Sharon Kneiss
Vice President, Products Divisions
American Chemistry Council

Good afternoon. I am Sharon Kneiss, vice president of products divisions at the American Chemistry Council and I want to welcome everyone on today’s teleconference about the safety of polycarbonate bottles and epoxy linings of cans. I am joined by Doctor Steve Hentges, senior director of the Bisphenol-A/Polycarbonate Group of the American Chemistry Council.

Thank you for joining us today. We plan to update you on what we’re doing to address recent concerns raised about the safety and use of BPA-containing products. Many of you, or your customers may have received inquiries about the safety of bisphenol A and whether it can continue to be used in the products that you manufacture. The companies that manufacture these products want you to know that based on the science and on the evaluations of FDA, we are confident in their safety. We are responding quickly to concerns and we want to answer any of your questions today.

Recent media reports and study announcements have confused and frightened the public. Those reports really began about two weeks ago when interviews conducted by Today Show set the stage for concern through gross inaccuracies in its reporting. Since then, two reports have been released — one from the U.S National Toxicology Program and the second from the Canadian Ministry of Health. Media coverage of those events has significantly fueled concerns with the public, and you may be hearing some of those concerns from your customers. We want to give you some context and our perspective on those reports, and of course answer any questions you might have.

The National Toxicology Program’s draft report (referred to as a Brief) on bisphenol was released last Monday for public comment. This report is a follow-up to an expert panel review that was completed late last year. The conclusions from the expert panel report and the NTP report are similar.

• No serious or high level concerns were identified in either report.
• Both reports indicate “negligible concern” for adults — the lowest rating in the NTP scale and “some concern” for infants and children — the third lowest rating on NTP’s 5 level scale.

Nevertheless, media coverage has mischaracterized the conclusions as suggesting new direction is being given by NTP about the use of bisphenol A. This is inaccurate. In fact, NTP does not make any recommendations about the use or regulation of bisphenol A at all, except to highlight areas where additional scientific research would be valuable.

The finding of “some concern” for infants and children means there is not sufficient evidence to reach a conclusion either way whether bisphenol A causes that health effect in laboratory animals or not. The report also specifically states, “more research is needed to better understand [the] implications [of the studies] for human health.”

When read in the context of NTP’s evaluation system and its report, “some concern” means that a health effect has not been clearly demonstrated in the studies with laboratory animals, and certainly has not been demonstrated in humans. The bottom line of the CERHR expert panel report and the NTP report is that additional research is needed before a conclusion can be drawn. Early this year we launched research designed in accordance with internationally recognized protocols to explore alleged neurobehavioral impacts. The results will be ready within a year’s time. That data will be published in the peer-reviewed scientific literature and provided to FDA and other relevant government agencies.

Overall, the NTP report is consistent with the many other evaluations that have been conducted by governmental agencies in the US, Europe and Japan, all of which have concluded that polycarbonate bottles and epoxy lined cans are safe for use. The conclusions of NTP and other government agencies include the following points:

• Human exposure to bisphenol A is far below levels deemed by governments around the world as safe
• “There is no direct evidence that exposure of people to bisphenol A adversely affects reproduction or development.”
• “When considered together, the results of “low” dose studies of bisphenol A provide limited evidence for adverse effects on development in laboratory animals.”

Perhaps of greater public interest is the report issued on Friday from the Canadian Ministry of Health. Indeed, the report will set forth a new regulatory process in Canada. But, importantly, the report found that exposure to BPA for both adults and children are below safe exposure levels established by the government.

Canada, admitting to being “aggressive in their precaution,” is proposing to withdraw baby bottles from the market. Nevertheless, they have advised parents to continue to use those bottles until the Government determines a path forward. They propose working with industry to find alternatives to polycarbonate baby bottles and other materials used for food safety.

Some retailers and manufacturers have announced plans to phase-out BPA or withdraw products containing BPA from their shelves. We will work to ensure that the safety and benefits of BPA products are clearly understood by retailers so they can have all the information they need as they are making market decisions.

In the short-term, and in light of public concern that has resulted from recent media reporting, the American Chemistry Council and its member companies are calling upon FDA to expedite an updated review of the science which includes consideration of the draft NTP brief. As such, we hope that the leading regulatory agency charged with protecting the public’s health, including evaluating the safety of food containers, will put to rest questions about the safety of bisphenol A. We hope others will join us in the call for this review — and that FDA will move quickly to reach its conclusion and end the confusion for consumers.

In these early phases of our efforts, we are aggressively correcting the alarming and unfounded accusations against these products as reported in the media. We have been speaking to the media through dozens of interviews. We are aggressive about getting our message out broadly and have appeared on morning talk shows, including the Today Show and Good Morning America.

We’ve created a website — factsonplastic.org, which provides great resources and information about the safety profile of bisphenol-A. And in order to be sure we understand the public reaction and what thought leaders are saying, we are constantly monitoring blogs and other media outlets. We recently hired a managing director to strengthen our relationships with key retailers and will work with him to address retailer concerns.

We will be moving this week to a longer term strategy, including expanded communications to underscore the benefits of these products and what the science says about their safety, to encourage decisions to be made based on this science, and to move beyond the immediate overreaction to recent events. And we will continue to urge FDA to update its review.

We do plan to keep you updated on developments and our activities and we solicit your thoughts on the best way to accomplish that.

As manufacturers of plastic products, we are committed to the safety of our products. We owe it to the public to correct the inaccuracies and mischaracterizations about plastic bottles and the materials used in the manufacture of such plastics, such as bisphenol A used to make polycarbonate plastic and epoxy can linings.

With that, we would be happy to answer questions.