Date: Jul 01, 2008
Joan Sylvain Baughan and Lester Borodinsky, Ph.D., played an active role in the project on emerging nanotechnologies sponsored by the Woodrow Wilson Center for Scholars and Grocery Manufacturers/Food Products Association (GMA/FPA). The project was designed to evaluate the regulatory pathway to commercialization of engineered nanoscale materials (ENMs) used in food and food packaging, and assess the adequacy of the regulatory systems currently in place at FDA and the Environmental Protection Agency (EPA) to assure the safety of ENMs when used in these applications. The project culminated in a report authored by Michael Taylor, professor at the George Washington University School of Public Health and Health Services (and former Deputy Commissioner for Policy at FDA and former Administrator of the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS)), entitled "Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues," which was published in July, 2008.
The report discussed how the existing FDA and EPA regulatory systems apply to food packaging products made with ENMs and highlighted the legal, scientific, and technical issues that could necessitate ENM-specific guidance from the Agencies. These issues included (1) whether current food additive regulations and Food-Contact Notifications (FCNs) for conventional-sized food-contact substances are applicable to their nanosized counterparts, and (2) whether an independent Generally Recognized as Safe (GRAS) determination for ENMs in food packaging would be feasible. Further, the report discussed whether there are circumstances in which it would be necessary, or at the least advantageous, for a food-additive petition, rather than an FCN, to be filed for an ENM used in food packaging in order to ensure safety.
In addition to the identification of legal and policy issues, the report identified technical and scientific issues that arise under FDA's chemistry and toxicology guidance. The report noted that these issues arise because ENMs typically have novel properties compared to their conventional-sized counterparts, which could affect how they can be quantified and tested for purposes of safety evaluations, as well as how they interact with other materials and biological systems. Regarding potential chemistry issues, the report highlighted possible challenges in adequately characterizing an ENM's identity, properties, and impurities, as well as methodology and validation for migration studies. As to toxicology considerations, the report addressed the suitability of current exposure trigger levels for toxicity testing, the appropriateness of current data requirements and testing protocols, and the utility of current toxicology data for conventional-sized materials for evaluating their ENM counterparts.
Joan Baughan co-chaired the Working Group on Law, Policy, and Process with Michael Taylor. She also participated in the Science Working Group, along with Keller and Heckman's Lester Borodinsky and Ruby Grinolds.