Category: Government Agencies


In January, a bill was introduced in Congress proposing an act to assist governments on all levels to investigate disease clusters.  The short title is the “Strengthening Protections for Children and Communities From Disease Clusters Act,” and is referred to as the Disease Clusters Act.  Disease clusters are generally defined as “the occurrence of a greater-than-expected number of cases of a particular disease within a group of individuals, a geographical area, or a period of time.”  Sec. 5(4)(A).  Because children are more susceptible than adults to the risks of environmental pollutants and toxic substances – due to a variety of developmental and environmental factors – the act proposes to facilitate investigation of disease clusters and the potential hazardous substances that may cause those diseases.  The act would grant authority to EPA to develop regulations and to coordinate efforts and funding with states and communities.  Sec. 3 & 4.

Disease clusters are well known in toxic torts.  The existence of a disease cluster does not necessarily mean that a causal connection can be drawn between the disease and substances to which the population was exposed.  Recent examples have been breast cancer clusters in Long Island and autism clusters in New Jersey or among children who have received certain vaccines.  While it is possible that environmental or product-related connections could yet be discovered, to date reliable science has not been able to make those connections.  In contrast, in Woburn, Massachusetts, in the 1980s, citizens discovered a cluster of childhood leukemia.  Grass roots investigation, followed by an epidemiological study performed by Harvard University, demonstrated a connection between chemicals in the drinking water supply of two of the wells that supplied the part of town where the ill children lived.  The story of this community and the subsequent litigation have been described in Jonathan Harr’s book, “A Civil Action,” and the movie adaptation.

As the Woburn example demonstrates, it is important to investigate disease clusters.  But it is equally important to recognize that sometimes a disease cluster is coincidental.  The proposed legislation would treat all disease clusters alike in the initial phases of investigation, using the best available science.  And some might criticize an outlay of resources for an uncertain enterprise.

Where does nanotechnology enter this picture?  The act makes no mention of any specific potential hazards, though it does reference environmental pollutants and toxic substances and indicates that the substances may be present in the air, water, ground, drinking water supply, waste sites, and any other place, whether or not already regulated by another statute.  Sec. 5(7).  Nanomaterials in the environment would fall within the definitions in the act.  The act would be a way to examine the health and environmental effects of nanotechnology that may not be captured – or yet captured – under existing regulatory schemes.

The down side, however, is that citizens shouldn’t have to wait until disease clusters manifest for potential hazards to be studied.  Diseases such as cancer caused by exposures to toxic substances generally manifest symptoms after a latency period that could be as long as several years.  The same is true of developmental delays in children.  It is always preferable to prevent the problem in the first instance.  But the law recognizes that that is not always possible.  This disease cluster act would be a post hoc solution, after some people have already become ill.  But it could prevent others from suffering the same fate.

The bill is sponsored by Senators Barbara Boxer and Mike Crapo.  It was referred to the Committee on the Environment and Public Works, which favorably and without amendment reported it to Congress on June 9, 2011.

 The bill may be read in its entirety at

white-house-south-2007-djIn a June 9, 2011, memorandum to the heads of U.S. executive departments and agencies, entitled Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, the White House confirmed its commitment to a “science-based” approach to health and safety matters related to nanotechnology.  The memorandum issued from the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the U.S. Trade Representative. The memorandum described its approach as

“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.”

The memorandum went on to explain that the approach it establishes is inherent in the risk-based approach commonly used by federal agencies such as the FDA, but is grounded in best available, and evolving, science.

 This is a tall order.  It is important that the White House explicitly addressed nanotechnology and nanomaterials, rather than using the vague term “emerging technologies,” as it has done in the past.  But perhaps the most significant part of the memorandum is in its elevation of the science-based approach over other possible approaches (technology-based, economics-based, etc.) to the study and regulation of nanomaterials.

 Intending to provide guidance to existing federal agencies, the memorandum stated:  “Federal agencies should avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.”  Consumer trust, the memorandum went on to say, is important in encouraging technological innovation.

 On the one hand, the memorandum eased industry concerns that nanotechnology will be viewed as “bad” and all nanomaterials as “hazardous” because of the flurry of attention focused on the technologies and the concerns voiced by various groups.  But on the other hand, the message is clear that science will govern the study of nanomaterials and any decisions about whether or how to regulate.  And that is also a message to industry to come forward with the science that the agencies need.

 The memorandum also announced the creation of an interagency working group to coordinate this basic framework across agency lines, promote coordination of regulatory activities, and share information.

 How is this policy likely to play out in the relevant departments and agencies?  Here are a couple of recent steps that illustrate the initial approach:

 ●  On June 10, 2011, the FDA issued a Draft Guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, to provide manufacturers, suppliers, importers, and other stakeholders with the FDA’s “current thinking” on the subject.  The Draft Guidance was issued in conjunction with the White House memorandum.  The document provided no definitions, nor did it provide any information on the regulatory status of any products.  Rather, the document stated that its purpose is “to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nano-technology in FDA-regulated products.”

 The FDA Draft Guidance is available at

 ●  A similar document was issued by EPA setting forth its proposed policy for obtaining data on nanoscale materials in pesticides, pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Another important aspect of what EPA is considering is a case-by-case analysis of whether a nanoscale ingredient in a pesticide is considered “new” for the purpose of study and regulation.  This is a sharp departure from EPA’s earlier stance that it would consider all nanoscale ingredients as “new,” whether or not a non-nanoscale form of the ingredient was already registered under FIFRA.  The new approach is consistent with the urging of the White House memorandum that agencies avoid generalizations about nanomaterials and based all decision on the scientific evidence.

 The prepublication version of this notice is available at


The White House memo is available at

On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation.”  Speakers came from all sectors, including private law firms and industry.

Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.

1.  Size.  It really is all about size.  Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation.  Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.

2.  Progress.  Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology.  There is a pervasive concern about the prevalence of these technologies and the paucity of studies.

3.  Fragmentation.  Attention to the potential issues raised by nanotechnology continues to be highly fragmented.  There has been intensely focused attention to some issues, but others remain to be addressed.

For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products.  Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.”  Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials.  Other applications are pending for registration of pesticides containing nanomaterials.  EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product.  Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide.  But risks assessment lags behind.  According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”

Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar).  But progress in one area does not necessarily mean progress elsewhere.  The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches.  And standardization remains a debatable issue in itself.

4.  Industry Uncertainty.  Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful.  The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.

5.  Bottom Line.  The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.

Other speakers at the webinar included representatives of:

Nanotechnologies Industries Association, Brussels, Belgium

Chemical Control Division, Office of Pollution Prevention and Toxics, EPA

U.S. Consumer Product Safety Commission

California Nanotechnology Initiative

California Department of Toxic Substances Control

Environmental Defense Fund, Inc.

. . . and several attorneys in private practice

nano 6Last week, the news media reported the results of a study conducted by Navy Capt. Mark Lyles, the chair of medical sciences and biotechnology at the Center for Naval Warfare Studies at the Naval War College, which purported to explain the cause of a wide range of symptoms and illnesses experienced by current and former U.S. troops in Iraq, Afghanistan, and Kuwait.  Minute dust particles containing toxic metals, bacteria, and other substances may be responsible for such health problems as cancers, respiratory ailments, heart disease, and neurological conditions in vets.  The key to the particular toxicity of the substances, as contained in the dust, is thought to be the tiny size of the particles.  For various reasons, the dust in that region of the world is much finer than ordinary dust, and the tiny particles are easily inhaled deep into the lungs, where disease processes can begin.

Although these dust particles are not the same as nanoparticles, this study raises a red flag about the need for caution about exposures to nanoparticles, whether in the workplace or the environment.  As repeatedly noted in this blog, the size of nanoparticles is key to their behavior, and some early studies have indicated that toxicity may increase as the size of particles decreases.  As the President’s Cancer Panel stated in its 2008-2009 Annual Report, the small size of nanoparticles means that “they can be inhaled, ingested, and absorbed through the skin, entering the blood stream, penetrating cells throughout the body (including the brain), and perhaps interfering with DNA processes.” (p. 40)  In the environment, the particles could potentially wreak ecological havoc.  Several studies have shown that some kinds of nanoparticles have leached into the environment, thus red-flagging the need for determining exactly how they affect the environment.

It is a fact of contemporary life that devastating results could come from exposure to engineered particles just as much as from biological organisms or a toxic soup of substances in the soil-dust of the planet.  With engineered nanomaterials, it is currently anyone’s guess as to when, how, or if such devastating results could occur.

At best, this new study of war dust is a reminder of the present, urgent need to conduct health and safety studies on nanomaterials.  At worst, it is a portent of things to come.


For a news report on the Navy researcher’s results, see

white-house-south-2007-djWhen it comes to new technologies, government goals are to both encourage innovation and assure the safety of the public.  Achieving the right balance between these goals is often a challenge.

In March 2011, the heads of executive departments and agencies in the federal government received a memo from the Office of Science Technology and Policy, the Office of Information and Regulatory Affairs, and the U.S. Trade Representative elucidating these goals.  Nanotechnology was in the forefront of their thoughts and was mentioned specifically in the first sentence of the memo.  The memo announced the development of broad principles by the White House Emerging Technologies Interagency Policy Coordinating Committee (ETIPC), emphasizing the need for “not only coordinated research and development but also appropriate and balanced oversight.”

The list of broad factors in pursuit of these goals, in the order presented in the memo, is:

●  Scientific Integrity

            ○  Use of best available scientific evidence

            ○  New information should be developed and taken into account

●  Public Participation

            ○  Promoting accountability

●  Communication

            ○  Communicate potential risks and benefits of the technologies to the public

●  Benefits and costs

●  Flexibility

○  To accommodate new information regarding the technologies and their applications

●  Risk assessment and risk management

            ○  Goal of consistency across agencies and across technologies

●  Coordination

            ○  Among agencies, with state authorities, and with stakeholders

●  International cooperation

●  Approach to Regulation

On the subject of regulation, decisions should be based on “the best reasonably obtainable scientific, technical, economic, and other information.”  The memo recommends a risk-utility balancing approach to regulation, and expressly states that sometimes the option will be simply not to regulate.  There is mention of protection of health and the environment, but always as part of a balanced equation with innovation.

These are all appropriate goals.  For each one, however, achieving an appropriate and effective balance will be difficult and time consuming.  In the aggregate, it will mean some considerations will likely be placed on the back burner while others are advanced.  Agencies should be careful not to leave the health and safety concerns behind in the interests of supporting technological innovation.  Regulators should not allow the technology to get too far ahead of risk assessment.  Accordingly, promoting risk assessment should be a major priority.

Perhaps the most important principle is this:  Proceed in such a manner so that there will be no regrets.


The memorandum is available at