Executive Office of the President Executive Office of the President Executive Office of the President 

Office ofManagement and Budget United SJ Office of Science and Technology Policy ijNTradg R25wentative 

MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES 

FROM: John P. Holdren )~~ Assistant to the Pres(dlmt for Science and Technology 

Director, Office of Science and Technology Policy 

Cass R. Sunstein , ~.') Administrator, Offi'Ee of Information and Regulatory Affairs 

Office of Management and Budget 

Chief 

Islam A. 

Agric

Siddiqui ultural ~ 

Negotiator 

Office of the United States Trade Representative 

SUBJECT: Policy Principles for the U.S. Decision-Making Concerning Regulation 

and Oversight of Applications ofNanotechnology and Nanomaterials 

/

'" "Our regulatory system must protect public health, welfare, safety, and our environment 

while promoting economic growth, innovation, competitiveness, andjob creation. It 

must be based on the best available science. " 

President Obama. Executive Order 13563. January 18. 2011. 

/ '" 

The ability to image, measure, model, and manipulate matter on the nanoscale is leading to new 

technologies and promising new materials and applications across many fields - including medicine, 

information technology, aerospace, energy, and transportation - that will affect virtually every sector of 

our economy and our daily lives. Examples of potential nanotechnology applications include smart anticancer therapeutics, solar cells as cheap as paint, and the next revolution in computing. Companies are 

already offering nanotechnology-enabled products with breakthrough capabilities in areas such as disease 

detection, lighter and stronger materials, and next-generation batteries. 

Advances in nanotechnology can drive economic growth, create quality jobs, and address a broad range of 

national challenges. Realizing these possibilities requires continued research, accelerated innovation, and 

flexible, adaptive, science-based approaches to regulation that protect public health, safety, and the 

environment while promoting economic growth, innovation, competitiveness, exports, and job creation. 
The National Nanotechnology Initiative (NNI), one of the Obama Administration's top science and 

technology priorities, has invested almost $14 billion in research and development since its inception in 

FY 2001. A key goal of the NNI is the responsible development of nanotechnology, which requires 

maximizing the benefits of nanotechnology while understanding and managing the relevant risks. As the 

President's Council of Advisors on Science and Technology noted, "In the absence of sound science on 

the safe use of nanomaterials and of technologies and products containing them, the chance of 

unintentionally harming people and the environment increases. At the same time, uncertainty and 

speculation about potential risks threaten to undermine consumer and business confidence." Accordingly, 

the Federal Government has significantly increased funding on the environmental, health and safety 

dimensions of nanotechnology, from $37.7 million in FY 2006 to $123 .5 million in FY 2012. 

The National Economic Council (NEC), the Office of Management and Budget (OMB), the Office of 

Science and Technology Policy (OSTP), and the Office of the U.S. Trade Representative (USTR) led a 

multi-agency consensus-based process to develop a set of principles to guide development and 

implementation of policies for the oversight of nanotechnology applications and nanomaterials. This 

document is intended to summarize generally applicable principles relevant to promoting a balanced, 

science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner 

that protects human health, safety, and the environment without prejudging new technologies or creating 

unnecessary barriers to trade or hampering innovation. These principles build on the foundation provided 

by current regulatory statutes and do not supersede existing legal authorities or hinder Federal agencies 

from enforcing or applying their existing statutory and regulatory authority as mandated by law. Federal 

agencies that have regulatory responsibilities, such as the U.S. Environmental Protection Agency, the U.S. 

Food and Drug Administration, and the Occupational Safety and Health Administration, must continue to 

implement sound policies to protect public health, safety, and the environment. 

The Federal Government is responsible for protecting human health and the environment and takes 

regulatory and oversight actions to ensure the safe production, processing, use, and disposal of many 

kinds of products - including foods and consumer products, chemicals used in the workplace, medical 

products, and pesticides. This framework for oversight and regulation of nanomaterials and applications 

of nanotechnology builds on existing laws and individual authorities, such as the risk-based approaches 

currently in use by some Federal agencies to meet this overarching responsibility. A fundamental element 

of these risk-based approaches is to examine those characteristics and properties of a material that are 

relevant to considerations about human and environmental safety-such as exposure, biodistribution 

(including absorption, distribution, metabolism, and excretion), persistence, bioaccumulation, toxicity, 

and pharmacokinetics- and therefore present issues of potential regulatory relevance. Such risk-based 

approaches reflect awareness that regulation should be grounded in the best available science and able to 

evolve as scientific insights mature and the body of evidence grows and evolves. Consistent with current 

law, regulatory agencies should take a science-based approach to risk management. 

Descriptors for Regulatory Purposes 

Nanotechnology has been described by the NNI as "the understanding and control of matter at dimensions 

between approximately 1 and 100 nanometers, where unique phenomena enable novel applications." l Size 

is by far the driving characteristic in all of the definitions developed for nanotechnology and 

nanomaterials to date. Materials in the nanoscale may have properties that are different from those of the 

I National Nanotechnology Initiative Website, http://www.nano.gov/htmVfacts/whatIsNano.html. 

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conventionally-scaled material. The appearance of unique properties can also occur, however, even 

where the material or end product itself is not within the nanoscale range. Most definitions of 

nanomaterials contain a size-specific range (e.g., within the nanoscale range, which is commonly referred 

to as approximately 1-100 nm) along at least one dimension, but some definitions apply the size range to 

two or more dimensions--using either external or internal structures as units to be measured. Some 

definitions also include criteria related to physical or chemical characteristics (e.g. size distribution, 

shape, charge, or the ratio of surface area to volume) or to the display of unique or novel properties or 

"nanoscale phenomena." 

The NNI description provides a valuable reference point. For oversight and regulation, however, the 

critical issue is whether and how such new or altered properties and phenomena emerging at the nanoscale 

create or alter the risks and benefits of a specific application. A focus on novel properties and phenomena 

observed in nanomaterials may ultimately be more useful than a categorical definition based on size 

alone. Properties and phenomena emerging at the nanoscale enable applications that may alter the safety, 

effectiveness, performance, or quality ofproducts- giving rise to both risks and benefits. These properties 

and phenomena may be due to altered physical, chemical, or biological properties, or other distinct 

characteristics of materials in the nanoscale. These changes may positively or negatively affect not only 

the safety, effectiveness, performance, or quality of the products, but also their impact on public health 

and the environment. 

For purposes of simplicity and comprehension, the remainder of this document will refer to materials or 

products or other applications that involve the use of nanotechnology simply as "nanomaterials". In this 

document, the term will also be used when referring broadly to regulatory oversight that is exercised over 

the life cycle ofthe material, the product that may contain it, or products produced using the material. 

Framework for the Review and Oversight of Nanomaterials 

As noted above, existing regulatory statutes provide a firm foundation for the regulation and oversight of 

nanornaterials; in particular these statutes address a range of potential applications for the technology. 

Under the relevant statutes, Federal agencies have the authority to evaluate safety, effectiveness, public 

health, and environmental impact of these applications. In exercising their authority, agencies seek to use 

the best available scientific and technical information to take into account the unique properties and 

behaviors associated with nanomaterials. 

For purposes of regulation and oversight, Federal agencies focus on whether the properties or phenomena 

observed in nanomaterials (and/or their applications) present issues related to risk, safety, benefits, or 

other regulatory criteria. Federal agencies should avoid making scientifically unfounded generalizations 

that categorically judge all applications of nanotechnology as intrinsically benign or harmful. In this 

regard, identification of specific risks in the context in which they arise--based on scientific evidence to 

support that judgment- will help to ensure that perceptions of specific nanomaterials are based on 

scientific evidence rather than unsupported generalizations. 

Building consumer trust and confidence in a sound regulatory regime is integral to fostering innovation 

and promoting the responsible development of nanotechnology applications. Federal agencies will strive 

to provide their stakeholders with clear information that delineates the specific risks identified and the 

context in which they arise. It is important that Federal agencies manage expectations realistically-­

neither overselling nor underselling the potential benefits or risks. 

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This framework is expected to evolve in response to the experiences of the Federal agencies and other 

stakeholders. As noted above, future scientific and other developments will almost certainly lead to 

refmements in agencies' approaches. Indeed, as experience with other technological innovations has 

shown, scientific progress and greater awareness of the effects of emerging technologies have enabled 

regulatory approaches to be modified to reflect a more complete understanding of the potential risks and 

benefits involved. A similar evolution is anticipated in the regulation and oversight of nanomaterials . . 

Over time, modifications may need to be made through administrative or legislative actions. 

In addressing issues raised by nanomaterials, agencies will adhere to the Principles for Regulation and 

Oversight of Emerging Technologies. Specifically, to the extent permitted by law, Federal agencies will: 

• 	 To ensure scientific integrity, base their decisions on the best available scientific evidence, 

separating purely scientific judgments from judgments of policy to the extent feasible; 

• 	 Seek and develop adequate information with respect to the potential effects of nanomaterials on 

human health and the environment and take into account new knowledge when it becomes 

available; 

• 	 To the extent feasible and subject to valid constraints (involving, for example, national security 

and confidential business information), develop relevant information in an open and transparent 

manner, with ample opportunities for stakeholder involvement and public participation; 

• 	 Actively communicate information to the public regarding the potential benefits and risks 

associated with specific uses of nanomate rials; 

• 	 Base their decisions on an awareness of the potential benefits and the potential costs of such regulation 

and oversight, including recognition of the role of limited information and risk in decision making; 

• 	 To the extent practicable, provide sufficient flexibility in their oversight and regulation to 

accommodate new evidence and learning on nanomaterials; 

• 	 Consistent with current statutes and regulations, strive to reach an appropriate level of consistency 

in risk assessment and risk management across the Federal Government, using standard oversight 

approaches to assess risks and benefits and manage risks, considering safety, health and 

environmental impacts, and exposure mitigation; 

• 	 Mandate risk management actions appropriate to, and commensurate with, the degree of risk 

identified in an assessment. 

• 	 Seek to coordinate with one another, with state authorities, and with stakeholders to address the 

breadth of issues, including health and safety, economic, environmental, and ethical issues (where 

applicable) associated with nanomaterials; and 

• 	 Encourage coordinated and collaborative research across the international community and 

clearly communicate the regulatory approaches and understanding of the United States to 

other nations. 

Because nanotechnology is a rapidly emerging field of research and development, protection of public 

health and the environment makes it essential that regulatory agencies gather information on an ongoing 

basis about developments in both basic science and applications. Agencies may use the authority 

provided by their existing statutes to gather information. In all domains, compliance with law is of course 

required. If statutory frameworks limit mandatory reporting or other information gathering systems to 

those circumstances where a risk or 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 

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careful to avoid actions that could improperly characterize nanomaterials as inherently hazardous or 

benign. 

To further understanding, enhance risk management, improve risk and hazard communication, and 

promote coordination, simplification, and harmonization in regulatory actions, a working group 

established by OSTP, OMB, and USTR will coordinate an approach and choice of terminology relevant to 

the regulation and oversight of nanomaterials. This working group will further develop this framework, 

acting consistently with current law and applying the framework to new circumstances and the wide 

variety of nanomaterials. Moreover, the interagency working group will enable the relevant regulatory 

agencies to remain involved in and influence ongoing research into nanotechnology, identifying possible 

areas of uncertainty and concerns of regulatory significance. Wherever possible, agency input into 

research direction should be used as a critical part of relevant information gathering. 

In sum, agencies will continue their science-based approaches subject to the particular rules governing 

each area of regulatory oversight and their existing statutory authorities. Federal agencies that have 

regulatory responsibilities must continue to implement sound policies to protect public health, safety, and 

the environment. Technical assessments underlying regulatory and other risk management responses will 

be evidence-based and application-specific as appropriate under the applicable regulatory programs, 

taking into account the effects of nanomaterials in the particular biological and mechanical context of 

each application and their intended use. 

Nanomaterials should not be deemed or identified as intrinsically benign or harmful in the absence of 

supporting scientific evidence, and regulatory action should be based on such scientific evidence. Where 

there is evidence of either safety or likely harm, the corresponding regulatory actions are usually clear. 

For some statutes, the mere existence of a hazard, regardless of the probability of it causing harm, may 

trigger some form of regulatory action. In general, however, and to the extent consistent with law, 

regulation should be based on risk, not merely hazard, and in all cases the identification of hazard, risk or 

harm must be evidence-based. In applying these principles, regulators should use flexible, adaptive, and 

evidence-based approaches that avoid, wherever possible, hindering innovation and trade while fulfilling 

the Federal Government's responsibility to protect public health and the environment. 

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