Eye On Nanotechnology Regulations In The U.S. And EU
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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.
No Call — Yet— For Product Labeling
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.
Because the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials, the Task Force does not believe there is a basis for saying that, as a general matter, a product containing nanoscale materials must be labeled as such. Therefore the Task Force is not recommending that the agency require such labeling at this time.
Report at 35 (emphasis added).
Scientific State of the Art Still Too Immature for Consensus Building
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:
Identifying precisely what qualifies as a nanoscale material is difficult and currently a subject of substantial discussion in the scientific, regulatory, and standards communities. As a result, developing a comprehensive description of products that are currently produced with nanotechnology, or may be produced with this technology in the future, would be difficult at best, and likely infeasible.
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:
The available information does not suggest that all materials with nanoscale dimensions will be hazardous. Furthermore, if all nanoscale materials are compared to all non-nanoscale materials, whether larger or smaller, it is not apparent that the nanoscale materials as a group would have more inherent hazard. However, consideration of the basic science of how materials interact with biological systems does indicate that a material’s properties can change when size is increased or decreased into, or varied within, the nanoscale range.
Id. at 11 (emphasis added).
Calls for FDA Guidance and Industry Data-Gathering
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.
A Post-Script to Consumers from the FDA on Nanotechnology
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."
For the most part, FDA experts believe that nanotechnology products present challenges similar to those FDA faces for products of other emerging technologies. FDA experts recognize, however, that product safety and effectiveness can change as size goes up or down within the nanoscale, adding additional complexity to the product review. It’s also possible that nanotechnology will be used in a wide variety of products, such as foods, drugs, cosmetics, and medical devices. The agency expects that many of the nanotechnology products it will regulate will span the regulatory boundaries between drugs, medical devices, and biologics. These, then, would be regulated under the rules established for ‘combination products.4
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.
REACH and Nanotechnology
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:
[A]lthough the existing toxicological and ecotoxicological methods are appropriate to assess many of the hazards associated with nanoparticles, they may not be sufficient to address all the hazards. Because of uncertainties, the current risk assessment procedures require modification for nanoparticles. Knowledge gaps have been confirmed in areas such as nanoparticle characterization, detection and measurement; their fate and persistence in humans and the environment; and all aspects of the associated toxicology and ecotoxicology. These should be addressed to allow satisfactory risk assessments for humans and ecosystems.
EU Report at 9.
Summary: Regulation by Litigation?
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.
1. See, e.g.,"Nanotechnology Law & Commerce: Doing Business at One-Billionth of a Meter," In re Products Liability at 12 (July 2007);"Nanotechnology: A Regulatory Void," In re Products Liability at 17 (April 2007);"Uncharted Products Liability Waters: Nanotechnology," In re Products Liability at 10 (Nov. 2006).
2. See http://www.fda.gov/nanotechnology/taskforce/report2007.html.
3. The Woodrow Wilson International Center’s Nanotech Project maintains a publicly accessible database identifying products labeled as containing nanoscale materials. See http://www.nanotechproject.org/index.php?d=44&id=44&action=view&p=17 (last visited Oct. 3, 2007).
4. See www.fda.gov/consumer/updates/nanotech072507.html.
5. See REACH in Brief, http://ec.europa.eu/enterprise/reach/overview_en.htm".; see also www.ec.europa.eu/enterprise/reach/faq_en.htm.
6. After December 1, 2008, existing substances that have not been preregistered under REACH can no longer be sold in the EU.
7. See ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/com_2007_0505_f_en.pdf.