Category: Safety

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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EU Environmental Groups Call for “Nano Patch”

Posted Apr.19, 2013 under European Union, Health, International Nanoregulation, Regulation, Safety

nano 5This blog has regularly addressed the quandary of whether existing regulatory laws are sufficient to deal with the risks of the marketing and use of nanomaterials or if additional legal frameworks are necessary.  Three European environmental groups have determined that additional safeguards are indeed required. 

On November 13, 2012, the Geneva-based Center for International Environmental Law (CIEL), Friends of the Earth Germany (BUND), and London-based ClientEarth proposed a draft EU regulation in response to a European Commission report published in October 2012, Second Regulatory Review on Nanomaterials.  The groups argued that the Commission insufficiently addressed problems with the European Union’s REACH.

The Commission had concluded that nanomaterials did not require separate EU regulations, declaring that REACH provided the “best possible framework for the risk management of nanomaterials when they occur as substances and mixtures.” (High Time to Act: A Proposal for a “Nano Patch” for EU Regulation, at 3).

Attorneys for the environmental groups attacked REACH’s inherent loopholes and the lack of safety assessment before nanomaterials are placed on the market – two substantial issues whose appraisal was glaringly absent in the Commission’s Regulatory Review. 

Specifically, the groups argued that REACH provided regulators and the public with little to no information regarding the dangers and risk management of nanomaterials.  The environmental groups’ proposed “nano patch” on REACH aims to close these loopholes by employing the following mechanisms:

·        Documenting the hazards and risks in all relevant regulatory frameworks

·        Registering the nanomaterials and requiring operators to report the quantities of substances and their uses in the produced, distributed or imported nanoform

·        Labeling nanomaterials found in consumer products, including adding the suffix “nano” to the name of the ingredient

Some may find the proposed “nano patch” to be a bit oppressive and chilling to the progression of nanotechnology, but we just don’t know enough yet about the environmental and health effects of public consumption of nanomaterials. Regulation of some degree – but what degree – is clearly called for.  And while the United States has been the leader in some areas of regulation, it appears that for the time being, the EU may be the frontrunner in the nanontechnology regulatory race. Perhaps the U.S. should lace up and catch up. 

The draft EU regulation from the environmental groups – High Time to Act: A Proposal for a “Nano Patch” for EU Regulation – is available at:

http://www.ciel.org/Publications/Nanopatch_EU_Nov2012.pdf.

This post was written by guest blogger Holly Frey.  See her information here.

 

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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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Checks and Balances

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

usalawyerstoday.com

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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The Role of the National Academies in Studying Nanotechnology: Current Developments

Posted Jan.21, 2012 under Chemicals, Drugs, Environment, EPA, Food, Health, National Academies, Pesticides, Research, Safety

ref1394_x180-fThe National Academies have promised a report by the end of January 2012 on priorities (both short- and long-term) for studying the health, safety, and environmental effects of nanotechnology.  According to the National Academies, this report will address the following matters:  the properties of engineered nanomaterials; methods and technologies for “detecting, measuring, analyzing, and monitoring” engineered nanomaterials; what studies are needed; what testing methods need to be developed; the models for predicting impacts that should be developed; research priorities; and the criteria for evaluating research progress.  In its “Statement of Task,” the National Research Council has explained:

“The committee will take into consideration current and emerging uses of engineered nanomaterials and the scientific uncertainties related to physical and chemical properties, potential exposures, toxicity, toxicokinetics, and environmental fate of these materials.”

I will discuss the report when it is issued.  More information on the National Academies’ research strategy is available at

http://dels.nas.edu/Study-In-Progress/Research-Strategy-Environmental-Health/BEST-K-08-01-A#

This is a promising developing to look forward to, but as with all things, the proof is in the, er, nanopudding (sorry, couldn’t resist).  Initiating a task such as this is daunting, with the result a framework for assessment, not the ultimate assessment.  But it is a necessary step in what is certain to be a long process.

In a separate project, the National Academies are considering more than the health, safety, and environmental effects of nanotechnology.  Pursuant to the Nanotechnology Research and Development Act (Pub. L. No. 108-153), Congress has mandated triennial reviews of the National Nanotechnology Initiative (NNI).  The National Academies’ National Research Council convened a committee to conduct the second such triennial review, and its report is due in 2013.  Much of the review will entail examining the economic impact of nanotechnology and ways to measure the value of nanotechnologies.

Information on the triennial review project is available at

http://www8.nationalacademies.org/cp/projectview.aspx?key=49409

The two projects discussed in this post demonstrate the efforts to address the two important aspects of progress in the uses of nanotechnology – understanding the health, safety, and environmental effects, and measuring the economic benefits of nanotechnology.

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Progress . . . and its Inevitable Consequences

Posted Jan.18, 2012 under Data storage, Environment, Health, Research, Safety, Workplace

chip-makerAn interesting and potentially revolutionary development in magnetic storage of data was announced a couple of weeks ago.  Researchers at I.B.M. have reported the development of a new class of nanomaterials that could lead to the development of new, significantly smaller memory chips and disk drives that will both hold vast amounts of information and use less power than the current class of silicon chips.  The report (Loth, Baumann, Lutz, Eigler, and Heinrich, Bistability in Atomic-Scale Antiferromagnets) appears in the journal Science at Vol. 335, no. 6065, pp. 196-99 (Jan. 13, 2012), and has been widely reported in the news media.  There is much excitement over this development, both for its inherent promise for data storage and for its potential in other areas.  Analysts have suggested that other new nanomaterials may be forthcoming using some of the same general methodologies and approaches of these researchers.

 Among other media sources, this development has been reported in the New York Times:

John Markoff, “New Storage Device is Very Small, at 12 Atoms,” N.Y. Times, Jan. 12, 2012, available at

www.nytimes.com/2012/01/13/science/smaller-magnetic-materials-push-boundaries-of-nanotechnology.html?_r=1&scp=1&sq=nanomaterials&st=c

So while we are wowed by such progress, it only begs the same old question of what should be done to determine the hazards that the technology might pose to workers, the general public, and the environment.  As with so many of the technological developments using nanomaterials, there is little discussion of potential hazards at this juncture.  But when will we give some serious thought to them?  After the products are developed and marketed?  After adverse effects are manifested?  So maybe there won’t be any adverse effects.  But do we know that as we continue to be dazzled by the potential technological developments in the nanoworld?  At the risk of sounding very non-technological, maybe we need to refer back to that old adage – better to be safe than sorry.

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