviewable agency action, and (ii) the PVC plaintiff had standing to challenge the proposed dioxin listing, but (iii) the court was required to defer to the agency's interpretation of the criteria supporting the listing. On November 23, 2001, the DC Circuit Court of Appeals affirmed the holdings of Judge Sullivan. Read D.C. Circuit Opinion. Read Inside EPA article on DC Circuit Opinion.

Several of the key pleadings and legal memoranda in the case may be viewed by clicking below.

  1. Amended Complaint

  2. Defendants' Motion to Dismiss

  3. Opposition to Motion to Dismiss

  4. Plaintiffs' Application for Preliminary Injunction

  5. Opposition to Preliminary Injunction

  6. Plaintiffs' Motion for Summary Judgement

  7. Plaintiffs' Reply To Defendants' Opposition To Application For Preliminary Injunction

  8. Defendants' Renewed Motion to Dismiss and/or for Summary Judgment

  9. Memorandum in Opposition to Defendants' Renewed Motion to Dismiss and/or for Summary Judgement

  10. Reply to Defendants' Opposition to Plaintiffs' Cross-Motion for Summary Judgement

  11. Appellants' Motion for Injunction Pending Appeal (D.C. Cir.)

  12. Appellees' Motion for Summary Affirmance, and Opposition to Appellants' Motion for Injunction Pending Appeal (D.C. Cir.)

  13. Appellants' Response to Motion for Summary Affirmance, and Reply to Response to Motion for Injunction Pending Appeal

  14. D.C. Circuit Rejects NTP Motion for Summary Affirmance in Tozzi Suit

  15. Plaintiffs File DC Circuit Brief in NTP Dioxin Case

  16. Government's Opposition Brief (pdf 130 kb)

  17. Appellants' Reply (pdf 74 kb)

  18. DC Circuit Ruling