FDA urged to explain plan for dual regs on bisphenol A

By Rory Harrington

- Last updated on GMT

Related tags Bisphenol a Regulation Fda

The US chemical industry said it needs more information on a call by the FDA for plastic manufacturers to submit products containing bisphenol A (BPA) to a different regulatory system.

The American Chemistry Council (ACC) was responding to proposals laid out in the recent Food and Drug Administration statement on the chemical which urged plastic producers to voluntarily allow their BPA-containing materials to be scrutinised under a “more modern framework”​ rather than the current 40-year-old regulations.

The trade body told FoodProductionDaily.com it needed clarification on how the FDA would administer two parallel frameworks and has asked for a meeting with the agency in the near future.

In its update published earlier this month, the US safety watchdog said the present BPA regulatory system “limits the oversight and flexibility of the FDA​”. Instead the body proposed that companies voluntarily submit products containing BPA for scrutiny to the Food Contact Notification Program (FCNP). Since 2000, all new food contact substances have been regulated under this system. The FDA said it believed this program was “more robust and appropriate for the oversight of BPA than the current one”.


Steven Hentges, Ph.D., of the American Chemistry Council’s Polycarbonate/BPA Global Group, said the benefits of the FCNP were recognised by both FDA and industry.

But he added: “It is not yet clear how this programme designed for new substances will apply to a substance such as BPA that is already FDA-regulated for polycarbonate plastic and epoxy resins. One of the benefits of the notification programme is a tighter linkage between FDA and the marketplace where FDA-regulated products are used, which provides FDA with better quality data for use in their safety assessments. In that regard, application of the notification program to BPA is a means to an important end.”

The ACC stressed it was looking forward to working constructively with the FDA but said the practical difficulties of running two systems in tandem would have to be explored. The question of how overseas manufacturers that export into the US would be regulated would be just one of a number of issues to resolve, said Hentges.

“Practically speaking, you cannot have two regulatory processes operating in parallel that may conflict,” ​he added. “It is going to be hugely complicated and it is not entirely clear how this would work. We do not currently have enough information. We want to see what the FDA is trying to accomplish and then work with them to get there in the most efficient way.”

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