Small particles may present big regulatory issues

Not small matters in the sense that they will have small consequences, but small in the old-fashioned sense.
The subject today is “engineered nanoscale materials.” An emerging science, “nanotechnology” has already proven to have promising applications for a whole range of technologies, including drugs, food ingredients, and food packaging. But there are questions about whether the existing legal framework is sufficient to address the special challenges presented by ENMs.

An ENM is one with a particle size of 100 nanometers or smaller. A nanometer is one billionth of a meter. That’s about 1⁄100,000 of the width of human hair.

Such particles are already in use in a range of consumer products, including paints, coatings, clothing, drugs, cosmetics, foods, and, most relevantly here, food packaging.

When you intentionally make particles so very small, they often can have different characteristics and perform differently than the traditional-sized particle of the chemical. The nanoparticle has a lot more surface area than the larger particle, and it can be stronger or more effective at various chemical and physical properties. Carbon nanostructures and metal oxides have already been manipulated for beneficial properties at nanoscale.

Various regulatory agencies and other institutions have begun to examine a range of important regulatory issues raised by ENMs. One that has examined the regulatory challenges presented by these materials has been the Project on Emerging Nanotechnologies within the Washington, D.C.-based Woodrow Wilson International Center for Scholars, in collaboration with the Grocery Manufacturers Assn., an industry trade group. The participants included government representatives from the Food and Drug Administration, the U.S. Department of Agriculture, and the Environmental Protection Agency; representatives of industry (I was one of them); various trade organization representatives; and consumer advocacy organizations.

Called the Case Study Project, the effort was spearheaded by Michael R. Taylor, a former FDA and USDA official who is now a research professor at George Washington University School of Public Health and Health Services.

The Case Study Project’s report was issued this spring. It was authored by Mr. Taylor and was based on the work of three working groups: one on law, policy, and process; one on science; and one on industry stewardship.

The primary focus of the group’s discussions was the adequacy of existing regulatory frameworks to properly address the new and different safety challenges raised by ENMs, with respect to human and animal health, as well as environmental exposure, in the context of food packaging.

The project undertook an examination of food packaging as one of its first orders of business. This was certainly logical, since the use of nanotechnology is already being explored in packaging. The project created three imaginary “case studies” in which particular product types were imagined, and questions were discussed about whether these products could be properly evaluated under the existing regulatory regime for food contact notifications, food additive petitions, GRAS substances, and related principles.

The report concluded that the most challenging issues relate to the application of scientific and technical criteria for evaluating the food safety aspects of ENMs in food packaging, in light of their novel properties.

It has been recognized that nanomaterials are sometimes capable of entering and interacting with the body in ways that differ from their traditional forms. However, it was not possible yet to generalize about when such materials will exhibit certain characteristics, and when they won’t.

The report also indicated, “The applicable laws are by design stringent in imposing on sponsors the burden of proof on the safety of food contact substances, and FDA and EPA implement these laws in keeping with sound safety assessment principles that impose significant data collection requirements on sponsors. This approach provides a high level of consumer protection, but, given the current state of scientific knowledge and need for case-by-case evaluation, it also will require scientific investment and innovation in order to satisfy established regulatory standards.”

The report generally concludes that the regulatory framework is strict and sufficient to address the special challenges of ENMs. One of its primary conclusions, though, was that ENMs would have to be evaluated on a case-by-case basis to determine whether any individual project presented new and different safety issues and if so, how they might be sufficiently evaluated.

The report advises those who are developing ENMs for use in food contact substances to engage in early consultation with FDA to assure that their particular material will be adequately addressed by existing safety requirements. The report recognizes that FDA might decide that a food contact material incorporating a nanoscale material presents unique safety questions that require a full Food Additive Petition and its related notice-and-comment rulemaking procedures, rather than the usually quicker Food Contact Notification process. But the existing law already allows FDA to do that when FDA determines that a petition, rather than an FCN, is “necessary to provide adequate assurance of safety.”

Moreover, because the science of nanotechnology is still emerging in a variety of technological contexts, the likelihood of reaching a conclusion that a given ENM is “Generally Recognized As Safe” is small, at least for most materials and for the near future.

At the end of the day, nanotechnology is still new, and its novelty virtually guarantees that all packagers will hear more about it—in this space and elsewhere—in the coming years as regulators at FDA and other agencies continue to grapple with the issue of whether they think the safety of these revolutionary products is sufficiently assured by current provisions.

Eric can be reached at greenberg@efg-law.com,
and visit his firm’s Web site at www.ericfgreenbergpc.com.