John Balbus, M.D., M.P.H., is Chief Health Scientist.

Some 216 delegates representing 26 countries converged on the largest city in China last week for the 7^th meeting of the International Standards Organization (ISO) Technical Committee (TC 229) on Nanotechnologies.

In China, the turtle symbolizes cosmic order, strength, endurance and wisdom.  In the US, the turtle has come to symbolize slow progress and not keeping up with the times.  Which representation better captures what's going on in ISO's TC 229?   Maybe a little of both.

ISO is an international voluntary standard-setting organization comprised of national delegations (each country has one vote) that are dominated by government and industry interests.  Most of ISO's work is devoted to harmonizing and standardizing industrial processes and products to facilitate commerce and global trade.  But a significant portion entails the development of environmental, health and safety (EHS) standards, like the ISO 14000 series.  For better or worse, these standards tend to emphasize implementing corporate management systems and procedures over achieving specific measureable results. 

There are three levels of documents that come out of ISO.  The first is a technical report, which does not carry the force of a standard or require broad consensus, making it the easiest to adopt.  Next is a technical specification, which again is short of a standard but represents a stronger consensus of the countries participating.  Getting a full standard passed is the hardest and usually takes years.

Countries are starting to put forward a number of documents addressing EHS for nanotechnology.  But given the early state of the science, most of these documents are technical reports or technical specifications.  The expectation is that it will take a few years for the science and practice to evolve to the point where developing full standards will be practical.  In the meantime, technical reports and technical specifications can provide useful guidance now, and potentially serve as the basis for standards development later. 

It's all pretty bureaucratic, but ISO is one of very few ways to influence corporate behavior on a global basis.

As I reported in my last post, the US delegation brought to ISO a proposal to use the EDF-DuPont Nano Risk Framework (NRF) as a basis for an ISO Technical Report.  The Shanghai meeting marked the first international discussion of this proposal.  Former EDF staffer (now consultant) Scott Walsh and I went to Shanghai as US experts on the project group for this document.

The Nanomaterial Risk Evaluation Framework (NMREF), as the ISO version is provisionally titled, was generally well-received by the international delegates.  While some concerns were raised about how OECD guidelines and the European Union's REACH Regulation might conflict with elements of the starting document, there was no opposition to some of the most important elements of the Framework, such as taking a lifecycle approach, information-driven decision-making, and emphasis on transparency.  And the mood for moving forward was very positive.

There are other projects underway within the EHS workgroup.  These range from detailed testing methods to general guidelines for workplace handling of nanomaterials.   In addition, the committee created a new group on nanotechnology and sustainability.  And the groups working on material specifications are including guidelines for incorporating EHS information in every specification.

Is ISO the global key to ensuring safe development of nanomaterials?  Probably not.  For starters, all ISO standards are voluntary — they don't carry the force of law.  Ensuring that all nanomaterials are carefully assessed and that all companies take the necessary precautions to limit uses and releases of potentially harmful materials will require sound regulations. 

But there are a couple of reasons to ride the turtle for now.  First, there are enormous gaps in regulatory frameworks in most if not all countries.  Until those gaps are filled, many companies will look to ISO documents for operational guidance.  And second, as countries around the world decide how to adapt or extend current regulations to the special case of nanomaterials, ISO will play a role in validating and disseminating concepts to be used in the development of regulations.

So while the turtle moves slowly, it has set out on its way, and we're doing what we can to make sure it gets steered in the right direction.

John Balbus, M.D., M.P.H., is Chief Health Scientist.

At its most recent meeting a few weeks ago, the US Technical Advisory Group (TAG) to the International Standards Organization (ISO) Technical Committee on Nanotechnologies approved a motion to have ISO develop a Technical Report based on the EDF-Dupont Nano Risk Framework (NRF). Or to put it another way in acronym-laden Washington-speak, the US TAG to the ANSI-accredited ISO TC229 approved a TR based on the EDF-DD NRF. 

The motion to submit the NRF as the basis for this ISO technical report did not come from either EDF or Dupont. Other members of the TAG took this on and helped adapt the NRF for submission to the ISO. The vote was unanimous: All 21 members were in favor of moving the NRF forward in this way.

Surprising? In some ways yes, some ways no. A technical report is not a standard, and so countries and companies will not be bound to apply the report fully to their practices as they would an ISO standard. Nonetheless, representatives of a number of US industries are supporting the information-based approach to nanotechnology risk management incorporated in the NRF. And those of us concerned about the health effects of nanomaterials can support that.

The next step will be convening the TAG in Shanghai in November to review the document and start taking comments from the other country delegations. EDF will be there to try to ensure that the principles and science-based prudent approaches of the NRF are supported and are retained in the official ISO guidance.

I have just finished reading yet another depressing/infuriating publication by the Woodrow Wilson Center's Project on Emerging Nanotechnologies. The new report delineates the many limitations faced by the Consumer Product Safety Commission (CPSC) in addressing nanotechnology health risks.  The law governing the CPSC has significant weaknesses that prevent it from meeting critical needs, such as constraints on the ability to collect data, require reporting of known hazards, order recalls and promulgate mandatory safety standards.

The PEN report includes several recommendations that CPSC maximize its regulatory authority under the Consumer Products Safety Act (CPSA), and to coordinate with EPA and FDA.  The report also calls on Congress to amend the CPSA to strengthen the regulatory hand of the agency.  On paper, this seems relatively simple yet implementation will require significant political will – an attribute that seems to be in short supply these days.  That's why I'm depressed.

I'm infuriated because of the many ways PEN identifies in which a law that was conceived to protect public health has been eroded, including amendments that limit agency power (pages 15 and 17), insufficient funding (and even a political appointee who rejected funding increases) (pages 10 and 13), and inadequate staffing for enforcement (pages 16 – 17).   This neglect spans more than two decades.  With such an inglorious history, it's hard to be optimistic that change will come.

These systemic weaknesses also affect the capacity of CPSC to address hazards from conventional chemicals, with the continuing effect of toxic ignorance reinforced in the PEN report.  Of course, nanomaterials come with unique challenges relative to conventional chemicals, since nanomaterials can vary greatly in chemical composition as well as physical shape and design that can affect all aspects of health and safety risk.  As PEN's Andrew Maynard notes in his recent blog, consumer products are most likely to be the point of consumer exposures.  EPA and FDA face similar difficulties in the regulation of chemicals – and nanomaterials – used in consumer products and cosmetics. The government definitely will need some new tools in the tool box.

It is becoming increasingly clear that appropriate reform of the Toxic Substances Control Act (TSCA) can also help boost the ability of CPSC and other federal agencies to address the challenges of nanomaterials and other emerging chemicals of concern.  The Kid Safe Chemicals Act (KSCA) would substantially amend TSCA.  Among other provisions, it would require manufacturers to submit to EPA a minimum dataset on a chemical's uses, environmental and human health hazards, and exposure potential, including information critical to assessing nanomaterial risks. 

All agencies would benefit from access to the "go-to" database that KSCA calls for.  This basic chemical information could be used by any agency to help identify and prioritize hazards relevant to its mission.  CPSC could use this information to help identify chemicals of high concern for children – be they nano-scale or not.  FDA could use the database to determine if some of the most commonly used chemicals in cosmetics, which also have uses that fall under TSCA, require scrutiny.

Since the publication of the PEN report, Congress amended the CPSA to strengthen protection of children from harmful products.  In addition to essentially banning lead and certain phthalates from children's products, the CPSC will receive increased funding to boost staffing level, and laboratory and computer resources.  The CPSC will create a consumer-accessible database of safety concerns associated with products, and states will have the authority to enforce the CPSA. 

What's not clear is if these important and necessary upgrades to the CPSA will substantially improve the capacity of the CPSC to monitor and address any safety concerns that may be associated with nanotechnology in consumer products.  While the amendment directly tackles several notorious chemicals of concern, it does not appear to consider how the CPSC might generally respond to emerging concerns, such as those posed by new synthetic chemicals or novel technologies.  Time will tell if we have been given duct tape to patch holes rather than the hammer and nails required for new construction.

It’s been a few months now since the White House took the unusual step of articulating some “Principles for Nanotechnology EH&S Oversight.” Given recent events, it’s worth again reflecting on this official memorandum, which was signed by the heads of the White House’s Council on Environmental Quality (CEQ) and Office of Science and Technology Policy (OSTP) and sent to the heads of all federal agencies and departments.

Despite the title, it’s very hard not to read this document as one intended primarily to throw up barriers to effective oversight.

Consider the following features of the Principles memorandum:

• As Andrew Maynard has already pointed out, it clearly prioritizes nanotechnology’s potential benefits over its potential risks: How else to explain that the foremost purpose of the principles is to ensure that any oversight is “cognizant of the potential benefits”? This would be one thing in a document describing the overall federal approach to nanotechnology; it’s quite another in a document that is ostensibly about oversight.

• It claims that statutory authorities are adequate and no changes are needed. Over the past couple of years, this has become a constant refrain of government officials across the board. While most independent analyses conclude that nanomaterials fall generally within the scope of existing environmental statutes, major challenges in actually implementing or applying each relevant authority to nanomaterials have also been identified, for example, here and here. In future posts, I’ll explore this question in relation to the Environmental Protection Agency’s (EPA) exercising of its authorities under the Toxic Substances Control Act (TSCA).

• It argues that “standard” risk assessment and risk management approaches can and should be used for NMs without modification – very different from the conclusions of a scientific expert committee in the European Union, which identified numerous areas where modification and enhancements are needed.

• It then advances a series of statements to govern the “regulatory path forward” that are either patently obvious (e.g., “Regulation should focus where need exists”), or invoke criteria being used elsewhere to undermine or slow regulatory action: Regulatory actions should not impede innovation; they should be performance-based; they should be case-by-case; their benefits should outweigh their costs.

Finally, the document methodically lists all of the regulatory hoops agencies already have to jump through, even going so far as to provide a handy weblink to each of them – as if regulatory agencies were not already acutely aware of the hurdles that any proposed regulation faces these days.

So what exactly was the purpose of issuing this document? It’s not as if there was a need to rein in upstart federal agencies chomping at the bit to regulate nanotechnology. Such agencies have been decidedly unable or unwilling even to require nanotech companies to identify themselves or submit whatever information they happen to have. Instead, EPA dallied for more than two years before finally launching its open-ended voluntary reporting program, and at the same time effectively exempted new nano forms of all chemicals on the TSCA Inventory from meeting requirements applicable to any other new chemical.

The Food and Drug Administration’s Nanotechnology Task Force, meanwhile, appears to have reversed FDA’s earlier position that suggested nanomaterials are really nothing new – but then recommends only that the agency issue guidance for manufacturers to use on a voluntary basis. While acknowledging there are major gaps in available information – especially for those classes of products, such as cosmetics, for which FDA has no pre-market approval authority – the task force does not recommend taking any steps, beyond conducting more research, to address these serious problems.

Frankly, given this reality on the ground in Washington, it’s hard not to see the Principles memorandum as yet another manifestation of the conflict of interest emerging between the dual roles the National Nanotechnology Initiative (NNI) has been charged with, one that creates a false choice between promoting the development of nanotechnology and exercising effective and timely oversight.

Just when you thought it might never emerge, the National Nanotechnology Initiative’s (NNI) Strategy for Nanotechnology-Related Environmental, Health and Safety Research [2.2 MB PDF] finally hit the streets last week.

It’s got good, bad and ugly. The good news is that here, at last, is a report from NNI that actually reads more like a strategy and less like yet another laundry list of research needs. The bad news is that key elements of a full strategy are still nowhere to be found.

As a depiction of what the NNI’s research agencies have been up to, the report advances publicly available information considerably. For the first time, NNI has provided a detailed, if somewhat dated, list of projects – 246 in all – completed or in progress during FY2006. For each project there is even a handy hyperlink to a more detailed abstract of the project. That’s good to see, and took a lot of work to compile, no doubt.

But here’s the bad news: No dollar figures are provided for the individual projects, only aggregated funding estimates for broad categories of research – despite the maddening fact that NNI obviously must have had such raw data in order to provide the aggregated totals. And the list of projects includes ones that are clearly not directly relevant to understanding risk; for just one example, see project A2-4 Diffraction Studies of Glasses, Liquids, and Nanoclusters.

Even NNI admits its tally includes tangential projects, though the disclaimer is buried in the fine print and far removed from the dollar figures, which are displayed prominently in the Executive Summary and NNI’s press release. This obfuscation is hardly a way to quell the longstanding suspicion that NNI routinely over-counts what it is spending on risk-relevant research.

The report usefully describes the state of research efforts under each of its 25 research priorities, identifying which aspects are getting ample attention and which are not. A good start, but that’s essentially where it stops. A real strategy would take it the next step, by indicating how much more actually needs to be spent in each area to address the identified deficiencies or gaps, how the funding will be provided, and who will take responsibility for ensuring the work gets done.

Indeed, NNI seems so averse to putting someone in charge that it can’t even bring itself to identify lead agencies for each major research area, instead designating them as merely “coordinating agencies.” There’s no indication as to how decisions will get made or how funding will be allocated or shifted to research areas not currently receiving enough, other than the usual lip service paid to the need for a “coordinated interagency approach.”

Now for the ugly. A disturbing sentence appears in the report’s description of its strategy implementation framework (on page 46): "Gaps identified in the research that supports regulatory decision making should not be addressed at the cost of broad-based fundamental research – to do so would ultimately undercut the U.S. nanotechnology initiative as a whole."

In other words, NNI says it’s okay with them if gaps persist on the risk questions, if filling them would mean taking money away from research to advance nanotechnology. This is another clear indication of the lower priority NNI actually gives to the risk side of the equation, and of the growing conflict of interest between the promotional and oversight roles NNI has been charged with.

These shortcomings in NNI’s new strategy reinforce how essential it is to have an independent, expert body – the National Academy of Sciences – step in, not only to review the strategy report (that’s soon to get underway), but also to help craft an effective federal nano risk research strategy and oversee its implementation. Happily, Congress has requested just that, calling on the U.S. Environmental Protection Agency to contract, by March 21^st, with NAS for this much-needed more extended involvement.