by Jeffrey W. Card, Ph.D., and Berna Magnuson, Ph.D.
“If nanotechnology is a racehorse, then industry is a jockey whipping it along to market at a breakneck pace. The regulatory community is a poor old trainer limping along in the backstretch, pleading to wrap the horse's legs for safety" (Houston Chronicle, 2007).
This quote from the June 25, 2007 edition of the Houston Chronicle summarizes what many still see as the current state of affairs regarding the regulation of nanotechnology and nanomaterials in the marketplace. Recent figures provided by the Project on Emerging Nanotechnologies appear to support this contention (PEN, 2011). As of March 2011, the Project’s inventory of nanotechnology-based consumer products included 1,317 products or product lines, representing a more than 24-fold increase since the inventory’s inception in 2006. Health and fitness products represented the largest product category with 738 items, including 143 cosmetics and 33 sunscreens. Given that this inventory is for consumer products (i.e., those that are not subject to pre-market authorization), a major question is: Who is ensuring the safety of these products and the nanomaterials they contain, and how is this being accomplished? Similarly, how are nanotechnology-enabled products that do require pre-market authorization being evaluated and regulated?
Regulating an Unknown
The regulation of products of nanotechnology is a dynamic and evolving activity, due largely to the wide spectrum of nanomaterials, nano-enabled products, and applications that are being developed and the uncertainties that are associated with defining, characterizing, and appropriately testing for efficacy and safety. Government agencies and other organizations worldwide are formulating means by which to categorize and catalogue nanomaterials (or products containing nanomaterials), assess their safety, understand the potential risks associated with their manufacture and use, and ultimately ensure that appropriate measures are taken to protect humans and the environment from any potential deleterious effects. However, there are a number of factors that contribute to the difficulty in establishing regulatory practices for nanomaterials. These factors include, but are not limited to, defining and establishing a universal nomenclature system, characterizing hazards, assessing exposure, determining environmental fate and persistence, and measuring, sampling and monitoring nanomaterials in different media.
While efforts are underway to address all of these variables, arguably the greatest challenge associated with regulating the use of nanomaterials is their potential risks are largely unknown. It is well established that risk is a function of hazard and exposure. In the case of nanomaterials, however, it is extremely difficult to assess risk, and thereby establish regulatory guidelines based on risk, because hazards and potential exposures to nanomaterials have not been adequately characterized.
Regional Approaches to Regulating Nanomaterials
United States
FDA regulates drugs, drug delivery systems, cosmetics, medical devices, vaccines and food products on a “product-by-product" basis and, as such, does not regulate nanotechnology or nanomaterials per se. Rather, the stage at which FDA becomes involved in the regulation of nanotechnology-derived products depends on the actual product as opposed to its component materials or method of manufacture. Some nanotechnology-based products are likely to span regulatory boundaries between drugs, medical devices and biological—although there are established pathways to regulate such combination products. In this regard, the primary mode of action of the nanotechnology-derived product will determine the regulatory framework (e.g., drug, medical device or biological product).
In 2006, FDA formed a Nanotechnology Task Force that was charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials. The Nanotechnology Task Force issued a report in 2007 stating FDA’s authority over products subject to premarket authorization (e.g., drugs, biological products, devices, and food and color additives) is comprehensive and provides FDA with the ability to obtain detailed scientific information needed to assess the safety and, as applicable, effectiveness of products, including relevant effects of nanoscale materials (FDA, 2007). For products not subject to premarket authorization (e.g., dietary supplements, cosmetics and food ingredients that are GRAS [generally recognized as safe]), FDA is encouraged to work with manufacturers of these products and assist them in identifying data to substantiate the safety of products containing nanoscale materials, including chronic toxicity and other long-term toxicity data as appropriate. The Nanotechnology Task Force also noted “nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified both because nanotechnology can be used in, or to make, any FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range" (FDA, 2007).
With specific reference to drug products, FDA’s Center for Drug Evaluation and Research recently issued a Manual of Policies and Procedures describing what elements of nanomaterials to look for when reviewing drug applications relevant to nanotechnology (FDA, 2010). This is intended to help reviewers document in their reviews relevant information related to chemistry, manufacturing and controls when an application is for a drug product containing nanomaterials. The manual indicates that a nanotechnology drug product database will be generated that will “ultimately be used to develop policy regarding these products".
With regard to consumer products, as with other compounds that are incorporated into consumer products, the U.S. Consumer Product Safety Commission (CPSC) has stated that potential safety and health risks of nanomaterials can be assessed under existing CPSC statutes, regulations and guidelines (U.S. CPSC, 2005). Neither the Consumer Product Safety Act (CPSA) nor the Federal Hazardous Substances Act (FHSA) requires the pre-market registration or approval of products. As such, the CPSC generally does not evaluate a product’s potential risk to the public until after it has been distributed in commerce. With regard to potential safety effects, the reporting obligation of manufacturers, retailers and distributors of products composed of or containing nanomaterials are the same as those of other products, namely to report to the CPSC immediately if information is obtained that reasonably supports the conclusion that a product “fails to comply with an applicable consumer product safety rule, contains a defect that could create a substantial product hazard, or creates an unreasonable risk of serious injury or death" (U.S. CPSC, 2005).