Worldwide: Small Is the New Big: Eye On Nanotechnology Regulations In The U.S. And EU

In past issues, we have discussed the growing use of nanotechnology in a wide array of consumer, medical, food and industrial products.¹ Among other things, we’ve noted that the incorporation of nanoparticles — which may be as small as several molecules — into such products has led to expressions of concern by scientists and regulators about the safety of such novel substances, particularly when used in products intended for human consumption. Nanotechnology is one of the fastest growing commercial technologies — one eventually expected to cut a very wide swath across the global economy — and many public agencies and academic institutions are launching comprehensive efforts to understand its benefits and potential risks. Recently, both the U.S. FDA and the European Union have issued reports concerning nanotechnology and product safety. Both bodies largely conclude that private industry must consider the special risks of nanotechnology in complying with existing regulatory requirements — even though official nanotechnology-specific regulatory regimes are likely a long way off.

FDA Nanotechnology Task Force Report

In 2006, the FDA commissioned a Nanotechnology Task Force to look into a wide range of nanotechnology issues falling within the FDA’s regulatory ambit. Following public hearings, "Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force" was issued on July 25,2007 ("Report").² The Task Force was appointed partly in response to vocal calls for FDA regulation of nanomaterials by public interest groups, such as the International Center for Technology Assessment.

The FDA Nanotechnology Task Force largely concluded that— for now — current FDA regulatory and rule-making authority is sufficient to address health risks that may emerge from nanotechnology- based products. Notably, in light of the limits of current science, it specifically declined to recommend the adoption of any new labeling rules requiring identification of the presence of nanoscale materials.

Report at 35 (emphasis added).

In reaching its conclusions, the Task Force stressed the current lack of scientific and regulatory consensus both as to what constitutes a "nanoparticle"and how to determine whether "nanomaterials" might implicate special health concerns. More to the point, it concludes:

Id. at 7.³

Notwithstanding an appreciation that the reduction and manipulation of materials at the nanoscale range can substantively alter their physical properties and "inter[action] with biological systems," the Report concludes that there are no intrinsic properties of nanoscale materials that automatically raise health and safety concerns as such. To wit:

Id. at 11 (emphasis added).

Nonetheless, the Report suggests specific FDA action with regard to emerging issues of safety and health pertaining to the use of nanotechnology. In this regard, its recommendations to the FDA include a proposal that the agency issue industry guidance for the identification of particle size in OTC drugs, food and color additives as well as certain dietary supplements. It also recommends that the FDA request data from regulated entities in order to identify previously approved food and color additives and OTC drug products now containing nanoscale versions of previously approved ingredients. Id. at 30.

Regarding prescription drugs and biologic products, the Report notes that existing FDA regulations already require agency notification when changes to the composition or manufacture of such products have "a substantial potential" to create "an adverse effect" on the product. It notes, too, that "[c]hanges to a product to introduce nanoscale ingredients or processing would trigger change notification chemistry supplements and permit [the] FDA to review and approve the revised formulation. Depending on the change, the resulting product might be considered a new product for which a new approval is needed." Id. at 23.

The FDA, of course, is already authorized to require "particle size data" in support of new drug applications. As the Report notes, the FDA requests information on particle size when the agency considers such information relevant to determining whether a particular human drug product or class of human drug products is safe and effective. If the FDA determines such data are needed for a class of drugs, FDA may issue guidance to applicants recommending that they be submitted in the original application. Id. at 22. Although FDA authority is somewhat limited in respect of products "not subject to premarket authorization" requirements, the Report adds that "the agency’s authority is comprehensive with regard to products subject to premarket authorization such as drugs, devices, biological products, and food and color additives. "Id. at 30.

Summarizing the Report’s findings, the FDA highlighted the Task Force’s conclusion that current FDA regulations already require manufacturers to ascertain and report risks attributable to the incorporation of certain nanomaterials, and — further — that products straddling the borders of its regulatory authority would be regulated as "combination products."

The REACH Protocol and the EU Action Plan for Nanotechnology

Recently, the European Union passed a regulation closely regulating chemicals and other substances manufactured in or exported to EU nations. Known as REACH (for "Registration, Evaluation and Authorization of Chemicals"), it requires that extensive registration, data-sharing and technical evaluations be filed with the appropriate EU and member-state agencies for a wide array of chemicals and substances, including those involving nanotechnology.⁵

The REACH system establishes a single regulatory framework for the registration, evaluation and authorization of chemicals coming to or from the EU. Beginning June 1, 2008, it will require corporations to gather and disclose information on the properties of substances which they manufacture in or import to the EU in an amount of at least one ton per year and to demonstrate safety of use.⁶ (Previous legislation required member state regulatory authorities to prove the existence of a risk in order to ban a substance.) This information must then be sent to the European Chemicals Agency, located in Helsinki, Finland, which will manage the registration of these substances by setting up a database. Unregistered substances may not be manufactured in or exported to the EU. Thereafter, EU member states must assess the registration dossiers and grant or refuse authorizations for substances considered to pose a risk to health or the environment. Adopted at the end of 2006, the REACH system replaces 40 prior national legislative acts of EU member states.

As for nanotechnology specifically, EU regulatory and scientific advisory groups have reached conclusions essentially identical to those of the FDA Nanotechnology Task Force: more study is required before the development of nanotechnologyspecific regulatory regimes can be formulated, but, in the meanwhile, existing regulations put the onus on industry to identify and address the potential hazards of nanotechnology as nanomaterials are incorporated into products entering the stream of commerce.

To this end, on September 6, 2007, the EU issued a report called,"Nanosciences and Nanotechnologies: An action plan for Europe 2005-2009: First Implementation Report 2005-2007" ("EU Report").⁷ This report discusses the findings of the EU’s primary consultative body for nanotechnology risk assessment— the Scientific Committee on Emerging and Newly Identified Risks. Endorsing this group’s finding, and echoing the FDA Nanotechnology Task Force’s approach, the EU Report states:

EU Report at 9.

Both the FDA and the EU have attempted to put the immediate burden on industry to identify and describe safety and health issues posed by nanotechnology under existing regulatory schemes designed to address traditional risk/benefit profiles of substances and consumer products. Both bodies make clear that regulatory regimes specific to health concerns unique to nanotechnology will not emerge anytime soon. At the same time, each notes the need for continued scientific study and development of definitions, standards and risk profiles for specific classes of nanomaterials prior to the development of any such regulatory regimes.

What this means, unfortunately, is that until such time as clear nanotechnology-specific regulatory guidelines are forthcoming, innovative manufacturers and others are likely to be subjected to uncertainty,which could lead to regulation by litigation.