• Top Science, Trade, and Regulatory Advisors Set the Tone for Securing US Lead in Nanotechnology Regulation and Take Aim at EPA Pesticide Office Proposal
  • August 1, 2011
  • Law Firm: Keller and Heckman LLP - Washington Office
  • In the State of the Union Address on January 18, 2011, President Obama articulated a three-prong approach to regulatory policy. He reminded Americans that:

    "Our regulatory system must protect public health, welfare, safety and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science."

    More recently, in a statement titled, "Policy Principles for U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials," the President's top science, trade, and regulatory policy advisors articulate how environmental health and safety (EHS), economic growth, and best available science should be applied to nanotechnology. The June 9, 2011 Federal Policy Statement on Nanotechnology was initialed by John Holdren, the Director of the Office of Science and Technology Policy, Islam Siddiqui, the Chief Agricultural Negotiator in the U.S. Trade Representative's Office, and Cass Sunstein, the Administrator of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB), through which all agency proposals and rules pass before their public release.

    The Obama Administration's Federal Policy Statement on Nanotechnology deserves to be highly influential. It provides direction for regulators and discusses the key concepts clearly in an understandable way. What is most refreshing about the Federal Policy Statement on Nanotechnology is its reminder that nanotechnology can and should be embraced by agencies with the same degree of guarded acceptance as they have greeted other advancements in manufacturing and technology. The reminder to agencies to adhere to business as usual comes off as genuinely original in its approach.

    Through the policies of successive Administrations and backed by repeated Congressional authorizations and appropriations, America is vested in nanotechnology, having spent almost $14 billion in research and development since 2001. Through this federal funding investment, we will own, possess, use, and manage the tangibles and intangibles of nanotechnology. To aid in this task, the Federal Policy Statement on Nanotechnology reminds us that the concept of "responsible development" of nanotechnology is broken down into the following essentials: "maximizing the benefits of nanotechnology while understanding and managing the relevant risks."

    Indeed, the primary aim of the Federal Policy Statement on Nanotechnology is to provide certain key principles to "guide development and implementation of policies for the oversight of nanotechnology applications and nanomaterials." These principles are intended to apply to emerging technologies generally and are designed to keep EHS, economic competitiveness, and the use of best available science in balance. In fact, a number of statements take aim at a pending proposal by the Environmental Protection Agency's (EPA's) use of its mandatory substantial risk information reporting authority, Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), to gather information on the use of nanoscale ingredients in pesticides. Agencies are cautioned that:

    "[i]f statutory frameworks limit mandatory reporting or other information gathering systems to those circumstances where a risk to harm has already been identified, and there is an insufficient basis to establish such risk of harm, agencies should explore other legally available means to obtain the information necessary to assess risk and possible harms. In pursuing these strategies, agencies should be careful to avoid actions that could improperly characterize nanomaterials as inherently hazardous or benign."

    Alternatively, EPA is proposing to collect information on the use of nanoscale ingredients in pesticides by using Data Call-In notices (DCIs) pursuant to Section 3(c)(2)(B) of FIFRA. In contrast to Section 6(a)(2), the DCI process is preferred for its neutrality and there is an established legal basis for using the neutral DCI process for information gathering.

    In another apparent contradiction to the Federal Policy Statement on Nanotechnology, EPA is proposing to establish a formal, rebuttable presumption that applications for the registration of a pesticide product containing active or inert nanoscale materials will be processed as "new" active or inert ingredients. The application review process for a new pesticide takes many years and EPA's fee for reviewing the application is over $2 million alone. This aspect of EPA's proposal simply cannot be reconciled with the directive to regulate nanomaterials "in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation." Public comments on how EPA's preferred approach will stifle new markets for the pesticide industry for years into the future are currently being accepted - and must be submitted to EPA on or before August 17, 2011. 76 Fed. Reg. 41178 (July 13, 2011).

    The Federal Policy Statement on Nanotechnology calls to our attention that existing regulatory frameworks like FIFRA are expressly designed to examine the characteristics and properties of a material that have potential "regulatory relevance." The Federal Policy Statement on Nanotechnology, with the input of the President's top scientific advisor(s), lists these relevant characteristics and properties, including "exposure, biodistribution (including adsorption, distribution, metabolism, and excretion), persistence, bioaccumulation, toxicity, and pharmacokinetics." Noticeably absent from this list is a pronouncement on size at the nanoscale. As a general matter, we are being directed to regulate not based on size, but rather to responsibly identify and manage potential adverse effects and distinguish nanomaterials when and if appropriate. This policy direction is being supported by a steady increase in government funding for EHS research for nanotechnology applications from $37.7 million in fiscal year (FY) 2006 to $123.5 million in FY 2012.

    At the moment, definitional attempts for nano-objects highlight the size range of approximately 1 to 100 nanometers. From a science-based perspective, this is the range in which some surprising shifts in how a material behaves are being observed. The definition approach to focus on size is one way of directing public attention to promising areas of materials science at a time when our understanding of these property shifts is at an early stage. In time, it is believed that fundamental shifts in the performance properties of nano-objects as well as a description of their primary areas of intended use will manifest themselves in science-based definitions.

    Regrettably, in some cases, our early attempts to define what is currently known or can be measured with good certainty (e.g., size) have been met by scientifically unfounded generalizations that size denotes hazard as a regulatory matter. The Federal Policy Statement on Nanotechnology provides an important and timely reminder of the distinction between defining technological advances and responsibly managing them, and how this distinction should not be blurred in a rush to judgment on nanotechnology.

    The Federal Policy Statement on Nanotechnology by the President's top science, trade, and regulatory advisors also serves as an important reminder that there is nothing so different about nanotechnology from other emerging technologies past and present that warrants having an agency depart from using best available science. It recognizes that most of the applications of nanotechnology that are and will be regulated by Federal agencies for the foreseeable future fall under the rubric of "incremental" technology advances which are essentially on the continuum of colloidal and materials science. See Wood, et al.'s, "Crystallizing the Nanotechnology Debate," Tech. Anal. & Strategic Mgmt 13-27 (2008). Nanotechnology, as it is currently practiced by the agencies and the public, has placed a new perspective on many long-established products. Validating early stage position papers by the American Bar Association (ABA), the Federal Policy Statement on Nanotechnology acknowledges that established legal frameworks are working to incorporate nanotechnology into their fabric.

    A welcome path forward has finally emerged in the U.S. for responsible stewardship of nanomaterials and products derived from them. The policy approach espoused by the President's top science, trade, and regulatory advisors is a challenge to stand by traditional risk assessment principles without compromise. It recognizes that "a focus on novel properties and phenomena observed in nanomaterials may ultimately be more useful than a categorical definition based on size alone." The President's top science, trade, and regulatory advisors have set the tone that adhering to science-based guidelines is necessary to responsibly evaluate the impacts of nanotechnology on human health and the environment. Interagency coordination will be integral, however, to ensure that any one agency does not mischaracterize - either positively or negatively - nanomaterials and products. Their focus on the practical --- rather than the theoretical - applications of nanotechnology moves the technology and the economy forward.