Category: Government Agencies

National Nanotechnology Initiative’s Ongoing Strategizing

Posted Jun.17, 2013 under Environment, Government Agencies, Government standards, Health, National Nanotechnology Initiative, Regulation, Research, Safety

nano 3The National Nanotechnology Initiative (NNI) recently held a Stakeholder Workshop for the purpose of assessing and strategizing in anticipation of the next version of the NNI Strategic Plan, a draft of which is due in late 2013 or early 2014.  Stakeholders from industry, government, and academia attended the workshop.  Participants considered questions related to technical challenges; commercial nanotechnology; environmental, health, and safety considerations; infrastructure needs; and ethical, legal, and societal implications of nanotechnology.

On the subject of environmental, health, and safety considerations, one report from the workshop indicated that NIOSH officials have recommended folding these matters into the other goals, rather than maintaining a separate approach.  The officials noted that of the $1.65 billion in federal funding allocated in FY2013 for nanotechnology research and development, environmental, health, and safety initiatives constituted only 7.6% of those funds.

Some of the other issues addressed, according to the report were:

1.  Improving communication among researchers.

2.  Balancing availability of research with confidentiality of proprietary information.

3.  Developing a common dose metric for research.

This news report may be found by subscription at:

Robert Iafolla, Include Safety, Environmental Concerns in Strategic Plan, Nano Researcher Say, 115 BNA Daily Env’t Rep. A-8 (June 14, 2013), available at

http://www.bloomberglaw.com/document/XE9G8OHO000000?campaign=bnaemaillink&issue=20130614&jcsearch=bna%2520a0d9h7q4n9&js=0&sitename=bna&subscriptiontype=bnaden#jcite

 

Whatever steps may be necessary to ensure that environmental, health, and safety concerns are at the forefront of the discussion about nanotechnology should be made a priority.

 

A detailed presentation of the Questions for Stakeholders for discussion at the 2013 NNI Strategic Planning Stakeholder Workshop, with further links, may be found at:

http://nano.gov/sites/default/files/questions_for_stakeholders_final_numbered.pdf

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Moving Toward Consistent Health Data

Posted May.08, 2013 under Carbon nanotubes, Environment, Government Agencies, Health, Nanotoxicology, Research, Safety, Workplace

Lab beakerOne of the hallmarks of scientific knowledge is the ability of researchers to replicate results.  This has eluded scientists studying the health effects of exposure to nanomaterials for a variety of reasons.  Among the factors are:  the unavailability of standardized engineered nanomaterials for testing; differences among the many manufacturers of nanomaterials; lack of standard protocols; and variations in toxicity among particles due to the way the particles behave in certain situations. 

To attempt to resolve these problems, dozens of researchers from universities and NIOSH participated in what has been called the NanGo Consortium to conduct health studies on engineered nanomaterials using the same materials and developing standard protocols.  The program was developed by the National Institute of Environmental Health Sciences (NIEHS).

The inter-laboratory, multi-investigator Consortium defined some of the challenges it faced as follows:

“In addition to dose, there are multiple factors that influence the toxicity of ENMs, including surface characteristics, charge, and shape. Size alone is a major determinant as many bulk materials that are relatively inert become toxic when produced at the nanoscale. . . . Determination of which ENMs will present the greatest potential threat to human health depends on relative toxicity, and on the potential for exposure.”  (pp. 5-6)

The Consortium conducted two broad sets of studies.  The first involved rats and mice exposed to carbon nanotubes and titanium dioxide, and measured pulmonary inflammation.  The Consortium concluded:  “The results presented and discussed herein demonstrate that a standard protocol can be used across multiple laboratories to yield similar results in the pulmonary inflammatory response.” (pp. 6-7)  The researchers are optimistic that with this start, there will be opportunities to determine the impact that exposure to nanomaterials may have on human at the preventive stage.

The second study examined the effects of carbon nanotubes, titanium dioxide, and zinc oxide in vitro in laboratory container studies.  The Consortium noted:  “A significant finding of this study was that the development of harmonized in vitro assay protocols made it possible to achieve reproducible results among different laboratories.” (p. 16)  This study, the Consortium concluded, “provides new information on the relative in vitro bioactivity of a large group of diverse ENM that can be used to inform future strategies for in vitro testing and predicting in vivo outcomes.” (p. 6)

These studies move researchers in the direction of being able to replicate results and ultimately draw reliable conclusions about the potential health hazards of exposure to nanomaterials, leading to effective regulation.

The NIEHS NanoGo Consortium reports are available at

http://ehp.niehs.nih.gov/wp-content/uploads/121/4/ehp.1205693.pdf

http://ehp.niehs.nih.gov/wp-content/uploads/121/4/ehp.1306561.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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Checks and Balances

Posted May.24, 2012 under Cosmetics, Courts, Environment, FDA, Food, Government Agencies, Health, Litigation, Regulation, Safety

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Sometimes the Government  just might work as it was intended.

In an earlier post, I reported on a lawsuit brought by a coalition of environmental and consumer safety groups requesting declaratory and injunctive relief under the Administrative Procedure Act to force the FDA to respond to a 2006 petition seeking action by the agency to assure the safety of members of the public exposed to nanomaterials, particularly nanoparticles in sunscreens.  On May 14, 2012, the coalition voluntarily dismissed its action, International Center for Technology Assessment v. Hamburg, a case that had been brought in federal court for the Northern District of California (No. 11-6592).

In other posts on this blog, I have reported on the draft guidances recently issued by the FDA on the safety of nanomaterials in food, food packaging, and cosmetics, as well as the upcoming International Cooperation on Cosmetics Regulation (ICCR), to be hosted by the FDA.  The coalition has withdrawn its lawsuit because the FDA has in fact finally responded to the earlier petition by issuing the draft guidances.  Although attorneys for the coalition have emphasized that the FDA’s response does not propose all the relief the coalition sought in its lawsuit, at the present time the FDA is showing interest in the safety of engineered nanomaterials in products within the agency’s jurisdiction.  The lawsuit had sought, among other things, regulation of these nanomaterials.  But the FDA guidance documents made recommendations for voluntary measures by industry, not new regulation.  This, of course, leaves open the possibility of a future lawsuit challenging the steps taken – or not taken – by the FDA in furtherance of the safety initiatives.

Our high school civics classes teach us that the tripartite structure of the federal Government is intended to allow the various parts of the Government to act as a check on the actions or inactions of the other parts.  In recent years, the judicial system has been much maligned.  In the matter of nanomaterials and the FDA, the threat of judicial intervention – being told by the courts what it should do – was likely one (and only one) motivation for the FDA to pursue a safety agenda for nanomaterials.  Instead of needlessly consuming resources at this stage, the coalition withdrew its lawsuit when the FDA moved forward on this subject.  So let’s give a hand all around for the Government working as it was intended.

The withdrawal of the coalition’s lawsuit was reported by

Pat Rizzuto, Coalition Withdraws Lawsuit Against FDA Following Agency’s Release of Guidance, 100 Daily Env’t Rep. (BNA) A-15 (May 24, 2012) (by subscription)

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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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Safer Food? A Spoonful of Caution May Go a Long Way

Posted Apr.22, 2012 under FDA, Food, Government Agencies, Health, Regulation, Safety

The FDA is on the move.  OnApril 20, 2012, it issued two draft guidances pertaining to the effects of nanotechnology on food and cosmetics.  In the cosmetics document, the FDA cautions safety and does little more.  But in the food safety document, the FDA moves in the directing of setting forth steps to be taken by food manufacturers to prove the safety of any food and food packaging using nanotechnology.  This heightened scrutiny for food products containing nanoparticles is an affirmative move on the part of the FDA to regulate nanotechnology.

 In the April 20 food safety guidance document, the FDA states:

 “The manufacturing process of a food substance is considered for the purposes of safety assessment only insofar as it may affect the properties and safety of the finished product.”

 The FDA goes on to say that “[t]he particle size distribution of a food substance may affect its ability to be absorbed by the body or to migrate from food packaging into food.”  The FDA explicitly states that manufacturing processes involving nanotechnology are included within the scope of the guidance document.

 The FDA states that it does not intend to judge any substances containing nanoparticles as being harmful – or not – but that use of nanotechnology in food may warrant certain assessments in determining the safety of the food.  The FDA states:

 “The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit examination. . . . For example, so-called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”

In other words, safety assessments in this area should be based on criteria for food substances in the nanometer range, and that could require new and different assessment methodologies.  However, the FDA has said that it will continue to regulate nanotechnology products under its existing statutory authorities, e.g. regulations on food color, additives, and packaging.

So does the guidance represent a step forward?  I think it does, if for no other reason than it explicitly recognizes that there may be discrete safety issues raised by the use of nanotechnology in food.  The guidance is not self-executing; it is currently available for public comment.  It represents a step in the right direction.  Its recommendations are preliminary, it seems to me.  Going forward, further consideration needs to be given to the issues it raises to determine if regulation specific to products using nanotechnology is warranted.  This should be only the beginning.

 

The draft guidance is Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, available at

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm300661.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=food%20ingredients%20and%20packaging%20guidance%202012&utm_content=2

 

 

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National Academies Report Available Now in Prepublication Copy

Posted Jan.29, 2012 under Environment, EPA, Government Agencies, Health, National Academies, Regulation, Research, Safety

white-house-south-2007-djIn my most recent entry, I noted that the National Academies would be releasing a report by the end of January that focuses on researching the health and safety aspects of nanotechnology.  The report, A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, was released January 25 in prepublication (i.e. uncorrected) copy.  A download, with significant restrictions, is available at http://www.nas.edu/catalog.php?record_id=13347

The study was initiated by EPA, which asked the National Research Council of the National Academies to conduct an independent study with the goal of developing a research strategy.  The report sets forth a conceptual framework for research on the environmental, health, and safety impacts of engineered nanomaterials (ENMs).

 The report explains why ENMs are difficult to place into a system of risk analysis.  In this blog, I’ve discussed the fact that the tiny size of nanomaterials gives them characteristics and risks different from the same materials in larger dimensions.  The report points out the vast diversity of characteristics of ENMs, as well as the fact that those characteristics may behave differently depending upon the environment in which the materials are located, including changing characteristics as the nanoparticles migrate.  Furthermore, the uncertainty about risks in all sectors – among developers, regulators, and consumers – demands a uniform strategy for assessing risks.  The report points out that little research has been done to date, notwithstanding the fact that even more complex ENMs will soon be available.

In other words, we needed a research protocol for identifying, analyzing, and managing the environmental, health, and safety hazards of ENMs yesterday.

One of the most significant points made in the report was the identification of “critical research gaps” that must be addressed.  Examples of some of the gaps:

More is known about inhalation risks than other routes of exposure because of earlier research on the effects of particle inhalation on the human body.

Basic information is lacking on the chemical and physical properties of the ENMs currently out there.

Gaps in knowledge exist regarding how ENMs move through and interact with the human body and in the environment.

How research is conducted in the laboratory must be modified to provide accurate information about the risks.  Standard testing protocols must be developed.

 The report goes on, and in the months to come I will look at various aspects of the report in individual posts on this blog. 

 Consistent with its findings, the report recommended changing the structure of the National Nanotechnology Initiative (NNI), which is too vast and fragmented to be effective in the ways that are critical.  The NNI’s authority covers essentially only coordination functions.  The report recommends that the entity that manages and implements the report’s strategy be one with “top-down” management and budget authority over the research.  This may not be the NNI at all.  The report notes that the NNI’s objective of promoting the development and uses of nanomaterials may conflict with its role in identifying and appropriately managing the risks of the technology.  Accordingly, the report recommends separating those objectives and restructuring the NNI.

It’s another beginning.  The follow-up report, in which the committee promised to assess progress toward the goals set forth in this report, isn’t due for a couple of years.  In the meantime, ENMs will continue to proliferate.  My recommendation is that all sectors exercise all due caution until more is known.

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Let the Lawsuits Begin

Posted Dec.28, 2011 under Cosmetics, Courts, Drugs, Environment, FDA, Food, Government Agencies, Health, Litigation, Regulation, Safety

prod liab imageIt had to happen sooner or later.  And it’s happening now.  A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA).  The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products.  The requested relief is detailed on pages 3-4 of the petition.  The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).

The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.

Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment.  This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure.  Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.

In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners.  There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.

The greatest significance of this lawsuit is that it puts nanotechnology into the courts.  This may be the first time, but it certainly won’t be the last time.

The 80-page petition is available at

http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf

The 2007 Nanotechnology Task Force report is available at

http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForceReport2007/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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The Bigger Picture: Thinking About Technology, Nano and Otherwise

Posted Sep.25, 2011 under Environment, Evidence, Government Agencies, Litigation, Products Liability, Supreme Court, Toxic Torts
usalawyerstoday.com

usalawyerstoday.com

Wondering where we’ve been for the past month?

 My summer was spent thinking and writing about technology – all sorts of technology.  It got me thinking about how technology has changed our lives and how it is poised to change all aspects of the law.  Let me share with you my summer projects, which go well beyond nanotechnology issues.  I hope it will enable me to put the legal issues of nanotechnology in a broader context going forward.

 1.  Neuroscience and Tort Law.  I and my co-author (and co-blogger) Eric Laury embarked upon a project more than a year ago to examine how the so-called “new neuroscience” will impact tort law.  By “new neuroscience” we mean mostly functional neuroimaging (fMRI and SPECT), but also any other neuroscientific methods to examine the human brain, including brain wave technology.   Our approach to this extensive law review article was both doctrinal (i.e. how the new neuroscience will eventually change the rules of tort doctrine) and practical (i.e. the problems of incorporating it in tort litigation, particularly under the rules of evidence).  We spent a lot of time predicting the effect that the new neuroscience will eventually have in the courtroom.  Professor Stephen Morse at UPenn Law School has pointed out that much of what we currently know as legal doctrine is based upon “folk psychology” – that is, what we believe causes people to act the way they do.  The new neuroscience will eventually change the law by changing our understanding of human behavior.

 2.  Cell Phones.  I also found myself writing a piece on cell phones and product liability.  In particular, I looked at whether actions claiming the telecommunications industry should be marketing cell phones with headsets to protect against the hazards of radio frequency (“RF”) emissions should be allowed, or whether they are preempted by regulations granting the FCC the authority to set radiation standards for cell phones.  The question, it turns out, it much more complicated than one might think and involves several federal statutes and regulations, including the two major statutes governing the wireless networks in this country.  The Supreme Court will consider a petition for certiorari in Farina v. Nokia, 625 F.3d 97 (3d Cir. 2010), early in the new term.  Even if cert is not granted, this topic likely will continue to make waves in the courts.  My article appears on the BNA subscription service at 39 Prod. Safety & Liab. Rep. (BNA) 871 (Aug. 5, 2011) and 26 Toxics L. Rep. (BNA) 949 (Aug. 10, 2011).  It also appears in U.S. Law Week at 80 U.S.L.W. 321 (Sept. 13, 2011).

 3.  Nanotechnology and the Environment.   I also wrote a short article to be published in the “Insight” section of the upcoming Natural Resources & Environment journal, which is the journal of the ABA Environmental Law Section.  My goal was to alert attorneys to some of the regulatory initiatives either in the works or in the pipeline.  The piece focuses on TSCA, FIFRA, OSHA, and foreign initiatives (EU, Australia).  It was interesting to look at the impact of nanomaterials exclusively from the environmental (outdoors and indoors) perspective.

So while I may not have been spending a lot of time blogging about nanotechnology and the law, I was busy getting the bigger picture on technology.

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