ABSTRACT
This chapter outlines the challenges facing the U.S. Food and Drug Administration (FDA) as it braces to regulate the use of nanotechnology in advanced forms of food packaging. Food packaging is a key focus of companies seeking to promote the commercialization of nanotechnology. One respected industry analyst has reported that there are already 250 packaging products on the market incorporating substances manufactured using nanotechnology, often referred to as nanopackaging. These products generated over $860 million in sales worldwide last year, and the same analyst projects that within 10 years, nanopackaging will be a $30 billion market.*
The Center for Food Safety and Applied Nutrition (CFSAN) is the arm of the FDA responsible for the regulation of packaging materials for food products. CFSAN has substantial experience in regulating materials at the molecular level, since one of its principal concerns is the possible migration of substances from packaging material to the food with which they may come into contact. The migration occurs in very small amounts. For example, one of the criteria for exemption from regulation is whether the use of the material results in a dietary concentration of 0.5 parts per billion (ppb). Consequently, the guidance documents and other materials issued to assist industry in preparing submissions are written to address materials at that level. However, the issue will be whether the present system is adequate to cope with the novel considerations raised by nanotechnology. Those considerations revolve, in part, around whether the nanoscale version of known substances or the nanomanufactured version of new substances that do not occur naturally present different issues relating to toxicity, route of exposure, and transmigration potential than those presented by the macrosized versions of the substances. The second and equally important issue is whether there are differences in how the nanoscale materials migrate into food, and if so, whether such differences are significant.**
In addressing these issues, the chapter will first briefly discuss the regulatory scheme for the regulation of food packaging. Then, the food packaging uses being investigated and promoted will be examined, followed by
an assessment of the adequacy of the system in place to address the novel issues embodied in the use of nanotechnology.
