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From Health Law Daily, May 16, 2013

Federal court rejects industry challenge to placement of styrene in Report on Carcinogens

By Sarah E. Baumann, JD

A federal court rejected the styrene industry’s challenge to HHS’ placement of styrene in its Twelfth Report on Carcinogens as a substance “reasonably anticipated to be a human carcinogen” (Styrene Information and Research Center, Inc. v Sebelius, May 15, 2013, Walton, R). The court determined that HHS violated neither the Administrative Procedure Act (APA) (5 U.S.C. sec. 704) nor the Public Health Service Act (42 U.S.C. sec. 241(b)(4)). It granted the agency’s motion for summary judgment and denied the industry’s motion for the same.

Report on Carcinogens. Pursuant to the Public Health Service Act, HHS’ National Toxicology Program (NTP) publishes a biennial report listing all substances known or reasonably anticipated to be human carcinogens. As part of this process, the NTP nominates, selects, and announces candidate substances, and solicits public comments. It then performs a scientific review, preparing a draft background document that is publically reviewed by an expert panel and internally reviewed by two independent federal committees. The NTP then drafts substance profiles that are peer reviewed by the Board of Scientific Counselors to ensure that the scientific information is technically correct. Finally, the NTP submits the final draft of the Report on Carcinogens to the Secretary. Upon approval, the report is transmitted to Congress and published in the Federal Register and NTP publications.

Substances are “known” to be human carcinogens when there is sufficient evidence of carcinogenicity from human studies, indicating a causal relationship. Substances are “reasonably anticipated” to be human carcinogens where there is (1) limited evidence of carcinogenicity in humans, (2) sufficient evidence of carcinogenicity in animal studies, or (3) less than sufficient evidence of carcinogenicity in humans or animals, but the substance belongs to a related class of substances previously listed in a Report on Carcinogens or where other convincing relevant information exists.

Styrene. Styrene is “a liquid derived from petroleum and natural gas byproducts that is used to manufacture a variety of consumer goods,” that was nominated based on a reputable international agency’s findings of limited carcinogenicity in animals and humans. Throughout the process of review by various committees, all but one committee member voted to place styrene in the Report as a substance reasonably anticipated to be a human carcinogen. A handful of committee members suggested listing it as a substance known to be a human carcinogen.

The Styrene Information and Research Center, Inc. (Styrene Center), a trade association comprising 95 percent of the North American styrene industry, and Dart Container Corporation (Dart), a manufacturer of styrene-based products, sued Secretary Kathleen Sebelius and HHS on the date that the report was released. United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, along with a non-profit organization whose mission is to minimize chemical risks, and a doctor specializing in occupational medicine (collectively, the Intervenors) intervened in the suit.

Exhaustion of administrative remedies. Styrene Center and Dart facially challenged the NTP Listing Criteria, arguing that it contravened a congressional mandate that authorized it to list substances “reasonably” expected to cause cancer and not merely “suspected” of doing so. The court determined that, although the HHS promulgated the Listing Criteria in 1996, Styrene Center and Dart were not precluded from challenging them beyond the six year statute of limitations because the rule was only recently enforced and the plaintiffs had been adversely affected. However, despite the fact that Styrene and Dart submitted public comments on four occasions, they never raised the issue that the Listing Criteria violated the Public Health Service Act, even making representations that they approved of the criteria. As a result, the court determined that they had failed to exhaust their administrative remedies

APA violations. Styrene Center and Dart alleged that the NTP violated the APA by failing to conform with its own guidelines, including the guideline that data in the background document “must come from publicly available, peer-reviewed sources” and directing an expert panel to “peer review the background document.” However, they effectively conceded the issue by failing to respond to HHS’ argument that the claim was not reviewable, since it challenged an action committed to agency discretion by law. The court noted, however, that it would have granted summary judgment on the merits, since there were no “judicially manageable standards” by which it could review the agency action. Furthermore, the NTP’s decision to stagger the public comment periods did not contravene any procedure required by law.

Arbitrary and capricious. Finally, the court determined that HHS’ decision to list styrene in the Report on Carcinogens was neither arbitrary nor capricious, despite Styrene Center’s and Dart’s argument that HHS based its decision on a misleading document. First, the court determined that it not review the document itself, but could only review the agency’s decision based on documents that were before it at the time of decision. Because the disputed document was clearly before the agency, the court based its determination on the agency’s contemporaneous explanation of its decision. HHS credibly reported that it based its decision on limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in animals with no showing of bad faith or improper behavior. It made no specific reference to the document at issue and the court could not infer that HHS based its determination on that document. However, the document appeared to support HHS’ decision, as did various other documents that the agency reviewed.

The court thus granted motions for summary judgment filed by Sebelius, HHS, and the Intervenors and denied Styrene Center’s and Dart’s motions for summary judgment.

The case number is 11-1079 (RBW).

Attorneys: Douglas James Behr (Keller & Heckman, LLP) for Styrene Information and Research Center, Inc. and Dart Container Corporation. Eric B. Beckenhauer, U.S. Department of Justice, for the U.S. Department of Health and Human Services and Secretary Kathleen Sebelius.

Companies: Styrene Information and Research Center, Inc.; Dart Container Corporation; U.S. Department of Health and Human Services

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