Category: Safety

A Novel Idea – Improve Education!

Posted Jan.11, 2011 under Governmental Interaction, Health, Nanotoxicology, Regulation, Research, Safety, Workplace

nano 3On November 30, 2010, the American Industrial Hygiene Association (AIHA), in commenting on the draft 2010 strategic plan of the National Nanotechnology Initiative (NNI), recommended that nanomaterial safety be incorporated in graduate curricula.  AIHA lamented that many recent American graduate school degree recipients are ill-equipped to effectively assess the industrial health and safety risks of nanomaterials in industrial settings.  And, as AIHA pointed out, many recent grads have already had significant exposures to nanomaterials.

 The beginnings of a solution are relatively simple.  AIHA has recommended that the consortium of federal agencies involved in implementing the NNI strategic plan develop guidelines for graduate research programs.  The draft plan itself contains suggestions for actions by the National Institute for Occupational Safety and Health (NIOSH), such as investigation of a broad spectrum of nanomaterials and recommendation of safe exposure limits.

 The full solution may be much more complex, however.

 This issue reminds me of a broader concern that receives news coverage from time to time.  Maybe not often enough.  We frequently hear that the United States continues to lag behind the rest of the developed world in student science performance.  The Organization for Economic Cooperation and Development (OECD), of which the United States is a member, keeps track of such things.  In the most recent rankings of science performance among OECD nations (updated rankings due soon), the United States continued to be below average and ranked 22.

 The bar is being set a little higher for science performance in the schools with the proliferation of nanotechnologies and their highly sophisticated use in many products and medical procedures.  AIHA has said that many newly minted scientists “are unaware of the fundamentals of nanomaterial safety.”  Beyond assuring that nanomaterial safety fundamentals are taught and implemented in graduate programs, nanotechnology and nanomaterial safety should become a part of the basic science curriculum at every relevant level of American education.

 Source:

Greg Hellman, Industrical Hygienists Say Nanomaterial Safety Should be Part of Graduate Curriculums, BNA Chemical Regulation Rptr, Nov. 30, 2010

 Some information on OECD rankings is available at

http://ourtimes.wordpress.com/2008/04/10/oecd-education-rankings/

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TSCA Regulation Moves Forward – Slowly

Posted Nov.29, 2010 under Bionanotechnology, Chemicals, Cosmetics, Environment, EPA, European Union, Governmental Interaction, Health, Nanosilver, Nanotubes, Pesticides, Regulation, Safety, Statutes

nano 3On November 22, 2010, EPA submitted a proposed rule under Section 8(a) of TSCA to the Office of Management and Budget for its review.  The proposed rule includes reporting requirements for manufacturers of nanoscale materials and could be published in the Federal Register for public comment in December.

 The first of three proposed rules expected in 2011, this proposed rule would require disclosure of information on manufacturing and processing, as well as on exposure and release of nanomaterials.  This is merely a prelude to any actual regulation of the industries and processes making use of nanotechnology.  It is a critical step toward reducing risks to human health and the environment.  But it also highlights the fact that regulation of nanomaterials is a long, slow process that may not yield satisfactory results for many years.

 In September, an EPA representative told members of the nanomaterials industry, “We are at the stage where we really don’t have a clear idea of how to manage risk. . . . The more information we can collect through regulation—on what is being manufactured, toxicity data, and the development of the proper protocols for measuring toxic effects of the nanomaterial—the better off we will be to manage the risk and demonstrate to the American people we have a handle on the issue.”

 The current proposal can be seen as early steps in risk assessment, but far from the risk management eventually envisioned by EPA.

The European Union may be further ahead.  On November 24, 2010, the European Parliament voted to extend its restriction on many hazardous substances to most electrical and electronic products, but stopped short of imposing a restriction on nanosilver and carbon nanotubes.  Observers say that it is likely that these substances will be incorporated into the law when the law comes up for review in three years.  Thus, the EU may be heading toward management of the risks of nanotechnology more quickly than the U.S.

 Even so, why so slow?  Regulators should get moving on resolving obstacles such as the scope of nanoscale definitions, deciding how much data is enough before effective regulation may be accomplished, and whether small businesses warrant an exception to regulation.

 

Sources (all by BNA subscription):

225 BNA Daily Env’t Rptr. A-6 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr. 1149 (Nov. 24, 2010)

34 BNA Chemical Reg. Rptr 960 (Oct. 4, 2010)

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Are Nano Checks and Balances in the Near Future?

Posted Nov.09, 2010 under Artificial Molecular Machines, Bionanotechnology, Chemicals, Cosmetics, Environment, EPA, European Union, Food, Governmental Interaction, Health, International Nanoregulation, Pesticides, Regulation, Research, Safety
www.h20technologies.com

www.h20technologies.com

The U.S. National Nanotechnology Initiative (NNI) Strategic Plan Draft was posted at http://strategy.nano.gov for public comment on November 1, 2010.  The NNI was launched in 2001 with 8 agencies and now consists of the nanotechnology-related activities of 25 agencies.  Fifteen of these agencies have R&D budgets related to nanotechnology.

In reflecting on the 10-year history of U.S. nanotechnology research and development, the NNI Draft highlights its work as having “established a thriving nanotechnology R&D environment, laid the crucial groundwork for developing commercial applications and scaling up production, and created demand for many new nanotechnology and manufacturing jobs in the near-term.”  (Draft, p. 1)  Looking to the future, the NNI notes that nanotechnology R&D is “far from full realization.”  (Draft, p. 2)  The goals of the NNI continue to be broad:  continued development of R&D; developing the technologies into products for commercial and consumer use; and developing the physical and human resources to achieve these goals.

Goal 4 of the Draft Strategic Plan is “Support responsible development of nanotechnology,” including the twin goals of understanding and managing the risks of the technologies.  Among the NNI participating agencies in 2010 are EPA, FDA, National Institutes of Health (NIH), and National Institute for Occupational Safety and Health (NIOSH).

The NNI Draft Strategic Plan focuses directly on the benefits of nanotechnology, rather than the risks.  But many of the participating agencies – and many more – need to be involved on the risk side of the proverbial risk-benefit analysis.  This is happening, as reported previously in posts on this blog ranging from FIFRA to TSCA to the FDCA.

 But equally important is the need for communication and coordination on both the benefits and risks of nanotechnology.  And that extends beyond governmental regulation to businesses and nongovernmental organizations (NGOs).

Aside from governmental action, various voluntary initiatives and partnerships have emerged.  A report out of the Woodrow Wilson  International Center for Scholars, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight:  Charting a Path,” gives an overview of the initiatives – some publicly sponsored, some developed by business, and some representing joint business-NGO partnerships.  These initiatives have the common, though separate, goal of developing a strategy to oversee environmental, health, and safety risks raised by nanomaterials.  The report is available at http://www.nanotechproject.org/publications/archive/voluntary/

Three initiatives discussed in some detail in the report are:

 ●  “Nano Risk Framework,” jointly developed by duPont and the Environmental Defense Fund (EDF)

 ●  “Responsible Nano Code,” sponsored by stakeholders from the United Kingdom

 ●  “Nanoscale Materials Stewardship Program,” developed by EPA

 The report critically analyzes these specific initiatives – as well as others more generally – and concludes that they have a welcome role in the future of nanotechnology safety and health efforts.

The ideal world does not exist, of course.  But in this world, a strategy that incorporates the risks and benefits of these developing technologies and brings together as many varied interests as possible representing all affected parties, including the environment, is warranted.  It can provide needed checks and balances along the way.

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Will Nanoparticles Be the New Asbestos?

Posted Oct.18, 2010 under Environment, Health, Litigation, Nanobiotechnology, Nanotoxicology, Nanotubes, Products Liability, Research, Safety, Toxic Torts
http://www.techwall.org

http://www.techwall.org

The course of asbestos litigation is well known, as is the fact that there appears to be no end in sight.  Is nanotechnology producing the next asbestos?  Some groups are working to prevent nanoparticle litigation from following in the steps of asbestos litigation.

In 2009, the United Kingdom’s Institute of Occupational Medicine (IOM) issued a report asking the question whether High Aspect Ratio Nanoparticles (HARN) – most notably, carbon nanotubes – create some of the same health risks as asbestos fibers.  The fiber-like features of HARN, although man-made rather than naturally occurring, may or may not interact with the human body in asbestos-like ways. The importance of determining whether HARN raise similar health risks cannot be overstated.  These issues have yet to be resolved, with potential health risks lurking in the interim.  As is often the case, development of new technology has flown past the scientific community’s ability to determine and assess the technology’s risks.

Looking back at the history of asbestos litigation, some burning questions need resolution sooner rather than later.  For example:

●  Do HARN fibers remain in vivo or do they degrade before disease processes are initiated?

●  If HARN are shown to persist in the body, what is the likely impact on workers?  In the asbestos context, the impact was seen in thousands of workers who developed debilitating progressive obstructive lung disease and/or malignant mesothelioma.  Do HARN have the capacity to produce similar health problems?

●  Even if HARN do not appear to behave directly like asbestos fibers, could HARN cause other, unknown, adverse health effects?

●  What broader impact might HARN have outside the workplace, including consumer and environmental exposures?

Are we headed down the same litigation road with HARN that we traveled with asbestos?

The asbestos litigation debacle in the United States began modestly enough with workers’ compensation claims, which were first denied and eventually routinely paid.  When asbestos insulation workers successfully brought actions against the manufacturers of the products they used in the workplace, the litigation expanded exponentially and has continued to challenge the court systems.

How can we avoid another asbestos?  The answer begins with research, knowledge, and awareness.

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Nanolessons from the BPA Debate

Posted Sep.12, 2010 under Chemicals, Cosmetics, Drugs, Environment, EPA, Food, Health, Nanotoxicology, Pesticides, Research, Safety

Lab beakerThe New York Times recently published an article reviewing the state of research on the adverse health effects of the chemical bisphenol-A (known as BPA), which is found in plastic used for many consumer products.  BPA is a hot topic right now, both in the health and political arenas.  The reason is that BPA has been shown in some studies to mimic the hormone estrogen, which is considered an “endocrine disruptor” capable of causing harm to humans.  But whether BPA, in mimicking estrogen, actually causes harm has yet to be determined.

Some of the concerns about conducting and interpreting the health studies on BPA are instructive as we go forward with studies on the health effects of nanosubstances.

 Some particularly instructive observations in the article are:

 1.  Some scientists have noted the conflicting results in existing studies.  Some have suggested that the inconsistent results are, at least in part, a function of different laboratories studying the chemical in different ways:  “Animal strains, doses, methods of exposure and the results being measured – as crude as body weight or as delicate as gene expression in the brain – have all varied, making it difficult or impossible to reconcile the findings,” according to the article.

 2.  Even when experiments appear to be conducted identically, the interpretations may vary among scientists of different disciplines, using different standards.

 3.  In studying BPA and many other chemicals and substances (including nanosubstances), it is particularly important to be aware of the different ways the substance may act on adults, children, and fetuses exposed in utero.  Moreover, adverse impacts on fetuses include not just fetal development; a person born with fetal exposure could develop future exposure-related health problems during his or her lifetime.

 4.  Private laboratories tend to be the first to use new advances in research, while the government researchers tend to lag behind.  It is not clear which type is likely to yield the more accurate results – the new techniques or the tried-and-true techniques.

 In thinking about studying the health effects of nanotechnology-based substances, it is important to keep in mind these points.  Because nanosubstances are available for so many and varied uses, determining the actual health impacts will take time, money, and a coordinated effort among scientific disciplines.

Now is the time to move forward with just such a coordinated effort.

 The article on BPA is available at:

http://www.nytimes.com/2010/09/07/science/07bpa.html?th&emc=th

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The Gulf Spill and 9/11: What These Disasters Can Teach Us About Studying the Health Impacts of Nanotechnology

Posted Sep.02, 2010 under Chemicals, Cosmetics, Drugs, Environment, EPA, Food, Governmental Interaction, Health, Nanomedicine, Nanotoxicology, Pesticides, Research, Safety
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What do the Gulf oil spill, the attacks on the World Trade Center on September 11, 2001, and nanotechnology have in common?  On the surface, it would seem to be nothing.  But all three involve responses to potential health and environmental threats that are instructive about how we as a society respond to such threats.  Collectively, they raise some important issues regarding how our society views health and environmental risks in general.

 Don’t get me wrong.  In no way am I suggesting that nanotechnology is comparable to the disasters at Ground Zero or in the Gulf.  Rather, I am asking that you look at how government and funded research institutes manage long-term health and environmental effects that occur as a result of chronic low-dose exposures over time.  The potential health hazards of nanotechnology fall into the long-term category.  We don’t expect to see any acute health problems associated with nanotechnology, but we should be concerned about long-term exposures, and existing efforts to study the effects should be expanded.

 Let’s contrast what happens when there is a disaster.

 On August 19, 2010, administration officials reaffirmed their commitment to the recovery and restoration of the Gulf in the aftermath of the Deepwater Horizon oil rig explosion and the subsequent movement of oil into the waters and the ecosystems of the Gulf.  The media outlets have been full of video, photographs, and articles about the efforts of many organizations, companies, and governmental entities to clean up and minimize the potential harm to natural resources, the environment, and all forms of life.

 Not so long ago, something similar went on at Ground Zero in the aftermath of the collapse of the World Trade Center towers following the 9/11 terrorist attacks.  Early on, the focus of efforts at Ground Zero was on the search for survivors.  On September 29, the focus turned to recovery and cleanup, including removal of debris.  But even before that date, the federal, state, and local governments were engaged in managing the environmental disaster that resulted from the release of hazardous substances into the air, including asbestos, silica, lead, mercury, polycyclic aromatic hydrocarbons (PAHs), dioxin, polyvinyl chloride (PVC), Freon, and polychlorinated biphenyls (PCBs), to name a few.  Workers from FDNY, NYPD, Port Authority of New York and New Jersey, emergency medical personnel, and a host of volunteers worked at the site.

 It is easy to assign massive resources to the acute phase of a disaster, but much harder to sustain interest and funding as time goes on.  Eventually the media will move on to other stories now that the Macondo well is just about sealed, as it eventually did when the cleanup at Ground Zero was completed.  Funds have been established to make payments, lawsuits commenced.  But what lingers is the reality of long-term health effects that could emerge over time – ecosystem damage or cancer or other health risks.  Society has a certain myopia about such things.  Perhaps it is human nature to not want to think about the health problems that could arise years down the line.

 The protracted task of developing valid scientific studies on the health effects of any exposures, including nanoparticles, and interpreting the results is as essential as responding to the acute phase of a disaster.  Disasters like the Gulf spill and 9/11 suggest a kind of false dichotomy – that acute harms are more worthy of recognition in the law than chronic long-term harms.  The long-term harms may seem less urgent, but there is nevertheless an urgency about them as well.

 For example, following the Exxon Valdez oil spill in 1989, no concerted effort was made to assess the health effects of the cleanup on workers.  Years later, surveys told the story of respiratory and neurological illness.  This month, the National Institute of Environmental Health Sciences announced it would begin a study of the potential health effects of exposures of workers and residents as a result of the Gulf oil spill.  Even in the 9/11 context, where health screenings of Ground Zero responders have been ongoing since 2002, and a data base has been established, acceptable compensation has come nearly a decade after the disaster.  The law is slower to recognize the harms from chronic exposures, and slower to act to both compensate the injured and prevent further harm.  Clearly, some of this is a result of symptoms and other harms emerging over time.  But this is all the more reason to be vigilant and investigative from the start.

 Far from the spotlight of a high-profile disaster, and in the absence of a clearly exposed population to screen, studies on the health and environmental effects of exposures to substances about which we know little is essential.

 As mentioned, nanotechnology is not a disaster.  Far from it.  It is a means for creating better medical therapies, making some of our technology perform better, and offering consumers desirable features in everyday products such as textiles and cosmetics.  But this does not eliminate the need to make a concerted effort to study the long-term health and environmental effects of nanoparticles and nanomaterials.  No matter how long it takes; no matter how far out of the spotlight.

 For those interested in knowing more about the toxic aftermath of Ground Zero, see my article, Toxic Torts at Ground Zero, 39 ARIZ. ST. L.J. 383 (2007).

On the need for studies of the health impact of the Gulf spill, see

Gina M. Solomon & Sarah Janssen, Health Effects of the Gulf Oil Spill, J.A.M.A. (Aug. 16, 2010), available at http://jama.ama-assn.org/cgi/content/full/jama.2010.1254v1

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More New Interpretations of Federal Statutes: Pesticides

Posted Aug.15, 2010 under Chemicals, Environment, Governmental Interaction, Health, Regulation, Safety, Statutes
www.singularityhub.com

www.singularityhub.com

I previously discussed the recent efforts to expand and revise the interpretations of the Toxic Substances Control Act (TSCA) and the Food, Drug and Cosmetic Act (FDCA) to reach nanotechnology.  Simultaneously, efforts have been ongoing to expand and revise the interpretation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – the federal pesticide statute – to similarly encompass nanotechnology.  In particular, the proposed interpretation would require any nanoscale material used in a pesticide to be considered a new substance, and subject to adverse effects determinations in place for new substances, even if a non-nanoscale form of the same material has already been in a product registered under the act.

 This proposed FIFRA interpretation is clearly part of the trend to bring nanotechnology under existing regulations and confirm the authority of existing agencies to make determinations about the safety of nanomaterials.  But is this a good idea?

 One bone of contention in the proposed FIFRA interpretation is the proposed application of Section 6(a)(2) to require pesticide manufacturers to report the deliberate inclusion of intentionally produced nanomaterials in their products.  Section 6(a)(2) is often referred to as the “adverse effects” section of FIFRA.  The implication, therefore, would be that nanomaterials would be presumed to have adverse effects.  EPA says otherwise, however, stating that the proposed interpretation would emphasize data collection, while also including adverse effects.  EPA also says that the proposed interpretation would reach substances other than nanomaterials.

 The nanotechnology-related industries have reacted with sharp criticism of the proposed interpretation, though they continue to recognize that regulation is inevitable.  Several industry groups, most notably the American Chemistry Council, have expressed concern that the proposed interpretation would “stigmatize” all uses of nanotechnology in pesticides, especially because it would use the “adverse effects” section of FIFRA as the primary means of regulation.  They say other sections of FIFRA would be more neutral and less stigmatizing.  This may be the case and deserves further consideration.  On the other hand, if those other sections do not permit EPA to conduct the kind of safety analyses permitted under Section 6(a)(2), there would be no advantage to the public in applying the other sections instead.

 Furthermore, industry groups have rallied around the general debate over the health and safety of nanomaterials.  FIFRA officials have cited existing studies tending to show risks to human health and the environment from nanomaterials.  An industry group, the Silver Nanotechnology Working Group, has claimed that concerns for health and the environment are overstated, insisting that long-term data show nanomaterials to be safe.  This debate seems to be premature.  It makes little sense at such an early juncture – when some data exists, but more is clearly warranted – to argue that minimal regulation is the best way to go.

 Another major concern of industry has been the costs of preparing and producing the data that would be required under the proposed interpretation.

 (The reactions of government officials and industry mentioned above were reported in:  Pat Rizzuto, EPA Developing New Interpretation, Policy on Pesticide Law for Nanoscale Ingredients, 121 Daily Env’t Rpt. (BNA) B-1 (June 25, 2010).)

 As I’ve said before, there are positives and negatives to the trend of broadening the interpretation of existing federal statutes to include nanotechnology.  Some may be:

 Positives:

●  No need to wait for Congress to act

●  Officials are already familiar with the statutes, so start-up would be minimal

●  Health and environmental concerns would start to be addressed without substantial delay

●  Nanotechnology’s discrete uses may best be regulated within statutes and by agencies that are more specialized, each dealing with different uses

 Negatives:

●  Is piecemeal regulation the best way to go, or is wholesale regulation a better approach?

●  Industry’s concerns may be ignored as the existing agencies go forward with the new interpretations

●  Potential conflicting decisions and interpretations among the various federal statutes

●  It is not at all clear that existing regulation, even if reinterpreted, reaches all of the unique issues presented by nanotechnology

 ***These concerns, and others, should be weighed in determining the best way to regulate nanotechnology.***

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Following the TSCA Bill

Posted Aug.01, 2010 under Chemicals, Environment, Governmental Interaction, Health, Nanotubes, Regulation, Research, Safety, Statutes
www.h20technologies.com

www.h20technologies.com

I previously commented on the House bill that would amend the Toxic Substances Control Act (TSCA) by updating it to include more substances, more disclosure, and expedited review by EPA.  On July 29, 2010, the House Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection held a hearing on the bill (H.R. 5820).  Certain themes emerged from this hearing.

 Theme 1:  The Economy.

 ●  Jobs.  All agreed that a major goal should be to avoid the loss of more jobs.  This may mean that legislation updating TSCA may proceed more slowly than the current bill would require.  This, in turn, would stall regulation of nanotechnology through TSCA.

 ●  Expense and difficulty of compliance.  Cal Dooley, President and CEO for the American Chemistry Council, representing the large chemical manufacturers in the industry, expressed concern that the increased burden and costs on manufacturers, and the longer time frame for EPA to review submissions, would result in a delay in bringing new chemicals to market and would force manufacturers to other countries.  He stated:  “We would export innovation and jobs instead of products.”

 ●  Foreign competition.  This theme was especially emphasized by Beth D. Bosley on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA), representing small chemical manufacturers.  She argued that H.R. 5820 “poses overwhelming challenges for the industry,” including the loss of innovation and chemical manufacturing to foreign markets.  She feared that the “substantive loss of high-paying manufacturing jobs will result.”

 Theme Two:  Defining a Scientific Standard

 ●  The Hearing indicated that this is certain to be a sticking point in the debate to come over H.R. 5820.

 ●  Cal Dooley of the American Chemistry Council stated:  “[T]he safety standard as established in this bill sets such an impossibly high hurdle for all chemicals in commerce that it would produce technical, bureaucratic, and commercial barriers so significant they would be the law’s undoing.”

 ●  In contrast, Richard Denison, a Senior Scientist of the Environmental Defense Fund, praised H.R. 5820 for assuring that “the best and latest science” be used for risk-based safety determinations.

 Theme Three:  Impact on Industry Innovation

 ●  Some witnesses presented testimony that H.R. 5820 would spur industry innovation by raising U.S. chemical standards to a level that would allow American companies to compete in a global economy where disclosure of information has become important.

 ●  In contrast, as the representatives of the chemical industry argued, concerns exist that innovation in the chemical industry will be exported abroad and that proprietary information will be compromised.

 What about nanotechnology?

 Though not a pervasive theme, the Hearing had some mention of nanotechnology.  Richard Denison, a Senior Scientist with the Environmental Defense Fund, said the following about the current state of nanotechnology regulation:

 “EPA has had little choice but to resort to pleading with the emerging nanotechnology industry to provide, through a voluntary program, the most basic information EPA feels it needs to decide how best to regulate these materials – only to see a level of participation best described as paltry.  Such materials can by no means be assumed to be benign; for example, one class of nanomaterials – multi-walled carbon nanotubes – behaves in a manner that is ominously similar to asbestos.”

 http://energycommerce.house.gov/documents/20100729/Denison.Testimony.07.29.2010.pdf

 Regulation of nanotechnology is coming, one way or another.  It is time to have a full discussion and debate on how best to achieve that, for the interests of the public, workers, and industry.  Currently, it appears that debate on the bill will resume in earnest when the next Congress convenes.  Let’s hope that the debate addresses these critical questions.

 Transcripts and video from the hearing may be accessed at

 http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2095:hearing-on-hr-5820-the-toxic-chemicals-safety-act-of-2010&catid=129:subcommittee-on-commerce-trade-and-consumer-protection&Itemid=70

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A Tale of Two Bills – Nudging Toward Nanoregulation

Posted Jul.27, 2010 under Cosmetics, Environment, Governmental Interaction, Health, Products Liability, Regulation, Research, Safety, Statutes

prod liab imageIt’s fair to say that the United States has not yet tiptoed into the waters of regulating nanotechnology directly.  Rather, new efforts at regulation of chemicals and consumer products tend toward indirect regulation.  That is, these efforts would strengthen and expand existing federal regulation.  Two examples are recent bills introduced in the House of Representatives that would amend the Toxic Substances Control Act (TSCA) and the Food Drug and Cosmetic Act (FDCA) for substances and products that may or may not contain nanomaterials.  As discussed in a previous entry in this blog, placing nanomaterials under the same regulatory standards as non-nano substances is a subject that requires discussion on its own.

 Is the current trend toward indirect regulation a good idea?  It’s certainly easier and more efficient in the short run to promulgate broad regulations that encompass a variety of substances and uses, and to amend existing statutes.  And there is no doubt that these statutes needed updating to reflect scientific advancement and new risks.  But there is a danger that regulators – and the public – would be left with the impression that once these statutes have been updated, all substances are sufficiently regulated.  With the products of nanotechnology being so diverse, it is likely that many substances would slip through the cracks of the new legislation.

 Let’s look at the two recently introduced bills.  The Toxic Chemicals Safety Act of 2010 (H.R. 5820) would amend TSCA by requiring the chemical industry to provide EPA with minimum essential data on chemical characteristics, toxicity, exposure, and use, whereupon EPA would undertake an expedited process to reduce exposures to toxic substances in the population.  An important feature of the bill provides for public disclosure of non-confidential and otherwise non-exempt information.  The text of the bill may be found at

http://energycommerce.house.gov/documents/20100722/HR5820.pdf

The current text of TSCA is at 15 U.S.C. §§ 2601 et seq.

The other recently introduced bill is the Safe Cosmetics Act of 2010 (H.R. 5786), which contains provisions for protecting consumers from carcinogenic and other toxic ingredients in certain previously unregulated household products, such as perfumes, shaving creams, shampoos, and deodorants.  Like the proposed TSCA amendment, a major purpose of this bill is to update the existing FDCA and its regulations and to disclose the information regarding hazards to the public, in this case primarily through product labels.  Currently, the cosmetics industry is mostly self-regulated, and members of the industry have complained that this new bill lacks appropriate standards and would place an undue burden on the FDA.  Instead, the industry has proposed its own new requirements.

 H.R. 5786 also references nanoparticles, clearly indicating that nanotechnology was intended to be part of the amendment.  For example, Sec. 618(a)(5) requires that cosmetic manufacturers submit various information to the FDA, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.”  Sec. 618(e) goes on to authorize the Secretary of Health and Human Services to require that

 “(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.”

 The text of this bill may be found at

http://www.govtrack.us/congress/billtext.xpd?bill=h111-5786

 Both bills seem to be a step in the right direction.  But in the context of nanotechnology, complicated questions persist.  For example:

●  Would these updated statutes reach the products of nanotechnology as effectively as they would reach substances and products that have no nano-contents?

 ●  Because benign substances may behave differently at the nanolevel, would such regulation miss potential toxic effects?

●  What science would be behind the decisions to disclose toxicity?

●  Should nanotechnology be regulated separate from chemicals and consumer products?

● Which alternative makes the most sense?

 These and others are the questions that Congress and regulators – and all those who may be potentially exposed – need fully discussed in the coming months and years.

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Standardizing Nanodefinitions

Posted Jul.07, 2010 under Governmental Interaction, Nanobiotechnology, Nanotoxicology, Regulation, Safety, Statutes
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Let’s face it:  Industry would just as soon be left alone.  But in this modern society, that’s simply not possible.  Government regulation is necessary to advance policy goals, which include the safety and health of the general public.  Industry recognizes this, of course, and wants to be able to undertake its activities knowing what the government requires (mandatory) and expects (voluntary) of it.  This is even more critical in the world of global commerce, where an industry may be subject to varying – and sometimes even contradictory – standards in different countries.  In the United States alone, separate state regulation of nanotechnology could lead to confusing and incompatible standards.

 Isn’t the nanotechnology industry entitled to a uniform set of definitions to be able to interpret and apply regulatory standards?

 This is the gist of an article that appeared recently in the BNA Daily Environment Report at

Pat Rizzuto & Bill Pritchard, Industry Developing Nanoengineered Goods Frustrated by Regulators’ Lack of Definitions, 93 Daily Envt. Rpt. (BNA) B-1 (May 17, 2010) (available by subscription)

In recent months, various bodies have been attempting to address this issue, but it is likely that nothing representing a consensus may emerge soon.  Yet, there may be some urgency to the task.  As reported in the article, one industry executive in a company developing electronics using nanomaterials said that regulatory certainty is necessary in determining whether to move its operations from the United States to China.  The article went on to discuss the efforts that many countries are making to develop standard definitions for nanomaterials.  This, of course, is only a precursor to regulation.  There is currently no agreement as to what the size of a particle means in the regulatory world and whether a workable definition should be based solely on size.

The International Organization for Standardization (ISO) hopes to have a set of definitions by the end of the year.  The article goes on to indicate that a coalition of businesses may become involved in developing standardized definitions.

 The European Commission’s Joint Research Commission (JRC) released a report July 2, 2010, emphasizing the need for a uniform definition of the term “nanomaterial” and providing “practical guidance for a definition for regulatory purposes.”  The report recommends the following criteria, suggesting that a definition:

  •  only concern particulate nanomaterials,
  •  be broadly applicable in EU legislation, and in line with other approaches worldwide,
  • use size as the only defining property.

European Commission, Joint Research Centre, Considerations on a Definition of Nanomaterial for Regulatory Purposes 5 (2010).

 The JRC report may be accessed at

 http://ec.europa.eu/dgs/jrc/downloads/jrc_reference_report_201007_nanomaterials.pdf

 Clearly, we have not yet arrived at the point of being able to speak the same nanolanguage around the world.  Every nanostep helps, however.  But time is of the essence.  And consensus is crucial.

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