Styrene Carcinogen Listing Survives Challenge

WASHINGTON (CN) - The U.S. government can classify styrene as a carcinogen, a federal judge ruled, rejected a challenge from the product's friends in the industry.

In a sometimes withering opinion, U.S. District Judge Reggie Walton concluded plaintiffs The Dart Container Corp. and the Styrene Information and Research Center had "taken a scattershot approach in attacking the Secretary's listing decision, with little discussion of the actual justification for the decision set forth in the substance profile for styrene.

"Insofar as the plaintiffs do attack that document, though, their arguments fall flat," Walton wrote.

Derived from petroleum and natural gas byproducts, styrene is used to make a variety of consumer goods, including food containers.

The National Toxicology Program of the U.S. Department of Health and Human Services nominated styrene for inclusion in its biannual report on carcinogens in 2004. 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."

Health and Human Services Secretary Kathleen 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 based on alleged violations of the Administrative Procedures Act, the Public Health Service Act, the Information Quality Act, and the due process clause of the Fifth Amendment.

Judge Walton ordered HHS to release some records on its classifying of styrene as a carcinogen in April 2012, but rejected a request for other records.

The court's latest ruling, filed Wednesday, meticulously unravels the plaintiffs' request for summary judgment, finding that most of their claims lacked merit, while concluding others had simply been abandoned and were therefore null and void.

"The plaintiffs assert, for the first time in their opposition brief and without citing any case authority, that HHS's listing of styrene is entitled to no deference because (1) the recommendations of the scientific review panels were not binding on HHS; (2) the listing process is biased toward approval; and (3) the scientific review was fractured and limited," Walton wrote. "Setting aside that these arguments were likely waived since they were not first presented to the agency ... none of the arguments present legal grounds for withholding deference to HHS's scientific judgments."

"For instance, the plaintiffs contend that the substance profile for styrene misconstrues a 2006 study of men employed in the synthetic rubber industry conducted by Dr. Elizabeth Delzell and others ('Delzell Study') as supporting the proposition that humans exposed to styrene face an increased risk of non-Hodgkin's lymphoma," Walton continued. "Yet, contrary to the plaintiffs' assertion, the Delzell Study's abstract explicitly states that '[s]tyrene' was 'associated positively with NHL [non-Hodgkin's lymphoma].'"

Consistent with this finding, "the report cites the Delzell Study along with two other studies in observing that '[i]ncreased risks for leukemia, lymphoma, or all lymphohematopoietic cancer were found among styrene-exposed workers in both the reinforced-plastics and styrene-butadiene rubber industries,'" according to the ruling.

"The court does not discern, nor do the plaintiffs explain, how this statement misconstrues the Delzell Study," Walton added. "And even if it did, that misconstruction would not be fatal to the Secretary's listing decision because the substance profile cites several other studies (which the plaintiffs do not address) showing '[e]levated risks of lymphohematopoietic cancer' among workers exposed to styrene." (Parentheses in orginal.)

Because the report provides an independently sufficient basis to list styrene in the report under the listing criteria, the secretary's listing decision can be upheld on this ground alone, according to the ruling.

The plaintiffs further asserted that Health and Human Services had arbitrarily applied the listing because the scientists who participated in the expert panel and the board of 28 scientific counselors each relied on the data in his or her field of expertise in evaluating styrene.

Walton disagreed that this evidence proved that there was "no true consensus" on the ultimate decision to list styrene.

"There is nothing arbitrary about having experts review only the data that they are qualified to analyze," Walton wrote. "And although the plaintiffs claim this process led to a lack of consensus regarding the ultimate listing decision, that argument overlooks the bifurcated nature of the Listing Criteria, which allows listing based on either 'limited evidence' of carcinogenicity in humans or 'sufficient evidence' of carcinogenicity in animals.

"Given these criteria, it was not arbitrary and capricious for HHS to have different scientists reviewing different sets of data during the listing review process."

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit