Medical Device Daily National Editor

Nanomaterial science and research would appear to be heading toward an escalating debate between the private and governmental sectors, one in which government oversight is found wanting – and far from "over-arching."

A study report just released by the National Research Council (NRC; Washington) takes aim at the National Nanotechnology Initiative (NNI; Arlington, Virginia), the intergovernmental U.S. agency tasked with coordinating the nanotechnology research and oversight being conducted by various federal agencies.

Of the 15 members of the writing committee, 11 are with universities or an academic association. So: a realistic look at governmental failings, or a snooty look at government by a committee overweighted with academics?

The press statement summarizing the conclusions of the NRC study pulls no punches: It says that the report identifies "serious weaknesses" in the plan for coordinating the research by governmental agencies related to the potential health and environmental risks posed by nanomaterials. It says that any "effective" national plan is necessary for "the successful development and public acceptance of nanotechnology-enabled products," and the report provides a laundry list of things missing in the governmental nanotech strategy.

In general, the report says that a government plan for nanotechnology research should be "robust" and "over-arching" in order to be truly comprehensive.

The NNI outlined its strategy in documents released earlier this year, and, importantly, the office that oversees NNI asked the NRC to review the plan. The NRC report thus represents a type of self-analysis.

The report notes that the NCR committee did not look into the risks of nanomaterials currently be used – which it puts at about 600, with several thousands patents already granted for nanotechnology – but rather focused on what its members considered necessary for research related to future nanotech products. And it underlines the fact that many people will be using and exposed to an increasing number of such products, with unknown risks, including possible "toxic properties."

In terms of the use of nanotechnology in the medical arena, the report says that the "Nanomaterials and Human Health" section of the plan fails to provide a truly comprehensive evaluation "of how nanomaterials are absorbed and metabolized by the body and how toxic they are at realistic exposure levels."

Following are some of the over conclusions developed by the NRC report:

• The NNI plan fails to provide a clear picture of the current understanding of the risks of nanomaterials or where that understanding should be "in 10 years."

• The plan does not include research goals to ensure that nanotechnologies "are developed and used as safely as possible."

• The research needs listed in the plan are "valuable" but "incomplete," because missing crucial elements for understanding the health and safety impacts of nanomaterials.

• In assessing gaps in existing research, the plan overstates the degree to which already funded studies are meeting the need for research on health and environmental risks, the report says. "For example, more than half of the currently funded projects on nanotechnology and human health are aimed at developing therapies for diseases. While this research is important, it will not shed light on health risks that may be posed by nanomaterials."

• The plan fails to note the current lack of studies on how to manage consumer and environmental risks, such as how to manage accidents and spills or mitigate exposure through consumer products.

• The NNI's strategy does not adequately incorporate input from industries that produce and use nanotechnologies, environmental and consumer advocacy groups, and other stakeholders, which is necessary to identify deficiencies in research strategies. It says:

"On their own, federal agencies tend to ask what research they can do within their existing capabilities, rather than asking what research should be done."

• The plan lacks accountability. While agencies such as the National Institutes of Health, U.S. Environmental Protection Agency, and the FDA, and others have roles in overseeing nanotechnology research, "there is no single organization or person that will be held responsible for whether the strategy delivers results."

• The plan overstates the amount of federal funding "specifically to address nanotechnology-related environmental health and safety issues. The report says the actual amount allocated for this "may be inadequate" and "Probably less than half of the research projects described in the plan will ultimately yield useful data to support regulatory decision making."

The report makes two recommendations to which the NNI responded to fairly specifically by means of a statement from the National Nanotechnology Coordinating Office (NNCO).

The report says future activities should include "a broader group of stakeholders, and would consider the untapped knowledge of non-government researchers and academics," utilizing research from "academia, industry, consumer and environmental groups," and others.

The NNCO statement called this "a worthy goal which the NNI is already pursuing."

The report also recommends structural changes to the NNI granting it new budgetary authority.

But the NNCO says that this issue "was not within the scope of the NRC panel review, and the concept is also in conflict with currently established Federal organizational structure and would require extensive review and analysis and Congressional oversight."

While poking holes in various aspects of the NNI's strategy and priorities, the NRC analysis does not identify any reasons for the many weaknesses in the plan.

One of the members of the committee writing the report is Andrew Maynard, chief science advisor for the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars (Washington).

Maynard told Medical Device Daily that addressing this issue was not part of the task defined for the committee.

But offering his own opinion, he said, "There is only so much the government can do internally" and that government generally tends to "justify what it's already doing."

He said that he hopes that the report will provide the encouragement to seek other resources and "bring more people" into the process. This, he said would result in a clearer perspective that is "not so constrained."

Maynard said that the committee's work was relatively short term in nature, since it only began shortly after the NNI plan was released in February, and that it now has no further responsibility.

But he noted that further, longer-term assessment of the government's strategy is being undertaken by the National Academy of Science (Washington).