The U.S. District Court for the District of Columbia recently rejected industry challenges to an agency's decision to list the chemical styrene in the Twelfth Report on Carcinogens as "reasonably anticipated" to be a cancer-causing agent. A major styrene trade association and a manufacturer of the substance had sued the U.S. Department of Health and Human Services (HHS) for including styrene in the report.

The Listing of Styrene in the Report on Carcinogens

The Public Health Service Act of 1978 directs the Secretary of HHS to prepare a Report on Carcinogens every other year that identifies substances with the potential to cause cancer. The National Toxicology Program (NTP) prepares the report to be issued on behalf of the Secretary of HHS. NTP does not issue or enforce regulations; it only conducts its own evaluations of the scientific evidence on carcinogens and publishes its conclusions.

The statute requires that the report contain a list of all substances that are "known to be carcinogens" or "may reasonably be anticipated" to be carcinogens. Under NTP criteria, a substance is known to be a human carcinogen if there is sufficient evidence of carcinogenicity from studies in humans. A substance is reasonably anticipated to be a human carcinogen if there is some evidence of carcinogenicity from studies in humans, evidence of carcinogenicity from animal studies, or other evidence to suggest a substance causes cancer.

The NTP nominated styrene for review in 2004 after an international body listed styrene as "possibly carcinogenic to humans." After a seven-year, multistep review process that included peer review and an opportunity for public comment, NTP finalized the report, which lists styrene as "reasonably anticipated to be a human carcinogen." The Secretary of HHS approved and published the report on June 10, 2011. The same day, the styrene industry filed suit challenging the listing.

Industry's Legal Challenge to the Styrene Listing

The Styrene Information and Research Council (SIRC), the major trade association for the styrene industry, and Dart Container Corporation, a manufacturer of styrene, raised several procedural challenges to the listing, none of which the court found persuasive.

They claimed that NTP's report violated the Administrative Procedure Act (APA) because it was issued "without observance of procedure required by law." The court considered the argument that NTP violated its own procedures concerning the timing of peer review and public comment periods but ultimately rejected the claim. The opinion noted that the industry "plaintiffs may question the wisdom" of NTP's approach, but did not show that NTP failed to observe a procedure required by law.

The suit also argued that HHS's listing of styrene violated the APA's arbitrary and capricious standard. The standard is highly deferential to agency action but does require that the agency "examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made." The court concluded that HHS provided sufficient justification for the decision to list styrene in the report's substance profile. Moreover, the administrative record adequately supported the agency's explanation.

In denying the challenges to the listing and affording deference to the agency's scientific judgments, the court rejected what is just the latest effort in a broad attack on NTP and the Report on Carcinogens. Since styrene's nomination in 2004, SIRC and other members of the styrene industry have campaigned aggressively to prevent or overturn the listing. As part of this campaign, the styrene industry solicited the help of the Small Business Administration's Office of Advocacy, as we explained in a January report.

Industry and the Office of Advocacy's Fight against the Listing

The Office of Advocacy has responsibility for ensuring that federal agencies evaluate the small business impacts of the rules they adopt. However, the office became involved in the scientific assessment of styrene after being contacted by SIRC and the American Composite Manufacturers Association (ACMA). After relaying ACMA's concerns to HHS, the Office of Advocacy submitted its own criticism of the NTP listing of styrene.

In a November 2011 letter, the office expressed concern about "the quality of [the Report on Carcinogens'] scientific analysis, the robustness of the scientific process, including procedures for peer review and public comment procedures, and that [the Report on Carcinogens] is duplicative of other federal chemical risk assessment programs, particularly the IRIS." These comments repeated the talking points provided by ACMA and SIRC.

In fact, Office of Advocacy staff admitted they made no effort to verify industry's claims at a hearing on the Report on Carcinogens, held by the House Science Committee and Small Business Committee in April 2012. After hearing the testimony, Rep. Brad Miller (D-NC) commented that the Office of Advocacy "relied for their scientific judgment and process comments on the information provided by Styrene lobbyists, so their testimony was really just an echo of what we heard from the Dow Chemical industry scientist."

Dow Chemical is a founding member of SIRC. Two of the association's websites are registered to the Management Information Systems Director at the American Chemistry Council (ACC). One of SIRC's lobbying firms also lobbied for ACC, while another of its firms lobbied for Dow Chemical. As our report concluded, "The Office of Advocacy became involved in the styrene issue in response to a request by the affected trade associations, which are dominated by big businesses or their lobbyists, and its comments repeated their arguments."

Many of the industry claims on which the Office of Advocacy relied have now been discredited and rejected by the district court. While the office criticized the report's scientific analysis and process, the court emphasized that deference is given to an agency's evaluation of scientific data within its technical expertise. The opinion explained that courts do not review scientific judgments of the agency "as the chemist, biologist, or statistician that [they] are qualified neither by training nor experience to be."

NTP was right to move forward with its styrene listing. The public has a right to know whether common chemicals pose a cancer risk, and the court was correct to reject the bullying tactics of the styrene industry.