Dart Container's Decades-Long Battle To Keep Polystyrene From Being Labeled A Carcinogen Nearing An End. . .

I suppose much of this would not have involved legacy Solo Cup at all, given that to the best of my knowlege, Solo Cup no longer manufactures or sells styrene food packaging products.

But Dart Container certainly still does. In fact, it is one of the largest in the US, and seems to be the moving force behind an advocacy group called The Styrene Information & Research Center ("SIRC"). Dart, along with SIRC, is litigating whether HHS improperly added styrene to the list of carcinogens in 2011. The litigation is pending before the very-able US District court Judge Reggie Walton, with a briefing schedule on a motion for summary judgment (made by HHS, to summarily dismiss the litigation) next up.

HHS’s National Toxicology Program (the “NTP”) prepares a biennial Report on Carcinogens. HHS listed styrene in the 12th Edition of that report, as a "reasonably anticipated" human carcinogen. A substance under consideration for listing undergoes a multi-step review process. First, the NTP publishes notice in the Federal Register, and prepares a draft background document reviewing the scientific literature and the public comments. Next, a panel of scientific experts (“the Expert Panel”) conducts a peer review of the background document and issues a report containing comments and a listing recommendation. Based on the Expert Panel report and the public comments, the NTP prepares a draft Report on Carcinogens, and submits it to the Secretary of HHS for approval. That all took place from May 2004 to mid-2011.

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 based on limited evidence of carcinogenicity in humans and sufficient evidence in animals”, and on June 10, 2011, HHS Secretary Kathleen Sebelius signed the final Twelfth Report on Carcinogens, which so listed styrene. Dart and SIRC filed a federal suit the same day. [Long chains of the styrene molecules, imaged at right, may be bound together, or polymerized, into the plastic polystyrene, as shown in the diagram, below, center. That is what many of Dart's food containers are made from -- the same base compound originally known as benzene -- later renamed as styrene.]

At bottom, Dart and SIRC allege that HHS misused its regulatory authority in adding styrene to the list, because HHS allegedly didn't review enough of the science that Dart claims is favorable to it, in suggesting that perhaps the cancers seen in mice won't be seen in humans. As a general rule, federal regulatory agencies enjoy wide discretion to make such findings, and are presumed to be acting non-capriciously when they do so. So, even before the last set of papers that SIRC has been able to pry loose from HHS's cache of internal drafts (in preparing to add styrene to the naughty list), Dart faced a tall order here.

But, as you'll see below, that order just got taller, with the latest document-release, from HHS under Judge Walton's memorandum opinion -- click it to enlarge (that's from the last page of an internal HHS set of documents filed with Judge Walton (a very-large 50Mb 50 page PDF file), last week):



In addition, Dart is battling away in California, also with the help of SIRC, against state-wide, and city by city sales-bans -- on its styrene food-container products. I'll eventually get into the very-exspansive bans under consideration in Santa Cruz, California in a subsequent post, but for now know that Dart is going to have to spend pretty heavily to keep styrene on the market in many locales around Carmel, California.

Of course, it won't help them if Judge Walton ultimately rules that HHS's classification of styrene as "reasonably anticipated to be a human carcinogen" was appropriate, from a regulatory-proceduire/expert scientific point of view.

Finally, now -- to be fair -- here is a link to a site detailing SIRC's side of this story.