Styrene Makers Fight Carcinogen Ruling
WASHINGTON (CN) - A federal judge granted a motion to compel the U.S. Department of Health and Human Services to release records on its classifying of styrene as a carcinogen, but rejected a request for other records.
The Dart Container Corp. and the Styrene Information and Research Center sued U.S. Health and Human Services Secretary Kathleen Sebelius and her agency, seeking to block styrene's inclusion in the department's Twelfth Report on Carcinogens.
Derived from petroleum and natural gas byproducts, styrene is used to make a variety of consumer goods, including food containers. Every two years, the HHS's National Toxicology Program prepares a report on carcinogens, then follows a mandated procedure for promulgating its findings.
The procedure includes publishing a notice in the Federal Register, and preparing a draft background document reviewing the scientific literature and the public comments.
Next, a panel of scientific experts conducts a peer review of the background document and issues a report with comments and a listing recommendation, based on the expert panel report and the public comments.
Finally, the National Toxicology Program prepares a draft report on carcinogens, and submits it to the HHS secretary for approval.
On May 19, 2004, the National Toxicology Program set this process in motion when it nominated the chemical styrene for listing in the Twelfth Report on Carcinogens.
Ultimately, the expert panel voted 8-2 to recommend that "styrene ... be listed in the [Report on Carcinogens] as reasonably anticipated to be a human carcinogen base on limited evidence of carcinogenicity in humans and sufficient evidence in animals."
Secretary Sebelius signed the final report, which listed styrene, on June 10, 2011. The plaintiffs sued that day, seeking declaratory and injunctive relief to withdraw the report and its conclusions about styrene.
The plaintiffs asserted claims under the Administrative Procedure Act, the Public Health Service Act, the Information Quality Act, and the Due Process Clause of the Fifth Amendment.
Calling the agency's decision to list styrene as a carcinogen "arbitrary and capricious," plaintiffs asked the court to compel HHS to add several documents and communications to the administrative record and compel discovery.
The plaintiffs alleged, among other things, that the expert panel performed independent, non-peer-reviewed analysis rather than a peer review of publicly available scientific literature, that the expert panel was biased, that the NTP failed to weight all relevant evidence, and that NTP's conclusion that styrene is "reasonably anticipated" to be a human carcinogen is inconsistent with the findings of the Agency for Toxic Substance and Disease Registry, an operating division of HHS, whose findings were based on the same scientific evidence as the NTP's listing decision.
The HHS responded by insisting the plaintiffs failed to resolve discovery disputes outside of the courtroom, and that supplementing the administrative record would be inappropriate because it would prejudice the proceedings in the ongoing action, implying that the agency had an improper motive when it excluded the material in the first place.
On review, U.S. District Judge Reggie B. Walton granted the plaintiff's motion for the inclusion of "subgroup reports" prepared during expert panel review, finding the subgroup drafts were an integral part of the panel's peer review process and influenced its recommendations.
"The mere fact that the subgroup drafts were not ultimately passed on to the final decision-maker does not lead to the conclusion that they were not before the agency ... accordingly, the subgroup draft documents are not extra-record evidence," Walton wrote.
But Walton took a different position on several other documents and communications plaintiffs' said were vital to their position.
For instance, the plaintiffs contended that the administrative record is incomplete because it contains only results, and not the NTP's underlying statistical analyses. Walton called that request speculative.
"In contrast to the request for the subgroup reports, the plaintiffs' request for the NTP's independent analyses lacks concrete detail and specificity. As a result, the Court finds that the plaintiffs have not rebutted the presumption that the agency properly designated the administrative record with respect to these documents," Walton wrote.
The judge also rejected the inclusion of a letter to Sebelius from Dr. Christopher Portier, director of the Agency for Toxic Substance and Disease Registry, in which Portier opined that the NTP's decision to list styrene as "reasonably anticipated to be a human carcinogen" does not contradict the ATSDR's November 2010 Toxicology Profile on Styrene, which found that styrene "may possibly be a human carcinogen."
Walton found that the Portier letter, any correspondence relating to the letter, and inclusion of the ATSDR's Cancer Policy Chart, were pre-decisional and deliberative.
"For the foregoing reasons, the Court concludes that the plaintiffs' motion to supplement the record must be granted in part and denied in part," Walton wrote. "Specifically, the motion is granted as to the plaintiffs' request for the subgroup reports of the Expert Panel. However, the plaintiffs' motion to supplement the record with the NTP's independent analyses and statistical calculations of data from the styrene background document must be denied. The Court also concludes that the plaintiffs' motion to supplement the record must be denied with respect to documents relating to the Portier Letter and the ATSDR Cancer Policy Chart as identified in the plaintiffs' document requests."