Caprio.
Accepting an invitation from the new Republican U.S. House majority to help get regulators to back off industry, a nanotechnology trade group is asking a congressional committee to pressure regulators to avoid “unnecessary public alarms.”
That request came in the form of a letter from the NanoBusiness Alliance, a consortium of nanotechnology companies.
And it has provoked criticism from nano-watchers concerned about public health and the environment.
The letter, signed by Vincent Caprio (pictured), the alliance’s executive director, came in response to a call from U.S. Rep. Darrell Issa, a California Repubican who is the new chairman of the House Oversight and Government Reform Committee.
Issa asked business and industry groups to tell his panel which rules and regulations they think are harming growth and innovation. The Environmental Protection Agency (EPA) has taken tentative steps to consider regulating some nanomaterials, part of a a fast-growing industry. Much, however, is unknown about these materials, including what kinds of health risks they might pose.
Caprio sent the letter last month. (Read it here.) He wrote that nanotechnology “holds great promise for continued innovation across many sectors of our economy.” But there is a problem, Caprio wrote: the fractured nature of the federal government’s efforts to oversee the broad sector.
The letter goes on to target the EPA’s plans, which have been in the works for months but not yet formally released. These plans include compelling manufacturers to provide specific data about their products, and potentially requiring testing of some substances and increased reporting of information on others.
Nanotechnology involves making medicines and consumer products, from air purifiers to sunscreen and bicycle frames, by using the super-properties of super-small particles. But the very property that makes these products useful — their tiny size — might also make them dangerous, both in the short and long term.
This uncertainty has created a tension between nano boosters, who laud the promise of the broad array of applications, and those who are urging caution until more is known about the risk to workers, consumers, animals and the environment.
Whether that slowdown should come from the companies making these products, or from government regulators around the world, is a crucial question. The NanoBusiness Alliance letter comes down squarely on one side of this debate.
The EPA’s potential moves “may adversely impact the nanotechnology industry through direct regulatory compliance costs, or more dangerously, by raising unnecessary public alarms through unfounded and inconsistent characterizations of nanotechnology materials,” Caprio’s letter says.
“Because EPA’s current approach to implementing its authority is unclear, we are concerned that regulatory requirements may be imposed unnecessarily,” the letter continues. “Part of our concern is that the cost for compliance is potentially very high and in some instances, given the lack of accepted analytical methods, test results may not yield accurate safety data. This could result in prohibitive compliance costs for uncertain improvements in environmental outcomes, and reinforce unfounded characterizations that all nanoscale materials are likely to be environmental or health threats.”
The alliance’s members would be willing to work with the EPA to get the agency the information it needs, according to the letter, but regulations are unnecessary and too restrictive.
The letter also references one of the hottest catch phrases in politics right now, “job creation,” and references the fact that the federal government, through research funding and the National Nanotechnology Initiative, has been one of nanotechnology’s biggest boosters. Regulations might push development overseas, Caprio writes.
“Certainly, it would be important for the U.S. to benefit from the research funded by taxpayers through job creation here rather than sending the new jobs to other parts of the world that can capitalize on our investments without facing regulatory obstacles,” the letter says.
The missive is raising eyebrows around the relatively small world of nanotechnology policy.
Richard Denison, a senior scientist at the Environmental Defense Fund, blogged about the letter as part of a larger post on the nano-regulation landscape. In an interview, he called the EPA’s actions sorely needed, and the alliance’s position shortsighted.
“All of these things are basically in my view long overdue and they basically provide a foundation of information from which EPA can then decide what, if any, further regulations might be warranted,” Denison said. “But without that information, EPA is in a position where you don’t really have a handle on what is happening, and no ability to assure the public or other stakeholders that they are safe.”
The agency has already tried a voluntary reporting policy, Denison said. The program ended in 2009, and the agency itself says that the effort left “a significant number” of data gaps.
Denison’s organization has worked with DuPont to create the “Nano Risk Framework.” He said that in general there has been a strong willingness among companies to cooperate with the EPA and other regulatory agencies, such as the Food and Drug Administration. That’s because catching a serious risk involved with nanotechnology after it’s caused big problems would be bad for everyone.
“This is very disappointing,” Denison said. “I think this industry has every interest in having a system in place that assures the public that EPA and other agencies have a handle on this issue.”
Another nano expert, Andrew Maynard, said the letter was “like going back to sort of old school thinking here, that the EPA is against industry.”
“This is exactly what we’ve tried to avoid with nanotechnology,” added Maynard, the director of the University of Michigan Risk Science Center. “We’ve tried to be proactive in making evidence-based decisions.”
The alliance’s members are mostly smaller companies, so it’s not surprising that they might be concerned, Maynard said.
“If you’re a small company, bad regulation or overburdening regulation can be the death knell for you,” he said. “To some extent, their concerns are legitimate … there’s nothing worse than regulations that aren’t evidence-based.”
But hard evidence is exactly what regulators — as well as academics and industry — are seeking, through a broad range of experiments and other research aimed at identifying potential problems with nanomaterials.
Denison said it seems as if the window of opportunity for cooperation has closed, which could pose a problem moving forward. Talk of stifling innovation fails to consider the effects of one widely-publicized problem with a nano-based product or application, he said.
“I just think the bigger risk to this industry is some bad apple out there producing a material or using it in a way that creates a real problem,” he said. “All boats rise and fall together in a situation like this.”