Court May Stay 9th RoC "Known Carcinogen" Listing in Tozzi v. HHS

U.S. District Court Judge Emmet Sullivan heard oral argument June 14, 2000 in the 13-month old case of Tozzi v. Department of Health and Human Services, D.D.C. Civ. No. 99-1170. The court hearing was open to the public despite an earlier gag order following the government's introduction of materials under seal on May 4.

At issue in the case was whether National Toxicology Program officials violated NTP's own listing criteria by proposing to list dioxin in the 9th Report on Carcinogens under the "known" carcinogen category without a finding of "sufficient" human epidemiological evidence. NTP claims that the agency may use so-called "mechanistic" data to bolster the less-than-sufficient epidemiological evidence.

Judge Sullivan questioned both sides' attorneys closely, and observers present were unwilling to speculate how the court would rule. The judge first challenged plaintiffs' attorney, Charles Fromm, to explain how the plaintiffs had met the requirements for "standing", that is, how the proposed listing would actually harm the plaintiffs. Fromm responded that the plaintiffs -- several restaurant interests and a PVC medical device manufacturer -- faced economic harm from lost sales and damage to business reputation if their products were linked to known human carcinogens. In response to the court's assertion that the harm was too speculative, Fromm cited affidavits demonstrating that the PVC manufacturer had already lost some sales because of dioxin-related public concerns and other developments in California. These developments included the adoption of anti-dioxin resolutions by three Bay area municipalities. Fromm also noted the public uproar following EPA's release of its draft dioxin reassessment in May and statements in the EPA report concerning dioxin levels in food.

Judge Sullivan was also critical of the government's position on the standing issue, however, demanding that the Assistant U.S. Attorney arguing the case identify what possible plaintiffs would have standing if none of these entities did. After some back and forth, the government's attorney admitted that perhaps no plaintiffs could have standing, but he maintained that the point for the court was that the plaintiffs in this case had not met the standing requirements.

The judge also attacked the government over two exhibits that seemed to indicate that the agency had never intended to broaden the "known" criteria to permit consideration of mechanistic data. Mechanistic data were first allowed into the RoC review process in 1996, and an HHS press release and NIEHS official journal article at the time the 1996 revised criteria were issued indicate that only the "reasonably anticipated" criteria -- not "known" criteria -- were being revised. The government attorney responded that these documents were "simply wrong".

The court asked whether the agency was entitled to substantial deference in its application of the listing criteria, and plaintiffs' attorney Fromm responded that no such deference was warranted because the court was not being asked to second-guess the agency on a matter of scientific expertise. Fromm also cited case precedent holding that an agency is entitled to no deference where the agency's interpretation of a rule is contrary to the rule's plain meaning or where contemporaneous evidence from time the rule was issued indicates a contrary agency intent.

Judge Sullivan stated that if he found in favor of the government, he may stay his ruling to allow plaintiffs time to file an appeal.