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Today, Kimbrell and Salvi debate government oversight of nanotech research and business. Previously, they defined the scope of nanotechnology, discussed its potential drawbacks and predicted its future. They'll conclude their debate tomorrow with a discussion on ethical issues surrounding nanotech.

Don't trust self-regulationBy George A. Kimbrell
Governments must oversee nanotechnologies and nanomaterials, not industries. Proponents of nanotechnology argue that government oversight and the public disclosure of company safety data are not needed often with the following explanation: "Trust us. Why would anyone make an unsafe product?" Unfortunately, some corporations have a long history of knowingly manufacturing unsafe products; cigarettes and asbestos come to mind. Moreover, polls show that people overwhelmingly do not trust industry with the job of protecting their health; instead, they trust government regulators. And rightly so: A family's health and safety, not to mention the well-being of the environment, should not rest on a corporate cost-benefit analysis; it should be entrusted to those governmental bodies statutorily charged with protecting public health and safety.

On Monday, we discussed that nanotech is already a commercial reality spanning many industries with public and environmental exposures happening daily. And on Tuesday, we discussed the risks therein. Thus we can anticipate and quickly dispatch the industries' stalling protestations that oversight measures are not yet needed.

What should such regulation look like? In 2007, a broad international coalition of consumer, public health, environmental, labor and civil society organizations released "Principles for the Oversight of Nanotechnologies and Nanomaterials" (PDF). The document has more than 80 organizational signatories spanning six continents. It calls on government bodies, policymakers, industries, organizations and all other relevant actors to endorse and take actions to incorporate its fundamental good governance principles.

Here is the summary:

  1. A Precautionary Foundation: Product manufacturers and distributors must bear the burden of proof to demonstrate the safety of their products: if there is no independent health and safety data review, then there is no market approval.
  2. Mandatory Nano-specific Regulations: Nanomaterials should be classified as new substances and subject to nano-specific oversight and testing. Voluntary initiatives are not sufficient.
  3. Health and Safety of the Public and Workers: The prevention of exposure to nanomaterials that have not been proved safe must be undertaken to protect the public and workers.
  4. Environmental Protection: A full lifecycle analysis of environmental impacts must be completed prior to commercialization.
  5. Transparency: All nanoproducts must be labeled and safety data made publicly available.
  6. Public Participation: There must be open, meaningful and full public participation at every level.
  7. Inclusion of Broader Impacts: Nanotechnology's wide-ranging effects, including ethical and social impacts, must be considered.
  8. Manufacturer Liability: Nano-industries must be accountable for liabilities incurred from their products.

Below are a few additional comments parts of the report:

First, the European Union recently enacted a new general chemical law based on the precautionary principle; the U.S. will eventually follow suit. Regulation underpinned by a precautionary approach is even more criticalfor new technological systems such as nanotechnologies, which create substances that can be fundamentally novel and unpredictable, where long-term health and environmental impacts have not been adequately studied and where existing oversight mechanisms are inadequate.

Second, laws and regulations must be amended to account for the new challenges raised by nanomaterials. The risk assessments, oversight triggers, toxicity parameters and threshold minimums used by health and environmental protection laws are designed for bulk (or non-nano) materials. Conventional methods for indentifying, monitoring, measuring and controlling nanoparticles are inappropriate and insufficient; new protocols are required. Nano-specific testing must be developed because the adverse effects of nanomaterials cannot be reliably predicted from the known toxicity of the bulk material. Nanotoxicology is an emerging field in its own right.

Third, voluntary initiatives are wholly inadequate to oversee nanotechnology, as they delay or weaken essential regulation, forestall public involvement and limit public access to vital environmental safety and health data. Voluntary programs lack incentives for "bad actors" or those with risky products to participate, leaving out the entities most in need of regulation. Experience has borne this out, as Great Britain last year instituted a nanomaterials voluntary program and thus far has received only a half-dozen submissions (PDF). A long-delayed U.S. program has similar failings (PDF).

George A. Kimbrell is staff attorney for the International Center for Technology Assessment, where he works on legal and policy issues related to nanotechnology, biotechnology and climate-change technologies.


Nanotech firms welcome safety rulesBy Aatish Salvi
George, you imply that companies are shirking their responsibility as stewards of nanotechnology. This implication is patently false. For more than two years, the nanotech industry has called for significant increases in funding for environmental, health and safety research on nanotechnology. Nanotech companies been actively engaged with government agencies, having invited such agencies into their facilities sharing data for some time now. As a result of the data collected, agencies such as the National Institute for Occupational Safety and Health (NIOSH) have been able to make initial safety recommendations.

If, as you say, "People overwhelmingly trust regulators with the job of protecting their health," then perhaps so should you. We don't need "nano-specific regulations" because nanomaterials and nanotech companies are answerable to the U.S. Environmental Protection Agency, the Occupation Safety and Health Administration and other regulatory agencies, and are governed (and punishable) by the same regulations and laws that apply to all other manufacturers. These laws regulate nanotech for everything from manufacturing, worker safety and transport to disposal and emissions. The need is for more information so that the agencies are better informed about the different types of nanomaterials and can interpret how the existing regulations should apply. The EPA has very recently published an extensive research plan (PDF) that details its initiatives to gather this data. Our call to lawmakers in Washington is to provide the EPA the necessary funding to execute this plan.

There is a rational and good reason for companies to want agencies to be fully informed. We need to have certainty about exactly how the existing regulations apply to our products and materials. Without that certainty, raising capital, getting insurance and selling products to consumers are all made much more difficult.

In Washington this week, representatives of nanotech companies and I met with Assistant James B. Gulliford, an assistant administrator at the EPA, and Charles M. Auer, director of the EPA's Office of Pollution Prevention and Toxics (OPPT), to discuss how companies can best work with government agencies. During that discussion, several of the companies agreed to share data on their materials with the EPA and to discuss further research they can perform to help the EPA understand how the class of materials they make work. Of course, companies need to know that their patents, trade secrets and other confidential information will be protected. Our strategy is to entrust the EPA and NIOSH with information in confidence, have the agencies review the data and report their conclusions to the public.

George, you claim that the voluntary programs are "wholly inadequate." You claim that such programs "lack incentives for 'bad actors' or those with risky products to participate, leaving out the entities most in need of regulation." Laws are meant as a deterrent and retribution, but they cannot make people be good. If someone wanted to be a "bad actor," it wouldn't matter if the request to report was mandatory or voluntary. The disincentive to act badly for nanotech companies already exists in the forms of the Toxic Substances Control Act, Clean Air Act, Clean Water Act and others. These laws are strict in their punishment of any manufacturer that causes harm.

You suggest that we follow the European Union's lead in terms of nanotech regulation. The United States has more research institutions, publishes more papers and has more nanotech companies than Europe by far. Our agencies and labs have done much more environmental, health and safety research to date than theirs have. Following them would be like the tail wagging the dog.

I am glad to hear people think the U.S. agencies are trustworthy. I think so too. They have been dealing with technological change for decades and have a lot of institutional knowledge — both from their successes and mistakes. They have a plan to deal with nanotech, and the industry supports that plan. We want communication to the public to come from government agencies that rely on data, not from organizations that rely on rhetoric.

Aatish Salvi is vice president of the NanoBusiness Alliance.

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