Category: Governmental Interaction

EU Progress, EPA Action, and More

Posted Jun.27, 2013 under Carbon nanotubes, Chemicals, Environment, EPA, European Union, Governmental Interaction, International Nanoregulation, Regulation, Safety

NASA stock photos

NASA stock photos

It’s a busy time for potential regulators of nanomaterials.  This post will point to some of the recent activities, in the United States and abroad.

 The Organization for Economic Cooperation and Development’s (OECD) Cooperative Chemical Assessment Program (CoCAP) has long been working to assess the hazards of chemicals across international lines.  OECD has now decided that CoCAP has served its purpose and must be replaced by a different organization at the end of 2014.  One reason for the change is that the activities of the EU’s REACH program and research in the United States have become the primary assessment mechanisms, rendering CoCAP’s current activities unnecessary.  The new program is still in the planning stages, but will involve the development and implementation of new methodologies.

This sounds like progress.  As this blog often has noted, nanotechnology assessment has received more attention in the international arena than in the United States, and this is another example of an international organization moving forward.

A summary of CoCAP may be accessed at:

http://www.oecd.org/env/ehs/risk-assessment/oecdcooperativechemicalsassessmentprogramme.htm

 A report of the announcement to replace CoCAP appeared in

Rick Mitchell, Multi-Nation Group to Replace Program That Weighs High-Volume Chemical Hazards, 28 Toxics L. Rep. (BNA) 707 (June 27, 2013) (by subscription)

Speaking of the EU, the European Commission is seeking suggestions on better applying the REACH assessment to nanomaterials.  The official document seeking comments states:

“Specifically, the policy initiative shall provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with the aims of REACH Article 1(1) ‘to ensure a high level of protection of   human health and the environment, including the promotion of alternative methods for assessment of hazards of substance, as well as the free circulation of substances on theinternal market while enhancing competitiveness and innovation’.”

The Commission is reaching out to all interested stakeholders to provide “the best possible evidence base for its work.”

The official announcement, with information on submitting comments, is available at:

http://ec.europa.eu/environment/consultations/nanomaterials_2013_en.htm

In another demonstration of international cooperation, the United States and Canada have developed a uniform classification system for industrial nanomaterials.  The U.S.-Canada Regulatory Cooperation Council’s (RCC) working group has been involved in this process since 2011 as part of a broader initiative to bring about uniformity in addressing nanotechnology.  This latest step is part of a continuing process.  This blog has previously discussed the work of the RCC here.

Here in the United States, EPA has issued its final significant new use rules (SNURs) for 17 substances, mostly constituting substances at the nanoscale, which will go into effect on August 26, 2013.  Fifteen of the seventeen SNURs are based upon TSCA section 5(e) consent orders issued by EPA and reflect the substance of the orders.  With regard to the other two SNURs, “EPA determined that one or more of the criteria of concern . . . were met.”  (Final Rule, p. 6)  In the Final Rule, EPA responded to various comments, including those directed at workplace safety.  This blog will address those comments at a later date.

The Final Rule is available at:

https://www.federalregister.gov/articles/2013/06/26/2013-15032/significant-new-use-rules-on-certain-chemical-substances

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The Long Road to Nanoregulation

Posted Oct.11, 2012 under Environment, Governmental Interaction, Health, International Nanoregulation, Regulation, Safety

The Canada-U.S. Regulatory Cooperation Council (RCC) has announced a pilot program to examine the differences between risk assessment practices for nanomaterials in both countries with the goal of identifying and sharing the best practices.  The RCC was initiated in 2011 by President Obama and Prime Minister Harper to coordinate the risk assessment practices of the two countries on a scale broader than nanotechnology.  Within the RCC, the Nanotechnology Working Group has focused specifically on looking into the potential risks of nanomaterials.

The Nanotechnology Work Plan generated by the RCC Nanotechnology Working Group states the following as the desirable outcome of the Group’s efforts:

“Share information and develop common approaches [between the two countries], to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc.  Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.”

The stated purpose of the common approaches would be to “help ensure consistency for industry and consumers in both countries.”

The Working Group sees its ultimate task as the development of “a model framework providing key elements and approaches to regulating products and applications of emerging technologies with respect to potential impacts on the environment, human health, food or agriculture.”

All quite worthy goals.  But as with so many efforts to understand the potential health and environmental risks of nanomaterials, this effort has its pluses and minuses.

The best features of the RCC initiative are international governmental cooperation and sharing of expertise and experience.  But some of the same frustrations evident in the nanotechnology risk assessment and regulatory arena still exist.  For example, we are still looking at a protracted process of risk assessment, followed by a protracted process of developing regulations.  As part of that, the group must still agree upon a taxonomy and risk assessment goals and specific procedures.  And most certainly there will be fragmentation and duplication of efforts between North America and the rest of the world.

It’s still a good idea.  But let’s not expect too much too soon.

The Nanotechnology Work Plan is available at

http://www.trade.gov/rcc/documents/Nanotechnology.pdf

 

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Exposures to Nanomaterials – Same Old Dilemma, Different Venue

Posted Jun.26, 2012 under Carbon nanotubes, EPA, Government Agencies, Government standards, Governmental Interaction, Health, Nanotubes, Research, Safety

Many of the posts on this blog have addressed the regulation dilemma of whether to incorporate nanomaterials into the existing regulatory framework or develop separate regulations to manage their potential hazards.  This same dilemma is playing out in a slightly different way through a public-private partnership on exposures to carbon nanotubes in consumer products.

The NanoRelease project is engaged in this effort, with the support of numerous organizations, including U.S. EPA, Environment Canada, HealthCanada, and the American Chemistry Council.  Undertaken by the Government of Canada, the project has selected multi-walled carbon nanotubes in polymer to begin its study of the nature of exposures to nanomaterials.  The study includes determining likely release scenarios, evaluating release measurements, and considering needs for laboratory testing.  The research foundation has stated:  “The NanoRelease project will foster the safe development of nanomaterials by supporting development of methods to understand the release of nanomaterials used in products.”  Among other things, the group pledges to develop a “state of the science” report.

A summary of the project is available at

www.ilsi.org/ResearchFoundation/Documents/NR%20Orientation%20Powerpoint%20Presentation.pdf

Both the National Institute of Occupational Safety and Health (NIOSH) and the Consumer Product Safety Commission (CPSC) are very interested in the ongoing process.  But will the ultimate result be “consensus standards” for nanomaterials that are efficient and effective?  Will consensus standards be followed by industry without a direct mandate?

Bloomberg BNA’s Daily Environment Reporter quoted John Howard, the director of NIOSH, as saying:  “We want to make sure that if we are developing consensus standards . . . that people are reading them and that people are adhering to them.  Otherwise heavy-handed government regulation – that industry always objects to – will come into fore and then we’ll have a less effective control system, a less efficient risk management system.”  (quoted in Pat Rizzuto, Regulators, Industry Sorting Through Potential Exposures to Carbon Nanotubes, 122 Daily Env’t Rep. (BNA) A-9 (June 26, 2012) (by subscription))

Will industry and governments agree on standards?  If so, some measure of regulation will be necessary, but probably not the “heavy-handed” sort that concerned Dr. Howard.  Consensus standards can be incorporated into existing regulatory regimes, perhaps rendering unnecessary separate extensive regulation for nanomaterials.  But essentially we are circling the same issue over and over again:  Is it possible to avoid separate, independent, and perhaps “heavy-handed” regulation of nanomaterials in the interest of public health and safety?  No question that it is an important issue.  And it remains unanswered.

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. . . And the Cosmetics Shoe Drops

Posted May.19, 2012 under Cosmetics, European Union, FDA, Government Agencies, Governmental Interaction, Health, International Nanoregulation, Nanosilver, Regulation, Safety

Earlier I reported that the FDA had recently shown some intense interest, per its recent draft guidance document, in the safety of food and food packaging products containing nanomaterials.  In contrast, the FDA seemed to merely urged caution to the cosmetics industry about nanoparticles in their products.  Now, however, the FDA appears to be on the move toward giving nanomaterials in cosmetics their fair amount of attention.

In July, the FDA will host the International Cooperation on Cosmetics Regulation (ICCR), which is expected to include cosmetics regulators fromCanada, the EU,Japan,Brazil,China,Australia, and other countries.  The conference is scheduled to include opportunities for participation by the industry and any other interested parties.  Nanomaterials represent only one item on the agenda (which includes alternatives to animal studies and regulation of trace elements of substances such as lead).

The conference’s interest in nanoparticles in cosmetics will be focused on methods to characterize nanoparticle ingredients with safety in mind.  The primary interest is in the use of nanoscale titanium dioxide and zinc oxide in sunscreen products.

T he upside to the attention FDA is giving to nanoparticles in cosmetics is that it begins a long process of deciding how to determine safety, whether to regulate, and whether new regulations for nanoparticles in sunscreens and other cosmetics will be necessary.  Recently, the FDA postponed the effective date of new labeling for sunscreens until after the current summer season.  Perhaps information learned about nanosubstances in sunscreens will make its way onto those new labels, or at least some version of the labels in the future.

Another upside is the use of an international forum including not just regulators, but industry attendees and others to identify the issues raised by nanoparticles in cosmetics.  A theme of this blog has been the need for a “same-page” approach in the international commercial arena.

The downside is the long slog of regulatory information gathering and activity – and sometimes inactivity.  And it is altogether possible that the various jurisdictions will go their own ways in approaching the subject.

After the ICCR meets in July, I will report on the proceedings.  For access to the official announcement of the conference, and for information from the FDA on previous ICCR conferences, reports, and other materials, see

 http://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm

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Regulatory Confusion and the Need for Consistency

Posted Dec.15, 2011 under Chemicals, Environment, EPA, Government Agencies, Governmental Interaction, Health, International Nanoregulation, Regulation, Safety

ef_2009_345796_1 US CapitolFor those of you who are following this blog, I’ll apologize for letting nearly two months slip away since the previous post.  The reason has to do with my co-blogger, Eric Laury.  After passing both the Pennsylvania and New Jersey bar exams, Eric took a job in a law firm in Denver, which means he is now studying for the Colorado bar exam.  I have every reason to believe that Eric will resume writing for this blog after things settled down for him, but likely as an occasional blogger.  I congratulate him on his success and look forward to our continued collaboration.

Among this week’s news in the world of nanotechnology law is word that the U.S. government is in the grip of regulatory confusion.  If you’ve been reading this blog, that’s nothing new, but there now seems to be official consensus that there is no consensus.

This consensus on non-consensus was a major focus of a workshop in Washington on December 13 and 14 organized by the National Institute of Standards and Technology (NIST) and the American National Standards Institute (ANSI).  One of the themes of the workshop came from several participants, including EPA which noted that there is no agreement internationally on either toxicity testing protocols or the proper methodology for measuring release of nanoparticles into the environment.  A similar theme was pressed by the CPSC.  The chair of the Nanotechnology Panel of the American Chemistry Council echoed the concerns of the governmental agencies, emphasizing that industry needs to have clear rules to develop safe products.

Moreover, the participants expressed concern for the disconnect between the various sectors – government, business, and consumers – over the need for and type of regulation for the products of nanotechnology.

All well and good.  But this workshop has that déjà vu feeling.  Haven’t we been hearing this over and over for some time now?  It also has a certain circular logic to it, which goes something like this:  “Before we regulate, we need to know what the hazards are and what to regulate, but if we can’t agree on how to assess the hazards and what needs to be regulated, then we can’t regulate.”

 Think about it.

 The following article reported the events of the workshop:

Pat Rizzuto, Regulators Say They Lack Consensus-Based Standards for Key Aspects of Nanomaterials, 241 Daily Envt’l Rep. (BNA) A-8 (Dec. 15, 2011) (by subscription only)

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Proposed Disease Cluster Legislation: What’s Nanotechnology Got to Do With It?

Posted Jun.26, 2011 under Environment, EPA, Government Agencies, Governmental Interaction, Health, Regulation, Safety, Toxic Torts

capitol_building_

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

http://www.govtrack.us/congress/billtext.xpd?bill=s112-76

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White House Takes a Science-Based Approach to the Study and Regulation of Nanotechnology

Posted Jun.15, 2011 under Cosmetics, Drugs, Environment, EPA, FDA, Food, Government Agencies, Governmental Interaction, Health, Pesticides, Regulation, Safety, Statutes, Workplace

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

http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

 ●  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

http://www.epa.gov/pesticides/regulating/prepub-nanopest.pdf

 

The White House memo is available at

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf

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What’s New in Nanogovernance? A Brief View from All Sectors

Posted May.29, 2011 under Chemicals, Cosmetics, Environment, EPA, European Union, Government Agencies, Governmental Interaction, Health, Nanosilver, Pesticides, Regulation, Safety
usalawyerstoday.com

usalawyerstoday.com

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

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Balancing Innovation and Oversight – A Tall Order

Posted Apr.27, 2011 under Environment, EPA, Government Agencies, Governmental Interaction, Health, Regulation, Research, Safety

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

http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies.pdf

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Thinking Again about Nanoparticles and Asbestos

Posted Mar.29, 2011 under Asbestos, Environment, EPA, Governmental Interaction, Health, Litigation, Nanotubes, Products Liability, Regulation, Research, Safety, Toxic Torts, Workplace

asbestos-fibreEarlier, I wrote about some potential similarities between asbestos personal injury litigation and the litigation that is certain to come over nanoparticles and human health.  I will be writing on and off about this topic going forward as well.  I can’t emphasize enough the urgency of avoiding another disaster like asbestos litigation, which has clogged the courts since the 1970s.

For example, engineered nanomaterials are being placed into building materials.  In the first instance, these materials are being designed and manufactured in the primary workplace environment, thus potentially exposing workers to hazards about which little or nothing is known.  Another set of workers, those using the building materials in the secondary workplace, run the risk of exposure to potentially harmful substances.

The history of asbestos shows that the early studies were conducted on asbestos textile factory workers, but that meaningful studies on workers out in the field who were installing the materials lagged far behind.  Then, when the studies began to raise danger signals, the industry ignored those signals until the specter of mass litigation and government regulation forced recognition.  By then it was too late.

Nanomaterials present some of the same workplace issues, particularly when used in building materials.  The hazards of the primary workplace may be different from those in the secondary workplace.  Studies must be conducted on both types of environments.

Further, there is a third concern, which also mirrors the asbestos experience.  At some point down the line (years or decades), the anticipated life of the materials will expire, just as asbestos insulation materials have done.  At that point, degeneration of the materials could put nanomaterials into the environment to a degree that could endanger the safety of persons in the vicinity.

In the case of nanomaterials, do we know any of this for certain?  No.  But at the present time we know almost nothing about any of these safety issues.  In December, the National Institute for Occupational Safety and Health (NIOSH) proposed a workplace exposure limit for carbon nanotubes and nanofibers.  This is a start; but without hard data, it is really only a guess.  And it is not necessarily consistent with limits for other substances.

While the industries creating and using nanomaterials will likely take seriously the lessons of asbestos, more should be done up front to ascertain the seriousness and scope of the hazards that the materials may present.  Now is the time.  If the hazards outrun the studies, the finish line will be litigation.

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