Author disclosures: All authors are employed by The Pew Charitable Trusts, 901 E St., NW Washington, DC 20004, U.S.A. Funding for the workshop and preparation of this article was provided solely by The Pew Charitable Trusts.
2 Comprehensive Reviews in Food Science and Food Safety
Perspectives on How FDA Assesses Exposure to Food Additives When Evaluating Their Safety: Workshop Proceedings
Article first published online: 3 JAN 2013
© 2012 The Pew Charitable Trusts
Comprehensive Reviews in Food Science and Food Safety
Volume 12, Issue 1, pages 90–119, January 2013
How to Cite
Alger, H. M., Maffini, M. V., Kulkarni, N. R., Bongard, E. D. and Neltner, T. (2013), Perspectives on How FDA Assesses Exposure to Food Additives When Evaluating Their Safety: Workshop Proceedings. Comprehensive Reviews in Food Science and Food Safety, 12: 90–119. doi: 10.1111/j.1541-4337.2012.00216.x
- Issue published online: 3 JAN 2013
- Article first published online: 3 JAN 2013
- Manuscript Accepted: 4 OCT 2012
- Manuscript Received: 2 OCT 2012
Food additives and substances considered “generally recognized as safe” must not be allowed in food unless there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. Scientists determine safety by ensuring that the expected exposure is less than the acceptable daily intake. The U.S. Food and Drug Administration (FDA) provides guidance documents to assist safety assessors in this analysis. A November 2011 workshop sponsored by The Pew Charitable Trusts, the Institute of Food Technologists, and the journal Nature reviewed the agency's exposure assessment approaches. More than 70 experts from government (including FDA), industry, academia, and public interest organizations examined the principles underlying dietary exposure assessments for substances added to human food, and responded to questions about current methods. FDA's approach was seen as serving the agency reasonably well, but participants identified opportunities for improvement. Although reaching a consensus was not a goal, general agreements emerged that FDA should develop a science-based framework to prioritize and reassess prior safety decisions, and conduct more extensive postmarket monitoring. Participants discussed the possibility of harmonizing different approaches to assess dietary exposure. They generally agreed that collaboration, communication, and exchanging scientific information between agencies and stakeholders would help assessors use the most current information to make better decisions. Participants identified data gaps and opportunities to fill the gaps using new tools and technologies. Participants generally agreed on the need to consider all dietary sources in a cumulative dietary exposure assessment.