– Executive Summary –

Technological advancements are an important part of human existence. From the dawn of humans’ emergence as the dominant species on earth, the ability to create and use tools has been a primary accelerator of that dominance. Tools have been used to make life easier but also to make even better tools and later machines, which eventually led to complex computing. Each of these advancements has led to new plains of discovery, capabilities, and achievement, but also to new and unexpected dangers.

As new technologies are developed, there are some that affect only a minute section of the world’s population, but others are revolutionary and have the potential to directly or indirectly affect every human on earth and even the earth’s ecology. Many scientists suggest that nanotechnology is one of these revolutionary technologies. The idea that nanotechnology represents revolutionary change leads many to believe that regulating this emerging technology is of paramount importance.

Presently, the regulatory framework for nanotechnology consists of existing regulating entities addressing concerns about nanotechnology under current rules and laws. If nanotechnology does develop to be the dramatic influence many predict it will be, it is fair to question whether existing agencies, rules, and laws are sufficient to address regulation, product approval, policy advice, and industry monitoring for the emerging field of nanotechnology.

  1. OBJECT, METHOD, LIMITS, AND OUTPUT

The objective of this thesis is to aid and inform the regulatory decisions of policymakers by mapping the regulatory landscape of nanotechnology, reviewing current regulatory frameworks, and making recommendations on the appropriate regulatory framework for nanotechnology. This thesis identifies the relevant federal stakeholders in relation to nanotechnology, gives a brief description of the state of the technology, analyzes applicable laws related to the technology that have already been enacted, and examines the regulatory framework of aviation and biotechnology. This thesis is aimed primarily at those delivering regulation in national agencies, regulatory policymakers, and other concerned stakeholders and citizens focused on the safe development and production of new technologies.

Additionally, this research advances the establishment of a regulatory framework for nanotechnology. As the technology matures, policymakers will be faced with unique regulatory challenges. Now is the time to begin identifying the best regulatory framework for nanotechnology; it is important not to wait until a crisis occurs.

The method used to achieve these thesis objectives was an investigation into the background, current state, and future projections of nanotechnology development, a federal stakeholder analysis, a review of current nanotechnology-related policy and legislation, and an examination of the regulatory framework in the aviation and biotechnology industries. The researcher generated a list of stakeholders based on organizational publications, stated interest in nanotechnology, membership to nanotechnology organizations such as the National Nanotechnology Initiative (NNI), and implied interest in nanotechnology. The scope of this research is focused on mapping the regulatory landscape of nanotechnology and reviewing current regulatory frameworks. The research describes the background, current state, and future projections of some leading minds in the field of the technology, but it does not attempt to predict future advances in nanotechnology. However, it does relate realistic probabilities based on research. The output of this research is a set of recommendations for policymakers and other nanotechnology stakeholders. The goal for these recommendations is that they will serve as a starting point for establishing a regulatory framework for nanotechnology in the United States.

  1. FINDINGS

Mapping the regulatory landscape of nanotechnology has revealed several key findings:

  1. The regulatory landscape of nanotechnology is vast and has many stakeholders and potential pitfalls to regulation.
  2. There is very little consensus on many aspects of nanotechnology. Researchers disagree on the definition, rate of technological advancement, proper regulation, potential dangers, future state, or end use of the technology. The one thing nearly everyone agrees on is that nanotechnology will potentially be one of the most important technologies of this century.
  3. The scope of nanotechnology’s influence reaches across several industries and sectors of society. As it matures, there will likely be no part of society untouched by this emerging technology.
  4. The current state of nanotechnology is a robust one, with more than 1,800 products known or thought to be using the technology.[1] Despite this proliferation, the environmental, health, and safety implications of nanoengineered materials throughout a nanotechnology product’s life cycle remain largely unexplored.
  5. The current regulatory approach to nanotechnology is to address it under existing laws; however, these laws may not be sufficient to address the future challenges of nanotechnology. For instance, the Consumer Product Safety Commission, which is tasked with ensuring products are safe for consumers, lacks the funding and personnel to properly address nanotechnology in products already in the marketplace.
  6. Nanotechnology is important to the long-term health of the U.S. economy. The U.S. government has invested significant resources in the advancement of nanotechnology research. For instance, the NNI has received nearly $24 billion in federal funding since 2001.[2]
  7. There have been many pieces of legislation directly or indirectly related to nanotechnology. Most legislation focuses on research and development, not on regulation.
  8. Despite their very disparate missions, many federal agencies are involved in nanotechnology research, development, and regulation.
  9. Aviation and biotechnology have different regulatory frameworks that can inform the recommendation for nanotechnology’s regulatory framework.
  10. RECOMMENDATIONS

The recommendations of this thesis come as a result of identifying obstacles to regulation and determining, based on stakeholder analysis and the regulatory landscape, which would be the best framework for nanotechnology regulation. The first recommendation is to follow the advice of Jeffrey Matsuura and “display confidence in their existing regulatory systems by relying on those rules and processes to oversee the ongoing introduction of nanotechnology into additional commercial applications,” while addressing the limitations of this approach.[3] The primary limitation is the high level of technical expertise required for understanding the technology and therefore for recommending policy or enacting rules or regulations. The primary regulatory institutions should be those identified as high-power, high-interest on the stakeholder matrix: the Environmental Protection Agency, U.S. Food and Drug Administration, Consumer Product Safety Commission (CPSC), and National Institute for Occupational Safety and Health. To ensure the appropriate level of expertise is available for regulatory decisions, it is recommended that each of these four agencies sponsor an Advisory Committee of technical and industry experts under the guidelines of the Federal Advisory Committee Act of 1972 (Public Law 92-463). These advisory committees will provide relevant and objective advice which is open to the public for review. Following this recommendation would set up the United States for success regulating the nanotechnology now and in the future, no matter how it develops.

The second recommendation of this thesis is to conduct, through the National Science Foundation (NSF), a multiyear comprehensive study to determine the environmental, health, safety risks, and impacts of nanoengineered materials. Without knowing the risks associated with the technology, one cannot reasonably determine what future regulation should look like. Once researchers identify the risks, policymakers can enact reasonable regulation.

The third recommendation is to review funding for the CPSC. According to research, the CPSC is too undermanned and underfunded to accomplish its mission, especially in light of the many products now using nanoengineered materials.[4] Congress should review this agency to identify to what extent funding and manning should be increased.

The fourth recommendation of this thesis is to increase public awareness of nanotechnology and promote public engagement through an education program providing government funded literature and public television/radio programming. An engaged and educated public is necessary to guard against the damage of misinformation regarding nanotechnology.

The fifth recommendation is to fund a scholarship program, through the NSF, for students seeking advanced degrees in nanotechnology-related research fields. The research reveals how the United States is falling behind other developed countries in the science, technology, engineering and math fields of learning.[5] A scholarship program designed for nanotechnology will not only help to address this problem but also provide the expertise of the future needed to guide regulation as the technology matures.

The sixth and final thesis recommendation is to continue funding nanotechnology research in the federal budget. This research shows agencies such as the NNI are playing and will continue to play an important role in the future of nanotechnology development.

[1] Marina E. Vance et al. “Nanotechnology in the Real World: Redeveloping the Nanomaterial Consumer Products Inventory,” Beilstein Journal of Nanotechnology 6 (August 2015): 1769–1780, doi:10.3762/bjnano.6.181, https://www.beilstein-journals.org/bjnano/content/pdf/2190-4286-6-181.pdf.

[2] “NNI Budget,” National Nanotechnology Initiative, accessed December 30, 2017, https://www.nano.gov/about-nni/what/funding.

[3] Jeffrey H. Matsuura, Nanotechnology Regulation and Policy Worldwide (Norwood, MA: Artech House, Inc., 2006), 4.

[4] E. Marla Felcher, The Consumer Product Safety Commission and Nanotechnology (PEN 14) (Washington, DC: Pew Charitable Trusts Project on Emerging Nanotechnologies, 2008), http://www.nanotechproject.org/process/assets/files/7033/pen14.pdf.

[5] Niall McCarthy, “The Countries with The Most STEM Graduates” [infographic], Forbes, February 2, 2017, https://www.forbes.com/sites/niallmccarthy/2017/02/02/the-countries-with-the-most-stem-graduates-infographic/#267a23ea268a.

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