Society For Risk Analysis Annual Meeting 2013

Session Schedule & Abstracts

* Disclaimer: All presentations represent the views of the authors, and not the organizations that support their research. Please apply the standard disclaimer that any opinions, findings, and conclusions or recommendations in abstracts, posters, and presentations at the meeting are those of the authors and do not necessarily reflect the views of any other organization or agency. Meeting attendees and authors should be aware that this disclaimer is intended to apply to all abstracts contained in this document. Authors who wish to emphasize this disclaimer should do so in their presentation or poster. In an effort to make the abstracts as concise as possible and easy for meeting participants to read, the abstracts have been formatted such that they exclude references to papers, affiliations, and/or funding sources. Authors who wish to provide attendees with this information should do so in their presentation or poster.

Common abbreviations

Symposium: A New Look at the Toxicity of Bisphenol A and Public Health

Room: Key Ballroom 2   3:30 PM - 5:40 PM

Chair(s): Sara Henry, Rita Schoeny

Sponsored by DRSG

M4-B.1  15:30  Regulation and science of BPA. Aungst JL*; U.S. food and Drug Administration

Abstract: Bisphenol A (BPA), a component of polycarbonate resin, which is used in some hard plastic bottles and can coatings, has been the subject of regulatory and political activity, intense international scrutiny, and hundreds of research studies in the past two decades. In 2008, FDA released a draft safety assessment on BPA and since then has continued to release updates from the Agency’s ongoing review of the safety of BPA. Separate from the safety review, FDA has responded to multiple inquiries from the media, organizations, and individuals, citizen’s and food additive petitions, some which have resulted in regulatory actions. FDA’s research initiative addressing the safety of low doses of BPA, including assessment of the novel endpoints where concerns have been raised, includes multiple studies currently in progress at the FDA National Center for Toxicological Research and additional collaborations through the National Toxicology Program and National Institute of Environmental Health. The purpose of this presentation is to provide an update on current FDA activities, describing previous regulatory actions, and an overview of recent FDA research and collaborations.

M4-B.2  15:50  Human health risks related to the presence of BPA in foodstuffs: the assessment of the European Food Safety Authority (EFSA). Castoldi AF*, Husøy T, Leclercq C, Theobald A, Pratt I; EFSA, Parma, Italy; Norwegian Scientific Committee for Food Safety (VKM), Oslo, Norway; Council for Research and experimentation in Agriculture (C.R.A.), Rome, Italy

Abstract: In the European Union (EU) the use of BPA is authorized (with a migration limit of 0.6 mg/kg food) in all food contact materials other than polycarbonate plastic baby bottles. For the latter articles a temporary ban was decided on a precautionary basis, because of the scientific uncertainties around BPA’s potential effects on the developing organism, expressed by EFSA in 2010. EFSA has thus undertaken a re-evaluation of the health risks for the European population related to the presence of BPA in foodstuffs, encompassing both a new hazard characterization and an updated exposure assessment in light of the most recent scientific evidence (December 2012). In the EFSA evaluation of 2010 the Tolerable Daily Intake (TDI) of 0.05 mg BPA/kg bw/day was based on the NOAEL of 5 mg/kg bw/day from a multi-generation reproductive toxicity study in rats, to which an uncertainty factor of 100 (to account for inter- and intra-species differences) was applied. For the new risk assessment of BPA a weight of evidence approach is being applied to all publicly available toxicological data on humans, laboratory animals and in vitro according to the endpoint of toxicity and taking into account the developmental stage of the subject at the time of exposure. Occurrence data for BPA in the EU have been collected through literature search and an ad hoc call for data addressed to Members States, research institutions, industries, etc. Both average and high chronic total exposure to BPA are being estimated considering different sources and routes of exposure (oral, inhalation and dermal) in the EU population. Specific scenarios are being developed to cover the exposure patterns in the different age classes and vulnerable groups (fetuses, infants and young children) and in specific groups of consumers. The EFSA’s characterization of BPA-related health risks for the various subgroups of the EU population is still ongoing and the outcome will be presented at the SRA meeting.

M4-B.3  16:10  Challenges and approaches for evidence integration regarding endocrine disruption, exemplified by the case of bisphenol A. Rhomberg LR*; Gradient

Abstract: As least in part, the often rancorous debates about scientific support regarding endocrine disruption in general – and more particularly about nonmonotonic dose-response curves and the application of hormonal mode-of-action data not tied to clear adverse effects – may be ascribed to lack of clearly agreed upon approaches for integration of diverse and unfamiliar lines of evidence. The debate on the possible low-dose effects of bisphenol A exemplifies many of these issues. This perspective talk examines the issues and suggests approaches to weight of evidence and integration among lines of evidence. Endocrine disruption is a mode of action, not an endpoint, and so traditional endpoint-oriented toxicity testing may need different kinds of examination. Endocrine activity is inherently about modulation of physiological states through small changes in low concentrations of causative agents, so low-dose issues, shapes of dose-response curves, and effects of natural background processes need special consideration. This puts a premium on consistency of effects and their dose dependence across studies and on a plausible hormonally mediated mechanism in assessing effects that also applies with a consistent rationale across endpoints and studies. The application of these principles to evaluation of bisphenol A low-dose toxicity is discussed.

M4-B.4  16:30  BPA by the numbers: How the media framed risk. Butterworth T*; George Mason University

Abstract: The controversy over the safety of the chemical bisphenol a (BPA) has been driven by extensive media coverage, with hundreds of stories over the past six years. This presentation will look at how that coverage framed the purported risk - and how it consistently avoided the key data, quantitative and contextual, that explained that risk.

M4-B.5  16:50  A new look at the toxicity of bisphenol A and public health policy making. Henry SH, Aungst J, Castoldi AF, Rhomberg L, Butterworth T, Fitzpatrick J*; Retired Food and Drug Admin., Food and Drug Admin., European Food Safety Authority, Gradient Corp., Science journalist/investigative reporter,

Abstract: A question and answer session with the presenters of this symposium and the audience will follow the panel discussion. Session will be moderated by Sara Henry and Julie Fitzpatrick

M4-B.6  17:10  Panel Discussion for A new look at the toxicity of bisphenol A and public health policy. Henry SH, Aungst J*, Castoldi AF, Rhomberg L, Butterworth J; Retired Food and Drug Administration, Food and Drug Admin., European Food Safety Authority, Gradient Corp., Science journalist/investigative reporter

Abstract: This panel discussion moderated by Sara Henry and Jason Aungst will allow presenters to interact with each other and then with the audience on the symposium topic of the toxicity of bisphenol and public health policy.

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